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MTRI

InMed Pharmaceuticals Inc.
NASDAQ · HEALTH CARE · PHARMACEUTICAL PREPARATIONS
18.60
+0.25 +1.36%
USD · close Nov 13

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How MTRI rewrote its risk factors

10-K ITEM 1A · FY2025 → FY2026
Text kept
76%
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Added
155
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Dropped
167
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Length
−11
words, now 42,524

New in FY2026

  • Management’s Discussion and Analysis of Financial Condition and Results of Operations ” of this Annual Report, and the following: ● Our ability to stem operating losses; ● Our ability to successfully identify and consummate strategic and/or transformative corporate opportunities, including the proposed merger transaction with Mentari Therapeutics, Inc., a Delaware corporation (“Mentari”), and transactions to obtain the additional financing that we need to fund our operations; ● Our ability to effectively research, develop, manufacture and commercialize pharmaceutical drug candidates that will treat diseases with high unmet medical needs; ● Our ability to commercialize and, where required, register products in the pharmaceutical R&D programs (“Product Candidates”) in the United States and other jurisdictions; ● Our success in initiating discussions with potential partners for licensing various aspects of our Product Candidates; ● Our ability to successfully scale up our IntegraSyn approach to cannabinoid manufacturing.
  • We have created genetically engineered microbes that produce proprietary enzymes, which are then used to optimize subsequent biotransformation reactions or other cost-effective manufacturing approaches so that it may be a potential manufacturing method in the future which could reduce the need to source active pharmaceutical ingredients (“APIs”) from third-party API manufacturers; ● The success of the key next steps in our manufacturing approaches, including continuing efforts to diversify the number of products produced, scaling-up the processes to larger vessels and identifying external vendors to assist in the commercial scale-up of the process; ● Our ability to successfully make determinations as to which research and development programs to continue based on several strategic factors; ● Our ability to continue to outsource the majority of our research and development activities through scientific collaboration agreements and arrangements with various scientific collaborators, academic institutions and their personnel; ● Our ability to continue to outsource the majority of our research and development activities through scientific collaboration agreements and arrangements with various scientific collaborators, academic institutions and their personnel; ● The success of work to be conducted under the research and development collaboration between us and various contract development and manufacturing organizations (“CDMOs”); ● Our ability to develop our therapies through early human testing; ● Our ability to evaluate the financial returns on various commercialization approaches for our Product Candidates, such as a ‘go-it-alone’ commercialization effort, out-licensing to third parties, or co-promotion agreements with strategic collaborators; ● Our ability to find a partnership early in the development process for our various programs; ● Our ability to explore our manufacturing technologies as processes which may confer certain benefits, including cost, yield, speed, or all the above, when pursuing specific types of molecules, and filing a provisional patent application for same; ● Plans regarding our next steps, options, and targeted benefits of our manufacturing technologies; ● Our Products being bio-identical to the naturally occurring molecules, and offering superior ease, control and quality of manufacturing when compared to alternative methods; ● U.S.
  • Food and Drug Administration (“FDA”) regulatory acceptance of Product Candidates for potential use in the pharmaceutical industry; ● Our ability to successfully file, prosecute and defend patent applications; ● The potential for any of our patent applications to provide intellectual property protection for us; ● The termination or renegotiation of our supplier, technology and other material contracts, including the invoking of force majeure or termination clauses, and actual or threatened claims of our failure to comply with any obligations set forth under such contracts; ● The adequacy of, or gaps in, insurance coverage upon the occurrence of a catastrophic or other material adverse event, as well as our ability to secure insurance coverage for clinical trial insurance; ● Developing patentable New Chemical Entities (“NCE”) which, if issued, will confer market exclusivity to us for the potential development into pharmaceutical Product Candidates, license, partner or sell to interested external parties; ● Our ability to initiate discussions and conclude strategic partnerships to assist with development of certain programs; ● Our ability to position ourselves to achieve value-driving, near term milestones for our Product Candidates with limited investment; ● Our ability to effectively execute our business strategy; ● The sufficiency of our internal controls, including any exposure arising from the failure to (i) establish and maintain effective internal control over financial reporting in accordance with applicable regulatory requirements, and (ii) fully remediate any material weakness identified with respect to such internal controls; ● Epidemics, pandemics, global health crises, or other public health events and concerns, and the effectiveness of associated vaccinations and treatments; ● Consolidation of our competitors and suppliers; ● Effects of new products and new technology on the market, including with respect to automation and the use of artificial intelligence; ● The impact of geopolitical, global, regional or local economic and financial market risks and challenges, applicability of foreign laws, including foreign labor and employment laws, foreign tax and customs regimes, and foreign currency exchange rate risk; ● Political disturbances, geopolitical instability and tensions, or terrorist attacks, and associated changes in global trade policies and economic sanctions, including, but not limited to, in connection with (i) global trade tensions; (ii) the Russo-Ukrainian war and (iii) any impact, effect, damage, destruction and/or bodily harm directly or indirectly relating to the ongoing hostilities in the Middle East; ● The outcome of any legal proceedings, disputes, claims and administrative proceedings that arise in the ordinary course of our business activities, including our ongoing matter with a third-party licensor; and ● Our failure to satisfy any applicable listing standards, including compliance with the minimum bid price rule, and the actual or threatened delisting of our securities by Nasdaq.
  • Overview We are a pharmaceutical drug development company with a pipeline of proprietary small molecule drug candidates that are preferential signaling ligands of the endogenous CB1 and CB2 receptors as well as other receptor targets linked to human disease.
  • On March 4, 2026, the InMed Board ratified, confirmed and approved the decision of the board members of BayMedica to wind down and exit BayMedica’s commercial operations business segment, which constitutes the only revenue-generating commercial operations of InMed.
  • As of June 30, 2026, BayMedica had wound down all of its operating activities, and had two remaining employees who departed on July 31, 2026, as well as a commercial lease which will terminate at the end of August.
  • Following the wind down of commercial operations, InMed’s remaining activities have consisted of preclinical development of its Product Candidates, including INM-901 for Alzheimer’s disease, INM-089 for dry Age-related Macular Degeneration or dry AMD, and INM-755 (cannabinol) cream.
  • InMed does not currently intend to devote significant resources to advancing these Product Candidates, and any further development of them would require InMed to obtain additional financing, of which there can be no assurance.
  • Our current potential pharmaceutical pipeline consists of three programs, with drug candidates targeting Alzheimer’s disease, dry AMD, and Epidermolysis Bullosa, or EB.
  • Across multiple preclinical studies, INM-901’s primary mechanism of action is the reduction of neuroinflammation, with statistically significant effects demonstrated in both ex vivo and in vivo models.
  • Additionally, INM-901 targets several other mechanisms of action, offering a unique treatment approach targeting several biological pathways associated with Alzheimer’s disease.
  • More recently, these findings translated into advanced human brain organoid systems, where INM-901 showed significant dose-dependent reductions in key pro-inflammatory markers.
  • Together, these data meaningfully de-risk the program and strengthen confidence as the program advances toward a pre-IND meeting and subsequent human clinical trials.
  • In the event that the Merger is not consummated, InMed’s development priorities for INM-901, subject to financing transactions to fund operations, include conducting a currently scheduled pre-IND meeting with the FDA in the third quarter of calendar 2026, continuing to execute on IND-enabling pharmacology and toxicology studies, continued development and scale up of drug substance and product manufacturing activities, and engaging regulatory and clinical experts to map out topline clinical design for first in human clinical trials.
  • Furthermore, subject to regulatory feedback and financing transactions to fund completion of IND-enabling activities, InMed targets submission of an IND and initiation of a Phase 1 clinical trial in calendar 2027.
  • In the event that the Merger is not consummated, InMed’s development priorities for INM-089, subject to financing transactions to fund operations, 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 development to support IND-enabling studies, and planning for a pre-IND meeting with the FDA in early calendar 2027.
  • While previous business development initiatives have been unsuccessful, we are open to strategic partnership opportunities for INM-755 in EB and other itch-related skin conditions.
  • Our manufacturing capabilities include traditional approaches such as chemical synthesis and biosynthesis, as well as a proprietary, integrated manufacturing approach called IntegraSyn.
  • Our principal mailing address is InMed Pharmaceuticals Inc., c/o Norton Rose Fulbright Canada LLP, Suite 1800, 500 West Georgia St, Vancouver, British Columbia, Canada V6B 0M3 and our telephone number is +1-604-669-7207.
  • As of August 31, 2026, we no longer occupy executive office space.
  • Each member of our management team has 20 to 30+ years of industry experience, including our Chief Executive Officer (“CEO”), Chief Operating Officer (“COO”), Chief Financial Officer (“CFO”), and SVP of Preclinical Drug Development.
  • Together, this management team has covered the spectrum of pharmaceutical drug discovery, preclinical research, formulation development, manufacturing, human clinical trials, regulatory submissions and approval, and global commercialization of pharmaceutical products.
  • As of September 1, 2026, inclusive of our management team, we had 6 full-time employees, and we also utilize the services of several consultants.
  • Examples of Current treatments in Neurodegenerative Diseases Brand Company Mechanism of Action Status Aducanumab (Aduhelm™) Biogen Anti-amyloid beta target both insoluble and soluble aggregates Approved June 2021, discontinued November 2024 Lecanemab (Leqembi ® ) Biogen/ Eisai Anti-amyloid beta, electively binds to large, soluble Aβ protofibrils Approved July 2023 Donanemab (Kisunla™) Eli Lilly Anti-amyloid beta, target pyroglutamated AB in plaques Approved July 2024 Gantenerumab Roche Anti-amyloid beta, target aggregated forms of AB including oligomers and plaques Phase 3 failed November 2022 Remternetug (LY3372993) Eli Lilly Anti-tau, O-GlcNAcase Inhibitor Phase 3 BIIB080 Biogen Anti-Tau, antisense oligonucleotide (ASO) Phase 2 Completed; advancing toward Phase 3 Semorinemab Genentech Anti-tau Phase 2 Failed Currently approved medications for AD generally fall into two main categories.
  • Furthermore, we have shown successful completion of pharmacokinetic (“PK”) studies in large animal models for its Alzheimer’s disease candidate INM-901.
  • 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.
  • Additionally, we have shown reduction of neuroinflammation in 3D human brain organoid models of Alzheimer’s disease.
  • 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.
  • Summary of INM-901 long-term 5xFAD study: ● Hippocampal RNA Expression - Several genes associated with inflammation, the endocannabinoid system, synaptic dysfunction and oxidative stress and apoptosis (cell death) were evaluated following treatment.
  • INM-901 Next Steps In the event that the Merger is not consummated, InMed’s development priorities for INM-901, subject to financing transactions to fund operations, include: ● Integrating results from a pre-IND meeting with the U.S.
  • Food and Drug Administration in the third quarter of 2026 into our development plans; ● 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; and ● Subject to regulatory feedback and completion of IND-enabling activities, InMed targets submission of an IND and initiation of a Phase 1 clinical trial in 2027.
  • Key Milestones ● November 2021 — we announced the filing of an international patent application demonstrating neuroprotection and enhanced neuronal function using a rare cannabinoid for the potential treatment of neurodegenerative diseases such as Alzheimer’s Disease, Parkinson’s Disease, Huntington’s Disease and others.
  • The rare cannabinoid included in the PCT application is new to InMed’s portfolio. ● November 2022 — we announced announces the launch of its neurodegenerative disease program (INM-900 series), investigating the effects of cannabinoid analogs in diseases such as Alzheimer’s, Huntington’s and Parkinson’s.
  • The collaboration project is entitled “Pharmacological Characterization of Phytocannabinoids and the Endocannabinoid System”. ● June 2023 — we announced that results from a neurodegenerative disease study was presented in a scientific poster at the Canadian Neuroscience Meeting in Montreal from May 28-31, 2023.
  • The InMed sponsored research, entitled “ Cannabinoids modulate cytotoxicity and neuritogenesis in Amyloid-beta-treated neuronal cells”, demonstrated the ability of a specific rare cannabinoid (“pCBx”) in our INM-900 series of potential candidates that reduces amyloid toxicity and tau protein expression while enhancing neuronal cell growth and neuritogenesis markers in vitro, all considered to be important targets in the potential treatment of neurodegenerative diseases such as Alzheimer’s. ● October 2023 — we announced the selection of a lead Alzheimer’s disease drug candidate, named INM-901, following positive results from several proof-of-concept studies in a validated Alzheimer’s disease treatment model.

and 115 more.

Gone since FY2025

  • Management’s Discussion and Analysis of Financial Condition and Results of Operations ” of this Annual Report, and the following: ● Our ability to stem operating losses and our ability to obtain additional financing to fund our operations; ● The revenues of BayMedica, LLC (“BayMedica”) and the commercial viability of its product portfolio; ● Our ability to effectively research, develop, manufacture and commercialize pharmaceutical drug candidates that will treat diseases with high unmet medical needs; ● The continued optimization of key, proprietary manufacturing approaches and technologies; ● Our ability to commercialize and, where required, register products in the pharmaceutical R&D programs (“Product Candidates”) and those targeted to the health and wellness sector (“Products”) in the United States and other jurisdictions; ● Our success in initiating discussions with potential partners for licensing various aspects of our Product Candidates; ● Our ability to successfully access existing manufacturing capacity via leases with third-parties or to transfer our manufacturing processes to contract manufacturing organizations; ● Our belief that our manufacturing approaches that we are developing are robust and effective and will result in commercially viable yields of cannabinoids and will be a significant improvement upon existing manufacturing platforms; ● Our ability to successfully scale up our IntegraSyn approach to cannabinoid manufacturing.
  • We have created genetically engineered microbes that produce proprietary enzymes, which are then used to optimize subsequent biotransformation reactions or other cost-effective manufacturing approaches so that it may be a potential manufacturing method in the future which could reduce the need to source active pharmaceutical ingredients (“APIs”) from third-party API manufacturers; ● The success of the key next steps in our manufacturing approaches, including continuing efforts to diversify the number of products produced, scaling-up the processes to larger vessels and identifying external vendors to assist in the commercial scale-up of the process; ● Our ability to successfully make determinations as to which research and development programs to continue based on several strategic factors; ● Our ability to continue to outsource the majority of our research and development activities through scientific collaboration agreements and arrangements with various scientific collaborators, academic institutions and their personnel; ● The success of work to be conducted under the research and development collaboration between us and various contract development and manufacturing organizations (“CDMOs”); ● Our ability to develop our therapies through early human testing; ● Our ability to evaluate the financial returns on various commercialization approaches for our Product Candidates, such as a ‘go-it-alone’ commercialization effort, out-licensing to third parties, or co-promotion agreements with strategic collaborators; ● Our ability to find a partnership early in the development process for our various programs; ● Our ability to explore our manufacturing technologies as processes which may confer certain benefits, including cost, yield, speed, or all the above, when pursuing specific types of molecules, and filing a provisional patent application for same; ● Plans regarding our next steps, options, and targeted benefits of our manufacturing technologies; ● Our Products being bio-identical to the naturally occurring molecules, and offering superior ease, control and quality of manufacturing when compared to alternative methods; ● U.S.
  • Food and Drug Administration (“FDA”) regulatory acceptance of Product Candidates for potential use in the pharmaceutical industry; ● Our ability to successfully file, prosecute and defend patent applications; ● The potential for any of our patent applications to provide intellectual property protection for us; ● The termination or renegotiation of our supplier, technology and other material contracts, including the invoking of force majeure or termination clauses, and actual or threatened claims of our failure to comply with any obligations set forth under such contracts; ● The adequacy of, or gaps in, insurance coverage upon the occurrence of a catastrophic or other material adverse event, as well as our ability to (i) expand our insurance coverage to include the commercial sale of Products and Product Candidates and (ii) secure insurance coverage for shipping and storage of Product Candidates, and clinical trial insurance; ● Developing patentable New Chemical Entities (“NCE”) which, if issued, will confer market exclusivity to us for the potential development into pharmaceutical Product Candidates, license, partner or sell to interested external parties; ● Our ability to initiate discussions and conclude strategic partnerships to assist with development of certain programs; ● Our ability to position ourselves to achieve value-driving, near term milestones for our Product Candidates with limited investment; ● Our ability to effectively execute our business strategy; ● The sufficiency of our internal controls, including any exposure arising from the failure to (i) establish and maintain effective internal control over financial reporting in accordance with applicable regulatory requirements, and (ii) fully remediate any material weakness identified with respect to such internal controls; ● Epidemics, pandemics, global health crises, or other public health events and concerns, and the effectiveness of associated vaccinations and treatments; ● Consolidation of our competitors and suppliers; ● Effects of new products and new technology on the market, including with respect to automation and the use of artificial intelligence (“AI”); ● The impact of geopolitical, global, regional or local economic and financial market risks and challenges, applicability of foreign laws, including foreign labor and employment laws, foreign tax and customs regimes, and foreign currency exchange rate risk; ● Political disturbances, geopolitical instability and tensions, or terrorist attacks, and associated changes in global trade policies and economic sanctions, including, but not limited to, in connection with (i) the Russo-Ukrainian war and (ii) any impact, effect, damage, destruction and/or bodily harm directly or indirectly relating to the ongoing hostilities in the Middle East; ● The outcome of any legal proceedings, disputes, claims and administrative proceedings that arise in the ordinary course of our business activities, including our ongoing matter with a third party licensor; and ● Our failure to satisfy any applicable listing standards, including compliance with the minimum bid price rule, and the actual or threatened delisting of our securities by Nasdaq.
  • Overview We are a pharmaceutical company developing a pipeline of proprietary small molecule drug candidates that are preferential signaling ligands of the endogenous CB1 and CB2 receptors as well as other receptor targets linked to human disease.
  • Together with our wholly owned subsidiary, BayMedica, LLC, or BayMedica, we also have significant know-how in developing proprietary manufacturing approaches to produce and sell bulk rare cannabinoids as ingredients for various market sectors.
  • Our current potential pharmaceutical pipeline consists of three programs, with drug candidates targeting Alzheimer’s disease, dry Age-Related Macular Degeneration, or dry AMD, and Epidermolysis Bullosa, or EB.
  • Combined, these mechanisms of action may offer a unique treatment approach targeting several biological pathways associated with Alzheimer’s disease.
  • We are also pursuing strategic partnership opportunities for INM-755 in EB and other itch-related skin conditions.
  • Together with BayMedica, our manufacturing capabilities include traditional approaches such as chemical synthesis and biosynthesis, as well as a proprietary, integrated manufacturing approach called IntegraSyn.
  • BayMedica’s commercial business specializes in the B2B commercialization of bulk rare, non-intoxicating cannabinoids as raw materials for the Health and Wellness sector that are bioidentical to those found in nature.
  • Our principal executive offices are located at Suite 1445, 885 West Georgia Street, Vancouver, BC, V6C 3E8 and our telephone number is +1-604-669-7207.
  • Each member of our management team has 20 to 30+ years of industry experience, including our Chief Executive Officer (“CEO”), Chief Operating Officer (“COO”), Chief Financial Officer (“CFO”), General Manager and VPs of Preclinical Drug Development, Discovery Research, Chemistry, Synthetic Biology and of Sales & Marketing.
  • Together, this management team has covered the spectrum of pharmaceutical drug discovery, preclinical research, formulation development, manufacturing, human clinical trials, regulatory submissions and approval, and global commercialization of pharmaceutical and wellness products.
  • As of September 12, 2025, inclusive of our management team, we had 13 full-time employees, and we also utilize the services of several consultants.
  • We are committed to growing our business over the long-term.
  • Our Business Strategy Our goal is to develop a pipeline of prescription-based Product Candidates targeting treatments for diseases with high unmet medical needs. ● Develop and produce proprietary small molecule Product Candidates for use in our drug development programs ● Advance pharmaceutical drug Product Candidates through preclinical and clinical development, thereby establishing important human proof-of-concept in multiple therapeutic applications These activities are at various stages of development, including, with INM-901 (for the treatment of Alzheimer’s disease), INM-089 (for the treatment of dry AMD) and INM-755 (for the treatment of symptoms related to EB).
  • We have the internal capabilities to design and execute, together with multiple external vendors, the preclinical experimentation and clinical studies required to advance pharmaceutical drug candidates towards commercialization. ● Actively seek avenues to accelerate drug development via licensing, partnering or sale to external companies We do not currently have an internal organization for the sales, marketing and distribution of pharmaceutical products.
  • With respect to the commercialization of each Product Candidate, we may therefore rely on (i) a “go-it-alone” commercialization effort; (ii) out-licensing to third parties; or, (iii) co-promotion agreements with strategic collaborators for our Product Candidates.
  • The decision to pursue a “go-it-alone” commercialization effort versus out-licensing to third parties will depend on various factors including, but not limited to, the complexity of the Product Candidate and process, the expertise required and related cost of building any such infrastructure for our Product Candidates.
  • For INM-755 in EB, further advancement is contingent on identifying drug development and commercial partnerships.
  • The optimal commercial strategy for the INM-901 and INM-089 compounds will be evaluated in due course. ● Expand portfolio and revenues of Products into the existing distribution network and to end-product manufacturers of specialty health and wellness products ● Develop cost effective and scalable manufacturing processes for high quality Products and Product Candidates as APIs for our core internal drug candidate pipeline and for licensing opportunities of non-core drug candidates.
  • Our Strengths We are a pharmaceutical drug development company as well as a developer and supplier of rare, naturally occurring cannabinoids that is focused on commercializing important medicines to treat diseases with high unmet medical needs.
  • Our key strengths include the following: Experienced executive team and board of directors with proven track records.
  • One key critical success factor in the field of pharmaceutical drug development is the experience and skill set of the individuals leading us.
  • We have been successful in attracting and retaining executive and directors with extensive experience in all facets of the pharmaceutical industry, including fundamental research and development, multiple manufacturing techniques, drug formulation, clinical trial execution, regulatory approvals, pharmaceutical commercialization, company and capital formation, business development, legal, and corporate governance.
  • Our leadership team is well-poised to lead us through all facets of drug development and product commercialization, either internally or externally via partnerships.
  • It is this group of individuals that will help optimize our chances for success.
  • Scope of research and robust pharmaceutical pipeline Over several years of dedicated research, we have built a robust pipeline of drug development candidates, including two preclinical programs targeting Alzheimer’s (INM-901) and ocular diseases (INM-088 for glaucoma and INM-089 for AMD), as well as a completed Phase 2 study in dermatology (INM-755).
  • The INM-089 and INM-901 preclinical programs offer a differentiated treatment approach using proprietary, disease-modifying small molecules that target the CB1 and CB2 receptors, which management believes is a key strength of the Company.
  • Our management team believes that our combined manufacturing technologies provide us with a competitive advantage to utilize the most cost-efficient methodology (i.e. chemical synthesis, biosynthesis and IntegraSyn) for the development and commercialization of new Products and Product Candidates to a wide spectrum of market opportunities.
  • Early mover status as a B2B supplier of non-intoxicating rare cannabinoids to the health and wellness sector.
  • As demonstrated by the launch of several non-intoxicating rare cannabinoids into the health and wellness sector, the team at BayMedica has substantial expertise in the commercial manufacturing scale-up to produce rare cannabinoids at large scale as well as extensive sales and marketing expertise.
  • This know-how is important to establishing an early-mover status and to maintain cost leadership with regards to specific rare cannabinoids.
  • Diverse portfolio of patent applications covering a spectrum of commercial opportunities.
  • Success in pharmaceutical markets often rests with the strength of intellectual property, including patents, to protect our commercialization interests.
  • We have filed several patents on our novel findings and expect to continue to do so.
  • The acquisition of BayMedica brought several additional new patent families to bolster our manufacturing as well as drug development opportunities.
  • Examples of Current treatments in Neurodegenerative Diseases Brand Company Mechanism of Action Status Aducanumab (Aduhelm™) Biogen Anti-amyloid beta target both insoluble and soluble aggregates Approved June 2021, discontinued November 2024 Lecanemab (Leqembi ® ) Biogen/ Eisai Anti-amyloid beta, electively binds to large, soluble Aβ protofibrils Approved January 2023 Donanemab (Kisunla™) Eli Lilly Anti-amyloid beta, target pyroglutamated AB in plaques Approved July 2024 Gantenerumab Roche Anti-amyloid beta, target aggregated forms of AB including oligomers and plaques Phase 3 failed November 2022 Remternetug (LY3372993) Eli Lilly Anti-tau, O-GlcNAcase Inhibitor Phase 3 BIIB080 Biogen Anti-Tau, antisense oligonucleotide (ASO) Phase 2 Semorinemab Genentech Anti-tau Phase 2 Failed Currently approved medications for AD generally fall into two main categories.
  • Summary of INM-901 Iong-term 5xFAD study: ● Hippocampal RNA Expression - Several genes associated with inflammation, the endocannabinoid system, synaptic dysfunction and oxidative stress and apoptosis (cell death) were evaluated following treatment.
  • INM-901 Next Steps Research & Development ● Additional proof-of-concept (“PoC”) studies are planned to further elucidate the various effects of INM-901 in AD disease ● On-going Chemistry, Manufacturing and Controls (“CMC”) activities for drug substance and oral drug product ● On-going studies of receptor interactions (mechanism of action (“MoA”)) and Distribution/Metabolism/Pharmacokinetics (“DMPK”) ● Dose Ranging and other non-GLP studies, with GLP studies to follow ● Seeking business development partnerships Key Milestones ● November 3, 2021 — we announced the filing of an international patent application demonstrating neuroprotection and enhanced neuronal function using a rare cannabinoid for the potential treatment of neurodegenerative diseases such as Alzheimer’s Disease, Parkinson’s Disease, Huntington’s Disease and others.

and 127 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2025 ↗, FY2026 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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