NGM NGM Biopharmaceuticals Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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Aldafermin (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 |
|---|---|---|
|
NGM621
Geographic atrophy
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Phase 1/2
Phase 1/2
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Phase 2 initiation announced July 27, 2020.
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NGM120
Cachexia syndrome
|
Phase 1b
Phase 1b
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Phase 1a/1b trial ongoing.
|
|
Aldafermin (ALPINE 4)
NASH cirrhosis
|
Phase 2b
Phase 2b
|
Phase 2b trial ongoing.
|
Latest News
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– Event to showcase NGM's multi-therapeutic area pipeline, including its oncology portfolio and Geographic Atrophy and NASH programs –
– Planned presentations from NGM management, NGM scientists and leading industry physicians –
– Fireside chat with executives from Merck Research Laboratories –
SOUTH SAN FRANCISCO, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NGM) (NASDAQ:NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced it will host a virtual R&D Day on December 9, 2020 at 12:00 pm ET.
The R&D Day will highlight NGM's productive, 100+ researcher-led discovery engine and feature NGM's pipeline of drug candidates in liver and metabolic diseases (aldafermin and MK-3655), retinal disease (NGM621) and cancer (NGM120 and NGM707). NGM also plans to unveil an additional oncology candidate at the event.
Members of NGM's management and senior NGM scientists will present the company's pipeline of programs and the unmet patient needs each aims to address. Guest speakers will include:
- Daniel Von Hoff, M.D., F.A.C.P., Distinguished Professor, The Translational Genomics Research Institute
- Arun Sanyal, M.D., Professor, Internal Medicine, Virginia Commonwealth University
- Robert Schreiber, Ph.D., Distinguished Professor, Pathology & Immunology, Washington University School of Medicine
- Charles Wykoff, M.D., Ph.D., Director of Research at Retina Consultants Houston
As part of the event, NGM will host a fireside chat with Roger M. Perlmutter, M.D., Ph.D., President, Merck Research Laboratories, and Dean Y. Li, M.D., Ph.D., Senior Vice President of Discovery Sciences and Translational Medicine, Merck Research Laboratories, to discuss the collaboration between NGM and Merck. The two companies have an ongoing broad, multi-year strategic collaboration to discover, develop and commercialize novel therapies across a wide range of therapeutic areas.
A live webcast of the event will be available at ir.ngmbio.com under ‘Events & Presentations'. A replay of the webcast will be archived on the NGM website for one year following the presentation.
To register for the NGM R&D Day, please sign up here.
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
[email protected]Media Contact:
Liz Melone
[email protected] -
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--Single and multiple intravitreal injections of NGM621 appeared safe and well tolerated in first-in-human study, with no patients experiencing serious adverse events, drug-related AEs, intraocular inflammation or choroidal neovascularization--
--The serum pharmacokinetics (PK) of NGM621 were linear and dose-proportional--
--NGM621 ocular PK/pharmacodynamics (PD) modeling supports potential for up to every eight-week dosing regimen--
--Enrollment of the CATALINA Phase 2 study of NGM621 in patients with geographic atrophy underway with the first patient dosed in July 2020--
SOUTH SAN FRANCISCO, Calif., Nov. 13, 2020 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NASDAQ:NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, announced that findings from its Phase 1 clinical study of NGM621, an anti-complement C3 antibody, in patients with geographic atrophy (GA) were presented today at the American Academy of Ophthalmology 2020 Virtual. The poster presentation titled, "Inhibition of Complement Component 3 in GA With NGM621: Phase 1 Dose-Escalation Study Results," was given by the study's lead investigator Charles C. Wykoff, M.D., Ph.D., Director of Research at Retina Consultants Houston and the Greater Houston Retina Research Foundation. The presentation is available on the NGM Bio website here.
The primary objective of the Phase 1 trial was to assess the safety and tolerability of single and multiple intravitreal (IVT) injections of NGM621 in patients with GA. Secondary objectives were to characterize the serum PK of single or multiple doses of NGM621. The study enrolled 15 patients across three single-ascending dose cohorts of NGM621, 2 mg, 7.5 mg and 15 mg, the maximum planned dose in the study, and a multiple dose cohort that received two 15 mg doses separated by four weeks. Patients were dosed sequentially and followed closely over 12 weeks.
In the study, NGM621 was well tolerated, with no patients experiencing serious adverse events (SAEs), drug-related adverse events (AEs), intraocular inflammation, endophthalmitis or choroidal neovascularization (CNV). No dose-related safety patterns or concerns were reported. Ocular AEs observed were mild in severity and representative of those commonly associated with IVT injections. No vision-related safety signals were detected. On average, patients maintained their visual acuity over the 12-week follow-up study duration.
The serum PK of NGM621 was linear and dose-proportional. Based on ocular PK/PD modeling, NGM621 is predicted to achieve >90% reduction in free C3 in the eye for 7 weeks following a single IVT dose of 15 mg. Taken together, the PK profile of NGM621 demonstrated in the Phase 1 study and subsequent PK/PD modeling support up to an every eight-week (or every other month) dosing regimen of NGM621 at the 15 mg dose level. NGM621 serum exposure was below concentrations expected to produce systemic complement inhibition after IVT injection of the 15 mg dose. No anti-drug antibodies were detected in any patient at any timepoint.
"The findings from this first-in-human study of NGM621 in patients with geographic atrophy give us important insights regarding the potential of this therapeutic to address this progressive and devastating disease," said Dr. Wykoff. "The favorable safety and tolerability profile seen in this study, combined with the potential for every other month dosing suggest NGM621 may be valuable as a complement C3 inhibitor to treat geographic atrophy. I look forward to continuing to advance our clinical understanding of NGM621 in the ongoing, double-masked Phase 2 CATALINA study."
GA, an advanced form of age-related macular degeneration, 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. It is being tested in the Phase 2 CATALINA trial to evaluate its effects on disease progression when given every four weeks or every eight-weeks.
"We are very pleased to see NGM621's exciting preclinical data now translating in the clinic as expected. These results support our belief that NGM621 may have a highly differentiated therapeutic profile in the complement inhibition space, and we look forward to building on this body of data with our ongoing Phase 3-enabling CATALINA study," said Hsiao D. Lieu, M.D., Chief Medical Officer at NGM Bio. "We recognize the difficult and far-reaching impact geographic atrophy can have on patients' quality of life, and we are committed to advancing this promising therapeutic candidate for these patients."
More details on the Phase 2 CATALINA study can be found at this link on clinicaltrials.gov.
About NGM621 and Complement C3 Inhibition
NGM621 is a humanized IgG1 monoclonal antibody engineered to potently inhibit complement C3. It is being evaluated with dosing every four weeks and every eight-weeks. NGM621 is not pegylated. 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).
NGM621 was discovered by NGM under its strategic collaboration with Merck.
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.
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 "potential," "suggesting," "look forward," "advance," "belief," "engineered to," "aspire", "appeared" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to: the therapeutic potential and profile of NGM621, including the potential to slow the progression of GA, to prevent CNV development and potently inhibit C3, and the potential for up to every eight week dosing of NGM621; the enrollment and potential results of the Phase 2 CATALINA study of NGM621 for the treatment of patients with GA; NGM's commitment and ability to advance potentially first-in-class and transformative medicines for patients 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, the risk that NGM's ongoing or future clinical studies in humans may show that NGM621 is not a tolerable and effective treatment for geographic atrophy or that every eight week dosing with NGM621 is not possible 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 NGM's quarterly report on Form 10-Q for the quarter ended September 30, 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]
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- NGM continues to demonstrate the productivity of its research discovery engine and progress against its multi-therapeutic area pipeline:
-- Initiated a Phase 2 clinical trial of NGM621, an anti-complement C3 antibody, in patients with geographic atrophy (GA)
-- Announced expansion of oncology portfolio with first immuno-oncology candidate, NGM707, a novel dual antagonist antibody inhibiting ILT2 and ILT4 - NGM has $287.9 million in cash, cash equivalents and marketable securities as of September 30, 2020
- NGM will present first-in-human results from Phase 1 study of NGM621 in patients with GA at the upcoming American Academy of Ophthalmology (AAO) Virtual Annual Meeting on November 13, 2020
- NGM will conduct an R&D Day showcasing its portfolio on December 9, 2020
SOUTH SAN FRANCISCO, Calif., Nov. 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 quarter ended September 30, 2020.
"We made notable progress across our pipeline this past quarter, as we continue to pursue a portfolio of product candidates directed to biologically powerful targets," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM. "Since mid-July, we have initiated a Phase 2 clinical trial of NGM621, our anti-complement C3 antibody, designed to slow disease progression in people with geographic atrophy, and we have disclosed our first immuno-oncology development candidate, NGM707, a novel dual antagonist antibody inhibiting ILT2 and ILT4, designed to potentially improve patient immune responses to tumors."
Dr. Woodhouse continued, "We look forward to our upcoming R&D Day on December 9th, where we will showcase not only our exciting portfolio of programs but also highlight the talented NGM scientists whose expertise, creativity and passion have enabled our track record of rapid innovation and sustained productivity."
Key Third Quarter and Recent Highlights
Liver and metabolic diseases
- Completed enrollment in Phase 2b ALPINE 2/3 study of aldafermin in NASH patients. NGM completed 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 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. NGM expects to report topline findings from the study in the second quarter of 2021.
- Ongoing enrollment in Phase 2b ALPINE 4 study of aldafermin in NASH patients with compensated cirrhosis. NGM 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 doubleblind, randomized, placebo-controlled Phase 2 study (Cohort 4) of aldafermin in NASH patients presented at The Digital International Liver Congress™ 2020 and published in Gastroenterology. Cohort 4 demonstrated statistically significant dual activity in both 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.
Retinal diseases
- Initiated Phase 2 CATALINA study of NGM621 in patients with GA. In July, NGM began 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 in patients with GA secondary to age-related macular degeneration. NGM anticipates enrolling 240 patients diagnosed with GA in one or both eyes.
- NGM will present results from a Phase 1 study of NGM621 in patients with GA at the American Academy of Ophthalmology (AAO) Virtual Annual Meeting on November 13, 2020 at 10:00 a.m. ET. NGM completed the Phase 1 study with single- and multiple-dose IVT injections of NGM621 in patients with GA. The AAO presentation will be the first-in-human data presented on NGM621 in GA.
Cancer
- Expanded oncology portfolio with first immuno-oncology development candidate, NGM707, a dual antagonist antibody inhibiting ILT2 and ILT4. These receptors represent key myeloid and lymphoid checkpoints, and may restrict anti-tumor immunity, enable tumors to evade immune detection and contribute to T cell checkpoint resistance. NGM plans to initiate first-in-human testing of NGM707 in mid-2021 in patients with advanced solid tumors.
- Ongoing 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.
Merck Collaboration
Merck has a one-time option to license NGM pipeline programs – other than 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 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 MK-3655, previously referred to as NGM313.
Third Quarter Financial Results
- For the quarter ended September 30, 2020, NGM reported a net loss of $29.8 million, compared to a net loss of $10.9 million for the corresponding period in 2019.
- Related party revenue from our collaboration with Merck for the quarter ended September 30, 2020 was $23.5 million, compared to $21.6 million for the corresponding period in 2019.
- Research and development expenses for the quarter ended September 30, 2020 were $47.0 million, compared to $29.0 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 related to our aldafermin, NGM621, NGM120 and NGM707 programs, and personnel-related expenses driven by increased headcount.
- General and administrative expenses for the quarter ended September 30, 2020 were $6.5 million, compared to $5.6 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, as well as external expenses to support our operations as a public company.
- Cash, cash equivalents and short-term marketable securities were $287.9 million as of September 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 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.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "will," "planned," "pursue," "look forward," "expects," ‘designed to," "anticipates," "plans," "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 intentions to present at future events; the productivity of NGM's research and advancement of NGM's clinical and preclinical pipeline; 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; and the design, timing, enrollment, safety, tolerability and efficacy of, and continued development of, NGM's product candidates, including aldafermin, NGM621, NGM707 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 "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 June 30, 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 Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Related party revenue $ 23,482 $ 21,568 $ 67,601 $ 72,461 Operating expenses: Research and development 46,979 28,953 123,912 87,299 General and administrative 6,460 5,612 19,849 17,208 Total operating expenses 53,439 34,565 143,761 104,507 Loss from operations (29,957 ) (12,997 ) (76,160 ) (32,046 ) Interest income 260 1,984 1,823 5,138 Other income (expense), net (68 ) 96 (159 ) 54 Net loss $ (29,765 ) $ (10,917 ) $ (74,496 ) $ (26,854 ) Net loss per share, basic and diluted $ (0.43 ) $ (0.17 ) $ (1.09 ) $ (0.60 ) Weighted average shares used to compute net loss per share, basic and diluted 68,815,696 65,948,207 68,174,654 44,828,596 (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)September 30, December 31, 2020 2019 Assets Current assets: Cash and cash equivalents $ 253,976 $ 245,598 Short-term marketable securities 33,973 98,913 Related party receivable from collaboration 7,215 5,206 Prepaid expenses and other current assets 7,076 5,531 Total current assets 302,240 355,248 Property and equipment, net 15,773 19,475 Restricted cash 1,499 1,874 Other non-current assets 6,570 3,806 Total assets $ 326,082 $ 380,403 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 1,613 $ 9,026 Accrued liabilities 28,579 22,991 Deferred rent, current 2,938 2,829 Deferred revenue, current 4,586 4,872 Total current liabilities 37,716 39,718 Deferred rent, non-current 7,179 9,392 Other non-current liabilities 4,315 — Early exercise stock option liability 169 574 Total liabilities 49,379 49,684 Commitments and contingencies Stockholders' equity: Preferred stock, $0.001 par value; 10,000,000 shares authorized;
no shares issued or outstanding as of September 30, 2020 and
December 31, 2019, respectively— — Common stock, $0.001 par value; 400,000,000 shares authorized;
68,934,767 and 66,960,279 shares issued and outstanding as of
September 30, 2020 and December 31, 2019, respectively69 67 Additional paid-in capital 547,259 526,771 Accumulated other comprehensive gain 15 25 Accumulated deficit (270,640 ) (196,144 ) Total stockholders' equity 276,703 330,719 Total liabilities and stockholders' equity $ 326,082 $ 380,403 - NGM continues to demonstrate the productivity of its research discovery engine and progress against its multi-therapeutic area pipeline:
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SOUTH SAN FRANCISCO, Calif., Nov. 11, 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 three upcoming investor conferences.
Wednesday, November 18, 2020
Event: Jefferies Virtual London Healthcare Conference
Time: 12:00 pm ETWednesday, November 18, 2020
Event: Stifel 2020 Virtual Healthcare Conference
Time: 2:40 pm ETMonday, November 23, 2020
Event: 32nd Annual Piper Sandler Virtual Healthcare Conference
Time: 12:00 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 90 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
[email protected]Media Contact:
Liz Melone
[email protected] -
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--Humanized IgG1 monoclonal antibody engineered to potently inhibit complement C3, with the potential for extended every eight-week dosing without pegylation--
--Phase 2 (CATALINA) study of NGM621 in patients with GA currently underway--
SOUTH SAN FRANCISCO, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- NGM Biopharmaceuticals, Inc. (NASDAQ:NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announced that data from its Phase 1 study of NGM621, a potent anti-complement C3 antibody, will be featured in a poster presentation at the American Academy of Ophthalmology (AAO) 2020 Virtual. The presentation will include detailed first-in-human safety, tolerability and pharmacokinetics (PK) findings from single and multiple intravitreal injections of NGM621 in patients with geographic atrophy (GA).
Details of the poster presentation are as follows:
Abstract Title: Inhibition of Complement Component 3 in GA With NGM621: Phase 1 Dose-Escalation Study Results
Presenter Author: Charles C. Wykoff, M.D., Ph.D., Director of Research at Retina Consultants Houston and the Greater Houston Retina Research Foundation
Date and Time: Nov. 13, 2020 at 10:00 AM ETAll presentations will be available on the NGM Bio website at https://www.ngmbio.com/rd/presentations-and-publications/.
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 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.
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 "suggesting," "aspire," "potential," "engineered to" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to: the therapeutic potential and potential extended dosing of NGM621; NGM's ability to advance potentially transformative medicines for patients 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, the risk that NGM's ongoing or future clinical studies in humans may show that NGM621 is not a tolerable and effective treatment for geographic atrophy or that extended dosing with NGM621 is not possible 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 NGM's quarterly report on Form 10-Q for the quarter ended June 30, 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: Media Contact: Alex Schwartz Liz Melone [email protected] [email protected]
