On April 23, 2025 AB Science SA (Euronext – FR0010557264 – AB) reported that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) granted orphan drug status to AB8939 for the treatment of acute myeloid leukemia (AML) (Press release, AB Science, APR 23, 2025, View Source [SID1234652043]).

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AB8939 had already obtained orphan drug designation from the US Food and Drug Administration (FDA) in AML.

Granting of this orphan drug status in the EU is a significant milestone because it means that the COMP considered that AB8939 offers a significant benefit to people suffering from this condition in addition to existing treatments.

Indeed, the criteria to obtain orphan drug designation at EMA differ from those at FDA and are very stringent for the following reasons :

-There must be no satisfactory method of diagnosis, prevention or treatment of the condition or, if such a method exists, the medicinal product must offer a significant benefit to patients. -Because the application is based on an assumption of significant benefit, a comparison with authorized treatments is required.

-Significant benefit means that a medicine produces a clinically relevant advantage or makes a major contribution to patient care, as compared with existing methods to treat the condition. Thus, orphan designation is given to a product that will improve patients’ current treatment, having considered what else is available.

-To follow the spirit of the orphan legislation, which makes it clear that an orphan application may bemade at any stage of the development, significant benefit will be based on the available evidence at the stage of designation.

In support of the significant benefit of AB8939 in AML, AB Science has released preclinical data from mouse models demonstrating a significant benefit of AB8939 treatment over current therapies, such as cytarabine, azacitidine (Vidaza) and venetoclax (Venclexta). This included:

-Efficacy on resistant cells: AB8939 manages to have an effect on the cancer cells (blasts) of AML patients, even when these cells are resistant to other drugs such as vincristine or cytarabine. For example, 45% of vincristine-resistant cells and 66% of cytarabine-resistant cells still respond to AB8939, including in severe cases with complex genetic mutations (MECOM, TP53).

-Convincing results in xenograft models derived from refractory AML patients: In these mouse models which mimick human AML, AB8939 reduces tumors and prolongs survival, even when cells areresistant to cytarabine. -Additive effect with reference treatments: When used with other treatments (cytarabine, Vidaza or venetoclax), AB8939 further improves results. For example, with venetoclax, it eliminates cancer cells in the blood, spleen and bone marrow, without serious side effects

-Furthermore, unlike venetoclax, AB8939 does not cause blood toxicity (hematotoxicity) and appears to act synergistically with other treatments, reinforcing its efficacy.

AB Science also presented preliminary efficacy and safety data from phase 1 of AB8939 as a monotherapy, with a 3-day treatment cycle (stage 1 of phase 1) and a 14-day treatment cycle (stage 2 of phase 1).

Professor Olivier Hermine, President of AB Science’s Scientific Committee, member of the French Academy of Sciences and Head of the Hematology Department at Necker Hospital, commented: "This designation testifies to the potential of AB8939 for the treatment of AML. Indeed, AB8939 has shown activity as a monotherapy on Ara-C-resistant patient lines, including in unfavorable genetic situations (MECOM, TP53 mutations) that have resisted all treatments administered to date, as well as a synergistic effect with the reference treatments Vidaza and Venclexta. The ongoing Phase 1 trial will now evaluate the combination of AB8939 with these reference treatments in refractory patients".

About AB8939

AB8939 is a new synthetic molecule which jointly targets cancer cells, by destabilizing the microtubules essential for cell division, and cancer stem cells, by inhibiting enzymes (ALDH1A1 and ALDH2) essential for maintaining their physiological state and survival. The molecule ‘1-{4-[2-(5-ethoxymethyl-2-methylphenylamino)-oxazol-5-yl]phenyl}imidazolidin-2-one’ is the chemical name of AB8939. The intellectual property of AB8939 is 100% owned by AB Science.

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 Pfizer Inc. (NYSE: PFE) reported that it will showcase data across its portfolio of potential breakthrough cancer medicines at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30 to June 3 in Chicago (Press release, Pfizer, APR 23, 2025, View Source [SID1234652075]). Data from more than 60 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 9 oral presentations and 6 rapid oral presentations, will be presented across Pfizer’s key tumor areas, including breast, genitourinary, hematologic, and thoracic cancers, as well as colorectal cancer.

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"This has already been a significant year for Pfizer’s Oncology pipeline, with multiple Phase 3 data readouts and regulatory approvals, and the initiation of pivotal registrational programs across our major tumor areas of focus," said Chris Boshoff, MD, PhD, Chief Scientific Officer and President, Research & Development, Pfizer. "The depth and diversity of our data presentations at ASCO (Free ASCO Whitepaper) are building on that momentum to bring us closer to our goal of delivering eight breakthrough cancer medicines by 2030."

Pfizer will have two late-breaking oral presentations featured in ASCO (Free ASCO Whitepaper)’s embargoed pre-meeting press briefing on May 27. These include the primary analysis of the pivotal overall survival (OS) and progression-free survival (PFS) results from the Phase 3 BREAKWATER study investigating BRAFTOVI (encorafenib) in combination with cetuximab (marketed as ERBITUX) and mFOLFOX6 in patients with BRAF V600E-mutant metastatic colorectal cancer,* as well as the first presentation of the PFS results from the Phase 3 VERITAC-2 study of vepdegestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer (a/mBC) in partnership with Arvinas.**

Pfizer will share additional updates from key late-stage programs, including five-year survival data from the Phase 3 ARCHES study of XTANDI (enzalutamide) in combination with androgen deprivation therapy in metastatic hormone-sensitive prostate cancer (mHPSC),*** and the first combination data for ELREXFIO (elranatamab) + daratumumab + lenalidomide from the ongoing MagnetisMM-6 study in patients with transplant-ineligible (TI) newly diagnosed multiple myeloma (NDMM).

Pfizer will also share new findings highlighting the company’s strategy to explore novel vedotin antibody-drug conjugates (ADCs) in combination with immune checkpoint inhibitors to potentially enhance anti-tumor activity. For the first time, Pfizer will present encouraging Phase 1 data on two novel investigational ADCs in combination with pembrolizumab in thoracic cancers: sigvotatug vedotin (SV), an integrin beta-6 (IB6)-directed ADC, in lung cancer and head and neck cancers, and PDL1V (PF-08046054), a PD-L1 directed ADC, in head and neck cancers. Additionally, new exploratory analyses will be presented from the pivotal EV-302 trial with PADCEV (enfortumab vedotin) in combination with KEYTRUDA (pembrolizumab) in patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).****

Several presentations will highlight updated results from ongoing Phase 1 studies that inform the dosing strategy in registrational programs for two molecules targeting epigenetic regulators: mevrometostat, an investigational EZH2 inhibitor being evaluated in combination with XTANDI for metastatic castration-resistant prostate cancer (mCRPC); and PF-07248144, a potential first-in-class KAT6 inhibitor for ER+/HER2- metastatic breast cancer (mBC).

"Our data at ASCO (Free ASCO Whitepaper) this year reflect how we are strategically progressing our deep pipeline of next generation cancer medicines while simultaneously extending the impact of our foundational therapies to reach more people living with cancer," said Megan O’Meara, Head of Early-Stage Development and Interim Head of Late-Stage Development, Pfizer Oncology. "Important early-stage updates highlight our extensive pipeline and depth within our core cancer types, as we advance up to nine new pivotal Phase 3 trials this year."

Key ASCO (Free ASCO Whitepaper) Presentations

Colorectal Cancers

BRAFTOVI: A late-breaking session will detail PFS and OS results from the Phase 3 BREAKWATER study of BRAFTOVI in combination with cetuximab and mFOLFOX6 chemotherapy in BRAF V600E-mutant metastatic colorectal cancer, further establishing the benefit of the BRAFTOVI combination regimen following its FDA accelerated approval in late 2024. These pivotal study results follow the topline results announcement for PFS and OS and the objective response rate (ORR) results presented at ASCO (Free ASCO Whitepaper) GI. These new data will also be featured in the ASCO (Free ASCO Whitepaper) press program.
Breast Cancer

Vepdegestrant: In a late-breaking session, PFS data will be presented for the first time from the Phase 3 VERITAC-2 study of vepdegestrant, a PROTAC ER degrader, in ER+/HER2− a/mBC. These detailed data follow the topline results from VERITAC-2 announced earlier this year and will also be featured in the ASCO (Free ASCO Whitepaper) press program.
PF-07248144 (KAT6 inhibitor): A rapid oral presentation will highlight dose optimization data from an ongoing Phase 1 study for PF-07248144, a potential first-in-class KAT6 inhibitor, in patients with ER+/HER2− mBC. These results support the recommended dosing for PF-07248144 ahead of the Phase 3 trial initiation in second-line mBC planned for 2H 2025.
IBRANCE (palbociclib): Roche will present detailed results from the OS analysis of the Phase 3 INAVO120 study investigating ITOVEBI (inavolisib) in combination with IBRANCE and fulvestrant in patients with PIK3CA-mutated, HR+/HER2-, endocrine-resistant, locally a/mBC. This presentation will be featured in ASCO (Free ASCO Whitepaper)’s embargoed pre-meeting press briefing on May 21.
Genitourinary Cancers

XTANDI: Five-year follow-up overall survival data from the ARCHES study of XTANDI in combination with androgen deprivation therapy in patients with mHSPC will be featured in an oral presentation. In addition, updates from the Astellas-supported, investigator-sponsored ENZAMET Phase 3 research study, led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) and sponsored by the University of Sydney, will also be presented, including 8 year-outcomes in men with mHSPC. These presentations further underscore the value of XTANDI across approved indications.
Mevrometostat: A poster presentation will highlight pharmacokinetic and safety data from the ongoing Phase 1 study for mevrometostat, an investigational EZH2 inhibitor, in combination with XTANDI. These updated data further inform the dosing strategy for mevrometostat in a robust registrational program that includes two Phase 3 trials in mCRPC, and a third trial in metastatic castration-sensitive prostate cancer (mCSPC) that is planned to start in 1H 2025.
PADCEV: Additional updates from the Phase 3 EV-302 study of PADCEV in combination with KEYTRUDA in previously untreated la/mUC will be presented, including an oral presentation with exploratory analysis of responders.
Hematologic Cancers

ELREXFIO: Initial safety and efficacy results from Part 1 of the ongoing MagnetisMM-6 study of ELREXFIO in combination with daratumumab and lenalidomide in patients with newly diagnosed MM that are not eligible for transplant will be presented as an oral presentation. Part 1 of the ongoing MagnetisMM-6 study evaluates the optimal dose of the ELREXFIO combination regimen in patients with RRMM or NDMM to determine the recommended phase 3 dose for part 2.
Thoracic Cancers

Sigvotatug vedotin (SV): Phase 1 results for SV, an IB6-directed vedotin ADC, in combination with pembrolizumab in non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) will be featured in a rapid oral presentation. This initial combination data for SV with pembrolizumab support a Phase 3 study in first line PD-L1-High NSCLC, initiated this year. The data also support the overall SV trial program that includes an ongoing Phase 3 monotherapy trial in second line+ NSCLC.
PDL1V (PF-08046054): Two poster presentations will highlight interim Phase 1 results for PDL1V, a PD-L1 directed vedotin ADC, as monotherapy in NSCLC and initial safety and efficacy data in combination with pembrolizumab in patients with first-line recurrent or metastatic (r/m) HNSCC. These data provide additional support for the initiation of the two pivotal Phase 3 trials planned for PDL1V in 2025 in second line+ NSCLC and first line r/mHNSCC.
Additional information on key Pfizer-sponsored abstracts, including date and time of presentation, follows in the chart below. A complete list of Pfizer-sponsored accepted abstracts is available here.

Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented at ASCO (Free ASCO Whitepaper), which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries starting May 22, 2025.

COLORECTAL CANCERS

Oral Presentation (Abstract LBA3500)

Friday, May 30, 2:45-5:45 PM CDT

First-line encorafenib + cetuximab + mFOLFOX6 in BRAF V600E-mutant metastatic colorectal cancer (BREAKWATER): progression-free survival and updated overall survival analyses

Elez et al

BREAST CANCER

Rapid Oral Presentation (Abstract 1020)

Friday, May 30, 2:45-4:15 PM CDT

Dose optimization of PF-07248144, a first-in-class KAT6 inhibitor, in patients (pts) with ER+/HER2− metastatic breast cancer (mBC): Results from phase 1 study to support the recommended phase 3 dose (RP3D)

LoRusso et al

Oral Presentation (Abstract LBA1000)

Saturday, May 31, 1:15-4:15 PM CDT

Vepdegestrant, a PROTAC estrogen receptor (ER) degrader, vs fulvestrant in ER-positive/human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer: Results of the global, randomized, phase 3 VERITAC-2 study

Hamilton et al

GENITOURINARY CANCERS

Oral Presentation (Abstract 4502)

Sunday, June 1, 9:45 AM-12:45 PM CDT

Exploratory analysis of responders from the phase 3 EV-302 trial of enfortumab vedotin plus pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC)

Gupta et al

Oral Presentation (Abstract 5005)

Tuesday, June 3, 9:45 AM-12:45 PM CDT

ARCHES 5-year follow-up overall survival (OS) analysis of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC)

Armstrong et al

Poster Presentation (Abstract 4571)

Monday, June 2, 9:00 AM-12:00 PM CDT

EV-302: Long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC)

Bedke et al

Poster Presentation (Abstract 5046)

Monday, June 2, 9:00 AM-12:00 PM CDT

Safety and pharmacokinetics of mevrometostat (M) in combination with enzalutamide (E) in patients with metastatic castration-resistant prostate cancer (mCRPC)

Matsubara et al

HEMATOLOGIC CANCERS

Oral Presentation (Abstract 7504)

Tuesday, June 3, 9:45 AM-12:45 PM CDT

Elranatamab in combination with daratumumab and lenalidomide (EDR) in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant: Initial results from MagnetisMM-6 part 1

Quach et al

THORACIC CANCERS

Rapid Oral Presentation (Abstract 3010)

Monday, June 2, 8:00-9:30 AM CDT

Sigvotatug vedotin (SV), an investigational integrin beta-6 (IB6)–directed antibody‒drug conjugate (ADC), and pembrolizumab combination therapy: Initial results from an ongoing phase 1 study (SGNB6A-001)

Sehgal et al

Poster Presentation (Abstract 6033)

Monday, June 2, 9:00 AM-12:00 PM CDT

Initial safety and efficacy of PDL1V (PF-08046054), a vedotin-based ADC targeting PD-L1, in combination with pembrolizumab in patients with recurrent or metastatic (R/M) HNSCC

Gillison et al

Poster Presentation (Abstract 8611)

Saturday, May 31, 1:30-4:30 PM CDT

Interim results of PDL1V (PF-08046054), a vedotin-based ADC targeting PD-L1, in patients with NSCLC in a phase 1 trial

Fontana et al

*The BREAKWATER trial was conducted with support from ONO Pharmaceutical, Merck KGaA, Darmstadt, Germany and Eli Lilly and Company.
**Pfizer and Arvinas have a global collaboration for the co-development and co-commercialization of vepdegestrant.
***XTANDI is jointly developed and commercialized by Pfizer and Astellas in the United States.
****Pfizer and Astellas have a clinical collaboration agreement with Merck to evaluate the combination of PADCEV and KEYTRUDA in patients with previously untreated metastatic urothelial cancer.

Prescribing Information for Pfizer Medicines

Please see full Prescribing Information for BRAFTOVI.

Please see full Prescribing Information, including BOXED WARNING, for ELREXFIO (elranatamab-bcmm).

Please see full Prescribing Information for IBRANCE (palbociclib) tablets and IBRANCE (palbociclib) capsules.

Please see full Prescribing Information, including BOXED WARNING, for PADCEV (enfortumab vedotin).

Please see full Prescribing Information for XTANDI (enzalutamide).

On April 23, 2025 Adcendo ApS ("Adcendo"), a biotech company focused on the development of first and best-in-class ADCs for the treatment of cancers with high unmet medical need, reported it will be presenting data on its two novel ADC programs ADCE-T02, targeting Tissue Factor, and ADCE-D01, targeting uPARAP, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held in Chicago, Illinois, from April 25th to April 30th, 2025 (Press release, ADCendo, APR 23, 2025, View Source [SID1234652044]).

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ADCE-T02 is a potential best-in-class Topo-1 inhibitor-based ADC targeting Tissue Factor (TF). Tissue Factor is clinically validated target overexpressed in a broad range of solid tumors, with limited expression in normal tissues. ADCE-T02 is composed of a next-generation TF targeting antibody conjugated to an exatecan-based T-1000 payload, a clinically validated linker-payload technology. ADCE-T02 shows strong anti-tumor activity in a wide range of solid tumor models and is well tolerated in non-human primate toxicology studies with no evidence of toxicity from earlier generation TF ADCs. A phase 1 clinical trial in advanced solid tumors is ongoing in both Australia and the United States. Australian recruitment is underway and enrollment in the United States will be initiated in the near future [NCT06597721].

ADCE-D01 is a first-in-class ADC targeting uPARAP conjugated to the Topo-1 inhibitor payload P-1021. uPARAP is a novel endocytic ADC target that is overexpressed in tumors of mesenchymal origin, such as sarcomas, while exhibiting restricted expression in normal tissues. ADCE-D01 is composed of a first-in-class uPARAP-targeting antibody conjugated to an optimized, clinically validated linker payload technology, selected for its superior efficacy and tolerability. Preclinically, ADCE-D01 shows strong anti-tumor activity in a range of mesenchymal tumor models including soft tissue sarcoma and is well tolerated in non-human primate toxicology studies with a favorable safety profile and no evidence of target-specific toxicity. A phase 1 clinical trial in advanced soft tissue sarcomas is enrolling in the United States and is under regulatory review in the European Union [NCT06797999].

Dominik Mumberg, PhD, Chief Scientific Officer at Adcendo, said: "We are excited to share the promising preclinical data for ADCE-T02 and ADCE-D01 demonstrating strong anti-tumor activity across a broad range of epithelial and mesenchymal tumor models with highly favourable tolerability profiles. We look forward to advancing both programs in our phase 1 Tiffany-01 and ADCElerate1 trials to help cancer patients in need of novel therapeutic options."

Details of the poster presentations are as follows:

Date & Time: April 29th, 9.00am – 12.00pm CT
Session Title: Antibodies and Antibody-Drug Conjugates
Poster Section: 36

Board Number: 14, Abstract number: 4778
Presentation title: ADCE-T02: A first-in-class topoisomerase-1 inhibitor-based antibody drug conjugate against tissue factor demonstrates excellent preclinical efficacy and tolerability
Authors: T. T. Poulsen1, Y. Zhang2, J. Zhang2, H. Shi2, S. Liu3, X. Meng2, M. Gillberg1, D. Mumberg1
1 Adcendo ApS, Copenhagen, Denmark. 2 Multitude Therapeutics, Shanghai, China. 3 Multitude Therapeutics, Redwood City, CA, USA

Board Number: 20, Abstract number: 4784
Presentation title: ADCE-D01: a first in class antibody-drug conjugate against urokinase plasminogen activator receptor-associated protein (uPARAP) demonstrates excellent preclinical efficacy and tolerability
Authors: J. Wardman1, A. Bie1, C. Côme1, P. Barkholt1, S. van Putten1, C. Løkke1, I. Gregersen1, J. Lange1, M. Gilberg1, K. Bannister1, M. Krogh-Madsen1, T. T. Poulsen1, C. Nielsen1, L. Engelholm2, N. Behrendt2, C. Lynch1, P. Hemmingsen1, D. Mumberg1
1 Adcendo ApS, Copenhagen, Denmark. 2 The Finsen Laboratory, Rigshospitalet/BRIC, Copenhagen University, Copenhagen, Denmark

Abstracts are available in an online itinerary planner (ADCE-T02 abstract; ADCE-D01 abstract), and will be available in an online only supplement to the AACR (Free AACR Whitepaper) journal Cancer Research one month after the conference. Electronic posters will be made available for registered conference participants from April 25th, 2025, through the conference web portal.

About antibody-drug conjugates (ADCs):

ADCs are a class of highly potent biopharmaceutical drug composed of a targeting antibody linked to a biologically active drug or cytotoxic compound. ADCs combine the unique and very sensitive targeting capabilities of antibodies, with the potent effects of the conjugated cytotoxic drugs, allowing sensitive discrimination between healthy and cancer tissues.

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.