On August 12, 2025 Artios Pharma Limited ("Artios"), a biopharmaceutical company committed to realizing the therapeutic power of targeting the DNA damage response ("DDR") in cancer, reported the appointment of Mike Andriole as Chief Executive Officer (CEO) and Director (Press release, Artios Pharma, AUG 12, 2025, View Source [SID1234655127]). He joins the company with a biopharmaceutical career that spans nearly 25 years, marked by a consistent theme of focused execution across clinical, corporate, and strategic development. His appointment supports the company’s transition into a late-stage clinical organization preparing for the potential commercialization of alnodesertib (formerly ART0380) in ATM-deficient solid tumors. Mike Andriole succeeds Niall Martin, Artios’ founding CEO, who will remain an advisor to the company through a transition period.

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"On behalf of the Board, I’m thrilled to welcome Mike Andriole to Artios. As the company advances its lead program into later stages of clinical development, Mike’s extensive late-stage oncology experience and strategic focus make him a perfect fit to lead Artios," said Samantha Truex, newly appointed Board Chair. "I’d like to thank Niall for his outstanding leadership and dedication. He has built Artios based on fundamental scientific leadership in the DDR space and has been instrumental in guiding Artios from its discovery platform roots to having two DNA damage response-based therapeutic candidates in the clinic."

"Artios is entering its next chapter with tremendous momentum as a leader in the DDR field capable of redefining standards of care in the treatment of certain solid tumors," said Mike Andriole, Chief Executive Officer of Artios. "I’m excited to lead the company at this pivotal stage and build on its strong scientific foundation as we take alnodesertib into late-stage development and prepare for potential commercialization. I look forward to collaborating with the talented Artios team to deliver on our mission to bring life-changing first-in-class therapies to patients worldwide who have few treatment options."

Mike Andriole joins Artios after having most recently served as President, CEO and Director of Chimerix, Inc., where he led the company’s acquisition and development of dordaviprone (Modeyso), a first-in-class small molecule imipridone approved on August 6, 2025, as the first treatment for recurrent H3 K27M-mutant diffuse midline glioma, a type of malignant brain tumor in children and young adults. Chimerix was acquired in April 2025 by Jazz Pharmaceuticals in a $935 million all-cash transaction. Previously, he was Chief Financial Officer and head of corporate development at Endocyte, Inc., where he led a series of strategic transactions that culminated in a $2.1 billion all-cash acquisition by Novartis driven by the late-phase development of its first-in-class targeted radioligand therapy, Lu177-PSMA-617, which later became the first product approved specifically for PSMA-positive metastatic castration resistant prostate cancer (Pluvicto). Earlier in his career, Mike spent 16 years at Eli Lilly and Company in various financial, marketing, and global business development roles.

About Alnodesertib (ART0380)

Alnodesertib, formerly known as ART0380, is a first-in-class, orally administered, selective small molecule inhibitor of ataxia-telangiectasia and Rad3-related protein (ATR). Artios’ differentiated approach combines alnodesertib with a low dose of the chemotherapy irinotecan, targeting cancers with high endogenous replication stress, such as those with ATM protein deficiency. Data presented at the AACR (Free AACR Whitepaper) Annual Meeting 2025 from the ongoing STELLA Phase 1/2a clinical trial demonstrated a 50% confirmed overall response rate (cORR) in patients with ATM-negative solid tumors at the recommended Phase 2 dose (RP2D), along with a favorable safety profile. In addition, the data highlighted two confirmed complete responses in patients with heavily pretreated pancreatic cancer as well as partial responses in patients with pancreatic cancer, colorectal cancer, and six other ATM deficient tumor types.

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.

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."

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.

On August 12, 2025 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported financial results for the second quarter ended June 30, 2025, and provided operational updates (Press release, ADC Therapeutics, AUG 12, 2025, View Source [SID1234655123]).

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"Entering the second half of 2025, we have streamlined our strategic focus and strengthened our financial foundation, which now allows us to pursue multiple promising opportunities to expand ZYNLONTA into earlier lines of therapy in DLBCL and indolent lymphomas," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We recently shared impressive efficacy data from our LOTIS-7 study of ZYNLONTA plus glofitamab in patients with relapsed or refractory DLBCL and have additional key clinical milestones anticipated through 2026. These milestones include LOTIS-5 achieving the prespecified PFS event target this year and a ZYNLONTA sBLA filing anticipated in 2026, in addition to ongoing Phase 2 investigator-initiated trials in indolent lymphomas. We remain committed to executing our strategy with discipline as we pursue the substantially larger therapeutic opportunity for ZYNLONTA."

Second Quarter 2025 Operational Updates & Recent Highlights

•Completed private investment in public equity (PIPE) financing extending expected cash runway to 2028. The Company entered into a securities purchase agreement for the sale of its equity securities to certain institutional investors in a $100 million PIPE financing, of which the net proceeds of $93.1 million are anticipated to fund multiple catalysts supporting ZYNLONTA’s clinical development and commercialization activities.
•LOTIS-7 data presentations at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress (EHA2025) and the 18th International Conference on Malignant Lymphoma (ICML) highlighted high response rates and manageable safety and tolerability of ZYNLONTA plus glofitamab (COLUMVI) in patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL). As of the April 2025 cutoff, data from the Phase 1b clinical trial showed an overall response rate (ORR) of 93.3% and a complete response (CR) of 86.7% among the 30 efficacy evaluable patients enrolled in the study. Among the 41 safety evaluable patients, the combination was generally well tolerated with a manageable safety profile and no dose-limiting toxicities across dose levels. The Company expects to engage with the U.S. Food and Drug Administration (FDA) and provide an update on the LOTIS-7 trial in the second half of 2025. Once sufficient data with longer follow-up is available, the Company plans to pursue publication and compendia inclusion in the first half of 2027.

•LOTIS-5 remains on track to reach prespecified progression-free survival (PFS) events by the end of 2025. After the prespecified number of PFS events is reached and data are available, the Company expects to provide topline data on the Phase 3 confirmatory trial evaluating ZYNLONTA in combination with rituximab in patients with 2L+ DLBCL. A potential supplemental Biologics License Application (sBLA) submission to regulatory authorities is anticipated in the first half of 2026, with potential confirmatory approval in 2L+ DLBCL and publication and compendia inclusion in the first half of 2027.
•Updated data from the investigator-initiated trial presented at ICML demonstrated the potential of ZYNLONTA as a monotherapy in r/r marginal zone lymphoma. The updated data presented by Izidore S. Lossos, MD, Chief, Division of Hematology Lymphoma Section, at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, demonstrated an ORR of 84.6% (22/26) and a CR of 69.2% (18/26) with a manageable safety profile. The Phase 2, single-arm, open-label, multicenter trial is being conducted at the Sylvester Comprehensive Cancer Center, City of Hope, Emory Winship Cancer Institute and Vanderbilt-Ingram Cancer Center. The Company plans to assess a potential regulatory pathway. In addition, once sufficient data is available, a potential publication and compendia inclusion is anticipated in the first half of 2027.
•IND-enabling activities advancing for PSMA-targeting ADC. IND-enabling activities are underway for the Company’s exatecan-based, prostate-specific membrane antigen (PSMA)-targeting ADC, which has been selected for advancement. Completion of these activities is expected by the end of 2025.
•Announced strategic restructuring and prioritization plan, discontinuing early development efforts for the remaining preclinical programs in solid tumors and focusing on ZYNLONTA. As research and development efforts and related programs are closed out, the Company plans to shut down its UK facility and reduce the global workforce across functions by approximately 30%, which is expected to be substantially completed by September 30, 2025.

Second Quarter and First Half 2025 Financial Results

•Product Revenues: Net product revenues were $18.1 million for the second quarter ended June 30, 2025, and $35.5 million for the first six months of 2025 as compared to $17.0 million and $34.9 million for the same periods in 2024. The period-over-period changes were primarily driven by higher sales price and variability in sales volume.
•Research and Development (R&D) Expense: R&D expense was $30.1 million for the three months ended June 30, 2025, and $59.0 million for the six months ended June 30, 2025, as compared to $24.3 million and $50.0 million for the same periods in 2024. The increases in R&D costs were driven by timing and enrollment of our ZYNLONTA clinical trials LOTIS-5 and LOTIS-7, and an increase in IND-enabling activities for our PSMA-targeting ADC. These increases were partially offset by a reduction in spending on discontinued programs.
•Selling and Marketing (S&M) Expense: S&M expense was $10.1 million and $20.7 million for the three and six months ended June 30, 2025, respectively, compared to $10.7 million and $22.1 million for the same periods in 2024. The period-over-period decreases were primarily due to a reduction in marketing and advertising expenses.
•General & Administrative (G&A) Expense: G&A expense was $8.8 million and $18.8 million for the three and six months ended June 30, 2025, respectively, compared to $10.2 million and $22.7 million for the same periods in 2024. The reductions in G&A expense were primarily due to lower external professional fees.
•Restructuring, impairment and other related costs: In connection with the strategic reprioritization and restructuring plan announced in June 2025, the Company incurred $13.1 million in restructuring and impairment costs for the three and six months ended June 30, 2025, which consisted of $6.7 million in employee severance and related benefit costs, and $6.4 million in non-cash impairment of assets in connection with the close down of the UK facility.
•Net Loss: Net loss for the quarter ended June 30, 2025, was $56.6 million, or a net loss of $0.50 per basic and diluted share, as compared to a net loss of $36.5 million, or a net loss of $0.38 per basic and diluted share, for the same period in 2024. Net loss for the six months ended June 30, 2025 was $95.2 million, or a net loss of $0.86 per basic and diluted share, as compared to a net loss of $83.2 million, or a net loss of $0.93 per basic and diluted share for the six months ended June 30, 2024. The higher net loss of the three- and six-month periods are primarily due to the increase in R&D expense and the restructuring, impairment and related costs incurred in connection with the strategic reprioritization and restructuring plan.
•Adjusted Net Loss: Adjusted net loss, which is a non-GAAP financial measure, was $28.7 million, or an adjusted net loss of $0.25 per basic and diluted share for the quarter ended June 30, 2025, as compared to adjusted net loss of $24.4 million, or $0.25 per basic and diluted share, for the same period in 2024. Adjusted net loss for the six months ended June 30, 2025, was $52.6 million, or an adjusted net loss of $0.48 per basic and diluted share, as compared to net loss of $55.5 million, or an adjusted net loss of $0.62 per basic and diluted share for the six months ended June 30, 2024. The increase in adjusted net loss for the three-month period is due to higher R&D costs. The decrease in adjusted net loss per share for the six-month period is primarily attributable to a higher number of weighted average shares outstanding.
•Cash and cash equivalents: As of June 30, 2025, cash and cash equivalents were $264.6 million, compared to $250.9 million as of December 31, 2024. In June 2025, the Company entered into securities purchase agreements for the sale of its equity securities to certain institutional investors in a $100.0 million PIPE financing, which resulted in net proceeds of $93.1 million, extending the expected cash runway into 2028.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss second quarter 2025 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events & Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.