UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
_______________________________________________________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 3, 2022
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(Exact Name of Registrant as Specified in its Charter)
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(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||
| (Address of principal executive offices) | (Zip Code) | |||||||
Registrant’s telephone number, including area code: (781 ) 996-0955
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 3, 2022, the Company issued a press release (the “Press Release”) announcing its preliminary financial results for the quarter ended June 30, 2022. The Press Release is attached hereto as Exhibit 99.1.
The preliminary financial results are estimates and subject to completion of the applicable quarter-end closing procedures. The Company’s actual results for the quarter ended June 30, 2022 may vary from these estimates. In addition, estimated financial information is necessarily speculative in nature, and it can be expected that some or all of the assumptions underlying the estimated financial results described in the Press Release will not materialize or will vary significantly from actual results. Accordingly, undue reliance should not be placed on these estimates.
The information in Exhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information in Exhibit 99.1 shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit Number | Description | |||||||
| 99.1 | ||||||||
| 104 | The cover page on this Current Report on Form 8-K, formatted in Inline XBRL | |||||||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MORPHIC HOLDING, INC. | ||||||||
| Date: August 3, 2022 | By: | /s/ Marc Schegerin | ||||||
| Marc Schegerin, M.D. | ||||||||
| Chief Financial Officer and Chief Operating Officer | ||||||||
Exhibit 99.1
Morphic Announces Corporate Highlights and Financial Results for the Second Quarter 2022
Continued enrollment of EMERALD-1 phase 2a trial of MORF-057 in patients with ulcerative colitis
Announced key appointments and advancements in leadership team
Ended second quarter 2022 with $397.6 million in cash and equivalents
Cash runway extended into second half of 2025
WALTHAM, Mass. – August 3, 2022 – 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 second quarter of 2022.
Second Quarter 2022 and Recent Corporate Highlights
•Continued enrollment of EMERALD-1 (MORF-057-201) phase 2a study
◦EMERALD-1, an open-label multi-center study of MORF-057 enrolling up to 35 patients with moderate to severe ulcerative colitis (UC), who will receive 100 mg BID (twice daily), continues to progress as planned
◦EMERALD-2 (MORF-057-202), a global phase 2b double-blind randomized placebo-controlled trial of MORF-057, is now expected to begin in the fourth quarter of 2022 and top line results are expected in the first half of 2025
•Announced several key leadership appointments and promotions
◦Appointed Joanne Gibbons as Senior Vice President of Regulatory Affairs
▪Ms. Gibbons has nearly 25 years of experience in Regulatory Affairs and Clinical Development, both in the development of novel drugs and the expansion of marketed products
◦Named Dr. Bruce Rogers as President of Morphic Therapeutic
▪Dr. Rogers previously served as Morphic’s Chief Scientific Officer from 2016
▪Dr. Rogers has over 25 years of biopharmaceutical experience, including 18 years of experience in roles of increasing responsibility at Pfizer
◦Named Dr. Blaise Lippa as Chief Scientific Officer of Morphic
▪Dr. Lippa previously served as Morphic’s Senior Vice President of Molecular Discovery and was part of the founding team at Morphic
▪Dr. Lippa has over 20 years of experience in the biopharmaceutical industry, including time at Pfizer and Cubist, prior to its acquisition by Merck
•Advanced the Company’s research and development collaboration with Janssen, focused on an antibody activator of a high potential integrin target
•Concluded the Company’s research and development collaboration efforts with AbbVie
◦Morphic successfully delivered on the terms of the AVB6 collaboration and Morphic and AbbVie are in the process of drafting a joint publication for the AVB6 program
“Morphic is confidently climbing through a vital period in our development as the EMERALD clinical trials of MORF-057 in UC move forward flat out,” commented Praveen Tipirneni, MD, Chief Executive Officer of Morphic Therapeutic. “The EMERALD-1 phase 2a study is progressing according to plan and our esprit de corps continues to strengthen through several senior appointments. Most notably, we announced the promotion of two key longstanding and high performing executives, Bruce Rogers and Blaise Lippa, and the addition of our new SVP of Regulatory Affairs, Joanne Gibbons. With the additional capital raised in the second quarter and refined operating plans, we have bolstered our financial position and extended our cash-runway into 2025, well after the primary endpoint readout of the EMERALD-2 phase 2b study.”
Financial Results for the Second Quarter 2022
•Net income for the quarter ended June 30, 2022 was $26.8 million or $0.68 per share compared to a net loss of $27.8 million or $0.77 per share for the same quarter last year
•Revenue was $60.2 million for the quarter ended June 30, 2022, compared to $3.8 million for the same quarter last year. The increase was primarily due to the forthcoming conclusion of the collaboration with AbbVie which resulted in $57.7 million recognition of collaboration revenue in the quarter ended June 30, 2022
•Research and development expenses were $25.7 million for the quarter ended June 30, 2022, as compared to $24.6 million for the same quarter last year. The increase was primarily attributable to higher clinical and development costs along with higher pre-clinical and phase 2 clinical trial costs to support our lead product candidate MORF-057
•General and administrative expenses were $8.2 million for the quarter ended June 30, 2022, compared to $7.1 million for the same quarter last year. The increase was due to increased non-cash stock-based compensation expense and higher payroll costs
As of June 30, 2022, Morphic had cash, cash equivalents and marketable securities of $397.6 million, compared to $380.7 million as of March 31, 2022. We have updated our current operating plan with the receipt of $39.2 million in net proceeds raised under our ATM; the focusing and reduction in the scope of our partnered programs; a proactive pipeline prioritization and the implementation of increased operational efficiencies. Morphic believes its cash, cash equivalents and marketable securities as of June 30, 2022, will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2025.
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 collaborations with Janssen and 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 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 MORF-057 phase 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 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 Securities and Exchange Commission, including Morphic’s or a partner’s ability to complete a current or future clinical trial of any of our current or future product candidates, develop or obtain regulatory approval for or commercialize any product candidate, Morphic’s ability to protect intellectual property, the potential impact of the COVID-19 pandemic, and the sufficiency of our cash, cash equivalents and investments to fund our operations. 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.
-Financial Tables to Follow-
Morphic Holding, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
| Collaboration revenue | $ | 60,236 | $ | 3,848 | $ | 62,618 | $ | 7,114 | |||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Research and development | 25,652 | 24,552 | 52,115 | 43,165 | |||||||||||||||||||
| General and administrative | 8,234 | 7,139 | 15,825 | 13,091 | |||||||||||||||||||
| Total operating expenses | 33,886 | 31,691 | 67,940 | 56,256 | |||||||||||||||||||
| Income (loss) from operations | 26,350 | (27,843) | (5,322) | (49,142) | |||||||||||||||||||
| Other income: | |||||||||||||||||||||||
| Interest income, net | 482 | 35 | 669 | 63 | |||||||||||||||||||
| Other income (expense), net | 11 | (7) | 12 | (20) | |||||||||||||||||||
| Total other income, net | 493 | 28 | 681 | 43 | |||||||||||||||||||
| Income (loss) before provision for income taxes | 26,843 | (27,815) | (4,641) | (49,099) | |||||||||||||||||||
| Provision for income taxes | (2) | — | (2) | — | |||||||||||||||||||
| Net income (loss) | $ | 26,841 | $ | (27,815) | $ | (4,643) | $ | (49,099) | |||||||||||||||
| Net income (loss) per share, basic | $ | 0.70 | $ | (0.77) | $ | (0.12) | $ | (1.41) | |||||||||||||||
| Net income (loss) per share, diluted | $ | 0.68 | $ | (0.77) | $ | (0.12) | $ | (1.41) | |||||||||||||||
| Weighted average common shares outstanding, basic | 38,244,547 | 36,179,085 | 37,692,049 | 34,863,056 | |||||||||||||||||||
| Weighted average common shares outstanding, diluted | 39,554,651 | 36,179,085 | 37,692,049 | 34,863,056 | |||||||||||||||||||
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
| June 30, 2022 | December 31, 2021 | ||||||||||
| Assets | |||||||||||
| Cash, cash equivalents and marketable securities | $ | 397,560 | $ | 408,135 | |||||||
| Other current assets | 9,059 | 10,199 | |||||||||
| Total current assets | 406,619 | 418,334 | |||||||||
| Other assets | 7,256 | 7,956 | |||||||||
| Total assets | $ | 413,875 | $ | 426,290 | |||||||
| Liabilities and Stockholders' Equity | |||||||||||
| Current liabilities | $ | 19,684 | $ | 38,264 | |||||||
| Long-term liabilities | 6,201 | 51,327 | |||||||||
| Total liabilities | 25,885 | 89,591 | |||||||||
| Total stockholders' equity | 387,990 | 336,699 | |||||||||
| Total liabilities and stockholders' equity | $ | 413,875 | $ | 426,290 | |||||||
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Contacts
Morphic Therapeutic
Chris Erdman
chris.erdman@morphictx.com
617.686.1718