Dare Bioscience Inc

Current report

On February 13, 2025, Nasdaq notified us that because we did not regain compliance with the Minimum MVLS Rule by February 10, 2025, our common stock is subject to delisting from Nasdaq unless we timely request a hearing before the Nasdaq Hearing Panel, or the Panel.

Current report

On February 20, 2025, we requested a hearing before the Panel, which request stayed the delisting of our common stock pending the decision of the Panel following the hearing and the expiration of any extension period that may be granted by the Panel. At the hearing, which occurred on March 25, 2025, we presented our multi-step plan for regaining compliance with Nasdaq Listing Rule 5550(b) by either satisfying the Minimum MVLS Rule or Nasdaq Listing Rule 5550(b)(1), or the Stockholders’ Equity Rule, which requires a company to maintain stockholders’ equity of at least $2.5 million. A company will satisfy the continued listing requirement in Nasdaq Listing Rule 5550(b) if it satisfies either the Minimum MVLS Rule or the Stockholders’ Equity Rule.

Current report

On April 9, 2025, Nasdaq notified us that the Panel granted our request for an extension until August 12, 2025 to demonstrate compliance with Nasdaq Listing Rule 5550(b).

Current report

On April 29, 2025, we submitted to the Panel a modified multi-step plan for regaining compliance, or our Plan, which the Panel approved. Our Plan includes, among other things, increasing our stockholders’ equity by May 31, 2025 and to increase it further by July 15, 2025.

Current report

The Panel’s determination to grant our request for an extension is subject to certain conditions, including, among others, that we make progress in executing against our Plan by the dates specified in our Plan and that on or before August 12, 2025 (a) we publicly disclose transactions we undertook to increase our stockholders’ equity and provide an indication of our stockholders’ equity following such transactions, and (b) we provide the Panel with an update on our fundraising plans and income projections for the next 12 months. We intend to publicly disclose or provide, as the case may be, the information required by the Panel’s determination within the timeframe required thereby. While we are actively pursuing a range of initiatives aimed at executing against our Plan, no assurances can be given that we will be successful in doing so or that we will satisfy either the Stockholders’ Equity Rule or the Minimum MVLS Rule by August 12, 2025. If we fail to execute on our Plan to the Panel’s satisfaction and remain non-compliant with Nasdaq’s continued listing requirements, the Panel may take action to delist our common stock before August 12, 2025, even though the Panel granted us conditional continued listing until August 12, 2025. As is customary, the Panel also reserved the right to reconsider the terms of the extension it granted based on any event, condition or circumstance that exists or develops that would, in the opinion of the Panel, make continued listing of our common stock inadvisable or unwarranted.

Previous report

The Revenue Sharing Threshold may never be achieved and, as a result, we may not realize any future income based on sales of XACIATO.

Previous report

We have sold our right, title and interest in 100% of the royalties and potential milestone payments we would otherwise have the right to receive under our license agreement with Organon based on net sales of XACIATO, net of payments to upstream third-party licensors and UiE. Whether we receive any future income based on net sales of XACIATO will depend on whether the Revenue Sharing Threshold is reached, which may not occur. Whether the Revenue Sharing Threshold is reached will depend, in part, on Organon’s future commercial success with XACIATO, which is outside of our control, and the successful development and commercialization of Ovaprene and/or Sildenafil Cream, which are subject to significant risks and uncertainties, some of which are outside of our control, as discussed in Part I, Item 1A. Risk Factors of our 2023 10-K.

Previous report

The grants and other non-dilutive funding awards supporting several of our development programs do not guarantee that the pre-clinical or clinical development work being funded will be successful or that we will be able or will choose to fund the additional development work that will be required in the future to advance the product candidates toward regulatory approval.

Previous report

The grants supporting pre-clinical development of DARE-LARC1, DARE-LBT, and activities to aid in the identification and development a novel non-hormonal intravaginal contraceptive candidate, and the ARPA-H funding we expect to receive in support of DARE-HPV’s development do not guarantee that pre-clinical or, as applicable, clinical development will be successful, or, even if we are successful with all specified development activities, that we will be able or will choose to fund the additional clinical and nonclinical development work that will be required in the future to advance the product candidates toward regulatory approval. Further, the grant agreements or other non-dilutive funding award agreements supporting these development programs generally feature milestone-based payments and there is no assurance that we will be able to achieve or otherwise demonstrate satisfaction of the specified development and reporting milestones required to receive future payments under the agreements. Additionally, the counterparties to these agreements may modify, suspend, discontinue payment of funds or terminate the agreements in certain circumstances largely in their discretion. Accordingly, we may never receive future payments under these agreements or realize the full potential amount of the grant or other funding award.

Previous report

We have a period of 180 days, or until February 10, 2025, to regain compliance with the minimum MVLS rule. We will regain compliance if at any time during the 180 day period, our MVLS closes at $35.0 million or more for a minimum of 10 consecutive business days. If we do not regain compliance prior to February 10, 2025, Nasdaq will notify us that our securities are subject to delisting, at which time we may appeal the delisting determination to a Nasdaq hearings panel. There can be no assurance that, if we were to appeal the delisting determination, such an appeal would be successful.

Previous report

The sale of our common stock in ATM offerings or under our equity line arrangement may cause substantial dilution to our existing stockholders, and such sales, or the anticipation of such sales, may cause the price of our common stock to decline.

Previous report

We have used at-the-market, or ATM, offerings to fund a significant portion of our operations in prior years, and we may continue to use ATM offerings to raise additional capital in the future. For example, in 2021, we sold an aggregate of approximately 3.0 million shares of our common stock in ATM offerings. We sold substantially fewer shares in ATM offerings in 2022 and 2023 and to-date in 2024, however, we may sell significant amounts of shares in ATM offerings again in the future. In addition, we may sell up to $15.0 million in shares of our common stock under our equity line arrangement. The purchase price for the shares we may sell under our equity line arrangement will vary based the market price of our common stock at the time we initiate a sale. While sales of shares of our common stock in ATM offerings and under our equity line arrangement may enable us to raise capital at a lower cost compared with other types of equity financing transactions; such sales may result in substantial dilution to our existing stockholders, and such sales, or the anticipation of such sales, may cause the trading price of our common stock to decline.