MTCR Metacrine Inc.
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MET642
Non-alcoholic steatohepatitis (NASH
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Phase 2a
Phase 2a
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MET409 with Empagliflozin
Type 2 Diabetes and Nonalcoholic steatohepatitis (NASH)
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Phase 2a
Phase 2a
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Latest News
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• Topline results from a Phase 2a trial of MET409 in combination with empagliflozin in patients with NASH and type 2 diabetes now expected in the fourth quarter of 2021
• Interim data from the Phase 2a trial of MET642 in NASH patients on track to be reported in the fourth quarter of 2021
SAN DIEGO, May 13, 2021 (GLOBE NEWSWIRE) -- 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 Ended
March 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 [email protected]
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SAN DIEGO, May 11, 2021 (GLOBE NEWSWIRE) -- Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical company pioneering differentiated therapies for patients with liver and gastrointestinal diseases, today announced that Preston Klassen, M.D., MHS, president and chief executive officer, will present virtually at the 2021 RBC Global Healthcare Conference at 5:25 p.m. ET on Tuesday, May 18, 2021.
A live webcast of the presentation will be available at https://investors.metacrine.com/events-and-presentations. A replay of the webcast will be archived for 30 days following the conference.
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.
Investor & Media Contact
Steve Kunszabo
Metacrine, Inc.
+1 (858) 369-7892
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SAN DIEGO, April 05, 2021 (GLOBE NEWSWIRE) -- Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical company pioneering differentiated therapies for patients with liver and gastrointestinal diseases, today announced the appointment of Julia C. Owens, Ph.D. to the Company's board of directors, effective April 1, 2021. Dr. Owens will serve as a member of the Compensation Committee.
"We're excited to welcome Julia as a new independent director," commented Richard Heyman, Ph.D., Metacrine's chairman. "She is an accomplished biopharmaceutical executive, with an established track record in building companies, business development, capital formation and strategic partnerships. Julia's perspective will provide our board with valuable insights as we look ahead to important operating and clinical development milestones."
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.
"I'm impressed with Metacrine's progress advancing its potential best-in-class FXR programs," said Dr. Owens. "Non-alcoholic steatohepatitis (NASH) is an epidemic in the making with no approved treatments, and will soon become the leading cause of liver transplants in the U.S. It's an important time for our industry as we bring forward treatments for these patients, and I'm thrilled to join a passionate board of directors with a unified vision."
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 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," "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) 369-7892 [email protected]
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Interim Data from the Phase 2a Trial of MET642 in NASH Patients On-Track to be Reported in the Fourth Quarter of 2021
Topline Results from a Phase 2a Trial of MET409 in Combination with Empagliflozin in
Patients with NASH and Type 2 Diabetes Expected in the First Half of 2022Industry Veteran, Jeff Jonker, Appointed to Board of Directors
Conference Call to be Held Today at 8:30 a.m. ET
SAN DIEGO, March 18, 2021 (GLOBE NEWSWIRE) -- 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 Information
Metacrine 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 Metacrine
Metacrine, 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 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 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) 369-7892
[email protected]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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SAN DIEGO, March 11, 2021 (GLOBE NEWSWIRE) -- Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical company focused on discovering and developing differentiated therapies for patients with liver and gastrointestinal diseases, today announced that final results from the company's Phase 1 trial of MET642, a farnesoid X receptor (FXR) agonist in development for the treatment of non-alcoholic steatohepatitis (NASH), will be presented as a distinguished abstract at the 2021 NASH-TAG Conference. The conference is taking place March 11-13, 2021 in Park City, Utah and virtually on-line.
Expanding on initial findings reported in December 2020, MET642 demonstrated both an encouraging safety and tolerability profile in healthy volunteers, and sustained FXR target engagement after 14 days of daily oral dosing. There were no serious adverse events, and all treatment-emergent adverse events were mild to moderate in severity. MET642 exhibited significant FXR target engagement up to 24 hours after once-daily oral dosing, as evidenced by robust suppression of 7α-hydroxy-4-cholesten-3-one (C4), a key pharmacodynamic marker of FXR activation, at all dose levels. Of equal importance, MET642 was not associated with increased levels of low-density lipoprotein (LDL) cholesterol or reports of pruritus, known side effects reported with other FXR development candidates.
"We believe that a unique chemical scaffold and continuous target engagement are key to optimizing the therapeutic benefits of FXR agonism for the treatment of NASH," said Hubert C. Chen, M.D., chief medical officer of Metacrine. "We are encouraged by the overall clinical profile of MET642 to date. We are very pleased to have recently initiated our Phase 2a trial in patients with NASH to further elucidate the therapeutic potential of MET642 and look forward to sharing interim data from that study later this year."
About the Trial
The MET642 Phase 1 trial was a first-in-human, randomized, placebo-controlled, double-blind, single-ascending dose (SAD) and multiple-ascending dose (MAD) trial, in which healthy volunteers received a single oral dose of MET642 ranging from 10 mg to 300 mg in the SAD cohorts and daily oral doses ranging from 2.5 mg to 10 mg for 14 days in the MAD cohorts.About the Abstract
"MET642, FXR agonist with a unique chemotype, demonstrates a safe, sustained profile in a 14-day randomized study in healthy subjects", is to be presented by Richard Pencek, Ph.D., executive director of clinical science at Metacrine. Co-authors include Kyoung-Jin Lee, Ph.D. and Jonathan Lee.About Non-alcoholic Steatohepatitis (NASH)
Non-alcoholic steatohepatitis, or NASH, is a liver disease characterized by excess liver fat, inflammation and fibrosis. In 2015, there were an estimated 17 million people in the United States with NASH, which is expected to increase to an estimated 27 million people by 2030. Left untreated, patients' disease may progress to liver failure, which is life-threatening without a successful liver transplant. NASH is expected to become the leading cause for liver transplants in the United States. Additionally, patients with NASH often present with metabolic disease and other co-morbidities, which is likely to require combination therapy. Currently, there are no approved therapies for NASH.About Metacrine
Metacrine, Inc. (NASDAQ:MTCR) is a clinical-stage biopharmaceutical company building a differentiated pipeline of therapies to treat liver and gastrointestinal (GI) diseases. Metacrine has developed a proprietary farnesoid X receptor (FXR) platform utilizing a unique chemical scaffold, which has demonstrated a differentiated and 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 non-alcoholic steatohepatitis (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.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. Forward-looking statements contained in this press release include statements regarding the therapeutic potential of 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; and the potential for its FXR product candidates to be long-term therapies for NASH. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies and uncertainties related to the regulatory approval path for the NASH indication. Words such as "may," "could," "will," "encourage," "expect," "plan," "aim," "anticipate," "estimate," "intend," "potential," "prepare" 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 November 12, 2020, 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
[email protected]