On May 10, 2021 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported financial results for the first quarter ended March 31, 2021 (Press release, NanoString Technologies, MAY 10, 2021, View Source [SID1234579581]).

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First Quarter Financial Highlights

Product and service revenue of $31.4 million, 28% year-over-year growth
Instrument revenue of $11.7 million, 19% year-over-year growth. Instrument revenue includes $7.0 million of GeoMx Digital Spatial Profiler (DSP) instrument revenue
Consumables revenue of $16.0 million, 39% year-over-year growth. Consumables revenue includes $2.7 million GeoMx DSP consumables revenue
Service revenue of $3.7 million, 17% year-over-year growth
Cash, cash equivalents and short-term investments balance of $409.9 million
"Spatial Biology is in a period of tremendous growth, revolutionizing research in fields from oncology to COVID-19. During Q1, NanoString extended its lead in this exciting market, with strong demand for our GeoMx DSP, a record number of new peer-reviewed publications, and growing excitement generated by our Spatial Molecular Imager," said Brad Gray, president and CEO of NanoString. "The launch of our GeoMx Whole Transcriptome Atlas is off to a great start, and is now driving more than 60% of new projects in our GeoMx Technology Access Program. Meanwhile, our nCounter business showed continued durability, with steady demand for new instruments continuing more than a decade after the platform’s introduction."

GeoMx DSP

GeoMx Installed Base: Grew installed base to approximately 160 GeoMx DSP Systems at March 31, 2021, as compared to approximately 55 at March 31, 2020
GeoMx Whole Transcriptome Atlas: Began commercial shipments of the GeoMx Whole Transcriptome Atlas in the first quarter
GeoMx Technology Access Program (TAP): Generated approximately 95 new GeoMx TAP orders in the first quarter, of which over 60% utilized the GeoMx Whole Transcriptome Atlas
GeoMx Publications: Increased cumulative peer-reviewed publications to 47 as of March 31, 2021, with a record 12 new publications during the quarter
2021 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Conference: Highlighted an emerging body of spatial biology research that included eight abstracts that utilized GeoMx DSP, four of which were presented by investigators from the GeoMx Breast Cancer Consortium
Illumina Accelerator and Doloromics GeoMx Collaboration: Announced a collaboration with Illumina Accelerator and Doloromics that will leverage high-resolution spatial profiling for the development of a new generation of pain therapeutics
nCounter

nCounter Installed Base: Grew installed base to approximately 995 nCounter Analysis Systems at March 31, 2021, as compared to approximately 865 systems at March 31, 2020
nCounter Publications: Surpassed 4,300 cumulative peer-reviewed publications utilizing nCounter technology at March 31, 2021
2021 AACR (Free AACR Whitepaper) Conference: Highlighted the use of the nCounter Analysis System in approximately 45 scientific abstracts
Corporate

Appointment of New Board Members: Expanded the Board of Directors with the appointments of Dana Rollison, Ph.D., and Janet George. Dr. Rollison is vice president, chief data officer and associate center director of Data Science for the Moffit Cancer Center. Ms. George is group vice president of Autonomous Enterprise, Advanced Analytics with Machine Learning, and Artificial Intelligence for Oracle
First Quarter Financial Results

We have elected to present selected non-GAAP, or adjusted, financial measures, including Adjusted EBITDA. These adjusted financial measures are calculated excluding certain items that may make it more challenging to compare our GAAP operating results across periods. Such items may include collaboration revenue, stock-based compensation, depreciation and amortization, or one-time charges such as transaction related fees and expenses or restructuring charges and severance costs. A reconciliation of adjusted financial measures to the nearest comparable GAAP financial measure can be found in the notes and table at the end of this press release.

Supplemental Information

As a supplement to the table above, we have posted to the investor relations section of our website, at www.nanostring.com, supplemental financial data that includes our adjusted financial measures as compared to the nearest comparable GAAP financial measures, for the first quarter of 2021 and for each quarter of and the full year of 2020.

Conference Call

Management will host a conference call today beginning at 1:30 pm PT / 4:30 pm ET to discuss these results and answer questions. Investors and other interested parties can register for the call in advance by visiting View Source After registering, an email confirmation will be sent, including dial-in details and unique conference call codes for entry. Registration is open throughout the call, but to ensure connection for the full call, registration in advance is recommended. The link to the webcast and audio replay will be made available at the Investor Relations website: www.nanostring.com. A replay of the call will be available beginning May 10, 2021 at 7:30pm ET through midnight ET on May 17, 2021. To access the replay, dial (800) 585-8367 or (416) 621-4642 and reference Conference ID: 9493413. The webcast will also be available on our website for one year following the completion of the call.

Non-GAAP, or Adjusted, Financial Information

We believe that the presentation of non-GAAP, or adjusted, financial information provides important supplemental information to management and investors regarding financial and business trends relating to our financial condition and results of operations. Reconciliation of adjusted financial measures to the most directly comparable financial result as determined in accordance with GAAP are included at the end of this press release following the accompanying financial data. A reconciliation of adjusted guidance measures to corresponding GAAP measures is not available on a forward-looking basis without unreasonable effort due to the uncertainty regarding certain expenses that may be incurred in the future. For further information regarding why we believe that these adjusted measures provide useful information to investors, the specific manner in which management uses these measures, and some of the limitations associated with the use of these measures, please refer to "Notes Regarding Non-GAAP Financial Information" at the end of this press release.

On May 10, 2021 Veracyte, Inc. (Nasdaq: VCYT), a global genomic diagnostics company, reported its executive leadership succession plan, with industry veteran Marc Stapley to succeed Veracyte cofounder, Bonnie Anderson, as chief executive officer (Press release, Veracyte, MAY 10, 2021, View Source [SID1234579579]). Ms. Anderson will move into an active executive chairman role, serving as a trusted advisor to Mr. Stapley, for the next few years to ensure a smooth transition, and will continue to serve on the board. Mr. Stapley will also join Veracyte’s board. The CEO succession is effective June 1, 2021, with Mr. Stapley joining the board after Veracyte’s 2021 Annual Meeting of Stockholders on June 7, 2021.

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"Since Veracyte’s beginning, we have set out on an ambitious vision to become a global genomic diagnostics enterprise that leverages deep insights to transform care at every step of the patient’s journey, from early detection of cancer and other diseases, to diagnosis and treatment decisions," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "Today, the pieces are in place to execute and further build upon that vision. Our broad menu of current and pipeline tests span the care continuum across a wide range of diseases. Further, with exclusive access to our best-in-class diagnostics platform, we are uniquely poised to bring our highly differentiated and clinically impactful tests to benefit patients globally.

"Now is the perfect time to implement Veracyte’s CEO succession plan," continued Ms. Anderson. "We are thrilled that Marc has agreed to join Veracyte as CEO and I am excited to work closely with him to achieve our vision and guide the company to achieve its full potential."

Ms. Anderson cofounded Veracyte in 2008 and served as the company’s president and CEO until 2016, when she was also appointed chairman of the board. She led Veracyte’s initial public offering in 2013, has spearheaded commercialization of its market-leading products and has overseen the company’s global expansion.

"Veracyte is uniquely positioned in the genomic testing market with its breadth and depth of offerings, centralized and distributed tests, significant global opportunity and highly talented team," said Mr. Stapley. "Bonnie and the Veracyte team have put in place the key strategic pieces upon which to build and execute on multiple avenues of growth. I look forward to bringing my industry experience to bear as we forge ahead with our global expansion plans and improve outcomes for patients worldwide."

Mr. Stapley will join Veracyte from his current role as the chairman and chief executive officer of Helix, Inc., a leading population genomics company. Under Mr. Stapley’s leadership, Helix has built one of the largest COVID-19 testing labs in the United States and has become a national leader in viral surveillance. Mr. Stapley was appointed CEO in April 2019 and has been a member of Helix’s board of directors since 2015, when the company was founded.

Prior to Helix, Mr. Stapley served in key executive leadership positions at Illumina, Inc., the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. While at Illumina, Mr. Stapley served as chief financial officer, chief administrative officer, and executive vice president over the course of seven years, where he led many functions including G&A, corporate strategy, business development, population genomics and government affairs.

Before joining Illumina, Mr. Stapley was senior vice president, finance at Pfizer Inc. and was responsible for global financial processes and systems, leading integration efforts for key acquisitions and providing oversight to the company’s largest technology investment program. Prior to that he served in a variety of senior finance roles at Alcatel-Lucent, Cadence Design Systems, Inc, and Coopers & Lybrand.

John Bishop, Veracyte’s lead independent director and former chairman and CEO of Cepheid, said, "On behalf of the entire board of directors at Veracyte, we welcome Marc to the company in the CEO role. His broad global leadership experience, proven track record of strategic execution and strong commercial expertise makes him well suited to lead the company forward, with Bonnie at his side. There is a lot of work ahead of us and we are delighted to have Marc’s leadership as we enter this next phase of Veracyte’s growth."

Conference Call and Webcast Details

In a separate press release issued today, Veracyte announced its financial results for the first quarter ended March 31, 2021.

The company will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss its first quarter 2021 financial results, as well as the succession plan. The conference call will be webcast live from the company’s website and will be available via the following link: View Source A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

On May 10, 2021 Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company reported first quarter 2021 results and provides a general business update on May 10, 2021 (Press release, Tocagen, MAY 10, 2021, View Source [SID1234579578]).

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"Forte has continued to make excellent progress in the fist quarter of 2021. As we have previously highlighted, our randomized clinical trial of FB-401 in atopic dermatitis patients 2 years of age and older, including adolescents and adults, completed enrollment. We expect to report the topline results from that trial in the third quarter of 2021. There is a significant unmet need for safe effective therapies, particularly for children suffering from atopic dermatitis and we are hopeful that FB-401 will address that need," said Paul Wagner, Ph.D., CEO of Forte Biosciences. "In addition to the operational progress, two more patents have now issued, bringing the total number of patents covering FB-401 and our process to eleven as we continue to expand the intellectual property protection."

First Quarter 2021 Results

First Quarter 2021 Business Highlights

In September 2020, Forte initiated a multi-center, placebo-controlled clinical trial of its lead product candidate, FB-401 which was expected to enroll approximately 124 pediatric, adolescent and adult atopic dermatitis subjects aged 2 years of age and older. Enrollment was completed in March 2021 with 154 subjects. Additional information about our Phase 2 trial can be found at ClinicalTrials.gov using the identifier NCT04504279.

Forte ended the first quarter of 2021 with approximately $54.8 million in cash and cash equivalents which Forte believes is sufficient to fund operations for at least the next 12 months. Cash utilization for the first quarter of 2021 was $4.0 million. Forte had approximately 13.5 million shares of common stock outstanding as of March 31, 2021.

First Quarter 2021 Operating Results

Research and development expenses were $3.3 million and $1.4 million for the three months ended March 31, 2021 and 2020, respectively. The increases in 2021 were primarily due to manufacturing, clinical, regulatory and other expenses, including non-cash stock-based compensation, as Forte continues to advance FB-401 through Phase 2 clinical trials.

General and administrative expenses were $1.4 million and $0.7 million for the three months ended March 31, 2021 and 2020, respectively. The increases in 2021 were primarily due to legal, professional, insurance and other expenses as a result of being a public company as well as increases in payroll and related expenses including non-cash stock-based compensation expense as we increased our headcount.

Losses per share were $0.36 and $0.97 for the three months ended March 31, 2021 and 2020, respectively.

Additional detail on our financial results for the first quarter of 2021 can be found in Forte’s Form 10-Q as filed with the SEC on May 10, 2021. You can also find more information in the investor relations section of our website at www.fortebiorx.com.

Conference Call and Webcast Information

Forte management will host a conference call and webcast on Wednesday, May 10th at 4.30 PM Eastern Time. Participants may access the call by dialing 877-705-6003 (Domestic) or 201-493-6725 (International). The conference ID number is: 13719507.

On May 10, 2021 Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases and cancers) and central nervous system disorders, reported recent highlights and developments as well as financial results for the first quarter ended March 31, 2021, which include (Press release, Omeros, MAY 10, 2021, View Source [SID1234579577]):

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OMIDRIA revenues for the first quarter of 2021 were $21.1 million compared to $10.6 million in the fourth quarter of 2020. The increase over the prior quarter reflects limited fourth-quarter sales due to delayed confirmation (issued in December) by the Centers for Medicare and Medicaid Services (CMS) that OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3% receives separate payment when used in the ambulatory surgery center (ASC) setting.
Net loss in the first quarter of 2021 was $35.1 million, or $0.57 per share, including non-cash expenses of $4.1 million, or $0.07 per share. This compares to a net loss of $37.3 million, or $0.60 per share, which included non-cash expenses of $3.5 million, or $0.07 per share, for the previous quarter.
At March 31, 2021, Omeros had cash, cash equivalents and short-term investments available for operations of $100.5 million.
Dosing of patients with narsoplimab in the I-SPY COVID-19 platform trial began in March 2021. The platform trial, sponsored by Quantum Leap Healthcare Collaborative and partly funded by BARDA, is enrolling patients nationwide to evaluate potential therapies for the treatment of critically ill COVID-19 patients.
Omeros’ Biologics License Application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangipathy (HSCT-TMA or TA-TMA) is under priority review by the U.S. FDA with an action date of July 17, 2021 under the Prescription Drug User Fee Act (PDUFA).
In late April, the Centers for Disease Control and Prevention (CDC) and CMS approved a new ICD-10 diagnosis code for TA-TMA, creating a disease-specific code by which facilities will bill for services, and two new ICD-10 procedural codes that allow physicians to bill for the administration of narsoplimab.
"2021 is off to a strong start as we make great progress toward the anticipated launch of narsoplimab for TA-TMA while building momentum with our ophthalmic drug OMIDRIA following CMS’ confirmation of separate payment for OMIDRIA in the ASC setting," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "Narsoplimab dosing is well underway in the I-SPY COVID-19 platform trial, and the need for a therapeutic to treat critically ill COVID-19 patients is receiving increased focus from both U.S. and international agencies. Looking further across our franchise of complement inhibitors, two other narsoplimab Phase 3 programs are running in IgA nephropathy and aHUS, we expect initial data readout next month from the Phase 1 trial of our MASP-3 inhibitor OMS906, and our subcutaneously delivered long-acting MASP-2 inhibitor OMS1029 is slated to enter the clinic in the first half of next year. Our preclinical programs are also progressing, led by our efforts to deliver a GPR174 inhibitor to the clinic as quickly as possible. With the PDUFA date for narsoplimab in TA-TMA rapidly approaching, we remain committed to bringing a long line of important, first-in-class drugs to market."

First Quarter and Recent Developments

Recent developments regarding OMIDRIA include the following:
Omeros continued to add new ASC customers in the first quarter of 2021, including seven large ASC chains and private equity groups. The total number of purchasing ASCs increased by 43% in the first quarter over the previous quarter.
A manuscript on pain control and reduction of opioid use intraoperatively with the use of OMIDRIA during cataract surgery has been submitted for publication. Another manuscript on the perioperative use of opioids in cataract surgery pain management and the role of non-opioid alternatives like OMIDRIA has also been submitted for publication.
The Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act has been re-introduced in the Senate. The NOPAIN Act would extend separate payment for non-opioid alternatives like OMIDRIA in both ASCs and hospital outpatient departments on a renewable five-year basis. Currently, OMIDRIA is separately paid in the ASC setting.
Recent developments regarding narsoplimab, Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) in advanced clinical programs for the treatment of TA-TMA, immunoglobulin A (IgA) nephropathy, atypical hemolytic uremic syndrome (aHUS) and critically ill COVID-19 patients, include the following:
Data from the pivotal trial of narsoplimab in TA-TMA was featured in a podium presentation at the annual European Society for Blood and Marrow Transplantation (EBMT) meeting in March.
An abstract on narsoplimab treatment in adults with high-risk TA-TMA has also been accepted for oral presentation at the 2021 Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in June.
Discussions with the U.S. and foreign governments regarding funding and manufacturing support for narsoplimab are ongoing.
Updates regarding Omeros’ other development programs and platforms include the following:
Omeros has completed all of the intravenous cohorts and the first subcutaneous dosing cohort in the single-ascending-dose study in its Phase 1 clinical trial evaluating OMS906, the company’s inhibitor of MASP-3, the key activator of the alternative pathway of complement. Initial data from the placebo-controlled, double-blind, single-ascending-dose and multiple-ascending-dose trial are expected later this quarter.
A paper detailing the mechanism of action of PDE7 inhibition in nicotine addiction will soon be published in the peer-reviewed Journal of Neuroscience. Omeros has completed a successful Phase 1 trial with OMS527, its PDE7 inhibitor.
Financial Results

For the first quarter of 2021, OMIDRIA revenues were $21.1 million compared to $10.6 million for the fourth quarter of 2020. The uncertainty around OMIDRIA’s reimbursement status affected revenues in the fourth quarter and extending into early February 2021.

Total costs and expenses for the first quarter of 2021 were $51.7 million compared to $47.2 million for the first quarter of 2020. The increase was primarily due to research and development expenses related to narsoplimab manufacturing. Until approval for narsoplimab in TA-TMA is certain, manufacturing costs for narsoplimab are expensed as incurred instead of included as inventory.

For the three months ended March 31, 2021, Omeros reported a net loss of $35.1 million, or $0.57 per share, which included non-cash expenses of $4.1 million, or $0.07 per share. This compares to a net loss in the previous quarter of $37.3 million, or $0.60 per share, which included non-cash expenses of $3.5 million, or $0.07 per share.

As of March 31, 2021, the company had $100.5 million of cash, cash equivalents and short-term investments. The company also has a line of credit, which permits borrowing up to the lesser of 85 percent of eligible accounts receivable less certain reserves and $50.0 million.

On March 1, 2021, the company entered into an "at the market" sales agreement which allows the company to sell, from time to time, up to $150.0 million of its common stock.

Conference Call Details

Omeros’ management will host a conference call to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time. To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 6999269. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 6999269.

To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at View Source

On May 10, 2021 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage precision oncology company focused on developing targeted drugs to inhibit frontier targets that drive and sustain RAS-addicted cancers, reported its financial results for the first quarter of 2021 and provided a corporate update (Press release, Revolution Medicines, MAY 10, 2021, View Source [SID1234579576]).

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"Revolution Medicines has made excellent progress reinforcing our belief that the company’s cohesive portfolio of innovative clinical and preclinical assets will power compelling rational, mechanism-based combination treatments that provide benefit to patients with RAS-addicted cancers," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines.

"We presented data at the AACR (Free AACR Whitepaper) Annual Meeting 2021 demonstrating the attractive preclinical profiles of two pioneering RAS(ON) inhibitor candidates that are currently undergoing IND-enabling development, RMC-6291 (KRASG12C) and RMC-6236 (RASMULTI). These first examples of RAS(ON) inhibitors intended for human use exhibit differentiated breadth, depth and durability of anti-tumor effects in human cancer models. Further, an important recent scientific paper described multiple genetic mutations causing clinical resistance to leading KRASG12C(OFF) inhibitors but with preserved sensitivity to RAS(ON) inhibitors from our collection. We believe that RMC-6291, RMC-6236 and additional emerging inhibitors in our portfolio hold great promise for use in treating, and overcoming resistance in, patients with a diverse range of RAS-addicted cancers lacking adequate targeted therapeutics.

"The company also continues broad-based initiatives with our RAS Companion Inhibitor portfolio. For RMC-4630 (SHP2), combination approaches with multiple direct RAS inhibitors remain a high-priority treatment strategy supported by the clinical and preclinical anti-tumor activity, resistance and safety data observed to date across these classes of targeted agents. Amgen’s CodeBreaK 101c study evaluating the combination with sotorasib has demonstrated acceptable tolerability, has cleared early dose levels and is currently dosing patients at the target dose of RMC-4630 (200 mg on a Day 1/Day 2 weekly schedule). We also continue evaluating a second, distinct group of treatment strategies for RMC-4630 in combination with established drugs that potently suppress the RAS signaling pathway, including cobimetinib, a MEK inhibitor and osimertinib, an EGFR inhibitor, to determine whether enhanced pathway inhibition from these drug combinations delivers sufficient anti-tumor activity and tolerability to confer clinical benefit.

"We are also pleased to have begun clinical evaluation of RMC-5552 (mTORC1/4EBP1) in a monotherapy dose-escalation study. In aggregate, these projects with our RAS Companion Inhibitor portfolio, including continued IND-enabling development of RMC-5845 (SOS1), support our long-term goal of combining these assets with RAS(ON) Inhibitors on behalf of patients selected by molecular tumor features.

"To support the expanded and advancing pipeline, Revolution Medicines successfully completed a financing in the first quarter that helped position the company with a strong balance sheet."

R&D Highlights

RAS(ON) Inhibitors – Revolution Medicines continues maturing its first-in-class RAS(ON) Inhibitor platform, including an expansive collection of tri-complex inhibitors targeting diverse oncogenic RAS variants through highly differentiated chemical and pharmacologic profiles.

Potential advantages of RAS(ON) Inhibitors – A recent paper in Cancer Discovery by Dr. Ryan Corcoran’s team at the Massachusetts General Hospital/Harvard Medical School identified multiple resistance mutations that bypass the effects of three first-generation KRASG12C(OFF) inhibitors. Importantly, the researchers found that a KRASG12C-selective RAS(ON) tool compound from the Revolution Medicines portfolio, RM-018, retained potent binding and inhibitory activity against tumor cells harboring an on-target mutation that conferred resistance to all three KRASG12C(OFF) inhibitors tested.

RMC-6291 (KRASG12C)

RMC-6291 is a first-in-class, potent, oral and selective tri-complex inhibitor of KRASG12C(ON) and NRASG12C(ON) with an attractive and differentiated preclinical profile designed to address persistent unmet needs for patients with cancers caused by KRASG12C or NRASG12C.
Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 showed superior anti-tumor activity for RMC-6291 in preclinical lung and colorectal cancer models driven by a KRASG12C mutation.
The company remains on track to submit an investigational new drug (IND) application in the first half of 2022.

RMC-6236 (RASMULTI)

RMC-6236 is a first-in-class, potent, oral RAS-selective tri-complex, RASMULTI(ON) inhibitor with an attractive preclinical profile and is designed to treat cancers caused by multiple RAS variants for which no targeted treatment is currently available.
Data presented at the recent AACR (Free AACR Whitepaper) meeting demonstrated deep anti-tumor activity of RMC-6236 in preclinical lung, colorectal and pancreatic cancer models driven by various mutations that are common drivers of human cancers, including KRASG12V and KRASG12D.
The company remains on track to submit an IND 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 remains on track 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, both as monotherapy and in several current and planned combinations.
RMC-4630 and KRASG12C inhibitor sotorasib

To date, the available data from the ongoing Amgen-sponsored CodeBreaK 101c study of the RMC-4630 and sotorasib combination has demonstrated acceptable tolerability and cleared early dose levels.
The CodeBreaK 101c study is currently dosing patients at the target dose of RMC-4630 (200 mg on a Day 1 / Day 2 weekly schedule, the full dose used by the company in monotherapy) in combination with sotorasib. The company looks forward to selection of a combination dose for this study in the second half of 2021.
RMC-4630 and AstraZeneca KRASG12C inhibitor

AstraZeneca plans to evaluate RMC-4630 in combination with an emerging asset targeting KRASG12C(OFF) from AstraZeneca’s portfolio
RMC-4630 and MEK inhibitor cobimetinib (Cotellic)

Phase 1b/2 study of this combination is ongoing, including in expansion cohorts of patients with KRASMUTANT colorectal cancer at the recommended Phase 2 dose and schedule (RP2DS) for this combination. The company continues to expect preliminary safety and clinical activity data from this expansion study in 2022.
RMC-4630 and EGFR inhibitor osimertinib (Tagrisso)

Dosing and enrollment continue in the Phase 1b study of this combination and the company continues to expect initial tolerability and pharmacokinetic (PK) data in the second half of 2021.
RMC-4630 and PD-1 inhibitor pembrolizumab (Keytruda)

Sanofi-sponsored Phase 1 study of this combination continues. The RP2DS for this combination is expected in the first half of 2021 and expansion cohorts evaluating this combination in patients with non-small cell lung cancer (NSCLC) are planned.
RMC-4630 monotherapy

Presented dose escalation activity data set from the ongoing Phase 1 study at the recent AACR (Free AACR Whitepaper) meeting, showing anti-tumor activity and safety and tolerability that is consistent with on-pathway inhibition, delivering on a corporate milestone.
Data presented at AACR (Free AACR Whitepaper) meeting showed reduction of variant allele frequency in circulating tumor DNA (ctDNA) samples from patients treated with RMC-4630 for cancers carrying KRASG12C or NF1LOF, further validating the expected clinical mechanism of action of RMC-4630.
RMC-5552 (mTORC1/4EBP1 Inhibitor) – RMC-5552 is a potent, selective bi-steric inhibitor of mTORC1 that suppresses phosphorylation and inactivation of 4EBP1.

Dosing and enrollment are underway in the recently initiated Phase 1 monotherapy dose-escalation study, delivering on a corporate milestone. The company continues to expect initial safety, PK and single agent activity data in 2022.
Preclinical data presented at the recent AACR (Free AACR Whitepaper) meeting demonstrated that bi-steric mTORC1-selective inhibitors drive significant anti-tumor activity as monotherapy and in combination with KRASG12C inhibitors in genetically-defined preclinical models of human cancers.
The company intends to evaluate RMC-5552 in combination with RAS inhibitors for the treatment of tumors driven by co-occurring RAS mutations and genomic activation of the mTORC1 pathway.

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 remains on track to submit an IND in the second half of 2021 to enable an initial monotherapy dose escalation study and intends to evaluate RMC-5845 for treatment of certain genetically defined RAS-dependent cancers.
Corporate Highlights

Completed upsized financing to strengthen balance sheet and support advancement of expanding pipeline – Public offering of common stock in February 2021 raised net proceeds of $281 million, enabling the company to advance its pipeline, including RAS(ON) Inhibitors RMC-6291 and RMC-6236, through early Phase 1 signal-seeking clinical studies.

Flavia Borellini, Ph.D. joins existing board members Elizabeth McKee Anderson and Neil Exter as Class I director nominee – 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.
First Quarter 2021 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities were $681.6 million as of March 31, 2021, compared to $440.7 million as of December 31, 2020. The increase was primarily due to proceeds from the company’s equity public offering in February 2021.

Revenue: Total revenue, consisting of revenue from the company’s collaboration agreement with Sanofi, was $10.1 million for the quarter ended March 31, 2021, compared to $11.5 million for the quarter ended March 31, 2020. The decrease was due to lower reimbursed research and development services for RMC-4630 resulting from lower manufacturing costs.

R&D Expenses: Research and development expenses were $40.9 million for the quarter ended March 31, 2021, compared to $27.5 million for the quarter ended March 31, 2020. 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.

G&A Expenses: General and administrative expenses were $6.7 million for the quarter ended March 31, 2021, compared to $5.2 million for the quarter ended March 31, 2020. The increase was primarily due to an increase in personnel-related expenses related to additional headcount, and an increase in stock-based compensation.

Net Loss: Net loss was $37.2 million for the quarter ended March 31, 2021, compared to net loss of $19.5 million for the quarter ended March 31, 2020.

2021 Financial Guidance

Revolution Medicines continues to expect 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.