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 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 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported corporate updates and announced financial results for the quarter ended June 30, 2025 (Press release, Allogene, AUG 13, 2025, View Source [SID1234655190]).

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"This quarter marked a significant inflection point for Allogene as we advance the streamlined ALPHA3 trial toward its next key milestone, initiate clinical enrollment in our first autoimmune indications with ALLO-329, and aligned with the FDA on a pivotal path forward for ALLO-316 in solid tumors," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Our progress reflects a focused and disciplined execution strategy, and a clear path to value creation as we advance the next wave of scalable and accessible cell therapies with potentially durable results."

Program Updates
Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL
The Company has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen to be used in its ALPHA3 study. The amended ALPHA3 trial now proceeds as a randomized study with two arms, comparing cema-cel after standard FC lymphodepletion to observation, the current standard of care.

The selection of FC as the lymphodepletion regimen in the ALPHA3 trial reflects strategic advantages supported by preliminary safety and biomarker data. Early observations indicate an encouraging minimal residual disease (MRD) conversion rate and a favorable safety profile when cema-cel is administered following standard FC. The regimen also offers operational benefits, including ease of administration and the potential for broader adoption within community cancer centers, and is enthusiastically supported by study investigators. In contrast to the relapsed/refractory setting, where a higher disease burden may necessitate more intensive lymphodepletion, standard FC may be sufficient to support the eradication of microscopic disease in earlier lines of treatment.

The next milestone will be the futility analysis comparing MRD conversion between the two arms and is expected to occur 1H 2026. The Company expects to provide the rates of MRD conversion between the two arms at the time of this announcement. To date, over 50 clinical sites are activated across the United States and Canada, including community cancer centers and major academic institutions.

ALLO-329: CD19/CD70 Dual CAR with Dagger Technology in AID
The Phase 1 RESOLUTION basket trial in rheumatology launched in Q2 2025 and represents a significant step in evaluating CAR T therapy across multiple autoimmune conditions, including systemic lupus erythematosus (with or without lupus nephritis), idiopathic inflammatory myopathies, and systemic sclerosis. The trial features two lymphodepletion arms: one with cyclophosphamide alone and one with no lymphodepletion. The first clinical update, expected in 1H 2026, will include biomarker data and clinical proof-of-concept data.

ALLO-329 is a first-in-class allogeneic CD19/CD70 dual CAR T product designed to target both CD19+ B cells and CD70+ activated T cells, which are key drivers of autoimmune disease. It leverages CRISPR-based site-specific integration and incorporates the Company’s clinically validated Dagger technology, which aims to reduce or eliminate the need for lymphodepletion to facilitate broader CAR T adoption in autoimmune indications.

ALLO-316: TRAVERSE Trial in RCC
ALLO-316 is the only allogeneic CAR T therapy to show potential in solid tumors. Enrollment has been completed in the Phase 1b cohort, which evaluated the safety and efficacy of ALLO-316 at DL2 (80M CAR T cells) in patients with heavily pretreated advanced or metastatic RCC. The Company presented updated Phase 1b cohort data in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and has since met with the FDA to align on the design of a pivotal trial, laying the groundwork for potential partnership discussions to advance the program.

2025 Second Quarter Financial Results

Research and development expenses were $40.2 million for the second quarter of 2025, which includes $2.6 million of non-cash stock-based compensation expense.
General and administrative expenses were $14.3 million for the second quarter of 2025, which includes $6.1 million of non-cash stock-based compensation expense.
Net loss for the second quarter of 2025 was $50.9 million, or $0.23 per share, including non-cash stock-based compensation expense of $8.7 million and non-cash impairment of long-lived asset expense of $2.4 million.
The Company had $302.6 million in cash, cash equivalents, and investments as of June 30, 2025.
The Company’s cash runway is expected to extend into the second half of 2027. Guidance for 2025 is an expected decrease in cash, cash equivalents, and investments of approximately $150 million. GAAP Operating Expenses are expected to be approximately $230 million, including estimated non-cash stock-based compensation expense of approximately $45 million. These estimates exclude any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. PT/5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

On August 12, 2025 Adaptimmune Therapeutics plc (NASDAQ: ADAP) reported financial results and provided a business update for the second quarter ended June 30, 2025 (Press release, Adaptimmune, AUG 13, 2025, View Source [SID1234655189]).

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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "The launch of TECELRA continued to accelerate through Q2 with an increase of over 150% in patients invoiced and in revenue. The full network of ATCs is close to completion with 30 now accepting referrals. Our manufacturing organization continues to deliver with a 100% commercial manufacturing success rate through to the end of Q2. The transaction with US WorldMeds will ensure that patient access to TECLRA continues and also places lete-cel in capable hands leading up to its planned launch in 2026. As we noted when we announced the transaction on July 28, this deal follows an extensive review of strategic alternatives and represents the best path forward for Adaptimmune, our patients and stakeholders. Since closing the transaction on July 31, we have repaid our debt facility with Hercules Capital and are restructuring to support the assets transferred to US WorldMeds, and to maximize value from our remaining assets including programs targeting PRAME and CD70."

Financial Results for the six months ended June 30, 2025

● Cash / liquidity position: As of June 30, 2025, Adaptimmune had cash and cash equivalents of $26.1 million and Total Liquidity1 of $26.1 million, compared to $91.1 million and $151.6 million respectively, as of December 31, 2024.
● Revenue: Revenue for the three and six months ended June 30, 2025, was $13.7 million and $21.0 million respectively, compared to $128.2 million and$133.9 million for the same periods in 2024. Revenue from development activities decreased by 96% for the six months ended June 30, 2025, compared to the same period in 2024. This decline was primarily due to the termination of the Genentech collaboration in April 2024 which resulted in the recognition of a cumulative catch-up adjustment of $101.3 million for the six months ended June 30, 2024. The product revenue has increased due to product sales commencing following the FDA approval of TECELRA on August 1, 2024.
● Research and development (R&D) expenses: R&D expenses for the three and six months ended June 30, 2025, were $23.0 million and $51.8 million respectively, compared to $40.4 million and $75.7 million for the same periods in 2024. R&D expenses decreased due to a decrease in the average number of employees engaged in R&D following the restructuring and reprioritization of activities that was announced in November 2024 and a decrease in subcontracted expenditure and manufacturing facilities expenses , offset by a decrease in offsetting reimbursements receivable for R&D tax and expenditure credits.

● Selling, general and administrative (SG&A) expenses: SG&A expenses for the three months and six months ended June 30, 2025, were $18.5 million and $41.8 million respectively, compared to $19.1 million and $38.8 million for the equivalent periods in 2024. SG&A expenses increased due to restructuring charges for the restructuring program initiated in the fourth quarter of 2024 for which there was no equivalent in the same periods of 2024 which was partially offset by a decrease in share-based compensation expense due to forfeitures arising as a result of this restructuring program. Also, there was an increase in accounting, legal and professional fees due to fees relating to business development work.
● Net loss: Net loss attributable to holders of the Company’s ordinary shareholders for the three months and six months ended June 30, 2025, were $30.3 million and $77.9 million respectively ($(0.02) and $(0.05) per ordinary share), compared to profits of $69.5 million and $21.0 million ($0.05 and $0.01 per ordinary share), for the equivalent periods in 2024.

As a result of the transaction with US WorldMeds and repayment of all sums under the loan agreement with Hercules Capital Inc, we consider that the cash and cash equivalents of the Company will be sufficient to meet our planned operating requirements through the 12 months following the filing of our Quarterly Report for the second quarter of 2025.

On August 13, 2025 XOMA Royalty Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its 2025 second quarter and year to date financial results and highlighted recent actions that have the potential to deliver shareholder value (Press release, Xoma, AUG 13, 2025, View Source [SID1234655165]).

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"We continue to add to our diversified portfolio of both early- and late-stage assets through disciplined capital deployment and creative financial structures," stated Owen Hughes, Chief Executive Officer of XOMA Royalty. "Recently approved drugs are addressing key unmet patient needs, which is driving increased royalty receipts, and we await data from several key Phase 3 assets over the coming quarters."

Royalty and Milestone Acquisitions

Company

Asset and Transaction Detail

BioInvent XOMA Royalty deployed $20 million to purchase the future mezagitamab royalty and milestone interests held by BioInvent and will pay an additional $10 million as the asset achieves a certain regulatory milestone. With its existing entitlement, plus the newly acquired economics from BioInvent, XOMA Royalty will be entitled to milestones of up to $16.25 million from Takeda and mid-single digit royalties on future mezagitamab commercial sales.
LAVA Therapeutics XOMA Royalty will secure an economic interest in two partnered assets through the Company’s recently announced acquisition of LAVA. The partnered assets are PF-08046052, which is being developed by Pfizer, and JNJ-89853413, which is being developed by Johnson & Johnson.
Company Acquisitions

Company

Transaction Details

Turnstone Biologics XOMA Royalty and Turnstone Biologics entered into a definitive merger agreement, whereby XOMA Royalty will acquire Turnstone for $0.34 in cash per share of Turnstone common stock plus one non-transferable contingent value right (CVR). The transaction closed on August 11.
HilleVax XOMA Royalty and HilleVax have entered into a definitive merger agreement, whereby XOMA Royalty will acquire HilleVax for $1.95 per share upon closing. HilleVax stockholders also will receive a CVR that entitles them to receive certain potential payments following the closing of a pro rata portion of any remaining HilleVax cash in excess of $102.95 million; certain savings realized related to HilleVax’ office lease obligations, and should XOMA Royalty sell or out license the HilleVax norovirus programs within two years after the acquisition closes, 90% of any net proceeds received within five years by XOMA Royalty. The acquisition is expected to be completed in September.
LAVA Therapeutics XOMA Royalty and LAVA Therapeutics have entered into a definitive merger agreement, whereby XOMA Royalty will acquire LAVA for between $1.16 and $1.24 in cash per share of LAVA common stock plus one non-transferable CVR representing the right to receive 75% of the net proceeds related to LAVA’s two partnered assets and 75% of any proceeds related to the sale or out license of LAVA’s unpartnered programs. The acquisition is expected to close in the fourth quarter of 2025.
XenoTherapeutics Acquisition of ESSA Pharma XOMA Royalty acted as structuring agent and is providing short-term financing for XenoTherapeutics’ acquisition of ESSA Pharma.
Kinnate XOMA Royalty sold the remaining Kinnate pipeline assets for a total of up to $270 million in upfront and milestone payments, plus royalties on commercial sales at rates ranging from low-single digits to mid-teens. In July, the Kinnate CVRs holders received their 85% share of the modest upfront payments.
Pipeline Partner Updates through August 8, 2025

Partner

Event

Rezolute
In May, the company announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to its investigational therapy, ersodetug, for the treatment of hypoglycemia caused by tumor HI.1

In May, Rezolute announced the completion of enrollment in the Phase 3 sunRIZE study. Topline data are anticipated in December of 2025.2 As a result of Rezolute completing enrollment in the study, XOMA Royalty received a $5 million milestone payment.

Takeda The first patient was dosed in Takeda’s Phase 3 clinical trial investigating mezagitamab as a treatment for adults with chronic primary immune thrombocytopenia (ITP). This achievement resulted in XOMA Royalty receiving a $3.0 million milestone payment, net, during the second quarter.
Day One Biopharmaceuticals Ipsen, Day One’s partner outside of the U.S., announced its Marketing Authorization Application (MAA) for tovorafenib as a treatment for pediatric low-grade glioma (pLGG) had been accepted for review by the European Medicines Agency (EMA)3.
Zevra Therapeutics On July 28, Zevra announced it had submitted an MAA to EMA for the evaluation of arimoclomol for the treatment of Niemann-Pick Disease Type C (NPC)4.
Gossamer Bio On June 16, Gossamer announced it had completed enrollment in the ongoing Phase 3 PROSERA Study that is evaluating seralutinib in Functional Class II and III pulmonary atrial hypertension (PAH) patients 5. Topline results continue to be anticipated in February 20266.
Daré Biosciences Announced positive interim safety and efficacy results from its ongoing Phase 3 clinical trial evaluating the contraceptive effectiveness, safety, and acceptability of Ovaprene, an investigational monthly, hormone-free intravaginal contraceptive.

Anticipated 2025 Partner Events of Note

Partner

Event

Rezolute
Topline data from sunRIZE Phase 3 clinical trial, which is investigating ersodetug in infants and children with congenital hyperinsulinism (cHI). Topline data are expected in December 20252.

First patient dosed in the Phase 3 registrational study for ersodetug for the treatment of hypoglycemia due to tumor hyperinsulinism8.

Takeda First patient dosed in Takeda’s Phase 3 clinical trial investigating mezagitamab as a treatment for adults with IgA Nephropathy.
Gossamer Bio Activates first clinical sites for the global, registrational Phase 3 SERANATA Study examining seralutinib in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) in the fourth quarter5.
Daré Bioscience
Makes Sildenafil Cream, 3.6% available commercially via prescription in the fourth quarter of 2025 as a compounded drug under Section 503B of the Federal Food, Drug, and Cosmetic Act.9

Commencement of one of two registrational Phase 3 clinical trials investigating Sildenafil Cream, 3.6%, for the treatment of female sexual arousal disorder10.

Second Quarter and Year to Date 2025 Financial Results

Tom Burns, Chief Financial Officer of XOMA Royalty, commented, "In the first six months of 2025, we have received $29.6 million in cash from partners, of which $16.0 million were royalty payments related to commercial sales and $13.6 million in milestone payments and fees. In the second quarter, we received $11.7 million in cash, $2.6 million from our partners’ commercial sales and $9.0 million from milestones and fees. Our partners’ product marketing activities continue to be well executed and as new commercial opportunities within our portfolio emerge, our line of sight to becoming cash flow positive on a consistent basis exclusively from the cash payments received from royalties grows clearer. With this outlook, we deployed $1.8 million to repurchase 81,682 shares of our common stock in the second quarter, bringing the total number of shares repurchased in 2025 to over 107,500 shares."

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Income and Revenue: Income and revenue for the three and six months ended June 30, 2025, were $13.1 million and $29.0 million, respectively, as compared with $11.1 million and $12.6 million for the corresponding periods of 2024. The increase in both periods presented was primarily driven by increased income related to VABYSMO and OJEMDA.

Research and Development (R&D) Expenses: R&D expenses for the three and six months ended June 30, 2025, were $0.1 million and $1.4 million, respectively, compared with $1.2 million for each of the corresponding periods of 2024. The R&D expenses in the first quarter of 2025 and the three- and six-month periods of 2024 were related to the clinical trial costs incurred subsequent to XOMA Royalty’s acquisition of Kinnate in April 2024 related to KIN-3248 and the associated wind-down activities.

General and Administrative (G&A) Expenses: G&A expenses for the three and six months ended June 30, 2025, were $7.8 million and $15.9 million, respectively, as compared with $11.0 million and $19.5 million for the corresponding periods of 2024. The decrease in the second quarter of 2025 compared to the second quarter of 2024 was primarily due to the $3.6 million in exit packages paid to Kinnate senior leadership in the second quarter of 2024.

In 2025, XOMA Royalty’s G&A expenses included non-cash stock-based compensation expenses during the three and six months ended June 30, 2025, of $1.6 million and $3.6 million, respectively, as compared to $2.7 million and $5.5 million for the corresponding periods of 2024. The 2024 periods reflect non-cash stock-based compensation related to the appointment of Mr. Hughes to full-time Chief Executive Officer and issuance of performance stock units.

Credit Losses on Purchased Receivables: In the second quarter of 2024, XOMA Royalty recorded a one-time, non-cash credit loss on purchased receivables of $9.0 million and a corresponding reduction of royalty receivables of $9.0 million associated with the Aronora assets. To date there have been no credit losses in 2025.

Amortization of Intangible Assets: Amortization of intangible assets relates to the IP acquired in the Company’s acquisitions of Pulmokine in November 2024 and the mezagitamab economics from the BioInvent transaction in May 2025. Amortization of non-cash intangible assets were $0.7 million and $1.2 million for the three and six months ended June 30, 2025.

Gain on Acquisition of Kinnate: In the second quarter of 2024, XOMA Royalty recorded a $19.3 million gain on the acquisition of Kinnate due to the fair value of net assets that exceeded total purchase consideration.

Interest Expense: For the three and six months ended June 30, 2025, interest expense was $3.2 million and $6.7 million, respectively, as compared with $3.4 million and $7.0 million for the corresponding periods of 2024. Interest expense relates to the Blue Owl Loan established in December 2023.

Other Income, net: For the three and six months ended June 30, 2025, other income, net was $7.8 million and $7.7 million, respectively, as compared with $2.1 million and $4.0 million for the corresponding periods of 2024. The increases for the periods presented were primarily driven by increases in the fair value of XOMA Royalty’s investments in equity securities.

Net Income: XOMA Royalty reported net income of $9.2 million and $11.6 million for the three and six months ended June 30, 2025, as compared to $16.0 and $7.4 million in the corresponding periods of 2025.

Cash Position: On June 30, 2025, XOMA Royalty had cash and cash equivalents of $78.5 million (including $3.4 million in restricted cash), compared with cash and cash equivalents of $106.4 million (including $4.8 million in restricted cash) on December 31, 2024.

In the second quarter of 2025, XOMA Royalty received $11.7 million in cash receipts including $2.6 million in royalties and commercial payments and $9.0 million in milestones and fees. During the second quarter of 2025, XOMA Royalty deployed $20 million to acquire additional economics in mezagitamab, repurchased approximately 81,700 shares of XOMA Royalty common stock for a cost of $1.8 million, and paid $1.4 million in dividends on the XOMA Royalty Perpetual Preferred stocks. In the first six months of 2025, XOMA Royalty received $29.6 million in cash receipts, including $16.0 million in royalties and commercial payments and $13.6 million in milestone payments and fees. During the first half of 2025, XOMA Royalty deployed $25.0 million to acquire additional assets for its royalty and milestone portfolio, repurchased approximately 107,500 shares of its common stock for a cost of $2.4 million, and paid $2.7 million in dividends on the XOMA Royalty Perpetual Preferred stocks.