Indicate by check mark whether the registrant files
or will file annual reports under cover Form 20-F or Form 40-F.
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Exhibit 99.1
SL Science Holding
Limited Submits Orphan Drug Designation Request to the U.S. FDA for GDT Cell Therapy Targeting Glioblastoma
Taipei, TAIWAN, July 10, 2026 (GLOBE
NEWSWIRE) -- SL Science Holding Limited (“SL Science” or the “Company”) (Nasdaq: SLBT), a Taiwan-headquartered
biomedical company specializing in developing innovative cellular and gene therapies, today announced that the Company has submitted
an Orphan Drug Designation (ODD) request to the U.S. Food and Drug Administration (FDA) for its Gamma Delta T (GDT) cell therapy product,
Vdelta2+ Gamma Delta T Cells, for the treatment of glioblastoma multiforme (GBM). The FDA's Office of Orphan Products Development (OOPD)
has formally acknowledged receipt of the request and is proceeding with review on additional files about the product
The research team of JY BioMed (“JY
BioMed”), licensor of the Company’s GDT cell therapy technology will present at the 20th World Congress of Basic
and Clinical Pharmacology (WCP 2026) held at July 12-17, 2026 in Melbourne, Australia. JY BioMed will present the Company’s
GBM treatment asset themed by “Intracranial γδ T Cell Therapy Eliminates Glioblastoma in Preclinical Models”.
Representatives from SL Science will also be present at the event. WCP is among the most influential international pharmacology congresses
in the world, convening leading researchers and clinical scientists from across the globe. Presenting at the event reflects the growing
international recognition of GDT cell therapy as a serious candidate in solid tumor oncology.
Designation Details
The ODD request was submitted pursuant
to Section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb).
Product: Vdelta2+ Gamma Delta
T Cells
Disease / Condition: Glioblastoma
Multiforme (GBM)
Designation Request Number:
DRU-2026-11528
Date of Receipt: March 30,
2026
The GDT Platform: A Differentiated
Mechanism
SL Science's GDT cell therapy platform
offers a distinct immunological mechanism. Unlike conventional T cell therapies, GDT cells recognize and target tumor cells independent
of major histocompatibility complex (MHC) presentation, enabling direct cancer cell engagement and overcoming the key challenges of tumor
heterogeneity and immune evasion in solid tumors.
The GDT technology is licensed from
JY BioMed, the intellectual property holder of the GDT platform. The submission of the ODD request for GDT cell therapy product for the
treatment of GBM marks an important regulatory milestone in advancing GDT cell therapy toward clinical development in brain cancer.
Addressing a Critical Unmet Medical
Need
Glioblastoma multiforme is among the
most aggressive and lethal forms of primary brain cancer. Under current standard of care, median survival is around 15 months, and patients
may face severely limited effective treatment options, representing one of the largest unmet medical needs in oncology.
ODD is granted by the FDA to therapies
targeting diseases affecting fewer than 200,000 patients in the United States annually. ODD formally recognizes the unmet medical need
and may provide regulatory support, including potential access to accelerated review pathways and related policy incentives, to help
bring innovative therapies to patients more efficiently.
“Submitting the ODD is a critical
step forward in our strategy to accelerate the clinical development of our GDT cell platform," said Mr. William Wang, Chairman
and Chief Executive Officer of SL Science. “Glioblastoma is a devastating disease with a median survival rate of around15 months,
representing a significant unmet medical need and commercial opportunity. By leveraging our platform's unique ability to bypass the defenses
solid tumors use to evade standard therapies, we believe this product candidate has the potential to redefine the immuno-oncology landscape
and deliver meaningful value to both patients and our shareholders."
About SL Science Holding Limited
SL Science Holding Limited is a biomedical
company specializing in developing innovative cellular and gene therapies. Established with a commitment to advancing regenerative medicine
and cancer treatment, the Company hopes to utilize immune cell technologies to target cancer, thus potentially offering expansive medical
applications for its products. With proprietary technologies such as Gamma Delta T cells targeting solid tumor indications including
pancreatic and brain cancers, SL Science aims to create cellular therapies that we believe have the potential to revolutionize the cell
therapy and immuno-oncology sector within the broader biopharmaceutical industry. For more information, please visit the Company's website
at: https://www.slbtgroup.com/ and follow SLBT on X, LinkedIn, FB, IG and Threads.
Forward-Looking Statements
This press release contains certain
forward-looking statements within the meaning of the federal securities laws with respect to the business of SL Science. These forward-looking
statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,”
“estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,”
“may,” “should,” “will,” “would,” “will be,” “will continue,”
“will likely result,” and similar expressions. Forward-looking statements are predictions, projections, and other statements
about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties.
Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including but
not limited to: the ability to successfully implement the Company’s business plans and clinical trials; the ability to obtain and
maintain necessary regulatory approvals for its product candidates; the potential for its regenerative medicine products to reach commercialization;
and the ability to recognize the anticipated benefits of the business combination. The Company assumes no obligation to update these
forward-looking statements, except as required by applicable law.
Contact Details:
SL Science Holding Limited
Tel: +886-2-26516826
Email: ir@slbtgroup.com
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Email: services@wfsir.com
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