On August 13, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS and OTC: APTOF), a clinical-stage precision oncology company developing a tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), reported financial results for the second quarter ended June 30, 2025, and provided a corporate update (Press release, Aptose Biosciences, AUG 13, 2025, View Source [SID1234655191]).

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"During the second quarter, the TUSCANY triplet trial continued to progress well. Our investigators are eager to improve outcomes for patients with mutations that are especially difficult to treat in AML, and we continue to observe exciting safety and activity with the addition of TUS to the VEN+AZA standard treatment," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "We look forward to providing updates to the data we presented at EHA (Free EHA Whitepaper) in June."

Key Corporate Highlights

Tuspetinib Data Reported at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress in Oral Presentation – Tuspetinib based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 trial with the goal of creating a one-of-a-kind frontline therapy for newly diagnosed AML patients that is safe and active across diverse AML populations (mutation agnostic triplet frontline therapy), including patients without FLT3 mutations (wildtype FLT3). Data from the first two cohorts, with a 40 mg or 80 mg dose of tuspetinib in the TUS+VEN+AZA combination, reveal promising clinical safety and antileukemic activity and were presented in an oral presentation at EHA (Free EHA Whitepaper) 2025 in June (press release here) by Dr. Gabriel Mannis, Associate Professor of Medicine, Stanford University School of Medicine, and an investigator in the TUSCANY study. Dr. Mannis also noted three patients were rapidly enrolled on the third dose cohort of 120 mg TUS in the TUS+VEN+AZA triplet, and that no DLTs were observed. Among the key findings: Multiple CRs were achieved, at the initial dose of 40 mg (3 of 4 CRs and minimal residual disease (MRD)-negative) and at the 80 mg dose (3 of 3 CR/CRi). Regardless of FLT3, TP53, NPM1, or myelodysplasia related mutation status, TUS demonstrated activity in newly diagnosed AML patients. MRD-negative responses were achieved across diverse genetic populations, including in subjects with biallelic TP53 mutations and complex karyotypes. In addition, TUS can be administered safely with standard-of-care dosing of VEN/AZA, and TUS PK properties are not significantly altered by VEN, AZA, antifungals or food. No prolonged myelosuppression was noted in Cycle 1 in the absence of AML and there were no treatment-related deaths with 9 out of 10 enrolled subjects remaining on study treatment.
TUS Continues to Demonstrate Safety and CRs at 120 mg Dose in the TUSCANY Triplet Trial; 160 mg Dose Cohort Now Open After Dose Escalation Decision by CSRC – The fourth dosing cohort of 160 mg of TUS in the TUS+VEN+AZA TUSCANY trial is now open for enrollment after the CSRC reviewed the current data from the 120 mg TUS dose cohort. All patients treated in the 120 mg dose cohort remain on study while enrollment is open for the 160 mg dose cohort.
Aptose Clinical Data Accepted for Poster Presentation at European School of Haematology (ESH) 7th International Conference – Aptose recently was notified that its abstract "TUSCANY Study of Safety and Efficacy of Tuspetinib plus Standard of Care Venetoclax and Azacitidine in Study Participants with Newly Diagnosed AML Ineligible for Induction Chemotherapy" was accepted for a poster presentation at the ESH 7th International Conference on Acute Myeloid Leukemia "Molecular and Translational": Advances in Biology and Treatment, being held October 16-18, 2025 in Estoril, Portugal.
Aptose and Hanmi Enter Loan Agreement to Advance Development of Tuspetinib in Triplet Therapy for AML – During the quarter, Aptose announced that it entered into a loan agreement with Hanmi Pharmaceutical Co. Ltd. ("Hanmi"). The Loan Agreement is an uncommitted facility for up to US$8.5million, administered through multiple advances for the purpose of continued clinical development of TUS (press release here). To date, Aptose has received an aggregate of US$5.6M under the Loan Agreement.
Aptose Trading on OTCQB Market – On July 1st, Aptose announced that it had been upgraded to list for trading on the OTCQB Market under the ticker symbol "APTOF," in addition to the Company’s continued listing on the Toronto Stock Exchange (TSX) under the symbol "APS." The OTCQB Market is for early stage and developing U.S. and international companies. Companies listed on the OTCQB Market are current in their reporting and undergo an annual verification and management certification process. Investors can find Real-Time quotes and market information for the company on www.otcmarkets.com.
Aptose Selects Ernst & Young as its New Independent Auditor and will Hold a Reconvened Meeting of its Shareholders on August 22, 2025 – Earlier this month, Aptose announced that its Board of Directors unanimously approved the selection of Ernst & Young LLP ("EY") as the Company’s independent registered public accounting firm to serve as the Company’s independent auditor. The Company had adjourned its Annual and Special Meeting of shareholders held on May 27, 2025 (the "Meeting"), for the purposes of completing its search for a successor independent auditor, and will reconvene the Meeting of shareholders on August 22, 2025 at 10:00 a.m. (Eastern Time) (the"Reconvened Meeting") to vote on the appointment of EY. Shareholders are invited to attend the Reconvened Meeting by using the live webcast link here: https://meetings.lumiconnect.com/400-935-182-032. Only registered shareholders and duly appointed proxyholders as of the record date on April 22, 2025, will be entitled to vote and ask questions at the Reconvened Meeting.

Completed and Planned Value-Creating Milestones

2025: 1H

Reported safety and efficacy with 40mg TUS+VEN+AZA
Reported safety and efficacy with 80mg TUS+VEN+AZA

2025: European Hematology Association (EHA) (Free EHA Whitepaper)

Report maturing data from TUS+VEN+AZA triplet study

2025: 2H

Reported safety and efficacy with 120 mg TUS+VEN+AZA
CSRC review of data; decision to dose escalate to 160 mg TUS+VEN+AZA
Report evolving data from 120 mg TUS+VEN+AZA triplet

2025: American Society of Hematology (ASH) (Free ASH Whitepaper)

Report response rate and durability of TUS+VEN+AZA triplet
Select TUS dose for TUS+VEN+HMA triplet Ph 2/3 PIVOTAL trials
Prepare for initiation of Ph 2/3 PIVOTAL program

FINANCIAL RESULTS OF OPERATIONS
Aptose Biosciences Inc.
Statements of Operations Data
(unaudited)
($ in thousands, except for share and per share data)

Three months ended
June 30, Six months ended
June 30,
2025 2024 2025 2024
Expenses:
Research and development $ 3,298 $ 4,413 $ 5,662 $ 10,858
General and administrative 3,623 2,932 6,720 6,247
Operating expenses 6,921 7,345 12,382 17,105
Other (loss) income, net (122 ) 93 (204 ) 213
Net loss $ (7,043 ) $ (7,252 ) $ (12,586 ) $ (16,892 )
Net loss per share, basic and diluted $ (2.76 ) $ (12.99 ) $ (5.38 ) $ (33.91 )
Weighted average number of common shares outstanding used in the calculation of basic and diluted loss per common share 2,552,429 558,476 2,340,535 498,113

Net loss for the quarter ended June 30, 2025 decreased by $0.2 million to $7.0 million, as compared to $7.3 million for the comparable period in 2024. Net loss for the six months ended June 30, 2025 decreased by $4.3 million to $12.6 million, as compared to $16.9 million for the comparable period in 2024.

Aptose Biosciences Inc.
Balance Sheet Data
(unaudited)
($ in thousands)

June 30, December 31,
2025 2024
Cash, cash equivalents and restricted cash equivalents $ 1,298 $ 6,707
Working capital (5,729 ) 5,053
Total assets 5,591 10,127
Long-term liabilities 10,962 10,193
Accumulated deficit (553,553 ) (540,967 )
Shareholders’ deficit (14,371 ) (4,543 )

Total cash, cash equivalents and restricted cash equivalents as of June 30, 2025 were $1.3 million. The Company does not have sufficient cash to fund operations and relies on advances made by Hanmi to fund operations. The Company is actively deploying financing and cost reduction efforts to extend cash runway.
As of August 8, 2025, we had 2,552,429 common shares of the Company ("Common Shares") issued and outstanding. In addition, there were 38,211 Common Shares issuable upon the exercise of outstanding stock options and there were 1,267,585 Common Shares issuable upon the exercise of the outstanding warrants.

RESEARCH AND DEVELOPMENT EXPENSES

Research and development expenses for the three and six months ended June 30, 2025 and 2024 were as follows:

Three months ended Six months ended
June 30, June 30,
(in thousands) 2025 2024 2025 2024

Program costs – Tuspetinib $ 2,233 $ 2,666 $ 3,712 $ 6,589
Program costs – Luxeptinib 100 304 198 512
Program costs – APTO-253 - (9 ) - 13
Personnel related expenses 952 1,379 1,598 3,333
Stock-based compensation 13 70 154 398
Depreciation of equipment - 3 - 13
Total $ 3,298 $ 4,413 $ 5,662 $ 10,858

Research and development expenses decreased by $1.1 million to $3.3 million for the quarter ended June 30, 2025, as compared to $4.4 million for the comparable period in 2024. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for tuspetinib were $2.2 million for the quarter ended June 30, 2025, compared with $2.7 million for the comparable period in 2024. The lower program costs for tuspetinib in the current period are attributable to reduced activity in our APTIVATE clinical trial, reduced manufacturing activity, and related expenses.
Program costs for luxeptinib decreased by approximately $0.2 million primarily due to lower clinical trial and manufacturing activities.
The Company discontinued further development of APTO-253.
Personnel-related expenses decreased by $0.4 million due to lower headcount for research and development personnel in the current quarter.
Stock-based compensation decreased by $57,000 in the quarter ended June 30, 2025, compared to the comparable period in 2024, primarily due to stock options forfeited and/or vested in prior periods that are no longer being expensed resulting in lower expense in the current period.

Research and development expenses decreased by $5.2 million to $5.7 million for the six months ended June 30, 2025, as compared to $10.9 million for the comparable period in 2024. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for tuspetinib were $3.7 million for the six months ending June 30, 2025, compared to $6.6 million for the comparable period in 2024. The increased costs associated with the TUSCANY study were offset by a decrease in tuspetinib development expenses during the current period. This reduction is due to the conclusion of activities in our APTIVATE clinical trial during the current period, compared to higher APTIVATE activities during the six months ended June 30, 2024, as well as lower manufacturing and related development costs.
Program costs for luxeptinib decreased by approximately $0.3 million primarily due to lower clinical trial and manufacturing activities.
The Company discontinued further development of APTO-253.
Personnel-related expenses decreased by $1.7 million due to lower headcount for research and development personnel in the current quarter.
Stock-based compensation decreased by approximately $0.2 million in the six months ended June 30, 2025, compared to the comparable period in 2024, primarily due to stock options forfeited and/or vested in prior periods that are no longer being expensed resulting in lower expense in the current period.

On August 13, 2025 Aethlon Medical, Inc. (the Company or Aethlon) (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, reported financial results for its fiscal first quarter ended June 30, 2025, and provided an update on recent developments (Press release, Aethlon Medical, AUG 13, 2025, View Source [SID1234655213]).

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Key First Quarter Highlights

First Cohort Complete in Australian Hemopurifier cancer trial — all patients treated without device-related serious adverse events and no dose-limiting toxicities observed
Amended Protocol broadens patient eligibility to allow all treatment regimens that include an anti-PD-1 agent
Preclinical Data: 98.5% removal of platelet-derived extracellular vesicles (EVs) in simulated 4-hour treatment
Long COVID Pre-Clinical Research collaboration with UCSF advances, with findings presented at the prestigious Keystone Symposium
Operating Expenses Reduced by 31.6%, enhancing operational efficiency
Clinical Progress in Cancer Trial

Ongoing progress continues in the Australian Oncology trial evaluating the Hemopurifier in participants with solid tumors that have not responded to anti-PD-1 immunotherapy.

Aethlon successfully completed the first treatment cohort in its safety, feasibility, and dose-finding study. This initial cohort involved single Hemopurifier treatments for participants with tumors unresponsive to PD-1 inhibitors such as pembrolizumab (Keytruda) or nivolumab (Opdivo). Treatments were completed at Royal Adelaide Hospital and Royal North Shore Hospital between late January and June 2025. All participants tolerated the 4-hour Hemopurifier treatment without device-related deficiencies or immediate complications, and no dose-limiting toxicities or device-related serious adverse events were observed at the pre-specified 7-day safety follow-up. One participant subsequently died from disease progression, unrelated to the Hemopurifier treatment, and was only able to complete one week of follow-up.

On July 11, 2025, the independent Data Safety Monitoring Board (DSMB) convened to review the safety data from the three participants in this first cohort. Following closed-session deliberations, the DSMB recommended advancing to the second treatment cohort, in which participants will receive two Hemopurifier treatments within a one-week period.

All three clinical sites in Australia are actively screening patients for the cohort two under an amended protocol. The amendment expands eligibility to patients receiving either monotherapy or combination therapy that includes Pembrolizumab or Nivolumab, better reflecting current standards of care and broadening the potential patient pool.

Meanwhile, Professor Georges Grau’s laboratory at the University of Sydney continues to analyze central lab samples from the first patient cohort to assess the effects of the Hemopurifier on extracellular vesicle counts and anti-tumor T cell activity. Initial observations from this analysis are expected in September 2025.

As a reminder, the primary endpoint of the approximate 9 to 18-participant trial is safety. Eligible patients with solid tumors with stable or progressive disease receive escalating doses of Hemopurifier treatment across sequential cohorts – one, two, and three Hemopurifier treatments administered over the course of a single week. In addition to evaluating safety, the study is designed to assess whether reducing the concentration of extracellular vesicles (EVs) may improve the body’s own natural ability to attack tumor cells. These exploratory findings are expected to inform the design of future efficacy and safety trials, including a Premarket Approval (PMA) study.

We believe the unmet need remains significant: currently, only approximately 30-40% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. EVs produced by tumors are believed to contribute to both cancer progression and resistance to anti-PD-1 therapies. The Hemopurifier, designed to selectively bind and remove EVs from the bloodstream, has demonstrated EV reduction in preclinical studies using plasma from cancer patients, and may improve therapeutic response rates to anti-PD-1 antibodies.

India Update

While the Company received formal approval from India’s Central Drugs Standard Control Organization (CDSCO) to initiate a similar oncology trial at Medanta Medicity Hospital, subsequent timeline discussions with our India-based CRO indicated the first patient treatment would likely not occur until the beginning of 2026. Given this extended timeline and with careful consideration of both projected costs and our broader strategic priorities, we made the decision not to proceed with the India study. We believe this allows us to focus our resources on advancing our ongoing trial in Australia, which remains better aligned with our goal of generating timely clinical data to support a potential PMA trial.

Preclinical Study Supports Broader Applications

On May 12, 2025, results from Aethlon’s preclinical ex vivo study were published in bioRxiv, with a manuscript now under review at a peer-reviewed journal. The study showed that the Hemopurifier, utilizing Aethlon’s proprietary Galanthus nivalis agglutin (GNA) affinity resin, removed 98.5% of platelet -derived extracellular vesicles (PD-EVs) from healthy human plasma during a timepoint equivalent to a 4-hour HP treatment. Excessive levels of PD-EVs have been associated with a wide range of conditions, including cancer, lupus, systemic sclerosis, multiple sclerosis, Alzheimer’s disease, sepsis, and acute and Long COVID. We believe these findings support the scientific rationale behind Aethlon’s ongoing oncology trial in Australia and suggest broader potential applications of the Hemopurifier in other EV-associated diseases.

Scientific Collaboration in Long COVID Research

On August 12th, 2025, Aethlon presented a poster at the Keystone Symposium on Long COVID and Other Post-Acute Infection Syndromes held in Santa Fe, New Mexico. Long COVID, characterized by persistent symptoms following acute COVID-19 infection, affect approximately 44 and 48 million people in the United States alone with an estimated economic burden of 2 billion dollars among those with symptoms lasting a year. Despite the scope of this public health challenge, no specific treatments are currently available, highlighting a significant unmet medical need.

EVs have been implicated in the pathogenesis of Long COVID. Building on prior evidence that the Aethlon Hemopurifier can remove EVs in a patient with severe acute COVID-19 infection, the Company hypothesized EVs from individuals with Long COVID may also express surface mannose sugar that binds to its proprietary GNA. Aethlon partnered with investigators at the University of California San Francisco Medical Center Long COVID clinic to obtain samples from participants with Long COVID as well recovered COVID -19 participants as controls.

The data presented at the symposium demonstrated that both large and small EVs from Long COVID patients bound to the GNA lectin and the Hemopurifier’s lectin affinity resin, supporting the potential utility of the device in affected individuals.

The full poster will soon be available for public viewing on the Aethlon Medical website.

Operational Achievements

"In the first quarter, we advanced our lead oncology program, delivered preclinical results supporting broader applications including Long COVID — all while significantly reducing operating expenses," said James Frakes, Chief Executive Officer of Aethlon Medical. "We remain committed to driving the Hemopurifier toward regulatory approval and unlocking its potential across multiple disease areas."

Financial Results for the Fiscal First Quarter Ended June 30, 2025

As of June 30, 2025, Aethlon had a cash balance of approximately $3.8 million.

For the three months ended June 30, 2025, consolidated operating expenses were approximately $1.8 million, representing a decrease of approximately $800,000 or approximately 31.6%, compared to approximately $2.6 million for the same period in 2024. This reduction was primarily driven by lower payroll and related expenses, professional fees, and general and administrative costs.

Payroll and related expenses declined by approximately $674,000, largely due to the absence of a $321,000 in severance expense recorded in the prior-year quarter related to the separation of an executive. In addition, the Company realized a $286,000 reduction in compensation costs as a result of lower headcount, as well as a $67,000 decrease in stock-based compensation tied to the same reduction in the workforce.

Professional fees decreased by an approximate $138,000, primarily due to a $104,000 reduction in legal fees following the transition to a new legal firm, a $34,000 decrease in scientific consulting costs after the conclusion of a project, a $23,000 reduction in audit-related fees. Additionally contract labor costs decreased by $18,000 due to the completion of a regulatory project and shift to lower-cost quality management system consultants. These reductions were partially offset by a $42,000 increase in investor relations expenses related to the special meeting of stockholders held during the quarter.

General and administrative expenses declined by an approximate $17,000, primarily driven by a $31,000 reduction in insurance costs, partially offset by a $26,000 increase in clinical trial-related expenses. Other variances included a mix of increases and decreases across multiple categories, none of which were individually significant, resulting in an overall decline.

As a result of the above factors, operating loss for the quarter decreased to $1.8 million compared to $2.6 million for the three months ended June 30, 2024.

Other Income

Other income totaled $30,532 for the three months ended June 30, 2025, compared to $49,418 in the prior-year period. In both quarters, other income was primarily interest income earned on cash balances.

The consolidated balance sheets for June 30, 2025 and March 31, 2025, along with the consolidated statements of operations for the three months ended June 30, 2025 and 2024, are included at the end of this release.

Conference Call

Management will host a conference call today, Wednesday, August 13, 2025, at 4:30 p.m. ET to review the company’s financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference call by navigating to View Source Please note that registered participants will receive their dial-in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:

PARTICIPANT DIAL IN (TOLL-FREE): 1-844-836-8741
PARTICIPANT INTERNATIONAL DIAL IN: 1-412-317-5442

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through September 13, 2025. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada toll-free at 1-855-669-9658. The replay conference ID number is 1454680.

On August 13, 2025 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, reported financial results for the second quarter ended June 30, 2025, and provided recent business highlights (Press release, Aura Biosciences, AUG 13, 2025, View Source [SID1234655192]).

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"We continued to focus on execution in our clinical programs in the second quarter, including our ongoing global Phase 3 CoMpass trial in early choroidal melanoma and our Phase 1b/2 trial in NMIBC," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "With the successful completion of our recent equity financing, we believe we are well positioned to advance the clinical development of bel-sar in our ocular and urologic oncology programs, where we believe our unique mechanism of action has the potential to meaningfully impact the lives of patients."

Recent Pipeline Developments

Early Choroidal Melanoma

Ongoing Phase 3 CoMpass Trial: CoMpass is the first registration-enabling study in early choroidal melanoma. The study is a global, Phase 3, randomized trial evaluating bel-sar treatment against a sham control arm utilizing an enrichment strategy to enroll approximately 100 patients with documented tumor growth.

The CoMpass trial is actively enrolling globally. To identify patients meeting the enrichment criteria of documented growth, the Company implemented a pre-screening ‘run in’ period. Investigators have registered over 240 patients in this pre-screening tool as having met initial enrollment criteria for the study, highlighting the global need for a frontline vision-preserving therapy. With this progress globally, the Company believes study enrollment may be completed as early as the end of 2025.

The Company previously received Orphan Drug Designation from the FDA and the European Medicines Agency and Fast Track designation from the FDA for the treatment of early choroidal melanoma. The CoMpass trial is under a Special Protocol Assessment agreement with the FDA.

Additional Ocular Oncology Indications

In addition to early choroidal melanoma, bel-sar is in development for metastases to the choroid and cancers of the ocular surface. These three ocular oncology indications have a collective annual incidence of greater than 60,000 patients in the United States and Europe.

Metastases to the Choroid

Metastases to the choroid is an indication with high unmet medical need and no approved therapies. Bel-sar has the potential to treat a wide variety of tumor types that metastasize from several primary tumors. The Company has initiated a Phase 2 clinical trial in metastases to the choroid from breast and lung cancer and have activated sites with patients in prescreening in the United States. The Company is currently implementing a protocol amendment for the Phase 2 trial to broaden the inclusion criteria beyond breast and lung cancer to include all metastases from different solid tumors, an approach supported by pre-clinical models that demonstrate robust efficacy across a range of solid tumors. The Company believes that this approach, in addition to advancing bel-sar in metastases to the choroid, can provide clinical insights into multiple tumor types that could be impacted by bel-sar. The Company expects initial data from this trial in 2025.

Metastases to the choroid represents the second potential ocular oncology indication for bel-sar, affecting approximately 20,000 patients annually in the United States and Europe. The Company previously received FDA Fast Track designation for bel-sar in this indication.

Cancers of the Ocular Surface

The Company’s third potential ocular oncology indication is cancers of the ocular surface, which affects approximately 35,000 patients in the United States and Europe annually and has no approved therapies. The Company’s pre-clinical activities in cancers of the ocular surface remain on track, and we plan to have initial data from an early proof of concept Phase 1 clinical trial in 2026.

Bladder Cancer

Ongoing Phase 1b/2 Trial: Based on the positive data from the Phase 1 window of opportunity trial, the Company is advancing the development of bel-sar in NMIBC. The ongoing Phase 1b/2 trial will evaluate additional doses and cycles of bel-sar in approximately 26 intermediate and high-risk NMIBC patients. The trial will evaluate two approaches: an immune ablative design and a multimodal neoadjuvant design. In the immune ablative approach, bel-sar will be administered in two cycles without the need for a transurethral resection of the bladder tumor (TURBT). In the multimodal neoadjuvant cohorts, bel-sar will be administered in two cycles ahead of TURBT. For both approaches, patients will be monitored for response assessments and recurrence at 3, 6, 9, and 12 months. This trial is actively enrolling and remains on track.

Patent Application Filed for New Formulation of Bel-sar for Use in Bladder Cancer: The Company has filed a patent application with the U.S. Patent and Trademark Office for a new formulation of bel-sar for use in urologic oncology, which if issued, would provide patent coverage for this formulation into 2046. This new formulation is designed to enable convenient in-office urologist procedures with enhanced storage and handling at refrigerated conditions (2-8 Celsius).

Second Quarter 2025 Financial Results

•
As of June 30, 2025, Aura had cash and cash equivalents and marketable securities totaling $177.3 million. The Company believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into the first half of 2027.

•
Research and development expenses increased to $22.9 million for the three months ended June 30, 2025 from $16.9 million for the three months ended June 30, 2024, primarily due to ongoing clinical and CRO costs associated with the progression of our global Phase 3 trial of bel-sar in early choroidal melanoma and manufacturing and development costs for bel-sar.

•
General and administrative expenses decreased to $5.7 million for the three months ended June 30, 2025 from $5.9 million for the three months ended June 30, 2024. General and administrative expenses include $1.8 million and $1.6 million of stock-based compensation for the three months ended June 30, 2025 and 2024, respectively. The decrease was primarily driven by reduced professional fees.

•
Net loss for the three months ended June 30, 2025 was $27.0 million compared to $20.3 million for the three months ended June 30, 2024.

On August 13, 2025 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported financial results for the second quarter ended June 30, 2025, and provided a business update, including highlights of pipeline progress (Press release, Enliven Therapeutics, AUG 13, 2025, View Source [SID1234655214]).

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"We made tremendous progress this quarter. Notably, we reported updated positive clinical data for ELVN-001, which continue to compare favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs despite being evaluated in a more heavily pre-treated patient population," said Sam Kintz, Co-founder and Chief Executive Officer of Enliven. "These results reinforce our belief that ELVN-001 could ultimately compete across all lines of CML therapy based on its differentiated efficacy, tolerability and convenience – attributes that position it to be a potential best-in-class therapy for people living with CML. Building on the strength of these findings, we expect to initiate our first Phase 3 pivotal trial in 2026 and remain confident in ELVN-001’s potential within the CML treatment landscape. We also strengthened our balance sheet through our recent public offering, which generated gross proceeds of approximately $230 million and extended our cash runway into the first half of 2029."

Pipeline Updates

ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia (CML).

In June 2025, the Company announced positive updated data from the ongoing ENABLE Phase 1 clinical trial evaluating ELVN-001 in patients with previously treated CML (NCT05304377) in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress.
As of the April 28, 2025, cutoff date, 25 of 53 (47%) evaluable patients were in major molecular response (MMR) by 24 weeks, with 13 of 41 (32%) achieving and 12 of 12 (100%) maintaining MMR.
ELVN-001 remains well-tolerated across all evaluated doses.
These data continued to compare favorably to precedent Phase 1 MMRs for approved BCR::ABL1 tyrosine kinase inhibitors (TKIs), particularly given the more heavily pretreated patient population in the ELVN-001 clinical trial.
Specifically, the achieved MMR rate by 24 weeks of 32% compares favorably with historical data from less heavily pretreated patients receiving asciminib, which showed achieved MMR rates of 24% in the Phase 1 trial and 25% in the ASCEMBL Phase 3 trial.
The Company plans to initiate a Phase 3 pivotal trial in 2026.
Second Quarter 2025 Financial Results

Cash Position: As of June 30, 2025, the Company had cash, cash equivalents and marketable securities totaling $490.5 million, which is expected to provide cash runway into the first half of 2029.
Research and development (R&D) expenses: R&D expenses were $21.5 million for the second quarter of 2025, compared to $18.8 million for the second quarter of 2024.
General and administrative (G&A) expenses: G&A expenses were $7.1 million for the second quarter of 2025, compared to $5.8 million for the second quarter of 2024.
Net Loss: Enliven reported a net loss of $25.3 million for the second quarter of 2025, compared to a net loss of $20.0 million for the second quarter of 2024.

On August 13, 2025 BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported Q2 2025 financial results alongside clinical and corporate milestones (Press release, BeyondSpring Pharmaceuticals, AUG 13, 2025, View Source;utm_medium=rss&utm_campaign=beyondspring-reports-second%25e2%2580%2591quarter-2025-financial-results-and-provides-corporate-update-accelerates-momentum-with-promising-clinical-advances-and-strategic-leadership-appointment [SID1234655193]).

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"At the heart of BeyondSpring’s pipeline is Plinabulin, a first-in-class agent potentially redefining cancer treatment by harnessing the body’s own immune system," said Dr. Lan Huang, Co-Founder, Chair, and CEO. "Plinabulin’s ability to mature dendritic cells in human studies, bridges innate and adaptive immunity, offering potentially new hope to the 60% of NSCLC patients whose disease progresses after checkpoint inhibitor therapy. In our global Phase 3 trial (Dublin-3, published in LANCET Respiratory Medicine), plinabulin and docetaxel combination compared to standard of care docetaxel alone, delivered durable survival benefits alongside reduced chemotherapy-induced neutropenia — a combination with strong potential to influence standards of care."

Dr. Huang added, "BeyondSpring’s impact extends beyond Plinabulin. As SEED Therapeutics’ ("SEED") founding shareholder, BeyondSpring, along with cornerstone investors and research collaborators Eli Lilly and Eisai, has supported SEED’s pioneering work in targeted protein degradation. SEED’s oral RBM39 molecular glue degrader, ST-01156, recently received FDA clearance to enter clinical trials, targeting aggressive cancers including Ewing Sarcoma and KRAS-driven tumors, with U.S. leading cancer institutions driving development forward."

Key Milestones:

ASCO 2025 Presentation on Plinabulin Effect in Re-sensitizing Tumors Progressed on Prior PD-1/L1 Inhibitors: New data from a phase 2 study evaluating pembrolizumab in combination with Plinabulin and docetaxel in metastatic NSCLC patients who progressed on prior PD-1/L1 inhibitors, showed encouraging efficacy and safety data. The combination demonstrated median progression-free survival (PFS) of 6.8 months, confirmed objective response rate (ORR) of 18.2%, duration of response (DOR) of 7.2 months, disease control rate (DCR) of 77%, and overall survival (OS) of 78% at 15 months.
Med (Cell Press) Publication on Plinabulin Mechanism in Dendritic Cell Maturation in Human Studies with MD Anderson Collaboration: Plinabulin, when used in combination with radiation and a checkpoint inhibitor, rapidly induces dendritic cell (DC) maturation in multiple cancer types in patients who failed prior immunotherapy. The combination was associated with tumor responses across eight types of cancer in patients previously refractory to immune checkpoint inhibitor (ICI) therapy, including NSCLC, head and neck cancer, and Hodgkin lymphoma. The study reported an ORR of 23% and a DCR of 54%. Importantly, the research identified a potential predictive biomarker, baseline GEF-H1 immune signature, which may support patient selection and clinical response prediction.
SEED’s IND Clearance from US FDA for Lead Oncology Asset RBM39 Degrader ST-01156: The U.S. Food and Drug Administration (FDA) cleared SEED’s Investigational New Drug (IND) application for ST-01156, a brain penetrant, novel orally administered molecular glue degrader targeting RBM39.
AACR 2025 Presentation on SEED’s Two Key Preclinical Advancements: 1) ST-01156 demonstrated complete tumor regression in Ewing Sarcoma models, and its corresponding mechanism, and 2) a dual-degrader approach showed promising activity in KRAS G12D target degradation and KRAS G12D-driven tumors.

SEED Strengthened Leadership: Dr. Bill Desmarais, Ph.D., MBA, joins SEED Therapeutics as CFO and Chief Business Officer, bringing two decades of leadership in finance, business development, and strategic expertise in biopharma and biotech.
Second Quarter Financial Results1

Continuing operations:

Research and development (R&D) expenses were $1.0 million for the quarter ended June 30, 2025 compared to $0.8 million for the quarter ended June 30, 2024. The $0.2 million increase was primarily due to higher professional service fees in regulatory and CMC activities as well as increased costs for Plinabulin research.
General and administrative (G&A) expenses were $0.9 million for the quarter ended June 30, 2025, compared to $1.8 million for the quarter ended June 30, 2024. The $0.9 million decrease was primarily due to lower professional service costs in consulting for business development initiatives, and lower salary expenses driven by decrease in administrative headcount.
Net loss: $1.9 million for the quarter ended June 2025, compared to $2.7 million for the quarter ended June 2024
Cash and cash equivalents: $9.5 million as of June 30, 2025, compared to $2.9 million as of December 2024
Discontinued operations:

Net loss: $2.8 million for the quarter ended June 2025, compared to $1.4 million for the quarter ended June 2024
Current assets: $15.7 million as of June 2025, compared to $25.3 million as of December 2024
Year to Date Financial Results1

Continuing Operations:

Research and development (R&D) expenses were $1.9 million for the six months ended June 30, 2025 compared to $1.6 million for the six months ended June 30, 2024. The $0.3 million increase was primarily due to higher professional service fees in regulatory and CMC activities as well as increased costs for Plinabulin research.
General and administrative (G&A) expenses were $2.7 million for the six months ended June 30, 2025, compared to $3.1 million for the six months ended June 30, 2024. The $0.4 million decrease was primarily due to lower salary expenses resulting from decrease in administrative headcount, and lower company overhead expenses mainly due to decrease in investor relations services and D&O insurance related costs.
Net loss: $4.5 million for the six months ended June 2025, compared to $4.7 million for the six months ended June 2024
Discontinued operations:

Net income (loss): $1 million for the six months ended June 2025, compared to ($2.6 million) for the six months ended June 2024
Note 1: Accounting Update

Following definitive agreements in January 2025 to sell the majority of its Series A-1 Preferred Shares in SEED Therapeutics, BeyondSpring now reports SEED’s financial results as discontinued operations under ASC 205-20. BeyondSpring currently owns approximately 40% of SEED and upon completion of the future sale transactions BeyondSpring would own approximately 14% of SEED’s outstanding shares.