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Bolt Biotherapeutics Reports First Quarter 2025 Financial Results and Provides Business Update

On May 12, 2025 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the first quarter ended March 31, 2025, and provided a business update (Press release, Bolt Biotherapeutics, MAY 12, 2025, View Source [SID1234652870]).

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"We continue to make progress advancing our pipeline of first-in-class, novel immunotherapies," said Willie Quinn, Chief Executive Officer. "We recently presented promising early clinical data for BDC-3042 at AACR (Free AACR Whitepaper) and launched a process to find a partner to accelerate BDC-3042 development. We also just opened enrollment for the first next-generation Boltbody ISAC in our pipeline, BDC-4182. We are excited to see what our ISAC platform technology can do for gastric and gastroesophageal cancer patients. We continue to be good stewards of capital as we execute against our mission to deliver new treatment options to patients with cancer."

Recent Highlights and Anticipated Milestones

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Clinical data from Phase 1 dose-escalation study of BDC-3042 presented at AACR (Free AACR Whitepaper) Annual Meeting 2025 in April 2025. 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). The dose-escalation data support the selection of 10 mg/kg q2w as a recommended Phase 2 dose (RP2D), alongside potential exploration of other doses and schedules. The results support further clinical development in NSCLC and other post-immunotherapy settings, as patients previously treated with PD-(L)1 inhibitors appear to have more dectin-2 expression and may experience improved outcomes. Bolt is running a process to find a partner with resources to accelerate development and optimize commercialization.
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BDC-4182 Phase 1 study for patients with gastric and gastroesophageal cancer opened for enrollment in April 2025. 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. Preclinically, monotherapy treatment with BDC-4182 generated complete regressions in multiple models and BDC-4182 was tolerated in toxicology studies. BDC-4182 outperformed cytotoxic claudin 18.2 ADCs, using MMAE or TOPO1, in multiple preclinical studies.
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Presented preclinical results for next-generation Boltbody ISACs targeting CEA and PD-L1 at AACR (Free AACR Whitepaper) Annual Meeting 2025 in April 2025.

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Bolt’s lead CEA-targeting ISAC comprises a novel, fully human antibody with high affinity and selectivity to CEACAM5 (CEA), and not to other members of the CEACAM family, conjugated to a propriety TLR7/8 agonist via a non-cleavable linker. This ISAC drives enhanced phagocytosis of CEA-positive tumor cells and stimulates production of critical immune-activating cytokines including IL-12p70, IFNg, and TNFa. The next-generation CEA ISAC induced complete and durable anti-tumor responses in mice and was well-tolerated in NHPs.
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Bolt’s PD-L1 ISAC utilizes a novel human anti-PD-L1 antibody conjugated to a TLR7/8 agonist via a non-cleavable linker. This ISAC leverages a unique mechanism of action due to its ability to target both tumor and immune cells that express PD-L1. Preclinical results demonstrated that PD-L1 ISACs represent a compelling new approach to treat cancer, leveraging mechanisms that are distinct from and potentially complementary to conventional PD-1/PD-L1 blockade.
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Collaborations with Genmab and Toray continue to progress. Genmab and Bolt have now selected a second product to advance into development, while the companies also continue 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 $58.0 million as of March 31, 2025. Cash on hand is expected to fund multiple milestones and operations through mid-2026.

First Quarter 2025 Financial Results

• Collaboration Revenue – Total collaboration revenue was $1.2 million for the quarter ended March 31, 2025, compared to $5.3 million for the same quarter in 2024. Revenue in the comparative periods was generated from services performed under the R&D collaborations as we fulfill our performance obligations. The decrease in revenue in the comparative period was mainly due to the $3.5 million revenue recognized under the Amended Innovent Agreement, as we completed our performance obligation to Innovent.

• Research and Development (R&D) Expenses – R&D expenses were $9.5 million for the quarter ended March 31, 2025, compared to $16.5 million for the same quarter in 2024. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses, a decrease in clinical expenses primarily related to the discontinued development of trastuzumab imbotolimod, formerly known as BDC-1001 in May 2024.

• General and Administrative (G&A) Expenses – G&A expenses were $3.8 million for the quarter ended March 31, 2025, compared to $5.8 million for the same quarter in 2024. 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.

• Loss from Operations – Loss from operations was $12.1 million for the quarter ended March 31, 2025, compared to $17.1 million for the same quarter in 2024.

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.

Black Diamond Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update

On May 12, 2025 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported financial results for the first quarter ended March 31, 2025, and provided a corporate update (Press release, Black Diamond Therapeutics, MAY 12, 2025, View Source [SID1234652869]).

"We continue to execute on enrollment in our BDTX-1535 Phase 2 trial for the treatment of newly diagnosed patients with EGFRm NSCLC and look forward to providing a clinical update in the fourth quarter of 2025," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "Our recently announced global licensing agreement with Servier for BDTX-4933 provides us with a strong cash position and runway into the fourth quarter of 2027. Pending FDA feedback in the fourth quarter of 2025, we believe we are well-positioned to begin pivotal development of BDTX-1535 in the first half of 2026."

Recent Developments & Upcoming Milestones:

BDTX-1535:

In the fourth quarter of 2025, Black Diamond expects to disclose initial Phase 2 clinical data for BDTX-1535 in newly diagnosed patients with non-classical epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) (NCT05256290) and plans to solicit U.S. Food and Drug Administration (FDA) feedback on a potential pivotal registrational path.
In April 2025, investigators at the Ivy Brain Tumor Center presented a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting titled: A Phase 0/1 ‘trigger’ trial of BDTX-1535 in recurrent glioblastoma (GBM) patients with EGFR alterations or fusions. The data showed encouraging pharmacokinetic and safety data for BDTX-1535 in recurrent EGFR-positive GBM patients, providing a strong rationale for the program’s continued expansion into newly diagnosed EGFR-positive GBM patients.
In March 2025, the investigator sponsored Phase 0/1 trial was expanded into newly diagnosed GBM patients with epidermal growth factor receptor (EGFR) alterations. The trial is sponsored by the Ivy Brain Tumor Center in Phoenix, Arizona (NCT06072586).
Corporate

In March 2025, Black Diamond announced a global licensing agreement with Servier Pharmaceuticals LLC (Servier) for BDTX-4933, a small molecule designed by Black Diamond to address unmet medical needs in RAF/RAS-mutant solid tumors. Pursuant to the terms of the agreement, Servier will lead the development activities and the worldwide commercialization of BDTX-4933 across multiple indications, including NSCLC, with potential applications in other solid tumors. Under the agreement, Black Diamond received an upfront payment of $70.0 million in March 2025 and will be eligible to receive up to $710.0 million in development and commercial sales milestone payments, along with tiered royalties based on global net sales.
Financial Highlights

Cash Position: Black Diamond ended the first quarter of 2025 with approximately $152.4 million in cash, cash equivalents, and investments compared to $98.6 million as of December 31, 2024. Net cash provided by operations was $53.4 million for the first quarter of 2025 compared to net cash used in operations of $21.2 million for the first quarter of 2024.
Research and Development Expenses: Research and development (R&D) expenses were $10.5 million for the first quarter of 2025, compared to $13.5 million for the same period in 2024. The decrease in R&D expenses was primarily due to workforce efficiencies and increased focus on advancing and optimizing development plans for BDTX-1535.
General and Administrative Expenses: General and administrative (G&A) expenses were $5.0 million for the first quarter of 2025, compared to $6.7 million for the same period in 2024. The decrease in G&A expenses was primarily due to the restructuring announced in October 2024.
Net Income/Loss: Net income for the first quarter of 2025 was $56.5 million, as compared to a net loss of $18.2 million for the same period in 2024.
Financial Guidance

Black Diamond ended the first quarter of 2025 with approximately $152.4 million in cash, cash equivalents and investments, which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the fourth quarter of 2027.

Bio-Techne to Showcase Next-Generation Solutions for Gene and Cell Therapy at American Society of Gene & Cell Therapy 2025

On May 12, 2025 Bio-Techne Corporation (NASDAQ: TECH) reported it will showcase its latest spatial biology and cell and gene therapy workflow solutions at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2025 meeting taking place in New Orleans between May 13th – 17th at the New Orleans Ernest N. Morial Convention Center (Press release, Bio-Techne, MAY 12, 2025, View Source [SID1234652866]).

Bio-Techne will feature its cutting-edge advancements for cell and gene therapy development and manufacturing at booth 1537. Highlights include the new RNAscope protease-free workflow for visualization of biodistribution of AAV vectors, transgene mRNA, small RNAs (ASO, siRNA, miRNA) along with functional RNA and protein markers. Bio-Techne’s booth will also showcase its solutions to improve cell therapy workflows, including the ProPak GMP cytokines in dose-optimized, single-use bags with weldable tubing for closed-system cell therapy manufacturing, and new AI-modified, designer proteins. The next-generation Simple Western Leo System will also be featured, with this state-of-the-art instrument enabling the simultaneous processing of up to 100 samples in a single 3-hour run.

Leading researchers along with Maithreyan Srinivasan, PhD, Chief Scientific Officer, Advanced Cell Diagnostics (ACD), a Bio-Techne brand, will present the latest innovations with RNAscope technology at ACD’s symposium on Wednesday, May 14th at 8:30 am in room 383-385. This session will highlight NextGen RNAscope Multiomics Solutions for Spatial Precision: AAV, small RNA, CAR-T, and Beyond. Our distinguished guest speakers include:

Adrian Veres, MD, PhD, Cofounder & Chief Scientific Officer at Dyno Therapeutics will present on "In Vivo Validation of AI-designed AAV Capsids for Targeted Gene Delivery to NHPs."
William (Wes) Salomon, PhD, Senior Director, Delivery Biology, Tessera Therapeutics will speak on "Visualizing RNA Gene Writer Activity in Mouse Liver for the Potential Therapeutic Correction of Monogenic Disease Mutations."
Another talk, moderated by Edward Pavina (Bio-Techne) will be presented on Thursday, May 15th from 12:15 – 1:15 PM in Room 383: "Protein Quantitation Applications to Advance Gene Therapy Development – From Discovery Through Analytical Development" with guest Speakers Julyana Acevedo PhD, Analytical Development Scientist, Sangamo Therapeutics and Nicolas Tricaud PhD, Co-founder, CEO/CS, Nervosave Therapeutics.

"Bio-Techne is leading the forefront of advancing cell and gene therapy development with cutting edge tools and technologies," commented Kim Kelderman, President and Chief Executive Officer of Bio-Techne. "This conference highlights the frontier of pre-clinical and clinical advanced therapeutic development and paves the way for building safe and effective therapies for a multitude of disorders."

For Research Use Only. Not for use in diagnostic procedures.

BeyondSpring Reports First‑Quarter 2025 Financial Results and Provides Corporate Update

On May 12, 2025 BeyondSpring Inc. (NASDAQ: BYSI), a clinical‑stage global biopharmaceutical company focused on developing cancer therapeutics, reported its unaudited financial results for the quarter ended March 31, 2025, and provided a corporate update (Press release, BeyondSpring Pharmaceuticals, MAY 12, 2025, View Source;utm_medium=rss&utm_campaign=beyondspring-reports-first%25e2%2580%2591quarter-2025-financial-results-and-provides-corporate-update [SID1234652865]).

"Plinabulin has now been administered to more than 700 patients with a favorable safety profile. By promoting dendritic‑cell maturation, it offers a potential option for the approximately 60 percent of cancer patients who progress on PD‑1/L1 inhibitors," said Dr. Lan Huang, Co‑Founder, Chair, and Chief Executive Officer of BeyondSpring. "Early readouts in metastatic NSCLC and Hodgkin lymphoma who failed PD-1/L1 inhibitors showed durable responses that deserve further evaluation."

Dr. Huang added, "Within SEED, our RBM39 molecular‑glue degrader achieved complete tumor regression in mechanism-targeted Ewing sarcoma models and is on track for an IND submission mid‑year. We are also pursuing additional mechanism-targeted larger indications including liver cancer and KRAS‑mutant tumors with leading centers including Dana‑Farber, Memorial Sloan Kettering, and MD Anderson."

Recent Highlights
Plinabulin Clinical Presentations

March 2025 (Oral Presentation at the Immuno-Oncology 360o Summit in Boston): Plinabulin combination regimen showed clinically meaningful responses in patients of multiple cancer types who failed prior immunotherapies, including NSCLC and Hodgkin lymphoma, with prolonged PFS.
Phase 1 investigator-initiated study of Plinabulin + PD-1/PD-L1 inhibitor + radiation (MD Anderson Cancer Center) showed promising data in re-sensitizing Hodgkin lymphoma for patients who failed 12 to 16 prior lines of treatments including stem cell transplant, CAR-T, and PD-1 inhibitor with duration of response of over 19 months.

SEED Therapeutics Program

RBM39 molecular‑glue degrader produced durable tumor regression in Ewing sarcoma animal models; IND‑enabling studies underway.
Dual‑PROTAC approach using two E3 ligases overcame the hook effect in KRAS G12D cell lines; manuscript in preparation.
Corporate and Financial
As a result of BeyondSpring entering into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED in January 2025, SEED’s operations met the criteria as discontinued operations under ASC 205-20 for financial reporting purposes. SEED’s financials results are now presented as "discontinued operations" under U.S. GAAP. SEED continues to operate independently. BeyondSpring currently owns approximately 40% of the outstanding equity interest in SEED.

Selected Unaudited Financial Data
Q1 2025 Q1 2024 Change (%)
R&D expense from continuing operations ($ 000s) 874 721 21%
G&A expense from continuing operations ($ 000s) 1,736 1,334 30%
Net loss from continuing operations ($ 000s) 2,584 2,080 24%

Aurinia Pharmaceuticals Reports Financial Results for the Three Months Ended March 31, 2025

On May 12, 2025 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) reported financial results for the three months ended March 31, 2025 (Press release, Aurinia Pharmaceuticals, MAY 12, 2025, View Source [SID1234652864]).

First Quarter 2025 Financial Results

Total Revenue: For the three months ended March 31, 2025, total revenue was $62.5 million, up 24% from $50.3 million in the same period of 2024.
Net Product Sales: For the three months ended March 31, 2025, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $60.0 million, up 25% from $48.1 million in the same period of 2024.
License, Collaboration and Royalty Revenue: For the three months ended March 31, 2025, license, collaboration and royalty revenue, which includes manufacturing services revenue from Aurinia’s collaboration partner, Otsuka, was $2.5 million, up 14% from $2.2 million in the same period of 2024.
Net Income (Loss): For the three months ended March 31, 2025, net income (loss) was $23.3 million, compared to $(10.7) million in the same period of 2024.
Cash Flow Provided by (Used in) Operating Activities: For the three months ended March 31, 2025, cash flow provided by (used in) operating activities was $1.3 million, compared to $(18.6) million in the same period of 2024. Excluding $11.1 million of cash payments made in connection with the November 2024 restructuring, cash flow generated from operations was $12.4 million for the three months ended March 31, 2025.
Cash Position

As of March 31, 2025, Aurinia had cash, cash equivalents, restricted cash and investments of $312.9 million, compared to $358.5 million at December 31, 2024. For the three months ended March 31, 2025, the Company repurchased 5.8 million of its common shares for $47.4 million.

Full Year 2025 Total Revenue and Net Product Sales Guidance

For 2025, Aurinia is reiterating its established total revenue guidance in the range of $250 million to $260 million and net product sales guidance in the range of $240 million to $250 million.

"We are pleased to report continued positive growth and momentum for LUPKYNIS in the first quarter of 2025 and are looking forward to a strong performance this year," stated Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Following the recent update to the American College of Rheumatology lupus nephritis treatment guideline, which recommends the incorporation of drugs like LUPKYNIS into first-line therapy, our commercial organization is focused on educating rheumatologists about the benefits of initiating LUPKYNIS earlier in the treatment paradigm. We also remain on track to report initial results from our Phase 1 study of AUR200, a dual inhibitor of B cell activating factor (BAFF) and a proliferation inducing ligand (APRIL), later this quarter."

Webcast & Conference Call Details

A webcast and conference call will be hosted today, May 12, at 8:30 a.m. ET. The link to the audio webcast is available here. To join the conference call, please dial 877-407-9170/+1 201-493-6756. A replay of the webcast will be available on Aurinia’s website.