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, 2021.
“We are looking forward to a catalyst-rich year
in 2022 for AMT,” said Tahir Mahmood, Ph.D., chief executive
officer and co-founder of AMT. “The Company is well-prepared and
continuing to scale as we anticipate four significant Phase 2
readouts for oral AMT-101 and further advance oral AMT-126, for
treating intestinal and other inflammatory indications, with our
deep understanding in mucosal immunology.”
Recent Business Highlights and
Anticipated Milestones
- Four ongoing Phase 2 trials for
AMT-101, a GI-selective, oral IL-10 fusion:
- FILLMORE monotherapy trial for
patients with chronic pouchitis expected to be first top-line data
readout in H1 2022
- MARKET combination trial of oral
AMT-101 with anti-TNFα in biologic-naïve patients with
moderate-to-severe UC; Top-line data readout in H1 2022
- LOMBARD monotherapy trial for
biologic-naïve and experienced patients with moderate-to-severe UC;
Top-line data readout in H2 2022
- CASTRO combination trial of oral
AMT-101 with anti-TNFα for patients with RA who are partial or
non-responders to anti-TNFα therapy; Top-line data readout in H2
2022
- Ongoing Phase 1 trial with AMT-126,
a GI-selective, oral IL-22 fusion:
- Phase 1 development plan includes
healthy volunteers and patients
- Broad potential in multiple indications in patients with
impaired intestinal epithelial barrier function
- Program update from oral AMT-126 in H1 2022
- Announced Board of Directors appointments
- John W. Smither appointed to Board of Directors and named Audit
Committee Chair
- Graham K. Cooper named Executive Chair
- Helen S. Kim named Lead Independent Director
- Integrated corporate headquarters, research labs and oral
biologics GMP manufacturing facility into a single new site in
South San Francisco, CA to support growth of clinical activities
and pipeline expansion
- Hosted virtual Research & Development Day to highlight
novel oral biologics technology platform, clinical programs and
research activities
- Announced new respiratory carrier technology and presented
preclinical data on the approach
- Featured distinguished inflammatory bowel disease (IBD) and
rheumatology key opinion leaders
Financial Results for the Fourth Quarter
and Full Year Ended December 31, 2021
Research and development (R&D)
expenses. Total R&D expenses for the fourth quarter of
2021 were $21.7 million, compared to $14.8 million for the same
period in 2020. The increase was primarily due to higher expenses
associated with increased headcount, facilities related expenses,
clinical trials, and materials. Total R&D expenses for the year
ended December 31, 2021 were $71.4 million, compared to $53.9
million for the year ended December 31, 2020. The increase was
primarily due to higher expenses associated with increased
headcount, facilities related expenses, and clinical trials.
General and administrative (G&A)
expenses. Total G&A expenses for the fourth quarter of
2021 were $9.0 million, compared to $4.3 million for the same
period in 2020. The increase was primarily due to an increase in
personnel costs and professional fees. Total G&A expenses for
the year ended December 31, 2021 were $29.3 million, compared to
$12.7 million for the year ended December 31, 2020. The increase
was primarily due to an increase in personnel costs and
professional fees.
Net loss. Net loss for the
fourth quarter of 2021 was $30.2 million, compared to a net loss of
$19.1 million for the same period in 2020. Net loss for the year
ended December 31, 2021 was $100.3 million, compared to $66.6
million for the year ended December 31, 2020.
Cash, cash equivalents, and
investments. As of December 31, 2021 and 2020, cash, cash
equivalents, and investments were $159.8 million and $129.9
million, respectively.
About AMT-101AMT-101 is a novel GI-selective,
oral fusion of IL-10 and AMT’s proprietary carrier molecule,
currently in development in four Phase 2 clinical trials in IBD and
RA. AMT-101 is designed to cross the intestinal epithelial (IE)
barrier with limited entry into the bloodstream, thereby focusing
IL-10 at the primary site of inflammation in UC, along the
intestinal tissue lamina propria, potentially avoiding the side
effects observed with systemic administration.
About AMT-126AMT-126 is a novel GI-selective,
oral fusion of IL-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 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 pathophysiology of 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
and the extent to which it may enable the development of new
products and AMT’s internal manufacturing capabilities, statements
regarding scaling our organization, growth of clinical activities,
or pipeline expansion, statements regarding the optimization or
expansion of our product development plans or the design of future
clinical trials, statements regarding the potential of AMT-101,
AMT-126, AMT’s respiratory carrier technology or regarding AMT-101
and AMT-126 clinical trials, including the timing of data readouts
from such trials, advancing product candidates to future phases of
development, and program updates, milestones for 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
“believe,” “estimate,” “intend,” “may,” “plan,” “potentially,”
“will,” “expect,” “enable,” “likely” 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.Condensed Balance
Sheets(unaudited) (in thousands, except
share and per share amounts)
|
|
As of December 31, |
|
|
|
2021 |
|
|
2020 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
159,821 |
|
|
$ |
5,843 |
|
Short-term investments |
|
|
— |
|
|
|
124,026 |
|
Prepaid expenses |
|
|
6,685 |
|
|
|
1,311 |
|
Other current assets |
|
|
594 |
|
|
|
321 |
|
Total current assets |
|
|
167,100 |
|
|
|
131,501 |
|
Property and equipment,
net |
|
|
6,998 |
|
|
|
8,447 |
|
Operating lease right-of-use
assets, net |
|
|
38,142 |
|
|
|
— |
|
Finance lease right-of-use
assets, net |
|
|
652 |
|
|
|
— |
|
Restricted cash |
|
|
1,025 |
|
|
|
108 |
|
Other assets |
|
|
121 |
|
|
|
127 |
|
Total assets |
|
$ |
214,038 |
|
|
$ |
140,183 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,211 |
|
|
$ |
3,174 |
|
Accrued expenses |
|
|
8,226 |
|
|
|
4,173 |
|
Operating lease liabilities, current |
|
|
3,584 |
|
|
|
— |
|
Finance lease liabilities, current |
|
|
237 |
|
|
|
— |
|
Deferred rent, current |
|
|
— |
|
|
|
83 |
|
Capital lease obligations, current |
|
|
— |
|
|
|
232 |
|
Total current liabilities |
|
|
14,258 |
|
|
|
7,662 |
|
Operating lease
liabilities |
|
|
35,785 |
|
|
|
— |
|
Finance lease liabilities |
|
|
167 |
|
|
|
— |
|
Other liabilities |
|
|
241 |
|
|
|
— |
|
Deferred rent |
|
|
— |
|
|
|
444 |
|
Capital lease obligations |
|
|
— |
|
|
|
404 |
|
Total liabilities |
|
|
50,451 |
|
|
|
8,510 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock |
|
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
403,228 |
|
|
|
271,000 |
|
Accumulated other comprehensive income |
|
|
— |
|
|
|
27 |
|
Accumulated deficit |
|
|
(239,645 |
) |
|
|
(139,358 |
) |
Total stockholders’ equity |
|
|
163,587 |
|
|
|
131,673 |
|
Total liabilities and stockholders’ equity |
|
$ |
214,038 |
|
|
$ |
140,183 |
|
|
|
|
|
|
|
|
|
|
Applied Molecular Transport
Inc.Condensed Statements of Operations and
Comprehensive Loss (unaudited)(in
thousands, except share and per share amounts)
|
|
Three Months Ended |
|
|
Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
21,683 |
|
|
$ |
14,751 |
|
|
$ |
71,448 |
|
|
$ |
53,936 |
|
General and administrative |
|
|
9,008 |
|
|
|
4,342 |
|
|
|
29,341 |
|
|
|
12,746 |
|
Total operating expenses |
|
|
30,691 |
|
|
|
19,093 |
|
|
|
100,789 |
|
|
|
66,682 |
|
Loss from operations |
|
|
(30,691 |
) |
|
|
(19,093 |
) |
|
|
(100,789 |
) |
|
|
(66,682 |
) |
Interest income, net |
|
|
522 |
|
|
|
42 |
|
|
|
626 |
|
|
|
229 |
|
Other expense, net |
|
|
(34 |
) |
|
|
(30 |
) |
|
|
(124 |
) |
|
|
(111 |
) |
Net loss |
|
$ |
(30,203 |
) |
|
$ |
(19,081 |
) |
|
$ |
(100,287 |
) |
|
$ |
(66,564 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.78 |
) |
|
$ |
(0.55 |
) |
|
$ |
(2.67 |
) |
|
$ |
(2.91 |
) |
Weighted-average shares of
common stock outstanding, basic and diluted |
|
|
38,536,106 |
|
|
|
34,945,569 |
|
|
|
37,591,505 |
|
|
|
22,878,325 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(30,203 |
) |
|
$ |
(19,081 |
) |
|
$ |
(100,287 |
) |
|
$ |
(66,564 |
) |
Other comprehensive (loss)
income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized (loss) gain on investments |
|
|
(1 |
) |
|
|
(4 |
) |
|
|
(27 |
) |
|
|
33 |
|
Amounts recognized for net realized gains included in net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(19 |
) |
Total comprehensive loss |
|
$ |
(30,204 |
) |
|
$ |
(19,085 |
) |
|
$ |
(100,314 |
) |
|
$ |
(66,550 |
) |
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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