VERAXA Biotech Announces Regulatory Progress with its BiTAC®-TCE Development Plan

Rhea-AI Summary

VERAXA Biotech (NASDAQ: VRXA) reported that Germany’s Paul-Ehrlich-Institute (PEI) provided Scientific Advice on the biological rationale and non-clinical development plan for its lead BiTAC-TCE program. The feedback supports VERAXA’s dual-targeting, conditionally active BiTAC-TCE format and offers initial de-risking and greater clarity for its development strategy.

According to VERAXA, preclinical data presented at AACR 2026 showed the BiTAC-TCE candidate selectively attacked cancer cells expressing both targets, spared single-target cells, and achieved a superior safety profile with similar efficacy versus a traditional TCE, suggesting a potentially improved therapeutic index.

Positive

• Regulatory Scientific Advice received from German PEI on BiTAC-TCE plan
• Feedback supports biological rationale and non-clinical development strategy for lead BiTAC-TCE
• AACR 2026 data showed selective dual-target killing and sparing of single-target cells
• Preclinical results indicated superior safety with matching efficacy versus traditional TCE in studies

Negative

• BiTAC-TCE program remains at non-clinical, preclinical data stage with no human trial results disclosed
• Regulatory interaction described as Scientific Advice only, not an approval for clinical use

News Market Reaction – VRXA

-2.75%

4 alerts

-2.75% Session close to close

+3.1% Peak Tracked

$308.27M Market Cap

0.1x Rel. Volume

In the Jul 20 session, VRXA declined 2.75%, reflecting a moderate negative market reaction. Argus tracked a peak move of +3.1% during that session. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The July 6 business update recorded a 7.35% 24-hour move, while recent news responses were mixed. Th...

Analysis

The July 6 business update recorded a 7.35% 24-hour move, while recent news responses were mixed. This announcement adds regulatory context; low short positioning is a sourced risk factor, and ongoing development milestones remain relevant.

Key Figures

Target molecules: 2 target molecules Data presentation: April 2026

2 metrics

Target molecules 2 target molecules BiTAC-TCE mechanism

Data presentation April 2026 AACR Annual Meeting

Historical Context

5 past events · Latest: Jul 13 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jul 13	AI partnership	Positive	-2.7%	Announced Ardigen collaboration to support AI-enabled BiTAC pipeline development
Jul 06	Business update	Positive	+7.3%	Provided partnering strategy and candidate development timelines
Jul 02	Development milestone	Positive	+18.3%	Initiated ATUM cell-line development for lead BiTAC-TCE program
Jun 24	R&D expansion	Positive	-21.0%	Expanded Heidelberg R&D hub by more than 60%
Jun 18	Preclinical data	Positive	-23.2%	Reported BiTAC-ADC proof-of-concept and partnering discussions

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent positive development announcements produced mixed reactions, with three of five events diverging from the announcement sentiment.

Key Terms

scientific advice, pharmacokinetics, therapeutic index, bispecific t cell engagers, +2 more

6 terms

scientific advice regulatory

"received Scientific Advice from the German regulatory authority"

Scientific advice is guidance from independent experts or regulatory bodies that interprets scientific evidence—such as clinical data, laboratory results, or risk assessments—to inform decisions about products, approvals, or policies. It matters to investors because this input can shape regulatory outcomes, timelines, and market expectations in sectors like pharmaceuticals, biotech, and chemicals; think of it as an expert second opinion that helps reduce uncertainty about whether a product or filing will meet official standards.

pharmacokinetics medical

"proposed safety assessments and pharmacokinetics strategy"

Pharmacokinetics is the study of how a substance, such as a drug or chemical, moves through and is processed by the body over time. It tracks how it is absorbed, distributed, broken down, and eventually eliminated. For investors, understanding pharmacokinetics helps gauge the effectiveness, safety, and potential risks of new medications or treatments, which can influence a company’s success and valuation in the healthcare industry.

therapeutic index medical

"possibility of a meaningfully improved therapeutic index"

The therapeutic index is a measure of a drug’s safety margin—the gap between the dose that produces a desired effect and the dose that causes harmful effects. For investors, a larger therapeutic index means a wider safety cushion, lower risk of dangerous side effects, smoother regulatory review and broader market acceptance, all of which can reduce clinical and commercial risk and affect a drug developer’s valuation.

bispecific t cell engagers medical

"including bispecific T cell engagers, bispecific ADCs"

Engineered proteins that act like a two-sided connector: one side binds a T cell (an immune cell) and the other side binds a target on a diseased cell, bringing the immune cell close enough to attack and kill the target. They matter to investors because they are a distinct class of immunotherapy with clinical trial, regulatory and commercial implications—think of them as a matchmaker that directs the body's soldiers to a specific enemy, which can drive company value and partnership interest.

in vitro medical

"candidate performed as intended in vitro and in vivo"

In vitro describes laboratory tests performed on cells, tissues, or biological molecules outside a living body—literally “in glass,” such as in test tubes or dishes. For investors, in vitro results are an early sign that a drug or technology has a desired effect under controlled conditions, but they don’t guarantee it will work or be safe in animals or people; think of them as a prototype tested on a bench rather than in real-world use.

in vivo medical

"candidate performed as intended in vitro and in vivo"

In vivo describes tests or experiments performed inside a living organism, such as an animal or human, to observe how a drug, device or biological process behaves in a real, functioning body. Investors care because in vivo results reveal safety, effectiveness and possible side effects that lab tests cannot, much like road-testing a prototype car in traffic rather than only on a bench — outcomes can strongly influence regulatory approval, clinical success and a company’s valuation.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Scientific Advice from the German Regulatory Authority supports the biological rationale and proposed development approach for VERAXA's BiTAC-TCE technology and product candidate, providing an initial de-risking of the development path for this novel therapeutic modality

ZURICH, SWITZERLAND – July 20, 2026 – VERAXA Biotech AG (NASDAQ: VRXA; “VERAXA), an emerging leader in designing novel cancer therapies, today announced that it has received Scientific Advice from the German regulatory authority, the Paul-Ehrlich-Institute (PEI), regarding the underlying biology and proposed non-clinical development plan for its most-advanced development program based on its proprietary BiTAC-TCE technology.

In the PEI’s Scientific Advice procedure, drug developers can consult with regulatory experts on how to best evaluate their new drug candidates with a key focus on safety and tolerability. The advice was given in a meeting in which VERAXA presented the scientific rationale for the BiTAC-TCE mechanism together with its proposed safety assessments and pharmacokinetics strategy. The supportive feedback indicates that the authorities understand the biological concept behind the dual-targeting, conditionally active BiTAC-TCE format, which provides an initial derisking of the development path and greater clarity as the Company advances its BiTAC-TCE program.

“Scientific Advice on the first therapeutic candidate based on a novel platform is an important early validation, and the feedback we received is encouraging,” said Christoph Erkel, Ph.D., Vice President, Research & Development of VERAXA. “It indicates that the regulatory authorities understand the biological rationale behind our BiTAC-TCE technology approach and gives us greater clarity on the development path we have proposed. For our new modality, such early alignment is crucial to make sure that we progress as efficiently as possible towards the clinics.”

Initial data from VERAXA's most advanced BiTAC-TCE program were presented at the American Association for Cancer Research (AACR) Annual Meeting 2026, in April. In those studies, VERAXA's BiTAC-TCE candidate performed as intended in vitro and in vivo, attacking cancer cells displaying both target molecules while sparing cells expressing only one of the two targets. The data demonstrated a superior safety profile with matching efficacy compared with a more traditional TCE, pointing to the possibility of a meaningfully improved therapeutic index. The related posters are available on the VERAXA website at www.veraxa.com.

About VERAXA Biotech AG (NASDAQ: VRXA)

At VERAXA, we are building a premier engine for the discovery and development of next-generation antibody-based therapeutics, including bispecific T cell engagers, bispecific ADCs and other innovative formats. Powered by a suite of transformative technologies and guided by rigorous quality-by-design principles, we are rapidly advancing our pipeline of ADCs and proprietary BiTAC formats into clinical development and beyond. VERAXA was founded on scientific breakthroughs made at the European Molecular Biology Laboratory (EMBL), a world-renowned institution known for pioneering life science research and cutting-edge technology.

For regular updates about VERAXA Biotech, visit https://investors.veraxa.com/ or follow us on LinkedIn, X (formerly known as Twitter) and Bluesky.

BiTAC® is a registered trademark of VERAXA Biotech GmbH.

Forward-looking Statements

This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that address activities, events, or developments that VERAXA Biotech AG (the "Company") intends, expects, plans, projects, believes, or anticipates will or may occur in the future are forward-looking statements, including with respect to the anticipated timing for clinic development of its pipeline candidates or the likelihood of regulatory approval thereof. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements contained on this press release should be evaluated together with the many uncertainties that affect the Company's business, particularly those identified in the risk factors section of the Company’s registration statement on Form F-4. These documents are available from the Securities and Exchange Commission, the Company website or from Company Investor Relations.

In addition, any information contained in this press release was current as of the date presented and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our estimates change, whether as a result of new information, future events or otherwise. Consequently, the company will not update the information contained in this press release and investors should not rely upon the information as current or accurate after the presentation date.

Contact

VERAXA Biotech AG – Corporate
Christoph Antz, Ph.D.
Chief Executive Officer, Co-Founder
investors@veraxa.com

For Media and Investors – U.S.
Brandon Weiner
ICR Healthcare
VERAXA@icrhealthcare.com

For Media and Investors – EU
Mario Brkulj
investors@veraxa.com

Attachment

• 20260720_VERAXA_PEI_Advice_FINAL

FAQ

What regulatory milestone did VERAXA Biotech (NASDAQ: VRXA) announce on July 20, 2026?

VERAXA Biotech announced receiving Scientific Advice from Germany’s Paul-Ehrlich-Institute (PEI) on its BiTAC-TCE program. According to VERAXA, the advice supports the biological rationale and proposed non-clinical development plan, offering initial clarity and de-risking for this novel therapeutic modality.

What is VERAXA Biotech’s BiTAC-TCE technology and how does it work?

VERAXA’s BiTAC-TCE is a dual-targeting, conditionally active T cell engager format for cancer therapy. According to VERAXA, the candidate attacks cancer cells displaying both target molecules while sparing cells expressing only one, aiming to improve safety while maintaining anti-tumor activity.

What preclinical results did VERAXA Biotech report for its BiTAC-TCE candidate at AACR 2026?

VERAXA reported that its BiTAC-TCE candidate performed as intended in vitro and in vivo at AACR 2026. According to VERAXA, it selectively killed dual-target cancer cells, spared single-target cells, and showed a superior safety profile with matching efficacy versus a traditional TCE.

How does the Paul-Ehrlich-Institute’s Scientific Advice impact VERAXA Biotech’s BiTAC-TCE development?

The PEI’s Scientific Advice provides early regulatory feedback on VERAXA’s BiTAC-TCE biology and non-clinical plan. According to VERAXA, this alignment de-risks the proposed development path and helps guide efficient progression of the BiTAC-TCE program toward clinical evaluation.

Is VERAXA Biotech’s BiTAC-TCE cancer therapy in clinical trials yet?

Based on VERAXA’s announcement, the BiTAC-TCE program is currently in the non-clinical development stage. According to VERAXA, existing data are from in vitro and in vivo studies, and the Scientific Advice focused on its proposed non-clinical development plan, not ongoing human trials.

What potential safety advantages does VERAXA’s BiTAC-TCE candidate show over traditional T cell engagers?

VERAXA’s BiTAC-TCE candidate showed a superior safety profile with similar efficacy compared to a traditional TCE in preclinical studies. According to VERAXA, selective killing of dual-target cells while sparing single-target cells may contribute to a meaningfully improved therapeutic index.