SOUTH SAN FRANCISCO, Calif., May 04, 2023 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a clinical-stage biotechnology company focused on discovering and developing transformative therapeutics for patients, today reported financial results for the quarterly period ended March 31, 2023 and provided business highlights.
“We are pleased with the results of the ALPINE 4 trial supporting the therapeutic potential of aldafermin in patients with advanced NASH. We continue to make progress on our corporate strategy with the initiation of Phase 2 expansion cohorts in our proof-of-concept trial of NGM707 and the extension of our expected cash runway. With these activities, we are optimizing our resource allocation strategy towards advancing our solid tumor oncology portfolio in the clinic, while our discovery engine continues to generate new product candidates,” said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. “I would like to extend my sincere gratitude and thanks to NGM Bio’s departing staff impacted by our recent restructuring for their significant contributions and unwavering commitment to discovering and developing novel, life-changing medicines for people whose health and lives are disrupted by disease.”
Key First Quarter and Recent Highlights
Corporate Updates
Solid Tumor Oncology
Phase 2b ALPINE 4 Trial Topline Results
“On behalf of the entire NGM Bio team, I’d like to thank the ALPINE 4 investigators and clinical trial staff, our employees who contributed to this effort and, most importantly, the patients who participated in the study,” said Hsiao D. Lieu, M.D., Chief Medical Officer at NGM Bio. “We are encouraged that we continue to see evidence of the potential therapeutic activity of aldafermin, including on the ELF biomarker that has been correlated to patient outcomes, and we look forward to having conversations with potential partners to determine further development of the program.”
First Quarter 2023 Financial Results
About NGM Biopharmaceuticals, Inc.
NGM Bio is focused on discovering and developing novel, life-changing medicines for people whose health and lives have been disrupted by disease. The company’s biology-centric drug discovery approach aims to seamlessly integrate interrogation of complex disease-associated biology and protein engineering expertise to unlock proprietary insights that are leveraged to generate promising product candidates and enable their rapid advancement into proof-of-concept studies. As explorers on the frontier of life-changing science, NGM Bio aspires to operate one of the most productive research and development engines in the biopharmaceutical industry. All therapeutic candidates in the NGM Bio pipeline have been generated by its in-house discovery engine, always led by biology and motivated by unmet patient need. Today, the company has four solid tumor oncology programs in clinical development. Visit us at www.ngmbio.com for more information.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
1 A 0.3 mg aldafermin cohort was part of the original design of the trial and enrolled 7 patients prior to being discontinued in favor of enrolling more patients in the 1 mg and 3 mg arms of the trial. Patients in the 0.3 mg arm were primarily evaluated for safety.
Abbreviations (in Alphabetical Order)
F4=Stage 4 Liver Fibrosis; ILT2=Immunoglobin-Like Transcript 2; ILT3=Immunoglobin-Like Transcript 3; ILT4=Immunoglobin-Like Transcript 4; LAIR1=Leukocyte-Associated Immunoglobulin-Like Receptor 1; NASH=non-alcoholic steatohepatitis
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “will,” “could,” “expect,” “expected,” “potential,” “promising,” “aspires,” “aims,” “look forward to” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to: the therapeutic potential of NGM Bio’s product candidates; NGM Bio’s continued pipeline development, including identification and engagement of third-party partners for potential future business development arrangements (“BD Arrangements”) to determine further development of aldafermin, and research and development and discovery engine output; NGM Bio’s expectation of continued decreasing revenue from Merck; the costs, timing and financial impact of the restructuring; NGM Bio extending its expected cash runway and the timing thereof; and other statements that are not historical fact. Because such statements deal with future events and are based on NGM Bio’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of NGM Bio could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to failure or delays in successfully initiating, enrolling, reporting data from or completing clinical studies, as well as the risks that results obtained in preclinical or clinical trials to date may not be indicative of results obtained in future trials; NGM Bio’s reliance on its amended collaboration with Merck; NGM Bio’s ability to identify and engage third-party partners for BD Arrangements, if any, and its ability to attract such partners; the time-consuming and uncertain regulatory approval process; NGM Bio’s reliance on third-party manufacturers for its product candidates and the risks inherent in manufacturing and testing pharmaceutical products; the sufficiency of NGM Bio’s cash resources and expected cash runway, including the risk that NGM Bio could utilize its available capital resources sooner than it currently expects and its need for additional capital; macroeconomic conditions (such as the impacts of the ongoing COVID-19 pandemic and the conflict between Russia and Ukraine, global economic slowdown, increased inflation, rising interest rates and recent and potential future bank failures); and other risks and uncertainties affecting NGM Bio and its development programs, including those discussed in the section titled “Risk Factors” in NGM Bio’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the United States Securities and Exchange Commission (“SEC”) on February 28, 2023 and future filings and reports that NGM Bio makes from time to time with the SEC. Except as required by law, NGM Bio assumes no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.
Investor Contact: [email protected] | Media Contact: [email protected] |
NGM BIOPHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended March 31, | |||||||
2023 | 2022 | ||||||
Related party revenue | $ | 2,247 | $ | 20,948 | |||
Operating expenses: | |||||||
Research and development | 40,857 | 42,806 | |||||
General and administrative | 11,584 | 10,723 | |||||
Total operating expenses | 52,441 | 53,529 | |||||
Loss from operations | (50,194 | ) | (32,581 | ) | |||
Interest income, net | 2,584 | 176 | |||||
Other expense, net | (37 | ) | (45 | ) | |||
Net loss | $ | (47,647 | ) | $ | (32,450 | ) | |
Net loss per share, basic and diluted | $ | (0.58 | ) | $ | (0.42 | ) | |
Weighted average shares used to compute net loss per share, basic and diluted | 82,008 | 78,023 | |||||
NGM BIOPHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share amounts)
(Unaudited)
March 31, 2023 | December 31, 2022* | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 67,549 | $ | 73,456 | |||
Short-term marketable securities | 163,455 | 198,036 | |||||
Related party receivable from collaboration | 1,257 | 7,580 | |||||
Prepaid expenses and other current assets | 8,769 | 9,787 | |||||
Restricted cash | 1,499 | — | |||||
Total current assets | 242,529 | 288,859 | |||||
Property and equipment, net | 7,966 | 8,496 | |||||
Operating lease right-of-use asset | 1,586 | 2,096 | |||||
Restricted cash | 2,455 | 3,954 | |||||
Other non-current assets | 4,301 | 3,997 | |||||
Total assets | $ | 258,837 | $ | 307,402 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 13,293 | $ | 8,453 | |||
Accrued liabilities | 20,161 | 33,638 | |||||
Operating lease liability, current | 4,073 | 5,385 | |||||
Contract liabilities | 376 | 366 | |||||
Total current liabilities | 37,903 | 47,842 | |||||
Total liabilities | 37,903 | 47,842 | |||||
Commitments and contingencies | |||||||
Stockholders' equity: | |||||||
Preferred stock, $0.001 par value | — | — | |||||
Common stock, $0.001 par value | 82 | 82 | |||||
Additional paid-in capital | 850,229 | 841,413 | |||||
Accumulated other comprehensive loss | (97 | ) | (302 | ) | |||
Accumulated deficit | (629,280 | ) | (581,633 | ) | |||
Total stockholders' equity | 220,934 | 259,560 | |||||
Total liabilities and stockholders' equity | $ | 258,837 | $ | 307,402 |
___________
* Derived from the audited consolidated financial statements.
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