On November 7, 2025 Coherus Oncology, Inc. (NASDAQ: CHRS), reported new multiomic tumor and blood-based biomarker data from the dose expansion arm of its ongoing Phase 1b clinical trial evaluating CHS-114, a selective, cytolytic anti-CCR8 antibody, as monotherapy and in combination with toripalimab in patients with recurrent/metastatic HNSCC. These data are being presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held November 5-9, 2025, in National Harbor, Maryland.

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This interim analysis from the dose expansion phase demonstrates that CHS‑114-mediated immune activation is significantly enhanced and sustained with toripalimab in HNSCC study participants. In on-treatment tumor biopsies, CHS‑114 depleted CCR8+ Tregs, but not CCR8- Tregs, and increased CD8+ T cells in the tumor microenvironment (TME), indicating TME remodeling for antitumor immune activation and establishing proof of mechanism. To date, CHS‑114, as monotherapy or in combination with toripalimab has a manageable safety profile, with promising early antitumor activity in HNSCC.

"These data extend the data we presented at AACR (Free AACR Whitepaper) and are important for 3 key development aims. Firstly, showing selective depletion of CCR8+ Tregs and not CCR8- Tregs or CD8 and CD4 T cells, shows the drug does what it was intended to do. This coupled with the acceptable safety profile further supports that CCR8 is proving to be a tumor selective target that now allows the field to remove Tregs in cancer. Secondly, showing statistically significant increase in immune activation using multiple biomarker assays further supports the development plan to advance CHS-114 in combination with toripalimab or with other immune activators. Importantly, we have seen a partial response in a refractory head and neck cancer patient in the initial testing of the safety of this combination," said Theresa LaVallee, Ph.D., Coherus Oncology’s Chief Scientific and Development Officer. "And third, the data support the 2 doses of CHS-114 are pharmacologically active leading to substantial Treg depletion in tumors and immune activation. The ongoing enrollment in the dose optimization arm of the study, evaluating CHS-114 and toripalimab, sets us up to address the FDA’s Project Optimus and define a phase 2 dose."

Multiomic Clinical Biomarker Data from CHS-114 Phase 1 Dose Expansion and Safety Arms in HNSCC Participants

Immune profiling of blood from HNSCC participants from 2 pharmacologically active doses of CHS-114 monotherapy expansion arm (n=10) and in combination with toripalimab safety arm (n=6) showed:

CHS-114 demonstrated robust depletion of target CCR8+ Tregs and spared non-CCR8+ Tregs, CD4+ T cells and CD8+ T cells in PBMCs from HNSCC participants throughout the treatment cycle.

CHS-114 demonstrated significant increases in peripheral immune activation of CD8+ T cell cytotoxicity, activation and proliferation and inflammatory cytokine levels compared with pretreatment levels.

CHS‑114 with toripalimab mediated a robust and significant increase in CD8+ T cell proliferation (Ki67) and Th1 inflammatory cytokines that was sustained through the dosing cycle.
Immune profiling of pretreatment and on-treatment tumor tissue tumor tissue samples from HNSCC participants from monotherapy expansion (n=10) and combination with toripalimab (n=2) cohorts showed:

CHS-114 treatment decreased CCR8+ Treg density by 74% and total FOXP3+ Treg density by 43%, while sparing CCR8- Tregs demonstrating selective and robust depletion of target Tregs.
Furthermore, CHS-114 treatment increased CD8+ T cell density by 73% and CD8+ T cell /CCR8+ Treg ratio by 12-fold, demonstrating a remodeling of the TME.
Data confirm CHS-114 selectivity, the 2 doses evaluated are pharmacologically active and establish proof of mechanism in tumor tissue.
SITC 2025 Presentation Details
Abstract # 640: CHS-114, an anti-CCR8 cytolytic monoclonal antibody demonstrates selective intratumoral Treg depletion and favorable immune remodeling in participants with advanced solid tumors.

Date: Saturday, November 8, 2025, 10 a.m. – 6:35 p.m. ET
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center
About the CHS-114 Phase 1/1b Study

The Phase 1 study (NCT05635643) is a dose escalation, dose optimization, and expansion study evaluating CHS-114 as a monotherapy and in combination with toripalimab, a next-generation PD-1 inhibitor. Arm 1a (first-in-human dose escalation) enrolled 20 patients with advanced solid tumors including 2 patients with HNSCC and evaluated multiple dose levels (5-1200 mg) of CHS-114 monotherapy. Arm 1b evaluated two pharmacologically active doses of CHS-114 monotherapy in 13 HNSCC patients with required paired tumor biopsies. Arm 2 evaluated the safety of two pharmacologically active doses of CHS-114 with toripalimab in 7 patients. Arm 3 is evaluating two pharmacologically active doses of CHS-114 with toripalimab in 40 patients with second-line HNSCC. Primary objectives of the Phase 1 study are to optimize the CHS-114 dose(s) for expansion and evaluate the safety of CHS-114 with and without toripalimab. Secondary objectives are to evaluate the preliminary antitumor activity and the PK of CHS-114 with and without toripalimab and assess biomarkers, including changes in regulatory T cells (Tregs) and CD8+ T cells in paired tumor biopsies and other immune biomarkers.

About CHS-114

CHS-114, an afucosylated, cytolytic CCR8 monoclonal antibody, is designed to selectively target human CCR8 and preferentially kill CCR8+ Tregs within the tumor microenvironment while preserving CD8+ effector T cells and Tregs in normal tissue. In preclinical studies, CHS-114 induced antibody-dependent cellular cytotoxicity (ADCC) and/or antibody-dependent cellular phagocytosis (ADCP) to deplete tumoral CCR8+ Tregs. In addition, treatment with CHS-114 alone reduced tumor growth in murine models, and enhanced antitumor activity was observed in combination with anti-PD-1 treatment. CHS-114 is currently being evaluated in combination with toripalimab in two Phase 1b clinical trials in patients with advanced solid tumors, including head and neck cancer (NCT05635643), colorectal cancer, gastric cancer, and esophageal cancer (NCT06657144).

(Press release, Coherus Oncology, NOV 7, 2025, View Source [SID1234659632])

On November 7, 2025 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of its lead immune-activating antibody therapeutic imneskibart (AU-007), reported promising new Phase 2 data from its ongoing study of imneskibart in patients with checkpoint inhibitor (CPI)-refractory melanoma and non-small cell lung cancer (NSCLC). The data were shared in a poster session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting in National Harbor, Maryland.

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The new Phase 2 data demonstrate sustained and significant anti-tumor activity in patients with melanoma that progressed on prior doublet CPI therapy and early signals of objective responses in patients with NSCLC whose tumors progressed on prior CPI therapy, with or without chemotherapy. These findings strengthen previously reported results that a combination of imneskibart and low-dose, subcutaneous aldesleukin (recombinant human IL-2) exhibits unique activity in the interleukin-2 (IL-2) class. The data also reinforce that a persistent reduction in regulatory T cells (Tregs) coupled with a higher CD8/Treg ratio is associated with longer overall survival (OS), progression-free survival (PFS) and time on treatment for patients.

"Today’s data provide the most compelling support yet for our long-held view that imneskibart is clearly differentiated and has unmatched competitive advantages within the IL-2 class," said Aron Knickerbocker, Aulos Bioscience’s president and chief executive officer. "We’re now seeing its ability to achieve deep and durable tumor shrinkages by expanding T effector and natural killer cells and activating the immune system, while reducing Tregs that suppress the immune system. No other molecule shows the same ability to increase the CD8/Treg ratio as imneskibart. What excites our team most is the clear link that we see between a higher CD8/Treg ratio and longer treatment duration as well as overall survival, which is making a real difference in patients’ lives."

Key findings from the Phase 1/2 study of imneskibart, including the Phase 2 expansion cohorts in CPI-refractory melanoma and NSCLC, with data available on 93 patients as of the data cutoff date of September 29, 2025, are as follows:

Strong signal of anti-tumor activity in patients with melanoma who received imneskibart and low-dose aldesleukin without CPI therapy

Six of 14 patients who received imneskibart and one loading dose of low-dose, subcutaneous aldesleukin continue on treatment, with ongoing deep and durable tumor shrinkages observed in patients who had progressed after receiving doublet CPI therapy (prior anti-CTLA-4 and anti-PD-1 and/or anti-PD-1 and anti-LAG-3).
Three patients with the deepest tumor reductions continued treatment beyond one year: one patient with a 48% tumor reduction continued on treatment for 14 months; another patient with a 58% tumor reduction continues on treatment for more than 18 months; and a third patient with a complete response (100% reduction) in the target lesions continues on treatment for more than 21 months.
Early signs of anti-tumor activity in melanoma patients who received imneskibart, low-dose aldesleukin and nivolumab

Three of five patients with melanoma that progressed on prior doublet CPI therapy, and who received imneskibart as well as one loading dose of low-dose, subcutaneous aldesleukin and nivolumab (checkpoint inhibitor; anti-PD-1), continue on treatment.
No dose-limiting toxicity occurred in the safety run-in.
Initial signs of anti-tumor activity in very early clinical data were observed with the lower aldesleukin dose (45K IU/kg) used in the safety run-in. Now that the safety run-in has been cleared, patients are receiving the recommended Phase 2 aldesleukin dose of 135K IU/kg as a low, subcutaneous loading dose on Day 1. Imneskibart is given at 9 mg/kg intravenously (IV) every two weeks (Q2W), and nivolumab is given as 480 mg IV every four weeks (Q4W).
Early evidence of clinical activity in patients with PD-L1+ NSCLC who received imneskibart and low-dose aldesleukin alone or in combination with avelumab

Initial signal of anti-tumor activity was observed in patients with PD-L1+ NSCLC who failed on prior CPI therapy with or without chemotherapy and received imneskibart and one loading dose of low-dose, subcutaneous aldesleukin alone or in combination with avelumab (checkpoint inhibitor with ADCC effector function; anti-PD-L1).
Two patients with NSCLC that progressed on prior anti-PD-1 therapy-based regimens received imneskibart (9 mg/kg) Q2W and one loading dose of low-dose, subcutaneous aldesleukin in combination with avelumab (800 mg) Q2W. These patients experienced a 43% and 48% tumor reduction and one continues on treatment. Four of nine patients treated with the imneskibart/aldesleukin/avelumab regimen experienced tumor reductions.
Long-running complete responses observed in patients with cancers other than melanoma and NSCLC

One patient with metastatic bladder cancer that progressed on an anti-PD-L1 treatment was treated with imneskibart Q2W and one loading dose of low-dose, subcutaneous aldesleukin, and has an ongoing confirmed metabolic complete response. This patient is now testing negative for circulating tumor DNA (ctDNA) and continues on treatment for nearly three years.
One patient with metastatic nasopharyngeal head and neck cancer that progressed on five prior systemic therapies received imneskibart and low-dose, subcutaneous aldesleukin Q2W. This patient experienced a confirmed complete response after 20 months and continues on treatment.
Combination of imneskibart and low-dose, subcutaneous aldesleukin continues to exhibit unique pharmacodynamic (PD) effects in the IL-2 class, with a higher peripheral blood CD8/Treg ratio associated with better efficacy

Longer durations of OS, PFS and time on treatment were observed in patients with melanoma who achieved at least a 2.1-fold increase over their baseline CD8/Treg ratio.
Durable decreases in Tregs and corresponding increases in CD8/Treg ratios were observed in patients with melanoma.
The mean peripheral blood Treg absolute cell counts continue to decrease after dosing with imneskibart and low-dose, subcutaneous aldesleukin.
The addition of nivolumab to imneskibart and low-dose, subcutaneous aldesleukin (45K IU/kg, the dose assessed in the safety run-in) does not affect the reduction achieved in the peripheral Treg population in the emerging data.
Continued mild and tolerable safety profile observed in all dose cohorts in Phase 1 and 2

Most drug-related adverse events (AEs) were mild, Grade 1 or 2, with imneskibart and one loading dose of low-dose, subcutaneous aldesleukin alone or in combination with avelumab or nivolumab.
A low rate of drug-related Grade 3 and 4 AEs previously observed with imneskibart and one loading dose of low-dose, subcutaneous aldesleukin continues to be observed with maturing data.
The addition of avelumab or nivolumab to imneskibart and one loading dose of low-dose, subcutaneous aldesleukin does not increase the rate of drug-related Grade 3 and 4 AEs in the emerging data.
The most common Grade 3 or 4 AE was transient (3-7 days) lymphopenia that was not associated with adverse outcomes in any patient. Transient lymphopenia is a known effect of IL-2 treatment as lymphocytes traffic out of blood and into tissue.
One patient receiving imneskibart and one loading dose of low-dose, subcutaneous aldesleukin experienced Grade 4 cytokine release syndrome (CRS). It resolved without tocilizumab using steroids, IV fluids and brief vascular pressor support. This patient was noted retrospectively to have subclinical elevated IL-6 (5x upper limit of normal) serum levels, likely due to an active case of gout at baseline.
The Phase 1/2 study of imneskibart is an open label dose escalation and expansion study, with the Phase 1 portion now complete. Phase 2 expansion cohorts evaluating imneskibart and a single loading dose of low-dose, subcutaneous aldesleukin continue to enroll patients with unresectable locally advanced or metastatic cutaneous melanoma who have failed prior doublet CPI therapy as well as patients with PD-L1+ NSCLC who have failed prior CPI therapy.

Phase 2 cohorts with checkpoint inhibitors also continue to enroll patients. In melanoma, a cohort evaluating imneskibart and a single subcutaneous loading dose of low-dose aldesleukin combined with nivolumab as a second-line treatment for cutaneous melanoma is enrolling patients who have not received a prior BRAF/MEK inhibitor. In NSCLC, a cohort is enrolling to evaluate imneskibart and low-dose, subcutaneous aldesleukin combined with avelumab in PD-L1+ NSCLC in patients who have failed prior CPI therapy with or without chemotherapy. Aulos anticipates presenting comprehensive clinical data from these Phase 2 expansion cohorts by mid-2026.

The poster, "Imneskibart, a human monoclonal antibody (mAb) that binds IL-2 and prevents CD25 binding, + low-dose subcutaneous IL-2: Phase 2 update on CPI-refractory melanoma and non-small cell lung cancer (NSCLC)," (Abstract 651) is accessible to meeting registrants as an electronic poster on the SITC (Free SITC Whitepaper) 2025 virtual meeting platform. It is also available on the Aulos Bioscience website in the Abstracts and Publications section.

To learn more about the imneskibart clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626). For patients and providers in the U.S., please visit www.solidtumorstudy.com. For patients and health professionals in Australia, please visit www.solidtumourstudy.com.

About Imneskibart
Imneskibart (AU-007) is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, imneskibart redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. Imneskibart also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

(Press release, Aulos Bioscience, NOV 7, 2025, View Source [SID1234659631])

On November 7, 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 third quarter ended September 30, 2025, and provided a corporate update.

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"We are pleased to share data at SITC (Free SITC Whitepaper) this weekend from an analysis of our ASPEN-06 trial demonstrating compelling benefit in all outcomes measured for patients with high CD47-expressing HER2-positive gastric cancer treated with evorpacept in combination with trastuzumab, ramucirumab, and paclitaxel," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "This insight is guiding our targeted clinical development strategy for breast cancer where we will be enrolling patients with HER2-positive tumors that have previously received ENHERTU and we will evaluate responses by CD47-expression level in our Phase 2 ASPEN-09-Breast Cancer trial. Additionally, we are excited about the progress of our ALX2004 clinical program, where we are currently enrolling the second dose cohort at 2mg/kg after clearing the dose 1 cohort at 1mg/kg, a milestone for this Phase 1 program. We look forward to providing an update with initial safety data from this program in the first half of next year. Given the promising preclinical findings we have seen to date for ALX2004 which demonstrate a favorable toxicity profile and potent anti-tumor activity, we remain very optimistic about the potential success for this approach in treating EGFR+ tumors."

"The analysis from the evorpacept gastric cancer data is especially interesting for two reasons. First, it is great to see this level of improvement across all efficacy measures among HER2-positive gastric cancer patients with CD47-high expression. Second, I’m eager to evaluate this approach for patients with HER2+ breast cancer in the ASPEN-09 trial since we will be combining evorpacept and chemotherapy with trastuzumab, the same HER2-targeted antibody used in the gastric cancer study," said Peter Schmid, FRCP, M.D., Ph.D., Professor of Cancer Medicine; Centre Lead, Centre of Experimental Cancer Medicine; Director, Barts Breast Cancer Centre at Queen Mary University of London. "We hope that by using this combination we are able to offer meaningful clinical benefit to patients with HER2-positive breast cancer who have previously received ENHERTU, and we know this is a patient population in need of new targeted therapies."

ALX Oncology Q3 2025 Highlights and Recent Developments

In a 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 benefit in patients with retained HER2 expression. Retained HER2 expression is defined as patients who are HER2-positive on a tumor biopsy after receiving a HER2-targeted treatment or by HER2 amplification in circulating tumor DNA (ctDNA). Data to be highlighted as part of a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on November 8th.
In patients with retained HER2+ and CD47-high gastric cancer (n=43), evorpacept + HERCEPTIN (trastuzumab), CYRAMZA (ramucirumab) and paclitaxel (TRP) had a 65.0% objective response rate (ORR) versus 26.1% ORR for TRP, while patients with HER2+ and CD47-low gastric cancer (n=47), evorpacept + TRP had a 37.5% ORR compared to 26.1% ORR for TRP.
The duration of response (DOR) was three times longer in the evorpacept + TRP arm relative to TRP in these patients. Evorpacept + TRP had a median DOR of 25.5 months versus 8.4 months median DOR for TRP, while patients with HER2+ and CD47-low gastric cancer, had a median DOR of 11.2 months for evorpacept + TRP compared to 12 months for TRP. Progression free survival (PFS) and overall survival (OS) data were evaluated in these patients. Treatment with evorpacept + TRP resulted in a PFS of 18.4 months versus 7.0 months for TRP, hazard ratio (HR) of 0.39. Treatment with evorpacept + TRP resulted in an OS of 17 months versus 9.9 months for TRP, HR of 0.63.
These emerging clinical data demonstrating improved outcomes in patients with CD47-high expression in retained HER2+ gastric cancer from ASPEN-06 support the hypothesis that CD47 expression could be a key predictive biomarker for evorpacept efficacy in other settings. The Phase 2 ASPEN-09-Breast Cancer clinical trial of evorpacept plus trastuzumab and physician’s choice chemotherapy in patients with HER2+ breast cancer previously treated with ENHERTU (fam-trastuzumab deruxtecan-nxki) is on track to begin enrollment in Q4 2025, with interim data expected in Q3 2026. This trial will evaluate efficacy by CD47 expression levels. A trial-in-progress poster outlining the details of the trial design was recently presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting.
Enrollment began in August 2025 in the Phase 1 clinical trial for ALX2004, a novel antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors and has cleared the first dose level. Trial-in-progress and preclinical data posters were recently showcased at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) Annual Meeting.
ALX2004 demonstrated potent preclinical anti-tumor activity in EGFR-expressing in vivo tumor models across multiple tumor types with differing levels of EGFR expression and varied mutational status across the EGFR signaling pathway. A favorable preclinical safety profile, including no skin toxicity or interstitial lung disease, was observed in NHP toxicology studies at clinically relevant doses.
The ongoing Phase 1 dose escalation trial includes patients with relapsed/refractory EGFR-expressing solid tumors and remains on track to share initial safety data in 1H 2026. The Phase 1 trial is currently enrolling the second dose cohort at 2 mg/kg as no dose-limiting toxicities were observed in the first cohort at 1 mg/kg.
Detailed results from the Phase 2 clinical trials for ASPEN-03 and ASPEN-04, which evaluated evorpacept treatment plus KEYTRUDA (pembrolizumab), a PD-1 inhibitor, or pembrolizumab in combination with chemotherapy, respectively, for the treatment of recurrent, unresectable or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) were presented at ESMO (Free ESMO Whitepaper) in October 2025. As was reported in the topline results announced in May, the trials did not meet their primary endpoints. The Company will not pursue evorpacept in combination with PD-1 inhibitors at this time.
ALX Oncology is prioritizing evorpacept development in combination with anti-cancer antibodies that directly induce antibody-dependent cellular phagocytosis (ADCP), the primary proposed mechanism of action for evorpacept, based on benefit demonstrated in the ASPEN-06 clinical trial and others in non-Hodgkin lymphoma (NHL), and HER2+ Breast Cancer.
The Company appointed Board Member Barbara Klencke, M.D., as interim Chief Medical Officer. Dr. Klencke is an accomplished clinical leader with a distinguished track record in oncology drug development. Dr. Klencke has more than 30 years of experience in patient care, academic and scientific research, and clinical drug development in hematology and oncology. She has deep R&D expertise and has made significant contributions to the development, approval and commercialization of numerous oncology products through various executive leadership roles at a range of small, mid-sized and large biotech companies including Sierra Oncology (acquired by GSK), Onyx Pharmaceuticals (acquired by Amgen) and Genentech, a member of the Roche Group. She holds a Bachelor of Science degree from Indiana University and an M.D. from the University of California, Davis. In addition to ALX Oncology, Dr. Klencke is an independent board director of Xencor and TScan Therapeutics.
Upcoming Clinical Milestones

ASPEN-09-Breast Cancer: Remains on track for FPI in Q4 2025 and interim data readout anticipated in Q3 2026.
ALX2004: Phase 1 trial enrollment began in August and remains on track to deliver initial safety data in 1H 2026.
Third Quarter 2025 Webcast Information
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 Third 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

A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website, www.alxoncology.com. An archived webcast will be available on the Company’s website after the event.

Date & Time: Friday, November 7 at 5:30 a.m. PT / 8:30 a.m. ET

Webcast Access: View Source;tp_key=b49359356f

Third Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of September 30, 2025, were $66.5 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 September 30, 2025, were $17.4 million compared to $26.5 million for the prior-year period or a decrease of $9.0 million. This decrease was primarily attributable to a decrease of $3.5 million in stock-based compensation expense, a $3.2 million in personnel and related costs, $2.6 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, and a decrease of $1.9 million in preclinical costs due to pipeline prioritization strategy. These decreases were partially offset by an increase of $2.5 million due to a development milestone achieved.
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 September 30, 2025, were $5.1 million compared to $6.1 million for the prior year period or a decrease of $1.0 million. This decrease was primarily attributable to a decrease in stock-based compensation expense.
Net loss: GAAP net loss was ($22.1) million for the three months ended September 30, 2025, or ($0.41) per basic and diluted share, as compared to a GAAP net loss of ($30.7) million for the three months ended September 30, 2024, or ($0.58) per basic and diluted share. The lower net loss is primarily attributed to lower R&D expenses. Non-GAAP net loss was ($19.6) million for the three months ended September 30, 2025, as compared to a non-GAAP net loss of ($23.7) million for the three months ended September 30, 2024. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

(Press release, ALX Oncology, NOV 7, 2025, View Source [SID1234659630])

On November 6, 2025 BeOne Medicines reported third quarter 2025 results.

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(Presentation, BeOne Medicines, NOV 6, 2025, View Source [SID1234661792])

On November 6, 2025 Mabqi reported the formation of a strategic partnership with Abzena, the leading end-to-end integrated CDMO for complex biologics and bioconjugates. This collaboration will integrate Mabqi’s antibody discovery capabilities with Abzena’s development and manufacturing services, offering biopharma customers a more streamlined, end-to-end drug development solution.

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The partnership’s combined offerings will leverage Mabqi’s LiteMab Antibody Discovery Studio for hit screening, characterization, and hit selection by using universal & pH-sensitive libraries to identify top lead candidates, and utilize Abzena’s capabilities for developability, cell line development, process development, and GMP manufacturing. Both organizations have extensive expertise in supporting a broad range of modalities, including monoclonal antibodies (mAbs), mAb fragments, bi- and multi-specifics, and bioconjugates.

"Our strategic partnership with Abzena marks a significant milestone in offering an integrated antibody discovery-through-development solution by combining our complementary scientific expertise and advanced capabilities", said Sylvain Yon, CEO of Mabqi. "Beyond scientific excellence and innovation, what truly sets this collaboration apart is the exceptional human fit between our teams ensuring smooth cooperation, shared dedication to innovation and customer-focused relationship. Together, we are poised to accelerate the development of differentiated therapeutic antibodies that can make a meaningful impact for patients worldwide."

(Press release, Mabqi, NOV 6, 2025, View Source [SID1234661413])