On May 4, 2022 Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, reported corporate highlights and financial results for the first quarter of 2022 (Press release, Morphic Therapeutic, MAY 4, 2022, View Source [SID1234613482]).
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First Quarter 2022 and Recent Corporate Highlights
Launched EMERALD-1 (MORF-057-201) phase 2a study
EMERALD-1 is an open-label multi-center study of MORF-057 enrolling up to 35 patients with moderate to severely active ulcerative colitis (UC) who will be treated with 100 mg BID (twice daily)
EMERALD-2 (MORF-057-202), a global phase 2b double-blind randomized placebo-controlled trial of MORF-057, is expected to begin in the third quarter of 2022 and then run in parallel with EMERALD-1
Presented new preclinical data at ECCO 2022 expanding understanding of α4β7-expressing immune cells and further describing MORF-057 dose-response
Data from multiple preclinical studies in animals strongly correlated with human trials and demonstrate clear MORF-057 dose-response
Results also show changes in lymphocyte populations and CCR9 transcripts consistent with α4β7 inhibition mechanism of action
Announced several key leadership appointments
Dr. Brihad Abhyankar, MS, FRCS, FFPM was appointed Vice President, Clinical Development and will lead the EMERALD-1 and EMERALD-2 phase 2 trials of MORF-057 in UC
Dr. Abhyankar has directly relevant experience to the MORF-057 development program after serving as executive medical director of clinical science at Takeda, where he directed strategy for global clinical development and played a key role in the development, approval, and the life cycle management of ENTYVIO or vedolizumab
Dr. Abhyankar has over 20 years of biopharmaceutical industry experience and 10 years of training and practice in surgery and medicine
Aaron Pelta was promoted to Senior Vice President, Business and Corporate Development
Mr. Pelta previously served as Morphic’s Vice President of Businesses Development and leads partnering, commercial planning and portfolio strategy
Mr. Pelta has 20 years of biopharmaceutical business experience including leadership roles at Arsanis, Shire and Cubist Pharmaceuticals
Focused the Company’s research and development collaboration efforts with AbbVie and Janssen on higher-potential integrin targets in multiple undisclosed therapeutic areas
Thanked Nilesh Kumar, Ph.D., for his contributions as a member of the Morphic Board of Director upon his departure after five years of leadership and collaboration
"Morphic made the most significant clinical advance in our Company’s history with the launch of the EMERALD phase 2a study of MORF-057 in UC during the first quarter of 2022," commented Praveen Tipirneni, MD, President and Chief Executive Officer of Morphic Therapeutic. "In addition, we bolstered the Morphic team with the addition of Brihad Abhyankar, a proven leader in the GI development arena an expert in α4β7 for the treatment of UC. We will continue to make important progress in the MORF-057 development program with the launch of the EMERALD-2 global randomized controlled phase 2b study in the coming months."
Financial Results for the First Quarter 2022
Net loss for the quarter ended March 31, 2022 was $31.5 million or $0.85 per share compared to a net loss of $21.3 million or $0.63 per share for the same quarter last year.
Revenue was $2.4 million for the quarter ended March 31, 2022, compared to $3.3 million for the same quarter last year.
Research and development expenses were $26.5 million for the quarter ended March 31, 2022, as compared to $18.6 million for the same quarter last year. The increase was primarily attributable to higher manufacturing and development costs along with higher pre-clinical and phase 2 clinical trial costs to support our lead product candidate MORF-057.
General and administrative expenses were $7.6 million for the quarter ended March 31, 2022, compared to $6.0 million for the same quarter last year. The increase was due to increased non-cash stock-based compensation expense and higher payroll costs.
As of March 31, 2022, Morphic had cash, cash equivalents and marketable securities of $380.7 million, compared to $408.1 million as of December 31, 2021. The Morphic believes its cash, cash equivalents and marketable securities as of March 31, 2022, will be sufficient to fund operating expenses and capital expenditure requirements through year-end 2024.