Inovio Pharmaceuticals(INO) - 2021 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended Q4 2021 with $401.3 million in cash, cash equivalents, and short-term investments, a decrease from $411.6 million as of December 31, 2020 [40] - Total revenue for Q4 2021 was $839,000, down from $5.6 million in Q4 2020, and for the full year, revenue was $1.8 million compared to $7.4 million in 2020 [40] - Total operating expenses increased to $106.3 million for Q4 2021 and $303 million for the full year, compared to $34.9 million and $131.5 million for the same periods in 2020 [41] - The net loss for Q4 2021 was $106.9 million or $0.50 per share, and for the full year, it was $303.7 million or $1.45 per share, compared to a net loss of $24.3 million or $0.14 per share in Q4 2020 [42] Business Line Data and Key Metrics Changes - The company completed full enrollment of 192 participants for the Phase 2 trial of INO-4700 against MERS, which is being conducted in Jordan, Lebanon, and Kenya [24] - Full enrollment was also achieved for the Phase 1b trial of INO-4500 for Lassa fever, with 220 participants enrolled in Ghana [25] - Enrollment of 46 participants was completed for the Phase 1b trial of INO-4201 for Ebola [26] Market Data and Key Metrics Changes - The company noted that while over 63% of the global population has received at least one vaccine dose, first dose vaccination rates in certain countries remain below 12% [10] - The company highlighted the ongoing need for improved access to vaccines and boosters globally, particularly in low to middle-income countries [10] Company Strategy and Development Direction - The company plans to seek regulatory approval to amend the primary endpoint for the Phase 3 INNOVATE trial from prevention of all symptomatic disease to prevention of severe disease [12] - The company is evaluating the feasibility of an additional ex-U.S. heterologous boost trial for INO-4800, comparing it to previously approved vaccines [15] - A memorandum of understanding was signed with Colombia's Ministry of Health to explore collaboration in developing and producing vaccines and biopharmaceuticals locally [38] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of T cell responses in protecting against severe disease and the durability of vaccine protection [11][23] - The company expressed confidence in the INO-4800 vaccine's ability to maintain T cell responses against various COVID-19 variants, including Omicron [56] - Management is optimistic about the potential of their DNA medicines platform to address global health needs as COVID-19 transitions from a pandemic to an endemic stage [20] Other Important Information - The company completed the 52-week safety follow-up of REVEAL1 participants, showing VGX-3100 remained well tolerated [31] - The WHO selected INO-4800 for the Solidarity Trial Vaccines, a large international randomized control trial [20] Q&A Session Summary Question: Will biomarker data be used in the REVEAL2 trials? - Management confirmed that they are advancing biomarker development with QIAGEN to identify signatures that predict responses to VGX-3100 [50][51] Question: How is the company addressing the INNOVATE trial amid Omicron? - Management stated that they are proactively seeking to amend the trial's primary endpoint and are confident in the vaccine's T cell response against severe disease [55][56] Question: What are the expectations for regulatory approval steps? - Management outlined that amending the primary endpoint involves modifying the protocol and obtaining approvals from regulatory bodies [62] Question: When will results from the Phase 2 trial of the MERS vaccine be reported? - Management indicated that results are expected by Q3 of the current year as enrollment is ongoing [88]