Metacrine Reports Third-Quarter 2021 Results
November 11 2021 - 8:00AM
Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical
company pioneering differentiated therapies for patients with
gastrointestinal and liver diseases, today reported its
third-quarter 2021 financial results.
“Our recent monotherapy and combination trial results
demonstrate the strong therapeutic profile of our FXR program in
non-alcoholic steatohepatitis (NASH), while also highlighting the
potential of these agents as an important part of combination
therapy,” said Preston Klassen, M.D., MHS, CEO, Metacrine.
“Primarily because of the significant capital required to continue
advancing our product candidates, we’ve halted future clinical
development of our FXR program in NASH and will focus our financial
resources and clinical development effort on moving MET642 into a
Phase 2 trial in ulcerative colitis in the first half of 2022. In
addition, we continue to advance our HSD discovery program as an
exciting target in NASH and other liver diseases.”
Recent Clinical Development Milestones &
Outlook
- A strategic
re-prioritization of the Company’s clinical development
programs – After a rigorous assessment of its NASH and
inflammatory bowel disease programs, including the significant
capital required to progress these large clinical development
programs, the Company recently announced it is prioritizing its
financial resources and clinical development effort to advance
MET642 into a Phase 2 trial in ulcerative colitis in the first half
of 2022. Metacrine has halted future development of its FXR program
in NASH.
- MET642 Phase
2a monotherapy trial interim results – Metacrine reported
interim results from its Phase 2a clinical trial evaluating the
efficacy and safety of MET642 in approximately 60 NASH patients
after 16 weeks of treatment. MET642 lowered liver fat content, with
mean relative reductions of 26.9±27.8 percent in the 3 mg cohort
and 9.3±55.8 percent in the 6 mg cohort, compared with 7.5±21.0
percent in the placebo arm. MET642 was generally well-tolerated,
with no treatment-related serious adverse events (AEs).
Mild-moderate pruritus was reported in one patient in the 3 mg
cohort and one patient in the 6 mg cohort. No pruritus-related
treatment discontinuations occurred. The Company expects to report
completed topline study results in the first half of 2022.
- MET409 Phase
2a combination trial results – Metacrine reported topline
results from its Phase 2a trial evaluating MET409 in combination
with empagliflozin (Jardiance®), a sodium-glucose cotransport-2
(SGLT2) inhibitor, in patients with type 2 diabetes and NASH. All
regimens had favorable safety profiles and were generally
well-tolerated, with no treatment-related serious AEs.
Mild-moderate pruritus was reported in 0%-6% of patients across all
groups. No pruritus-related treatment discontinuations occurred in
any of the cohorts. Secondary assessment of liver fat content at 12
weeks indicated reduction in liver fat, as measured by MRI-PDFF, in
both monotherapy arms and demonstrated additive effects in the
combination regimen.
Third-Quarter 2021 Financial Results
- Cash
Balance – Cash, cash equivalents and short-term
investments were $61.7 million as of September 30, 2021.
- R&D
Expenses – Research and development expenses were $14.1
million for the three months ended September 30, 2021, as compared
to $6.2 million for the prior-year period. The increase was
primarily driven by higher clinical development costs related to
the advancement of the Company’s MET409 and MET642 programs.
- G&A
Expenses – General and administrative expenses were $4.0
million for the three months ended September 30, 2021, as compared
to $2.7 million for the same period in the prior year. The increase
was attributable to higher employee-related costs and expenses
associated with operating as a publicly traded company.
- Net
Loss – Net loss was $18.3 million for the three months
ended September 30, 2021, as compared to $9.1 million for
prior-year quarter.
About Metacrine
Metacrine, Inc. is a clinical-stage biopharmaceutical company
building a pipeline of differentiated therapies to treat
gastrointestinal and liver diseases. Metacrine has developed a
proprietary farnesoid X receptor (FXR) platform utilizing a unique
chemical scaffold. To learn more, visit www.metacrine.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Statements in
this press release that are not purely historical are
forward-looking statements. Such forward-looking statements
include, among other things, statements about the design, progress,
timing, scope and results of clinical trials; the anticipated
timing of disclosure of results of clinical trials; plans for
initiating future clinical trials and studies; statements regarding
the therapeutic potential of MET409 and MET642; and plans for
advancing the clinical development of Metacrine’s FXR program.
Words such as “may,” “will,” “expect,” “plan,” “aim,” “projected,”
“likely,” “anticipate,” “estimate,” “intend,” “potential,”
“prepare,” “perceived,” “believes” and similar expressions (as well
as other words or expressions referencing future events, conditions
or circumstances) are intended to identify forward-looking
statements. These forward-looking statements are based on
Metacrine’s expectations and assumptions that may never materialize
or prove to be incorrect. Each of these forward-looking statements
involves risks and uncertainties. Actual results may differ
materially from those projected in any forward-looking statements
due to numerous risks and uncertainties, including but not limited
to: risks and uncertainties regarding regulatory approvals for
MET409 or MET642; potential delays in initiating, enrolling or
completing any clinical trials; potential adverse side effects or
other safety risks associated with Metacrine’s product candidates;
competition from third parties that are developing products for
similar uses; and Metacrine’s ability to obtain, maintain and
protect its intellectual property. Information regarding the
foregoing and additional risks may be found in the section entitled
“Risk Factors” in Metacrine’s Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission (the “SEC”) on August
12, 2021, and in Metacrine’s other filings with the SEC. All
forward-looking statements contained in this press release speak
only as of the date on which they were made. Except as required by
law, Metacrine assumes no obligation to update any forward-looking
statements contained herein to reflect any change in expectations,
even as new information becomes available.
Metacrine,
Inc. |
Unaudited
Condensed Consolidated Statements of Operations and Comprehensive
Loss |
(In thousands) |
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
September 30, |
|
September 30, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
14,072 |
|
|
$ |
6,217 |
|
|
$ |
36,297 |
|
|
$ |
19,973 |
|
General and administrative |
|
4,007 |
|
|
|
2,693 |
|
|
|
11,695 |
|
|
|
6,087 |
|
Total operating expenses |
|
18,079 |
|
|
|
8,910 |
|
|
|
47,992 |
|
|
|
26,060 |
|
Loss from
operations |
|
(18,079 |
) |
|
|
(8,910 |
) |
|
|
(47,992 |
) |
|
|
(26,060 |
) |
Total other
income (expense) |
|
(249 |
) |
|
|
(144 |
) |
|
|
(689 |
) |
|
|
(428 |
) |
Net
loss |
$ |
(18,328 |
) |
|
$ |
(9,054 |
) |
|
$ |
(48,681 |
) |
|
$ |
(26,488 |
) |
Metacrine,
Inc. |
Unaudited
Condensed Consolidated Balance Sheets |
(In thousands) |
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2021 |
|
|
|
2020 |
|
Assets |
|
|
|
Current
assets: |
|
|
|
Cash, cash equivalents, and short-term investments |
$ |
61,728 |
|
|
$ |
96,176 |
|
Prepaid expenses and other current assets |
|
3,852 |
|
|
|
5,847 |
|
Total current assets |
|
65,580 |
|
|
|
102,023 |
|
Property and
equipment, net |
|
415 |
|
|
|
634 |
|
Operating
lease right-of-use asset |
|
1,077 |
|
|
|
1,579 |
|
Other
non-current assets |
|
438 |
|
|
|
- |
|
Total assets |
$ |
67,510 |
|
|
$ |
104,236 |
|
Liabilities and Stockholders’ Equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
323 |
|
|
$ |
334 |
|
Accrued and other current liabilities |
|
9,574 |
|
|
|
3,692 |
|
Current portion of long-term debt |
|
459 |
|
|
|
- |
|
Total current liabilities |
|
10,356 |
|
|
|
4,026 |
|
Long-term
debt, net of debt discount |
|
9,106 |
|
|
|
9,372 |
|
Other
long-term liabilities |
|
926 |
|
|
|
1,559 |
|
Stockholders’ equity |
|
47,122 |
|
|
|
89,279 |
|
Total liabilities and stockholders’ equity |
$ |
67,510 |
|
|
$ |
104,236 |
|
Investor & Media Contact
Steve Kunszabo
Metacrine, Inc.
+1 (858) 369-7892
skunszabo@metacrine.com
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