Biotherapeutic Co. Offers Potential Curative Alternative For Thyroid Disease
Research Report

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In a February 3, 2025 research note, Leede Financial analyst Dr. Douglas Loe maintained a Speculative Buy rating on Sernova Biotherapeutics Inc. (SVA:TSX.V; SEOVF:OTCQB; PSH:XETRA) with a CA$1.50 target price, following the company's filing of a new IND for Cell Pouch in thyroid disease.

The company filed an IND with the FDA to commence Phase I testing of its Cell Pouch implantable cell reservoir device for hypothyroidism post-thyroidectomy. This represents the second formal clinical trial for Cell Pouch, alongside the ongoing 17-patient Phase I/II type I diabetes study at the University of Chicago.

The thyroid disease program is supported by previously published preclinical data from 2022, conducted in collaboration with the University of British Columbia. The study demonstrated that "thyroid tissue deployed into a subcutaneously-implanted Cell Pouch remained viable and able to release thyroglobulin during the three-month study duration."

While specific trial details weren't provided, the analyst expects the study size and duration to mirror the ongoing diabetes trial using autologous self-donated tissue. Feedback on the IND is anticipated by the end of the current quarter, with potential Phase I/II trial commencement by FQ3 2025.

The analyst notes that the current standard of care relies on hormone supplementation through products like Sanofi's Synthroid or IBSA's Tirosint, both of which are now genericized. Cell Pouch offers a potential curative alternative by enabling signal-responsive thyroxine production through implanted thyroid cells.

The CA$1.50 target price is based on a blend of NPV (35% discount rate) and multiples of F2030 EBITDA/EPS forecasts, with the analyst's view supported by Cell Pouch's potential as "a well-vascularized subcutaneously-implanted, cell function-preserving minimally fibrosed cell reservoir."

The share price at the time of the report of CA$0.22 represents a potential return of 582% to Leede's CA$1.50 target price.