On November 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 third quarter ended September 30, 2025, and provided recent business highlights.

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"In the third quarter, we remained focused on clinical execution in both our 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 Biosciences. "Enrollment has taken longer than we expected in early choroidal melanoma due to the requirement to document active tumor growth prior to patient enrollment and other unique enrollment challenges with the first Phase 3 trial in this rare indication. In 2025, we implemented measures to address these operational challenges and have experienced improved enrollment in recent months. We believe we are now in a position to provide guidance regarding the topline data readout for the study."

"Our NMIBC trial remains on track, with data expected in mid-2026. Recently presented Phase 1 trial immune profiling data reinforce bel-sar’s distinct dual mechanism, driving focal anti-tumor immune activation. We believe these findings highlight bel-sar’s potential as a differentiated frontline, organ-preserving treatment to deliver durable responses across the bladder cancer spectrum and in other solid tumors."

Recent Pipeline Developments

Early Choroidal Melanoma

Ongoing Phase 3 CoMpass Trial: CoMpass is the first registration-enabling trial in early choroidal melanoma. The trial 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. We believe the study enrollment has been slower than expected due to the operational challenges of implementing the first Phase 3 trial in this rare indication across global sites and the requirement of active growth in our inclusion criteria, which often requires sites to follow patients for variable periods of time until they demonstrate required growth.

Approximately 90% of targeted clinical sites are now activated, and we have implemented measures to address multiple operational challenges. Our patient identification tool has shown strong growth, with more than 400 patients having been entered since June 2024, and the current number of potentially eligible patients having increased to 280. We believe this highlights the enrollment opportunity and the significant unmet need.

Based on trial activity in recent months and the growing number of potentially eligible patients, the Company currently expects that it can complete CoMpass enrollment in 2026 and provide topline data readout for the 15-month primary endpoint in the fourth quarter of 2027. This estimate assumes enrollment rates that are generally consistent with the rates experienced in recent months.

Currently, there are no approved vision-preserving therapies for patients with early choroidal melanoma. The standard of care remains radiotherapy, which frequently results in irreversible vision loss. Bel-sar has the potential to become the first frontline vision-preserving therapy in this setting. 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.

Bladder Cancer

Additional Phase 1 Biological Activity Data Presented at the 45th Congress of the Société Internationale d’Urologie (SIU): Multiplex immune fluorescence data from the Phase 1 trial of bel-sar demonstrating robust induction of adaptive immune memory in patients with non-muscle invasive bladder cancer (NMIBC) were presented by Seth P. Lerner, M.D., Professor of Urology at Baylor College of Medicine at SIU, held October 29–November 1, 2025, in Edinburgh, United Kingdom: link. These multiplex immune fluorescence data (n=5 patients from the Phase 1 trial) further characterize the previously announced results from the Company’s completed Phase 1 clinical trial of bel-sar in patients with NMIBC.

These data revealed that a single focal administration of bel-sar induced adaptive immune memory through generation of de novo mature tertiary lymphoid structures (TLS) in 3/5 participants evaluated. Bel-sar also generated innate and adaptive effectors regardless of immune environment and converted immune-cold or exhausted lesions into active, immune-hot microenvironments. In treated lesions, natural killer cell density increased up to 40x, CD4+ cytolytic T cell density increased up to 7x, and CD4+ and CD8+ memory T cells were observed after bel-sar treatment.

This biological activity profile reinforces bel-sar’s potential as a frontline therapy designed to treat the tumor, activate durable anti-tumor immunity, and reduce recurrence risk across the bladder cancer spectrum.

Ongoing Phase 1b/2 Trial: This trial will evaluate additional doses and cycles of bel-sar in approximately 26 intermediate and high-risk NMIBC patients. 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, with initial three-month clinical data expected in mid-2026.

Metastases to the Choroid

The Company has dosed the first patient in an ongoing Phase 2 clinical trial in metastases to the choroid. A protocol amendment has now been implemented to expand the entry criteria to include all metastases arising from different solid tumors to facilitate enrollment into the study and broaden the proof of concept for bel-sar in this indication. This approach is supported by preclinical models that demonstrate robust efficacy across multiple primary solid tumors. The Company is evaluating further expansion of the inclusion criteria for this trial to address the high unmet medical need. With a four-week efficacy endpoint, the Company expects early proof of concept data from this trial in 2026.

Metastases to the choroid is an indication with high unmet medical need and no approved therapies with an incidence of 20,000 patients annually in the United States and Europe. Bel-sar has the potential to treat a wide variety of tumor types in the choroid that metastasize from various primary tumors. The Company previously received FDA Fast Track designation for bel-sar in this indication.

Cancers of the Ocular Surface

The Company is planning to initiate a Phase 1 proof-of-concept trial to assess safety, feasibility and tumor response through histopathologic evaluation at a 2–4-week time point. Development activities for this program remain on track, with early proof of concept data from Australian clinical sites expected in 2026.

Cancers of the ocular surface affect approximately 35,000 patients in the United States and Europe annually and are associated with a particularly high incidence in regions such as Australia. There are currently no approved therapies for these tumors.

Third Quarter 2025 Financial Results

•
As of September 30, 2025, the Company had cash and cash equivalents and marketable securities totaling $161.9 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. The Company remains focused on driving a cash-efficient operation to deliver data across its pipeline.

•
Research and development expenses increased to $22.2 million for the three months ended September 30, 2025 from $17.0 million for the three months ended September 30, 2024, primarily due to ongoing clinical and clinical research organization (CRO) costs associated with the progression of our global Phase 3 trial of bel-sar in early choroidal melanoma and higher personnel expenses related to growth of our Company.

•
General and administrative expenses decreased to $5.7 million for the three months ended September 30, 2025 from $6.2 million for the three months ended September 30, 2024. General and administrative expenses include $1.7 million and $1.6 million of stock-based compensation for the three months ended September 30, 2025 and 2024, respectively. The decrease was primarily driven by reduced professional fees.

•
Net loss for the three months ended September 30, 2025 was $26.1 million compared to $21.0 million for the three months ended September 30, 2024.

(Press release, Aura Biosciences, NOV 13, 2025, View Source [SID1234659892])

On November 13, 2025 Arbutus Biopharma Corporation (Nasdaq: ABUS) ("Arbutus" or the "Company"), a clinical-stage biopharmaceutical company focused on infectious disease, reported third quarter 2025 financial results and provided a corporate update.

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"The strength of our third quarter performance reflects our disciplined focus on executing strategic priorities," said Lindsay Androski, President and CEO of Arbutus. "We are also excited to share additional analysis of imdusiran clinical data being conducted as part of our ongoing strategic review. Notably, in addition to the eight patients who initially achieved functional cure with imdusiran at 60mg in our Phase 2a trials, forty more patients across all cohorts discontinued nucleos(t)ide analogue therapy after meeting study-defined criteria. In total, a combined 46% of all Phase 2a patients were able to discontinue all treatment. All but one patient who achieved functional cure or who we are following after discontinuing nucleos(t)ide analogue therapy remain off all treatment long-term, now exceeding two years for some patients. Across our Phase 1b and Phase 2a trials, imdusiran has demonstrated sustained benefits in chronic hepatitis B patients, regardless of baseline hepatitis B surface antigen levels, hepatitis B virus DNA presence or absence, and hepatitis B e-antigen positivity or negativity. We remain dedicated to accelerating the development and potential approval of imdusiran."

LNP Litigation

Arbutus continues to consult closely with and support its exclusive licensee, Genevant Sciences, to protect and defend Arbutus’s intellectual property, which is the subject of on-going lawsuits against Moderna and Pfizer/BioNTech. The Company, together with Genevant, is seeking fair compensation for Moderna’s and Pfizer/BioNTech’s use of Arbutus’s patented LNP technology that was developed with great effort and at a great expense, and without which Moderna’s and Pfizer/BioNTech’s COVID-19 vaccines would not have been successful.
In the Moderna U.S. litigation, fact discovery, expert discovery and summary judgment briefing have been completed. A jury trial is scheduled for March 2026. In March 2025, the Company, alongside Genevant Sciences, filed five international lawsuits against Moderna and its affiliates seeking to enforce patents protecting the Company’s patented LNP technology across 30 countries. Public oral hearings for two of the five cases which are before the Unified Patent Court are scheduled for May 2026, and a trial in the Canadian case is set to begin in September 2027.
The claim construction hearing for the lawsuit against Pfizer/BioNTech occurred in December 2024, and the court issued a claim construction ruling in September 2025, which construed the disputed claim terms in a manner the Company generally considers to be favorable.
Corporate Updates

The Company showcased four poster presentations featuring data from its hepatitis B virus (HBV) programs at AASLD 2025. One poster presented new analysis from the Company’s IM-PROVE I Phase 2a clinical trial showing beneficial clinical outcomes were observed across all evaluated HBV genotypes (A to E). The Company also had a Poster of Distinction highlighting AB-101’s maximal PD-L1 receptor occupancy between 68-100% at a 30mg daily dose.
Today, the Company published an updated Corporate Presentation on its website, which includes the results of its recently completed analysis of imdusiran clinical data.
In addition to the eight functional cures, an additional 40 patients across all cohorts in its Phase 2a trials met study-defined criteria for nucleos(t)ide analogue (NA) therapy discontinuation.
In total, 46% (48/105) of all Phase 2a patients either achieved functional cure or remained off NA therapy for at least 48 weeks after discontinuing NA therapy following treatment with imdusiran.
Eighteen patients consented to long-term follow-up, including all functionally cured patients and 10 patients who discontinued NA therapy. To date, 94% of those follow-up patients have remained off all treatment for between 58 to 109 weeks. One functionally cured patient seroreverted but remains virally suppressed and off all treatment.
Additionally, 56% (5/9) of Phase 1b patients (only received imdusiran and NA therapy) who elected to discontinue NA therapy, remained off all treatment for at least 3 years.
Imdusiran has also demonstrated steep and durable declines in HBV DNA, and, with NA therapy, achieved full HBV DNA suppression significantly faster than NA therapy alone. By week 18 of treatment with imdusiran and NA therapy, 100% of Phase 1b HBV DNA positive patients achieved HBV DNA levels below the level of quantification, The eight Phase 2a patients who achieved functional cure continue to have HBV DNA levels below the level of quantification.
In 30 hepatitis B e-antigen (HBeAg) positive patients in our Phase 1 and 2a trials, HBeAg decreased in all patients in a dose-dependent manner.
Financial Results

Cash, Cash Equivalents and Investments

As of September 30, 2025, the Company had cash, cash equivalents and investments in marketable securities of $93.7 million compared to $122.6 million as of December 31, 2024. During the nine months ended September 30, 2025, the Company used $35.0 million in operating activities, which included one-time payments related to its restructuring efforts. This was partially offset by $3.9 million of proceeds from the exercise of stock options.

Revenue

Total revenue was $0.5 million for the quarter ended September 30, 2025, compared to $1.3 million for the same period in 2024. The decrease of $0.8 million was due to a decrease in license royalty revenues, primarily due to a decline in Alnylam’s sales of ONPATTRO.

Operating Expenses

Research and development expenses were $5.8 million for the quarter ended September 30, 2025, compared to $14.3 million for the same period in 2024. The decrease of $8.5 million was due primarily to cost savings from the Company’s decisions to streamline the organization to focus its efforts on advancing the clinical development of imdusiran and AB-101, which included ceasing all discovery efforts, discontinuing its IM-PROVE III clinical trial, and reducing the Company’s workforce.

General and administrative expenses were $3.0 million for the quarter ended September 30, 2025, compared to $4.5 million for the same period in 2024. This decrease was due primarily to cost-cutting efforts by the Company, which drove reductions in employee compensation-related expenses and legal fees.

Restructuring costs in the quarter ended September 30, 2025 were $0.1 million, and all remaining restructuring-related payments are expected to be made by the first quarter of 2026.

Net Loss

For the quarter ended September 30, 2025, the Company’s net loss was $7.7 million, or a loss of $0.04 per basic and diluted common share, as compared to a net loss of $19.7 million, or a loss of $0.10 per basic and diluted common share, for the quarter ended September 30, 2024.

Outstanding Shares

As of September 30, 2025, the Company had 192.0 million common shares issued and outstanding, as well as 14.9 million stock options and unvested restricted stock units outstanding.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF INCOME AND LOSS
(in thousands, except share and per share data)

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
Revenue
Collaborations and licenses $ 280 $ 767 $ 11,809 $ 2,861
Non-cash royalty revenue 249 572 1,223 1,736
Total Revenue 529 1,339 13,032 4,597
Operating expenses
Research and development 5,778 14,273 20,235 45,227
General and administrative 3,044 4,537 12,204 17,396
Change in fair value of contingent consideration 268 344 827 735
Restructuring costs 98 3,625 12,636 3,625
Total operating expenses 9,188 22,779 45,902 66,983
Loss from operations (8,659 ) (21,440 ) (32,870 ) (62,386 )
Other income
Interest income 952 1,747 3,191 5,121
Interest expense (23 ) (29 ) (79 ) (107 )
Foreign exchange (loss) gain (12 ) 5 13 (16 )
Total other income 917 1,723 3,125 4,998
Income tax expense — — — —
Net loss $ (7,742 ) $ (19,717 ) $ (29,745 ) $ (57,388 )
Net loss per common share
Basic and diluted $ (0.04 ) $ (0.10 ) $ (0.16 ) $ (0.31 )
Weighted average number of common shares
Basic and diluted 191,778,950 188,997,194 191,347,969 184,244,819

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)

September 30, 2025
December 31, 2024
Cash, cash equivalents and marketable securities, current $ 93,702 $ 122,623
Accounts receivable and other current assets 3,740 4,693
Total current assets 97,442 127,316
Property and equipment, net of accumulated depreciation and impairment 137 3,309
Right of use asset — 1,048
Other non-current assets 131 34
Total assets $ 97,710 $ 131,707

Accounts payable and accrued liabilities $ 4,653 $ 7,564
Deferred license revenue, current — 7,571
Lease liability, current 531 483
Total current liabilities 5,184 15,618
Liability related to sale of future royalties 3,684 4,829
Deferred license revenue, non-current — 2,863
Contingent consideration 11,052 10,225
Lease liability, non-current 391 806
Total stockholders’ equity 77,399 97,366
Total liabilities and stockholders’ equity $ 97,710 $ 131,707

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)

Nine Months Ended September 30,
2025 2024
Net loss $ (29,745 ) $ (57,388 )
Non-cash items 6,609 5,453
Change in deferred license revenue (10,434 ) (880 )
Other changes in working capital (1,387 ) (1,720 )
Net cash used in operating activities (34,957 ) (54,535 )
Net cash provided by investing activities 16,941 9,537
Issuance of common shares pursuant to the Open Market Sale Agreement — 44,124
Cash provided by other financing activities 4,081 6,451
Net cash provided by financing activities 4,081 50,575
Effect of foreign exchange rate changes on cash and cash equivalents 13 (16 )
(Decrease) / Increase in cash and cash equivalents (13,922 ) 5,561
Cash and cash equivalents, beginning of period 36,330 26,285
Cash and cash equivalents, end of period 22,408 31,846
Investments in marketable securities 71,294 85,725
Cash, cash equivalents and marketable securities, end of period $ 93,702 $ 117,571

About Imdusiran (AB-729)

Imdusiran is an RNAi therapeutic specifically designed to reduce all hepatitis B viral proteins and antigens including HBsAg, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to control the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine ("GalNAc") delivery technology enabling subcutaneous delivery. To date, Arbutus has reported a total of eight patients with cHBV who have achieved a functional cure following treatment with imdusiran and NA therapy in combination with either IFN or low dose nivolumab plus an immunotherapeutic, with seven out of the eight patients continuing to sustain functional cure for over a year after treatment. An additional 40 patients across our Phase 2a clinical trials were able to remain off NA therapy for at least 48 weeks after discontinuing NA therapy following treatment with imdusiran. Clinical data generated thus far has shown imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in HBsAg and hepatitis B virus DNA.

About HBV

Hepatitis B is a potentially life-threatening liver infection caused by HBV. HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. cHBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from cHBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from cHBV infection. Approximately 1.1 million people die every year from complications related to cHBV infection despite the availability of effective vaccines and current treatment options.

(Press release, Arbutus Biopharma, NOV 13, 2025, View Source [SID1234659891])

On November 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 third quarter ended September 30, 2025, and provided a corporate update.

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"Tuspetinib in combination with VEN+AZA standard treatment (TUS+VEN+AZA) has been highly active and so well tolerated in newly diagnosed AML patients with 40 mg, 80 mg, and 120 mg TUS, we dose escalated to the 160 mg TUS dose level in the triplet," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "Patients evaluated at the higher dose levels of 80 mg and 120 mg TUS have all (6/6; 100%) achieved CR/CRh responses, exceeding the 66% rate expected from VEN+AZA alone. We now are dosing at 160 mg TUS, and we look forward to providing further updates next month at ASH (Free ASH Whitepaper)."

Key Corporate Highlights

Tuspetinib Data Reported at European School of Haematology (ESH) 7th International Conference Data from the ongoing TUSCANY trial of tuspetinib in combination with venetoclax and azacitidine (TUS+VEN+AZA) were presented in a poster presentation, "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," at the European School of Haematology (ESH) 7th International Conference on Acute Myeloid Leukemia "Molecular and Translational": Advances in Biology and Treatment, held in October in Estoril, Portugal. Data from 10 patients in the TUSCANY trial across all three cohorts, 40 mg, 80 mg or 120 mg TUS dose in TUS+VEN+AZA, reveal promising clinical safety and antileukemic activity and support the use of TUS with standard of care treatment across a broad range of AML populations, including those carrying adverse mutations regardless of FLT3 mutation status.

As reported, the addition of TUS to VEN+AZA achieved CR/CRh responses in 6/6 (100%) patients treated at the higher dose levels of 80 mg and 120 mg TUS, exceeding the 66% rate expected from VEN+AZA alone. Overall, TUS+VEN+AZA has delivered CR/CRh responses in 9/10 (90%) patients. CR/CRh responses were achieved across diverse mutational subtypes including unmutated FLT3, FLT3-ITD, NPM1c, biallelic TP53 with complex karyotype, RAS, and myelodysplasia related mutations. MRD-negativity with TUS+VEN+AZA was observed in 7/9 (78%) of responding patients by central flow cytometry, and hematopoietic stem cell transplants (HSCT) have been completed in 2 patients to date.

Aptose Clinical Data Accepted for Poster Presentation at ASH (Free ASH Whitepaper) – Aptose was notified that its abstract, "TUSCANY Study demonstrates safety and efficacy of tuspetinib plus standard of care venetoclax and azacitidine in patients with newly diagnosed AML ineligible for induction chemotherapy," has been selected for poster presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. The meeting is scheduled to take place December 6-9, 2025, in Orlando, Florida. The abstract accepted for presentation can be viewed online at the ASH (Free ASH Whitepaper) conference website here, and will appear in the November supplemental issue of Blood. The actual presentation will include more recent updates and additional data not found in the abstract.
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)

Reported 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
2025: European School of Haematology (ESH) 7th International Conference

Reported excellent safety across three TUS dose levels of TUS+VEN+AZA
Reported CR/CRh responses in patients with biallelic TP53 mutations
Reported evolving data from 120 mg TUS+VEN+AZA triplet
2025: American Society of Hematology (ASH) (Free ASH Whitepaper)

Report evolving response rate and durability data from four (4) dose levels of TUS+VEN+AZA triplet
Report safety and tolerability of TUS with VEN+AZA in combination with unadjusted dosing of VEN+AZA
FINANCIAL RESULTS OF OPERATIONS
Aptose Biosciences Inc.
Statements of Operations Data
(unaudited)
($ in thousands, except for share and per share data)

Three months ended
September 30,
Nine months ended
September 30,
2025
2024
2025
2024
Operating expenses:
Research and development $ 2,205 $ 4,702 $ 7,867 $ 15,560
General and administrative 2,708 2,263 9,428 8,510
Total operating expenses 4,913 6,965 17,295 24,070
Other (expense) income, net (210 ) 12 (414 ) 225
Net loss $ (5,123 ) $ (6,953 ) $ (17,709 ) $ (23,845 )
Net loss per share, basic and diluted $ (2.01 ) $ (11.33 ) $ (7.34 ) $ (44.41 )
Weighted average number of common shares outstanding used in the calculation of basic and diluted loss per common share
2,552,429 613,604 2,411,943 536,891

Net loss for the quarter ended September 30, 2025 decreased by $1.8 million to $5.1 million, as compared to $7.0 million for the comparable period in 2024. Net loss for the nine months ended September 30, 2025 decreased by $6.1 million to $17.7 million, as compared to $23.8 million for the comparable period in 2024.

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

September 30, December 31,
2025
2024
Cash, cash equivalents and restricted cash equivalents $ 1,637 $ 6,707
Working capital (3,302 ) 5,053
Total assets 6,341 10,127
Long-term liabilities 18,712 10,193
Accumulated deficit (558,676 ) (540,967 )
Shareholders’ deficit (19,450 ) (4,543 )

Total cash, cash equivalents and restricted cash equivalents as of September 30, 2025 were $1.6 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 November 7, 2025, there were 2,552,429 common shares of the Company ("Common Shares") issued and outstanding. In addition, there were 37,370 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 nine months ended September 30, 2025 and 2024 were as follows:

Three months ended
Nine months ended
September 30,
September 30,
(in thousands) 2025
2024
2025
2024

Program costs – Tuspetinib $ 1,423 $ 4,067 $ 5,135 $ 10,656
Program costs – Luxeptinib 91 (225 ) 290 287
Program costs – APTO-253 - - - 13
Personnel related expenses 661 941 2,258 4,274
Stock-based compensation 30 (81 ) 184 317
Depreciation of equipment - - - 13
Total $ 2,205 $ 4,702 $ 7,867 $ 15,560

Research and development expenses decreased by $2.5 million to $2.2 million for the quarter ended September 30, 2025, as compared to $4.7 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 $1.4 million for the quarter ended September 30, 2025, compared with $4.1 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 increased by approximately $0.3 million during the three months ended September 30, 2025 compared to the comparable period in 2024 due to a refund provided by one of our clinical vendors during the three months ended September 30, 2024.
The Company discontinued further development of APTO-253.
Personnel-related expenses decreased by $0.3 million due to lower headcount for research and development personnel in the current quarter.
Stock-based compensation increased by $0.1 million in the quarter ended September 30, 2025, compared to the comparable period in 2024, primarily due to forfeitures recognized during the three months ended September 30, 2024 in connection with employee terminations during the period.
Research and development expenses decreased by $7.7 million to $7.9 million for the nine months ended September 30, 2025, as compared to $15.6 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 $5.1 million for the nine months ending September 30, 2025, compared to $10.7 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 nine months ended September 30, 2024, as well as lower manufacturing and related development costs.
Program costs for luxeptinib remained consistent during the nine months ended September 30, 2025 compared to the comparable period in 2024.
The Company discontinued further development of APTO-253.
Personnel-related expenses decreased by $2.0 million due to lower headcount for research and development personnel in the current quarter.
Stock-based compensation decreased by approximately $0.1 million in the nine months ended September 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.

(Press release, Aptose Biosciences, NOV 13, 2025, View Source [SID1234659890])

On November 13, 2025 Adagene Inc. ("Adagene") (Nasdaq: ADAG) and Third Arc Bio, Inc. ("Third Arc Bio"), reported a licensing agreement under which Third Arc Bio will utilize Adagene’s SAFEbody technology platform to generate masked CD3 T cell engagers against unique tumor associated antigens. Under the terms of the agreement, Third Arc Bio will receive rights to research, develop and commercialize two candidate molecules worldwide. Adagene will receive an upfront payment of $5 million and is eligible to receive development and commercial-based milestones of up to $840 million (if all milestones and conditions are achieved) as well as royalties on end-user sales. In addition, Adagene has a no-cost option to develop and commercialize these candidate molecules in Greater China, Singapore and South Korea.

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Peter Luo, Ph.D., Chief Executive Officer of Adagene said, "Our SAFEbody technology allows activation of an antibody when it reaches the tumor microenvironment. The resulting wider therapeutic index from improved safety allows for higher dosing and potentially better efficacy, as seen from the data we continue to generate with muzastotug. We’re thrilled that Third Arc Bio will be utilizing our SAFEbody technology for a portion of their exciting pipeline programs."

"Our agreement with Adagene will allow Third Arc Bio to advance highly innovative molecules with a superior therapeutic index and help build on our growing portfolio of novel CD3- and CD28-targeting T cell engagers," said Peter Lebowitz, M.D., Ph.D., Chief Executive Officer of Third Arc Bio. "Adagene’s SAFEbody technology expands the reach of our ArcStim Platform to additional novel targets."

(Press release, Adagene, NOV 13, 2025, View Source [SID1234659889])

On November 12, 2025 BetaGlue Therapeutics ("BetaGlue" or the "Company") a clinical-stage oncology company developing an innovative radiotherapy solution for the targeted treatment of solid tumours, reported that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has approved the Clinical Trial Application for YntraDose in unresectable Locally Advanced Pancreatic Ductal Adenocarcinoma (LA-PDAC).

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The clinical study is an early feasibility clinical investigation and will assess safety and performance in patients with unresectable locally advanced pancreatic ductal adenocarcinoma. LA-PDAC remains a significant health concern and an unmet medical need. The incidence of LA-PDAC has increased by 1.0% per year since the late 1990s, and it is projected to become the second-leading cause of cancer-related mortality by 2030.

"The approval by the MHRA represents a fundamental milestone in the clinical development of YntraDose and a meaningful step forward in our commitment to innovation in oncology," said Alexis Peyroles, CEO of BetaGlue Therapeutics. "This authorization enables us to initiate our first clinical study in the UK in Q1 2026, marking a critical step toward delivering a novel therapeutic option for patients with unresectable locally advanced pancreatic cancer, one of the most aggressive and deadly malignancies. We are proud of the dedication shown by our team and Clinical Advisory Board and grateful for the collaborative engagement with regulatory authorities".

(Press release, BetaGlue Therapeutics, NOV 12, 2025, View Source [SID1234661240])