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Aura Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights

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

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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.

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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.

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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.

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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])

Aprea Therapeutics Announces Oversubscribed $30 Million Private Placement

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").

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])

Aprea Therapeutics Highlights Positive Emerging Clinical Activity for WEE1 Inhibitor, APR-1051, with a Confirmed Partial Response in the Ongoing Phase 1 ACESOT-1051 Trial

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 the confirmation of a partial response (PR) in its ongoing ACESOT-1051 trial evaluating APR-1051, a potent and selective WEE1 kinase inhibitor.

The confirmed PR was observed in a patient with PPP2R1A-mutated endometrial cancer who is currently being treated at the 220 mg once daily dose level. Aprea announced on February 18, 2026 that, at their first imaging assessment, this patient achieved a 50% reduction in target lesion size (meeting RECIST criteria for partial response) as well as a reduction in CA-125 levels. This response was subsequently confirmed at the second image assessment, with an additional 9.5% reduction in target lesion size, and a reduction in CA-125 to 40.2U/ml (from 362 U/mL at baseline).

ACESOT-1051 is a biomarker focused Phase 1 trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of APR-1051 in patients with advanced solid tumors harboring cancer-associated genetic alterations. A total of 24 patients have been treated to date, at doses ranging from 10 mg to 220 mg once daily. Two patients have achieved partial responses, both with endometrial cancers harboring PPP2R1A mutations. One of these responses has been confirmed, as described above. Both patients remain on treatment.

Five other patients in ACESOT-1051 have achieved a best overall response of stable disease, including patients with HPV+ head and neck squamous cell carcinoma (HNSCC), colorectal and endometrial cancers with relevant genomic alternations. APR-1051 has been generally safe and well tolerated with the most common adverse events reported as Grade 1 or 2, primarily consisting of nausea and fatigue.

"The data emerging from the ACESOT-1051 trial continue to support the clinical potential of APR-1051, with confirmation of a partial response in the 220 mg cohort indicating evidence of sustained anti-tumor activity," said Eugene Kennedy, MD, Chief Medical Advisor at Aprea. "APR-1051 appears to be generally well-tolerated with an encouraging therapeutic window and overall, these findings strengthen our confidence in the ability of this candidate to successfully target WEE1 in genetically defined cancers, where patients face significant unmet need."

Dose escalation is ongoing, with plans to advance to Dose Level 9 (300 mg once daily) in the second quarter of 2026. In parallel, the company plans to enroll additional patients as specified in the protocol based on the understanding that their tumor types or specific mutations gives them an increased probability of responding to this class of potential therapeutics. This includes patients with uterine serous carcinoma (a subset of endometrial), colorectal and HPV+ tumors. For more information on ACESOT-1051, refer to ClinicalTrials.gov NCT06260514.

(Press release, Aprea, MAR 30, 2026, View Source [SID1234664017])

Anixa Biosciences Announces Presentation of its Ovarian Cancer CAR-T Therapy Clinical Trial at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer

On March 30, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that Dr. Robert Wenham, Chair of the Gynecologic Oncology Department at Moffitt Cancer Center and principal investigator for the Company’s ongoing ovarian cancer CAR-T therapy Phase 1 trial, will be presenting at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, being held April 10 – 13, 2026, in San Juan, Puerto Rico.

Dr. Wenham’s presentation, titled "Phase 1 clinical trial of autologous T cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor (FSHR) in recurrent ovarian cancer," will discuss the clinical trial design and objectives, as well as the current status of Anixa’s ongoing Phase 1 clinical trial of lira-cel.

The SGO Annual Meeting on Women’s Cancer stands as the foremost educational and scientific gathering for professionals dedicated to the treatment and care of individuals with gynecologic cancer, bringing together global experts in gynecologic oncology to share the latest scientific advancements, participate in educational programs, and network with peers.

About Lira-cel, Anixa’s CAR-T Therapy for Recurrent Ovarian Cancer
Liraltagene autoleucel, or lira-cel, uniquely targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian cells, tumor vasculature, and certain cancer cells, but not in healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies.

(Press release, Anixa Biosciences, MAR 30, 2026, View Source [SID1234664016])

Insilico Medicine Announces Global R&D Collaboration with Lilly

On March 29, 2026 Insilico Medicine ("Insilico", HKEX: 3696), a clinical-stage biotechnology company powered by generative artificial intelligence (AI) and automation, reported a drug discovery collaboration with Eli Lilly and Company ("Lilly") that uses Insilico’s AI engine to accelerate the discovery and development of novel therapeutics across multiple therapeutic areas.

The agreement grants Lilly an exclusive worldwide license for the development, manufacturing, and commercialization of potentially best-in-class, novel oral therapeutics in preclinical development for certain indications. In addition, Insilico and Lilly will collaborate on multiple R&D programs focused on targets selected by Lilly, by combining Insilico’s state-of-the-art Pharma.AI platforms with Lilly’s development capabilities and deep disease-area expertise.

"From its inception, Insilico Medicine has been developing deep learning for end-to-end drug discovery. By deploying frontier AI technologies that scale from biomarkers to life models, world models of human and animal life, we can identify multi-purpose targets driving multiple diseases at the same time," said Alex Zhavoronkov, PhD, founder and CEO of Insilico Medicine. "Working with Lilly, we aim to deliver transformative therapies that treat diseases with high unmet need. This collaboration is a testament to the power of AI in tackling the most complex challenges in human health."

Under the terms of the agreement, Insilico is eligible to receive an $115 million upfront payment, followed by development, regulatory, and commercial milestones that could bring the total deal value to approximately $2.75 billion, plus tiered royalties on future sales.

"Insilico’s AI-enabled discovery capabilities represent a powerful complement to Lilly’s deep expertise in clinical development across multiple therapeutic areas," said Andrew Adams, Group Vice President of Molecule Discovery at Lilly. "This collaboration allows us to explore novel mechanisms and accelerate the identification of promising therapeutic candidates across multiple disease areas."

(Press release, Insilico Medicine, MAR 29, 2026, View Source [SID1234664001])