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

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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.

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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.

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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.

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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.

On August 13, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) from the global ARROS-1 Phase 1/2 clinical trial, in addition to preliminary data for TKI-naïve patients, will be presented as part of the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer (WCLC 2025) (Press release, Nuvalent, AUG 13, 2025, View Source [SID1234655215]). The conference is hosted by the International Association for the Study of Lung Cancer and is being held September 6-9, 2025, in Barcelona, Spain.

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"Since the inception of our ROS1 research program, collaboration with physician-scientists has been central to understanding the specific opportunities for a new therapeutic option to make a meaningful impact for patients living with ROS1-positive NSCLC. This collaboration helped to shape our vision for a future where physicians and their patients facing their next treatment decision do not have to choose between tolerability and efficacy," said Christopher Turner, M.D., Chief Medical Officer of Nuvalent. "We are highly encouraged by these pivotal results for zidesamtinib in a TKI pre-treated ROS1-positive NSCLC population as well as the preliminary results in a TKI-naïve population, and look forward to engaging with the global lung cancer community on this important milestone at WCLC."

Details of the presentation are as follows:
Title: Pivotal ARROS-1 efficacy and safety data: zidesamtinib in TKI pre-treated patients with advanced/metastatic ROS1+ NSCLC
Session: PL02 – Presidential Symposium 1
Session Date and Time: Sunday, September 7, 2025, 8:15 a.m. – 10:30 a.m. CEST
Presenting Author: Alexander Drilon, M.D. (Memorial Sloan Kettering Cancer Center, New York, USA)

The company has initiated its rolling NDA submission for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive NSCLC. The FDA agreed to accept the NDA for participation in the Real-Time Oncology Review (RTOR) pilot program, which facilitates earlier submission of topline efficacy and safety results prior to the submission of the complete application to support an earlier start to the FDA’s evaluation of the application. Completion of the NDA submission is targeted for the third quarter of 2025, and the company continues to engage with the FDA on potential opportunities for line-agnostic expansion.

About Zidesamtinib and the ARROS-1 Phase 1/2 Clinical Trial
Zidesamtinib is an investigational, novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC.

Zidesamtinib is currently being investigated in the ARROS-1 trial (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ROS1-positive NSCLC patients who previously received at least one ROS1 TKI, or patients with other ROS1-positive solid tumors who had been previously treated. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of zidesamtinib, with additional objectives including determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The ongoing global, single arm, open label Phase 2 portion is designed with registrational intent for TKI-naïve and TKI pre-treated patients with advanced ROS1-positive NSCLC.