On August 14, 2025 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported its unaudited financial results for the quarter ended June 30, 2025, and provided a corporate update (Press release, BioLineRx, AUG 14, 2025, View Source [SID1234655281]).

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"Since our last quarterly update, we have been acutely focused on evaluating a broad range of potential pipeline expansion opportunities where we can leverage our clinical and regulatory expertise, and track record of drug approval success, to drive new innovation in areas of need," said Philip Serlin, Chief Executive Officer of BioLineRx. "Today, I am pleased to report that discussions with potential partners continue to progress. Our balance sheet is strong, our organization is lean, and we are seeing promising opportunities that fit well within our criteria – most notably a clear and efficient development pathway. I remain confident that we could potentially execute a transaction this year that will expand our pipeline and provide fresh opportunities for clinical success and long-term value creation."

Financial Updates

With $28.2 million on its balance sheet as of June 30, 2025, BioLineRx is guiding to a cash runway into the first half of 2027. This represents an improvement as compared to the Company’s previous cash runway guidance into the second half of 2026.
Clinical Updates
Motixafortide
Pancreatic Ductal Adenocarcinoma (mPDAC)

Enrollment activities continue in the CheMo4METPANC Phase 2b clinical trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx. The CheMo4METPANC trial is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapy (gemcitabine and nab-paclitaxel).
A prespecified interim analysis is planned when 40% of progression-free survival (PFS) events are observed.
An abstract featuring updated data from the pilot phase of the ongoing CheMo4METPANC clinical trial was presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting in May. Key highlights include:
– Four of 11 patients remained progression-free after more than one year.
– Two patients underwent definitive treatment for metastatic pancreatic cancer: one had complete resolution of all radiologically detected liver lesions and underwent radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response.
– An analysis of pre- and on-treatment biopsies revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination.
Sickle Cell Disease (SCD) & Gene Therapy

Ongoing Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease continues to progress. The trial is sponsored by Washington University School of Medicine in St. Louis, and results are anticipated in the second half of 2025.
A second study, sponsored by St. Jude Children’s Research Hospital, continues to enroll patients. The study is a multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with Sickle Cell Disease (SCD).
APHEXDA Performance Update

APHEXDA generated sales of $1.7 million in the second quarter of 2025, providing royalty revenue to the Company of $0.3 million.
Financial Results for the Quarter Ended June 30, 2025

Total revenues for the second quarter of 2025 were $0.3 million, reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Total revenues in 2025 are not comparable to the same period in 2024, which included direct commercial sales by BioLineRx prior to the Ayrmid transaction in November 2024.

Cost of revenues for the second quarter of 2025 was immaterial, compared to cost of revenues of $0.9 million for the second quarter of 2024. Cost of revenues in 2025 are not comparable to the same period in 2024, which included cost of sales from direct commercial sales by BioLineRx prior to the Ayrmid transaction in November 2024.

Research and development expenses for the second quarter of 2025 were $2.3 million, compared to $2.2 million for the second quarter of 2024. The increase resulted primarily from certain one-time costs associated with the PDAC study at Columbia University, offset by lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount.

There were no sales and marketing expenses for the second quarter of 2025, compared to $6.4 million for the second quarter of 2024. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid transaction.

General and administrative expenses for the second quarter of 2025 were $0.2 million, compared to $1.6 million for the second quarter of 2024. The decrease resulted primarily from the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria, a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, as well as small decreases in a number of general and administrative expenses.

Net non-operating expenses for the second quarter of 2025 were $1.9 million, compared to net non-operating income of $7.8 million for the second quarter of 2024. Non-operating income (expenses) for both periods primarily relate to fair-value adjustments of warrant liabilities on the balance sheet, as a result of changes in the Company’s share price

Net financial income for the second quarter of 2025 was $0.2 million, compared to net financial expenses of $1.6 million for the second quarter of 2024. Net financial income (expenses) for both periods primarily relate to loan interest paid, partially offset by investment income earned on bank deposits and gains on foreign currency (primarily NIS) cash balances due to the strengthening of the NIS during the period. The significant decrease in financial expenses in the 2025 period results from a substantial paydown of the BlackRock loan balance in November 2024, following the transaction with Ayrmid.

Net loss for the second quarter of 2025 was $3.9 million, compared to net income of $0.5 million for the second quarter of 2024.

As of June 30, 2025, the Company had cash, cash equivalents, and short-term bank deposits of $28.2 million, sufficient to fund operations, as currently planned, into the first half of 2027.
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until August 16, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

On August 14, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biopharmaceutical company developing therapeutics using its proprietary INTASYL siRNA gene silencing technology to eliminate cancer, reported its financial results for the quarter ended June 30, 2025 and provided a business update (Press release, Phio Pharmaceuticals, AUG 14, 2025, View Source [SID1234655312]).

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Recent Corporate Updates

PH-762 Clinical Progress

Phio’s ongoing Phase 1b dose escalation clinical trial (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cutaneous squamous cell carcinoma (cSCC), Stage 4 melanoma, and Stage 4 Merkel cell carcinoma. To date, a total of 15 patients with cutaneous carcinomas have been treated across four cohorts in the Phase 1b trial. These cohorts included 13 patients with cSCC, one patient with metastatic melanoma and one patient with metastatic Merkel cell carcinoma. There have been no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients who received intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort. No patients exhibited clinical progression of disease during the treatment phase of this trial.

The cumulative pathologic responses in the 13 patients with cSCC include five with complete response (100% clearance), one patient with a near complete response (>90% clearance), one with a partial response (>50% clearance) and six patients with a pathologic non-response (< 50% clearance).

The Merkel cell carcinoma patient with stage 4 metastatic disease had a pathological partial response (>50% clearance). The melanoma patient was a non-responder (<50% clearance).

Phio is now enrolling what is expected to be the 5th and final cohort in the Phase 1b trial.

In addition, the Company entered into a comprehensive drug substance development services agreement with a U.S. manufacturing company. The company will provide analytical and process development and cGMP manufacture of Phio’s lead development compound PH-762.

Scientific News

In May 2025, Phio delivered a podium presentation for its INTASYL self-delivering siRNA technology at the Society of Investigative Dermatology (SID). The Company presented its Phase 1b clinical trial results to date. The Company also delivered podium presentations on its INTASYL compounds PH-762 and PH-894 in April 2025 at the 11th Annual Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (ITOC 11) conference in Munich, Germany. In June 2025, Phio presented interim data on its Phase 1b clinical trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference.

Subsequent Events

On July 25, 2025, the Company entered into warrant inducement agreements with certain holders of the Company’s existing warrants to purchase an aggregate of 928,596 shares of common stock in connection with the exercise of common stock warrants issued between December 2024 and January 2025 with exercise prices between $2.00 and $2.485 per share. In connection with this financing, the Company raised approximately $2.2 million after expenses.

Financial Results

Cash Position

At June 30, 2025, the Company had cash and cash equivalents of approximately $10.8 million as compared with approximately $5.4 million at December 31, 2024.

Research and Development Expenses

Research and development expenses for the three months ended June 30, 2025 were $1.1 million compared to $0.9 million for the same period in 2024. The increase in research and development expenses was primarily driven by higher CRO pass-through costs associated with increased patient enrollment, as well as higher consulting and salary-related costs.

Research and development expenses for the six months ended June 30, 2025 were $1.9 million compared to $2.0 million for the same period in 2024. The fluctuation was immaterial and within expected operating ranges.

General and Administrative Expenses

General and administrative expenses for the three months ended June 30, 2025 were $1.2 million compared to $1.0 million for the same period in 2024. The increase in general and administrative expenses was primarily driven by an increase in salary-related costs.

General and administrative expenses for the six months ended June 30, 2025 were $2.2 million compared to $1.8 million for the same period in 2024. The increase in general and administrative expenses was primarily driven by an increase in salary-related costs.

Net Loss

Net loss was $2.2 million for the three months ended June 30, 2025 compared with $1.8 million for the same period in 2024. The increase in net loss was due to the changes in research and development and general and administrative expenses as described above.

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.