NGM NGM Biopharmaceuticals Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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NGM621
Geographic atrophy
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Phase 1/2
Phase 1/2
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NGM282 - ALPINE 2/3
Non-alcoholic steatohepatitis (NASH)
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Phase 2b
Phase 2b
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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Aldafermin (NGM282)
Non-alcoholic steatohepatitis (NASH)
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Phase 2
Phase 2
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Phase 2 preliminary top-line results from the 24-week cohort (Cohort 4) met primary endpoint - February 24, 2020.
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NGM120
Cachexia syndrome
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Phase 1b
Phase 1b
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Phase 1a/1b trial initiation announced February 11, 2020.
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Latest News
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--Sustained progress across clinical development programs spanning liver, retinal and metabolic diseases and cancer--
--Aldafermin continues to advance toward late-stage clinical development in non-alcoholic steatohepatitis (NASH) with ongoing Phase 2b ALPINE 2/3 and ALPINE 4 clinical studies--
--Initiated Phase 2 CATALINA study of NGM621, a complement C3 inhibitory antibody to treat patients with geographic atrophy (GA)--
--$312.1 million in cash, cash equivalents and marketable securities as of June 30, 2020--
SOUTH SAN FRANCISCO, Calif., Aug. 12, 2020 (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 June 30, 2020.
"We continue to progress across our clinical-stage programs spanning liver, retinal and metabolic diseases as well as cancer, despite the ongoing challenges presented by the COVID-19 pandemic, thanks to the dedication and tireless efforts of our team, and the ongoing support and commitment from our clinical collaborators," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. "We're thrilled to have achieved our most recent clinical milestone, the advancement of NGM621 into Phase 2 development for the treatment of patients with GA. GA is a highly prevalent and progressive retinal degenerative disease that can have a devastating, irreversible impact on patients' vision and quality of life. Based on NGM621's novel profile as a complement C3 inhibitory monoclonal antibody, we believe it has the potential to be an important treatment option for this significantly underserved patient population. It is gratifying to now have two programs in Phase 2 clinical development in two distinct therapeutic areas, both for the treatment of serious unmet needs."
Dr. Woodhouse further commented, "Within the diverse NASH development landscape, we are pleased with the impressive and highly consistent clinical performance of aldafermin to date, with robust, placebo-controlled data demonstrating statistically significant dual activity in reversing fibrosis and resolving NASH. Our Phase 2b ALPINE 2/3 and ALPINE 4 clinical studies remain on track, and we are hard at work on Phase 3 readiness in anticipation of an ALPINE 2/3 topline data readout in the first half of next year."
Key Second Quarter and Recent Highlights
Liver and metabolic disease
- Continued enrollment in Phase 2b ALPINE 2/3 study of aldafermin in NASH. NGM has continued enrollment in the Phase 2b ALPINE 2/3 clinical study of aldafermin in patients with biopsy-confirmed NASH and stage 2 or 3 (F2-F3) liver fibrosis. The 24-week study is designed to enroll approximately 150 patients and will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo. Enrollment activities have increased since our first quarter update, and we reiterate our expectation of announcing topline data from the study in the first half of 2021.
- Continued enrollment in Phase 2b ALPINE 4 study of aldafermin in NASH patients with compensated cirrhosis. NGM has continued enrollment in the Phase 2b ALPINE 4 study of aldafermin in patients with biopsy-confirmed compensated NASH cirrhosis (F4). The 48-week study is designed to enroll approximately 150 patients and will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo.
- Data from 24-week double‑blind, randomized, placebo-controlled Phase 2 study (Cohort 4) of aldafermin in NASH patients published in Gastroenterology. Comprehensive findings and analysis from the 24-week Cohort 4 reported by NGM in February 2020 were published this month in the journal Gastroenterology. The 24-week double-blind, randomized, placebo-controlled Phase 2 clinical study demonstrated statistically significant dual activity in reversing fibrosis and resolving NASH. In the study, 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.
- Continued enrollment in Phase 1 study of NGM395 in overweight and obese healthy adults. NGM has continued to enroll patients in a Phase 1 single ascending dose clinical study evaluating the safety, tolerability and pharmacokinetics of NGM395, a long-acting growth differentiation factor 15 (GDF15) analog, in overweight and obese but otherwise healthy adults.
- Completed Phase 1 study of NGM217 in adults with autoimmune diabetes. We recently completed a Phase 1 study of NGM217, an antibody binding an undisclosed target, which assessed the safety, tolerability and pharmacokinetics of NGM217 in adults with autoimmune diabetes. The study demonstrated that NGM217 was well tolerated. However, as NGM continues to advance multiple clinical‑stage programs and anticipates advancing earlier-stage discovery programs into clinical development, the company has decided to suspend activities related to NGM217 to concentrate its resources on the development of other product candidates.
Retinal disease
- Initiated Phase 2 CATALINA study of NGM621 in patients with GA. As announced in July 2020, NGM initiated the Phase 2 CATALINA study, a multicenter, randomized, double-masked, sham-controlled clinical trial to evaluate the safety and efficacy of intravitreal injections (IVT) of NGM621 in patients with GA secondary to age-related macular degeneration (AMD). Dysregulated activation of the complement system, a key component of the immune system, has been implicated in the onset and progression of GA. NGM621 is a humanized IgG1 monoclonal antibody engineered to potently inhibit activity of complement C3 with the treatment goal of reducing disease progression in patients with GA, and with the potential for extended every eight week dosing without PEGylation. Designed as a Phase 3-enabling study, the Phase 2 CATALINA study is expected to enroll 240 patients diagnosed with GA in one or both eyes.
NGM also successfully completed a first-in-human open-label Phase 1 study in which treatment with single- and multiple-dose IVT injections of NGM621 in patients with GA was well tolerated, supporting advancement to the Phase 2 CATALINA study. NGM plans to present the data from the Phase 1 study at the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting from November 13-15, 2020. In addition, NGM presented NGM621 preclinical findings at The Association for Research in Vision and Ophthalmology Annual Meeting, held virtually in June 2020. The presentations are available on NGM's website.
Cancer
- Continued enrollment in Phase 1a/1b study of NGM120 in patients with cancer anorexia/cachexia syndrome (CACS) and cancer. NGM continues to enroll patients in a Phase 1a/1b clinical study to evaluate NGM120, a first-in-class antagonistic antibody that binds glial cell-derived neurotrophic factor receptor alpha-like (GFRAL), and inhibits GDF15 signaling, for the potential treatment of CACS and cancer. CACS is the uncontrolled wasting of both skeletal muscle and fat that is a common co-morbidity of cancer and is associated with shortened survival in cancer patients.
Corporate
- Expanded leadership with key management team and board appointments. NGM announced the appointment of a new executive team member, Siobhan Nolan Mangini, as Chief Financial Officer effective July 13, 2020 and announced the appointment of Carole Ho, M.D. to its Board of Directors. Dr. Ho currently serves as Chief Medical Officer and Head of Development at Denali Therapeutics.
Merck Collaboration
Merck has a one-time option to license NGM pipeline programs, other than NGM's wholly-owned programs aldafermin 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, in certain cases, to co-fund development and participate in a global cost and revenue share arrangement of up to 50%. The agreement also provides 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 NGM313, also referred to as MK‑3655.
Second Quarter Financial Results
- For the quarter ended June 30, 2020, NGM reported a net loss of $25.6 million compared to a net loss of $7.7 million for the corresponding period in 2019.
- Related party revenue from our collaboration with Merck for the quarter ended June 30, 2020 was $19.8 million compared to $25.3 million for the corresponding period in 2019. The decrease in related party revenue was primarily attributable to the completion of all remaining obligations associated with the upfront payment at the conclusion of the initial five-year term of the Merck collaboration.
- Research and development expenses for the quarter ended June 30, 2020 were $38.5 million compared to $28.8 million for the corresponding period in 2019. The increase in research and development expenses was mainly attributable to increases in external research and development expenses associated with the advancement of NGM's growing pipeline, primarily expenses related to our aldafermin, NGM621 and NGM395 programs, and personnel-related expenses driven by increased headcount.
- General and administrative expenses for the quarter ended June 30, 2020 were $6.8 million compared to $6.2 million for the corresponding period in 2019. The increase in general and administrative expenses was primarily attributable to increases in personnel-related expenses driven by increased headcount and legal expenses to support our operations as a public company.
- Cash, cash equivalents and short-term marketable securities were $312.1 million as of June 30, 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, retinal and metabolic 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.
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 "progress," "advance," "believe," "potential," "continue," "expect," "anticipates," "plans" 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 advancement of NGM's clinical and preclinical pipeline; the impact of the ongoing COVID-19 pandemic on clinical trial plans and timelines, including enrollment, activation and initiation of additional trial sites and results of NGM's clinical trials; the continued progress of, and the timing of enrollment and results of, NGM's clinical trials, including timing of topline results of the ALPINE 2/3 study and the presentation of data from the Phase 1 study of NGM621 in patients with GA; the potential of NGM621 to be an important treatment option for patients with GA; NGM's ability to advance aldafermin toward Phase 3 clinical development for NASH patients; the safety, tolerability and efficacy of NGM's product candidates; and continued development of additional product candidates, including NGM621, NGM395 and NGM120. 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 aldafermin is not a tolerable and effective treatment for NASH patients; 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 for aldafermin and its other product candidates; 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 "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 March 31, 2020 and future filings and reports that NGM makes from time to time with the United States Securities and Exchange Commission. 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
[email protected]Media Contact:
Liz Melone
[email protected]NGM BIOPHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(Unaudited)Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 Related party revenue $ 19,755 $ 25,341 $ 44,119 $ 50,893 Operating expenses: Research and development 38,494 28,819 76,933 58,346 General and administrative 6,794 6,229 13,389 11,596 Total operating expenses 45,288 35,048 90,322 69,942 Loss from operations (25,533 ) (9,707 ) (46,203 ) (19,049 ) Interest income 388 2,044 1,563 3,154 Other expense, net (471 ) (6 ) (91 ) (42 ) Net loss $ (25,616 ) $ (7,669 ) $ (44,731 ) $ (15,937 ) Net loss per share, basic and diluted $ (0.38 ) $ (0.13 ) $ (0.66 ) $ (0.47 ) Weighted average shares used to compute 68,305,056 61,044,450 67,850,640 34,078,099 (1) net loss per share, basic and diluted (1) In April 2019, the Company completed its initial public offering (IPO) and concurrent private placement with Merck Sharp & Dohme Corp., in which the Company issued an aggregate of 7,521,394 and 4,121,683 shares of common stock, respectively, and all of the then outstanding shares of convertible preferred stock were automatically converted into shares of common stock upon the closing of the IPO. NGM BIOPHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)June 30, December 31, 2020 2019* Assets Current assets: Cash and cash equivalents $ 249,317 $ 245,598 Short-term marketable securities 62,778 98,913 Related party receivable from collaboration 3,079 5,206 Prepaid expenses and other current assets 7,448 5,531 Total current assets 322,622 355,248 Property and equipment, net 17,321 19,475 Restricted cash 1,874 1,874 Other non-current assets 5,467 3,806 Total assets $ 347,284 $ 380,403 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 1,934 $ 9,026 Accrued liabilities 26,792 22,991 Deferred rent, current 2,902 2,829 Deferred revenue, current 2,074 4,872 Total current liabilities 33,702 39,718 Deferred rent, non-current 7,941 9,392 Other non-current liabilities 4,188 — Early exercise stock option liability 289 574 Total liabilities 46,120 49,684 Commitments and contingencies Stockholders' equity: Preferred stock, $0.001 par value; — — Common stock, $0.001 par value; 69 67 Additional paid-in capital 541,833 526,771 Accumulated other comprehensive gain 137 25 Accumulated deficit (240,875 ) (196,144 ) Total stockholders' equity 301,164 330,719 Total liabilities and stockholders' equity $ 347,284 $ 380,403 *The Condensed Consolidated Balance Sheet as of December 31, 2019 has been derived from the audited financial statements as of that date.
- Continued enrollment in Phase 2b ALPINE 2/3 study of aldafermin in NASH. NGM has continued enrollment in the Phase 2b ALPINE 2/3 clinical study of aldafermin in patients with biopsy-confirmed NASH and stage 2 or 3 (F2-F3) liver fibrosis. The 24-week study is designed to enroll approximately 150 patients and will assess the efficacy, safety and tolerability of 0.3 mg, 1 mg and 3 mg doses of aldafermin compared to placebo. Enrollment activities have increased since our first quarter update, and we reiterate our expectation of announcing topline data from the study in the first half of 2021.
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SOUTH SAN FRANCISCO, Calif., July 31, 2020 (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 two upcoming investor conferences.
Monday, August 10, 2020
Event: BTIG Biotechnology Conference 2020
Time: 11:00 am ETThursday, August 13, 2020
Event: Canaccord Genuity 40th Annual Growth Conference
Time: 9:00 am ETA live webcast of these presentations 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 disease, retinal disease, cancer and metabolic disease. 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 Contacts:
Sylvia Wheeler and Alexandra Santos
[email protected]
[email protected]
[email protected]Media Contact:
Liz Melone
[email protected] -
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-- Multicenter, randomized, double-masked, sham-controlled study will evaluate safety and efficacy of
intravitreal injections of NGM621 every four or eight weeks for 48 weeks ---- GA is a progressive, irreversible retinal degenerative disease with no approved therapies --
-- NGM621, a monoclonal antibody, is engineered to potently inhibit complement C3 with the
treatment goal of reducing disease progression in patients with GA --SOUTH SAN FRANCISCO, Calif., July 27, 2020 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM) (NASDAQ:NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced it has initiated the Phase 2 CATALINA study, a multicenter, randomized, double-masked, sham-controlled clinical trial, to evaluate the safety and efficacy of intravitreal injections (IVT) of NGM621 in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). GA, an advanced form of AMD, is a progressive retinal degenerative disease associated with irreversible loss of vision, diminished quality of life and eventual blindness. Dysregulated activation of the complement system, a key component of the immune system, has been implicated in the onset and progression of GA. NGM621 is a humanized IgG1 monoclonal antibody engineered to potently inhibit activity of complement C3 with the treatment goal of reducing disease progression in patients with GA, and with the potential for every eight week dosing.
"The NGM621 program exemplifies our strategy to target powerful, disease-driving biology to deliver transformative medicines for patients across a range of therapeutic areas and diseases with high unmet need," Hsiao D. Lieu, M.D., Chief Medical Officer at NGM Bio. "We are very encouraged by the preclinical data and Phase 1 safety and tolerability data for NGM621. Recognizing the severe, life-altering impact GA has on patients' lives, we are working to rapidly advance NGM621 through clinical development. We believe NGM621 offers a unique profile with best-in-class potential and could represent an important therapeutic advance for patients with GA."
NGM621 was discovered by NGM under its strategic collaboration with Merck. NGM successfully completed a first-in-human open-label Phase 1 study in which treatment with single- and multiple-dose IVT injections of NGM621 in patients with GA was well tolerated, supporting continued development. NGM plans to present the data from the Phase 1 study at an upcoming medical conference. NGM recently presented NGM621 preclinical findings at The Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, held virtually in June 2020. The presentations are available on NGM's website here.
"As a retina specialist who manages patients with GA, I see first-hand the progressive and eventually devastating impact this disease can have on patients' quality of life. The insidious loss of vision leads to difficulty with everyday tasks and social isolation, in many cases robbing patients of their independence and ability to do things they enjoy. Often these patients live in fear of going blind, knowing that currently nothing can be done to slow their disease progression," said Charles C. Wykoff, M.D., Ph.D., Director of Research at Retina Consultants Houston and the Greater Houston Retina Research Foundation. "Complement inhibition continues to be a promising approach to slowing GA progression. I am pleased to see NGM621 move into a rigorous Phase 2 study and am encouraged by the data to date with this antibody that blocks C3 activation. I look forward to seeing how NGM621's C3 inhibition translates into clinical benefit."
About the NGM621 Phase 2 CATALINA Study Design
Designed as a Phase 3-enabling study, the Phase 2 CATALINA study will enroll 240 patients diagnosed with GA in one or both eyes. The primary objectives of this multicenter, randomized, double-masked, sham-controlled study are to evaluate the efficacy and safety of NGM621 IVT injections compared to sham control. Patients will be randomized to one of four treatment groups in a ratio of 2:1:2:1 to receive IVT injections of NGM621 or sham every four weeks or every eight weeks for a total of 48 weeks, and monitored for an additional four weeks upon treatment completion. The primary efficacy endpoint is change from baseline in the square root of GA lesion area at 48 weeks, as measured by fundus autofluorescence (FAF) imaging compared to sham control. The primary safety endpoints will evaluate the incidence and severity of ocular and systemic adverse events from treatment with NGM621 compared to sham control.
For more information, please visit the study listing on clinicaltrials.gov.
About NGM621 and Complement C3 Inhibition
NGM621 is a humanized IgG1 monoclonal antibody engineered to potently inhibit complement C3, with the potential for extended every eight week dosing without pegylation. In preclinical models, NGM621's high affinity binding to C3 has demonstrated the potential for potent C3 inhibition. In addition, in well validated animal models of laser-induced choroidal neovascularization (CNV), C3 inhibition has demonstrated the ability to reduce retinal vascular leakage, suggesting the potential for NGM621 to prevent CNV development.
C3 is a key component of the complement system, which helps orchestrate the body's response to infection and maintains tissue homeostasis. The complement cascade can be activated through its three distinct pathways – classical, lectin and alternative – all of which converge to activate C3. When this cascade is dysregulated, the immune response may lead to the development and progression of GA. Inhibition of C3 represents a promising therapeutic approach that broadly inhibits downstream effector functions triggered by the excessive activation of C3, including inflammation, activation of the adaptive immune system, opsonization (the marking of a pathogen to be destroyed by phagocytes, a type of immune cell), phagocytosis and cell lysis (cell death).
About AMD and GA
AMD is a leading cause of vision loss and blindness in people over the age of 65 in the US and other industrialized countries.i The two advanced stages of the disease are called neovascular (wet) AMD and geographic atrophy.
GA is estimated to impact about 1 million people in the USii and over 5 million people worldwideiii. In patients with GA, single or multiple areas in the macular region of the retina become atrophic, forming distinct lesions that expand and coalesce over time. Enlargement of these lesions can lead to loss of vision and irreversible blindness. GA is often bilateral, meaning it occurs in both eyes. While there are approved treatments for wet AMD, there are currently no approved treatments for GA.
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 cardio-metabolic, liver, oncologic and retinal diseases. 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 "with the goal of," "engineered to," "working to," "advance," "potential," "target," "believe," "could," "plans," "will," "look forward," "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 strategy to deliver transformative medicines for patients across a range of therapeutic areas through the clinical development of NGM621 and other product candidates; the design, timing, enrollment and potential results of NGM's Phase 2 CATALINA study of NGM621 for the treatment of patients with GA secondary to AMD; the potential of NGM621 as a best-in-class product candidate for the treatment of patients with GA; the potential therapeutic effects, benefits and dosing schedule of NGM621 and the role of NGM621 as a potential potent C3 inhibitor that may reduce disease progression in patients with GA; NGM's plans to present the data from its completed Phase 1 study at an upcoming medical conference; 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 forward-looking statements in this press release. These risks and uncertainties include, 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 receiving regulatory clearance for, enrolling or completing clinical studies and the risk that NGM's clinical studies in humans may show that NGM621 is not a safe and effective treatment for patients with GA; the risk that the results obtained to date in NGM's clinical trials may not be indicative of results obtained in pivotal or other late-stage trials; the evolving effects of the COVID-19 pandemic, which may significantly impact (i) our business and operations, including activities at our headquarters in the San Francisco Bay Area and our clinical trial sites, as well as the business or operations of our manufacturers, contract research organizations or other third parties with whom we conduct business, (ii) our ability to access capital and (iii) the value of our common stock; the time-consuming and uncertain regulatory approval process; NGM's reliance on third-party manufacturers for NGM621 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 described under the caption "Risk Factors" in NGM's quarterly report on Form 10-Q for the quarter ended March 31, 2020 and future filings and reports that NGM makes from time to time with the United States Securities and Exchange Commission. 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:
Sylvia Wheeler and Alexandra Santos
[email protected]
[email protected]
[email protected]Media Contact:
Liz Melone
[email protected]________________________
i Flaxman SR, Bourne RRA, Resnikoff S, et al. Global causes of blindness and distance vision impairment 1990-2020: a systematic review and meta-analysis. Lancet Glob Health. 2017;5(12): 1221-1234.
ii Friedman DS, O'Colmain BJ, Munoz B, et al. Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol. 2004;122(4):564-572.
iii Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040; a systematic review and meta-analysis. Lancet 2014; 2:e106-116.
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SOUTH SAN FRANCISCO, Calif., June 08, 2020 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM) (NASDAQ:NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced the appointment of Carole Ho, M.D. to its Board of Directors. Dr. Ho currently serves as Chief Medical Officer and Head of Development at Denali Therapeutics.
"Carole's background as a physician-scientist with deep industry expertise is ideally suited to NGM's culture and vision, and we are thrilled to welcome her to our Board," said David J. Woodhouse, Ph.D., NGM's Chief Executive Officer. "We continue to advance aldafermin, our lead candidate for the treatment of non-alcoholic steatohepatitis, or NASH, toward late-stage development and commercialization. Simultaneously, we are progressing clinical programs in oncology and ophthalmology, including NGM621, our anti-complement C3 antibody program for geographic atrophy. Given Carole's experience spanning early- to late-stage clinical development, we look forward to her insights as we design and execute our late-stage NASH clinical development program and other clinical programs and translate various exciting, novel early-stage opportunities into viable clinical development candidates."
Dr. Ho commented, "NGM has carved out a prominent position in the NASH development landscape with aldafermin. In addition, powered by its deep biologics and biology research engine, coupled with a strong clinical development infrastructure, NGM has built a pipeline that extends well beyond NASH. It takes creativity and a thoughtful strategy, particularly for an emerging growth company, to nurture clinical programs to fruition in multiple therapeutic areas. I look forward to working with David, my fellow NGM board members and the NGM team to maximize the breadth of opportunities for NGM and, in turn, for patients."
In her role as Chief Medical Officer and Head of Development at Denali since 2015, Dr. Ho has built an integrated development organization that is responsible for guiding therapeutic candidates from pre-IND enabling studies through to ultimate approval. Prior to joining Denali, Dr. Ho served as Vice President of Early Clinical Development at Genentech, where she was responsible for the delivery of pivotal trial-ready therapeutic candidates for all non-oncology indications, including CV-metabolism, ophthalmology, neurology, infectious disease, respiratory, rheumatology and gastroenterology. During her eight years at Genentech, Dr. Ho held several senior leadership roles across multiple early- and late-stage clinical programs in various therapeutic areas. Earlier in her career, Dr. Ho served as a visiting scientist at Genentech in the laboratory of Marc Tessier-Lavigne, Ph.D., and also as a Faculty Member in the Department of Neurology at Stanford University.
Dr. Ho completed her residency in neurology at Harvard Medical School at the Massachusetts General Hospital / Brigham and Women's Hospital, where she served as Chief Resident. She earned her M.D. from Cornell University and her B.S. in biochemical sciences from Harvard College. In addition to her appointment to NGM's Board, Dr. Ho also serves on the Board of Directors of Beam Therapeutics.
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 cardio-metabolic, liver, oncologic and ophthalmic diseases. 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 "look forward," "advance," "progress," "position," "maximize" 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: advancement of aldafermin toward late-stage development and other preclinical and clinical development progress; NGM's potential breadth of opportunities; 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 forward-looking statements in this press release. These risks and uncertainties include, 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 pivotal or other late-stage trials, and the risk that NGM's ongoing or future clinical studies in humans may show that aldafermin is not a tolerable and effective treatment for NASH patients; the evolving effects of the COVID-19 pandemic on NGM's business and operations, as well as those of third parties on which NGM relies; 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 described under the caption "Risk Factors" in NGM's quarterly report on Form 10-Q for the quarter ended March 31, 2020 and future filings and reports that NGM makes from time to time with the United States Securities and Exchange Commission. 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:
Sylvia Wheeler and Alexandra Santos
[email protected]
[email protected]
[email protected]Media Contact:
Liz Melone
[email protected] -
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SOUTH SAN FRANCISCO, Calif., May 29, 2020 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NASDAQ:NGM), a biotechnology company focused on 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 two upcoming investor conferences.
Wednesday, June 3, 2020
Event: Jefferies Virtual Healthcare Conference
Time: 3:30 pm ETWednesday, June 10, 2020
Event: Goldman Sachs 41st Annual Global Healthcare Conference
Time: 1:20 pm ETA live webcast of these presentations 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 developing novel therapeutics based on scientific understanding of key biological pathways underlying cardio-metabolic, liver, oncologic and ophthalmic diseases. 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 Contacts:
Sylvia Wheeler and Alexandra Santos
[email protected]
[email protected]
[email protected]Media Contact:
Liz Melone
[email protected]