On August 10, 2020 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial and operating results for the second quarter ended June 30, 2020 and provided a business update (Press release, Radius, AUG 10, 2020, View Source [SID1234563283]).

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"Completing the elacestrant transaction was an important step forward for the company, centering our clinical and regulatory strategy while strengthening ourselves from a financial perspective," said Kelly Martin, CEO of Radius Health. Martin commented further that "in the near-term, our focus will include completing our Phase 3 pivotal trial enrollments while adjusting our commercial and marketing efforts to focus on high-risk osteoporosis patients."

Business Update

Commercial

Second quarter 2020 U.S. net sales of TYMLOS were $50.1 million, a 22% increase over the second quarter of 2019.

Business Development

In July, Radius entered into an exclusive global license agreement for development and commercialization of elacestrant with Menarini Group. Under the agreement, Menarini Group will be responsible for worldwide commercialization of elacestrant, after the completion of EMERALD Phase 3 study and, assuming positive results, successful registration of elacestrant.

Radius will continue to be responsible for the conduct and completion of the Phase 3 EMERALD study through NDA filing. The Company expects over $100 million of expenses associated with this activity will be reimbursed by Menarini.

As part of the agreement, Radius received an upfront payment of $30 million, and is eligible to receive up to $20 million on the achievement of certain development and regulatory milestones and up to $300 million on the achievement of certain sales milestones. Menarini Group will make tiered, low to mid-teen percentage royalty payments to Radius Health on global net sales.

Clinical Development Update

Abaloparatide-patch

The wearABLe Phase 3 study with abaloparatide-patch in postmenopausal osteoporosis continues to advance its enrollment globally. Completion of enrollment remains on track for the later part of third quarter of 2020.

Abaloparatide-SC

The ATOM Phase 3 Study, which is assessing the efficacy and safety of abaloparatide-SC in men with osteoporosis, is expected to complete recruitment this week with the enrollment of one more patient.

Teijin Pharma Limited, Radius’ partner for abaloparatide-SC in Japan, submitted a New Drug Application for abaloparatide-SC in Japan for the treatment of osteoporosis in patients who are at high risk for fractures, based on the positive results of their Phase III study. The study achieved its efficacy endpoint and showed an acceptable safety profile. Detailed results of this trial are planned to be presented at a global medical conference in the second half of this year.

Elacestrant

The EMERALD Phase 3 study is on schedule to complete target recruitment in the fourth quarter of 2020.

Second Quarter 2020 Financial Results

Three Months Ended June 30, 2020

For the three months ended June 30, 2020, Radius reported a net loss of $43.9 million, or $0.95 per share, compared to a net loss of $35.5 million, or $0.77 per share, for the three months ended June 30, 2019.

For the three months ended June 30, 2020, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, depreciation, non-cash interest obligations under debt obligations, impairment of operating lease right of use assets, and amortization of intangible assets, was $31.2 million, or $0.67 per share, compared to non-GAAP adjusted net loss of $25.4 million, or $0.55 per share, for the three months ended June 30, 2019.

For the three months ended June 30, 2020, TYMLOS net product revenues were $50.1 million compared to approximately $41.0 million for the three months ended June 30, 2019.

For the three months ended June 30, 2020, research and development expense was $44.9 million compared to $27.2 million for the three months ended June 30, 2019, an increase of $17.7 million, or 65%. This increase was primarily driven by a $13.9 million increase in abaloparatide-patch program costs, a $5.2 million increase in elacestrant program costs, a $0.2 million increase in abaloparatide-SC program costs, and a $0.2 million increase in compensation expenses. These increases were offset by a decrease of $0.8 million in RAD140 program cost, a $0.4 million decrease in occupancy and depreciation, a $0.4 million decrease in travel and entertainment expense, a $0.1 million decrease in professional fees, and a $0.1 million decrease in other operating costs.

For the three months ended June 30, 2020, selling, general and administrative expense was $38.2 million compared to $40.1 million for the three months ended June 30, 2019, a decrease of $1.9 million, or 5%. This decrease was primarily the result of a $2.0 million decrease in travel and entertainment expenses, a $1.1 million decrease in professional support costs, a $0.3 million decrease in occupancy and depreciation costs, and a $0.3 million decrease in other operating costs. These decreases were partially offset by a $1.8 million increase in compensation costs.

Six Months Ended June 30, 2020

For the six months ended June 30, 2020, Radius reported a net loss of $81.5 million, or $1.76 per share, compared to a net loss of $78.2 million, or $1.70 per share, for the six months ended June 30, 2019.

For the six months ended June 30, 2020, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, depreciation, non-cash interest obligations under debt obligations, impairment of operating lease right of use assets, and amortization of intangible assets, was $58.6 million, or $1.26 per share, compared to non-GAAP adjusted net loss of $57.2 million, or $1.25 per share, for the six months ended June 30, 2019.

For the six months ended June 30, 2020, TYMLOS net product revenues were $98.0 million compared to approximately $70.9 million for the six months ended June 30, 2019.

For the six months ended June 30, 2020, research and development expense was $83.9 million compared to $50.4 million for the six months ended June 30, 2019, an increase of $33.5 million, or 66%. This increase was primarily driven by a $25.0 million increase in abaloparatide-patch project costs, a $8.7 million increase in project costs for elacestrant, a $0.6 million increase in abaloparatide-SC project costs, a $0.8 million increase in professional fees services, and a $0.4 million increase in compensation expenses. These increases were partially offset by a $1.0 million decrease in RAD140 project costs, a $0.3 million decrease in occupancy and depreciation costs, and a $0.7 million decrease in travel and entertainment expenses.

For the six months ended June 30, 2020, selling, general and administrative expense was $74.7 million compared to $81.3 million for the six months ended June 30, 2019, a decrease of $6.6 million, or 8%. This decrease was primarily the result of a $4.0 million decrease in professional fees, a $2.5 million decrease in travel and entertainment expenses, a $0.8 million decrease in occupancy and depreciation costs and a $0.2 million decrease in other operating expense. These decreases were offset by a $0.8 million increase in compensation related expenses.

As of June 30, 2020, Radius had $126.3 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of June 30, 2020, we believe that, prior to the consideration of potential proceeds from partnering and/or collaboration activities, we have sufficient capital to fund our development plans, U.S. commercial and other operational activities for at least twelve months from the date of this press release.

Webcast and Conference Call

In connection with today’s reporting of Second Quarter 2020 Financial Results, Radius will host a conference call and live audio webcast at 8:30 a.m. ET today, August 10, 2020, to review the commercial, research and development, and financial highlights and provide a Company update.

Conference Call Information:

Date: August 10, 2020

Time: 8:30 a.m. ET

Domestic Dial-in Number: (866) 323-7965

International Dial-in Number: (346) 406-0961

Conference ID: 6334188

Live webcast: View Source

A live audio webcast of the call can be accessed from the Investors section of the Company’s website, www.radiuspharm.com. The full text of the announcement and financial results will also be available on the Company’s website.

For those unable to participate in the conference call or webcast, a replay will be available on Thursday, August 10, 2020 at 11:30 a.m. ET and will be archived on the Company’s website for 90 days. To access the replay, dial (855) 859-2056 for U.S. or (404) 537-3406 for International, using conference ID number 6334188.

On August 10, 2020 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing AK002 for the treatment of eosinophil and mast cell-related diseases, reported financial results for the second quarter ended June 30, 2020 and provided an update of its ongoing development activities (Press release, Allakos, AUG 10, 2020, View Source [SID1234563282]).

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Business Updates

Patient enrollment was initiated in a randomized, double-blind, placebo-controlled Phase 3 study of AK002 in patients with eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD). Topline data are expected in the second half of 2021.

Patient enrollment was initiated in a randomized, double-blind, placebo-controlled Phase 2/3 study of AK002 in patients with eosinophilic esophagitis (EoE). Topline data are expected in the second half of 2021.

The Phase 1 safety, tolerability and pharmacokinetics study of the subcutaneous formulation of AK002 is fully enrolled. Results are expected in the second half of 2020.

The non-interventional study examining the prevalence of EG, EoD, and mast cell gastrointestinal disease (MGID) in patients with chronic functional gastrointestinal disease is fully enrolled. Results are expected in the second half of 2020.

Announced positive clinical safety and efficacy results from a six-month, open-label Phase 1 study of AK002 in patients with MGID in March 2020.

Announced positive interim safety and efficacy results from the open-label, long-term extension component of the ENIGMA study with AK002 in patients with EG and/or EoD. The results were accepted for oral presentation and presented virtually at the Digestive Disease Week (DDW) Annual Meeting in May 2020.

The nonproprietary (generic) name of AK002 was changed from antolimab to lirentelimab as a result of trademark issues identified outside of the United States. Lirentelimab has been adopted by the United States Adopted Names (USAN) Council and World Health Organization (WHO) International Nonproprietary Names (INN) Program.
Second Quarter 2020 Financial Results

Research and development expenses were $28.3 million in the second quarter of 2020 as compared to $14.1 million in the same period in 2019, an increase of $14.2 million.

General and administrative expenses were $12.1 million in the second quarter of 2020 as compared to $5.9 million in the same period in 2019, an increase of $6.2 million.

Allakos reported a net loss of $39.3 million in the second quarter of 2020 as compared to $19.1 million in the same period in 2019, an increase of $20.2 million. Net loss per basic and diluted share was $0.80 for the second quarter of 2020 compared to $0.44 in the same period in 2019.

Allakos ended the second quarter of 2020 with $454.9 million in cash, cash equivalents and marketable securities.

On August 10, 2020 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the quarter ended June 30, 2020 (Press release, Galectin Therapeutics, AUG 10, 2020, View Source [SID1234563281]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Harold H. Shlevin, Ph.D., President and Chief Executive Officer of Galectin Therapeutics, said, "We are excited to have initiated the NASH-RX trial, having enrolled our first patient in June and continuing to enroll patients at several of our sites in our clinical trial of belapectin targeting cirrhotic NASH patients. If the results of the NASH-RX trial are compelling, there could be the potential for accelerated FDA approval and/or partnership opportunity with a pharmaceutical company. Later this quarter, we plan to host a conference call with the Investment Community for a more thorough discussion of the NASH-RX trial, its current status, our updated strategy, and to take questions."

Richard E. Uihlein, Chairman of the Board, added, "The protocol of the NASH-RX trial has been designed to provide belapectin with the best chance to demonstrate efficacy and safety, and I am very pleased this trial is now underway. Belapectin is targeting NASH cirrhosis patients, those who can no longer expect to benefit from increased exercise or an improved diet as may benefit many of those with earlier stages of NASH. And, belapectin (formerly known as GR-MD-02) is the first drug that has been shown to prevent the development of esophageal varices in patients with compensated NASH cirrhosis. If confirmed, these results would constitute a significant benefit for patients. Consequently, we believe our drug targets NASH at a very critical point of its development, as it represents an opportunity to prevent the progression of liver damage, and thereby save lives."

The NASH-RX trial will use an adaptive design to confirm dose selection and reaffirm the efficacy data observed in the NASH-CX trial and, with pre-planned adaptations, inform the larger Phase 3 trial component. In June 2020, we enrolled our first patients in the NASH-RX trial. NASH-RX is expected to enroll approximately 315 NASH patients in the Phase 2b part of the trial at approximately 130 sites in 12 countries in North America, Europe, Asia and Australia.

Galectin plans to host a conference call with the investment community in the third quarter to provide a more comprehensive description and update on the status of the trial and to take questions. The date and time of the call and how to participate will be published in advance of the planned call.

Financial Results

For the three months ended June 30, 2020, the Company reported a net loss applicable to common stockholders of $6.2 million, or ($0.11) per share, compared to a net loss applicable to common stockholders of $3.1 million, or ($0.06) per share for the three months ended June 30, 2019. The increase is due to 2020 research and development expense related to the Company’s NASH-RX trial.

Research and development expense for the three months ended June 30, 2020 was $4.7 million compared with $1.5 million for the three months ended June 30, 2019. The increase was primarily due to costs related to our NASH-RX clinical trial, along with preparations and some preclinical activities incurred in support of the clinical program, such as development and reproductive toxicity studies, clinical supplies and other supportive activities. General and administrative expenses for the three months ended June 30, 2020, were $1.4 million, down from $1.5 million for the three months ended March 31, 2019, primarily due to a decrease in stock-based compensation expenses.

As of June 30, 2020, the Company had $40.8 million of cash and cash equivalents. The Company also has a $10 million unsecured line of credit, under which no borrowings have been made to date. The Company believes it has sufficient cash, including availability under the line of credit, to fund currently planned operations and research and development activities through at least September 30, 2021.

The Company expects that it will require more cash to fund operations after September 30, 2021 and believes it will be able to obtain additional financing as needed. The total cost to obtain the interim analysis data of the planned trial, including general overhead, is currently estimated to be approximately $90 million. These costs will require additional funding. There can be no assurance that we will be successful in obtaining financing to support our operations beyond September 30, 2021, or, if available, that any such financing will be on terms acceptable to us.

About Belapectin (GR-MD-02)

Belapectin (GR-MD-02) is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis.

About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis

Non-alcoholic steatohepatitis (NASH) has become a common disease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. Approximately 8,890 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.

On August 10, 2020 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported financial results for the second quarter of 2020 ended June 30, 2020 and provided an update on the Company’s recent and future developments (Press release, Pieris Pharmaceuticals, AUG 10, 2020, View Source [SID1234563280]).

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"We look forward to beginning the phase 2 trials of our lead clinical programs, PRS-343 and PRS-060, later this year. In preparation for the phase 2 trial of PRS-343 with ramucirumab and paclitaxel, we have signed a clinical trial collaboration agreement for supply of ramucirumab with Lilly, which will give us the ability to explore the potential merits of this combination regimen while managing costs efficiently," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "We also have made measurable progress in our collaboration with Seattle Genetics, achieving a key preclinical milestone for the first of up to three bispecific programs we are developing as part of that alliance."
•PRS-060: Pieris and AstraZeneca are preparing to initiate the phase 2a study of PRS-060/AZD1402 in in the fourth quarter of 2020. The study of PRS-060/AZD1402, which is being developed for the treatment of moderate-to-severe asthma, will be sponsored, funded, and delivered by AstraZeneca. Upon completion of that study, Pieris will have the options to co-develop and, subsequently, co-commercialize PRS-060/AZD1402 in the United States.
•PRS-343: Pieris is working towards the initiation of a phase 2 single-arm study of PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with ramucirumab and paclitaxel in the second line of treatment of HER2-positive gastric cancer later this year. The U.S. Food and Drug Administration (FDA) has provided input on the design of the planned proof-of-concept study, and, pending the successful completion of an additional in-use and compatibility study in connection with the partial clinical hold placed on the phase 1 studies of the drug candidate, which the company is designing with input from FDA and plans to initiate later this month, the Company expects to initiate a phase 2 study in second-line gastric cancer in combination with the standard of care this year. Although Pieris cannot enroll new patients into the phase 1 studies of PRS-343 until resolution of this partial hold, currently-enrolled patients may continue to receive treatment. Additionally, Pieris will present phase 1 dose-escalation monotherapy and combination with atezolizumab data for PRS-343 in an oral presentation session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020.

•Ramucirumab Drug Supply Agreement: Pieris has entered into a clinical trial collaboration agreement with Eli Lilly and Company to evaluate the safety and efficacy of combining Pieris’ PRS-343 with Lilly’s ramucirumab, a VEGFR2 antagonist FDA-approved for multiple types of solid tumors, and paclitaxel in second-line treatment of HER2-positive gastric cancer in a phase 2 study. Under the terms of the agreement, Lilly will supply Pieris with ramucirumab, as well as collaborate on data from the trial.

•Seattle Genetics Collaboration: Pieris achieved a key preclinical milestone for one of the programs in the collaboration, a bispecific tumor-targeted costimulatory agonist, triggering a $5 million milestone payment. The program is one of up to three potential programs in the Seattle Genetics alliance, and the achieved milestone further validates Pieris’ approach and leadership in immuno-oncology bispecifics, complementing the encouraging clinical data seen with PRS-343. Pieris has handed the program over to Seattle Genetics, who is responsible for further advancement and funding of the asset.

•Servier Collaboration: Pieris and Servier continue development of PRS-344 and PRS-352. Pieris anticipates filing an IND application for PRS-344, a 4-1BB/PD-L1 bispecific, next year. The Company holds exclusive commercialization rights for PRS-344 in the United States and will receive royalties on ex-U.S. sales by Servier for this program. Pieris is also focused on completing the non-GLP preclinical work for PRS-352, a preclinical-stage program addressing undisclosed targets, and expects to hand it over to Servier in the fourth quarter of this year.

•Preclinical Respiratory Pipeline: Beyond PRS-060, Pieris continues to advance three discovery programs in its five-program respiratory collaboration with AstraZeneca. Pieris expects AstraZeneca will initiate the fourth discovery program in the collaboration later this year. The Company also continues to advance several proprietary discovery-stage respiratory programs. Pieris expects to share data and rationale for advancement of one of its proprietary programs in later this year.

Fiscal Year Financial Update:
Cash Position – Cash, cash equivalents, and investments totaled $77.2 million for the quarter ended June 30, 2020, compared to a cash, cash equivalents, and investments balance of $104.2 million for the quarter ended December 31, 2019. The decrease was due primarily to operating cash expenses and capital as well as one-time expenditures associated with the move to a new R&D facility in Hallbergmoos, Germany in the first quarter of 2020.
R&D Expense – R&D expenses were $11.3 million for the quarter ended June 30, 2020, compared to $13.4 million for the quarter ended June 30, 2019. The decrease in R&D expenses was due primarily to lower manufacturing spending on PRS-344, PRS-060, and other preclinical programs, lower costs on non-core programs, and lower travel-related expenditures due to COVID-19 restrictions, all partially offset by an increase in allocated IT and facility costs due to the move to the new facility and higher personnel costs.
G&A Expense – G&A expenses were $4.6 million for the quarter ended June 30, 2020, compared to $4.2 million for the quarter ended June 30, 2019. The increase in G&A expenses was due primarily to higher legal expense, audit expense, and allocated IT and facility costs due to the move to the new facility. These increases were partially offset by lower personnel costs, professional services, and travel-related expenditures due to COVID-19 restrictions.
Net Loss – Net loss was $5.0 million or $(0.09) per share for the quarter ended June 30, 2020, compared to a net loss of $11.8 million or $(0.24) per share for the quarter ended June 30, 2019.
Conference Call:
Pieris management will host a conference call beginning at 8:00 AM EDT on Monday, August 10, 2020, to discuss the first quarter financial results and provide a corporate update. Individuals can join the call by dialing +1-877-407-8920 (US & Canada) or +1-412-902-1010 (International). An archived replay of the call will be available by dialing +1-877-660-6853 (US & Canada) or +1-201-612-7415 (International) and providing the Conference ID #: 13661472.

On August 10, 2020 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage precision oncology company focused on developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, reported its financial results for the second quarter and six months ended June 30, 2020, and provided an update on its R&D pipeline and other corporate developments (Press release, Revolution Medicines, AUG 10, 2020, View Source [SID1234563279]).

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"Revolution Medicines continues pursuit of its ambitious R&D strategy on behalf of cancer patients with RAS-addicted tumors. Our cohesive pipeline focuses on multiple key nodes within RAS signaling and interconnected pathways to enable combination treatment approaches that may be needed to maximize patient benefit in these vexing cancers," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines.

"In the second quarter, we made broad progress across our portfolio of targeted inhibitors. RMC-4630, our clinical stage inhibitor of SHP2 and a potential backbone in combination treatments, showed further evidence of clinical activity against genetically-defined tumors. Importantly, combination studies of RMC-4630 with the KRASG12C inhibitor, AMG 510 (sotorasib), and the checkpoint inhibitor, Keytruda (pembrolizumab), were initiated. We also introduced a potential role for our second clinical candidate, RMC-5552, in combination therapy against cancers carrying dual RAS/mTOR pathway mutations. Further, we made substantial progress toward nomination of a first development candidate from our innovative family of targeted RAS(ON) inhibitors. Finally, just after the quarter, we completed a successful first follow-on financing further strengthening our financial position to enable the continued advancement of our deep R&D pipeline."

Highlights

RMC-4630 interim Phase 1 data support benefits of intermittent dosing and expanded clinical activity in genetically-defined tumors – Revolution Medicines’ ongoing Phase 1 monotherapy and Phase 1b/2 combination clinical trials continue to enroll. During the second quarter, Revolution Medicines reported interim data from the company’s Phase 1 monotherapy trial that support the benefits of intermittent dosing schedules, provided updated evidence of anti-tumor activity in non-small cell lung cancer patients carrying KRAS mutations, and revealed new anti-tumor activity in patients with tumors harboring NF1LOF mutations.

RMC-4630 program bolstered with the initiation of two new combination clinical trials — During the quarter, the company re-affirmed its strategic focus on targeted drug combinations as it continued to implement a range of studies featuring RMC-4630 as a backbone investigational drug in combination therapies. These efforts included the initiation of two new clinical trials, the first evaluating RMC-4630 in combination with Amgen’s investigational KRASG12C(OFF) inhibitor AMG 510 (sotorasib), and the second in combination with the checkpoint inhibitor, pembrozilumab (Keytruda). The company plans to initiate a third study evaluating a combination with the EGFR inhibitor osimertinib (Tagrisso) in 2020 as a substudy of the ongoing RMC-4630-02 clinical trial. While the COVID-19 pandemic may indirectly cause delays with the initiation and enrollment of clinical studies, the company is currently unaware of any pandemic-related factor that is expected to materially impact its timelines.

Findings published in Cancer Research support combination of RMC-4630 with checkpoint inhibitor – During the second quarter, Revolution Medicines researchers described ways in which a SHP2 inhibitor enhances the immune response to tumors, representing a second type of anti-tumor mechanism beyond its direct effects within cancer cells themselves. The paper also reported deep and durable tumor growth inhibition following combination treatment with a SHP2 inhibitor and an anti-PD-1 inhibitor in mouse cancer models, yielding complete tumor regressions and sustained immunological memory. This work provides a compelling mechanism-based rationale for the combination clinical study with RMC-4630 and pembrolizumab initiated this quarter.

In vivo data reveal activity of innovative mTORC1-selective inhibitor in RAS tumors and provide additional motivation for advancement of RMC-5552 into clinical development – During the quarter, Revolution Medicines reported new in vivo data supporting that RMC-5552, the company’s second clinical candidate, may increase anti-tumor activity in combination with KRASG12C inhibitors in cancers with RAS/mTOR pathway co-mutations that can cause resistance to single agent treatment. The company remains on track to be IND-ready with this compound by the end of 2020.

Mutant-selective RAS(ON) inhibitor program in vivo data demonstrate tumor regression following oral administration – Revolution Medicines is developing a portfolio of mutant-selective RAS(ON) inhibitors that it believes may be the first potent, selective, cell-active inhibitors of the active, GTP-bound form of RAS, or RAS(ON). During the second quarter, the company reported new in vivo data demonstrating that orally administered KRASG12C(ON) inhibitors from its proprietary collection drive tumor regression. The company continues to optimize these inhibitors and plans to nominate its first development candidate from this portfolio in 2020Multiple presentations at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II –Revolution Medicines had a strong presence at AACR (Free AACR Whitepaper) in June, presenting three posters and hosting an educational session spanning multiple company programs. The presentations included:

SHP2 inhibition as the backbone of targeted therapy combinations for the treatment of cancers driven by oncogenic mutations in the RAS pathway

Positioning a selective, bi-steric inhibitor of mTORC1 as a combination partner in RAS-driven cancers

Dual inhibition of SHP2 and CDK4/6 leads to immunological memory and immune-mediated anti-tumor activity in a mouse syngeneic model of breast cancer

Corporate Highlights

Appointment of new board members – During the quarter, Revolution Medicines added significant financial and transactional expertise to its board of directors with the appointments of Eric T. Schmidt, Ph.D. and Peter Svennilson.

Dr. Schmidt’s experience spans both finance and life sciences, having previously served for more than two decades as a biotechnology research analyst. In this capacity, Dr. Schmidt most recently served as managing director and senior biotechnology analyst at Cowen, and previously as vice president and biotechnology research analyst at UBS Securities. Dr. Schmidt is currently the chief financial officer of Allogene Therapeutics, a clinical-stage biotechnology company pioneering the development of allogenic cell therapies for cancer.

Mr. Svennilson has worked in venture capital and finance for more than 35 years and founded The Column Group in 2007. As former chairman of Aragon Pharmaceuticals and Seragon Pharmaceuticals, Mr. Svennilson was directly involved in the sale of these companies to Johnson & Johnson and Genentech/Roche, respectively. Previously, as a founder and managing partner of Three Crowns Capital, he played a key role in the financing of numerous, high profile biotechnology companies including, Tularik, Chemocentryx, Five Prime Therapeutics, and others.

Reported new evolutionary example of tri-complex modality for "undruggable" protein targets – During the second quarter, Revolution Medicines reported a natural product and semi-synthetic analogues that potently bind to CEP250, a human protein involved in replication of SARS-CoV-2 virus that is expected to be refractory to pharmaceutical drug discovery, by forming selective, high-affinity tri-complexes with an intracellular chaperone protein. This finding further demonstrates the potential for the company’s tri-complex modality to be useful in developing drugs against "featureless" disease targets. Revolution Medicines out-licensed intellectual property based on these findings to Ginkgo Bioworks to develop the natural product and related compounds for potential application in the treatment of infectious diseases, possibly including COVID-19.

Completed Follow-On Financing – Subsequent to the quarter end, the company completed a follow-on public equity offering. The upsized financing raised gross proceeds of $179.4 million before deducting underwriting discounts, commissions and other offering expenses payable by Revolution Medicines, further strengthening its balance sheet to support multiple clinical milestones and extend the company’s runway.

Second Quarter 2020 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities were $325.4 million as of June 30, 2020, compared to $122.8 million as of December 31, 2019. The increase was primarily due to proceeds from the IPO in February 2020. Proceeds from the recently completed offering are not included in the June 30, 2020 cash, cash equivalents and marketable securities balance.

Revenue: Total revenue, consisting of revenue from the company’s collaboration agreement with Sanofi, was $10.0 million for the quarter ended June 30, 2020, compared to $12.3 million for the quarter ended June 30, 2019. This decrease was due to lower reimbursed research and development services in the quarter ended June 30, 2020 for RMC-4630 resulting from lower manufacturing costs, which were partially offset by higher clinical trial costs. During the quarter ended June 30, 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 $32.9 million for the quarter ended June 30, 2020, compared to $20.1 million for the quarter ended June 30, 2019. This increase was primarily due to an increase in research expenses associated with the company’s pre-clinical research portfolio, and an increase in personnel-related expenses related to additional headcount, partially offset by lower costs related to RMC-4630.

G&A Expenses: General and administrative expenses were $5.1 million for the quarter ended June 30, 2020, compared to $2.7 million for the quarter ended June 30, 2019. This increase was primarily due to an increase in expenses associated with operating as a public company.

Net Loss: Net loss was $27.2 million for the quarter ended June 30, 2020, compared to net loss of $10.1 million for the quarter ended June 30, 2019.