PharmaTher Closes Sale of Ketamine ANDA, Sharpening Focus on Long-Acting Injectable Ketamine Franchise

Rhea-AI Summary

PharmaTher (OTCQB: PHRRF) closed the sale of its Ketamine Hydrochloride Injection ANDA #217858 to a sterile-injectables company on December 2, 2025, receiving a confidential upfront cash payment and remaining eligible for milestone and seven-year profit-sharing payments.

The transaction could generate more than US$25 million over time, subject to commercial performance, and frees PharmaTher to focus on its patented long-acting injectable (LAI) ketamine program with Oakwood Laboratories via an exclusive evaluation and option-to-license agreement.

Positive

• Confidential upfront cash received at closing
• Deal includes milestone payments tied to cumulative sales
• Seven-year profit-sharing after first commercial sale
• Transaction could generate more than US$25M over time
• Strategic focus on patented LAI ketamine with Oakwood
• Clear near-term 6-month catalyst roadmap for development

Negative

• Upfront payment amount is undisclosed, reducing cash clarity
• Future payments are contingent on commercial performance
• Program success depends on Oakwood collaboration and option exercise
• Regulatory path via 505(b)(2) requires FDA alignment and trials

News Market Reaction

-5.33%

1 alert

-5.33% News Effect

On the day this news was published, PHRRF declined 5.33%, reflecting a notable negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Ketamine ANDA number: ANDA #217858 Transaction potential: more than US$25 million Profit-sharing term: seven years +1 more

4 metrics

Ketamine ANDA number ANDA #217858 Abbreviated New Drug Application for Ketamine Hydrochloride Injection USP

Transaction potential more than US$25 million Total potential from ANDA sale over time, subject to performance

Profit-sharing term seven years Profit-sharing payments following first commercial sale

Milestone horizon 6 months Expected timeline for multiple data, regulatory and partnering inflection points

Market Reality Check

Price: $0.0648 Vol: Volume 66,780 is well bel...

low vol

$0.0648 Last Close

Volume Volume 66,780 is well below the 20-day average of 367,351 ahead of this announcement. low

Technical Shares at $0.083, trading below the $0.19 200-day moving average and far under the $0.55 52-week high.

Peers on Argus

Peers were mixed: HRGN down 14.03%, OTLC down 2.36%, while others like ACUT, DVH...

Peers were mixed: HRGN down 14.03%, OTLC down 2.36%, while others like ACUT, DVHGF, and BMNDF were flat. With PHRRF down 1.93%, moves appear more stock-specific than sector-driven.

Historical Context

5 past events · Latest: Dec 02 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 02	Asset sale / strategy	Positive	-5.3%	Closed ketamine ANDA sale with upside over US$25M and profit sharing.
Nov 17	Licensing strategy	Positive	-9.2%	Exclusive Oakwood LAI ketamine evaluation and option-to-license agreement announced.
Oct 17	Regulatory recognition	Positive	-4.2%	FDA CNPV selection of ketamine and reiterated upside from ANDA sale.
Oct 16	Phase 3 preparation	Positive	-8.2%	Preparing Pre-Phase 3 FDA package for LID-Parkinson’s ketamine trial.
Oct 15	AI platform launch	Positive	-5.8%	Launched KetAImine AI platform to expand ketamine portfolio and partnerships.

Pattern Detected

Over the last five news events, shares moved lower after each announcement despite generally positive strategic and clinical updates, indicating a pattern of negative price reactions to ostensibly favorable news.

Recent Company History

Over recent months, PharmaTher has highlighted multiple ketamine-focused initiatives. These include the ANDA sale with up to US$25 million potential, advancement of a Phase 3 package for LID-Parkinson’s disease, launch of the KetAImine™ AI discovery platform, and securing exclusive rights to a long-acting injectable ketamine program. Each event was followed by a negative price reaction, and today’s closing of the ANDA sale continues that strategic shift toward differentiated ketamine franchises.

Market Pulse Summary

The stock moved -5.3% in the session following this news. A negative reaction despite the non-diluti...

Analysis

The stock moved -5.3% in the session following this news. A negative reaction despite the non-dilutive transaction fits the recent pattern, where the past 5 news events each saw post-announcement declines. The ANDA sale offers potential of more than US$25 million and seven years of profit sharing, while sharpening focus on the LAI franchise. Yet, the share price had been trading well below the $0.19 200‑day average, suggesting a fragile backdrop before this announcement.

Key Terms

abbreviated new drug application, long-acting injectable, 505(b)(2), cmc, +3 more

7 terms

abbreviated new drug application regulatory

"sale of its Abbreviated New Drug Application (ANDA #217858) for Ketamine"

An abbreviated new drug application is a regulatory submission used to gain approval to market a generic version of an already approved prescription medicine by showing it is equivalent in effect and safety to the original product, without repeating full clinical trials. For investors, an approval signals a lower-cost competitor entering the market that can quickly capture sales from the branded drug, similar to a generic knock‑off replacing a name‑brand item on store shelves.

long-acting injectable medical

"focus on the development and commercialization of the patented long-acting injectable ("LAI") ketamine"

A long-acting injectable is a medication formulated to be given by shot that releases its active ingredient slowly over weeks or months so a patient needs fewer doses. For investors, these products can change a drug’s market value by improving patient convenience and adherence, extending patent life or pricing opportunities, and requiring different manufacturing and regulatory steps compared with daily pills — much like swapping many small payments for a single, larger subscription.

505(b)(2) regulatory

"The Company intends to pursue a 505(b)(2) regulatory pathway with an initial focus"

A 505(b)(2) is an FDA drug approval pathway that lets a company win approval by relying partly on existing studies or published data instead of doing all new clinical trials. Think of it like building a renovated house using the original foundation: it can be faster and less costly than a full new-drug route, reducing development risk and expense. Investors care because it can speed market entry, lower capital needs, and offer opportunities for exclusivity or competitive advantage.

cmc technical

"Advancing formulation and CMC activities in collaboration with Oakwood to support"

Chemistry, Manufacturing, and Controls (CMC) describes the technical documentation and processes that show how a drug or medical product is made, tested for consistent quality, and kept stable from batch to batch. Investors care because strong CMC means a product can be manufactured reliably at scale and meet regulatory standards—similar to proving a recipe can be cooked the same way in any kitchen before restaurants expand—affecting approval, production costs, and potential revenue.

pre-ind regulatory

"including potential pre-IND discussions to align on study design and safety"

"Pre-ind" is short for "pre-indication" and refers to the period before a formal announcement or official signal that a significant change or event is about to happen, such as a company preparing to release important news. For investors, it can signal a time of increased activity or uncertainty, as market participants try to interpret hints and anticipate future developments. Recognizing pre-ind conditions helps investors make more informed decisions ahead of major shifts.

treatment-resistant depression medical

"indications such as treatment-resistant depression (TRD), major depressive disorder"

A form of major depression that does not improve after a person has tried standard treatments such as common antidepressant medications and therapy; think of it as a stubborn problem that doesn’t respond to the usual fixes. It matters to investors because it represents a large unmet medical need and a higher-risk, higher-reward area for drug developers, with potential for premium pricing, regulatory scrutiny, and durable demand if an effective new therapy is approved.

major depressive disorder medical

"indications such as treatment-resistant depression (TRD), major depressive disorder (MDD)"

A clinical condition characterized by persistent, severe low mood, loss of interest in daily activities, and reduced ability to function at work or home, lasting weeks or longer. It matters to investors because it drives demand for treatments and mental health services, affects workforce productivity and absenteeism, influences health-care and insurance costs, and shapes risks and opportunities for companies developing drugs, therapies or workplace programs—like a long-lasting storm that lowers economic output.

AI-generated analysis. Not financial advice.

Toronto, Ontario--(Newsfile Corp. - December 2, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty life sciences company focused on unlocking the therapeutic potential of ketamine for neuropsychiatric disorders, today announced it has closed the previously announced sale of its Abbreviated New Drug Application (ANDA #217858) for Ketamine Hydrochloride Injection USP to a leading sterile-injectables pharmaceutical company.

At closing, PharmaTher received a confidential upfront cash payment and remains eligible to receive additional milestone payments based on cumulative sales thresholds, as well as profit-sharing payments for seven years following first commercial sale. In total, the transaction provides the potential to generate more than US$25 million over time, subject to commercial performance.

The sale strengthens PharmaTher's focus on the development and commercialization of the patented long-acting injectable ("LAI") ketamine program being advanced under an exclusive evaluation and option-to-license agreement with Oakwood Laboratories, LLC.

"Closing the ANDA sale marks the start of PharmaTher's next chapter," said Fabio Chianelli, Chairman and Chief Executive Officer of PharmaTher. "We have converted a legacy generic asset into non-dilutive capital and long-term upside, and we are now fully focused on building a differentiated, long-acting ketamine franchise for neuropsychiatric disorders."

PharmaTher's LAI ketamine program leverages Oakwood's microsphere-based sustained-release technology, designed to enable subcutaneous or intramuscular administration with controlled drug release over weeks to months. The Company intends to pursue a 505(b)(2) regulatory pathway with an initial focus on high-value neuropsychiatric indications such as treatment-resistant depression (TRD), major depressive disorder (MDD), and Parkinson's disease.

"We believe long-acting ketamine is the natural evolution of today's ketamine treatment model," added Mr. Chianelli. "A convenient, less frequent injectable option has the potential to improve adherence, reduce clinic burden, and expand access while preserving ketamine's rapid antidepressant benefits."

Near-Term Value-Creating Milestones

With the ANDA sale closed and its LAI strategy defined, PharmaTher is focused on executing a clear, catalyst-rich plan over the coming quarters. The Company's priorities include:

• Advancing formulation and CMC activities in collaboration with Oakwood to support clinical-grade supply;
• Refining the 505(b)(2) regulatory strategy and planned clinical development pathway for TRD, MDD and Parkinson's disease;
• Preparing for formal FDA interactions, including potential pre-IND discussions to align on study design and safety requirements;
• Prioritizing additional neuropsychiatric indications where long-acting ketamine may offer differentiated benefit and attractive market opportunities; and
• Evaluating strategic partnering and non-dilutive funding opportunities as the program matures.

PharmaTher expects that successful execution of these milestones could create multiple data, regulatory, and partnering inflection points over the next 6 months.

About PharmaTher

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a specialty life sciences company focused on unlocking the therapeutic potential of ketamine for neuropsychiatric disorders. For more information, visit PharmaTher.com.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary and Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of applicable securities laws, which reflect the Company's current expectations regarding future events. Forward-looking statements are often, but not always, identified by words such as "aim", "anticipate", "believe", "could", "estimate", "expect", "intend", "may", "plan", "potential", "projected", "proposed", "seek", "should", "will", "would", and similar expressions. Forward-looking statements in this press release include, without limitation, statements relating to (i) potential milestone and profit-sharing payments under the ANDA sale, (ii) the commercial performance of the ANDA product, (iii) the development, regulatory pathway, and potential approval of the Company's LAI ketamine program, (iv) the size and growth of the market opportunity for ketamine-based therapies, and (v) the Company's ability to achieve future development, regulatory, partnering, and financial milestones. These forward-looking statements are based on reasonable assumptions made by the Company as of the date hereof but are subject to a number of known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or implied. Such risks and uncertainties include, among others: the commercial performance of the ANDA product; the Buyer's ability to obtain and maintain all necessary regulatory approvals; the Company's ability to successfully develop, manufacture, and commercialize its LAI ketamine program; the outcome and timing of regulatory interactions and clinical trials; market acceptance and competitive dynamics; the availability of capital; and the other risk factors described under the heading "Risk Factors" in the Company's management's discussion and analysis for the year ended May 31, 2025, dated September 26, 2025, available under the Company's profile on SEDAR+ at www.sedarplus.ca.

Readers are cautioned not to place undue reliance on forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and the Company does not undertake any obligation to update or revise such information, whether as a result of new information, future events, or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein.

This news release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/276630

FAQ

What did PharmaTher announce about the ANDA sale on December 2, 2025 (PHRRF)?

PharmaTher closed the sale of ANDA #217858, received a confidential upfront cash payment, and remains eligible for milestones and seven-year profit sharing.

How much can PharmaTher (PHRRF) potentially earn from the ANDA transaction?

The transaction provides the potential to generate more than US$25 million over time, subject to commercial performance.

What strategic shift did PharmaTher (PHRRF) announce after the ANDA sale?

PharmaTher said it will sharpen focus on its patented long-acting injectable ketamine program being advanced with Oakwood Laboratories.

What regulatory pathway will PharmaTher (PHRRF) pursue for its LAI ketamine program?

The company intends to pursue a 505(b)(2) regulatory pathway with planned FDA interactions including potential pre-IND discussions.

What near-term milestones did PharmaTher (PHRRF) list after the ANDA closing?

Priorities include advancing formulation and CMC with Oakwood, refining the 505(b)(2) strategy, preparing for FDA interactions, and evaluating partnerships.