Source: Dr. Douglas Loe 11/12/2024

Sernova Corp. (SVA:TSX.V; SEOVF:OTCQB; PSH:XERTA) should benefit from Sana Biotechnology's recent prioritization of its diabetes-targeted cell therapy programs, reported Leede Financial Inc. analyst Dr. Douglas Loe in a Nov. 6 research note. Now Sana's clinical programs in oncology and Huntington's disease are a secondary focus.

"Our model assumes that Sernova's cell reservoir device Cell Pouch will itself remain focused on Type 1 diabetes, and we are thus encouraged to see a U.S. peer prioritize its pipeline in ways that are consistent with our own views on how priorities in regenerative medicine will evolve in coming years," Loe wrote.

500% Potential Return

Leede has a CA$1.50 per share target price on Sernova, trading at the time of the report at about CA$0.25 per share, noted Loe.

"At current price levels, our price target corresponds to a one-year return of 500%, a return that we believe is imminently achievable by 2025E but likely with a milestone-driven, and not a linear, trajectory," the analyst wrote.

The company is a Speculative Buy.

Synergistic Potential Exists

Loe highlighted that Sernova and Sana could benefit from aligning their programs, on a timeline providing synergies to both.

"We are encouraged to see a leading regenerative firm choose to expedite its diabetes cell therapy program in preference to other initiatives that it could fund if it chose to," Loe wrote. "This is consistent with our own view that the most attractive medical market for regenerative firms, and for Sernova, to target is the large and growing diabetes market both for economic and technical reasons."

Sana's Diabetes Programs

Sana's primary focus is its program to treat Type 1 diabetes with its Phase 1-stage, hypo-immune platform (HIP)-modified primary pancreatic islet cell therapy UP421 and its preclinical HIP-modified, stem cell-derived pancreatic islet platform SC451.

Through this platform, regenerative cell therapies can be modified genetically to evade immune detection post implantation. This is achieved by reducing expression of major histocompatibility-complex, classes one and two human leukocyte antigens while increasing expression of CD24. This is a surface protein found on stem cells in the pancreas.

Sernova's Cell Reservoir Platform

As for Sernova, it has a well-vascularized, sustainably functioning cell reservoir platform, Cell Pouch, proven for some time. Development of regenerative islet platform technology is now catching up. Sernova has a clinical trial underway that combines the two technologies. This Phase 1 trial in diabetes, in partnership with the University of Chicago, already has shown "impressive long-term insulin independence data" up to five years in some study participants.

This is "well beyond what we believe is a reasonable threshold for the U.S. Food and Drug Administration to require for future Cell Pouch approval, at least for Type 1 diabetes," Loe wrote.

Currently, with regard to this program, Sernova optimizing background immunosuppression in Cell Pouch patients. Details of its new immunosuppressive regimen are expected in the biotech's next Phase 1 study update, likely in early H1/25.

"Future enrollees could be subjected to novel immunosuppressive therapies that conceivably could extend islet survival and perhaps even reduce the immunosuppressive burden that transplant patients must endure at present," Loe commented.

Further, Sernova is considering conducting a Phase 1 study using its Cell Pouch and Evotec AG's stem-cell-derived iBeta platform to treat diabetes. Before this can happen, though, Evotec needs to be able to produce iBeta at a clinical scale, which Loe expects can happen by H2/25.

"We see no reason why Sana and its UP421/SC451 modified islet platforms could not be incorporated into a Cell Pouch environment as a way to sustain their therapeutic half-life in the body post-implantation," wrote Loe.

Possible Stock Price Movers

Loe provided a handful of potential catalysts for Sernova's share price. They are:

1) Sernova's conclusion of its ongoing Phase 1 study in Type 1 diabetes with the University of Chicago, which Loe asserted should happen a quickly as possible given available capital. Also, the biotech should incorporate into this trial or a separate one to commence soon after, regeneratively produced pancreatic islets.

2) Sernova, in partnership with Sana, launching a Phase 1 iBeta/Cell Pouch trial late next year, which could boost Sernova's share price.

3) Sernova identifying additional developers of regenerative cell therapies with which it could combine Cell Pouch in mutually beneficial ways.

4) Sernova starting clinical programs in hemophilia A and in thyroid disease, expected to happen in the coming quarters.

5) Sernova incorporating its confocal cell coating technology into one or more future protocols for stem cell-derived pancreatic islet production, even its current Phase 1 diabetes trial with the University of Chicago. Before this can happen, however, coating polymer composition and manufacturing methodologies must be honed to meet good manufacturing practices specifications.

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Important Disclosures:

1. Sernova Corp. has a consulting relationship with Street Smart an affiliate of Streetwise Reports. Street Smart Clients pay a monthly consulting fee between US$8,000 and US$20,000.
2. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Sernova Corp.
3. Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.
4. This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
5. This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

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Disclosures for Leede Financial Inc., Sernova Corp., November 6, 2024

Important Information and Legal Disclaimers Leede Financial Inc. (Leede) is a member of the Canadian Investment Regulatory Organization (CIRO) and a member of the Canadian Investor Protection Fund (CIPF). This document is not an offer to buy or sell or a solicitation of an offer to buy or sell any security or instrument or to participate in any particular investing strategy. Data from various sources were used in the preparation of these documents; the information is believed but in no way warranted to be reliable, accurate and appropriate. All information is as of the date of publication and is subject to change without notice. Any opinions or recommendations expressed herein do not necessarily reflect those of Leede. Leede cannot accept any trading instructions via e-mail as the timely receipt of e-mail messages, or their integrity over the Internet, cannot be guaranteed. Dividend yields change as stock prices change, and companies may change or cancel dividend payments in the future. All securities involve varying amounts of risk, and their values will fluctuate, and the fluctuation of foreign currency exchange rates will also impact your investment returns if measured in Canadian Dollars. Past performance does not guarantee future returns, investments may increase or decrease in value, and you may lose money. Leede employees may buy and sell shares of the companies that are recommended for their own accounts and for the accounts of other clients. Disclosure codes are used in accordance with Policy 3600 of CIRO.

The analyst or any associate of the analyst responsible for the report or public comment hold shares or is short any of the company's securities directly or through derivatives.

Leede provided investment banking services for the company during the 12 months preceding the publication of the research report.

Dissemination All final research reports are disseminated to existing and potential institutional clients of Leede Financial Inc. (Leede) in electronic form to intended recipients thorough e-mail and third-party aggregators. Research reports are posted to the Leede website and are accessible to customers who are entitled to the firm’s research. Reproduction of this report in whole or in part without permission is prohibited.

Research Analyst Certification The Research Analyst(s) who prepare this report certify that their respective report accurately reflects his/her personal opinion and that no part of his/her compensation was, is, or will be directly or indirectly related to the specific recommendations or views as to the securities or companies. Leede Financial Inc. (Leede) compensates its research analysts from a variety of sources and research analysts may or may not receive compensation based upon Leede investment banking revenue.

Canadian Disclosures This research has been approved by Leede Financial Inc. (Leede), which accepts sole responsibility for this research and its dissemination in Canada. Leede is registered and regulated by the Canadian Investment Regulatory Organization (CIRO) and is a member of the Canadian Investor Protection Fund (CIPF). Canadian clients wishing to effect transactions in any designated investment discussed should do so through a Leede Registered Representative.

U.S. Disclosures This research report was prepared by Leede Financial Inc. (Leede). Leede is registered and regulated by the Canadian Investment Regulatory Organization (CIRO) and is a member of the Canadian Investor Protection Fund (CIPF). This report does not constitute an offer to sell or the solicitation of an offer to buy any of the securities discussed herein. Leede is not registered as a broker-dealer in the United States and is not subject to U.S. rules regarding the preparation of research reports and the independence of research analysts. Any resulting transactions should be effected through a U.S. broker-dealer.

( Companies Mentioned: SVA:TSX.V;SEOVF:OTCQB;PSH:XERTA, )

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