NGM NGM Biopharmaceuticals Inc.

26.77
+0.02  (+0%)
Previous Close 26.75
Open 26.79
52 Week Low 14.93
52 Week High 32.12
Market Cap $2,060,115,734
Shares 76,956,135
Float 31,194,692
Enterprise Value $1,774,194,470
Volume 72,046
Av. Daily Volume 199,590
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Upcoming Catalysts

Drug Stage Catalyst Date
Aldafermin (NGM282) - ALPINE 2/3
Non-alcoholic steatohepatitis (NASH)
Phase 2b
Phase 2b
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NGM120
Pancreatic Cancer
Phase 1b
Phase 1b
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Drug Pipeline

Drug Stage Notes
NGM438
Oncology
Phase 1
Phase 1
Phase 1 trial to be initiated 4Q 2021.
NGM707
Oncology
Phase 1
Phase 1
Phase 1 trial to be initiated mid-2021.
NGM621 (CATALINA)
Geographic atrophy
Phase 2
Phase 2
Phase 2 enrollment to be completed mid-2021.
Aldafermin (NGM282) - (ALPINE 4)
NASH cirrhosis
Phase 2b
Phase 2b
Phase 2b trial ongoing.

Latest News

    • Expect to report topline data from Phase 2b ALPINE 2/3 clinical trial of aldafermin in patients with NASH with F2 and F3 liver fibrosis in the second quarter
    • Continued enrollment in Phase 2 CATALINA study of NGM621 in patients with geographic atrophy and expect to complete enrollment by mid-year
    • Achieved key milestone in oncology portfolio with initiation in January of a Phase 2 placebo-controlled component of ongoing Phase 1/2 clinical trial of NGM120, testing NGM120 in combination in patients with metastatic pancreatic cancer
    • Strengthened capital position with completion of public offering of NGM common stock in January, raising net proceeds of $134.6 million
    • $412.7 million in cash, cash equivalents and marketable securities as of March 31, 2021…
    • Expect to report topline data from Phase 2b ALPINE 2/3 clinical trial of aldafermin in patients with NASH with F2 and F3 liver fibrosis in the second quarter

    • Continued enrollment in Phase 2 CATALINA study of NGM621 in patients with geographic atrophy and expect to complete enrollment by mid-year
    • Achieved key milestone in oncology portfolio with initiation in January of a Phase 2 placebo-controlled component of ongoing Phase 1/2 clinical trial of NGM120, testing NGM120 in combination in patients with metastatic pancreatic cancer
    • Strengthened capital position with completion of public offering of NGM common stock in January, raising net proceeds of $134.6 million
    • $412.7 million in cash, cash equivalents and marketable securities as of March 31, 2021

    SOUTH SAN FRANCISCO, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM) (NASDAQ:NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today provided business highlights and reported financial results for the period ending March 31, 2021. 

    "In the first quarter of 2021, we achieved a key milestone in our oncology portfolio with the initiation of the randomized, placebo-controlled component of our NGM120 study in patients with metastatic pancreatic cancer," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. "We also continued to make progress across our four other ongoing Phase 2 and Phase 2b programs. We remain on track to report topline data from our Phase 2b ALPINE 2/3 clinical study of aldafermin in patients with NASH in the second quarter and we expect to complete enrollment in our Phase 2 CATALINA clinical study of NGM621 in patients with geographic atrophy by mid-year. Our team continues to work diligently to advance our two lead immuno-oncology product candidates into the clinic later this year."

    Dr. Woodhouse continued, "We demonstrated strong pipeline and corporate execution despite the continued challenges presented by the COVID-19 pandemic and continue to focus on our mission to translate powerful biology with urgency and rigor to deliver life-changing medicines."

    Key First Quarter and Recent Highlights

    Liver and metabolic diseases

    • Anticipate reporting topline data from the Phase 2b ALPINE 2/3 study of aldafermin in patients with NASH with liver fibrosis stage 2 or 3 (F2-F3) in the second quarter. ALPINE 2/3 is a Phase 2b clinical study of aldafermin in patients with biopsy-confirmed NASH and liver fibrosis F2 or F3. The 24-week study will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo. The primary objective of the ALPINE 2/3 study is to evaluate a dose response showing an improvement in liver fibrosis by ≥ 1 stage with no worsening of steatohepatitis at week 24.
    • Continued enrollment in Phase 2b ALPINE 4 study of aldafermin in patients with NASH with liver fibrosis stage 4 (F4) and compensated cirrhosis. NGM continued enrollment in the Phase 2b ALPINE 4 clinical study of aldafermin in patients with biopsy-confirmed NASH with F4 liver fibrosis and compensated cirrhosis. The 48-week study is designed to enroll approximately 160 patients and will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo. The primary objective of ALPINE 4 is to evaluate a dose response showing an improvement in liver fibrosis by ≥ 1 stage with no worsening of steatohepatitis at week 48.
    • Merck continued the Phase 2b study of MK-3655 in patients with NASH with F2-F3 liver fibrosis. In November 2020, Merck initiated a global Phase 2b multicenter study of MK-3655 for the treatment of F2-F3 NASH. The 52-week randomized, double-blind study is designed to enroll approximately 320 patients and will assess the efficacy, safety and tolerability of 50 mg, 100 mg and 300 mg doses of MK-3655 compared to placebo. The primary objective of the Phase 2b study is NASH resolution without worsening of fibrosis after 52 weeks. Merck licensed MK-3655 following NGM's completion of a proof-of-concept study. NGM retains an option, at the initiation of the first Phase 3 clinical trial for MK-3655, to either receive milestone and royalty payments or to co-fund development and participate in a global cost and revenue sharing arrangement of up to 50% for MK-3655.

    Retinal diseases

    • Expect to complete enrollment in the Phase 2 CATALINA study of NGM621 in patients with GA by mid-year. NGM continues to enroll patients in the Phase 2 CATALINA study, a multi-center, randomized, double-masked, sham-controlled clinical trial to evaluate the safety and efficacy of intravitreal (IVT) injections of NGM621 every four weeks or every eight weeks in patients with geographic atrophy (GA) in one or both eyes secondary to age-related macular degeneration. NGM anticipates completing enrollment by mid-year. The primary endpoint is the rate of change in GA lesion area, as measured by fundus autofluorescence imaging, over 52 weeks of treatment.
    • Presented Phase 1 safety and pharmacokinetics (PK) data for NGM621 in patients with GA at the Angiogenesis, Exudation, and Degeneration 2021 - Virtual Edition. Single and multiple IVT injections of NGM621 appeared safe and well tolerated in this first-in-human study, with no patients experiencing serious adverse events, drug-related adverse events, endophthalmitis, intraocular inflammation or choroidal neovascularization. The serum PK of NGM621 was linear and dose-proportional. Based on ocular PK/pharmacodynamics (PD) modeling, NGM believes NGM621 has the potential for up to an every eight-week dosing regimen.

    Cancer

    • Initiated a Phase 2 placebo-controlled component of an ongoing Phase 1/2 study of NGM120 in January, testing NGM120 as a first-line treatment in combination with gemcitabine and Abraxane® (paclitaxel protein bound) in patients with metastatic pancreatic cancer. NGM initiated a multi-center, randomized, single-blind (sponsor unblinded), placebo-controlled component of NGM120 in combination with gemcitabine and Abraxane as a first line treatment in patients with metastatic pancreatic cancer as part of its ongoing Phase 1/2 trial. This Phase 2 component of the Phase 1/2 study is designed to enroll approximately 60 patients and will assess the efficacy, safety and tolerability of NGM120 or placebo in combination with gemcitabine and Abraxane against both cancer and cancer-related cachexia endpoints. The Phase 1a/1b dose-finding portion of the study is still ongoing, and NGM expects to report interim results from that portion of the study in the second half of the year.
    • Continued to progress two new oncology clinical candidates, NGM707 and NGM438, toward the clinic. These programs are part of NGM's strategy to treat cancer through myeloid reprogramming that reverses immune suppression in the tumor microenvironment. NGM707 is a dual antagonist antibody that inhibits Immunoglobulin-like transcript 2 (ILT2) and Immunoglobulin-like transcript 4 (ILT4). NGM438 is an antagonist antibody that inhibits Leukocyte-associated immunoglobulin-like receptor 1 (LAIR1). NGM expects to initiate a first-in-human Phase 1 trial for NGM707 in patients with advanced solid tumors in mid-2021 and for NGM438 in patients with advanced solid tumors during the fourth quarter.

    Corporate

    • Completed a public offering of common stock. In January, NGM completed an underwritten public offering of 5,324,074 shares of its common stock for net proceeds to NGM of $134.6 million, which included the full exercise by the underwriters of their over-allotment option to purchase additional shares, at a price to the public of $27.00 per share.
    • Nomination of Roger M. Perlmutter for election to Board of Directors. On April 28, 2021, NGM announced that the company has nominated Roger M. Perlmutter, M.D., Ph.D. to stand for election to the company's board of directors at its June 8, 2021 annual meeting of stockholders. Dr. Perlmutter brings decades of expertise and renowned leadership in drug discovery and development with global healthcare companies including Merck and Amgen.
    • Extended deadline for Merck collaboration extension notice. Merck has a unilateral option to extend the research and early development phase of its ongoing strategic collaboration with NGM, which would, if exercised by Merck, extend the research phase of the collaboration for an additional two-year period from March 2022 to March 2024. Merck was required to notify NGM of its unilateral decision whether to exercise its option in March 2021, but in order to allow the parties to negotiate potential modifications to the terms of the collaboration agreement, on March 12, 2021, Merck and NGM agreed to extend the deadline for Merck's decision until June 30, 2021. NGM expects that any modified collaboration would result in a level of annual research support from Merck during any extension of the current research phase after March 2022 that is meaningfully lower than the annual research support Merck provided NGM during the initial five-year term and the first extension period. NGM also expects that if Merck and NGM are unable to reach agreement on modified terms, Merck will not elect to extend the research phase of the collaboration and that NGM's obligation to fund its own research and development efforts will substantially increase after March 2022.

    First Quarter 2021 Financial Results

    • NGM reported a net loss of $27.5 million for the quarter ended March 31, 2021, compared to a net loss of $19.1 million for the same period in 2020.
    • Related party revenue from our collaboration with Merck was $21.6 million for the quarter ended March 31, 2021, compared to $24.4 million or the same period in 2020. The decrease in related party revenue of $2.8 million in 2021 was primarily attributable to a decrease in the recognition of the initial upfront payment received from Merck in 2015 that was included in the transaction price and fully recognized by March 2020.
    • Research and development, or R&D, expenses were $40.7 million for the quarter ended March 31, 2021, compared to $38.4 million for the same period in 2020. R&D expenses increased $2.3 million in 2021, primarily due to a $3.5 million increase in personnel-related expenses and an increase in external expenses driven by our ongoing clinical and pre-clinical studies of NGM621, NGM438 and NGM707. These increases were partially offset by a decrease of $4.6 million in our manufacturing activities and ongoing clinical trials of aldafermin and $1.2 million in external expenses related to our other development programs.
    • General and administrative expenses were $8.7 million for the quarter ended March 31, 2021, compared to $6.6 million for the same period in 2020. The $2.1 million increase in general and administrative expenses in 2021 was primarily attributable to increases in personnel-related expenses driven by increased headcount, as well as external expenses to support our operations as a public company.
    • Cash, cash equivalents and short-term marketable securities were $412.7 million as of March 31, 2021, compared to $295.2 million as of December 31, 2020.

    Merck Collaboration

    Under the current terms of NGM's collaboration with Merck, Merck has a one-time option to license NGM pipeline programs – other than aldafermin, NGM386 and NGM395 – following human proof-of-concept trials under the terms of the companies' ongoing strategic collaboration. Upon exercising any such option, Merck would lead global product development and commercialization for the resulting products, if approved. Prior to Merck initiating a Phase 3 study for a licensed program, NGM may elect to either receive milestone and royalty payments or to co-fund development and participate in a global cost and revenue share arrangement of up to 50%. The current terms of the collaboration also provide NGM with the option to participate in the co-promotion of any co-funded program in the United States. In January 2019, Merck exercised its first option under the collaboration to license MK-3655, previously referred to as NGM313. As described above, the parties continue to negotiate potential modifications to the terms of the collaboration.

    About NGM Biopharmaceuticals, Inc.

    NGM is a biopharmaceutical company focused on discovering and developing novel therapeutics based on scientific understanding of key biological pathways underlying liver and metabolic diseases, retinal diseases and cancer. We leverage our biology-centric drug discovery approach to uncover novel mechanisms of action and generate proprietary insights that enable us to move rapidly into proof-of-concept studies and deliver potential first-in-class medicines to patients. At NGM, we aspire to operate one of the most productive research and development engines in the biopharmaceutical industry. Visit us at www.ngmbio.com for more information.

    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 "anticipates," "will," "build," "vision," "designed to," "potential," "aspire," "continue," "expect," "plan" 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 mission to build a biologic therapeutics company that delivers lifechanging medicines for patients; the availability and anticipated timing of topline data from Phase 2b ALPINE 2/3 clinical trial of aldafermin and interim results from the Phase 1a/1b dose-finding portion of the Phase 1/2 clinical trial of NGM120; the timing of initiation of Phase 1 clinical trials for NGM707 and NGM438 and NGM's strategy to treat cancer through myeloid reprogramming; the timing of completion of enrollment in the Phase 2 CATALINA study of NGM621; the therapeutic potential of NGM's product candidates, including the potential for every eight-week dosing for NGM621; NGM and Merck potentially reaching agreement on the terms of a modified collaboration and NGM's expectations that any modified collaboration would result in a meaningfully lower level of annual research support from Merck during any extension of the current research phase, if any, and that if Merck and NGM are unable to reach agreement on modified terms, Merck will not elect to extend the research phase of the collaboration and NGM's obligation to fund its own research and development efforts will substantially increase after March 2022; Dr. Perlmutter's potential election to NGM's board of directors; and other statements that are not historical fact. 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, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully enrolling or completing clinical studies, the risk that the results obtained to date in NGM's clinical trials may not be indicative of results obtained in subsequent pivotal or other late-stage trials and the risk that NGM's ongoing or future clinical studies may show that aldafermin, or Merck's ongoing or future clinical studies of MK-3655, are not tolerable and effective treatments for patients with NASH and the risk that its other product candidates may also not be tolerable and effective treatments in their planned indications; the risks that Merck may elect not to extend the research phase of the collaboration and NGM may otherwise be unable to reach agreement with Merck on the terms of a modified collaboration and, regardless of whether NGM and Merck reach agreement on the terms of a modified collaboration, NGM expects that Merck will not provide research funding for certain of NGM's product candidates and the NGM's collaboration with Merck otherwise involves numerous other risks, any of which could materially and adversely affect NGM's business and financial condition; the ongoing COVID-19 pandemic, which has adversely affected, and could materially and adversely affect in the future, NGM's business and operations, including NGM's clinical trials; the time-consuming and uncertain regulatory approval process; NGM's reliance on third-party manufacturers for aldafermin and its other product candidates; the sufficiency of NGM's cash resources and need for additional capital; and other risks and uncertainties affecting NGM and its development programs, including those discussed in the section titled "Risk Factors" in NGM's annual report on Form 10-K for the year ended December 31, 2020 filed with the United States Securities and Exchange Commission (SEC) on March 15, 2021 and future filings and reports that NGM makes from time to time with the SEC. 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.

    Investor Contact:

    Alex Schwartz

    Media Contact:

    Liz Melone

    NGM BIOPHARMACEUTICALS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (In thousands, except share and per share amounts)

    (Unaudited)

     Three Months Ended

    March 31,
     2021 2020
    Related party revenue$21,575   $24,364  
    Operating expenses:   
    Research and development40,699   38,439  
    General and administrative8,721   6,595  
    Total operating expenses49,420   45,034  
    Loss from operations(27,845)  (20,670) 
    Interest income, net114   1,175  
    Other income, net187   380  
    Net loss$(27,544)  $(19,115) 
    Net loss per share, basic and diluted$(0.36)  $(0.28) 
    Weighted average shares used to compute net loss per share, basic and diluted76,034,145   67,396,229  
            

    NGM BIOPHARMACEUTICALS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands) 

    (Unaudited)

     March 31,

    2021
     December 31,

    2020*
    ASSETS   
    Current assets:   
    Cash and cash equivalents$148,113   $147,017  
    Short-term marketable securities264,543   148,139  
    Related party receivable from collaboration325   333  
    Related party contract asset4,600   6,100  
    Prepaid expenses and other current assets8,268   6,837  
    Total current assets425,849   308,426  
    Property and equipment, net13,733   14,526  
    Restricted cash1,499   1,499  
    Other non-current assets4,460   4,592  
    Total assets$445,541   $329,043  
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Current liabilities:   
    Accounts payable$7,535   $9,663  
    Accrued liabilities29,763   29,945  
    Deferred rent, current3,011   2,975  
    Total current liabilities40,309   42,583  
    Deferred rent, non-current5,655   6,417  
    Total liabilities45,964   49,000  
    Commitments and contingencies   
    Stockholders' equity:   
    Preferred stock, $0.001 par value;     
    Common stock, $0.001 par value;77   71  
    Additional paid-in capital725,693   578,599  
    Accumulated other comprehensive income (loss)(18)  4  
    Accumulated deficit(326,175)  (298,631) 
    Total stockholders' equity399,577   280,043  
    Total liabilities and stockholders' equity$445,541   $329,043  

    ___________

    * Derived from the audited consolidated financial statements.



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  1. SOUTH SAN FRANCISCO, Calif., April 28, 2021 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM) (NASDAQ:NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, announced today the nomination of Roger M. Perlmutter, M.D., Ph.D., to stand for election to the company's board of directors at its June 8, 2021 annual meeting of stockholders.

    Dr. Perlmutter brings a wealth of expertise in drug discovery and development as a highly accomplished biopharma industry leader and academic with over 35 years of experience. Dr. Perlmutter is currently Chairman of Merck Research Laboratories, and for the previous nearly eight years was executive vice president of Merck & Co. and president of Merck Research…

    SOUTH SAN FRANCISCO, Calif., April 28, 2021 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM) (NASDAQ:NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, announced today the nomination of Roger M. Perlmutter, M.D., Ph.D., to stand for election to the company's board of directors at its June 8, 2021 annual meeting of stockholders.

    Dr. Perlmutter brings a wealth of expertise in drug discovery and development as a highly accomplished biopharma industry leader and academic with over 35 years of experience. Dr. Perlmutter is currently Chairman of Merck Research Laboratories, and for the previous nearly eight years was executive vice president of Merck & Co. and president of Merck Research Laboratories. While at Merck, Dr. Perlmutter played a pivotal role in the approval and development of numerous lifesaving medicines and, in particular, was responsible for the development of KEYTRUDA® (pembrolizumab), Merck's breakthrough anti-PD-1 therapy. Prior to Merck, Dr. Perlmutter was executive vice president and head of research and development at Amgen, where he was responsible for the registration of novel therapeutics in the areas of oncology, endocrinology, hematology, inflammation and osteoporosis, including Sensipar®, Prolia® and XGEVA®.

    "A true scientific pioneer, Roger's insights and extensive experience bringing powerful medicines from bench to bedside is ideal for NGM's biology-driven approach and our mission to deliver life-changing medicines," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. "We are thrilled with Roger's nomination and look forward to his many contributions as we advance our diverse clinical pipeline in liver and metabolic diseases, retinal diseases and oncology and continue to operate our highly productive discovery research engine."

    Dr. Perlmutter's nomination for election as a Class II director will be voted on at NGM's 2021 annual meeting of stockholders. Jin-Long Chen, Ph.D., NGM's Founder and Chief Scientific Officer and a current board member, will also stand for re-election as a Class II director. NGM's other two current Class II directors, David Schnell, M.D., and McHenry (Mac) T. Tichenor, Jr., who have served on our Board of Directors since January 2008 and March 2010, respectively, are resigning from NGM's Board of Directors, effective upon the expiration of their respective terms at the 2021 annual meeting, and are not standing for reelection.

    "As a luminary in our industry, Roger has an extensive track record leading highly productive teams translating breakthrough science into impactful medicines that treat grievous disease. Given the broad range of Roger's drug discovery and development expertise, we are honored that Roger has agreed to join the NGM board. His recent experience developing Keytruda is an especially powerful match with NGM's emerging oncology portfolio," said Bill Rieflin, Executive Chairman at NGM. "On behalf of our Board, I'd also like to thank David and Mac for their decade of devoted service and intellectual contributions to NGM's evolution."

    "I have dedicated my professional career to developing medicines that improve and extend life, and NGM is fundamentally driven by the same motivation," said Dr. Perlmutter. "In particular, I have long-admired Dr. Jin-Long Chen, with whom I was privileged to work at Amgen, and I am impressed by the way that his ability to elucidate important new biological principles through careful experimentation has enabled NGM to develop a broad pipeline of innovative therapeutic candidates. As a future member of NGM's board, I look forward to helping to advance NGM's mission: to deliver transformative medicines to patients."

    Dr. Perlmutter has served as a director on numerous corporate boards in the U.S. and Europe, and currently serves on the Board of insitro, a privately held machine learning-driven drug discovery and development company.

    Prior to assuming leadership roles in the biopharmaceutical industry, Dr. Perlmutter was a professor in the Departments of Immunology, Biochemistry and Medicine at the University of Washington, Seattle, and also served as Chairman of its Department of Immunology, where he was at the same time an investigator of the Howard Hughes Medical Institute. Dr. Perlmutter was also previously both a Distinguished Fellow and past president of the American Association of Immunologists and is a Fellow of the American Academy of Arts and Sciences and the American Association for the Advancement of Science. Dr. Perlmutter graduated from Reed College in 1973 and received his M.D. and Ph.D. degrees from Washington University in St. Louis in 1979.

    About NGM Biopharmaceuticals, Inc.

    NGM is a biopharmaceutical company focused on discovering and developing novel therapeutics based on scientific understanding of key biological pathways underlying liver and metabolic diseases, retinal diseases and oncology. We leverage our biology-centric drug discovery approach to uncover novel mechanisms of action and generate proprietary insights that enable us to move rapidly into proof-of-concept studies and deliver potential first-in-class medicines to patients. At NGM, we aspire to operate one of the most productive research and development engines in the biopharmaceutical industry, with multiple programs in clinical development. Visit us at www.ngmbio.com for more information.

    Important Additional Information and Where to Find It

    NGM, its directors and certain of its executive officers may be deemed to be participants in the solicitation of proxies from stockholders in connection with NGM's 2021 annual meeting of stockholders (the "2021 Annual Meeting"). NGM will file with the SEC and make available to its stockholders a proxy statement in connection with such solicitation. NGM STOCKHOLDERS ARE STRONGLY ENCOURAGED TO READ SUCH PROXY STATEMENT (INCLUDING ANY AMENDMENTS AND SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.

    Information regarding the names of NGM's directors and executive officers and their respective interests in NGM by security holdings or otherwise are set forth in NGM's proxy statement for the 2020 annual meeting of stockholders filed with the SEC on April 8, 2020 and will be set forth in NGM's proxy statement for the 2021 Annual Meeting, which documents are or will be available at NGM's investor relations website at https://ir.ngmbio.com/financial-information/sec-filings. To the extent holdings of such participants in NGM's securities have changed since the amounts described in the 2020 proxy statement, or if a particular participant's holdings are not set forth in the 2020 proxy statement, such holdings (or changes thereto) have been reflected in subsequent statements of beneficial ownership on file with the SEC and will be reflected in NGM's proxy statement for the 2021 Annual Meeting. Information regarding the special interests of such participants, if any, in the matters to be voted on at the 2021 Annual Meeting will be included in the 2021 proxy statement referred to above. You can obtain free copies of these referenced documents as described below.

    The proxy statement for the 2021 Annual Meeting (and any amendments or supplements thereto) and any other relevant documents and other material filed by NGM with the SEC, are or will be available for no charge at the SEC's website at www.sec.gov and at NGM's investor relations website at https://ir.ngmbio.com/financial-information/sec-filings. Copies may also be obtained free of charge by contacting NGM by mail at 333 Oyster Point Boulevard, South San Francisco, California 94080, Attn: Secretary, or by telephone at (650) 392-1768.

    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 "mission," "advance," "continue," "will" 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 mission to deliver life-changing medicines; NGM advancing its clinical pipeline in liver and metabolic diseases, retinal diseases and oncology and continuing to operate its highly productive discovery research engine; Dr. Perlmutter joining the NGM Board; and other statements that are not historical fact. 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, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully enrolling or completing clinical studies, the risk that the results obtained to date in NGM's clinical trials may not be indicative of results obtained in subsequent pivotal or other late-stage trials and the risk that ongoing or future clinical studies may not show that NGM's product candidates are tolerable and effective; the ongoing COVID-19 pandemic, which has adversely affected, and could materially and adversely affect in the future, NGM's business and operations, including NGM's clinical trials; the time-consuming and uncertain regulatory approval process; NGM's reliance on third-party manufacturers for aldafermin and its other product candidates; the holding of and the results of voting at the 2021 Annual Meeting; the sufficiency of NGM's cash resources and need for additional capital; and other risks and uncertainties affecting NGM and its development programs, including those discussed in the section titled "Risk Factors" in NGM's annual report on Form 10-K for the year ended December 31, 2020 filed with the United States Securities and Exchange Commission ("SEC") on March 15, 2021 and future filings and reports that NGM makes from time to time with the SEC. 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.

    Investor Contact:

    Alex Schwartz

    Media Contact:

    Liz Melone





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  2.  Significant progress made across liver and metabolic diseases, retinal diseases and cancer during fourth quarter 2020:
       Presented first-in-human results from Phase 1 clinical trial of NGM621 in patients with geographic atrophy (GA) at the American Academy of Ophthalmology (AAO) 2020 Virtual
       Merck advanced collaboration compound MK-3655 into a global Phase 2b clinical trial in patients with non-alcoholic steatohepatitis (NASH)
       Announced expansion of NGM's oncology portfolio with addition of two product candidates, NGM707, a dual antagonist antibody inhibiting ILT2 and ILT4, and NGM438, an antagonist antibody inhibiting LAIR1
     Recently initiated placebo-controlled expansion of Phase1b clinical trial of NGM120 in patients with metastatic
     Significant progress made across liver and metabolic diseases, retinal diseases and cancer during fourth quarter 2020:
       Presented first-in-human results from Phase 1 clinical trial of NGM621 in patients with geographic atrophy (GA) at the American Academy of Ophthalmology (AAO) 2020 Virtual
       Merck advanced collaboration compound MK-3655 into a global Phase 2b clinical trial in patients with non-alcoholic steatohepatitis (NASH)
       Announced expansion of NGM's oncology portfolio with addition of two product candidates, NGM707, a dual antagonist antibody inhibiting ILT2 and ILT4, and NGM438, an antagonist antibody inhibiting LAIR1
     Recently initiated placebo-controlled expansion of Phase1b clinical trial of NGM120 in patients with metastatic pancreatic cancer
     NGM anticipates reporting topline data from Phase 2b ALPINE 2/3 clinical trial in second quarter 2021
     $295.2 million in cash, cash equivalents and marketable securities as of December 31, 2020, which amount does not include net proceeds of approximately $134.7 million from the public offering of NGM common stock completed in January 2021

    SOUTH SAN FRANCISCO, Calif., March 04, 2021 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM) (NASDAQ:NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today provided business highlights and reported financial results for the periods ending December 31, 2020.

    "Our vision at NGM is to build an iconic biologic therapeutics company that delivers transformative medicines for patients. Our team made notable progress across multiple fronts in 2020: presenting aldafermin Cohort 4 data and NGM621 first-in-human data at major medical conferences, advancing multiple programs into Phase 2 clinical testing and announcing the expansion of our oncology portfolio including the nomination of two immuno-oncology candidates," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. "Behind every disease name and statistic, whether it is NASH, cancer-related cachexia, geographic atrophy or solid tumor cancers, are countless individuals who are hoping for better treatment options, all of whom fuel our motivation and mission to improve human health."

    Key Fourth Quarter and Recent Highlights

    Liver and metabolic diseases

     Anticipate reporting topline data from the Phase 2b ALPINE 2/3 study of aldafermin in patients with NASH in second quarter 2021. ALPINE 2/3 is a Phase 2b clinical study of aldafermin in patients with biopsy-confirmed NASH and liver fibrosis stage 2 or 3 (F2-F3). The 24-week study is assessing the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo. The primary objective of the ALPINE 2/3 study is to evaluate a dose response showing an improvement in liver fibrosis by ≥ 1 stage with no worsening of steatohepatitis at week 24.
     Continued enrollment in Phase 2b ALPINE 4 study of aldafermin in patients with NASH with liver fibrosis stage 4 (F4) and well-compensated cirrhosis. NGM continued enrollment in the Phase 2b ALPINE 4 clinical study of aldafermin in patients with biopsy-confirmed NASH with F4 liver fibrosis and well-compensated cirrhosis. The 48-week study is designed to enroll approximately 160 patients and will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo. The primary objective of ALPINE 4 is to evaluate a dose response showing an improvement in liver fibrosis by > 1 stage with no worsening of steatohepatitis at week 48.
     Presented data from 24-week double-blind, randomized, placebo-controlled Phase 2 study (Cohort 4) of aldafermin in NASH patients at AASLD The Liver Meeting®. Cohort 4 demonstrated statistically significant dual activity in fibrosis improvement and NASH resolution in patients with F2 and F3 liver fibrosis. Analysis of Cohort 4 data at AASLD also showed that 30% of patients with more advanced F3 liver fibrosis treated with aldafermin 1 mg achieved fibrosis improvement >1 stage without worsening of NASH compared to 0% in the placebo arm. In Cohort 4, aldafermin continued to demonstrate a favorable tolerability profile. Cohort 4 was the final reported cohort from NGM's adaptive Phase 2 clinical study of aldafermin in NASH and the results observed in Cohort 4 were consistent with data from the three previous cohorts.
     Merck initiated Phase 2b study of MK-3655 (formerly NGM313) in patients with NASH with F2-F3 liver fibrosis. In November, Merck initiated a global Phase 2b multicenter, randomized, double-blind study of MK-3655 in patients with biopsy-confirmed NASH. The 52-week study is designed to enroll approximately 320 patients and will assess the efficacy, safety and tolerability of 50 mg, 100 mg and 300 mg doses of MK-3655 administered every 4 weeks compared to placebo in patients with biopsy-confirmed NASH and F2-F3 liver fibrosis. The primary objective of the Phase 2b study is NASH resolution without worsening of fibrosis after 52 weeks. Merck licensed MK-3655 following NGM's completion of a proof-of-concept study.

    Retinal diseases

     Continued enrollment in Phase 2 CATALINA study of NGM621 in patients with Geographic Atrophy (GA). NGM continued enrollment in the Phase 2 CATALINA study, a multicenter, randomized, double-masked, sham-controlled clinical trial to evaluate the safety and efficacy of intravitreal (IVT) injections of NGM621 every four weeks or every eight weeks in patients with GA secondary to age-related macular degeneration. The primary endpoint is the rate of change in GA lesion area, as measured by fundus autofluorescence imaging over 52 weeks of treatment.
     Presented Phase 1 safety and pharmacokinetics data for NGM621 in patients with GA at the American Academy of Ophthalmology 2020 Virtual. Single and multiple IVT injections of NGM621 appeared safe and well tolerated in this first-in-human study, with no patients experiencing serious adverse events, drug-related AEs, endophthalmitis, intraocular inflammation or choroidal neovascularization. The serum PK of NGM621 was linear and dose-proportional.

    Cancer

     Completed enrollment in the Phase 1a/1b dose-finding study of NGM120 in patients with cancer in November 2020. NGM completed enrollment in the Phase 1a/1b dose-finding trial to assess NGM120's effect on cancer-related cachexia and cancer. This Phase 1a/1b study was conducted in two cohorts: a Phase 1a cohort evaluating NGM120 as a monotherapy in patients with select advanced solid tumors and a Phase 1b cohort evaluating NGM120 in combination with gemcitabine and Abraxane® (paclitaxel protein bound) in patients with metastatic pancreatic cancer.
     Initiated placebo-controlled, proof-of-concept expansion of Phase 1b dose-finding study of NGM120 as a first-line treatment in patients with metastatic pancreatic cancer in January 2021. NGM initiated a multi-center, randomized, single-blind (sponsor unblinded), placebo-controlled expansion of the ongoing Phase 1a/1b study to evaluate NGM120 in combination with gemcitabine and Abraxane as a first-line treatment in patients with metastatic pancreatic cancer.
     Announced two new oncology clinical candidates, NGM707 and NGM438, in fourth quarter 2020. NGM707 is a dual antagonist antibody that inhibits Immunoglobulin-like transcript 2 (ILT2) and Immunoglobulin-like transcript 4 (ILT4). NGM438 is an antagonist antibody that inhibits Leukocyte-associated immunoglobulin-like receptor 1 (LAIR1).

    Fourth Quarter and Full Year 2020 Financial Results

     NGM reported a net loss of $28.0 million and $102.5 million for the quarter and year ended December 31, 2020, respectively, compared to a net loss of $15.9 million and $42.8 million for the corresponding periods in 2019.
     Related party revenue from our collaboration with Merck was $19.8 million and $87.4 million for the quarter and year ended December 31, 2020, respectively, compared to $31.1 million and $103.5 million for the corresponding periods in 2019. The decrease in related party revenue of $16.1 million in 2020 was primarily attributable to a decrease in the recognition of the initial upfront payment received from Merck in 2015 that was included in the transaction price and fully recognized by March 2020.
     Research and development, or R&D, expenses were $40.1 million and $164.0 million for the quarter and year ended December 31, 2020, respectively, compared to $42.0 million and $129.3 million for the corresponding periods in 2019. R&D expenses increased $34.7 million in 2020, primarily due to an increase in external expenses driven by our manufacturing activities and ongoing clinical trials of aldafermin, NGM621, NGM120 and NGM395 and an increase in costs associated with pre-clinical IND-enabling studies for NGM707 and NGM438.  The increase in R&D expenses in 2020 also included an increase in personnel-related expenses partially offset by a decrease in unallocated R&D expenses related to multiple R&D programs.
     General and administrative expenses were $7.4 million and $27.2 million for the quarter and year ended December 31, 2020, respectively, compared to $6.4 million and $23.6 million for the corresponding periods in 2019. The $3.6 million increase in general and administrative expenses in 2020 was primarily attributable to increases in personnel-related expenses driven by increased headcount, as well as external expenses to support our operations as a public company.
     Cash, cash equivalents and short-term marketable securities were $295.2 million as of December 31, 2020, compared to $344.5 million as of December 31, 2019.

    About NGM Biopharmaceuticals, Inc.

    NGM is a biopharmaceutical company focused on discovering and developing novel therapeutics based on scientific understanding of key biological pathways underlying liver and metabolic diseases, retinal diseases and cancer. We leverage our biology-centric drug discovery approach to uncover novel mechanisms of action and generate proprietary insights that enable us to move rapidly into proof-of-concept studies and deliver potential first-in-class medicines to patients. At NGM, we aspire to operate one of the most productive research and development engines in the biopharmaceutical industry. Visit us at www.ngmbio.com for more information.

    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 "anticipates," "will," "build," "vision," "iconic", "designed to," "potential," "aspire" 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 vision to build an iconic biologic therapeutics company that delivers transformative medicines for patients; the availability and anticipated timing of topline data from Phase 2b ALPINE 2/3 clinical trial of aldafermin; the therapeutic potential of NGM's product candidates; and other statements that are not historical fact. 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, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully enrolling or completing clinical studies, the risk that the results obtained to date in NGM's clinical trials may not be indicative of results obtained in subsequent pivotal or other late-stage trials and the risk that NGM's ongoing or future clinical studies may show that aldafermin, or Merck's ongoing or future clinical studies of MK-3655, are not tolerable and effective treatments for patients with NASH; the ongoing COVID-19 pandemic, which has adversely affected, and could materially and adversely affect in the future, NGM's business and operations, including NGM's clinical trials; the time-consuming and uncertain regulatory approval process; NGM's reliance on third-party manufacturers for aldafermin and its other product candidates; the sufficiency of NGM's cash resources and need for additional capital; and other risks and uncertainties affecting NGM and its development programs, including those discussed in the section titled "Risk Factors" in Exhibit 99.1 to NGM's current report on Form 8-K filed with the United States Securities and Exchange Commission (SEC) on January 6, 2021 and future filings and reports that NGM makes from time to time with the SEC. 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.

     Investor Contact:Media Contact:
     Alex SchwartzLiz Melone
       





    NGM BIOPHARMACEUTICALS, INC.


    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (In thousands, except share and per share amounts)

    (Unaudited)

     Three Months Ended  Year Ended
     December 31,  December 31,
     2020  2019  2020  2019(1) 
    Related party revenue$19,767  $31,083  $87,368  $103,544 
    Operating expenses:               
    Research and development 40,060   41,954   163,972   129,253 
    General and administrative 7,380   6,423   27,229   23,631 
    Total operating expenses 47,440   48,377   191,201   152,884 
    Loss from operations (27,673)  (17,294)  (103,833)  (49,340)
    Interest income 116   1,554   1,939   6,692 
    Other expense, net (434)  (201)  (593)  (147)
    Net loss$(27,991) $(15,941) $(102,487) $(42,795)
    Net loss per share, basic and diluted$(0.40) $(0.24) $(1.50) $(0.85)
    Weighted average shares used to compute net loss per share, basic and diluted 69,370,960   66,532,038   68,475,378   50,297,524 

    _______

    (1)    Derived from the audited consolidated financial statements.





    NGM BIOPHARMACEUTICALS, INC.


    CONDENSED CONSOLIDATED BALANCE SHEETS

    (In thousands)

     December 31,  December 31, 
     2020  2019(1) 
     (unaudited)     
    ASSETS       
    Current assets:       
    Cash and cash equivalents$147,017  $245,598 
    Short-term marketable securities 148,139   98,913 
    Related party receivable from collaboration 333   5,206 
    Related party contract asset 6,100   - 
    Prepaid expenses and other current assets 6,837   5,531 
    Total current assets 308,426   355,248 
    Property and equipment, net 14,526   19,475 
    Restricted cash 1,499   1,874 
    Other non-current assets 4,592   3,806 
    Total assets$329,043  $380,403 
    LIABILITIES AND STOCKHOLDERS' EQUITY       
    Current liabilities:       
    Accounts payable$9,663  $9,026 
    Accrued liabilities 29,945   22,991 
    Deferred rent, current 2,975   2,829 
    Contract liabilities -   4,872 
    Total current liabilities 42,583   39,718 
    Deferred rent, non-current 6,417   9,392 
    Early exercise stock option liability -   574 
    Total liabilities 49,000   49,684 
    Commitments and contingencies       
    Stockholders' equity:       
    Preferred stock, $0.001 par value;     
    Common stock, $0.001 par value; 71   67 
    Additional paid-in capital 578,599   526,771 
    Accumulated other comprehensive gain 4   25 
    Accumulated deficit (298,631)  (196,144)
    Total stockholders' equity 280,043   330,719 
    Total liabilities and stockholders' equity$329,043  $380,403 

    _______

    (1)    Derived from the audited consolidated financial statements.





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  3. --Placebo-controlled study to evaluate potential of NGM120, a novel inhibitor of GDF15/GFRAL pathway, to treat cancer and cancer-related cachexia--

    --Cachexia, a wasting syndrome, is a common co-morbidity of cancer and associated with shortened survival--

    --Expansion follows completion of enrollment in open-label dose-escalation safety portion of Phase 1a/1b study in patients with select advanced solid tumors and metastatic pancreatic cancer--

    --NGM120 program builds on discoveries by NGM scientists related to GDF15 pathway biology, including identifying its cognate receptor, GFRAL--

    SOUTH SAN FRANCISCO, Calif., March 02, 2021 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NASDAQ:NGM), a biotechnology company focused on discovering…

    --Placebo-controlled study to evaluate potential of NGM120, a novel inhibitor of GDF15/GFRAL pathway, to treat cancer and cancer-related cachexia--

    --Cachexia, a wasting syndrome, is a common co-morbidity of cancer and associated with shortened survival--

    --Expansion follows completion of enrollment in open-label dose-escalation safety portion of Phase 1a/1b study in patients with select advanced solid tumors and metastatic pancreatic cancer--

    --NGM120 program builds on discoveries by NGM scientists related to GDF15 pathway biology, including identifying its cognate receptor, GFRAL--

    SOUTH SAN FRANCISCO, Calif., March 02, 2021 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NASDAQ:NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced it has dosed the first patient in an expansion of its ongoing Phase 1b proof-of-concept study of NGM120 in patients with metastatic pancreatic cancer. NGM120 is an antagonistic antibody that binds glial cell-derived neurotrophic factor receptor alpha-like (GFRAL) and inhibits growth differentiation factor 15 (GDF15) signaling. This placebo-controlled study will evaluate the effect of NGM120 on both cancer and cancer-related cachexia. Cachexia is the uncontrolled wasting of both skeletal muscle and fat linked to many cancers. It is estimated to affect 60% to 80% of advanced cancer patients and to be responsible for approximately 30% of all cancer deaths1. This proof-of-concept expansion represents a pre-planned progression of an ongoing Phase 1a/1b dose-finding clinical trial NGM is conducting in patients with select advanced solid tumors and metastatic pancreatic cancer.

    NGM is a leader in research elucidating the central role of the GDF15/GFRAL pathway in promoting tumor-associated appetite regulation, metabolic regulation and immune modulation. Through systematic screening of human secreted factors in preclinical models, NGM identified that GDF15 expression has the ability to promote an outsized effect in weight loss. Evidence has also shown that serum levels of GDF15 are elevated in patients with a number of tumor types, including non-small cell lung cancer, melanoma, pancreatic, prostate, colorectal, gastric, esophageal and ovarian cancer, and are associated with a worse prognosis in multiple cancers.  

    As published in Nature, NGM was the first to identify GDF15's cognate receptor, GFRAL, and the associated signaling pathway2. This discovery enabled the development of NGM120, a proprietary inhibitory antibody binding to GFRAL that is designed to block the effects of elevated GDF15 levels. In preclinical studies, NGM has demonstrated that blocking the interaction between GDF15 and GFRAL both reduces tumor-associated weight loss and slows tumor growth. In a murine pancreatic tumor model, treatment with NGM120s, an anti-GFRAL antibody similar to NGM120, resulted in greater tumor shrinkage as well as improved survival versus the control arm. In a murine cancer cachexia model, NGM120s rapidly reversed tumor-induced weight loss. In addition, in a murine model of chemotherapy-induced weight loss, administration of NGM120s preserved lean mass and muscle function in animals treated with cisplatin, while treatment with cisplatin alone resulted in greater than 20% weight loss.

    "We are pleased to advance NGM120 into a placebo-controlled, Phase 1b expansion in patients with metastatic pancreatic cancer. Patients with this aggressive disease are in particularly dire need of therapeutic solutions to fight their disease and enhance their quality of life," said Alex DePaoli, M.D., Senior Vice President, Chief Translational Officer at NGM. "Our approach of targeting the GDF15 receptor, GFRAL, gives NGM120 a novel profile in the GDF15 inhibition space and enables us to evaluate NGM120 as a potential treatment for both cancer-related cachexia and the underlying cancer."

    About the Design of the NGM120 Phase 1b Expansion

    In February 2020, NGM initiated a Phase 1a/1b multi-site, open-label, dose-escalation clinical study to evaluate the safety, tolerability and pharmacokinetics of NGM120 as a monotherapy in patients with select advanced solid tumors (Cohort 1) and in combination with gemcitabine and Abraxane® (paclitaxel protein bound) in patients with metastatic pancreatic cancer (Cohort 2). Entry criteria included elevated serum levels of GDF15. Cohorts 1 and 2 are fully enrolled.

    The Phase 1b expansion portion of the study will evaluate the safety, tolerability and efficacy of NGM120 as a first-line treatment in 60 patients with metastatic pancreatic cancer. Entry criteria includes elevated serum GDF15 levels. The study is a randomized, single-blind (sponsor unblinded), placebo-controlled, multi-center trial. Patients will be randomized 1:1 to receive either NGM120 or placebo monthly in combination with the first-line standard of care, gemcitabine and Abraxane. The study will have both cancer and cachexia endpoints, including overall response rate (ORR), progression-free survival (PFS), overall survival (OS), body weight change, lean body mass change, patient reported outcomes and functional status changes.

    About NGM120

    NGM120 is an antagonistic antibody that binds glial cell-derived neurotrophic factor receptor alpha-like (GFRAL) and inhibits growth differentiation factor 15 (GDF15) signaling. NGM scientists have made several important discoveries related to GDF15, including identification of its cognate receptor, GFRAL. GFRAL is expressed in a specific region of the hindbrain, partially outside the blood brain barrier, and is believed to initiate signaling through multiple pathways, including the autonomic nervous system. NGM120 binds with high affinity to GFRAL to prevent the formation of the GDF15 co-receptor complex and its mediated signaling.

    About Cachexia

    Cachexia is a wasting syndrome common in cancer patients, and a frequent co-morbidity of the disease. Cachexia is associated with increased hospitalization and shortened survival compared to cancer patients who do not exhibit the syndrome. While cachexia can occur in all types of cancer, particularly high incidence rates are observed in pancreatic, gastric, colorectal and esophageal cancers, as well as non-small cell lung cancer. There are no FDA-approved therapies for cachexia.

    About NGM Biopharmaceuticals, Inc.

    NGM is a biopharmaceutical company focused on discovering and developing novel therapeutics based on scientific understanding of key biological pathways underlying liver and metabolic diseases, retinal diseases and oncology. We leverage our biology-centric drug discovery approach to uncover novel mechanisms of action and generate proprietary insights that enable us to move rapidly into proof-of-concept studies and deliver potential first-in-class medicines to patients. At NGM, we aspire to operate one of the most productive research and development engines in the biopharmaceutical industry, with multiple programs in clinical development. Visit us at www.ngmbio.com for more information.

    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 "build," "plans," "designed to," "continue," "potential" 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 design, timing, enrollment and potential results of NGM's Phase 1a/1b clinical trial of NGM120, including the Phase 1b expansion in patients with metastatic pancreatic cancer; the potential of NGM120 as a novel treatment for cachexia and the underlying cancer, as well as its potential to enhance patient quality of life; and the therapeutic effects and benefits of NGM120 and the role of the GDF15/GFRAL pathway. 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, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success, including risks related to failure or delays in successfully enrolling or completing clinical studies, the risk that the results obtained to date in NGM's clinical trials may not be indicative of results obtained in subsequent pivotal or other late-stage trials, and the risk that NGM's ongoing or future clinical studies in humans may show that NGM120 is not a tolerable and effective treatment for cachexia and underlying cancers; the ongoing COVID-19 pandemic, which has adversely affected, and could materially and adversely affect in the future, our business and operations; the time-consuming and uncertain regulatory approval process; NGM's reliance on third-party manufacturers; the sufficiency of NGM's cash, cash equivalents and short-term marketable securities and need for additional capital; and other risks and uncertainties affecting NGM and its development programs, as well as those discussed in the sections titled "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Risk Factors" in our quarterly report on Form 10-Q for the quarter ended September 30, 2020, the section titled "Risk Factors" in exhibit 99.1 to our current report on Form 8-K filed with the United States Securities and Exchange Commission (SEC) on January 6, 2021 and future filings and reports that NGM makes from time to time with the SEC. 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.

    Investor Contact:

    Alex Schwartz

    Media Contact:

    Liz Melone

    1 = Haehlinget al, J. Cachexia Sarcopenia Muscle, 2010

    2 = Hsu et. al., Nature 2017



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  4. SOUTH SAN FRANCISCO, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM) (NASDAQ:NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced that David J. Woodhouse, Ph.D., Chief Executive Officer, will present an overview of the company and provide a business update at the Cowen 41st Annual Health Care Conference on Thursday, March 4, at 11:10 am ET.

    A live webcast of the presentation will be available under the Investors and Media section of NGM's website at https://ir.ngmbio.com/events-presentations. A replay of the presentation will be archived on NGM's site for 30 days following the event.

    About NGM Biopharmaceuticals, Inc.

    NGM is a biopharmaceutical…

    SOUTH SAN FRANCISCO, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM) (NASDAQ:NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced that David J. Woodhouse, Ph.D., Chief Executive Officer, will present an overview of the company and provide a business update at the Cowen 41st Annual Health Care Conference on Thursday, March 4, at 11:10 am ET.

    A live webcast of the presentation will be available under the Investors and Media section of NGM's website at https://ir.ngmbio.com/events-presentations. A replay of the presentation will be archived on NGM's site for 30 days following the event.

    About NGM Biopharmaceuticals, Inc.

    NGM is a biopharmaceutical company focused on discovering and developing novel therapeutics based on scientific understanding of key biological pathways underlying liver and metabolic diseases, retinal diseases and cancer. We leverage our biology-centric drug discovery approach to uncover novel mechanisms of action and generate proprietary insights that enable us to move rapidly into proof-of-concept studies and deliver potential first-in-class medicines to patients. At NGM, we aspire to operate one of the most productive research and development engines in the biopharmaceutical industry, with multiple programs in clinical development. Visit us at www.ngmbio.com for more information.

    Investor Contact:

    Alex Schwartz

    Media Contact:

    Liz Melone



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