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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2023
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _____ to _____
Commission
file number: 001-35570
SONNET
BIOTHERAPEUTICS HOLDINGS, INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware |
|
20-2932652 |
(State
or Other Jurisdiction of |
|
(I.R.S.
Employer |
Incorporation
or Organization) |
|
Identification
No.) |
100
Overlook Center, Suite 102, Princeton, NJ |
|
08540 |
(Address
of Principal Executive Offices) |
|
(Zip
Code) |
(609)
375-2227
(Registrant’s
Telephone Number, Including Area Code)
Not
applicable
(Former
Name, Former Address and Former Fiscal Year, if Changed Since Last Report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.0001 per share |
|
SONN |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). ☒ Yes ☐ No
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
|
|
|
|
Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
|
|
|
|
|
|
Emerging
growth company |
☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
☐
Yes ☒ No
There
were 38,511,014 shares of common stock, par value $0.0001 per share of Sonnet BioTherapeutics Holdings, Inc. issued and outstanding as
of August 7, 2023.
Sonnet
BioTherapeutics Holdings, Inc. and Subsidiaries
SONNET
BIOTHERAPEUTICS HOLDINGS, INC.
INDEX
TO THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
PART
I – FINANCIAL INFORMATION
ITEM
1: FINANCIAL STATEMENTS.
Sonnet
BioTherapeutics Holdings, Inc.
Consolidated
Balance Sheets
(unaudited)
| |
June
30, | | |
September
30, | |
| |
2023 | | |
2022 | |
Assets | |
| | | |
| | |
Current
assets: | |
| | | |
| | |
Cash | |
$ | 7,021,071 | | |
$ | 3,052,879 | |
Incentive
tax receivable | |
| 749,169 | | |
| 717,305 | |
Prepaid
expenses and other current assets | |
| 1,862,683 | | |
| 1,643,743 | |
Total
current assets | |
| 9,632,923 | | |
| 5,413,927 | |
Property
and equipment, net | |
| 36,577 | | |
| 46,211 | |
Operating
lease right-of-use asset | |
| 209,944 | | |
| 256,594 | |
Deferred
offering costs | |
| — | | |
| 113,280 | |
Other
assets | |
| 155,366 | | |
| — | |
Total
assets | |
$ | 10,034,810 | | |
$ | 5,830,012 | |
Liabilities
and stockholders’ equity (deficit) | |
| | | |
| | |
Current
liabilities: | |
| | | |
| | |
Related-party
notes payable | |
$ | — | | |
$ | 748 | |
Accounts
payable | |
| 3,024,441 | | |
| 4,752,340 | |
Accrued
expenses and other current liabilities | |
| 3,315,404 | | |
| 3,193,972 | |
Operating
lease liability | |
| 70,446 | | |
| 51,328 | |
Deferred
income | |
| 55,882 | | |
| 166,431 | |
Total
current liabilities | |
| 6,466,173 | | |
| 8,164,819 | |
Operating
lease liability | |
| 150,185 | | |
| 203,912 | |
Total
liabilities | |
| 6,616,358 | | |
| 8,368,731 | |
Commitments
and contingencies (Note 4) | |
| - | | |
| - | |
Stockholders’
equity (deficit): | |
| | | |
| | |
Preferred
stock; $0.0001 par value: 5,000,000 shares authorized. No shares issued or outstanding | |
| — | | |
| — | |
Common
stock; $0.0001 par value: 125,000,000 shares authorized; 38,389,648 and 5,544,528 issued and outstanding at June 30, 2023 and September
30, 2022 | |
| 3,839 | | |
| 554 | |
Additional
paid-in capital | |
| 109,981,627 | | |
| 88,871,786 | |
Accumulated
deficit | |
| (106,567,014 | ) | |
| (91,411,059 | ) |
Total
stockholders’ equity (deficit) | |
| 3,418,452 | | |
| (2,538,719 | ) |
Total
liabilities and stockholders’ equity (deficit) | |
$ | 10,034,810 | | |
$ | 5,830,012 | |
See
accompanying notes to unaudited interim consolidated financial statements
Sonnet
BioTherapeutics Holdings, Inc.
Consolidated
Statements of Operations
(unaudited)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three
Months Ended June 30, | | |
Nine
Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Collaboration
revenue | |
$ | 36,850 | | |
$ | 62,071 | | |
$ | 110,550 | | |
$ | 287,190 | |
Operating
expenses: | |
| | | |
| | | |
| | | |
| | |
Research
and development | |
| 2,409,471 | | |
| 5,648,952 | | |
| 9,972,055 | | |
| 16,320,090 | |
General
and administrative | |
| 1,542,689 | | |
| 2,280,345 | | |
| 5,330,967 | | |
| 6,259,494 | |
Total
operating expenses | |
| 3,952,160 | | |
| 7,929,297 | | |
| 15,303,022 | | |
| 22,579,584 | |
Loss
from operations | |
| (3,915,310 | ) | |
| (7,867,226 | ) | |
| (15,192,472 | ) | |
| (22,292,394 | ) |
Foreign
exchange (loss) gain | |
| (31,432 | ) | |
| (9,794 | ) | |
| 36,517 | | |
| 5,894 | |
Net
loss | |
$ | (3,946,742 | ) | |
$ | (7,877,020 | ) | |
$ | (15,155,955 | ) | |
$ | (22,286,500 | ) |
Per
share information: | |
| | | |
| | | |
| | | |
| | |
Net
loss per share, basic and diluted | |
$ | (0.13 | ) | |
$ | (1.82 | ) | |
$ | (0.86 | ) | |
$ | (5.17 | ) |
Weighted
average shares outstanding, basic and diluted | |
| 29,376,018 | | |
| 4,330,489 | | |
| 17,568,549 | | |
| 4,314,635 | |
See
accompanying notes to unaudited interim consolidated financial statements
Sonnet
BioTherapeutics Holdings, Inc.
Consolidated
Statements of Changes in Stockholders’ (Deficit) Equity
(unaudited)
| |
Shares | | |
Amount | | |
capital | | |
deficit | | |
Total | |
| |
Common
stock | | |
Additional
paid-in | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
capital | | |
deficit | | |
Total | |
Balance
at October 1, 2022 | |
| 5,544,528 | | |
$ | 554 | | |
$ | 88,871,786 | | |
$ | (91,411,059 | ) | |
$ | (2,538,719 | ) |
Sale
of common stock, net of issuance costs | |
| 2,416,487 | | |
| 242 | | |
| 4,451,770 | | |
| — | | |
| 4,452,012 | |
Net
share settlement of warrants | |
| 3,026 | | |
| — | | |
| — | | |
| — | | |
| — | |
Share-based
compensation | |
| — | | |
| — | | |
| 91,617 | | |
| — | | |
| 91,617 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (5,542,142 | ) | |
| (5,542,142 | ) |
Balance
at December 31, 2022 | |
| 7,964,041 | | |
| 796 | | |
| 93,415,173 | | |
| (96,953,201 | ) | |
| (3,537,232 | ) |
Sale
of common stock, net of issuance costs | |
| 12,255,830 | | |
| 1,226 | | |
| 14,514,742 | | |
| — | | |
| 14,515,968 | |
Net
share settlement of warrants | |
| 231,481 | | |
| 23 | | |
| (23 | ) | |
| — | | |
| — | |
Issuance
of common stock on vesting of restricted stock units | |
| 47,018 | | |
| 5 | | |
| (5 | ) | |
| — | | |
| — | |
Share-based
compensation | |
| — | | |
| — | | |
| 56,998 | | |
| — | | |
| 56,998 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (5,667,071 | ) | |
| (5,667,071 | ) |
Balance
at March 31, 2023 | |
| 20,498,370 | | |
| 2,050 | | |
| 107,986,885 | | |
| (102,620,272 | ) | |
| 5,368,663 | |
Sale
of common stock, net of issuance costs | |
| 3,660,000 | | |
| 366 | | |
| 1,945,311 | | |
| — | | |
| 1,945,677 | |
Net
share settlement of warrants | |
| 11,194,493 | | |
| 1,119 | | |
| (1,119 | ) | |
| — | | |
| — | |
Issuance
of common stock on vesting of restricted stock units | |
| 785 | | |
| — | | |
| — | | |
| — | | |
| — | |
Exercise
of warrants | |
| 3,036,000 | | |
| 304 | | |
| 545 | | |
| — | | |
| 849 | |
Share-based
compensation | |
| — | | |
| — | | |
| 50,005 | | |
| — | | |
| 50,005 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (3,946,742 | ) | |
| (3,946,742 | ) |
Balance
at June 30, 2023 | |
| 38,389,648 | | |
$ | 3,839 | | |
$ | 109,981,627 | | |
$ | (106,567,014 | ) | |
$ | 3,418,452 | |
See
accompanying notes to unaudited interim consolidated financial statements
Sonnet
BioTherapeutics Holdings, Inc.
Consolidated
Statements of Changes in Stockholders’ (Deficit) Equity
(unaudited)
| |
Common
stock | | |
Additional
paid-in | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
capital | | |
deficit | | |
Total | |
Balance
at October 1, 2021 | |
| 4,303,617 | | |
$ | 430 | | |
$ | 83,948,635 | | |
$ | (61,689,218 | ) | |
$ | 22,259,847 | |
Share-based
compensation | |
| — | | |
| — | | |
| 332,075 | | |
| — | | |
| 332,075 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (6,200,981 | ) | |
| (6,200,981 | ) |
Balance
at December 31, 2021 | |
| 4,303,617 | | |
| 430 | | |
| 84,280,710 | | |
| (67,890,199 | ) | |
| 16,390,941 | |
Issuance
of common stock on vesting of restricted stock units | |
| 893 | | |
| — | | |
| — | | |
| — | | |
| — | |
Share-based
compensation | |
| — | | |
| — | | |
| 350,891 | | |
| — | | |
| 350,891 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (8,208,499 | ) | |
| (8,208,499 | ) |
Balance
at March 31, 2022 | |
| 4,304,510 | | |
| 430 | | |
| 84,631,601 | | |
| (76,098,698 | ) | |
| 8,533,333 | |
Balance | |
| 4,304,510 | | |
| 430 | | |
| 84,631,601 | | |
| (76,098,698 | ) | |
| 8,533,333 | |
Issuance
of common stock on vesting of restricted stock units | |
| 324,768 | | |
| 32 | | |
| (32 | ) | |
| — | | |
| — | |
Share-based
compensation | |
| — | | |
| — | | |
| 107,892 | | |
| — | | |
| 107,892 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (7,877,020 | ) | |
| (7,877,020 | ) |
Balance
at June 30, 2022 | |
| 4,629,278 | | |
$ | 462 | | |
$ | 84,739,461 | | |
$ | (83,975,718 | ) | |
$ | 764,205 | |
Balance | |
| 4,629,278 | | |
$ | 462 | | |
$ | 84,739,461 | | |
$ | (83,975,718 | ) | |
$ | 764,205 | |
See
accompanying notes to unaudited interim consolidated financial statements
Sonnet
BioTherapeutics Holdings, Inc.
Consolidated
Statements of Cash Flows
(unaudited)
| |
2023 | | |
2022 | |
| |
Nine
Months Ended June 30, | |
| |
2023 | | |
2022 | |
Cash
flows from operating activities: | |
| | | |
| | |
Net
loss | |
$ | (15,155,955 | ) | |
$ | (22,286,500 | ) |
Adjustments
to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation | |
| 9,634 | | |
| 9,634 | |
Acquired
in-process research and development | |
| 282,000 | | |
| 871,877 | |
Amortization
of operating lease right-of-use asset | |
| 46,650 | | |
| 65,695 | |
Share-based
compensation | |
| 198,620 | | |
| 790,858 | |
Change
in operating assets and liabilities: | |
| | | |
| | |
Incentive
tax receivable | |
| (31,864 | ) | |
| — | |
Prepaid
expenses and other current assets | |
| (218,940 | ) | |
| (754,872 | ) |
Other
assets | |
| (155,366 | ) | |
| — | |
Accounts
payable | |
| (1,877,222 | ) | |
| (761,833 | ) |
Accrued
expenses and other current liabilities | |
| 264,872 | | |
| 893,728 | |
Operating
lease liability | |
| (34,609 | ) | |
| (66,991 | ) |
Deferred
income | |
| (110,549 | ) | |
| (287,190 | ) |
Net
cash used in operating activities | |
| (16,782,729 | ) | |
| (21,525,594 | ) |
Cash
flows from investing activities: | |
| | | |
| | |
Purchase
of in-process research and development | |
| (273,250 | ) | |
| (871,877 | ) |
Net
cash used in investing activities | |
| (273,250 | ) | |
| (871,877 | ) |
Cash
flows from financing activities: | |
| | | |
| | |
Proceeds
from sale of common stock, net of issuance costs | |
| 21,024,070 | | |
| — | |
Proceeds
from the exercise of warrants | |
| 849 | | |
| — | |
Repayments
of related party note | |
| (748 | ) | |
| — | |
Net
cash provided by financing activities | |
| 21,024,171 | | |
| — | |
| |
| | | |
| | |
Net
increase (decrease) in cash | |
| 3,968,192 | | |
| (22,397,471 | ) |
Cash,
beginning of period | |
| 3,052,879 | | |
| 27,622,067 | |
Cash,
end of period | |
$ | 7,021,071 | | |
$ | 5,224,596 | |
| |
| | | |
| | |
Supplemental
disclosure of non-cash operating, investing and financing activities: | |
| | | |
| | |
Net
settlement of warrants | |
$ | 1,142 | | |
$ | — | |
Acquired
in-process research and development in accounts payable | |
$ | 170,000 | | |
$ | — | |
Change
in operating right-of-use asset and liability due to amended lease | |
$ | — | | |
$ | 213,793 | |
Deferred
offering costs charged against proceeds from sale of common stock | |
$ | 32,340 | | |
$ | — | |
Issuance
of common stock on vesting of restricted stock units | |
$ | 5 | | |
$ | 33 | |
Common
stock issuance costs in accrued expenses and accounts payable | |
$ | 78,073 | | |
$ | — | |
| |
| | | |
| | |
See
accompanying notes to unaudited interim consolidated financial statements
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
1.
Organization and Description of Business
Description
of business
Sonnet
BioTherapeutics, Inc. (“Prior Sonnet”) was incorporated as a New Jersey corporation on April 6, 2015. Prior Sonnet completed
a merger with publicly-held Chanticleer Holdings, Inc. (“Chanticleer”) on April 1, 2020. After the merger, Chanticleer changed
its name to Sonnet BioTherapeutics Holdings, Inc. (“Sonnet” or the “Company”). Sonnet is a clinical stage, oncology-focused
biotechnology company with a proprietary platform for innovating biologic medicines of single- or bi-specific action. Known as FHAB™
(Fully Human Albumin Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and “hitch-hikes”
on human serum albumin (“HSA”) for transport to target tissues.
Sonnet’s
lead proprietary asset, SON-1010, is a fully human version of Interleukin 12 (“IL-12”), covalently linked to the FHAB
construct, for which Sonnet intends to pursue clinical development in solid tumor indications, including ovarian cancer, non-small cell
lung cancer and head and neck cancer. In March 2022, the FDA cleared Sonnet’s Investigational New Drug (“IND”) application
for SON-1010. This allowed the Company to initiate a U.S. clinical trial (SB101) in oncology patients with solid tumors during the second
calendar quarter of 2022. In September 2021, the Company created a wholly-owned Australian subsidiary, SonnetBio Pty Ltd (“Subsidiary”),
for the purpose of conducting certain clinical trials. Sonnet received approval and initiated an Australian clinical study (SB102) of
SON-1010 in healthy volunteers during the third calendar quarter of 2022. Interim safety and tolerability data from the SB101 and SB102
studies were reported in April 2023.
In
January 2023, Sonnet announced a collaboration agreement with Roche for the clinical evaluation of SON-1010 with atezolizumab (Tecentriq®).
The companies have entered into a Master Clinical Trial and Supply Agreement (“MCSA”), along with ancillary Quality and Safety
Agreements, to study the safety and efficacy of the combination of SON-1010 and atezolizumab in a platinum-resistant ovarian cancer (“PROC”)
patient setting. Further, the companies will provide SON-1010 and atezolizumab, respectively, for use in the Phase 1b/Phase 2a combination
safety, dose-escalation, and efficacy study (SB221). Part 1 of this 2-part study was recently approved by the local Human Research Ethics
Committee in Australia under CT-2023-CTN-01399-1 and the Therapeutic Goods Administration has been notified. Recruitment is expected
to begin imminently. As part of the ongoing cost-cutting evaluations, all antiviral development with SON-1010 has been suspended.
The
Company acquired the global development rights to its most advanced compound, SON-080, a fully human version of Interleukin 6 (“IL-6”),
in April 2020 through its acquisition of the outstanding shares of Relief Therapeutics SA. Sonnet is advancing SON-080 in target indications
of Chemotherapy-Induced Peripheral Neuropathy (“CIPN”) and Diabetic Peripheral Neuropathy (“DPN”). Sonnet received
approval to initiate an ex-U.S. Phase 1b/2a study with SON-080 in CIPN during the third quarter of 2022. The Data Safety Monitoring Board
(DSMB) overseeing the study is expected to meet during the third quarter of 2023. Following the completion of the DSMB review, we anticipate
announcing initial safety data from the CIPN study. Pursuant to a license agreement the Company entered with New Life Therapeutics Pte,
Ltd. (“New Life”) of Singapore in May 2021, Sonnet and New Life will be jointly responsible for developing SON-080 in DPN.
The objective will be to analyze the data and to consider initiating a Phase 2 study once the CIPN safety data has been evaluated.
SON-1210
(IL12-FHAB-IL15), Sonnet’s lead bi-specific construct, combines FHAB with fully human IL-12 and fully human
Interleukin 15 (“IL-15”). This compound is being developed for solid tumor indications, including colorectal cancer. In February
2023, the Company announced the successful completion of two IND-enabling toxicology studies with SON-1210 in non-human primates. Sonnet
is prepared to initiate the regulatory authorization process for SON-1210 in 2023, subject to having a partnering opportunity in place.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
SON-1410
(IL18-FHAB-IL12) is a bi-specific combination of Interleukins 18 (“IL-18”) and 12 (IL-12) for solid tumor
cancers. Cell line development for GMP application is underway. After some delays in 2023, process development activities will
continue into 2024, with the potential to generate a drug suitable for initial in vivo mice studies during the second half of
calendar year 2024.
The
Company has completed sequence confirmation for SON-3015 (anti-IL6-FHAB-anti-TGFβ). Early stage bi-specific drug has
been generated and is being stored for future use in in vivo mice studies. Sonnet has elected to place the SON-3015 development
program on hold for expense reduction purposes.
Liquidity
The
Company has incurred recurring losses and negative cash flows from operations since inception and it expects to generate losses from
operations for the foreseeable future primarily due to research and development costs for its potential product candidates. The Company
believes its cash of $7.0 million at June 30, 2023 will fund the Company’s projected operations into 2024. Substantial
additional financing will be needed by the Company to fund its operations. These factors raise substantial doubt about the Company’s
ability to continue as a going concern. The accompanying unaudited interim consolidated financial statements have been prepared on a
going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The
unaudited interim consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
The
Company plans to secure additional capital in the future through equity or debt financings, partnerships, collaborations, or other sources
to carry out the Company’s planned development activities. If additional capital is not available when required, the Company may
need to delay or curtail its operations until such funding is received. Various internal and external factors will affect whether and
when the Company’s product candidates become approved for marketing and successful commercialization. The regulatory approval and
market acceptance of the Company’s product candidates, length of time and cost of developing and commercializing these product
candidates and/or failure of them at any stage of the approval process will materially affect the Company’s financial condition
and future operations.
Operations
since inception have consisted primarily of organizing the Company, securing financing, developing its technologies through performing
research and development and conducting preclinical studies. The Company faces risks associated with companies whose products are in
development. These risks include the need for additional financing to complete its research and development, achieving its research and
development objectives, defending its intellectual property rights, recruiting and retaining skilled personnel, and dependence on key
members of management.
2.
Summary of Significant Accounting Policies
a.
Basis of presentation
The
accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting
principles (“U.S. GAAP”) for interim financial information as found in the Accounting Standards Codification (“ASC”)
and Accounting Standards Updates (ASUs”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management,
the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily
of accruals, estimates and assumptions that impact the unaudited interim consolidated financial statements) considered necessary to present
fairly the Company’s financial position as of June 30, 2023 and its results of operations for the three and nine months ended June
30, 2023 and 2022 and cash flows for the nine months ended June 30, 2023 and 2022. The unaudited interim consolidated financial statements
presented herein do not contain the required disclosures under U.S. GAAP for annual financial statements and should be read in conjunction
with the annual audited financial statements and related notes of Sonnet as of and for the year ended September 30, 2022 included in
the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2022. The results of operations for the interim
periods are not necessarily indicative of the results of operations to be expected for the full year.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
b.
Consolidation
The
unaudited interim consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany
accounts and transactions have been eliminated in consolidation.
c.
Use of estimates
The
preparation of the interim unaudited consolidated financial statements in conformity with U.S. GAAP requires management to make estimates
and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Significant estimates
and assumptions reflected in these unaudited interim consolidated financial statements include the accrual of research and development
expenses. Estimates and assumptions are periodically reviewed in-light of changes in circumstances, facts and experience. Changes in
estimates are recorded in the period in which they become known. Actual results could differ from management’s estimates.
d.
Reclassifications
Certain
amounts from the prior period have been reclassified to conform with the current period presentation.
e.
Incentive tax receivable
Subsidiary
is eligible to participate in an Australian research and development tax incentive program. As part of this program, Subsidiary is eligible
to receive a cash refund from the Australian Taxation Office for a percentage of the research and development costs expended by Subsidiary
in Australia. The cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian)
during the reimbursable period. The Company estimates the amount of cash refund it expects to receive related to the Australian research
and development tax incentive program and records the incentive when it is probable (i) the Company will comply with relevant conditions
of the program and (ii) the incentive will be received. As of June 30, 2023, the Company’s estimate of the amount of cash refund
it expects to receive for eligible spending related to the Australian research and development tax incentive program was $0.7 million.
For the three months ended June 30, 2023 and 2022, $0.3 million and $0.3 million, respectively,
for the expected net cash (payment) refund related to the tax incentive program was included as an offset to research and development
expenses. For the nine months ended June 30, 2023 and 2022, $0.8 million and $0.4 million, respectively, for the expected net
cash refund related to the tax incentive program was included in research and development expenses. In January 2023, the Company received
$1.1 million from the Australian government related to eligible research and development expenses for the year ended September 30, 2022.
In April 2023, the Company refunded the Australian government for $0.2 million due to new information on the Company’s clinical
trial studies.
R&D tax credit is an opportunity available with the State of New Jersey.
The company seeks to apply for such tax credits. There is no assurance that such tax credit could be made available.
f.
Property and equipment
Property
and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets. Expenditures
for repairs and maintenance that do not extend the estimated useful life or improve an asset are expensed as incurred. Upon retirement
or sale, the cost and related accumulated depreciation and amortization of assets disposed of are removed from the accounts, and any
resulting gain or loss is included in the consolidated statement of operations.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
g.
Collaboration revenue
Collaboration
arrangements may contain multiple components, which may include (i) licenses; (ii) research and development activities; and (iii) the
manufacturing and supply of certain materials. Payments pursuant to these arrangements may include non-refundable payments, upfront payments,
milestone payments upon the achievement of significant regulatory and development events, sales milestones and royalties on product sales.
The amount of variable consideration is constrained until it is probable that the revenue is not at a significant risk of reversal in
a future period.
In
determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under a collaboration arrangement,
the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of
whether the promised goods or services are performance obligations, including whether they are capable of being distinct; (iii) measurement
of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance
obligations; and (v) recognition of revenue as the Company satisfies each performance obligation.
The
Company applies significant judgment when evaluating whether contractual obligations represent distinct performance obligations, allocating
transaction price to performance obligations within a contract, determining when performance obligations have been met, and assessing
the recognition of variable consideration. When consideration is received prior to the Company completing its performance obligation
under the terms of a contract, a contract liability is recorded as deferred income. Deferred income expected to be recognized as revenue
within the twelve months following the balance sheet date is classified as a current liability. In May 2021, the Company entered into
a License Agreement (the “New Life Agreement”) with New Life. See Note 5 for further discussion of the New Life Agreement.
h.
Research and development expense
Research
and development expenses include all direct and indirect costs associated with the development of the Company’s biopharmaceutical
products. These expenses include personnel costs, consulting fees, and payments to third parties for research, development, and manufacturing
services. These costs are charged to expense as incurred.
At
the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward
completion of the related project, based on the measure of progress as defined in the contract. Factors the Company considers in preparing
the estimates include costs incurred by the service provider, milestones achieved, and other criteria related to the efforts of its service
providers. Such estimates are subject to change as additional information becomes available. Depending on the timing of payment to the
service providers and the progress that the Company estimates has been made as a result of the service provided, the Company will record
a prepaid expense or accrued liability relating to these costs. Upfront milestone payments made to third parties who perform research
and development services on the Company’s behalf are expensed as services are rendered. Contingent development or regulatory milestone
payments are recognized upon the related resolution of such contingencies.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
i.
Reverse stock split
On
September 16, 2022, the Company filed a Certificate of Amendment to its Certificate of Incorporation, as amended, with the Secretary
of State of the State of Delaware, which effected a 1-for-14 reverse stock split of the Company’s issued and outstanding shares
of common stock. As a result of the reverse stock split, every 14 shares of common stock issued and outstanding was converted into one
share of common stock. The reverse stock split affected all stockholders uniformly and did not alter any stockholder’s percentage
interest in the Company’s equity. No fractional shares were issued in connection with the reverse stock split. Stockholders who
would otherwise be entitled to a fractional share of common stock were instead entitled to receive a proportional cash payment. The reverse
stock split did not change the par value or authorized number of shares of common stock. All common share and per share amounts presented
in the unaudited interim consolidated financial statements and accompanying notes have been retroactively adjusted to reflect the reverse
stock split.
j.
Net loss per share
Basic
net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each
period (and potential shares of common stock that are exercisable for little or no consideration). Included in basic weighted-average
number of shares of common stock outstanding during the three and nine months ended June 30, 2023 are the pre-funded February 2023 and
June 2023 warrants with an exercise price of $0.0001 per share. Included in basic weighted-average number of shares of common stock outstanding
during the nine months ended June 30, 2023 and the three and nine months ended June 30, 2022 are the Series B warrants with an exercise
price of $0.0014 per share.
Diluted
loss per share includes the effect, if any, from the potential exercise or conversion of securities such as common stock warrants and
stock options which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average
number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities
are not included in the calculation as the impact is anti-dilutive.
The
following potentially dilutive securities have been excluded from the computation of diluted shares of common stock outstanding as they
would be anti-dilutive:
Schedule
of Potentially Dilutive Securities
| |
2023 | | |
2022 | |
| |
June
30, | |
| |
2023 | | |
2022 | |
Common
stock warrants August 2021 | |
| 2,827,708 | | |
| 2,827,708 | |
Underwriter
warrants August 2021 | |
| 50,416 | | |
| 50,416 | |
Private
warrants | |
| — | | |
| 7,549 | |
Chanticleer
warrants | |
| 1,267 | | |
| 1,267 | |
Series
C warrants | |
| 809,243 | | |
| 809,243 | |
Series
3 warrants | |
| 276,140 | | |
| — | |
Unvested
restricted stock units and awards | |
| 172,667 | | |
| 48,156 | |
Common
stock warrants February 2023 | |
| 5,981,482 | | |
| — | |
Underwriter
warrants February 2023 | |
| 972,222 | | |
| — | |
Common
stock private placement warrants June 2023 | |
| 5,000,000 | | |
| — | |
PA
warrants June 2023 | |
| 150,000 | | |
| — | |
Total
anti-dilutive weighted average shares | |
| 16,241,145 | | |
| 3,744,339 | |
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
k.
Recent accounting pronouncements
Recently
adopted
In
May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock
Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting
for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. The amendments in ASU 2021-04 provide
guidance to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified
written call options (for example, warrants) that remain equity classified after modification or exchange. The adoption of ASU 2021-04
on October 1, 2022 did not have any impact on the unaudited interim consolidated financial statements.
3.
Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consisted of the following:
Schedule
of Accrued Expenses and Other Current Liabilities
| |
June
30, | | |
September
30, | |
| |
2023 | | |
2022 | |
Compensation
and benefits | |
$ | 2,137,223 | | |
$ | 1,218,530 | |
Research
and development | |
| 854,280 | | |
| 1,593,922 | |
Professional
fees | |
| 321,396 | | |
| 378,890 | |
Other | |
| 2,505 | | |
| 2,630 | |
Accrued
expenses and other current liabilities | |
$ | 3,315,404 | | |
$ | 3,193,972 | |
4.
Commitments and Contingencies
Legal
proceedings
From
time to time, the Company is a party to various lawsuits, claims, and other legal proceedings that arise in the ordinary course of its
business. While the outcomes of these matters are uncertain, management does not expect that the ultimate costs to resolve these matters
will have a material adverse effect on the Company’s consolidated financial position, results of operations, or cash flows.
License
agreements
In
July 2012, the Company entered into a Discovery Collaboration Agreement (the “Collaboration Agreement”) with XOMA (US) LLC
(“XOMA”), pursuant to which XOMA granted to the Company a non-exclusive, non-transferable license and/or right to use certain
materials, technologies and related information related to discovery, optimization and development of antibodies and related proteins
and to develop and commercialize products thereunder. The Company is obligated to make contingent milestone payments to XOMA totaling
$3.8 million on a product-by-product basis upon the achievement of certain development and approval milestones related to a product.
The Company has also agreed to pay XOMA low single-digit royalties on net sales of products sold by the Company. Royalties on each product
are payable on a country-by-country basis until the later of (i) a specified period of time after the first commercial sale, and (ii)
the date of expiration of the last valid claim in the last-to-expire of the issued patents covered by the Collaboration Agreement. The
first milestone was achieved in April 2022, at which time the Company incurred a $0.5 million license fee which was recorded as acquired
in-process research and development.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
In
August 2015, the Company entered into a License Agreement (the “ARES License Agreement”) with Ares Trading, a wholly-owned
subsidiary of Merck KGaA (“ARES”). Under the terms of the ARES License Agreement, ARES has granted the Company a sublicensable,
exclusive, worldwide, royalty-bearing license on proprietary patents to research, develop, use and commercialize products using atexakin
alfa (“Atexakin”), a low dose formulation of human IL-6 in peripheral neuropathies and vascular complications. Pursuant to
the ARES License Agreement, the Company will pay ARES high single-digit royalties on net sales of products sold by the Company. Royalties
are payable on a product-by-product and country-by-country basis until the later of (i) a specified period of time after the first commercial
sale in such country, and (ii) the last date on which such product is covered by a valid claim in such country.
In
January 2019, the Company entered into a Frame Services and License Agreement (the “Cellca Agreement”) with Sartorius Stedim
Cellca GMBH (“Cellca”), pursuant to which Cellca has granted the Company a worldwide, non-exclusive, perpetual, non-transferable
license to develop, manufacture or have manufactured, use, sell, import, export and/or otherwise commercialize product based on Cellca’s
work to generate a specified transfected cell line and develop an upstream production process for such cell line. The Cellca Agreement
is effective unless terminated by either party by giving six months notice, or by giving 14 days notice if terminated for good cause.
The Company is obligated to make milestone payments to Cellca totaling up to $0.7 million upon the achievement of certain development
and approval milestones if the Buy-Out Option is not exercised. The Company has a Buy-Out Option that will be effective between the time
of completion of a clinical trial and the receipt of regulatory approval for commercialization of product. The cost to exercise the Buy-Out
Option increases on each anniversary of the commencement date of the Buy-Out Option Period, and ranges from $0.1 million to $0.6 million.
The cost to exercise the Buy-Out Option will replace the $0.6 million contingent milestone payment due upon final regulatory approval.
The first milestone was achieved in April 2022, at which time the Company incurred a $0.1 million license fee which was recorded as acquired
in-process research and development.
In
October 2021, the Company entered into a Non-Exclusive License Agreement (the “Brink Agreement”) with Brink Biologics Inc.
(“Brink”), pursuant to which Brink has granted the Company a non-exclusive, non-transferable license and limited right to
sublicense certain materials and related information to develop cell-based assays for batch, quality control, stability, efficacy, potency
or any other type of assay required for production and commercialization of products. During the product development phase, the Company
was obligated to make annual product development license fee payments of approximately $0.1 million. In April 2023, the Brink Agreement
was amended, effective November 2022, to reduce the annual license fee payments to $12,000 for storage. If materials are removed from
storage during the product development phase, the annual product development license fee of approximately $0.1 million will apply. If
a product achieves commercial status, the Company is obligated to make a commercial product license fee payment of approximately $0.1
million per commercial product. The amended agreement has an initial term of one year and will automatically renew for one additional
year unless terminated or converted to a product development license. After the second year, the license will automatically convert to
a full license requiring a product development or a commercial product license fee unless the parties mutually agree to terminate the
agreement. The Company incurred $12,000 in license fees during the nine months ended June 30, 2023,
which was recorded as acquired in-process research and development and included in research and development expenses in the unaudited
interim consolidated statement of operations. The Company incurred a $0.1 million
license fee which was recorded as acquired in-process research and development and included in research and development expenses in the
unaudited interim consolidated statement of operations for the nine months ended June 30, 2022.
In
February 2022, the Company entered into a Biological Materials License Agreement (the “InvivoGen Agreement”) with InvivoGen
SAS (“InvivoGen”), pursuant to which InvivoGen has granted the Company a worldwide, non-exclusive license to use certain
reporter cells for research, development and/or quality control purposes. The InvivoGen Agreement has an initial term of three years
and may be extended for two additional three-year periods upon written notice by the Company and payment of an approximately €0.1
million fee per extension (approximately $0.1 million as of June 30, 2023). No
license fees were incurred during the three and nine months ended June 30, 2023. The Company incurred a $0.1 million license fee
which was recorded as acquired in-process research and development and included in research and development expenses in the unaudited
interim consolidated statements of operations for the three and nine months ended June 30, 2022.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
In
March 2022, the Company entered into a Material Transfer and License Agreement (the “ProteoNic Agreement”) with ProteoNic
B.V. (“ProteoNic”), pursuant to which ProteoNic has granted to the Company a non-exclusive, non-transferable, non-sublicensable
(except as provided for in the ProteoNic Agreement) license for certain materials, including plasmids and DNA sequences used to generate
the vectors used in the Company’s cell lines, for the Company’s use in research, development and commercialization of product.
The license will continue until terminated by either party. The Company incurred a $24,600 license fee upon obtaining the license. The
Company is obligated to make contingent milestone payments to ProteoNic totaling up to €1.2 million (approximately $1.3 million
as of June 30, 2023) upon the achievement of certain development and commercialization milestones as outlined in the ProteoNic Agreement.
No license fees were incurred during the three and nine months ended June 30, 2023 or 2022.
Research
and development agreement
In
December 2021, the Company entered into a Research and Development Agreement (the “Navigo Agreement”) with Navigo Proteins
GmbH (“Navigo”), pursuant to which Navigo will perform specified evaluation and development procedures to evaluate certain
materials to determine their commercial potential. Under the terms of the Navigo Agreement, the Company has granted Navigo a royalty-free,
non-exclusive, worldwide, non-sublicensable, non-transferable right and license to use certain technology to perform the evaluation and
development activities, and Navigo has granted the Company (i) an exclusive, worldwide, perpetual, irrevocable, sublicensable, transferable,
royalty-free right and license to research, develop, use, sell, have sold, distribute, import or otherwise commercially exploit certain
materials, and (ii) a non-exclusive, worldwide, perpetual, sublicensable, non-transferable right and license to make or have made such
materials. The Company incurred a $0.1 million technology access fee upon execution of the Navigo Agreement, at which time it was recorded
as acquired in-process research and development. The Company is obligated to make contingent milestone payments to Navigo, as amended
in March 2023, totaling up to $1.0 million upon the achievement of certain evaluation and development milestones as outlined in the Navigo
Agreement. The first milestone was achieved in December 2022, at which time the Company incurred
a $0.1 million license fee which was recorded as acquired in-process research and development
and included as research and development expenses in the unaudited interim consolidated statement of operations for the nine months ended
June 30, 2023. The remaining evaluation milestones were achieved in April 2023, at which time the Company incurred $0.2 million which
was recorded as acquired in-process research and development and included as research and development expenses in the unaudited interim
consolidated statement of operations for the three months ended June 30, 2023.
Employment
agreements
The
Company has entered into employment contracts with its officers and certain employees that provide for severance and continuation of
benefits in the event of termination of employment either by the Company without cause or by the employee for good reason, both as defined
in the contract. In addition, in the event of termination of employment following a change in control, as defined, either by the Company
without cause or by the employee for good reason, any unvested portion of the employee’s initial stock option grant becomes immediately
vested.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
5.
Collaboration Revenue
Under
the New Life Agreement, the Company granted New Life an exclusive license (with the right to sublicense) to develop and commercialize
pharmaceutical preparations containing a specific recombinant human IL-6, SON-080 (the “Compound”) (such preparations, the
“Products”) for the prevention, treatment or palliation of diabetic peripheral neuropathy in humans (the “DPN Field”)
in Malaysia, Singapore, Indonesia, Thailand, Philippines, Vietnam, Brunei, Myanmar, Lao PDR and Cambodia (the “Exclusive Territory”).
New Life had the option to expand (1) the field of the exclusive license to include the prevention, treatment or palliation of chemotherapy-induced
peripheral neuropathy in humans (the “CIPN Field”), which option was non-exclusive and expired on December 31, 2021; and/or
(2) the territorial scope of the license to include the People’s Republic of China, Hong Kong and/or India, which option was exclusive
and expired on December 31, 2021.
The
Company will retain all rights to manufacture Compounds and Products anywhere in the world. The Company and New Life shall enter into
a follow-on supply agreement pursuant to which the Company shall supply to New Life Products for development and commercialization thereof
in the DPN Field in the Exclusive Territory on terms to be negotiated by the parties. The Company will also assist in transferring certain
preclinical and clinical development know-how that is instrumental in New Life’s ability to benefit from the license.
New
Life will bear the cost of, and be responsible for, among other things, conducting clinical studies and additional non-clinical studies
and other developmental and regulatory activities for and commercializing Products in the DPN Field in the Exclusive Territory.
New
Life paid the Company a $0.5 million non-refundable upfront cash payment in August 2020 upon executing a letter of intent to negotiate
a license agreement and a $0.5 million non-refundable upfront cash payment in June 2021 in connection with the execution of the New Life
Agreement. New Life is also obligated to pay a non-refundable deferred license fee of an additional $1.0 million at the time of the satisfaction
of certain milestones, as well as potential additional milestone payments to the Company of up to $19.0 million subject to the achievement
of certain development and commercialization milestones. In addition, during the Royalty Term (as defined below), New Life is obligated
to pay the Company tiered double-digit royalties ranging from 12% to 30% based on annual net sales of Products in the Exclusive Territory.
The “Royalty Term” means, on a Product-by-Product and a country-by-country basis in the Exclusive Territory, the period commencing
on the date of the first commercial sale (subject to certain conditions) of such Product in such country in the Exclusive Territory and
continuing until New Life ceases commercialization of such Product in the DIPN Field.
The
New Life Agreement will remain in effect on a Product-by-Product, country-by-country basis and will expire upon the expiration of the
Royalty Term for the last-to-expire Product in the last-to-expire country, subject to (i) each party’s early termination rights
including for material breach or insolvency or bankruptcy of the other party and (ii) the Company’s Buy Back Right and New Life’s
Give Back Right (as defined below).
In
addition, New Life granted to the Company an exclusive option to buy back the rights granted by the Company to New Life and the Company
granted New Life the right to give back the rights with respect to Products in the DPN Field in one or more countries in the Exclusive
Territory on terms to be agreed upon, which options will expire upon the initiation of a Phase III Trial for the applicable Product.
Revenue
recognition
The
Company first assessed the New Life Agreement under ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether
the New Life Agreement or units of accounts within the New Life Agreement represent a collaborative arrangement based on the risks and
rewards and activities of the parties. The Company applied relevant guidance from ASC 606, Revenue from Contracts with Customers
(“ASC 606”), to evaluate the appropriate accounting for the collaborative arrangement with New Life. In accordance with this
guidance, the Company identified the following obligations under the arrangement: (i) License to develop, market, import, use and commercialize
the Product in the Field in the Exclusive Territory (the “License”); and (ii) transfer of know-how and clinical development
and regulatory activities (“R&D Activities”). The options to expand the CIPN Field and territory as well as the future
supply agreement represent optional purchases, which are accounted for as separate contracts. The Company evaluated these separate contracts
and did not identify any material right to be present. The Company determined that License and the R&D services are not distinct
from each other and therefore combined these material promises into a single performance obligation.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
The
Company determined the initial transaction price of the single performance obligation to be $1.0 million, as the future development and
commercialization milestones, which represent variable consideration, are subject to constraint at inception. At the end of each subsequent
reporting period, the Company will reevaluate the probability of achievement of the future development and commercialization milestones
subject to constraint and, if necessary, will adjust its estimate of the overall transaction price. Any such adjustments will be recorded
on a cumulative catch-up basis. For the sales-based royalties, the Company will recognize revenue when the related sales occur.
Collaboration
revenue from the single performance obligation is being recognized over the estimated performance of the R&D services. The Company
recognized $36,850 and $0.1 million of collaboration revenue for the three and nine months ended June
30, 2023, respectively. The Company recognized $0.1 million and $0.3 million of collaboration revenue for the three and nine months
ended June 30, 2022, respectively.
6.
Stockholders’ Equity (Deficit)
The
Company entered into an At-the-Market Sales Agreement with BTIG, LLC (“BTIG”) on August 15, 2022 (the “2022 Sales
Agreement”). Pursuant to the 2022 Sales Agreement, the Company may offer and sell, from time to time, through BTIG, as sales
agent and/or principal, shares of its common stock having an aggregate offering price of up to $25.0
million, subject to certain limitations on the amount of common stock that may be offered and sold by the Company set forth in the
2022 Sales Agreement. Due to the offering limitations applicable to the Company, the Company filed prospectus supplements for the
sale of shares of its common stock for an aggregate offering price of up to $7.8
million pursuant to the 2022 Sales Agreement. During the nine months ended June 30,
2023, the Company sold an aggregate of 3,007,429
shares of common stock pursuant to the 2022 Sales Agreement with BTIG for gross proceeds of $5.8
million and net proceeds of $5.4
million. No shares were sold during the three months ended June 30, 2023. As of June
30, 2023, there are no registered shares remaining to be sold under the 2022 Sales Agreement.
On
February 10, 2023, the Company closed a public offering of common stock and certain warrants through Chardan Capital Markets, LLC and
EF Hutton, division of Benchmark Investments LLC as underwriters, for gross proceeds of $15.0 million and net proceeds of $13.6 million
through the issuance and sale of 11,664,888 shares of its common stock and, to certain investors, pre-funded warrants to purchase 2,224,000
shares of common stock, and accompanying common warrants to purchase up to an aggregate of 27,777,776 shares of its common stock (the
“February Offering”). Each share of common stock and pre-funded warrant to purchase one share of common stock was sold together
with a common warrant to purchase two shares of common stock. The public offering price of each share of common stock and accompanying
common warrant was $1.08 and the public offering price of each pre-funded warrant and accompanying common warrant was $1.0799.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
The
common stock warrants are immediately exercisable at a price of $1.08 per share of common stock, expire five years from the date of issuance
and contain an alternative cashless exercise provision whereby, subject to certain conditions, a warrant may be exercised in a cashless
transaction for shares of common stock at the rate of half a share of common stock per full share otherwise issuable upon a cash exercise.
The pre-funded warrants are immediately exercisable at any time, until exercised in full, at a price of $0.0001 per share of common stock.
In
addition, warrants to purchase 972,222 shares of common stock were issued to the underwriters as compensation for their services related
to the offering. These common stock warrants have an exercise price of $1.35 per share and expire five years from the date of issuance.
On
June 30, 2023, the Company closed a registered direct offering of common stock (and common stock equivalents in lieu thereof) and a concurrent
private placement of certain common stock warrants through Chardan Capital Markets, LLC as placement agent, for gross proceeds of $2.3
million and net proceeds of $1.9 million through the issuance and sale of 3,660,000 shares of its common stock, pre-funded warrants to
purchase 1,340,000 shares of common stock and accompanying common warrants to purchase up to an aggregate of 5,000,000 shares of its
common stock (the “June Offering”). Each share of common stock and pre-funded warrant to purchase one share of common stock
was sold together with a common warrant to purchase one share of common stock. The effective offering price of each share of common stock
(or common stock equivalent) and accompanying common warrant was $0.45.
The
common stock warrants are exercisable beginning December 30, 2023 at a price of $0.6749 per share of common stock and expire three and
half years from the date of issuance. The pre-funded warrants are immediately exercisable at any time, until exercised in full, at a
price of $0.0001 per share of common stock. All of the pre-funded warrants were exercised as of June 30, 2023.
In
addition, warrants to purchase 150,000 shares of common stock were issued to the placement agent as compensation for its services related
to the offering. These common stock warrants have an exercise price of $0.6749 per share, are exercisable beginning December 30, 2023
and expire three and a half years from the date of issuance.
Common
stock warrants
As
of June 30, 2023, the following equity-classified warrants and related terms were outstanding:
Schedule
of Warrants Outstanding
| |
Warrants
Outstanding | | |
Exercise
Price | | |
Expiration
Date |
Common
stock warrants August 2021 | |
| 2,827,708 | | |
$ | 11.90 | | |
August
24, 2024 |
Underwriter
warrants August 2021 | |
| 50,416 | | |
$ | 14.875 | | |
August
19, 2024 |
Chanticleer
warrants | |
| 1,267 | | |
$ | 819.00
- $ 1,274.00 | | |
April
30, 2027 - December 17, 2028 |
Series
C warrants | |
| 809,243 | | |
$ | 44.66 | | |
October
16, 2025 |
Series
3 warrants | |
| 276,140 | | |
$ | 4.074 | | |
August
15, 2027 |
Common
stock warrants February 2023 | |
| 5,981,482 | | |
$ | 1.08 | | |
February
10, 2028 |
Underwriter
warrants February 2023 | |
| 972,222 | | |
$ | 1.35 | | |
February
8, 2028 |
Common
stock private placement warrants June 2023 | |
| 5,000,000 | | |
$ | 0.6749 | | |
December
30, 2026 |
PA
warrants June 2023 | |
| 150,000 | | |
$ | 0.6749 | | |
December
30, 2026 |
| |
| 16,068,478 | | |
| | | |
|
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
During
the three months ended June 30, 2023, 21,861,332 of common stock warrants were net share settled, resulting in the issuance of 11,194,493
shares of common stock.
During
the nine months ended June 30, 2023, 22,324,294 of common
stock warrants were net share settled, resulting in the issuance of 11,425,974 shares of common
stock.
During
the three and nine months ended June 30, 2023, 3,036,000 of the pre-funded warrants were exercised on a cash basis. The Company received
de minimus proceeds in exchange for the issuance of 3,036,000 shares of common stock.
During
the nine months ended June 30, 2023, 3,026 of Series
B warrants were net share settled, resulting in the issuance of 3,026 shares of common stock.
During
the nine months ended June 30, 2023, 7,549 of
private warrants expired.
7.
Share-Based Compensation
In
April 2020, the Company adopted the 2020 Omnibus Equity Incentive Plan (the “Plan”). On
January 1, 2023, the total number of shares authorized under the Plan increased to 318,561. There were 318,561 shares available
for issuance under the Plan as of June 30, 2023. The Plan increases the amount of shares issuable under the Plan by four percent
of the outstanding shares of common stock at each January 1, each year. The Plan permits the granting of share-based awards, including
stock options, restricted stock units and awards, stock appreciation rights and other types of awards as deemed appropriate, in each
case, in accordance with the terms of the Plan. The terms of the awards are determined by the Company’s Board of Directors.
Restricted
stock units
In
July of 2020, 46,703 restricted stock units (“RSUs”) were granted, 50% of which vested on April 2, 2021 and the remaining
50% vested on April 2, 2022. In March of 2021, an additional 3,357 RSUs were granted, 50% of which vested on March 25, 2022 and the remaining
50% vested on March 25, 2023. In December of 2021, 46,478 RSUs were granted, 100% of which vested on January 1, 2023. In December of
2022, 172,672 RSUs were granted, 100% of which vest on January 1, 2024.
In
January 2023, 121,366 of the RSUs granted in December 2022 were cancelled and subsequently reissued as restricted shares of the Company’s
common stock (“Restricted Stock Awards” or “RSAs”). The
RSAs have the same vesting conditions as the original RSUs issued in December 2022. The Company accounted for this as a stock
compensation modification resulting in $38,837 of incremental expense which will be recognized over the remaining vesting period.
Any
unvested RSUs or RSAs will be forfeited upon termination of services. The fair value of an RSU or RSA is equal to the fair market value
of the Company’s common stock on the date of grant. RSU and RSA expense is amortized straight-line over the vesting period.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
The
Company recorded share-based compensation expense associated with the RSUs and RSAs in its accompanying unaudited interim consolidated
statements of operations as follows:
Schedule
of Share-based Compensation Expense
| |
Three
Months Ended | | |
Nine
Months Ended | | |
Three
Months Ended | | |
Nine
Months Ended | |
| |
June
30, 2023 | | |
June
30, 2023 | | |
June
30, 2022 | | |
June
30, 2022 | |
Research
and development | |
$ | 24,554 | | |
$ | 102,807 | | |
$ | 64,476 | | |
$ | 394,558 | |
General
and administrative | |
| 25,451 | | |
| 95,813 | | |
| 43,416 | | |
| 396,300 | |
Share
Based Compensation | |
$ | 50,005 | | |
$ | 198,620 | | |
$ | 107,892 | | |
$ | 790,858 | |
The
following table summarizes RSU activity under the Plan:
Schedule
of Restricted Stock Units Activity
| |
RSU | | |
Weighted
Average Grant Date Fair Value | |
Unvested
balance at October 1, 2022 | |
| 47,798 | | |
$ | 7.89 | |
Granted | |
| 172,672 | | |
$ | 0.98 | |
Vested | |
| (47,803 | ) | |
$ | 0.57 | |
Forfeited/cancelled | |
| (121,366 | ) | |
$ | 0.97 | |
Unvested
balance at June 30, 2023 | |
| 51,301 | | |
$ | 0.54 | |
As
of June 30, 2023, total unrecognized compensation expense relating to unvested RSUs granted
was $24,389, which is expected to be recognized over a weighted-average period of less than one
year.
The
following table summarizes RSA activity under the Plan:
Schedule
of Restricted Stock Awards Activity
| |
RSA | | |
Weighted
Average Grant Date Fair Value | |
Unvested
balance at October 1, 2022 | |
| — | | |
$ | — | |
Granted | |
| 121,366 | | |
$ | 1.29 | |
Vested | |
| — | | |
$ | — | |
Forfeited/cancelled | |
| — | | |
$ | — | |
Unvested
balance at June 30, 2023 | |
| 121,366 | | |
$ | 1.29 | |
As
of June 30, 2023, total unrecognized compensation expense relating to unvested RSUs granted
was $75,623, which is expected to be recognized over a weighted-average period of less than one
year.
8.
Income Taxes
In
August 2022, the U.S. enacted the Inflation Reduction Act of 2022 (“IRA”). The IRA contains a number of tax-related provisions
that will be effective for tax years beginning after December 31, 2022, including a corporate alternative minimum tax of 15% on certain
large corporations and an excise tax of 1% on corporate stock repurchases. The Company is currently evaluating the various provisions
of the IRA and does not anticipate a material impact on its consolidated financial statements.
9.
Subsequent Events
The
Company has evaluated subsequent events from the balance sheet date through the date the unaudited interim consolidated financial statements
were available to be issued.
ITEM 2. MANAGEMENT’S DISCUSSION AND
ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The
following discussion and analysis of our financial condition and results of operations should be read together with our financial statements
and the related notes and the other financial information included elsewhere in this Quarterly Report. This discussion contains forward-looking
statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking
statements as a result of various factors, including those discussed below and elsewhere in this Quarterly Report, particularly those
under “Risk Factors.”
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations,
assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which
may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future
results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of
historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our
use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,”
“would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,”
“continue,” “plan,” “point to,” “project,” “predict,” “could,”
“intend,” “target,” “potential” and other similar words and expressions of the future.
There
are a number of important factors that could cause the actual results to differ materially from those expressed
in
any forward-looking statement made by us. These factors include, but are not limited to:
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our
lack of operating history and history of operating losses; |
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our
need for significant additional capital and our ability to satisfy our capital needs; |
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our
ability to complete required clinical trials of our products and obtain approval from the FDA or other regulatory agents in different
jurisdictions; |
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our
ability to maintain or protect the validity of our patents and other intellectual property; |
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our
ability to retain key executive members; |
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our
ability to internally develop new inventions and intellectual property; |
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interpretations
of current laws and the passages of future laws; |
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acceptance
of our business model by investors; |
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the potential impact of the recent COVID-19 pandemic on our operations,
including on our clinical development plans and timelines; |
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the
accuracy of our estimates regarding expenses and capital requirements; and |
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our
ability to adequately support growth. |
The
foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or
risk factors that we are faced with that may cause our actual results to differ from those anticipate in our forward-looking statements.
Please see “Risk Factors” for additional risks which could adversely impact our business and financial performance.
All
forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue
reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by
reference into this report. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking
statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and projections
in good faith and we believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs or projections
will result or be achieved or accomplished.
Overview
Sonnet
BioTherapeutics Holdings, Inc. (“Sonnet,” “we,” “us,” “our” or the “Company”),
is a clinical stage, oncology-focused biotechnology company with a proprietary platform for innovating biologic medicines of single-
or bi-specific action. Known as FHAB™ (Fully Human Albumin Binding), the technology utilizes a fully human single chain
antibody fragment that binds to and “hitch-hikes” on human serum albumin for transport to target tissues. We designed the
construct to improve drug accumulation in specific tissues, as well as to extend the duration of activity in the body. FHAB
development candidates are produced in a mammalian cell culture, which enables glycosylation, thereby reducing the risk of immunogenicity.
We believe our FHAB technology, for which we received a U.S. patent in June 2021, is a distinguishing feature of our biopharmaceutical
platform that is well suited for future drug development across a range of human disease areas, including in oncology, autoimmune, pathogenic,
inflammatory, and hematological conditions.
Our
current internal pipeline development activities are focused on cytokines, a class of cell signaling peptides that, among other important
functions, serve as potent immunomodulatory agents. Working both independently and synergistically, specific cytokines have shown the
ability to modulate the activation and maturation of immune cells that fight cancer and pathogens. However, because they do not preferentially
accumulate in specific tissues and are quickly eliminated from the body, the conventional approach to achieving a treatment effect with
cytokine therapy typically requires the administration of high and frequent doses. This can result in a reduced treatment effect accompanied
by the potential for systemic toxicity, which poses challenges to the therapeutic application of this class of drugs.
Our
lead proprietary asset, SON-1010, is a fully human version of Interleukin 12 (“IL-12”), covalently linked to the FHAB
construct, for which we intend to pursue clinical development in solid tumor indications, including ovarian cancer, non-small cell lung
cancer and head and neck cancer. In March 2022, the FDA cleared our Investigational New Drug (“IND”) application for SON-1010.
This allowed us to initiate a U.S. clinical trial (SB101) in oncology patients with solid tumors during the second calendar quarter of
2022. In September 2021, we created a wholly-owned Australian subsidiary, SonnetBio Pty Ltd, for the purpose
of conducting certain clinical trials. We received approval and initiated an Australian clinical study (SB102) of SON-1010 in healthy
volunteers during the third calendar quarter of 2022. Interim safety and tolerability data from the SB101 and SB102 studies were reported
in April 2023.
In
January 2023, we announced a collaboration agreement with Roche for the clinical evaluation of SON-1010 with atezolizumab (Tecentriq®).
The companies have entered into a Master Clinical Trial and Supply Agreement (“MCSA”), along with ancillary Quality and Safety
Agreements, to study the safety and efficacy of the combination of SON-1010 and atezolizumab in a platinum-resistant ovarian cancer (“PROC”)
patient setting. Further, the companies will provide SON-1010 and atezolizumab, respectively, for use in the Phase 1b/Phase 2a combination
safety, dose-escalation, and efficacy study (SB221). Part 1 of this 2-part study was recently approved by the local Human Research Ethics
Committee in Australia under CT-2023-CTN-01399-1 and the Therapeutic Goods Administration has been notified. Recruitment is expected
to begin imminently.
We
acquired the global development rights to its most advanced compound, SON-080, a fully human version of Interleukin 6 (“IL-6”),
in April 2020 through its acquisition of the outstanding shares of Relief Therapeutics SA. Sonnet is advancing SON-080 in target indications
of Chemotherapy-Induced Peripheral Neuropathy (“CIPN”) and Diabetic Peripheral Neuropathy (“DPN”). We received
approval to initiate an ex-U.S. Phase 1b/2a study with SON-080 in CIPN during the third quarter of 2022. The Data Safety Monitoring Board
(DSMB) overseeing the study is expected to meet during the third quarter of 2023. Following the completion of the DSMB review, we anticipate
announcing initial safety data from the CIPN study. Pursuant to a license agreement we entered with New Life Therapeutics Pte,
Ltd. (“New Life”) of Singapore in May 2021, Sonnet and New Life will be jointly responsible for developing SON-080 in DPN.
The objective will be to analyze the data and to consider initiating a Phase 2 study, once the CIPN safety data has been evaluated.
SON-1210
(IL12-FHAB-IL15), Sonnet’s lead bi-specific construct, combines FHAB with fully human IL-12 and fully human
Interleukin 15 (“IL-15”). This compound is being developed for solid tumor indications, including colorectal cancer. In February
2023, we announced the successful completion of two IND-enabling toxicology studies with SON-1210 in non-human primates. We are
is prepared to initiate the regulatory authorization process for SON-1210 in 2023, subject to having a partnering opportunity in place.
SON-1410
(IL18-FHAB-IL12) is a bi-specific combination of Interleukins 18 (“IL-18”) and 12 (IL-12) for solid tumor
cancers. Cell line development for GMP application is underway. After some delays in 2023, process development activities will
continue into 2024, with the potential to generate a drug suitable for initial in vivo mice studies during the second half
of the 2024 calendar year.
We
have completed sequence confirmation for SON-3015 (anti-IL6-FHAB-anti-TGFβ). Early stage bi-specific drug has been generated
and is being stored for future use in in vivo mice studies. We have elected to place the SON-3015 development program on hold
for expense reduction purposes.
As
part of the ongoing cost-cutting evaluations, all antiviral development with SON-1010 has been suspended.
We
have incurred recurring operating losses and negative cash flows since inception. Our ability to generate product or licensing revenue
sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of
our current or future product candidates. Our net losses were $15.2 million and $22.3 million for the nine months ended June 30, 2023
and 2022, respectively. As of June 30, 2023, we had cash of $7.0 million. We expect to continue to incur significant expenses and increasing
operating losses for at least the next several years. We expect that our expenses and capital requirements will increase substantially
in connection with our ongoing activities, particularly if and as we:
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conduct
additional clinical trials for product candidates; |
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continue
to discover and develop additional product candidates; |
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acquire
or in-license other product candidates and technologies; |
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maintain,
expand and protect our intellectual property portfolio; |
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hire
additional clinical, scientific and commercial personnel; |
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establish
a commercial manufacturing source and secure supply chain capacity sufficient to provide commercial quantities of any product candidates
for which we may obtain regulatory approval; |
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seek
regulatory approval for product candidates that successfully complete clinical trials; |
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establish
a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain regulatory approval; and |
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add
operational, financial and management information systems and personnel, including personnel to support our product development and
planned future commercialization efforts, as well as to support our operation as a public reporting company. |
We
will not generate revenue from product sales, if any, unless and until we receive licensing revenue and/or successfully complete clinical
development and obtain regulatory approval for our product candidates. If we obtain regulatory approval for any of our product candidates
and do not enter into a commercialization partnership, we expect to incur significant expenses related to developing our internal commercialization
capability to support product sales, marketing and distribution. We will continue to incur significant costs associated with operating
as a public company.
As
a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such
time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity,
debt financings or other capital sources, which may include collaborations with other companies or other strategic transactions. We may
not be able to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all.
If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, reduce or eliminate
the development and commercialization of one or more of our product candidates or delay our pursuit of potential in-licenses or acquisitions.
Because
of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased
expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not
become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable
to continue our operations at planned levels and be forced to reduce or terminate operations.
Since
our inception in 2015, we have devoted substantially all of our efforts and financial resources to organizing and staffing the Company,
business planning, raising capital, acquiring or discovering product candidates and securing related intellectual property rights and
conducting discovery, research and development activities for product candidates. We do not have any products approved for sale and have
not generated any revenue from product sales. We have funded our operations to date primarily with proceeds from sales of common stock,
warrants and proceeds from the issuance of convertible debt.
Components
of Results of Operations
Collaboration
Revenue
Collaboration
revenue is currently earned from the license arrangement entered into with New Life in May 2021, which granted New Life rights to an
exclusive license (with the right to sublicense) to develop and commercialize pharmaceutical preparations containing a specific recombinant
human IL-6, SON-080 (the “Compound”) (such preparations, the “Products”) for the prevention, treatment or palliation
of diabetic peripheral neuropathy in humans (the “DPN Field”) in the Exclusive Territory. We identified the following obligations
under the arrangement: (i) License to develop, market, import, use and commercialize the Product in the Field in the Exclusive Territory
(the “License”); and (ii) transfer of know-how and clinical development and regulatory activities (“R&D Activities”).
We determined that the License and the R&D Activities are not distinct from each other and, therefore, combined these material promises
into a single performance obligation. Under this agreement, we received upfront cash payments totaling $1.0 million, which were fully
allocated to the single performance obligation and are being recognized over the estimated performance period of R&D services.
Operating
Expenses
Research
and Development Expenses
Research
and development expenses consist primarily of costs incurred in connection with the discovery and development of our product candidates.
We expense research and development costs as incurred and such costs include:
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employee-related
expenses, including salaries, share-based compensation and related benefits, for employees engaged in research and development functions; |
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expenses
incurred in connection with the preclinical and clinical development of our product candidates, including under agreements with third
parties, such as consultants and clinical research organizations; |
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the
cost of manufacturing drug products for use in our preclinical studies and clinical trials, including under agreements with third
parties, such as consultants and contract manufacturing organizations; |
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facilities,
depreciation and other expenses, which include direct or allocated expenses for rent and maintenance of facilities and insurance; |
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costs
related to compliance with regulatory requirements; and |
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payments
made under third-party licensing agreements. |
We
recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided
by our service providers. This process involves reviewing open contracts and purchase orders, communicating with their personnel to identify
services that have been performed on our behalf, and estimating the level of service performed and the associated cost incurred for the
service when we have not yet been invoiced or otherwise notified of actual costs. Nonrefundable advance payments for goods or services
to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are recognized
as an expense when the goods have been delivered or the services have been performed.
Our
direct research and development expenses consist primarily of external costs, such as fees paid to outside consultants, CROs, CMOs and
research laboratories in connection with preclinical development, process development, manufacturing and clinical development activities.
Our direct research and development expenses also include fees incurred under third-party license agreements. We do not allocate employee
costs and costs associated with discovery efforts, laboratory supplies and facilities, including depreciation or other indirect costs,
to specific product candidates because these costs are deployed across multiple programs and as such, are not separately classified.
We use internal resources primarily to conduct our research and discovery as well as for managing preclinical development, process development,
manufacturing and clinical development activities. These employees work across multiple programs and therefore, we do not track costs
by product candidate.
We
will continue to incur research and development expenses for the foreseeable future as we attempt to advance development of our product
candidates. The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or
know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of our current pipeline
or any future product candidates we may develop due to the numerous risks and uncertainties associated with clinical development, including
risk and uncertainties related to:
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the
timing and progress of preclinical and clinical development activities; |
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the
number and scope of preclinical and clinical programs that we decide to pursue; |
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our
ability to maintain our current research and development programs and to establish new ones; |
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establishing
an appropriate safety profile with investigational new drug-enabling studies; |
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successful
patient enrollment in, and the initiation and completion of, clinical trials; |
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the
successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any
comparable foreign regulatory authority; |
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the
receipt of regulatory approvals from applicable regulatory authorities; |
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the
timing, receipt and terms of any marketing approvals from applicable regulatory authorities; |
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our
ability to establish new licensing or collaboration arrangements; |
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establishing
agreements with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if any of our
product candidates is approved; |
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development
and timely delivery of clinical-grade and commercial-grade drug formulations that can be used in our clinical trials and for commercial
launch; |
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obtaining,
maintaining, defending and enforcing patent claims and other intellectual property rights; |
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launching
commercial sales of product candidates, if approved, whether alone or in collaboration with others; |
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maintaining
a continued acceptable safety profile of the product candidates following approval; and |
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the
potential impact of COVID-19 on operations which may affect among other things, the timing of clinical trials, availability of raw
materials, and the ability to access and secure testing facilities. |
A
change in the outcome of any of these variables with respect to the development of our product candidates could significantly change
the costs and timing associated with the development of that product candidate. We may never succeed in obtaining regulatory approval
for any of our product candidates.
General
and Administrative Expenses
General
and administrative expenses consist primarily of salaries and related costs for personnel, including share-based compensation, in executive,
finance and administrative functions. General and administrative expenses also include direct and allocated facility-related costs as
well as professional fees for legal, patent, consulting, accounting, and audit services.
Our
general and administrative expenses will increase in the future as we increase our headcount to support continued research activities
and development of product candidates. We will continue to incur increased accounting, audit, legal, regulatory, compliance and director
and officer insurance costs as well as investor and public relations expenses associated with being a public company.
Foreign
Exchange Gain (Loss)
Foreign
exchange gain (loss) consists of exchange rate changes on transactions denominated in currencies other than the U.S. dollar.
Results
of Operations
Comparison
of the Three Months Ended June 30, 2023 and 2022
The
following table summarizes our results of operations for the three months ended June 30,
2023 and 2022:
| |
Three
Months Ended June 30, | | |
| |
| |
2023 | | |
2022 | | |
Change | |
Collaboration
revenue | |
$ | 36,850 | | |
$ | 62,071 | | |
$ | (25,221 | ) |
Operating
expenses: | |
| | | |
| | | |
| | |
Research
and development | |
| 2,409,471 | | |
| 5,648,952 | | |
| (3,239,481 | ) |
General
and administrative | |
| 1,542,689 | | |
| 2,280,345 | | |
| (737,656 | ) |
Total
operating expenses | |
| 3,952,160 | | |
| 7,929,297 | | |
| (3,977,137 | ) |
Loss
from operations | |
| (3,915,310 | ) | |
| (7,867,226 | ) | |
| 3,951,916 | |
Foreign
exchange (loss) gain | |
| (31,432 | ) | |
| (9,794 | ) | |
| (21,638 | ) |
Net
loss | |
$ | (3,946,742 | ) | |
$ | (7,877,020 | ) | |
$ | 3,930,278 | |
Collaboration
Revenue
We
recognized $36,850 of revenue related to the New Life Agreement during the three months ended June 30, 2023 compared to $62,071 during
the three months ended June 30, 2022. The decrease
of $25,221 was due to a delay in timing in the performance of R&D services.
Research
and Development Expenses
Research
and development expenses were $2.4 million for the three months ended June 30, 2023, compared to $5.6 million for the three months ended
June 30, 2022. The decrease of $3.2 million was primarily
due to the establishment of cost savings by transitioning product development activities to cost advantaged locations such as India and
Australia and by reducing expenditures on tertiary programs such as SON-3015, which has been placed on a development hold, as well as
a decrease in share-based compensation expense.
General
and Administrative Expenses
General
and administrative expenses were $1.5 million and $2.3 million for the three months ended June
30, 2023 and 2022, respectively. The decrease in general and administrative expenses is
a result of cost saving initiatives.
Comparison
of the Nine Months Ended June 30, 2023 and 2022
The
following table summarizes our results of operations for the nine months ended June 30,
2023 and 2022:
| |
Nine
Months Ended June 30, | | |
| |
| |
2023 | | |
2022 | | |
Change | |
Collaboration
revenue | |
$ | 110,550 | | |
$ | 287,190 | | |
$ | (176,640 | ) |
Operating
expenses | |
| | | |
| | | |
| | |
Research
and development | |
| 9,972,055 | | |
| 16,320,090 | | |
| (6,348,035 | ) |
General
and administrative | |
| 5,330,967 | | |
| 6,259,494 | | |
| (928,527 | ) |
Total
operating expenses | |
| 15,303,022 | | |
| 22,579,584 | | |
| (7,276,562 | ) |
Loss
from operations | |
| (15,192,472 | ) | |
| (22,292,394 | ) | |
| 7,099,922 | |
Foreign
exchange gain | |
| 36,517 | | |
| 5,894 | | |
| 30,623 | |
Net
loss | |
$ | (15,155,955 | ) | |
$ | (22,286,500 | ) | |
$ | 7,130,545 | |
Collaboration
Revenue
We
recognized $0.1 million of revenue related to the New Life Agreement during the nine months ended June 30, 2023 compared to $0.3 million
during the nine months ended June 30, 2022. The decrease of $0.2 million was due to a delay in
timing in the performance of R&D services.
Research
and Development Expenses
Research
and development expenses were $10.0 million for the nine months ended June 30, 2023, compared to $16.3 million for the nine months ended
June 30, 2022. The decrease of $6.3 million was primarily
due to the establishment of cost savings by transitioning product development activities to cost advantaged locations such as India and
Australia and by reducing expenditures on tertiary programs such as SON-3015, which has been placed on a development hold, as well as
a decrease in share-based compensation expense.
General
and Administrative Expenses
General
and administrative expenses were $5.3 million for the nine months ended June 30, 2023, compared to $6.3 million for the nine months ended
June 30, 2022. The decrease of $0.9 million relates
primarily to a decrease in share-based compensation expense and consulting expense related to investor relations. In addition, we are
managing expenses for liquidity purposes.
Liquidity
and Capital Resources
We
have funded operations to date primarily with proceeds from sales of our equity securities. We will need
to offer additional securities for sale in response to market conditions or other circumstances if we believe such a plan of
financing is required to advance our business plans and is in the best interests of our stockholders. There is no certainty that
equity or debt financing will be available in the future or that it will be at acceptable terms and at this time, it is not possible
to predict the outcome of these matters.
We
have incurred net losses of $15.2 million and $22.3 million for the nine months ended June 30,
2023 and 2022, respectively. We expect to continue to incur significant operational expenses and net losses in the upcoming 12 months
and beyond. Our net losses may fluctuate significantly from quarter to quarter and year to year, depending on the stage and complexity
of our R&D studies and related expenditures, the receipt of additional payments on the licensing of our technology, if any, and the
receipt of payments under any current or future collaborations we may enter into.
We
have evaluated whether there are conditions or events, considered in the aggregate, that raise substantial doubt about our ability
to continue as a going concern. We believe our cash of $7.0 million at June 30, 2023 will fund our projected operations into 2024.
We also expect about $1.5 Million to be received as tax credit, as in the previous years from Australia. Substantial additional
financing will be needed by us to fund our operations. These factors raise substantial doubt about our ability to continue as a
going concern.
The
following table summarizes our sources and uses of cash for each of the periods presented:
| |
Nine
Months Ended June 30, | |
| |
2023 | | |
2022 | |
Net
cash used in operating activities | |
$ | (16,782,729 | ) | |
$ | (21,525,594 | ) |
Net
cash used in investing activities | |
| (273,250 | ) | |
| (871,877 | ) |
Net
cash provided by financing activities | |
| 21,024,171 | | |
| — | |
Net
increase (decrease) in cash | |
$ | 3,968,192 | | |
$ | (22,397,471 | ) |
Operating
Activities
During
the nine months ended June 30, 2023, we used $16.8 million of cash in operating activities which was primarily attributable to our net
loss of $15.2 million,
a $0.3 million increase in prepaid expenses and other current assets primarily due to cash outflows for research and development activities,
a $1.7 million net decrease in accounts payable accrued expenses and a $0.1 million reduction in deferred income as we recognized collaboration
revenue from the New Life Agreement, offset by $0.3 million in acquired in-process research and development and $0.2 million in share-based
compensation expense.
During
the nine months ended June 30, 2022, we used $21.5 million of cash in operating activities which was primarily attributable to our net
loss of $22.3 million,
a $0.8 million increase in prepaid expenses and other current assets primarily due to cash outflows for research and development activities,
and a $0.3 million reduction in deferred income as we recognized collaboration revenue from the New Life Agreement, offset by $0.9 million
in acquired in-process research and development and $0.8 million in share-based compensation expense.
Investing
Activities
During
the nine months ended June 30, 2023, we used $0.3 million for the purchase of acquired in-process
research and development.
During
the nine months ended June 30, 2022, we used $0.9 million for the purchase of acquired in-process
research and development.
Financing
Activities
During
the nine months ended June 30, 2023, net cash provided by financing activities was $21.0
million, consisting of net proceeds from the sale of common stock under an at-the-market
facility and through registered public offerings.
During
the nine months ended June 30, 2022, we did not incur any cash inflows or outflows relating
to financing activities.
Funding
Requirements
We
expect to continue to incur significant expenses in connection with our ongoing activities, particularly as we advance preclinical activities
and clinical trials of product candidates in development. In addition, we expect to continue to incur costs associated with operating
as a public company. The timing and amount of our operating expenditures will depend largely on:
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the
scope, number, initiation, progress, timing, costs, design, duration, any potential delays, and results of clinical trials and nonclinical
studies for our current or future product candidates; |
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the
clinical development plans we establish for these product candidates; |
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the
number and characteristics of product candidates and programs that we develop or may in-license; |
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the
outcome, timing and cost of regulatory reviews, approvals or other actions to meet regulatory requirements established by the FDA
and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities to
require that we perform more studies for our product candidates than those that we currently expect; |
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our
ability to obtain marketing approval for product candidates; |
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the
cost of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights covering our product candidates; |
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our
ability to maintain, expand and defend the scope of our intellectual property portfolio, including the cost of defending intellectual
property disputes, including patent infringement actions brought by third parties against us or our product candidates; |
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the
cost and timing of completion of commercial-scale outsourced manufacturing activities with respect to product candidates; |
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● |
our
ability to establish and maintain licensing, collaboration or similar arrangements on favorable terms and whether and to what extent
we retain development or commercialization responsibilities under any new licensing, collaboration or similar arrangement; |
|
|
|
|
● |
the
cost of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory
approval in regions where we choose to commercialize our products on our own; |
|
|
|
|
● |
the
success of any other business, product or technology that we acquire or in which we invest; |
|
● |
the
costs of acquiring, licensing or investing in businesses, product candidates and technologies; |
|
|
|
|
● |
our
need and ability to hire additional management and scientific and medical personnel; |
|
|
|
|
● |
the
costs to operate as a public company in the United States, including the need to implement additional financial and reporting systems
and other internal systems and infrastructure for our business; |
|
|
|
|
● |
market
acceptance of our product candidates, to the extent any are approved for commercial sale; |
|
|
|
|
● |
the
effect of competing technological and market developments; and |
|
|
|
|
● |
the
potential impact of the COVID-19 pandemic on our clinical trials and operations. |
Until
such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity
offerings, debt financings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements with third parties.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of ours
may be materially diluted, and the terms of such securities could include liquidation or other preferences that adversely affect the
rights of our stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive
covenants that limit our ability to take specified actions, such as incurring additional debt, making capital expenditures or declaring
dividends. If we raise funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third
parties, we may have to relinquish valuable rights to technologies, future revenue streams, research programs or product candidates or
grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings
or other arrangements when needed, we may be required to delay, reduce or eliminate product development or future commercialization efforts,
sell off assets, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market.
February
2023 Offering
On
February 10, 2023, we closed a public offering of common stock and certain warrants through Chardan Capital Markets, LLC and EF Hutton,
division of Benchmark Investments LLC as underwriters, for net proceeds of $13.6 million through the issuance and sale of 11,664,888
shares of our common stock and, to certain investors, pre-funded warrants to purchase 2,224,000 shares of common stock, and accompanying
common warrants to purchase up to an aggregate of 27,777,776 shares of our common stock (the “February Offering”). Each share
of common stock and pre-funded warrant to purchase one share of common stock was sold together with a common warrant to purchase two
shares of common stock. The public offering price of each share of common stock and accompanying common warrant was $1.08 and the public
offering price of each pre-funded warrant and accompanying common warrant was $1.0799. The common warrants are immediately exercisable
at a price of $1.08 per share of common stock, expire five years from the date of issuance and contain an alternative cashless exercise
provision whereby, subject to certain conditions, a warrant may be exercised in a cashless transaction for shares of common stock at
the rate of half a share of common stock per full share otherwise issuable upon a cash exercise. The pre-funded warrants are immediately
exercisable at any time, until exercised in full, at a price of $0.0001 per share of common stock. In addition, warrants to purchase
972,222 shares of common stock were issued to the underwriters as compensation for their services related to the offering. These common
stock warrants have an exercise price of $1.35 per share and expire five years from the date of issuance.
June
2023 Offering
On
June 30, 2023, the Company closed a registered direct offering of common stock (and common stock equivalents in lieu thereof) and a concurrent
private placement of certain common stock warrants through Chardan Capital Markets, LLC as placement agent, for gross proceeds of $2.3
million and net proceeds of $1.9 million through the issuance and sale of 3,660,000 shares of its common stock, pre-funded warrants to
purchase 1,340,000 shares of common stock and accompanying common warrants to purchase up to an aggregate of 5,000,000 shares of its
common stock (the “June Offering”). Each share of common stock and pre-funded warrant to purchase one share of common stock
was sold together with a common warrant to purchase one share of common stock. The effective offering price of each share of common stock
(or common stock equivalent) and accompanying common warrant was $0.45. The common stock warrants are exercisable beginning December
30, 2023 at a price of $0.6749 per share of common stock and expire three and half years from the date of issuance. The pre-funded warrants
are immediately exercisable at any time, until exercised in full, at a price of $0.0001 per share of common stock. All of the pre-funded
warrants were exercised as of June 30, 2023. In addition, warrants to purchase 150,000 shares of common stock were issued to the placement
agent as compensation for its services related to the offering. These common stock warrants have an exercise price of $0.6749 per share,
are exercisable beginning December 30, 2023 and expire three and a half years from the date of issuance.
At-the-Market
Offering of Common Stock
We
entered into an At-the-Market Sales Agreement with BTIG, LLC (“BTIG”) on August 15, 2022 (the “2022 Sales
Agreement”). Pursuant to the 2022 Sales Agreement, we may offer and sell, from time to time, through BTIG, as sales agent
and/or principal, shares of our common stock having an aggregate offering price of up to $25.0 million, subject to certain
limitations on the amount of common stock that may be offered and sold by us set forth in the 2022 Sales Agreement. Due to the
offering limitations applicable to us, we filed prospectus supplements for the sale of shares of our common stock for an aggregate
offering price of up to $7.8 million pursuant to the 2022 Sales Agreement. During the nine months ended June
30, 2023, we sold an aggregate of 3,007,429 shares of common stock pursuant to the 2022 Sales Agreement with BTIG for gross
proceeds of $5.8 million and net proceeds of $5.4 million. No shares were sold during the three months ended June 30, 2023. As of June
30, 2023, there are no registered shares remaining to be sold under the 2022 Sales Agreement.
Critical
Accounting Policies and Estimates
Our
management’s discussion and analysis of financial condition and results of operations are based on our consolidated financial statements,
which have been prepared in accordance with U.S. GAAP. The preparation of these consolidated financial statements requires us to make
estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets
and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to
the accrual for research and development expenses. We base our estimates on historical experience, known trends and events, and various
other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about
the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions.
While
our significant accounting policies are described in more detail in the notes to the unaudited interim consolidated financial statements
included elsewhere in this Form 10-Q, we believe that the following accounting policies are those most critical to the judgments and
estimates used in the preparation of the consolidated financial statements.
Research
and Development Expenses
Research
and development expenses include all direct and indirect costs associated with the development of our biopharmaceutical products. These
expenses include personnel costs, consulting fees, and payments to third parties for research, development and manufacturing services.
These costs are charged to expense as incurred.
At
the end of each reporting period, we compare payments made to third-party service providers to the estimated progress toward completion
of the related project, based on the measure of progress as defined in the contract. Factors we consider in preparing the estimates include
costs incurred by the service provider, milestones achieved, and other criteria related to the efforts of our service providers. Such
estimates are subject to change as additional information becomes available. Depending on the timing of payment to the third-party service
providers and the progress we estimate has been made as a result of the service provided, we will record a prepaid expense or accrued
liability related to these costs. Contingent development or regulatory milestone payments are recognized upon the related resolution
of such contingencies. As of June 30, 2023, we did not make any material adjustments to
our prior estimates of accrued research and development expenses.
Recently
Issued Accounting Pronouncements
A
description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations
is disclosed in Note 2 to the unaudited interim consolidated financial statements included elsewhere in this Form 10-Q.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Not
applicable.
ITEM
4. CONTROLS AND PROCEDURES.
Evaluation
of Disclosure Controls and Procedures
We
evaluated, under the supervision and with the participation of the principal executive officer and principal financial officer, the effectiveness
of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities
and Exchange Act of 1934, as amended (“Exchange Act”)) as of June 30, 2023, the end of the period covered by this report
on Form 10-Q. Based on this evaluation, our Chairman, President and Chief Executive Officer (principal executive officer) and our Chief
Financial Officer (principal financial officer) have concluded that our disclosure controls and procedures were effective at the reasonable
assurance level at June 30, 2023.
Disclosure
controls and procedures are designed to provide reasonable assurance that information required to be disclosed by us in the reports that
we file or submit under the Exchange Act (i) is recorded, processed, summarized and reported within the time periods specified in the
SEC’s rules and forms, and (ii) is accumulated and communicated to management, including the principal executive officer and principal
financial officer, as appropriate, to allow timely decisions regarding required disclosures. In designing and evaluating the disclosure
controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide
only reasonable assurance of achieving the desired control objectives. Due to the inherent limitations of control systems, not all misstatements
may be detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns
can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by
collusion of two or more people, or by management override of the control. Controls and procedures can only provide reasonable, not absolute,
assurance that the above objectives have been met.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting during the three months ended June
30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART
II - OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS.
We
are subject to various legal proceedings from time to time in the ordinary course of business, which may not be required to be disclosed
under this Item 1. For the three-month period ending June 30, 2023 covered by this Quarterly
Report, there have been no reportable legal proceedings or material developments to previously reported legal proceedings.
ITEM
1A. RISK FACTORS.
As
a smaller reporting company, we are not required to provide the information required by this item. However, we direct you to the risk
factors included in the Risk Factors section in our Annual Report on Form 10-K for the year ended September 30, 2022 filed with the Securities
and Exchange Commission on December 15, 2022.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
None.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES.
None
noted.
ITEM
4. MINE SAFETY DISCLOSURES.
Not
applicable.
ITEM
5. OTHER INFORMATION.
None.
ITEM
6: EXHIBITS.
*
XBRL (Extensible Business Reporting Language) information is furnished and not filed or a part of a registration statement or prospectus
for purposes of Sections 11 or 12 of the Securities Act, is deemed not filed for purposes of Section 18 of the Exchange Act, and otherwise
is not subject to liability under these sections.
**
Furnished, not filed.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
|
SONNET
BIOTHERAPEUTICS HOLDINGS, INC. |
|
|
|
Date:
August 14, 2023 |
By: |
/s/
Pankaj Mohan |
|
|
Pankaj
Mohan |
|
|
President
and Chief Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
|
|
By: |
/s/
Jay Cross |
|
|
Jay
Cross |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial Officer and Principal Accounting Officer) |
Exhibit 31.1
Certification
of the Chief Executive Officer
Pursuant
to 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 302 OF
THE SARBANES-OXLEY
ACT OF 2002
I, Pankaj Mohan, certify that:
1. |
I have reviewed this quarterly report on Form 10-Q for the period ended June 30, 2023 of Sonnet BioTherapeutics Holdings, Inc.; |
|
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
|
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
|
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a. |
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
|
|
|
d. |
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
a. |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
|
|
|
b. |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
|
/s/ Pankaj Mohan |
|
Pankaj Mohan |
Date: August 14, 2023 |
Chief Executive Officer |
|
(Principal Executive Officer) |
Exhibit 31.2
Certification
of the Chief Financial Officer
Pursuant
to 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 302 OF
THE SARBANES-OXLEY
ACT OF 2002
I, Jay Cross, certify that:
1. |
I have reviewed this quarterly report on Form 10-Q for the period ended June 30, 2023 of Sonnet BioTherapeutics Holdings, Inc.; |
|
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
|
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
|
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a. |
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
|
|
|
d. |
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
a. |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
|
|
|
b. |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
|
/s/ Jay Cross |
|
Jay Cross |
Date: August 14, 2023 |
Chief Financial Officer |
|
(Principal Financial Officer) |
Exhibit 32.1
CERTIFICATION
OF CHIEF EXECUTIVE OFFICER
PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF
THE SARBANES-OXLEY
ACT OF 2002
I, Pankaj Mohan, certify that:
1. |
I am the Chief Executive Officer of Sonnet BioTherapeutics Holdings, Inc. (the “Issuer”). |
|
|
2. |
Attached to this certification is the Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 (the “Report”) filed by the Issuer with the Securities Exchange Commission pursuant to Section 13(a) or 15(d) of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), which contains financial statements. |
|
|
3. |
I hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge: |
|
● |
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and |
|
|
|
|
● |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Issuer. |
August 14, 2023 |
/s/ Pankaj Mohan |
|
Pankaj Mohan |
|
Chief Executive Officer |
|
(Principal Executive Officer) |
Exhibit 32.2
CERTIFICATION
OF CHIEF FINANCIAL OFFICER
PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF
THE SARBANES-OXLEY
ACT OF 2002
I, Jay Cross, certify that:
1. |
I am the Chief Financial Officer of Sonnet BioTherapeutics Holdings, Inc. (the “Issuer”). |
|
|
2. |
Attached to this certification is the Quarterly Report on Form 10-Q for the quarter year ended June 30, 2023 (the “Report”) filed by the Issuer with the Securities Exchange Commission pursuant to Section 13(a) or 15(d) of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), which contains financial statements. |
|
|
3. |
I hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge: |
|
● |
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and |
|
|
|
|
● |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Issuer. |
August 14, 2023 |
/s/ Jay Cross |
|
Jay Cross |
|
Chief Financial Officer |
|
(Principal Financial Officer) |
v3.23.2
Cover - shares
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Jun. 30, 2023 |
Aug. 07, 2023 |
Cover [Abstract] |
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Current Fiscal Year End Date |
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Entity File Number |
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Entity Registrant Name |
SONNET
BIOTHERAPEUTICS HOLDINGS, INC.
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v3.23.2
Consolidated Balance Sheets (Unaudited) - USD ($)
|
Jun. 30, 2023 |
Sep. 30, 2022 |
Current assets: |
|
|
Cash |
$ 7,021,071
|
$ 3,052,879
|
Incentive tax receivable |
749,169
|
717,305
|
Prepaid expenses and other current assets |
1,862,683
|
1,643,743
|
Total current assets |
9,632,923
|
5,413,927
|
Property and equipment, net |
36,577
|
46,211
|
Operating lease right-of-use asset |
209,944
|
256,594
|
Deferred offering costs |
|
113,280
|
Other assets |
155,366
|
|
Total assets |
10,034,810
|
5,830,012
|
Current liabilities: |
|
|
Accounts payable |
3,024,441
|
4,752,340
|
Accrued expenses and other current liabilities |
3,315,404
|
3,193,972
|
Operating lease liability |
70,446
|
51,328
|
Deferred income |
55,882
|
166,431
|
Total current liabilities |
6,466,173
|
8,164,819
|
Operating lease liability |
150,185
|
203,912
|
Total liabilities |
6,616,358
|
8,368,731
|
Commitments and contingencies (Note 4) |
|
|
Stockholders’ equity (deficit): |
|
|
Preferred stock; $0.0001 par value: 5,000,000 shares authorized. No shares issued or outstanding |
|
|
Common stock; $0.0001 par value: 125,000,000 shares authorized; 38,389,648 and 5,544,528 issued and outstanding at June 30, 2023 and September 30, 2022 |
3,839
|
554
|
Additional paid-in capital |
109,981,627
|
88,871,786
|
Accumulated deficit |
(106,567,014)
|
(91,411,059)
|
Total stockholders’ equity (deficit) |
3,418,452
|
(2,538,719)
|
Total liabilities and stockholders’ equity (deficit) |
10,034,810
|
5,830,012
|
Related Party [Member] |
|
|
Current liabilities: |
|
|
Related-party notes payable |
|
$ 748
|
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v3.23.2
Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Jun. 30, 2023 |
Sep. 30, 2022 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
5,000,000
|
5,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
125,000,000
|
125,000,000
|
Common stock, shares issued |
38,389,648
|
5,544,528
|
Common stock, shares outstanding |
38,389,648
|
5,544,528
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.2
Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Collaboration revenue |
$ 36,850
|
$ 62,071
|
$ 110,550
|
$ 287,190
|
Operating expenses: |
|
|
|
|
Research and development |
2,409,471
|
5,648,952
|
9,972,055
|
16,320,090
|
General and administrative |
1,542,689
|
2,280,345
|
5,330,967
|
6,259,494
|
Total operating expenses |
3,952,160
|
7,929,297
|
15,303,022
|
22,579,584
|
Loss from operations |
(3,915,310)
|
(7,867,226)
|
(15,192,472)
|
(22,292,394)
|
Foreign exchange (loss) gain |
(31,432)
|
(9,794)
|
36,517
|
5,894
|
Net loss |
$ (3,946,742)
|
$ (7,877,020)
|
$ (15,155,955)
|
$ (22,286,500)
|
Per share information: |
|
|
|
|
Net loss per share, basic |
$ (0.13)
|
$ (1.82)
|
$ (0.86)
|
$ (5.17)
|
Net loss per share, diluted |
$ (0.13)
|
$ (1.82)
|
$ (0.86)
|
$ (5.17)
|
Weighted average shares outstanding, basic |
29,376,018
|
4,330,489
|
17,568,549
|
4,314,635
|
Weighted average shares outstanding, diluted |
29,376,018
|
4,330,489
|
17,568,549
|
4,314,635
|
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v3.23.2
Consolidated Statements of Changes in Stockholders' (Deficit) Equity (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balance at Sep. 30, 2021 |
$ 430
|
$ 83,948,635
|
$ (61,689,218)
|
$ 22,259,847
|
Balance, shares at Sep. 30, 2021 |
4,303,617
|
|
|
|
Share-based compensation |
|
332,075
|
|
332,075
|
Net loss |
|
|
(6,200,981)
|
(6,200,981)
|
Balance at Dec. 31, 2021 |
$ 430
|
84,280,710
|
(67,890,199)
|
16,390,941
|
Balance, shares at Dec. 31, 2021 |
4,303,617
|
|
|
|
Balance at Sep. 30, 2021 |
$ 430
|
83,948,635
|
(61,689,218)
|
22,259,847
|
Balance, shares at Sep. 30, 2021 |
4,303,617
|
|
|
|
Net loss |
|
|
|
(22,286,500)
|
Balance at Jun. 30, 2022 |
$ 462
|
84,739,461
|
(83,975,718)
|
764,205
|
Balance, shares at Jun. 30, 2022 |
4,629,278
|
|
|
|
Balance at Dec. 31, 2021 |
$ 430
|
84,280,710
|
(67,890,199)
|
16,390,941
|
Balance, shares at Dec. 31, 2021 |
4,303,617
|
|
|
|
Share-based compensation |
|
350,891
|
|
350,891
|
Net loss |
|
|
(8,208,499)
|
(8,208,499)
|
Issuance of common stock on vesting of restricted stock units |
|
|
|
|
Issuance of common stock on vesting of restricted stock units, shares |
893
|
|
|
|
Balance at Mar. 31, 2022 |
$ 430
|
84,631,601
|
(76,098,698)
|
8,533,333
|
Balance, shares at Mar. 31, 2022 |
4,304,510
|
|
|
|
Share-based compensation |
|
107,892
|
|
107,892
|
Net loss |
|
|
(7,877,020)
|
(7,877,020)
|
Issuance of common stock on vesting of restricted stock units |
$ 32
|
(32)
|
|
|
Issuance of common stock on vesting of restricted stock units, shares |
324,768
|
|
|
|
Balance at Jun. 30, 2022 |
$ 462
|
84,739,461
|
(83,975,718)
|
764,205
|
Balance, shares at Jun. 30, 2022 |
4,629,278
|
|
|
|
Balance at Sep. 30, 2022 |
$ 554
|
88,871,786
|
(91,411,059)
|
(2,538,719)
|
Balance, shares at Sep. 30, 2022 |
5,544,528
|
|
|
|
Sale of common stock, net of issuance costs |
$ 242
|
4,451,770
|
|
4,452,012
|
Sale of common stock, net of issuance costs, shares |
2,416,487
|
|
|
|
Net share settlement of warrants |
|
|
|
|
Net share settlement of warrants, shares |
3,026
|
|
|
|
Share-based compensation |
|
91,617
|
|
91,617
|
Net loss |
|
|
(5,542,142)
|
(5,542,142)
|
Balance at Dec. 31, 2022 |
$ 796
|
93,415,173
|
(96,953,201)
|
(3,537,232)
|
Balance, shares at Dec. 31, 2022 |
7,964,041
|
|
|
|
Balance at Sep. 30, 2022 |
$ 554
|
88,871,786
|
(91,411,059)
|
(2,538,719)
|
Balance, shares at Sep. 30, 2022 |
5,544,528
|
|
|
|
Net loss |
|
|
|
(15,155,955)
|
Balance at Jun. 30, 2023 |
$ 3,839
|
109,981,627
|
(106,567,014)
|
3,418,452
|
Balance, shares at Jun. 30, 2023 |
38,389,648
|
|
|
|
Balance at Dec. 31, 2022 |
$ 796
|
93,415,173
|
(96,953,201)
|
(3,537,232)
|
Balance, shares at Dec. 31, 2022 |
7,964,041
|
|
|
|
Sale of common stock, net of issuance costs |
$ 1,226
|
14,514,742
|
|
14,515,968
|
Sale of common stock, net of issuance costs, shares |
12,255,830
|
|
|
|
Net share settlement of warrants |
$ 23
|
(23)
|
|
|
Net share settlement of warrants, shares |
231,481
|
|
|
|
Share-based compensation |
|
56,998
|
|
56,998
|
Net loss |
|
|
(5,667,071)
|
(5,667,071)
|
Issuance of common stock on vesting of restricted stock units |
$ 5
|
(5)
|
|
|
Issuance of common stock on vesting of restricted stock units, shares |
47,018
|
|
|
|
Balance at Mar. 31, 2023 |
$ 2,050
|
107,986,885
|
(102,620,272)
|
5,368,663
|
Balance, shares at Mar. 31, 2023 |
20,498,370
|
|
|
|
Sale of common stock, net of issuance costs |
$ 366
|
1,945,311
|
|
1,945,677
|
Sale of common stock, net of issuance costs, shares |
3,660,000
|
|
|
|
Net share settlement of warrants |
$ 1,119
|
(1,119)
|
|
|
Net share settlement of warrants, shares |
11,194,493
|
|
|
|
Share-based compensation |
|
50,005
|
|
50,005
|
Net loss |
|
|
(3,946,742)
|
(3,946,742)
|
Issuance of common stock on vesting of restricted stock units |
|
|
|
|
Issuance of common stock on vesting of restricted stock units, shares |
785
|
|
|
|
Exercise of warrants |
$ 304
|
545
|
|
849
|
Exercise of warrants, shares |
3,036,000
|
|
|
|
Balance at Jun. 30, 2023 |
$ 3,839
|
$ 109,981,627
|
$ (106,567,014)
|
$ 3,418,452
|
Balance, shares at Jun. 30, 2023 |
38,389,648
|
|
|
|
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v3.23.2
Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
9 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Cash flows from operating activities: |
|
|
Net loss |
$ (15,155,955)
|
$ (22,286,500)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation |
9,634
|
9,634
|
Acquired in-process research and development |
282,000
|
871,877
|
Amortization of operating lease right-of-use asset |
46,650
|
65,695
|
Share-based compensation |
198,620
|
790,858
|
Change in operating assets and liabilities: |
|
|
Incentive tax receivable |
(31,864)
|
|
Prepaid expenses and other current assets |
(218,940)
|
(754,872)
|
Other assets |
(155,366)
|
|
Accounts payable |
(1,877,222)
|
(761,833)
|
Accrued expenses and other current liabilities |
264,872
|
893,728
|
Operating lease liability |
(34,609)
|
(66,991)
|
Deferred income |
(110,549)
|
(287,190)
|
Net cash used in operating activities |
(16,782,729)
|
(21,525,594)
|
Cash flows from investing activities: |
|
|
Purchase of in-process research and development |
(273,250)
|
(871,877)
|
Net cash used in investing activities |
(273,250)
|
(871,877)
|
Cash flows from financing activities: |
|
|
Proceeds from sale of common stock, net of issuance costs |
21,024,070
|
|
Proceeds from the exercise of warrants |
849
|
|
Repayments of related party note |
(748)
|
|
Net cash provided by financing activities |
21,024,171
|
|
Net increase (decrease) in cash |
3,968,192
|
(22,397,471)
|
Cash, beginning of period |
3,052,879
|
27,622,067
|
Cash, end of period |
7,021,071
|
5,224,596
|
Supplemental disclosure of non-cash operating, investing and financing activities: |
|
|
Net settlement of warrants |
1,142
|
|
Acquired in-process research and development in accounts payable |
170,000
|
|
Change in operating right-of-use asset and liability due to amended lease |
|
213,793
|
Deferred offering costs charged against proceeds from sale of common stock |
32,340
|
|
Issuance of common stock on vesting of restricted stock units |
5
|
33
|
Common stock issuance costs in accrued expenses and accounts payable |
$ 78,073
|
|
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v3.23.2
Organization and Description of Business
|
9 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization and Description of Business |
1.
Organization and Description of Business
Description
of business
Sonnet
BioTherapeutics, Inc. (“Prior Sonnet”) was incorporated as a New Jersey corporation on April 6, 2015. Prior Sonnet completed
a merger with publicly-held Chanticleer Holdings, Inc. (“Chanticleer”) on April 1, 2020. After the merger, Chanticleer changed
its name to Sonnet BioTherapeutics Holdings, Inc. (“Sonnet” or the “Company”). Sonnet is a clinical stage, oncology-focused
biotechnology company with a proprietary platform for innovating biologic medicines of single- or bi-specific action. Known as FHAB™
(Fully Human Albumin Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and “hitch-hikes”
on human serum albumin (“HSA”) for transport to target tissues.
Sonnet’s
lead proprietary asset, SON-1010, is a fully human version of Interleukin 12 (“IL-12”), covalently linked to the FHAB
construct, for which Sonnet intends to pursue clinical development in solid tumor indications, including ovarian cancer, non-small cell
lung cancer and head and neck cancer. In March 2022, the FDA cleared Sonnet’s Investigational New Drug (“IND”) application
for SON-1010. This allowed the Company to initiate a U.S. clinical trial (SB101) in oncology patients with solid tumors during the second
calendar quarter of 2022. In September 2021, the Company created a wholly-owned Australian subsidiary, SonnetBio Pty Ltd (“Subsidiary”),
for the purpose of conducting certain clinical trials. Sonnet received approval and initiated an Australian clinical study (SB102) of
SON-1010 in healthy volunteers during the third calendar quarter of 2022. Interim safety and tolerability data from the SB101 and SB102
studies were reported in April 2023.
In
January 2023, Sonnet announced a collaboration agreement with Roche for the clinical evaluation of SON-1010 with atezolizumab (Tecentriq®).
The companies have entered into a Master Clinical Trial and Supply Agreement (“MCSA”), along with ancillary Quality and Safety
Agreements, to study the safety and efficacy of the combination of SON-1010 and atezolizumab in a platinum-resistant ovarian cancer (“PROC”)
patient setting. Further, the companies will provide SON-1010 and atezolizumab, respectively, for use in the Phase 1b/Phase 2a combination
safety, dose-escalation, and efficacy study (SB221). Part 1 of this 2-part study was recently approved by the local Human Research Ethics
Committee in Australia under CT-2023-CTN-01399-1 and the Therapeutic Goods Administration has been notified. Recruitment is expected
to begin imminently. As part of the ongoing cost-cutting evaluations, all antiviral development with SON-1010 has been suspended.
The
Company acquired the global development rights to its most advanced compound, SON-080, a fully human version of Interleukin 6 (“IL-6”),
in April 2020 through its acquisition of the outstanding shares of Relief Therapeutics SA. Sonnet is advancing SON-080 in target indications
of Chemotherapy-Induced Peripheral Neuropathy (“CIPN”) and Diabetic Peripheral Neuropathy (“DPN”). Sonnet received
approval to initiate an ex-U.S. Phase 1b/2a study with SON-080 in CIPN during the third quarter of 2022. The Data Safety Monitoring Board
(DSMB) overseeing the study is expected to meet during the third quarter of 2023. Following the completion of the DSMB review, we anticipate
announcing initial safety data from the CIPN study. Pursuant to a license agreement the Company entered with New Life Therapeutics Pte,
Ltd. (“New Life”) of Singapore in May 2021, Sonnet and New Life will be jointly responsible for developing SON-080 in DPN.
The objective will be to analyze the data and to consider initiating a Phase 2 study once the CIPN safety data has been evaluated.
SON-1210
(IL12-FHAB-IL15), Sonnet’s lead bi-specific construct, combines FHAB with fully human IL-12 and fully human
Interleukin 15 (“IL-15”). This compound is being developed for solid tumor indications, including colorectal cancer. In February
2023, the Company announced the successful completion of two IND-enabling toxicology studies with SON-1210 in non-human primates. Sonnet
is prepared to initiate the regulatory authorization process for SON-1210 in 2023, subject to having a partnering opportunity in place.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
SON-1410
(IL18-FHAB-IL12) is a bi-specific combination of Interleukins 18 (“IL-18”) and 12 (IL-12) for solid tumor
cancers. Cell line development for GMP application is underway. After some delays in 2023, process development activities will
continue into 2024, with the potential to generate a drug suitable for initial in vivo mice studies during the second half of
calendar year 2024.
The
Company has completed sequence confirmation for SON-3015 (anti-IL6-FHAB-anti-TGFβ). Early stage bi-specific drug has
been generated and is being stored for future use in in vivo mice studies. Sonnet has elected to place the SON-3015 development
program on hold for expense reduction purposes.
Liquidity
The
Company has incurred recurring losses and negative cash flows from operations since inception and it expects to generate losses from
operations for the foreseeable future primarily due to research and development costs for its potential product candidates. The Company
believes its cash of $7.0 million at June 30, 2023 will fund the Company’s projected operations into 2024. Substantial
additional financing will be needed by the Company to fund its operations. These factors raise substantial doubt about the Company’s
ability to continue as a going concern. The accompanying unaudited interim consolidated financial statements have been prepared on a
going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The
unaudited interim consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
The
Company plans to secure additional capital in the future through equity or debt financings, partnerships, collaborations, or other sources
to carry out the Company’s planned development activities. If additional capital is not available when required, the Company may
need to delay or curtail its operations until such funding is received. Various internal and external factors will affect whether and
when the Company’s product candidates become approved for marketing and successful commercialization. The regulatory approval and
market acceptance of the Company’s product candidates, length of time and cost of developing and commercializing these product
candidates and/or failure of them at any stage of the approval process will materially affect the Company’s financial condition
and future operations.
Operations
since inception have consisted primarily of organizing the Company, securing financing, developing its technologies through performing
research and development and conducting preclinical studies. The Company faces risks associated with companies whose products are in
development. These risks include the need for additional financing to complete its research and development, achieving its research and
development objectives, defending its intellectual property rights, recruiting and retaining skilled personnel, and dependence on key
members of management.
|
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v3.23.2
Summary of Significant Accounting Policies
|
9 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
2.
Summary of Significant Accounting Policies
a.
Basis of presentation
The
accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting
principles (“U.S. GAAP”) for interim financial information as found in the Accounting Standards Codification (“ASC”)
and Accounting Standards Updates (ASUs”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management,
the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily
of accruals, estimates and assumptions that impact the unaudited interim consolidated financial statements) considered necessary to present
fairly the Company’s financial position as of June 30, 2023 and its results of operations for the three and nine months ended June
30, 2023 and 2022 and cash flows for the nine months ended June 30, 2023 and 2022. The unaudited interim consolidated financial statements
presented herein do not contain the required disclosures under U.S. GAAP for annual financial statements and should be read in conjunction
with the annual audited financial statements and related notes of Sonnet as of and for the year ended September 30, 2022 included in
the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2022. The results of operations for the interim
periods are not necessarily indicative of the results of operations to be expected for the full year.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
b.
Consolidation
The
unaudited interim consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany
accounts and transactions have been eliminated in consolidation.
c.
Use of estimates
The
preparation of the interim unaudited consolidated financial statements in conformity with U.S. GAAP requires management to make estimates
and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Significant estimates
and assumptions reflected in these unaudited interim consolidated financial statements include the accrual of research and development
expenses. Estimates and assumptions are periodically reviewed in-light of changes in circumstances, facts and experience. Changes in
estimates are recorded in the period in which they become known. Actual results could differ from management’s estimates.
d.
Reclassifications
Certain
amounts from the prior period have been reclassified to conform with the current period presentation.
e.
Incentive tax receivable
Subsidiary
is eligible to participate in an Australian research and development tax incentive program. As part of this program, Subsidiary is eligible
to receive a cash refund from the Australian Taxation Office for a percentage of the research and development costs expended by Subsidiary
in Australia. The cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian)
during the reimbursable period. The Company estimates the amount of cash refund it expects to receive related to the Australian research
and development tax incentive program and records the incentive when it is probable (i) the Company will comply with relevant conditions
of the program and (ii) the incentive will be received. As of June 30, 2023, the Company’s estimate of the amount of cash refund
it expects to receive for eligible spending related to the Australian research and development tax incentive program was $0.7 million.
For the three months ended June 30, 2023 and 2022, $0.3 million and $0.3 million, respectively,
for the expected net cash (payment) refund related to the tax incentive program was included as an offset to research and development
expenses. For the nine months ended June 30, 2023 and 2022, $0.8 million and $0.4 million, respectively, for the expected net
cash refund related to the tax incentive program was included in research and development expenses. In January 2023, the Company received
$1.1 million from the Australian government related to eligible research and development expenses for the year ended September 30, 2022.
In April 2023, the Company refunded the Australian government for $0.2 million due to new information on the Company’s clinical
trial studies.
R&D tax credit is an opportunity available with the State of New Jersey.
The company seeks to apply for such tax credits. There is no assurance that such tax credit could be made available.
f.
Property and equipment
Property
and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets. Expenditures
for repairs and maintenance that do not extend the estimated useful life or improve an asset are expensed as incurred. Upon retirement
or sale, the cost and related accumulated depreciation and amortization of assets disposed of are removed from the accounts, and any
resulting gain or loss is included in the consolidated statement of operations.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
g.
Collaboration revenue
Collaboration
arrangements may contain multiple components, which may include (i) licenses; (ii) research and development activities; and (iii) the
manufacturing and supply of certain materials. Payments pursuant to these arrangements may include non-refundable payments, upfront payments,
milestone payments upon the achievement of significant regulatory and development events, sales milestones and royalties on product sales.
The amount of variable consideration is constrained until it is probable that the revenue is not at a significant risk of reversal in
a future period.
In
determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under a collaboration arrangement,
the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of
whether the promised goods or services are performance obligations, including whether they are capable of being distinct; (iii) measurement
of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance
obligations; and (v) recognition of revenue as the Company satisfies each performance obligation.
The
Company applies significant judgment when evaluating whether contractual obligations represent distinct performance obligations, allocating
transaction price to performance obligations within a contract, determining when performance obligations have been met, and assessing
the recognition of variable consideration. When consideration is received prior to the Company completing its performance obligation
under the terms of a contract, a contract liability is recorded as deferred income. Deferred income expected to be recognized as revenue
within the twelve months following the balance sheet date is classified as a current liability. In May 2021, the Company entered into
a License Agreement (the “New Life Agreement”) with New Life. See Note 5 for further discussion of the New Life Agreement.
h.
Research and development expense
Research
and development expenses include all direct and indirect costs associated with the development of the Company’s biopharmaceutical
products. These expenses include personnel costs, consulting fees, and payments to third parties for research, development, and manufacturing
services. These costs are charged to expense as incurred.
At
the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward
completion of the related project, based on the measure of progress as defined in the contract. Factors the Company considers in preparing
the estimates include costs incurred by the service provider, milestones achieved, and other criteria related to the efforts of its service
providers. Such estimates are subject to change as additional information becomes available. Depending on the timing of payment to the
service providers and the progress that the Company estimates has been made as a result of the service provided, the Company will record
a prepaid expense or accrued liability relating to these costs. Upfront milestone payments made to third parties who perform research
and development services on the Company’s behalf are expensed as services are rendered. Contingent development or regulatory milestone
payments are recognized upon the related resolution of such contingencies.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
i.
Reverse stock split
On
September 16, 2022, the Company filed a Certificate of Amendment to its Certificate of Incorporation, as amended, with the Secretary
of State of the State of Delaware, which effected a 1-for-14 reverse stock split of the Company’s issued and outstanding shares
of common stock. As a result of the reverse stock split, every 14 shares of common stock issued and outstanding was converted into one
share of common stock. The reverse stock split affected all stockholders uniformly and did not alter any stockholder’s percentage
interest in the Company’s equity. No fractional shares were issued in connection with the reverse stock split. Stockholders who
would otherwise be entitled to a fractional share of common stock were instead entitled to receive a proportional cash payment. The reverse
stock split did not change the par value or authorized number of shares of common stock. All common share and per share amounts presented
in the unaudited interim consolidated financial statements and accompanying notes have been retroactively adjusted to reflect the reverse
stock split.
j.
Net loss per share
Basic
net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each
period (and potential shares of common stock that are exercisable for little or no consideration). Included in basic weighted-average
number of shares of common stock outstanding during the three and nine months ended June 30, 2023 are the pre-funded February 2023 and
June 2023 warrants with an exercise price of $0.0001 per share. Included in basic weighted-average number of shares of common stock outstanding
during the nine months ended June 30, 2023 and the three and nine months ended June 30, 2022 are the Series B warrants with an exercise
price of $0.0014 per share.
Diluted
loss per share includes the effect, if any, from the potential exercise or conversion of securities such as common stock warrants and
stock options which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average
number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities
are not included in the calculation as the impact is anti-dilutive.
The
following potentially dilutive securities have been excluded from the computation of diluted shares of common stock outstanding as they
would be anti-dilutive:
Schedule
of Potentially Dilutive Securities
| |
2023 | | |
2022 | |
| |
June
30, | |
| |
2023 | | |
2022 | |
Common
stock warrants August 2021 | |
| 2,827,708 | | |
| 2,827,708 | |
Underwriter
warrants August 2021 | |
| 50,416 | | |
| 50,416 | |
Private
warrants | |
| — | | |
| 7,549 | |
Chanticleer
warrants | |
| 1,267 | | |
| 1,267 | |
Series
C warrants | |
| 809,243 | | |
| 809,243 | |
Series
3 warrants | |
| 276,140 | | |
| — | |
Unvested
restricted stock units and awards | |
| 172,667 | | |
| 48,156 | |
Common
stock warrants February 2023 | |
| 5,981,482 | | |
| — | |
Underwriter
warrants February 2023 | |
| 972,222 | | |
| — | |
Common
stock private placement warrants June 2023 | |
| 5,000,000 | | |
| — | |
PA
warrants June 2023 | |
| 150,000 | | |
| — | |
Total
anti-dilutive weighted average shares | |
| 16,241,145 | | |
| 3,744,339 | |
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
k.
Recent accounting pronouncements
Recently
adopted
In
May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock
Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting
for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. The amendments in ASU 2021-04 provide
guidance to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified
written call options (for example, warrants) that remain equity classified after modification or exchange. The adoption of ASU 2021-04
on October 1, 2022 did not have any impact on the unaudited interim consolidated financial statements.
|
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v3.23.2
Accrued Expenses and Other Current Liabilities
|
9 Months Ended |
Jun. 30, 2023 |
Payables and Accruals [Abstract] |
|
Accrued Expenses and Other Current Liabilities |
3.
Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consisted of the following:
Schedule
of Accrued Expenses and Other Current Liabilities
| |
June
30, | | |
September
30, | |
| |
2023 | | |
2022 | |
Compensation
and benefits | |
$ | 2,137,223 | | |
$ | 1,218,530 | |
Research
and development | |
| 854,280 | | |
| 1,593,922 | |
Professional
fees | |
| 321,396 | | |
| 378,890 | |
Other | |
| 2,505 | | |
| 2,630 | |
Accrued
expenses and other current liabilities | |
$ | 3,315,404 | | |
$ | 3,193,972 | |
|
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- DefinitionThe entire disclosure for accounts payable, accrued expenses, and other liabilities that are classified as current at the end of the reporting period.
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v3.23.2
Commitments and Contingencies
|
9 Months Ended |
Jun. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
4.
Commitments and Contingencies
Legal
proceedings
From
time to time, the Company is a party to various lawsuits, claims, and other legal proceedings that arise in the ordinary course of its
business. While the outcomes of these matters are uncertain, management does not expect that the ultimate costs to resolve these matters
will have a material adverse effect on the Company’s consolidated financial position, results of operations, or cash flows.
License
agreements
In
July 2012, the Company entered into a Discovery Collaboration Agreement (the “Collaboration Agreement”) with XOMA (US) LLC
(“XOMA”), pursuant to which XOMA granted to the Company a non-exclusive, non-transferable license and/or right to use certain
materials, technologies and related information related to discovery, optimization and development of antibodies and related proteins
and to develop and commercialize products thereunder. The Company is obligated to make contingent milestone payments to XOMA totaling
$3.8 million on a product-by-product basis upon the achievement of certain development and approval milestones related to a product.
The Company has also agreed to pay XOMA low single-digit royalties on net sales of products sold by the Company. Royalties on each product
are payable on a country-by-country basis until the later of (i) a specified period of time after the first commercial sale, and (ii)
the date of expiration of the last valid claim in the last-to-expire of the issued patents covered by the Collaboration Agreement. The
first milestone was achieved in April 2022, at which time the Company incurred a $0.5 million license fee which was recorded as acquired
in-process research and development.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
In
August 2015, the Company entered into a License Agreement (the “ARES License Agreement”) with Ares Trading, a wholly-owned
subsidiary of Merck KGaA (“ARES”). Under the terms of the ARES License Agreement, ARES has granted the Company a sublicensable,
exclusive, worldwide, royalty-bearing license on proprietary patents to research, develop, use and commercialize products using atexakin
alfa (“Atexakin”), a low dose formulation of human IL-6 in peripheral neuropathies and vascular complications. Pursuant to
the ARES License Agreement, the Company will pay ARES high single-digit royalties on net sales of products sold by the Company. Royalties
are payable on a product-by-product and country-by-country basis until the later of (i) a specified period of time after the first commercial
sale in such country, and (ii) the last date on which such product is covered by a valid claim in such country.
In
January 2019, the Company entered into a Frame Services and License Agreement (the “Cellca Agreement”) with Sartorius Stedim
Cellca GMBH (“Cellca”), pursuant to which Cellca has granted the Company a worldwide, non-exclusive, perpetual, non-transferable
license to develop, manufacture or have manufactured, use, sell, import, export and/or otherwise commercialize product based on Cellca’s
work to generate a specified transfected cell line and develop an upstream production process for such cell line. The Cellca Agreement
is effective unless terminated by either party by giving six months notice, or by giving 14 days notice if terminated for good cause.
The Company is obligated to make milestone payments to Cellca totaling up to $0.7 million upon the achievement of certain development
and approval milestones if the Buy-Out Option is not exercised. The Company has a Buy-Out Option that will be effective between the time
of completion of a clinical trial and the receipt of regulatory approval for commercialization of product. The cost to exercise the Buy-Out
Option increases on each anniversary of the commencement date of the Buy-Out Option Period, and ranges from $0.1 million to $0.6 million.
The cost to exercise the Buy-Out Option will replace the $0.6 million contingent milestone payment due upon final regulatory approval.
The first milestone was achieved in April 2022, at which time the Company incurred a $0.1 million license fee which was recorded as acquired
in-process research and development.
In
October 2021, the Company entered into a Non-Exclusive License Agreement (the “Brink Agreement”) with Brink Biologics Inc.
(“Brink”), pursuant to which Brink has granted the Company a non-exclusive, non-transferable license and limited right to
sublicense certain materials and related information to develop cell-based assays for batch, quality control, stability, efficacy, potency
or any other type of assay required for production and commercialization of products. During the product development phase, the Company
was obligated to make annual product development license fee payments of approximately $0.1 million. In April 2023, the Brink Agreement
was amended, effective November 2022, to reduce the annual license fee payments to $12,000 for storage. If materials are removed from
storage during the product development phase, the annual product development license fee of approximately $0.1 million will apply. If
a product achieves commercial status, the Company is obligated to make a commercial product license fee payment of approximately $0.1
million per commercial product. The amended agreement has an initial term of one year and will automatically renew for one additional
year unless terminated or converted to a product development license. After the second year, the license will automatically convert to
a full license requiring a product development or a commercial product license fee unless the parties mutually agree to terminate the
agreement. The Company incurred $12,000 in license fees during the nine months ended June 30, 2023,
which was recorded as acquired in-process research and development and included in research and development expenses in the unaudited
interim consolidated statement of operations. The Company incurred a $0.1 million
license fee which was recorded as acquired in-process research and development and included in research and development expenses in the
unaudited interim consolidated statement of operations for the nine months ended June 30, 2022.
In
February 2022, the Company entered into a Biological Materials License Agreement (the “InvivoGen Agreement”) with InvivoGen
SAS (“InvivoGen”), pursuant to which InvivoGen has granted the Company a worldwide, non-exclusive license to use certain
reporter cells for research, development and/or quality control purposes. The InvivoGen Agreement has an initial term of three years
and may be extended for two additional three-year periods upon written notice by the Company and payment of an approximately €0.1
million fee per extension (approximately $0.1 million as of June 30, 2023). No
license fees were incurred during the three and nine months ended June 30, 2023. The Company incurred a $0.1 million license fee
which was recorded as acquired in-process research and development and included in research and development expenses in the unaudited
interim consolidated statements of operations for the three and nine months ended June 30, 2022.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
In
March 2022, the Company entered into a Material Transfer and License Agreement (the “ProteoNic Agreement”) with ProteoNic
B.V. (“ProteoNic”), pursuant to which ProteoNic has granted to the Company a non-exclusive, non-transferable, non-sublicensable
(except as provided for in the ProteoNic Agreement) license for certain materials, including plasmids and DNA sequences used to generate
the vectors used in the Company’s cell lines, for the Company’s use in research, development and commercialization of product.
The license will continue until terminated by either party. The Company incurred a $24,600 license fee upon obtaining the license. The
Company is obligated to make contingent milestone payments to ProteoNic totaling up to €1.2 million (approximately $1.3 million
as of June 30, 2023) upon the achievement of certain development and commercialization milestones as outlined in the ProteoNic Agreement.
No license fees were incurred during the three and nine months ended June 30, 2023 or 2022.
Research
and development agreement
In
December 2021, the Company entered into a Research and Development Agreement (the “Navigo Agreement”) with Navigo Proteins
GmbH (“Navigo”), pursuant to which Navigo will perform specified evaluation and development procedures to evaluate certain
materials to determine their commercial potential. Under the terms of the Navigo Agreement, the Company has granted Navigo a royalty-free,
non-exclusive, worldwide, non-sublicensable, non-transferable right and license to use certain technology to perform the evaluation and
development activities, and Navigo has granted the Company (i) an exclusive, worldwide, perpetual, irrevocable, sublicensable, transferable,
royalty-free right and license to research, develop, use, sell, have sold, distribute, import or otherwise commercially exploit certain
materials, and (ii) a non-exclusive, worldwide, perpetual, sublicensable, non-transferable right and license to make or have made such
materials. The Company incurred a $0.1 million technology access fee upon execution of the Navigo Agreement, at which time it was recorded
as acquired in-process research and development. The Company is obligated to make contingent milestone payments to Navigo, as amended
in March 2023, totaling up to $1.0 million upon the achievement of certain evaluation and development milestones as outlined in the Navigo
Agreement. The first milestone was achieved in December 2022, at which time the Company incurred
a $0.1 million license fee which was recorded as acquired in-process research and development
and included as research and development expenses in the unaudited interim consolidated statement of operations for the nine months ended
June 30, 2023. The remaining evaluation milestones were achieved in April 2023, at which time the Company incurred $0.2 million which
was recorded as acquired in-process research and development and included as research and development expenses in the unaudited interim
consolidated statement of operations for the three months ended June 30, 2023.
Employment
agreements
The
Company has entered into employment contracts with its officers and certain employees that provide for severance and continuation of
benefits in the event of termination of employment either by the Company without cause or by the employee for good reason, both as defined
in the contract. In addition, in the event of termination of employment following a change in control, as defined, either by the Company
without cause or by the employee for good reason, any unvested portion of the employee’s initial stock option grant becomes immediately
vested.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
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v3.23.2
Collaboration Revenue
|
9 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Collaboration Revenue |
5.
Collaboration Revenue
Under
the New Life Agreement, the Company granted New Life an exclusive license (with the right to sublicense) to develop and commercialize
pharmaceutical preparations containing a specific recombinant human IL-6, SON-080 (the “Compound”) (such preparations, the
“Products”) for the prevention, treatment or palliation of diabetic peripheral neuropathy in humans (the “DPN Field”)
in Malaysia, Singapore, Indonesia, Thailand, Philippines, Vietnam, Brunei, Myanmar, Lao PDR and Cambodia (the “Exclusive Territory”).
New Life had the option to expand (1) the field of the exclusive license to include the prevention, treatment or palliation of chemotherapy-induced
peripheral neuropathy in humans (the “CIPN Field”), which option was non-exclusive and expired on December 31, 2021; and/or
(2) the territorial scope of the license to include the People’s Republic of China, Hong Kong and/or India, which option was exclusive
and expired on December 31, 2021.
The
Company will retain all rights to manufacture Compounds and Products anywhere in the world. The Company and New Life shall enter into
a follow-on supply agreement pursuant to which the Company shall supply to New Life Products for development and commercialization thereof
in the DPN Field in the Exclusive Territory on terms to be negotiated by the parties. The Company will also assist in transferring certain
preclinical and clinical development know-how that is instrumental in New Life’s ability to benefit from the license.
New
Life will bear the cost of, and be responsible for, among other things, conducting clinical studies and additional non-clinical studies
and other developmental and regulatory activities for and commercializing Products in the DPN Field in the Exclusive Territory.
New
Life paid the Company a $0.5 million non-refundable upfront cash payment in August 2020 upon executing a letter of intent to negotiate
a license agreement and a $0.5 million non-refundable upfront cash payment in June 2021 in connection with the execution of the New Life
Agreement. New Life is also obligated to pay a non-refundable deferred license fee of an additional $1.0 million at the time of the satisfaction
of certain milestones, as well as potential additional milestone payments to the Company of up to $19.0 million subject to the achievement
of certain development and commercialization milestones. In addition, during the Royalty Term (as defined below), New Life is obligated
to pay the Company tiered double-digit royalties ranging from 12% to 30% based on annual net sales of Products in the Exclusive Territory.
The “Royalty Term” means, on a Product-by-Product and a country-by-country basis in the Exclusive Territory, the period commencing
on the date of the first commercial sale (subject to certain conditions) of such Product in such country in the Exclusive Territory and
continuing until New Life ceases commercialization of such Product in the DIPN Field.
The
New Life Agreement will remain in effect on a Product-by-Product, country-by-country basis and will expire upon the expiration of the
Royalty Term for the last-to-expire Product in the last-to-expire country, subject to (i) each party’s early termination rights
including for material breach or insolvency or bankruptcy of the other party and (ii) the Company’s Buy Back Right and New Life’s
Give Back Right (as defined below).
In
addition, New Life granted to the Company an exclusive option to buy back the rights granted by the Company to New Life and the Company
granted New Life the right to give back the rights with respect to Products in the DPN Field in one or more countries in the Exclusive
Territory on terms to be agreed upon, which options will expire upon the initiation of a Phase III Trial for the applicable Product.
Revenue
recognition
The
Company first assessed the New Life Agreement under ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether
the New Life Agreement or units of accounts within the New Life Agreement represent a collaborative arrangement based on the risks and
rewards and activities of the parties. The Company applied relevant guidance from ASC 606, Revenue from Contracts with Customers
(“ASC 606”), to evaluate the appropriate accounting for the collaborative arrangement with New Life. In accordance with this
guidance, the Company identified the following obligations under the arrangement: (i) License to develop, market, import, use and commercialize
the Product in the Field in the Exclusive Territory (the “License”); and (ii) transfer of know-how and clinical development
and regulatory activities (“R&D Activities”). The options to expand the CIPN Field and territory as well as the future
supply agreement represent optional purchases, which are accounted for as separate contracts. The Company evaluated these separate contracts
and did not identify any material right to be present. The Company determined that License and the R&D services are not distinct
from each other and therefore combined these material promises into a single performance obligation.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
The
Company determined the initial transaction price of the single performance obligation to be $1.0 million, as the future development and
commercialization milestones, which represent variable consideration, are subject to constraint at inception. At the end of each subsequent
reporting period, the Company will reevaluate the probability of achievement of the future development and commercialization milestones
subject to constraint and, if necessary, will adjust its estimate of the overall transaction price. Any such adjustments will be recorded
on a cumulative catch-up basis. For the sales-based royalties, the Company will recognize revenue when the related sales occur.
Collaboration
revenue from the single performance obligation is being recognized over the estimated performance of the R&D services. The Company
recognized $36,850 and $0.1 million of collaboration revenue for the three and nine months ended June
30, 2023, respectively. The Company recognized $0.1 million and $0.3 million of collaboration revenue for the three and nine months
ended June 30, 2022, respectively.
|
X |
- DefinitionThe entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants.
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v3.23.2
Stockholders’ Equity (Deficit)
|
9 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Stockholders’ Equity (Deficit) |
6.
Stockholders’ Equity (Deficit)
The
Company entered into an At-the-Market Sales Agreement with BTIG, LLC (“BTIG”) on August 15, 2022 (the “2022 Sales
Agreement”). Pursuant to the 2022 Sales Agreement, the Company may offer and sell, from time to time, through BTIG, as sales
agent and/or principal, shares of its common stock having an aggregate offering price of up to $25.0
million, subject to certain limitations on the amount of common stock that may be offered and sold by the Company set forth in the
2022 Sales Agreement. Due to the offering limitations applicable to the Company, the Company filed prospectus supplements for the
sale of shares of its common stock for an aggregate offering price of up to $7.8
million pursuant to the 2022 Sales Agreement. During the nine months ended June 30,
2023, the Company sold an aggregate of 3,007,429
shares of common stock pursuant to the 2022 Sales Agreement with BTIG for gross proceeds of $5.8
million and net proceeds of $5.4
million. No shares were sold during the three months ended June 30, 2023. As of June
30, 2023, there are no registered shares remaining to be sold under the 2022 Sales Agreement.
On
February 10, 2023, the Company closed a public offering of common stock and certain warrants through Chardan Capital Markets, LLC and
EF Hutton, division of Benchmark Investments LLC as underwriters, for gross proceeds of $15.0 million and net proceeds of $13.6 million
through the issuance and sale of 11,664,888 shares of its common stock and, to certain investors, pre-funded warrants to purchase 2,224,000
shares of common stock, and accompanying common warrants to purchase up to an aggregate of 27,777,776 shares of its common stock (the
“February Offering”). Each share of common stock and pre-funded warrant to purchase one share of common stock was sold together
with a common warrant to purchase two shares of common stock. The public offering price of each share of common stock and accompanying
common warrant was $1.08 and the public offering price of each pre-funded warrant and accompanying common warrant was $1.0799.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
The
common stock warrants are immediately exercisable at a price of $1.08 per share of common stock, expire five years from the date of issuance
and contain an alternative cashless exercise provision whereby, subject to certain conditions, a warrant may be exercised in a cashless
transaction for shares of common stock at the rate of half a share of common stock per full share otherwise issuable upon a cash exercise.
The pre-funded warrants are immediately exercisable at any time, until exercised in full, at a price of $0.0001 per share of common stock.
In
addition, warrants to purchase 972,222 shares of common stock were issued to the underwriters as compensation for their services related
to the offering. These common stock warrants have an exercise price of $1.35 per share and expire five years from the date of issuance.
On
June 30, 2023, the Company closed a registered direct offering of common stock (and common stock equivalents in lieu thereof) and a concurrent
private placement of certain common stock warrants through Chardan Capital Markets, LLC as placement agent, for gross proceeds of $2.3
million and net proceeds of $1.9 million through the issuance and sale of 3,660,000 shares of its common stock, pre-funded warrants to
purchase 1,340,000 shares of common stock and accompanying common warrants to purchase up to an aggregate of 5,000,000 shares of its
common stock (the “June Offering”). Each share of common stock and pre-funded warrant to purchase one share of common stock
was sold together with a common warrant to purchase one share of common stock. The effective offering price of each share of common stock
(or common stock equivalent) and accompanying common warrant was $0.45.
The
common stock warrants are exercisable beginning December 30, 2023 at a price of $0.6749 per share of common stock and expire three and
half years from the date of issuance. The pre-funded warrants are immediately exercisable at any time, until exercised in full, at a
price of $0.0001 per share of common stock. All of the pre-funded warrants were exercised as of June 30, 2023.
In
addition, warrants to purchase 150,000 shares of common stock were issued to the placement agent as compensation for its services related
to the offering. These common stock warrants have an exercise price of $0.6749 per share, are exercisable beginning December 30, 2023
and expire three and a half years from the date of issuance.
Common
stock warrants
As
of June 30, 2023, the following equity-classified warrants and related terms were outstanding:
Schedule
of Warrants Outstanding
| |
Warrants
Outstanding | | |
Exercise
Price | | |
Expiration
Date |
Common
stock warrants August 2021 | |
| 2,827,708 | | |
$ | 11.90 | | |
August
24, 2024 |
Underwriter
warrants August 2021 | |
| 50,416 | | |
$ | 14.875 | | |
August
19, 2024 |
Chanticleer
warrants | |
| 1,267 | | |
$ | 819.00
- $ 1,274.00 | | |
April
30, 2027 - December 17, 2028 |
Series
C warrants | |
| 809,243 | | |
$ | 44.66 | | |
October
16, 2025 |
Series
3 warrants | |
| 276,140 | | |
$ | 4.074 | | |
August
15, 2027 |
Common
stock warrants February 2023 | |
| 5,981,482 | | |
$ | 1.08 | | |
February
10, 2028 |
Underwriter
warrants February 2023 | |
| 972,222 | | |
$ | 1.35 | | |
February
8, 2028 |
Common
stock private placement warrants June 2023 | |
| 5,000,000 | | |
$ | 0.6749 | | |
December
30, 2026 |
PA
warrants June 2023 | |
| 150,000 | | |
$ | 0.6749 | | |
December
30, 2026 |
| |
| 16,068,478 | | |
| | | |
|
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
During
the three months ended June 30, 2023, 21,861,332 of common stock warrants were net share settled, resulting in the issuance of 11,194,493
shares of common stock.
During
the nine months ended June 30, 2023, 22,324,294 of common
stock warrants were net share settled, resulting in the issuance of 11,425,974 shares of common
stock.
During
the three and nine months ended June 30, 2023, 3,036,000 of the pre-funded warrants were exercised on a cash basis. The Company received
de minimus proceeds in exchange for the issuance of 3,036,000 shares of common stock.
During
the nine months ended June 30, 2023, 3,026 of Series
B warrants were net share settled, resulting in the issuance of 3,026 shares of common stock.
During
the nine months ended June 30, 2023, 7,549 of
private warrants expired.
|
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- DefinitionThe entire disclosure for equity.
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v3.23.2
Share-Based Compensation
|
9 Months Ended |
Jun. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Share-Based Compensation |
7.
Share-Based Compensation
In
April 2020, the Company adopted the 2020 Omnibus Equity Incentive Plan (the “Plan”). On
January 1, 2023, the total number of shares authorized under the Plan increased to 318,561. There were 318,561 shares available
for issuance under the Plan as of June 30, 2023. The Plan increases the amount of shares issuable under the Plan by four percent
of the outstanding shares of common stock at each January 1, each year. The Plan permits the granting of share-based awards, including
stock options, restricted stock units and awards, stock appreciation rights and other types of awards as deemed appropriate, in each
case, in accordance with the terms of the Plan. The terms of the awards are determined by the Company’s Board of Directors.
Restricted
stock units
In
July of 2020, 46,703 restricted stock units (“RSUs”) were granted, 50% of which vested on April 2, 2021 and the remaining
50% vested on April 2, 2022. In March of 2021, an additional 3,357 RSUs were granted, 50% of which vested on March 25, 2022 and the remaining
50% vested on March 25, 2023. In December of 2021, 46,478 RSUs were granted, 100% of which vested on January 1, 2023. In December of
2022, 172,672 RSUs were granted, 100% of which vest on January 1, 2024.
In
January 2023, 121,366 of the RSUs granted in December 2022 were cancelled and subsequently reissued as restricted shares of the Company’s
common stock (“Restricted Stock Awards” or “RSAs”). The
RSAs have the same vesting conditions as the original RSUs issued in December 2022. The Company accounted for this as a stock
compensation modification resulting in $38,837 of incremental expense which will be recognized over the remaining vesting period.
Any
unvested RSUs or RSAs will be forfeited upon termination of services. The fair value of an RSU or RSA is equal to the fair market value
of the Company’s common stock on the date of grant. RSU and RSA expense is amortized straight-line over the vesting period.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
The
Company recorded share-based compensation expense associated with the RSUs and RSAs in its accompanying unaudited interim consolidated
statements of operations as follows:
Schedule
of Share-based Compensation Expense
| |
Three
Months Ended | | |
Nine
Months Ended | | |
Three
Months Ended | | |
Nine
Months Ended | |
| |
June
30, 2023 | | |
June
30, 2023 | | |
June
30, 2022 | | |
June
30, 2022 | |
Research
and development | |
$ | 24,554 | | |
$ | 102,807 | | |
$ | 64,476 | | |
$ | 394,558 | |
General
and administrative | |
| 25,451 | | |
| 95,813 | | |
| 43,416 | | |
| 396,300 | |
Share
Based Compensation | |
$ | 50,005 | | |
$ | 198,620 | | |
$ | 107,892 | | |
$ | 790,858 | |
The
following table summarizes RSU activity under the Plan:
Schedule
of Restricted Stock Units Activity
| |
RSU | | |
Weighted
Average Grant Date Fair Value | |
Unvested
balance at October 1, 2022 | |
| 47,798 | | |
$ | 7.89 | |
Granted | |
| 172,672 | | |
$ | 0.98 | |
Vested | |
| (47,803 | ) | |
$ | 0.57 | |
Forfeited/cancelled | |
| (121,366 | ) | |
$ | 0.97 | |
Unvested
balance at June 30, 2023 | |
| 51,301 | | |
$ | 0.54 | |
As
of June 30, 2023, total unrecognized compensation expense relating to unvested RSUs granted
was $24,389, which is expected to be recognized over a weighted-average period of less than one
year.
The
following table summarizes RSA activity under the Plan:
Schedule
of Restricted Stock Awards Activity
| |
RSA | | |
Weighted
Average Grant Date Fair Value | |
Unvested
balance at October 1, 2022 | |
| — | | |
$ | — | |
Granted | |
| 121,366 | | |
$ | 1.29 | |
Vested | |
| — | | |
$ | — | |
Forfeited/cancelled | |
| — | | |
$ | — | |
Unvested
balance at June 30, 2023 | |
| 121,366 | | |
$ | 1.29 | |
As
of June 30, 2023, total unrecognized compensation expense relating to unvested RSUs granted
was $75,623, which is expected to be recognized over a weighted-average period of less than one
year.
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.2
Income Taxes
|
9 Months Ended |
Jun. 30, 2023 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
8.
Income Taxes
In
August 2022, the U.S. enacted the Inflation Reduction Act of 2022 (“IRA”). The IRA contains a number of tax-related provisions
that will be effective for tax years beginning after December 31, 2022, including a corporate alternative minimum tax of 15% on certain
large corporations and an excise tax of 1% on corporate stock repurchases. The Company is currently evaluating the various provisions
of the IRA and does not anticipate a material impact on its consolidated financial statements.
|
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v3.23.2
Subsequent Events
|
9 Months Ended |
Jun. 30, 2023 |
Subsequent Events [Abstract] |
|
Subsequent Events |
9.
Subsequent Events
The
Company has evaluated subsequent events from the balance sheet date through the date the unaudited interim consolidated financial statements
were available to be issued.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.23.2
Summary of Significant Accounting Policies (Policies)
|
9 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of presentation |
a.
Basis of presentation
The
accompanying unaudited interim consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting
principles (“U.S. GAAP”) for interim financial information as found in the Accounting Standards Codification (“ASC”)
and Accounting Standards Updates (ASUs”) of the Financial Accounting Standards Board (“FASB”). In the opinion of management,
the accompanying unaudited interim consolidated financial statements include all normal and recurring adjustments (which consist primarily
of accruals, estimates and assumptions that impact the unaudited interim consolidated financial statements) considered necessary to present
fairly the Company’s financial position as of June 30, 2023 and its results of operations for the three and nine months ended June
30, 2023 and 2022 and cash flows for the nine months ended June 30, 2023 and 2022. The unaudited interim consolidated financial statements
presented herein do not contain the required disclosures under U.S. GAAP for annual financial statements and should be read in conjunction
with the annual audited financial statements and related notes of Sonnet as of and for the year ended September 30, 2022 included in
the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2022. The results of operations for the interim
periods are not necessarily indicative of the results of operations to be expected for the full year.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
|
Consolidation |
b.
Consolidation
The
unaudited interim consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany
accounts and transactions have been eliminated in consolidation.
|
Use of estimates |
c.
Use of estimates
The
preparation of the interim unaudited consolidated financial statements in conformity with U.S. GAAP requires management to make estimates
and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Significant estimates
and assumptions reflected in these unaudited interim consolidated financial statements include the accrual of research and development
expenses. Estimates and assumptions are periodically reviewed in-light of changes in circumstances, facts and experience. Changes in
estimates are recorded in the period in which they become known. Actual results could differ from management’s estimates.
|
Reclassifications |
d.
Reclassifications
Certain
amounts from the prior period have been reclassified to conform with the current period presentation.
|
Incentive tax receivable |
e.
Incentive tax receivable
Subsidiary
is eligible to participate in an Australian research and development tax incentive program. As part of this program, Subsidiary is eligible
to receive a cash refund from the Australian Taxation Office for a percentage of the research and development costs expended by Subsidiary
in Australia. The cash refund is available to eligible companies with annual aggregate revenues of less than $20.0 million (Australian)
during the reimbursable period. The Company estimates the amount of cash refund it expects to receive related to the Australian research
and development tax incentive program and records the incentive when it is probable (i) the Company will comply with relevant conditions
of the program and (ii) the incentive will be received. As of June 30, 2023, the Company’s estimate of the amount of cash refund
it expects to receive for eligible spending related to the Australian research and development tax incentive program was $0.7 million.
For the three months ended June 30, 2023 and 2022, $0.3 million and $0.3 million, respectively,
for the expected net cash (payment) refund related to the tax incentive program was included as an offset to research and development
expenses. For the nine months ended June 30, 2023 and 2022, $0.8 million and $0.4 million, respectively, for the expected net
cash refund related to the tax incentive program was included in research and development expenses. In January 2023, the Company received
$1.1 million from the Australian government related to eligible research and development expenses for the year ended September 30, 2022.
In April 2023, the Company refunded the Australian government for $0.2 million due to new information on the Company’s clinical
trial studies.
R&D tax credit is an opportunity available with the State of New Jersey.
The company seeks to apply for such tax credits. There is no assurance that such tax credit could be made available.
|
Property and equipment |
f.
Property and equipment
Property
and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets. Expenditures
for repairs and maintenance that do not extend the estimated useful life or improve an asset are expensed as incurred. Upon retirement
or sale, the cost and related accumulated depreciation and amortization of assets disposed of are removed from the accounts, and any
resulting gain or loss is included in the consolidated statement of operations.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
|
Collaboration revenue |
g.
Collaboration revenue
Collaboration
arrangements may contain multiple components, which may include (i) licenses; (ii) research and development activities; and (iii) the
manufacturing and supply of certain materials. Payments pursuant to these arrangements may include non-refundable payments, upfront payments,
milestone payments upon the achievement of significant regulatory and development events, sales milestones and royalties on product sales.
The amount of variable consideration is constrained until it is probable that the revenue is not at a significant risk of reversal in
a future period.
In
determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under a collaboration arrangement,
the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of
whether the promised goods or services are performance obligations, including whether they are capable of being distinct; (iii) measurement
of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance
obligations; and (v) recognition of revenue as the Company satisfies each performance obligation.
The
Company applies significant judgment when evaluating whether contractual obligations represent distinct performance obligations, allocating
transaction price to performance obligations within a contract, determining when performance obligations have been met, and assessing
the recognition of variable consideration. When consideration is received prior to the Company completing its performance obligation
under the terms of a contract, a contract liability is recorded as deferred income. Deferred income expected to be recognized as revenue
within the twelve months following the balance sheet date is classified as a current liability. In May 2021, the Company entered into
a License Agreement (the “New Life Agreement”) with New Life. See Note 5 for further discussion of the New Life Agreement.
|
Research and development expense |
h.
Research and development expense
Research
and development expenses include all direct and indirect costs associated with the development of the Company’s biopharmaceutical
products. These expenses include personnel costs, consulting fees, and payments to third parties for research, development, and manufacturing
services. These costs are charged to expense as incurred.
At
the end of the reporting period, the Company compares payments made to third-party service providers to the estimated progress toward
completion of the related project, based on the measure of progress as defined in the contract. Factors the Company considers in preparing
the estimates include costs incurred by the service provider, milestones achieved, and other criteria related to the efforts of its service
providers. Such estimates are subject to change as additional information becomes available. Depending on the timing of payment to the
service providers and the progress that the Company estimates has been made as a result of the service provided, the Company will record
a prepaid expense or accrued liability relating to these costs. Upfront milestone payments made to third parties who perform research
and development services on the Company’s behalf are expensed as services are rendered. Contingent development or regulatory milestone
payments are recognized upon the related resolution of such contingencies.
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
|
Reverse stock split |
i.
Reverse stock split
On
September 16, 2022, the Company filed a Certificate of Amendment to its Certificate of Incorporation, as amended, with the Secretary
of State of the State of Delaware, which effected a 1-for-14 reverse stock split of the Company’s issued and outstanding shares
of common stock. As a result of the reverse stock split, every 14 shares of common stock issued and outstanding was converted into one
share of common stock. The reverse stock split affected all stockholders uniformly and did not alter any stockholder’s percentage
interest in the Company’s equity. No fractional shares were issued in connection with the reverse stock split. Stockholders who
would otherwise be entitled to a fractional share of common stock were instead entitled to receive a proportional cash payment. The reverse
stock split did not change the par value or authorized number of shares of common stock. All common share and per share amounts presented
in the unaudited interim consolidated financial statements and accompanying notes have been retroactively adjusted to reflect the reverse
stock split.
|
Net loss per share |
j.
Net loss per share
Basic
net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each
period (and potential shares of common stock that are exercisable for little or no consideration). Included in basic weighted-average
number of shares of common stock outstanding during the three and nine months ended June 30, 2023 are the pre-funded February 2023 and
June 2023 warrants with an exercise price of $0.0001 per share. Included in basic weighted-average number of shares of common stock outstanding
during the nine months ended June 30, 2023 and the three and nine months ended June 30, 2022 are the Series B warrants with an exercise
price of $0.0014 per share.
Diluted
loss per share includes the effect, if any, from the potential exercise or conversion of securities such as common stock warrants and
stock options which would result in the issuance of incremental shares of common stock. For diluted net loss per share, the weighted-average
number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities
are not included in the calculation as the impact is anti-dilutive.
The
following potentially dilutive securities have been excluded from the computation of diluted shares of common stock outstanding as they
would be anti-dilutive:
Schedule
of Potentially Dilutive Securities
| |
2023 | | |
2022 | |
| |
June
30, | |
| |
2023 | | |
2022 | |
Common
stock warrants August 2021 | |
| 2,827,708 | | |
| 2,827,708 | |
Underwriter
warrants August 2021 | |
| 50,416 | | |
| 50,416 | |
Private
warrants | |
| — | | |
| 7,549 | |
Chanticleer
warrants | |
| 1,267 | | |
| 1,267 | |
Series
C warrants | |
| 809,243 | | |
| 809,243 | |
Series
3 warrants | |
| 276,140 | | |
| — | |
Unvested
restricted stock units and awards | |
| 172,667 | | |
| 48,156 | |
Common
stock warrants February 2023 | |
| 5,981,482 | | |
| — | |
Underwriter
warrants February 2023 | |
| 972,222 | | |
| — | |
Common
stock private placement warrants June 2023 | |
| 5,000,000 | | |
| — | |
PA
warrants June 2023 | |
| 150,000 | | |
| — | |
Total
anti-dilutive weighted average shares | |
| 16,241,145 | | |
| 3,744,339 | |
Sonnet
BioTherapeutics Holdings, Inc.
Notes
to Unaudited Interim Consolidated Financial Statements
|
Recent accounting pronouncements |
k.
Recent accounting pronouncements
Recently
adopted
In
May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock
Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting
for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. The amendments in ASU 2021-04 provide
guidance to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified
written call options (for example, warrants) that remain equity classified after modification or exchange. The adoption of ASU 2021-04
on October 1, 2022 did not have any impact on the unaudited interim consolidated financial statements.
|
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v3.23.2
Summary of Significant Accounting Policies (Tables)
|
9 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Schedule of Potentially Dilutive Securities |
The
following potentially dilutive securities have been excluded from the computation of diluted shares of common stock outstanding as they
would be anti-dilutive:
Schedule
of Potentially Dilutive Securities
| |
2023 | | |
2022 | |
| |
June
30, | |
| |
2023 | | |
2022 | |
Common
stock warrants August 2021 | |
| 2,827,708 | | |
| 2,827,708 | |
Underwriter
warrants August 2021 | |
| 50,416 | | |
| 50,416 | |
Private
warrants | |
| — | | |
| 7,549 | |
Chanticleer
warrants | |
| 1,267 | | |
| 1,267 | |
Series
C warrants | |
| 809,243 | | |
| 809,243 | |
Series
3 warrants | |
| 276,140 | | |
| — | |
Unvested
restricted stock units and awards | |
| 172,667 | | |
| 48,156 | |
Common
stock warrants February 2023 | |
| 5,981,482 | | |
| — | |
Underwriter
warrants February 2023 | |
| 972,222 | | |
| — | |
Common
stock private placement warrants June 2023 | |
| 5,000,000 | | |
| — | |
PA
warrants June 2023 | |
| 150,000 | | |
| — | |
Total
anti-dilutive weighted average shares | |
| 16,241,145 | | |
| 3,744,339 | |
|
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v3.23.2
Accrued Expenses and Other Current Liabilities (Tables)
|
9 Months Ended |
Jun. 30, 2023 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued Expenses and Other Current Liabilities |
Accrued
expenses and other current liabilities consisted of the following:
Schedule
of Accrued Expenses and Other Current Liabilities
| |
June
30, | | |
September
30, | |
| |
2023 | | |
2022 | |
Compensation
and benefits | |
$ | 2,137,223 | | |
$ | 1,218,530 | |
Research
and development | |
| 854,280 | | |
| 1,593,922 | |
Professional
fees | |
| 321,396 | | |
| 378,890 | |
Other | |
| 2,505 | | |
| 2,630 | |
Accrued
expenses and other current liabilities | |
$ | 3,315,404 | | |
$ | 3,193,972 | |
|
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v3.23.2
Stockholders’ Equity (Deficit) (Tables)
|
9 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Schedule of Warrants Outstanding |
As
of June 30, 2023, the following equity-classified warrants and related terms were outstanding:
Schedule
of Warrants Outstanding
| |
Warrants
Outstanding | | |
Exercise
Price | | |
Expiration
Date |
Common
stock warrants August 2021 | |
| 2,827,708 | | |
$ | 11.90 | | |
August
24, 2024 |
Underwriter
warrants August 2021 | |
| 50,416 | | |
$ | 14.875 | | |
August
19, 2024 |
Chanticleer
warrants | |
| 1,267 | | |
$ | 819.00
- $ 1,274.00 | | |
April
30, 2027 - December 17, 2028 |
Series
C warrants | |
| 809,243 | | |
$ | 44.66 | | |
October
16, 2025 |
Series
3 warrants | |
| 276,140 | | |
$ | 4.074 | | |
August
15, 2027 |
Common
stock warrants February 2023 | |
| 5,981,482 | | |
$ | 1.08 | | |
February
10, 2028 |
Underwriter
warrants February 2023 | |
| 972,222 | | |
$ | 1.35 | | |
February
8, 2028 |
Common
stock private placement warrants June 2023 | |
| 5,000,000 | | |
$ | 0.6749 | | |
December
30, 2026 |
PA
warrants June 2023 | |
| 150,000 | | |
$ | 0.6749 | | |
December
30, 2026 |
| |
| 16,068,478 | | |
| | | |
|
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v3.23.2
Share-Based Compensation (Tables)
|
9 Months Ended |
Jun. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Share-based Compensation Expense |
The
Company recorded share-based compensation expense associated with the RSUs and RSAs in its accompanying unaudited interim consolidated
statements of operations as follows:
Schedule
of Share-based Compensation Expense
| |
Three
Months Ended | | |
Nine
Months Ended | | |
Three
Months Ended | | |
Nine
Months Ended | |
| |
June
30, 2023 | | |
June
30, 2023 | | |
June
30, 2022 | | |
June
30, 2022 | |
Research
and development | |
$ | 24,554 | | |
$ | 102,807 | | |
$ | 64,476 | | |
$ | 394,558 | |
General
and administrative | |
| 25,451 | | |
| 95,813 | | |
| 43,416 | | |
| 396,300 | |
Share
Based Compensation | |
$ | 50,005 | | |
$ | 198,620 | | |
$ | 107,892 | | |
$ | 790,858 | |
|
Schedule of Restricted Stock Units Activity |
The
following table summarizes RSU activity under the Plan:
Schedule
of Restricted Stock Units Activity
| |
RSU | | |
Weighted
Average Grant Date Fair Value | |
Unvested
balance at October 1, 2022 | |
| 47,798 | | |
$ | 7.89 | |
Granted | |
| 172,672 | | |
$ | 0.98 | |
Vested | |
| (47,803 | ) | |
$ | 0.57 | |
Forfeited/cancelled | |
| (121,366 | ) | |
$ | 0.97 | |
Unvested
balance at June 30, 2023 | |
| 51,301 | | |
$ | 0.54 | |
|
Schedule of Restricted Stock Awards Activity |
The
following table summarizes RSA activity under the Plan:
Schedule
of Restricted Stock Awards Activity
| |
RSA | | |
Weighted
Average Grant Date Fair Value | |
Unvested
balance at October 1, 2022 | |
| — | | |
$ | — | |
Granted | |
| 121,366 | | |
$ | 1.29 | |
Vested | |
| — | | |
$ | — | |
Forfeited/cancelled | |
| — | | |
$ | — | |
Unvested
balance at June 30, 2023 | |
| 121,366 | | |
$ | 1.29 | |
|
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v3.23.2
Schedule of Potentially Dilutive Securities (Details) - shares
|
9 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
16,241,145
|
3,744,339
|
Common Stock Warrants August 2021 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
2,827,708
|
2,827,708
|
Underwriter Warrants August 2021 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
50,416
|
50,416
|
Private Warrants [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
|
7,549
|
Chanticleer Warrants [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
1,267
|
1,267
|
Series C Warrants [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
809,243
|
809,243
|
Series 3 Warrants [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
276,140
|
|
Unvested Restricted Stock Units and Awards [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
172,667
|
48,156
|
Common Stock Warrants February 2023 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
5,981,482
|
|
Underwriter Warrants February 2023 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
972,222
|
|
Common Stock Private Placement Warrants June 2023 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
5,000,000
|
|
PA Warrants June 2023 [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total anti-dilutive weighted average shares |
150,000
|
|
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Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($)
|
Jun. 30, 2023 |
Sep. 30, 2022 |
Payables and Accruals [Abstract] |
|
|
Compensation and benefits |
$ 2,137,223
|
$ 1,218,530
|
Research and development |
854,280
|
1,593,922
|
Professional fees |
321,396
|
378,890
|
Other |
2,505
|
2,630
|
Accrued expenses and other current liabilities |
$ 3,315,404
|
$ 3,193,972
|
X |
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v3.23.2
Commitments and Contingencies (Details Narrative) € in Millions |
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
|
|
Apr. 30, 2023
USD ($)
|
Apr. 30, 2022
USD ($)
|
Mar. 31, 2022
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022
USD ($)
|
Jun. 30, 2023
EUR (€)
|
Mar. 31, 2023
USD ($)
|
Jan. 31, 2019
USD ($)
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
Payment to acquire in process research and development |
|
|
|
|
|
$ 273,250
|
$ 871,877
|
|
|
|
Research and development expense |
|
|
|
$ 2,409,471
|
$ 5,648,952
|
9,972,055
|
16,320,090
|
|
|
|
Discovery Collaboration Agreements [Member] | XOMA [Member] |
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
|
3,800,000
|
|
$ 3,800,000
|
|
|
|
|
Discovery Collaboration Agreements [Member] | XOMA [Member] | In Process Research and Development [Member] |
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
Annual license fee |
|
$ 500,000
|
|
|
|
|
|
|
|
|
Cellca Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
Description of milestone payments |
|
|
|
|
|
The Company is obligated to make milestone payments to Cellca totaling up to $0.7 million upon the achievement of certain development
and approval milestones if the Buy-Out Option is not exercised.
|
|
|
|
|
Cellca Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
|
|
|
|
|
|
|
$ 700,000
|
The Cellca Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
|
600,000
|
|
$ 600,000
|
|
|
|
|
The Cellca Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
Payment for annual license fee obligation |
|
|
|
600,000
|
|
600,000
|
|
|
|
|
The Cellca Agreement [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
Payment for annual license fee obligation |
|
|
|
100,000
|
|
100,000
|
|
|
|
|
The Cellca Agreement [Member] | In Process Research and Development [Member] |
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
Commercial product license fee payment obligation |
|
$ 100,000
|
|
|
|
|
|
|
|
|
The Brink Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
Commercial product license fee payment obligation |
|
|
|
100,000
|
|
100,000
|
|
|
|
|
Payment of annual license fee |
|
|
|
12,000
|
|
12,000
|
|
|
|
|
The Brink Agreement [Member] | In Process Research and Development [Member] |
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
Annual license fee |
|
|
|
|
|
12,000
|
100,000
|
|
|
|
Commercial product license fee payment obligation |
|
|
|
100,000
|
|
100,000
|
|
|
|
|
Invivo Gen Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
Annual license fee |
|
|
|
0
|
|
0
|
|
|
|
|
Payment for annual license fee obligation |
|
|
|
100,000
|
|
100,000
|
|
€ 0.1
|
|
|
Invivo Gen Agreement [Member] | In Process Research and Development [Member] |
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
Annual license fee |
|
|
|
|
100,000
|
|
100,000
|
|
|
|
Proteo Nic Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
|
1,300,000
|
|
1,300,000
|
|
€ 1.2
|
|
|
Annual license fee |
|
|
|
$ 0
|
$ 0
|
0
|
$ 0
|
|
|
|
Proteo Nic Agreement [Member] | In Process Research and Development [Member] |
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
Annual license fee |
|
|
$ 24,600
|
|
|
|
|
|
|
|
Navigo Agreement [Member] | Navigo Proteins GmbH [Member] | Technology Service [Member] |
|
|
|
|
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
|
|
|
|
Milestone payments |
|
|
|
|
|
|
|
|
$ 1,000,000.0
|
|
Payment to acquire in process research and development |
|
|
|
|
|
100,000
|
|
|
|
|
Research and development expense |
|
|
|
|
|
$ 100,000
|
|
|
|
|
Milestone payment |
$ 200,000
|
|
|
|
|
|
|
|
|
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v3.23.2
Collaboration Revenue (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
9 Months Ended |
Jun. 30, 2021 |
Aug. 31, 2020 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Collavorative arrangement right and obligation |
|
|
|
|
New Life is also obligated to pay a non-refundable deferred license fee of an additional $1.0 million at the time of the satisfaction
of certain milestones, as well as potential additional milestone payments to the Company of up to $19.0 million subject to the achievement
of certain development and commercialization milestones. In addition, during the Royalty Term (as defined below), New Life is obligated
to pay the Company tiered double-digit royalties ranging from 12% to 30% based on annual net sales of Products in the Exclusive Territory.
The “Royalty Term” means, on a Product-by-Product and a country-by-country basis in the Exclusive Territory, the period commencing
on the date of the first commercial sale (subject to certain conditions) of such Product in such country in the Exclusive Territory and
continuing until New Life ceases commercialization of such Product in the DIPN Field.
|
|
Performance obligation |
|
|
|
|
$ 1,000,000.0
|
|
Collaboration revenue |
|
|
$ 36,850
|
$ 100,000
|
100,000
|
$ 300,000
|
License Agreement [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Proceeds for negotiate license agreement |
|
$ 500,000
|
|
|
|
|
New Life Agreement [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Proceeds for negotiate license agreement |
$ 500,000
|
|
|
|
|
|
Future milestone payments |
|
|
1,000,000.0
|
|
1,000,000.0
|
|
Milestone payments |
|
|
$ 19,000,000.0
|
|
$ 19,000,000.0
|
|
New Life Agreement [Member] | Minimum [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Royalties, percentage |
|
|
12.00%
|
|
12.00%
|
|
New Life Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Royalties, percentage |
|
|
30.00%
|
|
30.00%
|
|
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v3.23.2
Schedule of Warrants Outstanding (Details)
|
Jun. 30, 2023
$ / shares
shares
|
Common Stock Warrants August 2021 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
2,827,708
|
Exercise Price | $ / shares |
$ 11.90
|
Expiration date |
Aug. 24, 2024
|
Underwriter Warrants August 2021 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
50,416
|
Exercise Price | $ / shares |
$ 14.875
|
Expiration date |
Aug. 19, 2024
|
Chanticleer Warrants [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
1,267
|
Chanticleer Warrants [Member] | Minimum [Member] |
|
Class of Warrant or Right [Line Items] |
|
Exercise Price | $ / shares |
$ 819.00
|
Expiration date |
Apr. 30, 2027
|
Chanticleer Warrants [Member] | Maximum [Member] |
|
Class of Warrant or Right [Line Items] |
|
Exercise Price | $ / shares |
$ 1,274.00
|
Expiration date |
Dec. 17, 2028
|
Series C Warrants [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
809,243
|
Exercise Price | $ / shares |
$ 44.66
|
Expiration date |
Oct. 16, 2025
|
Series 3 Warrants [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
276,140
|
Exercise Price | $ / shares |
$ 4.074
|
Expiration date |
Aug. 15, 2027
|
Common Stock Warrants February 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
5,981,482
|
Exercise Price | $ / shares |
$ 1.08
|
Expiration date |
Feb. 10, 2028
|
Underwriter Warrants February 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
972,222
|
Exercise Price | $ / shares |
$ 1.35
|
Expiration date |
Feb. 08, 2028
|
Common Stock Private Placement Warrants June 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
5,000,000
|
Exercise Price | $ / shares |
$ 0.6749
|
Expiration date |
Dec. 30, 2026
|
PA Warrants June 2023 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
150,000
|
Exercise Price | $ / shares |
$ 0.6749
|
Expiration date |
Dec. 30, 2026
|
Warrant [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of warrants, outstanding | shares |
16,068,478
|
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v3.23.2
Stockholders’ Equity (Deficit) (Details Narrative) - USD ($)
|
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
9 Months Ended |
|
Jun. 30, 2023 |
Feb. 10, 2023 |
Aug. 15, 2022 |
Jun. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Dec. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 30, 2023 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Offering price for common stock |
|
|
|
|
$ 1,945,677
|
$ 14,515,968
|
$ 4,452,012
|
|
|
|
|
Number of shares sold |
|
|
|
|
0
|
|
|
|
|
|
|
Proceeds from sale of common stock |
|
|
|
|
|
|
|
|
$ 21,024,070
|
|
|
Private warrants expired |
|
|
|
|
|
|
|
|
7,549
|
|
|
Series B Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Net share settlement of warrants, shares |
|
|
|
|
|
|
|
|
3,026
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Offering price for common stock |
|
|
|
|
$ 366
|
$ 1,226
|
$ 242
|
|
|
|
|
Sale of common stock, net of issuance costs, shares |
|
|
|
|
3,660,000
|
12,255,830
|
2,416,487
|
|
|
|
|
Net share settlement of warrants, shares |
|
|
|
|
11,194,493
|
231,481
|
3,026
|
|
|
|
|
Common Stock [Member] | Series B Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Sale of common stock, net of issuance costs, shares |
|
|
|
|
|
|
|
|
3,026
|
|
|
Prefunded Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Sale of common stock, net of issuance costs, shares |
|
|
|
|
3,036,000
|
|
|
|
3,036,000
|
|
|
Warrants exercised |
|
|
|
|
3,036,000
|
|
|
|
3,036,000
|
|
|
Common Stock Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Sale of common stock, net of issuance costs, shares |
|
|
|
|
11,194,493
|
|
|
|
11,425,974
|
|
|
Net share settlement of warrants, shares |
|
|
|
|
21,861,332
|
|
|
|
22,324,294
|
|
|
Chardan Capital Markets LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Sale of common stock, net of issuance costs, shares |
3,660,000
|
|
|
|
|
|
|
|
|
|
|
Purchase of warrants |
5,000,000
|
|
|
5,000,000
|
5,000,000
|
|
|
5,000,000
|
5,000,000
|
|
|
Exercisable price |
$ 0.45
|
|
|
$ 0.45
|
$ 0.45
|
|
|
$ 0.45
|
$ 0.45
|
|
|
Proceeds from issuance of private placement |
|
|
|
$ 2,300,000
|
|
|
|
$ 1,900,000
|
|
|
|
2022 Sales Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Offering price for common stock |
|
|
$ 7,800,000
|
|
|
|
|
|
|
|
|
Gross proceeds from sale agreement |
|
$ 15,000,000.0
|
|
|
|
|
|
|
|
|
|
Proceeds from sale of common stock |
|
$ 13,600,000
|
|
|
|
|
|
|
|
|
|
2022 Sales Agreement [Member] | Underwriter Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Purchase of warrants |
150,000
|
972,222
|
|
150,000
|
150,000
|
|
|
150,000
|
150,000
|
|
|
Exercisable price |
|
$ 1.35
|
|
|
|
|
|
|
|
|
|
2022 Sales Agreement [Member] | Underwriter Warrants [Member] | Forecast [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Exercisable price |
|
|
|
|
|
|
|
|
|
|
$ 0.6749
|
2022 Sales Agreement [Member] | Common Stock [Member] | Investors [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Sale of common stock, net of issuance costs, shares |
|
11,664,888
|
|
|
|
|
|
|
|
|
|
2022 Sales Agreement [Member] | Prefunded Warrant [Member] | Investors [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Purchase of warrants |
|
2,224,000
|
|
|
|
|
|
|
|
|
|
Exercisable price |
|
$ 0.0001
|
|
|
|
|
|
|
|
|
|
Share price |
|
$ 1.0799
|
|
|
|
|
|
|
|
|
|
2022 Sales Agreement [Member] | Prefunded Warrant [Member] | Chardan Capital Markets LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Purchase of warrants |
1,340,000
|
|
|
1,340,000
|
1,340,000
|
|
|
1,340,000
|
1,340,000
|
|
|
2022 Sales Agreement [Member] | Common Warrant [Member] | Investors [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Purchase of warrants |
|
27,777,776
|
|
|
|
|
|
|
|
|
|
Exercisable price |
|
$ 1.08
|
|
|
|
|
|
|
|
|
|
2022 Sales Agreement [Member] | Common Warrant [Member] | Chardan Capital Markets LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Exercisable price |
$ 0.0001
|
|
|
$ 0.0001
|
$ 0.0001
|
|
|
$ 0.0001
|
$ 0.0001
|
|
|
2022 Sales Agreement [Member] | Common Warrant [Member] | Chardan Capital Markets LLC [Member] | Forecast [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Exercisable price |
|
|
|
|
|
|
|
|
|
|
$ 0.6749
|
2022 Sales Agreement [Member] | BTIG LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Offering price for common stock |
|
|
$ 25,000,000.0
|
|
|
|
|
|
|
|
|
Number of shares sold |
|
|
|
|
|
|
|
|
3,007,429
|
|
|
Gross proceeds from sale agreement |
|
|
|
|
|
|
|
|
$ 5,800,000
|
|
|
Proceeds from sale of common stock |
|
|
|
|
|
|
|
|
$ 5,400,000
|
|
|
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v3.23.2
Schedule of Share-based Compensation Expense (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Share Based Compensation |
$ 50,005
|
$ 107,892
|
$ 198,620
|
$ 790,858
|
Restricted Stock Units (RSUs) [Member] | Research and Development Expense [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Share Based Compensation |
24,554
|
64,476
|
102,807
|
394,558
|
Restricted Stock Units (RSUs) [Member] | General and Administrative Expense [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Share Based Compensation |
$ 25,451
|
$ 43,416
|
$ 95,813
|
$ 396,300
|
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v3.23.2
Schedule of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs) [Member]
|
9 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Unvested beginning balance | shares |
47,798
|
Unvested weighted average grant fair value, beginning balance | $ / shares |
$ 7.89
|
Restricted stock unit, granted | shares |
172,672
|
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$ 0.98
|
Restricted stock unit, Vested | shares |
(47,803)
|
Weighted average grant fair value, Vested | $ / shares |
$ 0.57
|
Restricted stock unit, Forfeited/cancelled | shares |
(121,366)
|
Weighted average grant fair value, Forfeited/cancelled | $ / shares |
$ 0.97
|
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51,301
|
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$ 0.54
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v3.23.2
Schedule of Restricted Stock Awards Activity (Details) - Restricted Stock Awards (RSA) [Member]
|
9 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Unvested beginning balance | shares |
|
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|
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121,366
|
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$ 1.29
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|
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|
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|
Weighted average grant fair value, Forfeited/cancelled | $ / shares |
|
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121,366
|
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$ 1.29
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v3.23.2
Share-Based Compensation (Details Narrative) - USD ($)
|
1 Months Ended |
9 Months Ended |
|
Jan. 31, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Mar. 31, 2021 |
Jul. 31, 2020 |
Jun. 30, 2023 |
Jan. 01, 2023 |
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
Restricted stock units and vesting rights, description |
|
In December of
2022, 172,672 RSUs were granted, 100% of which vest on January 1, 2024.
|
In December of 2021, 46,478 RSUs were granted, 100% of which vested on January 1, 2023.
|
In March of 2021, an additional 3,357 RSUs were granted, 50% of which vested on March 25, 2022 and the remaining
50% vested on March 25, 2023.
|
In
July of 2020, 46,703 restricted stock units (“RSUs”) were granted, 50% of which vested on April 2, 2021 and the remaining
50% vested on April 2, 2022.
|
|
|
Number of shares granted |
|
172,672
|
46,478
|
3,357
|
46,703
|
|
|
Restricted stock, shares issued |
121,366
|
|
|
|
|
|
|
Stock compensation modification, incremental expense |
$ 38,837
|
|
|
|
|
|
|
Unrecognized compensation expense |
|
|
|
|
|
$ 24,389
|
|
Restricted Stock Units (RSUs) [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
Weighted average period |
|
|
|
|
|
1 year
|
|
Restricted Stock Awards (RSA) [Member] |
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
Unrecognized compensation expense |
|
|
|
|
|
$ 75,623
|
|
Restricted Stock Awards (RSA) [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
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|
|
|
|
|
1 year
|
|
2020 Omnibus Equity Incentive Plan [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
Number of shares available for issuance |
|
|
|
|
|
318,561
|
318,561
|
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Sonnet BioTherapeutics (NASDAQ:SONN)
過去 株価チャート
から 4 2024 まで 5 2024
Sonnet BioTherapeutics (NASDAQ:SONN)
過去 株価チャート
から 5 2023 まで 5 2024