On August 27, 2026 Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused biotechnology company developing therapies that selectively reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, reported that it has commenced a tranched registered public offering (the "Offering") of (i) American Depositary Shares ("ADSs"), each representing five hundred (500) ordinary shares of the Company, no par value per share, or in lieu of ADSs to certain investors, pre-funded warrants to purchase ADSs, (ii) accompanying Series A Warrants to purchase ADSs (or pre-funded warrants in lieu thereof), which are exercisable immediately at an exercise price equal to 115% of the initial public offering price per ADS and accompanying Warrants and expire upon the earlier of 30 days following the Company’s Stage IV triple-negative breast cancer (TNBC) data readout, expected in the second half of 2027, or the five-year anniversary of issuance, and (iii) accompanying Series B Warrants to purchase ADSs (or pre-funded warrants in lieu thereof), which are exercisable immediately at an exercise price equal to 125% of the initial public offering price per ADS and accompanying Warrants and expire upon the earlier of 30 days following the Company’s HR+/HER2- data readout, expected in the first half of 2028, or the five-year anniversary of issuance. All of the securities in the Offering are to be sold by Kazia.

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Leerink Partners and Guggenheim Securities are acting as joint bookrunning managers for the proposed Offering. BTIG, Needham & Company and Laidlaw & Company are acting as co-managers for the proposed Offering. The proposed Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Offering may be completed or as to the actual size or terms of the Offering.

Kazia intends to use the net proceeds from the Offering primarily to fund clinical development of paxalisib, including ongoing and planned studies in triple-negative breast cancer and HR+/HER2- breast cancer and other oncology indications, and for working capital and general corporate purposes.

The ADSs and warrants are being offered pursuant to a registration statement on Form F-3 (File No. 333-294392), which was previously filed with and subsequently declared effective by the Securities and Exchange Commission (the "SEC"). The Offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A copy of the preliminary prospectus supplement 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 at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained, when available, from Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected], or from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, telephone: (212) 518-9544, email: [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the Offering, 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.

(Press release, Kazia Therapeutics, AUG 27, 2026, View Source [SID1234670392])

On August 27, 2026 Daiichi Sankyo reported that the first patient has been dosed in a first-in-human phase 1 trial evaluating DS1025 in adult patients with advanced or metastatic solid tumors with disease progression on or after at least one prior line of standard therapy.

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DS1025 is a specifically engineered, investigational, potential first-in-class CD25 directed antibody drug conjugate (ADC) containing an immuno-oncology optimized cytotoxic payload discovered by Daiichi Sankyo (TSE:4568).

CD25 is a cell surface protein that is highly expressed on regulatory T cells (Treg cells) which suppresses the response of the immune system against cancer, 1 making it a promising therapeutic target. Currently, there are no CD25 directed ADCs approved for any type of cancer.

"While immunotherapies have transformed cancer treatment, continued innovation in leveraging pathways that can activate the immune system is needed," said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. "The initiation of this trial evaluating DS1025 reflects continued progress in advancing our pipeline through the development of novel antibody drug conjugates in order to deliver medicines that improve outcomes for patients with cancer."

About the Phase 1 Trial

The multicenter, open-label, first-in-human, dose escalation phase 1 trial will assess the safety, tolerability, pharmacokinetics and preliminary efficacy of DS1025 in patients with advanced or metastatic solid tumors with disease progression on or after at least one prior line of standard therapy.

The trial will evaluate primary endpoints of safety and tolerability, including dose-limiting toxicities and adverse events. Secondary endpoints include pharmacokinetics and immunogenicity. Exploratory endpoints include overall response rate, duration of response and time to response.

The trial is expected to enroll up to 45 patients across multiple sites in Asia and Europe. For more information, please visit ClinicalTrials.gov.

About CD25

CD25 is a cell surface protein that is highly expressed on regulatory T cells (Treg cells). Treg cells work to suppress the immune system, helping tumors evade the body’s natural ability to destroy abnormal cells and are thought to be a key contributor to resistance that develops with currently available immunotherapies.

About DS1025

DS1025 is an investigational, potential first-in-class CD25 directed ADC that builds on the DXd ADC Technology of Daiichi Sankyo by delivering an immuno-oncology optimized cytotoxic payload that works to deplete immunosuppressive T cells (Treg cells) in the tumor microenvironment and activate the immune system to detect and destroy cancer cells.

(Press release, Daiichi Sankyo, AUG 27, 2026, View Source [SID1234670390])

On August 27, 2026 Knight Therapeutics Inc. ("Knight") (TSX: GUD), a pan-American (ex-US) pharmaceutical company, reported that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.

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"This supplemental submission to ANVISA marks an important step in our efforts to expand MINJUVI’s potential in earlier lines of therapy in Brazil," said Samira Sakhia, President and Chief Executive Officer of Knight. "Patients with previously untreated DLBCL and HGBL continue to face significant unmet medical needs. We are encouraged by the clinical data supporting the addition of tafasitamab and look forward to working with regulators under Project Orbis to bring this potential new first-line treatment option to patients as quickly as possible."

In September 2021, Knight entered into an exclusive supply and distribution agreement with Incyte (NASDAQ:INCY), for the exclusive rights to distribute tafasitamab (commercialized as MONJUVI in the United States and MINJUVI ex-U.S.). Knight has launched MINJUVI in Brazil, Mexico and Argentina for use in combination with lenalidomide, followed by MINJUVI monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL, who are not eligible for autologous stem cell transplantation (ASCT). In March 2026, Knight announced the approval and launch of MINJUVI in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) in Brazil.1 Also in March 2026, Knight submitted MINJUVI for the same indication in Argentina and Mexico.

This supplemental submission to ANVISA builds on those approvals, seeking a first-line indication for MINJUVI based on results from the Phase 3 frontMIND trial.

About MINJUVI

MINJUVI (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., MONJUVI is approved for use in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).2

Additionally, MONJUVI received approval in the U.S. in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).2 This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, MINJUVI received conditional marketing authorization from the European Medicines Agency in combination with lenalidomide, followed by MINJUVImonotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Additionally, MINJUVI is approved for use in Europe in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy.3

In Japan, MINJUVI is approved for use in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).4 MINJUVI is also approved for use in Japan in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory FL (2L+ FL).5

XmAb is a registered trademark of Xencor, Inc.

MONJUVI and MINJUVI are registered trademarks of Incyte. All other trademarks are the property of their respective owners.

About Diffuse Large B-Cell Lymphoma (DLBCL)

Diffuse Large B-Cell Lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) in adults worldwide, accounting for a third of all NHLs and ranging between 20%−50% by country.6 DLBCL commonly presents with enlarged lymph nodes or rapidly growing mass along with B symptoms, which include fever, night sweats, and weight loss. The B symptoms can be seen in 30% of patients. Bone marrow involvement is more common in indolent disease and can be seen in up to 50% of the cases.7 Each year, approximately 25,000 people in the U.S. and up to projected 28,000 people in Western Europe are diagnosed with DLBCL.8,9 In Brazil, data from The Department of Information Technology of the Brazilian Public Unified Healthcare System (DataSUS) reported DLBCL as the most frequently diagnosed NHL with 39,012 cases reported between 2008 – 2017. With about 40% of DLBCL patients not responding to initial therapy or relapsing thereafter,10,11 there is a high medical need for new, effective therapies, particularly for high-risk patients.

About High-grade B-Cell Lymphoma (HGBL)

High-grade B-Cell Lymphoma (HGBL) is a rare and aggressive category of B-cell non-Hodgkin lymphoma (NHL) defined by the World Health Organization (WHO).12 It comprises two principal subtypes based on specific genetic characteristics: DLBCL/HGBL with MYC and BCL2 rearrangements, which encompasses most lymphomas previously known as double- or triple-hit lymphoma, and HGBL, not otherwise specified (NOS), a heterogeneous subtype defined by high-grade morphology in the absence of these genetic rearrangements.12,14 HGBL shares clinical features with DLBCL, including rapidly enlarging lymph nodes and B symptoms such as fever, night sweats, and weight loss, and accurate diagnosis requires expert pathologic review incorporating cytomorphology, immunohistochemistry, and fluorescence in situ hybridization (FISH).12,15 The aggressive nature of HGBL and the failure of intensified therapy to improve overall survival underscore the significant unmet need for more effective treatment options.12,13

About frontMIND trial

The frontMIND trial (NCT04824092) is a randomized, double-blind, placebo-controlled, global Phase 3 study in patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).16

The study enrolled 899 adults (≥18 to ≤80 years) and is evaluating the efficacy and safety of tafasitamab and lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) compared with R-CHOP.16

The primary endpoint of the study is investigator-assessed progression-free survival (PFS) using the Lugano 2014 criteria. Key secondary endpoints include event-free survival (EFS) by investigator assessment and overall survival (OS).16

For more information about the frontMIND trial, please visit View Source

(Press release, Knight Therapeutics, AUG 27, 2026, View Source [SID1234670386])

On August 27, 2026 Biogen Inc. (Nasdaq: BIIB) reported that Christopher A. Viehbacher, President and Chief Executive Officer, will participate in a fireside chat during the Morgan Stanley 24th Annual Global Healthcare Conference. The webcast will be live on Monday, Sept 14, 2026, at 9:15 a.m. ET. To access the live webcast, please visit the Investors section of Biogen’s website at investors.biogen.com. An archived version of the webcast will be available for at least 30 days following the presentation.

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(Press release, Biogen, AUG 27, 2026, View Source [SID1234670385])

On August 27, 2026 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR T cell and in vivo CAR T therapies for autoimmune diseases, hematologic malignancies and solid tumors, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-212 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The Company plans to initiate Phase 1 enrollment in patients with mCRPC in the fourth quarter of 2026.

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"ADI-212 marks an important milestone in Adicet’s strategy to address the complexity of solid tumors and represents an important addition to our portfolio of allogeneic gamma delta 1 cell therapies and in vivo CAR T programs," said Blake Aftab, Ph.D., Chief Scientific Officer of Adicet Bio. "Designed as a single off-the-shelf product, ADI-212 incorporates multiple platform enhancements by combining gene-editing and the expression of novel immune-stimulating molecules intended to strengthen anti-tumor potency, including improved antigen engagement, capacity for durable tumor-killing and active modulation of tumor microenvironment. The successful IND clearance reinforces our commitment to advancing innovative therapies for patients with cancer."

About ADI-212

ADI-212 is a next-generation gene-edited, armored cell therapy candidate targeting prostate-specific membrane antigen (PSMA), engineered to express a novel CAR binder designed to enhance tolerability and tumor specific recognition. The program combines membrane-tethered IL-12 armoring and CRISPR/Cas9-mediated disruption of subunit 12 of the mediator complex (MED12) designed to improve potency in solid tumors and enable multiple anti-tumor mechanisms within the tumor microenvironment.

(Press release, Adicet Bio, AUG 27, 2026, View Source [SID1234670384])