On April 28, 2025 NEC reported Financial Results for the Fiscal Year Ended March 31, 2025 (Presentation, NEC, APR 28, 2025, View Source [SID1234654110]).

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On April 28, 2025, BeiGene, Ltd. (the "Company") reported its 2024 Annual Report (the "STAR Annual Report") with the Science and Technology Innovation Board (the "STAR Market") of the Shanghai Stock Exchange, which was prepared in accordance with the listing rules of the STAR Market and the applicable securities laws and regulations of the Peoples’ Republic of China (the "PRC" and the "PRC Securities Laws") (Press release, BeiGene, APR 28, 2025, View Source [SID1234652221]). The STAR Annual Report is available to the public in Chinese language only on the website maintained by the Shanghai Stock Exchange at www.sse.com.cn.

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As required by the PRC Securities Laws, the STAR Annual Report contains additional financial information of the Company’s gross profit margin ratio, research and development expenses allocated by key products and other research and development projects and production, sales and inventory stock units for the year ended December 31, 2024 (the "Reporting Period"), prepared in accordance with the China Accounting Standards for Business Enterprises – Basic Standard ("CAS") and other applicable PRC accounting rules, guidance and interpretations (together with CAS, "PRC GAAP"), including but not limited to the China Securities Regulatory Commission’s Compilation Rule for Information Disclosure by Companies Offering Securities to the Public No. 15 – General Rules for Financial Statement (2023 revised), and Compilation Rule for Information Disclosure by Companies Offering Securities to the Public No. 24-Special Provisions on Information Disclosure in Financial Statements of Pilot Innovative Red-chip Companies on the Sci-Tech Innovation Board. The key differences between such financial information prepared in accordance with PRC GAAP and those prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP") for the Reporting Period, which was previously filed with the U.S. Securities and Exchange Commission, are summarized below.

Key Differences between PRC GAAP and U.S. GAAP

Share-based Compensation

Under U.S. GAAP, the Company elects to recognize share-based compensation expenses using the straight-line method for all employee equity awards granted with graded vesting based on service conditions, provided that the amount of compensation cost recognized at any date is at least equal to the portion of the grant-date value of the options that are vested as of that date.

Under PRC GAAP, the Company recognizes share-based compensation expense using the accelerated method for all employee equity awards granted with graded vesting.

Under PRC GAAP, the excess tax benefit resulting from the pre-tax deductible amount arising from U.S. employee share-based payments over the cumulative share-based payment-related expenses recognized for accounting purposes should be recorded in shareholders’ equity rather than in current income tax expenses/benefits under U.S. GAAP.

Leasing

Under U.S. GAAP, as a lessee, the Company recognizes a lease liability based on the present value of the total remaining lease payments, and a corresponding right-of-use assets. The Company subsequently recognizes operating lease expenses on a straight-line basis over the lease term.

PRC GAAP requires lessees to present interest expenses on the lease liability and depreciation on the right-of-use assets separately in the statements of operations. The combination of a straight-line depreciation of the right-of-use assets and the effective interest rate method applied to the lease liability will result in a higher total charge to profit or loss in the initial years of the leases and decreasing expenses during the latter part of the lease term.

Gross Profit Margin Ratio

As required by the PRC Securities Laws, the 2024 STAR Annual Report contained financial information regarding gross profit margin ratio by region, which was prepared in accordance with PRC GAAP. The corresponding financial information prepared in accordance with U.S. GAAP is presented below. Amounts reported herein are stated in thousands of U.S. dollars.

For the year ended December 31, 2024
For the year ended December 31, 2023
By Region Revenue COGS Gross Margin ratio Revenue COGS Gross Margin ratio
China 1,411,307
524,220
62.9%
1,101,951 352,706 68.0%
Ex-China 2,398,934
69,869
97.1% 1,356,828 27,214 98.0%
Total 3,810,241 594,089 - 2,458,779 379,920 -

Research and Development Expenses Allocated by Key Products and Other R&D Projects

As required by the PRC Securities Laws, the 2024 STAR Annual Report contains financial information regarding the research and development ("R&D") expenses allocated by key products, which was prepared in accordance with PRC GAAP. The corresponding financial information prepared in accordance with U.S. GAAP is presented below. Amounts reported herein are stated in thousands of U.S. dollars.

Pipeline Products/ Projects
For the year ended December 31, 2024
For the year ended December 31, 2023
Zanubrutinib 129,226 158,051
Tislelizumab 68,684 83,799
Bcl-2 (BGB-11417) 99,939 52,548
CDAC (BGB-16673) 20,380 3,584
CDK4 (BGB-43395) 6,078 1,734
Other R&D projects 215,139 251,701
R&D collaboration projects 189,214 100,115
Subtotal of external R&D expenses 728,660 651,532
Subtotal of internal R&D expenses 1,224,635 1,127,062
Total 1,953,295 1,778,594

Production, Sales and Inventory Stock Units

As required by the PRC Securities Laws, the 2024 STAR Annual Report contained financial information regarding the production, sales and inventory stock units of key products, which was prepared in accordance with PRC GAAP. The corresponding financial information prepared in accordance with U.S. GAAP is presented below.

Item Unit
Production or purchase quantity for the year ended December 31, 2024
Sales quantity for the year ended December 31, 2024
Stock quantity as of December 31, 2024
Key products vials
5,011,100
5,037,600
2,639,900

On April 28, 2025 Nerviano Medical Sciences S.r.l. (NMS), a clinical-stage oncology company developing targeted therapies across DNA damage response and kinase pathways, reported the initiation of two Phase 1 clinical trials evaluating its unique non-trapping, highly specific and brain penetrant PARP1 inhibitor NMS-293 in combination therapies for relapsed small cell lung cancer (SCLC) and BRCA wild-type ovarian cancer (Press release, Nerviano Medical Sciences, APR 28, 2025, View Source [SID1234652238]). NMS-293 represents a third generation of PARP1 inhibitor using non-trapping as a way to combine with DNA-damaging therapies while preserving bone marrow safety. In this way, NMS-293 addresses tumors outside of BRCA or homologous recombination (HR) repair mutations which is unique. BRCA/HR mutation therapies represent only a small minority of tumors, mainly subsets of pancreatic, breast, prostate and ovarian cancers. Thus, therapies that leverage DNA damage response but are not limited to synthetic lethality of BRCA/HR mutations such as NMS-293 combinations with DNA damaging agents could address many tumor types in the future.

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PARPA-293-004: NMS-293 with Temozolomide in Relapsed SCLC

This open-label, single-arm Phase 1 trial will enroll approximately 10 patients with relapsed SCLC who have progressed after platinum-based chemotherapy, immunotherapy and other standards of care. The objectives include safety and preliminary anti-tumor activity. This regimen is similar to the ongoing Phase 2 -002 study in relapsed high-grade glioma. Boosting temozolomide activity in this relapsed setting of SCLC could lead to accelerated registration pathways and future early line combination study options with a variety of DNA-damage modalities.

ClinicalTrials.gov Identifier: NCT06931626

PARPA-293-003: NMS-293 with Topotecan in BRCA Wild-Type Ovarian Carcinoma
This open-label Phase 1 study will enroll approximately 24 patients with recurrent ovarian cancer who have received platinum-based treatments and other standards of care, including patients with platinum resistance. The objectives include safety, dose-finding and preliminary anti-tumor activity. Boosting topotecan activity in patients with relapsed ovarian cancer could lead to accelerated registration pathways as well as various DNA-damaging modality combination options for future early line studies.

ClinicalTrials.gov Identifier: NCT06930755

The rationale for initiating these trials is supported by both preclinical evidence and emerging clinical data from temozolomide combination studies which revealed an unprecedented combination safety profile coupled with preliminary antitumor efficacy in high grade gliomas (Mahnke, DDR Summit 2025 and Guerts et al, AACR (Free AACR Whitepaper)-NCI-EORTC 2023) including glioblastoma (unpublished). NMS-293 is a highly novel third generation PARP1 inhibitor distinguished by non-trapping as shown preclinically with high potency, selectivity and brain penetrance. Taken together, the profile improves on poor bone marrow features of first and second generation trapping PARP1 inhibitors (Yap et al AACR (Free AACR Whitepaper) 2024) and thus removes traditional barriers of combining a DNA damage repair inhibitor with a DNA damaging agent to address non-BRCA mutation tumors.

"These trials represent our focused, mechanism-driven approach to improving treatment outcomes in areas of high unmet medical need including relapsed small cell lung and BRCA wild type ovarian cancers," said Lisa Mahnke, MD, PhD, Chief Medical Officer of NMS. "NMS-293 has the potential to establish a new third generation of PARP1 inhibitor and which is not being developed as a classical PARP1 inhibitor due its unique chemotype. NMS-293 is a highly potent, highly selective, non-trapping PARP1, inhibitor which is highly brain penetrant and which can be developed across many tumor types including brain tumors like GBM or others with or without brain metastases in combination with a variety of DNA-damaging modalities such as chemotherapies or ADC payloads to reach many non-BRCA-mutation tumors in the future."

On April 28, 2025 The Management Board of 4SC AG ("4SC") (Frankfurt Stock Exchange, Prime Standard: VSC; ISIN: DE000A14KL72) reported by the European Medicines Agency (EMA) that, based on the review of the final data and the company’s responses to the Day-180 Assessment Report, 4SC has been invited to an oral discussion before the Committee for Medicinal Products for Human Use (CHMP) at its meeting in late May (Press release, 4SC, APR 28, 2025, View Source [SID1234652255]). Following this meeting, the CHMP is expected to issue a decision on whether to issue a positive or negative recommendation on the company’s Marketing Authorization Application (MAA) for resminostat (Kinselby) in the EU.

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Information and explanations of the issuer regarding this announcement:

Future-oriented information
This release contains certain forward-looking statements that involve risks and uncertainties and reflect 4SC’s assessment as of the date hereof. Such forward-looking statements are neither promises nor guarantees, but are subject to numerous risks and uncertainties, many of which are beyond 4SC’s control, which could cause actual results to differ materially from those contemplated by such forward-looking statements. 4SC expressly disclaims any obligation to update or revise any forward-looking statements to reflect changed expectations or new events, conditions, or circumstances on which any such statements are based.

On April 28, 2025 GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, reported the presentation of preclinical data on GNX1021, its lead antibody-drug conjugate (ADC) program, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 (Press release, GlycoNex, APR 28, 2025, View Source [SID1234652270]). The presentation is part of a poster session held on April 28, 2025, at McCormick Place in Chicago.

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GNX1021 is a novel ADC that targets branched Lewis B/Y (bLeB/Y), a tumor-associated glycan highly expressed in gastric cancer and other solid tumors. The target has a distinct expression profile compared to HER2 and CLDN18—two well-known markers in gastric cancer—allowing GNX1021 to potentially treat patients who are not eligible for current HER2- or CLDN18-targeted therapies.

The poster presents preclinical data showing GNX1021’s antitumor activity in gastric cancer models with high bLeB/Y expression, along with a favorable safety profile in nonclinical studies. Findings suggest that GNX1021 may offer a differentiated therapeutic option for gastric cancer patients with limited targeted treatment choices.

"These data demonstrate the potential of GNX1021 to expand the treatment landscape for gastric cancer by targeting a glycan biomarker not addressed by existing therapies," said Dr. Mei-Chun Yang, CEO of GlycoNex. "As a first-in-class anti-glycan ADC, GNX1021 exemplifies our approach to developing next-generation oncology therapeutics designed to overcome tumor heterogeneity and drug resistance."

GlycoNex is advancing GNX1021 through IND-enabling preclinical development, with an IND submission planned for Q1 2026 and Phase 1 trial initiation expected in Q2 2026.

Presentation Details:

Event:

American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025

Session Category:

Experimental and Molecular Therapeutics

Session:

Growth Factor Receptors and Other Surface Antigens as Targets for Therapy 1

Abstract Title: (#2932)

GNX1021, a novel ADC targeting glycans with branched Lewis B/Y, demonstrated preclinical tumor control activity in gastric cancer models and favorable safety

Date and Time:

April 28, 2025; 2:00 pm CDT

Location:

McCormick Place Convention Center, Chicago

Poster Section 17, Poster Board 6