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Nature of Operations and Basis of Presentation
9 Months Ended
Sep. 30, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Nature of Operations and Basis of Presentation
1.
NATURE OF OPERATIONS AND BASIS OF PRESENTATION

Business

Acer Therapeutics Inc., a Delaware corporation (the “Company”), is a pharmaceutical company focused on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. The Company identifies and develops treatments where science can be applied in new ways for use in diseases with high unmet need.

In the U.S., OLPRUVA® (sodium phenylbutyrate) for oral suspension is approved for the treatment of urea cycle disorders (“UCDs”) involving deficiencies of carbamylphosphate synthetase (“CPS”), ornithine transcarbamylase (“OTC”), or argininosuccinic acid synthetase (“AS”). The Company also has a pipeline of investigational product candidates, including EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (“vEDS”) in patients with a confirmed type III collagen (COL3A1) mutation.

Going Concern

The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the U.S. (“GAAP”), which contemplate continuation of the Company as a going concern. The Company has incurred recurring losses from operations, negative cash flows from operations, has a net working capital deficiency, and has a net capital deficiency. During the three months ended September 30, 2023 the Company generated its first commercial product revenues, however until such time as revenues increase to a level higher than its ongoing operating costs and expenses, it will continue to be dependent on additional funding. Since inception, the Company has experienced significant losses and incurred negative cash flows from operations. The Company has spent, and expects to continue to spend, a substantial amount of funds in connection with implementing its business strategy, including its planned product development efforts and commercial activities.

As of September 30, 2023, the Company had cash and cash equivalents of $0.6 million and current liabilities of $61.7 million, which include $1.5 million associated with accrued payments to collaboration partner (see Note 3, Significant Accounting Policies, Revenue Recognition and Accounting for Collaboration Agreements, in the Notes to Condensed Financial Statements included in Part I, Item 1 of this Quarterly Report).

These factors individually and collectively raise substantial doubt about the Company’s ability to continue as a going concern on a standalone basis (assuming the Merger did not occur, see Note 2, Acquisition by Zevra, in the Notes to Condensed Financial Statements included in Part I, Item 1 of this Quarterly Report) for at least 12 months from the date these financial statements are available, or November 20, 2024. Subsequent to the close of the Merger, the Company would need a formal letter of support of its parent to eliminate the substantial doubt about its ability to continue as a going concern for the previously defined period which had not been formalized as of the filing of this 10-Q. The accompanying financial statements do not include any adjustments or classifications that may result from the possible inability of the Company to continue as a going concern.

Basis of Presentation

The accompanying condensed financial statements are unaudited and have been prepared in accordance with GAAP for interim financial information and with the instructions to Form 10-Q and Regulation S-X. The unaudited condensed financial statements have been prepared on the same basis as the audited annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s financial position, results of operations, stockholders’ deficit and cash flows for the periods presented. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any other future annual or interim period. The condensed balance sheet as of December 31, 2022, included herein, was derived from the audited financial statements as of that date but does not include all disclosures required by GAAP. These unaudited financial statements should be read in conjunction with the Company’s audited financial statements included in its Annual Report on Form 10-K for the year ended December 31, 2022.

Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).