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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section
13 or 15(d)
of the Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported): May 7, 2024
PROTAGONIST THERAPEUTICS, INC.
(Exact name of registrant as specified
in its charter)
Delaware |
|
001-37852 |
|
98-0505495 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
Protagonist Therapeutics, Inc.
7707 Gateway Blvd., Suite 140
Newark, California 94560-1160
(Address of principal executive offices,
including zip code)
(510) 474-0170
(Registrant’s telephone number, including
area code)
Not Applicable
(Former name or former address, if changed
since last report.)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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 $0.00001 |
|
PTGX |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ¨
Item 2.02. Results of Operations
and Financial Condition.
On May 7, 2024, Protagonist Therapeutics, Inc.
reported its financial results for the first quarter ended March 31, 2024. A copy of the press release titled “Protagonist
Reports First Quarter 2024 Financial Results and Provides Corporate Update” is furnished pursuant to Item 2.02 as Exhibit 99.1
hereto and is incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits.
(d) Exhibits
The information in this report, including the exhibit hereto, shall
not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise
subject to the liabilities of Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein
and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission
made by Protagonist Therapeutics, Inc., whether made before or after the date hereof, regardless of any general incorporation language
in such filing.
SIGNATURE
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 hereunto duly authorized.
|
Protagonist Therapeutics, Inc. |
Dated:
May 7, 2024 |
|
|
By: |
/s/
Asif Ali |
|
|
Asif Ali |
|
|
Chief Financial Officer |
Exhibit 99.1
Protagonist Reports First Quarter 2024 Financial
Results and Provides Corporate Update
Entered into a worldwide license and
collaboration agreement for rusfertide with Takeda; Cash runway extended through Q4 20271
Enrollment in both Phase 3 ICONIC LEAD and ICONIC
TOTAL trials of JNJ-2113 in patients with moderate to severe psoriasis is now complete
Data
from the Phase 2b FRONTIER 2, a 52-week long term extension study of JNJ-2113 presented at the American
Academy of Dermatology 2024 Annual Meeting in March
Expect to nominate a development candidate from
oral IL-17 program by end of 2024
Two articles published in the New England Journal
of Medicine reporting results from the Phase 2b FRONTIER 1 study with JNJ-2113 and the Phase 2 REVIVE study with rusfertide
NEWARK,
Calif., May 7, 2024 – Protagonist Therapeutics (Nasdaq: PTGX) (“Protagonist” or
“the Company”) today reported financial results for the first quarter ended March 31, 2024, and provided a corporate
update.
“The
first quarter of 2024 was an extremely busy and productive time for Protagonist,” said Dinesh V. Patel, Ph.D., the Company’s
President and CEO. “We announced a transformational partnership with Takeda to develop and commercialize rusfertide that allows
us to reinvest in our core competency in peptide therapeutics and expand our efforts to create a new pipeline of potential blockbusters
and highly differentiated development candidates. We expect to nominate
an oral IL-17 antagonist development candidate this year from our
internal discovery efforts.”
Dr. Patel continued: “We are
very pleased with our continued collaboration with Johnson & Johnson and their efforts to position JNJ-2113 as a centerpiece
of its immunology franchise with completion of the two Phase 3 trials in psoriasis expected by the end of the year. The Phase 2 results
recently featured in New England Journal of Medicine and the 52-week long-term extension data presented at the American Academy of Dermatology
conference show that JNJ-2113, the first and only targeted oral IL-23 receptor antagonist (IL23Ri) peptide, maintained skin clearance
in moderate-to-severe plaque psoriasis patients through one year and has the potential to be a best-in-class oral agent for psoriasis.
We look forward to its continued and expanded assessment across the spectrum of other IL-23-mediated diseases, including the results from
the Phase 2b ANTHEM study in ulcerative colitis.”
1 Based on Cash, Cash Equivalents and Marketable Securities
as of March 31, 2024, and including the $300m upfront payment received from the worldwide collaboration agreement with Takeda Pharmaceuticals
in April 2024, but excluding all future milestones expected with respect to JNJ-2113 and rusfertide.
First
Quarter 2023 Recent Developments and Upcoming Milestones
Rusfertide:
Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood
Disorders
| · | On January 31, 2024, the Company and Takeda announced a worldwide license and collaboration
agreement for rusfertide. The Company received an upfront cash payment of $300 million in April 2024 and is eligible
to receive up to $330 million in development, regulatory, and sales milestones, for a potential deal value of up to $630 million,
as well as an equal share of profits and losses in the United States and royalties on net sales outside the U.S. |
| · | Under the terms of the agreement, Protagonist has the right to opt-out of the 50:50 profit share. In that event, the company would
be eligible to receive additional cash payments of up to $400 million and enhanced milestones of up to $975 million, as well as royalties
on worldwide net sales. Takeda would maintain full ex-U.S. rights under either scenario. |
| · | On February 21, 2024, the complete Phase 2 REVIVE trial results, including efficacy and
safety, were published in the New England Journal of Medicine. |
| · | The Company expects to announce top-line data for the VERIFY study’s
32-week primary efficacy endpoint by the end of the first quarter of 2025. |
JNJ-2113:
Oral IL-23 Receptor Antagonist
| · | On February 7, 2024, the JNJ-2113 Phase
2b FRONTIER 1 trial results in adults living with moderate-to-severe plaque psoriasis were
published in the New England Journal of Medicine. |
| · | On March 11, 2024, the JNJ-2113 Phase 2b
FRONTIER 2 long term extension study results in adults living with moderate-to-severe plaque psoriasis were presented as a late breaking
oral presentation at the American Academy of Dermatology (AAD) 2024 Annual Meeting. The results demonstrated sustained efficacy and similar
safety results from Week 16 to Week 52, consistent with the previously reported FRONTIER 1 16-week Phase 2b study. |
| · | The Phase 3 ICONIC LEAD and ICONIC TOTAL studies, which began in Q4 of 2023
and have a 16-week primary endpoint assessment, have now completed enrollment.2 |
| · | The Phase 3 ICONIC ADVANCE 1 and ICONIC ADVANCE 2 studies, evaluating the
safety and efficacy of JNJ-2113 compared with both placebo and deucravacitinib, began in Q1 2024, and are anticipated to be completed
in Q1 20253. |
| · | The Phase
2b ANTHEM multicenter, randomized, placebo- controlled, dose-ranging study of JNJ-2113 for the treatment of moderately to severely active
ulcerative colitis continues to enroll, with an estimated completion date of Q2 20254. |
2
ICONIC-LEAD (NCT06095115) and ICONIC-TOTAL (NCT06095102)
3
ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604)
4
ANTHEM (NCT06049017)
Discovery Programs
| · | Protagonist announced an oral IL-17 discovery program in January 2024
with a development candidate expected to be announced by end of 2024. |
| · | The company is pursuing the discovery of novel oral peptides against various
clinically validated biological targets in hematology, inflammation, and immunomodulatory and metabolic diseases. |
First Quarter 2024 Financial Results
| · | Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents
and marketable securities as of March 31, 2024, were $322.6 million as compared to $341.6 million as of December 31, 2023. |
| |
Three Months Ended | |
| |
March 31, | |
(in thousands, except per share amounts) | |
2024 | |
2023 | |
License and collaboration revenue | |
$ | 254,953 | |
$ | - | |
Research and development expense | |
$ | 33,734 | |
$ | 27,416 | |
General and administrative expense | |
$ | 14,910 | |
$ | 8,605 | |
Net income (loss) | |
$ | 207,340 | |
$ | (33,725 | ) |
Basic earnings (loss) per share | |
$ | 3.41 | |
$ | (0.67 | ) |
Diluted earnings (loss) per share | |
$ | 3.26 | |
$ | (0.67 | ) |
| · | License and Collaboration Revenue: License and collaboration revenue of $255.0 million for March 31, 2024 consisted of:
(i) $254.1 million of the $300.0 million transaction price for the Takeda Collaboration Agreement allocated to the rusfertide license
delivered to Takeda upon effectiveness of the agreement on March 15, 2024, and (ii) $0.9 million allocated to development services
provided by us under the agreement during the last two weeks of March 2024. |
| · | Research and Development ("R&D") Expenses: The increase in R&D expenses from the prior year was primarily
due to an increase in rusfertide expenses related to the Phase 3 VERIFY clinical trial and an increase in pre-clinical and drug discovery
research expenses. |
| · | General and Administrative ("G&A") Expenses: The increase in G&A expenses from the prior year was primarily
due to $4.6 million in advisory and legal fees related to the Takeda collaboration and increases in stock-based compensation and other
personnel-related expenses. |
| · | Income Tax Expense: Income tax expense of $3.3 million for the three months ended March 31, 2024, consisted of tax related
to the upfront payment earned under the Takeda collaboration agreement. |
| · | Net Income (Loss): Net income was $207.3 million, or $3.41 per basic share and $3.26 per diluted share, for the first quarter
of 2024 as compared to a net loss of ($33.7) million, or ($0.67) per basic and diluted share, for the first quarter of 2023. |
About Protagonist
Protagonist
Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235)
in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and JNJ scientists
jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with JNJ and
followed it through IND-enabling pre-clinical and Phase 1 studies, with JNJ assuming responsibility for further clinical development.
Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development
program. The randomized portion of the Phase 2 REVIVE study was unblinded, showing positive results
and is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing.
Rusfertide will be
co-developed and co-commercialized with Takeda pursuant to a worldwide collaboration and license agreement with Takeda entered into in
January 2024 and became effective in March 2024. More information on Protagonist, its
pipeline drug candidates and clinical studies can be found on the Company's website at www.protagonist-inc.com.
Cautionary Note
on Forward-Looking Statements
This press release contains forward-looking
statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements
include statements regarding the potential benefits of JNJ-2113 and rusfertide, the timing of JNJ-2113 and rusfertide clinical trials,
and timing of developments in our discovery programs. In some cases, you can identify these statements by forward-looking words such as
"anticipate," "believe," "may," "will," "expect," or the negative or plural of these
words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties
that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to
develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen
and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory
approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that
have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates.
Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities
and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on
Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of
future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which
we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements
that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking
statements, whether as a result of new information, future events or otherwise, after the date of this press release.
Investor
Relations Contact
Corey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com
+1 212 915 2577
| Media Relations Contact
Virginia Amann
ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061
|
PROTAGONIST THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(Amounts in thousands except share and per share
data)
| |
Three Months Ended | |
| |
March 31, | |
| |
2024 | | |
2023 | |
License and collaboration revenue | |
$ | 254,953 | | |
$ | - | |
Operating expenses: | |
| | | |
| | |
Research and development (1) | |
| 33,734 | | |
| 27,416 | |
General and administrative (1) | |
| 14,910 | | |
| 8,605 | |
Total operating expenses | |
| 48,644 | | |
| 36,021 | |
Income (loss) from operations | |
| 206,309 | | |
| (36,021 | ) |
Interest income | |
| 4,376 | | |
| 2,491 | |
Other expense, net | |
| (19 | ) | |
| (195 | ) |
Income (loss) before income tax expense | |
| 210,666 | | |
| (33,725 | ) |
Income tax expense | |
| (3,326 | ) | |
| - | |
Net income (loss) | |
$ | 207,340 | | |
$ | (33,725 | ) |
Net income (loss) per share, basic | |
$ | 3.41 | | |
$ | (0.67 | ) |
Net income (loss) per share, diluted | |
$ | 3.26 | | |
$ | (0.67 | ) |
Weighted-average shares used to compute net income (loss) per share, basic | |
| 60,855,689 | | |
| 50,573,650 | |
Weighted-average shares used to compute net income (loss) per share, diluted | |
| 63,595,328 | | |
| 50,573,650 | |
(1) Amount
includes non-cash stock-based compensation expense.
PROTAGONIST THERAPEUTICS, INC.
Stock-based Compensation
(In thousands)
| |
Three Months Ended | |
| |
March 31, | |
| |
2024 | | |
2023 | |
Research and development | |
$ | 5,288 | | |
$ | 4,582 | |
General and administrative | |
| 4,064 | | |
| 3,002 | |
Total stock-based compensation expense | |
$ | 9,352 | | |
$ | 7,584 | |
PROTAGONIST THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
(In thousands)
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
Cash, cash equivalents and marketable securities | |
$ | 322,635 | | |
$ | 341,617 | |
Receivable from collaboration partner | |
| 300,043 | | |
| 10,000 | |
Working capital | |
| 587,643 | | |
| 334,303 | |
Total assets | |
| 629,276 | | |
| 357,951 | |
Accumulated deficit | |
| (408,370 | ) | |
| (615,710 | ) |
Total stockholders' equity | |
| 560,444 | | |
| 336,677 | |
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Protagonist Therapeutics (NASDAQ:PTGX)
過去 株価チャート
から 4 2024 まで 5 2024
Protagonist Therapeutics (NASDAQ:PTGX)
過去 株価チャート
から 5 2023 まで 5 2024