InMed Pharmaceuticals Reports Full Year Fiscal 2022

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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.

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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.

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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  
     
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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: cclancy@inmedpharma.com

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.



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