On March 24, 2022 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported financial results for the fiscal quarter ended December 31, 2021, and provided business updates (Press release, Erasca, MAR 24, 2022, View Source [SID1234610888]).

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"Erasca capped off a productive year by achieving all of our 2021 clinical and corporate milestones on or ahead of schedule," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "We initiated three HERKULES clinical trials in 2021 evaluating our ERK1/2 inhibitor ERAS-007 across tissue agnostic and tissue specific indications. We announced earlier this month that we entered into a clinical trial collaboration and supply agreement (CTCSA) with Lilly for the EGFR antibody cetuximab, which complements our previously announced CTCSA with Pfizer for the BRAF inhibitor encorafenib. ERAS-007 is being added to the standard of care regimen of encorafenib plus cetuximab in patients with BRAF V600E-mutant metastatic colorectal cancer as part of our ongoing HERKULES-3 trial, and we are excited about these agreements with Pfizer and Lilly. We will expand the evaluation of ERAS-007 into blood cancers with HERKULES-4, a master protocol for the treatment of patients with hematological malignancies with initial focus in acute myeloid leukemia (AML)."

Dr. Lim continued, "Our CNS-penetrant product candidates continued to advance well in 2021. First, in June 2021, we nominated ERAS-3490, a highly CNS-penetrant KRAS G12C inhibitor and our first homegrown development candidate. This molecule was specifically designed to cross the blood-brain barrier to address the propensity of non-small cell lung cancer to metastasize to the brain, and we are currently on track for an IND filing in the second half of 2022. Second, we were pleased to receive IND clearance of ERAS-801 for the treatment of patients with recurrent glioblastoma multiforme a quarter earlier than expected, and we dosed the first patient in THUNDERBBOLT-1 last month. ERAS-801 is an oral EGFR inhibitor with four times higher CNS penetration than approved EGFR inhibitors and the differentiated ability to target both oncogenic EGFR vIII mutations and wildtype alterations. Overall, our solid cash position, industry leading portfolio, and focused approach will enable us to continue to execute well in 2022."

Research and Development (R&D) Highlights

•Presented Preclinical Data for ERAS-801: In October 2021, Erasca announced the presentation of preclinical data for ERAS-801, a central nervous system (CNS)-penetrant epidermal growth factor
receptor (EGFR) inhibitor for the treatment of recurrent glioblastoma multiforme (GBM), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference on Brain Cancer
•Received FDA Clearance of IND Application for ERAS-801 in Recurrent Glioblastoma Multiforme: In December 2021, the United States Food and Drug Administration (FDA) cleared an investigational new drug (IND) application for ERAS-801
•Dosed First Patient in THUNDERBBOLT-1 Trial: In February 2022, Erasca dosed the first patient in THUNDERBBOLT-1, a Phase 1 trial evaluating ERAS-801 for the treatment of recurrent GBM
•Announced Six Poster Presentations at the 2022 AACR (Free AACR Whitepaper) Annual Meeting: In March 2022, Erasca announced six poster presentations, featuring programs with best-in-class potential, including ERK1/2 inhibitor ERAS-007, SHP2 inhibitor ERAS-601, and CNS-penetrant KRAS G12C inhibitor ERAS-3490. Erasca will be hosting an investor webinar on Tuesday, April 12, 2022, highlighting its 2022 AACR (Free AACR Whitepaper) presentations and featuring a presentation by key opinion leader Scott Kopetz, M.D., Ph.D., of MD Anderson Cancer Center

Corporate Highlights

•Added to the Nasdaq Biotechnology Index: In December 2021, Erasca was added to the NASDAQ Biotech Index (Nasdaq: NBI)
•Entered into an Early Collaboration with GCAR for ERAS-801: In December 2021, Erasca entered into an early collaboration with the Global Coalition for Adaptive Research (GCAR) to determine the feasibility of evaluating ERAS-801 as part of a seamless, international Phase 2/3 Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) trial sponsored by GCAR
•Strengthened Executive Leadership: In January 2022, Erasca appointed Lisa Tesvich-Bonora, Ph.D., as Chief People Officer and promoted Robert Shoemaker, Ph.D., to Senior Vice President of Research
•Entered into a Clinical Trial Collaboration and Supply Agreement with Lilly: Under this agreement, which Erasca announced in March 2022, Lilly will supply its EGFR inhibitor cetuximab (ERBITUX) at no cost in connection with a clinical proof-of-concept study evaluating ERAS-007 in combination with the BRAF inhibitor encorafenib and cetuximab for the treatment of patients with BRAF V600E-mutant metastatic colorectal cancer (CRC) as part of the ongoing Phase 1b/2 HERKULES-3 trial. This CTCSA complements the previously signed CTCSA with Pfizer for the BRAF inhibitor encorafenib (BRAFTOVI)

Key Upcoming Milestones

•HERKULES-1: Phase 1b/2 trial for ERAS-007/MAPKlamp in patients with advanced solid tumors
oInitial Phase 1b monotherapy data expected in second half of 2022
•HERKULES-3: Phase 1b/2 trial for ERAS-007 in patients with gastrointestinal (GI) malignancies
oInitial Phase 1b combination data expected between the fourth quarter of 2022 and the first half of 2023
•FLAGSHP-1: Phase 1/1b trial for ERAS-601 in patients with advanced solid tumors
oInitial Phase 1 monotherapy data expected in second half of 2022
oInitial Phase 1b combination data in triple wildtype (KRAS/NRAS/BRAF wildtype) CRC expected between the fourth quarter of 2022 and the first half of 2023
•ERAS-3490: CNS-penetrant KRAS G12C inhibitor
oIND filing expected in second half of 2022

Fourth Quarter and Full Year 2021 Financial Results

Cash Position: Cash, cash equivalents, and investments were $459.2 million as of December 31, 2021, compared to $118.7 million as of December 31, 2020. During 2021, Erasca completed an IPO raising net proceeds of $317.0 million, after deducting underwriting discounts, commissions, and other offering expenses. Erasca expects its current cash, cash equivalents, and investments balance to fund operations into 2024.

Research and Development (R&D) Expenses: R&D expenses were $24.1 million for the quarter ended December 31, 2021, compared to $10.1 million for the quarter ended December 31, 2020. The increase was primarily driven by expenses incurred in connection with clinical trials and preclinical studies, personnel costs due to increased headcount to support increased development activities, and outsourced services and consulting fees. Erasca also recorded $0 and $54.0 million of in-process research and development expense during the quarters ended December 31, 2021 and 2020 for upfront and milestone payments and stock issuances under certain of our acquisition and license agreements. R&D expenses were $73.9 million for the full year ended December 31, 2021, compared to $29.6 million for the full year ended December 31, 2020. Erasca also recorded $10.8 million and $71.7 million of in-process research and development expense during the full years ended December 31, 2021 and 2020, respectively, for upfront and milestone payments and stock issuances under certain of our acquisition and license agreements.

General and Administrative (G&A) Expenses: G&A expenses were $6.9 million for the quarter ended December 31, 2021, compared to $2.9 million for the quarter ended December 31, 2020. The increase was primarily driven by personnel costs, insurance costs, and facilities and related costs. G&A expenses were $22.6 million for the full year ended December 31, 2021, compared to $8.0 million for the full year ended December 31, 2020. For the full year ended December 31, 2021, $17.5 million was recorded as additional G&A expense for the common shares issued to the Erasca Foundation in conjunction with Erasca’s IPO.

Net Loss: Net loss was $30.5 million for the quarter ended December 31, 2021, compared to $61.9 million for the quarter ended December 31, 2020. For the full year ended December 31, 2021, Erasca reported a net loss of $122.8 million, inclusive of the $17.5 million in expense recorded for the common shares issued to the Erasca Foundation, or $(1.85) per basic and diluted share, compared to a net loss of $101.7 million, or $(4.83) per basic and diluted share, for the full year ended December 31, 2020.

On March 24, 2022 ​Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported financial results for the full year ended December 31, 2021 (Press release, Imago BioSciences, MAR 24, 2022, View Source [SID1234610887]).

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"I am very gratified by the clinical progress Imago has made in 2021, underlined by the positive and promising interim Phase 2 data in both essential thrombocythemia (ET) and myelofibrosis (MF) presented at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Additionally, Imago made great strides as a company with a successful initial public offering on Nasdaq and expansion of our Board," said Dr. Hugh Young Rienhoff, Jr., M.D, Chief Executive Officer of Imago BioSciences. "Looking ahead, we plan to further our clinical programs in 2022 and additionally anticipate initiating two investigator-sponsored clinical studies in the first half of the year: a Phase 1 study of bomedemstat in combination with atezolizumab for the treatment of small cell lung cancer, and a Phase 2 study of bomedemstat in combination with ruxolitinib for the treatment of MF. We are currently making preparations for a registrational study of bomedemstat for the treatment of ET, subject to the completion of the ongoing trial and a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in the second half of this year. Building on our strong progress in 2021 and balance sheet, we are eager to advance bomedemstat into a registrational study to address the serious needs of ET patients who are intolerant to hydroxyurea (HU) or have an inadequate response while also evaluating bomedemstat for other clinical indications."

Fourth Quarter 2021 and Subsequent Highlights

Presented Positive Data from Ongoing Phase 2 Study of Bomedemstat in Essential Thrombocythemia at ASH (Free ASH Whitepaper) 2021: In December 2021, Imago presented a positive data update at the 2021 ASH (Free ASH Whitepaper) Annual Meeting and Exposition from the ongoing Phase 2 clinical trial of bomedemstat in patients with essential thrombocythemia (ET). As a monotherapy in a 2nd line ET population, bomedemstat demonstrated significant and durable hematologic control and symptom improvement while maintaining normal hemoglobin levels. The updated data demonstrated bomedemstat reduced a platelet count in the normal range within eight weeks, a primary clinical objective. As of the data cut-off date in November, bomedemstat continued to be generally well-tolerated and demonstrated an encouraging safety profile in ET patients.

Presented Positive Data from Ongoing Phase 2 Study of Bomedemstat in Advanced Myelofibrosis at ASH (Free ASH Whitepaper) 2021: In December 2021, Imago presented a positive data update at the 2021 ASH (Free ASH Whitepaper) Annual Meeting and Exposition from the ongoing Phase 2 clinical trial of bomedemstat in patients with advanced myelofibrosis (MF). As of the data cut-off date in November, bomedemstat continued to be generally well-tolerated and demonstrated encouraging safety and distinct clinical benefit to patients, with 75% of the evaluable patients having a reduction in spleen volume from baseline.

Added Laurie Keating to Board of Directors: In November 2021, Imago appointed Laurie Keating, to its Board of Directors. Keating most recently served as Executive Vice President and Chief Legal Officer at Alnylam Pharmaceuticals where she led global public policy and government relations, legal, and intellectual property groups. She currently sits on the Board of Directors of Immuneering Corporation and chairs the Board of Directors of PepGen Inc. She has previously served as a director of privately held life sciences companies and MassBIO, a non-profit organization.

Added Michael Arenberg as Chief Operating and Business Officer: In March 2022, Mr. Arenberg joined the company after spending nearly 22 years at DURECT Corporation where he most recently served for the past three plus years as the company’s Chief Financial Officer. Before being appointed CFO, Mr. Arenberg held roles with increasing responsibilities including as Senior Vice President of Corporate and Business Development. Mr. Arenberg is a distinguished biopharmaceutical executive who will be charged with leading strategic operations, investor relations, commercial development and business development of Imago.

Appointed Laura G. Eichorn as Chief Financial Officer: Ms. Eichorn is a co-founding executive of Imago BioSciences who most recently served as our Chief Operating Officer and Interim Chief Financial Officer. She has more than 25 years of operational experience spanning finance, operations, human resources, and communications.
Fiscal Year 2021 Financial Results

Cash and Cash Equivalents: As of December 31, 2021, Imago had cash, cash equivalents, restricted cash and short-term investments of $217.4 million.

Research & Development (R&D) Expenses: R&D expenses were $11.7 million for the fourth quarter ended December 31, 2021 and $32.3 million for the full year ended December 31, 2021, as compared to $4.3 million for the quarter ended December 31, 2020, and $14.9 million for the full year ended December 31, 2020. The overall increase in R&D expense was related to continued development and manufacturing of drug supplies for our ongoing and planned clinical trials, continued clinical development activities due, in part, to increased consulting expenses added to support ongoing Phase 2 clinical trials in MF and ET, commencement of clinical pharmacology studies, commencement of a Phase 2 extension study for the continued treatment of patients currently enrolled in the ongoing ET and MF clinical trials, and an increase in personnel-related costs primarily due to growth in the number of research and development employees, including stock-based compensation expense, as we ramped up our operations.

General and Administrative (G&A) Expenses: G&A expenses were $3.1 million for the fourth quarter ended December 31, 2021 and $10.3 million for the full year ended December 31, 2021, as compared to $1.3 million for the quarter ended December 31, 2020 and $3.2 million for the full year ended December 31, 2020. The overall increase in G&A expense was primarily due to compensation and personnel-related costs, including stock-based compensation expense, and expenses associated with operating as a public company.

Net Loss: Net loss was $14.7 million for the fourth quarter ended December 31, 2021 and $42.3 million for the full year ended December 31, 2021, as compared to $5.6 million for the quarter ended December 31, 2020 and $17.8 million for the full year ended December 31, 2020.

On March 24, 2022 Scandion Oncology (Scandion) reported that the Annual Report 2021 is available on the company’s website (Press release, Scandion Oncology, MAR 24, 2022, View Source;annual-report-2021,c3531342 [SID1234610885]).

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The information was provided by the contact person above for publication on March 24, 2022, at 08.30 CET.

On March 24, 2022 Scenic Biotech reported Two independent studies were published this week on Scenic’s inflammation drug target QPCTL (Press release, Scenic Biotech, MAR 24, 2022, View Source [SID1234610883]). The studies were conducted by Genentech and Scenic’s SAB member Ton Schumacher at the Netherlands Cancer Institute. The publications provide proof of concept in preclinical models for the use of QPCTL inhibition in combination with other checkpoint inhibitors for the treatment of solid tumours.

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On March 24, 2022 Genagon Therapeutics reported that the European Patent Office has issued the Company European Patent No. 3568142, titled "Therapeutic Agents" (Press release, Genagon Therapeutics, MAR 24, 2022, View Source;utm_medium=rss&utm_campaign=patent-granted [SID1234610882]). The patent covers, among other things, the use of a polypeptide capable of binding to proteins in the TGFb superfamily. These claims protect inventions which are central to the Company’s programs for treating cancer and strengthen its main business focus.

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CEO Moa Fransson comments: "These claims protect inventions which are central to the Company’s programs for treating cancer and strengthen its main business focus".