InMed Pharmaceuticals(INM) - 2019 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - R&D expenses for Q4 2019 were CAD2.45 million, a significant increase from CAD580,000 in Q4 2018. For the full fiscal year 2019, R&D expenses totaled CAD5.64 million compared to CAD1.93 million in fiscal 2018, primarily due to increased spending on preclinical studies for INM-755 [36][39] - G&A expenses remained stable at approximately CAD1 million for both Q4 2019 and Q4 2018, but increased to CAD3.80 million for the full year 2019 from CAD3.37 million in 2018, reflecting higher staffing costs [38][39] - The company recorded a net loss of CAD4.27 million for Q4 2019 and CAD13.26 million for the full year, compared to a net loss of CAD3 million and CAD8.5 million for the same periods in 2018 [39][40] - As of June 30, 2019, cash and short-term investments totaled CAD18 million, a decrease of CAD8.4 million during the year, primarily due to cash outflows from operating activities [41] Business Line Data and Key Metrics Changes - The INM-755 program for Epidermolysis Bullosa (EB) is transitioning to a single cannabinoid formulation, with initial human clinical trials expected to begin in the Netherlands later in 2019 [7][10] - The INM-088 program for glaucoma has switched from INM-085 to INM-088, which has shown specific advantages in preclinical testing [17][18] - The biosynthesis program aims to optimize cannabinoid manufacturing through bacterial biofermentation, with ongoing scale-up efforts and the exploration of alternative biosynthesis processes [21][22][24] Market Data and Key Metrics Changes - The Netherlands was chosen for initial human clinical trials due to its efficient regulatory review process, which is favorable for cannabinoid research [10][50] - The company is exploring global regulatory applications for the Phase I/II study in EB patients, which will require multiple submissions due to the rarity of the disease [51][52] Company Strategy and Development Direction - The company aims to build a leadership position in cannabinoid manufacturing while continuing to develop its drug product candidates [21][25] - There is a focus on leveraging the investment in INM-755 for potential applications in other dermatological conditions beyond EB [14] - The company is also considering alternative delivery technologies for its products to ensure optimal drug delivery [102] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting aggressive timelines for clinical trials and regulatory applications, despite the complexities involved [53][54] - The company is well-positioned financially to support ongoing R&D efforts, with cash reserves expected to last until approximately the end of Q3 2020 [42][100] Other Important Information - Recent personnel changes include the addition of Catherine Sazdanoff to the Board of Directors and the hiring of Bruce Colwill as CFO [27][30] - The company is actively pursuing a patent strategy to protect its innovations and proprietary know-how [85][91] Q&A Session Summary Question: Why did the company break up the Phase I study into two parts? - The first study focuses on intact skin to assess tolerability before proceeding to wounded skin, which is crucial for safety considerations [46][47] Question: What does the Clinical Trial Application process in the Netherlands entail? - The process is well-defined and allows for parallel reviews by the Ethics Committee and Health Authority, making it quicker than in other jurisdictions [50] Question: How is the EB community organized for global trials? - The EB community is well-connected through organizations like Debra International, which supports patient care and connects families to medical resources [75][76] Question: What milestones should be expected in the next year? - Key milestones include finalizing the upstream fermentation process and downstream purification processes by the end of the year [62][63] Question: What is the status of the company's capital raising efforts? - The company has CAD18 million on the balance sheet and is considering additional capital raises if opportunities arise [100][101]