On September 1, 2026 Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing multi-node therapies for cancer patients, including its lead program PIKTOR, reported that management will participate in the following upcoming investor conferences:

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Wells Fargo 21st Annual Healthcare Conference
Tuesday, September 8, 2026
1×1 investor meetings
Boston, MA

Citi Biopharma Back to School Summit
Wednesday, September 9, 2026
Fireside chat at 10:00 a.m. ET
New York, NY

Cantor Global Healthcare Conference 2026
Thursday, September 10, 2026
Fireside chat at 8:35 a.m. ET
New York, NY
Webcast Link

Morgan Stanley 24th Annual Global Healthcare Conference
Monday, September 14 & Wednesday, September 16, 2026
Fireside chat at 9:15 a.m. EDT on Wednesday
New York, NY
Webcast Link

Baird Global Healthcare Conference
Tuesday, September 15, 2026
Fireside chat at 10:15 a.m. ET
New York, NY

H.C. Wainwright 28th Annual Global Investment Conference
Wednesday, September 16, 2026
Fireside chat at 10:30 a.m. ET
New York, NY

Deutsche Bank 2026 Healthcare Summit
Thursday, September 17, 2026
1×1 investor meetings
New York, NY
Live webcasts of the Cantor and Morgan Stanley fireside chats can be accessed via the Events and Presentations section of the Faeth website at investors.faeththerapeutics.com. Replays will be available for approximately 90 days following the event.

(Press release, Faeth Therapeutics, SEP 1, 2026, View Source [SID1234670504])

On September 1, 2026 BigHat Biosciences, a clinical-stage, AI-driven protein therapeutics platform company, reported that the first patient has been dosed in its Phase 1 clinical trial evaluating BHB810, a novel, potentially best-in-class Cadherin-17 (CDH17)-directed VHH-Fc antibody-drug conjugate (ADC) for the treatment of gastric cancer and other advanced gastrointestinal (GI) malignancies. BHB810 was engineered using BigHat’s AI-powered antibody design platform to combine potent antitumor activity against CDH17-expressing tumors with a differentiated safety profile and favorable manufacturability.

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"The treatment of the first patient with BHB810 marks an important step forward in our mission to enable transformative AI-designed therapeutics and comes during a period of steady momentum for BigHat, as we continue to advance both our pipeline of novel therapeutics and AI platform," said Peyton Greenside, co-founder and CEO of BigHat. "This is the first program we’ve taken from AI-generated design into human studies, validating the ability of our platform to identify and develop promising antibodies into clinic-ready therapeutics. BHB810 could offer a differentiated approach to address a target that has been difficult to drug well, and we are excited by the potential to offer a much-needed new treatment option for patients living with GI cancers."

The first-in-human, Phase 1 dose escalation trial will evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BHB810. The trial will initially enroll patients with advanced gastric and gastroesophageal (GEJ) tumors.

"Despite recent advances, patients with advanced gastric cancers and other GI malignancies continue to face substantial unmet medical needs," said Principal Investigator Alexander Spira, M.D., Ph.D., Chief Executive Officer and Chief Scientific Officer of NEXT Oncology-Virginia and Co-Director of the Virginia Cancer Specialists Research Institute. "We are excited to help advance BHB810, a potentially best-in-class CDH17-targeted antibody-drug conjugate developed using BigHat’s AI-driven antibody engineering platform, as a potential new treatment option for patients."

Across a preclinical program spanning nearly 30 patient- and cell-derived tumor models, including gastric cancers with low and heterogeneous CDH17 expression, BHB810 drove complete or near-complete tumor clearance. Its compact antibody format and highly stable payload technology also translated into a favorable safety profile in preclinical studies.

Beyond BHB810, BigHat is developing a portfolio of investigational therapeutics. BHB299, an avidity-driven TCE targeting CEACAM6 for the treatment of solid tumors, is expected to enter the clinic in 2027. BigHat has also successfully designed multiple antibody therapeutics with leading pharmaceutical companies, including Merck and Johnson & Johnson, in addition to multiple active collaborations, including one with Eli Lilly to design antibodies with enhanced functionality to benefit patients with chronic disease.

(Press release, BigHat Biosciences, SEP 1, 2026, View Source [SID1234670503])

On September 1, 2026 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono") reported that it has entered into a drug discovery partnership agreement with Aitia, Inc. (Headquarters: Cambridge, Massachusetts, USA; CEO: Colin Hill; "Aitia").

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Under the terms of the agreement, Aitia will utilize its REFS technology to build Gemini Digital Twins (GDTs) of neurological diseases and identify new therapeutic targets and biomarkers. Ono will have an exclusive worldwide option right to research, develop, and commercialize drug candidates to the targets identified by Aitia.

"Ono has long been committed to creating innovative medicines for diseases with high unmet medical needs, including neurological diseases. Through this collaboration, we are delighted to leverage cutting-edge REFS technology to identify true therapeutic targets in neurological diseases, where disease mechanisms are complex and not yet fully understood. We believe this will accelerate the development of innovative medicines. We will continue to expand our R&D pipeline in the neurology field and strive to deliver new treatments to patients," said Seishi Katsumata, Corporate Officer / Executive Vice President, Discovery & Research of Ono.

"We are honored to partner with Ono, a company with a strong track record in the neurology field. By utilizing our state-of-the-art causal AI-powered REFS technology, we are confident that we can build Gemini Digital Twins that uncover true disease mechanisms and therapeutic targets that could not be identified with conventional AI, thereby accelerating the development of new therapies," said Colin Hill, CEO and co-founder of Aitia.

About REFS Technology
REFS technology is a groundbreaking drug discovery platform developed exclusively by Aitia, utilizing advanced causal AI. By integrating and analyzing patient clinical information and omics data through causal AI simulations, this technology creates virtual patient models (Gemini Digital Twins), from which it is possible to predict new therapeutic targets and disease hypotheses based on causal relationships—something that conventional correlation-based AI cannot achieve. In particular, Aitia’s REFS technology is expected to enable the discovery of previously unknown disease mechanisms and drug targets in the highly challenging neurology field, where disease mechanisms remain poorly understood.

(Press release, Ono, SEP 1, 2026, View Source [SID1234670502])

On September 1, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its upcoming Investor R&D Day in London and participation in September 2026 investor conferences.

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IDEAYA Biosciences Investor R&D Day in London, United Kingdom
Monday, November 16th, 2026, at 5:00 PM GMT

IDEAYA management will discuss the company’s MTAP/CDKN2A and KRAS development strategy in pancreatic cancer, including new preclinical data and rational combination strategies designed to address tumor heterogeneity and adaptive plasticity
The event will feature Dr. Frank McCormick of the UCSF Helen Diller Family Comprehensive Cancer Center
Advance registration is required for both in-person and virtual attendance. To register, please visit View Source

Wells Fargo 21st Annual Healthcare Conference
Tuesday, September 8th, 2026, at 3:00 PM ET, Boston, Massachusetts

Fireside chat with Yujiro S. Hata, Chairman and Chief Executive Officer, and Joshua Bleharski, Chief Financial Officer, hosted by Eva Fortea-Verdejo, Ph.D., Executive Director, Equity Research, Biotechnology
Cantor Global Healthcare Conference 2026
Wednesday, September 9th, 2026, at 11:30 AM ET, New York, New York

Fireside chat with Yujiro S. Hata, Chairman and Chief Executive Officer, hosted by Li Watsek, Director, Biotechnology Analyst
Citi’s 2026 Biopharma Back to School Conference
Thursday, September 10th, 2026, at 1:40 PM ET, New York, New York

Fireside chat with Yujiro S. Hata, Chairman and Chief Executive Officer, and Joshua Bleharski, Chief Financial Officer, hosted by Yigal D. Nochomovitz, Ph.D., Director, SMid Cap Biotech Analyst
Morgan Stanley 24th Annual Global Healthcare Conference
Monday, September 14th, 2026, at 7:00 AM ET, New York, New York

Fireside chat with Yujiro S. Hata, Chairman and Chief Executive Officer, hosted by Ryuk Byun, MD, Managing Director
A live audio webcast of the events will be available under the "Investors/Events" section of the IDEAYA website at View Source and/or through the conference host. A replay of the webcasts will be accessible for 30 days following the live events.

(Press release, Ideaya Biosciences, SEP 1, 2026, View Source [SID1234670501])

On September 1, 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 new preclinical data demonstrating the safety and anti-tumor activity of paxalisib in HR+/HER2- breast cancer, including evidence that paxalisib resensitized CDK4/6 inhibitor-resistant tumors to standard-of-care therapy. Based on these findings, the Company is moving rapidly to expand its ongoing TNBC clinical trial into hormone receptor-positive ("HR+"), HER2-negative ("HER2-") advanced breast cancer to evaluate this effect directly and filed a related provisional patent application.

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"HR+/HER2- breast cancer accounts for approximately 60–70% of all breast cancer diagnoses, and we expect nearly 322,000 new cases in the U.S. alone this year," said Dr. John Friend, Chief Executive Officer of Kazia Therapeutics. "That scale, combined with the persistent need for better options once patients progress on standard therapy, represents a significant area of unmet medical need where paxalisib may play a role. Our preclinical data showing statistically significant, additive antitumor activity when paxalisib is combined with standard-of-care therapy gives us strong confidence in this approach, and we are moving quickly to bring this combination into the clinic for these patients. With the completion of our recent financing, based on our current plans and projections, we now have the capital in place to fund this program through completion."

In addition to these findings, paxalisib in combination with fulvestrant, and paxalisib in combination with fulvestrant and palbociclib, showed consistent safety and resulted in statistically significant reductions in tumor volume across preclinical models. Kazia has filed a patent that is supported by the Company’s preclinical findings and has identified a high-risk subset of metastatic HR+/HER2- breast cancer defined by a novel PI3K/mTOR biomarker, with tissue- and blood-based tests associated with poor survival. Extensive benchmarking studies show that paxalisib can resensitize treatment-resistant tumors to combination therapy through a distinct epigenetic mechanism, an effect not observed with gedatolisib, an FDA-approved intravenous PI3K/mTOR inhibitor, indicating a paxalisib-specific effect rather than a class effect. In a HR+ xenograft model, paxalisib in combination with fulvestrant and palbociclib reduced tumor burden without added toxicity and showed primary tumor growth inhibition comparable to gedatolisib in combination with the same regimen.

"Our extensive benchmarking shows that paxalisib is differentiated in targeting the PI3K/mTOR–epigenetic resistance axis and importantly, this is not a class effect," said Dr. Sudha Rao, Chief Scientific Officer, Kazia Therapeutics. "Paxalisib’s unique attributes are uncovering a broader role for PI3K/mTOR beyond conventional cytoplasmic signalling, with alternative pathways that may drive metastatic disease and resistance. In HR+ breast cancer, we have identified a novel epigenetic PI3K/mTOR biomarker, with both liquid and tissue tests, that is enriched in patients with poor prognosis. This gives us the opportunity to enrich for the patients where this biology matters most and brings precision medicine to HR+ breast cancer."

This benchmarking work is ongoing, and Kazia expects to present additional data later this year, including further cellular, molecular and epigenetic characterization of paxalisib relative to other PI3K/mTOR inhibitors.

Current development strategies in this setting have primarily focused on sequencing additional lines of endocrine therapy, targeted agents or antibody-drug conjugates after resistance emerges. Kazia’s preclinical findings suggest that paxalisib may address resistance mechanisms at an earlier biological level through epigenetic and transcriptional effects that extend beyond conventional PI3K/mTOR pathway inhibition.

Alongside its IP filing, Kazia is amending the protocol of its ongoing TNBC clinical trial to add a three-arm expansion evaluating paxalisib in patients with pre-treated HR+/HER2- metastatic breast cancer. Patients will be randomized to one of three arms: paxalisib at 15mg plus fulvestrant (hormone therapy), with CDK4/6 inhibitor palbociclib; paxalisib at 30mg plus fulvestrant, with palbociclib; or a standard-of-care comparator arm of fulvestrant. The primary endpoint is safety and tolerability, with progression-free survival, overall response rate and overall survival as secondary endpoints.

The Company expects sites for this expansion to be activated and the first patient enrolled before the end of 2026, with full enrollment anticipated by the end of 2027. Clinical updates are anticipated throughout 2027, with a full readout anticipated in 2028.

(Press release, Kazia Therapeutics, SEP 1, 2026, View Source;breast-cancer-supported-by-preclinical-data-showing-strong-clinical-activity-and-safety-in-hr-breast-cancer-302865460.html [SID1234670500])