On July 8, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported that the first patient has been dosed in the Phase 1 portion of a Phase 1/2 clinical study evaluating its potential best-in-class EGFR/HER3 bispecific antibody-drug conjugate, AVZO-1418, in patients with advanced solid tumors (Press release, Avenzo Therapeutics, JUL 8, 2025, View Source [SID1234654280]).

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"AVZO-1418 represents a unique approach to deliver a single targeted therapy to patients with diverse tumor types driven by EGFR and HER3 co-expression," said Anthony Tolcher, M.D., FRCPC, CEO and Founder, NEXT Oncology. "We believe this bispecific approach has the potential to improve tumor cell selectivity and maximize therapeutic impact across multiple solid tumor types that share this biology."

The Phase 1/2 first-in-human, open-label clinical study is designed to assess the safety, tolerability, and preliminary clinical activity of AVZO-1418 as a single agent and in combination therapy in patients with advanced solid tumors.

"We are proud to have dosed the first patient just over a month after receiving IND clearance," said Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer of Avenzo Therapeutics. "This milestone highlights the strong momentum behind our program. We plan to evaluate this bispecific ADC in a range of indications – including lung, breast, and head and neck cancers – where treatment options remain limited, including for patients who have progressed on standard therapies."

On July 8, 2025 Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ADRX-0405, for the treatment of patients with gastric cancer (Press release, Adcentrx Therapeutics, JUL 8, 2025, View Source [SID1234654279]).

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ADRX-0405 is a STEAP1 ADC being evaluated in the Phase 1a portion of an ongoing Phase 1a/b clinical trial (NCT06710379) for the treatment of select advanced solid tumors, including metastatic castration resistant prostate cancer, gastric cancer, and non-small cell lung cancer. While STEAP1 is primarily associated with prostate cancer, there is a meaningful amount of target expression in gastric cancer, making this a potential indication of interest for future clinical development.

"Receiving orphan drug designation from FDA is a notable milestone for Adcentrx and reinforces the potential for ADRX-0405 to improve the lives of patients with gastric cancer," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "We are encouraged by the progress of our Phase 1a trial and look forward to further evaluating the safety, tolerability and anti-tumor activity of ADRX-0405 in gastric and other cancers."

Gastric cancer, or stomach cancer, is a serious malignancy that develops in the stomach lining and is often diagnosed at advanced stages. The American Cancer Society estimates there will be 30,300 new cases of gastric cancer in the U.S. in 2025, meeting FDA’s criteria for a rare disease. The orphan drug designation is a program designed to stimulate the development of treatments for rare diseases, defined as conditions affecting fewer than 200,000 people in the U.S. Benefits of this designation include access to grant funding and scientific assistance, tax credits for qualified clinical trials, waiver of Prescription Drug User Fee Act (PDUFA) application fees, and the potential for seven years of market exclusivity following regulatory approval.

About ADRX-0405

ADRX-0405 is a clinical-stage next-generation ADC targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers with limited expression in normal healthy tissue. The ADC is composed of a humanized IgG1 antibody coupled with a novel topoisomerase inhibitor linker-payload through Adcentrx’s innovative i-Conjugation technology platform – a core component in the design of the company’s ADCs. The platform utilizes a cleavable linker and stable conjugation chemistry to enhance payload delivery. This novel technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) to maximize payload delivery to solid tumors. ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple animal tumor models. ADRX-0405 is currently being evaluated in a Phase 1a/b clinical trial.

For more information about the ADRX-0405 Phase 1a/b clinical trial, please refer to the Study ID NCT06710379 on ClinicalTrials.gov.

On July 8, 2025 AB Science S.A. (the "Company" or "AB Science", Euronext – FR0010557264 – AB) reported the successful completion of a capital increase of a total gross amount of EUR 1.925 million subscribed by a limited number of investors (the "Private Placement") (Press release, AB Science, JUL 8, 2025, View Source [SID1234654278]).

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The Private Placement is not subject to a prospectus requiring an approval from the French Financial Market Authority (Autorité des Marchés Financiers – the "AMF"). In accordance with Article 1.5.(ba) of the Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, as amended (the "Prospectus Regulation"), the Company file with the AMF a document containing the information set out in Appendix IX of the Prospectus Regulation (the "Information document"), copies of which will be available free of charge on the Company’s website at www.ab-science.com and on the AMF’s website at www.amf-france.org.

Use of proceeds

The Company intends to use the net proceeds of the Private Placement to finance its ongoing activities, with a focus on the clinical development of the AB8939 program.

This transaction strengthens the Company’s cash position and enables it to cover its financing needs in 2025 and beyond the next 12 months, taking into account the explanations set out in section 5.2.1.5 (note 2) of the 2024 financial report.

Terms and conditions of the Private Placement

The Private Placement, for a total amount of EUR 1.925 million (including share issue premium), was carried out through the issuance, without preferential subscription rights and without a priority subscription period, of 1,645,302 new ordinary shares in the Company (the "New Shares"), each with one share warrant attached (a "BSA" and, together with the New Share to which it is attached, an "ABSA"), as part of a share capital increase with cancellation of shareholders’ preferential subscription rights for the benefit of investors within the category of persons defined by the 16th resolution of the Combined General Meeting of the Company’s shareholders of June 30, 2025 (the "General Meeting"), in accordance with Article L. 225-138 of the French commercial code (the "Private Placement").

The issue of the ABSAs, representing approximately 2.47% of the Company’s share capital, on a non-diluted basis, before completion of the Private Placement, and 2,41% of the Company’s share capital, on a non-diluted basis, after completion of the Private Placement, was decided on July 7, 2025 by the Chief Executive Officer, pursuant to the delegation of competence granted to him by the board of directors dated July 7, 2025, pursuant to the delegation of competence granted to it under the 16th resolution of the General Meeting .

The issue price of one ABSA is EUR 1.17 (including share issue premium), representing a facial discount of 24.36% (i.e. EUR 0.38) to the volume-weighted average price of the AB Science shares on the regulated market of Euronext Paris ("Euronext Paris") over the three trading days preceding the setting of such issue price, i.e. July 7, 4 and 3, 2025 (the "3-day VWAP").

The issue price of an ABSA, including the theoretical value of the BSA attached to it (as described below, together with the exercise price of such BSA) represents a total 18.84% discount per AB Science share to the 3-day VWAP, consistent with the maximum discount authorized by the General Meeting pursuant to its 16th resolution.

Terms and conditions of the BSA

One BSA is attached to each New Share.

One BSA entitles their holder to subscribe to one new ordinary share of the Company, at a price of EUR 1.78 per ordinary share.

The BSAs may be exercised at any time within 60 months of their issuance. In the event all BSAs are exercised, a total number of 1,645,302 additional ordinary shares of the Company will be issued, representing additional total proceeds of approximately EUR 2.93 million.

The theoretical value of each BSA, assuming a volatility of 34.355%1 and based on closing price as of July 7, 2025, is equal to EUR 0.4392 using Black & Scholes model.

The BSAs will be immediately detached (détachés) from the New Shares upon issuance and are expected to be listed on Euronext Growth Paris ("Euronext Growth Paris") on or prior to July 14, 2025.

Impact of the Private Placement on the Company’s shareholding

Following the issuance of the ABSAs, the Company’s total share capital will be EUR 681,937.55 (or EUR 698,390.57 in the event of exercise of all BSAs). It will be comprised of 61,431,076 ordinary shares (or of 63,076,378 ordinary shares in the event of exercise of all BSAs) with a par value of EUR 0.01. There will be no change on the number of preferred shares.

On the basis of the share capital of the Company immediately after completion of the Private Placement, the interest of a shareholder who held 1.00% of the Company’s share capital prior to the above-mentioned capital increase and who did not subscribe to it now stands at 0.98% on a non-diluted basis and 0.79% on a diluted basis.

Admission to trading of the New Shares

The New Shares are expected to be admitted to trading on the regulated market of Euronext Paris on July 10, 2025.

The New Shares will be subject to the provisions of the Company’s by-laws and will be assimilated to existing shares upon final completion of the Private Placement. They will bear current dividend rights and will be admitted to trading on the same listing line as the Company’s existing shares under the same ISIN code FR0010557264 – AB.

Lock-up commitments

The Company has signed a lock-up commitment (to the benefit of the investors) pursuant to which it has agreed to a lock-up period of 45 calendar days from the date of the settlement and delivery of the Private Placement, subject to certain customary exceptions.

The directors and officers of the Company have signed a lock-up commitment pursuant to which they have agreed to a lock-up period of 90 calendar days from the date of the settlement and delivery of the Private Placement, subject to certain customary exceptions.

Indicative timetable

July 7, 2025 Decisions of the Board of Directors deciding the principle of the Private Placement.
July 7, 2025 Decisions of the Chief Executive Officer setting the terms and conditions of the Private Placement (including the subscription price of the ABSAs and the gross amount of the Private Placement).
July 8, 2025 Publication of this press release.
Publication of the Information Document.
July 10, 2025 Publication of the Euronext notice of admission of the New Shares to trading on Euronext Paris.
July 10, 2025 Settlement-delivery of the ABSAs – Detachment of the BSA – Start of trading of the New Shares on Euronext Paris.
July 14, 2025 Admission of the BSAs on Euronext Growth Paris.
Risk factors

AB Science draws the attention of the public to the risk factors relating to the Company and its business described in its annual management reports and press releases, which are available free of charge on the Company’s website (www.ab-science.com).

In addition, the main risks specific to securities are as follows:

The existing shareholders who do not participate in the Private Placement will see their shareholding in the share capital of AB Science diluted, and this shareholding may also be diluted in the event of exercise of the BSA, as well as in the event of new securities transactions.

The volatility and liquidity of AB Science shares could fluctuate significantly. The market price of the Company’s shares may fluctuate and fall below the subscription price of the shares issued in the context of the Private Placement. The sale of Company shares may occur on the secondary market, after the Private Placement, and have a negative impact on the Company share price.

About masitinib

Masitinib is a novel oral tyrosine kinase inhibitor that is being developed to target mast cells and macrophages, key immune cells, through inhibition of a limited number of kinases. Due to its unique mode of action, the Company believed that masitinib can be developed in a wide range of diseases, including oncology, inflammatory diseases, and certain central nervous system diseases. In oncology, through its immunotherapy activity, masitinib may have an effect on survival, alone or in combination with chemotherapy. Through its activity on mast cells and microglial cells and therefore its inhibitory effect on the activation of the inflammatory process, masitinib may have an effect on the symptoms associated with certain inflammatory and central nervous system diseases.

About AB8939

AB8939 is a new synthetic microtubule-destabilizing drug candidate. Preclinical data suggests that AB8939 has broad anticancer activity, with a notable advantage over standard chemotherapies that target microtubules of being able to overcome P-glycoprotein (Pgp) and myeloperoxidase (MPO) mediated drug resistance. Development of drug resistance often restricts the clinical efficacy of microtubule-targeting chemotherapy drugs (for example, taxanes and vinca alkaloids); thus, AB8939 has the potential to be developed in numerous oncology indications.

On July 8, 2025 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported that the World Health Organization (WHO) has formally granted the International Non-Proprietary Name (INN) of amsulostat to its advanced clinical development asset SNT-5505 (Press release, Syntara, JUL 8, 2025, View Source [SID1234654266]).

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Commonly known as a generic name, an INN is a globally recognised, unique name for a pharmaceutical substance or active ingredient.

Amsulostat is an innovative oral therapy currently in clinical development for myelofibrosis (MF), a debilitating bone marrow disorder characterised by fibrosis that severely impacts blood cell production.

Recent interim Phase 2 clinical trial results, which demonstrated promising efficacy and an excellent safety profile in combination with ruxolitinib, underscore the potential of amsulostat as a differentiated treatment option for patients with MF who exhibit suboptimal responses to existing therapies.

The designation of an INN represents an important milestone in the drug development process, providing global recognition of amsulostat’s unique chemical identity and facilitating clearer communication among healthcare professionals and regulatory bodies worldwide.

Syntara CEO Gary Phillips said: "After very recently being awarded Fast Track Designation by the FDA, the granting of amsulostat as the INN for SNT-5505 is another important step forward, reflecting the drug’s unique mechanism of action and clinical promise. We remain focused on advancing amsulostat through clinical development to address significant unmet medical needs in myelofibrosis and other fibrotic diseases."

On July 7, 2025 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported two important developments that aim to reinforce the global positioning of potential first-in-class radioenhancer JNJ-1900 (NBTXR3), which is licensed by Janssen Pharmaceutica NV, a Johnson & Johnson company (Press release, Nanobiotix, JUL 7, 2025, View Source [SID1234654360]).

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Health authorities in major European countries have agreed to formally reclassify JNJ-1900 (NBTXR3) from a medical device to a drug, completing a process initiated by Johnson & Johnson to harmonize the product candidate’s regulatory status with classifications already in place in the United States and other major markets. The reclassification follows updated insights into the product candidate’s mechanism of action.

In parallel, Nanobiotix has filed a new composition of matter patent for JNJ-1900 (NBTXR3) that aims to reinforce the intellectual property foundation supporting the product candidate.

"These updates reflect our continued commitment to the JNJ-1900 (NBTXR3) program," said Laurent Levy, co-founder and chairman of the executive board at Nanobiotix. "We are pleased with the progress achieved with health authorities and proud to continue advancing this potential first-in-class product candidate toward patients in need."

JNJ-1900 (NBTXR3) is currently the subject of a comprehensive global clinical development program across multiple tumor types and therapeutic combinations, including a pivotal Phase 3 trial in head and neck cancer.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.