On November 4, 2021 Morphic Therapeutic (Nasdaq: MORF), a biotechnology company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, reported corporate highlights and financial results for the third quarter of 2021 (Press release, Morphic Therapeutic, NOV 4, 2021, View Source [SID1234594561]).
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Recent Highlights and Outlook
Presented positive phase 1 data at the European Crohn’s and Colitis Organisation (ECCO) Virtual Congress 2021, fully supporting MORF-057’s target product profile as an oral inhibitor of the α4β7 integrin
MORF-057 was well tolerated in all dose cohorts with no safety signals identified
Pharmacodynamic data, including α4β7 receptor saturation at 100 mg BID administered orally, strongly supported MORF-057’s ability to replicate the mechanism of approved therapeutic vedolizumab, administered via IV infusion
MORF-057’s dose-dependent and consistent pharmacokinetic data support twice daily dosing profile and enable plans to evaluate once-daily dosing in phase 2b
Lymphocyte subset changes strongly demonstrate early in-human evidence for MORF-057’s small molecule α4β7 inhibition to replicate the published data on mechanism of action from approved biologic therapeutics in inflammatory bowel disease (IBD)
Planned initiation of MORF-057 phase 2a remains on track for first quarter 2022
All phase 2 readiness work, including chronic toxicology studies, on track and scheduled for completion in fourth quarter 2021
Study to include 30-35 patients with moderate to severe ulcerative colitis treated with 100 mg BID (twice daily) with 12-week induction phase and rollover to 40 additional weeks maintenance phase in patients
The primary endpoint is change in Robarts Histopathologic Index (RHI) at 12 weeks
Global phase 2b randomized controlled trial of MORF-057 to commence after phase 2a initiation and then run in parallel
Welcomed Nisha Nanda, Ph.D., to the Morphic Board of Directors, an experienced leader in preclinical and clinical-stage development strategy across multiple therapeutic areas
Received acceptance to present preclinical data from our αvβ8 inhibitor program at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting
Announced the planned resignation of Peter G. Linde, M.D., Chief Medical Officer, effective December 31, 2021. Dr. Linde has notified the Company that he is departing for personal reasons but will remain with the Company through year end to assist with an orderly transition of responsibilities
"MORF-057’s performance in phase 1 studies exceeded our internal modelling across all key criteria and we are now finalizing preparations for the initiation of the MORF-057 phase 2 program in patients with moderate-to-severe ulcerative colitis," said Praveen Tipirneni, M.D., President and Chief Executive Officer of Morphic Therapeutic. "Developing MORF-057 with our MInT platform has generated an array of learnings that feed into our earlier proprietary pipeline, driving advances in Morphic’s programs in immuno-oncology and other indications. In particular, we are looking forward to the presentation of new preclinical data from our αvβ8 program demonstrating the strong anti-tumor activity of a Morphic αvβ8 small molecule inhibitor dosed in combination with a checkpoint inhibitor and radioimmunotherapy in a tumor that is unresponsive to respective monotherapies or conventional radioimmunotherapy."
Financial Results for the Third Quarter 2021
Net loss for the quarter ended September 30, 2021 was $25.0 million or $0.69 per share, basic and diluted compared to net income of $5.4 million or $0.17 per share, diluted for the same quarter last year
Revenue was $3.1 million for the quarter ended September 30, 2021, compared to $25.8 million for the same quarter last year. The decrease was primarily due to the receipt of a $20 million payment triggered by AbbVie exercising their option to Morphic’s αvβ6 program during the quarter ended September 30, 2020
Research and development expenses were $21.0 million for the quarter ended September 30, 2021 as compared to $16.0 million for the same quarter last year. The increase was primarily due to clinical trial costs associated with MORF-057, along with manufacturing costs associated with the upcoming phase 2 clinical trial
General and administrative expenses were $7.3 million for the quarter ended September 30, 2021, compared to $4.8 million for the same quarter last year. The increase was due to an increase in headcount and higher professional and consulting costs associated with Morphic operating as a public company
As of September 30, 2021, Morphic had cash, cash equivalents and marketable securities of $427.6 million, compared to $228.3 million as of December 31, 2020. Morphic believes its cash, cash equivalents and marketable securities as of September 30, 2021, will be sufficient to fund operating expenses and capital expenditure requirements until the end of 2024.