-Initiated and completed enrollment for EMERALD-1 phase 2a trial of MORF-057 in ulcerative colitis; topline data expected 2Q23-
-Launched EMERALD-2 phase 2b global randomized trial of MORF-057 in ulcerative colitis-
-Ended 2022 with
2022 and Recent Corporate Highlights
EMERALD phase 2 trials of MORF-057 in ulcerative colitis
- Completed enrollment of the EMERALD-1 open-label phase 2a trial of MORF-057 in patients with moderate to severe ulcerative colitis (UC)
- Study met target enrollment in the third quarter of 2022
- EMERALD-1 topline results expected in the second quarter of 2023 including primary endpoint (change in Roberts Histopathological Index (RHI)), key secondary measures including modified mayo clinical score (mMCS), safety and pharmacokinetic data
- Initiated EMERALD-2 phase 2b study of MORF-057 in patients with moderate to severe UC
- EMERALD-2 is a global phase 2b randomized, double-blind, placebo-controlled trial of MORF-057 in patients with moderate-to-severe ulcerative colitis
- The primary endpoint of EMERALD-2 is clinical remission rate as measured by mMCS at 12 weeks and is expected to report in the first half of 2025
MORF-057 Preclinical and Phase 1 Studies
- Presented new MORF-057 preclinical and clinical data at
European Congress for Crohn’s and Colitis, the United European Gastroenterology Week, and theAmerican College of Gastroenterology further supporting the ongoing EMERALD phase 2 trials in UC
Integrin Science and Technology
- Celebrated the publication in the scientific journal Cell by
Albert Lin , PhD andTimothy Springer , PhD, describing critical insights into the function of integrins, a central biologic receptor class, based on conformation changes- The discovery made by Drs. Lin and Springer led directly to the foundation of Morphic Therapeutic
Dr. Springer is the Latham Family Professor atHarvard Medical School and recipient of the 2022 Lasker Prize for his pioneering work with integrins, and a founder, Director, andSAB member ofMorphic Dr. Lin is Executive Director of Biology atMorphic and a founder ofMorphic
Morphic Operations
- Strengthened the
Morphic team across research, regulatory, clinical, and executive functions- Key additions in 2022 included: the appointment of Dr Brihad Abhyankar as Vice President, Clinical Operations.
Dr. Abhyankar was recently promoted to Senior Vice President, Clinical Development, the appointment ofJoanne Gibbons as Senior Vice President of Regulatory Affairs.Ms. Gibbons was recently promoted to Senior Vice President, Regulatory Affairs and Quality
- Key additions in 2022 included: the appointment of Dr Brihad Abhyankar as Vice President, Clinical Operations.
“Morphic executed well against our corporate objectives in 2022 which has positioned us ideally for a strong 2023, a key year in the clinical development of MORF-057, our oral a4b7 inhibitor in phase 2 studies for UC,” commented
Financial Results for the Full Year 2022
- Net loss for the year ended
December 31, 2022 , was$59.0 million or$1.55 per share compared to a net loss of$95.5 million or$2.67 per share for the year endedDecember 31, 2021 . - Revenue was
$70.8 million for the year endedDecember 31, 2022 , compared to$19.8 million for the year endedDecember 31, 2021 . The change was primarily due to recognition of revenue due to the conclusion of the AbbVie collaboration and reduction in the scope of the Janssen collaboration. - Research and development expenses were
$102.1 million for the year endedDecember 31, 2022 , as compared to$87.8 million for the year endedDecember 31, 2021 . The increase was primarily attributable to higher manufacturing and development costs along with clinical trial costs to support our lead product candidate MORF-057. - General and administrative expenses were
$32.1 million for the year endedDecember 31, 2022 , compared to$27.8 million for the year endedDecember 31, 2021 . The increase was due to increased headcount and higher professional and consulting costs associated with ongoing business development activities andMorphic operating as a public company.
As of
About MORF-057
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. EMERALD-1 has completed enrollment of the main cohort of 30-35 patients who will be treated with 100 mg BID (twice daily) at sites in
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 (twice daily) 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.
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 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 initiation, execution and completion of the future MORF-057 phase 2 clinical trial, 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 and the ability of MORF-057 to treat inflammatory bowel disease, including ulcerative colitis, or related indications. 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 in this press release and other risks set forth in our filings with the
-Financial tables to Follow-
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share data)
| Year Ended | ||||||
| 2022 | 2021 | |||||
Collaboration revenue | $ | 70,808 | $ | 19,794 | |||
Operating expenses: | |||||||
Research and development | 102,062 | 87,789 | |||||
General and administrative | 32,142 | 27,811 | |||||
Total operating expenses | 134,204 | 115,600 | |||||
Loss from operations | (63,396 | ) | (95,806 | ) | |||
Other income: | |||||||
Interest income, net | 4,567 | 272 | |||||
Other expense, net | (145 | ) | (8 | ) | |||
Total other income, net | 4,422 | 264 | |||||
Loss before provision for income taxes | (58,974 | ) | (95,542 | ) | |||
Provision for income taxes | (67 | ) | — | ||||
Net loss | $ | (59,041 | ) | $ | (95,542 | ) | |
Net loss per share, basic and diluted | $ | (1.55 | ) | $ | (2.67 | ) | |
Weighted average common shares outstanding, basic and diluted | 38,112,498 | 35,797,969 |
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
Assets | |||||
Cash, cash equivalents and marketable securities | $ | 348,248 | $ | 408,135 | |
Other current assets | 13,934 | 10,199 | |||
Total current assets | 362,182 | 418,334 | |||
Other assets | 6,407 | 7,956 | |||
Total assets | $ | 368,589 | $ | 426,290 | |
Liabilities and Stockholders' Equity | |||||
Current liabilities | $ | 17,126 | $ | 38,264 | |
Long-term liabilities | 2,344 | 51,327 | |||
Total liabilities | 19,470 | 89,591 | |||
Total stockholders' equity | 349,119 | 336,699 | |||
Total liabilities and stockholders' equity | $ | 368,589 | $ | 426,290 |
Contact
Morphic Therapeutic
chris.erdman@morphictx.com
617.686.1718
Source: Morphic Therapeutic
2023 GlobeNewswire, Inc., source