PolyPid(PYPD) - 2024 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of June 30, 2024, the company had cash, cash equivalents, and short-term deposits of $9.3 million, excluding the gross proceeds of approximately $8.1 million from the PIPE financing closed in August [14] - For the three months ended June 30, 2024, research and development expenses were $4.8 million, an increase from $4 million in the same period of 2023, driven by the ramp-up of the ongoing SHIELD II Phase 3 trial [14] - The company reported a net loss of $6.3 million for the second quarter of 2024, compared to a net loss of $5.8 million in the second quarter of 2023 [15] Business Line Data and Key Metrics Changes - Marketing and business development expenses for the three months ended June 30, 2024, were $265,000, down from $357,000 during the prior year period [14] - General and administrative expenses decreased to $1.1 million for the three months ended June 30, 2024, from $1.5 million in the same period of 2023, reflecting ongoing cost containment efforts [15] Market Data and Key Metrics Changes - The SHIELD II trial has now enrolled approximately 320 subjects, with about 50 centers open across multiple countries, including the US, Germany, Italy, Ireland, Portugal, Hungary, and Israel [6] - The company anticipates that the interim analysis will occur once approximately 400 patients complete the 30-day follow-up, expected in the fourth quarter of 2024 [7] Company Strategy and Development Direction - The company is focused on the ongoing SHIELD II pivotal trial for D-PLEX100, aiming for a potential NDA submission in the US based on the results [9] - The recent financing of $8.1 million extends the company's cash runway into the first quarter of 2025, with potential additional funding if warrants are exercised [10] - The company is also progressing on commercialization discussions for D-PLEX100 in various geographies, expecting to sign deals before the data release [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term prospects of D-PLEX100, particularly in light of the normalization of surgical environments post-COVID and the expected return to pre-COVID infection rates [22] - The Data Safety Monitoring Committee has recommended continuing the SHIELD II study without modifications, indicating no safety issues related to D-PLEX100 have been observed to date [9] Other Important Information - The company has restructured its existing secured loan agreement with Kreos, deferring over $2 million of repayment until April 2025 [10] - Ms. Dalit Hazan has been promoted to Deputy CEO, reflecting her contributions to the company's clinical strategy and regulatory affairs [11] Q&A Session Summary Question: What are the options for the interim analysis announcement? - Management clarified that they will not know the infection rate until the study's endpoint is reached, and the Data Safety Monitoring Board (DSMB) will provide one of three recommendations regarding the study's continuation [16] Question: Are warrants exercisable if the trial size increases? - Management confirmed that warrants are exercisable at any time within the next two years, with specific conditions related to the trial's progress [17] Question: Any updates on partnering D-PLEX100 in additional geographies? - Management indicated ongoing discussions for commercialization deals in Europe and expects to finalize agreements before data release [18] Question: Timing for the completion of the interim analysis? - Management expects to announce reaching 400 patients, followed by a two-month process for the DSMB recommendation, with interim data anticipated in the fourth quarter of 2024 [19][20] Question: Market dynamics for the SHIELD II target indication? - Management believes that the market environment will resemble pre-COVID conditions, which is encouraging for the study's outcomes [21][22] Question: Expected changes in G&A spending after positive interim analysis? - Management does not foresee substantial increases in G&A expenses, as most marketing responsibilities will fall on partners [24]