Metacrine Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results
March 18 2021 - 6:30AM
Metacrine, Inc. (Nasdaq: MTCR), a clinical-stage biopharmaceutical
company focused on discovering and developing differentiated
therapies for patients with liver and gastrointestinal diseases,
today reported recent business highlights and fourth quarter and
full year 2020 financial results.
“We have made significant progress with our potential
best-in-class FXR agonist program, and given the strength of our
scientific capabilities, remain diligently focused on both the
advancement and expansion of our pipeline,” said Preston Klassen,
M.D., MHS, president and chief executive officer of Metacrine.
“Importantly, by the end of this year, we expect to have data from
the MET642 trial in NASH patients, and select the optimal candidate
to advance into late-stage development for this significant
indication, with no approved treatment today. We also expect to
have progressed our Phase 2a trial evaluating MET409 in combination
with empagliflozin in patients with both type 2 diabetes mellitus
and NASH and begun preparation for our planned expansion into IBD.
2021 is set to be a year of meaningful clinical progression with
milestones that bring us closer to achieving our vision of
transforming human health for patients with liver and GI
diseases.”
MET409 Program Highlights
- MET409 NASH Proof-of-Concept Trial Results Published in
the Journal of Hepatology: In February 2021, results from
a 12-week, randomized, placebo-controlled Phase 1b trial of MET409,
one of two novel farnesoid X receptor (FXR) agonists developed by
Metacrine, in patients with non-alcoholic steatohepatitis (NASH)
were published in the Journal of Hepatology. In the trial, MET409,
at 50 mg, achieved approximately 38% mean relative liver fat
reduction and was associated with a 16% overall pruritus rate, with
no discontinuations due to pruritus, and a 7% LDL-cholesterol
increase, findings that are favorable and perceived as
class-leading for FXR agonists.
- MET409 Phase 2a Combination Trial with Empagliflozin in
Patients with Type 2 Diabetes and NASH Initiated: In
January 2021, the first patient was treated in Metacrine’s Phase 2a
trial evaluating MET409 (50 mg) in combination with empagliflozin
(Jardiance®), a sodium-glucose cotransport-2 (SGLT2) inhibitor, in
patients with both type 2 diabetes mellitus and NASH. The 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. Metacrine expects to report topline data in the
first half of 2022.
MET642 Program Highlights
- MET642 Phase 1 Data Presented at the 2021 NASH-TAG
Conference: A poster highlighting the final results from
Metacrine’s Phase 1 trial of MET642, the company’s second FXR
agonist, in healthy volunteers was presented at the 2021 NASH-TAG
Conference. These data build upon the preliminary Phase 1 results
reported in December 2020, which showed that treatment with MET642
was generally well-tolerated, with no incidence of pruritus or
increases in LDL-cholesterol at all doses evaluated. MET642 also
demonstrated a sustained pharmacokinetic profile and robust FXR
target engagement after 14 days of daily oral dosing in healthy
volunteers.
- Initiated a Phase 2a Monotherapy Trial of MET642 in
Patients with NASH: In March 2021, the first patient was
treated in Metacrine’s Phase 2a trial evaluating MET642 in patients
with NASH. The Phase 2a clinical trial is a 16-week, randomized,
placebo-controlled, multi-center trial evaluating the safety,
tolerability and pharmacological activity, as measured by MRI-PDFF,
at 3 mg and 6 mg dose levels. The two doses are projected to
suppress 7α-hydroxy-4-cholesten-3-one (C4), a blood biomarker of
bile acid synthesis that decreases with FXR activation, to levels
that are likely to result in meaningful reductions in liver fat
content. The trial will enroll up to 180 patients in the United
States. An interim analysis is planned in the fourth quarter of
2021, after approximately 60 patients have completed 16 weeks of
treatment, with topline trial results of up to 180 patients
expected to be reported in the first half of 2022.
- MET642 Granted Fast Track Designation as a Treatment
for NASH: In January 2021, the U.S. Food & Drug
Administration (FDA) granted Fast Track designation to MET642 for
the treatment of NASH. Fast Track is a process designed to
facilitate the development and expedite the review of drugs
designed to treat serious diseases or conditions that have the
potential to fill an unmet medical need for such diseases or
conditions.
Business Highlights
- Industry Veteran, Jeff
Jonker, Appointed to Board of Directors: In March 2021,
Metacrine appointed Jeff Jonker to its board of directors. Mr.
Jonker currently serves as a senior advisor for Ambys Medicines,
where he was previously the president and chief executive officer
and a director. During his tenure at Ambys Medicines, Mr. Jonker
leveraged the company’s $140 million Series A financing and
strategic partnership with Takeda to establish a pioneering cell
therapy platform, including the build out of a cGMP cell therapy
manufacturing facility to enable clinical and commercial supply of
human hepatocytes. Prior to Ambys Medicines, Mr. Jonker served as
president of NGM Biopharmaceuticals, where he led the advancement
of the company’s robust pipeline, including therapeutics for
immune-oncology, retinal, liver and metabolic diseases. Mr. Jonker
holds a J.D. from Columbia University School of Law, an M.LITT.
from the University of St. Andrews and a B.A. from Claremont
McKenna College.
Upcoming Milestones
- Metacrine expects to report topline data of an interim analysis
from its Phase 2a, 16-week, randomized, placebo-controlled trial
evaluating MET642 in patients with NASH in the fourth quarter of
2021 after approximately 60 patients have completed 16 weeks of
treatment, with topline trial results of up to 180 patients
expected to be reported in the first half of 2022.
- Metacrine expects to report topline data from its Phase 2a
trial evaluating MET409 in combination with empagliflozin in
patients with both type 2 diabetes mellitus and NASH in the first
half of 2022.
Fourth Quarter and Full Year 2020 Financial
Results
- Capital Position: Cash, cash equivalents and
short-term investments were $96.2 million as of December 31, 2020.
The company believes that its cash, cash equivalents and short-term
investments as of December 31, 2020 will be sufficient to fund its
current operating plan through 2022.
- R&D Expenses: Research and development
expenses were $6.8 million for the fourth quarter of 2020 and
$26.8 million for the full year ended December 31, 2020,
compared to $6.5 million for the fourth quarter of 2019 and $26.0
million for the full year ended December 31, 2019. The increase in
research and development expenses was primarily attributable to the
continued investment in the clinical development and manufacturing
activities associated with the advancement of MET409 and
MET642.
- G&A Expenses: General and administrative
expenses were $3.8 million for the fourth quarter of 2020 and
$9.9 million for the full year ended December 31, 2020,
compared to $1.0 million for the fourth quarter of 2019 and $4.0
million for the full year ended December 31, 2019. The increase in
general and administrative expenses was primarily attributable to
increased headcount, non-cash stock-based compensation and costs
associated with operating as a publicly traded company upon
completion of the company’s initial public offering in September
2020.
- Net Loss: Net loss was $10.8 million for the
fourth quarter of 2020 and $37.3 million for the full year
ended December 31, 2020, compared to $7.4 million for the
fourth quarter of 2019 and $28.9 million for the full year
ended December 31, 2019.
Conference Call InformationMetacrine will host
a conference call today, March 18, at 8:30 a.m. ET. To participate
in the conference call, please dial (833) 614-1526 (domestic) or
(520) 809-9922 (international) and refer to conference ID 4995715.
A webcast will be available in the investor section of the
company's website at www.metacrine.com and will be archived for 60
days following the call.
About MetacrineMetacrine, Inc. (Nasdaq: MTCR)
is a clinical-stage biopharmaceutical company building a
differentiated pipeline of therapies to treat liver and
gastrointestinal (GI) diseases. The company’s most advanced
programs, MET409 and MET642, target the farnesoid X receptor (FXR),
which is central to modulating liver and GI diseases. Both MET409
and MET642 are currently being investigated in clinical trials as
potential new treatments for non-alcoholic steatohepatitis
(NASH).
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 regarding the therapeutic
potential of MET409 and MET642; statements regarding Metacrine’s
timelines; 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; the potential for
its FXR product candidates to be long-term therapies for NASH;
plans for expansion of Metacrine’s FXR program into IBD; and the
potential benefits of MET642’s Fast Track designation. Words such
as “may,” “will,” “expect,” “plan,” “aim,” “anticipate,”
“estimate,” “intend,” “potential,” “prepare”, “perceived” 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.
Contact:Steve Kunszabo(858)
369-7892investors@metacrine.com
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|
|
Metacrine, Inc. |
|
Unaudited Condensed Consolidated Statements of
Operations |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Years Ended December 31, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
6,817 |
|
|
$ |
6,476 |
|
|
$ |
26,790 |
|
|
$ |
25,973 |
|
|
General and administrative |
|
|
3,813 |
|
|
|
974 |
|
|
|
9,900 |
|
|
|
4,031 |
|
|
Total operating expenses |
|
|
10,630 |
|
|
|
7,450 |
|
|
|
36,690 |
|
|
|
30,004 |
|
|
Loss from operations |
|
|
(10,630 |
) |
|
|
(7,450 |
) |
|
|
(36,690 |
) |
|
|
(30,004 |
) |
|
Total other income (expense) |
|
|
(186 |
) |
|
|
53 |
|
|
|
(614 |
) |
|
|
1,071 |
|
|
Net loss |
|
$ |
(10,816 |
) |
|
$ |
(7,397 |
) |
|
$ |
(37,304 |
) |
|
$ |
(28,933 |
) |
|
Metacrine, Inc. |
|
Unaudited Condensed Consolidated Balance
Sheets |
|
(in thousands) |
| |
|
|
|
|
|
|
|
December 31, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash, cash equivalents, and short-term investments |
|
$ |
96,176 |
|
|
$ |
55,651 |
|
|
Prepaid expenses and other current assets |
|
|
5,847 |
|
|
|
1,692 |
|
|
Total current assets |
|
|
102,023 |
|
|
|
57,343 |
|
|
Property and equipment, net |
|
|
634 |
|
|
|
735 |
|
|
Operating lease right-of-use asset |
|
|
1,579 |
|
|
|
2,203 |
|
|
Total assets |
|
$ |
104,236 |
|
|
$ |
60,281 |
|
|
Liabilities, Convertible Preferred Stock, and Stockholders’
Equity (Deficit) |
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
334 |
|
|
$ |
239 |
|
|
Accrued and other current liabilities |
|
|
3,692 |
|
|
|
4,149 |
|
|
Total current liabilities |
|
|
4,026 |
|
|
|
4,388 |
|
|
Long-term debt, net of debt discount |
|
|
9,372 |
|
|
|
9,099 |
|
|
Other long-term liabilities |
|
|
1,559 |
|
|
|
2,566 |
|
|
Convertible preferred stock |
|
|
- |
|
|
|
122,465 |
|
|
Stockholders’ equity (deficit) |
|
|
89,279 |
|
|
|
(78,237 |
) |
|
Total liabilities, convertible preferred stock, and stockholders’
equity (deficit) |
|
$ |
104,236 |
|
|
$ |
60,281 |
|
| |
|
|
|
|
|
|
|
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