VANCOUVER, British Columbia, Sept. 23, 2022 (GLOBE NEWSWIRE) — InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a pacesetter within the pharmaceutical analysis, growth and manufacturing of uncommon cannabinoids and cannabinoid analogs, at the moment reported monetary outcomes for the fiscal yr ended June 30, 2022.
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The Company’s full monetary statements and associated MD&A for the fiscal yr ended June 30, 2022, can be out there at www.inmedpharma.com and at www.sedar.com.
Eric A. Adams, InMed CEO, states, “In the final quarter of our fiscal 2022, as well as throughout the previous fiscal year, we have made important advancements in our pharmaceutical drug development programs, including expanding our Phase 2 clinical trial for the treatment of symptoms related to epidermolysis bullosa to include adolescents, and initiating a research collaboration agreement to further screen cannabinoid analogs for potential therapeutic uses. As announced on September 8, 2022, we have made the decision reduce the efforts of our subsidiary, BayMedica, to pursue commercialization of rare cannabinoids in the health & wellness sector. Moving forward, the Company is realigning its focus and resources towards advancing our pharmaceutical drug development programs with the aim of achieving important milestones in the coming quarters and year.”
Business Update
Pharmaceutical Development Programs
INM-755 for the remedy of Epidermolysis Bullosa (“EB”)
Enrollment and affected person remedy within the Company’s Phase 2 medical trial, 755-201-EB, continued all through the fourth quarter and, so far, 9 sufferers been enrolled and accomplished remedy within the examine. The 755-201-EB examine is designed to enroll as much as 20 sufferers. InMed is evaluating the protection of INM-755 (cannabinol) cream and its preliminary efficacy in treating signs and wound therapeutic over a 28-day remedy interval. This examine marks the primary time cannabinol (“CBN”) has superior to a Phase 2 medical trial to be investigated as a therapeutic choice to deal with a illness.
In the fiscal fourth quarter, primarily based on the protection knowledge of the primary 5 grownup sufferers who accomplished remedy with INM-755 CBN cream for the remedy of EB within the Phase 2 medical trial, an unbiased Data Monitoring Committee (“DMC”) agreed it’s secure to permit the enrollment of adolescent sufferers, outlined as individuals aged twelve to seventeen. The first adolescent affected person with EB has been enrolled into the medical trial and has accomplished remedy on the medical website in Greece throughout the summer season.
Following a interval of downtime throughout the summer season months, affected person screening and enrollment has now recommenced at websites throughout Europe. The Company anticipates that the inclusion of adolescents could have a constructive affect on the enrollment charge for the rest of the medical trial. Enrollment is anticipated to finish throughout the calendar yr 2022.
InMed’s Phase 2 medical trial now has 9 medical trial websites absolutely activated to display and enroll sufferers. Two extra websites are anticipated to be absolutely activated quickly. The medical trial is going down in seven nations together with Austria, Germany, Greece, France, Italy, Israel and Spain.
INM-088 for the remedy of glaucoma
In the fourth fiscal quarter, the Company accomplished a pre-Investigational New Drug (“pIND”) software dialogue with the U.S. Food and Drug Administration (“FDA”) concerning manufacturing, preclinical research and early medical growth plans for INM-088, a CBN formulation in growth for glaucoma. The Company gained alignment with FDA on the design of the preliminary Phase 1-2 medical trial to assemble preliminary knowledge on the protection and efficacy of INM-088 remedy. Management expects to file regulatory functions within the first half of the calendar yr 2024 to provoke a human medical trial.
As referenced in a current worldwide journal publication [Biochimica et Biophysical Acta (BBA) – Molecular Basis of Disease, Volume 1868, Issue 3, 1 March 2022, 166325], InMed’s preclinical analysis demonstrates that CBN is efficient at offering neuroprotection to the retinal ganglion cells and lowering intraocular stress in glaucoma fashions, and outperformed a number of different naturally occurring cannabinoids, together with tetrahydrocannabinol (“THC”).
New cannabinoid analogs and different R&D packages
Advancing the analysis and growth of cannabinoid analogs stays a excessive precedence for the Company. In April 2022, the Company introduced the publication of a patent software in North America for a number of cannabinoid analogs. This patent software, overlaying probably a whole bunch of latest chemical entities, has broad claims directed to their molecular construction, therapeutic makes use of and strategies of producing.
In addition, the Company additionally initiated a analysis collaboration settlement with the Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila (Italy) within the laboratory of Dr. Mauro Maccarrone. Dr. Maccarrone’s lab can be screening the Company’s novel cannabinoid analogs to research pharmacological properties and potential therapeutic makes use of.
In April, BayMedica introduced it is going to be offering uncommon cannabinoids to be used in Radicle Science, Inc.’s Radicle Energy uncommon cannabinoid examine to evaluate the consequences of delta-9 (“d-9”) dominant tetrahydrocannabivarin (“THCV”) on power, focus/consideration, urge for food and weight/BMI. BayMedica is supplying its extremely pure d-9 dominant THCV, formulated right into a proprietary lozenge manufactured by Trokie. The Study has been ongoing all through the summer season and outcomes are anticipated in October 2022.
The Company continues to advance discovery work for the potential use of cannabinoid analogs to enhance neuronal perform and supply neuroprotection for treating neurodegenerative issues akin to Alzheimer’s illness, Parkinson’s illness and Huntington’s illness. To date, screening for this indication has yielded fascinating analog candidates and the Company will proceed to proceed with its plan to search out an acceptable compound for a preclinical growth program.
BayMedica business actions
As beforehand introduced on September 8, 2022, the Company can be lowering its deal with the BayMedica business business focused to the well being & wellness sector. BayMedica will proceed to discover potential alternatives for structured provide agreements, business collaborations and evaluate different strategic options for the business facet of its business. The analysis and growth actions centered on the technology of proprietary cannabinoid analogs to assist the Company’s pharmaceutical drug growth packages will proceed at BayMedica.
Corporate
Subsequent to fiscal yr finish, Michael Woudenberg was appointed Chief Operating Officer of the Company, overseeing all day-to-day operations. Mr. Woudenberg was beforehand Senior Vice President of Chemistry, Manufacturing and Controls and has been an integral a part of the manager workforce for the final 4 years, supporting a number of capabilities inside the group.
In the second half of fiscal 2022 and throughout the subsequent months, InMed and its BayMedica subsidiary carried out vital value saving measures, together with some personnel adjustments. These initiatives included a discount in whole headcount and voluntary wage reductions for a number of members of administration. These adjustments have resulted in a discount by roughly 25% of the present workforce. This discount in headcount, together with different value discount initiatives, is predicted to lead to human useful resource expense financial savings of roughly 30% on an annualized foundation. As a part of these reductions, InMed President and CEO Eric A. Adams volunteered a 28% discount in wage as in comparison with the earlier yr. Also, as a part of these expense discount initiatives, no worker obtained an annual efficiency bonus for fiscal yr 2022.
Along with ongoing value saving initiatives, within the fourth quarter and subsequent months, the Company efficiently performed a sequence of financing occasions to additional capitalize the Company and its ongoing growth packages. In June 2022, the Company closed a registered direct providing and concurrent personal placement for whole proceeds of roughly $5 million. In August 2022, the Company introduced a share consolidation of 1:25 with the intention to regain compliance with Nasdaq’s continued itemizing necessities and subsequently obtained notification of compliance on September 21, 2022 from the change. Most just lately, on September 13, 2022, the Company closed an extra $6 million personal placement with two healthcare-focused institutional traders.
Financial and Operational Highlights:
For the yr ended June 30, 2022, the Company recorded a web lack of $18.6 million, or $33.17 per share, in contrast with a web lack of $10.2 million or $37.96 per share, for the earlier yr.
Research and growth and patents bills have been $7.3 million for yr ended June 30, 2022, in contrast with $5.3 million for the yr ended June 30, 2021. The enhance in analysis and growth and patents bills was as a result of inclusion of BayMedica working outcomes following the acquisition date and as a consequence of elevated actions associated to the INM-755 Phase 2 medical trial.
The Company incurred basic and administrative bills of $6.9 million for the yr ended June 30, 2022, representing a 54% enhance on the earlier yr. The enhance is as a result of inclusion of BayMedica working outcomes following the acquisition date, a mixture of adjustments together with investor relations bills, accounting charges and authorized charges and considerably greater insurance charges ensuing from our itemizing on the Nasdaq capital market.
The Company realized gross sales of $1.1 million in our BayMedica section for the yr ended June 30, 2022, the results of the manufacturing and sale of bulk uncommon cannabinoid merchandise following the acquisition of BayMedica in October 2021. As the yr ended June 30, 2021 predated the acquisition of BayMedica, there aren’t any comparable revenues in 2021.
As of June 30, 2022, the Company’s money, money equivalents and short-term investments have been $6.2 million. Subsequent to the current financing on September 13, 2022, the Company has a present money place of roughly $10 million. Based on the present forecast, which is topic to potential revisions sooner or later, the Company’s present money reserves are estimated to final into the second half of fiscal 2023, and presumably into the primary quarter of fiscal 2024, (being the third calendar quarter of 2023), relying on the extent and timing of realizing revenues from the sale of BayMedica stock in addition to the extent and timing of the Company working bills.
As a results of the choice to refocus on its core business within the pharmaceutical drug growth space and scale back efforts in BayMedica’s business business, the Company incurred a non- money impairment of intangible property and goodwill of $3.5 million within the BayMedica section for the yr ended June 30, 2022.
Outlook
As the Company enters fiscal 2023, administration could be very inspired by the energy of its pharmaceutical packages, with a number of materials milestones anticipated within the coming quarters. Completing enrollment and concluding the Phase 2 medical trial in EB can be an vital milestone for InMed and, if these outcomes are constructive, could assist potential partnerships for the subsequent growth phases of this system. The Company additionally appears ahead to finishing the remaining preclinical work on the glaucoma program with the objective of transferring into human trials in 2024. Importantly, advancing to human trials in a illness indication with a really massive affected person inhabitants like glaucoma can be a major growth for the Company. Management appears ahead to updating traders over the approaching months.
Table 1: Consolidated Balance Sheets:
| InMed Pharmaceuticals Inc. | ||||
| CONSOLIDATED BALANCE SHEETS | ||||
| As at June 30, 2022 and 2021 | ||||
| Expressed in U.S. Dollars | ||||
| June 30, | June 30, | |||
| 2022 | 2021 | |||
| ASSETS | $ | $ | ||
| Current | ||||
| Cash and money equivalents | 6,176,866 | 7,363,126 | ||
| Short-term investments | 44,804 | 46,462 | ||
| Accounts receivable | 88,027 | 11,919 | ||
| Inventories | 2,490,854 | – | ||
| Prepaids and different property | 797,225 | 956,762 | ||
| Total present property | 9,597,776 | 8,378,269 | ||
| Non-Current | ||||
| Property, gear and ROU property, web | 904,252 | 326,595 | ||
| Intangible property, web | 2,108,915 | 1,061,697 | ||
| Other property | 176,637 | 14,655 | ||
| Total Assets | 12,787,580 | 9,781,216 | ||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||
| Current | ||||
| Accounts payable and accrued liabilities | 2,415,265 | 2,134,878 | ||
| Current portion of lease obligations | 404,276 | 80,483 | ||
| Acquisition consideration payable | 500,000 | – | ||
| Total present liabilities | 3,319,541 | 2,215,361 | ||
| Non-current | ||||
| Lease obligations | 389,498 | 189,288 | ||
| Total Liabilities | 3,709,039 | 2,404,649 | ||
| Shareholders’ Equity | ||||
| Common shares, no par worth, limitless approved shares: | ||||
| 650,667 (June 30, 2021 – 322,028) issued and excellent | 70,718,461 | 60,587,417 | ||
| Additional paid-in capital | 31,684,098 | 21,513,051 | ||
| Accumulated deficit | (93,452,587 | ) | (74,852,470 | ) |
| Accumulated different complete revenue | 128,569 | 128,569 | ||
| Total Shareholders’ Equity | 9,078,541 | 7,376,567 | ||
| Total Liabilities and Shareholders’ Equity | 12,787,580 | 9,781,216 | ||
| Table 2: Consolidated Statements of Operations and Comprehensive Loss: | ||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||
| For the yr ended June 30, 2022 and 2021 | ||||
| Expressed in U.S. Dollars | ||||
| Year Ended | ||||
| June 30 | ||||
| 2022 | 2021 | |||
| $ | $ | |||
| Sales | 1,089,435 | – | ||
| Cost of gross sales | 545,889 | – | ||
| Gross revenue | 543,546 | – | ||
| Operating Expenses | ||||
| Research and growth and patents | 7,282,615 | 5,338,084 | ||
| General and administrative | 6,867,030 | 4,479,333 | ||
| Amortization and depreciation | 185,657 | 120,866 | ||
| Impairment of intangible property and goodwill | 3,472,593 | – | ||
| Total working bills | 17,807,895 | 9,938,283 | ||
| Other Income (Expense) | ||||
| Interest and different revenue | 96,090 | 16,017 | ||
| Finance expense | – | (360,350 | ) | |
| Unrealized acquire on by-product warrants legal responsibility | – | 242,628 | ||
| Warrant modification expense | (1,314,307 | ) | – | |
| Foreign change loss | (117,551 | ) | (163,101 | ) |
| Net loss for the yr | (18,600,117 | ) | (10,203,089 | ) |
| Other Comprehensive Gain | ||||
| Foreign foreign money translation acquire | – | 430,443 | ||
| Total complete loss for the yr | (18,600,117 | ) | (9,772,646 | ) |
| Net loss per share for the yr | ||||
| Basic and diluted | (33.17 | ) | (37.96 | ) |
| Weighted common excellent widespread shares | ||||
| Basic and diluted | 560,829 | 268,793 | ||
| Table 3: Consolidated Statements of Cash Flows: | ||||
| InMed Pharmaceuticals Inc. | ||||
| CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||
| For the years ended June 30, 2022 and 2021 | ||||
| Expressed in U.S. Dollars | ||||
| 2022 | 2021 | |||
| Cash supplied by (utilized in): | $ | $ | ||
| Operating Activities | ||||
| Net loss for the interval | (18,600,117 | ) | (10,203,089 | ) |
| Items not requiring money: | ||||
| Amortization and depreciation | 185,657 | 120,866 | ||
| Share-based compensation | 697,894 | 610,193 | ||
| Shares issued for providers | 79,879 | – | ||
| Amortization of right-of-use property | 326,133 | 107,828 | ||
| Loss on disposal of property | 11,355 | 555 | ||
| Interest revenue obtained on short-term investments | (115 | ) | 131 | |
| Unrealized acquire on by-product warrants legal responsibility | – | (242,628 | ) | |
| Unrealized international change loss | 1,770 | (445 | ) | |
| Impairment of intangible property and goodwill | 3,472,593 | – | ||
| Payments on lease obligations | (341,862 | ) | (93,951 | ) |
| Finance expense | – | 360,350 | ||
| Warrant modification expense | 1,314,307 | – | ||
| Changes in non-cash working capital: | ||||
| Inventories | (2,003,732 | ) | – | |
| Prepaids and different property | 190,661 | (823,172 | ) | |
| Other non-current property | (61,432 | ) | (14,161 | ) |
| Accounts receivable | (40,008 | ) | 40,198 | |
| Accounts payable and accrued liabilities | (811,599 | ) | 346,685 | |
| Deferred income | (5,142 | ) | – | |
| Total money utilized in working actions | (15,583,758 | ) | (9,790,640 | ) |
| Investing Activities | ||||
| Cash acquired from acqusition of BayMedica | 91,566 | – | ||
| Acquisition consideration payable | (300,457 | ) | – | |
| Purchase of property and gear | (39,108 | ) | (1,725 | ) |
| Loan receivable | (425,000 | ) | – | |
| Total money utilized in investing actions | (672,999 | ) | (1,725 | ) |
| Financing Activities | ||||
| Shares issued for money | 17,146,114 | 12,472,500 | ||
| Share issuance prices | (1,784,791 | ) | (1,617,778 | ) |
| Repayment of debt | (290,826 | ) | – | |
| Total money supplied by financing actions | 15,070,497 | 10,854,722 | ||
| Effects of international change on money and money equivalents | – | 494,960 | ||
| Increase (lower) in money throughout the interval | (1,186,260 | ) | 1,557,317 | |
| Cash and money equivalents starting of the interval | 7,363,126 | 5,805,809 | ||
| Cash and money equivalents finish of the interval | 6,176,866 | 7,363,126 | ||
About InMed: InMed Pharmaceuticals is a world chief within the pharmaceutical analysis, growth and manufacturing of uncommon cannabinoids and cannabinoid analogs, together with medical and preclinical packages focusing on the remedy of ailments with excessive unmet medical wants. We even have vital know-how in creating proprietary manufacturing approaches to supply cannabinoids for numerous market sectors. For extra info, go to www.inmedpharma.com and www.baymedica.com.
Investor Contact:
Colin Clancy
Vice President, Investor Relations
T: +1.604.416.0999
E: [email protected]
Cautionary Note Regarding Forward-Looking Information:
This information launch comprises “forward-looking information” and “forward-looking statements” (collectively, “forward-looking information”) inside the that means of relevant securities legal guidelines. Forward-looking info is predicated on administration’s present expectations and beliefs and is topic to numerous dangers and uncertainties that might trigger precise outcomes to vary materially from these described within the forward-looking statements. Forward-looking info on this information launch contains statements about: initiating a analysis collaboration settlement to additional display cannabinoid analogs for potential therapeutic makes use of: realigning its focus and sources in direction of advancing its pharmaceutical drug growth packages with the intention of reaching vital milestones within the coming quarters and yr; evaluating the protection of INM-755 (cannabinol) cream and its preliminary efficacy in treating signs and wound therapeutic over a 28-day remedy interval; anticipating that the inclusion of adolescents could have a constructive affect on the enrollment charge for the rest of the medical trial; enrollment is anticipated to finish throughout the calendar yr 2022; expectation for 2 extra websites to be absolutely activated quickly; anticipating to file regulatory functions within the first half of the calendar yr 2024 to provoke a human medical trial; advancing the analysis and growth of cannabinoid analogs stays a excessive precedence for the Company; the analog patent software, probably overlaying a whole bunch of latest chemical entities, having broad claims directed to their molecular construction, therapeutic makes use of and strategies of producing; the screening the Company’s novel cannabinoid analogs to research pharmacological properties and potential therapeutic makes use of; advancing discovery work for the potential use of cannabinoid analogs to enhance neuronal perform and supply neuroprotection for treating neurodegenerative issues; persevering with to proceed with our plan to search out an acceptable compound for a preclinical growth program; persevering with to discover potential alternatives for structured provide agreements, business collaborations and evaluate different strategic options for the business facet of its business; persevering with analysis and growth actions centered on the technology of proprietary cannabinoid analogs to assist the Company’s pharmaceutical drug growth packages; implementing vital value saving measures in an effort to streamline operations; discount in headcount, together with different value discount initiatives, is predicted to lead to human useful resource value financial savings of roughly 30% on an annualized foundation; present forecast, which is topic to potential revisions sooner or later, the Company’s present money reserves are estimated to final into the second half of fiscal 2023, and presumably into the primary quarter of fiscal 2024; being inspired by the energy of its pharmaceutical packages, with a number of materials milestones anticipated within the coming quarters; the potential for partnerships for the subsequent growth phases of the EB program if Phase 2 outcomes are constructive.
With respect to the forward-looking info contained on this information launch, InMed has made quite a few assumptions. While InMed considers these assumptions to be affordable, these assumptions are inherently topic to vital business, financial, aggressive, market and social uncertainties and contingencies.
Additionally, there are identified and unknown danger elements which might trigger InMed’s precise outcomes, efficiency or achievements to be materially completely different from any future outcomes, efficiency or achievements expressed or implied by the forward-looking info contained herein. A whole dialogue of the dangers and uncertainties dealing with InMed’s stand-alone business is disclosed in InMed’s Annual Report on Form 10-Okay and different filings with the Securities and Exchange Commission on www.sec.gov.
All forward-looking info herein is certified in its entirety by this cautionary assertion, and InMed disclaims any obligation to revise or replace any such forward-looking info or to publicly announce the results of any revisions to any of the forward-looking info contained herein to replicate future outcomes, occasions or developments, besides as required by legislation.
