Applied Molecular Transport Reports Third Quarter 2022 Financial Results and Provides Corporate Update
07 Noviembre 2022 - 3:01PM
Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a
clinical-stage biopharmaceutical company, today provided a
corporate update and reported financial results for the third
quarter ended September 30, 2022.
“Our recent end of Phase 2 meeting with FDA,
based on the positive top-line data from our FILLMORE monotherapy
trial in patients with chronic pouchitis, was an important
milestone for the company” said Tahir Mahmood, Ph.D., chief
executive officer and co-founder of AMT. “As we remain focused on
Phase 3 advancement for this important indication, we also recently
completed enrollment of our AMT-101 UC monotherapy trial and look
forward to sharing top-line data.”
Recent Business Highlights and
Anticipated Milestones
- Two ongoing Phase 2 trials for
AMT-101, a GI-selective, oral fusion of IL-10 and AMT’s proprietary
carrier molecule:
- LOMBARD monotherapy trial in
biologic-naïve and experienced patients with moderate-to-severe UC;
trial enrollment complete and top-line data readout anticipated in
late 2022 or early 2023
- CASTRO combination trial with
anti-TNFα in patients with RA who are partial or non-responders to
anti-TNFα therapy; top-line data readout anticipated in 2023
- Company held end of Phase 2 meeting with FDA to discuss
advancing AMT-101 monotherapy to Phase 3 in chronic pouchitis, an
orphan indication with no FDA-approved products
- Announced Phase 2 top-line data from the AMT-101 MARKET
combination trial with anti-TNFα in biologic-naïve patients with
moderate-to-severe UC
- Post hoc analysis suggests combination treatment with AMT-101
earlier in the course of disease (within 5 years from initial
diagnosis) may be more beneficial than anti-TNFα alone
- AMT-101 appeared safe and well-tolerated through the 8-week
treatment period
Financial Results for the Third Quarter
Ended September 30, 2022
Research and development (R&D)
expenses. Total R&D expenses for the third quarter of
2022 were $18.2 million, compared to $18.4 million for the same
period in 2021. The overall decrease was primarily related to lower
expenses associated with personnel-related costs, clinical trials
and materials, partially offset by an increase in other research
and development expenses attributable to activation of the
Company’s oral biologics GMP manufacturing facility.
General and administrative (G&A)
expenses. Total G&A expenses for the third quarter of
2022 were $7.3 million, compared to $7.6 million for the same
period in 2021. The overall decrease was primarily due to lower
professional fees, partially offset by increases in
personnel-related and facilities-related expenses.
Net loss. Net loss for the
third quarter of 2022 was $25.2 million, compared to $26.0 million
for the same period in 2021. Stock-based compensation and
depreciation and amortization for the third quarter of 2022 was
$6.5 million, compared to $5.8 million for the same period in
2021.
Cash and cash equivalents. As
of September 30, 2022, cash and cash equivalents were $76.0
million. The Company believes its cash and cash equivalents will be
sufficient to allow the Company to fund its current operating plan
for at least the next twelve months.
About AMT-101
AMT-101 is a novel GI-selective, oral fusion of
IL-10 and AMT’s proprietary carrier molecule, currently in
development in Phase 2 clinical trials for chronic pouchitis, UC
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 IBD, along the
intestinal tissue lamina propria, potentially avoiding the side
effects observed with systemic administration.
About Applied Molecular Transport
Inc.AMT is a clinical-stage biopharmaceutical company
developing novel oral biologic product candidates, by leveraging
its technology platform to design and advance a multi-product
pipeline to treat autoimmune, inflammatory, metabolic and other
diseases. AMT is developing its oral biologic product candidates in
patient-friendly oral dosage forms that are designed to either
target local intestinal tissue or enter systemic circulation to
precisely address the relevant pathophysiology of disease. 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’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, statements regarding
the potential of, and expectations regarding, AMT’s technology
platform, product candidates and programs, including AMT-101;
statements regarding AMT’s expectations relating to its milestones,
clinical trials and clinical development, including timing of data
readouts from its AMT-101 clinical trials; statements regarding the
sufficiency of the Company’s cash resources; and statements by
AMT’s chief executive officer and co-founder. 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)
|
September 30, |
|
December 31, |
|
|
2022 |
|
|
|
2021 |
|
Assets |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
76,020 |
|
|
$ |
159,821 |
|
Prepaid expenses |
|
3,210 |
|
|
|
6,685 |
|
Other current assets |
|
1,047 |
|
|
|
594 |
|
Total current assets |
|
80,277 |
|
|
|
167,100 |
|
Property and
equipment, net |
|
8,780 |
|
|
|
6,998 |
|
Operating
lease right-of-use assets, net |
|
33,446 |
|
|
|
38,142 |
|
Finance
lease right-of-use assets, net |
|
639 |
|
|
|
652 |
|
Restricted
cash |
|
916 |
|
|
|
1,025 |
|
Other
assets |
|
549 |
|
|
|
121 |
|
Total assets |
$ |
124,607 |
|
|
$ |
214,038 |
|
Liabilities and stockholders’ equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
1,374 |
|
|
$ |
2,211 |
|
Accrued expenses |
|
8,043 |
|
|
|
8,226 |
|
Operating lease liabilities, current |
|
4,449 |
|
|
|
3,584 |
|
Finance lease liabilities, current |
|
258 |
|
|
|
237 |
|
Total current liabilities |
|
14,124 |
|
|
|
14,258 |
|
Operating
lease liabilities |
|
31,785 |
|
|
|
35,785 |
|
Finance
lease liabilities |
|
59 |
|
|
|
167 |
|
Other
liabilities |
|
244 |
|
|
|
241 |
|
Total liabilities |
|
46,212 |
|
|
|
50,451 |
|
Commitments
and contingencies |
|
|
|
Stockholders’ equity: |
|
|
|
Common stock |
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
421,762 |
|
|
|
403,228 |
|
Accumulated deficit |
|
(343,371 |
) |
|
|
(239,645 |
) |
Total stockholders’ equity |
|
78,395 |
|
|
|
163,587 |
|
Total liabilities and stockholders’ equity |
$ |
124,607 |
|
|
$ |
214,038 |
|
|
|
|
|
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, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
18,238 |
|
|
$ |
18,350 |
|
|
$ |
75,386 |
|
|
$ |
49,765 |
|
General and administrative |
|
7,288 |
|
|
|
7,641 |
|
|
|
28,738 |
|
|
|
20,333 |
|
Total operating expenses |
|
25,526 |
|
|
|
25,991 |
|
|
|
104,124 |
|
|
|
70,098 |
|
Loss from
operations |
|
(25,526 |
) |
|
|
(25,991 |
) |
|
|
(104,124 |
) |
|
|
(70,098 |
) |
Interest income, net |
|
321 |
|
|
|
5 |
|
|
|
393 |
|
|
|
104 |
|
Other income (expense), net |
|
(1 |
) |
|
|
(6 |
) |
|
|
5 |
|
|
|
(90 |
) |
Net
loss |
$ |
(25,206 |
) |
|
$ |
(25,992 |
) |
|
$ |
(103,726 |
) |
|
$ |
(70,084 |
) |
Net loss per
share, basic and diluted |
$ |
(0.65 |
) |
|
$ |
(0.68 |
) |
|
$ |
(2.68 |
) |
|
$ |
(1.88 |
) |
Weighted-average shares of common stock outstanding, basic and
diluted |
|
38,914,570 |
|
|
|
38,437,096 |
|
|
|
38,769,226 |
|
|
|
37,273,178 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
Net
loss |
$ |
(25,206 |
) |
|
$ |
(25,992 |
) |
|
$ |
(103,726 |
) |
|
$ |
(70,084 |
) |
Other
comprehensive loss: |
|
|
|
|
|
|
|
Unrealized loss on investments |
|
— |
|
|
|
(5 |
) |
|
|
— |
|
|
|
(26 |
) |
Total
comprehensive loss |
$ |
(25,206 |
) |
|
$ |
(25,997 |
) |
|
$ |
(103,726 |
) |
|
$ |
(70,110 |
) |
|
|
|
|
|
|
|
|
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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