Evotec-Partner Bayer Starts Phase 2 Study for Treatment of Patients with Alport Syndrome

Rhea-AI Summary

Evotec (NASDAQ:EVO) confirmed that partner Bayer has initiated a Phase 2 clinical study of BAY 3401016, a monoclonal antibody targeting Semaphorin-3A (Sema3A) for the treatment of Alport syndrome.

The randomized, double-blind, placebo-controlled Phase 2a ASSESS study with an extension phase will enroll participants aged 18 to 45. Under the 2016 collaboration, Evotec is eligible for a milestone payment upon first patient dosing, which Bayer expects in early 2026, and for further development and sales milestones plus tiered royalties if the program advances to commercialization.

Positive

• Phase 2 start for BAY 3401016 in Alport syndrome
• Evotec eligible for milestone upon first patient dosing expected early 2026
• Program originates from a 2016 Evotec–Bayer collaboration
• Evotec eligible for future milestones and tiered royalties

Negative

• Study enrolment restricted to ages 18–45
• Financial upside is contingent on Bayer progress through development and commercialization

News Market Reaction

+1.10%

1 alert

+1.10% News Effect

On the day this news was published, EVO gained 1.10%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Study phase: Phase 2 / Phase 2a Participant age range: 18–45 years First dosing timing: Early 2026 +1 more

4 metrics

Study phase Phase 2 / Phase 2a BAY 3401016 ASSESS study for Alport syndrome

Participant age range 18–45 years Inclusion criteria for Phase 2a ASSESS study

First dosing timing Early 2026 Expected first patient dosing milestone for BAY 3401016

Collaboration start August 2016 Start of Evotec–Bayer kidney disease collaboration

Market Reality Check

Price: $3.66 Vol: Volume 151,517 is 1.42x t...

normal vol

$3.66 Last Close

Volume Volume 151,517 is 1.42x the 20-day average of 106,485, indicating elevated interest ahead of the Phase 2 update. normal

Technical Price at 3.07 is trading below the 200-day MA of 3.76 and remains 39.8% under the 52-week high.

Peers on Argus

EVO gained 3.45% while peers showed mixed moves: TLRY up 3.82%, HROW up 1.98%, P...

EVO gained 3.45% while peers showed mixed moves: TLRY up 3.82%, HROW up 1.98%, PCRX up 1.42%, AMPH up 0.35%, DVAX down 0.82%. No clear, uniform sector trend explains EVO’s move.

Historical Context

5 past events · Latest: Dec 08 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 08	Asset sale closing	Positive	-3.5%	Closed Toulouse site sale to Sandoz with sizeable cash and potential milestones.
Dec 04	Clinical trial update	Positive	+1.1%	Partner Bayer advanced BAY 3401016 into Phase 2a for Alport syndrome.
Nov 12	Milestone payment	Positive	+5.7%	US$5m milestone from BMS after FDA IND acceptance for CELMoD candidate.
Nov 05	Earnings update	Negative	-15.7%	9M 2025 results showed revenue decline and adjusted EBITDA loss despite guidance.
Nov 04	Strategic transaction	Positive	-1.2%	Announced >US$650m Sandoz transaction and royalties on biosimilar portfolio.

Pattern Detected

Recent news shows mixed price reactions: positive partnership and deal announcements sometimes saw negative moves, while regulatory and clinical milestones tended to align positively with the stock.

Recent Company History

Over the last months, Evotec reported several strategic and clinical milestones. A major agreement and subsequent closing with Sandoz involved potential payments above US$650m, but both announcements were followed by modest share price declines. In contrast, a US$5m milestone from Bristol Myers Squibb and the initial Phase 2 Alport syndrome update saw positive reactions of 5.72% and 1.1%, respectively. The 9M 2025 results, featuring lower revenues and an EBITDA loss, coincided with a sharper -15.74% move, underscoring sensitivity to earnings quality.

Market Pulse Summary

This announcement highlights progression of Evotec’s Bayer-partnered kidney program into a randomize...

Analysis

This announcement highlights progression of Evotec’s Bayer-partnered kidney program into a randomized, double-blind, placebo-controlled Phase 2a trial for Alport syndrome, with a key milestone expected in early 2026. In recent months, the company combined large strategic transactions and milestone receipts with mixed share reactions, and earnings quality influenced sentiment. Investors may watch trial execution, future milestone disclosures, and upcoming financial updates to contextualize this partnership-driven pipeline progress.

Key Terms

phase 2, monoclonal antibody, mAb, semaphorin-3a, +4 more

8 terms

phase 2 medical

"Bayer AG has initiated a Phase 2 clinical study of a kidney disease program"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

monoclonal antibody medical

"The study drug, BAY 3401016, a monoclonal antibody ("mAb") targeting the protein"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

mAb medical

"BAY 3401016, a monoclonal antibody ("mAb") targeting the protein Semaphorin-3A"

A mAb (monoclonal antibody) is a lab-made protein designed to recognize and bind a specific target on cells or pathogens, like a custom-made key that fits one lock. Investors care because mAbs are often developed as therapies or diagnostic tools whose clinical trial results, regulatory approvals, production capacity, and patent status can drive significant revenue swings and affect a company’s valuation and risk profile.

semaphorin-3a medical

"targeting the protein Semaphorin-3A ("Sema3A") is being developed"

Semaphorin-3A is a naturally occurring signaling protein that acts like a traffic signal for cells, telling nerve fibers, blood vessel cells, and immune cells where to grow or move. Investors watch it because changes in its levels or activity are linked to diseases such as nerve injury, cancer, and inflammatory conditions, making it a potential target for drugs, diagnostics, or biomarkers that can drive clinical progress and commercial value.

randomized medical

"ASSESS study is a randomized, double-blind, placebo-controlled, parallel group Phase 2a"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

double-blind medical

"ASSESS study is a randomized, double-blind, placebo-controlled, parallel group Phase 2a"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"ASSESS study is a randomized, double-blind, placebo-controlled, parallel group Phase 2a"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

alport syndrome medical

"as a potential treatment for Alport syndrome, a rare genetic kidney disease"

Alport syndrome is a genetic condition that affects the kidneys, ears, and eyes, often leading to kidney problems and hearing loss over time. For investors, understanding it is important because health issues linked to genetic diseases can influence the pharmaceutical and healthcare sectors, impacting companies involved in developing treatments or diagnostics for such conditions. It highlights how medical advancements and genetic research can create opportunities or risks in related markets.

AI-generated analysis. Not financial advice.

• Phase 2 clinical trial initiated to evaluate SEMA3A mAb as potential treatment for Alport syndrome

• Milestone payment to Evotec expected upon first dosing of first study participant in early 2026

HAMBURG, DE / ACCESS Newswire / December 4, 2025 / Evotec SE (Frankfurt Stock Exchange:EVT, SDAX/TecDAX, Prime Standard, ISIN: DE0005664809, WKN 566480; NASDAQ:EVO) today announced that its partner Bayer AG has initiated a Phase 2 clinical study of a kidney disease program originating from the multi-target research collaboration between Evotec and Bayer in kidney diseases. Under the terms of the collaboration agreement, Evotec is eligible to receive a milestone payment upon first patient dosing, which is expected in early 2026. The study drug, BAY 3401016, a monoclonal antibody ("mAb") targeting the protein Semaphorin-3A ("Sema3A") is being developed as a potential treatment for Alport syndrome, a rare genetic kidney disease.

Bayer's ASSESS study is a randomized, double-blind, placebo-controlled, parallel group Phase 2a study with an extension phase to evaluate the efficacy and safety of BAY 3401016 in participants aged 18 to 45 with Alport syndrome. The program originates from a strategic collaboration, which Evotec and Bayer entered in August 2016. Under the terms of the agreement, Evotec is eligible to receive further development and sales milestones as well as tiered royalties of net sales contingent upon the future progress during clinical development and potential commercialization of a drug in the future.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We are very pleased that our jointly developed antibody, BAY 3401016, for the treatment of Alport syndrome has advanced into Phase 2 of clinical development. Alport syndrome primarily damages the kidney, often starting at childhood and worsening through life. This debilitating disease significantly impacts patient's quality of life through both the symptoms and disease management, especially in later stages of kidney disease. New therapeutic options that enable better quality of life are urgently needed for individuals and families affected by this disease. The initiation of this study represents an important and hopeful step forward. We congratulate Bayer on the Phase 2 launch and are proud to support the advancement of this program."

About Semaphorin-3A
Semaphorin-3A ("Sema3A") is an extracellular guidance protein and a well-known regulator of the actin cytoskeleton. Alterations of the actin cytoskeleton, particularly of podocytes, are a key pathophysiological feature of Alport syndrome, a rare genetic kidney disease with progressive loss of filtration capacity, leading to end stage renal disease, progressive hearing loss and variable vision impairment. Sema3A is upregulated in injured human kidneys and implicated in the development and progression of acute and chronic kidney diseases. The monoclonal antibody ("mAb") developed by Bayer in partnership with Evotec blocks Sema3A activity and is currently investigated as a potential treatment of Alport syndrome, aiming to delay disease progression and onset of end-stage renal disease.

About Alport Syndrome
Alport syndrome is a genetic condition characterized by kidney disease, hearing loss, and eye abnormalities. Most affected individuals experience progressive loss of kidney function, which may lead to end-stage kidney disease. People with Alport syndrome also frequently develop sensorineural hearing loss in late childhood or early adolescence. The eye abnormalities characteristic of this condition seldom lead to vision loss. In 80% of cases, Alport syndrome is inherited in an X-linked manner and is caused by genetic changes in the COL4A5 gene. In the remaining cases, it may be inherited in either an autosomal recessive, or rarely in an autosomal dominant manner. In these cases, the condition is caused by genetic changes in the COL4A3 or COL4A4 genes. Diagnosis of the condition is based on family history of the condition, clinical signs, and specific testing such as a kidney biopsy. The diagnosis can be confirmed by genetic testing.

About Evotec SE
Evotec is a life science company that is pioneering the future of drug discovery and development. By integrating breakthrough science with AI-driven innovation and advanced technologies, we accelerate the journey from concept to cure - faster, smarter, and with greater precision.

Our expertise spans small molecules, biologics, cell therapies and associated modalities, supported by proprietary platforms such as Molecular Patient Databases, PanOmics and iPSC-based disease modeling.

With flexible partnering models tailored to our customers' needs, we work with all Top 20 Pharma companies, over 800 biotechs, academic institutions, and healthcare stakeholders. Our offerings range from standalone services to fully integrated R&D programs and long-term strategic partnerships, combining scientific excellence with operational agility.

Through Just - Evotec Biologics, we redefine biologics development and manufacturing to improve accessibility and affordability.

With a strong portfolio of over 100 proprietary R&D assets, most of them being co-owned, we focus on key therapeutic areas including oncology, cardiovascular and metabolic diseases, neurology, and immunology.

Evotec's global team of more than 4,800 experts operates from sites in Europe and the U.S., offering complementary technologies and services as synergistic centers of excellence. Learn more at www.evotec.com and follow us on LinkedIn and X/Twitter @Evotec.

Forward-looking statements
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec's securities. Words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "should," "target," "would" and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec's expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec's expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For further information, please contact:

Media
Susanne Kreuter
VP Head of Strategic Marketing
Susanne.Kreuter@evotec.com

Investor Relations
Volker Braun
EVP Head of Global Investor Relations & ESG
Volker.Braun@evotec.com

SOURCE: Evotec SE

View the original press release on ACCESS Newswire

FAQ

What did Evotec announce about BAY 3401016 and Alport syndrome (EVO) on December 4, 2025?

Evotec said partner Bayer initiated a randomized Phase 2a study of BAY 3401016 for Alport syndrome and Evotec is eligible for a milestone at first patient dosing.

When is Evotec expected to receive the Phase 2 milestone payment for BAY 3401016 (EVO)?

Evotec expects a milestone payment upon first patient dosing, which Bayer expects to occur in early 2026.

What is the design of Bayer’s ASSESS Phase 2 study for BAY 3401016 (EVO)?

The ASSESS study is a randomized, double-blind, placebo-controlled Phase 2a trial with an extension phase in participants aged 18 to 45.

How does the Evotec–Bayer collaboration affect Evotec shareholders (EVO)?

Evotec is eligible for development and sales milestones plus tiered royalties contingent on future clinical progress and potential commercialization by Bayer.

Does the Phase 2 study cover pediatric Alport syndrome patients for BAY 3401016 (EVO)?

No; the announced Phase 2a study enrolls participants aged 18 to 45, so pediatric patients are not included in this trial.