Metacrine Accelerates MET409 Clinical Development Milestone and Reports First-Quarter 2021 Results
May 13 2021 - 4:05PM
Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical
company pioneering differentiated therapies for patients with liver
and gastrointestinal diseases, today updated a key clinical
development milestone and reported its first-quarter 2021 financial
results.
“As I look ahead to the second half of 2021, we are nearing
significant clinical development milestones for both our MET409 and
MET642 programs,” said Preston Klassen, M.D., MHS, CEO, Metacrine.
“Importantly, we moved up our MET409 combination trial readout to
the fourth quarter of 2021, and affirmed that we are on track to
share data from an interim analysis of the MET642 trial in
non-alcoholic steatohepatitis (NASH) patients during the same
period. I am proud of our team for rapidly progressing
patient enrollment for both of these studies, bringing us closer to
advancing our program into late-stage development in both NASH and
our planned expansion into IBD in 2022.”
Klassen continued, “Our potentially best-in-class FXR agonist
platform supports our vision of bringing new therapies to patients
that desperately need treatment options. We believe that the wider
therapeutic index demonstrated by our NASH program will address the
risk/benefit profile necessary to treat patients with the promise
of expanded treatment options, including combination with other
agents. We are well-capitalized to achieve our next set
of objectives and remain focused on advancing and expanding our
pipeline in the months ahead.”
Key Clinical Development Milestones &
Outlook
- MET409 Phase
2a combination trial results now expected in the fourth quarter of
2021 - Metacrine now expects to report topline data from
its Phase 2a trial evaluating MET409 (50mg) in combination with
empagliflozin (Jardiance®), a sodium-glucose cotransport-2 (SGLT2)
inhibitor in patients with both type 2 diabetes and NASH, in the
fourth quarter of 2021 (previously first half of 2022). SGLT-2
inhibitors, in addition to affording glycemic control and
cardiovascular/renal benefits, have demonstrated positive effects
on liver fat reduction. A daily oral combination treatment with an
FXR agonist and SGLT-2 inhibitor could benefit patients with NASH
and type 2 diabetes, who are believed to be at greater risk for
liver disease progression. The MET409 Phase 2a
clinical trial is a 12-week, randomized, placebo-controlled,
multi-center trial evaluating the safety, tolerability and
pharmacological activity, as measured by reductions in liver fat
content with magnetic resonance imaging-derived proton density fat
fraction (MRI-PDFF). The trial will enroll up to 120 patients in
the United States.
- MET642 Phase
2a monotherapy trial interim analysis on-track for the fourth
quarter of 2021 - The Company plans to report topline data
of an interim analysis from its Phase 2a, 16-week, randomized,
placebo-controlled, multi-centered trial evaluating MET642 in
patients with NASH in the fourth quarter of 2021 after
approximately 60 patients have completed 16 weeks of treatment.
Topline trial results of up to 180 patients are anticipated in the
first half of 2022. The MET642 Phase 2a clinical trial
is evaluating the safety, tolerability and pharmacological
activity, as measured by MRI-PDFF, at 3 mg and 6 mg dose
levels.
Recent Business Highlights
- In April 2021,
Metacrine appointed Julia C. Owens, Ph.D. to the Company’s board of
directors. Dr. Owens currently serves as the executive chairperson
for Millendo Therapeutics, Inc., a company that she co-founded in
2012. For nine years, she served as the president and chief
executive officer of Millendo, establishing its strategy, building
its endocrine disease pipeline and attracting a world class team.
Under her leadership, the company raised $195 million from both the
private and public markets, and advanced four distinct product
candidates into clinical studies in six different indications,
including four Phase 2 programs and a pivotal study. Prior to
co-founding Millendo, she served as senior vice president,
corporate development and strategy at Lycera Corp. Dr. Owens also
held business development roles at QuatRx Pharmaceuticals, which
was acquired by Shionogi following the approval of Osphena®, and at
Tularik Inc. (acquired by Amgen). She is on the board of the
Biotechnology Innovation Organization (BIO), the Leadership Council
of the University of Michigan Life Sciences Institute, and the
Investment Advisory Board of the Michigan Biomedical Venture Fund.
Dr. Owens holds a Ph.D. in biochemistry from the University of
California, San Francisco and a B.S. in chemistry and B.A. in
molecular and cellular biology from the University of California,
Berkeley.
First-Quarter 2021 Financial Results
- Cash
Balance - Cash, cash equivalents and short-term
investments were $84.5 million as of March 31, 2021.
- R&D
Expenses - Research and development expenses were $10.9
million for the three months ended March 31, 2021, as compared to
$6.4 million for the prior-year period. The increase
was primarily driven by higher clinical development related to the
advancement of the Company’s MET409 and MET642 programs.
- G&A
Expenses - General and administrative expenses were $3.7
million for the three months ended March 31, 2021, as compared to
$1.6 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 $14.8 million for the three months
ended March 31, 2021, as compared to $8.1 million for prior-year
quarter.
About Metacrine
Metacrine, Inc. is a clinical-stage biopharmaceutical company
building a pipeline of differentiated therapies to treat liver and
gastrointestinal diseases. Metacrine has developed a proprietary
farnesoid X receptor (FXR) platform utilizing a unique chemical
scaffold, which has demonstrated an improved therapeutic profile in
clinical trials. The Company’s two product candidates, MET409 and
MET642, are currently being investigated in clinical trials as
potential new treatments for NASH. MET409 has completed a 12-week
monotherapy trial in patients with NASH and is being evaluated in a
12-week combination trial with empagliflozin in patients with both
NASH and type 2 diabetes. MET642 has completed a 14-day Phase 1
trial in healthy volunteers and is being evaluated in a 16-week
monotherapy trial in patients with NASH. To learn more, visit
www.metacrine.com.
Forward-Looking Statements This 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; the differentiated
nature of Metacrine’s FXR program; plans underlying Metacrine’s
clinical trials; plans for advancing the clinical development of
Metacrine’s FXR program; the potential best-in-class nature of
Metacrine’s FXR program; and the potential for its FXR product
candidates to be long-term therapies for NASH. 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 Annual Report on Form 10-K filed with the
Securities and Exchange Commission (the “SEC”) on March 18, 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 |
(in thousands) |
|
|
|
|
|
|
|
|
Three Months EndedMarch 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
$10,857 |
|
|
$6,361 |
|
|
General and administrative |
|
|
3,696 |
|
|
|
1,601 |
|
|
Total operating expenses |
|
|
14,553 |
|
|
|
7,962 |
|
|
Loss from operations |
|
|
(14,553 |
) |
|
|
(7,962 |
) |
|
Total other income
(expense) |
|
|
(215 |
) |
|
|
(150 |
) |
|
Net loss |
|
$(14,768 |
) |
|
$(8,112 |
) |
|
Metacrine, Inc. |
Unaudited Condensed Consolidated Balance
Sheets |
(in thousands) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2021 |
|
2020 |
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash, cash equivalents, and short-term investments |
|
$84,457 |
|
$96,176 |
Prepaid expenses and other current assets |
|
6,257 |
|
5,847 |
Total current assets |
|
90,714 |
|
102,023 |
Property and equipment, net |
|
555 |
|
634 |
Operating lease right-of-use
asset |
|
1,415 |
|
1,579 |
Total assets |
|
$92,684 |
|
$104,236 |
Liabilities and
Stockholders' Equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$325 |
|
$334 |
Accrued and other current liabilities |
|
4,911 |
|
3,692 |
Total current liabilities |
|
5,236 |
|
4,026 |
Long-term debt, net of debt
discount |
|
9,434 |
|
9,372 |
Other long-term liabilities |
|
1,354 |
|
1,559 |
Stockholders’ equity |
|
76,660 |
|
89,279 |
Total liabilities and stockholders’ equity |
|
$92,684 |
|
$104,236 |
Investor & Media Contact
Steve Kunszabo
Metacrine, Inc.
+1 (858) 369-7892
skunszabo@metacrine.com
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