WALTHAM, Mass., April 25, 2023 (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 first quarter 2023.
First Quarter 2023 and Recent Corporate Highlights
EMERALD Phase 2 trials of MORF-057 in ulcerative colitis
MORF-057 Preclinical and Phase 1 Studies
Emerging Pipeline
“Q1 was a pivotal quarter for Morphic, with the EMERALD-1 study reporting positive topline results, including clinically meaningful activity and favorable tolerability. In addition, we extended our cash runway into the second half of 2026, well beyond the primary endpoint readout of EMERALD-2, the phase 2b randomized study of MORF-057 in UC, in the first half of 2025,” commented Praveen Tipirneni, MD, Chief Executive Officer of Morphic Therapeutic. “Our clinical team has done an excellent job executing on the EMERALD studies and we are thrilled with the potential benefit that MORF-057 has now demonstrated in patients. The significant extension of cash runway enables the later stage clinical development of MORF-057 and development of our pipeline of emerging integrin therapies.”
Financial Results for the First Quarter 2023
As of March 31, 2023, Morphic had cash, cash equivalents and marketable securities of $421 million, compared to $348 million as of December 31, 2022, with the increase primarily due to a private placement of Morphic’s common stock and pre-funded warrants with certain existing investors that was completed in February 2023. Morphic believes its cash, cash equivalents and marketable securities as of March 31, 2023, will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2026.
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, like vedolizumab, 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 avoiding inflammation that is associated with IBD.
About the EMERALD-1 Study
EMERALD-1 (MORF-057-201) is an open-label multi-center phase 2a trial designed to evaluate the efficacy, safety, and tolerability of MORF-057 in adults with moderate to severe ulcerative colitis. The 35 patients enrolled in the main cohort of the EMERALD-1 study have been treated with 100 mg BID (twice daily) at sites in the United States and Poland. The primary endpoint of the trial was the change in Robarts Histopathology Index (RHI), a validated instrument that measures histological disease activity in ulcerative colitis at 12 weeks compared to baseline. Patients will continue for an additional 40 weeks of maintenance therapy followed by a 52-week assessment. Secondary and additional pre-specified measures in the EMERALD-1 study include change in the modified Mayo clinic score, safety, pharmacokinetic parameters and key pharmacodynamic measures including α4β7 receptor occupancy and lymphocyte subset trafficking.
About the EMERALD-2 Study
EMERALD-2 (MORF-057-202) is a global phase 2b randomized, double-blind, placebo-controlled trial of MORF-057 that is currently enrolling patients with moderate-to-severe ulcerative colitis. The primary endpoint of EMERALD-2 is clinical remission rate as measured by the Modified Mayo Clinic Score (mMCS) at 12 weeks. EMERALD-2 will also measure several secondary and exploratory endpoints based on the mMCS as well as histologic, pharmacokinetic and pharmacodynamic measures, and safety parameters. Patients in the EMERALD-2 study will be randomized to receive either 200 mg BID MORF-057, 100 mg BID MORF-057, a QD (once daily) dose of MORF-057, or a placebo dose. Following the 12-week induction phase, all patients will receive MORF-057 for 40 weeks of maintenance dosing. For more information about the EMERALD clinical trials of MORF-057, please click here.
About Morphic Therapeutic
Morphic Therapeutic is a biopharmaceutical company developing a portfolio of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular, and metabolic diseases, fibrosis, and cancer. Morphic is also advancing its pipeline and discovery activities in collaboration with Schrödinger 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 Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, and of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the MInT technology platform’s ability to discover drug candidates; Morphic’s plans to develop and commercialize oral small-molecule integrin therapeutics and any proposed timing thereof; the execution, timing and completion of the EMERALD-1 and EMERALD-2 clinical trials; any expectations about safety, efficacy, timing and ability to commence or complete clinical studies and/or trials and to obtain regulatory approvals for MORF-057 and other candidates in development; the timing of further data presentation; the ability of MORF-057 to treat IBD, including ulcerative colitis, or related indications; the ability of αvβ8 small molecule inhibitors to treat myelofibrosis and pulmonary hypertensive diseases; the company’s cash position and anticipated runway. 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 disclosed in this press release and other risks set forth in our filings with the Securities and Exchange Commission, including Morphic’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed with the SEC on February 23, 2023 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 filed with the SEC on April 25, 2023. These forward-looking statements speak only as of the date hereof and Morphic specifically disclaims any obligation to update these forward-looking statements, 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 March 31, | |||||||
| 2023 | 2022 | ||||||
Collaboration revenue | $ | 521 | $ | 2,382 | ||||
Operating expenses: | ||||||||
Research and development | 30,449 | 26,463 | ||||||
General and administrative | 9,277 | 7,591 | ||||||
Total operating expenses | 39,726 | 34,054 | ||||||
Loss from operations | (39,205 | ) | (31,672 | ) | ||||
Other income: | ||||||||
Interest income, net | 3,100 | 187 | ||||||
Other income, net | 2 | 1 | ||||||
Total other income, net | 3,102 | 188 | ||||||
Loss before provision for income taxes | (36,103 | ) | (31,484 | ) | ||||
Provision for income taxes | (32 | ) | — | |||||
Net loss | (36,135 | ) | (31,484 | ) | ||||
Net loss per share, basic and diluted | $ | (0.90 | ) | $ | (0.85 | ) | ||
Weighted average common shares outstanding, basic and diluted | 40,112,416 | 37,133,412 | ||||||
Morphic Holding, Inc. Condensed Consolidated Balance Sheets (unaudited) (in thousands) | |||||
March 31, 2023 | December 31, 2022 | ||||
Assets | |||||
Cash, cash equivalents and marketable securities | $ | 421,279 | $ | 348,248 | |
Other current assets | 14,466 | 13,934 | |||
Total current assets | 435,745 | 362,182 | |||
Other assets | 6,202 | 6,407 | |||
Total assets | $ | 441,947 | $ | 368,589 | |
Liabilities and Stockholders’ Equity | |||||
Current liabilities | $ | 13,481 | $ | 17,126 | |
Long-term liabilities | 1,951 | 2,344 | |||
Total liabilities | 15,432 | 19,470 | |||
Total stockholders’ equity | 426,515 | 349,119 | |||
Total liabilities and stockholders’ equity | $ | 441,947 | $ | 368,589 | |
Contacts
Morphic Therapeutic
Chris Erdman
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617.686.1718
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Market Cap: | US$2.860B |
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