'The second fiscal quarter of 2020 saw InMed establish a leadership position in the clinical development of rare cannabinoids with the initiation of Phase 1 trials with INM-755 in healthy subjects,' stated President and Chief Executive Officer,
Research & Development Update: Biosynthesis manufacturing technology. During 2Q20, we continued to advance our biosynthesis methodology for efficient cannabinoid production at scale and suitable for pharmaceutical applications. Hiring leading contract development manufacturing organizations (CDMOs), we have identified several prospective pathways that may lead to even more attractive methods for the production of rare cannabinoids.
INM-755 for the treatment of the epidermolysis bullosa (EB). On
INM-088 for the treatment of glaucoma. Preclinical pharmacology testing and formulation optimization for INM-088 are ongoing with InMed continuing to anticipate selecting its final formulation and commencing advanced in vivo studies in this fiscal quarter. Subject to the results of those studies, InMed expects to commence IND-enabling preclinical toxicology studies commencing in the second half of calendar 2020.
Results of Operations (expressed in Canadian Dollars):
For the three and six months ended
Research and development expenses were
The Company incurred general and administrative expenses of
The Company also incurred non-cash, share-based payments, in connection with the grant of stock options, of
The Company's financial results for the six months ending
At
At
The Company's full financial statements and related MD&A for the three and six months ended
About InMed:
About Cannabinol (CBN): CBN is a rare cannabinoid with unique physiological properties that may result in distinct therapeutic and safety characteristics relative to the more commonly known cannabinoids tetrahydrocannabinol (THC) and cannabidiol (CBD).
About INM-755
INM-755 is a CBN cream intended as a topical therapy to treat epidermolysis bullosa (EB) and potentially other dermatological diseases. Preclinical data demonstrate that INM-755 may help relieve hallmark EB symptoms, such as inflammation and pain, as well potentially restore the integrity of the skin in a subset of EB Simplex patients.
About Epidermolysis Bullosa (EB): EB is the collective name of a group of genetic disorders of connective tissues affecting individuals from birth and is characterized by fragile skin that is easily damaged, leading to extensive blistering and wounding. The blisters may appear in response to minor injury, even from heat, rubbing, scratching or adhesive tape. The disease has no definitive cure and all currently used treatments are directed towards symptomatic relief.
About INM-088
InMed is developing INM-088 as a CBN eye drop formulation targeting reduction of the intraocular pressure associated with glaucoma as well as being designed to serve as a neuroprotectant to the retinal ganglion cells.
About Glaucoma
Glaucoma is a group of eye conditions characterized by abnormally high pressure in the eye, which can damage the membranes of the retina and the head of the optic nerve, leading to blindness. Glaucoma is the second leading cause of blindness worldwide and can occur at any age but is more common in older adults.
Cautionary Note Regarding Forward-Looking Information:
This news release contains 'forward-looking information' and 'forward-looking statements' (collectively, 'forward-looking information') within the meaning of applicable securities laws. Forward-looking information is based on management's current expectations and beliefs and is subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Forward-looking information in this news release includes statements about: establishing a leadership position in the clinical development of rare cannabinoids; optimizing biosynthesis-based methods at scale for producing cannabinoids at lower cost, higher yield and at pharmaceutical-grade purity; developing even more attractive methods for the production of rare cannabinoids; achieving full enrollment in the 755-101-HV Phase 1 clinical trial of INM-755 in the first quarter of calendar 2020; filing a CTA for a second Phase 1 trial, 755-102-HV, in the current calendar quarter with trial initiation in the second calendar quarter of 2020; selecting our final formulation for INM-088 and commencing advanced in vivo studies in this fiscal quarter; commencing IND-enabling preclinical toxicology studies commencing in the second half of calendar 2020; developing a pipeline of cannabinoid-based medications in diseases with high unmet medical need; delivering new therapeutic alternatives to patients that may benefit from cannabinoid-based medicines; being able to develop CBN based products with distinct therapeutic and safety characteristics; IMN-755 being able to potentially relieve EB symptoms, such as inflammation and pain, as well potentially restore the integrity of the skin in a subset of EB Simplex patients and developing INM-088 as a CBN eye drop formulation to potentially reduce intraocular pressure associated with glaucoma as well as potentially providing neuroprotection. With respect to the forward-looking information contained in this news release, InMed has made numerous assumptions regarding, among other things: continued and timely positive preclinical and clinical efficacy data; the speed of regulatory approvals; the ability to contract with suitable partners; demand for InMed's products and continued economic and market stability. While InMed considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies. Additionally, there are known and unknown risk factors which could cause InMed's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained herein. Known risk factors include, among others: preclinical and clinical testing may not produce the desired results on a timely basis, or at all; regulatory applications may not be approved on a timely basis, or at all; cannabis licensing/importing issues may delay our projected development timelines; suitable partners may not be located; economic or market conditions may worsen; our existing cash runway may not allow us to complete our forthcoming significant milestones; the development of a proprietary biosynthesis manufacturing technology for the production of pharmaceutical-grade cannabinoids as well as a pipeline of medications targeting diseases with high unmet medical need may not be as successful as desired, if at all. A more complete discussion of the risks and uncertainties facing InMed is disclosed in InMed's most recent Annual Information Form and other continuous disclosure filed with Canadian securities regulatory authorities on SEDAR at www.sedar.com.
All forward-looking information herein is qualified in its entirety by this cautionary statement, and InMed disclaims any obligation to revise or update any such forward-looking information or to publicly announce the result of any revisions to any of the forward-looking information contained herein to reflect future results, events or developments, except as required by law.
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