Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a
clinical-stage biopharmaceutical company, today provided a
corporate update and reported financial results for the first
quarter ended March 31, 2021.
“Our proprietary technology platform and
internal CMC capabilities have enabled AMT to generate
differentiated novel oral biologics, and this broad platform
continues to generate exciting pipeline opportunities,” said Tahir
Mahmood, Ph.D., chief executive officer and co-founder of AMT.
“Following the initiation of our second clinical program, oral
AMT-126, in a Phase 1a trial in healthy volunteers, we further
strengthened our balance sheet with a successful follow-on offering
in April. Importantly, these proceeds will enable AMT to optimize
the development plan for oral AMT-126 and our next pipeline
programs as they advance towards the clinic. We continue to believe
that our most advanced programs, AMT-101 and AMT-126, have broad
potential for targeting intestinal and systemic inflammatory
indications and other diseases. With topline readouts from the four
Phase 2 trials beginning in the second half of the year, we expect
the next twelve to eighteen months to be a data-rich period for the
company.”
Recent Business Highlights
- Initiated Phase 2 trials for oral
AMT-101:
- MARKET combination trial of oral
AMT-101 with anti-TNFα in biologic-naïve patients with
moderate-to-severe ulcerative colitis (UC)
- FILLMORE monotherapy trial for
patients with chronic pouchitis
- CASTRO combination trial of oral
AMT-101 with anti-TNFα for patients with rheumatoid arthritis who
are partial or non-responders to anti-TNFα therapy
- Expanded clinical pipeline with
second wholly internally-developed biologic therapeutic, 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; Expect to conduct a Phase 1b trial in patients with
impaired intestinal epithelial barrier function.
- Closed an underwritten public offering in April of 2,875,000
shares of our common stock, at a public offering price of $42.00
per share, resulting in net proceeds of approximately $112.9
million. Cash, cash equivalents, and investments as of March 31,
2021 pro-forma for the public offering were approximately
$229.1M.
- Successfully manufactured oral
AMT-101 and AMT-126 GMP biologics at AMT’s internal manufacturing
facility
- Received acceptance for our
submission to present the full AMT-101 Phase 1b multiple ascending
dose UC data set at the ECCO’21 Virtual Congress in July 2021
- Strengthened the executive
leadership team with key new hires, including Douglas Rich, chief
technical officer, and Earl Douglas, executive vice president and
general counsel
Anticipated Upcoming
Milestones
- Top-line data readouts from the
four oral AMT-101 Phase 2 trials beginning in 2H 2021 and into
2022
- Top-line oral AMT-126 Phase 1a/b
data in healthy volunteers and patients in 2022
Financial Results for the First Quarter
Ended March 31, 2021
Research and development (R&D)
expenses. Total R&D expenses for the first quarter of
2021 were $14.9 million, compared to $13.0 million for the same
period in 2020. The increase was primarily due to higher expenses
associated with clinical trials, preclinical studies, compensation
and facilities related expenses, offset by a decrease in materials
and contract manufacturing.
General and administrative (G&A)
expenses. Total G&A expenses for the first quarter of
2021 were $5.6 million, compared to $2.5 million for the same
period in 2020. The increase was primarily due to an increase of
$1.9 million in personnel and administrative costs due to an
increase in headcount and an increase of $1.1 million in
professional fees.
Net loss. Net loss for the
first quarter of 2021 was $20.5 million, compared to $15.3 million
for the same period in 2020.
Cash, cash equivalents, and
investments. As of March 31, 2021, cash, cash equivalents,
and investments were $108.3 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 epithelial (IE) 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 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 epithelial (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 intestinal 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 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 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 and AMT’s internal
manufacturing capabilities, statements regarding the optimization
of our product development plans or the design of future clinical
trials, statements regarding the potential of AMT-101 and AMT-126
or regarding AMT-101 and AMT-126 clinical trials, including the
timing of data readouts from such trials and our ability to
replicate past clinical development strategies, statements
regarding the potential for AMT’s product candidates to treat or
provide clinically meaningful outcomes for certain medical
conditions or diseases, and assumptions regarding the biological
mode of action of our product candidates and the potential to avoid
side effects with our product candidates. In some cases, you can
identify forward-looking statements by terminology such as
“estimate,” “intend,” “may,” “plan,” “potentially,” “will,”
“expect,” “enable” 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. Actual
events, trends or results could differ materially from the plans,
intentions and expectations disclosed in these forward-looking
statements based on various factors. Information regarding the
foregoing and additional risks may be found in the section entitled
“Risk Factors” in AMT’s Annual and Quarterly Reports on Form 10-K
and 10-Q filed with the Securities and Exchange Commission (the
“SEC”), 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)
|
|
March 31, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
26,202 |
|
|
$ |
5,843 |
|
Short-term investments |
|
|
82,063 |
|
|
|
124,026 |
|
Prepaid expenses |
|
|
2,648 |
|
|
|
1,311 |
|
Deferred offering costs |
|
|
659 |
|
|
|
— |
|
Other current assets |
|
|
393 |
|
|
|
321 |
|
Total current assets |
|
|
111,965 |
|
|
|
131,501 |
|
Property and equipment,
net |
|
|
6,999 |
|
|
|
8,447 |
|
Operating lease right-of-use
assets, net |
|
|
5,450 |
|
|
|
— |
|
Finance lease right-of-use
assets, net |
|
|
796 |
|
|
|
— |
|
Restricted cash |
|
|
1,025 |
|
|
|
108 |
|
Other assets |
|
|
169 |
|
|
|
127 |
|
Total assets |
|
$ |
126,404 |
|
|
$ |
140,183 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,208 |
|
|
$ |
3,174 |
|
Accrued expenses |
|
|
4,094 |
|
|
|
4,173 |
|
Operating lease liabilities, current |
|
|
2,377 |
|
|
|
— |
|
Finance lease liabilities, current |
|
|
235 |
|
|
|
— |
|
Deferred rent, current |
|
|
— |
|
|
|
83 |
|
Capital lease obligations, current |
|
|
— |
|
|
|
232 |
|
Total current liabilities |
|
|
8,914 |
|
|
|
7,662 |
|
Operating lease
liabilities |
|
|
3,589 |
|
|
|
— |
|
Finance lease liabilities |
|
|
344 |
|
|
|
— |
|
Deferred rent |
|
|
— |
|
|
|
444 |
|
Capital lease obligations |
|
|
— |
|
|
|
404 |
|
Total liabilities |
|
|
12,847 |
|
|
|
8,510 |
|
Commitments and contingencies
(Note 6) |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value, 450,000,000 shares authorized as
of March 31, 2021 and December 31, 2020; 35,250,650 and 35,121,360
shares issued and outstanding as of March 31, 2021 and December 31,
2020, respectively |
|
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
273,348 |
|
|
|
271,000 |
|
Accumulated other comprehensive income |
|
|
25 |
|
|
|
27 |
|
Accumulated deficit |
|
|
(159,820 |
) |
|
|
(139,358 |
) |
Total stockholders’ equity |
|
|
113,557 |
|
|
|
131,673 |
|
Total liabilities and stockholders’ equity |
|
$ |
126,404 |
|
|
$ |
140,183 |
|
|
|
|
|
|
|
|
|
|
Applied Molecular Transport
Inc.Statements of Operations and Comprehensive
Loss (in thousands, except share and per share
amounts)
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2021 |
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
14,881 |
|
|
$ |
12,954 |
|
General and administrative |
|
|
5,599 |
|
|
|
2,489 |
|
Total operating expenses |
|
|
20,480 |
|
|
|
15,443 |
|
Loss from operations |
|
|
(20,480 |
) |
|
|
(15,443 |
) |
Interest income, net |
|
|
40 |
|
|
|
83 |
|
Other (expense) income, net |
|
|
(22 |
) |
|
|
49 |
|
Net loss |
|
$ |
(20,462 |
) |
|
$ |
(15,311 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.58 |
) |
|
$ |
(2.06 |
) |
Weighted-average shares of
common stock outstanding, basic and diluted |
|
|
35,217,773 |
|
|
|
7,417,440 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(20,462 |
) |
|
$ |
(15,311 |
) |
Other comprehensive (loss)
income: |
|
|
|
|
|
|
|
|
Unrealized (loss) gain on investments |
|
|
(2 |
) |
|
|
6 |
|
Total comprehensive loss |
|
$ |
(20,464 |
) |
|
$ |
(15,305 |
) |
|
|
|
|
|
|
|
|
|
Refer to the Company’s applicable SEC filings for previously
reported periods.
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
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