On March 1, 2021 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 full year 2020 (Press release, Morphic Therapeutic, MAR 1, 2021, View Source [SID1234575814]).
2020 and Recent Corporate Highlights
Filed first IND of an oral integrin drug candidate, MORF-057, generated by Morphic’s MInT Platform and initiated first clinical study of MORF-057 in healthy volunteers in Phase 1 clinical trial of oral IBD candidate, MORF-057, after acceptance of IND by Food and Drug Administration
Announced positive preliminary results from Phase 1 single ascending dose portion of MORF-057 Phase 1 clinical trial including:
MORF-057 well tolerated in all five dose cohorts ranging from 25 mg to 400 mg
MORF-057 achieved greater than 95% mean receptor occupancy of α4β7 at the three highest dose levels
Phase 1 multiple ascending dose and food effect trials ongoing with full data anticipated to be presented mid-year 2021
Received $20 million payment upon AbbVie exercise of a license option under the companies’ research and development collaboration agreement to develop Morphic’s αvβ6 integrin inhibitors, including the compounds MORF-720 and MORF-627
Expanded research and development collaboration with Janssen through a third integrin program
Presented promising preclinical data supporting MORF-057 as an oral integrin targeting α4β7 at UEG Week 2020, Digestive Disease Week 2020, European Crohn’s and Colitis Organization (ECCO)
Advanced novel integrin-targeted candidates generated by the MInT Platform against integrins αvβ1 and αvβ8 for the treatment of fibrosis and cancer
Ended the year with $228.3 million in cash and equivalents and marketable securities, providing runway into 2023
"The past year challenged how we work and live but the Morphic team came together to drive tremendous advances in the creation of oral integrin therapies. Most notably in 2020, our lead oral candidate in IBD, MORF-057, completed preclinical testing with strong proof-of-concept and entered the clinic. In an important milestone for Morphic, we have already delivered positive preliminary results from the MORF-057 Phase 1 trial. The data show a favorable tolerability profile as well as strong pharmacodynamic data that suggest α4β7 inhibition may be on par with the approved intravenous blockbuster, vedolizumab. Further, we expanded our strategic collaborations with AbbVie and Janssen to explore a broader scope of integrin drug targets and potentially boost our partnered pipeline," commented Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic. "In the year ahead, with a strong financial base, we are able to focus on advancing the clinical development of MORF-057 and our promising preclinical programs targeting αvβ1 and αvβ8, as well as continuing to expand the MInT Platform that generates this pipeline of novel integrin therapeutic candidates."
Financial Results for the Full Year 2020
Net loss for the year ended December 31, 2020, was $45.0 million or $1.47 per share compared to a net loss of $43.3 million or $2.69 per share
Revenue was $44.9 million for the year ended December 31, 2020 compared to $17.0 million for the year ended December 31, 2019. The increase was mainly due to AbbVie’s option exercise on our αvβ6 integrin inhibitor program in the third quarter of 2020 for $20 million
Research and development expenses were $73.6 million for the year ended December 31, 2020 as compared to $53.7 million for the year ended December 31, 2019. 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 $18.5 million for the year ended December 31, 2020, compared to $10.2 million for the year ended December 31, 2019. The increase 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 December 31, 2020, Morphic had cash, cash equivalents and marketable securities of $228.3 million, compared to $237.0 million as of December 31, 2019. Morphic believes its cash, cash equivalents and marketable securities as of December 31, 2020, will be sufficient to fund operating expenses and capital expenditure requirements into 2023.