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Sonesitatug vedotin demonstrated a statistically significant and highly clinically meaningful improvement in overall survival in 2nd and later-line CLDN18.2-positive advanced gastric/GEJ cancers

On July 27, 2026 Astrazeneca reported positive high-level results from the CLARITY-Gastric01 global Phase III trial showed that sonesitatug vedotin (Sone-Ve) demonstrated a statistically significant and highly clinically meaningful improvement in overall survival (OS) in 2nd and later-line Claudin 18.2-positive advanced gastric cancers versus investigator’s choice of therapy. The trial included patients with locally advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or oesophageal adenocarcinoma (EAC) with Claudin 18.2 (CLDN18.2) expression on at least 25% of tumour cells at any staining intensity.

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The trial had dual primary endpoints of OS in 3rd and later-line treatment and progression-free survival (PFS) in the overall trial population. The trial met the dual primary endpoint of OS in 3rd and later-line treatment, and a key secondary endpoint of OS in the overall trial population of patients treated in the 2nd and later-line setting, demonstrating a statistically significant and highly clinically meaningful improvement.

For the other dual primary endpoint of PFS as assessed by blinded independent central review (BICR), results showed a trend toward improved PFS in patients treated in the 2nd and later-line setting but did not reach statistical significance.

The majority of patients with gastric/GEJ cancers are diagnosed at an advanced or metastatic stage, where the prognosis is especially poor and treatment options are limited, with less than 20% surviving more than one year.1,2 CLDN18.2 has emerged as an important therapeutic target for these patients, with an estimated 60% of gastric/GEJ cancers expressing CLDN18.2 in 25% or more of tumour cells.3 Each year, there are roughly 183,500 patients in the US, EU, China and Japan treated in the 2nd and later-line setting for advanced or metastatic CLDN18.2-positive, non-HER2-positive gastric/GEJ cancers.4

Rui-Hua Xu, M.D., Ph.D., Professor in the Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China, and principal investigator of the trial said: "Metastatic gastric cancer is an aggressive disease with very limited options once patients progress after first-line treatment. Sone-Ve is the first CLDN18.2-targeted antibody drug conjugate to demonstrate an overall survival benefit in this setting and has the potential to establish a new precision treatment for a broader population of patients with CLDN18.2 expression."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, said: "Sone-Ve has the potential to reshape the treatment of gastric cancer by replacing classic chemotherapy with this novel targeted antibody drug conjugate to improve outcomes for patients. These transformative results from the first Phase III readout for Sone-Ve, together with our broad development programme, highlight the potential for Sone-Ve to become an important new medicine in CLDN18.2-positive cancers."

Sone-Ve was well tolerated, and its profile was consistent with the known safety profile of Sone-Ve with no new safety signals identified.

Sone-Ve is a potential global first-in-class CLDN18.2-targeting antibody drug conjugate (ADC) with a monomethyl auristatin E (MMAE) payload.

These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

Sone-Ve has received Orphan Drug Designation from the US Food and Drug Administration and the European Commission for the treatment of gastric and GEJ cancers. It has also received Breakthrough Designation in China for the 2nd-line treatment of gastric cancer.

Notes

Gastric and GEJ cancers
Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-leading cause of cancer-related death.5 Nearly one million new patients were diagnosed with gastric cancer in 2024, with approximately 650,000 deaths reported globally. In many regions, its incidence has been increasing in patients younger than 50 years old, along with other gastrointestinal (GI) malignancies.5

GEJ cancer is a type of gastric cancer that arises from and spans the area where the oesophagus connects to the stomach.6

Most advanced gastric cancer patients will eventually experience disease progression after standard 1st-line therapies, and subsequent lines yield poor outcomes, with median survival of 5-9 months for patients receiving 2nd and later-line systemic treatments.7-9

CLARITY-Gastric01
CLARITY-Gastric01 is a randomised, open-label, sponsor-blinded, multicentre, global Phase III trial evaluating Sone-Ve as a 2nd and later-line therapy for patients with advanced or metastatic gastric cancer, GEJ cancer, or EAC with CLDN18.2 expression in 25% or more of tumour cells, with IHC+ of any intensity. In the trial, patients were randomised 1:1:1 in Stage 1 (dose selection) to Sone-Ve monotherapy 2.2 mg/kg or 1.8 mg/kg every three weeks, or investigator’s choice of therapy, the comparator arm. In Stage 2, the trial continued with Sone-Ve 2.2 mg/kg as the recommended Phase III dose.

The efficacy analyses from this study will also provide the basis to evaluate the clinical performance of the Ventana SP455 assay for the identification of patients with advanced or metastatic gastric, GEJ or EAC cancers expressing CLDN18.2 who may benefit from Sone-Ve.

The trial is being conducted in 175 centres across 19 countries, including in North America, Europe, South America and Asia. Its dual primary endpoints are PFS as assessed by BICR in the 2nd and later-line setting and OS in the 3rd and later-line setting. A key secondary endpoint is OS in the 2nd and later-line setting.

Sonesitatug Vedotin (Sone-Ve)
Sone-Ve is a novel ADC targeting CLDN18.2, a protein found in the stomach lining and a validated therapeutic target in oncology, particularly for GI cancers. Sone-Ve consists of an anti-CLDN18.2 monoclonal antibody, a protease-degradable linker and a cytotoxic small molecule MMAE payload.

AstraZeneca entered into a global exclusive licence agreement with KYM Biosciences to develop and commercialise Sone-Ve in March 2023.

In addition to CLARITY-Gastric01, Sone-Ve is being evaluated in the CLARITY-Gastric02 Phase III trial in combination with capecitabine, with or without rilvegostomig, as a 1st-line treatment for advanced or metastatic gastric cancer, GEJ cancer and EAC. In Phase II development, Sone-Ve is being evaluated in patients with advanced solid tumours in multiple combinations across settings, including in CLDN18.2-positive pancreatic and biliary tract cancers (BTC).

(Press release, AstraZeneca, JUL 27, 2026, View Source [SID1234669432])

Nidlegy™ Marketing Authorization Application Resubmitted to EMA

On July 27, 2026 Philogen S.p.A. (BIT:PHIL) reported the submission of an updated Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy, an investigational product for the neoadjuvant treatment of adult patients with locally advanced, fully resectable melanoma.

The updated submission is based on clinical data from the randomized Phase III PIVOTAL study (PHL19IL2TNF-02/15; NCT02938299). Compared with the MAA submitted in June 2024, the updated dossier is based on a longer median patient follow-up (33 months as opposed to 21 months) and includes additional posthoc analyses focused on event-free survival. Clinical data supporting the 2024 submission were published in Annals of Oncology (Kähler et al., Annals of Oncology, 2025, 36, 1166). The updated data forming the basis of this resubmission have been accepted for publication in the Journal of Clinical Oncology (doi 10.1200/JCO26-00852) and are expected to be published online in the coming weeks.

In the PIVOTAL study, Nidlegy reduced the risk of relapse or death compared with the control arm, and its safety profile was characterized mostly by low-grade, local adverse events. The updated application also includes additional Chemistry, Manufacturing and Controls (CMC) information intended to address the outstanding questions raised during the previous procedure.

Additional supporting data included in the dossier comprise efficacy and safety data from the Phase II study PH-L19IL2TNF-02/12 (NCT02076633), safety data from the ongoing Phase III NeoDREAM study PHL19IL2TNF-01/18 (NCT03567889), and safety data from the Phase II study PH-L19IL2TNFNMSC-04/19 (NCT04362722) in non-melanoma skin cancer.

Prof. Dr. Dario Neri, Chief Executive Officer and Chief Scientific Officer of Philogen, commented: "Philogen remains fully committed to advancing Nidlegy in melanoma and non-melanoma skin cancers. Since the previous MAA procedure, our team has worked intensively to address the clinical and CMC questions raised during the review. In parallel, we have continued to expand the global Phase III NeoDREAM melanoma study and have launched additional registrational studies in non-melanoma skin cancers. We are encouraged by the data generated to date and will continue working with our partners and regulators with the aim of bringing this innovative treatment to patients in need."

Nidlegy is partnered with Sun Pharma for the treatment of Skin Cancers in Europe, New Zealand and Australia.

About Nidlegy (Daromun)

Nidlegy is a biopharmaceutical product, proprietary to Philogen, designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF. The two ingredients are manufactured independently and mixed prior to intralesional administration. The L19 antibody is specific to the Extra Domain B of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are pro-inflammatory cytokines with a potent anti-tumor activity. Nidlegy is currently being investigated in two Phase III clinical trials for the treatment of locally advanced melanoma, and in Phase II clinical trials for the treatment of High-Risk Basal Cell Carcinoma and other non-melanoma skin cancers.

About the PIVOTAL Phase III study

PIVOTAL is a phase III, international, multi-center, randomized, comparator-controlled, parallel-group study evaluating the efficacy and safety of intratumoral injections of Nidlegy as a neoadjuvant treatment, followed by standard-of-care treatment (surgery), as opposed to standard-of-care treatment (i.e., surgery alone), in melanoma patients with locally advanced, fully resectable cutaneous, sub-cutaneous (including satellite/in transit metastases), or nodal metastases accessible to intratumoral injection. For both arms, adjuvant treatment with approved drugs was allowed. Nidlegy was injected intralesionally up to four times, once a week, before surgery. The trial enrolled 256 patients in Europe across 22 clinical centers in Germany, Italy, France and Poland.

About locally advanced fully resectable melanoma

Melanoma is a skin tumor which begins when melanocytes start growing without control. Melanocytes are found in the basal layer of the epidermis at the boundary with the next layer (the dermis). Locally advanced melanoma is a metastatic cancer in which neoplastic lesions have spread to drainage areas of regional lymph nodes and can appear as micrometastases, satellite/in transit metastases, and/or lymph node metastases. To date, patients with resectable disease receive surgery, possibly followed by approved adjuvant systemic therapies. There is no approved drug for the treatment of locally advanced fully resectable melanoma in the neoadjuvant setting.

(Press release, Philogen, JUL 27, 2026, View Source [SID1234669431])

OPKO Health Reports Second Quarter 2026 Business Highlights and Financial Results

On July 27, 2026 OPKO Health, Inc. (OPKO) (NASDAQ: OPK), a fully-integrated healthcare company focused on delivering next-generation solutions for serious diseases across established global markets, reported business highlights and financial results for the second quarter ended June 30, 2026.

Highlights from the second quarter of 2026 and recent weeks included the following:

•
ModeX presented data on multispecific antibody targeted in vivo CAR T cell programs at the American Society of Gene + Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, with plans to enter Phase 1 studies later this year or in early 2027. Leveraging its multispecific technology, ModeX’s in vivo CAR T platform uses antibody-targeted lipid nanoparticles to deliver CAR-encoding genes directly to selected immune cell subsets, generating functional CAR T cells in vivo and potentially overcoming limitations of ex vivo and other in vivo CAR T approaches. Efforts are currently underway to begin a company-sponsored phase 1 study in autoimmune disease in late 2026 or early 2027 at the same time that opportunities for collaboration with large pharma partners are being explored.
•
Initiated and enrolling patients in MDX2003 Phase 1 clinical trial in relapsed or refractory B-cell lymphoma. MDX2003 (CD19 x CD20 x CD3 x CD28) is a novel tetraspecific T-cell engager-expander designed to optimize sustained T-cell function and address the two most common and validated targets in lymphomas and leukemias. The MDX2003 Phase 1 study is evaluating safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in adults with B-cell lymphomas through dose-escalation and dose-expansion cohorts. B-cell lymphoma, a form of non-Hodgkin lymphoma represents the most common lymphoma subtype, accounting for approximately 85% of cases.
•
Initiated MDX2301 Phase 1 clinical trial for the prevention of COVID-19, with plans to complete enrollment in the third quarter 2026 and early data to be presented in late 2026 or early 2027. MDX2301 is a tetravalent bispecific antibody designed to neutralize known SARS-CoV-2 variants while maintaining breadth and reducing the potential for resistance. The Phase 1 trial is evaluating safety, tolerability, and pharmacokinetics across multiple routes of administration in healthy volunteers and immunocompromised adults at high risk for severe COVID-19. This trial is being funded by the Biomedical Advanced Research and Development Authority (BARDA).
•
Continued progress across additional ModeX clinical trials. MDX2001, a tetraspecific T cell engager directed to solid tumors that express Trop2 and c-Met, is proceeding with Phase 1 enrollment as planned. MDX2004 a trispecific immune rejuvenator that stimulates through CD3, CD28 and 4-1BBL, also continues Phase 1 enrollment as planned at sites in Australia and Israel.

We expect to report initial safety, tolerability, pharmacokinetic and immune data in the first half of 2027.
•
Initiated the Phase 1/2a clinical study of OPK-88006 in healthy and presumed MASH participants. OPK-88006, a dual GLP-1/Glucagon agonist administered subcutaneously, has begun enrolling participants in the US. The objectives of this study are to assess the safety and pharmacokinetic of single ascending doses in healthy volunteers. Second part of the trial is to evaluate the clinical effects of OPK-88006 administered weekly for 16 weeks in presumed Metabolic Dysfunction Associated Steatohepatitis (MASH) subjects.
•
OPKO Biologics presented preclinical data on long acting Growth Hormone Receptor Antagonist OPK8801001 at the Endocrine Society (ENDO) 2026 annual meeting, with plans to advance the program to clinical trials at the end of 2026. In animals, including non-human primates data showed that OPK8801001 achieved robust, dose-dependent, and sustained suppression of insulin-like growth factor-1 (IGF-1), a marker of disease activity in acromegaly, a rare endocrine disorder caused by excess growth hormone. The findings support its potential as a weekly alternative to current daily acromegaly treatments. In vitro, OPK8801001 showed ~20-fold greater growth hormone receptor antagonism than established Pegvisomant therapy.
•
OPKO’s strategic partner, Entera Bio, presented preclinical data on the EB612 and EB618 pipeline programs at the Endocrine Society (ENDO) 2026 annual meeting, with ongoing studies advancing both programs toward first-in-human clinical evaluation. Both programs are being co-developed by OPKO and Entera. EB612 is a proprietary first-in-class long-acting PTH(1-34) analog formulated with Entera’s N-Tab oral peptide platform. In preclinical models, EB612 achieved robust bioavailability and sustained increases in calcium, supporting its potential as an oral hormone replacement therapy for patients with hypoparathyroidism. EB618 is a first-in-class oral dual GLP-1/glucagon receptor agonist for obesity and metabolic disorders. In non-human primates, EB618 showed dose-proportional pharmacokinetics and a robust effect on blood glucose.
We are pleased to congratulate our partner, Entera Bio, on its announcement today of its oversubscribed $275 million private placement, which underscores the strength of its scientific platform and provides substantial support for the continued advancement of its development programs.

•
Expanded Nicoya Agreement to Support RAYALDEE Commercialization in Greater China. Under the amended agreement, OPKO received a 15% equity stake in Nicoya in exchange for a revised tiered royalty and transfer price schedule. In connection with the amendment, OPKO received an initial tranche of Series A-2 Preferred Shares and expects to close on the second equity issuance of Series A-2 Preferred Shares in the third quarter of 2026. The amended arrangement also expands the field of use while reinforcing Nicoya’s commitment to commercialize RAYALDEE in Greater China. The milestone structure under the original agreement remains unchanged with OPKO eligible to receive up to $115 million upon the achievement of development, regulatory and sales-based milestones.
Second Quarter Financial Results

•
Consolidated: Consolidated total revenues for the second quarter of 2026 were $163.5 million compared with $156.8 million for the 2025 period, with the increase principally resulting from higher revenue from the transfer of intellectual property and other, partially offset by lower revenue from services following the September 2025 sale of our oncology assets to Labcorp. Operating loss for the second quarter of 2026 improved to $7.0 million compared with operating loss of $60.0 million for the corresponding 2025 quarter. Net loss for the second quarter of 2026 was $8.4 million, or $0.01 per share, compared with net loss of $148.4 million, or $0.19 per share, for the corresponding 2025 quarter.
•
Pharmaceuticals: Revenue from products in the second quarter of 2026 was $42.9 million compared with $40.7 million in the second quarter of 2025, driven by higher sales volumes from OPKO’s Spanish and Mexican operations and by a positive net foreign exchange impact of $1.8 million. Revenue from Rayaldee increased to $8.1 million in the second quarter of 2026, compared to $7.2 million for the same period in 2025, primarily due to favorable gross-to-net adjustments. These positive drivers were partially offset by a decrease of approximately $1.7 million in product revenue from other international operations. Revenue from the transfer of intellectual property and other rose to $46.1 million, up from $15 million in 2025, primarily driven by $29.4 million in revenue recognized from shares received in connection with an amendment to our license agreement with Nicoya who is beginning to commercialize Rayaldee in China. Also contributing to the increases was higher partnership revenue, including NGENLA profit share of $6.4 million compared with $6.1 million in the corresponding 2025 quarter, as well as combined revenue from Eli Lilly and Regeneron of $4.3 million in the second quarter of 2026. The increase was partially offset by a decrease in revenue recognized under the BARDA contract, which totaled $5.0 million in the second quarter of 2026 compared with $6.5 million for the same period in 2025. Total costs and expenses were $88.2 million in the second quarter of 2026 compared with $84.4 million in the prior-year period. Operating income was $0.8 million in the second quarter of 2026, which included $18.5 million in depreciation and amortization expense, compared with operating loss of $28.7 million in the second quarter of 2025, which included $18.1 million of depreciation and amortization expense.
•
Diagnostics: Revenue from services in the second quarter of 2026 was $74.5 million compared with $101.1 million in the prior-year period, which included $24.9 million of revenue related to the oncology assets sold to Labcorp in September 2025. Total costs and expenses were $69.8 million in the second quarter of 2026 compared with $119.3 million in the second quarter of 2025, which included $29.4 million of costs and expenses related to oncology assets that were sold to Labcorp. Operating expenses were offset by an earnout received of $18.1 million related to the assets sold to Labcorp in September 2025. Income from operations was $4.8 million in the second quarter of 2026, which included $3.9 million of depreciation and amortization expense, compared with operating loss of $18.2 million in the same 2025 period, which included $4.9 million of depreciation and amortization expense.
•
Cash, cash equivalents, marketable securities and restricted cash: Cash, cash equivalents, marketable securities and restricted cash were $314.4 million as of June 30, 2026. As of June 30, 2026, approximately $105.3 million of OPKO’s common stock had been repurchased under the program authorized in July 2025, including $13.2 million in the second quarter of 2026. Approximately $94.7 million remained authorized and available for future repurchases.
Financial Guidance

The table below contains financial guidance for the 2026 third quarter and full year financial guidance (in millions):

For the three months ended

For the year ended

September 30, 2026

December 31, 2026

Low

High

Low

High

Revenue:

Services revenue

296

306

Product revenue

164

174

IP and other revenue

100

105

Total revenue

131

142

560

585

Included in revenue

Pfizer gross profit share

BARDA

Total costs and expenses

180

190

710

740

R&D included in costs and expenses

125

135

Conference Call and Webcast Information

OPKO’s senior management will provide a business update, discuss second quarter financial results, provide financial guidance and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. ET. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed through OPKO’s Investor Relations here.

A telephone replay will be available until August 5, 2026, by dialing 855-669-9658 (U.S.) or 412-317-0088 (International) and providing the passcode 2140261. A webcast replay will be available beginning approximately one hour after the completion of the live conference call

(Press release, Opko Health, JUL 27, 2026, View Source [SID1234669430])

Champions Oncology Reports Record Annual Revenue of $59 Million

On July 27, 2026 Champions Oncology, Inc. (Nasdaq: CSBR), a global leader in clinically relevant oncology research models and translational solutions, reported its financial results for the fiscal year and fourth quarter ended April 30, 2026.

Fourth Quarter and Other Financial Highlights:
•Record annual revenue of $59.4 million
•Fourth quarter revenue of $13.8 million
•Fourth quarter oncology services margin of 51%
•Adjusted EBITDA of $158,000 for the quarter and $1.6 million for the fiscal year
•Adjusted EBITDA income all four quarters in FY 2026
•Continued investment in radiopharmaceuticals, the data platform and commercial organization

Robert Brainin, CEO of Champions, commented, "Fiscal 2026 marked a year of meaningful progress in executing our strategic priorities as we delivered record annual revenue while continuing to invest in the capabilities we believe will support our next phase of growth. Our core research services business performed well as we advanced several strategic initiatives, including expanding our radiopharmaceutical platform, strengthening our data strategy, making meaningful progress toward the commercial application of Corellia’s technology, and growing our commercial organization. We believe these investments strengthen our competitive position and expand our opportunities for long-term growth, and we remain focused on building on this momentum."

David Miller, CFO of Champions added, "Our financial results for fiscal 2026 reflect the strength of our core research services business. We delivered record annual revenue despite the absence of the prior year’s significant data licensing transaction and generated positive Adjusted EBITDA in each quarter of the fiscal year, reflecting our disciplined approach to managing our cost structure while continuing to invest in our strategic initiatives. We remain focused on allocating capital prudently to support the Company’s long-term growth objectives."

Fourth Quarter Financial Results

Total oncology revenue for the fourth quarter of fiscal 2026 was $13.8 million, compared to $12.4 million for the same period last year, an increase of 12%. Total costs and operating expenses for both the fourth quarter of fiscal 2026 and 2025 were $14.4 million.

Exhibit 99.1
For the fourth quarter of fiscal 2026, Champions reported a loss from operations of $522,000, which includes $357,000 in stock-based compensation, $322,000 in depreciation and amortization, and a $1,000 charge on the disposal of lab equipment, compared to a loss from operations of $2.0 million, inclusive of $131,000 in stock-based compensation, $394,000 in depreciation and amortization, and a $293,000 charge on the disposal of lab equipment in the fourth quarter of fiscal 2025. Adjusted EBITDA income, which is defined as net income excluding stock-based compensation, depreciation and amortization expenses, a loss on the sale and / or disposal of lab equipment, other income, and taxes, was $158,000 for the quarter, compared to an adjusted EBITDA loss of $1.2 million in the prior year period.

Cost of oncology revenue was $6.8 million for three months ended April 30, 2026, as compared to $7.3 million for the three months ended April 30, 2025, a decrease of $462,000 or 6%. The reduction reflected continued cost discipline, lower outsourced research services expenses, including the continued transition of certain radiopharmaceutical activities in-house, and lower compensation expense. Combined with higher revenue, these factors generated improved operating leverage and increased oncology services margin to 51% from 41% in the prior-year period. Oncology services margin and profit are defined below in our Non-GAAP financial information discussion.
Research and development, sales and marketing, and general and administrative expenses remained well controlled during the quarter as the Company continued to invest in strategic growth initiatives. Research and development expense was $2.1 million for the three months ended April 30, 2026, compared to $2.0 million in the prior-year period. Sales and marketing expense increased to $2.8 million from $2.3 million in the prior-year period, primarily reflecting investments to expand the Company’s commercial capabilities across both its core research services business and data platform. General and administrative expense increased modestly to $2.6 million from $2.5 million, primarily reflecting higher compensation, including stock-based compensation, and information technology investments supporting the continued growth of the business.

Net cash used in operating activities for the quarter was approximately $2.2 million, driven primarily by working capital timing rather than underlying operating performance. The decrease reflected higher accounts receivable due to the timing of customer collections and a reduction in deferred revenue. Net cash used in investing activities for the quarter was approximately $44,000 for the purchase of lab and computer equipment. Net cash used in financing activities for the quarter was $19,000 resulting from financing lease payments. The Company ended the quarter with a cash position of $4.9 million and no debt.

Year-to-Date Financial Results

Total oncology revenue for fiscal year 2026 was $59.4 million, an increase of 4%, compared to $56.9 million for fiscal year 2025. The increase was driven by continued strength in the Company’s core research services business, which more than offset the absence of approximately $4.5 million of data license revenue recognized in the prior fiscal year that did not recur in fiscal 2026. Total operating expenses increased $8.2 million to $60.6 million from $52.4 million in the prior year, primarily reflecting approximately $3.0 million of higher outsourced radiopharmaceutical costs incurred while supporting customer programs prior to transitioning certain activities in-house, as well as continued investment in the Company’s commercial organization and data platform.

For the twelve months ended April 30, 2026, Champions reported a loss from operations of $1.1 million, which includes $1.2 million in stock-based compensation, $1.4 million in depreciation and amortization, and a $111,000 loss on the disposal of laboratory equipment, compared to income from operations of $4.6 million in the prior year, which included $654,000 in stock-based compensation, $1.6 million in depreciation and amortization, and a $293,000 loss on disposal of laboratory equipment. The year-over-year comparison reflects the absence of the prior year’s non-recurring data license revenue, together with the Company’s continued investments in its commercial organization, data platform, and radiopharmaceutical capabilities. Adjusted EBITDA was $1.6 million for fiscal year 2026, compared to $7.1 million for the prior fiscal year.

Cost of oncology revenue was $30.9 million for the twelve months ended April 30, 2026, an increase of $2.5 million or 8.8%, compared to $28.4 million for the twelve months ended April 30, 2025. The increase was primarily due to outsourced laboratory services incurred to perform radiopharmacology studies while the Company continued to build its internal radiopharmacology capabilities. Oncology services margin was 48% for the twelve months ended April 30, 2026, compared to 50% for the prior year. The decrease in margin primarily reflected these temporary outsourced laboratory costs.

Research and development expense was $9.1 million for fiscal year 2026, an increase of $2.3 million, or 33%, compared to $6.8 million for the prior year. The increase primarily reflected continued investment in the Company’s data platform, including higher sequencing and laboratory costs. Sales and marketing expense was $9.3 million for fiscal year 2026, an increase of $1.8 million, or 23%, compared to $7.5 million for fiscal year 2025. The increase was primarily due to the continued expansion of the Company’s sales teams supporting both its core research services and data offerings. General and administrative expense was $11.2 million for fiscal year 2026, an increase of $1.8 million, or 19%, compared to $9.3 million for fiscal year 2025. The increase primarily reflected higher compensation, including stock-based compensation, and increased information technology investments to support the continued growth of the business.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. ET (1:30 p.m. PT) to discuss its fourth quarter financial results. To participate in the call, please call 888-506-0062 (domestic) or 973-528-0011 (international) ten minutes ahead of the call and enter the access code 347142. A replay of the call will be available by dialing 877-481-4010 (Domestic) or 919-882-2331 (International) and entering passcode: 54320, or by accessing the investors section of the company’s website within 72 hours.

Full details of the Company’s financial results will be available on later today and no later than Wednesday July 29, 2026 in the Company’s Form 10-K at View Source

(Press release, Champions Oncology, JUL 27, 2026, View Source [SID1234669429])

bioAffinity Technologies Publishes New Clinical Framework Addressing Growing Market for Pulmonary Nodule Risk Stratification and Early Lung Cancer Detection Using CyPath® Lung

On July 27, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, reported the publication of a comprehensive clinical review and white paper authored by Chief Medical Officer Gordon H. Downie, MD, PhD, that presents a practical clinical framework for incorporating CyPath Lung into pulmonary nodule evaluation and cancer surveillance.

Titled "Lung Nodules, Lung Microenvironment, Predictive Models and Clinician Risk Stratification Using CyPath Lung Testing for Early Diagnosis of Lung Cancer," the paper examines the growing clinical challenge of evaluating pulmonary nodules as lung cancer screening expands, incidental findings increase, artificial intelligence identifies even more incidental nodules, and more patients require long-term surveillance following cancer treatment.

"Pulmonary medicine is entering a new era in which clinicians are evaluating more pulmonary nodules than ever before, driving a rapidly growing need for better risk stratification," said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. "Dr. Downie’s white paper demonstrates how CyPath Lung can provide physicians with clinically meaningful information that complements imaging and clinical assessment, helping them make more confident decisions about which patients require invasive procedures and which can be safely monitored."

Drawing on the three years of commercial experience since CyPath Lung entered the market, the publication discusses how the noninvasive test has demonstrated consistent clinical performance in helping physicians stratify malignancy risk and guide patient management, including clinical case studies illustrating how CyPath Lung helped clarify challenging cases in which imaging findings and predictive models alone produced uncertain or conflicting assessments.

The publication explores how advances in understanding the lung microenvironment are reshaping the evaluation of pulmonary nodules. Unlike blood-based diagnostics, CyPath Lung analyzes sputum collected directly from the lungs, providing objective, real-time information from the lung microenvironment to help clarify complex or conflicting clinical presentations.

The paper also reviews the strengths and limitations of existing predictive models and emphasizes that no single diagnostic tool should be used in isolation. Instead, it proposes specialty-specific clinical pathways that integrate CyPath Lung into three care settings:

● Primary care practices managing incidentally discovered pulmonary nodules
● Pulmonary nodule programs and interventional pulmonology practices evaluating patients for biopsy
● Oncology practices conducting surveillance of cancer survivors

"Every patient presents a unique clinical picture," Dr. Downie said. "The objective is not to replace clinician gestalt or existing guidelines, but to provide an additional data point when clinical findings are uncertain or contradictory. CyPath Lung’s interrogation of the lung microenvironment gives physicians information that has not previously been available through traditional imaging or blood-based testing."

The white paper highlights the growing recognition that the lung possesses a unique microenvironment distinct from blood, reflecting local immune responses, inflammation, genetic alterations and tumor biology. By evaluating sputum directly from the lungs, CyPath Lung measures these biologic changes and identifies porphyrin-labeled malignant cells through proprietary flow cytometry and artificial intelligence analysis.

The complete white paper is available at https://bit.ly/cypath-lung-whitepaper3

About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.

(Press release, BioAffinity Technologies, JUL 27, 2026, View Source [SID1234669428])