On November 12, 2019 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 third quarter of 2019 (Press release, Morphic Therapeutic, NOV 12, 2019, View Source [SID1234551238]).
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"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.