UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 25, 2023
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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:
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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 April 25, 2023, Morphic Holding, Inc. (the “Company”) issued a press release (the “Press Release”) announcing its financial results for the quarter ended March 31, 2023. The Press Release is attached hereto as Exhibit 99.1.
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 8.01 Other Events.
On April 25, 2023, the Company issued a press release announcing positive topline results from the main cohort (n=35) of the EMERALD-1 open-label, single-arm Phase 2a trial of MORF-057 at dose of 100 mg twice daily in patients with moderate to severe ulcerative colitis.
In this cohort of EMERALD-1, MORF-057 achieved its primary endpoint, demonstrating a statistically significant reduction of 6.4 points (p=0.002) from baseline at Week 12 as measured by the Robarts Histopathology Index Score. In an important exploratory measure of that study, 25.7% of patients achieved clinical remission by modified Mayo Clinic Score. MORF-057 was generally well tolerated with no safety signal observed. Additionally, MORF-057 achieved saturation of α4β7 receptor and demonstrated changes in α4β7 lymphocyte subsets that are consistent with Phase 1 MORF-057 data.
The Company expects to present additional details at a future medical conference.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K 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 statements regarding the clinical development of MORF-057. 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 the Company’s 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 the Company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties disclosed in this Current Report on Form 8-K and other risks set forth in the Company’s filings with the Securities and Exchange Commission. Forward-looking statements in this Current Report on Form 8-K 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.
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, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MORPHIC HOLDING, INC. | ||||||||
| Date: April 25, 2023 | 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 First Quarter 2023
-In EMERALD-1 Phase 2a trial in patients with ulcerative colitis, MORF-057 meets primary endpoint and demonstrates clinically meaningful improvements across secondary and exploratory measures with no safety signal observed -
-EMERALD-2 Phase 2b Trial of MORF-057 progressing on track-
-Ended first quarter 2023 with $421 million in cash, cash equivalents, and marketable securities, extending runway into second half of 2026-
WALTHAM, Mass. – April 25, 2023 – 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
•Announced positive topline results from the main cohort of the EMERALD-1 open-label, single-arm Phase 2a trial of MORF-057 at a dose of 100 mg BID (twice daily) in patients with moderate to severe ulcerative colitis (UC)
•In EMERALD-1, MORF-057
◦Achieved primary endpoint with statistical significance, demonstrating a reduction of 6.4 points (p=0.002) from baseline at week 12 in the Robarts Histopathology Index (RHI) Score
◦Achieved a 25.7% remission rate according to Modified Mayo Clinic Score (mMCS)
◦Was generally well tolerated and with no safety signal observed
◦Achieved saturation of α4β7 receptor and demonstrated changes in α4β7 lymphocyte subsets that are consistent with Phase 1 MORF-057 data
•Continued ramp-up and enrollment of EMERALD-2 Phase 2b study of MORF-057 in patients with moderate to severe UC
◦EMERALD-2 is global Phase 2b randomized, double-blind, placebo-controlled trial of MORF-057 enrolling patients with moderate-to-severe ulcerative colitis
◦The primary endpoint of EMERALD-2 is the 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 data at European Crohn’s and Colitis Organization Annual Meeting 2023 demonstrating the activity of α4β7 inhibition in animal models of inflammatory bowel disease (IBD), further support the ongoing EMERALD Phase 2 clinical trials of MORF-057 in IBD
Emerging Pipeline
•Defined myelofibrosis as a new therapeutic area, for development of Morphic’s selective αvβ8 small molecule inhibitors and the role of αvβ8 inhibition in the suppression of TGFB activation, which is implicated in myelofibrotic disease
•Announced a new small molecule integrin inhibitor program for the treatment of pulmonary hypertensive diseases targeting an undisclosed integrin receptor
“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 in the first half of 2025, the phase 2b randomized study of MORF-057 in UC,” 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
•Net loss for the quarter ended March 31, 2023, was $36.1 million or $0.90 per share compared to a net loss of $31.5 million or $0.85 per share for the same quarter last year
•Revenue was $0.5 million for the quarter ended March 31, 2023, compared to $2.4 million for the same quarter last year
•Research and development expenses were $30.4 million for the quarter ended March 31, 2023, as compared to $26.5 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 $9.3 million for the quarter ended March 31, 2023, compared to $7.6 million for the same quarter last year. The increase was primarily due to increased non-cash stock-based compensation expense and higher payroll costs
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 | |||||||
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Contacts
Morphic Therapeutic
Chris Erdman
chris.erdman@morphictx.com
617.686.1718