SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 28, 2021
INMED PHARMACEUTICALS INC.
(Exact Name of Company as Specified in Charter)
(State or Other Jurisdiction
(Commission File Number)
InMed Pharmaceuticals Inc.
Suite 310 - 815 W. Hastings Street,
|(Address of Principal Executive Offices)||(Zip Code)|
Company’s telephone number, including area code: (604) 669-7207
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
|☐||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|☐||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|☐||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|☐||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||
|Name of each exchange|
on which registered
|Common Shares, no par value||INM||The Nasdaq Stock Market LLC|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure.
On April 28, 2021, representatives of the Company will be making a presentation using slides containing the information attached to this Current Report on Form 8-K as Exhibit 99.1 (the “Corporate Presentation”) and incorporated herein by reference. The Company expects to use the Corporate Presentation, in whole or in part, and possibly with modifications, in connection with presentations to investors, analysts and others. A copy of the Corporate Presentation will be available on the “Investors” section of the Company’s website at www.inmedpharma.com although we reserve the right to discontinue that availability at any time.
By filing this Current Report on Form 8-K and furnishing the information contained herein, the Company makes no admission as to the materiality of any information in this report that is required to be disclosed solely by reason of Regulation FD.
The information contained in the Corporate Presentation is summary information that is intended to be considered in the context of the Company's Securities and Exchange Commission (“SEC”) filings and other public announcements that the Company may make, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is warranted. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.
The information set forth in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information set forth in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
|Item||9.01. Financial Statements and Exhibits.|
The following exhibits shall be deemed to be furnished, and not filed:
|99.1||Corporate Presentation utilized April 28, 2021.|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|INMED PHARMACEUTICALS INC.|
|Date: April 28, 2021||By:|
/s/ Bruce Colwill
Chief Financial Officer
U N L O C K I N G T H E P O T E N T I A L O F C A N N A B I N O I D M E D I C I N E S Company Webinar April 2021 :IN :I NM *common shares to be delisted from the TSX on or about May 7, 2021 www.inmedpharma.com
Forward Looking Statements This presentation contains forward - looking statements and forward - looking information within the meaning of applicable securities laws (collectively, “forward - looking statements”) including, among others, statements concerning: unlocking the full potential of cannabinoid pharmaceuticals; anticipated clinical development activities, timelines, catalysts, and milestones; the potential benefits of product candidates; anticipated revenue and market opportunities; and the continued availability of key personnel. All statements other than statements of historical fact are statements that could be deemed forward - looking statements. With respect to the forward - looking information contained in this presentation, the Company has made numerous assumptions regarding, among other things: continued and timely positive preclinical and clinical efficacy data; the speed of regulatory approvals; demand for the Company’s products; continued availability of key personnel; continued access to sufficient capital to fund operations; and continued economic and market stability. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from those described in the forward - looking statements. These risks and uncertainties include, among others: the possibility that clinical trials will not be successful, or be completed, or confirm earlier clinical trial results; risks associated with obtaining funding from third parties; risks related to the timing and costs of clinical trials; key personnel may become unable to serve the Company; the need for receipt of regulatory approvals; and economic and market conditions may worsen. Readers are cautioned that the foregoing list is not exhaustive. A more complete discussion of the risks and uncertainties facing the Company appears in the Company’s filings with the Securities and Exchange Commission and in the Company’s annual information form dated September 23, 2020, a copy of which is available on SEDAR at www.sedar.com. The Company undertakes no obligation to update the forward - looking statements contained herein or to reflect events or circumstances occurring after the date hereof, except as required by law. 2
3 Er i c A . A dam s, MIB S Chief Executive Officer Br u ce S. Co l w ill, C P A , CA Chief Financial Officer 30+ years of experience in global biopharma leadership: business development, sales, marketing, a n d M & A w it h e n G e n e, Q L T , A bb o t t , F r e s e n i u s 25+ years of financial leadership with private and public companies; executing IPO, equity and debt financings G e n e r a l F u s io n , E n t r é e R e so u r c e s, N e u r ome d P ha r ma Today’s Presenters
A Differentiated Cannabinoid Pharmaceutical Company Focused on the Therapeutic Application of Cannabinoids for the Treatment of Diseases with High Unmet Medical Needs Researching the therapeutic potential of rare cannabinoids beginning with cannabinol ( CBN ) Selecting innovative, topically applied cannabinoid therapies where we can establish a proprietary foothold in treating diseases with high unmet medical needs, starting with dermatology and ocular diseases Developing IntegraSyn - a flexible, integrated cannabinoid manufacturing system using novel proprietary enzyme(s) to efficiently produce bio - identical, economical, pharmaceutical - grade cannabinoids 4
Wide Range of Medicinal Properties - Primarily based on non - clinical research CBC, CBD, CBDa , CBG, CBN, THC, THCa Inflammation Arthritis CBC, CBD, CBN, THC, THCv Pain CBC, CBD, CBN, THC Insomnia CBD, CBN, THC Fibromyalgia CBD, THC Spinal injury Phantom limb Migraine/headache Cramps THC Sleep apnea THC Tourette’s CBD, CBN, THCa , THCv Epilepsy Seizures CBD, CBN, THC, THCa Multiple Sclerosis CBC, CBD, CBG, CBGa , THC, THCa Alzheimer’s Parkinson’s CBD, CBG, CBN, THC, THCa Spasticity CBC, CBD, CBG, CBN, THCv Osteoporosis CBC, CBD, CBG, CBN, THCa ALS THC Appetite loss CBD, THC Anorexia Cachexia Gastrointestinal disorders Nausea CBD, THCv Diabetes CBD, THC, THCv Crohn’s CBC, CBD, CBG, THC, THCa Cancer symptoms CBD, THC Hypertension THC Fatigue Asthma CBN Glaucoma, ocular disease EB & other dermatology CBD, CBG Anxiety CBD, THC ADD/ADHAD Stress CBD, THC, THCv Bipolar OCD PTSD CBC, CBD, CBN, THC Depression PAIN/SLEEP NEUROLOGICAL GASTRO - INTESTINAL MOOD/BEHAVIOUR OTHER >$8B TAM >$510M in CBD Sales for GW
6 Note: lists are not exhaustive Tapping into the Potential of Rare Cannabinoids 100+ Rare Cannabinoids 2 – 20% <1% Major Cannabinoids THC CBD • Epilepsy • Anxiety • Stress Disorder • Pain • Inflammation • Nausea • Stress Disorder • Sleep Apnea CBG, CBGA, CBGV, CBGVA, THC, THCA, THCVA, CBC, CBCV, CBCVA, CBD, CBDA, CBC, CBCA, CBN, CBNA… • The 100+ rare cannabinoids occur in extremely low amounts in the cannabis plant • The cost of isolating sufficient quantities of these cannabinoids in order to conduct research can be prohibitive
Progress with IntegraSyn Ρ 7
8 Limitations of Traditional Cannabinoid Production Approaches Bioburden/stress on microbe may limit final yields May not produce bio - identical cannabinoid depending on cannabinoid complexity BIOSYNTHESIS CHEMICAL SYNTHESIS EXTRACTION Access to rare cannabinoids prohibitively expensive
9 IntegraSyn Ρ is InMed’s integrative cannabinoid manufacturing approach IntegraSyn Ρ : Biosynthesis Evolved Minimizes bioburden on fermentation microbe Flexibility to shift from production of one cannabinoid to a range of cannabinoids Optimized steps to produce high - yield, pharma - grade cannabinoids at commercial scale Transferable technology to facilitate scale - up, manufacturing and supply Commonly available and cost - efficient starting materials • Enzymes developed for the IntegraSyn Ρ approach can be implemented across all manufacturing approaches • Multiple enzymes may be required depending on the target cannabinoid
10 IntegraSyn Ρ Achieves 2 g/L Cannabinoid Yield 2021 • Achieved 2g/L cannabinoid yield with IntegraSyn Ρ • Signals commercial viability and supports large - scale production • Yields higher than current industry standards • Lowered overall manufacturing costs through process optimization • Enables a cost - effective solution to cannabinoid production
2021 Targeting Pharmaceutical Quality Cannabinoids More about GMP manufacturing types in the Learn section of our website.
12 GMP – Good Manufacturing Practices IntegraSyn TM : High - level Time & Event Schedule 2021 Achieve 2g/L cannabinoid yield, signaling commercial viability Continue to identify potential partnerships for IntegraSyn TM with commercial cannabinoid manufacturers Optimize pathways for production of additional cannabinoids Demonstrate end - to - end process integration and GMP - readiness Produce batch with target output of 1kg of selected cannabinoid via GMP - ready process Completed In - progress
INM - 755 for Epidermolysis Bullosa (EB) 11
Epidermolysis Bullosa (EB) 14 • Epidermolysis bullosa (EB) is a group of rare genetic skin diseases characterized by fragile skin that blisters easily from minimal friction that causes shearing of the skin layers. • The most common form is EB Simplex (EBS), ~55% of all EB patients. • The affected population is estimated to be between 12,500 and 25,000 in the United States. • No therapies approved specifically for the treatment of EB wounds and other symptoms. • INM - 755 is being developed for symptomatic relief in all EB patients and may have further utility in enhancing skin integrity in subset of EBS patients. Photograph of Dystrophic EB
Clinical Trial Applications Filed in Multiple Countries for Phase 2 in EB 2021 • CTA filings submitted in Austria, Israel, and Serbia for a Phase 2 Clinical Trial with INM - 755 cream • Additional submissions slated for France, Germany, Greece, and Italy during the next several weeks. • Anticipated study on track to begin in 3Q 2021 CTA filings to National Competent Authorities serve the same purpose as filing INDs to the U.S. FDA.
INM - 755: High - Level Time/Event Schedule 16 2021 Report results from 755 - 102 - HV Finalize and file regulatory submissions (CTAs) for 755 - 201 - EB trial Finalize manufacturing methods and process to support 755 - 201 - EB Produce clinical trial supplies Initiate 755 - 201 - EB trial in multiple European jurisdictions Conduct KOL meetings and initial data screening to support 2 nd indication for INM - 755 Completed In - progress
INM - 088 for Glaucoma 14
Potential Roles for CBN in Glaucoma • Direct neuroprotection for the retina and optic nerve, independent of intraocular pressure (IOP) reduction • Reduce IOP in the affected eyes via increased fluid drainage Target Effects of CBN Build Up of Aqueous Humor Fluid Optic N e r v e Pressure R e t in a Several cannabinoids demonstrate increased drainage, leading to reduced IOP 18 InMed data suggest CBN is the cannabinoid of choice for neuroprotection in the eye
19 INM - 088: High - Level Time/Event Schedule Engage leading ocular clinical research organization to develop clinical game plan Scale - up INM - 088 drug product (CBN+MiDROPS®) Publish key CBN data in peer - reviewed journal Conduct non - GLP dose ranging studies Complete pre - IND package and FDA Pre - IND Meeting (if needed) Initiate toxicology studies (2021 - 22) in preparation for clinical trials 2021 Completed In - progress
Nature of Relationship InMed will explore the therapeutic potential in neuroprotection of specific cannabinoid analog compounds chosen from BayMedica’s library. BayMedica will assess the potential of InMed’s high - efficiency enzymes for the production of cannabinoids in its manufacturing technologies. The licensing agreement with EyeCRO grants InMed an exclusive, worldwide license to develop and commercialize prospective therapeutic formulations combining MiDROPS ® . InMed and Almac have been engaged in optimizing the upstream cannabinoid assembly processes as well as downstream purification to achieve cost efficient, GMP - grade active pharmaceutical ingredients for prescription - based medications. InMed completed its collaborat ion with NRC - IRAP and continues to further develop the E. coli biofermentation and scale - up processes with UBC . Business Development: Collaborations and Licensing Note: List is not exhaustive 20
21 Key Accomplishments and Goals Highlights from 2020 Key Goals for 2021 INM - 755 in Dermatology Completed 2 Phase 1 human clinical trials (normal and wounded skin) Initiate and begin enrollment of EB patients in Ph 2 trial INM - 088 in Ocular Disease Completed in vivo PoC , formulation/ delivery studies; Licensed MiDROPS ® delivery technology; filed PCT patent Scaling - up manufacturing for drug product; conduct dose ranging and IND - enabling toxicology in preparation for IND filing in 1H22 IntegraSyn TM for Cannabinoid Manufacturing Improved yields and process; filed multiple patents; initiated BayMedica collaboration Identify partnerships for licensing opportunities; demonstrate GMP readiness; Complete 1kg batch production. Administration US$8M IPO and Nasdaq listing (“INM”) US$4.5M Private Placement in February TSX voluntary delisting
Q&A Session Eric A. Adams Chief Executive Officer firstname.lastname@example.org +1 - 604 - 669 - 7207 Bruce S. Colwill Chief Financial Officer email@example.com +1 - 604 - 669 - 7207 :IN :I NM *common shares to be delisted from the TSX on or about May 7, 2021 www.inmedpharma.com Edison Grou p Joseph Green firstname.lastname@example.org Laine Yonker email@example.com