Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a
clinical-stage biopharmaceutical company, today reported financial
results for the third quarter ended September 30, 2020.
“We continue to make important progress in the
development of our differentiated oral biologic drug candidates in
a number of indications,” said Tahir Mahmood, Ph.D., chief
executive officer and co-founder of AMT. “We recently advanced oral
AMT-101 into a Phase 2 monotherapy trial in patients with
ulcerative colitis (UC). In addition, we continue the planned
expansion of this comprehensive clinical program with two
additional Phase 2 trials of AMT-101 in combination with anti-TNFα
therapy in biologic-naïve patients with moderate to severe UC and
as a monotherapy in patients with pouchitis, both initiating by
year-end. We are also looking forward to the initiation of the
fourth Phase 2 trial for AMT-101 in combination with anti-TNFα in
rheumatoid arthritis patients who are partially responding to
anti-TNFα therapy. Furthermore, given the broad potential of our
technology platform as an engine for the development of novel oral
biologics, we continue to work on expanding our deep pipeline into
additional indications and therapeutic areas and look forward to
sharing updates on our progress.”
Recent Business Highlights
- Announced dosing of the first
patient in the LOMBARD Phase 2 monotherapy trial evaluating the
efficacy and safety of oral AMT-101 in patients with moderate to
severe UC
- Successfully manufactured AMT-101
and AMT-126 clinical biologic drug supply 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 (November 2020 issue)
Anticipated Upcoming
Milestones
- Initiate the remaining Phase 2
trials for oral AMT-101:
- MARKET clinical trial of oral
AMT-101 in combination with anti-TNFα, in biologic-naïve, moderate
to severe UC patients by year-end
- FILLMORE clinical trial of oral
AMT-101 for the treatment of pouchitis by year-end
- CASTRO clinical trial of oral
AMT-101 in combination with anti-TNFα for the treatment of
rheumatoid arthritis in 1H 2021
- Anticipate top-line data readouts
from the four AMT-101 Phase 2 trials beginning in 2H 2021 and into
1H 2022
- File IND/CTA for AMT-126, a
gastrointestinal (GI)-selective oral fusion of hIL-22, to treat
serious diseases associated with intestinal epithelial (IE) barrier
defects by year-end
Financial Results for the
Third Quarter Ended
September 30, 2020
Research and development (R&D)
expenses. Total R&D expenses for the third quarter of
2020 were $13.4 million, compared to $6.9 million for the same
period in 2019. The increase was primarily due to higher expenses
associated with clinical trials, preclinical studies, materials,
compensation, and facilities related expenses, offset by a decrease
in contract manufacturing due to internal capabilities.
General and administrative (G&A)
expenses. Total G&A expenses for the third quarter of
2020 were $3.4 million, compared to $1.0 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
third quarter of 2020 was $16.8 million, compared to $7.9 million
for the third quarter of 2019.
Cash, cash equivalents,
and investments. As of September 30, 2020, cash, cash
equivalents, and investments were $147.3 million.
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 tablet and capsule forms that are designed to
either target local GI 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’s Phase 2 clinical
trials for AMT-101 including the timing of such trials, the timing
of the filing of IND/CTA for AMT-126, AMT’s ability to leverage its
technology to expand its pipeline, presentations regarding
AMT-101’s Phase 1b dataset, and AMT-101 top-line data readouts
including the timing of such readouts. 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; potential
delays and disruption resulting from the COVID-19 pandemic; 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 November 12, 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)
|
|
September 30, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019(*) |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
11,314 |
|
|
$ |
12,727 |
|
Short-term investments |
|
|
135,940 |
|
|
|
19,676 |
|
Prepaid expenses |
|
|
1,816 |
|
|
|
532 |
|
Deferred offering costs |
|
|
— |
|
|
|
366 |
|
Other current assets |
|
|
79 |
|
|
|
152 |
|
Total current assets |
|
|
149,149 |
|
|
|
33,453 |
|
Property and equipment,
net |
|
|
8,437 |
|
|
|
4,091 |
|
Long-term investments |
|
|
— |
|
|
|
249 |
|
Restricted cash |
|
|
108 |
|
|
|
108 |
|
Other assets |
|
|
127 |
|
|
|
632 |
|
Total assets |
|
$ |
157,821 |
|
|
$ |
38,533 |
|
Liabilities,
convertible preferred stock and stockholders’ equity
(deficit) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,705 |
|
|
$ |
2,666 |
|
Accrued expenses |
|
|
4,692 |
|
|
|
1,315 |
|
Deferred rent, current |
|
|
65 |
|
|
|
13 |
|
Capital lease obligations, current |
|
|
229 |
|
|
|
42 |
|
Total current liabilities |
|
|
7,691 |
|
|
|
4,036 |
|
Deferred rent |
|
|
473 |
|
|
|
526 |
|
Capital lease obligations |
|
|
463 |
|
|
|
58 |
|
Total liabilities |
|
|
8,627 |
|
|
|
4,620 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Series A convertible preferred
stock, $0.0001 par value, 0 shares authorized, issued, and
outstanding as of September 30, 2020 and 5,157,213 shares
authorized, issued and outstanding, as of December 31, 2019;
liquidation value of $0 as of September 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 September 30, 2020 and 3,992,919 shares
authorized, issued and outstanding as of December 31, 2019;
liquidation value of $0 as of September 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 September 30, 2020 and 4,816,160 shares
authorized, issued and outstanding as of December 31, 2019;
liquidation value of $0 as of September 30, 2020 and $41,949
as of December 31, 2019 |
|
|
— |
|
|
|
41,868 |
|
Stockholders’ equity
(deficit): |
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value, 450,000,000 and 32,000,000 shares
authorized as of September 30, 2020, and December 31, 2019,
respectively; 34,880,411 and 7,360,738 shares issued and
outstanding as of September 30, 2020 and December 31, 2019,
respectively |
|
|
3 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
269,437 |
|
|
|
1,078 |
|
Accumulated other comprehensive income |
|
|
31 |
|
|
|
13 |
|
Accumulated deficit |
|
|
(120,277 |
) |
|
|
(72,794 |
) |
Total stockholders’ equity (deficit) |
|
|
149,194 |
|
|
|
(71,702 |
) |
Total liabilities, convertible preferred stock and stockholders’
equity (deficit) |
|
$ |
157,821 |
|
|
$ |
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 |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
13,395 |
|
|
$ |
6,890 |
|
|
$ |
39,185 |
|
|
$ |
17,756 |
|
General and administrative |
|
|
3,428 |
|
|
|
1,008 |
|
|
|
8,404 |
|
|
|
2,510 |
|
Total operating expenses |
|
|
16,823 |
|
|
|
7,898 |
|
|
|
47,589 |
|
|
|
20,266 |
|
Loss from operations |
|
|
(16,823 |
) |
|
|
(7,898 |
) |
|
|
(47,589 |
) |
|
|
(20,266 |
) |
Interest income, net |
|
|
59 |
|
|
|
36 |
|
|
|
187 |
|
|
|
107 |
|
Other expense, net |
|
|
(29 |
) |
|
|
(3 |
) |
|
|
(81 |
) |
|
|
(15 |
) |
Net loss |
|
$ |
(16,793 |
) |
|
$ |
(7,865 |
) |
|
$ |
(47,483 |
) |
|
$ |
(20,174 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.48 |
) |
|
$ |
(1.07 |
) |
|
$ |
(2.53 |
) |
|
$ |
(2.74 |
) |
Weighted-average shares of
common stock outstanding, basic and diluted |
|
|
34,767,308 |
|
|
|
7,360,738 |
|
|
|
18,770,153 |
|
|
|
7,360,738 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(16,793 |
) |
|
$ |
(7,865 |
) |
|
$ |
(47,483 |
) |
|
$ |
(20,174 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains on investments |
|
|
29 |
|
|
|
3 |
|
|
|
37 |
|
|
|
3 |
|
Amounts recognized for net realized gains included in net loss |
|
|
— |
|
|
|
— |
|
|
|
(19 |
) |
|
|
— |
|
Total comprehensive loss |
|
$ |
(16,764 |
) |
|
$ |
(7,862 |
) |
|
$ |
(47,465 |
) |
|
$ |
(20,171 |
) |
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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