On August 14, 2026 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager TriKE platform, reported second quarter 2026 financial results for the period ended June 30, 2026.

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"We now have two TriKE candidates actively enrolling patients and look forward to additional updates later this year," said Michael Breen, Executive Chairman and Chief Executive Officer. "Utilizing our deep platform expertise, our discovery efforts continue to be extremely productive, and we anticipate announcing IND clearance for an additional TriKE pipeline asset in 2026. With sufficient cash runway through Q4 2026, we look forward to providing updates on all programs in the second half of 2026."

GTB-3650 TriKE for CD33 positive leukemias

The ongoing Phase 1 dose escalation study is evaluating GTB-3650 for relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. Enrollment is ongoing, with Cohort 4 complete and enrollment of Cohort 5 in progress. The Company expects to provide an update in the 2H 2026.

Dose escalation may continue up to Cohort 7 as necessary with the potential to evaluate GTB-3650 in a total of 14 patients (two patients per cohort). GTB-3650 is dosed in two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The trial aims to assess the safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity.

GTB-5550 TriKE for B7H3 positive solid tumor cancers

The ongoing Phase 1 trial with GTB-5550 is the first nanobody TriKE tested with more patient-friendly subcutaneous dosing. The Phase 1a dose escalation portion of the trial is focused primarily on enrolling prostate cancer patients and will evaluate up to 6 dose levels to identify the maximum tolerated dose (MTD). Enrollment in Cohort 1 is complete and enrollment in Cohort 2 is in progress. The Company expects to provide an update in the 2H 2026.

After the dose escalation phase, the Phase 1b expansion component will enroll patients with up to 7 different tumor types (castration-resistant prostate cancer, ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer) and further evaluate its safety, tolerability and preliminary anti-tumor activity.

GTB-5550 will be administered by subcutaneous (SQ) injection in the abdominal area for 5 consecutive days during Week 1 and Week 2 followed by 2 weeks of no treatment. One treatment cycle is 4 weeks in duration. Subsequent cycles receive treatment three times weekly for 2 weeks followed by 2 weeks of no treatment. A minimum of 2 cycles is planned, and patient-appropriate disease reassessment is performed after 2 cycles and every 8-12 weeks thereafter. Treatment may continue until disease progression, unacceptable toxicity, patient refusal, or treatment is no longer in the best interest of the patient. Patients are followed for 12 months to determine progression free survival (PFS) and overall survival (OS). More details can be found on clinicaltrials.gov with the identifier: NCT07541573.

Second Quarter Ended June 30, 2026 Financial Summary

Cash Position: The Company had cash and cash equivalents of approximately $5.1 million as of June 30, 2026, which is anticipated to be sufficient to fund the Company’s operations through the fourth quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were approximately $1.1 million compared to $0.4 million for the same comparable quarter of 2025. The $0.7 million increase was primarily due to an increase in materials and production costs. R&D expenses primarily relate to the Company’s continued licensing, development, production, and clinical trials of its most advanced TriKE product candidates GTB-3650 and GTB-5550 along with the progression on other promising product candidates. In late June 2024, the Company received clearance from the Food and Drug Administration with respect to its IND application in relation to its next generation GTB-3650 camelid nanobody product. Study enrollment began in early 2025 and the Company has advanced into the clinic with the first four cohorts now enrolled. In January 2026, the Company received clearance from the FDA on its IND Application for GTB-5550. The first patient in a Phase 1 dose escalation basket trial was dosed in May 2026.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the second quarter of 2026 were approximately $3.4 million compared to $1.1 million for the same comparable quarter of 2025. The $2.3 million increase was primarily due to an increase in marketing expenses, and to a lesser extent, legal and consulting fees.

Loss from Operations: The Company reported a loss from operations for the second quarter of 2026 of approximately $4.5 million compared to $1.5 million for the same comparable quarter of 2025. The $3 million increase was primarily due to a $2.3 million increase in SG&A expenses, and a $0.7 million increase in R&D expenses, as described above.

Net Loss: The Company reported a net loss for the second quarter of 2026 of approximately $4.5 million, compared to $30.2 million for the same comparable quarter of 2025. The $25.7 million decrease consisted primarily of the initial recognition of Greenshoe Rights liability of $28.7 million (non-cash and non-recurring) which occurred in the same comparable quarter of 2025 and did not occur in the current quarter, slightly offset by an increase in R&D and SG&A expenses, as described above.

(Press release, GT Biopharma, AUG 14, 2026, View Source [SID1234670148])

On August 14, 2026 (the "Closing"), Werewolf Therapeutics, Inc. (the "Company") reported to have entered into an asset purchase agreement (the "Purchase Agreement") with EMD Serono Research & Development Institute Inc. ("EMD"), pursuant to which, and subject to the terms and conditions thereof, the Company sold to EMD (the "Asset Sale") technology comprising (i) its pre-clinical INDUCER platform, including all patents and know-how related thereto, pre-clinical compounds and related intangible assets, and (ii) its INDUKINE platform, including certain patents, certain know-how related thereto, and pre-clinical compounds, excluding the clinical development programs for WTX-124 and WTX-330 (collectively, the "Transferred Assets"). The Company retains all rights necessary for the continued development of its WTX-124 and WTX-330 clinical programs.

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Pursuant to the Purchase Agreement and related ancillary agreements, in consideration for the Transferred Assets, EMD agreed to pay to the Company upfront consideration of $28.0 million and an additional $5.0 million upon the completion of the transfer of the Transferred Assets technology.

The Purchase Agreement contains customary representations, warranties and covenants of each of the Company and EMD. The Purchase Agreement further provides that, subject to certain limitations, the Company and EMD will each indemnify the other for certain losses arising from such breaches of representations, warranties and covenants and liabilities allocated to such party pursuant to the terms of the Purchase Agreement.

In addition, the Purchase Agreement contains a non-competition covenant pursuant to which the Company agreed not to exploit certain compounds, products or programs claimed in the Transferred Intellectual Property (as defined in the Purchase Agreement) that are directed to the same tumor target as any Transferred Compound (as defined in the Purchase Agreement) for a period of twenty-four (24) months after the Closing, subject to customary exceptions for change of control transactions.

The foregoing description of the terms of the Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the terms and conditions of the Purchase Agreement, a copy of which the Company intends to file with a subsequent Securities and Exchange Commission report.

Simultaneously with the execution of the Purchase Agreement, on August 14, 2026 the Company entered into a license agreement (the "License Agreement") with EMD pursuant to which EMD granted the Company an exclusive license to certain patents included in the Transferred Assets that enable the Company to exploit and perform clinical development programs for WTX-124 and WTX-330.

Additionally, under the License Agreement, EMD granted to the Company certain licenses to enable the Company to grant certain licenses to (i) Harpoon Therapeutics, Inc. ("Harpoon") under that certain Second Amended and Restated Assignment and License Agreement between the Company and Harpoon dated December 20, 2019 (the "Harpoon License") and (ii) Jazz Pharmaceuticals Ireland Limited ("Jazz") under the Company’s existing license agreement with Jazz that was entered into in connection with that certain Asset Purchase Agreement dated as of May 7, 2026 by and between the Company and Jazz, under which the Company has granted a non-exclusive license to certain technology originally licensed to the Company under the Harpoon License.

The foregoing description of the terms of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the License Agreement, a copy of which the Company intends to file with a subsequent Securities and Exchange Commission report.

(Filing, Werewolf Therapeutics, AUG 14, 2026, View Source [SID1234670253])

On August 14, 2026 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical stage biopharmaceutical company targeting transformative therapies for immune-mediated diseases, reported second quarter 2026 financial results as well as recent business highlights.

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"I am pleased with our progress this quarter, advancing our pipeline and strengthening our position for long-term growth," said Shao-Lee Lin, M.D., Ph.D., president and chief executive officer of Cue Biopharma. "The CUE-221 license agreement augments our portfolio and opportunities and the higher expenditures this quarter reflect expected one-time non-cash items and payments related to the transaction. Combined with our recent CUE-221 IND submission, financing with high-quality investors, and strategic leadership additions, we believe we are well positioned for the next phase of execution. We look forward to anticipated CUE-221 Phase 2 data by the end of this quarter and remain on track to initiate a CUE-401 Phase 1 study by the end of the year."

Business, Financial and Leadership Highlights

Milestones
CUE-221

Recently submitted an IND to the FDA in food allergy applications
Phase 2 data readout in Chronic Spontaneous Urticaria anticipated by the end of the third quarter of 2026
CUE-401

Company anticipates submitting an IND to the FDA and initiating a Phase 1 clinical study by year-end 2026
Financial and Corporate

Completed a private placement for gross proceeds of $50 million primarily to support clinical development, pipeline advancement, and infrastructure growth
Leadership

Dr. Dominic Borie, Chief Medical Officer and Head of Research and Development, physician-scientist and immunology leader with deep expertise in immunology, joined Cue to help advance key clinical programs in allergic and autoimmune diseases
Mr. James M. Ahlers, Chief Financial Officer, a veteran biotechnology finance executive, joined Cue to help strengthen the Company’s financial leadership and the infrastructure needed to support execution of its corporate strategy
Second Quarter 2026 Financial Results
Second quarter revenue was $7.9 million, compared to $3.0 million in the second quarter of 2025. The increase in 2026 was due to revenue earned from the Boehringer Ingelheim collaboration and license agreement upon achievement of a preclinical milestone, triggered in the second quarter of 2026.

Research and development expenses were $49.0 million for the three months ended June 30, 2026, compared to $7.9 million in 2025. The increase primarily consisted of one-time cash payments of approximately $20.0 million, including the upfront payment to Ascendant and transaction-related costs. Additionally, approximately $20.0 million of expense was recognized as the fair value of warrants issued to Ascendant pursuant to the license agreement, with a corresponding credit to shareholders’ equity resulting in no net impact on stockholders’ equity.

General and administrative expenses were $46.6 million for the three months ended June 30, 2026, compared to $3.7 million in 2025. The increase was primarily attributable to one-time expenses incurred in connection with the Company’s strategic transformation, including approximately $23.0 million related to integration with a newly assembled, complementary management team and transaction-related costs, as well as approximately $19.7 million of non-cash stock-based compensation expense recognized during the quarter.

Other income and expense for the three months ended June 30, 2026, primarily comprised a net non-cash loss of $63.1 million related to the license agreement with Ascendant. As a result, a loss on issuance of liability-classified warrants was recognized, partially offset by a gain on the fair value measurement of warrants issued.

Net loss for the three months ended June 30, 2026 was $153.1 million, compared to $8.5 million in 2025. The increase was primarily due to one-time non-cash losses accounted for in other income, and one-time expenses related to the license agreement.

As of June 30, 2026, the Company had $17.4 million in cash and cash equivalents after incurring one-time cash outflows related to the license agreement. Subsequent to June 30, 2026, the Company completed a $50 million private placement financing.

(Press release, Cue Biopharma, AUG 14, 2026, View Source [SID1234670123])

On August 14, 2026 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines targeting cancer, autoimmune, and inflammatory diseases, reported financial results for the three months ended June 30, 2026 and provided a corporate update.

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"We are delighted to have the opportunity to present new clinical data at oral sessions at two major upcoming medical conferences for our most advanced pipeline candidates, MDNA11 and bizaxofusp," said Fahar Merchant, Ph.D., President and CEO of Medicenna. "During the first quarter, we continued to execute against the milestones we outlined earlier this year, and our key programs remain on track. Completion of enrolment in ABILITY-1 is expected this quarter, with updated MDNA11 clinical results to be provided during an oral presentation at an upcoming conference and to explore with regulators on a potential expedited registrational development path. We also look forward to presenting new clinical data on bizaxofusp in an oral session at an upcoming conference. While NEO-CYT continues to enrol at multiple centres in Italy, we continue to advance MDNA113 to support an IND submission with plans to commence a first-in-human study in 2027. We look forward to a data-rich period during the remainder of this year."

Program highlights for the three months ended June 30, 2026, along with recent developments, include:

MDNA11: IL-2 Superkine Program

Previously reported results from the Phase 1/2 ABILITY-1 study showed deep and durable anti-tumor activity in difficult-to-treat solid tumors, including response rates in the 30-40% range in second- and third-line settings or as the next line of therapy following resistance to checkpoint inhibitors
Enrolment in the monotherapy and combination expansion cohorts of ABILITY-1 remains on track for completion in Q3 2026
Medicenna plans to present updated MDNA11 clinical results in an oral presentation at an upcoming medical conference and to engage the FDA in an end-of-Phase 1 meeting to explore with regulators the potential for expedited registrational development path
The randomized Phase 1b NEO-CYT study continues to enrol patients with melanoma and is evaluating MDNA11 prior to surgery with preliminary clinical data expected in Q4 2026
MDNA113: First-in-Class Anti-PD-1-IL-2 Bifunctional Superkine

Anti-PD-1-IL-2 bispecifics have emerged as a promising class of immuno-oncology therapies due to cis-binding synergies
At the 2026 AACR (Free AACR Whitepaper) Annual Meeting, the Company presented preclinical data highlighting the differentiated potential of MDNA113, its IL-13Rα2-targeted anti-PD-1-IL-2 bifunctional Superkine designed for tumor targeting and activation within the tumor microenvironment
The AACR (Free AACR Whitepaper) presentation showed that MDNA113 could be administered at dose levels consistent with or exceeding standard-of-care commercial anti-PD-1 therapies, including doses up to 50 mg/kg in non-human primates
The data also demonstrated differentiated safety and dosing capabilities compared with a competing anti-PD-1-IL-2α-biased design
Planning is underway for an IND submission and commencing a Phase 1 clinical trial in 2027
Bizaxofusp (formerly MDNA55): Empowered IL-4 Superkine Program

The Company continues to pursue partnership opportunities for bizaxofusp, its Phase 3-ready IL-4 Empowered Superkine for recurrent glioblastoma (rGBM). Bizaxofusp has been evaluated in 118 patients with high-grade gliomas, including 112 patients with rGBM, and has received Fast Track designation from the FDA and Orphan Drug designations from the FDA and EMA.

Updated bizaxofusp data will be presented in an oral presentation at an upcoming medical conference
Quarterly Financial Results

Medicenna ended the first quarter ended June 30, 2026 with cash and cash equivalents of $5.7 million, compared with $6.3 million as at March 31, 2026. During the quarter, the Company received $4.4 million in gross proceeds from the previously announced public offering. Subsequent to the quarter end, the Company also received $1.3 million from the Australian R&D incentive program. As previously disclosed, the Company has also entered into a term sheet in respect of a structured financing arrangement with Sorbie Bornholm LP and Sorbie Investments LLP ("Sorbie") pursuant to which the Company may ultimately receive more or less than $8.0 million (the "Sorbie Transaction"), subject to certain terms and conditions. The completion of the Sorbie Transaction and the execution of the required documentation are each subject to the satisfaction of customary closing conditions, including the receipt of all necessary regulatory and stock exchange approvals. The proceeds from these financings, together with cash on hand, are expected, if completed as contemplated, to provide the Company with sufficient capital to execute its current planned expenditures into the second quarter of the 2027 calendar year.

For the three months ended June 30, 2026, the Company reported total operating costs of $5.4 million, compared with total operating costs of $5.5 million for the three months ended June 30, 2025. The relatively stable operating costs reflect similar levels of operating activity during the two periods.

Net loss for the three months ended June 30, 2026, was $5.1 million ($0.06 loss per share), compared to a net loss of $4.9 million ($0.06 loss per share) for the three months ended June 30, 2025. The slight increase in net loss during the current period relative to the three months ended June 30, 2025 was primarily due to $0.2 million decrease in finance income and a $0.8 million reduction in the fair value gain recognized on the derivative warrant liability, partially offset by a $0.8 million decrease in foreign exchange losses.

Research and development expenses of $4.3 million were incurred during the three months ended June 30, 2026, compared with $4.2 million incurred during the three months ended June 30, 2025. The relatively stable R&D expenses reflect similar levels of operating activity during the two periods.

General and administrative expenses of $1.2 million were incurred during the three months ended June 30, 2026, compared with $1.3 million during the three months ended June 30, 2025. The slight decrease in G&A expense over the comparable quarter is primarily attributable to a decrease in public company expenses due to a reduced level of legal expenses in the current period relative to the comparable quarter.

Medicenna’s financial statements for the three months ended June 30, 2026 and the related management’s discussion and analysis (MD&A) will be made available under Medicenna’s issuer profile on SEDAR+ at www.sedarplus.ca.

(Press release, Medicenna Therapeutics, AUG 14, 2026, View Source [SID1234670149])

On August 14, 2026 Cerenome, Inc. (Nasdaq: CNSY) ("Cerenome" or the "Company"), a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted therapeutics, and artificial intelligence, reported financial results for the second quarter ended June 30, 2026, and provided an overview of recent and upcoming business highlights.

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"Our team made substantial progress this quarter in advancing our integrated CNS oncology platform including a full repositioning and rebranding of the Company," said Marc H. Hedrick, M.D., M.B.A., Cerenome President and Chief Executive Officer. "For the remainder of the year, I expect the progress to accelerate across all verticals, highlighted by our buildout of the diagnostic commercial organization."

Q2 2026 AND RECENT HIGHLIGHTS

Corporate

•
Rebranded from Plus Therapeutics, Inc. to Cerenome, Inc., effective August 3, 2026, with the Company’s common stock trading on the Nasdaq Capital Market under the ticker symbol "CNSY"

REYOBIQ Development

•
Continued enrollment in the ReSPECT-LM multiple-dose clinical trial. As of June 30, 2026, approximately one-third of patients had been enrolled, with no dose-limiting toxicities observed to date, supporting the development of a recommended Phase 2 dose/dosing regimen by year-end
•
Continued enrollment in the ReSPECT-GBM Phase 2 trial. Current enrollment rates indicate full enrollment in 2026 followed by a data readout and a subsequent End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA)
•
Initial site activation of the ReSPECT-PBC pediatric brain cancer Phase 1 trial at Lurie Children’s Hospital. First dosing expected in the third quarter of 2026.
•
Continued commercial-level manufacturing scale-up and supply chain enhancement for REYOBIQ drug supply

CNSide CSF Assay Platform

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Performed 232 CNSide cerebrospinal fluid tests during the first half of 2026 and continued to grow the number of ordering providers and institutions
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Achieved the 2026 corporate objective for contracted commercial payer coverage of 150 million covered lives by mid-year
•
Received Medicare Provider Transaction Access Number and dedicated American Medical Association billing identifier for CNSide
•
Partnered with Genomic Testing Cooperative to integrate next-generation sequencing into the CNSide platform
•
Achieved College of American Pathology or CAP accreditation, the gold standard in laboratory quality assurance, for Cerenome’s CLIA laboratory in Houston, TX
•
Partnered with Xifin, Inc., the market leader in artificial intelligence enabled revenue cycle management for diagnostic providers, to serve as our billing and clearinghouse partner

Data & Artificial Intelligence

•
Partnered with Ephemeral Technologies to develop native artificial intelligence, a corporate operating system and data infrastructure designed to integrate therapeutic, diagnostic and bioinformatic data sets and to facilitate advanced data analytics and machine learning across Cerenome’s CNS oncology platform

SECOND QUARTER 2026 FINANCIAL RESULTS

•
Cash, cash equivalents and investments were $8.6 million as of June 30, 2026 and December 31, 2025.

•
Recognized $0.4 million in grant revenue from CPRIT for the advancement of REYOBIQ in LM in the second quarter of 2026, compared with $1.4 million in grant revenue from CPRIT for the same program in the second quarter of 2025
•
Operating loss for the second quarter of 2026 was $9.1 million, compared with an operating loss of $1.5 million for the second quarter of 2025. The change primarily reflects expansion of CNSide commercial operations and continued funding of the REYOBIQ Phase 2 trial
•
Net loss for the second quarter of 2026 was $9.0 million, or $1.31 per basic share, compared with net income of $5.2 million, or $0.62 per basic share, for the second quarter of 2025, which included a $6.5 million change in fair value of derivative instruments

AFFIRMED ANTICIPATED MILESTONES AND OUTLOOK FOR 2026

The Company is affirming the milestone framework and outlook it provided when reporting full-year 2026 financial results, as follows:

REYOBIQ Clinical Program

•
Define the optimal dose/dosing interval for REYOBIQ in Leptomeningeal Metastases
•
Complete enrollment in the ReSPECT-GBM Phase 2 trial for glioblastoma; data is expected in Q1 2027, followed by an End-of-Phase 2 meeting with the FDA
•
Begin enrollment in the ReSPECT-PBC pediatric brain cancer Phase 1 trial
•
Complete commercial manufacturing scale-up for REYOBIQ

CNSide Commercial Rollout

•
Expand U.S. commercial payer coverage beyond 150 million covered lives
•
Secure Medicare coverage and reimbursement
•
Achieve an annualized run-rate of test orders exceeding 1,250
•
Expand the CNSide assay platform to include a comprehensive portfolio of clinically relevant test for patients at risk for CNS cancers

About Leptomeningeal metastases (LM)

Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)

REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high-dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off-target risks and improve outcomes for CNS cancer patients versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials, respectively. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Cerenome, AUG 14, 2026, View Source [SID1234670124])