TM
Biology-driven discovery. Life-changing medicines.
Corporate Overview
January 2022
NASDAQ: NGM
©2022 NGM Bio
Safe Harbor Statement
The following presentation contains forward-looking statements, including, but not limited to, statements regarding potential indications for, planned and continued development of, and therapeutic potential of, product candidates in NGM Bio's pipeline, including NGM120, NGM707, NGM831, NGM438, NGM621, MK-3655 and aldafermin; the planned timing of initiation, enrollment, data readouts and results of NGM Bio's clinical trials, including with respect to topline data for NGM621; potential future late-stage development of product candidates in NGM Bio's pipeline, including NGM621 and aldafermin; the potential activity, complementarity, safety, tolerability and efficacy of NGM's product candidates, including the potential of NGM Bio's oncology product candidates to become next- generation treatment options; NGM Bio's belief that myeloid cell reprogramming can be an important additional approach to augment anti-tumor immunity and that its portfolio of product candidates provide multiple opportunities to harness that biology; the design of NGM Bio's and Merck's clinical trials of NGM's product candidates; the preliminary findings in the Phase 1a/1b study of NGM120 providing encouraging initial signals of anti-cancer activity; the preliminary findings in the Phase 1a study of NGM707 and anticipated timing thereof; the availability and anticipated timing of topline data from Phase 2 CATALINA study of NGM621 in patients with geographic atrophy; the continuation of the Phase 2b ALPINE 4 trial of aldafermin; potential activities under NGM's amended collaboration with Merck and the potential receipt of milestone and royalty payments by NGM under the amended collaboration with Merck; the potential roles of regulating the GDF15/GFRAL pathway and ILT2, ILT4, ILT3 and LAIR1 in cancer, the powerful biology of the GDF15 pathway, the potential consequences of ILT2, ILT4, ILT3 and LAIR1 blockade and the opportunity for next generation myeloid checkpoint inhibitors to address limitations of existing immunotherapies; and the potential for NGM621 to have an opportunity for differentiation for the treatment of geographic atrophy and opportunities to achieve category leadership, and its potential for every 8-week dosing; potential option exercises by Merck under NGM Bio's amended collaboration with Merck; NGM Bio's opportunities for value creation and its ability to deliver powerful treatments; NGM Bio's strategy, including its myeloid reprogramming strategy, and potential impact of its portfolio prioritization; NGM Bio's potential near-term catalysts; and any other statements other than statements of historical facts. Because such statements deal with future events and are based on NGM Bio's current plans, objectives, estimates and expectations, they are subject to various significant risks and uncertainties and actual results, performance and achievements and the timing of events could differ materially from those described in or implied by the statements herein. Such risks and uncertainties include, without limitation, those 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 initiating, enrolling or completing clinical studies, the risk that NGM Bio's ongoing or future clinical studies in humans may show that NGM Bio's product candidates are not tolerable or effective treatments, the risk that preclinical studies or modeling may not be indicative of results in future human clinical trials, the risk that preliminary results from clinical studies may not be predictive of the final results of such studies, the risk that success in earlier-stage clinical studies does not ensure that later clinical trials evaluating NGM Bio's product candidates will generate the same results or otherwise provide adequate data to demonstrate the effectiveness and safety of such product candidates, and the risk that others may discover, develop or commercialize products before or more successfully than NGM Bio, including in NASH and/or geographic atrophy (GA); the ongoing COVID-19 pandemic which has adversely affected, and could materially and adversely affect in the future, NGM Bio's business and operations, including NGM Bio's ability to timely supply, initiate, enroll and complete its ongoing and future clinical trials; the time-consuming and uncertain regulatory approval process, including the risk that NGM Bio or Merck, as applicable, may not receive marketing approvals for any of NGM Bio's product candidates in a timely manner, or at all; seeking and maintaining protection of intellectual property; NGM Bio's reliance on third party manufacturers and delays or problems in the manufacture or testing of product candidates; NGM Bio's dependence on its amended collaboration with Merck for the development and potential commercialization of product candidates falling within the scope of the amended collaboration and its ability to maintain the amended collaboration, including the risk that if Merck were to breach or terminate the amended collaboration or Merck's development funding obligations thereunder, NGM Bio would not obtain all of the anticipated financial and other benefits of the amended collaboration, and the development and/or commercialization of NGM Bio's product candidates falling within the scope of the amended collaboration could be delayed, perhaps substantially; the sufficiency of NGM Bio's cash resources, including to fund development programs that fall outside of the narrower scope of NGM Bio's amended collaboration with Merck, and need for additional capital; and other risks and uncertainties affecting NGM Bio and its research and development programs, including those described under the caption "Risk Factors" and elsewhere in NGM Bio's quarterly report on Form 10-Q for the quarter ended September 30, 2021 filed with the United States Securities and Exchange Commission (SEC) on November 4, 2021 and future filings and reports of NGM Bio with the SEC. The forward-looking statements contained in the following presentation are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by NGM Bio on its website or otherwise. NGM Bio undertakes no obligation to update or supplement any forward-looking statements after the date hereof, or to update the reasons why actual results may differ or differ materially from those anticipated in the forward-looking statements.
2
Our Approach Integrates Biology and Protein Engineering Expertise into the Drug Discovery and Development Process
PROTEIN | EXPANSIVE PIPELINE |
ENGINEERING | |
3 Therapeutic Areas |
Delivering powerful therapies
7
5
4
Disclosed Programs
Programs in Clinical Development
Ph2/Ph2b Studies Ongoing
EXPERIMENTAL
BIOLOGY
3
Reproducible Drug Discovery Process Has Been Applied Successfully Across Biological Frontiers
EXPERIMENTAL BIOLOGY | 7 | Disclosed Programs |
High-throughput | Receptor-ligand | NGM |
deorphanization | ||
in vivo screening | 707 | |
Human | NGM | |
genetics / systems | ||
438 | ||
biology | ||
DeliveringNGM
powerful831 therapies
NGM
120
Multi-format | Antibody | NGM |
engineering | ||
biologics | 621 | |
capabilities |
Aldafermin
MK
3655
PROTEIN ENGINEERING
4
Our Expansive Pipeline
ONCOLOGY
Preclinical | Phase 1 | Phase 2 | Phase 3 | Rights |
NGM707 | ILT2/ILT4 Dual | Advanced Solid | PHASE 1/2 | Initial Ph1a Data Expected in 2H22 | Global | ||
Antagonist Antibody | Tumors | ||||||
NGM831 | ILT3 Antagonist | Advanced Solid | IND-ENABLING STUDIES | Ph1 Initiation Expected 1Q22 | Global | ||
Antibody | Tumors | ||||||
NGM438 | LAIR1 Antagonist | Advanced Solid | |||||
IND-ENABLING STUDIES | Ph1 Initiation Expected 2Q22 | Global | |||||
Antibody | Tumors | ||||||
NGM120 | GFRAL Antagonist | Cancer & Cancer- | PHASE 1A/1B1 | Additional Ph1a/1b Data | Global | ||
Antibody | related Cachexia | Expected 2H22 | |||||
Metastatic Pancreatic | Placebo-controlled | Global | |||||
Cancer & Cancer- | PHASE 2 | ||||||
Expansion Enrolling | |||||||
related Cachexia | |||||||
RETINAL
NGM621 | Anti-Complement | Geographic Atrophy | PHASE 2 |
C3 Antibody |
Topline Data Expected 4Q22
Merck option at PoC; if optioned, NGM to receive milestones + double-digit royalties or up to 50% profit/cost share2
LIVER & METABOLIC
MK-3655 | FGFR1c/KLB | NASH F2/F3 | Merck optioned at PoC; NGM to | ||||
PHASE 2B | Enrolling | receive milestones + double-digit | |||||
(NGM313) | Agonist Antibody | royalties or up to 50% profit/cost | |||||
share2 | |||||||
Aldafermin | FGF19 Analog | NASH F4 | Topline ALPINE 4 Data | ||||
PHASE 2B | Global | ||||||
Expected in 1H23 | |||||||
1 Phase 1a cohort = monotherapy; Phase 1b cohort = in combination with standard-of-care treatment of gemcitabine + Nab-paclitaxel
2At NGM's option at Phase 3 | 5 |
NASH = non-alcoholic steatohepatitis; FGF = fibroblast growth factor; KLB = klotho beta; C3 = Component 3; GFRAL = glial cell-derived neurotrophic factor receptor alpha-like; ILT2 = Immunoglobulin-like transcript 2; ILT4 = Immunoglobulin-like transcript 4; ILT3 = Immunoglobulin-like transcript 3; LAIR1 = Leukocyte-associatedimmunoglobulin-like receptor 1; F2/F3/F4 = stage 2 or 3 or 4 liver fibrosis; PoC = proof of concept
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NGM Biopharmaceuticals Inc. published this content on 10 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 January 2022 14:07:03 UTC.