RVMD Revolution Medicines Inc - Ordinary Shares
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
RMC-4630 - RMC-4630-01
Solid tumors
|
Phase 1
Phase 1
|
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
|
|
RMC-4630 and AMG 510
Solid tumors
|
Phase 1b
Phase 1b
|
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
|
|
RMC-5552
Solid tumors
|
Phase 1
Phase 1
|
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
|
|
RMC-4630 and cobimetinib - RMC-4630-02
Solid tumors
|
Phase 1/2
Phase 1/2
|
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
RMC-4630 and Keytruda
Non-small cell lung cancer (NSCLC) and colorectal cancer
|
Phase 1b
Phase 1b
|
Phase 1b initiation of dosing announced June 22, 2020.
|
Latest News
-
View Full Article Hide Full Article
REDWOOD CITY, Calif., May 03, 2021 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (NASDAQ:RVMD), a clinical-stage precision oncology company focused on developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, today highlights the nomination of a slate of three individuals for election/reelection to its board of directors. Flavia Borellini, Ph.D. has been nominated by the company's board of directors for election as a first-time Class I director, joining current Class I directors Elizabeth McKee Anderson and Neil Exter, who were nominated for reelection. These nominees will be voted on at the June 22, 2021 Revolution Medicines annual meeting of stockholders.
Dr. Borellini has more than 25 years of executive management experience in the pharmaceutical and biotechnology industry, with a particular focus on global development of targeted oncology drugs, from preclinical to commercial stage. She is the former chief executive officer for Acerta Pharma, where she oversaw the successful development and approval of Calquence® (acalabrutinib), a selective Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of mantle cell lymphoma. During her career, Dr. Borellini has also held key senior level positions within AstraZeneca, most recently global franchise head, hematology, with responsibility for the hematology portfolio in the company's oncology business unit. While at AstraZeneca, she led the global development, approval, and commercialization of Tagrisso® (osimertinib), a first-in-class epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor for the treatment of non-small cell lung cancer (NSCLC) caused by the T790M mutation.
Prior to her tenure with AstraZeneca, Dr. Borellini spent nearly seven years at Genentech, a member of the Roche Group. During this time, she led the global development, approval and launch of Zelboraf® (vemurafenib), a first-in-class BRAF inhibitor for the treatment of melanoma caused by the V600E BRAF mutation. Dr. Borellini also served as the program leader for Herceptin® (trastuzumab), a targeted treatment for HER2 receptor positive cancers, including breast cancer, and Tarceva® (erlotinib), an EGFR tyrosine kinase inhibitor for the treatment of NSCLC and pancreatic cancer.
Ms. Anderson, a member of the Revolution Medicines board of directors since 2015, previously held several leadership positions at Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, which included responsibility for global therapeutic area strategy and portfolio assets for immunology and oncology. She played key roles in the launch or lifecycle management of several brands including Stelara®, Simponi®, Velcade®, and Remicade®. Ms. Anderson also served as the worldwide vice president and commercial leader in the infectious diseases and vaccines global commercial strategy organization at Janssen Pharmaceuticals.
Mr. Exter, a member of Revolution Medicines board from 2014 to 2016 and since 2019, has served as a partner of Third Rock Ventures for nearly 15 years. In this role he plays an integral role in the formation, development and business strategy for Third Rock's portfolio companies and has served in key leadership roles in several portfolio companies. Prior to joining Third Rock, Mr. Exter was chief business officer of Alantos Pharmaceuticals prior to its acquisition by Amgen, and earlier served as vice president for Millennium Pharmaceuticals, where he directed in-licensing and M&A.
In related news, Peter Svennilson will no longer serve as a director after completion of his term at the company's annual meeting of stockholders.
"As a pioneer in the field of precision oncology with extensive experience in the biotechnology and biopharmaceutical industries and service as a director for other companies, Dr. Borellini would be an excellent addition to our board of directors," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "We are excited about the nomination of all three of these outstanding individuals who bring a mix of skills, experiences and backgrounds to our board. We look forward to working with each of them to help guide our mission to develop targeted oncology therapies on behalf of patients battling RAS-addicted cancers. We would also like to thank Peter for his contributions during his tenure on the board."
About Revolution Medicines, Inc.
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company possesses sophisticated structure-based drug discovery capabilities built upon deep chemical biology and cancer pharmacology know-how and innovative, proprietary technologies that enable the creation of small molecules tailored to unconventional binding sites.
The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. RAS(ON) Inhibitors in development include RMC-6291 and RMC-6236, and a pipeline of research compounds targeting additional RAS variants. RAS Companion Inhibitors in development include RMC-4630, RMC-5552, and RMC-5845.
Important Additional Information and Where to Find It
Revolution Medicines, its directors and certain of its executive officers may be deemed to be participants in the solicitation of proxies from stockholders in connection with Revolution Medicines' 2021 annual meeting of stockholders (the "2021 Annual Meeting"). Revolution Medicines filed with the SEC and made available to its stockholders a proxy statement in connection with such solicitation on April 28, 2021. REVOLUTION MEDICINES 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 Revolution Medicines' directors and executive officers are set forth in Revolution Medicines' proxy statement for the 2021 Annual Meeting, which documents are available at Revolution Medicines' investor relations website at https://ir.revmed.com/investor-relations. Information regarding the special interests of such participants, if any, in the matters to be voted on at the 2021 Annual Meeting are 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 Revolution Medicines with the SEC, are available for no charge at the SEC's website at www.sec.gov and at Revolution Medicines' investor relations website at https://ir.revmed.com/investor-relations. Copies may also be obtained free of charge by contacting Revolution Medicines by mail at 700 Saginaw Drive, Redwood City, California 94063, Attn: Secretary, or by telephone at (650) 481-6801.
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 Revolution Medicines' mission to develop targeted oncology therapies on behalf of patients battling RAS-addicted cancers, the director nominees and the outcome of the Revolution Medicines' 2021 Annual Meeting; and other statements that are not historical fact. Because such statements deal with future events and are based on Revolution Medicines's current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Revolution Medicines 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 Revolution Medicines' 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 Revolution Medicines' product candidates are tolerable and effective; the ongoing COVID-19 pandemic, which has adversely affected, and could materially and adversely affect in the future, Revolution Medicines' business and operations, including Revolution Medicines' clinical trials; the time-consuming and uncertain regulatory approval process; Revolution Medicines' 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 Revolution Medicines' cash resources and need for additional capital; and other risks and uncertainties affecting Revolution Medicines' and its development programs, including those discussed in the section titled "Risk Factors" in Revolution Medicines' 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 2, 2021 and future filings and reports that Revolution Medicines makes from time to time with the SEC. Except as required by law, Revolution Medicines 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.
Contacts:
For Investors:
Vida Strategic Partners
Stephanie Diaz
415-675-7401
[email protected]For Media:
Vida Strategic Partners
Tim Brons
415-675-7402
[email protected]
-
View Full Article Hide Full Article
First-in-Class Bi-steric mTORC1 Inhibitor Advances into Clinical Development
Newly Issued U.S. Patent Further Strengthens RMC-5552 IP Portfolio
REDWOOD CITY, Calif., April 21, 2021 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (NASDAQ:RVMD), a clinical-stage precision oncology company focused on developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, today announced dosing of the first patient in a multicenter Phase 1/1b clinical trial evaluating RMC-5552, the company's investigational first-in-class bi-steric mTORC1 inhibitor as a monotherapy. The trial is an open-label dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of RMC-5552 in patients with advanced relapsed/refractory solid tumors. Results from this study will inform Revolution Medicines' identification of the maximum tolerated dose (MTD) and selection of recommended Phase 2 dose and schedule (RP2DS) for further evaluation of the compound.
RMC-5552 is a potent and selective inhibitor of mTORC1 that is being developed as an anticancer therapeutic for patients with solid tumors that have hyperactivation of the mTOR pathway, including certain RAS-addicted cancers. The compound is designed to inhibit mTORC1 and preserve the natural tumor suppressive activity of 4EBP1, without the undesired inhibition of mTORC2. RMC-5552 has demonstrated antitumor activity in a wide variety of preclinical models. Revolution Medicines has also reported in vivo data demonstrating that RMC-5552 may increase antitumor activity in combination with KRASG12C inhibitors in lung and colon cancers harboring KRAS mutations and co-mutations in the mTOR signaling pathway that can cause resistance to single agent RAS inhibition.
"The initiation of the RMC-5552 clinical program is the first step in the evaluation of our first-in-class, bi-steric mTORC1 inhibitor as a RAS Companion Inhibitor for the treatment of tumors driven by co-occurring RAS mutations and genomic activation of the mTORC1 pathway, which account for a significant proportion of RAS-addicted cancers," said Steve Kelsey, M.D., president, research and development at Revolution Medicines. "These co-occurring mutations may contribute to resistance to single-agent RAS inhibitors, and the potential to add RMC-5552 to RAS-directed therapies aligns nicely with our strategy of developing rational, biomarker-driven drug combinations that can achieve maximum clinical benefit in patients with RAS-driven cancers. We also look forward to evaluating RMC-5552 in selected indications where mTORC1 is activated independently of RAS."
New Patent Issuance for RMC-5552 and Related Compounds
In additional news regarding the RMC-5552 program, Revolution Medicines today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 10,980,889. This patent provides, in part, composition of matter protection for RMC-5552, as well as related compounds in the company's proprietary series of selective mTORC1 inhibitors.
About mTORC1
The mTOR Complex 1 (mTORC1) is a central node within the mTOR signaling pathway and a critical regulator of metabolism, growth and proliferation in cancer cells. Oncogenic mutations of genes upstream of mTOR, including PI3 kinase, PTEN, and STK11, can drive abnormal activation of mTORC1 and subsequent inactivation of the tumor suppressor 4EBP1. Selective inhibition of mTORC1 to reactivate 4EBP1 is a potential therapeutic strategy for patients with tumors bearing such mutations. These mutations are often co-occurring with RAS mutations in RAS-addicted tumors and combinations of mTORC1 and RAS-targeted inhibitors may be of particular benefit in this context.
About Revolution Medicines, Inc.
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company possesses sophisticated structure-based drug discovery capabilities built upon deep chemical biology and cancer pharmacology know-how and innovative, proprietary technologies that enable the creation of small molecules tailored to unconventional binding sites.
The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. RAS(ON) Inhibitors in development include RMC-6291 and RMC-6236, and a pipeline of research compounds targeting additional RAS variants. RAS Companion Inhibitors in development include RMC-4630, RMC-5552, and RMC-5845.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered "forward-looking statements," including without limitation statements regarding the tolerability and potential efficacy of Revolution Medicines' clinical candidates, including RMC-5552; the outcome of the company's clinical trials, including the Phase 1/1b study of RMC-5552; identification of the MTD and selection of a RP2DS for RMC-5552; the strategy of developing drug combinations that can achieve maximum clinical benefit; and Revolution Medicines' plans to evaluate RMC-5552 in selected indications where mTORC1 is activated independently of RAS. Forward-looking statements are typically, but not always, identified by the use of words such as "may," "will," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company's ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company's capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines' Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 2, 2021, and its future periodic reports to be filed with the Securities and Exchange Commission. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
Contacts: For Investors: Vida Strategic Partners Stephanie Diaz 415-675-7401 [email protected] For Media: Vida Strategic Partners Tim Brons 415-675-7402 [email protected]
-
View Full Article Hide Full Article
REDWOOD CITY, Calif., March 11, 2021 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (NASDAQ:RVMD), a clinical-stage precision oncology company focused on developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, today announced the company will make six presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2021 being held April 10-15, 2021 in a virtual format.
Details of the planned presentations are as follows:
Oral Presentation:
Title: Anti-tumor activity and tolerability of the SHP2 inhibitor RMC-4630 as a single agent in patients with RAS-addicted solid cancers Abstract Number: LB001 Session: Late-Breaking Minisymposium 1 Date/Time: April 10, 2021 at 2:05 p.m. Eastern Poster Presentations:
Title: First-in-class, orally bioavailable KRASG12V(ON) tri-complex inhibitors, as single agents and in combinations, drive profound anti-tumor activity in preclinical models of KRASG12V mutant cancers Abstract Number: 1260 Session: Novel Antitumor Agents Date/Time: April 10, 2021 at 8:30 a.m. Eastern Title: A next generation tri-complex KRASG12C(ON) inhibitor directly targets the active, GTP-bound state of mutant RAS and may overcome resistance to KRASG12C(OFF) inhibition Abstract Number: 1261 Session: Novel Antitumor Agents Date/Time: April 10, 2021 at 8:30 a.m. Eastern Title: Discovery of a potent, selective, and orally bioavailable SOS1 inhibitor, RMC-023, an in vivo tool compound that blocks RAS activation via disruption of the RAS-SOS1 interaction Abstract Number: 1273 Session: Novel Antitumor Agents Date/Time: April 10, 2021 at 8:30 a.m. Eastern Title: Modulation of innate and adaptive immunity in blood and tumor of patients receiving the SHP2 inhibitor RMC-4630 Abstract Number: LB050 Session: Immune Response to Therapies Date: April 10, 2021 at 8:30 a.m. Eastern Title: Confirmation of target inhibition and anti-tumor activity of the SHP2 inhibitor RMC-4630 via longitudinal analysis of ctDNA in a phase 1 clinical study Abstract Number: LB054 Session: Liquid Biopsies: Circulating DNA Date: April 10, 2021 at 8:30 a.m. Eastern Additional information on the AACR Annual Meeting 2021 is available through the AACR website at: https://www.aacr.org/meeting/aacr-annual-meeting-2021/
About Revolution Medicines, Inc.
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company possesses sophisticated structure-based drug discovery capabilities built upon deep chemical biology and cancer pharmacology know-how and innovative, proprietary technologies that enable the creation of small molecules tailored to unconventional binding sites.
The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. RAS(ON) Inhibitors in development include RMC-6291, RMC-6236, and a pipeline of research compounds targeting additional RAS variants. RAS Companion Inhibitors in development include RMC-4630, RMC-5552, and RMC-5845.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered "forward-looking statements," including without limitation statements regarding Revolution Medicines' progress across its R&D pipeline of RAS(ON) Inhibitors and RAS Companion Inhibitors. Forward-looking statements are typically, but not always, identified by the use of words such as "may," "will," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including Revolution Medicines' programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Revolution Medicines' ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Revolution Medicines' capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines' Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 2, 2021, and its future periodic reports to be filed with the Securities and Exchange Commission. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
Contacts: For Investors: Vida Strategic Partners Stephanie Diaz 415-675-7401 [email protected] For Media: Vida Strategic Partners Tim Brons 415-675-7402 [email protected]
-
View Full Article Hide Full Article
REDWOOD CITY, Calif., March 09, 2021 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (NASDAQ:RVMD), a clinical-stage precision oncology company developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, today announced that the company will participate in two upcoming investor conferences. Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines, will deliver a corporate presentation at the Oppenheimer 31st Annual Healthcare Conference and be the featured speaker in a fireside chat at the J.P. Morgan 10th Annual Napa Valley Forum.
Details of these events are as follows:
- Oppenheimer 31st Annual Healthcare Conference
Conference Date: March 16-18, 2021
Presentation Time/Date: 1:10 – 1:40 p.m. Eastern on Tuesday, March 16, 2021
Format: Virtual conference
- J.P. Morgan 10th Annual Napa Valley Forum
Conference Date: March 29-31, 2021
Fireside Chat Time/Date: 2:00 – 2:45 p.m. Eastern on Monday, March 29, 2021
Format: Virtual conference
About Revolution Medicines, Inc.
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company possesses sophisticated structure-based drug discovery capabilities built upon deep chemical biology and cancer pharmacology know-how and innovative, proprietary technologies that enable the creation of small molecules tailored to unconventional binding sites.
The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. RAS(ON) Inhibitors in development include RMC-6291, RMC-6236, and a pipeline of research compounds targeting additional RAS variants. RAS Companion Inhibitors in development include RMC-4630, RMC-5552, and RMC-5845.
Contacts: For Investors: Vida Strategic Partners Stephanie Diaz 415-675-7401 [email protected] For Media: Vida Strategic Partners Tim Brons 415-675-7402 [email protected]
- Oppenheimer 31st Annual Healthcare Conference
-
View Full Article Hide Full Article
Advanced and Expanded Portfolio of RAS(ON) Inhibitors; Two Assets Entered IND-Enabling Development
Continued Progress in Development of RAS Companion Inhibitors to Support Targeted Combination Therapies
Strengthened Balance Sheet – Completed Financing Raising $281 Million in Net Proceeds
REDWOOD CITY, Calif., March 02, 2021 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (NASDAQ:RVMD), a clinical-stage precision oncology company focused on developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, today announced its financial results for the fourth quarter and year ended December 31, 2020, and provided a corporate update.
"Revolution Medicines has achieved multiple significant milestones, furthering the company's position as a leading precision oncology company dedicated to the development of innovative targeted medicines and treatment regimens to address significant unmet needs for patients with RAS-addicted cancers," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines.
"Our exceptional team delivered two pioneering RAS(ON) inhibitor development candidates into IND-enabling development, RMC-6291 and RMC-6236. RMC-6291 targets the oncogenic KRASG12C(ON) variant through a highly differentiated anti-tumor profile. RMC-6236 uniquely targets numerous RAS(ON) variants responsible for many cancers. We believe these two development candidates hold great promise for potential use in treating patients with a diverse range of RAS-addicted cancers, and we are actively advancing both toward the clinic.
"The company has also made great progress with our RAS Companion Inhibitor portfolio. Our most advanced candidate RMC-4630, a SHP2 inhibitor, is being evaluated in multiple studies to position it as a backbone for targeted combination therapies. We received FDA clearance to begin clinical evaluation of RMC-5552, a potent mTORC1-selective inhibitor, and plan to initiate a monotherapy dose-escalation study imminently. Additionally, we have advanced RMC-5845, our potent, selective, oral inhibitor of SOS1, a major switch in the cycling of RAS(OFF) to RAS(ON), into IND-enabling development.
"To support our expanded and advancing pipeline of development programs, Revolution Medicines recently completed an upsized financing, raising net proceeds of $281 million. We have made tremendous progress as a company and believe that our cohesive portfolio of innovative clinical and preclinical assets will permit rational, mechanism-based combinations and position Revolution Medicines to fulfill our mission."
R&D Highlights
RAS(ON) Inhibitors – Revolution Medicines continues maturing its first-in-class RAS(ON) platform, introducing an expansive collection of tri-complex inhibitors targeting diverse oncogenic RAS variants through highly differentiated chemical and pharmacologic profiles.
- Pioneering RAS(ON) assets, RMC-6291 (KRASG12C) and RMC-6236 (RASMULTI), enter IND-enabling development
○ RMC-6291 is a first-in-class, potent, oral and selective tri-complex inhibitor of KRASG12C(ON) and NRASG12C(ON) that has demonstrated deep and sustained anti-tumor activity in preclinical lung cancer models driven by a KRASG12C mutation. The company expects to submit an investigational new drug application (IND) for RMC-6291 in the first half of 2022.
○ RMC-6236 is a first-in-class, potent, oral RAS-selective tri-complex, RASMULTI(ON) inhibitor that has demonstrated pronounced anti-tumor activity in preclinical models of human lung, colorectal and pancreatic cancers caused by multiple RAS variants for which no targeted treatment is currently available. The company expects to submit an IND for RMC-6236 in the first half of 2022.
- Continued expansion of other RAS(ON) inhibitor programs – Revolution Medicines continues to progress an expanding portfolio of potent, cell-active RAS(ON) inhibitors with the potential to target RAS variants driving the vast majority of RAS-addicted cancers. In particular, the company's KRASG12D- and KRASG13C-selective programs continue to advance in lead optimization. The company expects to nominate a third development candidate from its RAS(ON) inhibitor portfolio in the second half of 2021.
RAS Companion Inhibitors – Revolution Medicines continues to advance and expand multiple clinical studies both as monotherapy and in targeted drug combinations designed to achieve maximum clinical benefit.
- RMC-4630 (SHP2 Inhibitor) – RMC-4630 is a potent, oral, selective inhibitor of the SHP2 protein, a central node in the RAS signaling pathway. Its development is being advanced in partnership with, and is primarily funded by, Sanofi.
○ RMC-4630 monotherapy has shown initial clinical anti-tumor activity in multiple cancer genotypes. The company has initiated an expansion cohort at the single agent recommended Phase 2 dose and schedule (RP2DS). The company expects to disclose a safety data set from the dose escalation portion of this trial in the first half of 2021.
○ RMC-4630 in combination with cobimetinib (Cotellic®) has shown initial clinical activity in patients with colorectal cancer driven by KRAS mutations. The company has initiated expansion cohorts evaluating patients with KRASMUTANT colorectal cancer at the RP2DS for this combination. The company expects preliminary safety and clinical activity data from this expansion study in 2022.
○ Studies evaluating RMC-4630 in combination with multiple inhibitors continue and are expanding.
▪ Dosing and enrollment continue in the Amgen-sponsored Phase 1 study of RMC-4630 in combination with Amgen's KRASG12C(OFF) inhibitor, AMG 510, or sotorasib. The company expects a RP2DS will be reached in the first half of 2021 with preliminary activity data in the second half of 2021.
▪ Dosing and enrollment continue in the Sanofi-sponsored Phase 1 study of RMC-4630 in combination with the PD-1 inhibitor, pembrozilumab (Keytruda®). The company expects a RP2DS will be reached for this combination in the first half of 2021.
▪ Dosing and enrollment continue in the Phase 1 study of RMC-4630 in combination with the EGFR inhibitor, osimertinib (Tagrisso®). The company expects initial tolerability and pharmacokinetic (PK) data from this combination in the second half of 2021.
▪ Announced a clinical collaboration agreement with AstraZeneca to study RMC-4630 in combination with an emerging asset targeting KRASG12C from AstraZeneca's portfolio.
- RMC-5552 (mTORC1/4EBP1 Inhibitor) – RMC-5552 is a potent mTORC1- selective inhibitor.
○ Received FDA clearance and initiation of clinical sites for Phase 1 monotherapy dose-escalation study is underway. The company expects to begin dosing patients with monotherapy in the first half of 2021 with initial safety, PK and single agent activity data expected in 2022.
○ The company intends to evaluate RMC-5552 in combination therapies with RAS inhibitors for patients with cancers harboring RAS/mTOR signaling co-mutations.
- RMC-5845 (SOS1 Inhibitor) – RMC-5845 is a potent, selective, oral inhibitor of SOS1, a major switch in the cycling of RAS(OFF) to RAS(ON).
○ The company intends to evaluate RMC-5845 for treatment of certain genetically defined RAS-dependent cancers.
○ Recently advanced into IND-enabling development. The company expects to submit an IND in the second half of 2021.
Corporate Highlights
- Completed upsized financing to strengthen balance sheet and support advancement of expanding pipeline – The company completed a public offering of common stock in February 2021, raising net proceeds of $281 million. The company plans to use these proceeds to advance the company's wholly-owned assets into clinical development.
- Sanofi collaboration continues to make progress – The company's funded collaboration with Sanofi for the clinical development of RMC-4630 continues to advance RMC-4630 as a backbone of combination therapy in RAS-addicted cancers.
Fourth Quarter and Full Year 2020 Financial Highlights
Cash Position: Cash, cash equivalents and marketable securities were $440.7 million as of December 31, 2020, compared to $122.8 million as of December 31, 2019. The increase was primarily due to proceeds from the company's initial public offering in February 2020 and follow-on equity public offering in July 2020. Proceeds from the recently completed offering are not included in the December 31, 2020 cash, cash equivalents and marketable securities balance.
Revenue: Total revenue, consisting of revenue from the company's collaboration agreement with Sanofi, was $8.8 million for the quarter ended December 31, 2020, compared to $12.1 million for the quarter ended December 31, 2019. Total revenue was $43.0 million for the year ended December 31, 2020, compared to $50.0 million for the year ended December 31, 2019. The decrease was due to lower reimbursed research and development services for RMC-4630 resulting from lower manufacturing costs. During the quarter and year ended December 31, 2019, the company incurred upfront manufacturing costs related to the supply of RMC-4630 for our clinical trials.
R&D Expenses: Research and development expenses were $37.0 million for the quarter ended December 31, 2020, compared to $27.5 million for the quarter ended December 31, 2019. Research and development expenses were $132.3 million for the year ended December 31, 2020, compared to $91.8 million for the year ended December 31, 2019. The increase was primarily due to an increase in research expenses associated with the company's pre-clinical research portfolio, an increase in personnel-related expenses related to additional headcount, and an increase in stock-based compensation, partially offset by lower costs related to RMC-4630.
G&A Expenses: General and administrative expenses were $5.8 million for the quarter ended December 31, 2020, compared to $4.2 million for the quarter ended December 31, 2019. General and administrative expenses were $21.4 million for the year ended December 31, 2020, compared to $12.4 million for the year ended December 31, 2019. The increase was primarily due to an increase in expenses associated with operating as a public company, an increase in personnel-related expenses related to additional headcount, and an increase in stock-based compensation.
Net Loss: Net loss was $34.2 million for the quarter ended December 31, 2020, compared to net loss of $14.6 million for the quarter ended December 31, 2019. Net loss was $108.2 million for the year ended December 31, 2020, compared to net loss of $47.7 million for the year ended December 31, 2019.
2021 Financial Guidance
Revolution Medicines expects full year 2021 GAAP net loss to be between $170 million and $190 million, which includes estimated non-cash stock-based compensation expense of $20 million to $25 million.
About Revolution Medicines, Inc.
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company possesses sophisticated structure-based drug discovery capabilities built upon deep chemical biology and cancer pharmacology know-how and innovative, proprietary technologies that enable the creation of small molecules tailored to unconventional binding sites.
The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. RAS(ON) Inhibitors in development include RMC-6291, RMC-6236, and a pipeline of research compounds targeting additional RAS variants. RAS Companion Inhibitors in development include RMC-4630, RMC-5552, and RMC-5845.
Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Tagrisso® is a registered trademark of the AstraZeneca group of companies. Cotellic® is a registered trademark of Genentech, Inc. (a member of the Roche Group).
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered "forward-looking statements," including without limitation statements regarding Revolution Medicines' development plans and timelines and its ability to advance its portfolio and R&D pipeline; dosing and enrollment in the company's clinical trials and the tolerability and potential efficacy of the company's candidates being studied; the ability of the company's therapies to inhibit frontier targets in RAS-addicted cancers; the company's plans to advance the IND-enabling development of RMC-6291, RMC-6236 and RMC-5845; results from the company's single-agent and combination studies of RMC-4630; the company's plans to study RMC-5552 as a monotherapy and in combination with RAS inhibitors; the growth and scope of the company's RAS(ON) Inhibitor platform; the potential advantages and effectiveness of the company's preclinical candidates, including its RAS(ON) Inhibitors; the company's plans to nominate a third development candidate from its family of RAS(ON) Inhibitors; and the company's plans to release data related to its RAS Companion Inhibitors. Forward-looking statements are typically, but not always, identified by the use of words such as "may," "will," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company's ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company's capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines' Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 2, 2021, and its future periodic reports to be filed with the Securities and Exchange Commission. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
REVOLUTION MEDICINES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)Three Months Ended
December 31,Year Ended
December 31,2020 2019 2020 2019 Revenue: Collaboration revenue, related party $ 8,751 $ 12,088 $ 42,983 $ 50,041 Total revenue 8,751 12,088 42,983 50,041 Operating expenses: Research and development 37,006 27,490 132,252 91,755 General and administrative 5,825 4,162 21,428 12,406 Total operating expenses 42,831 31,652 153,680 104,161 Loss from operations (34,080 ) (19,564 ) (110,697 ) (54,120 ) Other income, net: Interest income 252 618 2,238 2,189 Interest and other expense (14 ) (23 ) (71 ) (106 ) Total other income, net 238 595 2,167 2,083 Loss before income taxes (33,842 ) (18,969 ) (108,530 ) (52,037 ) Benefit from (provision for) income taxes (362 ) 4,373 371 4,373 Net loss $ (34,204 ) $ (14,596 ) $ (108,159 ) $ (47,664 ) Redeemable convertible preferred stock dividends - undeclared and cumulative — (4,251 ) (2,219 ) (14,238 ) Net loss attributable to common stockholders $ (34,204 ) $ (18,847 ) $ (110,378 ) $ (61,902 ) Net loss per share attributable to common stockholders - basic and diluted $ (0.52 ) $ (6.48 ) $ (2.01 ) $ (22.33 ) Weighted-average common shares used to compute net loss per share, basic and diluted 66,319,926 2,907,201 54,874,119 2,772,589
REVOLUTION MEDICINES, INC.
SELECTED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, unaudited)December 31, December 31, 2020 2019 Cash, cash equivalents and marketable securities $ 440,741 $ 122,758 Working capital (1) 406,946 90,929 Total assets 567,401 220,529 Deferred revenue 20,592 31,851 Total liabilities 92,725 67,994 Redeemable convertible preferred stock — 305,109 Total stockholders' equity (deficit) 474,676 (152,574 ) (1) Working capital is defined as current assets less current liabilities.
Contacts: For Investors: Vida Strategic Partners Stephanie Diaz 415-675-7401 [email protected] For Media: Vida Strategic Partners Tim Brons 415-675-7402 [email protected]
- Pioneering RAS(ON) assets, RMC-6291 (KRASG12C) and RMC-6236 (RASMULTI), enter IND-enabling development