Acurx Pharmaceuticals(US:ACXP)2022-03-17 15:14Financial Data and Key Metrics Changes - Acurx ended the fiscal year on December 31, 2021, with cash totaling $13 million, an increase from $3.2 million as of December 31, 2020, reflecting a net increase of $17.3 million from the IPO, offset by IPO-related costs of $2.5 million and operating expenditures of approximately $5 million for the year [17][18] - The company reported a net loss of $2.6 million or $0.26 per diluted share for Q4 2021, compared to a net loss of $1.1 million or $0.16 per diluted share for the same period in the prior year [20] - For the full year, the net loss was $12.7 million or $1.49 per diluted share, compared to a net loss of $4.6 million or $0.74 per diluted share for the year ended December 31, 2020 [20] Business Line Data and Key Metrics Changes - Research and development expenses for the year ended December 31, 2021, were $2 million, a slight decrease from $2.2 million in 2020, attributed to lower consulting expenses, partially offset by higher manufacturing costs related to the Phase 2b trial [18][19] - General and administrative expenses for the year were $10.8 million, significantly up from $2.4 million in the prior year, primarily due to non-cash stock-based compensation and increased professional fees [19] Market Data and Key Metrics Changes - The company initiated a Phase 2b clinical trial for its lead antibiotic candidate, ibezapolstat, in patients with C. difficile infection, with enrollment expected to be completed in the second half of 2022 [7][8] - Acurx's Phase 2a trial data indicated a 0% recurrence rate for C. difficile infection, positioning the company favorably against competitors [27] Company Strategy and Development Direction - Acurx is focused on aggressive business development, including territorial licensing deals for its second product candidate, ACX-375, which is currently in preclinical development [29] - The company aims to leverage its favorable clinical data to establish a strong position in the market, especially following recent failures of competitors in the C. difficile therapeutic space [24][26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the competitive landscape, noting that recent failures of competitors like Summit Therapeutics and Pfizer create opportunities for Acurx to capture market share in frontline therapy for C. difficile [24][27] - The company is actively pursuing non-dilutive grants and potential licensing deals to support its development programs, despite delays in legislative initiatives like the Pasteur Act due to shifting congressional priorities [35] Other Important Information - Acurx's IPO in June 2021 raised gross proceeds of $17.25 million, which has significantly bolstered its financial position [15] - The company has participated in various healthcare conferences to enhance its investor relations strategy [15] Q&A Session Summary Question: Can you talk about some of the recent challenges in the space and where Acurx fits now in that competitive landscape? - Management highlighted that recent failures of competitors like Summit and Pfizer have created a favorable environment for Acurx, positioning it well for frontline therapy [24][26] Question: Can you discuss potential business development activities, including regional partnerships? - Management confirmed an aggressive business development program with ongoing discussions for territorial licensing deals and other partnerships [29] Question: Is there an opportunity for labeling related to superiority or microbiome impact for ibezapolstat? - Management indicated that there is potential for exploring superiority endpoints in future trials, particularly in relation to microbiome impact [31][32] Question: Any updates on the Pasteur Act given the current geopolitical situation? - Management noted that while the Pasteur Act is still a priority, recent events have shifted congressional focus, potentially delaying its progress [35]