Theriva™ Biologics Licenses SYN-020 to Rasayana Therapeutics for Multiple Indications

Rhea-AI Summary

Theriva Biologics (NYSE American: TOVX) licensed SYN-020 to Rasayana Therapeutics in an exclusive, worldwide deal announced Feb 18, 2026. Theriva received a $300,000 upfront payment and may earn up to $38M in development, regulatory and sales milestones plus tiered single-digit royalties.

Rasayana will assume all development and commercialization costs; SYN-020 completed Phase 1 safety testing and is expected to enter Phase 2 under Rasayana's stewardship.

Positive

• Upfront payment of $300,000
• Potential milestone pool of $38M (development, regulatory, sales)
• Tiered single-digit royalties on net product sales
• Rasayana assumes development and commercialization costs
• SYN-020 was well tolerated in Phase 1 and ready for Phase 2

Negative

• Upfront cash is modest at $300,000, limited immediate revenue
• Theriva may forgo control and future upside by outsourcing development
• Royalties limited to single-digit percentages, capping long-term revenue share

News Market Reaction – TOVX

+6.25%

22 alerts

+6.25% News Effect

+77.9% Peak in 20 hr 16 min

+$451K Valuation Impact

$8M Market Cap

0.8x Rel. Volume

On the day this news was published, TOVX gained 6.25%, reflecting a notable positive market reaction. Argus tracked a peak move of +77.9% during that session. Our momentum scanner triggered 22 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $451K to the company's valuation, bringing the market cap to $8M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Upfront payment: $300,000 Total milestones: $38M Dev/Reg milestones: $16M +5 more

8 metrics

Upfront payment $300,000 Cash received at signing of SYN-020 license to Rasayana

Total milestones $38M Potential development, regulatory, and sales milestones for SYN-020

Dev/Reg milestones $16M Development and regulatory milestones under SYN-020 agreement

Sales milestones $22M Milestones tied to annual aggregate net sales of SYN-020

Phase 1 status Phase 1 completed SYN-020 well tolerated in Phase 1 clinical studies

Next stage Phase 2 planned SYN-020 poised to enter Phase 2 testing with Rasayana

Share price $0.1807 Latest close before licensing news

52-week range $0.1651 - $1.75 Price is 9.45% above low and 89.67% below high

Market Reality Check

Price: $0.1844 Vol: Volume 982,283 is about h...

low vol

$0.1844 Last Close

Volume Volume 982,283 is about half the 20-day average of 1,956,134, suggesting muted pre-news positioning. low

Technical Price 0.1807 is trading below the 200-day MA of 0.38 and far below the 1.75 52-week high.

Peers on Argus

TOVX was modestly down 0.71% with momentum peers like XRTX and BDRX also down (m...

2 Down

TOVX was modestly down 0.71% with momentum peers like XRTX and BDRX also down (median about -1.2%), pointing to broader biotech pressure alongside today’s company-specific licensing news.

Common Catalyst No same-day peer headlines; moves appear driven by general biotech sentiment plus company-specific developments.

Historical Context

5 past events · Latest: Feb 03 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 03	Clinical data update	Positive	+3.4%	Upcoming Phase 1 VCN-01 retinoblastoma data presentation at APAO 2026.
Dec 29	Regulatory guidance	Positive	+2.4%	EMA Scientific Advice supporting Phase 3 VCN-01 PDAC trial design.
Nov 12	Earnings and pipeline	Positive	+8.1%	Q3 2025 results with VIRAGE success and VCN-12 preclinical data plus cash runway.
Oct 24	Market activity notice	Neutral	+0.9%	Company response to unusual trading with no undisclosed material developments.
Oct 16	Warrant inducement financing	Negative	-48.7%	Dilutive warrant inducement raising about $4.0M in gross proceeds.

Pattern Detected

Recent news-driven moves generally aligned with headline tone, including a sharp selloff on the October 2025 warrant inducement financing.

Recent Company History

Over the past few months, Theriva focused on advancing its oncolytic virus program VCN-01, with positive VIRAGE Phase 2b data and EMA Scientific Advice for a Phase 3 PDAC trial, driving moves of +8.05% and +2.40%. An October 2025 warrant inducement for about $4.0M gross proceeds coincided with a -48.68% reaction, underscoring sensitivity to dilution. Today’s SYN-020 out-licensing shifts this GI asset to a partner while Theriva concentrates on its lead oncology program.

Regulatory & Risk Context

Active S-3 Shelf · $4.4 million

Shelf Active

Active S-3 Shelf Registration 2025-11-07

$4.4 million registered capacity

An effective Form S-3 on Nov 7, 2025 covers resale of up to 16,184,560 warrant shares by selling stockholders. Theriva is not selling shares under this prospectus and would only receive cash upon warrant exercise, after already obtaining approximately $4.4 million in gross proceeds from prior warrant exercises. This structure implies ongoing warrant-related overhang but no direct primary offering under the shelf.

Market Pulse Summary

The stock moved +6.3% in the session following this news. A strong positive reaction aligns with pri...

Analysis

The stock moved +6.3% in the session following this news. A strong positive reaction aligns with prior instances where Theriva moved on clinical and pipeline milestones, such as +8.05% after Q3 2025 data and cash runway disclosure. The SYN-020 deal adds up to $38M in milestones while shifting development costs to Rasayana. However, warrant-related overhang from prior financings, including the episode tied to a -48.68% move, and existing S-3 resale capacity could still influence how durable any spike proves.

Key Terms

intestinal alkaline phosphatase (IAP), microbiome, phase 1 clinical studies, phase 2 clinical testing, +2 more

6 terms

intestinal alkaline phosphatase (IAP) medical

"SYN-020 is a recombinant bovine intestinal alkaline phosphatase (IAP) produced..."

An enzyme made in the lining of the small intestine that helps break down molecules, calm local inflammation and neutralize harmful bacterial byproducts — like a microscopic cleaning crew that keeps the gut lining healthy. Investors watch it because it is a potential drug or supplement target and a biomarker in clinical trials: changes in its activity can influence the chances of regulatory approval, commercial demand and a company’s valuation.

microbiome medical

"and promote a healthy microbiome. These modes-of-action mean SYN-020..."

Microbiome is the community of tiny living organisms—bacteria, viruses, fungi and their genes—that live in a particular place, like the gut, skin or soil; think of it as a neighborhood of microscopic life that affects how that environment works. Investors care because changes or products that target the microbiome can alter health outcomes, crop yields or consumer product performance, creating new markets, regulatory risks and potential shifts in revenue for companies.

phase 1 clinical studies medical

"SYN-020 was well tolerated in Phase 1 clinical studies and is now poised..."

Phase 1 clinical studies are the first human tests of a new drug or medical treatment, conducted with a small group of healthy volunteers or patients to assess safety and how the body handles the treatment. For investors, these studies matter because they are the earliest real-world check on whether a therapy is safe enough to continue developing—like a prototype test flight whose results affect a project’s risk, timeline, and potential value.

phase 2 clinical testing medical

"and is now poised to enter Phase 2 clinical testing with Rasayana."

Phase 2 clinical testing is a mid-stage medical study that evaluates whether an experimental drug or treatment actually works for the intended illness and further assesses safety in a group of patients, typically from dozens to a few hundred people. For investors, Phase 2 is a key milestone because positive results increase the chance of approval and value, while failures often cut a program’s prospects — it’s like a midterm exam that helps decide whether a treatment should move on to the final, more expensive trials.

gut-organ axis medical

"targeting the Gut-Organ axis biology to discover and deliver transformative..."

A gut-organ axis is the two-way communication system between the digestive tract and another specific body organ (for example the brain, liver or lungs), where signals travel by nerves, hormones, immune molecules and metabolites produced by gut microbes. Investors should care because altering these pathways can change disease risk and treatment response, creating opportunities for new drugs, diagnostics and consumer health products — think of it as a business-relevant information highway linking gut health to organ outcomes.

tiered single digit royalties financial

"and sales milestones along with tiered single-digit royalties on net product sales..."

Royalty payments calculated as single-digit percentages of revenue that change depending on predefined levels or conditions — for example higher sales volumes, different products, or geographic markets. Think of it like a sliding-scale commission where the percent paid shifts at set thresholds; investors watch this because it directly reduces a company’s profit margins and future cash flow, affecting valuation and expected return on products covered by the agreement.

AI-generated analysis. Not financial advice.

- Theriva received a $300,000 upfront payment at signing and is eligible for up to $38M in development, regulatory, and sales milestones along with tiered single-digit royalties on net product sales -

- Rasayana to assume all responsibility and costs for SYN-020 development and commercialization -

ROCKVILLE, Md., Feb. 18, 2026 (GLOBE NEWSWIRE) -- Theriva™ Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today reported the out-licensing of SYN-020, to Rasayana Therapeutics, Inc., a privately-held company targeting the Gut-Organ axis biology to discover and deliver transformative gut-targeted medicines for patients with chronic inflammatory diseases.

SYN-020 is a recombinant bovine intestinal alkaline phosphatase (IAP) produced under cGMP conditions and formulated for oral delivery to the small intestine. It is designed to reduce fat absorption and intestinal inflammation; tighten the gut barrier to mitigate leaky gut; and promote a healthy microbiome. These modes-of-action mean SYN-020 has the potential to address multiple metabolic and inflammatory disorders and diseases associated with aging. SYN-020 was well tolerated in Phase 1 clinical studies and is now poised to enter Phase 2 clinical testing with Rasayana.

“We are extremely pleased to complete the license of SYN-020 to Rasayana, which will enable the advancement of this important GI asset from our portfolio while we focus on our lead pancreatic cancer program, VCN-01,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “We believe SYN-020 is a highly versatile asset with therapeutic opportunities in multiple high-value indications arising from GI dysfunction. The Rasayana team and advisors are world leaders in IAP and its clinical applications, and they are well positioned to advance SYN-020 development, ideally delivering benefits for patients and value for Theriva shareholders.”

“We are thrilled to partner with Theriva Biologics on the development of SYN-020,” said Vidisha Mohad, Founder and CEO of Rasayana Therapeutics. “SYN-020 offers a fundamentally innovative approach to addressing gastrointestinal dysfunction and its systemic health implications. Having worked on SYN-020 research during my postdoctoral training at Harvard, I have deep conviction in its underlying biology, scientific rigor, and therapeutic potential. Importantly, its cost-effective profile reflects our shared commitment to making transformative treatments accessible to patients who need them most. At Rasayana, we are focused on advancing therapies that target the Gut-Organ Axis to extend healthspan. SYN-020’s novel biology, strong safety profile, and compelling clinical data make it an ideal fit for our pipeline. We look forward to building on Theriva’s foundational work and accelerating this program to deliver meaningful outcomes for patients worldwide”.

Under the terms of the agreement, Rasayana is granted an exclusive, worldwide license, with the right to sublicense, to develop and commercialize SYN-020 for therapeutic and diagnostic use. Theriva received a $300,000 up-front payment at signing and is eligible for up to $16M in development and regulatory milestones, tiered single digit royalties on net product sales, and up to $22M in milestones payable upon achievement of certain annual aggregate net sales. Rasayana will assume all responsibility and costs for SYN-020 development and commercialization.

About Theriva™ Biologics, Inc.

Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company is advancing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; and (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. For more information, please visit Theriva Biologics’ website at www.therivabio.com.

About Rasayana Therapeutics, Inc.

Rasayana Therapeutics, Inc. is a biotechnology company targeting the Gut-Organ axis biology to address chronic inflammatory diseases. The company is pioneering a new class of gut-inflammation targeting therapies for gastrointestinal, cardiometabolic, and neurodegenerative diseases. Rasayana’s mission is to develop novel, cost-effective medicines that extend healthspan and improve quality of life for patients globally. For more information, visit Rasayana Therapeutics website at www.rasayanatherapeutics.com

Forward-Looking Statement

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, and include statements regarding SYN-020 having the potential to address multiple metabolic and inflammatory disorders and diseases associated with aging; SYN-020 being poised to enter into Phase 2 clinical testing with Rasayana; enabling the advancement of this important GI asset; SYN-020 being a highly versatile asset with therapeutic opportunities in multiple high-value indications arising from GI dysfunction; and Rasayana being well positioned to advance SYN-020 development and deliver benefits for patients and value for Theriva shareholders; and SYN-020’s therapeutic potential accelerating the SYN-020 program to deliver meaningful outcomes for patients worldwide; and Theriva receiving up to $16M in development and regulatory milestones, tiered single digit royalties on net product sales, and up to $22M in milestones payable upon achievement of certain annual aggregate net sales . Important factors that could cause actual results to differ materially from current expectations include, among others, Rasayana’s ability to reach clinical milestones when anticipated including entering into Phase 2 clinical testing of SYN-020 , the ability generate clinical data that establishes SYN-020 may deliver benefits for patients and have therapeutic potential; Rasayana’s ability to achieve development and commercialization milestones as well as sales that result in payments to Theriva; SYN-020 and the Company’s product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results; the ability to complete clinical trials on time and achieve the desired results and benefits; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s and Rasyana’s ability to promote or commercialize their product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of the Company’s and Rasayana’s products, developments by competitors that render such products obsolete or non-competitive, the ability to maintain license agreements, the continued maintenance and growth of the Company’s patent estate, the ability to continue to remain well financed and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

For further information, please contact:

Investor Relations:
Kevin Gardner
LifeSci Advisors, LLC
kgardner@lifesciadvisors.com

Source: Theriva Biologics, Inc.

FAQ

What are the key financial terms of Theriva's SYN-020 license to Rasayana (TOVX)?

Theriva received a $300,000 upfront payment with up to $38M in milestones and tiered single-digit royalties. According to the company, milestones split into $16M for development/regulatory and $22M tied to annual net sales.

Who will pay for SYN-020 development and commercialization after the Rasayana license?

Rasayana will assume all responsibility and costs for SYN-020 development and commercialization. According to the company, Rasayana also has exclusive global rights and the right to sublicense the asset.

What is SYN-020 and what clinical status did Theriva report (TOVX)?

SYN-020 is an oral recombinant bovine intestinal alkaline phosphatase intended to reduce fat absorption and inflammation. According to the company, it was well tolerated in Phase 1 and is poised to enter Phase 2 under Rasayana.

How might the SYN-020 deal affect Theriva's near-term financial position (TOVX)?

Near-term cash impact is limited to the $300,000 upfront payment, with future potential from milestones and royalties. According to the company, additional payments depend on development, regulatory, and sales milestones.

What rights did Theriva grant Rasayana for SYN-020 in the Feb 18, 2026 agreement?

Theriva granted Rasayana an exclusive, worldwide license with rights to sublicense for therapeutic and diagnostic use. According to the company, this includes full development and commercialization authority and cost responsibility.