What Biosplice Therapeutics does

Biosplice Therapeutics, Inc. (formerly Samumed, rebranded 2021) is a San Diego-based clinical-stage biopharmaceutical company founded in 2008 that develops small-molecule therapeutics through a proprietary alternative splicing platform targeting the Wnt signaling pathway. Its lead asset, lorecivivint (SM04690), is an injectable intra-articular CLK2/DYRK1A inhibitor that has completed Phase 3 development for knee osteoarthritis, with an NDA submitted to the FDA in January 2026. Over 1,700 subjects have been treated across the lorecivivint clinical program, demonstrating statistically significant WOMAC Pain and Function improvements versus placebo and medial joint space width improvement suggesting disease-modifying potential in an indication with no approved disease-modifying drugs and over 50 million US patients.

The company's revenue model is currently pre-commercial and combines episodic licensing upfronts and potential royalties from regional partners with prospective direct product sales upon FDA approval. Biosplice out-licensed lorecivivint development and commercialization rights to Haisco for China (September 2021, $140 million upfront) and to Samil for South Korea (April 2021), generating non-dilutive capital and validating external commercial interest. Once approved, the company plans to commercialize lorecivivint in the US via enterprise field sales targeting rheumatologists and orthopedic surgeons who administer the injection in clinical settings. A second clinical asset, cirtuvivint, is being evaluated in an investigator-initiated Phase 1 ovarian cancer trial (combination with olaparib, dosed December 2025) and in an NCI-sponsored AML/MDS trial (initiated 2024). Additional programs in neurology, diabetes, and oncology are developed by affiliate TenaRx, Inc.

Biosplice is privately held and structured as a California corporation with 51-100 employees, headquartered at 6555 Nancy Ridge Drive, Suite 300, San Diego. The company has raised approximately $778 million in cumulative disclosed equity financing across 2013, 2018, and 2021 rounds, with the $120 million April 2021 round led by aMoon Fund and Eventide. Leadership includes founder and Executive Chairman Osman Kibar, CEO Erich Horsley (private equity background at Intervale Capital and Morgan Stanley), CFO Phil Wilson, CMO Dr. Yusuf Yazici (NYU rheumatologist with 250+ publications), and Chief Legal Officer Scott Bulcao. The board includes former Foundation Medicine CEO Troy Cox and Vickers Venture Partners founder Finian Tan, and the company has been recognized among 126 healthcare unicorn startups.

Name

Biosplice Therapeutics

Legal name

Biosplice Therapeutics, Inc.

Website

https://biosplice.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

51–100 employees

Short description

Biosplice Therapeutics is a clinical-stage biopharmaceutical company developing lorecivivint, a first-in-class injectable CLK2/DYRK1A inhibitor targeting the Wnt pathway for knee osteoarthritis, with an NDA submitted to the FDA in January 2026. The San Diego-based company serves rheumatologists and orthopedic surgeons via enterprise specialty sales and out-licenses China and Korea rights to Haisco and Samil.

Ownership category

akta.pro rank

Product category

Osteoarthritis Therapeutics

NAICS

Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Primary Care & General Medicine Pharmaceuticals (HLAIAAAA)

akta.pro secondary industry

Target Identification & Validation Platforms (omics-driven, chemoproteomics, genetic validation) (HLAAAIAI)

Keywords

• Osteoarthritis therapeutics
• Alternative splicing platform
• CLK2 DYRK1A inhibitors
• Wnt pathway modulation
• Intra-articular injection therapy

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Pharmaceutical product sales: Once approved, Biosplice will generate revenue through direct sales of lorecivivint as an injectable treatment for knee osteoarthritis. The company has completed Phase 3 trials and submitted NDA to FDA.
2. Licensing and royalty revenue: Biosplice has licensed development and commercialization rights for lorecivivint to Haisco for China (2021) and to Samil for South Korea (2021), generating upfront payments and potential royalties.
3. Regional partnerships: The company generates revenue through regional licensing partnerships including China and Korea, with potential for additional geographic expansion.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Biosplice Therapeutics develops investigational disease-modifying pharmaceutical products based on its proprietary alternative splicing platform. Its lead candidate, lorecivivint (SM04690), is an injectable small-molecule CLK2/DYRK1A inhibitor that modulates the Wnt pathway to provide both symptomatic relief and structural cartilage protection in knee osteoarthritis, with an NDA submitted to the FDA in January 2026. The company also develops cirtuvivint for oncology and operates additional programs in neurology, diabetes, and oncology through affiliate TenaRx, Inc.

Product overview

Biosplice Therapeutics is a biopharmaceutical company focused on developing novel therapeutics based on its alternative splicing platform. The company's primary product is lorecivivint (SM04690), an injectable small-molecule CLK2/DYRK1A inhibitor that modulates the Wnt pathway for knee osteoarthritis treatment. Additional programs in neurology, diabetes, and oncology are being developed by its affiliate TenaRx, Inc. The company submitted an NDA to the FDA for lorecivivint in early 2026 and is also conducting clinical trials in oncology with cirtuvivint.

Differentiator

Problem solved

Functional benefit

Products and services

• Lorecivivint (SM04690) Injectable small-molecule CLK2/DYRK1A inhibitor administered as a single intra-articular injection to provide disease-modifying treatment of knee osteoarthritis, offering both symptomatic pain/function relief and structural cartilage protection for adult patients who have failed conservative therapies. Targeted at rheumatologists and orthopedic surgeons.
• Cirtuvivint Investigational DYRK1A inhibitor drug candidate being evaluated in combination with olaparib for the treatment of BRCA/HRD platinum-resistant ovarian cancer, with the goal of overcoming resistance to PARP inhibitors.

Quantifiable outcome

• Statistically significant improvements in WOMAC Pain versus placebo at 6 and 12 months following single injection in OA-07 Phase 3 study
• +3 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Ten partnerships are on record, tiered minor and core.

• University of Colorado Anschutz Cancer CenterminorStrategic or Co-development Partner · 22 December 2025Investigator-initiated Phase 1 clinical trial of cirtuvivint in combination with olaparib for BRCA/HRD platinum-resistant ovarian cancer being conducted at this site.
• National Cancer Institute (NCI)minorStrategic or Co-development Partner · 1 December 2025NCI-sponsored trial for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) initiated, with Biosplice's compounds being evaluated.
• HaiscocoreChannel Partner/ Reseller/ Distributor · 15 September 2021Biosplice licensed development and commercialization rights for lorecivivint to Haisco for the People's Republic of China. Haisco paid $140 million upfront to license Biosplice's Phase 3 osteoarthritis drug for the Chinese market.
• SamilcoreChannel Partner/ Reseller/ Distributor · 22 April 2021Biosplice licensed rights to lorecivivint to Samil for the Republic of Korea, enabling regional commercialization of the novel Phase 3 osteoarthritis drug candidate.
• Brigham and Women's Hospital at Harvard Medical SchoolminorStrategic or Co-development PartnerBiosplice sponsors the Osteoarthritis Registry of Biomarker and Imaging Trajectories (ORBIT), developed in collaboration with Brigham and Women's Hospital investigators to enhance understanding of knee osteoarthritis natural history.
• Foundation for the National Institutes of Health (FNIH) Biomarkers ConsortiumminorStrategic or Co-development PartnerBiosplice is a partner on the FNIH Biomarkers Consortium's PROGRESS OA Project, seeking to qualify imaging and biochemical biomarkers with the FDA as prognostic biomarkers of disease progression in knee osteoarthritis.
• Oxford UniversityminorStrategic or Co-development PartnerBiosplice supports STEpUP OA (Synovial fluid To define molecular Endotypes by Unbiased Proteomics in OA), an Oxford University-led partnership to characterize synovial fluid protein signatures of osteoarthritis patients.
• TenaRx, Inc.coreOthersAffiliate company developing Biosplice's active programs outside of lorecivivint including neurology, diabetes and oncology programs.
• Osteoarthritis Research Society International (OARSI)minorOthersBiosplice is a Corporate Member of OARSI, the leading medical society for advancing understanding, early detection, treatment, and prevention of osteoarthritis through exclusive dedication to research.
• International Cartilage Regeneration & Joint Preservation Society (ICRS)minorOthersBiosplice is a Corporate Member of ICRS, the main forum for international collaboration in cartilaginous tissue research and joint preservation, seeking to improve patients' quality of life and reduce degenerative joint disease impact.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Flexion Therapeutics (acquired by Pacira BioSciences): Developer of Zilretta, an intra-articular extended-release corticosteroid for knee OA pain, providing the most directly comparable commercial precedent for an injectable OA therapy with rheumatologist/orthopedic surgeon channel dynamics.
• Eupraxia Pharmaceuticals: Clinical-stage biotech developing EP-104IAR, an intra-articular sustained-release therapy for knee OA, sharing Biosplice's core route of administration and specialty physician targeting.
• UNITY Biotechnology: Clinical-stage company developing senolytic therapies for OA and other age-related musculoskeletal diseases, directly competing for the disease-modifying OA drug designation.
• Mesoblast: Cellular medicine company with a Phase 3 allogeneic mesenchymal precursor cell therapy for knee OA, representing an alternative modality competing for the same disease-modifying OA positioning.
• Kolon TissueGene: Developer of TG-C, a cell and gene therapy for knee OA, advancing an intra-articular biologic approach in late-stage trials and overlapping with Biosplice's structural disease-modification thesis.

Broad incumbents

• Bioventus: Public musculoskeletal specialty company with established OA offerings (hyaluronic acid injections, pain management portfolio), serving as a broader commercial incumbent in the same prescriber channels.
• Eli Lilly: Co-developer (with Pfizer) of tanezumab, an anti-NGF antibody for OA pain, representing the major pharma precedent in pursuing disease-relevant OA therapies and a potential partner/acquirer for lorecivivint.
• Pacira BioSciences: Acquirer of Flexion Therapeutics and operator of Zilretta in the OA space, providing a reference specialty pharma platform model for an intra-articular OA asset launch.

Emerging players

• Pliant Therapeutics: Clinical-stage biotech developing integrin-targeting small molecules in fibrosis and related indications, offering a comparable small-molecule biotech profile, capital base, and specialty clinical-development operating model.
• H3 Biomedicine (Eisai): Oncology-focused RNA splicing modulator company developing small molecules targeting aberrant RNA splicing in cancer, the closest direct comparator to Biosplice's alternative splicing platform approach.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/biospliceinc

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries1 record

Funding overview

Funding rounds6 records

Investors11 records

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Biosplice Therapeutics