BioLineRx Announces $3.75 Million Registered Direct Offering and Concurrent Private Placement

On August 28, 2026 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) ("BioLineRx" or the "Company"), a clinical-stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported that it has entered into a definitive agreement for the purchase of an aggregate of 1,348,921 of the Company’s American Depositary Shares (ADSs) (or ADS equivalents) at a purchase price of $2.78 per ADS (or per ADS equivalent) through a registered direct offering. In addition, the Company has agreed to issue accompanying warrants to purchase up to an aggregate of 2,023,382 ADSs, at a purchase price of $2.78 per ADS (or per ADS equivalent) via a concurrent private placement. The warrants will have an exercise price of $2.78 per ADS and will expire five years from the issuance date. Each ADS represents six hundred (600) ordinary shares, par value NIS 0.10 per share, of BioLineRx. The closing of the offering is expected to occur on or about August 31, 2026, subject to the satisfaction of customary closing conditions.

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Chardan is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be $3.75 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for research and development activities and working capital and general corporate purposes.

The ADSs (or ADS equivalents) offered in the registered direct offering (but excluding the securities offered in the private placement and the ADSs underlying the warrants) are being offered pursuant to a "shelf" registration statement (File No. 333-276323) filed with the Securities and Exchange Commission ("SEC") on December 29, 2023 and declared effective on January 5, 2024. The offering of the ADSs (or ADS equivalents) to be issued in the registered direct offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, by contacting Chardan at One Pennsylvania Plaza, Suite 4800, New York, NY 10119, by telephone at (646) 465-9065 or e-mail at [email protected].

The securities issued in the private placement and the unregistered warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the unregistered ADSs, the warrants and underlying ADSs may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

Warrant Amendment

In connection with the offering, on August 27, 2026, the Company entered into a warrant amendment (the "Warrant Amendment") pursuant to which the Company agreed to amend certain outstanding ordinary warrants to purchase 277,273 ADSs previously issued and held by the investor in the offering. Effective as of the closing of the Offering, the amended warrants (the "Amended Warrants") will have (i) a reduced exercise price of $2.78 per ADS, and (ii) an extended expiration date until August 31, 2031.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 the registration or qualification under the securities laws of any such state or jurisdiction

(Press release, BioLineRx, AUG 28, 2026, View Source [SID1234670414])

Mabqi announces presentation at Ion Channel-Targeted Drug Development Summit

On August 28, 2026 Mabqi reported it will participate in the Ion Channel-Targeted Drug Development Summit, taking place September 23–24 at Hotel Commonwealth in Boston, USA.

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Johanna Marines, Head of Preclinical Development at Mabqi, is invited to give an oral presentation on : Targeting TRPV6 with Bispecific Antibodies to Enable Selective Ion Channel Modulation for Anti-Tumor Activity in Oncology

The presentation will highlight TRPV6 as a promising oncology target, the mechanism of action of a TRPV6-targeting bispecific antibody, and preclinical in vitro and in vivo efficacy data supporting further clinical development.

The summit brings together leaders from biopharma and academia to advance selective and safe ion channel therapeutics through new approaches in electrophysiology, structural biology and translational science.

(Press release, Mabqi, AUG 28, 2026, View Source [SID1234670412])

Formosa Pharmaceuticals Files Clinical Trial Application for TSY-110, an Antibody-Drug Conjugate Biosimilar Targeting HER2-Positive Breast Cancers

On August 28, 2026 Formosa Pharmaceuticals, Inc. (TWSE: 6838), reported the submission of a Clinical Trial Application (CTA) to European regulatory authorities to conduct a pivotal clinical trial for TSY-110. TSY-110 is a biosimilar candidate referencing Roche’s antibody-drug conjugate (ADC) Kadcyla (ado-trastuzumab emtansine), indicated for HER2-positive metastatic and early-stage breast cancer.

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Designed following regulatory guidance from both US and EU authorities, the upcoming trial will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity profile of TSY-110 compared with the reference product. This milestone advances Formosa Pharmaceuticals’ and EirGenix’s shared goal of providing cost-effective biosimilar ADC treatments to patients across regulated global markets.

"Filing this CTA marks a significant achievement for Formosa Pharmaceuticals and underscores our strategic alliance with EirGenix," said Erick Co, Ph.D., President and Chief Executive Officer of Formosa Pharmaceuticals. "Antibody-drug conjugates have established themselves as mainstays in oncology, including HER2-positive breast cancer care, but patient access remains constrained by high treatment costs. Advancing TSY-110 into clinical evaluation is a momentous step toward fulfilling our goal of delivering world-class, accessible ADC options to oncologists and patients."

About TSY-110

TSY-110, also designated as EG12043, is an antibody-drug conjugate (ADC) biosimilar co-developed by Formosa Pharmaceuticals and EirGenix, Inc. (TWSE: 6589). The conjugate links HER2 monoclonal antibody, trastuzumab, with a cytotoxic payload (mertansine) to selectively eradicate HER2-overexpressing cancer cells while minimizing systemic toxicity. Comprehensive preclinical assessments demonstrate high biosimilarity, drug-antibody ratio (DAR) consistency, and comparable plasma kinetics to the reference product.

About HER2-Positive Breast Cancer Market

HER2-positive breast cancer accounts for a significant portion of all breast cancer diagnoses globally. Approximately 2.4 million breast cancer cases were diagnosed in 2024, with HER2+ disease affecting roughly 360,000 to 480,000 of these patients based on the standard 15–20% prevalence rate. HER2-targeted therapies continue to be a prominent tool in modern oncological care. Kadcyla, approved by the FDA in 2013, generated approximately $2.5 billion in global sales in 2025.

(Press release, Formosa Pharmaceuticals, AUG 28, 2026, View Source [SID1234670411])

Aprea Therapeutics Announces Expansion of Intellectual Property Portfolio for Precision Oncology Programs

On August 28, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, reported an update on its existing patent portfolio.

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"Our expanding patent portfolio reflects Aprea’s commitment to innovation and building a differentiated leadership position in precision medicine," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "A strong global intellectual property portfolio is a critical component of our strategy, supporting the advancement of potentially best in class oncology therapies while protecting the long-term value of our programs. We remain focused on strengthening our intellectual property position as we advance our pipeline and pursue new treatment options for patients with difficult-to-treat cancers."

The intellectual property covering Aprea’s WEE1 kinase inhibitor program includes two pending U.S. patent applications, one pending U.S. provisional application, two granted non-U.S. patents (Australia and Korea), and 12 pending non-U.S. patent applications. The WEE1 family of applications, if granted, will expire in 2047, not including any regulatory exclusivities that may be awarded. The WEE1-portfolio covers key aspects of the program, including proprietary compounds, pharmaceutical compositions, and methods of use. The Company’s lead WEE1 inhibitor, APR-1051, is currently being evaluated in the ACESOT-1051 Phase 1 clinical trial in advanced/metastatic solid tumors harboring certain cancer-associated gene alterations.

Aprea’s ATR inhibitor program is protected by a strong patent estate, including four granted U.S. patents, one pending U.S. application, and one pending international application. There are 22 granted non-U.S. patents and 13 pending non-U.S. patent applications. The granted patents will expire 2035-2037 and the pending applications, if granted, could extend exclusivity into 2045. Additional regulatory exclusivities up to five years may also be available. This portfolio comprehensively covers the program’s proprietary compounds, pharmaceutical compositions, and methods of use. During 2025, Aprea determined the recommended Phase 2 monotherapy dose (RP2D) of 1,100 mg once daily for ATRN-119 in the ABOYA-119 Phase 1/2a dose-escalation study and subsequently closed this study to focus resources on the clinical development of APR-1051. Building on the completion of dose escalation, the Company is considering further ATRN-119 development in combination approaches that could expand its therapeutic potential. Aprea believes ATRN-119’s mechanism of action, potentially favorable safety profile, and pharmacologic characteristics could make it an ideal candidate for combination with other anti-cancer therapies, including radiation therapy, chemotherapy, antibody-drug conjugates (ADCs) and immune checkpoint inhibitors.

(Press release, Aprea, AUG 28, 2026, View Source [SID1234670409])

DualityBio Enters a Global Collaboration and License Agreement with Genentech to Develop Next-Generation ADCs Built on DualityBio’s DUPAC Novel-Payload Platform

On August 28, 2026 DUALITYBIO Inc. (HKEX: 09606; "DualityBio" or the "Company") reported that it has entered into a collaboration and license agreement with Genentech, a member of the Roche Group, to develop next-generation antibody-drug conjugates ("ADCs") built on the Company’s proprietary DualityBio Unique Payload Antibody Conjugate ("DUPAC") platform.

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DUPAC is one of DualityBio’s four proprietary ADC platforms and is dedicated to payloads with novel mechanisms of action. It comprises multiple distinct payloads, each built on a unique antitumor mechanism, paired with optimized and compatible linker technologies designed for systemic stability and tumor-specific release. DUPAC payloads are engineered based on a common set of criteria: high potency, broad-spectrum activity across tumor types, a short systemic half-life permitting rapid clearance, and a bystander effect suited to heterogeneous solid tumors.

As topoisomerase inhibitor–based ADCs move into earlier lines of therapy across major solid tumor indications, patients who progress on this payload class represent a large and growing area of unmet medical need. The DUPAC platform is designed to retain antitumor activity in that setting and in tumors that are less responsive to topoisomerase inhibitor–based ADCs.

Under the terms of the agreement, Duality will generate and develop ADCs against Genentech defined oncology targets using payloads from the DUPAC platform. For the collaboration programs, DualityBio will lead discovery and early global clinical development. Genentech receives an exclusive, worldwide license to the collaboration ADCs, and will assume sole responsibility for further clinical development and commercialization after Phase 1a.

Under the agreement, DualityBio will receive an upfront payment of US$45 million and is eligible to receive more than US$1 billion in aggregate development, regulatory and commercial milestone payments across all programs, together with tiered royalties on annual net sales of approved products.

"As topoisomerase inhibitor–based ADCs achieve broad clinical success and move into earlier lines of therapy, a growing unmet medical need is emerging for patients whose tumors are resistant or refractory to this payload class. We built DUPAC to help address this challenge with a family of next-generation payloads designed to overcome resistance and enable each ADC program to expand the breadth of the underlying tumor biology. By combining DualityBio’s payload innovation and early-stage global clinical development capabilities with Genentech’s deep oncology expertise and worldwide development reach, we can advance these programs with greater speed and scale and bring differentiated medicines to more patients around the world," said Dr. John Zhu, Founder and Chief Executive Officer of DualityBio.

"By further enhancing targeted medicines like ADCs, we focus our innovation where the need is highest," said Boris L. Zaïtra, head of Roche Corporate Business Development. "Backed by Roche’s decades-long legacy in oncology, collaborating with partners such as DualityBio enables us to identify novel treatment options, such that we can tackle patients’ unmet needs in cancer care."

About DUPAC

DUPAC (DualityBio Unique Payload Antibody Conjugate) is DualityBio’s proprietary platform for ADC payloads with novel mechanisms of action, and one of four ADC technology platforms developed by the Company alongside DITAC, DIMAC and DIBAC. DUPAC encompasses several payloads, including DUP5, DUP9 and DUP10, each acting through a distinct antitumor mechanism. Preclinical data on DUP5-based ADCs and DUP9-based ADCs, including activity in tumor models relatively insensitive to topoisomerase inhibitor payloads and non-human primate tolerability, have been presented at multiple medical conferences, including AACR (Free AACR Whitepaper) 2025 (Abstract 5454), AACR (Free AACR Whitepaper)-NCI-EORTC International Conference 2025 (Abstract B129 and Abstract B130), and AACR (Free AACR Whitepaper) 2026 (Abstract 2657).

(Press release, DualityBio, AUG 28, 2026, View Source [SID1234670391])