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Nucleai Advances AI-Powered Tissue Intelligence Through Large-Scale Oncology ADC Collaboration

On August 11, 2026 Nucleai, a leader in AI-powered Tissue Intelligence, which integrates multimodal tissue image analysis with clinical data to deliver translational insights, reported an ongoing translational research collaboration with Gilead Sciences supporting its global antibody-drug conjugate (ADC) clinical development programs.

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As oncology drug development increasingly depends on understanding tissue biology in its spatial context, AI-powered tissue analytics are becoming an essential component of biomarker discovery and translational research. Pharmaceutical companies are increasingly adopting approaches that integrate tissue architecture, biomarker expression, and clinical outcomes to accelerate therapeutic development. Nucleai’s AI-native platform transforms routine pathology images into quantitative biological insights that accelerate biomarker discovery and support evidence-driven development decisions.

As part of its collaboration with Gilead, Nucleai has analyzed a large dataset of hematoxylin and eosin (H&E) and immunohistochemistry (IHC) whole-slide images across several clinical studies spanning multiple oncology indications, supporting Gilead’s global ADC clinical development programs through advanced AI-driven tissue analytics integrated with clinical outcomes. The collaboration has generated novel biological insights and candidate spatial biomarkers for future scientific presentations and publications.

The collaboration demonstrates how AI-powered Tissue Intelligence can standardize biomarker analyses while connecting tissue biology to clinical outcomes, creating a scalable foundation for translational research, biomarker development, and precision medicine.

"Precision oncology is entering a new phase, where understanding tissue architecture is becoming just as important as understanding molecular alterations," said Avi Veidman, Chief Executive Officer of Nucleai. "Tissue Intelligence is becoming a foundational capability for precision medicine, helping identify the patients most likely to benefit while enabling pharmaceutical companies to translate tissue biology into reproducible biomarkers that improve the speed and success of oncology drug development."

Unlike traditional image analysis approaches, Nucleai’s AI-native platform integrates computational pathology, spatial biology, clinical outcomes, and multimodal data into a unified framework. This enables standardized biomarker assessment from preclinical research through late-stage clinical development while revealing mechanisms of response, resistance, and disease progression.

The ongoing collaboration with Gilead and other leading pharmaceutical companies reflects growing industry recognition that AI-powered tissue analytics strengthen biomarker development and precision medicine across oncology portfolios. As target expression alone proves insufficient to explain ADC response, Nucleai’s Tissue Intelligence platform integrates protein expression with tissue architecture, tumor heterogeneity, and microenvironmental context to better characterize the biological drivers of therapeutic efficacy.

"Scale and reproducibility are becoming essential requirements for biomarker development," said Dr. Ken Bloom, Head of Pathology, Nucleai. "Our platform enables standardized spatial analyses across thousands of clinical samples while directly linking tissue biology to patient outcomes, generating evidence that can support translational research, biomarker qualification, and future companion diagnostic strategies."

Nucleai continues to expand collaborations with leading pharmaceutical companies to advance biomarker discovery, translational medicine, companion diagnostic development, and AI-powered Tissue Intelligence across the oncology development lifecycle.

(Press release, Gilead Sciences, AUG 11, 2026, View Source [SID1234669969])

AbCellera Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants

On August 11, 2026 AbCellera Biologics Inc. (Nasdaq: ABCL) ("AbCellera") reported that it has commenced an underwritten public offering of $200.0 million of its common shares and, in lieu of common shares to certain investors, pre-funded warrants to purchase its common shares. All of the common shares and pre-funded warrants are being offered by AbCellera. 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.

AbCellera intends to use the net proceeds from the offering to fund the continued research, development and clinical advancement of its internal pipeline, including its lead clinical program, ABCL635, as well as for working capital and other general corporate purposes.

Jefferies, J.P. Morgan, Cantor, UBS Investment Bank, and BMO Capital Markets are acting as joint book-running managers for the proposed offering.

The securities described above are being offered pursuant to a shelf registration statement on Form S-3ASR (No. 333-285367) that was filed with the U.S. Securities and Exchange Commission (the "SEC") on February 27, 2025 and automatically became effective upon filing. This proposed offering is being made only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement related to and describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and an accompanying prospectus related to the proposed offering may also be obtained, when available, from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at [email protected]; UBS Securities LLC, Attention: Prospectus Department, 11 Madison Avenue, New York, NY 10010, by email at [email protected]; or BMO Capital Markets Corp., Attn: Equity Syndicate Department, 151 W 42nd Street, 32nd Floor, New York, NY 10036, or by email at [email protected].

No securities are being offered or sold, directly or indirectly, in Canada or to any resident of Canada.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy 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 registration or qualification under the securities laws of that state or jurisdiction.

(Press release, AbCellera, AUG 11, 2026, View Source [SID1234669968])

New Drug Application for LAE002 (afuresertib) Accepted by China’s National Medical Products Administration

On August 11, 2026 Laekna (2105.HK) reported that the New Drug Application (NDA) for LAE002 (afuresertib) has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer (LA/mBC) with PIK3CA/AKT1/PTEN alterations, following recurrence or progression on or after endocrine therapy(-ies) (with or without a CDK4/6 inhibitor).

The NDA is supported by positive results from the Phase III Clinical Trial (AFFIRM-205) conducted in the aforementioned patient population. This pivotal study successfully met its primary endpoint of progression-free survival (PFS), demonstrating a highly statistically significant and clinically meaningful improvement over the control arm. LAE002 (afuresertib) also showed a favorable safety and tolerability profile. The detailed study results will be presented at an upcoming international scientific conference. We are collaborating with our strategic partner, Qilu Pharmaceutical, to expedite the regulatory approval and commercialization of LAE002 (afuresertib) in China.

"The NDA submission for LAE002 would not have been possible without the trust and support of every investigator, study participant, and partner. It is the result of the unwavering dedication and perseverance of the Laekna team over the years," said Dr. Chris Lu, Chairman and CEO of Laekna. "As a potential Class I novel drug for breast cancer and the first domestically developed AKT inhibitor in China, the clinical results of LAE002 (afuresertib) have demonstrated a best-in-class efficacy and safety profile. We look forward to its approval and commercial launch as soon as possible, bringing hope to patients and families affected by advanced breast cancer, and offering clinicians a novel therapeutic option."

Dr. Chris Lu further noted that, beyond breast cancer, the clinical development of LAE002 (afuresertib) for prostate cancer is also advancing rapidly. Laekna is actively pursuing strategic partnerships in ex-China regions to accelerate development and commercialization of LAE002 (afuresertib) in international markets, aiming to bring benefits to more patients overseas as soon as possible. He emphasized, "LAE002 (afuresertib) marks the first breakthrough of our innovative pipeline, as well as a significant milestone in our transition to the commercial stage. Across major therapeutic areas, including metabolic diseases and oncology, we will continue to develop innovative drugs that offer significant clinical value and global competitiveness, bringing greater benefits to patients and shareholders".

Laekna and Qilu Pharmaceutical entered into an exclusive licensing agreement for the China region in November 2025. Under the License Agreement, Laekna is eligible to receive up to RMB2,045 million in total in upfront and milestone payments and is also entitled to receive tiered royalties on future net sales of LAE002 (afuresertib) in the licensed territory, at percentages ranging from the low teens to the low twenties. Laekna plans to pursue strategic partnerships in ex-China regions to accelerate development and commercialization of LAE002 (afuresertib) in international markets.

About AKT Inhibitor

Capivasertib (Truqap‌) was the first approved AKT inhibitor from AstraZeneca, which was approved by the U.S. FDA for HR+/HER2- breast cancer in November 2023. In June 2026, the U.S. FDA further approved capivasertib (Truqap) in combination with abiraterone and prednisone for the treatment of PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC). This approval significantly broadens the therapeutic scope of AKT inhibition and highlights its potential to address unmet needs across multiple tumor types.

LAE002 (afuresertib) is a potent AKT inhibitor internally developed by Laekna that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3). It is one of the two most advanced AKT inhibitors globally in development for breast and prostate cancer. The Phase III clinical trial (AFFIRM-205), a multi-center, randomized, double-blind, placebo-controlled pivotal study, has met its primary endpoint of progression-free survival. It showed statistically significant and clinically meaningful benefits to patients with HR+/HER2- breast cancer and demonstrated a best-in-class efficacy and safety profile.

About Breast Cancer

Breast cancer has become the leading cause of death for women globally, with approximately 2.43 million new cases diagnosed each year and around 694,000 lives lost to the disease. In China, breast cancer ranks the second most common cancer among women, with approximately 70% of the patients found to be HR+/HER2-*.

Collectively, genetic alterations in PIK3CA, AKT1 and PTEN affect approximately 50% of patients with breast cancer. Although most patients with this subtype of breast cancer can initially benefit from first/second-line treatment by endocrine therapy + CDK4/6 inhibitors and/or chemotherapy, they may gradually develop drug resistance and result in treatment failure. Novel therapeutic options are urgently needed for patients after drug resistance. As an innovative therapy for drug-resistant patients with this subtype of breast cancer, AKT inhibitors offer new hope for them and their families.

(Press release, Laekna Therapeutics, AUG 11, 2026, View Source [SID1234669967])

Oncoinvent announces publication of normal tissue dosimetry results in Journal of Nuclear Medicine

On August 11, 2026 Oncoinvent, a biotech company developing a receptor-independent alpha radiopharmaceutical to eradicate cancer cells in the abdominal cavity after surgery with a single, targeted dose, reported the publication of clinical dosimetry data for Radspherin in the Journal of Nuclear Medicine, one of the leading peer-reviewed journals in the field.

The publication, titled ‘Normal Tissue Dosimetry of Intraperitoneal Radium-224-Microparticle Therapy: Data from First-in-Human Studies in Patients with Peritoneal Metastases’, reports results from nine patients enrolled in the dosimetry cohorts of the Phase 1 Radspherin studies in ovarian and colorectal cancer. Positive final data from these studies, previously reported by Oncoinvent, demonstrated a favorable safety profile and encouraging efficacy signals.

"In early-phase clinical studies, dosimetry is essential to understand how radiation exposure relates to potential toxicity and identify potential dose-limiting tissues," said Caroline Stokke, senior author of the publication, Head of Nuclear Medicine Physics at Oslo University Hospital and Chair of the European Association of Nuclear Medicine Dosimetry Committee. "This work also reflects the methodological complexity of dosimetry for alpha therapies, where imaging cannot always be directly applied. To address these challenges, we were able to use a combination approach, also including blood sampling and biokinetic modeling, to estimate normal tissue radiation exposure and provide a basis for evaluating safety."

The dosimetry study, conducted at The Norwegian Radium Hospital, part of Oslo University Hospital, evaluated how radiation from Radspherin is distributed to normal tissues following treatment. Results showed that absorbed radiation doses to normal organs were below levels commonly associated with risks for complications, including for organs typically regarded as activity-limiting such as the kidneys and red bone marrow.

"We are pleased to report the results from the outstanding work performed together with Oslo University Hospital published in the prestigious Journal of Nuclear Medicine," said Kari Myren, Chief Medical Officer at Oncoinvent. "Unintended radiation exposure to normal organs, especially for the kidneys and red bone marrow, frequently represents a limitation for obtaining therapeutic doses of radiopharmaceuticals. Our results indicate very low radiation exposure to healthy organs after treatment, which is consistent with the favorable safety profile observed in our clinical trials and supports the further development of Radspherin to provide hope for patients for whom very limited treatment options exist."

(Press release, Oncoinvent, AUG 11, 2026, View Source [SID1234669966])

Phio Pharmaceuticals Secures U.S. Notice of Allowance for INTASYL Composition Selectively Targeting BRD4 Protein with Compound PH-894

On August 11, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage biotechnology company developing immuno-oncology therapeutics based on its proprietary INTASYL gene-silencing technology, reported the receipt of a U.S. Notice of Allowance for a patent covering PH-894, further strengthening the Company’s intellectual property portfolio.

The patent allowance represents a critical milestone in protecting Phio’s strategic interest in the Company’s INTASYL platform. PH-894, designed to selectively silence BRD4, is a key regulator of gene expression associated with proliferative and infectious disease.

"Robust intellectual property protection is a continuous focus in our development strategy to advance novel immuno-oncology therapies and maximize the long-term value of the INTASYL platform," said Robert Bitterman, President and Chief Executive Officer of Phio Pharmaceuticals. "This patent advancement solidifies our commitment to advance PH-894 in the U.S. and pursue strategic collaborations internationally."

Phio has built a comprehensive patent estate supporting its INTASYL technology and therapeutic pipeline. The Company’s portfolio currently includes 54 issued patents covering INTASYL chemistry, specific gene targets, immuno-oncology compounds, and therapeutic applications across major global markets.

The newly allowed patent further reinforces Phio’s commitment to protecting its proprietary innovations and advancing next-generation cancer therapies based on targeted gene silencing.

(Press release, Phio Pharmaceuticals, AUG 11, 2026, View Source [SID1234669965])