On October 13, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, reported key progress in its global intellectual-property strategy for Z-endoxifen, including the issuance of an Israeli patent and continued renewals that reinforce protection for the Company’s lead program across major jurisdictions (Press release, Atossa Therapeutics, OCT 13, 2025, View Source [SID1234656601]). The Israeli patent (No. 304863), titled, "Methods for Making and Using Endoxifen," was granted on July 2, 2025, with priority to multiple U.S. provisional applications filed in 2017–2018.

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The allowed claims in Israel include oral, delayed-release (enteric) dosage forms comprising at least 90% by weight Z-endoxifen, with optional impurity limits (<2%), defined release characteristics in gastric and intestinal media, dose strengths (e.g., 1–4 mg and 8 mg), and pharmacokinetic performance targets (e.g., plasma exposures and steady-state levels). The claims also cover manufacturing methods that enrich the Z-isomer via stepwise crystallization and solvent control. These protections align with Atossa’s quality-by-design approach to deliver a consistent, high-purity Z-endoxifen product.

In parallel, Atossa received a Certificate of Patent Renewal from the Israel Patent Office confirming fee payment and renewal status for Patent No. 304863, further supporting the life-cycle management of Z-endoxifen IP in this jurisdiction.

"Strong, durable patents are foundational to our Z-endoxifen strategy," said Steven Quay, M.D., Ph.D., Atossa Therapeutics Chairman and CEO. "This new protection in Israel, together with our broader global filings, covers what we believe are the critical elements of product quality, performance, and manufacturing needed to bring Z-endoxifen to patients and to create long-term value for shareholders."

About the Patent Scope in Israel
The granted patent includes: (i) enteric oral formulations with ≥90% Z-endoxifen; (ii) optional impurity and residual-solvent limits; (iii) stability and delayed-release attributes (acid resistance and intestinal release); (iv) dose ranges including 1–4 mg and 8 mg; (v) PK targets such as steady-state plasma levels and exposure ranges; and (vi) a multi-step crystallization process to enrich the Z-isomer. Collectively, these claims support Atossa’s global protection for Z-endoxifen composition, performance, and process.

On October 13, 2025 Theolytics, a clinical-stage biotechnology company developing next-generation oncolytic immunotherapies, reported it will present a Trials in Progress Poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place in Berlin, Germany from October 17-21 (Press release, Theolytics, OCT 13, 2025, View Source [SID1234656586]). Dr Margaret Duffy, CSO and Dr Matilde Saggese, CMO will be attending and will showcase the OCTOPOD-IV Phase I/IIa clinical trial of THEO-260, a novel oncolytic immunotherapy, given by intravenous delivery in patients with ovarian cancer.

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Details of the ESMO (Free ESMO Whitepaper) presentation are:

Phase I/IIa, open-label, dose finding, safety and exploratory trial of THEO-260, a novel oncolytic immunotherapy, by intravenous delivery in patients with high grade serous or endometrioid ovarian cancer
· Presenter: Matilde Saggese, MD, MD (Res), CMO at Theolytics
· Presentation Number: 1238eTiP
· Session: Trials in Progress: – eTrial in Progress
· Session Time/ Place: Poster Session 2, Saturday 18 October 2025 [Messe Berlin]

The abstract is available online on the ESMO (Free ESMO Whitepaper) website.

OCTOPOD-IV (NCT06618235) is a first-in-human, multi-centre trial to assess safety, tolerability and preliminary efficacy of THEO-260 in patients with high-grade serous ovarian or endometrioid cancer. In addition, the trial is designed to determine the recommended Phase II dose and demonstrate THEO-260’s differentiated cancer-associated fibroblast ‘CAF-lytic’ mechanism of action in patients through comprehensive biomarker analysis.

Recruitment at UK clinical sites is ongoing and expansion into further international sites is planned (including Spain and Canada). A second clinical trial (OCTOPOD-IP) in the US, which will investigate intraperitoneal (IP) delivery of THEO-260 to advanced ovarian cancer patients, has also been initiated in collaboration with The University of Texas MD Anderson Cancer Center (NCT07211659).

Matilde Saggese, MD, MD (Res), Theolytics’ CMO, said, "Recruitment is now well under way for our first ever clinical trial with THEO-260. Ovarian cancer remains a leading cause of cancer-related death amongst women, but with THEO-260’s differentiated mechanism of action in targeting and eliminating ovarian patient cancer cells and cancer-associated fibroblasts, whilst triggering immunogenic cell death and promoting T-cell activation, we hope that we can deliver a therapy that transforms outcomes for women with this devastating disease."

Patients with epithelial ovarian cancer almost invariably develop platinum-resistant disease, for which the prognosis is very poor. Treatment in this setting is challenging due to the complexity of the tumour microenvironment (TME) and most immunotherapies including checkpoint blockade have not proven effective. This may be attributed to an immune suppressed and stromal rich TME, with up to 60% of the tumour volume comprising cancer-associated fibroblasts (CAFs). THEO-260 is a novel oncolytic immunotherapy specifically evolved to target stromal rich tumours. In preclinical studies, THEO-260 has been shown to kill cancer cells and CAFs, trigger immunogenic cell death, and promote T-cell activation.

On October 13, 2025 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported that it has entered into securities purchase agreements for the sale of its equity securities to certain institutional investors in a $60.0 million private investment in public equity ("PIPE") financing (Press release, ADC Therapeutics, OCT 13, 2025, View Source [SID1234656602]). In the PIPE, ADC Therapeutics is selling 11.3 million common shares at $4.00 per share and pre-funded warrants to purchase 3.8 million common shares at $3.90 per pre-funded warrant, which is the price per common share in the PIPE minus the exercise price of CHF 0.08 per pre-funded warrant.

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The PIPE is led by TCGX and includes participation from Redmile Group and other existing investors.

Gross proceeds from the PIPE financing are anticipated to be approximately $60.0 million before deducting placement agent fees and offering expenses. The PIPE is expected to close on October 27, 2025, subject to customary closing conditions. ADC Therapeutics intends to use the net proceeds from the PIPE to invest in the commercial expansion of ZYNLONTA and strengthen the balance sheet, in addition to funding working capital and general corporate purposes.

"This financing enhances our ability to prepare for and execute the potential relaunch of ZYNLONTA in 2027 and further strengthens our balance sheet relative to our previously disclosed cash runway into 2028," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We believe we are well-positioned to accelerate our trajectory towards long-term sustainable growth for our company. We look forward to upcoming data catalysts later this year and throughout 2026."

The company expects net product revenues from sales of ZYNLONTA to be approximately $15.8 million for the third quarter ended September 30, 2025, with cash and cash equivalents totaling $234.7 million as of September 30, 2025. Giving effect to the estimated net proceeds from the PIPE financing of approximately $57.6 million (after deducting placement agent fees and estimated offering expenses), the Company would have had approximately $292.3 million of cash and cash equivalents as of that date.

The offer and sale of the foregoing securities are made in a transaction not involving a public offering, and the foregoing securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act") or applicable state securities laws, and are being offered and sold in reliance on Section 4(a)(2) of the Securities Act. The securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and other applicable securities laws. ADC Therapeutics has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the common shares to be sold in the PIPE and the common shares issuable upon exercise of the pre-funded warrants to be sold in the PIPE.

Jefferies is acting as placement agent for the PIPE. Davis Polk & Wardwell LLP and Homburger AG are acting as legal advisors to ADC Therapeutics.

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

The Company has uploaded an updated corporate presentation to the Investor portion of its website.

About ZYNLONTA
ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On October 13, 2025 SystImmune, Inc., a clinical-stage biotechnology company, reported the treatment of the first patient in the IZABRIGHT-Breast01 study (NCT06926868), a global Ph2/3 registrational study of izalontamab brengitecan (iza-bren) in previously untreated triple negative breast cancer ineligible for anti-PD(L)1 drugs (Press release, SystImmune, OCT 13, 2025, View Source [SID1234656603]). This milestone triggered a one-time payment of $250 million by Bristol Myers Squibb (NYSE: BMY), pursuant to the 2023 collaboration and exclusive license agreement between SystImmune and Bristol Myers Squibb. SystImmune is further eligible to receive up to an additional $250 million in contingent near-term payments and additional payments of up to $7.1 billion contingent upon the achievement of certain development, regulatory and sales performance milestones.

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Iza-bren is a potential first-in-class bispecific topoisomerase 1 inhibitor-based antibody-drug conjugate (ADC) that targets both epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). It is being developed by SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin) in China and jointly developed by SystImmune and Bristol Myers Squibb in territories outside of China.

"This milestone marks a significant step forward in the global clinical development of iza-bren," said Dr. Yi Zhu, Chairman, SystImmune. "The robust data generated from our China-based trials have played an important role in accelerating development timelines and informing global strategy. We are encouraged by the achievement of this milestone and Bristol Myers Squibb’s commitment to this program. We look forward to bringing iza-bren to patients worldwide under our shared vision with Bristol Myers Squibb."

"Together with Bristol Myers Squibb, we have made significant progress in developing iza-bren globally. We remain deeply committed to delivering this potentially transformative therapy to patients with triple negative breast cancer and other solid tumors," said Dr. Jie D’Elia, CEO, SystImmune. "This $250 million milestone not only reflects the progress of our collaboration but also significantly reinforces our financial position, enabling us to accelerate the global development of our differentiated ADC portfolio."

Iza-bren is currently being evaluated in multiple ongoing clinical trials, including BL-B01D1-LUNG-101 (NCT05983432), IZABRIGHT-Lung01 (NCT07100080), IZABRIGHT-Bladder01 (NCT07106762), and studies in China conducted by Biokin. The program recently received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the treatment of patients with previously treated advanced EGFR-mutated non-small cell lung cancer.

About iza-bren
SystImmune, in collaboration with BMS outside of China, is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren’s dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren’s therapeutic novel Topo1i payload is released causing cytotoxic stress that leads to cancer cell death.

On October 13, 2025 Foundation Medicine, Inc., a precision medicine company transforming lives in cancer care and beyond, reported that the company and its research collaborators will present 11 abstracts demonstrating the value of high-quality biomarker tests to inform cancer care at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress from October 17-21 in Berlin, Germany (Press release, Foundation Medicine, OCT 13, 2025, View Source [SID1234656604]).

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Foundation Medicine’s research to be presented at the meeting spans seven disease areas and includes new insights from the company’s tissue-free monitoring assay FoundationOneMonitor, which will soon be available for clinical use. The abstract showcases that an early reduction of circulating tumor DNA using FoundationOne Monitor was associated with improved outcomes in patients with triple negative breast cancer.

Two additional studies spotlight data from FoundationOneRNA, a tissue-based RNA sequencing test for the detection of cancer-related fusions across 318 genes. Respectively, the results demonstrate the test’s strong concordance with results from the company’s FDA-approved tissue-based comprehensive genomic profiling test, FoundationOneCDx, as well as with IHC/FISH tests.

"At this year’s ESMO (Free ESMO Whitepaper) Congress, we’re looking forward to sharing our latest data which reinforces the value of our high-quality tests to support the best precision care for patients," says Foundation Medicine’s Vice President, Head of Clinical Development, Amaya Gascó, M.D., Ph.D. "In particular, a new study using FoundationOne Monitor demonstrates the test’s ability to inform a patient’s response to treatment and guide next steps in care. Additionally, our FoundationOne RNA studies highlight the powerful insights our RNA sequencing test can deliver as a complement to comprehensive genomic sequencing with FoundationOneCDx and other diagnostic tests, such as IHC/FISH, to provide healthcare providers with the confidence they need to make informed decisions for their patients."

To access all the abstracts being presented at the 2025 ESMO (Free ESMO Whitepaper) Congress, please visit ESMO (Free ESMO Whitepaper).com.

Follow Foundation Medicine on LinkedIn, X, Instagram and Bluesky for more updates from #ESMO25, and join us in person at Booth #3028 in Hall 3.2 for our "Booth Talk Series" where you will hear from our team of experts on the latest advancements that are driving innovation in precision diagnostics.

Complete list of Foundation Medicine’s abstracts at the 2025 ESMO (Free ESMO Whitepaper) Congress

Presentation Number

Title

Product

Saturday, October 18

Oral Presentation

2610MO

Genomic analysis of papillary renal cell carcinoma (PRCC): MET alterations are uncommon and enriched in patients of African ancestry

FoundationOneCDx

Poster Presentations

1146P

Genomic landscape of HRD signature (HRDsig), CCNE1 amplified (amp) and ERBB2 altered (alt) ovarian cancers (OC)

FoundationOneCDx

1936P

Genomic alterations (GA) in TP53 including the targetable TP53 Y220C mutation in clinically advanced non-small cell lung cancer (CANSCLC)

FoundationOneCDx

157P

Homologous recombination signature (HRDsig) in non-small cell lung cancer (NSCLC): Implications for PARP inhibitor (PARPi) treatment

FoundationOneCDx

1931P

Prevalence, co-alterations and preclinical characterization of FGFR variants of unknown significance in non-small cell lung cancer

FoundationOneCDx

Sunday, October 19

2150P

Homologous recombination deficiency signature in gastric adenocarcinoma

FoundationOneCDx

Monday, October 20

579P

Gene expression profiling by RNA sequencing accurately predicts estrogen, progesterone, and HER2 receptor status by immunohistochemistry in breast cancer

FoundationOneCDx, FoundationOneRNA

580P

Androgen receptor splice variant 7 (AR-V7) and ESR1 fusion detection in breast cancer utilizing comprehensive combined DNA and RNA sequencing

FoundationOneCDx, FoundationOneRNA

2697P

Comprehensive genomic profiling in chordoma by subtype classification

FoundationOneHeme, FoundationOne, FoundationOneCDx

2701P

Estrogen receptor and AKT pathways as potential novel targets for MDM2-amplified well-differentiated and dedifferentiated liposarcoma (WD/DD LPS)

FoundationOneHeme, FoundationOne, FoundationOneCDx

558P

Circulating tumor DNA dynamics correlate with response to carboplatin with or without nivolumab in metastatic TNBC

FoundationOneMonitor

Published Online

2525eP

RNA sequencing enhances TMPRSS2 fusion detection beyond DNA sequencing alone and reveals associations with androgen receptor (AR) biology in prostate cancer

FoundationOneCDx, FoundationOneRNA

1458eP

Ameloblastoma of the head and neck (HNAmelo): A biomarker and genomic landscape study

FoundationOneCDx

686eP

Clinical utility of DNA and RNA comprehensive genomic profiling (CGP) for the diagnostic workup of high grade gliomas (HGG)

FoundationOneCDx, FoundationOneRNA