Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a
clinical-stage biopharmaceutical company, today provided a
corporate update and reported financial results for the second
quarter ended June 30, 2022.
“We were pleased to recently announce that the
company has been granted an end of Phase 2 meeting with FDA, based
on the positive top-line data from our FILLMORE monotherapy trial
in patients with chronic pouchitis,” said Tahir Mahmood, Ph.D.,
chief executive officer and co-founder of AMT. “The company remains
focused on Phase 3 preparation for this important indication, and
also looks forward to our remaining two top-line readouts for oral
AMT-101 later this year and in 2023.”
Recent Business Highlights and
Anticipated Milestones
- Announced positive Phase 2 top-line data in the AMT-101
FILLMORE monotherapy trial for patients with chronic pouchitis, an
orphan indication with no FDA-approved products
- Company granted end of Phase 2 meeting with FDA to discuss
advancing to Phase 3
- AMT-101 demonstrated favorable
clinical activity and appeared safe and well-tolerated through the
12-week treatment period, in the most difficult-to-treat IBD
patients where rapid, symptomatic improvement is critical
- Met pre-specified efficacy
endpoints, and achieved meaningful responses in stool frequency and
histologic healing in both the 3mg and 10mg dosage groups
- Independent DMC recommended
advancing to Phase 3 with the 3 mg dose in chronic pouchitis
- Announced Phase 2 top-line data in the AMT-101 MARKET
combination trial with anti-TNFα in biologic-naïve patients with
moderate-to-severe UC
- Post hoc analysis suggests combination treatment earlier in the
course of disease may be beneficial
- Further analysis of patients with shorter duration of UC < 5
years ongoing
- AMT-101 appeared safe and well-tolerated through the 8-week
treatment period
- 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 for
biologic-naïve and experienced patients with moderate-to-severe UC;
Top-line data readout anticipated in H2 2022
- CASTRO combination trial with
anti-TNFα for patients with RA who are partial or non-responders to
anti-TNFα therapy; Top-line data readout anticipated in 2023
- Aligned senior management to
support the recently announced strategic plan and late-stage focus
of the company
- Shawn Cross named president and
chief operating officer
- Brandon Hants assumed role of chief
financial officer
Financial Results for the Second Quarter
Ended June 30, 2022
Research and development (R&D)
expenses. Total R&D expenses for the second quarter of
2022 were $25.9 million, compared to $16.5 million for the same
period in 2021. The overall increase was primarily related to
higher expenses associated with clinical trials, increased
headcount, facilities-related expenses and materials. Total R&D
expenses for the second quarter of 2022 included nonrecurring
charges related to the changes in its strategic plan of $3.1
million announced May 18, 2022.
General and administrative (G&A)
expenses. Total G&A expenses for the second quarter of
2022 were $10.1 million, compared to $7.1 million for the same
period in 2021. The overall increase was primarily due to increased
headcount, professional fees and facilities-related expenses. Total
G&A expenses for the second quarter of 2022 included
nonrecurring charges related to the strategic plan of $0.7
million.
Net loss. Net loss for the
second quarter of 2022 was $35.9 million, compared to $23.6 million
for the same period in 2021. Stock-based compensation and
depreciation and amortization for the second quarter of 2022 was
$6.5 million, compared to $5.1 million for the same period in
2021.
Cash, cash equivalents and
investments. As of June 30, 2022, cash and cash
equivalents were $95.8 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, 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)
|
|
June 30, |
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
95,830 |
|
|
$ |
159,821 |
|
Prepaid expenses |
|
|
4,347 |
|
|
|
6,685 |
|
Other current assets |
|
|
1,131 |
|
|
|
594 |
|
Total current assets |
|
|
101,308 |
|
|
|
167,100 |
|
Property and equipment,
net |
|
|
9,400 |
|
|
|
6,998 |
|
Operating lease right-of-use
assets, net |
|
|
34,512 |
|
|
|
38,142 |
|
Finance lease right-of-use
assets, net |
|
|
694 |
|
|
|
652 |
|
Restricted cash |
|
|
1,025 |
|
|
|
1,025 |
|
Other assets |
|
|
323 |
|
|
|
121 |
|
Total assets |
|
$ |
147,262 |
|
|
$ |
214,038 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,313 |
|
|
$ |
2,211 |
|
Accrued expenses |
|
|
9,616 |
|
|
|
8,226 |
|
Operating lease liabilities, current |
|
|
4,018 |
|
|
|
3,584 |
|
Finance lease liabilities, current |
|
|
262 |
|
|
|
237 |
|
Total current liabilities |
|
|
16,209 |
|
|
|
14,258 |
|
Operating lease
liabilities |
|
|
32,932 |
|
|
|
35,785 |
|
Finance lease liabilities |
|
|
125 |
|
|
|
167 |
|
Other liabilities |
|
|
244 |
|
|
|
241 |
|
Total liabilities |
|
|
49,510 |
|
|
|
50,451 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock |
|
|
4 |
|
|
|
4 |
|
Additional paid-in capital |
|
|
415,913 |
|
|
|
403,228 |
|
Accumulated other comprehensive income |
|
|
— |
|
|
|
— |
|
Accumulated deficit |
|
|
(318,165 |
) |
|
|
(239,645 |
) |
Total stockholders’ equity |
|
|
97,752 |
|
|
|
163,587 |
|
Total liabilities and stockholders’ equity |
|
$ |
147,262 |
|
|
$ |
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 |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
25,909 |
|
|
$ |
16,534 |
|
|
$ |
57,148 |
|
|
$ |
31,415 |
|
General and administrative |
|
|
10,113 |
|
|
|
7,093 |
|
|
|
21,450 |
|
|
|
12,692 |
|
Total operating expenses |
|
|
36,022 |
|
|
|
23,627 |
|
|
|
78,598 |
|
|
|
44,107 |
|
Loss from operations |
|
|
(36,022 |
) |
|
|
(23,627 |
) |
|
|
(78,598 |
) |
|
|
(44,107 |
) |
Interest income, net |
|
|
75 |
|
|
|
59 |
|
|
|
72 |
|
|
|
99 |
|
Other income (expense), net |
|
|
2 |
|
|
|
(62 |
) |
|
|
6 |
|
|
|
(84 |
) |
Net loss |
|
$ |
(35,945 |
) |
|
$ |
(23,630 |
) |
|
$ |
(78,520 |
) |
|
$ |
(44,092 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.93 |
) |
|
$ |
(0.62 |
) |
|
$ |
(2.03 |
) |
|
$ |
(1.20 |
) |
Weighted-average shares of
common stock outstanding, basic and diluted |
|
|
38,748,741 |
|
|
|
38,128,095 |
|
|
|
38,695,350 |
|
|
|
36,680,973 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(35,945 |
) |
|
$ |
(23,630 |
) |
|
$ |
(78,520 |
) |
|
$ |
(44,092 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on investments |
|
|
— |
|
|
|
(19 |
) |
|
|
— |
|
|
|
(21 |
) |
Total comprehensive loss |
|
$ |
(35,945 |
) |
|
$ |
(23,649 |
) |
|
$ |
(78,520 |
) |
|
$ |
(44,113 |
) |
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
Applied Molecular Transp... (NASDAQ:AMTI)
Gráfica de Acción Histórica
De Sep 2024 a Oct 2024
Applied Molecular Transp... (NASDAQ:AMTI)
Gráfica de Acción Histórica
De Oct 2023 a Oct 2024