Thursday 26 January 2023

US-based biopharmaceutical company Longevity Biomedical, Inc, which is focused on advancing new technologies across therapeutics, health monitoring and digital health solutions to increase human health span, and special purpose acquisition Company Denali Capital Acquisition Corp have entered into a definitive business combination agreement, the companies said.

Upon closing of the transaction pursuant to the BCA, the combined company will operate as Longevity Biomedical, Inc. and is expected to list on NASDAQ under the ticker symbol "LBIO."

Despite the rapid pace of global population aging, Longevity Biomedical 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 provider of advanced therapeutic, health monitoring and digital health technologies designed to restore tissue form and function and increase health span for the rapidly growing aging population.

To achieve this goal, Longevity intends to build on its existing platform of diversified, late-stage technologies by leveraging its seasoned executive team to continue acquiring first-in-class technologies, products and services that address the growing market of age-related diseases and conditions.

Longevity 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 is 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.

Previous clinical studies have demonstrated a nearly two-fold increase in complete vessel recanalization compared to thrombolytic drug therapy alone. The Phase 3 trial to support product approval is scheduled to begin in 2023.

LBI-001 combines 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 provided favorable safety data and demonstrated improvements in key visual measurements. Initiation of a randomized, placebo-controlled Phase 2 trial is expected in 2023.

LBI-101 is 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. Clinical studies of LBI-101 have demonstrated initial safety, biocompatibility, and new tissue formation without scarring typically associated with injections.

A Phase 2 trial is currently ongoing, with full results targeted for 2024.

LBI-002 is 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 will have, upon the closing of the transactions contemplated by the C&E Agreements described below, a pipeline of preclinical stage indications across its initial therapeutic areas of focus.

Longevity also plans to seek to acquire additional cutting-edge health technologies in the areas of health monitoring and digital health solutions.

The transaction represents a pro forma equity valuation of approximately USD 236.2m of the combined company, assuming no redemptions of Denali public shares by Denali's public shareholders.

The estimated cash proceeds available to the combined company from the transaction consists of Denali's USD 85.4m of cash held in trust.

The proceeds will be used to complete a Phase 3 study for LBI-201, complete a Phase 2 study for LBI-001, complete a Phase 2 and initiate a Phase 3 study for LBI-101, and complete the formulation and pre-clinical studies for LBI-002.

The combined company may seek a USD 30m pre-transaction PIPE that is expected to close concurrently with the closing of the transaction.

The board of directors of each of Denali and Longevity unanimously approved the transaction, which is expected to occur in Q2 2023.

The transaction will require the approval of the shareholders of Denali and Longevity, and is subject to other customary closing conditions including the receipt of certain SEC regulatory approvals.

US Tiger Securities, Inc. is acting as business combination advisor to Denali. Sidley Austin LLP is acting as legal advisor to Denali. Nelson Mullins Riley & Scarborough LLP is acting as legal advisor to Longevity.