InMed Announces Successful Completion of Pharmacokinetic Studies in Large Animal Model for Its Alzheimer's Disease Candidate INM-901

Rhea-AI Summary

Shoulder Innovations (NYSE: SI) announced the full commercial launch of the InSet™ 70 humeral stem on Sept. 22, 2025 in Grand Rapids, Mich.

The InSet™ 70 expands the company’s I-Series humeral stem line (which began with the InSet™ 95 in 2024), is cleared for both anatomic and reverse shoulder arthroplasty, and addresses indications including osteoarthritis, avascular necrosis, rheumatoid and traumatic arthritis, irreparable cuff tears, and certain revision cases.

Company statements highlight the InSet™ 70’s bone-sparing design, initial fixation comparable to the longer InSet™ 95, simplified surgical workflow, and claimed optimized biomechanics intended to support improved shoulder function for patients.

Insights

Medical Device Commercial Strategy Expert

Commercial launch of the InSet™ 70 broadens Shoulder Innovations' shoulder arthroplasty offering and may support US revenue growth if adoption follows.

What this does: The full commercial launch of the InSet™ 70 expands the I-Series humeral stem line alongside the existing InSet™ 95. A shorter, bone-sparing stem can address surgeon demand for options across anatomic and reverse shoulder arthroplasty, potentially increasing procedure-level share within the company’s addressable market.

Key dependencies and risks: Adoption depends on surgeon preference, clinical outcomes versus existing stems, inventory and reimbursement pathways, and penetration into high-volume centers. Clinical claims quoted are promotional; real-world fixation and functional benefits must be proven in routine practice to sustain uptake.

Concrete things to watch and timing: Monitor early commercial metrics such as procedure adoption rates, hospital purchasing agreements, and any presented or published outcome data over the next 12–18 months. Watch for surgeon-reported workflow impact and any competitive responses.

• Data demonstrate a favorable bioavailability profile of INM-901 oral formulation
• Data will support design and planning of first in human clinical trials
• Preparing for pre-IND meeting with the FDA

Vancouver, British Columbia--(Newsfile Corp. - November 18, 2025) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company developing a pipeline of proprietary small-molecule drug candidates for diseases with high unmet medical needs, today announced the successful completion of pharmacokinetic ("PK") studies in large animal models for its Alzheimer's disease candidate INM-901.

This marks the first preclinical study in which the oral formulation of INM-901 was administered in large animals. The results provide additional data in guiding decisions in the design of a human Phase 1 clinical trial program.

Positive PK and Neurological Assessment Results

Over a seven-day dosing period, the studies demonstrated robust bioavailability in in vivo models. INM-901 achieved what is anticipated to be therapeutic levels of systemic exposure, supporting its potential utility in neurodegenerative disorders such as Alzheimer's disease.

In addition, neurological assessments evaluating general attitude, behavior, and motor function revealed no adverse neural or behavioral effects, reinforcing the compound's favorable profile and supporting its continued advancement toward first-in-human clinical trials.

In parallel, InMed has completed additional chemistry, manufacturing, and controls ("CMC") development to scale the INM-901 manufacturing process in preparation for Investigational New Drug ("IND")-enabling studies and regulatory interaction with the Food and Drug Administration ("FDA').

Dr. Eric Hsu, Senior Vice President, Preclinical Research and Development at InMed, commented, "The successful completion of our first large animal PK study is very encouraging for the INM-901 program. The data supports the clinical applicability of our INM-901 oral formulation and provides important insights as we plan and design our IND-enabling studies and Phase 1 clinical trials. Furthermore, the neurological assessments strengthen our confidence in the compound's overall safety profile."

Next development steps:

• Advancing CMC activities for scale-up and supply
• Dose ranging studies in two species
• Preparing for a pre-IND meeting with the FDA
• GLP-enabling studies to support an IND submission

To learn more about the INM-901program, please visit the website at: https://www.inmedpharma.com/pharmaceutical/inm-901-for-alzheimers-disease/.

About InMed:

InMed Pharmaceuticals is a pharmaceutical drug development company focused on developing a pipeline of proprietary small molecule drug candidates targeting the CB1/CB2 receptors. InMed's pipeline consists of three separate programs in the treatment of Alzheimer's, ocular and dermatological indications. For more information, visit www.inmedpharma.com.

Investor Contact:
Colin Clancy
Vice President, Investor Relations
and Corporate Communications
T: +1.604.416.0999
E: ir@inmedpharma.com

Cautionary Note Regarding Forward-Looking Information:

This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking information") within the meaning of applicable securities laws. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "potential", "possible", "would" and similar expressions. Such statements, based as they are on current expectations of management, inherently involve numerous risks, uncertainties and assumptions, known and unknown, many of which are beyond our control. Forward-looking information is based on management's current expectations and beliefs and is subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Without limiting the foregoing, forward-looking information in this news release includes, but is not limited to, statements about: the efficacy of INM-901; the favorable bioavailability profile of INM-901 oral formulation; planning and preparation for pre-IND meeting with the FDA; positive results demonstrating robust bioavailability of INM-901; no adverse neural or behavioral effects using INM-901; the clinical applicability of our INM-901 oral formulation; INM-901's overall safety profile and next development steps including advancing CMC, dose ranging and GLP studies.

Additionally, there are known and unknown risk factors which could cause InMed's actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained herein. A complete discussion of the risks and uncertainties facing InMed's stand-alone business is disclosed in InMed's Annual Report on Form 10-K and other filings with the Securities and Exchange Commission on www.sec.gov.

All forward-looking information herein is qualified in its entirety by this cautionary statement, and InMed disclaims any obligation to revise or update any such forward-looking information or to publicly announce the result of any revisions to any of the forward-looking information contained herein to reflect future results, events or developments, except as required by law.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/274918

FAQ

What is the InSet™ 70 launched by Shoulder Innovations (NYSE: SI) on Sept. 22, 2025?

The InSet™ 70 is a new humeral stem in the I-Series, launched commercially in the U.S. and intended for anatomic and reverse shoulder arthroplasty.

How does the InSet™ 70 differ from the InSet™ 95 from 2024?

The InSet™ 70 offers a shorter, bone-sparing form factor while maintaining the company’s stated excellent initial fixation and simple workflow similar to the InSet™ 95.

What clinical indications does the InSet™ 70 cover for SI (NYSE: SI)?

Indications include non-inflammatory degenerative joint disease like osteoarthritis and avascular necrosis, rheumatoid and traumatic arthritis, irreparable cuff tears, and certain revision cases when sufficient bone stock remains.

When and where was Shoulder Innovations’ InSet™ 70 announced?

The company announced the full commercial launch on Sept. 22, 2025 in Grand Rapids, Michigan.

Will the InSet™ 70 be available across the United States immediately?

The company said the InSet™ 70 is being brought to market across the United States and was launched ahead of schedule.

What benefits did surgeons cite for the InSet™ 70 in the Sept. 22, 2025 announcement?

Surgeons cited bone-sparing utility, superb humeral fixation within reverse platforms, optimized biomechanics, and potential for improved shoulder function.