On May 8, 2025 Jabez Biosciences, Inc., a pioneering biotechnology company focused on innovative cancer therapies, reported the progress of its Phase 1 clinical trial for JBZ-001 (HOSU-53), a novel dihydroorotate dehydrogenase (DHODH) inhibitor, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held April 25-30, 2025, in Chicago, IL (Press release, Jabez Biosciences, MAY 9, 2025, View Source [SID1234652823]). The trial, conducted in collaboration with The Ohio State University Comprehensive Cancer Center—Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James), targets adults with advanced solid tumors and non-Hodgkin lymphoma.

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Asrar Alahmadi, MBBS, lead Principal Investigator of the Phase 1 trial and assistant professor in the College of Medicine at The Ohio State University, presented the clinical trial abstract entitled: An open-label phase 1 study to investigate JBZ-001 in adults with advanced solid tumors and non-Hodgkin lymphoma (Jabez Biosciences’ Clinical Trial NCT06801002 in Progress at OSUCCC—James) at the AACR (Free AACR Whitepaper) Annual Meeting at McCormick Place Convention Center, Chicago. The abstract was also published online in the Proceedings of the AACR (Free AACR Whitepaper) on April 25, 2025.

JBZ-001, an orally bioavailable small-molecule DHODH inhibitor, was designed to disrupt de novo pyrimidine nucleotide biosynthesis, a critical pathway for cancer cell proliferation. By targeting DHODH, the rate-limiting enzyme in this pathway, JBZ-001 demonstrated potential to induce cytotoxic effects in tumor cells, offering a promising new approach to cancer treatment. The development of JBZ-001 marks a significant milestone in Jabez Biosciences’ "bench-to-bedside" academic collaboration, with the compound receiving FDA approval for a commercial Investigational New Drug (IND) application in 2024.

The Phase 1 study, underway at OSUCCC – James, aims to assess the safety, tolerability, and preliminary efficacy of JBZ-001 in patients with advanced solid tumors and non-Hodgkin lymphoma. The trial’s open-label design allows for real-time evaluation of the drug’s effects, paving the way for future clinical development.

Jabez Biosciences expressed gratitude to its research partners for their collaboration in bringing JBZ-001 to this stage. The company remains focused on advancing its pipeline of targeted cancer therapies to address unmet medical needs.

For more information about Jabez Biosciences, Inc. and its clinical programs, please visit www.jabezbio.com. For details on the clinical trial, refer to ClinicalTrials.gov (NCT06801002).

On May 8, 2025 Takeda reported Quarterly Financial Report For the Quarter Ended March 31, 2025 (Presentation, Takeda, MAY 8, 2025, View Source [SID1234653732]).

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On May 8, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) (OTC Pink: AIMI) ("AIM" or the "Company") reported the presentation of clinical trial data involving AIM’s drug Ampligen by Pawel Kalinski, MD, PhD, at the recent Annual Meeting of the American Association of Immunologists held May 3-7, 2025, in Honolulu, HI (Press release, AIM ImmunoTech, MAY 8, 2025, View Source [SID1234652718]).

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The paper, titled "Systemic Infusion of dsRNA (Rintatolimod) plus IFN Promotes Selective Influx of CTLs (but not Treg) into the TME – Counteracting Chemokine Heterogeneity of the TME," discussed the unique two-level selectivity of action of Ampligen when used as a part of chemokine modulation and combined with PD-1 blockade or chemotherapy. Dr. Kalinski discussed the preclinical data and data from recently completed clinical trials showing the ability of Ampligen to selectively induce the desirable CTL-attracting chemokines, but not the counterproductive Treg-attracting chemokines, which differentiated it from poly-I:C. The second level of selectivity was the preferential activation of cancer tissues, rather than healthy tissues. The mechanistic data discussed by Dr. Kalinski indicate that the selectivity of Ampligen’s impact on the tumor microenvironment result from its avoidance of helicase-dependent activation of NFkB. This allows Ampligen to avoid the induction of TNFα and other NFkB-dependent undesirable inflammatory and suppressive factors, which are commonly induced by poly-I:C and other TLR ligands, and to focus its impact on the tumor tissues, which display elevated levels of endogenous NFkB.

AIM CEO Thomas K. Equels commented: "These findings and Dr. Kalinski’s analysis further support our belief in the potential of Ampligen as a powerful therapeutic for unmet medical needs, including deadly cancers."

On May 8, 2025 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2025 (Press release, Puma Biotechnology, MAY 8, 2025, View Source [SID1234652760]). Unless otherwise stated, all comparisons are for the first quarter of 2025 compared to the first quarter of 2024.

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Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the first quarter of 2025 was $43.1 million, compared to product revenue, net of $40.3 million in the first quarter of 2024.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $3.0 million, or $0.06 per basic and diluted share, for the first quarter of 2025, compared to net loss of $4.8 million, or $0.10 per basic and diluted share, for the first quarter of 2024.

Non-GAAP adjusted net income was $5.0 million, or $0.10 per basic and diluted share, for the first quarter of 2025, compared to non-GAAP adjusted net loss of $2.4 million, or $0.05 per basic share and diluted share, for the first quarter of 2024. Non-GAAP adjusted net income (loss) excludes stock-based compensation expense. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income (loss) and GAAP net income (loss) per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the first quarter of 2025 was $3.6 million, compared to $11.3 million provided by operating activities in the first quarter of 2024. At March 31, 2025, Puma had cash, cash equivalents and marketable securities of $93.2 million, compared to cash, cash equivalents and marketable securities of $101.0 million at December 31, 2024.

"We are pleased to report better than expected net income for the first quarter of 2025," said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. "We recently presented new clinical data on neratinib at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 and we look forward to important updates from our ongoing alisertib clinical studies later this year."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) presentation of interim data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (H2 2025); and (ii) presentation of additional interim data from the ALI-4201/ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (H2 2025)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX and royalty revenue. For the first quarter ended March 31, 2025, total revenue was $46.0 million, of which $43.1 million was net product revenue and $2.9 million was royalty revenue. This compares to total revenue of $43.8 million in the first quarter of 2024, of which $40.3 million was net product revenue and $3.5 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $42.0 million for the first quarter of 2025, compared to $46.1 million for the first quarter of 2024.

Cost of Sales

Cost of sales was $10.6 million for the first quarter of 2025, virtually unchanged from $10.7 million for the first quarter of 2024.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $17.6 million for the first quarter of 2025, compared to $21.8 million for the first quarter of 2024. The $4.2 million decrease resulted primarily from a decrease of $3.6 million in professional fees and expenses, primarily legal fees; a decrease of $0.2 million in payroll and related costs; and a decrease of $0.2 million in stock-based compensation.

Research and Development Expenses

Research and development expenses were $13.8 million for the first quarter of 2025, compared to $13.6 million for the first quarter of 2024. The $0.2 million increase resulted primarily from increases of $0.2 million in clinical trial expenses; and $0.2 million in consultants and contractors; partially offset by a decrease of $0.1 million in stock-based compensation.

Total Other Income (Expenses)

Total other expenses were $0.7 million for the first quarter of 2025, compared to total other expenses of $2.3 million for the first quarter of 2024. The $1.6 million decrease resulted primarily from a lower debt balance, which reflects principal payments of approximately $11.1 million per quarter.

Second Quarter and Full Year 2025 Financial Outlook

Second Quarter 2025

Full Year 2025 (current)

Full Year 2025 (previous)

Net Product Revenue

$48–$50 million

$192–$198 million

$192–$198 million

Royalty Revenue

$2–$3 million

$20–$24 million

$20–$24 million

License Revenue

$0 million

$0 million

$0 million

Net Income/(Loss)*

$4–$6 million

$23–$28 million

$23–$28 million

Gross to Net Adjustment

20%–21.5%

20.5%–21.5%

20.5%–21.5%

*The outlook above does not include any adjustments for tax valuation allowance.

Conference Call

Puma Biotechnology will host a conference call to report its first quarter 2025 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PT/4:30 p.m. ET on Thursday, May 8, 2025. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

On May 8, 2025 BioDlink, a leading global CDMO, reported that it congratulates its partner Junshi Biosciences (HKEX-1877; SSE-688180), on receiving Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) of China to initiate clinical trials for the JS212 injection — Junshi Biosciences’ first bispecific antibody-drug conjugate (ADC) (Press release, Shanghai Junshi Bioscience, MAY 8, 2025, View Source [SID1234652783]).

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JS212 represents a new class of bispecific ADCs that combine the humanized epidermal growth factor receptor and human epidermal growth factor receptor 3 bispecific antibody-drug conjugate to target both EGFR and HER3 — two proteins highly expressed in a variety of tumor cells, such as lung cancer, breast cancer, and head and neck cancer. As a bispecific ADC, JS212 has a key advantage over traditional ADCs that only target one protein: it can attack tumors via either EGFR or HER3, potentially increasing its effectiveness against a wider range of cancers and helping to overcome drug resistance.

Dr. Jun Liu, CEO and Executive Director of BioDlink, stated: "As a leader in ADC technology, BioDlink remains committed to technology innovation and one-stop solution platform for complex biologics. Our collaboration with Junshi Biosciences is built on mutual trust and deep experience in ADC research, development and manufacturing. The IND approval of JS212 — a technically demanding bispecific ADC —­ highlights our strong capabilities and strategic value we bring to partners pursuing next-generation biologics. We’re honored to support the advancement of this important program."

Dr. Jing Tong, Deputy Director of Junshi Biosciences’ Innovation Research Institute, shared: "We are very pleased with the ongoing and highly productive partnership with BioDlink. Their exceptional expertise and proven capabilities in ADC development and manufacturing have played a pivotal role in advancing JS212 to this important milestone. Throughout the collaboration, BioDlink has consistently demonstrated technical excellence, operational efficiency, and a deep understanding of complex bispecific ADCs. This approval marks a key collaboration milestone, and we look forward to deepening our cooperation as we work toward bringing innovative therapies to patients in the future."

BioDlink is committed to becoming a trusted CDMO biologics partner. The company operates a large-scale commercial biologics production site that meets international GMP standards and includes multiple integrated production lines for antibodies and ADCs.

With a comprehensive ADC platform supported by key R&D technologies, BioDlink enables efficient, centralized production of antibody intermediates, drug substances, and finished products. This setup accelerates timelines and reduces tech transfer costs. At the same time, BioDlink’s quality system is built according to international standards and has passed GMP audits in multiple countries, which can empower global customers.