Applied Molecular Transport Reports Second Quarter 2020 Financial Results
2020年8月12日 - 5:00AM
Applied Molecular Transport (Nasdaq: AMTI), a clinical-stage
biopharmaceutical company, today reported financial results for the
second quarter ended June 30, 2020.
“As we expected, 2020 has been a transformational year with the
successful execution of our initial public offering, the
appointment of key executives, the generation of important clinical
data for our lead product candidate AMT-101, and the advancement of
AMT-101 into a comprehensive Phase 2 clinical program during the
second half of this year,” said Tahir Mahmood, Ph.D., chief
executive officer and co-founder of AMT. “The AMT-101 Phase 1a/b
clinical data are a compelling validation of our technology
platform as an engine for developing differentiated oral biologics
product candidates including peptides, proteins, antibodies and RNA
therapeutics.”
Recent Business Highlights
|
• |
Completed a successful initial public offering with gross proceeds
of $177 million |
|
• |
Appointed experienced executives to build out AMT’s leadership team
across key functions, including clinical development, finance,
business development and strategy, and manufacturing |
|
• |
Presented preclinical data on AMT-101 (an oral gastrointestinal
tissue-targeted biologic rhIL-10 fusion) in a plenary session at
the European Crohn’s and Colitis Organisation (ECCO) annual meeting
demonstrating activity and efficacy of AMT-101 in an ulcerative
colitis (UC) model, offering potentially improved efficacy and
safety compared to systemically administered rhIL-10 |
|
• |
Completed a successful Phase 1a/b clinical trial for oral AMT-101
in healthy volunteers and UC patients |
|
|
|
• |
UC patients with active inflammation treated with AMT-101 showed
trends of improvement in objective disease markers such as fecal
calprotectin and histopathologic scores after only 14 days of
treatment |
|
|
|
• |
AMT-101 was well tolerated in both healthy volunteers and UC
patients |
|
• |
Activated AMT’s internal GMP biologics manufacturing facility |
|
• |
Selected as one of three finalists for the Fierce Innovations Award
for AMT-101 |
Anticipated Upcoming Catalysts
|
• |
Advancing oral AMT-101 into a comprehensive Phase 2 clinical
program including biologic-naïve and treatment-experienced UC
patients, in combination with anti-TNFα therapy in UC, and in
patients with pouchitis in 2020; and an additional combination
study with anti-TNFα therapy in patients with rheumatoid arthritis
is planned for 2021 |
|
• |
On track to submit an IND/CTA for AMT-126, a GI-selective oral
fusion of rhIL-22, by year-end 2020 for diseases related to
intestinal epithelium barrier defects driven by activation of the
innate immune system |
Financial Results for the Second Quarter Ended June 30,
2020
Research and development (R&D) expenses.
Total R&D expenses for the second quarter of 2020 were $12.8
million, compared to $6.5 million for the same period in 2019. The
increase was primarily due to higher expenses associated with
clinical trials, compensation, contract manufacturing and
facilities related expenses, offset by a decrease in other research
and development activities.
General and administrative (G&A) expenses.
Total G&A expenses for the second quarter of 2020 were $2.5
million, compared to $0.9 million for the same period in 2019. The
increase was primarily due to an increase in personnel costs and
professional fees.
Net loss. Net loss for the second quarter of
2020 was $15.4 million, compared to $7.3 million for the second
quarter of 2019.
Cash, cash equivalents, and investments. As of
June 30, 2020, cash, cash equivalents, and investments were $163.3
million, compared to $32.7 million as of December 31, 2019. The
increase was primarily driven by the company’s initial public
offering in June of this year.
About Applied Molecular Transport Inc.Applied
Molecular Transport Inc. is a clinical-stage biopharmaceutical
company leveraging its proprietary technology platform to design
and develop a pipeline of novel oral biologic product candidates to
treat autoimmune, inflammatory, metabolic, and other diseases.
AMT’s proprietary technology platform allows it to exploit existing
natural cellular trafficking pathways to facilitate the active
transport of therapeutic payloads across the intestinal epithelium
(IE) barrier. Active transport is an efficient mechanism that uses
the cell’s own machinery to transport materials across the IE
barrier. AMT believes that its ability to exploit this mechanism is
a key differentiator of its approach. AMT is developing oral
biologic product candidates in patient-friendly tablet and capsule
forms that are designed for either targeting local gastrointestinal
(GI) tissue or entering systemic circulation to precisely address
the relevant biology of a disease. AMT is building a portfolio of
oral product candidates based on its technology platform including
its lead product candidate, AMT-101, an oral GI-selective
interleukin 10 that has completed a Phase 1b clinical trial in
patients with ulcerative colitis (UC). AMT further plans to
initiate Phase 2 clinical trials of AMT-101 in UC and related
inflammatory indications. AMT’s technology platform enables it to
design and develop various oral biologic therapeutic modalities,
such as peptides, proteins, full-length antibodies, antibody
fragments, and RNA therapeutics, with potentially significant
advantages over existing marketed and development-stage drugs.
Cautionary Note Regarding Forward-Looking
Statements This press release contains forward-looking
statements as that term is defined in Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934.
Such forward-looking statements involve substantial risks and
uncertainties. All statements other than statements of historical
facts contained in this press release are forward-looking
statements. In some cases, you can identify forward-looking
statements by terminology such as “estimate,” “intend,” “may,”
“plan,” “potentially” “will” or the negative of these terms or
other similar expressions. We have based these forward-looking
statements largely on our current expectations and projections
about future events and trends that we believe may affect our
financial condition, results of operations, business strategy and
financial needs. These forward-looking statements are subject to a
number of risks, uncertainties and assumptions, including, among
other things: the timing of the initiation, progress and potential
results of our preclinical studies, clinical trials and our
research programs; our ability to use and expand our technology
platform to build a pipeline of product candidates; uncertainty of
developing biologic therapeutics; our ability to advance
product candidates into, and successfully complete, clinical
trials; the timing or likelihood of regulatory filings and
approvals; our estimates of the number of patients who suffer from
the diseases we are targeting and the number of patients that may
enroll in our clinical trials; the commercializing of our product
candidates, if approved; our ability and the potential to
successfully manufacture and supply our product candidates for
clinical trials and for commercial use, if approved; future
strategic arrangements and/or collaborations and the potential
benefits of such arrangements; our estimates regarding expenses,
future revenue, capital requirements and needs for additional
financing and our ability to obtain additional capital; the
sufficiency of our existing cash and cash equivalents to fund our
future operating expenses and capital expenditure requirements; our
ability to retain the continued service of our key personnel and to
identify, hire and retain additional qualified personnel; the
implementation of our strategic plans for our business and product
candidates; the scope of protection we are able to establish and
maintain for intellectual property rights, including our technology
platform, product candidates and research programs; our ability to
contract with third-party suppliers and manufacturers and their
ability to perform adequately; the pricing, coverage and
reimbursement of our product candidates, if approved; developments
relating to our competitors and our industry, including competing
product candidates and therapies; and other risks. Information
regarding the foregoing and additional risks may be found in the
section entitled “Risk Factors” in AMT’s Quarterly Report on Form
10-Q filed with the Securities and Exchange Commission (the “SEC”)
on August 11, 2020, and AMT’s future reports to be filed with the
SEC. These forward-looking statements are made as of the date of
this press release, and AMT assumes no obligation to update the
forward-looking statements, or to update the reasons why actual
results could differ from those projected in the forward-looking
statements, except as required by law.
|
Applied Molecular Transport Inc. |
Condensed Balance Sheets |
(unaudited) |
(in thousands, except share and per share amounts) |
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
2020 |
|
|
2019(*) |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
23,401 |
|
|
$ |
12,727 |
|
Short-term investments |
|
139,862 |
|
|
|
19,676 |
|
Prepaid expenses |
|
1,764 |
|
|
|
532 |
|
Deferred offering costs |
|
— |
|
|
|
366 |
|
Other current assets |
|
611 |
|
|
|
152 |
|
Total current assets |
|
165,638 |
|
|
|
33,453 |
|
Property and equipment,
net |
|
6,786 |
|
|
|
4,091 |
|
Long-term investments |
|
— |
|
|
|
249 |
|
Restricted cash |
|
108 |
|
|
|
108 |
|
Other assets |
|
128 |
|
|
|
632 |
|
Total assets |
$ |
172,660 |
|
|
$ |
38,533 |
|
Liabilities,
convertible preferred stock and stockholders’ equity
(deficit) |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
4,437 |
|
|
$ |
2,666 |
|
Accrued expenses |
|
2,288 |
|
|
|
1,315 |
|
Deferred rent, current |
|
48 |
|
|
|
13 |
|
Other current liabilities |
|
97 |
|
|
|
42 |
|
Total current liabilities |
|
6,870 |
|
|
|
4,036 |
|
Deferred rent |
|
496 |
|
|
|
526 |
|
Other liabilities |
|
185 |
|
|
|
58 |
|
Total liabilities |
|
7,551 |
|
|
|
4,620 |
|
Commitments and contingencies
(Note 6) |
|
|
|
|
|
|
|
Series A convertible preferred stock, $0.0001 par value, 0 shares
authorized, issued, and outstanding as of June 30, 2020 and
5,157,213 shares authorized, issued and outstanding, as of December
31, 2019; liquidation value of $0 as of June 30, 2020 and $33,000
as of December 31, 2019 |
|
— |
|
|
|
32,826 |
|
Series B convertible preferred stock, $0.0001 par value, 0 shares
authorized, issued, and outstanding as of June 30, 2020 and
3,992,919 shares authorized, issued and outstanding as of December
31, 2019; liquidation value of $0 as of June 30, 2020 and $31,025
as of December 31, 2019 |
|
— |
|
|
|
30,921 |
|
Series C convertible preferred stock, $0.0001 par value, 0 shares
authorized, issued, and outstanding as of June 30, 2020 and
4,816,160 shares authorized, issued and outstanding as of December
31, 2019; liquidation value of $0 as of June 30, 2020 and $41,949
as of December 31, 2019 |
|
— |
|
|
|
41,868 |
|
Stockholders’ equity
(deficit): |
|
|
|
|
|
|
|
Common stock, $0.0001 par value, 450,000,000 shares authorized as
of June 30, 2020 and 32,000,000 shares authorized as of December
31, 2019; 34,050,624 and 7,360,738 shares issued and outstanding as
of June 30, 2020 and December 31, 2019, respectively |
|
3 |
|
|
|
1 |
|
Additional paid-in capital |
|
268,588 |
|
|
|
1,078 |
|
Accumulated other comprehensive income |
|
2 |
|
|
|
13 |
|
Accumulated deficit |
|
(103,484 |
) |
|
|
(72,794 |
) |
Total stockholders’ equity (deficit) |
|
165,109 |
|
|
|
(71,702 |
) |
Total liabilities, convertible preferred stock and stockholders’
equity (deficit) |
$ |
172,660 |
|
|
$ |
38,533 |
|
__________________(*)
Derived from audited Financial Statements.
|
Applied Molecular Transport Inc. |
Condensed Statements of Operations and Comprehensive
Loss |
(unaudited) |
(in thousands, except share and per share amounts) |
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
June 30, |
|
|
June 30, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
12,836 |
|
|
$ |
6,500 |
|
|
$ |
25,790 |
|
|
$ |
10,866 |
|
General and administrative |
|
2,487 |
|
|
|
867 |
|
|
|
4,976 |
|
|
|
1,502 |
|
Total operating expenses |
|
15,323 |
|
|
|
7,367 |
|
|
|
30,766 |
|
|
|
12,368 |
|
Loss from operations |
|
(15,323 |
) |
|
|
(7,367 |
) |
|
|
(30,766 |
) |
|
|
(12,368 |
) |
Interest income |
|
48 |
|
|
|
58 |
|
|
|
131 |
|
|
|
59 |
|
Other expense, net |
|
(104 |
) |
|
|
— |
|
|
|
(55 |
) |
|
|
— |
|
Net loss |
$ |
(15,379 |
) |
|
$ |
(7,309 |
) |
|
$ |
(30,690 |
) |
|
$ |
(12,309 |
) |
Net loss per share, basic and
diluted |
$ |
(1.11 |
) |
|
$ |
(0.99 |
) |
|
$ |
(2.88 |
) |
|
$ |
(1.67 |
) |
Weighted-average shares of
common stock outstanding, basic and diluted |
|
13,869,040 |
|
|
|
7,360,738 |
|
|
|
10,643,240 |
|
|
|
7,360,738 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(15,379 |
) |
|
$ |
(7,309 |
) |
|
$ |
(30,690 |
) |
|
$ |
(12,309 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains on investments |
|
2 |
|
|
|
— |
|
|
|
8 |
|
|
|
— |
|
Amounts recognized for net realized gains included in net loss |
|
(19 |
) |
|
|
— |
|
|
|
(19 |
) |
|
|
— |
|
Total comprehensive loss |
$ |
(15,396 |
) |
|
$ |
(7,309 |
) |
|
$ |
(30,701 |
) |
|
$ |
(12,309 |
) |
|
Contacts: Sylvia WheelerPrincipal, Wheelhouse
Life Science Advisorsswheeler@wheelhouselsa.com
Alexandra SantosSenior Partner, Wheelhouse Life Science
Advisorsasantos@wheelhouselsa.com
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