Item 2.02 | Results of Operations and Financial Condition. |
Based on current estimates, as of December 31, 2022, Ambrx Biopharma Inc. (the “Company”) had cash, cash equivalents and marketable debt securities, available-for-sale of $101.3 million, of which $16.8 million were non-current marketable debt securities, available-for-sale.
The Company has not yet completed its year-end financial close process for the year ended December 31, 2022. These estimates of the Company’s cash, cash equivalents and marketable debt securities, available-for-sale, and non-current marketable debt securities, available-for-sale as of December 31, 2022 are preliminary, have not been audited and are subject to change upon completion of the Company’s financial statement closing procedures, and do not present all information necessary for an understanding of the Company’s financial condition as of December 31, 2022. The review of the Company’s financial statements for the year ended December 31, 2022 is ongoing and could result in changes to these amounts.
The Company’s independent registered public accounting firm has not audited, reviewed or performed any procedures with respect to these preliminary results and, accordingly, does not express an opinion or any other form of assurance about them.
Corporate Update
Based upon preliminary data with respect to ARX788, the Company’s proprietary anti-HER2 antibody-drug conjugate, the Company is currently evaluating conducting a small signal-finding Phase 2 study of ARX788 in HER2-positive metastatic breast cancer patients who were previously treated with Enhertu® (trastuzumab deruxtecan).
New York Stock Exchange Continued Listing Standard Compliance Confirmation
On November 23, 2022, the New York Stock Exchange (“NYSE”) notified the Company of its noncompliance with the NYSE’s continued listing standards because the average closing price of its American Depositary Shares (“ADS”), each representing seven ordinary shares, had fallen below $1.00 per ADS (the “Minimum Stock Price”) over a period of 30 consecutive trading days, which is the minimum average closing price per ADS required to maintain continued listing on the NYSE under Section 802.01C (“Section 802.01C”) of the NYSE Listed Company Manual (the “Minimum Average Closing Price”). On January 3, 2023, the NYSE provided confirmation to the Company that a calculation of the Company’s average ADS price for the 30 trading-days ended December 31, 2022 indicated that such price exceeded the Minimum Average Closing Price. Accordingly, the Company has regained compliance with the continued listing standards of Section 802.01C.
Forward-Looking Statements
This Current Report on Form 8-K includes certain “forward-looking statements” intended to qualify for the “safe harbor” from liability established by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements may be identified by the words “estimate,” “expect,” “evaluate,” “intend,” “will,” “could,” “potential” and similar expressions, and include, without limitation, express or implied statements regarding the Company’s preliminary estimates of cash, cash equivalents and marketable debt securities, available-for-sale, as of December 31, 2022, the Company’s clinical trial and product candidate strategy, including plans for any future clinical trials of ARX788, and the Company’s ability to maintain compliance with the NYSE’s continued listing standards. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, those risks and uncertainties associated with: risks related to preliminary financial results, including the risks that the preliminary financial results reported herein reflect information available to the Company only at this time and may differ from actual results, including in connection with the Company’s completion of financial closing procedures; risks associated with market conditions; risks and uncertainties associated with the Company’s business and finances in general; the Company’s ability to execute on its strategy including with respect to the timing of its research and development efforts, initiation of clinical trials and other anticipated milestones; risks associated with development of novel therapeutics,