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 Tvardi Therapeutics, Inc. ("Tvardi" or the "Company") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases, reported its financial and operating results for the second quarter ended June 30, 2026, and provided a business update.

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Recent Developments

Reported topline results from the healthy volunteer study of its next-generation STAT3 inhibitor, TTI-109, confirming prodrug design, improved tolerability and pharmacodynamic evidence of STAT3 target engagement.
TTI-109 delivered TTI-101-equivalent exposure with improved tolerability and, across the active dose range, reductions in cellular and humoral immune populations known to correlate with UC disease severity.
Selected UC as the initial disease indication for TTI-109, based on its ability to modulate multiple pathogenic pathways downstream of STAT3 simultaneously.
In UC, STAT3 acts as a single convergent node downstream of multiple signaling pathways implicated in disease progression, integrating immune dysregulation, inflammation and tissue remodeling.
These findings are further supported by published clinical studies linking reductions in activated STAT3 with higher rates of clinical remission across multiple UC therapeutic classes.
UC represents a large, underserved market, with more than 1.25 million patients diagnosed in the U.S. and an addressable market of approximately $3 billion in the U.S. and $9 billion globally.
Announced that the Company will host a KOL webinar on the clinical potential of TTI-109 in UC featuring Randy Longman, MD, PhD (Weill Cornell Medicine) on August 19, 2026, at 11:00 a.m. ET.
Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, "Since our last quarterly report, we have made significant progress in the clinical development of our STAT3 inhibitors. Regarding our next-generation STAT3 inhibitor, TTI-109, we were enthusiastic to see modulation of disease-relevant immune cell population even in healthy volunteers. We believe this bodes well for the development of TTI-109 in inflammatory and proliferative diseases, like UC."

Key Upcoming Milestones

August 19, 2026: KOL webinar with Randy Longman, M.D., Ph.D., on the UC treatment landscape and TTI-109. To register, please click here
4Q 2026: TTI-101 Phase 1b/2 HCC topline data
2027: Initiation of clinical trial of TTI-109 in UC, subject to clearance of Investigational New Drug (IND) application and additional funding
Second Quarter 2026 Financial Results

Research and development expenses for the three months ended June 30, 2026, were $4.0 million as compared to $5.8 million for the comparable period in 2025. The decrease was primarily driven by lower clinical costs associated with TTI-101, partially offset by higher development costs associated with TTI-109.

General and administrative expenses were $2.6 million for the three months ended June 30, 2026, as compared to $3.1 million for the three months ended June 30, 2025. The decrease was primarily driven by lower professional fees, reflecting higher accounting and consulting costs in the comparable 2025 period associated with the Company’s April 2025 merger, partially offset by higher legal and investor relations costs associated with operating as a public company.

Net loss for the three months ended June 30, 2026, was $6.5 million, compared to net income of $4.2 million for the three months ended June 30, 2025. Net income in the prior-year period reflected a $12.7 million non-cash gain from the change in fair value of the Company’s convertible notes, which converted into common stock in connection with the Company’s merger with Cara Therapeutics in April 2025.

Basic and diluted net loss per share attributable to common shareholders for the three months ended June 30, 2026, were both $(0.69). Basic net income per share attributable to common shareholders for the three months ended June 30, 2025 was $0.51, and diluted net loss per share for the same period was $(1.00), reflecting the dilutive impact of the Company’s convertible notes prior to their conversion into common stock in April 2025.

Cash, cash equivalents and short-term investments as of June 30, 2026, were $15.8 million, as compared to $30.8 million as of December 31, 2025. Tvardi anticipates that its existing cash, cash equivalents and short-term investments will be sufficient to fund operations, as currently planned, through the HCC topline readout into the third quarter of 2027. Advancing TTI-109 into UC and additional indications will require additional funding and IND clearance.

(Press release, Tvardi Therapeutics, AUG 14, 2026, View Source [SID1234670151])

On August 14, 2026 Adlai Nortye Ltd. (NASDAQ: ANL) (the "Company" or "Adlai Nortye"), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, reported its business highlights and its first half financial results for the period ended June 30, 2026.

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"We continue to execute well across our pipeline, with initial clinical data on track for both of our pan-RAS(ON) inhibitor-based assets in 2027," said Yang Lu, CEO and Chairman of Adlai Nortye. "In alignment with our goal of rapidly bringing a solution to cancer patients in the U.S. and globally, we are advancing our globalization strategy by expanding our clinical development, strategic, and operational capabilities in the United States and Singapore. This expansion will help to accelerate our clinical pipeline progress and strengthen our clinical operations to support our RAS program development. We believe these efforts will support the efficient global development of our pipeline and position the Company for long-term growth."

Research & Development (R&D) Highlights

AN9025

AN9025, an oral small molecule pan-RAS(ON) inhibitor with best-in-class potential, continues to be evaluated in a global Phase I clinical trial of patients with advanced or metastatic solid tumors harboring RAS mutations.

In February 2026, the first patient was dosed in the once-daily (QD) arm in the U.S.

In July 2026, the first patient was dosed in the intermittent once-weekly (QW) arm in the U.S.

Both the QD and QW dosing arms are enrolling concurrently in the U.S. and China.

Additional clinical trial sites in the U.S. will be activated in second half of 2026, in preparation for expansion cohorts.

The Company remains on track to share initial Phase Ia dose escalation data in the first half of 2027 from the QD arm, with a potential early look at the QW arm.
AN4035

AN4035 is a first-in-class RAS-inhibitor antibody drug conjugate (ADC) targeting CEACAM5, with a highly potent pan-RAS(ON) inhibitor payload.

In July 2026, the Company received Human Research Ethics Committee (HREC) approval in Australia for the Phase I clinical trial of AN4035 as monotherapy and in combination with cetuximab, in patients with CEACAM5-enriched, RAS-addicted solid tumors.

Investigational New Drug (IND) submissions to the U.S. FDA and China NMPA are expected to follow.

The Company is on track to dose the first patient with AN4035 in the second half of 2026, and initial clinical data is expected to be available in the second half of 2027.
AN8025

AN8025 is a next-generation tri-specific antibody fusion protein derived from an approved αPD-L1 antibody and fused with functionally optimized CD86 variant and LAG3 variant.

The global Phase I clinical study of AN8025 is currently ongoing in Australia and China.

The Company remains on track to complete dose escalation by the end of 2026.
AN0025

AN0025 is a small molecule EP4 antagonist designed to modulate the tumor microenvironment.

The randomized Phase II ARTEMIS (Augmenting RadioTherapy in REctal Cancer to Minimise Invasive Surgery) study of preoperative AN0025 and chemoradiotherapy combination in rectal cancer has completed enrollment and patient follow-up is ongoing.

The futility analysis of this Phase II study was successfully passed in March 2026, and the topline results are expected in the first half of 2027.
AN4005

AN4005 is an orally available, small-molecule PD-L1 inhibitor that demonstrates antitumor activity by the blockade of PD-1/PD-L1 interaction.

Despite encouraging preliminary results of favorable safety and tolerability in patients with advanced tumors, and preliminary efficacy in a tumor type known to respond to anti-PD-(L)1 therapy, moving forward as part of our strategic pipeline prioritization, we will de-prioritize the development of AN4005 as a monotherapy and remain open for collaboration to explore its potential as a combination partner.

A clinical update from the ongoing expansion cohorts is expected to be presented at the 2026 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting.
Corporate Highlights

In February 2026, the Company completed an oversubscribed private placement equity financing, raising $140 million, before deducting placement agent fees and other private placement expenses.

In April 2026, the Company completed an oversubscribed private placement equity financing, raising $150 million, before deducting placement agent fees and other expenses.

The Company recently expanded its Scientific Advisory Board with the appointment of two leading medical oncologists, Dr. David Hong of MD Anderson Cancer Center, and Dr. Piro Lito of Memorial Sloan Kettering Cancer Center.
Key Upcoming Milestones

AN9025: Initial Phase Ia clinical data from the QD arm, and possible early look at QW arm, are expected in 1H27

AN4035: Dosing of first patient in global Phase I trial is expected in 2H26, with initial clinical data in 2H27

AN8025: Phase I dose escalation completion expected by YE 2026
First Half Unaudited Financial Results

The consolidated financial statements of the Company are prepared in accordance with IFRS as issued by the International Accounting Standards Board (IASB). The consolidated financial statements are presented in US dollars, the Company’s functional and presentation currency.

As of June 30, 2026, cash and cash equivalents, together with short-term investments at amortized cost, amounted to US$231.9 million, compared with US$8.1 million as of December 31, 2025.

Net cash used in operating activities was US$15.4 million for the six months ended June 30, 2026, compared with US$15.1 million for the six months ended June 30, 2025.

Revenue increased to US$13.1 million for the six months ended June 30, 2026, from nil for the six months ended June 30, 2025, and was entirely attributable to revenue recognized under the Company’s exclusive license agreement with Jiangsu Aosaikang Pharmaceutical Co., Ltd. relating to AN9025, primarily in connection with upfront payments and development milestone achievements.

Research and development expenses decreased by 4% from US$15.2 million for the six months ended June 30, 2025 to US$14.6 million for the six months ended June 30, 2026, primarily due to lower preclinical development costs, as most of the Company’s major research and development programs remained in early-stage development and had not yet advanced into later-stage clinical trials.

General and administrative expenses increased by 43.1% from US$4.1 million for the six months ended June 30, 2025 to US$5.8 million for the six months ended June 30, 2026. The increase was primarily attributable to higher share-based compensation expense associated with the vesting of certain stock options.

Other gains and expenses, net, decreased by 37.1% from US$1.5 million for the six months ended June 30, 2025 to US$0.9 million for the six months ended June 30, 2026, primarily due to a reduction in government grants recognized during the period.

For the reasons described above, the Company’s net loss decreased by 70.9% to US$5.3 million for the six months ended June 30, 2026, from US$18.3 million for the six months ended June 30, 2025.

(Press release, Adlai Nortye Biopharma, AUG 14, 2026, View Source [SID1234670150])

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 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])