OPGEN INC

What's Changed

Facing potential Nasdaq delisting due to non-compliance with stockholders equity requirements; appeal in process to stay delisting.

Breakdown

Item 1A. Risk Factors

~~Reference is made to the Risk Factors included in our Annual Report on Form 10-K for the year ended Decem~~Except as set forth below, there have been no other material changes to our risk factors since our Annual Report on Form 10-K for the year ended December 31, 2023.

We cannot assure you that we will be able to continue to comply with the Nasdaq minimum stockholders equity requirement or other continued listing standards of the Nasdaq Capital Market. If we are unable to maintain compliance with such standards, we could be subject to delisting or other adverse action, which could negatively impact the trading of our common stock.

On June 5, 2024, the Company received a letter from the listing staff of The Nasdaq Stock Market LLC (Nasdaq) that the Company was no longer in compliance with the minimum stockholders equity requirement for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(b)(1) (the Stockholders Equity Rule). The Stockholders Equity Rule requires companies listed on the Nasdaq Capital Market to maintain stockholders equity of at least $2,500,000 or to meet alternatives of market value of listed securities or net income from continuing operations, which the Company does not currently meet. In response to the letter, the Company submitted its plan to regain compliance with the Stockholders Equity Rule to the Nasdaq Hearings Panel (the Panel) and requested additional time to regain compliance with such rule. On August 16, 2024, following the Panels review of the Companys plan to regain compliance, the Company received a letter (the Notice) indicating that the Panel had determined to deny the Companys request for continued listing on Nasdaq. Pursuant to the Notice, based on the preliminary nature of the Companys plan, the Panel determined that the Company did not provide a definitive plan evidencing its ability to achieve near- and long-term compliance with the Stockholders Equity Requirement. The Notice also provided that the Companys securities will be suspended from trading on the Nasdaq Capital Market at the opening of business on August 20, 2024. The Company submitted its appeal regarding the Panels determination on September 13, 2024 and requested that the Nasdaq Listing and Hearing Review Council review the decision of the Panel. Such appeal stayed the delisting of the Companys securities with Nasdaq and the filing of the Form 25 pending the Nasdaq Listing and Hearing Review Councils decision until the resolution of such review.

While the Company intends to comply with such conditions and rules, there can be no assurance that the Company will be able to regain or remain in compliance with the Stockholders Equity Rule or other applicable Nasdaq listing requirements on an ongoing and long-term basis or that the Nasdaq Listing and Hearing Review Council will grant the Company additional time to achieve compliance. If we are unable to satisfy these requirements or standards, we could be subject to delisting, which could have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so.

Adverse conditions affecting foreign financial institutions and credit markets could impair our liquidity or interrupt our access to our cash and cash equivalents, which could adversely affect our operations.

As of September 310, 2023.4, we had approximately $1.6 million of cash and cash equivalents. Our cash and cash equivalents are held in bank demand deposit accounts with a significant portion held in foreign bank accounts with foreign institutions. Disruptions in the foreign financial markets or with such foreign financial institutions may, in some cases, result in an inability for us to access our cash or cash equivalents, such as cash held in money market funds that traditionally have been viewed as highly liquid. Any failure of our counterparty financial institutions in which we have deposits may adversely impact our cash and cash equivalent positions and, in turn, our financial position and operations.

In addition, our cash and cash equivalents held in foreign institutions are not insured by the Federal Deposit Insurance Corporation (FDIC). Accordingly, in the event of any loss by such foreign institutions or if any such institutions experience financial difficulties, our cash and cash equivalents may not be insured, and we may not be able to recover the full amount of our assets, which could result in material financial losses.