On September 15, 2025 Champions Oncology, Inc. (Nasdaq: CSBR), a leading translational oncology research organization, reported its financial results for its first quarter of fiscal 2026, ended July 31, 2025 (Press release, Champions Oncology, SEP 15, 2025, View Source [SID1234655973]).

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First Quarter and Recent Highlights:

•Total revenue of $14 million
•Adjusted EBITDA of $60,000
•Appointment of Rob Brainin as Chief Executive Officer to lead the next phase of growth

Rob Brainin, newly appointed CEO of Champions, commented, "It is great to be joining Champions at such an exciting inflection point. Our core services business—the backbone of our company—is strengthening and well positioned for sustained growth. At the same time, we are scaling our emerging data platform, which has already shown encouraging traction with leading biopharma partners. These complementary growth engines give us the opportunity to deepen our scientific impact, deliver innovative solutions to patients and customers, and create durable long-term value for shareholders. In parallel, our Corellia team continues to generate data demonstrating the potential of the compounds in our pipeline. Over the coming quarters, I look forward to working closely with our talented team to sharpen our strategy, invest in key capabilities, and build on Champions’ culture of collaboration and scientific excellence."

David Miller, CFO of Champions, added, "We opened the fiscal year with $14 million in revenue and adjusted EBITDA of $60,000. While revenue was slightly lower than the first quarter of last year, we achieved solid sequential growth that met our expectations and provides a strong foundation for the year. As we move forward, we anticipate continued topline expansion and margin improvement driven by a healthy services pipeline and growing demand for our proprietary data offerings. Our financial discipline and focus on profitable growth give us the flexibility to invest in strategic initiatives that will position Champions for long-term success."

First Fiscal Quarter Financial Results

Total oncology revenue for the first quarter of fiscal 2026 was $14.0 million compared to $14.1 million for the same period last year, consisting of a $400,000, or 3% decline in service revenue and a $300,000 increase in data license revenue. Total costs and operating expenses for the first quarter of fiscal 2026 were $14.5 million compared to $12.7 million for the first quarter of fiscal 2025, an increase of $1.8 million or 14.1%.

For the first quarter of fiscal 2026, Champions reported a loss from operations of $527,000, including $208,000 in stock-based compensation, $358,000 in depreciation and amortization expenses, and a $20,000 charge for the disposal of lab equipment, compared to income from operations of $1.3 million, inclusive of $258,000 in stock-based compensation and $448,500 in depreciation and amortization expenses, in the first quarter of fiscal 2025. Adjusted EBITDA, which is defined as income from operations excluding stock-based compensation, depreciation and amortization expenses, and equipment disposal charges, was $59,000 for the first quarter of fiscal 2026 compared to adjusted EBITDA of $2.0 million in the first quarter of fiscal 2025.

Cost of oncology revenue was $8.0 million, up $923,000, or 13.1%, from $7.1 million in the same period last year. The increase primarily reflects higher outsourced lab services for radiolabeling work, which will vary from quarter to quarter. Importantly, as we migrate this work into our own labs in the coming quarters, we anticipate a reduction in cost of sales and improvement in gross margins. Gross margin for the quarter was 43% compared to 50% in the prior year.

Research and development expense for the three-months ended July 31, 2025 was $2.1 million, an increase of $628,000 or 43.2%, compared to $1.5 million for the three-months ended July 31, 2024. The increase reflected greater investment in sequencing and related costs to develop our data licensing platform. Sales and marketing expense for the three-months ended July 31, 2025 was $1.9 million, an increase of $176,000, or 10.5%, compared to $1.7 million for the three-months ended July 31, 2024. The increase was related to compensation expense to support the growth of our data license business. General and administrative expense for the three-months ended July 31, 2025 was $2.6 million, an increase of $43,000, or 1.7%, compared to $2.5 million for the three-months ended July 31, 2024 driven primarily from an increase in IT related costs.

Net cash provided by operating activities was approximately $600,000 for the quarter, supported by receivables conversion and normal working capital activity, partially offset by a quarterly net loss. Net cash used in investing activities for the three-months ended July 31, 2025 was approximately $46,000 for lab and computer equipment. Net cash used in financing activities for the three-months ended July 31, 2025 was $14,000 resulting from financing lease payments slightly offset by proceeds from options exercises.

The Company ended the quarter with cash on hand of approximately 10.3 million and no debt, providing us with a strong balance sheet and financial flexibility.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its third quarter financial results. To participate in the call, please call 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 261008, or provide the verbal reference "Champions Oncology".

On September 14, 2025 Phrontline Biopharma, a clinical-stage biotechnology company advancing a new generation of Antibody-Drug Conjugates (ADCs), reported that the first patient has been successfully dosed in its Phase 1 clinical trial of TJ101, the company’s lead asset targeting EGFR/B7-H3 with a proprietary linker-drug technology (Press release, Phrontline Biopharma, SEP 14, 2025, View Source [SID1234655968]).

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"This is a critical milestone for Phrontline as we advance our mission to deliver innovative ADC therapies that can meaningfully impact patients’ lives," said Zhaoyuan "Tony" Chen, Chief Executive Officer of Phrontline Biopharma. "The initiation of this study not only represents the progress of our lead candidate, TJ101, but also demonstrates the strength of our platform and the dedication of our team in advancing breakthrough science into the clinic. Running this trial in both China and the United States reflects our commitment to a truly global clinical development strategy and ensures early alignment with international regulatory standards."

The Phase 1 study of TJ101 will evaluate its safety, tolerability, pharmacokinetics, and preliminary antitumor activity across multiple solid tumor types. The study design includes dose escalation followed by expansion cohorts to further assess TJ101’s potential in a broad patient population.

"This first patient dosing is a major step forward in validating our ADC platform," said Martín Sebastian Olivo, MD, Chief Medical Officer of Phrontline Therapeutics. "Our team has worked tirelessly to design a program that explores the full clinical potential of TJ101 while also laying the groundwork for our broader pipeline of differentiated ADCs. Beyond TJ101, we are advancing a portfolio of next-generation bispecific dual payload ADCs, which aim to overcome resistance mechanisms seen with current therapies and broaden the scope of patients who may benefit."

Phrontline’s pipeline includes multiple early-stage ADC assets targeting high-value tumor antigens. The company’s dual payload platform leverages a modular design with optimized linker stability and distinct mechanisms of action, enabling improved tumor penetration and a stronger bystander effect.

"By combining scientific innovation with a clear clinical strategy, we are building a robust ADC pipeline that we believe can transform the standard of care in oncology," added Dr. Chen.

On September 12, 2025 Alphamab Oncology (Stock Code: 9966.HK) reported that the New Drug Application (NDA) for anbenitamab injection (KN026), independently developed by the Company and co-developed with JMT-Bio Technology Co., Ltd., a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), has been accepted by the National Medical Products Administration (NMPA). KN026 has been applied for as a Class 1 therapeutic biological product and the indication is for use in combination with chemotherapy for the treatment of patients with HER2-positive locally advanced, recurrent, or metastatic gastric or gastroesophageal junction cancer who have failed at least one prior systemic therapy (which must include trastuzumab in combination with chemotherapy).

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This NDA for KN026 is primarily based on a pivotal Phase II/III clinical trial (Study ID: KN026-001). Results from the first interim analysis of the Phase III clinical study demonstrated that, compared to the current standard of care, KN026 combined with chemotherapy significantly improved clinical efficacy, by prolonging progression-free survival (PFS) and overall survival (OS). Furthermore, the combination showed no new safety signals, with a low incidence of cardiotoxicity and low immunogenicity in terms of safety profile. Previously, results from the Phase II clinical study, presented at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, showed that KN026 in combination with chemotherapy achieved an objective response rate (ORR) of 40.0%, with a median PFS of 8.6 months as assessed by the independent review committee (IRC). KN026 was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the NMPA on November 4, 2023, and received Priority Review status on August 28, 2025.

Currently, there are no approved anti-HER2 therapies for the second-line treatment of HER2-positive gastric cancer. KN026 is the first HER2 bispecific antibody to demonstrate positive results in the second-line treatment of gastric cancer in China. Meanwhile, multiple pivotal Phase III clinical studies of KN026 in gastric cancer and breast cancer are undergoing smoothly, with the aim of benefiting more patients.

About KN026

KN026 is an anti-HER2 bispecific antibody independently developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can simultaneously bind two non-overlapping epitopes of HER2, leading to HER2 signal blockade. KN026 has demonstrated better tumor inhibition in HER2-positive tumor cell lines compared with trastuzumab and pertuzumab in combination. Additionally, KN026 has also shown inhibitory effect on tumor cells with trastuzumab-resistant cell lines.

The results of multiple clinical studies in different stages showed that KN026 has significant anti-tumor activities, even in heavily pretreated patients with HER2-positive breast cancer (BC) and gastric cancer (GC), including those with prior anti-HER2 treatment. Currently, several pivotal clinical trials of KN026 for the second-line or above treatment of HER2-positive GC/gastroesophageal junction cancer (GEJ), the first-line treatment of HER2-positive BC, neoadjuvant treatment for HER2-positive BC are being conducted. KN026 in combination with chemotherapy for the treatment of patients with HER2-positive GC (including GEJ) who have failed first-line standard treatment was granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA).

In August 2021, the Company entered an agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China, pursuant to which, JMT-Bio was granted exclusive license rights of KN026 for the development and commercialization in the indications of BC an GC/GEJ in Mainland China (excluding Hong Kong, Macau and Taiwan).

(Press release, Alphamab, SEP 12, 2025, View Source [SID1234656998])

On September 12, 2025 Oncotelic Therapeutics, Inc. (OTCQB: OTLC) ("OTLC" or the "Company"), a clinical-stage biopharmaceutical company developing transformative oncology and immunotherapy treatments, reported a summary of its major accomplishments over the past two years (Press release, Oncotelic, SEP 12, 2025, View Source [SID1234655949]). These milestones underscore meaningful clinical progress and regulatory validation across the Company’s lead drug candidates.

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Oncotelic’s pipeline includes multiple late-stage programs targeting oncology and rare diseases, with several drug candidates achieving significant clinical milestones

Two-Year Clinical Progress Snapshot

OT-101 (TGF-β inhibitor): Phase 3 for pancreatic cancer, with additional applications in ARDS/COVID-19
OXi4503 (vascular disrupting agent): Phase 2 in AML/MDS; advancing toward pivotal phase 3 design
CA4P / Fosbretabulin: Late-stage oncology asset currently under repositioning
AL-101 (intranasal apomorphine): Phase 2 for Parkinson’s disease and sexual dysfunctions
AL-102 (oligonucleotide antisense via intrathecal injection): Discovery stage for Alzheimer’s disease
Pediatric Rare Disease Programs: Targeting orphan indications with the potential to generate Priority Review Vouchers (PRVs)
Nanomedicine Pipeline: Advancing multiple 505(b)(2) drug candidates into clinical testing, leveraging the 505(b)(2) pathway-a faster and more cost-efficient route to market approval compared to a full New Drug Application (NDA).
"OTLC has achieved steady progress across multiple programs, strengthening our position as a late-stage biotech with broad value creation potential. Our pipeline addresses multi-billion-dollar markets with high unmet medical need," said Dr. Vuong Trieu, Chairman and CEO of Oncotelic.

On September 12, 2025 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported the first patient has been successfully dosed in a Phase 1b/II clinical trial (NCT07099430) evaluating Opamtistomig (LBL-024, PD-L1/4-1BB bispecific antibody) as monotherapy or in combination with other agents for the ‌first-line treatment of advanced melanoma (Press release, Nanjing Leads Biolabs, SEP 12, 2025, View Source [SID1234655948])‌‌.

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Opamtistomig‌, a uniquely designed PD-L1/4-1BB bispecific antibody that simultaneously blocks PD-1/L1-mediated immune suppression and enhances 4-1BB-regulated T-cell activation. This dual mechanism has the potential to convert "cold tumors" into "hot tumors", overcoming resistance to immunotherapy and improving response rates in hard-to-treat cancers.

In two prior clinical trials, Opamtistomig demonstrated promising efficacy and a favorable safety profile in patients with highly malignant, immune-cold extrapulmonary neuroendocrine carcinoma (EP-NEC), both as monotherapy and in combination with chemotherapy. Notably, patient enrollment was completed in August 2025 for a pivotal single-arm registration trial evaluating Opamtistomig monotherapy in EP-NEC.

In addition, multiple Phase 1b/II studies are ongoing to assess Opamtistomig combined with chemotherapy for:

First-line small cell lung cancer (SCLC)‌
‌First-and second-line non-small cell lung cancer (NSCLC)
This newly initiated Phase 1b/II multicenter trial, led by Professor Chen Yu from Fujian Cancer Hospital, with participation from multiple hospitals, aims to evaluate Opamtistomig’s efficacy and safety in advanced melanoma as monotherapy or in combination regimens.

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated:

"The continued clinical advancement of Opamtistomig in EP-NEC and other tumor types highlights its unique ability to activate T cells while releasing immune suppression, offering hope to patients with immune-cold tumors who have limited treatment options. With more than 10 indications currently targeted across nine clinical trials, we are committed to accelerating development and delivering breakthrough therapies that expand the benefits of immunotherapy to more patients worldwide."

About Opamtistomig

Opamtistomig (LBL-024) is a potential first-in-class bispecific antibody simultaneously targeting PD-L1 and the co-stimulatory receptor 4-1BB. It is the first 4-1BB-targeting bispecific antibody globally to reach the single arm pivotal trial stage as a monotherapy and holds promise to become the first approved treatment specifically for extrapulmonary neuroendocrine carcinoma (EP-NEC), a malignancy with significant unmet medical need.

Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig features a 2:2 format with two binding domains each for PD-L1 and 4-1BB, and an optimized affinity ratio. This design allows Opamtistomig to both reverse PD-L1–mediated immune suppression and selectively enhance T cell activation, resulting in potent, synergistic anti-tumor effects.

In two clinical trials in China, Opamtistomig has demonstrated promising efficacy and a favorable safety profile in patients with advanced EP-NEC, both as monotherapy and in combination with chemotherapy. The lack of a standard of care in EP-NEC supports the pursuit of accelerated approval through a single-arm pivotal study.

In recognition of its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) in China (October 2024), and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for neuroendocrine carcinoma (November 2024).

Notably, 4-1BB agonism can reactivate exhausted T cells and drive robust proliferation, making it particularly promising for PD-1/PD-L1-resistant or immunologically "cold" tumors. Beyond EP-NEC, Opamtistomig has been approved for clinical trials across multiple cancer types with high unmet need, including small cell lung cancer (SCLC), biliary tract cancer (BTC), ovarian cancer (OC), non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), and malignant melanoma. Encouraging clinical activity has already been observed in SCLC, BTC, OC, and other cancer types, supporting Opamtistomig’s potential as a broad-spectrum oncology therapy.

About Melanoma

Melanoma is a highly aggressive and life-threatening cutaneous malignancy, ranking as the third most common type of skin cancer. Although it represents only about 5% of all skin cancers, melanoma accounts for approximately 65% of skin cancer–related deaths.

Recent advances in immunotherapy—particularly PD-1/L1 and CTLA-4 inhibitors—have expanded treatment options and improved outcomes for many patients. However, melanoma epidemiology in China differs significantly from that of Western populations, with a predominance of acral and mucosal subtypes, which are considered "immunologically cold tumors."

Current immunotherapies, including PD-1/L1 and CTLA-4 inhibitors, show limited efficacy in these subtypes, with objective response rates (ORR) typically below 15%. Toripalimab, the only domestically developed PD-1 inhibitor approved as first-line therapy for Chinese melanoma patients, demonstrated an ORR of 11% and a median progression-free survival (PFS) of 2.3 months in registrational studies that primarily enrolled patients with acral and mucosal melanoma.

These data highlight a critical unmet medical need for more effective therapies for melanoma patients in China, particularly for those with acral and mucosal subtypes.