The Company has recognized recurring losses. At September 30, 2023, the Company had working capital of $14,808,866 and accumulated deficit of $62,722,785, cash and cash equivalents of $14,861,309, marketable securities of $1,970,260 and accounts payable, accrued expenses and other current liabilities of $2,741,806.

The future success of the Company is dependent on its ability to successfully obtain additional working capital, obtain regulatory approval for and successfully launch and commercialize its product candidates and to ultimately attain profitable operations. Historically, the Company has funded its operations primarily through cash received in connection with revenue from its various grant programs. In addition, in December 2020, June 2021 and January 2023, the Company raised approximately $14.6 million, $41.1 million and $8.6 million in net proceeds for working capital from its initial public offering (“IPO”), June 2021 Offering and January 2023 Offering, respectively.

The Company is subject to a variety of risks similar to other early-stage life science companies including, but not limited to, the successful development, regulatory approval, and market acceptance of the Company’s product candidates, development by its competitors of new technological innovations, protection of proprietary technology, and raising additional working capital. The Company has incurred significant research and development expenses and general and administrative expenses related to its product candidate programs. The Company anticipates costs and expenses to increase in the future as the Company continues to develop its product candidates.

The Company may seek to fund its operations through additional public equity, private equity, debt financings, or private foundations, Federal and industry stakeholder grants as well as other sources. However, the Company may be unable to raise additional working capital, or if it is able to raise additional capital, it may be unable to do so on commercially favorable terms. The Company’s failure to raise capital or enter into such other arrangements if and when needed would have a negative impact on the Company’s business, results of operations and financial condition and the Company’s ability to continue to develop its product candidates.

The Company estimates that its working capital at September 30, 2023 is sufficient to fund its normal operations into the fourth quarter of 2024.

On June 23, 2023, at the Company’s annual meeting of stockholders, the Company’s stockholders approved an amendment to the Company’s restated certificate of incorporation to grant discretionary authority to the board of directors to effect a reverse stock split of the Company’s common stock. Following the receipt of the stockholders’ approval, the Company’s board of directors approved the reverse stock split at the ratio of 1 post-split share for every 6 pre-split shares, which was effective as of June 30, 2023. On July 17, 2023, the Company received a letter from Nasdaq informing the Company that it has regained compliance with the Minimum Bid Price Rule.

The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.