On May 9, 2024 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported financial results for the first quarter ended March 31, 2024 and provided recent corporate and clinical updates (Press release, Gritstone Bio, MAY 9, 2024, View Source [SID1234642990]).

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"The preliminary Phase 2 data we recently shared are very promising as they suggest that GRANITE is potentially driving benefit in metastatic CRC patients and that our objective of unlocking immunologically ‘cold’ tumors to the benefits of immunotherapy may be within reach," said Andrew Allen, MD, PhD, Co-founder, President & CEO of Gritstone bio. "The emerging trend in progression-free survival, that we anticipate will strengthen as data mature, is particularly encouraging as it puts us in a strong position to potentially engage regulators later this year regarding a Phase 3 study for this common and difficult to treat disease. If successful, we see great potential for GRANITE to expand the scope of immunotherapy and bring meaningful clinical benefit to patients with metastatic CRC as well as other ‘cold’ tumors."

Dr. Allen added, "The progress in, and recognition of our other programs and capabilities is also encouraging. The recent paper in Nature Medicine highlights the scientific rigor with which we built our SLATE platform, describes the discovery of a previously unknown hierarchy of neoantigen immunodominance, and underscores the promise for the ongoing collaboration with Dr. Rosenberg of the NCI to evaluate our SLATE-KRAS vaccine in combination with an autologous T cell therapy. We also continue to push the boundaries of neoantigen identification with EDGE, our powerful AI-driven platform, that can now predict presentation of HLA Class I neoantigens with what we believe to be field-leading accuracy."

Corporate Updates

In April 2024, Gritstone completed an underwritten public offering resulting in gross proceeds of $32.5 million.
In April 2024, Gritstone appointed Stephen Webster to its Board of Directors. A veteran finance executive with over 30 years in the biotechnology industry, Mr. Webster has held several key roles and been involved in multiple strategic transactions. Mr. Webster was the Chief Financial Officer of Spark Therapeutics from July 2014 until its acquisition by Roche for $4.3 billion in December 2019.
Clinical Program Updates
Tumor-Specific Neoantigen Oncology Programs (GRANITE and SLATE)
GRANITE – Personalized neoantigen vaccine program
SLATE – "Off-the-shelf" neoantigen vaccine program

Preliminary results (n = 67) from the randomized Phase 2 study evaluating GRANITE as a front-line maintenance therapy in metastatic microsatellite-stable colorectal cancer (MSS-CRC) demonstrated a favorable trend in progression-free survival (PFS). Long-term circulating tumor DNA (ctDNA) data align with PFS trend and favor GRANITE vs. control patients.
Trend of extended PFS in GRANITE-treated vs. control patients, with greatest difference observed in high-risk group1 where clinical data are more mature.
Hazard ratio of 0.82 (18% relative risk reduction of progression or death with GRANITE vs. control) in the overall population, where clinical data are less mature ([95% CI, 0.34-1.67]; 62% censored)
Hazard ratio of 0.52 (48% relative risk reduction of progression or death with GRANITE vs. control) in a high-risk group1, where clinical data are more mature ([95% CI, 0.15-1.38]; 44% censored)
1High-risk subgroup defined as baseline ctDNA above the median value (2%) for the control group (ctDNA quantified as mean variant allele frequency [VAF] at time of study randomization).

Long-term ctDNA data align with PFS trend and favor GRANITE-treated vs. control patients
Analysis in the high-risk group1 showed that between first blood draw (time of randomization) and last blood draw (most recent study visit), ctDNA shifted from high (>2% VAF) to low (≤2% VAF) in 56% (9/16) of GRANITE patients vs 22% (2/9) of control patients. Progressive disease was observed in 44% (7/16) vs 78% (7/9), respectively, within this group.
Analysis in low-risk group (ctDNA negative group) showed sustained ctDNA negativity was observed in 67% (6/9) GRANITE recipients vs 38% (3/8) control patients. PD observed in 11% (1/9) and 38% (3/8) of these patients, respectively.
Gritstone expects to share mature PFS data and additional long-term ctDNA data in the third quarter of 2024.
In April 2024, Gritstone presented an update on its state-of-the-art neoantigen prediction platform, EDGE, at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego, CA. EDGE now predicts HLA Class I presentation, associated with CD8+ T cell induction, with >80% accuracy, a performance level that Gritstone believes to be leading the field. Gritstone is also advancing EDGE-II, a new model that has achieved superior predictive performance of HLA Class II presentation and CD4+ immunogenicity over publicly available models. The improvements leverage advances in protein large language models and in-house immunopeptidomics.

In March 2024, Nature Medicine published a paper detailing the development of our "off-the-shelf" neoantigen platform, SLATE. The paper described a novel immunodominance hierarchy of tumor neoantigens (including KRAS) that Gritstone discovered in Phase 1 translational studies and leveraged to develop SLATE-KRAS, a "pure" KRAS-directed vaccine candidate that demonstrated superior immunogenicity to the initial version in a subsequent Phase 2 study.

The clinical trial collaboration with the National Cancer Institute (NCI) to evaluate an autologous mutant KRAS-directed TCR-T cell therapy in combination with SLATE-KRAS, Gritstone’s KRAS-directed "off the shelf" vaccine candidate, is ongoing. The study is led by Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI’s Center for Cancer Research and builds into the growing interest in combining tumor-antigen specific cell therapy with matched vaccines. The IND was cleared by the U.S. Food and Drug Administration (FDA) in October 2023.

Infectious Disease Programs
CORAL – Next-generation SARS-CoV-2 vaccine program that serves as proof-of-concept for Gritstone’s samRNA platform and novel approach in infectious diseases.

In February 2024, Gritstone announced that it plans to incorporate GMP-grade materials in the manufacture of its self-amplifying mRNA (samRNA) candidate, resulting in a delay of the CORAL Phase 2b study (the anticipated 10,000 subject, comparative Phase 2b study contracted by the Biomedical Advanced Research and Development Authority [BARDA]2). This decision is expected to increase the regulatory utility of the study. Gritstone is currently preparing to launch the study and will do so as soon as the company is able.

In April 2024, Gritstone presented a poster highlighting the durability and potential broad utility of its samRNA COVID-19 vaccine at ESCMID Global 2024. The results, which were from the Phase 1 CORAL-CEPI study in South Africa, reinforced previous findings showing induction of broad and durable immune responses through 12 months.
HIV – Collaboration with Gilead under Gilead’s HIV Cure Program to research and develop vaccine-based HIV immunotherapy treatment

The collaboration to research and develop a vaccine-based HIV immunotherapy treatment continues under Gilead’s direction.
First Quarter 2024 Financial Results

Cash, cash equivalents, marketable securities and restricted cash were $52.8 million as of March 31, 2024, compared to $86.9 million as of December 31, 2023.
Research and development expenses were $33.0 million for the three months ended March 31, 2024 compared to $30.5 million for the three months ended March 31, 2023. The increase of $2.5 million was primarily attributable to a one-time severance charge and increases in facilities-related costs, offset by decreases in laboratory supplies, personnel-related costs and outside services.

General and administrative expenses were $8.5 million for the three months ended March 31, 2024 compared to $6.7 million for the three months ended March 31, 2023. The increase of $1.8 million was primarily attributable to increases in personnel-related expenses, facilities-related costs, outside services and a one-time severance charge.

Collaboration, license, and grant revenues were $1.7 million for the three months ended March 31, 2024. During the three months ended March 31, 2024, we recorded $0.4 million in grant revenue from the BARDA Contract, $1.0 million in grant revenue from CEPI, and $0.3 million in grant revenue from the Gates Foundation.
Conference Call & Webcast Details
A conference call and webcast will be held at 4:30pm ET today (May 9):

Conference call: 1-877-407-4018
Conference ID: 13746126
Webcast: View Source;tp_key=d0e680f7aa

An archived replay will be accessible at View Source for 30 days following the event.

2 This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00062.

On May 9, 2024 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, reported business highlights and financial results for the first quarter ended March 31, 2024 (Press release, Fate Therapeutics, MAY 9, 2024, View Source [SID1234642989]).

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"We made great progress across three key areas of clinical focus – we treated the first patient with our off-the-shelf FT819 CAR T-cell therapy for autoimmunity, we initiated patient enrollment without conditioning chemotherapy for our ADR-armed FT522 CAR NK cell therapy, and we treated the first patient with our multiplexed-engineered FT825 CAR T-cell therapy for solid tumors," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "As we look toward the middle of the year, we plan to expand clinical development in autoimmunity with our off-the-shelf FT819 and FT522 programs, where we believe our iPSC product platform is highly differentiated and has the potential to overcome numerous challenges that hinder treatment of patients with cell therapies, such as the requirement for apheresis and Cy / Flu conditioning, extended hospitalization, risk of secondary malignancies, and limited access. In addition, while we continue with the preclinical assessment of our next-generation, BCMA-targeted cell product candidates, we do not intend to further advance FT576 into Phase 1 dose expansion in relapsed / refractory multiple myeloma."

FT819 iPSC-derived CAR T-cell Program

First SLE Patient Treated in Phase 1 Autoimmunity Study. The multi-center, Phase 1 clinical trial for patients with systemic lupus erythematosus (SLE) is designed to evaluate the safety, pharmacokinetics, and anti-B cell activity of FT819, the Company’s off-the-shelf CD8αβ+ T-cell product candidate that incorporates a novel CD19-targeted 1XX chimeric antigen receptor (CAR) construct into the T-cell receptor alpha constant (TRAC) locus (NCT06308978). The first patient, a 27 year-old woman diagnosed with SLE over ten years ago who has refractory disease despite having been treated with multiple standard-of-care therapies, received conditioning chemotherapy followed by a single dose of FT819 at 360 million cells. The patient was discharged after a three-day hospital stay without any notable adverse events. In a "first-of-kind" translational assessment using a sample of the patient’s blood obtained prior to administration of conditioning chemotherapy, FT819 induced rapid and potent depletion of the patient’s CD19+ B cells in an ex vivo cytotoxicity assay.
Phase 1 BCM Study Data Establish Proof-of-Concept for Autoimmune Disease. At the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 27th Annual Meeting, the Company today presented preclinical and translational data from its FT819 Phase 1 study in relapsed / refractory B cell malignancies (BCM), which showed that a single dose of FT819 exhibits multiple mechanisms implicated in generating an immune reset in patients with B cell-mediated autoimmune diseases. Clinical observations included: dose-dependent pharmacokinetics, reaching Cmax at Day 8 with persistence through the first two weeks in the periphery; rapid, deep, and sustained CD19+ B cell depletion in the peripheral blood using standard Cy / Flu and alternative conditioning chemotherapy regimens; patient case studies of secondary and tertiary tissue trafficking, infiltration, and activity with CD19+ B cell elimination in tissue; and patient case studies of plasma cell depletion and B cell reconstitution, which showed recovery of naïve B cells with little to no recovery of activated memory B cells or plasmablasts.
Dose-escalation Completed in Phase 1 BCM Study with Further Clinical Development to Focus Exclusively on Autoimmunity. The Company has successfully completed dose escalation in its Phase 1 BCM study, demonstrating safety and tolerability of FT819 at a single dose up to 1.08 billion cells (NCT04629729), and intends to pursue further clinical development exclusively in autoimmunity. 43 heavily pre-treated patients (B cell lymphoma, n=25; chronic lymphocytic leukemia, n=12; and acute lymphocytic leukemia, n=6) were treated with conditioning chemotherapy and a single dose of FT819 across five dose levels. The safety and tolerability profile of FT819 was favorable, with no dose-limiting toxicities, no events of any grade of immune effector-cell associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GvHD), and low incidence (14%) of only low-grade cytokine release syndrome (CRS). There were no study discontinuations or deaths related to FT819. Clinical responses were observed across all three histologies. In 17 patients with aggressive large B cell lymphoma, 12 (71%) of whom had previously received autologous CD19-targeted CAR T-cell therapy, the overall response and complete response rates were 47% and 24%, respectively.
FT825 / ONO-8250 iPSC-derived CAR T-cell Program

First Patient Treated in Phase 1 Study with HER2-targeted CAR T-cell for Advanced Solid Tumors. Under its collaboration with Ono Pharmaceutical Co., Ltd. (Ono), the Company is conducting a multi-center, Phase 1 study to assess the safety, pharmacokinetics, and activity of FT825 / ONO-8250 as monotherapy and in combination with monoclonal antibody therapy in patients with advanced solid tumors (NCT06241456). The first patient was diagnosed with HER2-positive gastroesophageal junction (GEJ) adenocarcinoma, had progressed after receiving multiple lines of treatment including HER2-targeted therapies, and was administered standard conditioning chemotherapy followed by a single dose of FT825 / ONO-8250 as monotherapy at 100 million cells. Designed using the Company’s iPSC product platform, FT825 / ONO-8250 incorporates seven synthetic controls of cell function including a novel cancer-specific H2CasMab-2 CAR, which has exhibited similar potency with greater specificity for cancer cells expressing HER2 compared to trastuzumab in preclinical studies.
FT522 iPSC-derived CAR NK Cell Program

Conditioning-free Treatment Arm of Phase 1 BCL Study Open for Enrollment. FT522 is the Company’s off-the-shelf, CD19-targeted CAR NK cell product candidate and its first to incorporate Alloimmune Defense Receptor (ADR) technology, which is designed to reduce or eliminate the need for administration of conditioning chemotherapy to patients receiving cell therapies. In its ongoing multi-center, Phase 1 clinical trial of FT522 in patients with relapsed / refractory B-cell lymphoma (BCL) (NCT05950334), patient enrollment has now been initiated in the first three-dose cohort at 300 million cells per dose without conditioning chemotherapy (Regimen B). Three patients have been treated with conditioning chemotherapy in the first three-dose cohort at 300 million cells per dose (Regimen A). There were no dose-limiting toxicities and no events of any grade of CRS, ICANS, or GvHD, and dose escalation is ongoing at 900 million cells per dose.

ASGCT Presentation Data Show ADR Differentiation and Proof-of-Concept for Autoimmunity. At the ASGCT (Free ASGCT Whitepaper) conference, the Company today presented preclinical data as well as early translational data from its ongoing Phase 1 BCL study. In a novel re-challenge assay using peripheral blood mononuclear cells (PBMCs) from unmatched SLE donors, FT522 uniquely drove rapid and deep CD19+ B cell depletion, eliminated alloreactive T cells, and maintained functional persistence, indicating that FT522 can function effectively in the presence of an unmatched host immune system. The Company also shared initial clinical observations from the first two patients treated with FT522 in Regimen A, which showed rapid, deep, and sustained B-cell depletion in the periphery throughout the one-month treatment cycle. In addition, both patients showed enhanced persistence of FT522 in the periphery compared to clinical data observed with FT596, a prior-generation CD19-targeted CAR NK cell without ADR technology. The Company intends to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the middle of 2024 for the treatment of various autoimmune diseases with FT522, including without administration of conditioning chemotherapy to patients.
FT576 iPSC-derived CAR NK Cell Program

Dose Escalation Completed in Phase 1 Multiple Myeloma Study. The Company has completed dose escalation in its multi-center, Phase 1 clinical trial of FT576, its BCMA-targeted CAR NK cell product candidate, for relapsed / refractory multiple myeloma (NCT05182073). Using a standard conditioning chemotherapy regimen, 12 patients were treated with a three-dose treatment schedule at 1 billion cells per dose (n=6) or at 2.5 billion cells per dose (n=6) as monotherapy or in combination with CD38-targeted monoclonal antibody therapy. There were no dose-limiting toxicities and no events of any grade of CRS, ICANS or GvHD. Response assessment is ongoing at 2.5 billion cells per dose. Five of six (83%) heavily pre-treated patients achieved a clinical response at 1 billion cells per dose, including two penta-exposed patients treated with FT576 as monotherapy that achieved very good partial responses. The Company is continuing to assess the FT576 Phase 1 dose-escalation dataset and to preclinically evaluate the potential of its next-generation, BCMA-targeted cell product candidates, including for the treatment of multiple myeloma and autoimmune diseases, and does not intend to further advance FT576 into Phase 1 dose expansion in relapsed / refractory multiple myeloma.
First Quarter 2024 Financial Results

Cash & Investment Position: Cash, cash equivalents and investments as of March 31, 2024 were $391.1 million, which includes net proceeds from the closing of the Company’s approximately $80 million underwritten offering of common stock at $5.50 per share and approximately $20 million concurrent private placement of pre-funded warrants at $5.499 per pre-funded warrant in the first quarter of 2024.
Total Revenue: Revenue was $1.9 million for the first quarter of 2024, which was derived from the Company’s conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under its collaboration with Ono.

Total Operating Expenses: For the first quarter of 2024, GAAP operating expenses were $53.0 million, including research and development expenses of $32.1 million and general and administrative expenses of $20.9 million. Such amounts included $11.0 million of non-cash stock-based compensation expense.
Shares Outstanding: Common shares outstanding were 113.8 million, pre-funded warrants outstanding were 3.9 million, and preferred shares outstanding were 2.8 million, as of March 31, 2024. Each preferred share is convertible into five common shares.

Today’s Conference Call and Webcast

The Company will conduct a conference call today, Thursday, May 9, 2024 at 5:00 p.m. ET to review financial and operating results for the quarter and full year ended March 31, 2024. In order to participate in the conference call, please dial (833) 630-1956 (domestic) and (412) 317-1837 (international). The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

On May 9, 2024 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells, reported a business and financial update for the first quarter 2024 (Press release, Cue Biopharma, MAY 9, 2024, View Source [SID1234642988]).

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Recent Business Highlights

•
CUE-101 abstract accepted for an oral presentation and poster presentation at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting scheduled for May 31-June 4, 2024.
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CUE-102 abstract accepted for a poster presentation at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting scheduled for May 31-June 4, 2024.
•
Advanced preclinical CUE-401 program, in collaboration with Ono Pharmaceutical, with potential for broad application across multiple autoimmune and inflammatory diseases.
•
Expanded pipeline to include the preclinical CUE-500 series for the treatment of autoimmune and inflammatory diseases via T cell-mediated B cell depletion.
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Immuno-STAT platform posters for oncology and autoimmune diseases accepted for presentation at PEGS Boston Summit 2024 to be held May 13-14.

"We have made significant progress during the first quarter on several fronts, including further advancement of our CUE-101 clinical trial and a meeting with the FDA to define a registrational path forward for the program, as well as continued advancement of the Phase 1 clinical trial for CUE-102," said Daniel Passeri, chief executive officer of Cue Biopharma. "Additionally, important progress has been made advancing our autoimmune program CUE-401, in collaboration with Ono Pharmaceutical, and expanding our autoimmune pipeline with the bispecific Immuno-STAT CUE-500 series designed to redirect virus-specific T cells to deplete B cells in autoimmune and inflammatory diseases. We believe our strategy of demonstrating the transformative breakthrough potential of our platform to address a broad spectrum of indications from cancer and autoimmune disease positions us well to potentially deliver value creation for our shareholders."

First Quarter 2024 Financial Results

The Company reported collaboration revenue of $1.7 million and $0.2 million for the three months ended March 31, 2024 and 2023, respectively. The increase was due to revenue earned from our Collaboration and Option Agreement with Ono Pharmaceutical, which was executed in February 2023.

Research and development expenses were $10.2 million and $9.4 million for the three months ended March 31, 2024 and 2023, respectively. The increase was primarily due to an increase in clinical trial expenses.

General and administrative expenses were $4.2 million for both the three months ended March 31, 2024 and 2023.

As of March 31, 2024, the Company had $41.0 million in cash and cash equivalents. We expect our current cash and cash equivalents to fund operations into the first quarter of 2025.

On May 9, 2024 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team will present at the Bank of America Securities Health Care Conference on Wednesday, May 15, 2024, at 12:20 p.m. ET (Press release, CRISPR Therapeutics, MAY 9, 2024, View Source [SID1234642987]).

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A live webcast of the fireside chat will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following the presentation.

On May 9, 2024 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the first quarter ended March 31, 2024 (Press release, Crinetics Pharmaceuticals, MAY 9, 2024, View Source [SID1234642986]).

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"Building on the positive momentum from the first PATHFNDR readout in 2023, Crinetics began 2024 with continued strong performance. Our lead investigational compound, paltusotine, delivered positive data from two consecutive late-stage clinical trials in acromegaly and carcinoid syndrome. With our pivotal PATHFNDR Phase 3 program in acromegaly now complete, we are working diligently to submit an NDA in the second half of 2024. We also intend to discuss the positive results from our Phase 2 study in carcinoid syndrome with the FDA in preparation for the Phase 3 program, which is expected to be initiated by the end of this year," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics.

"The clinical trials for the second compound in our pipeline, atumelnant, which is being developed for the treatment of CAH and Cushing’s disease, continue to enroll patients. We plan to report initial results from a subset of patients from these trials in the second quarter," continued Dr. Struthers. "In the first quarter, we strengthened our balance sheet to support commercial readiness for a potential paltusotine launch in acromegaly, as well as to fund the development of our deep clinical and preclinical pipeline. The progress made across our pipeline positions the Company for long-term success and towards achieving our objective to become a fully integrated pharmaceutical company."

First Quarter 2024 and Recent Highlights:

Phase 3 PATHFNDR-2 study achieved primary and all secondary endpoints. In March, Crinetics reported positive topline results from its placebo-controlled Phase 3 study of paltusotine in non-pharmacologically treated participants with acromegaly. PATHFNDR-2 was designed to support a treatment indication in those with uncontrolled acromegaly.
Phase 2 study of paltusotine in carcinoid syndrome reported positive results. In March, Crinetics reported positive topline results from its open-label Phase 2 study of paltusotine in participants with carcinoid syndrome. Paltusotine was shown to result in rapid and sustained reductions in frequency and severity of flushing episodes and bowel movements.
Strengthened balance sheet with $350 million private placement financing. In February, Crinetics announced a private placement equity financing for gross proceeds of approximately $350 million.
Key Upcoming Milestones

Initial results from the ongoing Phase 2 studies of atumelnant* in congenital adrenal hyperplasia (CAH) and ACTH-dependent Cushing’s syndrome will be presented at the Endocrine Society’s annual meeting, ENDO 2024, being held June 1-4, 2024 in Boston. The Phase 2 studies are evaluating the safety, efficacy and pharmacokinetics of different doses of atumelnant in participants with CAH and Cushing’s disease.
Submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking regulatory approval of paltusotine for the treatment of acromegaly is anticipated in the second half of 2024.
Initiation of a Phase 3 program of paltusotine for carcinoid syndrome by the end of 2024, pending discussions with the FDA.
First Quarter 2024 Financial Results

Research and development expenses were $53.3 million for the three months ended March 31, 2024, compared to $38.5 million for the same period in 2023. The increases were primarily attributable to an increase in personnel costs of $9.4 million, increased outside services and facilities costs of $3.8 million, and increased spending on manufacturing and development activities of $1.4 million.
General and administrative expenses were $20.8 million for the three months March 31, 2024, compared to $12.2 million for the same period in 2023. The increases were primarily attributable to an increase in personnel costs of $5.6 million.
Net loss for the three months ended March 31, 2024, was $66.9 million, compared to a net loss of $46.0 million for the same period in 2023.Revenues were $0.6 million for the three months ended March 31, 2024, compared to $2.7 million for the same period in 2023.
Revenues were derived from licensing arrangements for our paltusotine product candidate in 2024 and for paltusotine and CRN01941 product candidates in 2023.
Unrestricted cash, cash equivalents, and investments totaled $901.0 million as of March 31, 2024, compared to $558.6 million as of December 31, 2023. On February 28, 2024, the company announced a private placement equity financing for gross proceeds of approximately $350 million. Based on its current projections, the company now expects that its cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan into 2028.
*Proposed international nonproprietary name under review.

Conference Call and Webcast Details
Management will hold a live conference call and webcast today, Thursday, May 9, 2024 at 4:30 p.m. ET. To participate, please dial 1-888-886-7786 (domestic) or 1-416-764-8658 (international) and refer to Conference ID 71864759. To access the webcast, click here. For instant telephone access, click the Call me link here. Following the live event, a replay will be available on the Investors section of the Company’s website.