On March 1, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported fourth quarter and full year 2021 financial results, and provided a business update (Press release, CytomX Therapeutics, MAR 1, 2022, View Source [SID1234609280]).

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"2021 was a successful year of sustained execution and delivery on CytomX’s commitment to destroying cancer differently, highlighted by the significant progress advancing our ongoing Phase 2 studies of praluzatamab ravtansine and CX-2029. Patient enrollment for the Phase 2 study of praluzatamab ravtansine in breast cancer remains on track and an initial data readout is anticipated in the second half of 2022. This approaching milestone follows our recent announcement of preliminary results for CX-2029 in the treatment of squamous lung and head and neck cancers," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX. "Our progress with CX-2029, announced in December, underscores our leadership as the first company to report results from a Phase 2 study for a conditionally activated biologic and we look forward to sharing additional data from our ambitious pipeline in the second half of 2022."

Dr. McCarthy added, "2021 was also marked by considerable progress in the earlier CytomX pipeline. CX-904, our conditionally activated T-cell-engaging bispecific antibody targeting EGFR and CD3, was advanced towards a first-in-human study and, as a result, CytomX now has six investigational products in clinical development across three therapeutic modalities. We also deepened our efforts in conditionally activated cytokines, a field in which we see broad and differentiated clinical opportunity. We have entered 2022 intensely focused on pipeline execution and plan to deliver important milestones this year."

Fourth Quarter Business Highlights and Recent Developments

Praluzatamab ravtansine – Praluzatamab ravtansine is a CD166-directed conditionally activated antibody-drug conjugate (ADC) wholly-owned by CytomX. Patient enrollment continued in the three-arm Phase 2 study of praluzatamab ravtansine in breast cancer. Arms A and B are evaluating praluzatamab ravtansine, as monotherapy, in patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-non-amplified breast cancer and triple-negative breast cancer (TNBC), respectively. Arm C is examining the combination of praluzatamab ravtansine and pacmilimab, CytomX’s proprietary conditionally activated anti-PD-L1 therapeutic candidate, in patients with TNBC.
CX-2029 – CX-2029 is a CD71-directed conditionally activated ADC being co-developed by CytomX and AbbVie. Preliminary data from the Phase 2 expansion study of CX-2029 were announced in December 2021, showing an objective response rate of 18.8 percent and disease control rate of 87.5 percent in 16 efficacy-evaluable patients with sqNSCLC. The safety profile in the expansion phase was consistent with previous Phase 1 observations, with no new safety signals identified and anemia was the most common Grade 3 or higher treatment-related adverse event.
CX-904 – CX-904 is a conditionally activated T-cell-engaging bispecific antibody (TCB) targeting the epidermal growth factor receptor (EGFR) on tumor cells and the CD3 receptor on T cells, and is being developed in collaboration with Amgen. In January 2022, the investigational new drug application for CX-904 was allowed to proceed by the U.S. Food and Drug Administration and CytomX is in the process of initiating a first-in-human Phase 1 study in patients with advanced solid tumors.
Ipilimumab Probody Program – BMS-986249 and BMS-986288 are Probody versions of the anti-CTLA4 antibody, ipilimumab and non-fucosylated ipilimumab, respectively. CytomX’s partner, Bristol Myers Squibb, continued to study BMS-986249 in a randomized Phase 2 study in combination with nivolumab, the anti-PD-1 antibody, versus ipilimumab plus nivolumab in patients with previously-untreated advanced melanoma. This novel combination is also being evaluated in advanced hepatocellular carcinoma, castration-resistant prostate cancer, and TNBC. Bristol Myers Squibb also continued to evaluate BMS-986288, as monotherapy and in combination with nivolumab, in a Phase 1 study in advanced solid tumors.
Preclinical Programs – CytomX continued to work on broadening the potential application of its versatile and tunable Probody platform to other product candidates, including potential first-in-class ADCs directed toward the epithelial cell adhesion molecule (EpCAM/Trop-1) and a conditionally activated cytokine, interferon alpha-2b.
Publication – CytomX continued to publish key results supporting its platform and pipeline, taking the total preclinical and clinical manuscripts published since 2021 to seven. First-in-human data in patients with advanced solid tumors was published in February 2022 in the peer-reviewed journal Clinical Cancer Research, validating CD166, for the first time, as a potential ADC target View Source
Priorities for 2022

Initiate a Phase 1 study of CX-904 in advanced solid tumors in the first half of 2022
Continue patient enrollment in the expansion phase of the Phase 2 study of CX-2029 and provide additional data updates in the second half of 2022
Report initial data from Arms A and B in the Phase 2 study of praluzatamab ravtansine in patients with breast cancer in the second half of 2022
Fourth Quarter and Full Year 2021 Financial Results
Cash, cash equivalents and investments totaled $305.2 million as of December 31, 2021, compared to $316.1 million as of December 31, 2020.

Total revenues were $19.7 million and $69.6 million for the three and twelve months ended December 31, 2021, respectively, compared to $16.4 million and $100.4 million for the corresponding periods in 2020. The increase in total revenues during the three months ended December 31, 2021 was largely related to the CD71 collaboration with AbbVie. The decrease in total revenues for the twelve months ended December 31, 2021 was mainly due to the $40.0 million milestone payment earned in the first quarter of 2020 under the CD71 Co-Development and Licensing Agreement with AbbVie.

Research and development expenses increased by $14.6 million and $1.3 million during the three and twelve months ended December 31, 2021, respectively, to $36.6 million and $114.2 million, compared to $22.0 million and $112.9 million for the corresponding periods in 2020. The increases were primarily driven by personnel expenses, clinical trial activities, and consulting and contract services to support our pre-clinical and clinical portfolio, which, for the twelve months ended December 31, 2021, was mostly offset by a decrease in licensing expenses.

General and administrative expenses increased by $0.3 million and $3.1 million during the three and twelve months ended December 31, 2021, respectively, to $9.5 million and $39.2 million, compared to $9.1 million and $36.0 million for the corresponding periods in 2020. The increase was mainly attributable to increase in personnel related and recruiting expenses.

Conference Call & Webcast Information
CytomX management will host a conference call and a simultaneous webcast today at 5:00 p.m. ET (2:00 p.m. PT) to discuss the financial results and provide a business update. To join the conference call, please dial (877) 809-6037 (domestic) or (615) 247-0221 (international) and reference the conference ID 8454049. A live webcast of the call can be accessed on the Events and Presentations page of CytomX’s website at View Source An archived replay of the webcast will be available on the Company’s website until March 8, 2022.

On March 1, 2022 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) and AK006 for the treatment of allergic and inflammatory diseases, reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Allakos, MAR 1, 2022, View Source [SID1234609279]).

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Recent Events

Initiated a Phase 2 randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with moderate-to-severe atopic dermatitis in the fourth quarter of 2021.

Reported topline data from ENIGMA 2, a Phase 3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with eosinophilic gastritis/eosinophilic duodenitis ("EG"/"EoD") in the fourth quarter of 2021.

Reported topline data from KRYPTOS, a Phase 2/3 randomized, double-blind, placebo-controlled study of lirentelimab in patients with eosinophilic esophagitis ("EoE") in the fourth quarter of 2021.
Upcoming Milestones

Hold an End-of-Phase 2 meeting with the FDA during second quarter of 2022 to discuss the Phase 2/3 KRYPTOS data and the development path with subcutaneous lirentelimab in patients with EoE.

Report topline data from the Phase 3 study of lirentelimab in patients with EoD (EoDyssey) in the third quarter of 2022.

Initiate a Phase 2b randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria in the middle of 2022.

Complete IND-Enabling studies of AK006 during 2022 and initiate the first-in-human study in the first half of 2023.
Fourth Quarter and Full Year 2021 Financial Results

Research and development expenses were $72.9 million in the fourth quarter of 2021 as compared to $28.5 million in the same period in 2020, an increase of $44.4 million. Research and development expenses were $196.3 million for the full year 2021 as compared to $105.5 million in the same period in 2020, an increase of $90.8 million.

General and administrative expenses were $23.2 million in the fourth quarter of 2021 as compared to $15.8 million in the same period in 2020, an increase of $7.4 million. General and administrative expenses were $75.1 million for the full year 2021 as compared to $51.5 million in the same period in 2020, an increase of $23.6 million.

Allakos reported a net loss of $94.4 million in the fourth quarter of 2021 as compared to $44.3 million in the same period in 2020, an increase of $50.1 million. Net loss per basic and diluted share was $1.73 for the fourth quarter of 2021 compared to $0.86 in the same period in 2020. Net loss was $269.9 million for the full year 2021 as compared to $153.5 million in the same period in 2020, an increase of $116.4 million. Net

loss per basic and diluted share was $5.01 for the full year 2021 compared to $3.10 in the same period in 2020.

Allakos ended the fourth quarter of 2021 with $424.2 million in cash, cash equivalents and marketable securities.

On March 1, 2022 NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, reported financial results for the full year and fourth quarter ending December 31, 2021 (Press release, NGM Biopharmaceuticals, MAR 1, 2022, View Source [SID1234609278]).

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"2021 was a meaningful year for NGM Bio. We made significant progress advancing our pipeline, which now includes five programs in the clinic, with four programs in Phase 2 trials," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. "2022 is poised to be one of the most eventful years in NGM Bio’s history with multiple milestones expected, including clinical data readouts from three of our programs, continued development across our pipeline and steady output from our research and discovery engine."

Key Fourth Quarter and Recent Highlights

Oncology

Progressed the Phase 1/2 trial of NGM707, an ILT2/ITL4 dual antagonist antibody product candidate, in patients with advanced solid tumors through multiple dose cohorts in the Phase 1a monotherapy dose escalation. Initial data readout from the Phase 1a portion of the trial is expected in the second half of 2022.
Continued to progress the Phase 1 portion of the PINNACLES trial of NGM120, an antagonist antibody product candidate that binds GFRAL and is designed to inhibit GDF15 signaling. The PINNACLES trial is evaluating NGM120 as a monotherapy in patients with advanced solid tumors and in combination with gemcitabine and Nab-paclitaxel in patients with metastatic pancreatic cancer. Additional clinical data from the Phase 1a and Phase 1b cohorts is expected in the second half of 2022.
Continued enrollment in the placebo-controlled Phase 2 portion of the PINNACLES trial, evaluating NGM120 in combination with gemcitabine and Nab-paclitaxel as a first-line treatment in patients with metastatic pancreatic cancer.
Retinal disease

Continued to advance the fully enrolled Phase 2 CATALINA trial of NGM621 in patients with GA. Topline data readout is expected in the fourth quarter of this year.
The FDA granted Fast Track designation to NGM621 for the treatment of patients with GA secondary to age-related macular degeneration in February 2022.
Liver and metabolic diseases

Completed enrollment in ALPINE 4, the Phase 2b trial of aldafermin in patients with compensated NASH cirrhosis (F4 NASH), in January 2022. Topline data readout is expected in the first half of 2023.
Updated the design of the ALPINE 4 trial, elevating the Enhanced Liver Fibrosis (ELF) test, a reproducible, quantitative non-invasive liver prognostic test that evaluates liver fibrosis and correlates to liver-related outcomes to be the primary endpoint for the trial. The ELF test is a composite blood test measuring the presence of three biomarkers associated with liver matrix metabolism. Liver biopsy data will also be measured and reported as a secondary endpoint upon completion of the trial.
Merck, known as MSD outside of the United States and Canada, continued to progress enrollment in a global Phase 2b trial of MK-3655 for the treatment of non-cirrhotic (F2/F3) NASH. MK-3655 is an agonistic antibody product candidate binding to fibroblast growth factor receptor 1c-beta-klotho that Merck licensed from NGM Bio.
Corporate Highlights

Entered into a clinical trial collaboration and supply agreement with Merck related to NGM Bio’s ongoing Phase 1/2 trial of NGM707 in combination with Merck’s KEYTRUDA (pembrolizumab) in December 2021.
Fourth Quarter and Full Year 2021 Financial Results

NGM Bio reported a net loss of $27.2 million and $120.3 million for the quarter and year ended December 31, 2021, respectively, compared to a net loss of $28.0 million and $102.5 million for the same periods in 2020.
Related party revenue from our collaboration with Merck was $21.0 million and $77.9 million for the quarter and year ended December 31, 2021, respectively, compared to $19.8 million and $87.4 million for the same periods in 2020. Related party revenue decreased $9.5 million in 2021 as compared to 2020 primarily due to the effects of amending and restating our collaboration agreement with Merck in June 2021.
Research and development (R&D) expenses were $38.7 million and $161.7 million for the quarter and year ended December 31, 2021, respectively, compared to $40.1 million and $164.0 million for the same periods in 2020. R&D expenses decreased $1.3 million in the quarter as compared to the prior year period primarily due to decreases in expenses for our manufacturing activities and our clinical trials of aldafermin. R&D expenses decreased $2.3 million in 2021 as compared to 2020 primarily due to decreases in expenses for our manufacturing activities and our clinical trials of aldafermin partially offset by increases in personnel-related expenses and external expenses driven by our ongoing clinical trials of NGM621, NGM120 and NGM707 and our preclinical studies of NGM438 and NGM831.
General and administrative expenses were $9.5 million and $36.9 million for the quarter and year ended December 31, 2021, respectively, compared to $7.4 million and $27.2 million for the same periods in 2020. The $9.6 million increase in general and administrative expenses in 2021 was primarily attributable to increases in compensation-related expenses driven by higher headcount and an increase in expenses associated with being a public company.
Cash, cash equivalents and short-term marketable securities were $366.3 million as of December 31, 2021, compared to $295.2 million as of December 31, 2020. NGM Bio believes its cash, cash equivalents and marketable securities will be sufficient to fund its planned operations into the first half of 2024.

On March 1, 2022 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported financial results and a corporate update for the year ended December 31, 2021 (Press release, Neoleukin Therapeutics, MAR 1, 2022, View Source [SID1234609277]).

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"We’ve made significant strides in 2021 that will drive our efforts in 2022, including the start of clinical development for NL-201, the generation of preclinical findings supporting NL-201’s activity in different indications and combinations, and highlighting new avenues for de novo protein design candidates and potential applications to expand our development pipeline," said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. "In 2022, we look forward to reporting interim data from our Phase 1 trial of NL-201, beginning a combination trial of NL-201 with pembrolizumab, initiating a Phase 1 trial of NL-201 in hematologic malignancies and continuing to pursue exciting avenues for additional de novo protein candidates."

NL-201 Clinical Development Update
NL-201 is a computationally designed de novo protein that is a mimetic of natural cytokines IL-2 and IL-15 designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without a bias toward cells expressing the IL-2 receptor alpha subunit (CD25). NL-201 is currently in a Phase 1 clinical trial for patients with relapsed and refractory solid tumors to assess safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity.
The open label Phase 1 trial of NL-201 is active at participating sites in the United States, Australia and Canada. Enrollment in the trial is progressing. Dose escalation is currently underway and will continue through 2022. Interim data is expected to be reported in the second half of 2022.

In January 2022, Neoleukin announced a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada). The agreement will allow for the evaluation of safety and efficacy of Neoleukin’s NL-201 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in an ongoing Phase 1 trial. Neoleukin will evaluate NL-201 plus pembrolizumab as part of the company’s ongoing Phase 1 trial in patients with advanced, relapsed or refractory solid tumors. Up to 132 patients will be enrolled in the combination arm of the study. The trial is assessing safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity.
In December 2021, Neoleukin announced the presentation of preclinical data on NL-201 in multiple myeloma at the 63RD American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. Additionally, a published abstract in Blood reported on NL-201 antitumor activity in preclinical studies of non-Hodgkin lymphoma. The preclinical multiple myeloma data, demonstrate the ability of NL-201 to prevent relapse in murine myeloma models following autologous stem cell transplant. Experimental results indicate that anti-myeloma activity is mediated by expansion of cytotoxic memory CD8 T cells and a decrease in T-regulatory CD4 cells in the bone marrow. Furthermore, NL-201 treated mice had an increase in bone marrow T-cells expressing granzyme B and a decrease in the T-cell exhaustion phenotype. Neoleukin believes that these findings support the further evaluation of NL-201 in hematologic malignancies.
In November 2021, Neoleukin announced the presentation of four abstracts highlighting new preclinical data on NL-201 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36TH Annual Meeting (SITC 2021). The presentation highlighted preclinical data on NL-201 alone and in several combination regimens. New data demonstrated that NL-201 can activate the tumor microenvironment and increase T-cell receptor diversity in preclinical models. Findings also indicated that local, intratumoral administration of NL-201 can control both the injected and distant tumors with improved tolerability compared to systemic administration in preclinical models.
Board of Directors Transition
Neoleukin reported the appointment of Rohan Palekar, Chief Executive Officer of 89bio, Inc. (NASDAQ:ETNB), to Neoleukin’s Board of Directors, and the departure of Lewis "Rusty" Williams, MD, PhD, from the board. Mr. Palekar’s career in the biopharmaceuticals industry spans more than 30 years, and he brings extensive strategic and operational experience spanning commercial and research and development functions.
Mr. Palekar has served as the CEO of 89bio since June 2018. Prior to that, Mr. Palekar served as President and CEO of Avanir Pharmaceuticals after a series of leadership roles in commercial and operations. Prior to Avanir, Mr. Palekar served as the Chief Commercial Officer of Medivation. Earlier in his career, Mr. Palekar spent 16 years at Johnson & Johnson in various senior commercial and strategic management roles including worldwide VP of Immunology. Mr. Palekar holds an MBA from the Amos Tuck School of Business Administration at Dartmouth College, a Chartered Accountant certification, and degrees in law and accounting from the University of Bombay.

Other Discovery Stage Efforts
In November 2021, Neoleukin delivered an oral presentation at the American College of Rheumatology Annual highlighting development of a potent and hyperstable computationally designed protein, Neo-5171, that blocks signaling by endogenous IL-2 and IL-15 with potential applications in inflammatory and autoimmune disorders. Neo-5171 is currently in the discovery development stage.
In addition to Neo-5171, Neoleukin’s discovery stage pipeline includes a Treg agonist targeting autoimmune and inflammatory conditions and a next- generation IL-2 / IL-15 agonist for oncology indications.
Summary of Financial Results
Cash Position: Cash and cash equivalents totaled $142.5 million as of December 31, 2021, compared to $192.6 million as of December 31, 2020.
Based upon current internal infrastructure and pipeline initiatives, Neoleukin believes it has sufficient cash to fund operations into the second half of 2023.
R&D Expenses: Research and development expenses for the year ended 2021 increased to $39.2 million from $24.3 million for the year ended 2020. The increase was primarily due to increased expenses incurred from clinical trial activities related to Neoleukin’s lead product candidate, NL-201, personnel-related costs, and in connection with the advancement of other Neoleukin technologies. The increase was also due to facility-related costs associated with the build-out of Neoleukin’s new headquarters and laboratory in Seattle, Washington.
G&A Expenses: General and administrative expenses for the year ended 2021 increased to $21.5 million from $17.2 million for the year ended 2020. The increase was primarily due to increases in personnel-related costs.
Gain on Sale of Aquinox Canada: The gain in the year ended 2020 relates to the sale of Aquinox Canada, a wholly owned subsidiary of Neoleukin. The gain of $7.8 million recognized was the total consideration of $8.2 million, less transaction costs of $0.4 million.
Net Loss: Net loss for the year ended 2021 was $60.7 million compared to a net loss of $33.3 million for the year ended 2020.
Conference Call Information
Neoleukin will host a conference call today to discuss 2021 financial results and provide a corporate update. Details as follows:
Webcast URL: View Source
The archived audio webcast will be available on the Investor Relations section of the Neoleukin website approximately two hours after the event and will be available for replay for at least 30 days after the event.

About NL-201
NL-201 is a de novo agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit (CD25). Previously presented preclinical data has demonstrated the ability of NL-201 to stimulate and expand CD8+ and NK cells at low doses with minimal impact on immunosuppressive regulatory T cells. Furthermore, NL-201 has demonstrated both monotherapy and combination activity across a wide range of preclinical syngeneic tumor models.

On March 1, 2022 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing novel targeted therapies for RAS-addicted cancers, reported that the company will participate in the Cowen 42nd Annual Health Care Conference(Press release, Revolution Medicines, MAR 1, 2022, View Source [SID1234609276]). Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines, will be the featured participant in a fireside chat at the event .

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Details of the company’s participation are as follows:

Cowen 42nd Annual Health Care Conference
Conference Date: March 7-9, 2022
Fireside Chat Time/Date: 11:10 a.m. Pacific on Monday, March 7, 2022
Format: Virtual conference; webcast available
To access the live webcast of the fireside chat, please visit the "Events & Presentations" page of Revolution Medicines’ website at View Source Additionally, a replay of the webcast will be available on the "Events & Presentations" page of the Revolution Medicines website for at least 14 days following the conference.