AtaiBeckley Announces New U.S. Patent Granted for EMP-01, Strengthening Intellectual Property Portfolio

Rhea-AI Summary

AtaiBeckley (NASDAQ: ATAI) announced a U.S. patent grant (No. 12,492,178) for EMP-01 (oral R‑MDMA), which the company says provides exclusivity through 2043. The patent covers a highly crystalline HCl salt form with high aqueous solubility and low hygroscopicity, attributes cited as beneficial for formulation, manufacture, and storage.

The company states this strengthens its intellectual property estate and supports advancement of EMP-01 toward clinical development; topline data from an exploratory Phase 2a study in adults with social anxiety disorder is expected in Q1 2026.

Positive

• U.S. patent No. 12,492,178 providing claimed exclusivity through 2043
• Patent claims cover a highly crystalline HCl salt form with high aqueous solubility
• Patent claims note low hygroscopicity, aiding formulation and storage
• Topline data from exploratory Phase 2a for social anxiety disorder expected in Q1 2026

Negative

• None.

Key Figures

Patent number 12,492,178 U.S. patent granted for EMP-01 (oral R-MDMA)

Exclusivity horizon 2043 Expected U.S. patent exclusivity for EMP-01 program

Phase Phase 2a Exploratory study of EMP-01 in social anxiety disorder

Topline data timing Q1 2026 Expected EMP-01 Phase 2a topline results

Market Reality Check

$4.29 Last Close

Volume Volume 2013850 is at 0.53x the 20-day average, indicating subdued trading activity pre‑announcement low

Technical Price 4.33 is trading above the 200-day MA of 3.26, indicating a prior uptrend into this patent news

Peers on Argus

Peers in Biotechnology showed mixed moves, with names like ATNF (+2.92%) and SYRE (+2.85%) up, while QURE (-3.17%) and VERV (-0.09%) were down. With ATAI down 1.37% pre‑news and no peers in the momentum scanner, trading pointed to stock‑specific dynamics rather than a clear sector trend.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 19	Leadership changes	Positive	-4.2%	Major executive reshuffle and board changes to bolster leadership bench.
Nov 13	Conference participation	Neutral	-4.6%	Jefferies healthcare conference fireside chat and investor meetings announcement.
Nov 12	Earnings and updates	Positive	-2.3%	Q3 2025 results with BPL‑003 progress, EMP‑01 enrollment, and funding runway.
Nov 10	Clinical data update	Positive	-0.2%	Positive Phase 2b OLE data for BPL‑003 in treatment‑resistant depression.
Nov 05	Strategic combination	Positive	-15.2%	Completion of atai–Beckley Psytech combination and pipeline/commercial plans.

Pattern Detected

Over the past month, shares declined after multiple generally constructive corporate, clinical, and strategic updates, suggesting a pattern of negative price reactions even to ostensibly positive news.

Recent Company History

In the last few months, AtaiBeckley reported several milestones, including completion of its strategic combination with Beckley Psytech on Nov 5, 2025, positive Phase 2b OLE data for BPL-003, and Q3 2025 results highlighting Breakthrough Therapy designation and funding into 2029. The company also refreshed leadership and participated in investor events. Despite these developments, each announcement saw negative 24‑hour price reactions. Today’s EMP‑01 patent grant adds further pipeline and IP strengthening to this sequence of news.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-09-29

The company has an effective S-3ASR filed on September 29, 2025, registering securities for resale. The shelf is active through September 29, 2028 and has been used in at least 3 prospectus supplements, including a 424B7 resale related to the Beckley Psytech acquisition and two 424B5 offerings, indicating established capacity for registered transactions.

Market Pulse Summary

This announcement adds a U.S. patent for EMP‑01 (oral R‑MDMA), extending expected exclusivity to 2043 and protecting a specific HCl salt form with favorable formulation attributes. It builds on earlier disclosures that EMP‑01’s Phase 2a social anxiety study is fully enrolled, with topline data anticipated in Q1 2026. Investors may track future updates on this trial alongside the broader BPL‑003 and VLS‑01 programs and note the company’s effective S-3ASR from September 29, 2025.

Key Terms

united states patent and trademark office regulatory

"the United States Patent and Trademark Office has granted a new patent"

A U.S. government agency that reviews and issues patents for inventions and registers trademarks for brand names and logos, acting like an official office that grants property deeds for ideas and branding. Investors care because patents and trademarks can create legal barriers to competition, support higher pricing, enable licensing revenue, and affect a company’s long‑term value and legal risk—so decisions by this office can materially influence a firm’s prospects.

hcl salt medical

"a highly-crystalline, thermodynamically stable HCl salt form of (R)-MDMA"

An HCl salt is a drug molecule combined with hydrochloric acid to form a stable, water-friendly version of the active ingredient; chemists often use this form to make medicines easier to dissolve, absorb and manufacture. For investors, whether a drug is an HCl salt matters because it can affect how a medication is made, how well it works, the ease of getting regulatory approval, manufacturing costs and patent or formulation strategies—similar to how turning fruit into jam can make it safer to ship, store and sell.

(r)-mdma medical

"HCl salt form of (R)-MDMA with high aqueous solubility"

(R)-MDMA is a specific mirror-image form of the psychoactive compound MDMA, like choosing a left glove instead of a right one; it is chemically nearly identical but can have different effects and safety profiles in the body. For investors, it matters because drug developers may pursue this variant in clinical trials and regulatory approvals where small chemical differences can change efficacy, side-effect risks, development costs, and the ultimate commercial opportunity or regulatory hurdles.

aqueous solubility technical

"with high aqueous solubility and low hygroscopicity"

Aqueous solubility is how much of a substance will dissolve in water. For pharmaceuticals and chemicals, it determines whether a drug can be absorbed in the body, mixed into formulations, or manufactured reliably — like how much sugar will dissolve in a cup of water before the rest sinks to the bottom. Low solubility can slow or block a product’s effectiveness and raise development, regulatory and production costs, making it a key factor for investors assessing risk and value.

hygroscopicity technical

"with high aqueous solubility and low hygroscopicity"

Hygroscopicity is the tendency of a material to吸吸? absorb or attract water vapor from the air, which can change its weight, texture and chemical behavior—like sugar clumping or salt dissolving when humidity rises. For investors this matters because moisture uptake can alter manufacturing processes, product stability, shelf life, packaging needs, regulatory compliance and shipping costs, thereby affecting yields, quality control and profitability for companies that make or handle moisture‑sensitive drugs, chemicals or consumer goods.

phase 2a medical

"exploratory Phase 2a study evaluating EMP-01 in adults"

Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.

social anxiety disorder medical

"Phase 2a study evaluating EMP-01 in adults with social anxiety disorder"

Social anxiety disorder is a mental health condition characterized by a strong fear of social situations where one might be judged or embarrassed. This fear can lead individuals to avoid social interactions, which may impact their personal and professional lives. For investors, understanding this condition is important because it can influence decision-making, communication, and overall well-being in the workplace.

AI-generated analysis. Not financial advice.

NEW YORK and AMSTERDAM, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Atai Beckley N.V. (NASDAQ: ATAI) (“AtaiBeckley” or the “Company”), a clinical-stage biopharmaceutical company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments, today announced that the United States Patent and Trademark Office has granted a new patent covering EMP-01 (oral R-MDMA), further strengthening the company’s intellectual property estate and long-term exclusivity for the program.

The newly granted U.S. patent, No. 12,492,178, includes claims to the drug substance of EMP-01, and is expected to provide exclusivity through 2043. This patent identifies a highly-crystalline, thermodynamically stable HCl salt form of (R)-MDMA with high aqueous solubility and low hygroscopicity, form-specific attributes that are beneficial during formulation development, drug product manufacture, as well as drug substance and drug product storage. This patent protects critical drug substance attributes of EMP-01 and supports the company's strategy to develop innovative, differentiated therapies designed to address significant unmet needs in mental health.

“This patent grant reinforces the strength of our science and our long-term commitment to building durable, defensible innovation,” stated Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-founder of AtaiBeckley. “EMP-01 is an important asset in our pipeline, and securing this patent issuance in the U.S. further strengthens our ability to advance the program while delivering meaningful value for patients and shareholders. We look forward to reporting topline data from the exploratory Phase 2a study evaluating EMP-01 in adults with social anxiety disorder in the first quarter of 2026.”

AtaiBeckley continues to expand its global patent portfolio across its pipeline to support clinical development, potential commercialization, and strategic flexibility as the company advances its mission to create new breakthroughs in mental health.

About EMP-01 (Oral R-MDMA)

EMP-01 is an oral formulation of R-3,4-methylenedioxy-methamphetamine (R-MDMA) that demonstrated a unique, dose-dependent subjective effect profile in a Phase 1 trial that was generally found to be more similar to classical psychedelics than to racemic MDMA. Anxiety disorders are the most common mental health disorders worldwide, affecting how one experiences worry, fear and anxiety in everyday situations. Social anxiety disorder (SAD) is an area of high unmet medical need with approximately 18 million people currently diagnosed in the United States and no novel molecules approved in over two decades. atai is currently enrolling patients into an exploratory, randomized, double-blind, placebo-controlled Phase 2 study to assess the safety, tolerability and efficacy of EMP-01 in adults with SAD. Topline data from the exploratory Phase 2a study is anticipated in the first quarter of 2026.

About AtaiBeckley N.V.

AtaiBeckley is a clinical-stage biopharmaceutical company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments. It was formed through the strategic combination of atai Life Sciences N.V. and Beckley Psytech Limited in November 2025. AtaiBeckley’s pipeline of novel therapies includes BPL-003 (mebufotenin benzoate nasal spray) for treatment-resistant depression (TRD), VLS-01 (buccal film DMT) for TRD and EMP-01 ((R)-MDMA HCI) for social anxiety disorder, which are in Phase 2 clinical development. It is also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and TRD. These programs aim to create new possibilities in mental health by providing effective, commercially scalable and convenient interventional psychiatry therapies that can integrate seamlessly into healthcare systems.

For the latest updates and to learn more about the AtaiBeckley mission, visit www.ataibeckley.com or follow the Company on LinkedIn and on X.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: our business strategy and plans; the potential, success and timing of development and progress of trials and related milestones of our product candidates such as EMP-01; expectations regarding our intellectual property portfolio, including our newly granted patent and plans for expansion of our patent portfolio; and the plans and objectives of management for future operations, research and development and capital expenditures.

Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in AtaiBeckley’s other filings with the SEC. AtaiBeckley disclaims any obligation to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.

Contact Information
Investor Contact:
IR@ataibeckley.com

Media Contact:
PR@ataibeckley.com

FAQ

What does AtaiBeckley's U.S. patent No. 12,492,178 mean for ATAI shareholders?

The patent is stated to provide intellectual property exclusivity for EMP-01 through 2043, which the company says can protect commercial opportunities and support long-term value.

What specific form of EMP-01 is covered by the new ATAI patent?

The patent covers a highly crystalline HCl salt form of (R)-MDMA with high aqueous solubility and low hygroscopicity, attributes noted as beneficial for drug development.

When will ATAI report clinical results for EMP-01 (oral R‑MDMA)?

AtaiBeckley expects to report topline results from the exploratory Phase 2a study in adults with social anxiety disorder in Q1 2026.

How long is exclusivity for EMP-01 claimed to last under the new patent?

The company states the newly granted patent is expected to provide exclusivity through the year 2043.

Does the ATAI patent impact EMP-01 manufacturing or storage?

The patent specifically notes form-specific attributes—high solubility and low hygroscopicity—that the company says benefit formulation development, manufacture, and storage.