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--Announced positive interim results from ongoing 24-week Phase 2 study evaluating--
--1 mg aldafermin (formerly NGM282) (Cohort 4) in non-alcoholic steatohepatitis (NASH) patients--
-- Anticipates full Cohort 4 data, including biopsy assessments, in Q1 2020--
--Disclosed complement C3 as the target for NGM621, an inhibitory antibody intended to treat patients with
dry age-related macular degeneration (AMD)--
SOUTH SAN FRANCISCO, Calif., Nov. 12, 2019 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM or the Company) (Nasdaq: NGM), a clinical stage biotechnology company focused on developing transformative therapeutics for patients, today reported business highlights and third quarter 2019 financial results for the period ending September 30, 2019.
“We continue to build momentum across our three therapeutic focus areas: metabolic disease, oncology and ophthalmic disease,” said David J. Woodhouse, Ph.D., chief executive officer of NGM. “We’re very encouraged by the interim results we reported last month from the 24-week cohort in our aldafermin Phase 2 study. Consistent with our prior Phase 2 readouts, these data reinforce that aldafermin rapidly returns patients to near normal levels of liver fat and other key inflammatory and fibrotic biomarker measures by 12 weeks, and that these clinically meaningful reductions are sustained through a 24-week period. We look forward to learning early next year whether extending the duration of improved liver health from 12 to 24 weeks will translate to histological benefit. With our ongoing Phase 2b ALPINE 2/3 study of aldafermin, we are working to build a strong clinical case for the efficacy and tolerability of aldafermin in treating NASH patients.”
Dr. Woodhouse continued, “We are also advancing a Phase 1 study of NGM621 in patients with dry AMD and are preparing to initiate a Phase 1a/1b study of NGM120 in patients with solid tumors, some of whom are afflicted with cancer anorexia-cachexia syndrome (CACS). Like NASH, dry AMD and CACS are diseases characterized by large unmet medical needs. We are working diligently to develop transformative medicines for those patients. These programs are part of our strategic collaboration with Merck, which has enabled us to broaden our pipeline into areas such as oncology and ophthalmology. We are also advancing another wholly-owned program, NGM395, a long-acting GDF15 receptor agonist, into a Phase 1 safety and tolerability study.”
Third Quarter 2019 and Recent Highlights
Third Quarter Financial Results
About NGM Biopharmaceuticals, Inc.
NGM is a clinical stage biopharmaceutical company focused on developing novel therapeutics based on scientific understanding of key biological pathways underlying cardio-metabolic, liver, oncologic and ophthalmic diseases. The company leverages its biology-centric drug discovery approach to uncover novel mechanisms of action and generate proprietary insights that enable it to move rapidly into proof-of-concept studies and deliver potential first-in-class medicines to patients. NGM aspires to operate one of the most productive research and development engines in the biopharmaceutical industry, with multiple programs in clinical development. Visit http://www.ngmbio.com for more information.
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 “plans,” “will,” “anticipate,” “intended,” “continue,” “look forward to,” “working to,” “preparing 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 NGM’s R&D engine and ability to build a robust pipeline of product candidates; the advancement of its clinical and preclinical pipeline; the timing, enrollment and results of NGM’s clinical trials, including the announcement of Cohort 4 topline results of the Phase 2 clinical study of aldafermin (NGM282) in patients with NASH and preliminary results of ALPINE 2/3; the safety, tolerability and efficacy of NGM’s product candidates; continued development of additional product candidates, including NGM621 in patients with dry AMD, NGM120 in patients with solid tumors and NGM395; NGM’s ability to fund its clinical programs and NGM’s financial outlook. Because such statements deal with future events and are based on NGM’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of NGM 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 those discussed in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our quarterly report on Form 10-Q for the quarter ended June 30, 2019 and future filings and reports that NGM makes from time to time with the United States Securities and Exchange Commission, including NGM’s quarterly report on Form 10-Q for the quarter ended September 30, 2019. Except as required by law, NGM 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.
Sylvia Wheeler and Alex Santos
NGM Biopharmaceuticals, Inc.
Unaudited Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
Three Months Ended
Nine Months Ended
|Related party revenue||$||21,568||$||20,815||$||72,461||$||61,546|
|Research and development||28,953||24,473||87,299||66,773|
|General and administrative||5,612||4,811||17,208||12,143|
|Total operating expenses||34,565||29,284||104,507||78,916|
|Loss from operations||(12,997||)||(8,469||)||(32,046||)||(17,370||)|
|Other income (expense), net||96||(14||)||54||103|
|Net loss per common share, basic and diluted||$||(0.17||)||$||(1.15||)||$||(0.60||)||$||(2.33||)|
|Weighted average shares used to compute net loss per
common share, basic and diluted
NGM Biopharmaceuticals, Inc.
Unaudited Condensed Consolidated Balance Sheets
|September 30,||December 31,|
|Cash and cash equivalents||$||303,016||$||56,923|
|Short-term marketable securities||53,557||149,710|
|Related party receivable from collaboration||—||3,669|
|Prepaid expenses and other current assets||7,747||4,255|
|Total current assets||364,320||214,557|
|Property and equipment, net||20,485||23,893|
|Deferred IPO costs||—||2,292|
|Other non-current assets||3,936||3,094|
|Liabilities, convertible preferred stock and stockholders' equity (deficit)|
|Deferred rent, current||2,792||2,683|
|Deferred revenue, current||14,624||19,025|
|Total current liabilities||40,478||41,486|
|Deferred rent, non-current||10,118||12,221|
|Deferred revenue, non-current||—||3,942|
|Early exercise stock option liability||833||1,559|
|Convertible preferred stock warrant liability||—||198|
|Commitments and contingencies|
|Convertible preferred stock, $0.001 par value;||—||294,874|
|Stockholders' equity (deficit):|
|Common stock, $0.001 par value;||66||7|
|Additional paid-in capital||519,224||39,258|
|Accumulated other comprehensive gain (loss)||99||(267||)|
|Total equity (deficit)||339,186||(108,195||)|
|Total liabilities, convertible preferred stock and stockholders' equity (deficit)||$||390,615||$||246,085|
*The Condensed Consolidated Balance Sheet as of December 31, 2018 has been derived from the audited financial statements as of that date.