InMed Pharmaceuticals Announces Positive Data from Human Brain Organoid Neuroinflammation Models Supporting the INM-901 Alzheimer's Disease Program

Rhea-AI Summary

InMed Pharmaceuticals (NASDAQ: INM) reported preclinical data showing INM-901 reduced neuroinflammation in two human 3D brain organoid models, including a Stem Pharm Alzheimer's disease model.

Findings showed dose-dependent reductions in IL-6 and IL-8, aligned with prior in vivo and ex vivo results, and support a planned pre-IND meeting in Q3 2026 and a targeted IND/Phase 1 start in 2027.

Positive

• Consistent anti-inflammatory effects across in vivo, ex vivo, and human organoids
• Dose-dependent reduction of key cytokines IL-6 and IL-8 in organoids
• Company targets IND submission and Phase 1 initiation in 2027

Negative

• Data limited to preclinical models; no human clinical efficacy yet
• IND timeline contingent on FDA feedback and completion of IND-enabling studies
• No quantitative clinical endpoints or human safety data provided

Key Figures

Pre-IND meeting timing: Q3/2026 Phase 1 trial target: 2027 Organoid models: 2 models

3 metrics

Pre-IND meeting timing Q3/2026 Planned pre-IND meeting with U.S. FDA for INM-901

Phase 1 trial target 2027 Targeted IND submission and initiation of first-in-human Phase 1 trial

Organoid models 2 models General LPS/IFN-γ neuroinflammation model and Alzheimer’s neuroinflammation model

Market Reality Check

Price: $0.8176 Vol: Volume 1,159,163 is 7.42x...

high vol

$0.8176 Last Close

Volume Volume 1,159,163 is 7.42x the 20-day average of 156,253, signaling unusually heavy trading ahead of this news. high

Technical Shares at 0.8176 are trading below the 200-day MA of 1.83 and remain 89.75% under the 52-week high.

Peers on Argus

Momentum scanner shows no peers in the same-direction move. Sector names are mix...

Momentum scanner shows no peers in the same-direction move. Sector names are mixed, with moves from -10.0% (CPHI) to +2.81% (RDHL), suggesting the INM reaction was stock-specific rather than a broad pharma rotation.

Historical Context

5 past events · Latest: Mar 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 09	Pipeline development update	Positive	-3.7%	Outlined 2026 priorities and INM-901/INM-089 progress toward IND and trials.
Mar 06	Business refocus	Negative	-3.7%	Winding down BayMedica operations and shifting focus to pharmaceutical pipeline.
Feb 11	Earnings and pipeline	Negative	-10.1%	Reported losses, lower BayMedica revenue, and flagged legislative risk to BayMedica.
Dec 17	AGM results	Positive	+7.5%	Shareholders approved directors, auditors, and SEPA share issuance of 20% or more.
Dec 12	Legislative risk update	Negative	-16.1%	Warned H.R. 5371 could materially harm BayMedica’s commercial cannabinoid business.

Pattern Detected

Across the last five news events, price moves aligned with news tone four times, with one notable divergence on a positive R&D update.

Recent Company History

Recent disclosures show InMed shifting away from BayMedica’s commercial rare-cannabinoid business toward its pharmaceutical pipeline, led by INM-901 for Alzheimer’s and INM-089 for dry AMD. Financial updates highlighted continued losses but cash of $7.0M and funding runway into Q4 2026. Governance items, including approval to issue 20% or more additional shares under a SEPA, were passed. Today’s organoid data further builds the INM-901 story following earlier preclinical neuroinflammation results and development timelines toward a Phase 1 trial in 2027.

Regulatory & Risk Context

Active S-3 Shelf · $50,000,000

Shelf Active

Active S-3 Shelf Registration 2026-03-20

$50,000,000 registered capacity

An effective-date-pending S-3 shelf filed on 2026-03-20 registers up to $50,000,000 of mixed securities, with no usage reported yet, giving the company flexibility to raise capital in multiple structures.

Market Pulse Summary

This announcement adds human brain organoid evidence to INM-901’s existing animal and ex vivo data, ...

Analysis

This announcement adds human brain organoid evidence to INM-901’s existing animal and ex vivo data, supporting its planned pre-IND meeting in Q3/2026 and targeted Phase 1 start in 2027. Recent history includes BayMedica’s wind-down, ongoing losses, and a newly filed $50,000,000 shelf registration from 2026-03-20. Investors may watch execution on IND-enabling studies, regulatory feedback, and any capital-raising under the shelf to gauge program and balance-sheet progress.

Key Terms

neuroinflammation, organoids, microglia, inflammasome, +2 more

6 terms

neuroinflammation medical

"demonstrating the effects of INM-901 in reducing neuroinflammation in 3D human brain organoid"

Neuroinflammation is the brain or spinal cord’s immune reaction to injury, infection, or abnormalities, where cells and molecules become active to protect or repair nervous tissue. It matters to investors because it underlies many neurological diseases and is a common target for drugs and diagnostic tools; positive or negative trial results, safety signals, or new therapies can change a company’s value much like a major repair plan or recall would affect a carmaker’s prospects.

organoids medical

"3D human brain organoid models of Alzheimer's disease.These studies, conducted in collaboration with Stem Pharm"

Miniaturized, simplified versions of human organs grown in the lab from stem cells that mimic key structure and function of real tissues. Like scale models used by architects, organoids let researchers test drugs, study disease and predict how human tissues will respond without using whole patients, which can speed development, reduce costs and lower risk for investors evaluating biotech pipelines and therapies.

microglia medical

"feature microglia, the brain's resident immune cells, and can be used to bridge"

Microglia are the brain’s resident immune cells that act like on-site janitors and security guards: they clear damaged cells and debris, patrol for threats, and coordinate local repair. For investors, microglia matter because they are a major target and biomarker in drug development for neurological and psychiatric conditions; therapies that modulate microglial activity can drive clinical trial outcomes, regulatory decisions, and the commercial value of biotech investments.

inflammasome medical

"INM-901 significantly reduced inflammasome activation and multiple pro-inflammatory cytokines"

A cellular protein assembly that senses danger or infection and turns on a rapid inflammatory response by activating enzymes that release signaling molecules and can trigger a controlled form of cell death. Think of it as a built‑in smoke detector and alarm system for immune cells: useful short-term to alert the body, but if it stays on it can cause chronic inflammation. Investors watch inflammasomes because they are drug targets and biomarkers that can affect a therapy’s effectiveness, safety profile, and regulatory path.

cytokines medical

"reduced inflammasome activation and multiple pro-inflammatory cytokines, including NLRP3, IL-1β, IL-6"

Small proteins produced by immune and other cells that act as on/off signals or “text messages,” telling cells to ramp up, calm down, grow, or move during infection, injury, or disease. Investors watch cytokines because they are common drug targets and biomarkers—changes in cytokine activity can make a therapy work, cause serious side effects, or determine clinical trial and regulatory outcomes, all of which affect a company’s value.

Phase 1 clinical trial medical

"targets submission of an IND and initiation of a Phase 1 clinical trial in 2027"

A phase 1 clinical trial is the first stage of testing a new drug or treatment in people, typically involving a small group to assess safety, how the body handles the treatment, and appropriate dosing. For investors, phase 1 results are an early risk check — like a test drive that can reveal fatal flaws or promising signals — and they often cause big changes in a drug’s perceived value and the company’s prospects.

AI-generated analysis. Not financial advice.

• Human Organoid Data Supports the Therapeutic Rationale for INM-901 Program Ahead of Human Clinical Trials
• Consistent Anti-Inflammatory Effects Demonstrate Translation from Animal Models to Three-Dimensional Human Brain Tissue Systems

Vancouver, British Columbia--(Newsfile Corp. - March 23, 2026) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company developing a pipeline of disease-modifying small molecule drug candidates targeting CB1 and CB2 receptors, today announced new preclinical data demonstrating the effects of INM-901 in reducing neuroinflammation in 3D human brain organoid models of Alzheimer's disease.

These studies, conducted in collaboration with Stem Pharm, Inc. ("Stem Pharm") using their proprietary platform of human neuro-immune organoids, represent a key step in translating prior animal model results for INM-901 into a human-relevant system, helping to de-risk the INM-901 program ahead of a first-in-human clinical trial.

The in vitro human organoid models represent some of the closest approximations to human brain tissue currently available, incorporating a complex cellular environment relevant to neurodegenerative disease. The organoids are composed of neurons, astrocytes, vascular cells and feature microglia, the brain's resident immune cells, and can be used to bridge the gap between traditional animal models and human clinical trials.

INM-901 was evaluated in two distinct human 3D organoid models: a general model of neuroinflammation induced with lipopolysaccharide ("LPS") and interferon-gamma ("IFN-γ"); and, Stem Pharm's proprietary neuroinflammation Alzheimer's disease model with specific features observed in Alzheimer's disease patients.

Key Observations:

• INM-901 demonstrated significant reduction in neuroinflammation in Stem Pharm's LPS-induced model and in their Alzheimer's disease model. A dose-dependent reduction of key pro-inflammatory markers such as IL-6 and IL-8 was seen in both neuroinflammation models.
• Effects align with prior findings from an in vivo Alzheimer's model and an ex vivo LPS-induced neuroinflammation model.
• Provides supportive evidence of mechanistic translation from animal models to human tissue systems.

The consistency of INM-901's anti-inflammatory effects across in vivo animal models, ex vivo systems and now human 3D brain organoids provide increasing confidence in the compound's potential to translate into clinical benefit in humans with neuroinflammatory conditions.

Dr. Eric Hsu, InMed SVP of Preclinical Research and Development, commented, "These results represent an important milestone for INM-901. We have now demonstrated consistent anti-neuroinflammatory effects across multiple in vivo and ex vivo studies, and, importantly, these findings have now been translated into advanced human brain organoid systems. This systematic validation significantly de-risks the program and strengthens our confidence as we advance INM-901 toward human clinical trials."

Key Datasets impacting Anti-Neuroinflammation to date:

• In a long-term mouse model mimicking Alzheimer's disease, INM-901 significantly reduced inflammatory biomarkers IFN-γ, TNF-α, IL-1β, KC-GRO, IL-2 and neurodegenerative marker neurofilament light chain ("NfL").
• INM-901 significantly reduced inflammasome activation and multiple pro-inflammatory cytokines, including NLRP3, IL-1β, IL-6, IL-2 and KC-GRO in an LPS-induced neuroinflammation ex vivo model, demonstrated anti-inflammatory effects independent of amyloid-beta or tau pathology.
• Reduction of neuroinflammation in 3D human brain organoid models of Alzheimer's disease.

Next Steps for the INM-901 Program for Alzheimer's Disease

• Conduct a pre-IND meeting with the U.S. Food and Drug Administration in Q3/2026.
• Continue to execute on IND-enabling pharmacology and toxicology studies.
• Continued development and scale-up of drug substance and product manufacturing activities to support IND enabling studies and submission.
• Engage regulatory/clinical experts in neurodegenerative diseases to map out topline clinical design for first-in-human clinical trials for the INM-901.
• Subject to regulatory feedback and completion of IND-enabling activities, the Company targets submission of an IND and initiation of a Phase 1 clinical trial in 2027.

Why Neuroinflammation Matters in Alzheimer's Disease

Recent drug development efforts in Alzheimer's disease have largely focused on amyloid plaque and tau pathology, leading to the first disease-modifying therapies in recent years. However, increasing attention is being directed toward neuroinflammation as a key underlying driver of disease progression. Studies presented at the recent global Alzheimer's conferences highlighted the relationship between inflammatory biomarkers and the risk of Alzheimer's disease and other dementias, underscoring the growing importance of targeting inflammation.

Current research has demonstrated significant progress in understanding disease mechanisms and clinical interventions, with inflammation emerging as a critical factor influencing long-term patient outcomes. As such, neuroinflammation is increasingly recognized as a strategic therapeutic target for next-generation Alzheimer's treatments.

About Stem Pharm, Inc.

Stem Pharm is developing next-generation neurologic drugs using a human-first approach. Stem Pharm's proprietary drug discovery platform is based on human 3D neuro-immune organoids that feature microglia and model neuroinflammation, which play a critical role in many neurological diseases. The company applies this platform to discover and validate disease targets and therapeutics for its internal programs in Alzheimer's disease, epilepsy, and brain cancer as well as for its biopharma partners' therapeutic programs. Stem Pharm is based in Madison, WI, a hub for innovative stem cell and biosciences research. For more information, visit stempharm.com.

About InMed:

InMed Pharmaceuticals is a pharmaceutical 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: developing a pipeline of disease-modifying small molecule drug candidates that target CB1/CB2 receptors; the potential efficacy of INM-901; INM-901's ability to treat Alzheimer's; marketability and uses for INM-901; reducing neuroinflammation in 3D human brain organoid models; demonstrating consistent anti-neuroinflammatory effects across multiple in vivo and ex vivo studies, and being translating into advanced human brain organoid systems; the advancement of CMC activities; the planning of GLP-enabling studies and the preparation of an IND submission the further development; planning for a pre-IND meeting in Q3 2026; engaging regulatory / clinical experts to map out topline clinical design for first in human clinical trials for the INM-901; and, targeting submission of an IND and initiation of a Phase 1 clinical trial in 2027.

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 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/289438

FAQ

What did InMed (INM) announce about INM-901 on March 23, 2026?

INM reported that INM-901 reduced neuroinflammation in human 3D brain organoid models, including an Alzheimer's model. According to the company, the studies showed dose-dependent reductions in IL-6 and IL-8 and aligned with prior in vivo and ex vivo findings, supporting advancement toward clinical testing.

How do INM-901 organoid results affect InMed's IND timeline for INM (INM)?

The organoid data support progression toward regulatory engagement and IND filing plans. According to the company, InMed plans a pre-IND meeting in Q3 2026 and targets IND submission and Phase 1 initiation in 2027, subject to completing IND-enabling studies and FDA feedback.

What specific inflammatory markers did INM-901 reduce in the organoid studies for INM (INM)?

INM-901 produced dose-dependent reductions in key pro-inflammatory markers IL-6 and IL-8 in both organoid models. According to the company, these reductions mirrored effects seen in prior animal and ex vivo models, suggesting mechanistic translation to human tissue systems.

Do the March 23, 2026 INM-901 results prove clinical benefit for InMed (INM)?

No, the results are preclinical and do not demonstrate clinical benefit in humans. According to the company, the data de-risk the program by showing translation into human organoids but human safety and efficacy require Phase 1 and later trials.

What are the next development steps for INM-901 according to InMed (INM)?

InMed plans a Q3 2026 pre-IND meeting with the FDA and further IND-enabling pharmacology, toxicology, and manufacturing work. According to the company, these activities aim to support an IND submission and potential Phase 1 start in 2027, pending regulatory feedback.