BRIM Biotechnology Board of Directors approves seasoned equity offering of USD 18 million to accelerate phase 3 development of lead asset BRM421 for dry eye syndrome

BRIM Biotechnology, Inc. (BRIM, TPEx 6885) reports that the Company’s Board of Directors has approved a proposal for a seasoned equity offering, following its recent emerging stock market (ESM) listing, to increase capital and advance its lead drug candidate, BRM421, to late-stage clinical trials for dry eye syndrome (DES).

The Board of Directors gathered for an interim meeting today to pass the plan to raise capital by issuing 20-24 million additional shares of common stock which are estimated to bring in NTD 500-600 million (~USD 17-20 million) with a tentative share price of NTD 25 (~USD 0.83).

BRM421 is a novel, first-in-class regenerative peptide therapy which, if successful, could offer patients complete relief from dry eye symptoms by stimulating the proliferation and differentiation of stem cells to repair damage to the cornea. BRM421 was developed using BRIM’s proprietary stem cell regenerative Pigment Epithelium-Derived Factor (PEDF) derived Short Peptide (PDSP) technology platform, which underpins several other products in its pipeline. With its unique mode of action, BRM421 has potential to become a first line treatment for DES around the world.

Preclinical studies for BRM421 have demonstrated safety and therapeutic effectiveness in DES animal models when there is no systemic exposure, or any organ toxicity detected. With this data, BRM421 was fast-tracked to directly enter a first-in-human (FIH) phase 2 study in 2016.

Both phase 2 and phase 2/3 studies to date have shown clinically meaningful efficacy with no safety concerns in the BRM421 treatment groups for DES patients. BRIM will continue discussions with the FDA on the design of the phase 3 study at the end-of-phase 2 (EOP2) meeting in Q4, 2022.

In previous type-C meetings, the FDA has agreed on the new formulation of BRM421 and the adjustment of the primary endpoints to better demonstrate the statistical and clinical meaningful efficacy in subsequent trials. Subject to the FDA agreeing to the phase 3 clinical trial design, BRIM plans to accelerate the development of the novel drug toward market approval.

The approval of the seasoned equity offering to accelerate the development of BRM421 by BRIM’s Board of Directors brings the company one step closer to achieving its vision of providing the millions of people around the world living with dry eye syndrome with an effective and affordable treatment option.