On May 12, 2022 Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a clinical stage company developing drugs for patients who have unmet medical conditions that require better treatment options to improve a patient’s survival and/or quality of life, reported financial results for the quarter ended March 31, 2022, and provided an update on its clinical programs (Press release, Processa Pharmaceuticals, MAY 12, 2022, View Source [SID1234614356]).

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Dr. David Young, CEO and chairman of Processa, commented, "We are on track to get important data from all our clinical programs over the remainder of this year that will elucidate the path to registration for these programs that each have a market that could exceed $1 billion.

The amended protocol for Next Generation Capecitabine will provide insights into the de novo formation of DPD by mid-summer and allow us to get to the MTD by year-end;
Our expanded outreach to find and enroll patients in the PCS499 uNL trial has identified new potential patients to complete enrollment for our interim analysis cohort mid-summer and interim results by year-end;
Enrollment in PCS12852 is going well and is expected to fully enroll patients and provide top line results before the end of the year; and
We expect to complete the initial development on the macromolecule assays that will be evaluated as potential biomarkers for PCS3117 and confirm our Regulatory Path with FDA by the end of the year."
Financial Results for the Quarter Ended March 31, 2022

We continue to manage our cash efficiently and had a cash balance of $14.4 million at March 31, 2022. We believe this will allow us to complete our three on-going clinical trials and fund our operations into the third quarter of 2023. During the three months ending on March 31, 2022 we spent cash of $1.8 million in our clinical trials and operations.

For the three months ended March 31, 2022, we reported a net loss of $3.2 million, or $0.20 per share compared to a net loss of $2.1 million, or $0.14 per share for the same period of 2021. The increase in our net loss relates primarily to increased clinical trial costs we incurred.

During the three months ended March 31, 2022, we incurred research and development expenses totaling $2.0 million compared to $1.5 million for the same period in 2021. The increase in our R&D expenditures was primarily due to costs we incurred in our active clinical trials. Our general and administrative expenses totaled $1.2 million for the three months ended March 31, 2022 compared to $717 thousand for the same period in 2021. The increase related primarily to increases in non-cash stock-based compensation along with other operating and consulting costs. We allocated $829 thousand of non-cash compensation costs between our R&D and G&A expenses.

As of March 31, 2022, we had 15.8 million shares of common stock outstanding.

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On May 12, 2022 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported updates and financial results for the first quarter ended March 31, 2022 (Press release, Poseida Therapeutics, MAY 12, 2022, View Source [SID1234614355]).

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"2022 is shaping up to be an exciting year for the Company, as we work to demonstrate the differentiation of our CAR-T programs in the clinic and advance our wholly owned and partnered gene therapy programs towards IND-enabling studies," said Mark Gergen, Chief Executive Officer of Poseida. "We now have three clinical CAR-T programs recruiting and enrolling, including two allogeneic product candidates, P-MUC1C-ALLO1 and P-BCMA-ALLO1 for solid tumors and multiple myeloma, respectively, as well as our P-PSMA-101 autologous CAR-T program for metastatic castrate resistant prostate cancer. As we and the industry navigate current market dynamics, we are focused on efficient resource utilization and prioritization, including our decision in the first quarter to reduce autologous manufacturing capacity as we focus on the emergence of our allogeneic CAR-T programs. Additionally, we are fortunate to be advancing our platform technologies with partners such as Takeda, and we continue to evaluate other partnership opportunities that may allow us to pursue more opportunities and get access to resources and non-dilutive capital."

Program Highlights

CAR-T Programs

The Company currently has three ongoing CAR-T programs in the clinic. These include two allogeneic CAR-T programs progressing in Phase 1 clinical trials: P-BCMA-ALLO1, which is being evaluated in patients with relapsed/refractory multiple myeloma (R/R MM), and P-MUC1C-ALLO1, which is being evaluated in a wide range of solid tumors derived from epithelial cells, including breast and ovarian cancers. These programs are moving forward with planned clinical data updates in each allogeneic program in the second half of 2022. The Company is also advancing its autologous P-PSMA-101 product candidate being developed to treat patients with metastatic castrate-resistant prostate cancer (mCRPC) in an ongoing Phase 1 dose escalation trial.

Gene Therapy Programs

The Company is advancing multiple gene therapy programs in liver-directed diseases, including its wholly owned P-OTC-101 program for the in vivo treatment of the urea cycle disease caused by congenital mutations in the ornithine transcarbamylase (OTC) gene. The Company is currently determining the best path forward for this program and will update expected timing on program advancement once that evaluation is complete.

The Company is also advancing its P-FVIII-101 program partnered with Takeda Pharmaceuticals USA, Inc. (Takeda), which is in development for the in vivo treatment of Hemophilia A. P-FVIII-101

utilizes piggyBac gene modification delivered via lipid nanoparticle and has demonstrated stable and sustained Factor VIII expression in animal models.

Financial Results for the First Quarter 2022

Revenues

Revenues were $1.4 million for the first quarter ended March 31, 2022, consisting of revenue earned from the collaboration and license agreement with Takeda that the Company entered into in the fourth quarter of 2021, compared to no revenue for the same period in 2021.

Research and Development Expenses

Research and development expenses were $48.9 million for the first quarter ended March 31, 2022, compared to $29.1 million for the same period in 2021. The increase was primarily related to a $8.1 million expense related to the Company’s decision to discontinue future manufacturing at one of the Company’s autologous contract manufacturers, as well as an increase in personnel expenses due to an increase in headcount, which included a $0.7 million increase in stock-based compensation expense, an increase in external costs related to the Company’s clinical stage programs due to an increased number of clinical trials ongoing, including enrollment, manufacturing and license fees for the P-PSMA-101 Phase 1 clinical trial, the P-BCMA-ALLO1 Phase 1 clinical trial and P-MUC1C-ALLO1 Phase 1 clinical trial, and an increase in external costs related to the Company’s preclinical stage programs.

General and Administrative Expenses

General and administrative expenses were $9.5 million for the first quarter ended March 31, 2022, compared to $8.4 million for the same period in 2021. The increase was primarily related to an increase in personnel expenses due to an increase in headcount, which included a $0.7 million increase in stock-based compensation expense.

Net Loss

Net loss was $58.1 million for the first quarter ended March 31, 2022 compared to net loss of $38.3 million for the same period in 2021.

Cash Position

As of March 31, 2022, the Company’s cash and cash equivalents balance was $183.5 million.

On May 12, 2022 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune and inflammatory diseases, reported financial results for the first quarter ended March 31, 2022 (Press release, Alpine Immune Sciences, MAY 12, 2022, View Source [SID1234614353]).

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"Our clinical pipeline of novel autoimmune and immuno-oncology candidates continues to make significant progress, as highlighted by the promising monotherapy dose escalation data presented at AACR (Free AACR Whitepaper) for davoceticept, a first-in-class CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies and monotherapy expansion cohorts are currently open for enrollment," said Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. "For ALPN-303, our next-generation dual BAFF/APRIL inhibitor, we look forward to sharing preliminary data from our phase 1 healthy volunteer study as part of a poster at the 2022 EULAR congress and to initiating patient-based studies by the end of 2022."
First Quarter 2022 and Recent Pipeline Updates
•Davoceticept monotherapy dose escalation data (NEON-1) presented in an oral mini-symposium at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, demonstrating tumor volume reduction in 23% of evaluable participants despite a highly heterogeneous, heavily pretreated, advanced solid tumor population. Monotherapy expansion cohorts are currently open for enrollment.
•Key preclinical rationale for davoceticept published in Nature Communications, showing its novel, first-in-class approach to engaging CD28 to enhance activation of T cells and drive anti-tumor activity.
•NEON-2 trial of davoceticept in combination with pembrolizumab placed on a partial clinical hold. Participants previously enrolled in the NEON-2 trial were able to continue to receive study drug; the NEON-1 monotherapy trial was not affected.
•Preliminary data for the first-in-human, phase 1 study of ALPN-303 in healthy volunteers to be presented as part of a poster at the 2022 European Alliance of Associations for Rheumatology (EULAR) Congress. Initiation of a phase 2 study in systemic lupus erythematosus (SLE) and at least one basket study in renal, hematologic and/or dermatologic indications planned by the end of 2022.
First Quarter 2022 Financial Results
As of March 31, 2022, we had cash, cash equivalents, and investments totaling $219.1 million. Net cash provided by operating activities for the quarter ended March 31, 2022 was $5.4 million compared to net cash used in operating activities of $16.0 million for the quarter ended March 31, 2021. Cash provided by operating activities was driven by the receipt of a $25.0 million upfront payment from Horizon, which was recorded as current and noncurrent deferred revenue on our Condensed Consolidated Balance Sheets. The Company recorded net losses of $7.5 million and $10.6 million for the quarters ended March 31, 2022 and 2021, respectively.
Collaboration revenue for the first quarter ended March 31, 2022 was $13.6 million compared to $3.2 million for the first quarter ended March 31, 2021. The 2022 amounts were attributable to revenue recognized under our AbbVie and Horizon Agreements, while 2021 revenue recognized solely relates to AbbVie.
Research and development expenses for the first quarter ended March 31, 2022 were $16.3 million compared to $10.4 million for the first quarter ended March 31, 2021. The increase was primarily attributable to our Synergy, NEON, and ALPN-303 studies, and increased personnel costs and direct research activities. These increases were partially offset by a decrease in contract manufacturing and process development for ALPN-303.
General and administrative expenses for the first quarter ended March 31, 2022 were $4.8 million compared to $3.3 million for the first quarter ended March 31, 2021. The increase was primarily attributable to increases in personnel costs.
The Company expects that its current cash resources will be sufficient to fund its planned operations into 2024.

On May 12, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported business highlights and financial results for the first quarter ended March 31, 2022 (Press release, Arcellx, MAY 12, 2022, View Source [SID1234614352]).

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"This is an exciting time for our company as we successfully completed our initial public offering in February, raising $142 million in gross proceeds and strengthened our balance sheet as we advance our pioneering platform to treat cancer and other incurable diseases," said Rami Elghandour, Arcellx’s chairman and chief executive officer. "In our first quarter as a public company, we continued to lay the foundation for our near-term and long-term success and our dedicated team made meaningful strides towards our 2022 milestones. We are looking forward to presenting additional patient and longer-term follow-up data on approximately 25 patients for our lead CART-ddBCMA program for patients with relapsed or refractory multiple myeloma (r/r MM) during an oral presentation at ASCO (Free ASCO Whitepaper) in June. Recently, we also advanced our development pipeline programs with the dosing of the first patient in our Phase 1 study evaluating ACLX-001 for patients with r/r MM utilizing our ARC-SparX technology. ARC-SparX has the potential to overcome some of the core challenges in cell therapy by reducing toxicities and addressing antigen heterogeneity, opening up significant market opportunities in harder to treat indications. In the second half of this year, we look forward to initiating our Phase 1 ARC-SparX clinical trial in patients with acute myeloid leukemia and high-risk myelodysplastic syndrome, our Phase 2 CART-ddBCMA pivotal trial in patients with r/r MM, and presenting longer-term patient data from our Phase 1 CART-ddBCMA expansion trial in r/r MM. The capstone of our progress is driven by our D-Domain technology which allows us to choose the right approach for the right indication, and we believe this differentiates our programs from traditional CAR-T therapies."

Recent Business Highlights

Clinical results from CART-ddBCMA Phase 1 study published in Blood Advances. On May 9, 2022, Arcellx announced the publication of clinical results from the dose escalation cohorts of its CART-ddBCMA Phase 1 study in patients with r/r MM in Blood Advances, the open-access journal of the American Society of Hematology (ASH) (Free ASH Whitepaper). The data demonstrate 100% ORR and 75% CR/sCR; and evidence of durable clinical benefit in a population with poor prognostic features were observed in the dose escalation cohorts with CART-ddBCMA. The full online publication can be accessed here.

Dosed first patient in Phase 1 clinical trial evaluating ACLX-001 utilizing the ARC-SparX platform for the treatment of patients with r/r MM. On May 10, 2022, Arcellx announced that the first patient was dosed in its open-label, multicenter Phase 1 clinical trial (NCT04155749) to evaluate the company’s novel dosable and controllable ARC-SparX program in patients with r/r MM. ARC-SparX is comprised of SparX (soluble protein antigen receptor X-linkers) proteins engineered to target BCMA on myeloma cells together with ARC-T (Antigen Receptor Complex-T) cells that are dosed separately and engineered to activate only when engaged with a SparX protein bound to a myeloma cell. Both the ARC cells and the SparX proteins utilize the company’s proprietary novel synthetic binding scaffold called the D-Domain.

CART-ddBCMA accepted as an oral abstract presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. On April 27, 2022, Arcellx announced the presentation of new clinical data from its CART-ddBCMA Phase 1 trial in patients with relapsed or refractory multiple myeloma in an oral abstract session at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7, 2022, in Chicago, Illinois.

Oral Presentation Details:

Title: Phase 1 Study of CART-ddBCMA in Relapsed or Refractory Multiple Myeloma
Speaker: Matthew J. Frigault, M.D., Assistant Director of the Cellular Therapy Service at Massachusetts General Cancer Center, and Instructor at Harvard Medical School
Session Type/Title: Oral Abstract Session/Hematologic Malignancies—Plasma Cell Dyscrasia
Session Date: Sunday, June 5, 2022
Session Time: 8:00 a.m. – 11:00 a.m. CDT
Location: McCormick Place Convention Center, Chicago, Illinois
Abstract Number: 8003

Live webcast event with management and panel of clinician experts. On Sunday, June 5, 2022, at 7:00 p.m. CDT, Arcellx will host a live webcast event with an expert panel of clinicians to discuss the clinical results from its CART-ddBCMA study being presented during ASCO (Free ASCO Whitepaper). The event will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcast will be archived and available for 30 days following the event.

First Quarter 2022 Financial Highlights

Cash, cash equivalents, and marketable securities:
As of March 31, 2022, Arcellx had cash, cash equivalents, and marketable securities of $210.9 million, which is anticipated to fund its operations into the second half of 2023.

R&D expenses:
Research and development expenses were $24.4 million and $8.5 million for the quarters ended March 31, 2022 and 2021, respectively, an increase of $15.9 million. This increase was driven by higher external costs associated with the advancement of our CART-ddBCMA clinical program, preclinical development of our other pipeline candidates, and increased headcount.

G&A expenses:
General and administrative expenses were $8.0 million and $2.8 million for the quarters ended March 31, 2022 and 2021, respectively, an increase of $5.2 million. This increase was driven by increased headcount, professional fees related to consulting and accounting, audit services, and other expenses.

Net loss:
Net loss was $32.4 million and $11.3 million for the quarters ended March 31, 2022 and 2021, respectively.

About the ARC-SparX Platform Technology
The ARC-SparX platform is designed to allow for controllability and adaptability to potentially reduce toxicities that are often associated with serious dose-limiting adverse events and to overcome tumor heterogeneity. It is a modular therapy which utilizes a universal ARC-T cell combined with an off-the-shelf SparX protein to separate the tumor-recognition and tumor-killing functions. SparX (soluble protein antigen-receptor X-linkers) proteins utilize our D-Domain technology engineered to recognize antigens on the surface of diseased cells and flags those cells for detection by the ARC-T cells. ARC-T cells express a D-Domain-based CAR engineered to specifically recognize a unique TAG in the SparX protein. ARC-T cells are dosed separately and only activated to kill the target cell when they encounter a SparX protein bound to the target antigen and thus are controlled through SparX dose modulation. Arcellx has developed a collection of SparX proteins that bind different antigens on the surface of diseased cells. Multiple SparX proteins with different antigen specificity can be administered to potentially address antigen heterogeneity or antigen escape that contribute to relapsed and refractory disease.

On May 12, 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 March 31, 2022, and provided business updates (Press release, Erasca, MAY 12, 2022, View Source [SID1234614351]).

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"This quarter, we continued to advance our pipeline well. In addition to progressing our ERK1/2 inhibitor ERAS-007 and our SHP2 inhibitor ERAS-601 in their respective clinical trials, we also achieved first patient dosing for our CNS-penetrant EGFR inhibitor ERAS-801," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "We presented preclinical data in six posters at this year’s AACR (Free AACR Whitepaper) meeting supporting the clinical development of our potentially best-in-class programs, including ERAS-007, ERAS-601, and ERAS-3490 (CNS-penetrant KRAS G12C inhibitor). We were delighted to host a webinar with Dr. Scott Kopetz from MD Anderson Cancer Center discussing the unmet need and therapeutic opportunities targeting cancers driven by the RAS/MAPK pathway, with a particular focus in gastrointestinal cancers."

Dr. Lim continued, "We remain on track to report Phase 1b monotherapy data for ERAS-007 in HERKULES-1 and Phase 1 monotherapy data for ERAS-601 in FLAGSHP-1 in the second half of 2022. These data will include preliminary monotherapy safety and pharmacokinetics to support dose selection for combinations of ERAS-007 and ERAS-601. We also remain on track to file an IND for ERAS-3490 in the second half of 2022. As we look ahead, our pipeline continues to demonstrate encouraging therapeutic potential, our cash position remains strong, and we are highly focused on continued execution throughout the year."

Research and Development Highlights

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 glioblastoma multiforme (rGBM)

Presented Six Posters at the 2022 AACR (Free AACR Whitepaper) Annual Meeting: In April 2022, Erasca presented six poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. These posters featured data supporting the clinical development of programs with best-in-class potential, including ERK1/2 inhibitor ERAS-007, SHP2 inhibitor ERAS-601, and central nervous system (CNS)-penetrant KRAS G12C inhibitor ERAS-3490

Hosted KOL Investor Webinar on AACR (Free AACR Whitepaper) Data: In April 2022, Erasca hosted an investor webinar highlighting its 2022 AACR (Free AACR Whitepaper) presentations and featuring a presentation by key opinion leader (KOL) Scott Kopetz, M.D., Ph.D., of MD Anderson Cancer Center

Corporate Highlights

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 (CTCSA) with Lilly: In March 2022, Erasca announced that it had entered into a CTCSA under which 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 agreement complements the CTCSA previously entered into with Pfizer for Pfizer’s BRAF inhibitor encorafenib (BRAFTOVI)

Expanded Board of Directors: In April 2022, Erasca appointed Jean Liu to its board of directors and to its audit committee

Opened New Corporate Headquarters: In April 2022, Erasca opened its new corporate headquarters in San Diego, CA, to accommodate and unify an expanded employee base

Key Upcoming Milestones

HERKULES-1: Phase 1b/2 trial for ERAS-007 in patients with advanced solid tumors
o
Initial Phase 1b monotherapy data expected in second half of 2022

HERKULES-3: Phase 1b/2 trial for ERAS-007 in patients with gastrointestinal malignancies

Initial 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

Initial Phase 1 monotherapy data expected in second half of 2022

Initial 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

IND filing expected in second half of 2022

First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $421.8 million as of March 31, 2022, compared to $459.2 million as of December 31, 2021. Erasca expects its current cash, cash equivalents, and marketable securities to fund operations into the second half of 2024.

Research and Development (R&D) Expenses: R&D expenses were $27.4 million for the quarter ended March 31, 2022, compared to $12.2 million for the quarter ended March 31, 2021. The increase was primarily driven by expenses incurred in connection with clinical trials, preclinical studies, and discovery activities, personnel costs due to increased headcount to support increased development activities, stock-based compensation expense, and outsourced service and consulting fees. Erasca also recorded

$2.0 and $3.7 million of in-process R&D expense during the quarters ended March 31, 2022 and 2021, 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 $7.1 million for the quarter ended March 31, 2022, compared to $3.7 million for the quarter ended March 31, 2021. The increase was primarily driven by stock-based compensation expense, insurance costs, personnel costs, and facilities and related costs.

Net Loss: For the quarter ended March 31, 2022, Erasca reported a net loss of $36.5 million, or $(0.31) per basic and diluted share, compared to a net loss of $18.0 million, or $(0.81) per basic and diluted share, for the quarter ended March 31, 2021.