Plus Therapeutics(PSTV) - 2020 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The operating cash burn for Q1 2020 was approximately $1.5 million, a decrease from $3.3 million in Q1 2019, primarily due to discontinued operations and reduced operating expenses [27] - The net loss for Q1 2020 was $1.1 million, compared to a net loss of $3.2 million in Q1 2019, attributed to discontinued operations and changes in fair value of warrants [27] - Total revenues for Q1 2020 were $0.1 million, down from $0.7 million in Q1 2019, mainly due to the closeout of a government contract with BARDA [28] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses in Q1 2020 were $0.9 million, down from $1.4 million in Q1 2019, due to decreased spending following the sale of the former Cell Therapy business [27] - Sales and marketing expenses remained consistent at approximately $0.1 million [28] - General and administrative (G&A) expenses increased to $1.5 million in Q1 2020 from $1.4 million in Q1 2019, driven by increased professional fees [28] Market Data and Key Metrics Changes - As of March 31, 2020, the company had $16.1 million in cash and $9.3 million in debt principal, with total liabilities at $20.8 million, down from $22 million at the end of 2019 [29] Company Strategy and Development Direction - The company aims to optimize the regulatory and clinical program for RNL for glioblastoma and plans to expand the Phase 1 trial from one to three sites [32] - The strategic focus includes leveraging non-dilutive funding sources and exploring additional indications for RNL, such as head and neck cancer and leptomeningeal carcinomatosis [41][42] - The company is committed to a disciplined approach in assessing new pipeline enhancement opportunities while focusing resources on RNL development [26][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position, noting that there have been no significant supply chain interruptions and no material impact on results for fiscal year 2020 due to COVID-19 [7][29] - The company is optimistic about the potential of the newly licensed RNL technology to redefine treatment for brain cancer and other poorly met cancer indications [10][12] Other Important Information - The company received a modest PPP loan approval but chose not to participate, citing its ability to operate normally during the pandemic [8] - The company donated personal protective equipment to frontline healthcare workers during the pandemic [9] Q&A Session Summary Question: Can you provide details on the Phase 1 trial enrollment? - The company has enrolled 13 patients so far and is currently treating the first patient in the fifth cohort, with plans to enroll between six to eight patients per cohort [36] Question: What outcomes are being measured in the Phase 2 trial? - The focus will be on survival as an outcome, with potential for exploring surrogate endpoints to expedite the clinical path [37] Question: Are there discussions with the FDA regarding fast track or orphan designation? - The company has not yet communicated with the FDA but considers it a priority to explore these designations [38] Question: What other indications are being considered for RNL? - Potential indications include head and neck cancer and leptomeningeal carcinomatosis, with ongoing analysis to determine the most promising opportunities [40][41] Question: Will the company focus on multiple indications simultaneously? - The company anticipates focusing on at least one additional indication, depending on capital availability and agency requirements [43] Question: Is the funding for RNL through the National Cancer Institute already secured? - Yes, the funding has been awarded and will be disbursed over time as the project progresses [46][47] Question: What is the current status of partnerships for DoxoPLUS and DocePLUS? - The company is seeking partnerships but has not yet found the right deal, focusing resources primarily on the RNL program [48] Question: How is the company's cash position for future operations? - The company has approximately 12 to 18 months of cash balance without raising additional capital, depending on the speed of RNL development [51]