1. WALTHAM, Mass. , Jan. 05, 2021 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced the expansion of its research and development collaboration with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The collaboration expansion involves the initiation of work on a third integrin target, with the collaboration scope to include activating antibodies against this new target. The agreement was facilitated by Johnson & Johnson Innovation.

    "Morphic's unique understanding of the integrin receptor enables a wide variety of therapeutic development…

    WALTHAM, Mass. , Jan. 05, 2021 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced the expansion of its research and development collaboration with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The collaboration expansion involves the initiation of work on a third integrin target, with the collaboration scope to include activating antibodies against this new target. The agreement was facilitated by Johnson & Johnson Innovation.

    "Morphic's unique understanding of the integrin receptor enables a wide variety of therapeutic development opportunities, and we are excited to expand our outstanding collaboration with Janssen to investigate new applications of our technology to discover novel antibodies of integrins," said Bruce Rogers, Ph.D., chief scientific officer, Morphic Therapeutic. "Morphic's goal is to create new integrin-targeted therapies for patients with serious diseases and we are grateful for Janssen's expertise in this mission."

    Under the terms of the original collaboration agreement, Morphic will receive a milestone payment for initiating work on the third target. As part of the expansion any new product candidates will be subject to milestones and royalties.

    About Integrins

    Integrins are a ubiquitous family of receptors expressed on the surface of most human cells. Integrins are dimers comprising one α (alpha) subunit and one β (beta) subunit. Integrin signaling controls a wide range of cellular processes, including cell survival, cell cycle progression, immune system activation, cell differentiation, and cell migration. Aberrant integrin signaling contributes to a diverse array of human diseases, including each of Morphic's focus areas of autoimmune diseases, fibrosis, and immuno-oncology.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary Morphic Integrin Technology (MInT) Platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking" statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Morphic's or our partners' plans or ability to develop, obtain approval for any indication or disease and/or commercialize any oral small-molecule integrin therapeutics. Statements including words such as "believe," "plan," "continue," "expect," "will be," "develop," "signal," "potential," "anticipate" or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause Morphic's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Morphic's ability to develop, obtain regulatory approval for and commercialize MORF-057, MORF-720, and other product candidates, the timing and results of preclinical studies and clinical trials, the potential impact of the COVID-19 pandemic, Morphic's ability to protect intellectual property; and other risks set forth in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Morphic specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

    Contacts

    Morphic Therapeutic

    Chris Erdman



    617.686.1718

    Media Contact

    Adam Silverstein, Ten Bridge Communications



    917.697.9313



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  2. WALTHAM, Mass., Dec. 30, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biotechnology company developing oral integrin therapies, today announced that Praveen Tipirneni, M.D., president and chief executive officer, will present at the virtual 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021 at 4:30 PM ET.

    A live webcast of the presentation will be available on the Investor section of Morphic's website at www.morphictx.com. An archived replay will be available on the company's website following the conference.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including…

    WALTHAM, Mass., Dec. 30, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biotechnology company developing oral integrin therapies, today announced that Praveen Tipirneni, M.D., president and chief executive officer, will present at the virtual 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021 at 4:30 PM ET.

    A live webcast of the presentation will be available on the Investor section of Morphic's website at www.morphictx.com. An archived replay will be available on the company's website following the conference.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular, and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen, and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Contacts

    Morphic Therapeutic

    Chris Erdman



    617.686.1718

    Media Contact

    Adam Silverstein, Ten Bridge Communications



    917.697.9313



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  3. WALTHAM, Mass., Dec. 04, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biotechnology company developing oral integrin therapies, today announced the appointment of Dr. Martin W. Edwards, to its Board of Directors. Dr. Edwards is a veteran leader in the drug development industry, recently retiring as a Senior Partner at Novo Ventures, the venture capital arm of Novo Holdings A/S, and currently a Director of several public biotechnology companies.

    "Martin has a track record of success and leadership spanning the entire spectrum of drug development. He now brings his insight and experience to Morphic at an auspicious time as we are developing a portfolio of integrin-targeted drug candidates across a broad range of indications…

    WALTHAM, Mass., Dec. 04, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biotechnology company developing oral integrin therapies, today announced the appointment of Dr. Martin W. Edwards, to its Board of Directors. Dr. Edwards is a veteran leader in the drug development industry, recently retiring as a Senior Partner at Novo Ventures, the venture capital arm of Novo Holdings A/S, and currently a Director of several public biotechnology companies.

    "Martin has a track record of success and leadership spanning the entire spectrum of drug development. He now brings his insight and experience to Morphic at an auspicious time as we are developing a portfolio of integrin-targeted drug candidates across a broad range of indications and stages of development," said Gustav Christensen, Chairman of the Morphic Board of Directors. "On behalf of the entire Morphic Team, I welcome Martin and look forward to his contributions."

    "Morphic Therapeutic has the unique capability to create oral therapeutics targeting the integrin receptors which have vast therapeutic potential," commented Dr. Edwards. "The MInT Platform has produced candidates to treat a variety of different diseases and now is a particularly important time for the company as MORF-057 progresses in phase 1 trials."

    Dr. Edwards is currently Chairman of KalVista Pharmaceuticals, Inc., and a member of the Board of Directors of Reata Pharmaceuticals, Inc., Verona Pharma PLC, and Inozyme Pharma, Inc. He recently retired as Senior Partner at Novo Holdings A/S. Prior to joining Novo Holdings A/S, Dr. Edwards was the Chief Executive Officer of ReNeuron Holdings. Prior to ReNeuron Holdings, Dr. Edwards was Corporate Vice President and Head of Drug Development for Novo Nordisk A/S, where he was responsible for all aspects of pre-clinical and clinical drug development. Earlier, he worked as Vice President Pharmacology and Medical Affairs of ZymoGenetics Inc. and then as Senior Vice President for Medical Affairs at Novo Nordisk USA. Dr. Edwards trained in physiology and medicine in Manchester, UK. He was elected as a Member of the Royal Colleges of Physicians, a Member with distinction of the Royal College of General Practitioners, a Fellow of the Faculty of Pharmaceutical Medicine and holds an MBA from the University of Warwick.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular, and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen, and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking" statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the MInT Platform's ability to discover drug candidates, Morphic's plans to develop and commercialize oral small-molecule integrin therapeutics, any expectations about safety, efficacy, timing and ability to commence or complete clinical studies and to obtain regulatory approvals for MORF-057 and other candidates in development, and the ability of MORF-057 and other candidates in development to treat serious chronic diseases.

    Statements including words such as "believe," "plan," "continue," "expect," "will," "develop," "signal," "potential," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements.

    Forward-looking statements are subject to risks and uncertainties that may cause Morphic's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including Morphic's or a partner's ability to develop, obtain regulatory approval for or commercialize any product candidate, Morphic's ability to protect intellectual property, the potential impact of the COVID-19 pandemic and the sufficiency of our cash, cash equivalents and investments to fund our operations. These forward-looking statements speak only as of the date hereof and Morphic specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

    Contacts

    Morphic Therapeutic

    Chris Erdman



    617.686.1718

    Media Contact

    Adam Silverstein, Ten Bridge Communications



    917.697.9313



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  4. WALTHAM, Mass., Nov. 17, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral therapies targeting integrins for the treatment of serious chronic diseases, today announced that members of the Morphic management are scheduled to participate in the Jefferies Virtual London Healthcare Conference with a Company presentation at 2:55 PM ET on Wednesday, November 18, 2020.

    A live webcast of the company presentation will be available on the Investor section of Morphic's website at www.morphictx.com. An archived replay will be available on the company's website following the conference.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing…

    WALTHAM, Mass., Nov. 17, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral therapies targeting integrins for the treatment of serious chronic diseases, today announced that members of the Morphic management are scheduled to participate in the Jefferies Virtual London Healthcare Conference with a Company presentation at 2:55 PM ET on Wednesday, November 18, 2020.

    A live webcast of the company presentation will be available on the Investor section of Morphic's website at www.morphictx.com. An archived replay will be available on the company's website following the conference.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Contacts

    Morphic Therapeutic

    Chris Erdman

     

    617.686.1718



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  5. Initiated phase 1 clinical trial for MORF-057 with results expected by mid-2021

    Presented data at UEG 2020 that reinforce preclinical potency and selectivity profile of MORF-057

    Received $20 million from AbbVie exercising option to αvβ6 integrin inhibitor program

    WALTHAM, Mass., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today reported corporate highlights and third quarter 2020 financial results.

    "During the third quarter, Morphic made the most noteworthy progress yet in our mission to deliver the first generation of oral medicines targeting integrin receptors. In September, we announced…

    Initiated phase 1 clinical trial for MORF-057 with results expected by mid-2021

    Presented data at UEG 2020 that reinforce preclinical potency and selectivity profile of MORF-057

    Received $20 million from AbbVie exercising option to αvβ6 integrin inhibitor program

    WALTHAM, Mass., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today reported corporate highlights and third quarter 2020 financial results.

    "During the third quarter, Morphic made the most noteworthy progress yet in our mission to deliver the first generation of oral medicines targeting integrin receptors. In September, we announced that the first healthy volunteers received MORF-057 in a phase 1 clinical trial designed to generate safety and pharmacokinetic data, as well as to measure levels of α4β7 receptor occupancy, a key potential proof-of-concept biomarker in inflammatory bowel disease," said Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic. "MORF-057 is the first in our pipeline of selective integrin inhibitor candidates generated by the MInT Platform to enter clinical trials. Further, AbbVie recently exercised its option to exclusively license our αvβ6 integrin inhibitor program for the treatment of fibrotic diseases. AbbVie's decision further validates the MInT Platform and our team's ability to generate high quality small molecule integrin inhibitors and to design and execute rigorous discovery and development programs."

    Morphic is developing MORF-057 as a selective, oral small molecule inhibitor of the α4β7 integrin, a target for the treatment of inflammatory bowel disease (IBD) with an initial focus on moderate-to-severe ulcerative colitis (UC). The mechanism of α4β7 inhibition to treat IBD has been clinically validated by the approved infused antibody therapy, vedolizumab.

    Third quarter and recent corporate highlights:

    • Initiated a phase 1 clinical trial of MORF-057 in healthy volunteers
      • The randomized, double-blind, placebo-controlled, single and multiple ascending dose study in healthy adults will evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of MORF-057; a concurrent food effect study will also be conducted
      • The full data set from the trial is expected to be presented at a major medical conference by mid-2021 with potential release of initial single-ascending dose cohort results in first quarter 2021, including key safety and receptor occupancy data



    • Announced AbbVie exercised its option to exclusively license the αvβ6 integrin inhibitor program for fibrotic diseases



      • AbbVie paid Morphic a license fee of $20.0 million, with future potential regulatory and commercial milestones and royalties from the sales of any commercialized candidates
      • The exclusive license covers Morphic's αvβ6 integrin specific program, including the compounds MORF-720 and MORF-627, discovered from the MInT Platform, Morphic's proprietary platform for the discovery of oral integrin drugs



    • Presented additional preclinical data on the MORF-057 program at United European Gastroenterology (UEG) Week Virtual 2020



      • The UEG data reinforce the high potency and selectivity of MORF-057 for its integrin target, α4β7, through ex vivo human translational biomarkers
      • These data further reinforce the potential for MORF-057 to act through the same clinically validated mechanism as the approved injectable, infused antibody, vedolizumab, but using a potentially more convenient oral small molecule
      • Notably, these data also validated a novel physiologically relevant assay to measure α4β7 receptor occupancy in human whole blood, a key pharmacodynamic marker being studied in the ongoing phase 1 clinical trial of MORF-057

    Financial Results for Third Quarter 2020

    Net income for the quarter ended September 30, 2020 was $5.4 million or $0.17 per share, diluted compared to a net loss of $8.9 million or $0.30 per share, basic and diluted for the same quarter last year.

    • Revenue was $25.8 million for the quarter ended September 30, 2020 compared to $5.7 million for the same quarter last year. The increase was primarily due the receipt of a $20.0 million payment triggered by AbbVie exercising their option to Morphic's αvβ6 program
    • Research and development expenses were $16.0 million for the quarter ended September 30, 2020, compared to $12.6 million in the same quarter last year. The $3.4 million increase year-over-year reflects clinical, development and manufacturing costs associated with our lead wholly owned α4β7 clinical program; and increased personnel-related costs to support continued progress with the company's pipeline
    • General and administrative expenses were $4.8 million for the quarter ended September 30, 2020, compared to $2.9 million in the same quarter last year. The $1.9 million increase year-over-year was primarily attributable to increased headcount and higher professional fees to operate as a public company along with consulting fees associated with ongoing business development activities

    As of September 30, 2020, Morphic had cash, cash equivalents, and marketable securities of $213.1 million, compared to $237.0 million at the end of 2019. Through utilization of at-the-market (ATM) offerings during the third quarter of 2020, Morphic raised net proceeds of $6.3 million. Morphic believes its cash, cash equivalents, and marketable securities balance as of September 30, 2020 will be sufficient to fund operating expenses and capital expenditure requirements into at least the end of 2022.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT Platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking" statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Morphic's or our partners' plans or ability to develop, obtain approval for any indication or disease and/or commercialize any oral small-molecule integrin therapeutics, including MORF-057, MORF-720, MORF-627, and any other candidates in development, the ability of MORF-057 to treat inflammatory bowel disease, the ability of MORF-720 and MORF-627 to treat idiopathic pulmonary fibrosis as well as other fibrotic diseases, the potential impact of the COVID-19 pandemic and the sufficiency of our cash, cash equivalents and investments to fund our operations. Statements including words such as "believe," "plan," "continue," "expect," "will be," "develop," "signal," "potential," "anticipate" or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause Morphic's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Morphic's ability to develop, obtain regulatory approval for and commercialize MORF-057, MORF-720, and other product candidates, the timing and results of preclinical studies and clinical trials, the potential impact of the COVID-19 pandemic, Morphic's ability to protect intellectual property; and other risks set forth in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Morphic specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

    -Financial Tables to Follow-



     
    Morphic Holding Inc.
    Condensed Consolidated Statements of Operations
    (unaudited)
    (in thousands, except share and per share data)
                 
                 
      Three Months Ended Nine Months Ended
    September 30 September 30
       2020   2019   2020   2019 
             
    Collaboration revenue$25,757  $5,675  $39,044  $17,311 
    Operating expenses:       
    Research and development 15,998   12,635   54,877   36,912 
    General and administrative 4,751   2,898   13,368   6,807 
    Total operating expenses 20,749   15,533   68,245   43,719 
    Income (loss) from operations 5,008   (9,858)   (29,201)   (26,408) 
    Interest income, net 231   1,298   1,524   3,480 
    Total other income 231   1,298   1,524   3,480 
    Income (loss) before benefit from

    (provision for) income taxes
     5,239   (8,560)   (27,677)   (22,928) 
    Benefit from (provision for) income taxes 115   (304)   427   (569) 
    Net income (loss)$5,354  $(8,864)  $(27,250)  $(23,497) 
    Net income (loss) per share, basic$0.18  $(0.30)  $(0.90)  $(2.06) 
    Net income (loss) per share, diluted$0.17  $(0.30)  $(0.90)  $(2.06) 
    Weighted-average common shares               
    outstanding - basic 30,533,847   29,999,170   30,368,437   11,393,192 
    Weighted-average common shares               
    outstanding - diluted 32,366,141   29,999,170   30,368,437   11,393,192 



      
    Morphic Holding Inc.
     Condensed Consolidated Balance Sheets 
     (unaudited)
     (in thousands)
         
      September 30, 2020  December 31, 2019 
    Assets   
     Cash, cash equivalents and marketable securities$213,146  $237,016 
     Other current assets 5,255   6,557 
     Total current assets 218,401   243,573 
     Other assets 3,177   3,862 
    Total assets$221,578  $247,435 
         
    Liabilities and Stockholders' Equity   
     Current liabilities$35,578  $35,350 
     Long-term liabilities 55,696   71,167 
     Total liabilities 91,274   106,517 
     Total stockholders' equity 130,304   140,918 
    Total liabilities and stockholders' equity$221,578  $247,435 
            

    Contacts

    Morphic Therapeutic

    Chris Erdman



    617.686.1718

    Media Contact

    Adam Silverstein, Ten Bridge Communications



    917.697.9313

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  6. -Data validate physiologically relevant assay used in MORF-057 Phase 1 studies to measure receptor occupancy of α4β7 integrin-
    -MORF-057, inhibitor of α4β7 integrin, in development to treat inflammatory bowel disease-

    WALTHAM, Mass., Oct. 12, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced a poster presentation with new preclinical data on MORF-057 at the UEG Week Virtual 2020 meeting. These new data support the profile of MORF-057 as a potent, selective, and orally available small molecule inhibitor of the integrin α4β7 and establish assays for key clinically relevant biomarkers in the…

    -Data validate physiologically relevant assay used in MORF-057 Phase 1 studies to measure receptor occupancy of α4β7 integrin-

    -MORF-057, inhibitor of α4β7 integrin, in development to treat inflammatory bowel disease-

    WALTHAM, Mass., Oct. 12, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced a poster presentation with new preclinical data on MORF-057 at the UEG Week Virtual 2020 meeting. These new data support the profile of MORF-057 as a potent, selective, and orally available small molecule inhibitor of the integrin α4β7 and establish assays for key clinically relevant biomarkers in the ongoing Phase 1 trial of MORF-057. MORF-057 is in clinical development as an oral small molecule inhibitor of the α4β7 integrin for the treatment of inflammatory bowel disease (IBD) with an initial focus on ulcerative colitis (UC).

    "The data presented at UEG Week 2020 expand on the results from previous studies demonstrating the high selectivity of MORF-057 for its integrin target, α4β7, through ex vivo human translational biomarkers," stated Bruce Rogers, PhD, chief scientific officer of Morphic. "Importantly, with these data, Morphic has validated a physiologically relevant assay to measure α4β7 receptor occupancy in human whole blood, an important pharmacodynamic marker being studied in the ongoing phase 1 trial of MORF-057. We are now focused on the translation of these promising preclinical data into clinical results from the Phase 1 study of MORF-057."

    Details of the Poster Presentation at UEG

    Title: Translational biomarkers for selective, oral, small molecule α4β7 inhibitor MORF-057

    Presenter: Maloy Mangada, PhD, Associate Director Translational Sciences, Morphic Therapeutic Inc.

    Contributors: Maloy Mangada, Naresh S. Redhu, Terence Moy, Ali Hussain, Vinod Yadav, Fu-Yang Lin, Brianna Bannister, Raegan Bonesteel, Sarah St. Gelais, Dan Cui, Andrew Sullivan, Liangsu Wang, Alex Lugovskoy, Kwangsoo Kim, Jessica Pondish, Peter Traber, Peter Linde, Dawn Troast, Cheng Zhong, Kristopher N. Hahn, Matthew G. Bursavich, Jamie Wong, Blaise Lippa, Bruce N. Rogers and Adrian S. Ray

    This UEG poster is available on the Morphic website on the Investor page.

    About MORF-057

    Morphic is developing MORF-057 as a selective, oral small molecule inhibitor of the α4β7 integrin for patients with inflammatory bowel disease (IBD). α4β7 has been clinically validated as a target for the treatment of IBD by the success of the approved injectable antibody therapeutic vedolizumab. MORF-057 is designed to block the interactions between α4β7 on the surface of lymphocytes and the mucosal endothelial cell ligand MAdCAM-1, substantially reducing lymphocyte migration from the bloodstream into intestinal mucosal tissues and causing inflammation that is associated with IBD.

    About Inflammatory Bowel Disease

    Inflammatory Bowel Disease (IBD) comprises several autoimmune and immune-mediated conditions characterized by chronic inflammation of the gastrointestinal tract. Ulcerative colitis and Crohn's disease are two most common types of IBD. In ulcerative colitis, inflammation is limited to the lining of the colon, whereas in Crohn's disease inflammation can segmentally affect any part of the gastrointestinal tract through the entire thickness of the bowel wall. Symptoms of these conditions include persistent diarrhea, abdominal pain, rectal bleeding, weight loss, and fatigue. Approved medications may not adequately control symptoms for many patients, and some develop complications that require surgical removal of the colon and rectum. According to a report by the Crohn's and Colitis Foundation, as of November 2014, there were approximately 1,687,000 people living with ulcerative colitis and Crohn's disease in the United States, with 71,000 new cases diagnosed per year. Among FDA approved therapies for use in moderate to severe IBD is vedolizumab, an injectable monoclonal antibody inhibitor of the integrin α4β7.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular, and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen, and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking" statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the MInT Platform's ability to discover drug candidates, Morphic's plans to develop and commercialize oral small-molecule integrin therapeutics, the execution of the phase 1 clinical trial as designed, any expectations about safety, efficacy, timing and ability to commence or complete clinical studies and to obtain regulatory approvals for MORF-057 and other candidates in development, and the ability of MORF-057 to treat inflammatory bowel disease or related indications.

    Statements including words such as "believe," "plan," "continue," "expect," "will," "develop," "signal," "potential," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements.

    Forward-looking statements are subject to risks and uncertainties that may cause Morphic's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including Morphic's or a partner's ability to develop, obtain regulatory approval for or commercialize any product candidate, Morphic's ability to protect intellectual property, the potential impact of the COVID-19 pandemic and the sufficiency of our cash, cash equivalents and investments to fund our operations. These forward-looking statements speak only as of the date hereof and Morphic specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

    Contacts

    Morphic Therapeutic

    Chris Erdman



    617.686.1718

    Media Contact

    Nichole Sarkis, Ten Bridge Communications



    774.278.8273

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  7. First orally available integrin inhibitor from MInT Platform to enter the clinic
    MORF-057, inhibitor of α4β7 integrin, in development to treat inflammatory bowel disease
    Phase 1 program to assess safety and pharmacokinetics of MORF-057 as well as α4β7 receptor occupancy as a clinically relevant biomarker

    WALTHAM, Mass., Sept. 23, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced that the first healthy volunteers have received MORF-057 in a phase 1 clinical trial designed to evaluate MORF-057's safety and pharmacokinetic profile in addition to predictive pharmacodynamic signals. MORF-057…

    First orally available integrin inhibitor from MInT Platform to enter the clinic

    MORF-057, inhibitor of α4β7 integrin, in development to treat inflammatory bowel disease

    Phase 1 program to assess safety and pharmacokinetics of MORF-057 as well as α4β7 receptor occupancy as a clinically relevant biomarker

    WALTHAM, Mass., Sept. 23, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced that the first healthy volunteers have received MORF-057 in a phase 1 clinical trial designed to evaluate MORF-057's safety and pharmacokinetic profile in addition to predictive pharmacodynamic signals. MORF-057 is in clinical development as an oral small molecule inhibitor of the α4β7 integrin for the treatment of inflammatory bowel disease (IBD) with an initial focus on ulcerative colitis (UC).

    "Morphic designed MORF-057 with its MInT Platform, a unique platform for the discovery and development of oral integrin drugs, to be a highly selective and potent orally administered inhibitor of the α4β7 integrin, a well-validated target in IBD. The initiation of clinical trials for MORF-057 marks a major step forward in this effort," stated Dr. Peter Linde, MD, chief medical officer of Morphic Therapeutic. "Based on its extensive preclinical data package, we believe that MORF-057 can selectively target the same clinically validated mechanism as the approved injectable antibody, vedolizumab, but utilizing a substantially more convenient oral small molecule. The MORF-057 phase 1 trial is designed to generate safety and pharmacokinetic data, as well as to provide key measures of α4β7 receptor occupancy, at multiple doses being evaluated in this program. These results may provide early clinical proof-of-concept for MORF-057 and we expect to present these data at a major medical conference in the first half of next year."

    About the MORF-057 Phase 1 Clinical Trial

    The phase 1 clinical trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MORF-057 dosed twice daily across three parts enrolling at least 76 healthy volunteers. The initial part of the phase 1 trial will evaluate single ascending doses in 40 or more volunteers across five or more dose cohorts of MORF-057. The second part of the trial will evaluate multiple ascending doses in 24 or more volunteers across at least three dose cohorts of MORF-057. A third part will evaluate the effect of food on the pharmacokinetic effects of MORF-057 in two cohorts of six subjects, each receiving MORF-057 in fed and fasting states. The phase 1 program is designed to generate important receptor occupancy data in each dose cohort that could potentially provide early clinical proof-of-concept and dose selection guidance for use in future studies of MORF-057.

    About MORF-057

    Morphic is developing MORF-057 as a selective, oral small molecule inhibitor of the α4β7 integrin for patients with inflammatory bowel disease (IBD). α4β7 has been clinically validated as a target for the treatment of IBD by the success of the approved injectable antibody therapeutic vedolizumab. MORF-057 is designed to block the interactions between α4β7 on the surface of lymphocytes and the mucosal endothelial cell ligand MAdCAM-1, substantially reducing lymphocyte migration from the bloodstream into intestinal mucosal tissues and causing inflammation that is associated with IBD.

    About Inflammatory Bowel Disease

    Inflammatory Bowel Disease (IBD) comprises several autoimmune and immune-mediated conditions characterized by chronic inflammation of the gastrointestinal tract. Ulcerative colitis and Crohn's disease are two most common types of IBD. In ulcerative colitis, inflammation is limited to the lining of the colon, whereas in Crohn's disease inflammation can segmentally affect any part of the gastrointestinal tract through the entire thickness of the bowel wall. Symptoms of these conditions include persistent diarrhea, abdominal pain, rectal bleeding, weight loss, and fatigue. Approved medications may not adequately control symptoms for many patients, and some develop complications that require surgical removal of the colon and rectum. According to a report by the Crohn's and Colitis Foundation, as of November 2014, there were approximately 1,687,000 people living with ulcerative colitis and Crohn's disease in the United States, with 71,000 new cases diagnosed per year. Among FDA approved therapies for use in moderate to severe IBD is vedolizumab, an injectable monoclonal antibody inhibitor of the integrin α4β7.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular, and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen, and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking" statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the MInT Platform's ability to discover drug candidates, Morphic's plans to develop and commercialize oral small-molecule integrin therapeutics, the execution of the phase 1 clinical trial as designed, any expectations about safety, efficacy, timing and ability to commence or complete clinical studies and to obtain regulatory approvals for MORF-057 and other candidates in development, and the ability of MORF-057 to treat inflammatory bowel disease or related indications.

    Statements including words such as "believe," "plan," "continue," "expect," "will," "develop," "signal," "potential," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements.

    Forward-looking statements are subject to risks and uncertainties that may cause Morphic's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including Morphic's or a partner's ability to develop, obtain regulatory approval for or commercialize any product candidate, Morphic's ability to protect intellectual property, the potential impact of the COVID-19 pandemic and the sufficiency of our cash, cash equivalents and investments to fund our operations. These forward-looking statements speak only as of the date hereof and Morphic specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

    Contacts

    Morphic Therapeutic

    Chris Erdman



    617.686.1718

    Media Contact

    Tom Donovan, Ten Bridge Communications



    857.559.3397

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  8. WALTHAM, Mass., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral therapies targeting integrins for the treatment of serious chronic diseases, today announced two presentations at the Jefferies Next Generation IBD Therapeutics Virtual Summit. Members of the Morphic management team are scheduled to participate in a panel discussion at 8:45 a.m. ET on Wednesday, September 23, 2020, as well as present a company overview at 1:00 p.m. ET on the same day.

    A live webcast of the company presentation will be available on the Investor section of Morphic's website at https://www.morphictx.com. An archived replay will be available on the company's website following the…

    WALTHAM, Mass., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral therapies targeting integrins for the treatment of serious chronic diseases, today announced two presentations at the Jefferies Next Generation IBD Therapeutics Virtual Summit. Members of the Morphic management team are scheduled to participate in a panel discussion at 8:45 a.m. ET on Wednesday, September 23, 2020, as well as present a company overview at 1:00 p.m. ET on the same day.

    A live webcast of the company presentation will be available on the Investor section of Morphic's website at https://www.morphictx.com. An archived replay will be available on the company's website following the conference.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Contacts

    Morphic Therapeutic

    Chris Erdman



    617.686.1718

    Media Contact

    Tom Donovan, Ten Bridge Communications



    857.559.3397

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  9. WALTHAM, Mass., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced participation in the following investor conferences:

    • Praveen Tipirneni, M.D., president and chief executive officer is scheduled to take part in a fireside chat at 8:40 am ET on Thursday, September 10 at the 2020 Wells Fargo Virtual Healthcare Conference
    • The Morphic management team will host virtual meetings during the Citi 15th Annual BioPharma Virtual Conference taking place from September 8 to 11

    A live webcast of the Wells Fargo session will be available on the Investors section of Morphic's website at https://www.morphictx.com

    WALTHAM, Mass., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced participation in the following investor conferences:

    • Praveen Tipirneni, M.D., president and chief executive officer is scheduled to take part in a fireside chat at 8:40 am ET on Thursday, September 10 at the 2020 Wells Fargo Virtual Healthcare Conference
    • The Morphic management team will host virtual meetings during the Citi 15th Annual BioPharma Virtual Conference taking place from September 8 to 11

    A live webcast of the Wells Fargo session will be available on the Investors section of Morphic's website at https://www.morphictx.com. An archived replay will be available on the company's website following the conference.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen, and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Contacts

    Morphic Therapeutic

    Chris Erdman



    617.686.1718

    Media Contact

    Tom Donovan, Ten Bridge Communications



    857.559.3397

     

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  10. AbbVie to pay Morphic license fee of $20 million, with future potential milestones and royalties

    AbbVie to lead further development and commercialization

    WALTHAM, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, and AbbVie (NYSE:ABBV) today announced that AbbVie has exercised a license option under the companies' research and development collaboration agreement to develop Morphic's αvβ6 integrin inhibitors for the treatment of fibrotic diseases including idiopathic pulmonary fibrosis (IPF) and additional indications. The αvβ6 integrin activates transforming growth factor beta (TGF-β…

    AbbVie to pay Morphic license fee of $20 million, with future potential milestones and royalties

    AbbVie to lead further development and commercialization

    WALTHAM, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, and AbbVie (NYSE:ABBV) today announced that AbbVie has exercised a license option under the companies' research and development collaboration agreement to develop Morphic's αvβ6 integrin inhibitors for the treatment of fibrotic diseases including idiopathic pulmonary fibrosis (IPF) and additional indications. The αvβ6 integrin activates transforming growth factor beta (TGF-β), a key driver of tissue fibrosis. The license covers αvβ6 integrin specific inhibitors discovered from Morphic's proprietary MInT Platform, including the compounds MORF-720 and MORF-627, which are supported by an extensive preclinical data package demonstrating potential as treatments for IPF as well as other fibrotic diseases. Pursuant to the agreement between Morphic and AbbVie, Morphic will receive a license fee of $20 million, with potential future development milestone payments and royalties from the sales of any commercialized candidates.

    "The preclinical data strongly support Morphic's selective small molecule inhibitors of αvβ6 for development in fibrotic disease. AbbVie has been an excellent partner through the preclinical development of this program and we believe that their decision to assume leadership for the next stages of development is a strong vote of confidence in our collaboration, as well as Morphic's MInT platform to generate orally available integrin inhibitors," said Praveen Tipirneni, MD, president and chief executive officer of Morphic Therapeutic.

    About the Morphic-AbbVie Agreement

    Under the terms of the original agreement, AbbVie paid Morphic an upfront payment of $100 million for exclusive license options on product candidates directed at multiple targets. For each target, Morphic will conduct R&D activities through the completion of IND-enabling studies, at which point AbbVie may pay a license fee to exercise its exclusive license option and assume responsibility for global development and commercialization. Morphic is also eligible for additional, undisclosed clinical and commercial milestone payments and tiered royalties on worldwide net sales for each compound. Morphic retains cost-sharing rights in the development of liver fibrosis indications, and may opt into paying a percentage of AbbVie's development costs in exchange for enhanced royalties. 

    About Fibrosis and TGF-β

    Fibrosis occurs when chronic inflammation or persistent injury leads to the development of excessive connective tissue, which can lead to organ damage and impaired function. Fibrotic diseases can affect nearly all tissues and organ systems and, due to limited treatment options, can cause serious illness and death.

    The pro-fibrotic cytokine TGF-β is a key regulator of fibrosis, but attempts to globally suppress its activity have suffered from a narrow therapeutic index (dose-limiting toxicity). Several integrins, such as αvβ6, play a dominant role in local activation of TGF-β in diseased tissues. Inhibition of these integrins is therefore a compelling strategy for treating chronic fibrotic diseases with significant advantage over global TGF-β inhibitors.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen, and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Morphic Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking" statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Morphic's or Morphic's partners' plan to develop and commercialize oral small-molecule integrin therapeutics; the ability of MORF-720, MORF-627 or another αvβ6 integrin inhibitor to treat idiopathic pulmonary fibrosis or any other fibrotic disease; and Morphic's expectations about timing and ability to obtain regulatory approvals for MORF-720, MORF-627 or any other of its product candidates. Statements including words such as "believe," "plan," "continue," "expect," "will be," "develop," "signal," "potential," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause Morphic's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Morphic's or, in the case of MORF-720, MORF-627 or another αvβ6 integrin inhibitor AbbVie's, ability to develop, obtain regulatory approval for and commercialize MORF-720, MORF-627 or another αvβ6 integrin inhibitor or any other product candidates, the timing and results of preclinical studies and clinical trials, Morphic's ability to protect intellectual property; and other risks set forth in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Morphic specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

    About AbbVie

    AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

    AbbVie Forward-Looking Statements

    Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties, including the impact of the COVID-19 pandemic on AbbVie's operations, results and financial results, that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits of the Allergan acquisition, failure to promptly and effectively integrate Allergan's businesses, significant transaction costs and/or unknown or inestimable liabilities, potential litigation associated with the Allergan acquisition, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission (SEC). AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

    Contacts

    Morphic Therapeutic

    Chris Erdman



    617.686.1718

    Media Contact

    Tom Donovan, Ten Bridge Communications



    857.559.3397

    Primary Logo

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  11. Company's first IND accepted by FDA for MORF-057 in IBD
    Phase 1 study expected to begin in third-quarter 2020
    Positive data presented at DDW 2020 further support MORF-057 preclinical profile

    WALTHAM, Mass., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today reported corporate highlights and second quarter 2020 financial results.

    "Morphic has made tremendous strides with our lead program, MORF-057, an oral small molecule inhibitor of α4β7 in development to treat inflammatory bowel disease. I'm so proud of the efforts of our team that has taken this program from the bench in Dr. Tim Springer's…

    Company's first IND accepted by FDA for MORF-057 in IBD

    Phase 1 study expected to begin in third-quarter 2020

    Positive data presented at DDW 2020 further support MORF-057 preclinical profile

    WALTHAM, Mass., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today reported corporate highlights and second quarter 2020 financial results.

    "Morphic has made tremendous strides with our lead program, MORF-057, an oral small molecule inhibitor of α4β7 in development to treat inflammatory bowel disease. I'm so proud of the efforts of our team that has taken this program from the bench in Dr. Tim Springer's Lab to the clinic in just a few short years," commented Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic. "We recently presented a substantive preclinical data set at Digestive Disease Week that support MORF-057's profile as a candidate for the treatment of IBD through the proven mechanism of α4β7 inhibition with many potential advantages, including oral administration. While we are just beginning our clinical journey, I congratulate the Morphic team for the achievement of these important milestones on our mission to deliver a new generation of oral integrin therapeutics."

    Peter Linde, M.D., Morphic's chief medical officer, added, "We expect to initiate a robust clinical development program for MORF-057 imminently, beginning with a phase 1 clinical trial designed to evaluate the safety, pharmacokinetic and pharmacodynamic profile of this compound with single and multiple ascending dose cohorts. The phase 1 trial will also generate important receptor occupancy data that we believe could provide early clinical proof of concept and dose selection guidance for use in future studies within the MORF-057 program in IBD patients."

    Morphic is developing MORF-057 as a selective, oral small molecule inhibitor of the α4β7 integrin, a target for the treatment of inflammatory bowel disease (IBD) with an initial focus on moderate-to-severe ulcerative colitis (UC). The mechanism of α4β7 inhibition to treat IBD has been clinically validated by the success of the approved infused antibody therapy, vedolizumab.

    Second quarter and recent corporate highlights:

    • Announced acceptance of the Investigational New Drug (IND) filing for MORF-057 by the U.S. Food and Drug Administration (FDA), with a phase 1 clinical trial in healthy subjects expected to begin in the third quarter of 2020
      • The phase 1 trial is a randomized, double-blind placebo-controlled single and multiple ascending dose study in healthy adults evaluating endpoints including safety, tolerability, and pharmacokinetic and pharmacodynamic measures, as well as a concurrent food effect study
      • The full data set from the MORF-057 phase 1 trial is expected to be presented by mid-2021
    • Presented new positive preclinical data supporting MORF-057 in models of increasing complexity at the virtual Digestive Disease Week 2020
      • These data demonstrated MORF-057's inhibition of α4β7 -expressing lymphocyte migration to the gut, a fundamental contributor to IBD, acting through the same mechanism of action as the approved antibody therapeutic, vedolizumab
      • Further, oral administration of a MORF-057 analog in non-human primate studies demonstrated saturation of the α4β7 receptor throughout the entire 7-day dosing period – receptor saturation at the dosages assessed in preclinical studies provide further evidence that MORF-057 is an extremely potent inhibitor of α4β7  and may produce clinical efficacy
    • Continued progress in our collaboration with AbbVie on the development of integrin inhibitors, including αvβ6 and other integrin targets
    • Appointed Marc Schegerin, M.D., MBA, as chief operating officer and chief financial officer; Dr. Schegerin was previously chief financial officer of ArQule until its acquisition by Merck. His prior roles include senior positions in finance, business development and healthcare investment banking

    COVID-19 Preparedness

    Morphic is not currently aware of any significant delay to its timelines due to the COVID-19 pandemic. In light of the evolving circumstances, Morphic will continue to assess any potential impact of the COVID-19 pandemic in dialogue with regulators, partners and vendors.

    Financial Results for Second Quarter 2020

    Net loss for the quarter ended June 30, 2020 was $15.9 million or $0.52 per share compared to a net loss of $9.4 million or $4.73 per share for the same quarter last year.

    • Revenue was $7.7 million for the quarter ended June 30, 2020 compared to $5.6 million for the same quarter last year. The increase was due to higher level of research & development efforts in collaboration agreements signed with AbbVie in October 2018 and Janssen in February 2019
    • Research and development expenses were $19.9 million for the quarter ended June 30, 2020, compared to $13.9 million in the same quarter last year. The $6.0 million increase year-over-year reflects development and manufacturing costs associated with lead wholly owned product candidate, MORF-057; research costs associated with preclinical studies related to our partnered product candidate MORF-720 with AbbVie; as well as increased personnel-related costs to support continued progress with the company's pipeline
    • General and administrative expenses were $4.2 million for the quarter ended June 30, 2020, compared to $2.1 million in the same quarter last year. The $2.1 million increase year-over-year was primarily attributable to increased headcount and higher professional fees to operate as a public company along with consulting fees associated with ongoing business development activities

    As of June 30, 2020, Morphic had cash, cash equivalents and marketable securities of $202.5 million, compared to $237.0 million at the end of 2019. Morphic believes its cash, cash equivalents and marketable securities balance as of June 30, 2020 will be sufficient to fund operating expenses and capital expenditure requirements at least through the end of 2022.

    Financial Tables Follow

     
     
     Morphic Holding Inc.
    Condensed Consolidated Statements of Operations
    (unaudited)
    (in thousands, except share and per share data)
                  
                  
      Three Months Ended Six Months Ended
     June 30 June 30
       2020    2019    2020    2019   
             
    Collaboration revenue$7,693  $ 5,567   $13,287  $ 11,635   
    Operating expenses:       
    Research and development 19,918    13,907    38,878    24,278   
    General and administrative 4,195    2,077    8,618    3,908   
    Total operating expenses 24,113    15,984    47,496    28,186   
    Loss from operations (16,420)   (10,417)   (34,209)   (16,551)  
    Interest income, net 407    1,119    1,293    2,182   
    Total other income 407    1,119    1,293    2,182   
    Loss before benefit from (provision for) income taxes (16,013)   (9,298)   (32,916)   (14,369)  
    Benefit from (provision for) income taxes 155    (135)   312    (264)  
    Net loss$(15,858)  $(9,433)  $(32,604)  $(14,633)  
    Net loss per share, basic and diluted$(0.52)  $(4.73)  $1.08   $(7.54)  
    Weighted-average common shares outstanding, basic and diluted 30,360,851    1,992,410    30,274,713    1,940,923   
                      



      
     Morphic Holding Inc.
     Condensed Consolidated Balance Sheets 
     (unaudited)
     (in thousands)
         
      June 30, 2020  December 31, 2019 
    Assets   
     Cash, cash equivalents and marketable securities$202,538  $237,016 
     Other current assets 6,072   6,557 
     Total current assets 208,610   243,573 
     Other assets 3,389   3,862 
    Total assets$211,999  $247,435 
         
    Liabilities and Stockholders' Equity   
     Current liabilities$45,284  $35,350 
     Long-term liabilities 51,798   71,167 
     Total liabilities 97,082   106,517 
     Total stockholders' equity 114,917   140,918 
    Total liabilities and stockholders' equity$211,999  $247,435 
             

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking" statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Morphic's plan to develop and commercialize oral small-molecule integrin therapeutics and Morphic's expectations about timing and ability to commence or complete clinical studies and to obtain regulatory approvals for MORF-057, MORF-720, and other candidates in development, the ability of MORF-057 to treat inflammatory bowel disease, the potential impact of the COVID-19 pandemic and the sufficiency of our cash, cash equivalents and investments to fund our operations. Statements including words such as "believe," "plan," "continue," "expect," "will be," "develop," "signal," "potential," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause Morphic's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Morphic's ability to develop, obtain regulatory approval for and commercialize MORF-057, MORF-720, and other product candidates, the timing and results of preclinical studies and clinical trials, the potential impact of the COVID-19 pandemic, Morphic's ability to protect intellectual property; and other risks set forth in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Morphic specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

    Contacts

    Morphic Therapeutic

    Chris Erdman



    617.686.1718

    Media Contact

    Tom Donovan, Ten Bridge Communications



    857.559.3397

    Primary Logo

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  12. Receptor occupancy, potency and selectivity data further build MORF-057 preclinical profile as an oral small molecule treatment candidate for IBD

    IND filing on track for mid-year and phase 1 clinical trial expected third-quarter 2020

    WALTHAM, Mass., June 29, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced a presentation highlighting Morphic's product candidate MORF-057 at the 2020 Digestive Disease Week (DDW) virtual event. The new data presented at DDW expand on Morphic's recent oral presentation at the 15th Congress of the European Crohn's and Colitis Organisation (ECCO), which support…

    Receptor occupancy, potency and selectivity data further build MORF-057 preclinical profile as an oral small molecule treatment candidate for IBD

    IND filing on track for mid-year and phase 1 clinical trial expected third-quarter 2020

    WALTHAM, Mass., June 29, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced a presentation highlighting Morphic's product candidate MORF-057 at the 2020 Digestive Disease Week (DDW) virtual event. The new data presented at DDW expand on Morphic's recent oral presentation at the 15th Congress of the European Crohn's and Colitis Organisation (ECCO), which support MORF-057's development as a potent, selective, and orally available small molecule inhibitor of the integrin α4β7, a validated target for the treatment of inflammatory bowel disease (IBD).

    "The data presented at DDW demonstrate that MORF-057 successfully targets the integrin α4β7 with high potency and selectivity. These studies recapitulate results from previous in vitro and in vivo models of increasing complexity and bolster the emerging profile of MORF-057 by demonstrating saturation of α4β7 in non-human primate receptor occupancy studies," commented Bruce Rogers, Ph.D., chief scientific officer of Morphic Therapeutic. "We believe a safe and effective oral inhibitor of α4β7 would provide a highly differentiated new treatment for IBD and we now look forward to filing the Investigational New Drug Application for MORF-057 and the initiation of clinical studies for this promising drug candidate."

    About the MORF-057 DDW Presentation

    The data presented at DDW demonstrate MORF-057's inhibition of α4β7-expressing lymphocyte migration to the gut, which is a fundamental contributor to IBD. In mice, its inhibitory activity demonstrated potency comparable to an anti-α4β7 antibody. In non-human primate (NHP) models, MORF-057 demonstrated important proof of mechanistic activity by driving accumulation of mucosal homing α4β7-high expressing T cells in the peripheral blood, in an analogous manner to the approved anti-α4β7 antibody, vedolizumab. Importantly, a MORF-057 analog demonstrated >90% receptor occupancy of α4β7 in NHPs, providing an important indicator of the product candidate's target engagement.

    In biochemical assays MORF-057 demonstrated high selectivity over a broad panel of integrins. These results were consistent in cell adhesion assays, where MORF-057 showed greater than 3,000-fold targeted selectivity of α4β7 integrin over its nearest family members, including α4β1. MORF-057 was designed to achieve high selectivity for α4β7 over α4β1 to help prevent unwanted localized immune suppression potentially leading to certain adverse opportunistic infections. In contrast to small molecule or antibody inhibitors of α4β1, a MORF-057 analog did not show a statistically significant increase in lymphocytes in mice in these studies.

    Details of the Poster Presentation at DDW 2020:



    TitlePreclinical Characterization of an Oral Small Molecule Inhibitor Targeting the Integrin α4β7 for the Treatment of Inflammatory Bowel Diseases (IBD)



    Presenter: Dr. Jamie Wong, Ph.D.



    Contributors: Jamie Wong, Matthew Bursavich, Natalia Blanco, Adam Camblin, Laura Cappellucci, Rhianna Cohen, Dan Cui, Kris Hahn, Megan Krumpoch, Dooyoung Lee, Fu-Yang Lin, Blaise Lippa, Alex Lugovskoy, Molly McShea, Maloy Mangada, Siavash Mostafavi, Terence Moy, Adrian Ray, Naresh Redhu, Allison Sang, Andrew Sullivan, Peter Traber, Dawn Troast, Cheng Zhong, Liangsu Wang, Bruce Rogers

    This DDW presentation is available on the Morphic website on the Investor page.

    About MORF-057

    Morphic is developing MORF-057 as a selective, oral small molecule inhibitor of the α4β7 integrin for patients with inflammatory bowel disease (IBD). α4β7 has been clinically validated as a target for the treatment of IBD by the success of the approved antibody therapeutic vedolizumab. MORF-057 is designed to block the interactions between α4β7 on the surface of lymphocytes and the mucosal endothelial cell ligand MAdCAM-1, preventing lymphocyte migration from the bloodstream into intestinal mucosal tissues and causing inflammation. 

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen, and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking" statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Morphic's plan to develop and commercialize oral small-molecule integrin therapeutics; the ability of MORF-057 to treat inflammatory bowel disease; and Morphic's expectations about timing and ability to obtain regulatory approvals for MORF-057 or any other of its product candidates. Statements including words such as "believe," "plan," "continue," "expect," "will be," "develop," "signal," "potential," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause Morphic's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Morphic's ability to develop, obtain regulatory approval for and commercialize MORF-720, MORF-057, and other product candidates, the timing and results of preclinical studies and clinical trials, the potential impact of the COVID-19 pandemic, Morphic's ability to protect intellectual property; and other risks set forth in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Morphic specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

    Contacts

    Morphic Therapeutic

    Chris Erdman



    617.686.1718

    Media Contact

    Tom Donovan, Ten Bridge Communications

     

    857.559.3397

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  13. WALTHAM, Mass., June 18, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral therapies targeting integrins for the treatment of serious chronic diseases, today announced that Praveen Tipirneni, M.D., president and chief executive officer, and Marc Schegerin, M.D., chief financial officer and chief operating officer, are scheduled to make a presentation at the BMO 2020 Prescriptions for Success Healthcare Virtual Conference at 11:00 a.m. ET on Tuesday, June 23, 2020. Morphic will give an update on the company's progress across its portfolio of oral small molecule integrin inhibitors.

    A live webcast of the presentation will be available on the Investors section of Morphic's…

    WALTHAM, Mass., June 18, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral therapies targeting integrins for the treatment of serious chronic diseases, today announced that Praveen Tipirneni, M.D., president and chief executive officer, and Marc Schegerin, M.D., chief financial officer and chief operating officer, are scheduled to make a presentation at the BMO 2020 Prescriptions for Success Healthcare Virtual Conference at 11:00 a.m. ET on Tuesday, June 23, 2020. Morphic will give an update on the company's progress across its portfolio of oral small molecule integrin inhibitors.

    A live webcast of the presentation will be available on the Investors section of Morphic's website at https://www.morphictx.com. An archived replay will be available on the company's website following the conference.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Contacts

    Morphic Therapeutic

    Chris Erdman



    617.686.1718

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  14. Data presented at ECCO Congress support MORF-057 in IBD; IND on track for mid-year

    Recent executive appointments of Peter Linde, M.D., as CMO and Marc Schegerin, M.D., as CFO and COO

    WALTHAM, Mass., May 06, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today reported corporate highlights and first quarter 2020 financial results.

    "During the first quarter of 2020 Morphic made critical steps toward our goal of creating oral drugs targeting integrins with major advances in our scientific and operational groups," commented Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic…

    Data presented at ECCO Congress support MORF-057 in IBD; IND on track for mid-year

    Recent executive appointments of Peter Linde, M.D., as CMO and Marc Schegerin, M.D., as CFO and COO

    WALTHAM, Mass., May 06, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today reported corporate highlights and first quarter 2020 financial results.

    "During the first quarter of 2020 Morphic made critical steps toward our goal of creating oral drugs targeting integrins with major advances in our scientific and operational groups," commented Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic. "At the ECCO meeting, we presented preclinical data that strongly support the development of our candidate MORF-057, an oral inhibitor of α4β7, which is on track to enter clinical studies for inflammatory bowel disease in the second half of this year. These data demonstrated high specificity for its intended biologic target and mechanistic equivalence to the approved intravenous therapeutic against α4β7, vedolizumab. We also bolstered our executive management team with the appointments of two industry veterans as chief medical officer and chief financial and operating officer. We are now focused on completing the necessary preparations for Phase 1 studies of MORF-057 as Morphic's lead oral integrin inhibitor."

    Recent Corporate Highlights:

    • Presented new preclinical data in both murine and non-human primate models at the ECCO Annual Congress supporting MORF-057, a novel small molecule inhibitor of the α4β7 integrin in development for inflammatory bowel disease
      ○ In these data, MORF-057 demonstrated high specificity for the α4β7 integrin and clear biologic activity through its intended mechanism of action, blocking the migration of α4β7-high-expressing lymphocytes
    • Made substantial progress in our collaboration with AbbVie on the development of integrin inhibitors, including αvβ6 and other integrin targets
    • Appointed Peter G. Linde, M.D., as chief medical officer; Dr. Linde was formerly vice president of medical research at Acceleron Pharma, and additionally has significant prior clinical program development experience with agents across multiple therapeutic areas at AbbVie and Johnson & Johnson
    • Appointed Marc Schegerin, M.D., as chief financial officer and chief operating officer; Dr. Schegerin was previously chief financial officer of ArQule until its acquisition by Merck. His prior roles include senior positions in finance, business development and healthcare investment banking

    COVID-19 Preparedness
    Morphic is not currently aware of any significant delay to timelines due to the COVID-19 pandemic.  In light of the evolving circumstances, Morphic will continue to assess any potential impact of the COVID-19 pandemic in dialogue with regulators, partners and vendors.

    Financial Results for First Quarter 2020
    Net loss for the quarter ended March 31, 2020 was $16.7 million, or $0.55 per share, compared to a net loss of $5.2 million, or $2.77 per share, for the same quarter last year.

    • Revenue was $5.6 million for the quarter ended March 31, 2020 compared to $6.1 million for the same quarter last year. The decrease was due to lower revenue recognized on the AbbVie collaboration offset by an increase in revenue recognized on the Company's collaboration with Janssen as a result of higher FTE reimbursements in the quarter ended March 31, 2020. 
    • Research and development expenses were $19.0 million for the quarter ended March 31, 2020, compared to $10.4 million in the same quarter last year. The $8.6 million increase year-over-year reflects higher development and manufacturing costs associated with lead product candidate, MORF-057, along with increased research costs associated with other early development candidates, as well as increased personnel-related costs to support continued progress with the company's pipeline.
    • General and administrative expenses were $4.4 million for the quarter ended March 31, 2020, compared to $1.8 million in the same quarter last year. The $2.6 million increase year-over-year was primarily attributable to increased headcount and higher professional and consulting fees associated with ongoing business activities and Morphic's operating as a public company.

    As of March 31, 2020, Morphic had cash, cash equivalents and marketable securities of $219 million, compared to $237 million as of December 31, 2019. Morphic believes its cash, cash equivalents and marketable securities as of March 31, 2020 will be sufficient to fund operating expenses and capital expenditure requirements at least through the end of 2022.

    About Morphic Therapeutic
    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Cautionary Note Regarding Forward-Looking Statements
    This press release contains "forward-looking" statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Morphic's plan to develop and commercialize oral small-molecule integrin therapeutics and Morphic's expectations about timing and ability to obtain regulatory approvals for MORF-057 and other candidates in development; Morphic's cash runway through 2022;  or the impact of the COVID-19 pandemic that may adversely affect our business. Statements including words such as "on track," "believe," "plan," "continue," "expect," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause Morphic's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Morphic's ability to develop, obtain regulatory approval for and commercialize MORF-057, MORF-720 and other product candidates, the timing and results of preclinical studies and clinical trials, Morphic's ability to protect intellectual property; and other risks set forth in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Morphic specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.


    Morphic Holding Inc.
    Condensed Consolidated Statements of Operations
    (unaudited)
    (in thousands, except share and per share data)
           
           
      Three Months Ended
     March 31
        2020     2019
           
    Collaboration revenue $ 5,594   $ 6,068
    Operating expenses:      
    Research and development   18,960       10,370
    General and administrative     4,423       1,832
    Total operating expenses     23,383       12,202
    Loss from operations     (17,789)       (6,134)
    Interest income, net     886       1,063
    Total other income     886       1,063
    Loss before benefit from (provision for) income taxes   (16,903)     (5,071)
    Benefit from (provision for) income taxes   157     (129)
    Net loss $ (16,746)   $   (5,200)
    Net loss per share, basic and diluted $ (0.55)   $ (2.77)
               
    Weighted-average common shares outstanding - basic and diluted   30,188,575     1,879,986
               
               
               
     
     
    Morphic Holding Inc.
    Condensed Consolidated Balance Sheets 
    (unaudited)
    (in thousands)
           
      March 31, 2020    December 31, 2019 
    Assets      
    Cash, cash equivalents and marketable securities $ 219,012   $   237,016
    Other current assets   6,541       6,557
    Total current assets   225,553       243,573
    Other assets   3,605       3,862
    Total assets $   229,158   $   247,435
           
    Liabilities and Stockholders' Equity      
    Current liabilities $ 36,841   $   35,350
    Long-term liabilities    64,182       71,167
    Total liabilities    101,023       106,517
    Total stockholders' equity   128,135       140,918
    Total liabilities and stockholders' equity $   229,158   $   247,435
               


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    Morphic Therapeutic
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  15. WALTHAM, Mass., April 29, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral therapies targeting integrins for the treatment of serious chronic diseases, today announced that the Morphic executive team is scheduled to make a virtual presentation at the BofA Securities 2020 Health Care Conference at 3:00 p.m. ET on Wednesday, May 13, 2020. Morphic will give an update on the company's progress across its portfolio of oral small molecule integrin inhibitors.

    A live webcast of the presentation will be available on the Investors section of Morphic's website at https://www.morphictx.com. An archived replay will be available on the company's website for up to 90 days after the…

    WALTHAM, Mass., April 29, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral therapies targeting integrins for the treatment of serious chronic diseases, today announced that the Morphic executive team is scheduled to make a virtual presentation at the BofA Securities 2020 Health Care Conference at 3:00 p.m. ET on Wednesday, May 13, 2020. Morphic will give an update on the company's progress across its portfolio of oral small molecule integrin inhibitors.

    A live webcast of the presentation will be available on the Investors section of Morphic's website at https://www.morphictx.com. An archived replay will be available on the company's website for up to 90 days after the conference.

    About Morphic Therapeutic
    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Contacts
    Morphic Therapeutic
    Chris Erdman

    617.686.1718

    Media Contact
    Tom Donovan, Ten Bridge Communications

    857.559.3397

     

    Primary Logo

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  16. WALTHAM, Mass., April 07, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced the appointment of Marc Schegerin, M.D., as chief financial officer and chief operating officer. Dr. Schegerin was most recently chief financial officer of ArQule and joins Morphic with extensive experience in the biotechnology space spanning clinical and business development, strategy, finance and operations.

    "Marc is a veteran industry professional with an accomplished and diverse background in healthcare investment banking, drug development and medicine," said Praveen Tipirneni, president and chief executive…

    WALTHAM, Mass., April 07, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced the appointment of Marc Schegerin, M.D., as chief financial officer and chief operating officer. Dr. Schegerin was most recently chief financial officer of ArQule and joins Morphic with extensive experience in the biotechnology space spanning clinical and business development, strategy, finance and operations.

    "Marc is a veteran industry professional with an accomplished and diverse background in healthcare investment banking, drug development and medicine," said Praveen Tipirneni, president and chief executive officer of Morphic Therapeutic. "With the appointment of Dr. Schegerin, and the recent hiring of Peter G. Linde, M.D., as chief medical officer, Morphic has strategically expanded its leadership to support the clinical development of our portfolio of small molecule integrin inhibitors and drive long-term value creation from the MInT platform."

    Before joining Morphic, Dr. Schegerin served as chief financial officer, treasurer and head of strategy & communications at ArQule, an oncology-focused drug developer, until its recent acquisition by Merck for $2.7 billion. Prior to this role, Dr. Schegerin served in various senior healthcare investment banking roles at CitiGroup and Bank of America Merrill Lynch. Dr. Schegerin has held industry management roles at Biogen and Sage Therapeutics as a program director responsible for the overall strategy and execution of drug development for a number of candidates after beginning his career in the healthcare group at Goldman Sachs.

    "Morphic's unique approach to developing orally administered, small molecule integrin inhibitors represent a long-awaited advance in the drug development field, potentially opening new indications to integrin modulation and a more accessible modality for patients," commented Dr. Schegerin. "Integrins are a diverse, near-ubiquitous family of proteins, and a portfolio of integrin-targeting therapies has the potential to transform treatment for many chronic diseases, from autoimmune disorders to cancer. As both a physician and life science executive, I am excited by the possibilities that Morphic's capabilities provide for both patients and healthcare broadly."

    Dr. Schegerin earned his M.D. from Dartmouth Medical School and MBA from the Tuck School of Business at Dartmouth. Prior to Dartmouth, he received undergraduate degrees in premedical studies from Harvard University and finance from Tulane University.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen, and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking" statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Morphic's plan to develop and commercialize oral small-molecule integrin therapeutics; the ability of MORF-057 to treat inflammatory bowel disease; and Morphic's expectations about timing and ability to obtain regulatory approvals for MORF-057 or any other of its product candidates. Statements including words such as "believe," "plan," "continue," "expect," "will be," "develop," "signal," "potential," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause Morphic's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Morphic's ability to develop, obtain regulatory approval for and commercialize MORF-720, MORF-057, and other product candidates, the timing and results of preclinical studies and clinical trials, Morphic's ability to protect intellectual property; the ongoing COVID-19 pandemic and other risks set forth in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Morphic specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

    Contacts

    Morphic Therapeutic

    Chris Erdman



    617.686.1718

    Media Contact

    Tom Donovan, Ten Bridge Communications



    857.559.3397

    Primary Logo

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  17. WALTHAM, Mass., March 17, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced the appointment of Peter G. Linde, M.D., as chief medical officer. Dr. Linde was previously vice president of medical research at Acceleron Pharma, Inc., where he was responsible for the design and execution of clinical trials with positive outcomes in both pulmonary and hematologic diseases. Dr. Linde will oversee the development of Morphic's small molecule integrin inhibitors as the company advances its oral integrin inhibitors toward clinical trials.

    "Dr. Linde has an extensive track record of driving clinical…

    WALTHAM, Mass., March 17, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced the appointment of Peter G. Linde, M.D., as chief medical officer. Dr. Linde was previously vice president of medical research at Acceleron Pharma, Inc., where he was responsible for the design and execution of clinical trials with positive outcomes in both pulmonary and hematologic diseases. Dr. Linde will oversee the development of Morphic's small molecule integrin inhibitors as the company advances its oral integrin inhibitors toward clinical trials.

    "Dr. Linde has an extensive track record of driving clinical advancement across multiple therapeutic areas including inflammatory, pulmonary and hematologic disease. Notably, his experience includes clinical studies in inflammatory bowel disease, the therapeutic target of MORF-057, our lead oral integrin inhibitor anticipated to enter the clinic this year," commented Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic. "On behalf of everyone at Morphic, I welcome Dr. Linde to the team. We look forward to his leadership in developing the processes, partners and resources to guide MORF-057 and our portfolio of additional product candidates through development."

    Dr. Linde brings more than 15 years of experience in pharmaceutical clinical development and research. Most recently he served as vice president of medical research at Acceleron Pharma, Inc., where he led study design and development for clinical trials in pulmonary and hematologic diseases. These studies included the recently successful Phase 2 study of sotatercept in pulmonary arterial hypertension as well as late-stage development work on luspatercept, which in 2019 obtained FDA approval for treatment of transfusion-dependent patients with beta-thalassemia. Prior to this role, Dr. Linde was a project leader in clinical asset development at AbbVie, Inc., where he guided the global development of renal and immunology products. Dr. Linde also served as a senior director of clinical development at FibroGen, Inc., developing trial protocols and leading clinical studies to treat anemia in hemodialysis patients. Dr. Linde began his pharmaceutical career developing new indications for the decompensated heart failure treatment NATRECOR® (nesiritide) as a director of clinical research at Johnson & Johnson, Inc.

    "Morphic is built on world-class insight into integrin biology, outstanding medicinal chemistry and a growing body of impressive preclinical data. It has also established itself as the leader in the discovery of small molecule drug candidates that specifically target this important receptor class. Oral integrin therapy has the potential to transform treatments for patients suffering from diseases spanning autoimmunity, fibrosis and cancer," said Dr. Linde. "I am very much looking forward to guiding the clinical development of Morphic's pipeline."

    Dr. Linde completed medical school at Stanford University and a residency at the University of Pennsylvania Medical Center in internal medicine. He then went on to complete two fellowships at Massachusetts General Hospital/Harvard Medical School in nephrology and transplantation. Following the completion of his core medical training, Dr. Linde spent approximately 10 years as a practicing clinician, clinical instructor and mentor at several institutions including Allegheny University, Massachusetts General Hospital, Brigham & Women's Hospital and San Francisco General Hospital. Dr. Linde earned his bachelor's degrees from the Massachusetts Institute of Technology in both chemical engineering as well as applied biology. He is also an inventor on multiple issued patents relating to stem cell and extracorporeal organ support technologies.

    NATRECOR® is a registered trademark of Johnson & Johnson.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen, and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking" statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Morphic's plan to develop and commercialize oral small-molecule integrin therapeutics; the ability of MORF-057 to treat inflammatory bowel disease; and Morphic's expectations about timing and ability to obtain regulatory approvals for MORF-057 or any other of its product candidates. Statements including words such as "believe," "plan," "continue," "expect," "will be," "develop," "signal," "potential," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause Morphic's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Morphic's ability to develop, obtain regulatory approval for and commercialize MORF-720, MORF-057, and other product candidates, the timing and results of preclinical studies and clinical trials, Morphic's ability to protect intellectual property; and other risks set forth in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Morphic specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

    Contacts
    Morphic Therapeutic
    Chris Erdman

    617.686.1718

    Media Contact
    Tom Donovan, Ten Bridge Communications

    857.559.3397

    Primary Logo

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  18. WALTHAM, Mass., Feb. 28, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral therapies targeting integrins for the treatment of serious chronic diseases, today announced that Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic, is scheduled to present at the 40th Annual Cowen Health Care Conference at 8:00 AM ET on Wednesday, March 4, 2020. Dr. Tipirneni will provide an update on the company's progress across its portfolio of oral small molecule integrin inhibitors.

    A live webcast of the presentation will be available on the Investors section of Morphic's website at https://www.morphictx.com. An archived replay will be available on the…

    WALTHAM, Mass., Feb. 28, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral therapies targeting integrins for the treatment of serious chronic diseases, today announced that Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic, is scheduled to present at the 40th Annual Cowen Health Care Conference at 8:00 AM ET on Wednesday, March 4, 2020. Dr. Tipirneni will provide an update on the company's progress across its portfolio of oral small molecule integrin inhibitors.

    A live webcast of the presentation will be available on the Investors section of Morphic's website at https://www.morphictx.com. An archived replay will be available on the company's website after the conference.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Contacts

    Morphic Therapeutic
    Chris Erdman

    617.686.1718

    Media Contact
    Tom Donovan, Ten Bridge Communications

    857.559.3397

    Primary Logo

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  19. WALTHAM, Mass., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today reported corporate highlights and financial results for the full year 2019.

    2019 and Recent Corporate Highlights

    • Completed a successful Initial Public Offering with gross proceeds of $103.5 million

    • Announced a partnership with Janssen for the discovery of novel oral integrin inhibitors

    • Presented preclinical data supporting MORF-057 as an oral inhibitor candidate targeting α4β7; IND expected in mid-2020

    • Advanced development of MORF-720 in IPF with AbbVie, IND anticipated by year-end 2020

    • Year-end cash, cash equivalents and…

    WALTHAM, Mass., Feb. 27, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today reported corporate highlights and financial results for the full year 2019.

    2019 and Recent Corporate Highlights

    • Completed a successful Initial Public Offering with gross proceeds of $103.5 million

    • Announced a partnership with Janssen for the discovery of novel oral integrin inhibitors

    • Presented preclinical data supporting MORF-057 as an oral inhibitor candidate targeting α4β7; IND expected in mid-2020

    • Advanced development of MORF-720 in IPF with AbbVie, IND anticipated by year-end 2020

    • Year-end cash, cash equivalents and marketable securities of $237.0 million expected to fund operating expenses and capital expenditures requirements at least through 2022

    "Morphic Therapeutic made tremendous progress in our mission to develop oral integrin therapeutics during 2019 across both the developmental and financial aspects of our business. Notably, we completed a successful IPO in July 2019 that provided us with substantial resources to advance our proprietary pipeline of integrin-targeted candidates. Further, we struck an important partnership with Janssen that supports the exploration of a broader scope of integrin drug targets," commented Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic. "Moving forward, Morphic began 2020 with important milestones that signal the near-term initiation of clinical trials of our development pipeline. We recently presented preclinical data at ECCO 2020 supporting MORF-057's mechanism of action as being analogous to that of approved therapeutic vedolizumab, with a potentially superior target interaction profile and oral administration."

    Financial Results for the Full Year 2019

    • Net loss for the year ended December 31, 2019, was $43.3 million or $2.69 per share compared to a net loss of $23.8 million or $22.28 per share for the year ended December 31, 2018.
    • Revenue was $17.0 million for the year ended December 31, 2019, compared to $3.4 million for the year ended December 31, 2018. The increase was due to collaboration agreements signed with AbbVie in October 2018 and Janssen in February 2019.

    • Research and development expenses were $53.7 million for the year ended December 31, 2019, as compared to $22.6 million for the year ended December 31, 2018. The increase was primarily attributable to higher development and manufacturing costs associated with our lead product candidates, MORF-057 and MORF-720, as well as increased personnel-related costs to support continued progress with the company's pipeline.

    • General and administrative expenses were $10.2 million for the year ended December 31, 2019, compared to $5.4 million for the year ended December 31, 2018. The increase year-over-year was primarily attributable to increased headcount and higher professional and consulting fees associated with ongoing business activities and Morphic's costs to operate as a public company.

    As of December 31, 2019, Morphic had cash, cash equivalents and marketable securities of $237.0 million, compared to $185.9 million as of December 31, 2018. Morphic believes its cash, cash equivalents and marketable securities as of December 31, 2019, will be sufficient to fund operating expenses and capital expenditure requirements at least through 2022.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen, and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking" statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Morphic's plan to develop and commercialize oral small-molecule integrin therapeutics and Morphic's expectations about timing and ability to obtain regulatory approvals for MORF-720, MORF-057, and other candidates in development and the sufficiency of our cash, cash equivalents and investments to fund our operations. Statements including words such as "believe," "plan," "continue," "expect," "will be," "develop," "signal," "potential," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause Morphic's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Morphic's ability to develop, obtain regulatory approval for and commercialize MORF-720, MORF-057, and other product candidates, the timing and results of preclinical studies and clinical trials, Morphic's ability to protect intellectual property; and other risks set forth in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Morphic specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

     
     
    Morphic Holding Inc.
     
    Condensed Consolidated Statements of Operations
     
    (unaudited)
     
    (in thousands, except share and per share data)
     
        Year Ended December 31, 
        2019     2018  
                 
    Collaboration revenue - AbbVie   $ 10,797     $ 3,358  
    Collaboration revenue - Janssen     6,180        
          16,977       3,358  
    Operating expenses:            
    Research and development     53,732       22,631  
    General and administrative     10,233       5,355  
    Total operating expenses     63,965       27,986  
    Loss from operations     (46,988 )     (24,628 )
    Other income:            
    Interest income, net     4,666       871  
    Other expense, net     (94 )     (74 )
    Total other income, net     4,572       797  
    Loss before provision for income taxes     (42,416 )     (23,831 )
    Provision for income taxes     (912 )      
    Net loss   $ (43,328 )   $ (23,831 )
    Net loss per share, basic and diluted     (2.69 )     (22.28 )
                 
    Weighted average common shares outstanding, basic and diluted     16,101,928       1,069,762  
                     


    Morphic Holding Inc.
     
    Condensed Consolidated Balance Sheets
     
    (unaudited)
     
    (in thousands)
     
        December 31,
    2019
      December 31,
    2018
    Assets            
    Cash, cash equivalents and marketable securities   $ 237,016   $ 185,901  
    Other current assets     6,557     1,222  
    Total current assets     243,573     187,123  
    Other assets     3,862     2,182  
    Total assets   $ 247,435   $ 189,305  
                 
    Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)            
    Current liabilities   $ 35,350   $ 34,903  
    Long-term liabilities     71,167     67,145  
    Total liabilities     106,517     102,048  
    Convertible preferred stock         139,809  
    Total stockholders' equity (deficit)     140,918     (52,552 )
    Total liabilities, convertible preferred stock and stockholders' equity (deficit)   $ 247,435   $ 189,305  
                   

    Contacts

    Morphic Therapeutic
    Chris Erdman

    617.686.1718

    Media Contact
    Tom Donovan, Ten Bridge Communications

    857.559.3397

    Primary Logo

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  20. Oral presentation at ECCO highlights MORF-057 as a potent, selective and orally available small molecule development candidate

    Mechanism of action demonstrated in in vitro and in vivo models

    WALTHAM, Mass., Feb. 14, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, announced an oral presentation today highlighting Morphic's product candidate MORF-057 at the 15th Congress of the European Crohn's and Colitis Organisation (ECCO). MORF-057 is in development as an oral inhibitor of the α4β7 integrin, a clinically proven target for the treatment of inflammatory bowel diseases (IBD).

    "The approved antibody therapeutic…

    Oral presentation at ECCO highlights MORF-057 as a potent, selective and orally available small molecule development candidate

    Mechanism of action demonstrated in in vitro and in vivo models

    WALTHAM, Mass., Feb. 14, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, announced an oral presentation today highlighting Morphic's product candidate MORF-057 at the 15th Congress of the European Crohn's and Colitis Organisation (ECCO). MORF-057 is in development as an oral inhibitor of the α4β7 integrin, a clinically proven target for the treatment of inflammatory bowel diseases (IBD).

    "The approved antibody therapeutic vedolizumab has provided validation of α4β7 as an effective target for the treatment of inflammatory bowel disease. However, a significant opportunity remains to address IBD with an orally administered therapeutic," commented Bruce Rogers, Ph.D., chief scientific officer of Morphic Therapeutic. "We are highly encouraged that the data presented at ECCO demonstrate MORF-057's favorable in vitro pharmacodynamic characteristics and these results are reinforced by the positive outcomes in in vivo models using oral administration of MORF-057. These data further strengthen our conviction to move MORF-057 forward into clinical studies as planned."

    MORF-057 was specifically designed to inhibit α4β7-mediated migration of α4β7-expressing lymphocytes to the gut, which is a fundamental contributor to IBD. The data presented at ECCO support MORF-057 as a potent, selective and orally bioavailable small molecule inhibitor of the α4β7 integrin. In the studies presented, MORF-057 showed greater than 41,600-fold selectivity for α4β7 over α4β1.1 High specificity for α4β7 over α4β1 is necessary to avoid inhibiting α4β1, which enables potentially pathological migration of lymphocytes to the central nervous system. Further, the data demonstrate that MORF-057 acts through its intended mechanism of action, by blocking the migration of α4β7-high-expressing lymphocytes. Notably, these results were replicated in both murine and primate models, with MORF-057 activity being equivalent to the murine equivalent of vedolizumab.

    Details of the Oral Presentation at ECCO 2020:
    Session: Current and novel targets for IBD agents
    Title: Discovery of highly selective small molecule oral inhibitors of integrin α4β7 for the treatment of inflammatory bowel diseases
    Presenter: Dr. Jamie Wong, Ph.D.
    Contributors: Matthew Bursavich, Natalia Blanco, Adam Camblin, Laura Cappellucci, Rhianna Cohen, Dan Cui, Megan Krumpoch, Cheng Zhong, Kristopher Hahn, Dooyoung Lee, Blaise Lippa, Fu-Yang Lin, Alex Lugovskoy, Molly McShea, Siavash Mostafavi, Terence Moy, Andrew Sullivan, Dawn Troast, Liangsu Wang, Bruce Rogers
    Presentation number: DOP64

    This ECCO presentation will be available on the Morphic website in the Investors section.

    About MORF-057
    Morphic is developing MORF-057 as a selective, oral small molecule inhibitor of the α4β7 integrin, a target for the treatment of inflammatory bowel diseases (IBD) that has been clinically validated by the success of the approved antibody therapeutic vedolizumab. α4β7 inhibition is intended to block the interactions between α4β7 on the surface of lymphocytes and the gut cell ligand MAdCAM-1, preventing lymphocyte migration from the bloodstream into intestinal mucosal tissues and causing inflammation. Morphic believes an approved oral α4β7 inhibitor has significant potential as a best-in-class medication for some types of IBD, and may offer therapeutic opportunity earlier in disease progression as a way of changing the course of disease for many patients.

    About Morphic Therapeutic
    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    1. ECCO presentation Wong, et al 2/14/20: selectivity was determined by comparing potency against α4β7 and α4β1 in RPMI8866 and Jurkat cell lines, respectively.

    Cautionary Note Regarding Forward-Looking Statements
    This press release contains "forward-looking" statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Morphic's plan to develop and commercialize oral small-molecule integrin therapeutics; the ability of MORF-057 or any α4β7-specific integrin inhibitors to treat inflammatory bowel disease; Morphic's ability to fund its operations; and Morphic's expectations about timing and ability to obtain regulatory approvals for MORF-057 or any α4β7-specific integrin inhibitors. Statements including words such as "believe," "develop," "support," "plan," "expect," "opportunity," or "potential" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause Morphic's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Morphic's ability to develop, obtain regulatory approval for and commercialize MORF-057 or any α4β7-specific integrin inhibitors and other product candidates, the timing and results of preclinical studies and clinical trials, Morphic's ability to protect intellectual property; and other risks set forth in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Morphic specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

    Contacts
    Morphic Therapeutic
    Chris Erdman
    SVP, Communications
     
    617.686.1718

    Media Contact
    Tom Donovan, Ten Bridge Communications
     
    857.559.3397

    Primary Logo

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  21. WALTHAM, Mass., Jan. 08, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced that Praveen Tipirneni, M.D., president and chief executive officer, is scheduled to present a corporate overview at the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020, at 8:00 a.m. PT.

    A live webcast of the presentation will be available on the Investors section of Morphic's website at https://www.morphictx.com. An archived replay will be available on the company's website for a period of 90 days after the conference.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical…

    WALTHAM, Mass., Jan. 08, 2020 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced that Praveen Tipirneni, M.D., president and chief executive officer, is scheduled to present a corporate overview at the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2020, at 8:00 a.m. PT.

    A live webcast of the presentation will be available on the Investors section of Morphic's website at https://www.morphictx.com. An archived replay will be available on the company's website for a period of 90 days after the conference.

    About Morphic Therapeutic

    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Morphic Contact
    Chris Erdman

    617.686.1718

    Media Contact
    Tom Donovan, Ten Bridge Communications

    857-559-3397

    Primary Logo

    View Full Article Hide Full Article
  22. WALTHAM, Mass., Nov. 18, 2019 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced that Praveen Tipirneni, M.D., president and chief executive officer, is scheduled to present a corporate overview at the Jefferies 2019 London Healthcare Conference on Thursday, November 21, 2019, at 1:20 p.m. GMT, in London.

    A live webcast of the presentation will be available on the Investors section of Morphic's website at https://www.morphictx.com. An archived replay will be available on the company's website for a period of 90 days after the conference.

    About Morphic Therapeutic
    Morphic Therapeutic is a biopharmaceutical…

    WALTHAM, Mass., Nov. 18, 2019 (GLOBE NEWSWIRE) -- Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today announced that Praveen Tipirneni, M.D., president and chief executive officer, is scheduled to present a corporate overview at the Jefferies 2019 London Healthcare Conference on Thursday, November 21, 2019, at 1:20 p.m. GMT, in London.

    A live webcast of the presentation will be available on the Investors section of Morphic's website at https://www.morphictx.com. An archived replay will be available on the company's website for a period of 90 days after the conference.

    About Morphic Therapeutic
    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Morphic Contact
    Robert E. Farrell, Jr., VP Finance/Operations and Treasurer

    781-996-0955

    Media Contact
    Tom Donovan, Ten Bridge Communications

    857-559-3397

    Primary Logo

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    • MORF-720, αvβ6-targeted oral integrin inhibitor IND now anticipated in the second half of 2020
    • α4β7-targeted oral integrin inhibitor candidate for IBD on track for IND by mid-2020
    • Morphic ends third quarter of 2019 with favorable cash, cash equivalents and marketable securities of $252 million

    WALTHAM, Mass., Nov. 12, 2019 (GLOBE NEWSWIRE) --  Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today reported corporate highlights and financial results for the third quarter of 2019.

    "Morphic began the third quarter of 2019 with a successful IPO, providing significant financial resources to fund the discovery and development of our…

    • MORF-720, αvβ6-targeted oral integrin inhibitor IND now anticipated in the second half of 2020
    • α4β7-targeted oral integrin inhibitor candidate for IBD on track for IND by mid-2020
    • Morphic ends third quarter of 2019 with favorable cash, cash equivalents and marketable securities of $252 million

    WALTHAM, Mass., Nov. 12, 2019 (GLOBE NEWSWIRE) --  Morphic Therapeutic (NASDAQ:MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, today reported corporate highlights and financial results for the third quarter of 2019.

    "Morphic began the third quarter of 2019 with a successful IPO, providing significant financial resources to fund the discovery and development of our portfolio of small-molecule integrin therapeutics," commented Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic. "As we look forward, we now believe that we will submit the IND for MORF-720, our oral αvβ6 inhibitor for patients with fibrotic disease being developed in collaboration with AbbVie, in the second half of 2020, based on the request for an additional preclinical study by the FDA. In Morphic's wholly-owned portfolio, we remain on track to file an IND for our oral inhibitor of α4β7 for patients with inflammatory bowel disease in mid-2020. Further, Morphic continues to refine and apply the MInT platform, a suite of technologies designed to streamline rapid and effective discovery of drug candidates across the entire integrin target class, where we have deep expertise."

    Third Quarter Highlights and Program Updates

    Oral Integrin Development Program Updates
    Oral αvβ6 Inhibition Program for Fibrotic Diseases

    • Morphic now believes that the IND submission for MORF-720, a selective oral αvβ6-specific integrin inhibitor will take place in the second half of 2020. Morphic has made this adjustment based on the request for an additional preclinical toxicology study received during pre-IND interactions with the FDA. Morphic's αvβ6 inhibitors remain subject to an exclusive license option pursuant to Morphic's collaboration agreement with AbbVie.

    Oral α4β7 Inhibition Program for Irritable Bowel Disease (IBD)

    • Morphic remains on track to submit the IND for its wholly owned oral inhibitor of α4β7 for the treatment of IBD in mid-2020 and begin clinical studies in the second half of 2020.

    Morphic's development portfolio is targeted to integrin receptors that are strongly implicated in diseases with validated clinical need. The company's lead programs are inhibitors of the integrins αvβ6 and α4β7, which Morphic's data suggests could be the basis of transformational treatments for patients with fibrotic diseases and inflammatory bowel disease (IBD), respectively. Fibrosis is a common feature of many chronic diseases involving tissue injury and can lead to the progressive failure of multiple organs, such as the lungs, liver, skin and kidney. IBD is a group of chronic autoimmune and inflammatory conditions of the gastrointestinal tract that include ulcerative colitis and Crohn's disease, among others.

    Financial Highlights

    • Morphic's initial public offering (IPO) of common stock on The Nasdaq Global Market, including full exercise of the underwriters' option to purchase additional shares of common stock, closed on July 1, 2019. The IPO generated gross proceeds of approximately $103.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

    Financial Results for Third Quarter 2019
    Net loss for the quarter ended September 30, 2019, was $8.9 million or $0.30 per share compared to a net loss of $7.1 million or $7.00 per unit (units were converted to shares as a result of converting from a limited liability company to a corporation prior to the IPO), for the same quarter last year.

    • Revenue was $5.7 million for the quarter ended September 30, 2019 compared to $0 for the same quarter last year. The increase was due to collaboration agreements signed by AbbVie in October 2018 and Janssen in February 2019.
    • Research and development expenses were $12.6 million for the quarter ended September 30, 2019, compared to $5.8 million in the same quarter last year. The $6.8 million increase year-over-year reflects higher development and manufacturing costs associated with our product candidate, MORF-720; research costs associated with preclinical studies; as well as increased personnel-related costs to support continued progress with the company's pipeline.
    • General and administrative expenses were $2.9 million for the quarter ended September 30, 2019, compared to $1.4 million in the same quarter last year. The $1.5 million increase year-over-year was primarily attributable to increased headcount and higher professional and consulting fees associated with ongoing business activities and Morphic's operating as a public company.

    As of September 30, 2019, Morphic had cash, cash equivalents and marketable securities of $251.7 million, compared to $185.9 million as of December 31, 2018. Morphic believes its cash, cash equivalents and marketable securities as of September 30, 2019, will be sufficient to fund operating expenses and capital expenditure requirements at least through the end of 2022.

    About Morphic Therapeutic
    Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company's unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking" statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Morphic's plan to develop and commercialize oral small-molecule integrin therapeutics and Morphic's expectations about timing and ability to obtain regulatory approvals for MORF-720 and α4β7-specific integrin inhibitors. Statements including words such as "looks forward to," "believe," "plan," "continue," "expect," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause Morphic's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Morphic's ability to develop, obtain regulatory approval for and commercialize MORF-720 and α4β7-specific integrin inhibitors and other product candidates, the timing and results of preclinical studies and clinical trials, Morphic's ability to protect intellectual property; and other risks set forth in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Morphic specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

    -Financial Tables to Follow-

    Morphic Holding Inc.
    Condensed Consolidated Statements of Operations
    (unaudited)
    (in thousands, except unit, share, per unit and per share data)
                     
        Three Months Ended
     September 30
      Nine Months Ended
     September 30
          2019     2018     2019     2018
                             
      Collaboration revenue $ 5,675   $   $ 17,311   $
    Operating expenses                      
      Research and development   12,635     5,767     36,912     15,344
      General and administrative   2,898     1,405     6,807     3,311
    Total operating expenses   15,533     7,172     43,719     18,655
    Loss from operations   (9,858)     (7,172)     (26,408)     (18,655)
      Interest income, net   1,392     111     3,574     214
      Other expense   (94)     (16)     (94)     (46)
    Total other income   1,298     95     3,480     168
    Loss before provision for income taxes   (8,560)     (7,077)     (22,928)     (18,487)
    Provision for income taxes   (304)         (569)    
    Net loss $ (8,864)   $ (7,077)   $ (23,497)   $ (18,487)
                             
    Net loss per share, basic and diluted $ (0.30)         $ (2.06)      
    Net loss per unit, basic and diluted       $ (7.00)         $ (18.28)
                             
    Weighted-average common shares outstanding - basic and diluted   29,999,170           11,393,192      
    Weighted-average common units outstanding - basic and diluted         1,011,227           1,011,227
                           


     
      Morphic Holding Inc.
      Condensed Consolidated Balance Sheets 
      (unaudited)
      (in thousands)
             
        September 30,
    2019
      December 31,
    2018 
    Assets      
      Cash, cash equivalents and marketable securities $ 251,746   $ 185,901
      Other current assets   5,290     1,222
      Total current assets   257,036     187,123
      Other assets   3,043     2,182
    Total assets $ 260,079   $ 189,305
             
    Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)      
      Current liabilities $ 26,479   $ 34,903
      Long-term liabilities   74,252     67,145
      Total liabilities   100,731     102,048
      Convertible preferred stock       139,809
      Total stockholders' equity (deficit)   159,348     (52,552)
    Total liabilities, convertible preferred stock and stockholders' equity (deficit) $ 260,079   $ 189,305
                 

    Contacts
    Morphic Therapeutic
    Chris Erdman

    617.686.1718

    Media Contact
    Tom Donovan, Ten Bridge Communications

    857.559.3397

     

    Primary Logo

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