Adlai Nortye Ltd. Reports Unaudited First Half 2026 Financial Results and Highlights Recent Operational Progress

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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])

Medicenna Therapeutics Reports First Quarter Fiscal 2027 Financial Results and Announces Oral Presentations at Upcoming Conferences

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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])

GT Biopharma Reports Second Quarter 2026 Financial Results

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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])

PMV Pharmaceuticals Reports Second Quarter 2026 Financial Results and Corporate Highlights

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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])

Silexion Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])