On October 7, 2025 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that findings highlighting the strong potential of circular single-stranded DNA (CssDNA) as a universal, efficient non-viral template for gene therapy, along with a comprehensive study of TALE base editors (TALEB) off-targets in the nuclear genome, will be presented at the European Society of Cell and Gene Therapy (ESGCT) annual congress, that will take place on October 7-10, 2025, in Sevilla, Spain (Press release, Cellectis, OCT 7, 2025, View Source [SID1234656480]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Poster presentation:

Title: Circularization of Single-Stranded DNA Donor Template Unleashes the Power of Non-Viral Gene Delivery for Long-Term HSCs editing

Presenter: Julien Valton, Ph.D., Vice President Gene Therapy at Cellectis

Date/Time: Wednesday, October 8, 2025 from 2:00 p.m. to 3:30 p.m. CET

Poster number: P0439

Over the past decade, non-viral DNA template delivery has been used with engineered nucleases to target single-stranded DNA sequences in hematopoietic stem and progenitor cells (HSPCs).

While developed for gene therapy purposes, so far this method has been restricting to gene corrections. To expand this scope, Cellectis developed an editing process using its gene editing technology and kilobase-long circular single-stranded DNA donor templates.

Research data show that:

· CssDNA editing process achieved high gene insertion frequency in viable HSPCs.

· CssDNA-edited HSPCs show a higher propensity to engraft and maintain gene edits in a murine model than adeno-associated viruses (AAV)-edited HSPCs.

These data highlight the strong potential of CssDNA as a universal and efficient non-viral DNA template for gene therapy applications.

The research was also presented as an oral presentation at the Homology-Directed Repair: The Path Forward Workshop in Sevilla on October 6, 2025.

Poster presentation:

Title: Comprehensive analysis of TALEB off-target editing

Presenter: Maria Feola, Ph.D., Senior Scientist, Team Leader Gene Editing at Cellectis

Date/Time: Thursday, October 9, 2025 from 2:00 p.m. to 3:30 p.m. CET

Poster number: P0506

TALE base editors (TALEB) are fusions of a transcription activator-like effector domain (TALE), split-DddA deaminase halves, and an uracil glycosylase inhibitor (UGI).

These recent additions to the genome editing toolbox can directly edit double strand DNA, converting a cytosine (C) to a thymine (T) through the formation of an uracil (U) intermediate without the need of DNA break. Base editing has great potential in therapeutic applications. However, being able to avoid potential off-target effects is key toward this goal.

To evaluate TALEB safety, Cellectis combined advanced bioinformatic predictions with multiple experimental approaches to investigate potential off-target effects in the nuclear genome of primary T cells.

The study found no evidence of biases towards off-site C-to-T editing at sites flanked by CTCF binding sites, a key DNA-binding protein that regulates genome organization and gene expression at genome wide level.

These results provide a strong framework for the safe development of TALEB in therapeutic cell engineering, supporting their potential for future nuclear and mitochondrial applications.

On October 7, 2025 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, reported the pricing of its previously announced underwritten public offering consisting of (i) 11,195,121 shares of its common stock and accompanying warrants to purchase an aggregate of 11,195,121 shares of common stock (or pre-funded warrants in lieu thereof) and (ii) in lieu of common stock, to certain investors, pre-funded warrants to purchase an aggregate of up to 1,000,000 shares of its common stock and accompanying warrants to purchase an aggregate of up to 1,000,000 shares of common stock (or pre-funded warrants in lieu thereof), at an exercise price of $0.0001 per pre-funded warrant (Press release, Biomea Fusion, OCT 7, 2025, View Source [SID1234656479]). In addition, Biomea has granted the underwriters a 30-day option to purchase up to an additional 1,829,268 shares of common stock and/or warrants to purchase 1,829,268 shares of common stock at the public offering price, less underwriting discounts and commissions. The common stock and pre-funded warrants are being sold in combination with an accompanying warrant to purchase one share of common stock (or a pre-funded warrant in lieu thereof) issued for each share of common stock or pre-funded warrant sold. The accompanying warrant has an exercise price of $2.50 per share, is immediately exercisable from the date of issuance and will expire three years from the date of issuance. The combined offering price of each share of common stock and accompanying common stock warrant is $2.05. The combined offering price of each pre-funded warrant and accompanying common stock warrant is $2.0499.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

All of the shares, pre-funded warrants and accompanying common stock warrants in the offering are being sold by Biomea. The gross proceeds to Biomea from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $25.0 million, excluding any exercise of the underwriters’ option to purchase additional shares and/or warrants. The offering is expected to close on October 8, 2025, subject to the satisfaction of customary closing conditions.

Jefferies is acting as sole book-running manager for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.

The shares of common stock, pre-funded warrants and common stock warrants and shares of common stock issuable upon the exercise of the pre-funded warrants and common stock warrants are being offered by Biomea pursuant to an effective shelf registration statement on Form S-3 (File No. 333-289262), that was previously filed with the U.S. Securities and Exchange Commission ("SEC") on August 5, 2025 and declared effective on August 15, 2025. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on October 6, 2025, and is available for free on the SEC’s website located at View Source The final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source

Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained from: Jefferies LLC by mail at Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On October 6, 2025 Daiichi Sankyo reported positive topline results from the TROPION-Breast02 phase 3 trial showed DATROWAY (datopotamab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progressionfree survival (PFS) compared to investigator’s choice of chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy was not an option.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

Approximately 70% of patients with metastatic TNBC are not candidates for immunotherapy, including all patients whose tumors do not express PD-L1 as well as patients with PD-L1 expressing tumors who cannot receive immunotherapy due to other factors.1 Chemotherapy remains the first-line standard of care for these patients.

"DATROWAY is the first antibody drug conjugate and the only therapy to significantly improve overall survival compared to chemotherapy in patients with metastatic triple negative breast cancer for whom immunotherapy is not an option," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "These landmark results from TROPION-Breast02 strengthen our confidence in our ongoing clinical development program for DATROWAY in triple negative breast cancer and other tumor types. We look forward to 2 discussing these data with global regulatory authorities and to bringing DATROWAY to patients with triple negative breast cancer as soon as possible."

"TROPION-Breast02 is the only trial ever to show an overall survival benefit in the first-line treatment of patients with metastatic triple negative breast cancer for whom immunotherapy is not an option," said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. "We expect today’s results will mark an inflection point in the treatment of these patients who have the poorest prognosis of any type of breast cancer and urgently need better options."

The safety profile of DATROWAY was consistent with previous clinical trials of DATROWAY in breast cancer. These data from TROPION-Breast02 will be presented at an upcoming medical meeting and shared with regulatory authorities.

Daiichi Sankyo and AstraZeneca are evaluating DATROWAY across stages and treatment settings of TNBC in three additional phase 3 trials. TROPION-Breast03 is evaluating DATROWAY as adjuvant therapy with or without AstraZeneca’s anti-PD-L1 therapy durvalumab versus investigator’s choice of therapy in patients with stage I-III TNBC with residual invasive disease after neoadjuvant systemic therapy. TROPIONBreast04 is evaluating neoadjuvant DATROWAY plus durvalumab versus neoadjuvant pembrolizumab plus chemotherapy in patients with stage II-III triple negative or hormone receptor (HR) low, HER2 low or negative breast cancer. TROPION-Breast05 is evaluating first-line DATROWAY with or without durvalumab versus investigator’s choice of therapy in patients with metastatic TNBC whose tumors express PD-L1.

About TROPION-Breast02

TROPION-Breast02 is a global, multicenter, randomized, open-label phase 3 trial evaluating the efficacy and safety of DATROWAY versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumors did not express PD-L1 as well as patients with PD-L1 expressing tumors who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrollment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as brain metastases.

The dual primary endpoints of TROPION-Breast02 are PFS assessed by blinded independent central review and OS. Key secondary endpoints include PFS as assessed by investigator, objective response rate, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov

About Triple Negative Breast Cancer

TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.3,4 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.5,6,7 Metastatic TNBC is the most aggressive type of breast cancer and has the worst prognosis, with median overall survival of just 12 to 18 months and only about 14% of patients living five years following diagnosis.

While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.5 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.5 For patients with metastatic disease with PDL1 expressing tumors, the addition of immunotherapy to chemotherapy has improved outcomes in the firstline setting.10,11 However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy remains the first-line standard of care.

TROP2 is a protein broadly expressed in several solid tumors, including TNBC. TROP2 is associated with increased tumor progression and poor survival in patients with breast cancer.

About DATROWAY

DATROWAY (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

DATROWAY (6 mg/kg) is approved in more than 35 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial.

DATROWAY (6 mg/kg) is approved in Russia and the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFRdirected therapy and platinum-based chemotherapy, based on the results from TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the U.S. may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the DATROWAY Clinical Development Program

A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including NSCLC, TNBC and urothelial cancer. The program includes eight phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other cancer treatments in various settings.

(Press release, Daiichi Sankyo, OCT 6, 2025, View Source [SID1234665028])

On October 6, 2025 Trogenix Ltd ("Trogenix"), a pioneering biotech company dedicated to developing innovative cancer therapies, reported the completion of its Series A financing, raising £70 million / $95 million. The funding will enable the rapid advancement of its robust pipeline of potentially curative cancer therapies across multiple aggressive solid tumours into the clinic.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Ken Macnamara, Chief Executive Officer at Trogenix, said:

"This significant investment accelerates our lead programme in glioblastoma and follow-on programme in colorectal cancer liver metastases through the clinic, advances our pipeline in liver and lung cancers, and further enhances our Odysseus platform. We are honoured to have the support of existing and new investors who share our mission to deliver breakthrough treatments and pursue cures for the thousands of patients and families facing devastating diagnoses each year."

The Series A financing was led by IQ Capital with participation from founding investor 4BIO Capital, returning investors Cancer Research Horizons, the Brain Tumor Investment Fund, and new investors Eli Lilly and Company, Meltwind, LongeVC, and Calculus Capital, as well as undisclosed private investors. The investment underscores the transformative, curative potential of Trogenix’s precision genetic medicines driven by the Company’s Odysseus platform that identifies and targets the universal vulnerabilities of solid tumours. Trogenix’s revolutionary technology delivers highly potent combination payloads that kill cancerous cells and stimulate the immune system whilst leaving surrounding healthy tissue untouched, thereby changing the treatment paradigm for cancer patients.

Max Bautin, Co-founder and Managing Partner at lead investor, IQ Capital, said:

"Our outsized investment in Trogenix in today’s selective funding landscape reflects our confidence in the company’s world-leading science, exceptional management team and a clear roadmap for delivery both in the clinic and commercially. We are particularly excited by the potential opportunities ahead across Trogenix’s pipeline and look forward to our future collaboration."

This investment in Trogenix also represents Cancer Research Horizons’ largest investment to-date, highlighting the transformational potential of Trogenix’s breakthrough technology in cancer treatment.

Iain Foulkes, Chief Executive Officer at Cancer Research Horizons, commented:

"Trogenix’s platform technology is a powerful example of the innovation we seek to accelerate. Representing our largest investment to date, this partnership reflects our commitment to advancing science with the potential to transform cancer treatment. As they advance into clinical trials for glioblastoma, one of the hardest to treat cancers, we’re pleased to support a team whose work could reshape therapeutic approaches and improve outcomes for patients facing the greatest need."

Dima Kuzmin, Co-founder and Managing Partner at founding investor, 4BIO Capital, and Chairman of Trogenix, added:

"We are proud to have supported Trogenix through the initial incubation stage and spin-out from the University of Edinburgh, and are very happy to continue our support alongside this strong syndicate. It is exciting to see the company forge ahead with its clinical development to deliver a pioneering portfolio of cancer therapies to patients in need."

(Press release, Trogenix, OCT 6, 2025, View Source [SID1234656873])

On October 6, 2025 MaxCyte, Inc. (Nasdaq: MXCT), a leading cell-engineering company providing enabling platform technologies to advance the discovery, development, and commercialization of next-generation cell-based therapeutics, reported the signing of a Strategic Platform License (SPL) agreement with Moonlight Bio, a preclinical-stage biotechnology company based in Seattle, Washington (Press release, Moonlight Bio, OCT 6, 2025, View Source [SID1234656512]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Moonlight Bio will deploy MaxCyte’s Flow Electroporation technology and ExPERT platform to support the scalable development and manufacturing of its T cell therapy pipeline.

"We’re proud to partner with Moonlight Bio as they advance their gene-edited cell therapies through clinical development," said Maher Masoud, President and CEO of MaxCyte. "Our globally supported, GMP-ready and regulatory-proven ExPERT platform is built to accelerate clinical and commercial manufacturing and enable robust, scalable cell engineering. We’re excited to support Moonlight Bio’s innovative approach to optimizing gene-editing outcomes and advancing next-generation T cell therapies."

"We look forward to collaborating with MaxCyte and leveraging their proven, GMP-compliant electroporation technology along with their deep scientific and regulatory expertise to build our clinical manufacturing process," said Jordan Jarjour, Chief Scientific Officer of Moonlight Bio. "At Moonlight Bio, we are committed to delivering T cell therapies that overcome the barriers to success in solid tumors, which account for the majority of the global cancer burden."

Under the SPL, Moonlight Bio obtains non-exclusive research, clinical, and commercial rights to use MaxCyte’s Flow Electroporation technology and ExPERT platform. In return, MaxCyte is entitled to receive annual licensing fees and program-related revenue.