Theriva Biologics Out-Licenses SYN-020 to Rasayana Therapeutics in Worldwide Biologics Licensing Agreement

Theriva Biologics (NYSE American: TOVX), a clinical-stage company headquartered in Rockville, Maryland, announced an exclusive worldwide SYN-020 license with Rasayana Therapeutics, a privately held biotechnology company based in Hyderabad, India. Under the biologics licensing agreement, Rasayana receives exclusive global rights, including sublicensing rights, to develop and commercialize SYN-020 — a recombinant bovine intestinal alkaline phosphatase formulated for oral delivery — for therapeutic and diagnostic use across multiple indications. Rasayana will assume all responsibility and costs for further clinical development and commercialization. The deal allows Theriva to divest a non-core gastrointestinal asset while concentrating resources on its lead oncology program, VCN-01, an oncolytic adenovirus in development for pancreatic cancer.

Theriva received a USD 300,000 upfront cash payment at signing. The company is eligible for up to USD 16 million in development and regulatory milestones, tiered single-digit royalties on net product sales, and up to USD 22 million in additional milestones tied to the achievement of certain annual aggregate net sales thresholds. The total potential value of the deal, excluding royalties, is approximately USD 38.3 million. No equity component or profit-sharing arrangement was disclosed. The milestone structure is heavily back-loaded: the near-term cash benefit to Theriva is limited to the USD 300,000 upfront, with the remaining value contingent on Rasayana's ability to advance SYN-020 through Phase 2 and Phase 3 trials, secure regulatory approval, and generate commercial revenue.

Deal Context

SYN-020 is a recombinant form of bovine intestinal alkaline phosphatase (IAP), produced under cGMP conditions and formulated as a delayed-release oral capsule designed for delivery to the small intestine. The molecule's proposed mechanisms of action include reduction of fat absorption and intestinal inflammation, reinforcement of intestinal barrier function to mitigate gut permeability, and promotion of a healthy microbiome composition. These properties position SYN-020 as a candidate across metabolic, inflammatory, and age-associated disorders linked to gastrointestinal dysfunction.

Theriva completed two Phase 1 studies of SYN-020 in healthy volunteers. A single ascending dose pharmacokinetics, safety, and tolerability study (NCT04815993) evaluated fecal presence and systemic absorption of the enzyme, consistent with a design intended to confirm local GI activity with minimal systemic exposure. A multiple ascending dose study (NCT05045833) further characterized the safety and tolerability profile. Both trials listed radiation enteritis as the condition of interest. According to Theriva, SYN-020 was well tolerated across both studies and is positioned to enter Phase 2 clinical testing under Rasayana's sponsorship. No IND filings, Fast Track designations, or other regulatory milestones for SYN-020 have been publicly disclosed beyond the completed Phase 1 work.

Theriva's rights to SYN-020 originate from an option agreement with Massachusetts General Hospital for an exclusive worldwide license to commercially develop the molecule. Any sublicense to Rasayana would be subject to upstream obligations Theriva holds under that agreement.

For Theriva, the out-licensing of SYN-020 reflects a continued narrowing of the company's pipeline toward oncology. Theriva's lead program, VCN-01, is an oncolytic adenovirus engineered to replicate selectively within tumor cells and degrade the tumor stroma, with clinical development focused on pancreatic cancer and retinoblastoma. The company also retains SYN-004 (ribaxamase), a beta-lactamase enzyme designed to protect the gut microbiome during intravenous antibiotic treatment, which has been studied in the context of acute graft-versus-host disease in allogeneic hematopoietic cell transplant recipients. By shedding SYN-020, Theriva eliminates the capital requirements associated with advancing a multi-indication GI program through Phase 2 and beyond while preserving economic upside through milestones and royalties. The company has disclosed limited cash runway, making the reduction in burn rate operationally relevant even if the upfront payment is modest.

For Rasayana Therapeutics, SYN-020 represents a foundational pipeline asset. The company was established by Vidisha Mohad, who worked on SYN-020 research during postdoctoral training at Harvard, providing a direct scientific connection to the molecule's preclinical and translational history. Rasayana's stated focus is on the Gut-Organ Axis — the biological interface between gastrointestinal inflammation and systemic disease in cardiometabolic, neurodegenerative, and inflammatory conditions. SYN-020's proposed ability to restore intestinal barrier function and modulate local inflammation aligns with that thesis. Rasayana was recognized as the seed company winner of the Aging Code competition ahead of BIO 2025, placing it among early-stage companies attracting attention in the longevity and healthspan space. No prior licensing deals, partnerships, or other formal business relationships between Theriva and Rasayana were identified; this transaction appears to be the first interaction between the two companies.

The SYN-020 alkaline phosphatase program enters a competitive landscape that includes several approved and investigational agents addressing radiation enteritis and broader GI mucosal protection. Approved therapies with relevance include amifostine (Ethyol), a free radical scavenger used as a radioprotectant, and teduglutide (Gattex, Takeda), a GLP-2 analog approved for short bowel syndrome with preclinical investigation in radiation enteropathy. Galera Therapeutics has advanced avasopasem manganese, a superoxide dismutase mimetic, through Phase 3 for radiation-induced oral mucositis, with potential applicability to GI radioprotection. SYN-020's differentiation, if validated in Phase 2, would rest on its oral, locally acting enzyme mechanism and its potential breadth across multiple GI-driven indications beyond radiation injury — a profile that none of the current competitors directly replicate. Whether Rasayana pursues radiation enteritis as the lead indication or pivots toward metabolic or inflammatory conditions will shape the competitive dynamics and regulatory path.

No other recent licensing transactions involving oral recombinant enzyme therapeutics targeting intestinal barrier function were identified in the public record during the period surrounding this deal.

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