On November 10, 2021 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical-stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), reported financial results for the third quarter ended September 30, 2021 and highlighted recent corporate updates (Press release, Imago BioSciences, NOV 10, 2021, View Source [SID1234595099]).

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"Over the third quarter we have built upon the momentum of our recent initial public offering and concurrent private placement that resulted in gross proceeds of $174.6 million to advance our novel LSD1 inhibitor, bomedemstat (IMG-7289), for the treatment of hematologic diseases of the bone marrow. We are also pleased to have been added to the Russell 2000 Index in late September, which has driven greater market awareness of Imago," said Dr. Hugh Y. Rienhoff, Jr., M.D, Chief Executive Officer of Imago BioSciences. "We are thrilled to have completed enrollment in our Phase 2 trial of bomedemstat for the treatment of myelofibrosis and look forward to providing data updates on this Phase 2 trial, along with our Phase 2 trial of bomedemstat for the treatment of essential thrombocythemia this year."

Recent Corporate Developments and Pipeline Updates

Announced Oral Data Presentations at the Upcoming 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. In November 2021, Imago announced that two abstracts have been accepted for oral presentation at the ASH (Free ASH Whitepaper), to be held December 11-14, 2021: "A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (bomedemstat) for the Treatment of Advanced Myelofibrosis"; and "A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (bomedemstat) for the Treatment of Essential Thrombocythemia (ET)".
Russell 2000 Index Inclusion: In September 2021, Imago announced its inclusion in the Russell 2000 Index as part of the Index’s quarterly IPO additions.
Granted Orphan Drug Designation for Bomedemstat in Essential Thrombocythemia (ET) from the European Medicines Agency (EMA): In July 2021, Imago announced that its lead asset, bomedemstat, was granted Orphan Drug Designation by the EMA for the treatment of ET. Under Orphan Drug Designation, bomedemstat potentially qualifies for incentives such as 10 years of market exclusivity, reduced fees for regulatory activities, and protocol assistance.
Successful Completion of Initial Public Offering (IPO): In July 2021, Imago completed an initial public offering and concurrent private placement with Pfizer resulting in gross proceeds of $174.6 million.
Third Quarter 2021 Financial Results

Cash and Cash Equivalents: As of September 30, 2021, Imago had cash, cash equivalents, restricted cash and short-term investments of $230.4 million.
Research & Development (R&D) Expenses: R&D expenses for the quarter ended September 30, 2021 were $8.7 million (including stock-based compensation expense of $0.2 million) as compared to $3.6 million for the same period in 2020. The overall increase in R&D expenses was related to the continuation of the Phase 2 clinical studies in ET and MF, as well as startup costs for a Phase 2 extension study to accommodate those patients who wish to continue to receive bomedemstat, continued development of commercial material and material to support the ongoing and new clinical trials, and salaries and non-cash stock-based compensation expense for R&D employees as we ramped up our operations.
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended September 30, 2021 were $3.0 million (including stock-based compensation expense of $0.5 million) as compared to $0.7 million for the same period in 2020.
Net Loss: Net loss for the quarter ended September 30, 2021 was $11.7 million compared to $4.3 million for the same period in 2020.

On November 10, 2021 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage precision oncology company developing targeted drugs to inhibit frontier targets that drive and sustain RAS-addicted cancers, reported its financial results for the third quarter and nine months ended September 30, 2021, and provided a corporate update (Press release, Revolution Medicines, NOV 10, 2021, View Source [SID1234595098]).

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"During the third quarter, the company’s unique capabilities and continuing momentum with our innovative RAS(ON) Inhibitors and RAS Companion Inhibitors strengthened Revolution Medicines’ leadership position in the quest to successfully treat RAS-addicted cancers. In our RAS(ON) Inhibitor portfolio, development candidates targeting KRASG12C (RMC-6291) and RASMULTI (RMC-6236) have shown compelling features and continue to advance toward the clinic. Exciting mutant-selective inhibitors of KRASG13C and KRASG12D have also emerged from our RAS(ON) drug discovery platform, and we expect to select another development candidate by year end," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines.

"We have expanded the evaluation of our SHP2 inhibitor, RMC-4630, in combination regimens with direct inhibitors of RAS. In particular, the company recently began recruiting patients in our RMC-4630-03 study under our global partnership with Sanofi and in collaboration with Amgen. This study is intended to further evaluate RMC-4630 and Lumakras in the treatment of lung cancer as a complement to the ongoing CodeBreaK 101c study of these compounds. In addition, we are gratified that Sanofi plans to sponsor a study of RMC-4630 in combination with Mirati’s KRASG12C inhibitor, adagrasib, also under our partnership."

RAS(ON) Inhibitors – Revolution Medicines continues to build on its innovative RAS(ON) Inhibitor platform, producing an expansive collection of tri-complex inhibitors targeting diverse oncogenic RAS variants through highly differentiated chemical and pharmacologic profiles.

RMC-6291 (KRASG12C) – RMC-6291 is a first-in-class, potent, oral and selective tri-complex inhibitor of KRASG12C(ON) with a differentiated preclinical profile designed to address persistent unmet needs for patients with cancers driven by KRASG12C.
The company recently reported data at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) demonstrating superior outcomes with orally administered RMC-6291 as compared to adagrasib in preclinical models of KRASG12C non-small cell lung cancer (NSCLC). In a head-to-head mouse clinical trial of 19 xenograft models, RMC-6291 demonstrated robust anti-tumor activity characterized by a 68% objective response rate, as compared to 42% for adagrasib in the same models. The company believes these findings support the potential for RMC-6291 as a best-in-class KRASG12C inhibitor.
The company remains on track to submit an Investigational New Drug application (IND) for RMC-6291 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 designed to treat cancers driven by a variety of KRAS mutations, including those that have emerged in patients following treatment with KRASG12C(OFF) inhibitors.
The company reported data at the AACR (Free AACR Whitepaper)-NCI-EORTC Conference demonstrating RMC-6236’s ability to induce significant regressions of NSCLC, pancreatic cancer and colorectal cancer (CRC) xenograft models driven by KRASG12V, KRASG12D, KRASG12C or KRASG12R. These findings add to the growing body of evidence that the company believes supports the potential of RMC-6236 as a first targeted therapy for treating many cancers for which no targeted treatment is currently available.
The company presented an expanded dataset at the Gastrointestinal Cancer Drug Development Summit demonstrating the ability of both RMC-6236 and RMC-6291 to drive tumor regressions in xenograft models of RAS-mutant CRC. The company believes these findings provide additional support for the potential of RAS(ON) inhibitors to deliver clinical benefit to patients with CRC.
Also during the AACR (Free AACR Whitepaper)-NCI-EORTC Conference, the company presented preclinical data from a combination study evaluating RMC-6236 with a PD-1 inhibitor. Results from this study demonstrated that RMC-6236 alone induces anti-tumor immunity in vivo, and also exhibits additive anti-tumor benefit with checkpoint inhibition as indicated by complete and durable responses.
The company remains on track to submit an IND for RMC-6236 in the first half of 2022.
Continued expansion of other RAS(ON) Inhibitor programs – Revolution Medicines continues to progress its growing portfolio of orally bioavailable, mutant-selective RAS(ON) Inhibitors designed to target RAS variants driving RAS-addicted cancers that are unserved by targeted drugs.
The company reported data at the AACR (Free AACR Whitepaper)-NCI-EORTC Conference showing the capacity of compounds from both its KRASG13C and KRASG12D programs to covalently and selectively modify their respective targets, the first compounds described with these properties. Covalent modification of KRASG12D was also demonstrated in vivo in a tumor xenograft model of KRASG12D-driven pancreatic cancer, with tumor regressions achieved following repeat oral dosing.
The company remains on track to nominate a third development candidate from its RAS(ON) inhibitor portfolio in 2021.
RAS Companion Inhibitors – Revolution Medicines continues to advance and expand multiple clinical studies of its RAS Companion Inhibitors designed to provide maximum clinical benefit in RAS-addicted cancers.

RMC-4630 (SHP2 Inhibitor) – RMC-4630, a potent, oral, selective inhibitor of the SHP2 protein, is being advanced in partnership with, and is primarily funded by, Sanofi.
RMC-4630 and KRASG12C inhibitor Lumakras (sotorasib)
Amgen’s CodeBreaK 101c study continues evaluating RMC-4630 in combination with sotorasib across multiple cancer types. To date this combination has demonstrated acceptable tolerability.
The company is actively recruiting patients for its global Phase 2 clinical trial evaluating the combination of RMC-4630 and sotorasib in patients with advanced NSCLC bearing the KRASG12C mutation. Revolution Medicines is sponsoring the RMC-4630-03 study under its global partnership with Sanofi and conducting the trial in collaboration with Amgen. The RMC-4630-03 study evaluating the combination in NSCLC patients is a complement to Amgen’s ongoing CodeBreaK 101c study exploring this combination across multiple cancer types. The company expects to have preliminary findings from the RMC-4603-03 study in the second half of 2022.
RMC-4630 and KRASG12C inhibitor adagrasib
Sanofi, the company’s global SHP2 development and commercialization partner, plans to sponsor a combination study under its global SHP2 partnership with the company evaluating RMC-4630 (also known as SAR442720) in combination with Mirati’s KRASG12C inhibitor, adagrasib. This study expands the evaluation of the potential benefit of adding RMC-4630 in this class of RAS inhibitors.
RMC-4630 and PD-1 inhibitor pembrolizumab (Keytruda)
The TCD16210 study sponsored by Sanofi continues evaluating RMC-4630 in combination with pembrolizumab, a PD-1 inhibitor. Sanofi is planning an expansion cohort with this combination in front-line PD-L1+ NSCLC.
RMC-5552 (mTORC1/4EBP1 Inhibitor) – RMC-5552 is a potent, selective bi-steric inhibitor of mTORC1 that suppresses phosphorylation and inactivation of 4EBP1.
Enrollment and dosing are underway in a Phase 1 monotherapy dose-escalation study. The company continues to expect initial safety, pharmacokinetic and single agent activity data in 2022.
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 expects RMC-5845 to be IND-ready by the end of 2021.
Third Quarter 2021 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities were $608.7 million as of September 30, 2021, compared to $440.7 million as of December 31, 2020. The increase was primarily due to proceeds from the company’s public equity offering in February 2021.

Revenue: Total revenue consists of revenue from the company’s collaboration agreement with Sanofi. During the third quarter of 2021, the company recorded a non-cash, non-recurring GAAP accounting adjustment that reduced collaboration revenue by $8.5 million. This non-cash revenue adjustment relates to the addition of the RMC-4630-03 study to the RMC-4630 development plan, and deprioritization of the RMC-4630-02 study. As a result of these development plan events, the company revised its estimate of the accounting transaction price and percentage of completion of work performed to date under its agreement with Sanofi, which resulted in a cumulative catch-up adjustment to collaboration revenue in this quarter. Total revenue, including the non-cash revenue adjustment, was $1.1 million for the quarter ended September 30, 2021, compared to $12.7 million for the quarter ended September 30, 2020. The decrease was primarily due to the non-cash revenue adjustment and lower reimbursed manufacturing costs.

R&D Expenses: Research and development expenses were $46.5 million for the quarter ended September 30, 2021, compared to $34.9 million for the quarter ended September 30, 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 $7.8 million for the quarter ended September 30, 2021, compared to $5.3 million for the quarter ended September 30, 2020. The increase was primarily due to an increase in stock-based compensation, an increase in personnel-related expenses related to additional headcount, and higher legal and accounting fees.

Net Loss: Net loss was $52.9 million for the quarter ended September 30, 2021, compared to a net loss of $27.2 million for the quarter ended September 30, 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 approximately $20 million.

Conference Call

Revolution Medicines will host a conference call and webcast this afternoon, November 10, 2021, at 4:30 PM Eastern (1:30 PM Pacific).

To listen to the conference call, please dial (833) 423-0425 or (918) 922-3069, provide conference ID: 9757524 and request the Revolution Medicines conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the Company’s website for at least 14 days.

On November 10, 2021 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported corporate updates and financial results for the third quarter ended September 30, 2021 (Press release, CymaBay Therapeutics, NOV 10, 2021, View Source [SID1234595097]).

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Sujal Shah, President and CEO of CymaBay, stated, "The third quarter of 2021 included key accomplishments that position CymaBay for long-term success. The non-dilutive, risk-sharing development financing agreement signed with Abingworth in July supports the completion of our ongoing phase 3 program for seladelpar in PBC. We now have over 100 sites activated across over 20 countries in our global registration study, RESPONSE, and expect these efforts to continue and ultimately drive the completion of enrollment in the first half of 2022. We are excited to also share additional data from our prior studies in PBC at The Liver Meeting 2021 that demonstrate improved benefit of seladelpar between one to two years of treatment and differentiation from other existing treatments in a population of patients with more advanced disease."

"As we approach the end of 2021, we are well positioned to deliver on our central focus of improving the lives of patients with PBC. Although the pandemic has presented our entire industry with evolving challenges, I am confident we have assembled talent across the organization that will allow us to achieve both our near term goals and our vision of establishing a pipeline of opportunities for patients with unmet need. I’m also proud of the relationships we have established with patient communities, the medical community and high quality investors that all support the work we are dedicated to day in and day out."

Upcoming and Recent Corporate Highlights

An oral presentation titled "Long-Term Safety and Efficacy of Seladelpar in Patients with Primary Biliary Cholangitis" will be delivered by Dr. Marlyn J. Mayo, MD, Professor and Liver Disease Specialist, University of Texas Southwestern Medical Center. This presentation will highlight the efficacy and safety of seladelpar during 2 years of treatment in patients with primary biliary cholangitis (PBC). The mean percent change in alkaline phosphatase (ALP) from baseline was -42% and -50% after 1 and 2 years, respectively. Over 2 years, there were sustained reductions in ALT, AST, and GGT. Total bilirubin and platelet levels remained stable. Seladelpar appeared safe and well-tolerated. These data support that long-term treatment with seladelpar resulted in continued improvement in markers of cholestasis after 1 year.
A clinical presentation titled "Efficacy and Safety of Seladelpar in Patients with Compensated Cirrhosis and Evidence of Portal Hypertension due to Primary Biliary Cholangitis" will be delivered by Dr. Cynthia Levy, MD, Professor of Medicine, University of Miami. This electronic poster presentation will highlight the treatment effects of seladelpar in compensated cirrhotic patients with portal hypertension after 3 months, which led to ALP changes of -30% in the 5 mg and -45% in the 10 mg groups. Total bilirubin, platelets, albumin, and INR either improved or remained stable. Seladelpar appeared safe and well-tolerated. Efficacy, safety, and tolerability in patients with compensated cirrhosis and portal hypertension was comparable to that of non-cirrhotic patients.
CymaBay will host a Post-AASLD KOL Call on seladelpar in PBC on Monday, November 15, at 4:30pm ET. The webinar will feature presentations by Dr. Marlyn J. Mayo, MD, and Dr. Cynthia Levy, MD, who will be reviewing the seladelpar abstracts presented at The Liver Meeting 2021. Dr. Dennis Kim, MD, Chief Medical Officer of CymaBay, will also discuss progress developing seladelpar for patients with PBC. The live and archived webcast will be accessible through this webcast link or through the Events section of the CymaBay website.
Continued enrollment in RESPONSE, a 52-week, placebo-controlled, randomized, global, Phase 3 registrational study evaluating the safety and efficacy of seladelpar in patients with PBC. This study is targeting enrollment of 180 patients who have an inadequate response to, or intolerance to, ursodeoxycholic acid, in a 2:1 randomization to oral, once daily seladelpar 10 mg or placebo. The primary outcome measure is the responder rate at 52 weeks. A responder is defined as a patient who achieves an alkaline phosphatase level < 1.67 times the upper limit of normal with at least a 15% decrease from baseline and has a normal level of total bilirubin. Additional key outcomes of efficacy will compare the rate of normalization of alkaline phosphatase at 52 weeks and the level of pruritus at 6-months for patients with moderate to severe pruritus at baseline assessed by a numerical rating scale recorded with an electronic diary.
Continued enrollment in ASSURE, an open-label, long-term study of seladelpar in patients with PBC intended to collect additional long-term safety data to support registration.
Supported enrollment efforts in a Phase 2a proof-of-pharmacology study to evaluate the potential for MBX-2982, a GPR119 agonist, to prevent hypoglycemia in patients with type 1 diabetes. The study is being conducted by the AdventHealth Translational Research Institute in Orlando, Florida and fully funded by The Leona M. and Harry B. Helmsley Charitable Trust with CymaBay retaining full rights to MBX-2982.
Executed a non-dilutive financing transaction with Abingworth LLP for the development of seladelpar in PBC. Under the terms of the agreement, CymaBay will receive up to $100 million of funding for seladelpar development costs, of which $75 million will be received in three installments over approximately six months. The first installment of $25 million was received in August and the second installment of $25 million was received in early November. CymaBay expects to receive the third $25 million installment in early February 2022 and has an option to receive an additional $25 million within approximately two months of the completion of enrollment of CymaBay’s Phase 3 RESPONSE clinical trial.
Held $113.8 million in cash, cash equivalents and short-term investments as of September 30, 2021. We believe that cash and investments on hand, together with additional funding amounts we expect to receive through the development financing agreement with Abingworth are sufficient to fund CymaBay’s operating plan into 2023.
Due to the ongoing effects of the global coronavirus pandemic, CymaBay continues to conduct its operations remotely for all employees, which has allowed business activities to continue as seamlessly as possible. The recent emergence of the Delta variant and other variants has led to uncertainty regarding the duration and effects that the pandemic will have on future operating milestones. CymaBay continues to closely monitor pandemic developments and their associated risks to the business, including the conduct of its clinical development of seladelpar, and will continue to take actions to mitigate them where possible. Further, all CymaBay’s actions will continue to be guided by a commitment to ensuring the health and safety of its employees as well as patients enrolled in its clinical studies.
Third Quarter and Nine Months Ended September 30, 2021 Financial Results

Research and development expenses for the three months ended September 30, 2021 and 2020 were $17.0 million and $7.7 million, respectively. Research and development expenses for the nine months ended September 30, 2021 and 2020 were $46.1 million and $25.2 million, respectively. Research and development expenses in the three and nine months ended September 30, 2021 were higher than the corresponding periods in 2020 primarily due to an increase in clinical trial activities associated with the development of seladelpar in PBC. In particular, cost increases were primarily driven by an expansion of our site activation, patient enrollment, and other clinical trial activities associated with RESPONSE and ASSURE, our two active global late-stage clinical trials in PBC. In the three and nine months ended September 30, 2020, costs incurred were primarily associated with startup activities for RESPONSE and ASSURE as well as costs to shutdown our Phase 3 PBC, Phase 2b NASH, and Phase 2 PSC clinical trials, and other studies, after the seladelpar development program was placed on hold from November 2019 through July 2020.

General and administrative expenses for the three months ended September 30, 2021 and 2020 were $5.2 million and $3.9 million, respectively. General and administrative expenses for the nine months ended September 30, 2021 and 2020 were $16.9 million and $11.5 million, respectively. General and administrative expenses in the three and nine months ended September 30, 2021 were higher than the corresponding periods in 2020 due to higher employee compensation associated with the hiring of additional personnel and an increase in consulting and other expenses upon resumption of development of seladelpar in the second half of 2020. In addition, general and administrative expenses during the three and nine months ended September 30, 2020, included restructuring charges of $0.6 million and $0.7 million, respectively, and no similar restructuring charges were incurred during the three and nine months ended September 30, 2021.

Net loss for the three months ended September 30, 2021 and 2020 was $22.7 million and $11.4 million, or ($0.33) and ($0.17) per diluted share, respectively. Net loss for the nine months ended September 30, 2021 and 2020 was $63.5 million and $35.2 million, or ($0.92) and ($0.51) per diluted share, respectively. Net loss was higher largely due to increases in clinical operating expenses, which were incurred following the resumption of our clinical development of seladelpar in PBC during the second half of 2020. We expect our operating expenses to increase in the future as we continue to execute on our clinical development plans.
Conference Call Details

CymaBay will host a conference call today at 4:30 p.m. ET to discuss third quarter 2021 financial results and provide a business update. To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13723498. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On November 10, 2021 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported financial results for the third quarter ended September 30, 2021, and provided an update on the company (Press release, Schrodinger, NOV 10, 2021, View Source [SID1234595096]).

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"We are very pleased with the progress we have made across the business so far this year. The level of engagement with senior R&D leaders across pharma and the growth we are seeing in new software customers suggests a shift in the drug discovery paradigm and a push to incorporate advanced computational approaches into projects at all stages," stated Ramy Farid, Ph.D., chief executive officer at Schrödinger. "As we approach year-end, we are continuing to focus on key strategic priorities, including advancing our internal pipeline. We are on track to submit an IND to the FDA for our MALT1 inhibitor program in the first half of next year, and we look forward to presenting additional preclinical data for this program at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting next month. We also recently selected a development candidate and initiated IND-enabling studies for our CDC7 inhibitor program, and we added a new oncology target, our fifth internal program, to our pipeline."

Recent Business Highlights
Collaborations Highlight Opportunities and Progress Across the Business

Entered collaboration with Centessa Pharmaceuticals Subsidiary, Orexia Therapeutics, focused on novel orexin receptor agonists: In October, Schrödinger and Centesa Pharmaceuticals Subsidiary, Orexia Therapeutics, announced a collaboration focused on the discovery of novel therapeutics targeting the orexin-2 receptor, which is known to play a role in a broad spectrum of sleep disorders, including narcolepsy. The collaboration provides Orexia with substantial access to Schrödinger’s entire computational platform as well as Schrödinger’s extensive expertise in ultra-large-scale deployment of its technology.

Under the terms of the agreement, Orexia is responsible for preclinical research activities, clinical development and commercialization of future product candidates discovered under the collaboration. Schrödinger received an upfront software access payment and may become eligible to receive certain preclinical, development, regulatory and commercial milestone payments, as well as low single digit royalties on global net sales.
Formed strategic collaboration with MD Anderson to accelerate development of WEE1 program: In October, Schrödinger and The University of Texas MD Anderson Cancer Center announced a two-year strategic research collaboration focused on accelerating and optimizing the development of Schrödinger’s WEE1 inhibitor program. The goal of the collaboration is to accelerate and optimize the clinical development path for Schrödinger’s WEE1 program through molecular biomarker-driven tumor type prioritization and patient stratification and to validate biomarkers to predict response or resistance to a WEE1 inhibitor. The joint team will seek to prioritize clinical studies of a WEE1 inhibitor as a single agent in selected cancer indications and in combinations for defined clinical subpopulations.
Completion of $100 million financing by strategic partner ShouTi: In October, Schrödinger’s partner, ShoutTi Inc., announced a $100 million series B financing to advance the company’s discovery platform, leveraging Schrödinger’s computational platform and expertise, and ShouTi’s structural biology and drug discovery expertise to design orally available medicines with properties that aim to overcome current limitations of biologic and peptide drugs. Schrödinger is a co-founder of ShouTi, which is advancing a pipeline focused on chronic diseases with high medical need, including cardiovascular, metabolic and pulmonary conditions.
Provided update on collaboration with Bristol Myers Squibb: Schrödinger reported that the companies have prioritized an undisclosed precision oncology target that will replace HIF-2 alpha. Additionally, Schrödinger and Bristol Myers Squibb recently expanded their collaboration with a new agreement to discover, develop and commercialize bifunctional degraders.
Internal Programs Expanding and Advancing

New preclinical data from multiple MALT1 inhibitors to be presented at ASH (Free ASH Whitepaper): Last week, Schrödinger announced that new preclinical data from its MALT1 program will be presented at the ASH (Free ASH Whitepaper) 2021 Annual Meeting, which is being held December 11 – 14 virtually and in person in Atlanta, GA. The poster presentation, "Characterization of Potent Paracaspase MALT1 Inhibitors for Hematological Malignancies" (Abstract #1187), is scheduled to take place on Saturday, December 11, from 5:30 p.m. – 7:30 p.m. ET. MALT1 is considered a potential therapeutic target for several non-Hodgkin’s B-cell lymphomas as well as chronic lymphocytic leukemia.

Schrödinger expects to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration for its MALT1 program in the first half of 2022.
Development candidate selected for CDC7 program: Schrödinger reported that it selected a development candidate and has initiated IND-enabling studies for its CDC7 inhibitor program. CDC7 is thought to be linked to cancer cells’ proliferative capacity and ability to bypass normal DNA damage responses. Targeting proteins that play important roles in DNA replication and replication stress, such as CDC7, is gaining momentum as a therapeutic approach for cancer.
Internal pipeline expanded to five programs: Schrödinger continued to advance its discovery efforts and reported that the company further expanded its internal pipeline with the addition of a fifth program, which is an undisclosed oncology target.
Third Quarter 2021 Financial Results

Total revenue was $29.9 million for the third quarter of 2021, a 16 percent increase compared to the third quarter of 2020.
Software revenue was $24.3 million for the third quarter of 2021, compared to $22.9 million for the third quarter of 2020. The six percent growth observed year-over-year was primarily due to increased sales from existing customers and the addition of new customers, partially offset by multi-year contracts that were executed in the third quarter of 2020, as well as the completion of a research project that was active in the third quarter of 2020.
Drug discovery revenue was $5.6 million for the third quarter of 2021, compared to $2.9 million in the third quarter of 2020. Third quarter 2021 drug discovery revenue included the recognition of $4.4 million of revenue from the company’s collaboration with Bristol Myers Squibb.
Gross profit was $11.1 million in the third quarter of 2021, compared to $15.3 million in the third quarter in 2020. Software gross margin was 73 percent in the third quarter of 2021, compared to 81 percent for the same period in the prior year, reflecting planned investments to drive and support large-scale adoption of Schrödinger’s platform as well as increased royalty expenses in the quarter.
Operating expenses for the third quarter of 2021 were $45.8 million, compared to $30.7 million in the third quarter of 2020, driven by expenses required to scale the company’s business, advance its internal drug discovery programs and continue to build a public company infrastructure.
Other expense, which included changes in fair value of equity investments and interest income, was $0.3 million in the third quarter of 2021 compared to income of $18.7 million for the third quarter of 2020 due to adjustments to the fair value of the company’s equity investments.
Net loss, after adjusting for non-controlling interest, was $35.0 million for the third quarter of 2021, compared to net income of $3.9 million for the third quarter of 2020, driven by adjustments to the fair value of the company’s equity investments as well as planned investments to advance the company’s growth strategy.
Cash, cash equivalents, restricted cash and marketable securities as of September 30, 2021, were $600.2 million, compared to $616.6 million as of June 30, 2021.
Full-Year 2021 Financial Outlook

As of November 10, 2021, Schrödinger expects total revenue to range from $124 million to $134 million for the fiscal year ending December 31, 2021. The company is maintaining its full-year software revenue expectation of $102 million to $110 million. The company is adjusting its full-year drug discovery revenue expectation to a range of $22 million to $24 million, updated from a previous expectation of $22 million to $32 million, primarily due to the timing of anticipated milestones from collaborators.

Schrödinger continues to aggressively fund R&D to advance its technology and drug discovery pipeline. The company continues to expect operating expense growth to be higher than the 42 percent annual growth rate reported in 2020 and expects software gross margin to be lower than the 81 percent reported in 2020.

Webcast and Conference Call Information

Schrödinger will host a conference call to discuss its third quarter financial results on Wednesday, November 10, 2021, at 4:30 p.m. ET. The conference call can be accessed live by dialing (833) 727-9520 (domestic) or +1 (830) 213-7697 (international) and referring to conference ID 2484045. The webcast can also be accessed under "News & Events" in the investors section of Schrödinger’s website, View Source The archived webcast will be available on Schrödinger’s website for approximately 90 days following the event.

On November 10, 2021 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, reported financial results for the third quarter 2021, and provided an update on its clinical programs (Press release, Equillium, NOV 10, 2021, View Source [SID1234595095]).

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"Following positive topline data from the EQUATE study, we started the third quarter by announcing our plans to advance itolizumab into a pivotal clinical study in first-line acute graft-versus-host disease, which we anticipate commencing early in the new year," said Bruce Steel, chief executive officer at Equillium. "Recent strategic activity in the GVHD therapeutic segment demonstrates industry’s recognition of the high unmet medical need for effective treatments for patients suffering from this deadly disease, and we believe our pivotal study could position itolizumab to become the first approved therapy to treat patients with acute GVHD in the first-line setting. We are also encouraged by the reductions in proteinuria observed in the subgroup data from the Type A portion of the EQUALISE study in patients with systemic lupus erythematosus, without lupus nephritis, that had elevated baseline urine protein/creatinine and albumin/creatinine ratios. Based on the Type A data we amended the protocol in the Type B portion to include newly diagnosed patients in addition to refractory patients and selected the 1.6 mg/kg dose. As a result of these protocol enhancements and due to challenges in patient recruitment amid the ongoing global pandemic, we now expect to announce interim data from the Type B portion of the study in patients with lupus nephritis mid-year 2022. We look forward to initiating our pivotal study in first-line acute GVHD early in the new year and presenting topline data from our EQUIP study in moderate to severe asthma before the end of this year."

Corporate & Clinical Highlights Since Beginning of Q3 2021:

Announced plans to initiate a pivotal study in first-line acute graft-versus-host disease (aGVHD) following positive topline results from the EQUATE study and an End-of-Phase 1 meeting with the FDA
Reported additional data from the EQUALISE study’s Type A systemic lupus erythematosus (SLE) patients, without lupus nephritis, that had elevated baseline urine protein/creatinine and albumin/creatinine ratios, demonstrating a mean decrease of 42% and 54%, respectively, at Day 57 following two doses of itolizumab
Presented multiple posters at the American College of Rheumatology (ACR), the American Society of Nephrology (ASN) and the American College of Allergy, Asthma and Immunology (ACAAI)
ASN & ACR
Sustained decrease in proteinuria observed in subgroup of SLE patients, without lupus nephritis, following two doses of itolizumab
Itolizumab was safe and well tolerated at doses ranging from 0.4 to 2.4 mg/kg
Dose dependent decreases in inflammatory marker CD6 following itolizumab administration
ACAAI
◦ Itolizumab was well tolerated in patients with moderate to severe uncontrolled asthma

Upcoming Catalysts:

EQUIP Phase 1b study: topline data in uncontrolled asthma expected Q4 2021
Initiate pivotal study in first-line aGVHD expected early 2022
EQUALISE Phase 1b study: interim data from Type B lupus nephritis patients expected mid-2022
Upcoming Catalysts:

EQUIP Phase 1b study: topline data in uncontrolled asthma expected Q4 2021
Initiate pivotal study in first-line aGVHD expected early 2022
EQUALISE Phase 1b study: interim data from Type B lupus nephritis patients expected mid-2022
Third Quarter 2021 Financial Results

Research and development (R&D) expenses for the third quarter of 2021 were $7.0 million, compared with $4.2 million for the same period in 2020. The increase was driven by greater clinical development expenses related to EQUIP primarily resulting from a lower R&D Tax Incentive benefit from the Australian Taxation Office and by start-up expenses related to our planned pivotal study in aGVHD, partially offset by lower costs related to a Phase 3 COVID-19 clinical trial that we decided not to commence. Greater employee compensation and benefit expenses driven by increased headcount and greater overhead expenses and costs related to our non-clinical research activities also contributed to the increase in R&D expense.

General and administrative (G&A) expenses for the third quarter of 2021 were $2.9 million, compared with $2.3 million for the same period in 2020. The increase was driven by greater employee compensation and benefit expenses primarily related to increased headcount and by greater overhead expenses, partially offset by a decrease in consulting expenses.

Net loss for the third quarter of 2021 was $10.3 million, or $(0.35) per basic and diluted share, compared with a net loss of $6.6 million, or $(0.31) per basic and diluted share for the same period in 2020. The increase in net loss was largely attributable to greater operating expenses.

Cash used in operations for the third quarter of 2021 was $7.0 million compared to $7.0 million in the second quarter of 2021.

Cash, cash equivalents and short-term investments totaled $90.7 million as of September 30, 2021, compared to $97.6 million as of June 30, 2021. Equillium believes that its cash and investments will be sufficient to fund its currently planned operations into 2023.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM signaling pathway to selectively downregulate pathogenic T effector cells while preserving T regulatory cells critical for maintaining a balanced immune response. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.