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NASDAQ:ACHV
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Achieve Life Sciences, Inc. (NASDAQ:ACHV) reported 2024 results sharing progress with the new drug application (NDA) for cytisinicline and narrowing its anticipated submission date to late 2Q:25. Chief Medical Officer Dr. Jacobs and her team are compiling the various required components for the document and are ensuring that all the required steps are completed. Over the last few months, Achieve has added new board members and executives and completed the initial portion of its ORCA-OL study which will generate critical safety data to be included in the NDA for smoking cessation. The R&D team held the end of Phase II (EoP2) meeting with the FDA to finalize the study design for the pivotal vaping trial. Management has shared its recent accomplishments at investor events including the Jefferies London Healthcare conference in November and the Piper Sandler Healthcare conference in December in New York. Management also participated in one-on-one meetings during the JP Morgan Healthcare Conference in San Francisco in January and the Barclays Healthcare Conference the day after the earnings report.
Financial and Operational Results
Achieve’s 2024 financial and operational results were provided in a press release, filing of Form 10-K and a webcast which provided an opportunity for analysts to ask questions. No revenues were reported for 2024. Operating expense was $39.1 million producing a net loss of ($39.8) million or ($1.24) per share. For the year ending December 31st, 2024 and versus the same comparable prior year period:
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Research & development expense totaled $22.8 million, up 44% from $15.8 million, due to the initiation and enrollment of the ORCA-OL open label safety trial in May 2024;
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General & administrative expense was $16.3 million, up 42% from $11.4 million on higher employee expenses, including commercial launch preparation costs, severance costs, consulting costs and legal expenses associated with patent activities and general corporate activities;
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Net other expense was ($758,000) vs. ($2.6) million as interest income was more than offset by interest expense lapping recognition of a loss on extinguishment of the 2023 SVB convertible term loan in the prior period;
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Net loss was ($39.8) million vs. ($29.8) million or ($1.24) and ($1.50) per share, respectively.
As of December 31st, 2024, cash and equivalents totaled $34.49 million. This amount compares to a $15.5 million balance in cash and equivalents held at the end of 2023 with the increase due to the February 2024 equity raise. Achieve carries convertible debt of $9.9 million on the balance sheet which includes accrued interest. The company refinanced its debt agreement with Silicon Valley Bank (SVB), extending maturity until the end of 2027. Achieve is eligible to draw an additional $5 million from the facility following FDA acceptance of its new drug application (NDA). Cash used in operations during 2024 was ($29.8) million versus ($24.5) million in the prior year period. Management estimates that the company has sufficient cash to support operations until 3Q:25.