Longevity Biomedical and SPAC Denali to create Nasdaq-listed longevity biopharm company

New company will focus on advancing new tech to promote human health and longevity.

Longevity Biomedical, a biopharmaceutical company focused on advancing new technologies across therapeutics, health monitoring and digital health solutions to increase human healthspan, and Denali Capital Acquisition Corporation, a publicly-traded special purpose acquisition company (SPAC), have announced that they have entered into a definitive business combination agreement (BCA).

Upon closing of the transaction, the new combined company will operate as Longevity Biomedical, Inc. and is expected to list on Nasdaq under the ticker symbol “LBIO.”

Longevity.Technology: The transaction, which is expected to compete in the second quarter of this year, will swell the coffers of the combined company with proceeds of $85.4m in cash; Denali will hold this in trust, and the money will be used to complete a retinal vein occlusion Phase II study, begin a Phase III study for its injectable tissue regeneration therapy and conclude a Phase III study for its ultrasonic device for treatment of ischemic stroke. The cash will also fund pre-clinical studies for Longevity Biomedical’s biosynthetic cornea.

Despite the rapid pace of global population aging, Longevity Biomedical says it believes the current market for longevity-related products and services is fragmented and that, particularly as it relates to low- and middle-income countries, it is difficult for healthcare consumers to find and purchase the products, technologies and services to address their individual aging needs.

To address this unmet need, Longevity Biomedical aims to become a consolidator and leading provider of advanced therapeutic, health monitoring and digital health technologies designed to restore tissue form and function and increase healthspan for the rapidly growing aging population. To achieve this goal, it intends to build on its existing platform of diversified, late-stage technologies by leveraging its team to continue acquiring first-in-class technologies, products and services that address the growing market of age-related diseases and conditions.

Longevity Biomedical has established an existing pipeline of late-stage, diversified therapeutic candidates addressing cardiovascular disease, ophthalmology and soft tissue reconstruction and repair through the proposed acquisitions of the following technologies:

  • LBI-201 – a non-invasive ultrasonic device being investigated for treatment of ischemic stroke, the second leading cause of death worldwide. It is designed for rapid, convenient delivery of transcranial ultrasound in combination with conventional thrombolytic drug therapy to increase restoration of blood flow in stroke patients with large vessel occlusions that do not have immediate access to thrombectomy facilities and services. A Phase 3 trial to support product approval is scheduled to begin in 2023. 
  • LBI-001 – combining intravenous administration of microspheres with non-invasive ultrasound as a potential treatment of retinal vein occlusion, one of the most common causes of retinal blindness worldwide. LBI-001 Phase 1 clinical results demonstrated improvements in key visual measurements. Initiation of a randomised, placebo-controlled Phase 2 trial is expected in 2023. 
  • LBI-101 – an off-the-shelf allogenic tissue biomaterial being investigated in a Phase 2 clinical study for permanent reconstruction of soft tissue affected by aging, traumatic injuries and surgical procedures. The injectable application is designed to stimulate tissue repair and regeneration, and a Phase 2 trial is currently ongoing, with full results targeted for 2024. 
  • LBI-002 – a biosynthetic cornea being investigated as a replacement product that will potentially address the significantly underserved market of corneal transplant patients who are reliant on a limited supply of human donor tissue. LBI-002 has similar optical properties as human tissue, enables nerve regeneration and epithelial growth and potentially eliminates the need for long-term immunosuppressive drugs to combat transplant rejection. Formulation and preclinical studies are scheduled to be initiated in 2023.

In addition to these clinical stage technologies, Longevity Biomedical will have, upon the closing of the transactions, a pipeline of preclinical stage indications across its initial therapeutic areas of focus. It also plans to seek to acquire additional cutting-edge health technologies in the areas of health monitoring and digital health solutions.

“Longevity Biomedical is dedicated to advancing science-driven solutions to improve human health. This business combination will provide the platform to advance cutting-edge technologies spanning multiple areas of unmet medical need for the aging population,” said Bradford A Zakes, Chief Executive Officer of Longevity Biomedical.

“The proceeds from this transaction will allow Longevity to reach significant clinical development milestones for our four leading technologies that have demonstrated successful results in clinical studies. In addition, Longevity will retain an opportunistic, visionary approach to future health advancements in the areas of health monitoring and digital health solutions [1].”

“Longevity is focused on offering impactful, meaningful health solutions and services that are readily accessible to the growing aging patient market,” said Mr Lei Huang, Chief Executive Officer of Denali.

“Longevity is acquiring a deep portfolio of health technologies and has an experienced leadership team with a visionary approach to addressing human health span. In addition to advancing these current late-stage technologies, the Company will be opportunistic in its efforts to bring the latest in human health advances to aging populations globally [1].”

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[1] https://longevitybiomedical.com/wp-content/uploads/2023/01/Longevity-Denali-Press-Release-BCA-Announcement-FINAL.pdf