Aprea Therapeutics Announces Additional Positive Clinical Activity for WEE1 Inhibitor, APR-1051, Including Second Partial Response in Ongoing ACESOT-1051 Trial

On February 18, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea" or the "Company"), a clinical-stage biopharmaceutical company developing innovative therapies that exploit cancer-specific vulnerabilities while minimizing damage to healthy cells, reported additional preliminary data from the ongoing Phase 1 ACESOT-1051 trial evaluating its investigational WEE1 kinase inhibitor APR-1051.

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The Company reported a second unconfirmed partial response at first on-treatment scan in a patient with advanced endometrial cancer being treated at the 220 mg dose level (Cohort 8).

At the first on-treatment imaging assessment of single dose daily APR-1051, the responding patient achieved a 50% reduction from baseline in target lesion measurements, consistent with partial response per RECIST v1.1 criteria. In addition, there was a notable decline in the tumor biomarker CA-125, with levels dropping from 362 U/mL at baseline to 47 U/mL (-87%), further supporting the anti-tumor activity of APR-1051. The patient’s tumor harbors a PPP2R1A mutation. To date, the patient had only Grade 1 treatment-emergent adverse effects and continues treatment.

The observed unconfirmed partial responses for both patients with PPP2R1A mutations require confirmation at subsequent imaging assessments to be designated as confirmed responses under standard criteria.

A further update from the trial is expected in the second quarter of 2026.

"We are encouraged to see a second patient in the ongoing ACESOT trial achieve an unconfirmed partial response," said Eugene Kennedy, MD, Chief Medical Advisor at Aprea. "We believe the magnitude of tumor reduction and the substantial drop in CA-125 in this patient provides further evidence of APR-1051’s biologic activity and potential therapeutic impact. Importantly, this patient was refractory to her most recent two prior therapies. The response in a tumor with a PPP2R1A alteration underscores the potential of genomically guided patient selection in our DDR program."

Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea, commented, "We believe the emergence of a second unconfirmed partial response strengthens the clinical trend we are observing as dose escalation progresses. These results reinforce our confidence in the therapeutic potential of WEE1 inhibition in genetically defined difficult-to-treat cancers. In addition, the good safety profile of APR-1051 to date supports our development strategy of a differentiated WEE1 inhibition through a potentially improved therapeutic index (TI), as low TI has been a major hurdle in the development of WEE1 inhibitors. We remain focused on advancing APR-1051 and look forward to providing further updates from this trial."

ACESOT-1051 Trial Key Findings to Date

The ongoing Phase 1 trial is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of APR-1051 in patients with advanced solid tumors. A total of 22 patients have been treated to date, at doses ranging from 10 mg to 220 mg.

Partial Responses: Two patients have achieved partial responses (unconfirmed) at their first scan, both with endometrial cancer, and with tumors harboring PPP2R1A mutations. These responses were observed at the 150 mg and 220 mg dose levels of APR-1051. Both patients remain on therapy.
Stable Disease: A total of five patients in the trial have had stable disease:
70 mg cohort: HPV-positive head and neck squamous cell carcinoma (HNSCC)
100 mg cohort: FBXW7-mutated colon cancer; KRAS & p53-mutated colon cancer; CCNE1 & TP53 mutated uterine cancer
150 mg cohort: FBXW7-mutated colon cancer
Favorable tolerability: APR-1051 has been generally well tolerated

Taken together, these data support the potential activity of APR-1051 in genomically defined cancers across multiple solid tumor types.

Enrollment in the 220 mg dose cohort continues, and the Company plans to further expand enrollment of PPP2R1A endometrial and HPV-positive HNSCC patients within the study.

About the ACESOT-1051 Trial

ACESOT-1051 is a first-in-human, open-label Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent APR-1051 in patients with advanced solid tumors harboring cancer-associated genetic alterations. The dose-escalation portion of the study is expected to enroll up to 50 patients. APR-1051 is administered orally once daily in continuous 28-day cycles. To date, enrollment has evaluated doses up to 150 mg, with the 220 mg cohort currently enrolling. For more information, visit ClinicalTrials.gov (NCT06260514).

(Press release, Aprea, FEB 18, 2026, View Source [SID1234662747])

Akari Therapeutics to Present at the 2026 Biocom Global Partnering & Investor Conference

On February 18, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel immuno-oncology payloads, reported that Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics, will present at the 2026 Biocom Global Partnering & Investor Conference, being held February 24–26, 2026, at The Lodge at Torrey Pines in San Diego, CA.

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Presentation details are as follows:

Date/Time: Wednesday, February 25, 2026, at 11:00 AM PST

Location: Track B

In addition to the presentation, management will be available to participate in in-person one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

(Press release, Akari Therapeutics, FEB 18, 2026, View Source [SID1234662746])

Leidos Posts Strong Fourth Quarter and Fiscal Year 2025 Results

On February 17, 2026 Leidos Holdings, Inc. (NYSE: LDOS) reported financial results for the fourth quarter and fiscal year 2025, highlighted by significant growth in priority markets, enhanced profitability, double-digit earnings growth, and excellent business development performance. In addition, Leidos established guidance for 2026 that forecasts continued growth in revenues and non-GAAP diluted earnings per share and robust cash flows provided by operating activities.

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(Press release, Leidos, FEB 17, 2026, View Source [SID1234669261])

BriaCell Receives Positive Recommendation from Data Safety Monitoring Board (DSMB) for Phase 3 Study in Metastatic Breast Cancer

On February 17, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that the independent Data Safety Monitoring Board (DSMB) has issued its fifth consecutive positive recommendation following review of safety data from BriaCell’s pivotal Phase 3 Bria-ABC study of Bria-IMT plus immune checkpoint inhibitor (CPI) in patients with metastatic breast cancer (NCT06072612).

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Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly in accordance with the study protocol. BriaCell’s ongoing pivotal Phase 3 study is being conducted under Fast Track designation granted by the US Food and Drug Administration (FDA), reflecting the significant unmet medical need in metastatic breast cancer.

"This marks the fifth consecutive DSMB review supporting the continued conduct of BriaCell’s pivotal Phase 3 Bria-ABC study," said Dr. William V. Williams, President and Chief Executive Officer of BriaCell. "We are encouraged by the DSMB’s ongoing confirmation of the safety profile of the Bria-IMT regimen and remain focused on advancing this program for patients with limited treatment options. We look forward to providing additional clinical updates as the study progresses."

(Press release, BriaCell Therapeutics, FEB 17, 2026, View Source [SID1234663697])

HCW Biologics Announces Pricing of $1.5 Million Follow-On Offering Priced At-The-Market Under NASDAQ Rules

On February 17, 2026 HCW Biologics Inc. (the "Company"), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies to extend health span by targeting the link between chronic inflammation and disease, reported the pricing of its follow-on offering of an aggregate of 2,477,292 units at a purchase price of $0.6055 per unit priced at-the-market under Nasdaq rules. Each unit consists of one share of common stock (or pre-funded warrant in lieu thereof) and one warrant, each to purchase one share of common stock. The warrant will have an exercise price of $0.6055 per share, will be exercisable upon shareholder approval, and will expire on the five-year anniversary from such date of shareholder approval. The shares of common stock (or pre-funded warrants) and the warrant comprising the units are immediately separable and will be issued separately in this offering. The closing of the offering is expected to occur on or about February 19, 2026, subject to the satisfaction of customary closing conditions.

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Maxim Group LLC is acting as the sole placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $1.5 million. The Company intends to use the net proceeds from this offering for funding preclinical and clinical development, including the clinical trials for HCW9302, and general corporate purposes.

In addition, the Company has entered into a privately negotiated agreement with the holder of certain existing outstanding warrants to purchase up to 3,020,410 shares of common stock (the "Existing Warrants") to reduce the exercise price of such Existing Warrants from $2.41 per share to $0.6055 per share. The reduction of the exercise price of the Existing Warrants is subject to shareholder approval.

The securities described above are being offered pursuant to a registration statement on Form S-1, as amended (File No. 333-293396), which was declared effective by the Securities and Exchange Commission (the "SEC") on February 17, 2026. The offering is being made only by means of a prospectus which forms a part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at www.sec.gov and may also be obtained by
contacting Maxim Group LLC at 300 Park Avenue, 16th Floor, New York, NY 10022, Attention: Prospectus Department, or by telephone at (212) 895-3745 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, 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, HCW Biologics, FEB 17, 2026, View Source [SID1234662783])