Full Press Release Details
Morphic Announces Corporate Highlights and Second Quarter 2020 Financial Results
Company's first IND accepted by FDA for MORF-057 in IBD
phase 1 study expected to begin in third-quarter 2020
Positive data presented at DDW 2020 further support MORF-057 preclinical profile
WALTHAM, Mass. - August 10, 2020 - 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 second quarter 2020 financial results.
"Morphic has made tremendous strides with our lead program, MORF-057, an oral small molecule inhibitor of 4 7 in development to treat inflammatory bowel disease. I'm so proud of the efforts of our team that has taken this program from the bench in Dr. Tim Springer's Lab to the clinic in just a few short years," commented Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic. "We recently presented a substantive preclinical data set at Digestive Disease Week that support MORF-057's profile as a candidate for the treatment of IBD through the proven mechanism of 4 7 inhibition with many potential advantages, including oral administration. While we are just beginning our clinical journey, I congratulate the Morphic team for the achievement of these important milestones on our mission to deliver a new generation of oral integrin therapeutics."
Peter Linde, M.D., Morphic's chief medical officer, added "We expect to initiate a robust clinical development program for MORF-057 imminently, beginning with a phase 1 clinical trial designed to evaluate the safety, pharmacokinetic and pharmacodynamic profile of this compound with single and multiple ascending dose cohorts. The phase 1 trial will also generate important receptor occupancy data that we believe could provide early clinical proof of concept and dose selection guidance for use in future studies within the MORF-057 program in IBD patients."
Morphic is developing MORF-057 as a selective, oral small molecule inhibitor of the 4 7 integrin, a target for the treatment of inflammatory bowel disease (IBD) with an initial focus on moderate-to-severe ulcerative colitis (UC). The mechanism of 4 7 inhibition to treat IBD has been clinically validated by the success of the approved infused antibody therapy, vedolizumab.
Second quarter and recent corporate highlights:
COVID-19 Preparedness
Morphic is not currently aware of any significant delay to its timelines due to the COVID-19 pandemic. In light of the evolving circumstances, Morphic will continue to assess any potential impact of the COVID-19 pandemic in dialogue with regulators, partners and vendors.
Financial Results for Second Quarter 2020
Net loss for the quarter ended June 30, 2020 was $15.9 million or $0.52 per share compared to a net loss of $9.4 million or $4.73 per share for the same quarter last year.
As of June 30, 2020, Morphic had cash, cash equivalents, and marketable securities of $202.5 million, compared to $237.0 million at the end of 2019. Morphic believes its cash, cash equivalents, and marketable securities balance as of June 30, 2020 will be sufficient to fund operating expenses and capital expenditure requirements at least through the end of 2022.
Financial Tables Follow
| Morphic Holding Inc. | ||||||||||||||||
| Condensed Consolidated Statements of Operations | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30 | June 30 | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Collaboration revenue | $ | 7,693 | $ | 5,567 | $ | 13,287 | $ | 11,635 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 19,918 | 13,907 | 38,878 | 24,278 | ||||||||||||
| General and administrative | 4,195 | 2,077 | 8,618 | 3,908 | ||||||||||||
| Total operating expenses | 24,113 | 15,984 | 47,496 | 28,186 | ||||||||||||
| Loss from operations | (16,420) | (10,417) | (34,209) | (16,551) | ||||||||||||
| Interest income, net | 407 | 1,119 | 1,293 | 2,182 | ||||||||||||
| Total other income | 407 | 1,119 | 1,293 | 2,182 | ||||||||||||
| Loss before benefit from (provision for) income taxes | (16,013) | (9,298) | (32,916) | (14,369) | ||||||||||||
| Benefit from (provision for) income taxes | 155 | (135) | 312 | (264) | ||||||||||||
| Net loss | $ | (15,858) | $ | (9,433) | $ | (32,604) | $ | (14,633) | ||||||||
| Net loss per share, basic and diluted | $ | (0.52) | $ | (4.73) | $ | 1.08 | $ | (7.54) | ||||||||
| Weighted-average common shares outstanding, basic and diluted | ||||||||||||||||
| 30,360,851 | 1,992,410 | 30,274,713 | 1,940,923 |
| Morphic Holding Inc. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (unaudited) | ||||||||
| (in thousands) | ||||||||
| June 30, 2020 | December 31, 2019 | |||||||
| Assets | ||||||||
| Cash, cash equivalents and marketable securities | $ | 202,538 | $ | 237,016 | ||||
| Other current assets | 6,072 | 6,557 | ||||||
| Total current assets | 208,610 | 243,573 | ||||||
| Other assets | 3,389 | 3,862 | ||||||
| Total assets | $ | 211,999 | $ | 247,435 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | $ | 45,284 | $ | 35,350 | ||||
| Long-term liabilities | 51,798 | 71,167 | ||||||
| Total liabilities | 97,082 | 106,517 | ||||||
| Total stockholders' equity | 114,917 | 140,918 | ||||||
| Total liabilities and stockholders' equity | $ | 211,999 | $ | 247,435 |
About Morphic Therapeutic
Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with AbbVie, Janssen and Schr dinger, Morphic is advancing its pipeline and discovery activities 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 "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Morphic's plan to develop and commercialize oral small-molecule integrin therapeutics and Morphic's expectations about timing and ability to commence or complete clinical studies and to obtain regulatory approvals for MORF-057, MORF-720, and other candidates in development, the ability of MORF-057 to treat inflammatory bowel disease, the potential impact of the COVID-19 pandemic and the sufficiency of our cash, cash equivalents and investments to fund our operations. Statements including words such as "believe," "plan," "continue," "expect," "will be," "develop," "signal," "potential," 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 related to Morphic's ability to develop, obtain regulatory approval for and commercialize MORF-057, MORF-720, and other product candidates, the timing and results of preclinical studies and clinical trials, the potential impact of the COVID-19 pandemic, Morphic's ability to protect intellectual property; and other risks set forth in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Morphic specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.
Tom Donovan, Ten Bridge Communications