On March 30, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported first-patient-in for a Phase 1 clinical trial combination study to evaluate IDE849, a potential first-in-class delta-like ligand 3 (DLL3)-targeting Topo-I-payload antibody drug conjugate (ADC) program, and IDE161, a potential first-in-class poly(ADP-ribose) glycohydrolase (PARG) inhibitor. The Phase 1 combination study will be evaluated in DLL3 upregulated solid tumor indications, including small cell lung cancer (SCLC), neuroendocrine tumors (NETs), neuroendocrine carcinomas (NECs), and melanoma.

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"We are excited about the progress in our Phase 1 IDE849 monotherapy study to determine the RP2D and to initiate a registrational study by year-end, and the advancement of our wholly owned first-in-class clinical combination of IDE849 and IDE161 in DLL3 upregulated solid tumor indications," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. "We are leveraging our deep scientific expertise in DNA damage repair to enable this rational combination with IDE161, with the goal of inducing accumulation of TOP1 lesions to enhance the clinical efficacy and durability of our proprietary TOP1-payload ADCs, including IDE849 and IDE034, a Phase 1 B7H3/PTK7 bispecific TOP1 ADC," said Michael White, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.

IDEAYA is advancing a multi-site global Phase 1 clinical trial for IDE849 in DLL3 upregulated solid tumor indications, including SCLC, NETs, and NECs, and melanoma (NCT07174583). The study will be enrolling patients globally, including in North America, Europe, Australia, South America, and Asia. In this ongoing Phase 1 dose escalation study, IDE849 is currently evaluating a 3.5 mg/kg IV dose once every 3-weeks (Q3W). Next, to determine the recommended Phase 2 dose (RP2D), IDEAYA is also enrolling patients in a IDE849 expansion cohort at the 2.4 mg/kg IV dose Q3W, where multiple partial responses (PRs) have been observed by RECIST 1.1, including 3 PRs out of 4 SCLC patients pre-treated with IMDELLTRA (tarlatamab-dlle). The preliminary safety and efficacy profile observed to date in the IDEAYA sponsored study is consistent with the clinical data presented by our China-region partner Jiangsu Hengrui Pharmaceuticals Co. Ltd., at the IASLC World Conference on Lung Cancer 2025 (WCLC 2025).

In addition, IDE849 is being evaluated in a clinical combination with IDEAYA’s potential first-in-class Phase 1 PARG inhibitor, IDE161. IDEAYA has presented preclinical combination mechanism and synergy efficacy data of IDE161/PARG with TOP1-payload based ADCs at WCLC 2025. IDE161 prevents the removal of poly(ADP-ribose) chains generated by PARP during the DNA damage response, leading to persistent PARylation and impaired resolution of DNA repair complexes. Together with TOP1-payload ADCs, this unique mechanism-of-action results in sustained TOP1 cleavage complexes and the accumulation of DNA damage that delivers enhanced anti-tumor activity. We believe this potential first-in-class combination has the potential to enhance durability of IDEAYA’s TOP1-payload based ADC pipeline, including IDE849 and IDE034 (Phase 1 B7H3/PTK7 Bispecific TOP1 ADC).

DLL3 has been reported to be upregulated in multiple solid tumor types, including in SCLC, NETs, NSCLC, melanoma, among others. DLL3 has limited extracellular expression in normal tissues, making it a promising potential therapeutic target in these solid tumors, for which there remains significant unmet medical need.

(Press release, Ideaya Biosciences, MAR 30, 2026, View Source [SID1234664037])

On March 30, 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 that it has entered into a securities purchase agreement for an oversubscribed private placement financing that is expected to result in total gross proceeds of approximately $30 million to the Company before deducting placement agent fees and other private placement expenses (the "Offering").

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The private placement was led by Soleus Capital with participation from other new investors, including Vestal Point Capital and Squadron Capital Management, existing investors and certain insiders of the Company.

In connection with the Offering the Company plans to sell (i) pre-funded warrants to purchase up to an aggregate of approximately 37.2 million shares of common stock ("Pre-Funded Warrants"), for a purchase price equal to $0.808, minus $0.001 per Pre-Funded Warrant, and (ii) warrants to purchase up to an aggregate of approximately 37.2 million shares of common stock. The warrants to be issued will have an exercise price of $0.683 per share, will be exercisable immediately upon issuance, and will expire on the earlier of (i) December 31, 2029, and (ii) 30 calendar days after the exercise of a holder’s Pre-Funded Warrant on a pro rata basis.

The gross proceeds to the Company from the Offering are estimated to be approximately $30 million before deducting the placement agent’s fees and other estimated Offering expenses. The Company intends to use the upfront net proceeds from the private placement for general corporate purposes and for research and development expenses. The Offering is expected to close on or about March 31, 2026, subject to the satisfaction of customary closing conditions.

In addition to the existing biomarker-enriched cohorts under evaluation in the ongoing ACESOT-1051 Phase 1 trial, Aprea plans to use commercially reasonable efforts to seek enrollment of at least 50 patients with uterine serous carcinoma (USC), as well as patients with Cyclin E-overexpressing, platinum-resistant ovarian cancer (PROC) in order to further assess APR-1051 in selected patient populations with high unmet medical need. The Company currently anticipates completing dose escalation of the ACESOT-1051 trial in the second quarter of 2027 and currently expects that the proceeds from the Offering will be sufficient to extend its cash runway into the first quarter of 2028, in each case, based on the Company’s current business plans and assumptions.

Oppenheimer & Co. Inc. is acting as the lead placement agent for the private placement. Maxim Group LLC is acting as co-lead placement agent for the private placement.

The offer and sale of the foregoing securities are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, 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 such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities purchased in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

(Press release, Aprea, MAR 30, 2026, View Source [SID1234664018])

On March 30, 2026 Certis Oncology, an AI-enabled translational science company, reported the launch of Certis Oncology Intelligence, an integrated platform designed to generate data-driven insights into therapeutic response by combining predictive modeling, agentic AI-enabled biological data exploration, and functional validation in clinically relevant cancer models.

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Certis Oncology Intelligence represents a new approach to translational research—one that connects computational prediction with real-world biological evidence in a continuous learning system.

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Certis Oncology Intelligence represents a new approach to translational research—one that connects computational prediction with real-world biological evidence in a continuous learning system.

"One of the central challenges in oncology drug development is that we generate enormous amounts of data, but struggle to translate that into reliable predictions of therapeutic response," said Peter Ellman, Certis President and CEO. "Certis Oncology Intelligence was built to close that gap—linking prediction, biological context, and experimental validation into a system that continuously learns and improves over time."

A Three-Layer Translational Intelligence System

Certis Oncology Intelligence is a secure, multi-tenant, closed loop system that integrates three data layers:

1.

Predictive Intelligence Layer— CertisAI

A patented, generalized drug-response foundation model trained to internalize relationships between chemical structure, tumor biology, and therapeutic response, CertisAI enables zero-shot prediction of how cancers are likely to respond to therapeutic agents, including novel compounds, even in the absence of prior experimental data.

This predictive layer can be fine-tuned using sponsor training data, producing powerful, custom computational models uniquely aware of each company’s novel chemical space.

2.

Exploration Layer — Agentic Biospecimen Management

Agentic biospecimen management enables researchers to dynamically query and analyze biological specimens together with their associated molecular and experimental datasets—offering a secure in silico environment in which to rapidly test hypotheses.

Within the Oncology Intelligence platform, licensors can integrate their own proprietary datasets—molecular profiles, drug-response screening results, target binding data, and other translational information accumulated across programs over many years.

By cross-referencing a company’s proprietary datasets with the platform’s foundational training data, the system can surface previously hidden relationships within each sponsor’s institutional knowledge base—generating new hypotheses, translational insights, and opportunities to advance or reprioritize therapeutic programs.

3.

Validation Layer—Functional Biological Evidence

A key differentiator of this platform is its ability to learn from continuous biological validation using experimental data generated either by Certis or by its collaborators. Validation data may include results from studies performed in human-concordant cancer models such as patient-derived xenografts (PDX), as well as in vitro assays, organoid models, or clinical trials.

Importantly, results from experimental studies are seamlessly fed back into the system as additional training data, continually improving predictive performance over time.

Unlocking the Value of Translational Data

The platform is designed to help pharmaceutical and biotechnology companies:

Integrate diverse datasets across programs and time
Identify biologically meaningful drivers of therapeutic response
Generate and test hypotheses more efficiently
Improve confidence in translational and clinical decision-making
By enabling organizations to extract new insights from existing data while continuously generating new evidence, Certis Oncology Intelligence offers a scalable foundation for more predictive and data-driven oncology development.

Availability

Certis Oncology Intelligence is available to pharmaceutical and biotechnology partners through licensing and collaborative engagements.

(Press release, Certis Oncology Solutions, MAR 30, 2026, View Source [SID1234664039])

On March 30, 2026 Medicilon reported a strategic cooperation signing ceremony with Suzhou Hailu Biotech, a wholly-owned subsidiary of Yangtze River Pharmaceutical Group. The collaboration will focus on deepening synergy in preclinical new drug R&D, project introduction, and global market expansion, with the goal of jointly building an efficient, open, and international R&D ecosystem spanning from source innovation to IND filing. This partnership is poised to lead the high-quality development and global advancement of China’s biomedical industry.

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Key executives from both organizations attended the ceremony and engaged in in-depth discussions on the cooperation’s vision and implementation roadmap. Representatives from Yangtze River Pharmaceutical Group included Ruwei Wang, Special Assistant to the Chairman and Head of the Group’s Pharmaceutical Research Institute; Jian Liu, Assistant to the Dean and Head of the Macromolecule Innovation Center; and Wenjun Shan, Head of the Small Molecule Innovation Center. From Medicilon, attendees included Chunlin Chen, Chairman and CEO; Jinna Cai, Director and Chief Business Officer; Guokai Chen, Director and Vice President of Investment & Financing; Jian Ge, Executive Vice President of the Preclinical Division; and Binbin Liu, Vice President of Operations.

Complementary Strengths to Accelerate One-Stop New Drug R&D

As a core biologic R&D platform and wholly-owned subsidiary of Yangtze River Pharmaceutical Group, Hailu Biotech has established a comprehensive macromolecule innovative drug R&D system covering target discovery, molecular design, and preclinical development. Leveraging its antibody discovery and engineering platforms, Hailu Biotech focuses on cutting-edge technologies such as monoclonal/bispecific antibodies, ADCs, and small nucleic acids, with a focus on oncology, metabolism, autoimmune diseases, and central nervous system disorders. The company is committed to addressing unmet clinical needs and delivering improved treatment options for patients through its leading technological capabilities.

Medicilon, a leading one-stop preclinical R&D CRO, offers end-to-end services spanning drug discovery, pharmaceutical research, and preclinical studies. The company operates a research system compliant with standards set by China’s NMPA, the U.S. FDA, OECD GLP, and AAALAC accreditation. Medicilon has also built specialized R&D service platforms for novel molecular drugs, including antibodies, ADCs, mRNA vaccines, small nucleic acids, PROTACs, and CGT. With a track record of mature technological platforms and successful cases, Medicilon has supported the global launch of multiple innovative drugs.

16 Years of Collaboration: From Project Partnership to Strategic Symbiosis
This strategic cooperation builds on a long-standing partnership between the two parties, which dates back to 2010. Over the past 16 years, Medicilon has established long-term cooperative relationships with Yangtze River Pharmaceutical Group and its subsidiaries, including Shanghai Haiyan Pharmaceutical Technology, Shanghai Hailu Biotechnology, Shanghai Haini Pharmaceutical, Nanjing Hailing Pharmaceutical, Guangzhou Hairui Pharmaceutical. Its services cover the entire preclinical R&D chain, encompassing small nucleic acids, small-molecule chemical drugs, and traditional Chinese medicines, empowering nearly 100 new drug R&D projects and supporting the approval and launch of key drugs such as Dezocine Injection, Omeprazole Enteric-coated Capsules, Levofloxacin Eye Drops, Ticagrelor Tablets, and Tacrolimus.

Shared R&D philosophies, aligned technical services, and consistent quality systems have fostered a mature and efficient collaboration mechanism between the two parties. This foundation of trust and business synergy has elevated their partnership from project-level cooperation to a strategic win-win alliance. Moving forward, the two parties will conduct customized R&D collaboration through flexible models such as commissioned R&D, FTE and FFS, covering one-stop preclinical services including early drug discovery, in vitro and in vivo efficacy studies, Chemistry, CMC, pharmacokinetics, safety evaluation, and regulatory registration. This integration will enable seamless process connection and efficient utilization of R&D resources.

"Bring In & Go Global": Building a Two-Way Ecosystem for Global Drug Outreach
In terms of business development, the two parties will jointly build a "bring in and go global" ecosystem to facilitate the integration of Chinese innovative drugs into the global market, featuring two-way empowerment and mutual promotion. To support global outreach, Medicilon will leverage its mature international platform and global network to connect Hailu Biotech with overseas partners, showcase innovative achievements through participation in top global industry conferences, and accelerate the overseas licensing and development of Hailu Biotech’s drug pipeline.
Meanwhile, Medicilon will use its international perspective and project resources to link Yangtze River Pharmaceutical Group with high-quality overseas innovative drug pipelines and targets, facilitating their development and equity cooperation in the Chinese market. Beyond accelerating the internationalization of individual projects, this ecosystem aims to create a sustainable two-way flow of technologies, resources, and markets, enhancing the global visibility and competitiveness of Chinese innovative drugs.

(Press release, Shanghai Medicilon, MAR 30, 2026, View Source [SID1234664154])

On March 30, 2026 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, reported financial results for the fourth quarter and year ended December 31, 2025, and provided recent business highlights.

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"2025 has been a year of focused execution across our clinical portfolio, with significant progress in trial enrollment, highlighted by the acceleration of our global Phase 3 CoMpass trial in early choroidal melanoma and continued enrollment in our Phase 1b/2 NMIBC trial," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura Biosciences. "Based on strong enrollment momentum, we now expect to complete CoMpass enrollment by mid-2026, with topline data anticipated in the second half of 2027. We believe bel-sar has the potential to become the first frontline, vision-preserving therapy for early choroidal melanoma. Our proof-of-concept trials to expand our ocular franchise also remain on track to deliver data in 2026. In NMIBC, we look forward to reporting initial three-month data mid-year to further define our potential as a frontline approach. We are also encouraged by our new formulation reaching 12-month stability, further expanding our opportunity in non-ocular solid tumors, starting with urologic oncology."

Recent Pipeline Developments

Early Choroidal Melanoma

Ongoing Phase 3 CoMpass Trial: CoMpass is the first registration-enabling study in early choroidal melanoma. This global, randomized Phase 3 trial is evaluating bel-sar versus a sham control using an enrichment strategy to enroll patients with documented tumor growth. Driven by strong global enrollment momentum, the Company now expects to complete enrollment by mid-2026, with topline data for the 15-month primary endpoint anticipated in the second half of 2027.

Our patient identification tool continues to expand, and we believe this growing pool of patients reflects the unmet need in early choroidal melanoma and the significant need for a vision preserving therapy.

Bel-sar has the potential to become the first frontline vision-preserving therapy in this setting. The Company previously received Orphan Drug Designation from the United States Food and Drug Administration (FDA) and the European Medicines Agency and Fast Track designation from the FDA for the treatment of early choroidal melanoma. The CoMpass trial is under a Special Protocol Assessment agreement with the FDA

Bladder Cancer

Ongoing Phase 1b/2 Trial: The ongoing trial evaluating additional doses and cycles of bel-sar across intermediate- and high-risk NMIBC patients continues to progress as planned, with initial 3-month clinical data expected in mid-2026.

The trial will evaluate two approaches: an immune ablative design and a neoadjuvant design. In the immune ablative approach, bel-sar is administered in two cycles without the need for a transurethral resection of the bladder tumor, or TURBT. In the neoadjuvant cohorts, bel-sar is administered in two cycles ahead of TURBT. For both approaches, the patients will be monitored for response assessments and reoccurrence at 3, 6, 9, and 12 months. The patients will also be monitored for safety.

Achieved 12-Month Stability of New Formulation for Use in Non-Ocular Solid Tumors, Beginning with Bladder Cancer: The Company has demonstrated 12-month stability for its new formulation designed for use in non-ocular solid tumors, beginning with urologic oncology. We believe this formulation reinforces the opportunity for product differentiation and, with simple refrigeration and no need for cold chain, is intended to support convenient in-office administration for urologists. The Company previously filed a patent application with the U.S. Patent and Trademark Office for this formulation, which, if issued, would be expected to provide patent coverage into 2046.

Metastases to the Choroid

The ongoing Phase 2 clinical trial of bel-sar in metastases to the choroid continues to enroll patients. The study is designed to include patients with choroidal metastases arising from a range of primary solid tumors and to evaluate early proof-of-concept based on a four-week efficacy endpoint. The Company remains on track to report early data from this trial in 2026.

Metastases to the choroid is an indication with high unmet medical need and no approved therapies, with an estimated incidence of approximately 20,000 patients annually across the United States and Europe. Bel-sar has the potential to treat a broad range of tumor types that metastasize to the choroid. The Company previously received FDA Fast Track designation for bel-sar in this indication.

Cancers of the Ocular Surface

The Company is initiating a Phase 1 proof-of-concept trial in Australia to assess safety, feasibility and tumor response through histopathologic evaluation at a 2–4-week time point. Development activities for this program are ongoing, with early proof-of-concept data expected in 2026.

Cancers of the ocular surface affect approximately 35,000 patients in the United States and Europe annually and are associated with a particularly high incidence in regions such as Australia. There are currently no approved therapies for these tumors.

Fourth Quarter and Full Year 2025 Financial Results

•
As of December 31, 2025, the Company had cash and cash equivalents and marketable securities totaling $144.2 million. The Company believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into the first quarter of 2027.

•
Research and development expenses were $21.9 million and $90.3 million for the three months and full year ended December 31, 2025, respectively, and $22.3 million and $73.3 million for the three months and full year ended December 31, 2024, respectively. The increase in the full year period was primarily due to ongoing clinical and clinical research organization (CRO) costs associated with the progression of our global Phase 3 trial of bel-sar in early choroidal melanoma and higher personnel expenses related to the growth of the Company.

•
General and administrative expenses decreased to $5.3 million and $22.5 million for the three months and full year ended December 31, 2025, respectively, from $5.5 million and $22.8 million for the three months and full year ended December 31, 2024, respectively. General and administrative expenses include $1.5 million and $1.4 million of stock-based compensation for the three months ended December 31, 2025 and 2024, respectively. The decrease in general and administrative expenses was primarily driven by reduced professional fees.

•
Net loss for the three months and full year ended December 31, 2025, was $25.6 million and $106.2 million, respectively, compared to $25.8 million and $86.9 million for the three months and full year ended December 31, 2024, respectively.

(Press release, Aura Biosciences, MAR 30, 2026, View Source [SID1234664019])