On March 24, 2025 Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, reported financial results for the full year ended December 31, 2024, and highlighted recent progress (Press release, Artiva Biotherapeutics, MAR 24, 2025, View Source [SID1234651394]).

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"2024 was a transformational year for Artiva including initiating dosing of AlloNK in patients with autoimmune disease across our trials, a successful initial public offering strengthening our balance sheet, and expanding key leadership across the organization with expertise in cell therapy and autoimmune disease," said Fred Aslan, M.D., CEO of Artiva. "We look forward to sharing initial data from our AlloNK program in autoimmune disease this year. We also look forward to sharing updated clinical data from our non-Hodgkin’s lymphoma (NHL) trial with AlloNK which continues to mature as one of the strongest data sets for the allogeneic field, demonstrating deep B-cell depletion, continued durability of response, and the compatibility of our treatment regimen with outpatient administration."

Recent Business Highlights

Corporate and Financial Updates

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Expanded Board of Directors: In January 2025, Artiva appointed Dan Baker, M.D., as an independent member of its Board of Directors. Dr. Baker brings over two decades of drug development experience in the pharmaceutical industry. He is currently the interim Chief Development Officer of Cue Biopharma, Inc., and previously held a 19-year tenure at Johnson & Johnson (Janssen/Centocor) most recently as the Vice President of Immunology R&D.
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Bolstered Key Development Leadership: Artiva appointed key leadership with cell therapy and autoimmune expertise across the development organization, including Benjamin Dewees as Senior Vice President (SVP), Regulatory Affairs, David Moriarty, Ph.D., as SVP, Clinical Operations, and Feng Xu as SVP, Biometrics. Collectively, the leadership team brings experience developing therapies targeting autoimmune indications including systemic lupus erythematosus (SLE), lupus nephritis (LN), rheumatoid arthritis (RA) and Sjogren’s disease from their tenures at companies such as Kyverna Therapeutics, Inc., Horizon Therapeutics plc and IGM Biosciences, Inc.
Upcoming Milestones

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Initial data for AlloNK (also known as AB-101) on autoimmune indications from at least one of the following trials expected in H1 2025:
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Artiva Sponsored Trial in SLE/ LN: Ongoing Phase 1/1b trial evaluating AlloNK in combination with rituximab or obinutuzumab in patients with SLE with or without LN.
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Ongoing IIT Basket Trial: Investigator-initiated basket trial (IIT) assessing the safety, tolerability, and clinical activity of AlloNK plus rituximab in patients with RA, pemphigus vulgaris, granulomatosis with polyangiitis/microscopic polyangiitis, and SLE. The trial is being conducted by Integral Rheumatology & Immunology Specialists, a community rheumatology clinic.
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Updated clinical data from the Phase 1/2 trial exploring AlloNK + rituximab in patients with relapsed/refractory B-cell NHL showing continued durability of response to be presented at a medical conference in 2025

Full Year 2024 Financial Results

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Cash, Cash Equivalents and Investments. As of December 31, 2024, Artiva had cash, cash equivalents, and investments of $185.4 million. This includes $179.0 million in gross proceeds from Artiva’s completed initial public offering in July 2024 in which it sold 14,920,000 shares of its common stock, including partial exercise of the overallotment option. Existing cash, cash equivalents, and investments as of December 31, 2024, are expected to fund operations at least through the end of 2026.
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Collaboration Revenue. Collaboration revenue was zero for the year ended December 31, 2024, compared to $32.9 million for the year ended December 31, 2023.
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Research and Development Expenses. Research and development expenses were $50.3 million for each of the years ended December 31, 2024 and 2023.
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General and Administrative Expenses. General and administrative expenses were $17.2 million for the year ended December 31, 2024, compared to $13.9 million for the year ended December 31, 2023.
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Other Income, net. Other income, net, was $1.9 million for the year ended December 31, 2024, compared to other income, net, of $2.0 million for the year ended December 31, 2023.
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Net Loss. Net loss totaled $65.4 million for the year ended December 31, 2024, as compared to net income of $28.7 million for the year ended December 31, 2023, with non-cash stock-based compensation expense of $7.0 million and $7.1 million for the years ended December 31, 2024 and 2023, respectively.

On March 24, 2025 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, reported its Vice President of Business Development, Mathew Lazarus, will be presenting at the 2025 Cancer Advocacy Group of Louisiana ("CAGLA") NeauxCancer Conference taking place on March 27-29, 2025 at the The Roosevelt Hotel in New Orleans (Press release, Pasithea Therapeutics, MAR 24, 2025, View Source [SID1234651369]).

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Mr. Lazarus’s presentation will provide an overview of Pasithea’s next generation macrocyclic MEK inihibitor, PAS-004, including interim safety, tolerability and pharmacokinetic (PK) data from the Company’s ongoing open-label dose escalation Phase 1 study in advanced cancer patients with MAPK pathway-driven advanced tumors. He will discuss the Company’s latest progress in clinical development and how Pasithea is advancing its next-generation molecule to transform cancer and NF1 treatment.

Details of the presentation are as follows:

Event: 2025 CAGLA NeauxCancer Conference
Date: March 28, 2025
Time: 11:00 AM CDT
Location: The Roosevelt New Orleans
Webcast: CAGLA 2025 Livestreams

The CAGLA NeauxCancer Conference is a premier gathering of leading oncology researchers, industry executives, and medical professionals focused on groundbreaking developments in cancer treatment and care.

For more information about the conference, visit View Source

On March 24, 2025 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, reported financial results for the fourth quarter and year ended December 31, 2024, and provided recent business highlights (Press release, Aura Biosciences, MAR 24, 2025, View Source [SID1234651395]).

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"We believe that bel-sar has the potential to transform the treatment paradigm in multiple rare oncology indications starting with ocular cancers and more broadly across many solid tumors such as bladder cancer. The data presented from the Phase 2 trial in early-stage choroidal melanoma and the Phase 1 trial in NMIBC demonstrated bel-sar’s potential as a front-line treatment option across multiple tumor types," said Elisabet de los Pinos, Chief Executive Officer of Aura Biosciences. "These data highlight the potential clinical benefit of a novel dual mechanism of action driven by highly targeted cytotoxicity and robust cell-mediated immunity. We look forward to continuing to advance our pipeline across multiple indications with high unmet patient need."

Recent Pipeline Developments

Early-Stage Choroidal Melanoma

Early-stage choroidal melanoma represents an area of high unmet need with no drugs approved. The Company previously received Orphan Drug Designation from the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and Fast Track designation from the FDA for the treatment of early-stage choroidal melanoma. The CoMpass trial is under a Special Protocol Assessment (SPA) agreement with the FDA.

Update on Ongoing Phase 3 CoMpass Trial: CoMpass is the first registration-enabling study in early-stage choroidal melanoma. The study is a global, Phase 3, randomized trial evaluating bel-sar treatment against a sham control arm and includes an enrichment strategy to enroll approximately 100 patients with documented tumor growth.

The CoMpass trial is actively enrolling globally. To identify appropriate patients to meet the enrichment strategy of documented growth, the Company has enabled a pre-screening ‘run in’ period. Globally, since June 2024, investigators have registered over 175 patients in pre-screening as having met initial enrollment criteria for the study. The acceleration in pre-screening is driven by increasing momentum in the United States and European Union.

Additional Ocular Oncology Indications:

In addition to early-stage choroidal melanoma, bel-sar is being explored for metastases to the choroid and cancers of the ocular surface. These three ocular oncology indications have a collective incidence of greater than 60,000 patients annually in the United States and Europe.

Metastases to the Choroid

The Company has initiated a Phase 2 clinical trial in metastases to the choroid and has sites activated with patients in prescreening. Metastases to the choroid is an indication with high unmet medical need and no approved therapies. The Company expects initial data from this trial in 2025.

Metastases to the choroid represents the second potential ocular oncology indication for bel-sar, affecting approximately 20,000 patients annually in the United States and Europe. The Company previously received FDA Fast Track designation for bel-sar in this indication.

Cancers of the Ocular Surface

The Company’s third potential ocular oncology indication is cancers of the ocular surface, which affects approximately 35,000 patients in the United States and Europe annually. The Company continues to advance its preclinical work designed to be IND-enabling in cancers of the ocular surface.

Bladder Cancer

Positive additional data from the Company’s Phase 1 trial of bel-sar in patients with NMIBC was presented at the 40th Annual European Association of Urology Congress. In totality, the data demonstrate clinical complete responses as well as robust cell mediated immunity across the intermediate- and high-risk disease spectrum.

These data now include the histopathological assessment of all 10 patients after treatment with light activation and the full evaluation of safety and tumor response in two additional patients with high-risk NMIBC. One patient with high-risk disease (due to BCG failure) demonstrated a clinical complete response. Further, to evaluate the local immune response after the treatment with bel-sar in the TME, multiplex immunofluorescence staining for key immune cell types was performed on tumor biopsies from three patients. These early observations show induction of effector immunity and the development of local active immunosurveillance, highlighting key features of bel-sar’s dual mechanism of action and the potential to translate into durable treatment responses. The Company previously announced early data from this Phase 1 trial in October 2024. Details of the updated results of the Phase 1 NMIBC trial can be found here.

Corporate Updates

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The Company will host a virtual urologic oncology investor event today, at 4:30 pm ET, featuring Neal Shore, MD, FACS (Carolina Urologic Research Center), Gary Steinberg, MD, FACS (Rush University) and Jennifer A. Linehan, MD (Saint John’s Cancer Institute), to discuss the data from the Phase 1 trial in NMIBC, as well as a bladder cancer program update including the Phase 1b/2 trial and future development plans. A replay of the webcast will be available following the event on the "Investors & Media" page under the "Events & Presentations" section of Aura’s website at View Source

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Tony Gibney joined the Company as Senior Finance and Strategy Advisor. Mr. Gibney is an experienced biotechnology leader and former investment banker who brings over 30 years of experience dedicated to advising biotechnology companies in the United States and Europe across their businesses, including corporate strategy, business development, finance and investor relations, among many others. Following his investment banking career, he has worked as Chief Business Officer at Achillion Pharmaceuticals, Inc. and Iveric Bio, Inc. and as Chief Business and Financial Officer at Fog Pharmaceuticals, Inc.

Full Year and Fourth Quarter 2024 Financial Results

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As of December 31, 2024, Aura had cash and cash equivalents and marketable securities totaling $151.1 million. The Company believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into the second half of 2026.

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Research and development expenses increased to $22.3 million and $73.3 million for the three months and full year ended December 31, 2024, respectively, from $20.3 million and $65.2 million for the three months and full year ended December 31, 2023, respectively, primarily due to ongoing clinical and contract research organization costs associated with the progression of the Company’s Phase 3 global trial and manufacturing and development costs for bel-sar.

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General and administrative expenses increased to $5.5 million and $22.8 million for the three months and full year ended December 31, 2024, respectively, from $4.5 million and $19.8 million for the three months and full year ended December 31, 2023, respectively. General and administrative expenses include $1.4 million and $1.2 million of stock-based compensation for the three months ended December 31, 2024 and 2023, respectively. The increase was primarily driven by personnel expenses, as well as increases in general corporate expenses related to the global growth of the Company.

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Net loss for the three months and full year ended December 31, 2024, was $25.8 million and $86.9 million, respectively, compared to $22.1 million and $76.4 million for the three months and full year ended December 31, 2023, respectively.

On March 24, 2025 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the third quarter ended December 31, 2024, and provided a business update (Press release, Bolt Biotherapeutics, MAR 24, 2025, View Source [SID1234651370]).

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"2024 was a transformational year for Bolt as we focused the company on efficient development of the programs that could be most impactful for patients," said Willie Quinn, Chief Executive Officer. "BDC-4182, our next-generation ISAC, is poised to enter the clinic in the second quarter. As the only ISAC targeting the validated tumor target claudin 18.2, we believe that BDC-4182 has the potential to offer a better option for patients with stomach and other claudin 18.2-expressing cancers. We are particularly excited about BDC-4182 as validation for our Boltbody ISAC approach. We’ve also completed enrollment and have cleared the DLT window for the highest dose level in the BDC-3042 Phase 1 dose escalation trial and will provide a data update next quarter at a medical meeting. BDC-3042 is our first-in-class dectin-2 agonist, and has potential across a broad range of solid tumors with high unmet medical need."

Recent Highlights and Anticipated Milestones

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Completed enrollment of the Phase 1 study of BDC-3042 in patients with advanced cancers. BDC-3042 is a proprietary agonist antibody that targets dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). This single-agent, dose-escalation Phase 1 clinical study is evaluating BDC-3042 in patients with metastatic or unresectable solid tumors including non-small cell lung cancer (NSCLC). BDC-3042 has been well tolerated with no dose-limiting toxicities (DLTs) and evidence of biological activity. Results from the trial will be presented at an upcoming medical meeting in the second quarter of 2025.
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Finalizing preparations for first-in-human trial of BDC-4182 in patients with gastric cancer. BDC-4182 is a next-generation BoltbodyTM ISAC clinical candidate targeting claudin 18.2, a clinically validated target in oncology with expression in gastric/gastroesophageal junction cancer, pancreatic cancer, and other tumor types. BDC-4182 has advanced into IND-enabling activities, supported by in vitro and in vivo experiments demonstrating potent anti-tumor activity in multiple preclinical models. BDC-4182 was tolerated in non-human primates at the highest dose tested (12mg/kg) with an acceptable safety profile. BDC-4182 outperformed cytotoxic claudin 18.2 ADCs, using MMAE or TOPO1, in syngeneic models. Key learnings were presented at SITC (Free SITC Whitepaper) 2024 and the dose escalation trial is planned to start in Australia in the second quarter of 2025.
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Collaborations with Genmab and Toray continue to progress. The Company continues to work with Genmab to discover and develop next-generation ISACs for the treatment of cancer. Genmab and the Company are working together to advance the collaboration’s first development candidate, and the collaboration also continues research and development on additional programs. The Toray collaboration combines the Company’s immunostimulatory linker-payloads with Toray antibodies targeting Caprin-1, a tumor-specific antigen that is strongly expressed on the cell membrane in multiple solid tumor types.
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Cash, cash equivalents, and marketable securities were $70.2 million as of December 31, 2024. Cash on hand is expected to fund multiple milestones and operations through mid-2026.

Fourth Quarter and Full Year 2024 Financial Results

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Collaboration Revenue – The Company recently reassessed its expected future performance obligations under the Genmab Agreement, and as a result reported no collaboration revenue for the quarter. Total collaboration revenue was $7.7 million for the fourth and full year ended December 31, 2024, respectively, compared to $2.1 million and $7.9 million for the same quarter and year in 2023,, respectively. Revenue in the comparative periods was generated from services performed under the R&D collaborations as we fulfill our performance obligations.

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Research and Development (R&D) Expenses – R&D expenses were $11.7 million for the quarter and $57.5 million for the full year ended December 31, 2024, respectively, compared to $16.3 million and $61.5 million for the same quarter and year in 2023, respectively. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of the May 2024 restructuring partially offset by an increase in contract manufacturing expenses.

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General and Administrative (G&A) Expenses – G&A expenses were $3.9 million for the quarter and $18.5 million for the full year ended December 31, 2024, respectively, compared to $5.5 million and $22.5 million for the same quarter and year in 2023, respectively. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of the May 2024 restructuring.

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Loss from Operations – Loss from operations was $16.9 million for the quarter and $73.0 million for the full year ended December 31, 2024, respectively, compared to $19.8 million and $76.2 million for the same quarter and year in 2023, respectively.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer.

On March 24, 2025 Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, reported an update on the company’s development pipeline and announced financial results for the fiscal year ended December 31, 2024 (Press release, Quince Therapeutics, MAR 24, 2025, View Source [SID1234651396]).

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Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, "Our Phase 3 pivotal NEAT clinical trial has exceeded 50% enrollment with 71 participants screened and 61 randomized. Recent and upcoming new site activations are expected to accelerate enrollment through our target completion date in the second quarter of 2025. Assuming target enrollment completion, topline results from the NEAT study are anticipated in the fourth quarter of 2025."

Pivotal Phase 3 NEAT Clinical Trial

Enrolled 61 participants to date in the company’s Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial to evaluate the neurological effects of eDSP (previously referred to as EryDex) in patients with Ataxia-Telangiectasia (A-T), including 54 participants in the six to nine year-old primary analysis population.
Transitioned 24 participants to date to the NEAT open label extension study (NCT06664853/IEDAT-04-2022). Participants who complete the full treatment period, complete study assessments, and provide informed consent are eligible to transition to an open label extension study.
Expect screening and randomization to accelerate in the coming weeks due to several new geographic regions and sites scheduled for activation.
Quince plans to enroll approximately 86 patients with A-T ages six to nine years old (primary analysis population) and approximately 20 patients with A-T ages 10 years or older.
Pivotal Phase 3 NEAT clinical trial is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA).
Expect to report Phase 3 NEAT topline results in the fourth quarter of 2025 with a New Drug Application (NDA) submission to the FDA and a Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) in 2026, assuming positive study results.
NEAT is an international, multicenter, randomized, double-blind, placebo-controlled study to evaluate the neurological effects of the company’s lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells), in patients with A-T.
Participants will be randomized (1:1) between eDSP or placebo and treatment will consist of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last visit completion in a rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo as per the SPA agreement with the FDA.
Pipeline and Corporate Updates

Generating Phase 2 clinical trial study designed to evaluate eDSP for the potential treatment of patients with Duchenne muscular dystrophy (DMD). Quince plans to initiate a DMD Phase 2 study in 2025, which the company expects to conduct utilizing capital efficient study approaches and with financial support from grant and/or opportunistic funding opportunities.
Published long-term safety data from patients with A-T treated with eDSP for a minimum of 24 months in Frontiers in Neurology in January 2025. The online publication titled Long-term safety of dexamethasone sodium phosphate encapsulated in autologous erythrocytes in pediatric patients with Ataxia-Telangiectasia can be accessed here.
Appointed Dr. William Whitehouse, Honorary Clinical Associate Professor of the School of Medicine at the University of Nottingham and recently retired Consultant Pediatric Neurologist at Nottingham Children’s Hospital, Nottingham University Hospitals NHS Trust, to the company’s Scientific Advisory Board (SAB).
Strengthened Quince’s growing intellectual property portfolio and long-term market position with the issuance of a Notice of Allowance from the U.S. Patent and Trademark Office’s (USPTO) in February 2025. This extends the company’s patent claims into 2036 in the U.S., supplementing its existing U.S. patent with coverage of patent claims related to method of treating patients with A-T using Quince’s proprietary process to encapsulate DSP in autologous red blood cells.
Held an investor webinar in February 2025 featuring key opinion leader (KOL) Dr. Mary Kay Koenig from UTHealth Houston with a discussion focused on addressing the high unmet need in A-T. During the investor webinar, Dr. Koenig 1) provided an A-T natural history overview, 2) detailed current symptomatic treatment approaches for patients with A-T, 3) discussed the competitive therapeutic A-T landscape, and 4) provided an overview of Quince’s Phase 3 NEAT clinical trial of eDSP for the treatment of A-T. A replay of the A-T KOL investor webinar is available here.
Fiscal Year 2024 Operating Highlights

Granted Fast Track designation from the FDA for Quince’s eDSP System for the treatment of patients with A-T in June 2024.
Published efficacy and safety results from the company’s Phase 3 ATTeST clinical trial evaluating eDSP for the treatment of A-T in medical journal The Lancet Neurology.
Participated at notable scientific meetings, including poster presentations at the 53rd Child Neurology Society (CNS) Annual Meeting and the 2024 International Congress for Ataxia Research (ICAR), where Quince presented data from its Phase 3 ATTeST clinical trial.
Completed an initial patient sizing project based on third-party analysis from IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics, which confirmed that the number of diagnosed patients with A-T in the U.S. is estimated to be to approximately 4,600.
Established a SAB comprised of leading experts in biochemistry, neurology, immunology, hematology, pharmacology, and clinical practice uniquely positioned to provide Quince with deep insights and advice to support advancement of the company’s drug programs.
Fiscal Year 2024 Financial Results

Reported cash, cash equivalents, and short-term investments of $40.8 million for the fiscal year ended December 31, 2024. Quince expects its existing cash runway to be sufficient to fund the company’s capital efficient development plan through Phase 3 NEAT topline results and into 2026. The company plans to be opportunistic from a financing perspective to extend its existing cash runway.
Reported research and development (R&D) expenses of $18.6 million for the fiscal year ended December 31, 2024. R&D expenses primarily included costs related to ongoing Phase 3 NEAT clinical trial activities and related manufacturing costs.
Reported general and administrative (G&A) expenses of $17.6 million for the fiscal year ended December 31, 2024. G&A expenses primarily included personnel-related and stock-based compensation expenses, commercial planning and new product planning expenses, and other professional administrative costs.
Reported a net loss of $56.8 million, or a net loss of $1.31 per basic and diluted share, for the fiscal year ended December 31, 2024. Weighted average shares outstanding for the year were 43.3 million.
Reported net cash used in operating activities of $31.9 million for the year ended December 31, 2024. Cash used in operating activities was primarily due to a net loss of $56.8 million for the period, adjusted for $25.4 million of non-cash items, including a $17.1 million goodwill impairment charge, $4.7 million in stock-based compensation, $4.0 million change in the fair value of contingent consideration liabilities, $1.7 million change in the fair value of long-term debt, and a net increase in operating assets of $2.6 million, offset by a net increase in accounts payable, and accrued expenses and other current liabilities of $ 2.1 million.
Made a cash milestone payment of $5.0 million to EryDel shareholders in the third quarter of 2024 following the achievement of the first patient enrolled in the NEAT study in the second quarter of 2024.