Purple Biotech Announces Three Posters Accepted for Presentation at the 2025 American Association for Cancer Research Meeting

On March 28, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported upcoming poster presentations including one for CM24 in the treatment of pancreatic cancer, and two for NT219 in the treatment of colorectal and head and neck cancers, at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting (2025 AACR (Free AACR Whitepaper)), scheduled to take place from April 25th to April 30th in Chicago (Press release, Purple Biotech, MAR 28, 2025, View Source [SID1234651586]). Presentation details are below:

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Abstract Title: Final analysis of the randomized Phase 2 cohort of CM24 with nivolumab and chemotherapy in pancreatic cancer & potential serum biomarkers

Session Title: Liquid Biopsy: Circulating Nucleic Acids 4 / Predictive Biomarkers 1

Session Date and Time: Wednesday, April 30, 9:00 a.m. – 12:00 p.m.

Abstract Title: APC-loss as a potential biomarker for NT219 treatment in colorectal cancer (CRC)

Session Title: Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes

Session Date and Time: Sunday, April 27, 2:00 – 5:00 p.m.

Abstract Title: NT219 overcomes immune evasion-resistant mechanisms in head and neck squamous cell carcinoma (HNSCC)

Session Title: Novel Drug Resistance Mechanisms

Session Date and Time: Monday, April 28, 2:00 – 5:00 p.m.

Sensei Biotherapeutics Reports Full Year 2024 Financial Results and Update on Clinical Progress

On March 28, 2025 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported financial results for the full year 2024, and provided corporate updates (Press release, Sensei Biotherapeutics, MAR 28, 2025, View Source [SID1234651587]).

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"2024 was a pivotal year for Sensei, as we advanced solnerstotug through dose expansion and began to demonstrate its clinical potential in patients who have progressed on and are resistant to PD-(L)1 therapy" said John Celebi, President and CEO of Sensei Bio. "The responses we’ve observed in PD-(L)1 resistant tumors are highly encouraging and we believe support solnerstotug’s differentiated approach to targeting VISTA. In the context of available data across checkpoint inhibitor regimens, solnerstotug stands out for its encouraging response rates and favorable tolerability profile in PD-(L)1 resistant tumors, a setting with limited treatment options and no approved therapies targeting VISTA. We are now focused on completing dose expansion for patients on study and finalizing a robust Phase 2 strategy."

Highlights and Milestones

Solnerstotug (formerly SNS-101) is a conditionally active antibody designed to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation) within the tumor microenvironment. VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates.

Sensei is conducting a multi-center Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of solnerstotug as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced solid tumors. Recent updates include:

Preliminary Activity in PD-(L)1 Resistant "Hot" Tumors
In March 2025, Sensei presented preliminary dose expansion data showing, as of the data cutoff of March 17, 2025:
Among 21 evaluable PD-(L)1 resistant "hot" tumor patients, the combination of solnerstotug + cemiplimab demonstrated a 14% ORR (overall response rate), which is almost 3x higher than historical PD-(L)1 rechallenge response rates (≤5%), and a 62% DCR (disease control rate), suggesting meaningful disease control in resistant tumors.
One durable complete response in a patient with Merkel Cell Carcinoma (MCC).
Two partial responses (PRs): one in a second MCC patient and one in a microsatellite instability-high (MSI-H) Colorectal Cancer (CRC) patient.
All patients with tumor shrinkage remain on treatment, suggesting potential for prolonged clinical benefit.
An additional 11 patients have not yet reached the first baseline scan, and an additional eight patients discontinued the study prior to any post-baseline scan.
All patients in this cohort had progressed on prior PD-(L)1.
Yesterday, Sensei hosted an investor webcast to discuss the dose expansion data, featuring Company leadership and Dr. Shiraj Sen, M.D., Medical Oncologist and Director of Clinical Research at NEXT-Oncology, Dallas, an investigator on the Phase 1/2 study. The replay of the webcast is available here.

Favorable Safety Profile:
Solnerstotug continues to be well tolerated, with no dose-limiting toxicities and the majority of AEs Grade 1 or 2 in severity to date. Out of 60 patients, there have been four (7%) cases of Grade 1 cytokine release syndrome (CRS), all mild and manageable. Two patients in the combination cohort experienced immune-mediated events.
Clinical Progress and Outlook:
Target enrollment (n=60) in the dose expansion cohort has been achieved.
Full expansion data expected by year-end 2025.
Scientific and Clinical Visibility:
Sensei presented new data and mechanistic insights across multiple forums in 2024:
SITC 2024: Spatial proteomic profiling of VISTA and PSGL-1 in diverse tumor types.
Nature Communications: Sensei published a peer-reviewed research paper in Nature Communications in April 2024 describing the mechanism of action of solnerstotug selectively targeting the active form of VISTA within the tumor microenvironment.
PEGS Europe, IO360, Keystone Symposia, and others: Continued showcasing of solnerstotug and the TMAb platform.
Corporate Updates

In Q4, Sensei implemented an organizational restructuring to streamline operations and focus resources on clinically advancing solnerstotug.
Appointed Josiah Craver as Senior Vice President of Finance and later as Principal Financial and Accounting Officer.
Named Ron Weitzman, M.D., F.A.C.P., as part-time Chief Medical Officer.
Year End 2024 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $41.3 million as of December 31, 2024, as compared to $65.8 million as of December 31, 2023. Sensei expects its current cash balance to fund operations into the second quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses were $18.6 million for the year ended December 31, 2024, compared to $18.3 million for the year ended December 31, 2023. The increase in R&D expenses was primarily attributable to higher expense associated with clinical trials and one-time employee termination benefits primarily offset by lower preclinical research expense and consulting fees.

General and Administrative (G&A) Expenses: G&A expenses were $13.0 million for the year ended December 31, 2024, compared to $18.8 million for the year ended December 31, 2023. The decrease in G&A expense was primarily attributable to lower costs for external professional services, lower personnel costs, and lower insurance costs.

Net Loss: Net loss was $30.2 million for the year ended December 31, 2024, compared to $34.1 million for the year ended December 31, 2023.

4SC AG provides results for financial year 2024 and outlook for 2025

On March 28, 2025 4SC AG (4SC, FSE Prime Standard: VSC) reported its financial results for the financial year ended 31 December 2024, presenting all material reporting period developments and providing an outlook for 2025 (Press release, 4SC, MAR 28, 2025, View Source [SID1234651591]). The full report is available at 4SC’s website.

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Jason Loveridge, Ph.D., CEO of 4SC, commented: "4SC continues to be one hundred percent focused on the development of resminostat and as such has now responded to the EMA’s180 Day Assessment Report within the required deadline. 4SC is now awaiting further feedback from the Committee for Medicinal Products for Human Use, which is still expected around the end of April 2025. Depending on the decision of the CHMP we will then consider what could be the future direction of the Company."

Key highlights of 2024
4SC had a very busy year in 2024, with key achievements summarized below, and further detail provided in respective press releases.

In February 2024, at an Extraordinary General Meeting the Management and Supervisory Boards fulfilled their duty to inform the shareholders of a loss amounting to half of the share capital in accordance with the rules pursuant to Section 92 (1) German Stock Corporation Act (AktG).
Also in February 2024, 4SC AG submitted its Marketing Authorisation Application (MAA) for resminostat in advanced CTCL to the European Medicines Agency (EMA) and this was accepted – by the EMA – as sufficient for examination by the beginning of March 2024.
In March 2024, 4SC entered into a second loan agreement with Santo Holding (Deutschland) GmbH (Santo Holding) giving the Company access to a further €3.5 million in available funding.
In April 2024, the company announced that the renowned dermato-oncology expert and principal investigator of the RESMAIN study, Professor Dr. Rudolf Stadler (University Hospital Johannes Wesling, Minden, Germany) presented landmark data from the pivotal RESMAN study of resminostat (Kinselby) at the 5th World Congress of Cutaneous Lymphomas (5WCCL), in Pasadena, California, USA.
Also in April 2024, 4SC received a Pediatric Investigation Plan (PIP) product-specific waiver from the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for resminostat (Kinselby).
In May 2024, 4SC entered into a partnership with Vuja De Sciences, Inc., New Jersey, USA (Vuja De) – a US based biotech company focused on evaluating domatinostat in combination with Rapamycin in cancers such as recurrent metastatic osteosarcoma and refractory sarcomas.
In July 2024, 4SC announced that it had been granted Orphan Drug Status for resminostat (Kinselby) in CTCL in Switzerland.
In September 2024, 4SC completed a capital increase from authorized capital by issuing a total of 792,080 of new no-par value bearer shares, each with a notional par value of €1.00. At a subscription price of €5.05 per offered share, 4SC secured gross proceeds of circa €4.0 As a result of the transaction, 4SC’s share capital increased from €10,114,009 to €10,906,089. The new shares were subscribed for by the Company’s main shareholder, Santo Holding. Statu­tory subscription rights were excluded pursuant to Section 186 Para. 3 sentence 4 of the German Stock Corporation Act (Aktiengesetz).
Business outlook for 2025
4SC is fully focused on the registration of resminostat (Kinselby) in the key geographies of the European Union, UK and Switzerland. Subject to a final decision from the EMA, the opportunity for value creation through the commercialization of resminostat (Kinselby) in the EU remains possible, but subject to very significant risk given EMA’s 180 Day Assessment Report issued in March 2025. 4SC AG has recently responded to the EMA’s Day-180 Assessment Report within the required deadline and expects to receive feedback from the Committee for Medicinal Products for Human Use (CHMP) around the end of April 2025. Depending on the decision of the CHMP the Management Board will then consider all options for the future direction of the Company.

In the meantime, it is likely that the Company will continue to report annual net losses in the short to medium term future.

4SC continued to hold discussions with potential partners in the pharmaceutical industry regarding resminostat (Kinselby) in 2024 and early 2025, but these are currently on hold until it is clear the MAA is approvable.

For Japan, 4SC has an ongoing Collaboration Agreement with Yakult Honsha for the commercialization of resminostat (Kinselby).

Cash balance development in full year 2024 and financial forecast
4SC’s cash balance/funds were at €8,311 thousand on 31 December 2024. The average monthly operating cash burn in 2024 was €626 thousand, which was between the forecast range of €600 thousand and €900 thousand for 2024. Taking into account the current financial planning and the intended operating activities, the Management Board estimates that currently available funds should be sufficient to finance 4SC for at least the next 12 months of operations and in particular, to receive a final decision from the EMA with respect to the company’s MAA for resminostat (Kinselby).

Whilst 4SC’s funds of €8,311 thousand (at the end of 2024) represent a solid cash position, management remains cautious as to 4SC’s ability to raise additional funds through further capital measurements and or to generate income from business partners.

For 2025, 4SC is expecting an average monthly use of cash from operations of between €400 thousand and €700 thousand. 4SC estimates that the net loss will decrease significantly in 2025 as compared to 2024, due mainly to the completion of the open label component of the RESMAIN study and the filling of responses to the EMA in relation to 4SC’s MAA in late 2024.

SkylineDx presents landmark findings from the largest prospective multicenter melanoma GEP trial at SSO 2025

On March 28, 2025 SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology , inflammatory and infectious diseases, proudly reported Dr. Tina Hieken, a surgical oncologist at Mayo Clinic and one of the principal investigators of the groundbreaking MERLIN_001 study, will present new data at the 2025 Society of Surgical Oncology (SSO) Annual Meeting (Press release, SkylineDx, MAR 28, 2025, View Source [SID1234651592]). Dr. Hieken’s presentation, titled Prospective Multicenter Evaluation (MERLIN_001 Trial) of a Clinicopathologic and Gene Expression Profile Test to Predict Sentinel Node Status in T1-T3 cN0 Melanoma, will showcase the final results of this pivotal study, which demonstrates the accuracy of the Merlin CP-GEP test in predicting sentinel lymph node (SLN) metastases in melanoma patients.

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The MERLIN_001 trial is the largest prospective, blinded study, to evaluate the Merlin CP-GEP test, which is the only commercially avialable GEP test that combines clinical, pathological, and gene expression data into a single algorithm to predict SLN positivity. The study was conducted at 9 renowned US hospitals, which are also top-ranking oncology academic centers. The study’s findings validate the test’s superior predictive accuracy compared to traditional clinical and pathological factors, which currently guide sentinel lymph node biopsy (SLNB) decisions in melanoma.

A total of 1,802 patients were included for whom SLN biopsy material was available. CP-GEP achieved an assay success rate of 97.7%, thus a total of 1,761 patients could be enrolled. The National Comprehensive Cancer Network (NCCN) clinical guidelines recommend SLNB surgery for patients with >10% risk of nodal metastases. This cohort had a 17.6% overall SLNB positivity rate, suggesting effective referral of patients based on current factors. However, 82.4% of patients had a negative sentinel node suggesting no therapeutic benefit from the sentinel node operation.

How did Merlin CP-GEP test provide more precise risk stratification, allowing physicians to further optimize SLNB referral decisions and personalize treatment plans? Key findings from the MERLIN_001 study:

In this cohort a total of 31 T1a patients with adverse features were referred for SLNB surgery. Merlin identified 80.6% as Low Risk for nodal metastases at a negative predictive value (NPV) of 100%. These patients could consider forgoing SLNB surgery as their risk of nodal metastases is close to 0%. Six patients were identified as Merlin High Risk. Their risk of metastases was with 16.7% well above the >10% guideline threshold, therefore these patients should be referred for surgery.
Among the 479 T1b patients, Merlin test identified 67.6% as Low Risk for nodal metastases with a 94.8% NPV. These patients could consider forgoing SLNB surgery as their risk of metastases is close to 5%. Additionally, T1b patients with a Merlin High Risk label had a 16.1% SLNB positivity rate and should be referred for surgery.
The study’s findings are particularly significant for T2a melanoma patients. This patient subgroup had an SLN positivity rate of 15.5%. Merlin test identified 36.6% as Low Risk at an NPV of 91.9%, reducing their metastatic risk below the 10% threshold for SLNB surgery recommendation. Reclassification of these T2a patients gives them access to more personalized treatment options.
The Merlin CP-GEP test also demonstrated exceptional performance in other subgroups, particularly in head and neck melanoma patients. SLNB surgery in this group poses unique challenges due to complex lymphatic drainage and vital anatomical structures. Merlin test identified 43.3% as Low Risk for nodal metastases with an NPV of 95.1%. These patients could consider forgoing SLNB surgery as their risk of metastases is below 5%.
"The MERLIN_001 study provides a transformative approach to melanoma risk assessment, ensuring that we can better personalize care for our patients. The test not only refines risk stratification but also addresses critical subgroups, such as head and neck melanoma patients and elderly individuals, who often face complex treatment decisions. By leveraging this groundbreaking tool, we can confidently guide SLNB recommendations and optimizing patient outcomes," said Dr. Tina Hieken.

"The MERLIN_001 study results are a breakthrough in melanoma care," said Dharminder Chahal, CEO of SkylineDx. "As the only company to have conducted this large, prospective, blinded trial of the Merlin CP-GEP test in collaboration with esteemed academic institutions in the U.S., we are committed to empowering clinicians with a rigorously validated test backed by high-quality evidence, ensuring patients receive the most informed care possible ."

The MERLIN_001 study represents a major milestone in melanoma research, with the potential to enhance clinical decision-making and improve patient outcomes. By offering more accurate risk assessments, the Merlin CP-GEP test empowers healthcare providers to tailor treatment plans to the specific needs of melanoma patients.

About the advanced cutaneous melanoma GEP test (Merlin CP-GEP test)
CP-GEP is a non-invasive prediction model for cutaneous melanoma patients and is the only commercially available GEP test that combines clinicopathologic (CP) variables with gene expression profiling (GEP) into a single integrated algorithm. This CP-GEP model is also the only GEP test that provides a binary stratification of all patients based on being High or Low Risk for metastasis and thereby assign them to the appropriate surgical action categories as listed in evidence-based cancer treatment, prevention and screening guidelines. The advanced generation CP-GEP model was developed by Mayo Clinic and SkylineDx BV and is the latest commercially launched GEP test, which has been clinically validated in multiple studies on a global basis. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com. The test has been launched in the United States and Europe as Merlin test. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase patient access.

Aptose Reports Year End 2024 Results and Corporate Highlights

On March 28, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), 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 year ended December 31, 2024, and provided a corporate update (Press release, Aptose Biosciences, MAR 28, 2025, View Source [SID1234651570]).

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"During 2024 and into 2025, we continue to advance our lead investigational drug tuspetinib in combination with venetoclax (VEN) and azacitidine (AZA) for frontline treatment of newly diagnosed acute myeloid leukemia (AML)," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "Tuspetinib brings favorable safety and broad activity across AML genetic subtypes to the TUS+VEN+AZA triplet therapy, which already has achieved complete remissions (CRs) in difficult-to-treat and underserved TP53-mutated/CK AML and FLT3-wildtype AML patients in our ongoing TUSCANY trial. We look forward to sharing more data as the trial evolves."

Key Corporate Highlights

Tuspetinib Phase 1/2 TUSCANY Trial Well Under Way with Responses Noted – Tuspetinib based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 trial with the goal of creating an improved frontline therapy for newly diagnosed AML patients that is active across diverse AML populations (mutation agnostic triplet frontline therapy), including FLT3-wildtype AML. This activity differentiates TUS from other drugs in development. In January 2025, Aptose announced initiation of dosing in the first TUSCANY trial cohort with the starting dose of 40 mg TUS in combination with standard-of-care doses of VEN+AZA. At 40 mg TUS, the triplet therapy achieved complete remissions (CRs) in difficult-to-treat TP53-muated AML and FLT3-wildtype AML patients, including a measurable residual disease (MRD) negative remission (press release here). In February 2025, amid the promising early results and favorable safety from patients treated at the 40 mg dose level, the Cohort Safety Review Committee (CSRC) monitoring the TUSCANY trial approved escalating to 80 mg TUS in the triplet therapy (press release here). Subjects have now begun treatment at the 80 mg TUS dose level of the triplet therapy and further recruitment is under way. No significant safety concerns have been reported to date, including no prolonged myelosuppression of subjects in remission. This TUS+VEN+AZA triplet therapy study in newly diagnosed AML was supported with robust safety and efficacy data from the TUS single agent dose escalation study and the TUS+VEN doublet APTIVATE study in relapsed or refractory (R/R) AML, both of which were completed during 2024 after treating more than 170 patients.
Financing Activity – During 2024, Aptose completed several financings for a total of approximately $37 million to support the TUS-based TUS+VEN+HMA triplet therapy development for AML. This included a $10 million loan Facility Agreement with Hanmi Pharmaceutical Co. Ltd. ("Hanmi"). Subsequently in March 2025, Hanmi and Aptose executed a Debt Conversion Agreement to convert a portion of the debt into equity, subject to Hanmi owning no more than 19.99% of the issued and outstanding common shares of Aptose. Therefore, an amount of $1.5 million has been converted into 409,063 common shares as of this date. Beyond the $10 million, Aptose and Hanmi are negotiating a new tuspetinib co-development collaboration agreement intended to provide additional funding to accelerate clinical development of tuspetinib. Aptose licensed tuspetinib from Hanmi Pharmaceutical in November 2021.
Aptose Signs CRADA with NCI – In December, Aptose announced that it entered into a Cooperative Research and Development Agreement ("CRADA") with the National Cancer Institute (NCI), part of the National Institutes of Health (press release here). Under the CRADA, the NCI and Aptose will collaborate on the clinical development of TUS, an inhibitor of key signaling kinases involved in myeloid malignancies, in the NCI Cancer Therapy Evaluation Program (CTEP) sponsored myeloMATCH trials employing combinations of targeted therapy for the treatment of molecularly defined AML and myelodysplastic syndromes (MDS) populations. These trials will be conducted by NCI’s National Clinical Trials Network (NCTN), with the participation of the NCI Community Oncology Research Program (NCORP) in the U.S. and Canada.
Aptose Meets Nasdaq Minimum Bid Compliance – Earlier this month, Aptose announced that it received a written notification from the Listing Qualifications Department of The Nasdaq Stock Market, LLC notifying the Company that it is in compliance with Nasdaq’s minimum bid price requirement (press release here). On March 14, 2025, Nasdaq confirmed that, for ten consecutive business days, the closing bid price of the Company’s common shares has been $1.00 per share or greater. Accordingly, the Company has regained compliance with Listing Rule 5550(a)(2). Separately, Aptose is not in compliance with the $2.5 million shareholders equity requirement and is operating under an exception granted by the Nasdaq Hearing Panel, which provides Aptose additional time to regain compliance, although there is no assurance that the Company will successfully achieve full compliance with the Nasdaq shareholders equity requirement.
Completed and Planned Value-Creating Milestones

2024 Accomplishments

Completed $10 million loan from Hanmi as Advance on Collaboration
Completed $8 million S-1 financing
Executed CRADA with NCI MyeloMATCH for tuspetinib in AML/MDS
Initiated dosing of TUS+VEN+AZA triplet therapy in newly diagnosed AML patients in TUSCANY trial
ASH: Reported CR/Safety from APTIVATE TUS and TUS+VEN trial
ASH: Reported dosing accrual from TUS+VEN+AZA triplet therapy trial
2025: 1H

Demonstrated safety and efficacy with 40mg TUS+VEN+AZA in triplet therapy trial
Dosing 80mg TUS in TUS+VEN+AZA dose cohort in triplet therapy trial
Executed Debt Conversion agreement with Hanmi
Expect to report CR/MRD/Safety data from TUS+VEN+AZA triplet therapy trial
Expect to execute Hanmi/Aptose Collaboration
EHA2025 Congress – Report maturing data readout from TUS+VEN+AZA triplet therapy trial
2025: 2H

Select optimal TUS doses for TUS+VEN+HMA triplet therapy Ph 2/3 pivotal trials
Prepare for Ph 2 portion of Ph 2 / Ph 3 pivotal program
American Society of Hematology (ASH) (Free ASH Whitepaper) Update
FINANCIAL RESULTS OF OPERATIONS
Aptose Biosciences Inc.
Statements of Operations Data
(unaudited)
($ in thousands, except for share and per share data)

Year ended
December 31,
2024 2023
Expenses:

Research and development $ 15,103 $ 36,765
General and administrative 11,154 15,591
Operating expenses 26,257 52,356
Other income, net 827 1,149
Net loss $ (25,430 ) $ (51,207 )

Net loss per share, basic and diluted $ (36.38 ) $ (227.43 )
Weighted average number of common shares outstanding used in computing net loss per share, basic and diluted 698,980 225,154

Net loss for the year ended December 31, 2024 decreased by $25.8 million to $25.4 million, as compared to $51.2 million for the comparable period in 2023.

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

December 31, December 31,
2024
2023
Cash, cash equivalents and restricted cash equivalents $ 6,707 $ 9,252

Working capital 5,071 (3,375 )
Total assets 10,127 12,989
Long-term liabilities 10,211 621
Accumulated deficit (540,967 ) (515,537 )

Shareholders’ deficit (4,543 ) (2,901 )

Total cash, cash equivalents and restricted cash equivalents as of December 31, 2024, were $6.7 million. Based on current operations, the Company expects that cash on hand and available capital provides the Company with sufficient resources to fund planned Company operations including research and development until April 2025.
As of March 21, 2025, we had 2,552,429 Common Shares issued and outstanding. In addition, there were 39,219 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

The research and development expenses for the years ended December 31, 2024 and 2023 were as follows:

Year ended
December 31,
(in thousands) 2024
2023
Program costs – Tuspetinib $ 9,606 $ 24,925
Program costs – Luxeptinib 422 3,510
Program costs – APTO-253 (19 ) 40
Personnel related expenses 4,735 6,878
Stock-based compensation 346 1,373
Depreciation of equipment 13 39
Total $ 15,103 $ 36,765

Research and development expenses decreased by $21.7 million to $15.1 million for year ended December 31, 2024, as compared to $36.8 million for the comparable period in 2023. 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 $9.6 million for the year ended December 31, 2024, compared with $24.9 million for the comparable period in 2023. The lower program costs for tuspetinib in the current year were due to reduced activity in our APTIVATE clinical trial, reduced manufacturing costs, and related expenses. In the comparable period in 2023, Tuspetinib program costs included the healthy volunteer study, which was completed in the same year.
Program costs for luxeptinib decreased by approximately $3.1 million primarily due to lower clinical trial and manufacturing activities.
Program costs for APTO-253 decreased by approximately $59 thousand. This reduction was due to the Company’s decision to discontinue further development of APTO-253.
Personnel-related expenses decreased by $2.1M due to lower headcount 2024.
Stock-based compensation decreased by approximately $1.0 million in the year ended December 31, 2024, primarily due to stock options granted with lower grant date fair values when compared to the options granted in the prior period, coupled with option forfeitures recorded in the current year.