ALX Oncology Reports Second Quarter 2025 Financial Results and Provides Corporate Update

On August 12, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or "the Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported financial results for the three and six months ended June 30, 2025, and provided a corporate update (Press release, ALX Oncology, AUG 12, 2025, View Source [SID1234655124]).

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"In the second quarter, we made significant advances in both our evorpacept and ALX2004 clinical programs," said Jason Lettmann, Chief Executive Officer of ALX Oncology. "On the evorpacept program, we are excited to share data demonstrating the potential of CD47 expression as a predictive biomarker and highlight a clear opportunity to identify patients most likely to achieve the greatest benefit. In this pre-planned analysis we saw that patients with high CD47 expression derived the most clinically meaningful response to evorpacept. These findings shape our clinical development strategy in breast cancer and support the potential to pursue targeted oncology approaches in additional tumor types, given the broad overexpression of CD47 in solid tumors and hematologic malignancies. Importantly, our optimization of the evorpacept clinical program has extended our cash runway into the first quarter of 2027, solidly positioning us to achieve multiple data milestones across our pipeline. In addition, execution is on track for the Phase 1 trial of our highly-differentiated, ADC candidate, ALX2004, which has best-in-class potential for the treatment of EGFR-expressing solid tumors and we anticipate dosing the first patient this month. Finally, I am delighted to announce that Dr. Dan Curran has been appointed to the Board of Directors. Dr. Curran’s illustrious career and breadth of experience across drug discovery and development, corporate strategy and business development, will offer invaluable perspective to help ALX Oncology reach key inflection points in the months ahead."

ALX Oncology Q2 2025 Highlights and Recent Developments

In this pre-planned exploratory analysis of the ASPEN-06 clinical trial in gastric cancer, CD47 overexpression was identified as a key predictive biomarker for response and durable clinical benefit.
In confirmed HER2-positive, CD47-high gastric cancer patients (n=43), evorpacept combined with HERCEPTIN (trastuzumab), CYRAMZA (ramucirumab) and paclitaxel (TRP) achieved an objective response rate (ORR) of 65% compared to 26% with TRP alone. In contrast, in confirmed HER2-positive, CD47-low gastric cancer patients (n=47), evorpacept plus TRP demonstrated a 39% ORR versus 25% with TRP alone.
Duration of response (DOR), progression free survival (PFS), and overall survival (OS) showed strong magnitude of benefit for evorpacept in CD47-high patients.
Full data set will be presented at an upcoming medical conference in the fourth quarter of 2025.
Based on the magnitude of benefit in patients with high CD47 expression in HER2+ gastric cancer, the ASPEN-Breast study in HER2+ breast cancer evaluating evorpacept in combination with trastuzumab and chemotherapy has been amended to a single-arm design in all previously treated HER2 positive patients and will be evaluated by CD47 expression.
The inclusion of both CD47-high and CD47-low patients in the revised single-arm ASPEN-Breast study supports the further evaluation of the predictive value of CD47 as a biomarker for evorpacept.
Revised study design is expected to optimize enrollment and allow for an interim data readout in Q3 2026. Our goal is that the results of this study will support a biomarker-driven registrational study in HER2 positive breast cancer.
Prioritized evorpacept development program to focus on demonstrated potential of CD47 approach in breast cancer and paused ASPEN-CRC study in colorectal cancer to extend cash runway.
Sanofi and ALX Oncology announce the dose escalation portion of the cohort testing evorpacept with SARCLISA (isatuximab-irfc) and dexamethasone within the randomized Phase 1/2 UMBRELLA study in patients with previously treated multiple myeloma is complete. Sanofi will begin the dose optimization portion of the study.
Received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) in April to advance clinical evaluation of ALX2004 for the treatment of epidermal growth factor receptor (EGFR)-positive solid tumors and dosing of the first patient in the Phase 1 clinical trial is anticipated in August.
The Phase 1 dose escalation trial will include patients with relapsed/refractory EGFR-expressing solid tumors, including non-small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma and esophageal squamous cell carcinoma. Initial safety data from the Phase 1 trial is expected to be available in 1H2026.
ALX2004 utilizes a proprietary topoisomerase I inhibitor payload and linker-payload platform, engineered to offer enhanced bystander effect with improved linker stability for on-target delivery of payload, and has an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies. Potent activity in tumor models supports its potential for treating patients with EGFR-expressing tumors. Preclinical model findings did not demonstrate EGFR-related skin toxicity at clinically relevant doses or payload-related interstitial lung disease, indicating a potentially differentiated safety profile.
With these strategic prioritizations, the Company extended its cash runway into Q1 2027. Data milestones expected for ALX2004 and evorpacept clinical programs in 2026 are included in Company’s expected cash runway.
As part of the Company’s commitment to advancing long term growth and operational excellence, Allison Dillon, Ph.D., previously Chief Business Officer has been appointed Chief Operating Officer, effective today.
The Company announces Daniel Curran, M.D., has been appointed to Board of Directors. Dr. Curran is a physician executive who brings extensive experience across business development, corporate strategy, drug discovery and development. Dr. Curran is currently a Managing Partner at Mountainfield Ventures and CEO at Timberlyne Therapeutics. He was previously at Takeda where he was Head of Rare Genetics and Hematology and achieved four global regulatory approvals during his tenure. Prior to this role he was Senior Vice President and Head of the Center for External Innovation (CEI) at Takeda, where he was responsible for all R&D business development, venture investments and academic alliances. Within this role, his team concluded more than 150 transactions, enhancing the pipeline with collaborations across numerous therapeutic areas and modalities. Dr. Curran received his M.D. from the University of Pennsylvania, School of Medicine and MBA from The Wharton School.
Upcoming Clinical Milestones

ASPEN-Breast Cancer: Patient dosing anticipated to begin in Q4 2025 based on updated protocol. Interim data from this trial anticipated in Q3 2026.
ALX2004: Patient dosing anticipated to begin in August; initial safety data from Phase 1 trial in EGFR-expressing solid tumors anticipated in 1H 2026.
Second Quarter 2025 Webcast Information

ALX Oncology will host a teleconference on Tuesday, August 12 at 1:30 p.m. PT/ 4:30 p.m. ET in conjunction with its financial results press release.

Webcast Access: View Source;tp_key=5393f7f102

Participant Listening Options by Phone: To access the conference call, please dial 1-877- 407-0752 or +1-201-389-0912, and ask to be joined into the ALX Oncology Second Quarter 2025 Financial Results Conference Call.
Another option for instant telephone access to the event is to use the Call me link below: View Source;passcode=13755276&h=true&info=company&r=true&B=6

Second Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of June 30, 2025, were $83.5 million. The Company believes its cash, cash equivalents and investments are sufficient to fund planned operations into Q1 of 2027.
Research and Development ("R&D") Expenses: R&D expenses consist primarily of preclinical, clinical and development costs related to the development of the Company’s current lead product candidate, evorpacept, and R&D personnel-related expenses including stock-based compensation. R&D expenses for the three months ended June 30, 2025, were $18.0 million compared to $34.7 million for the prior-year period or a decrease of $16.6 million. This decrease was primarily attributable to a decrease of $8.5 million in clinical and development costs primarily due to less manufacturing of clinical trial materials to support active clinical trials for our lead product candidate, evorpacept, a decrease of $4.1 million in stock-based compensation expense, and a decrease of $2.1 million in personnel and related costs, and a decrease of $1.7 million in preclinical costs due to pipeline prioritization strategy.
General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative personnel-related expenses, including stock-based compensation and other costs such as legal and other professional fees, patent filing and maintenance fees, and insurance. G&A expenses for the three months ended June 30, 2025, were $5.5 million compared to $6.9 million for the prior year period or a decrease of $1.4 million. This decrease was primarily attributable to a decrease in stock-based compensation expense.
Net loss: GAAP net loss was ($25.9) million for the three months ended June 30, 2025, or ($0.49) per basic and diluted share, as compared to a GAAP net loss of ($39.4) million for the three months ended June 30, 2024, or ($0.76) per basic and diluted share. The lower net loss is primarily attributed to lower R&D expenses, partially offset by a $3.2 million long-lived asset impairment charge recorded in the three months ended June 30, 2025 related to leased lab space following the workforce reduction in preclinical research announced in March 2025. Non-GAAP net loss was ($23.7) million for the three months ended June 30, 2025, as compared to a non-GAAP net loss of ($32.1) million for the three months ended June 30, 2024. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

Caris Life Sciences Reports Second Quarter 2025 Financial Results

On August 12, 2025 Caris Life Sciences, Inc. (Nasdaq: CAI), a leading, patient-centric, next-generation AI TechBio company, reported financial results for the quarter ended June 30, 2025 (Press release, Caris Life Sciences, AUG 12, 2025, View Source [SID1234655148]).

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Second Quarter 2025 Financial Highlights

Reported total revenue of $181.4 million, an increase of 81.3% over the corresponding prior year period.
Completed 50,032 clinical therapy selection cases, an increase of 22.0% over corresponding prior year period.
Reported gross margin of 62.7%, a 2,514 bps improvement over corresponding prior year period.
Reported net loss of $71.8 million, including $37.1 million of one-time expense associated with the conversion of redeemable convertible preferred stock, warrants and convertible notes from the initial public offering.
Achieved positive Adjusted EBITDA of $16.7 million.
Achieved positive net cash flow from operating activities of $7.3 million, and positive free cash flow of $5.9 million.
"Our second quarter results show the strength of our comprehensive approach and we look forward to continuing to build on this momentum into the second half of 2025," said David D. Halbert, Founder, Chairman and CEO of Caris Life Sciences.

Recent Operating Highlights

Surpassed 900,000+ profiles and 600,000+ total matched profiles.
529,000+ Whole Exome and 580,000+ Whole Transcriptome profiles.
Welcomed LSU LCMC Health Cancer Center as the 97th member of the Caris Precision Oncology Alliance.
Published landmark Caris Assure platform paper:
Validation of an AI-enabled exome/transcriptome liquid biopsy platform for early detection, MRD, disease monitoring, and therapy selection for solid tumors
Published a study evaluating the largest real-world cohort of tissue-agnostic indications:
Real-world evidence provides clinical insights into tissue-agnostic therapeutic approvals
Published original data in the New England Journal of Medicine independently validating findings on tumor-infiltrating clonal hematopoiesis (TI-CH).
Published manuscript on development and validation of proprietary GPSai.
GPSai: A clinically validated AI tool for tissue of origin prediction during routine tumor profiling
Raised $159.4 million in net proceeds from the pre-IPO financing on April 1, 2025, and $519.5 million in net proceeds from initial public offering in June 2025.
Second Quarter 2025 Summary Financial Results

(amounts in thousands, except case volume, average selling price ("ASP") and per share data)

Q2 2025

Q2 2024

% Change Y/Y

Total revenue

$ 181,398

$ 100,049

81.3

%

Molecular profiling services

162,924

87,656

85.9

%

Pharma research & developmental services

18,474

12,393

49.1

%

Total clinical case volume

50,032

40,998

22.0

%

MI Profile for therapy selection volume

42,886

36,426

17.7

%

Caris Assure for therapy selection volume

7,146

4,572

56.3

%

Total clinical ASP

$ 3,256

$ 2,138

52.3

%

MI Profile for therapy selection ASP

3,379

2,207

53.1

%

Caris Assure for therapy selection ASP

2,519

1,587

58.7

%

Total gross margin

62.7

%

37.5

%

25.2

%

Total operating expenses

$ 131,674

$ 104,565

25.9

%

Total loss from operations

$ (17,989)

$ (67,011)

73.2

%

Net loss

$ (71,790)

$ (66,186)

(8.5)

%

Net loss per share attributable to common shareholders, basic and diluted

$ (7.97)

$ (2.54)

(213.8)

%

Net cash provided by (used in) operating activities

$ 7,288

$ (62,926)

111.6

%

Non-GAAP measures(1)

Adjusted EBITDA

$ 16,713

$ (50,916)

132.8

%

Free cash flow

$ 5,902

$ (65,514)

109.0

%

Consolidated balance sheet data

June 30,

2025

December 31,

2024

Change

Cash, cash equivalents, restricted cash, and marketable securities

$ 724,936

$ 70,229

$ 654,707

Total outstanding debt, net of debt discounts

$ 373,706

$ 379,528

$ (5,822)

(1)

See "Non-GAAP Measures" below.

Second Quarter 2025 Financial Results

Total revenue was $181.4 million for the three months ended June 30, 2025, compared to $100.0 million for the three months ended June 30, 2024, an increase of $81.3 million, or 81.3%.

The increase in total revenue was driven primarily by an 85.9% growth in molecular profiling services revenue, which was $162.9 million for the three months ended June 30, 2025, compared to $87.7 million for the three months ended June 30, 2024. The increase in molecular profiling services revenue was primarily driven by an increase in total clinical case volume and ASP improvements across both therapy selection solutions.

Gross profit, calculated as total revenue less cost of services, for the three months ended June 30, 2025, and 2024, was $113.7 million and $37.6 million, respectively, representing a gross margin of 62.7% and 37.5%, respectively.

Operating expenses were $131.7 million for the three months ended June 30, 2025, compared to $104.6 million for the three months ended June 30, 2024, an increase of $27.1 million, or 25.9%. The increase was primarily driven by increased stock-based compensation expense and headcount-related costs.

Net loss was $71.8 million for the three months ended June 30, 2025, which includes $37.1 million one-time expense associated with the conversion of redeemable convertible preferred stock, warrants and convertible notes from the initial public offering, as compared to $66.2 million for the three months ended June 30, 2024. Net loss per share attributable to common shareholders, basic and diluted which includes a one-time deemed dividend of $384.4 million and one-time adjustments of redeemable convertible stock to redemption value of $61.0 million, was $7.97 per share for the three months ended June 30, 2025, as compared to $2.54 per share for the three months ended June 30, 2024.

Net cash provided by operating activities was $7.3 million for the three months ended June 30, 2025, as compared to net cash used in operating activities of $62.9 million for the three months ended June 30, 2024, a 111.6% improvement. The improvement was driven by improved reimbursement from molecular profiling services, including one-time catch up payments of $35.6 million related to first quarter 2025 MI Cancer seek cases.

2025 Financial Outlook and Guidance

Caris Life Sciences expects full year 2025 revenue to be in the range of $675.0 million to $685.0 million, representing growth of 64% to 66% compared to full year 2024. Clinical therapy selection volume is expected to be in the growth range of 19% to 21% compared to full year 2024.

Conference Call Information

Event: Caris Second Quarter 2025 Financial Results Conference Call

Date: Tuesday, August 12, 2025

Time: 3:30 p.m. CT (4:30 p.m. ET)

Webcast Link: View Source

Accompanying materials will be posted on our investor relations website at View Source prior to the conference call. A replay of the conference call will be available on our investor relations website shortly after the conclusion of the call.

Anixa Biosciences Announces Issuance of Additional U.S. Patent for CAR-T Technology

On August 12, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent Number 12,384,826 covering its chimeric antigen receptor-T cell (CAR-T) technology (Press release, Anixa Biosciences, AUG 12, 2025, View Source [SID1234655125]). This new patent extends protection of Anixa’s CAR-T technology to 2045.

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The allowed claims in this patent encompass core methods and compositions that are fundamental to Anixa’s innovative CAR-T approach. Anixa’s CAR-T platform is specifically designed to address the long-standing challenges of applying CAR-T therapies to solid tumors, positioning the program as a potential breakthrough in immuno-oncology. This newly issued patent builds on Anixa’s growing portfolio of CAR-T intellectual property, collectively designed to protect the platform’s use across multiple tumor types. This patent, along with others, was granted to The Wistar Institute and exclusively licensed to Anixa Biosciences. Anixa’s CAR-T technology is currently in a clinical trial at Moffitt Cancer Center, treating recurrent ovarian cancer patients.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "This issued patent further strengthens our growing intellectual property portfolio and reinforces the potential of our novel CAR-T program. Broadening patent protection is a vital step in supporting the program’s future success, both clinically and commercially."

Mabwell Announces First Patient Dosed in the US Clinical Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated with ADCs

On August 11, 2025 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported the first patient dosing in the U.S. for a clinical study of its novel nectin-4-targeting antibody-drug conjugate (Bulumtatug Fuvedotin, or BFv, R&D code: 9MW2821) in triple-negative breast cancer (TNBC) patients previously treated with antibody-drug conjugate (ADC) (Press release, Mabwell Biotech, AUG 12, 2025, View Source [SID1234655149]). This is the first overseas clinical study of 9MW2821, representing a significant step in Mabwell’s global development of ADC therapeutics.

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The multicenter clinical study (NCT06908928) aims to evaluate the efficacy and safety of BFv in TNBC patients previously treated with a taxane and an antibody-drug conjugate with a topoisomerase inhibitor payload. The first subject has been dosed at Memorial Sloan Kettering Cancer Center.

So far, treatment options for TNBC remain limited. While topoisomerase inhibitor-based ADCs (TOPi-ADCs) are emerging as a mainstream post-standard therapy option, a high proportion of patients progress after TOPi-ADC treatment, indicating significant unmet clinical needs due to the lack of alternative therapies.

BFv is a novel Nectin-4 targeting ADC leveraging next-generation site-specific conjugation technology. Composed of a novel antibody, an optimized linker, and cytotoxic payload MMAE (Monomethyl auristatin E), it has good profile of tumor binding and target specificity. BFv is protected by multiple patents in China and internationally through the PCT. Studies demonstrate its superior characteristics including more homogeneous components, significantly lower toxin release in plasma and enhanced cytotoxic payload delivery efficiency which leads to substantially increased intratumoral drug concentration.

Considering high expression of Nectin-4 in TNBC, BFv’s clinical study on TNBC imposes no biomarker screening requirements, holding potential for broad patient coverage and offering a novel therapeutic option for TNBC patients.

About Triple-negative breast cancer (TNBC)

TNBC accounts for approximately 15% to 20% of all breast cancer cases globally, and is generally thought as a subtype with the most malignancy due to the lack of specific therapeutic targets. The global number of incident cases of TNBC increased from 320.1 thousand in 2019 to 361.2 thousand in 2023, and is expected to further increase to 479.4 thousand in 2032. In China, the number of incident cases of TNBC increased from 49.5 thousand in 2019 to 54.8 thousand in 2023, and is expected to further increase to 65.4 thousand in 2032.

About Bulumtatug Fuvedotin

Bulumtatug Fuvedotin (BFv) is a novel Nectin-4 targeting ADC using Mabwell’s proprietary next-generation IDDC platform. It stands out as the first clinical-stage drug candidate among Chinese companies for this specific target. And it’s the first Nectin-4 targeting ADC to disclose clinical efficacy data in cervical, esophageal, and breast cancers. For urothelial carcinoma, both monotherapy and combination therapy with a PD-1 inhibitor have advanced to Phase III clinical studies, making it the first among Chinese candidates and second globally in this field, and have been granted Breakthrough Therapy Designation by CDE of NMPA in China. For cervical cancer, it is the first Nectin-4-targeting ADC worldwide to enter Phase III studies. BFv has been granted multiple Fast Track designations (including for locally advanced or metastatic Nectin-4-positive triple-negative breast cancer) and Orphan Drug designation by US FDA.

Aprea Therapeutics Reports Second Quarter 2025 Financial Results and Provides a Clinical Update

On August 12, 2025 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Aprea, AUG 12, 2025, View Source [SID1234655126]).

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"We are pleased with our progress in 2025, as emerging data from both of our lead programs demonstrate evidence of clinical activity," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "In the ACESOT-1051 trial of our oral WEE1 inhibitor APR-1051, we have observed three patients with stable disease to date, one in the 70mg cohort and two in the 100mg cohort, including an early clinical signal in an HPV-positive head and neck squamous cell carcinoma, and in rectal and uterine cancer patients. For our macrocyclic ATR inhibitor, ATRN-119, the ongoing dose escalation study has shown early activity, with seven patients achieving stable disease to date, including three with meaningful tumor shrinkage at the 550 mg twice daily dose. Overall, these early signs of clinical validation continue to strengthen our confidence in the potential of our DDR assets and to deliver meaningful therapeutic advances for patients with cancer."

Key Business Updates and Potential Upcoming Key Milestones

ACESOT-1051: A Biomarker Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051

APR-1051 is a potent and selective small molecule WEE1 inhibitor designed to potentially solve tolerability challenges of the WEE1 class and may achieve greater clinical activity than other programs currently in development. Aprea is advancing APR-1051 as monotherapy in cancers with well-defined biomarkers that may predict sensitivity to WEE1 inhibition. Among these, cancers over-expressing Cyclin E represent a high unmet medical need. Patients with Cyclin E over-expression have poor prognosis and, currently, lack effective therapies options.
Patients are currently being enrolled at the 100 mg once-daily dose level in the ongoing Phase 1 ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051). Based on data to date, APR-1051 has demonstrated an encouraging tolerability profile. Following successful clearance of the 100 mg cohort, dose escalation is expected to continue with enrollment at 150 mg level. Earlier in 2025, the dosing schedule was revised based on pharmacokinetic data to potentially further support a higher therapeutic window.
Enrollment criteria in the ACESOT-1051 trial have been expanded to include patients with HPV+ tumors. Evidence of early disease control has been observed in a patient diagnosed with HPV+ head and neck squamous cell carcinoma (HNSCC) treated with a subtherapeutic 70 mg once daily oral dose of APR-1051. At the first radiographic assessment, this patient was noted to have stable disease with a 5% tumor reduction.
Additional safety and efficacy data from the ACESOT-1051 study are anticipated in the second half of 2025, with completion of the dose-escalation phase expected in the first half of 2026. Aprea intends to submit an abstract to a major oncology conference.
Pending additional data, future arms of ACESOT-1051 may evaluate APR-1051 in combination with checkpoint inhibitors to address unmet medical needs across distinct patient populations.
For more information, refer to ClinicalTrials.gov NCT06260514.
Collaboration with MD Anderson Cancer Center

Aprea entered into a translational research collaboration with MD Anderson Cancer Center earlier in 2025. New preclinical results on APR-1051 showed: 1) potent single-agent activity for APR-1051 across a broad panel of human and murine head and neck cancer cell lines, including HPV+ subtypes, and 2) significant anti-tumor synergy with APR-1051 plus anti–PD-1 therapies in HPV+ HNSCC models, positioning APR-1051 as a candidate for combination-based clinical trials.
ABOYA-119: Ongoing Clinical Trial Evaluating ATR inhibitor, ATRN-119

ATRN-119 is a potent and highly selective first-in-class macrocyclic ATR inhibitor, designed and developed to be used in patients with mutations in DDR-related genes. Cancers with mutations in DDR-related genes represent a high unmet medical need. These patients often have a poor prognosis and currently lack effective therapeutics options.
ATRN-119 is being evaluated in the open-label Phase 1/2a clinical trial (ABOYA-119) as monotherapy in patients with advanced solid tumors having at least one mutation in a defined panel of DDR-related genes. Seven patients have demonstrated stable disease to date, with three patients in the 550 mg twice daily cohort showing tumor shrinkage of 7%, 14% and 21%. Dose limiting toxicity was observed in two patients at 550 mg twice daily. Patients are now being dosed at a 400 mg twice daily schedule to further refine and optimize therapeutic efficacy and tolerability.
Additional safety and efficacy data from ABOYA-119 are expected in the second half of 2025 and the recommended Phase 2 dose is expected to be identified in the first half of 2026.
Pending additional data, future arms of ABOYA-119 may evaluate ATRN-119 in combination with other therapies to address unmet medical needs for a distinct patient population.
For more information on ABOYA-119, please refer to clinicaltrials.gov NCT04905914.
Select Financial Results for the Second quarter Ended June 30, 2025

As of June 30, 2025, the Company reported cash and cash equivalents of $16.5 million compared to $22.8 million as of December 31, 2024. The Company believes its cash and cash equivalents as of June 30, 2025, will be sufficient to meet its currently projected operating expenses and capital expenditure requirements into Q2 2026.
For the second quarter ended June 30, 2025, the Company reported an operating loss of $3.4 million, compared to an operating loss of $3.8 million in the second quarter of 2024.
Research and Development (R&D) expenses were $1.9 million for the quarter ended June 30, 2025, compared to $2.6 million for the second quarter of 2024. The decrease in R&D expense was primarily related to higher expenses in 2024 related to study start up activities in preparation for enrollment of the first patient into ACESOT-105, our Phase 1 dose-escalation study of APR-1051, and a decrease in personnel costs.
General and Administrative (G&A) expenses were $1.6 million for the quarter ended June 30, 2025, compared to $1.9 million for the second quarter of 2024. The decrease in G&A expense was primarily related to a decrease in professional fees primarily related to legal expenses and a decrease in personnel costs.
The Company reported a net loss of $3.2 million ($0.53 per basic share) on approximately 6.1 million weighted average common shares outstanding for the quarter ended June 30, 2025, compared to a net loss of $3.5 million ($0.58 per basic share) on approximately 5.9 million weighted average common shares outstanding for the comparable period in 2024.