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]).

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"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.

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]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.

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]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"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%

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]).

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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.

On May 12, 2025 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported financial results for the first quarter ended March 31, 2025, and highlighted recent Company progress (Press release, ArriVent Biopharma, MAY 12, 2025, View Source [SID1234652863]).

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"We continued our strong execution across our oncology-focused pipeline and are preparing for several near-term milestones. Importantly, our late-stage firmonertinib program continues to show differentiated potential to address unmet needs across EGFR-mutant non-small cell lung cancer (NSCLC)," said Bing Yao, Chairman and Chief Executive Officer of ArriVent. "ARR-217 (MRG007), our recently acquired antibody drug conjugate (ADC) targeting the gastrointestinal marker CDH17 with best-in-class potential, is expected to be the first ADC from our pipeline to enter the clinic."

Dr. Yao continued, "In the year ahead, we plan to present updated data for firmonertinib in first line EGFR PACC mutant NSCLC, including Progression Free Survival (PFS) and duration of response, and provide our clinical development plan on the PACC program in the second quarter of 2025. We expect topline data in 2025 in our event-driven global pivotal Phase 3 study for firmonertinib monotherapy in first-line NSCLC harboring EGFR exon 20 insertion mutations."

First Quarter 2025 and Recent Highlights

Firmonertinib

● Completed enrollment for pivotal trial. During the first quarter of 2025, we completed enrollment in the the global pivotal Phase 3 FURVENT study of firmonertinib monotherapy in first-line NSCLC EGFR exon 20 insertion mutations (NCT05607550). Firmonertinib, an oral, highly brain-penetrant, and broadly active mutation-selective epidermal growth factor receptor (EGFR) inhibitor, received FDA Breakthrough Therapy Designation in this patient population.
Pipeline

● Expanded our pipeline to include ARR-217 (MRG007). In January 2025, ArriVent entered into a collaboration agreement with Lepu Biopharma for ARR-217, a CDH17-targeted ADC with the potential to treat gastrointestinal cancers. Under the agreement, ArriVent obtained the exclusive rights to develop and commercialize ARR-217 worldwide outside of greater China. In March 2025, our first IND was submitted in China with an initial clinical development focus in colorectal, pancreatic and other GI cancers. Pre-clinical data presented recently at the American Association