InMed Pharmaceuticals Reports Fourth Quarter and Full Year Fiscal 2019 Financial Results and Provides R&D and Business Update

TSX:IN
OTCQX:IMLFF

VANCOUVER, Sept. 19, 2019 /PRNewswire/ - InMed Pharmaceuticals Inc. ("InMed" or the "Company") (TSX:IN; OTCQX:IMLFF), a biopharmaceutical company developing 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 needs, today reported financial results for the three and twelve months ended June 30, 2019, which is the Company's fourth quarter of fiscal year 2019 ("4Q19").

Conference Call & Webcast:

Replays, Available through September 26, 2019:

The Company's full financial statements and related MD&A for the three and twelve months ended June 30, 2019 will be available at www.sedar.com on September 19, 2019.

"During the fourth quarter of fiscal 2019, InMed made significant strides in both its R&D and business strategy," stated President and Chief Executive Officer, Eric A. Adams. "The advancements in each of our biosynthesis, EB and glaucoma programs is evidence of not only significant progress in the development programs but also the strength of the InMed team.   Over the course of this next fiscal year," Mr. Adams concluded, "we will be focused on continuing to advance all three of these key programs while also looking to expand our profile in the investment community." 

Research & Development Update:

• Biosynthesis manufacturing technology. During 4Q19, we optimized several fermentation parameters (the Up Stream Process, or "USP") in order to maximize production yield, as well as initiated Down Stream Purification ("DSP") with a contract development manufacturing organization ("CDMO"). The Company worked with multiple external pharmaceutical CDMOs to concurrently conduct process development for both the USP and DSP. By the end of calendar 2019, the Company expects to have a clear indication as to the commercial yield and cost structure of its current biosynthesis process. Through ongoing R&D efforts, the Company is also exploring an alternative biosynthetic manufacturing process in addition to our existing 'traditional' E. coli biosynthesis process.
  
  
• INM-755 for the treatment of the epidermolysis bullosa (EB). As announced prior to 4Q19, the Company determined that the clinical development path forward with our investigational drug candidate for the treatment of EB, previously referred to as INM-750, would be optimized by transitioning to an alternative formulation, now designated as INM-755. During 4Q19 the Company continued to advance our preclinical pharmacology and toxicology studies in anticipation of our Clinical Trial Application and subsequent initiation of our first-in-man clinical trial prior to the end of this calendar year. The Company plans to execute these healthy volunteer trials in the Netherlands.
  
  
• INM-088 for Glaucoma. During 4Q19 the Company switched to a new drug candidate for the ocular program, now called INM-088 (formerly INM-085). This single cannabinoid product proved to confer specific advantages over our previous candidate, INM-085, in terms of in vitro results for the potential to treat glaucoma as well as other diseases of the eye. The Company anticipates being in advanced preclinical studies and formulation development prior to the end of the calendar year.

 Results of Operations (expressed in Canadian Dollars):

• For the three and twelve months ended June 30, 2019, the Company recorded a net loss of $4.27 million and $13.26 million, or $0.02 and $0.08 per share, respectively, compared with a net loss of $3.03 million and $8.52 million, or $0.02 and $0.06 per share, for the three and twelve months ended June 30, 2018.
  
  
• Research and development expenses were $2.45 million for 4Q19, compared with $0.58 million for the three months ended June 30, 2018. For the twelve months ended June 30, 2019, research and development expenses totaled $5.64 million, which compares with $1.93 million for the prior year fiscal 2018. The increase in research and development expenses in 4Q19 as compared to the same quarter in 2018 was primarily due to increased spending on INM-755 for clinical trial enabling preclinical safety pharmacology and toxicology studies, required for the regulatory filing to begin human clinical trials which we plan to initiate later this calendar year. In addition, we incurred higher costs for the purchase of the active pharmaceutical ingredients in INM-755 in advance of the planned clinical trial.
  
  
• The Company incurred general and administrative expenses of $1.07 million for 4Q19, compared with $0.98 million for the three months ended June 30, 2018. For the twelve months ended June 30, 2019, general and administrative expenses totaled $3.80 million, which compares with $3.37 million for prior year fiscal 2018. The increase in general and administrative expenses in 4Q19 as compared to the same quarter in 2018, was primarily due to increased accounting and legal expenses pertaining to certain corporate matters.
  
  
• The Company also incurred non-cash, share-based payments, in connection with the grant of stock options, of $0.75 million for 4Q19, compared with $1.51 million for the three months ended June 30, 2018. For the twelve months ended June 30, 2019, non-cash, share-based payments totaled $4.08 million, which compares with $3.20 million for fiscal 2018.
  
  
• At June 30, 2019, the Company's cash, cash equivalents and short-term investments were $18.04 million, which compares to $26.48 million at June 30, 2018. The $8.44 million decrease in cash, cash equivalents and short-term investments during the twelve months to June 30, 2019, was primarily due to cash outflows from operating activities.
  
  
• At June 30, 2019, the Company's total issued and outstanding shares were 172,283,633. Including outstanding stock options and warrants, as at June 30, 2019, the Company had 223,633,401 shares on a fully diluted basis. During the three months ending June 30, 2019, the weighted average number of common shares was 172,281,985, which is used for the calculation of loss per share for the quarter. Subsequent to June 30, 2019 13,862,127 warrants expired and 1,100,000 options were granted with 1,197,500 options being forfeited.
  

Table 1:  Consolidated statements of financial position (audited):

Table 2:  Consolidated statements of operations and comprehensive loss:

Table 3:  Consolidated statements of cash flows (audited):

The Company's full financial statements and related MD&A for the year ended June 30, 2018 are available at www.sedar.com.

About InMed:
InMed Pharmaceuticals is a biopharmaceutical company developing a proprietary biosynthesis manufacturing technology for the production of pharmaceutical-grade cannabinoids, as well as a pipeline of medications that target diseases with high unmet medical needs.  For more information, visit www.inmedpharma.com.

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: developing a proprietary biosynthesis platform technology for the manufacturing of pharmaceutical-grade cannabinoids as well as an R&D pipeline of medications targeting diseases with high unmet medical needs; continuing to advance our biosynthesis, EB and glaucoma programs while also looking to expand our profile in the investment community; having a clear indication as to the commercial yield and cost structure of the Company's current biosynthesis process by the end of calendar 2019; a Clinical Trial Application and subsequent initiation of a first-in-man clinical trial prior to the end of calendar 2019; being in advanced pre-clinical studies and formulation development for INM-088 prior to the end of the calendar year.

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 platform technology for the manufacturing of pharmaceutical-grade cannabinoids as well as an R&D pipeline of medications targeting diseases with high unmet medical needs 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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SOURCE InMed Pharmaceuticals Inc.