On March 24, 2022 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that the Company has dosed the first patient in ADVANCED-1, its Phase 1 clinical trial evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of non-muscle invasive bladder cancer (NMIBC) (Press release, Protara Therapeutics, MAR 24, 2022, View Source [SID1234610899]).

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"NMIBC is one of the most recurrent and difficult to treat cancers with very limited treatment options," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "We are thrilled to have dosed the first patient in our Phase 1 study in NMIBC and look forward to exploring TARA-002’s full potential in this pressing area of high unmet need."

ADVANCED-1 is a Phase 1 dose-finding, open-label trial (NCT05085977) evaluating TARA-002 in treatment-naïve and treatment-experienced NMIBC patients with high-grade carcinoma in situ (CIS) and high-grade papillary tumors (Ta). In the initial dose escalation phase of the trial, patients will receive six weekly intravesical doses of TARA-002. The primary objective of the trial is to evaluate the safety, tolerability and preliminary signs of anti-tumor activity of TARA-002, with the goal of establishing a recommended dose for a planned Phase 2 clinical trial.

"While bladder cancer is the 6th most common cancer in the United States today, with NMIBC representing approximately 80% of diagnoses, treatment options for these patients remain limited," said Edward M. Messing, M.D., Professor of Urology, Oncology and Pathology at the University of Rochester, and a principal investigator for the study. "There is an urgent need for new therapeutic interventions for these patients, as there continues to be an increase in recurrence, progression and an escalated number of patients needing cystectomies."

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and LMs for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan and Taiwan by Chugai Pharmaceutical Co., Ltd. Protara has successfully demonstrated manufacturing comparability between TARA-002 and OK-432.

When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a strong immune cascade. Neutrophils, monocytes and lymphocytes infiltrate the abnormal cells and various cytokines, including interleukins IL-2, IL-6, IL-8, IL-10, IL-12, interferon (IFN)-gamma, tumor necrosis factor (TNF)-alpha, granulocyte colony-stimulating factor, and granulocyte-macrophage colony-stimulating factor are secreted by immune cells to induce a strong local inflammatory reaction and destroy the abnormal cells.

About Non-Muscle Invasive Bladder Cancer

Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

On March 24, 2022 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, reported that management will participate in a fireside chat and presentation at the Innate Killer Summit 2022 being held in San Diego, CA from Wednesday, March 30 – Friday, April 1, 2022 (Press release, Wugen, MAR 24, 2022, View Source [SID1234610898]).

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The details of Wugen’s fireside chat and presentation are as follows:

• Format: Industry Leader’s Fireside Chat

Presenter: Dan Kemp, Ph.D., President and Chief Executive Officer, Wugen
Date & Time: Thursday, March 31, 2022 at 8:15 a.m. PT

• Format: Presentation titled "Characterizing an Ideal NK Cell Phenotype Leveraging Assays to Indicate Therapeutic Benefit"

Presenter: Ayman Kabakibi, Ph.D., Chief Operating Officer & Executive Vice President, Research & Development, Wugen
Date & Time: Thursday, March 31, 2022 at 11:30 a.m. PT

About WU-NK-101

WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness that makes it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary MonetaTM platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML) and solid tumors.

On March 24, 2022 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Werewolf Therapeutics, MAR 24, 2022, View Source [SID1234610895]).

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"This has been an exciting year for Werewolf as we executed our public offering and advanced our novel INDUKINE molecule pipeline. We expect to file the IND for our first candidate, WTX-124, in the second quarter of 2022, and the IND for our second candidate, WTX-330, early in the third quarter of 2022. The anticipated initiation of these clinical studies remains consistent with our previous expectations," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "We are pleased with the progress that we made in our first year as a public company and expect that 2022 will be a pivotal year for the Company as we anticipate entering the clinic and continue to progress our pipeline."

2021 Highlights
Completed upsized Initial Public Offering: In May 2021, Werewolf completed its Initial Public Offering (IPO) of 7,500,000 shares of common stock at a public offering price of $16.00 per share. Gross proceeds from the IPO were $120 million and net proceeds from the offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $109.2 million.
Entered clinical trial collaboration with Merck for Werewolf’s WTX-124 INDUKINE program: In August 2021, Werewolf announced that it entered into a clinical trial collaboration agreement with Merck, known as MSD outside the United States and Canada, to evaluate WTX-124, a systemically-delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE molecule, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, as a treatment for patients with solid tumors. The planned clinical trial will be conducted by Werewolf and is designed to evaluate the safety and preliminary efficacy of WTX-124 as a monotherapy and in combination with KEYTRUDA in patients with solid tumors.
Presented preclinical data on WTX-124, WTX-330, and WTX-613 at SITC (Free SITC Whitepaper) Annual Meeting: In November 2021, Werewolf presented preclinical data during the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) demonstrating the potential of INDUKINE molecules to drive targeted anti-tumor immune responses. Posters were presented for Werewolf’s three lead molecules : "WTX-124 is a novel IL-2 pro-drug that is conditionally activated in tumors and drives anti-tumor immunity in murine syngeneic cancer models;" "WTX-330, a conditionally activated IL-12 INDUKINE therapy, releases IL-12 selectively in the tumor microenvironment to activate anti-tumor immune responses and induce regressions in mouse tumor models" and; "WTX-613, a conditionally activated IFNα INDUKINE

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molecule, induces anti-tumor immune responses resulting in strong tumor growth control in syngeneic mouse tumor models."
The results from the presented studies for WTX-124 and WTX-330 will be included in the investigational new drug (IND) applications.
Presented INDUKINE Data at ASH (Free ASH Whitepaper) Annual Meeting: In December 2021, Werewolf presented preclinical data during the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrating interleukin-12 (IL-12) and interferon-α (IFNα) INDUKINE molecules inhibited syngeneic lymphoma tumor growth in mice, induced anti-tumor immune responses and were tolerated in non-human primates.
The preclinical data for the IL-12 and IFNα INDUKINE molecules demonstrated anti-tumor activity in the A20 B cell lymphoma model and the EG7.OVA T lymphoblast model. Both treatments were well tolerated by the mice at active dose levels. The IL-12 and IFNα INDUKINE molecules also strongly activated key immune cell populations in treated tumors, confirming the immune mechanism of anti-tumor activity.
Strengthened Board of Directors with the Addition of Two Industry Leaders: In May 2021, Werewolf appointed Mike Sherman to the Company’s Board of Directors. Mr. Sherman brings over 30 years of experience in advancing therapeutics to commercial launch and driving successful operations and strategic transactions.
Additionally, in October 2021, the Company appointed Meeta Chatterjee, Ph.D., to its Board of Directors. With over 30 years of broad strategic and operational experience, Dr. Chatterjee brings deep and proven expertise across biopharmaceutical R&D, operations, corporate strategy, and business development.
Enhanced Management and Operations Teams: In June 2021, the Company appointed Chulani Karunatilake, Ph.D., as Chief Technology Officer. Dr. Karunatilake brings more than 30 years of experience in Chemistry and Manufacturing Controls (CMC) process and strategy development and will oversee manufacturing operations in the newly formed role.
Since joining Werewolf, Dr. Karunatilake has built a CMC team with expertise to complement the world-class clinical organization led by Dr. Randi Isaacs, Werewolf’s CMO.
Added to the Nasdaq Biotechnology Index: In December 2021, Werewolf announced that it had been added to the Nasdaq Biotechnology Index. The Nasdaq Biotechnology Index (NBI) is designed to measure the performance of a set of securities listed on The Nasdaq Stock Market that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB). The Nasdaq Biotechnology Index is calculated under a modified market capitalization-weighted methodology. Companies in the Nasdaq Biotechnology Index must meet eligibility requirements, including minimum market capitalization, average daily trading volume and seasoning as a public company, among other criteria. Nasdaq selects constituents once annually in December.
Financial Results for the Fourth Quarter and Full Year 2021
•Cash position: As of December 31, 2021, cash and cash equivalents were $157.5 million, compared to $92.6 million as of December 31, 2020. The increase was primarily due to the receipt of $109.2 million in net proceeds from the initial public offering completed in May 2021, offset by operating expenses incurred during the period. Werewolf expects its existing cash and cash equivalents to enable the funding of its operating expenses and capital expenditure requirements through at least the second quarter of 2023.
•Research and development expenses: Research and development expenses were $13.4 million for the fourth quarter of 2021, compared to $5.3 million for the same period in 2020. Research

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and development expenses were $35.3 million for the full year 2021, compared to $16.6 million for the full year 2020. The increase in research and development expenses was primarily due to increased manufacturing, contract research organization, and personnel expenses incurred to advance the Company’s product candidates WTX-124, WTX-330 and WTX-613 and expand research and development activities.
•General and administrative expenses: General and administrative expenses were $4.5 million for the fourth quarter of 2021, compared to $2.1 million for the same period in 2020. General and administrative expenses were $14.8 million, compared to $5.8 million for the full year 2020. The increase in general and administrative expenses was primarily due to increased personnel, professional services, and other operating costs attributable to operating as a public company and the progression towards clinical development.
•Net loss: Net loss was $17.9 million for the fourth quarter of 2021, compared to $7.4 million for the same period in 2020. Net loss was $50.0 million for the full year 2021, compared to $15.0 million for the full year 2020.

On March 24, 2022 MEI Pharma, Inc. (NASDAQ: MEIP) and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), reported an update after a recent meeting with the U.S. Food Drug Administration (FDA) to discuss the pursuit of a marketing authorization for zandelisib, a phosphatidylinositol-3-kinase ("PI3K") inhibitor drug candidate, via the accelerated approval pathway under 21 CFR Part 314.500, Subpart H, based on data generated by the single arm Phase 2 TIDAL study (Press release, Kyowa Hakko Kirin, MAR 24, 2022, View Source [SID1234610893]). In the meeting, the FDA informed the companies of its position that a randomized trial is now needed to adequately assess drug efficacy and safety of PI3K inhibitor drug candidates, including zandelisib. Based on this view, the agency discouraged a filing based on the Phase 2 TIDAL study data and emphasized that the companies continue efforts with the ongoing, randomized Phase 3 COASTAL study as planned. Accordingly, in line with the FDA’s recommendation, the companies do not plan to submit an FDA marketing application based on the single arm Phase 2 TIDAL study. In addition, while the FDA stated that safety on the 60 mg intermittent schedule appears reasonable, it recommended continued dose exploration to further support the current dose and regimen.

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"The FDA’s current position on the assessment of benefit and risk of PI3K inhibitors solely based on single arm studies appears to have evolved, as evidenced by the position the FDA communicated at the recent meeting on zandelisib, and the upcoming ODAC meeting scheduled for April 21, 2022 to discuss whether randomized data should be required for the class of PI3K inhibitors to demonstrate appropriate evidence of efficacy and safety," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Clearly, the outcome of our recent FDA meeting is a disappointing development. Nonetheless we will continue to focus on the ongoing Phase 3 COASTAL study as we consider options that provide the most expeditious approval pathway utilizing randomized data, and which we believe will demonstrate the potential of zandelisib to help patients. Today’s announcement in no way diminishes our conviction to the development of zandelisib and the promise of its emerging clinical profile. Based on current projections, MEI believes we have sufficient cash for operations to complete the COASTAL study enrollment in 2024."

Dr. Gold continued: "In partnership with Kyowa Kirin, we remain committed to the ultimate potential of zandelisib to address important medical needs as a single agent or in combination with other therapies providing physicians, and their patients, important new treatment options. We plan on completing evaluation of the Phase 2 TIDAL study, and look forward to sharing final data later this year to further advance an understanding of zandelisib’s clinical utility."

"Our dialogue with the FDA has updated our understanding of the evolving regulatory view of the PI3K inhibitor drug class. With this knowledge, we can focus our efforts to advance the COASTAL program," said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D of Kyowa Kirin. "Our teams around the world have made steady progress to enroll patients and give us important momentum. Together with MEI Pharma, we will continue to work with the investigators, patients, and advocacy organizations to drive continued progress."

About 21 CFR Part 314.500, Subpart H
Under 21 CFR Part 314.500, Subpart H, a drug candidate may be eligible for accelerated approval if it is intended to treat a serious or life-threatening disease or condition, and the product would provide meaningful therapeutic benefit over existing treatments. Under accelerated approval, a product may be approved based on adequate and well-controlled clinical studies establishing that the product has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on the basis of an effect on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefits. As a condition of approval, the FDA may require that a sponsor receiving accelerated approval perform adequate and well-controlled post-marketing clinical studies to verify the predicted clinical benefit.

The FDA historically granted accelerated approval to PI3K inhibitors under 21 CFR Part 314.500, Subpart H for relapsed or refractory follicular and marginal zone lymphomas. Such approvals were granted with the expectation that confirmatory Phase 3 studies producing randomized data would follow the approval. Generally the FDA has expressed a preference for randomized trials however, the recent meeting with the FDA was the first instance that the agency informed the companies that data from a single arm study, such as the Phase 2 TIDAL clinical study, would not be adequate to evaluate benefit and risk under 21 CFR Part 314.500, Subpart H and that a randomized study is required to support a potential accelerated approval.

About Zandelisib
Zandelisib, a selective PI3Kδ inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies. Clinical trials are investigating the efficacy and safety of zandelisib as a single agent and in combination with other modalities while administered on an Intermittent Dosing Regimen (IDT). The IDT leverages molecular and biologic properties specific to zandelisib.

In November 2021, MEI Pharma announced data from ongoing Phase 2 TIDAL study (NCT03768505) evaluating zandelisib as a single agent for follicular lymphoma (FL) patients who received at least two prior systemic therapies. Zandelisib demonstrated a 70.3% objective response rate (ORR) as determined by Independent Review Committee (IRC) assessment in the primary efficacy population (n=91). In addition, 35.2% of patients achieved a complete response. At the time of the data cutoff, the data were insufficiently mature to accurately estimate duration of response (DOR). In line with previously reported data from the Phase 1B study, zandelisib was generally well tolerated. With 9.4 months (range: 0.8-24) median duration of follow-up in the total study population (n=121), interim data demonstrated a discontinuation rate due to any drug related adverse event of 9.9%. Patients enrolled in the study will continue to be followed for safety and DOR.

Ongoing zandelisib studies include the cohort in TIDAL evaluating patients with R/R marginal zone lymphoma (MZL) and continuing follow up in the cohort of the study evaluating patients with R/R FL. Also ongoing is the Phase 3 COASTAL study (NCT04745832) comparing zandelisib plus rituximab to standard of care chemotherapy plus rituximab, in patients with R/R FL or MZL who received more than one prior line of therapy, which must have included an anti-CD20 antibody in combination with chemotherapy or lenalidomide. COASTAL is intended to support marketing applications in the U.S. and globally.

Other ongoing studies include a Phase 2 pivotal study in Japan (NCT04533581) in patients with indolent B-cell non-Hodgkin’s lymphoma (iNHL) without small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), and Waldenström’s macroglobulinemia (WM) conducted by Kyowa Kirin.

In March 2020, the FDA granted zandelisib Fast Track designation for the treatment of adult patients with R/R follicular lymphoma who have received at least two prior systemic therapies. In November 2021, the FDA granted zandelisib Orphan Drug designation for the treatment of patients with follicular lymphoma.

In April 2020, MEI and Kyowa Kirin entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib. MEI and Kyowa Kirin will co-develop and co-promote zandelisib in the U.S., with MEI booking all revenue from the U.S. sales. Kyowa Kirin has exclusive commercialization rights outside of the U.S.

Conference Call and Webcast
MEI Pharma will host a conference call and webcast on March 24, 2022 at 4:30pm Eastern Time. To access the live call, please dial 1-833-974-2378 (United States) or 1-412-317-5771 (International). Please ask to join the MEI Pharma call. The event is also available via a live audio webcast at this link, and on the Investors section of MEI’s website at View Source A replay of the webcast will be archived on MEI’s website for at least 30 days following the event.

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.