Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a
clinical-stage biopharmaceutical company, today provided a
corporate update and reported financial results for the fourth
quarter and full year ended December 31, 2020.
“We have continued to leverage our proprietary
technology platform to rapidly advance our portfolio of
transformational oral biologic therapeutics into clinical
development,” said Tahir Mahmood, Ph.D., chief executive officer
and co-founder of AMT. “Recently, we achieved another significant
milestone for the company, initiating our second clinical program,
oral AMT-126, in a single ascending dose Phase 1a trial in healthy
volunteers. We continue to believe that our most advanced programs,
AMT-101 and AMT-126, have broad potential for targeting
gastrointestinal-focused, peripheral inflammation and other
diseases. Our proprietary technology platform and internal CMC
capabilities enable AMT to generate differentiated novel oral
biologics and this broad platform continues to generate exciting
pipeline opportunities. We look forward to sharing updates on our
continued progress across the business.”
Recent Business Highlights and 2020
Accomplishments
- Initiated four Phase 2 trials for
oral AMT-101:
- LOMBARD monotherapy trial in
biologic naïve and experienced patients with moderate-to-severe
UC
- MARKET combination trial of oral
AMT-101 with anti-TNFα, in biologic-naïve patients with
moderate-to-severe UC
- FILLMORE monotherapy trial for
patients with pouchitis
- CASTRO combination trial of oral
AMT-101 with anti-TNFα for patients with rheumatoid arthritis
- Expanded clinical pipeline with
second program, AMT-126, a GI-selective oral fusion of IL-22 and
our proprietary carrier molecule, for diseases associated with
intestinal epithelial barrier defects; Initiated Phase 1a trial in
healthy volunteers and expect the full Phase 1 development plan to
resemble our AMT-101 approach.
- Successfully manufactured oral
AMT-101 and AMT-126 clinical biologic material at AMT’s internal
GMP manufacturing facility
- Announced publication of preclinical data demonstrating
potential of AMT-101 for inflammatory diseases in The Journal of
Immunology
- Strengthened the executive
leadership team with key new hires, including Douglas Rich, chief
technical officer, and Earl Douglas, general counsel
- Closed an underwritten public offering, issuing 12,650,000
shares of common stock at an offering price of $14.00 per share,
resulting in gross proceeds of approximately $177.1 million
Anticipated Upcoming
Milestones
- Top-line data readouts from the
four oral AMT-101 Phase 2 trials beginning in 2H 2021 and into 1H
2022
- Top-line oral AMT-126 Phase 1a/b
data in healthy volunteers and patients in 2022
Financial Results for the Fourth Quarter
and Full Year Ended December 31, 2020
Research and development (R&D)
expenses. Total R&D expenses for the year ended
December 31, 2020 were $53.9 million, compared to $24.3 million for
the year ended December 31, 2019. The increase was primarily due to
higher expenses associated with clinical trials, preclinical
studies, materials, compensation, contract manufacturing and
facilities related expenses.
General and administrative (G&A)
expenses. Total G&A expenses for the year ended
December 31, 2020 were $12.7 million, compared to $4.0 million for
the year ended December 31, 2019. The increase was primarily due to
an increase in personnel costs and professional fees.
Net loss. Net loss for the year
ended December 31, 2020 was $66.6 million, compared to $28.0
million for the year ended December 31, 2019.
Cash, cash equivalents, and
investments. As of December 31, 2020, cash, cash
equivalents, and investments were $129.9 million.
About AMT-101AMT-101 is a novel
GI-selective, oral fusion of hIL-10 and AMT’s proprietary carrier
molecule, and is currently being developed in four Phase 2 clinical
trials in inflammatory bowel diseases and rheumatoid arthritis.
AMT-101 is designed to cross the intestinal epithelium barrier with
limited entry into the bloodstream, thereby focusing hIL-10 at the
primary site of inflammation for UC and potentially avoiding the
side effects observed with systemic administration. By design,
AMT-101 is actively transported through the IE barrier into the GI
tissue, the primary site of inflammation in UC.
About AMT-126AMT-126 is a novel
GI-selective, oral fusion of hIL-22 and AMT’s proprietary carrier
molecule currently in development for diseases related to
intestinal epithelial (IE) barrier defects. IL-22 is a cytokine
that repairs structural and functional defects of the IE barrier
and induces microbial defense. AMT-126 is designed to act locally
on the epithelial cells of the intestinal tissue, thereby repairing
the IE barrier and supporting mucosal healing, potentially
translating into clinically meaningful improvements in a broad
range of GI-focused, peripheral inflammatory and other
diseases.
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 diverse therapeutic modalities
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 additional oral biologic product
candidates in patient-friendly oral forms that are designed to
either target local gastrointestinal tissue or enter systemic
circulation to precisely address the relevant biology of a
disease.
AMT’s headquarters, internal GMP manufacturing
and lab facilities are located in South San Francisco, CA. For
additional information on AMT, please visit www.appliedmt.com.
Forward-Looking StatementsThis
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 including
statements relating to AMT’s plans, expectations, forecasts and
future events. Such forward-looking statements include, but are not
limited to, the potential of, and expectations regarding AMT’s
technology platform, statements regarding AMT-101 including the
progress of the Phase 2 clinical trials for AMT-101 and the timing
of data readouts from such trials, statements regarding AMT-126
including the progress of the Phase 1a/b clinical trial for AMT-126
and the timing of data readouts from such trials, the potential of
AMT-101 and AMT-126, AMT’s ability to leverage its technology to
expand its pipeline, and statements regarding the potential for
AMT’s products to treat certain medical conditions or diseases. 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; potential delays and disruption
resulting from the COVID-19 pandemic; 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 Annual Report on Form 10-K filed
with the Securities and Exchange Commission (the “SEC”) on March
19, 2021, 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.Balance Sheets (in thousands, except
share and per share amounts)
|
|
As of December 31, |
|
|
|
2020 |
|
|
2019 |
|
Assets: |
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
5,843 |
|
|
$ |
12,727 |
|
Short-term investments |
|
|
124,026 |
|
|
|
19,676 |
|
Prepaid expenses |
|
|
1,311 |
|
|
|
532 |
|
Deferred offering costs |
|
|
— |
|
|
|
366 |
|
Other current assets |
|
|
321 |
|
|
|
152 |
|
Total current assets |
|
|
131,501 |
|
|
|
33,453 |
|
Property
and equipment, net |
|
|
8,447 |
|
|
|
4,091 |
|
Long-term investments |
|
|
— |
|
|
|
249 |
|
Restricted cash |
|
|
108 |
|
|
|
108 |
|
Other
assets |
|
|
127 |
|
|
|
632 |
|
Total assets |
|
$ |
140,183 |
|
|
$ |
38,533 |
|
Liabilities, convertible preferred stock and stockholders’
equity (deficit): |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,174 |
|
|
$ |
2,666 |
|
Accrued expenses |
|
|
4,173 |
|
|
|
1,315 |
|
Deferred rent, current |
|
|
83 |
|
|
|
13 |
|
Capital lease obligations, current |
|
|
232 |
|
|
|
42 |
|
Total current liabilities |
|
|
7,662 |
|
|
|
4,036 |
|
Deferred
rent |
|
|
444 |
|
|
|
526 |
|
Capital
lease obligations |
|
|
404 |
|
|
|
58 |
|
Total liabilities |
|
|
8,510 |
|
|
|
4,620 |
|
Commitments and contingencies (Note 6) |
|
|
|
|
|
|
|
|
Series A
convertible preferred stock, $0.0001 par value, 0 shares
authorized, issued and outstanding as of December 31, 2020 and
5,157,213 shares authorized, issued and outstanding as of December
31, 2019; liquidation value of $0 and $33,000 as of December 31,
2020 and 2019, respectively |
|
|
— |
|
|
|
32,826 |
|
Series B
convertible preferred stock, $0.0001 par value, 0 shares
authorized, issued and outstanding as of December 31, 2020 and
3,992,919 shares authorized, issued and outstanding as of December
31, 2019; liquidation value of $0 and $31,025 as of December 31,
2020 and 2019, respectively |
|
|
— |
|
|
|
30,921 |
|
Series C
convertible preferred stock, $0.0001 par value, 0 shares
authorized, issued and outstanding as of December 31, 2020 and
4,816,160 shares authorized, issued and outstanding as of December
31, 2019; liquidation value of $0 and $41,949 as of December 31,
2020 and 2019, respectively |
|
|
— |
|
|
|
41,868 |
|
Stockholders’ equity (deficit): |
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value, 450,000,000 and 32,000,000 shares
authorized as of December 31, 2020 and 2019, respectively;
35,121,360 and 7,360,738 shares issued and outstanding as of
December 31, 2020 and 2019, respectively |
|
|
4 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
271,000 |
|
|
|
1,078 |
|
Accumulated other comprehensive income |
|
|
27 |
|
|
|
13 |
|
Accumulated deficit |
|
|
(139,358 |
) |
|
|
(72,794 |
) |
Total stockholders’ equity (deficit) |
|
|
131,673 |
|
|
|
(71,702 |
) |
Total liabilities, convertible preferred stock and stockholders’
equity (deficit) |
|
$ |
140,183 |
|
|
$ |
38,533 |
|
Applied Molecular Transport
Inc.Statements of Operations and Comprehensive
Loss (in thousands, except share and per share
amounts)
|
|
Year Ended December 31, |
|
|
|
2020 |
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
53,936 |
|
|
$ |
24,316 |
|
General and administrative |
|
|
12,746 |
|
|
|
3,974 |
|
Total operating expenses |
|
|
66,682 |
|
|
|
28,290 |
|
Loss from operations |
|
|
(66,682 |
) |
|
|
(28,290 |
) |
Interest income, net |
|
|
229 |
|
|
|
273 |
|
Other expense, net |
|
|
(111 |
) |
|
|
(26 |
) |
Net loss |
|
$ |
(66,564 |
) |
|
$ |
(28,043 |
) |
Net loss per share, basic and
diluted |
|
$ |
(2.91 |
) |
|
$ |
(3.81 |
) |
Weighted-average shares of
common stock outstanding, basic and diluted |
|
|
22,878,325 |
|
|
|
7,360,738 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(66,564 |
) |
|
$ |
(28,043 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
Net unrealized gains on investments |
|
|
33 |
|
|
13 |
|
Amounts recognized for net realized gain included in net loss |
|
|
(19 |
) |
|
|
— |
|
Total comprehensive loss |
|
$ |
(66,550 |
) |
|
$ |
(28,030 |
) |
Refer to the Company’s applicable filings with the SEC for
additional disclosures including our Annual Report on Form 10-K for
fiscal year 2020.
Investor Relations Contact:Andrew ChangHead,
Investor Relations & Corporate
Communicationsachang@appliedmt.com
Media Contacts:Alexandra SantosWheelhouse Life
Science Advisorsasantos@wheelhouselsa.com
Aljanae ReynoldsWheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
Applied Molecular Transp... (NASDAQ:AMTI)
Gráfica de Acción Histórica
De Jun 2024 a Jul 2024
Applied Molecular Transp... (NASDAQ:AMTI)
Gráfica de Acción Histórica
De Jul 2023 a Jul 2024