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])

On August 14, 2026 PMV Pharmaceuticals, Inc. ("PMV Pharma" or the "Company"; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.

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"The PYNNACLE clinical trial continues to progress remarkably well, thanks to the dedication and outstanding execution of the clinical investigators, their teams, and ours," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "We anticipate submitting an NDA for accelerated approval of rezatapopt for platinum-resistant/refractory ovarian cancer in the first quarter of 2027."

PYNNACLE Phase 2 Monotherapy Update:

Enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE clinical trial has been completed. The multicenter, single arm, registrational Phase 2 study is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C advanced solid tumors. PMV Pharma anticipates submitting an NDA for accelerated approval of rezatapopt as a treatment for platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation in the first quarter of 2027.

Second Quarter 2026 Financial Results

PMV Pharma ended the second quarter with $79.4 million in cash, cash equivalents, and marketable securities, compared to $112.9 million as of December 31, 2025. Net cash used in operations was $34.3 million for the six months ended June 30, 2026, compared to $36.6 million for the six months ended June 30, 2025.

Net loss for the quarter ended June 30, 2026, was $18.1 million compared to $21.2 million for the quarter ended June 30, 2025. The net loss decrease was primarily due to decreased contract research organization costs and reduced finance support costs.
R&D expenses were $14.7 million for the quarter ended June 30, 2026, compared to $18.4 million for the quarter ended June 30, 2025. The decrease in R&D expenses was primarily due to decreased contract research organization costs for the advancement of the rezatapopt program.
General and administrative (G&A) expenses were $4.2 million for the quarter ended June 30, 2026, compared to $4.5 million for the quarter ended June 30, 2025. The decrease in G&A expenses was primarily due to reduced personnel expenses and a decrease in finance support costs.
About Rezatapopt

Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation and Orphan Drug Designation for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

About the PYNNACLE Clinical Trial

The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the clinical trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C advanced solid tumors, conducted across approximately 70 sites.

For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).

(Press release, PMV Pharma, AUG 14, 2026, View Source [SID1234670147])

On August 14, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported financial results for the three-month and six-month periods ended June 30, 2026, and provided a business update.

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Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented: "The second quarter of 2026 and the period since that time have represented the most consequential stretch in Silexion’s history, as we have transitioned SIL204 from a preclinical and regulatory-preparation asset into an active Phase 2/3 clinical program. With clinical trial authorization from Germany’s BfArM added to the previously received approval from the Israeli Ministry of Health, and the successful initiation of our first clinical site at Tel Aviv Sourasky Medical Center at the end of July, our focus has shifted entirely to clinical execution. In parallel, we continued to expand the scientific profile of SIL204 with new immuno-oncology data supporting a coordinated immune-sensitization signature across four KRAS mutations, reinforcing the rationale for future combination with anti-PD-(L)1 checkpoint inhibitors. We believe this combination of clinical, regulatory, manufacturing, and translational progress positions Silexion at the beginning of what should be a defining stretch for the Company."

Mirit Horenshtein Hadar, Chief Financial Officer of Silexion, added: "During the second quarter and subsequent to quarter end, we successfully executed a series of financing transactions. Most recently, we closed a public offering with gross proceeds of approximately $2.5 million. All of those transactions were designed to strengthen our balance sheet and support the transition of SIL204 into its recently initiated Phase 2/3 Clinical Trial, bringing new hope to the patients who need it most, alongside supporting compliance with applicable Nasdaq continued listing requirements."

Recent Milestones & Business Highlights

Phase 2/3 Clinical Program Advanced Across Israel and Germany, and Successfully Initiated at Tel Aviv Sourasky Medical Center: During the second quarter and subsequent to quarter end, Silexion advanced SIL204 into active Phase 2/3 clinical evaluation in locally advanced pancreatic cancer. In April 2026, the Company submitted its Clinical Trial Application to Germany’s Federal Institute for Drugs and Medical Devices (BfArM) through the EU Clinical Trials Information System, with Germany serving as Reference Member State for the European program. In June 2026, the Company received CTA approval from BfArM, accompanied by a positive opinion from the Ethics Committee of the North Rhine Medical Association, adding Germany to the previously received approval from the Israeli Ministry of Health. In May 2026, the Company initiated GMP clinical supply manufacturing of SIL204 with a leading global contract development and manufacturing organization (CDMO), further supporting the operational readiness of the program. On July 29, 2026, subsequent to quarter end, Silexion successfully initiated the Phase 2/3 clinical trial at Tel Aviv Sourasky Medical Center ("TASMC" or "Ichilov"), one of Israel’s largest and most prominent academic medical centers, clearing the site to commence patient screening, with first patient dosing anticipated to follow. Additional Israeli and German trial sites are progressing through activation and are expected to join the program in the coming months.

Expanded Immuno-Oncology Profile for SIL204 – Coordinated Immune-Sensitization Signature Across Three Pathways and Four KRAS Mutations: During and subsequent to the second quarter, Silexion reported preclinical findings that extended SIL204’s therapeutic profile beyond direct anti-tumor activity into immune sensitization. In May 2026, the Company reported statistically significant upregulation of MHC-I following SIL204 treatment in human KRAS-mutant pancreatic and non-small cell lung cancer cells, supporting potential future evaluation alongside anti-PD-1 therapies including pembrolizumab (Keytruda). In August 2026, the Company reported additional statistically significant upregulation of FAS (CD95), the immune "death receptor," and downregulation of HLA-G, an established immune checkpoint, across three distinct KRAS mutations in pancreatic and non-small cell lung cancer cell lines. Taken together, these findings support a coordinated immune-sensitization signature across three key immune pathways — increased antigen presentation, restored susceptibility to immune-mediated apoptosis, and reduced immune checkpoint activity — observed across four KRAS mutations (G12D, G12V, G12C, and G12R), reinforcing the scientific rationale for combining SIL204 with anti-PD-(L)1 checkpoint inhibitor therapies.

Capital-Structure Actions to Support Clinical Execution and Continued Nasdaq Listing: During the second quarter and subsequent to quarter end, Silexion executed a series of financing transactions in support of the Phase 2/3 clinical program and support compliance with applicable Nasdaq continued listing requirements, including a May 2026 warrant exercise inducement transaction, ongoing sales of ordinary shares under the Company’s at-the-market facility, further partial conversions of principal under its related party promissory note, shareholder-approved successive increases in authorized share capital, and a 1-for-10 reverse share split effected on May 28, 2026. Most recently, on August 13, 2026, the Company closed a registered public offering with aggregate gross proceeds of approximately $2.5 million and net proceeds of approximately $2.1 million.

Financial Results for the Three Months Ended June 30, 2026

Research and development ("R&D") expenses for the three months ended June 30, 2026, were approximately $2.2 million, compared to approximately $1.0 million for the three months ended June 30, 2025, an increase of 120.0%. The increase resulted mainly from an increase in subcontractors’ and consultants’ expenses related to the operational ramp-up and preparations, required to support the initiation of our Phase 2/3 human clinical trial, which was initiated in July 2026.

General and administrative ("G&A") expenses for the three months ended June 30, 2026, were approximately $1.5 million, compared to approximately $1.3 million for the three months ended June 30, 2025, an increase of 15.4%. The increase resulted mainly from an increase in professional services costs, primarily related to consultants and other expenses associated with the costs of operating as a public company.

Financial expenses (income), net for the three months ended June 30, 2026, were approximately $(0.1) million of financial income, net, compared to approximately $0.2 million of financial expenses, net, for the three months ended June 30, 2025. The change was mainly due to the revaluation of the related party promissory note.

Net loss for the three months ended June 30, 2026, was approximately $3.6 million, compared to approximately $2.5 million for the three months ended June 30, 2025, an increase of 44.0%. The increase was mainly due to higher research and development expenses related to preparations for the human clinical trial initiated in July 2026, and higher general and administrative expenses, partly offset by a decrease in financial expenses, net, due to the revaluation of financial instruments.

Financial Results for the Six Months Ended June 30, 2026

R&D expenses for the six months ended June 30, 2026, were approximately $3.6 million, compared to approximately $1.6 million for the six months ended June 30, 2025, an increase of 125.0%. The increase was primarily attributable to higher subcontractors’ and consultants’ expenses related to the operational ramp-up and preparations, required to support the initiation of the Company’s Phase 2/3 human clinical trial, which was initiated in July 2026.

G&A expenses for the six months ended June 30, 2026, were approximately $2.8 million, compared to approximately $2.3 million for the six months ended June 30, 2025, an increase of 21.7%. The increase resulted mainly from an increase in professional services costs, primarily related to legal, consultants, and other expenses associated with the costs of operating as a public company.

Financial expenses (income), net for the six months ended June 30, 2026, were approximately $(0.1) million of financial income, compared to approximately $0.3 million of financial expenses for the six months ended June 30, 2025. The decrease was mainly due to the revaluation of the related party promissory note.

Net loss for the six months ended June 30, 2026, was approximately $6.3 million, compared to approximately $4.2 million for the six months ended June 30, 2025, an increase of 50.0%. The increase was mainly due to higher research and development expenses (mainly related to preparations for the human clinical trial, initiated in July 2026) and higher general and administrative expenses, partly offset by a decrease in financial expenses, net, due to the revaluation of financial instruments.

Balance Sheet

As of June 30, 2026, the Company had cash and cash equivalents of approximately $2.2 million, compared to approximately $6.0 million as of December 31, 2025.
During the second quarter and subsequent to quarter end, the Company strengthened its capital position through a series of financing transactions, most recently the closing on August 13, 2026, of a public offering yielding aggregate gross proceeds of approximately $2.5 million. As a result of these transactions and those detailed in the Company’s Quarterly Report on Form 10-Q, the Company estimates that its shareholders’ equity, as of June 30, 2026 (as adjusted to reflect the foregoing transactions to date), is currently approximately $3.2 million, which exceeds the Nasdaq Capital Market’s $2.5 million minimum shareholders’ equity requirement for continued listing. Accordingly, the Company believes that it has restored compliance with the applicable shareholders’ equity requirement.

(Press release, Silexion Therapeutics, AUG 14, 2026, View Source [SID1234670146])

On August 14, 2026 LeonaBio, Inc. (NASDAQ: LONA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, reported financial results for the quarter ended June 30, 2026, and provided recent pipeline and business updates.

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"We enter the second half of 2026 with a clear focus on executing our Phase 3 ELAINE-3 trial and advancing lasofoxifene toward what we believe could be a transformative treatment option for patients with ESR1-mutated metastatic breast cancer," said Mark Litton, Ph.D., President and Chief Executive Officer of LeonaBio. "We have enrolled 495 patients and remain on track to complete enrollment of ELAINE-3 in the fourth quarter of 2026 with topline data expected in the second half of 2027. As the treatment landscape for metastatic breast cancer continues to evolve, we believe the differentiated profile of lasofoxifene positions it to address a significant unmet need as a potential endocrine therapy partner and create opportunities beyond ELAINE-3, including additional combination strategies and future label expansions. The body of clinical and scientific evidence behind lasofoxifene supports our confidence in its potential to greatly benefit patients battling this difficult-to-treat form of breast cancer."

"As we approach the completion of enrollment in this Phase 3 registrational trial, we are investing today in critical CMC, regulatory, and commercial readiness activities to ensure we are well-positioned to bring this therapy to patients as quickly as possible, if approved. With our talented team and the potential to add up to an additional $146 million upon exercise of cash-exercisable warrants issued in our December 2025 financing, we believe LeonaBio is well-positioned to deliver on multiple value-creating milestones in the years ahead," added Dr. Litton.

Clinical Development & Pipeline Programs

Lasofoxifene – A third generation novel, nonsteroidal selective estrogen receptor modulator (SERM) with a unique binding profile, designed to confer potent activity against both wild-type and mutant estrogen receptors, including the clinically significant ESR1 mutations commonly associated with resistance to endocrine therapy in metastatic breast cancer.

In December 2025, LeonaBio acquired an exclusive global license (excluding Asia and certain countries in the Middle East) from Sermonix Pharmaceuticals, Inc. for rights to develop and commercialize lasofoxifene.

Lasofoxifene is being advanced in ELAINE-3, a Phase 3 clinical trial (NCT05696626), in combination with abemaciclib, a CDK4/6 inhibitor, as a targeted therapy for estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer, following progression on aromatase inhibitors and CDK4/6 inhibitors. The primary endpoint of the study is a statistically significant improvement in progression free survival (PFS), as determined by blinded, independent central review (BICR). ELAINE-3 aims to establish a new standard of care for this genetically defined patient group with limited treatment options.
The Company expects to complete enrollment of ~600 participants in the Phase 3 ELAINE-3 clinical trial in the fourth quarter of 2026 and to have topline data in the second half of 2027.
Lasofoxifene was previously evaluated in two Phase 2 studies in patients with ER+, HER2-negative locally advanced or metastatic breast cancer expressing an ESR1 mutation, ELAINE-1 and ELAINE-2.
ELAINE-1, an open-label, randomized trial comparing lasofoxifene to fulvestrant, showed improved outcomes for lasofoxifene as a potential monotherapy. Although the trial was not powered, results included longer median progression-free survival (5.6 vs. 3.7 months), higher objective response rates (13.3% vs. 2.9%) and a durable complete response lasting more than 2.5 years. The treatment was well-tolerated with patients reporting quality-of-life benefits.
ELAINE-2, an open-label study evaluating lasofoxifene in combination with abemaciclib, demonstrated clinical benefits in heavily pretreated patients, with a median progression-free survival of approximately 13 months, an objective response rate of 56% and a clinical benefit rate of 65.5%. The combination was generally well-tolerated with most adverse events being low grade.
In April 2026, LeonaBio hosted a virtual Key Opinion Leader event with two leading physicians in the breast cancer field to discuss the current and evolving treatment landscape in metastatic breast cancer and the potential for lasofoxifene to transform the standard of care for patients with treatment-resistant ER+, HER2-negative, ESR1-mutated metastatic breast cancer.
The event titled, "Modulation and Combination: the Potential for Lasofoxifene to Transform the Standard-of-Care in Metastatic Breast Cancer," featured a discussion with David Portman, M.D., Chief Executive Officer of Sermonix Pharmaceuticals and an oncology consultant to LeonaBio, along with two physician experts in the breast cancer field. A replay of the event is available on the LeonaBio website under "Events & Presentations" in the "Investor Relations" section here.

Brelgometon (ATH-1105) – A novel, orally available, brain-penetrant, next-generation small molecule drug candidate designed to positively modulate the neurotrophic HGF system for potential treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and Parkinson’s disease. Brelgometon is currently in clinical development for the potential treatment of ALS.

LeonaBio’s first-in-human Phase 1 double-blind, placebo-controlled clinical trial (NCT06432647) enrolled 80 healthy volunteers to evaluate single and multiple oral ascending doses of brelgometon, demonstrating a favorable safety and tolerability profile as well as dose-proportional pharmacokinetics and CNS penetration and supporting its advancement into a Phase 2 proof-of-concept trial.
The Company expects to provide an update on the timing of a proposed Phase 2 proof-of-concept clinical trial following completion of enrollment of the Phase 3 ELAINE-3 clinical trial as it continues to focus on its lasofoxifene program.

Corporate Updates

LeonaBio announced the appointment of Fred Callori, J.D., Natalie Holles and Peter B. Silverman, J.D. to its Board of Directors, effective as of May 5, 2026. The company also announced that John Fluke, Jr., who served on the Board since 2014, retired effective May 4, 2026.

Fred Callori, J.D., has served as a Partner and Managing Director at Perceptive Advisors LLC, an investment firm that specializes in investing in biotechnology stocks, since January 2018.
Natalie Holles has served as the Chief Executive Officer and member of the Board of Directors of Aura Biosciences, a clinical-stage biotechnology company, since April 2026. Ms. Holles served as the Chief Executive Officer of Third Harmonic Bio, a biopharmaceutical company, from August 2021 to December 2025.
Peter B. Silverman, J.D., served as Chief Operating Officer of Merus N.V. (formerly, Nasdaq: MRUS), a biotechnology company, from January 2023 until its acquisition by Genmab A/S in December 2025, and prior to that, Mr. Silverman held several leadership roles at Merus. Mr. Silverman has served as a member of the board of directors of Kinaset Therapeutics, a biopharmaceutical company, since January 2026.

Financial Results

Cash Position. Cash, cash equivalents and investments were $51.1 million as of June 30, 2026, compared to $88.3 million as of December 31, 2025. Net cash used in operations was $37.9 million for the quarter ended June 30, 2026, compared to $21.7 million for the quarter ended June 30, 2025. In conjunction with the December 2025 Sermonix license agreement, LeonaBio announced a $90 million private placement financing of common stock and warrants, with the Series A warrants providing, if exercised in full, up to an additional $146 million to support development through key clinical and regulatory milestones.
Research and Development (R&D) Expenses. R&D expenses were $12.9 million for the quarter ended June 30, 2026, compared to $3.7 million for the quarter ended June 30, 2025. The increase was driven primarily by clinical trial spend related to the ELAINE-3 trial for lasofoxifene.
General and Administrative (G&A) Expenses. G&A expenses were $6.6 million for the quarter ended June 30, 2026, compared to $3.6 million for the quarter ended June 30, 2025. The increase was driven primarily by personnel-related expenses, including stock-based compensation and professional service fees.
Net Loss. Net loss was $19.0 million, or $0.80 per share, for the quarter ended June 30, 2026, compared to a net loss of $7.0 million, or $1.78 per share, for the quarter ended June 30, 2025.

(Press release, LeonaBio, AUG 14, 2026, View Source [SID1234670145])