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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"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

On May 12, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that Dr. Pamela D. Garzone, Chief Development Officer of Anixa, will present a poster at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place on May 30 – June 3, 2025, in Chicago, Illinois (Press release, Anixa Biosciences, MAY 12, 2025, View Source [SID1234652862]). Lead author on the poster is Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt Cancer Center, and the principal investigator of the Phase 1 clinical trial of Anixa’s ovarian cancer CAR-T immunotherapy.

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Presentation Details:

Title: Phase 1 clinical trial of autologous T-cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor (FSHR) in recurrent ovarian cancer (OVCA)
Session: Developmental Therapeutics—Immunotherapy
Session Type: Poster Session
Date & Time: June 2, 2025, 1:30 PM – 4:30 PM CT
Abstract ID: TPS2682

On May 12, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that data from its OPTIMIZE-1 clinical trial will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Alligator Bioscience, MAY 12, 2025, View Source [SID1234652861]). The presentation, titled "Biomarkers associated with outcomes from OPTIMIZE-1: CD40 agonist mitazalimab with mFOLFIRINOX in patients with untreated metastatic pancreatic cancer," will take place during the Developmental Therapeutics—Immunotherapy session, focusing on tissue-based biomarkers. The presentation will be available at Poster Board #271.

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The ASCO (Free ASCO Whitepaper) Annual Meeting is the premier event for advancing clinical oncology, where professionals connect and collaborate. It also offers valuable business development opportunities, supporting Alligator’s efforts to expand mitazalimab’s potential and explore strategic collaborations.

Abstract Details:
• Title: Biomarkers associated with outcomes from OPTIMIZE-1: CD40 agonist mitazalimab with mFOLFIRINOX in patients with untreated metastatic pancreatic cancer
• First Author: Philippe Cassier
• Date and time: 2nd June 2025, 1.30 p.m. – 4:30 p.m CDT.
• Session Title: Developmental Therapeutics—Immunotherapy
• Sub Track: Tissue-Based Biomarkers
• Abstract Number: 2624
• Poster Board Number: 271
• Abstract link