InMed Provides Update on Pharmaceutical Development Programs - Advancing Lead Drug Candidates Towards IND and Clinical Trial

Rhea-AI Summary

InMed (NASDAQ: INM) outlines 2026 pharmaceutical development priorities, focusing on advancing INM-901 toward a pre-IND meeting in Q3 2026 and IND-enabling studies with a target to submit an IND and initiate a Phase 1 Alzheimer’s trial in 2027. Key preclinical findings show anti-neuroinflammatory effects, neuroprotection, neuritogenesis, behavioral gains, and oral bioavailability in large animals. The company also plans a pre-IND meeting for INM-089 in Q4 2026 and continues formulation, scale-up, and regulatory planning for both programs.

Positive

• Pre-IND meeting for INM-901 scheduled in Q3 2026
• Target to submit IND and start Phase 1 in 2027 for INM-901
• Preclinical biomarker reductions in 5xFAD and LPS neuroinflammation models
• Oral formulation achieved therapeutic exposure in a large animal model
• Drug substance/product scale-up and IND-enabling activities initiated

Negative

• No human clinical data yet; programs remain preclinical through 2026
• IND submission and Phase 1 start are subject to regulatory feedback
• Timelines are targets, not firm regulatory approvals or cleared INDs

News Market Reaction – INM

-3.73%

3 alerts

-3.73% News Effect

-14.1% Trough Tracked

-$104K Valuation Impact

$3M Market Cap

0.3x Rel. Volume

On the day this news was published, INM declined 3.73%, reflecting a moderate negative market reaction. Argus tracked a trough of -14.1% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $104K from the company's valuation, bringing the market cap to $3M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Target Phase 1 start: 2027 INM-901 pre-IND timing: Q3 2026 INM-089 pre-IND timing: Q4 2026 +1 more

4 metrics

Target Phase 1 start 2027 Planned initiation of Phase 1 clinical trial in Alzheimer’s disease for INM-901

INM-901 pre-IND timing Q3 2026 Planned pre-IND meeting with FDA for INM-901

INM-089 pre-IND timing Q4 2026 Planned pre-IND meeting with FDA for INM-089

Large-animal exposure Therapeutic levels achieved INM-901 oral formulation in large animal model

Market Reality Check

Price: $0.8000 Vol: Volume 102,332 is 1.09x t...

normal vol

$0.8000 Last Close

Volume Volume 102,332 is 1.09x the 20-day average of 93,550, indicating modestly elevated interest. normal

Technical Shares at $0.92 are trading below the 200-day MA of $1.93 and 88.47% under the 52-week high.

Peers on Argus

INM is up 4.53% with slightly elevated volume, while peers are mixed: SHPH up 7....

1 Up

INM is up 4.53% with slightly elevated volume, while peers are mixed: SHPH up 7.5%, RDHL, SBFM and PRFX down, and CPHI flat. With no broad, same-direction move among multiple peers, today’s action appears stock-specific.

Historical Context

5 past events · Latest: Feb 11 (Negative)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 11	Earnings and update	Negative	-10.1%	Q2 FY2026 losses, lower BayMedica revenue, pipeline progress but cash burn concerns.
Dec 17	Shareholder meeting	Positive	+7.5%	AGM approvals for directors, auditors and potential 20%+ share issuance under SEPA.
Dec 12	Legislative risk	Negative	-16.1%	Warning that H.R. 5371 could materially harm BayMedica’s rare‑cannabinoid business.
Nov 06	Earnings and update	Negative	-6.2%	Q1 FY2026 losses, declining BayMedica revenue, ongoing preclinical work on INM‑901 and INM‑089.
Oct 16	Board appointment	Positive	-5.5%	Appointment of experienced director to support clinical readiness and partnerships.

Pattern Detected

Recent history shows INM often trading lower on earnings and risk disclosures, with occasional positive reactions to shareholder and governance events.

Recent Company History

Over the last several months, InMed has reported earnings showing continuing losses and declining BayMedica revenue, while still funding operations into Q4 2026. Multiple updates highlighted progress for INM-901 in Alzheimer’s and INM-089 in dry AMD, alongside growing legislative risk to BayMedica. Governance events, including a new board appointment and shareholder approval for potential share issuance, framed capital and strategic flexibility. Today’s development update extends this trajectory by detailing preclinical gains and laying out a path toward FDA pre-IND meetings and a planned 2027 Phase 1 trial.

Market Pulse Summary

This announcement outlines substantial preclinical progress for INM-901 in Alzheimer’s disease and I...

Analysis

This announcement outlines substantial preclinical progress for INM-901 in Alzheimer’s disease and INM-089 in dry age-related macular degeneration, including biomarker, behavioral and exposure data, as well as planned FDA pre-IND meetings in Q3 and Q4 2026 and a targeted Phase 1 start in 2027. In context of earlier earnings and legislative headwinds, investors may track execution on IND-enabling studies, regulatory feedback, and the company’s ability to sustain funding through these milestones.

Key Terms

phase 1, cb1/cb2, blood-brain barrier, neuroinflammation, +3 more

7 terms

phase 1 clinical

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

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

cb1/cb2 medical

"drug candidates that target CB1/CB2 receptors, today provides a pharmaceutical"

CB1 and CB2 are two types of cannabinoid receptors—protein “locks” on cells that respond to natural or synthetic molecules related to cannabis. CB1 is mostly in the brain and affects mood, pain and coordination; CB2 is largely in the immune system and influences inflammation and immune response. For investors, these receptors are important because drugs that target them can create new treatments or carry safety and regulatory risks, so outcomes in research or approvals can strongly affect a company’s value.

blood-brain barrier medical

"agonist and can cross the blood-brain barrier with a specific focus on treating"

A protective barrier of tightly packed cells and supporting tissue that controls what substances in the blood can enter the brain, acting like a security checkpoint that keeps out most pathogens and many drugs while allowing essential nutrients through. For investors, the barrier matters because whether a therapy can cross or safely bypass it often determines clinical success, regulatory approval and commercial potential for treatments of brain disorders.

neuroinflammation medical

"specific focus on treating neuroinflammation in Alzheimer's disease"

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.

inflammasome medical

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

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"

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.

neurofilament light chain (nfl) medical

"KC-GRO, IL-2 and neurodegenerative marker neurofilament light chain (NfL)."

Neurofilament light chain (NfL) is a small structural protein released into spinal fluid and blood when nerve cells are injured or dying, so rising levels act like a smoke alarm for brain and nerve damage. Investors watch NfL because it can shorten drug development timelines and change market prospects: clear NfL signals may speed clinical trial decisions, support regulatory approval, and boost demand for diagnostics and treatments tied to neurodegenerative or acute neurological conditions.

AI-generated analysis. Not financial advice.

• Advancing Alzheimer's and Age-Related Macular Degeneration Programs Toward FDA Engagement and IND-Enabling Activities
• Targeting Initiation of Phase 1 Clinical Trial in Alzheimer's Disease in 2027

Vancouver, British Columbia--(Newsfile Corp. - March 9, 2026) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company focused on developing a pipeline of disease-modifying small molecule drug candidates that target CB1/CB2 receptors, today provides a pharmaceutical development outlook for 2026.

"Over the last several quarters, we made meaningful scientific and operational progress across our pipeline, particularly with INM-901, generating data that fundamentally strengthened its scientific rationale and strategic positioning in the Alzheimer's segment. These results support a differentiated approach to Alzheimer's disease that extends beyond single-target strategies. We further refined the program's direction and reinforced our conviction that targeting neuroinflammation is critical to addressing Alzheimer's disease progression," commented Eric A. Adams, InMed President and CEO.

"Looking ahead in 2026, our primary focus is executing activities toward a pre-IND meeting with the FDA in Q3 to discuss the INM-901 program, which we believe will be a key inflection point as we work toward IND submission and initiation of a Phase 1 clinical trial in 2027. In parallel, we will continue developing INM-089 and plan for a pre-IND meeting in Q4 2026."

INM-901 Program Outlook

INM-901 is a proprietary, orally bioavailable, disease-modifying small molecule drug candidate that is a preferential CB1/CB2 signaling agonist and can cross the blood-brain barrier with a specific focus on treating neuroinflammation in Alzheimer's disease. InMed believes INM-901 is uniquely positioned within the evolving Alzheimer's disease treatment landscape as increasing scientific consensus suggests that the disease is driven by multiple, interrelated biological pathways, rather than a single pathogenic mechanism.

InMed has generated preclinical evidence supporting that INM-901 exerts a therapeutic effect by directly attenuating neuroinflammation, which functions as a primary pathogenic driver for the Alzheimer's disease progression rather than a secondary or a reactive effect. Additional data on neuroprotection and neuritogenesis of INM-901 demonstrated a multifactorial mechanism of action, engaging several complementary pathways critical to mitigate neurodegeneration. By clarifying its focus, InMed strengthened the clinical and commercial rationale for INM-901 and positioned the program to pursue the most efficient and impactful path forward.

Scientific and Development Progress in 2025 include:

Key Anti-Neuroinflammation Progress

• In 5xFAD mouse model, 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 model, demonstrated anti-inflammatory effects independent of amyloid-beta or tau pathology.

Progress Across Additional Mechanisms Within Alzheimer's Pathology

• Neuroprotection: INM-901 significantly reduces amyloid beta-induced cell death.​
• Neuronal Regeneration: INM-901 promotes neurite outgrowth, indicating its ability to enhance neuronal connectivity and function.​
• Behavioral Improvements: In preclinical studies, INM-901 demonstrates positive trends in cognitive function, anxiety-related behavior, and sensory responsiveness​.
• Bioavailability: In large animal model, INM-901 oral formulation achieved anticipated therapeutic levels of systemic exposure​.
• Molecular Validation: mRNA data aligns with behavioral findings, supporting observed improvements in cognition, memory and neurogenesis.

Additional Drug Development Progression

• Initiation of the dose-ranging and exposure assessments supporting advancement toward IND-enabling studies.
• Progress in drug substance and drug product development, including formulation development and scale up to support dose ranging and future GLP studies.
• Advancement of drug product and drug substance analytical methods and stability assessments consistent with regulatory expectations.
• Initiation of a regulatory and clinical development framework to support first-in-human evaluation.

2026 Development Priorities for INM-901 include:

• 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 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.

As we move forward, the progress achieved to date reinforces our confidence in INM-901 and in our strategic direction with a disciplined focus on neuroinflammation with a clear development plan. We believe we are positioned to advance INM-901 efficiently and deliver meaningful long-term value for shareholders.

INM-089 Program Outlook

INM-089 is a small molecule drug candidate being studied for its potential as a treatment for dry age-related macular degeneration.

Scientific and development progress and plans include:

• Generation of data supporting continued evaluation of therapeutic potential.
• Completion of preclinical studies, including dose-ranging assessment, demonstrating dose proportionality and pharmacologically relevant concentration following dosing.
• Drug substance and drug product process in place to support IND enabling studies, with further optimization expected in advance of IND submission.
• Planning for a pre-IND meeting with the FDA in Q4 2026.

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; the advancement of chemistry, manufacturing, and controls (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; targeting submission of an IND and initiation of a Phase 1 clinical trial in 2027; potential efficacy, and marketability of INM-089 for dry age-related macular degeneration; preparing for a pre-IND meeting with the FDA in Q4 2026 for INM-089.

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/287694

FAQ

What is InMed’s timeline for INM-901 IND submission and Phase 1 (INM)?

InMed targets IND submission and initiation of a Phase 1 Alzheimer’s trial in 2027. According to the company, this is contingent on completing IND-enabling studies and regulatory feedback after a planned pre-IND meeting in Q3 2026.

What preclinical evidence supports INM-901’s Alzheimer’s potential (INM)?

INM-901 showed reduced neuroinflammatory biomarkers and neuroprotection in multiple models. According to the company, results include lowered IFN-γ, TNF-α, IL-1β, NLRP3 and improved neurite outgrowth, cognition trends, and systemic exposure in large animals.

When will InMed meet the FDA about INM-089 and what’s the plan (INM)?

InMed plans a pre-IND meeting for INM-089 in Q4 2026 as part of IND planning. According to the company, preclinical dose-ranging and process development are complete enough to support upcoming IND-enabling studies.

Does INM-901 have demonstrated oral bioavailability suitable for humans (INM)?

INM-901 achieved anticipated therapeutic systemic levels in a large animal oral formulation study. According to the company, this supports continued formulation scale-up and dose-ranging ahead of IND-enabling toxicology studies.

What are the main regulatory risks for InMed’s 2026 development plans (INM)?

Main risks include dependency on FDA feedback and completion of IND-enabling studies before human trials. According to the company, IND submission and Phase 1 initiation remain subject to regulatory review and successful GLP/IND-enabling outcomes.