On April 23, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported its results for the first quarter ending March 2025 (Press release, Alligator Bioscience, APR 23, 2025, View Source [SID1234652060]).

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" With the continued strengthening of mitazalimab’s clinical profile—including 24-month survival data, further dose validation, and positive regulatory alignment—we are well-positioned for Phase 3 initiation in the second half of 2025. Combined with enhanced financial flexibility following the rights issue and strategic portfolio optimization, we are advancing with confidence toward our goal of delivering transformative immunotherapies for patients with hard-to-treat cancers."
Søren Bregenholt, CEO of Alligator Bioscience
BUSINESS UPDATE
Mitazalimab

Announcement of encouraging overall survival benefit from the Phase 2 trial OPTIMIZE-1, with 24-month follow-up data showing a 29.4% survival rate for mitazalimab in combination with mFOLFIRINOX—three times higher than estimates for chemotherapy alone.
Top-line data from the 450 µg/kg back-filled cohort in OPTIMIZE-1 further support 900 µg/kg as the recommended Phase 3 dose.
Additional positive survival data for mitazalimab demonstrated through a literature-based indirect comparison, showing an incremental overall survival benefit and further supporting progression to Phase 3.
Successful completion of End-of-Phase 2 meeting with the FDA with positive feedback and alignment on clinical development strategy and Phase 3 trial design.
Company

Approval of rights issue and reverse share split at Extraordinary General Meetings held on 13 January and 27 March 2025, respectively.
Successful completion of rights issue in February 2025 with gross proceeds of SEK 153 million; BTUs converted and units issued to guarantors and Fenja Capital.
Peer-reviewed publication of data for ATOR-1017 (evunzekibart) in the Journal for ImmunoTherapy of Cancer confirming its immunomodulatory effects.
FDA grants Chinese Shanghai Henlius Orphan Drug Designation in gastric cancer for Alligator’s out-licensed candidate HLX22.
Publication of Alligator’s Annual Report for 2024 on 27 March 2025, outlining operational and financial highlights.
FINANCIAL SUMMARY FOR Q1 2025
The financial summaries for the quarterly periods ending 31 March 2025 and 31 March 2024 are presented below.

All amounts in MSEK,
unless specified January – March
2025 January – March
2024
Net sales - 7.0
Operating profit/loss -43.7 -59.6
Profit/loss for the period -8.3 -62.8
Cash flow for the period -34.6 -26.2
Cash and cash equivalents 28.9 40.0
Earnings per share before and after dilution, SEK -1.1 -95.4
The full report is attached as a PDF, and is also available on the company’s website: View Source

Alligator will host a webinar on Thursday, April 24 2025, at 2 p.m. CEST/ 8 a.m. EDT for investors, analysts and media, where CEO Søren Bregenholt and CFO Johan Giléus will present and comment on the January – March 2025 interim report, which will be followed by a Q&A session.

On April 23, 2025 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that preclinical efficacy of SLS009 in ASXL1 mutated colorectal cancer lines will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to take place May 30- June 3, 2025 in Chicago, Illinois (Press release, Sellas Life Sciences, APR 23, 2025, View Source [SID1234652059]).

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Poster presentation details:

Title: In vitro efficacy of CDK9 inhibitor tambiciclib (SLS009) in ASXL1 mutated colorectal cancer cell lines.

Session Date and Time: Monday, June 2, 2025, 1:30 PM-4:30 PM CDT

Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Location: Hall A – Posters and Exhibits

Abstract #: 3121

Poster Board #: 436

The full text of the abstract will be released by ASCO (Free ASCO Whitepaper) on May 22, 2025, at 5:00 PM EDT on asco.org/abstracts.

SLS009 is currently being investigated in a Phase 2 open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine including AML patients with ASXL1 mutations. Initial clinical safety and efficacy data are available. In addition, the study aims to identify biomarkers for the target patient population and enrichment for further trials. For more information on the study, visit clinicaltrial.gov identifier NCT04588922.

On April 23, 2025 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that the following presentations related to emiltatug ledadotin (Emi-Le; XMT-1660), Mersana’s B7-H4-directed Dolasynthen ADC, will be given at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting taking place May 30-June 3, 2025 at McCormick Place, Chicago, IL (Press release, Mersana Therapeutics, APR 23, 2025, View Source [SID1234652058]):

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Oral Presentation Details

Title: Initial Phase 1 Dose Escalation Data for Emiltatug Ledadotin (Emi-Le), a Novel B7-H4-Directed Dolasynthen Antibody-Drug Conjugate
Rapid Oral Session Title: Developmental Therapeutics
Date and Time: Monday, June 2, 2025 from 8:00-9:30 a.m. CT
Abstract Number: 3009
Presenter: Erika Hamilton, M.D., Director Breast Cancer Research Program, Sarah Cannon Research Institute in Nashville, Tennessee
This presentation will include clinical data from dose escalation and backfill cohorts across tumor types from the ongoing Phase 1 clinical trial of Emi-Le.

Poster Presentation Details

Title: Emiltatug Ledadotin (Emi-Le): A B7-H4-Directed Dolasynthen Antibody-Drug Conjugate (ADC) Being Investigated in Phase 1 Dose Expansion in Patients with Triple Negative Breast Cancer Who Received at Least One Prior Topoisomerase-1 Inhibitor ADC
Poster Session Title: Breast Cancer – Metastatic
Date and Time: Monday, June 2, 2025 from 9:00-12:00 p.m. CT
Abstract Number: TPS1141
Presenter: Hyo Han, M.D., H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida
This "trial-in-progress" presentation will focus on the design of the ongoing expansion portion of Mersana’s Phase 1 clinical trial of Emi-Le that is actively enrolling patients with triple negative breast cancer (TNBC) who have received one to four prior treatment lines, including at least one topoisomerase-1 inhibitor ADC.

Additionally, as previously announced, an oral presentation regarding Emi-Le will be given at the ESMO (Free ESMO Whitepaper) Breast Cancer 2025 Annual Congress in Munich, Germany on Thursday, May 15, 2025. This presentation will focus on TNBC clinical data from dose escalation and backfill cohorts from the Phase 1 clinical trial of Emi-Le.

About Emi-Le
Emi-Le is a B7-H4-directed Dolasynthen ADC with a precise, target-optimized drug-to-antibody ratio (DAR 6) and a proprietary auristatin payload with controlled bystander effect. This candidate is being investigated in a Phase 1 dose escalation and expansion trial in patients with solid tumors, including breast, endometrial and ovarian cancers as well as adenoid cystic carcinoma type 1. In the initial clinical data that were reported as of a December 13, 2024 data cutoff, Emi-Le was observed to be generally well tolerated with differentiated safety and tolerability profile. Additionally, confirmed objective responses were observed across all enrolled tumor types, including in patients with triple negative breast cancer (TNBC) who had previously been treated with a topoisomerase-1 inhibitor (topo-1) ADC.

The U.S. Food and Drug Administration has granted two Fast Track designations to Emi-Le for the treatment of 1) adult patients with advanced or metastatic triple-negative breast cancer, and 2) advanced or metastatic breast cancer in patients with human epidermal growth factor receptor 2 (HER2) low (IHC 1+ or IHC 2+/ISH–) or HER2-negative (IHC 0) disease, including TNBC, who have received a prior topo-1 ADC. For more information about Mersana’s ongoing Phase 1 trial of Emi-Le, please visit clinicaltrials.gov (NCT05377996).

On April 23, 2025 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that pre-clinical data for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 (IL-12) TIL cell therapy, will be presented at the 2025 AACR (Free AACR Whitepaper) Annual Meeting (Press release, Iovance Biotherapeutics, APR 23, 2025, View Source [SID1234652057]). In addition, five-year outcomes data from the C-144-01 study of lifileucel monotherapy in patients with advanced melanoma, and a poster on study design for lifileucel in frontline advanced non-small cell lung cancer, will be presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting.

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2025 AACR (Free AACR Whitepaper) Annual Meeting, April 25-30, 2025, Chicago, IL

Poster: IOV-5001, autologous tumor-infiltrating lymphocytes armored with inducible membrane-tethered interleukin-12, shows enhanced antitumor efficacy with an improved cellular state (Abstract 4863)
Session: Immune Fitness and Metabolic Regulation of Cancer Immunity, Tuesday, April 29, 2025, 9:00 am – 12:00 pm CDT
2025 ASCO (Free ASCO Whitepaper) Annual Meeting, May 30-June 3, 2025, Chicago, IL

Rapid Oral Presentation: Lifileucel in patients with advanced melanoma: 5-year outcomes of the C-144-01 study (Abstract 9515)
Session: Melanoma/Skin Cancers, Monday, June 2, 2025, 9:45 am – 11:15 am CDT
Trial-in-Progress Poster: Phase 2, multicenter study of the lifileucel regimen and pembrolizumab after frontline platinum-doublet chemotherapy and pembrolizumab in advanced non-small cell lung cancer (Abstract 133A)
Session: Lung Cancer—Non-Small Cell Metastatic, Saturday, May 31, 2025, 1:30 pm – 4:30 pm CDT
Iovance will host a panel discussion on the evening of Saturday, May 31, 2025 at 6 pm CDT (7 pm EDT) featuring key opinion leaders in melanoma. The live and archived webcast will be available in the Investors section of the company’s website at www.iovance.com.

On April 23, 2025 Intensity therapeutics presented its corporate presentation (Presentation, Intensity Therapeutics, APR 23, 2025, View Source [SID1234652056]).

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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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