SERDA Therapeutics Announces Completion of First Phase 1 Clinical Study of SN514

AMSTERDAM, THE NETHERLANDS

29 July 2024

SERDA Therapeutics, a biopharmaceutical companyfocused on developing improved treatments for burns and chronic wounds, today announced completionof its first Phase 1 human clinical study of SN514 hydrogel, an innovative enzymatic wound debriding agent,in healthy adult volunteers.

In preclinical studies, SN514 hydrogel showed outstanding efficacy and speed of action both with in vitrosubstrates and in vivo pig wound models. The first clinical safety question to be addressed was whetherhealthy skin at the edge of a wound (“periwound skin”) would require any type of protection against theenzyme when applied to the wound surface. The evaluator blinded, randomized study examined theimmediate and 21-day cumulative irritation potential of a range of enzyme concentrations formulated intothe proprietary hydrogel for off-the-shelf use, as well as the hydrogel vehicle itself. The use of a low irritantcontrol and a positive irritant control allowed calculation of total scores for dermal responses and othereffects according to the methodology of Berger and Bowman (Berger and Bowman 1982).

The findings indicate that protection of “periwound” skin is unlikely to be necessary in clinical use. Thecompany plans to present detailed results in December 2024 at the Innovations in Wound HealingConference in Islamorada, Florida.

SN514 hydrogel is easy to apply. It does not require expert medical professionals and can be self-administered or applied by caregivers. As a result, SN514 hydrogel is expected to reduce the cost-of-careassociated with severe burn wounds and chronic ulcers.

Gábor Heltovics, CEO of SERDA Therapeutics said:

“We are extremely pleased with the results of this first study, as it really sets the product apart from otherenzyme debriders... We remain confident that SN514hydrogel will be best-in-class for safe and effective debridement of burn wounds and chronic ulcers.”

Dr. Bert Slade, CMO of SERDA Therapeutics added:

“These encouraging findings confirm the design of our next planned Phase 1 study, a dose-rangingtolerability trial in deep partial thickness burn wounds.”

About SERDA therapeutics

SERDA Therapeutics is a leader in developing innovative treatments for severe wound care. With an agingpopulation and increasing diabetes prevalence, effective wound treatment is critical. Traditionaldebridement methods—surgical, mechanical, and enzymatic—are often painful and inefficient. SERDA’s solution is a hydrogel which offers an enzymatic wound debrider that has the potential to show fast speedof debridement, ease of use, high level of stability, and low-moderate irritation.

The terms “SERDA” and “SERDA therapeutics” are used to refer to SERDA bv.

For more information:‍

SERDA bv: website
Gábor Heltovics, CEO
Email: g.heltovics@serda-therapeutics.com

Paasheuvelweg 25, 1105 BP Amsterdam, the Netherlands

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Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example,statements regarding expected revenue growth, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe","estimate", "expect", "target", "consider" and similar expressions are generally intended to identifyforward-looking statements. Forward-looking statements involve known and unknown risks, uncertaintiesand other important factors that could cause actual results to differ materially from what is expressed orimplied by the statements. For SERDA, these factors include: risks related to government actions and otherrestrictive measures taken in response, reduced procedure capacity at medical facilities, or our ability toexecute business continuity plans, economic and financial conditions in the markets, especially thoseaffecting health care providers, price levels for pharmaceutical products, developments in therapeuticstandard, regulatory approvals, reimbursement decisions or other government actions, product defects orrecalls or other problems with quality management systems or failure to comply with related regulations;litigation relating to patent or other claims; legal compliance risks and related investigative, remedial orenforcement actions; disruption to our supply chain or operations or those of our suppliers, competition forqualified personnel; strategic actions, including acquisitions and dispositions, our success in performing duediligence, valuing and integrating acquired businesses; disruption that may result from transactions orother changes we make in our business plans or organization to adapt to market developments, andnumerous other matters that affect us or our markets, including those of a regulatory, political, economic,business, competitive or reputational nature. Any forward-looking statement is based on informationavailable to SERDA as of the date of the statement. All written or oral forward-looking statementsattributable to SERDA are qualified by this caution. SERDA does not undertake any obligation to update orrevise any forward-looking statement to reflect any change in circumstances or in SERDA's expectations.

Berger, R.S., and J.P. Bowman. 1982. 'A reappraisal of the 21-day cumulative irritation test in man', J Toxicol- Cut & Ocular Toxicol, 1: 109-15.