Dare Bioscience, Inc.

Current report

Our common stock could be subject to immediate suspension of trading from the Nasdaq Capital Market and delisting if we do not obtain a favorable outcome from the Nasdaq Hearing Panel following our upcoming hearing, which could, among other things, limit demand for our common stock, substantially impair our ability to raise additional capital and have an adverse effect on the market price of, and the efficiency of the trading market for, our common stock.

Current report

Our common stock is listed on the Nasdaq Capital Market. To maintain our listing we are required to satisfy continued listing requirements, including the requirements commonly referred to as the minimum bid price rule and with either the stockholders’ equity rule or the market value of listed securities rule. The minimum bid price rule requires that the closing bid price of our common stock be at least $1.00 per share, and the stockholders’ equity rule requires that our stockholders' equity be at least $2.5 million, or, alternatively, that the market value of our listed securities be at least $35 million or that we have net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the three most recently completed fiscal years.

Current report

We were not in compliance with the stockholders’ equity rule or the market value of listed securities rule from August 2024 until July 24, 2025, and we were not in compliance with the minimum bid price rule from July 2023 until July 2024 and from December 2022 until January 2023. Although we regained compliance with the applicable rule in each instance, there can be no assurance that we will continue to satisfy those or other continued listing requirements and maintain the listing of our common stock on the Nasdaq Capital Market.

Current report

When Nasdaq confirmed on July 24, 2025, that we regained compliance with the stockholders’ equity rule, it also informed us that, pursuant to Nasdaq Listing Rule 5815(d)(4)(B), we would be subject to a mandatory panel monitor for a period of one year from that date, and that if, within that one-year period, the Staff determines that we are out of compliance with the stockholders’ equity rule, the Staff will issue a delisting determination letter, and we will have an opportunity to request a new hearing with Nasdaq’s Hearings Panel. Notwithstanding Nasdaq Listing Rule 5810(c)(2), we will not be permitted to provide a plan of compliance to the Staff with respect to such non-compliance, the Staff will not be permitted to grant us additional time to regain compliance, and we will not be afforded a cure period pursuant to Nasdaq Listing Rule 5810(c)(3). The foregoing would limit our ability to remedy any future non-compliance with the stockholders’ equity rule, and would increase the likelihood that our common stock could be delisted, if we were to fall out of compliance with the stockholders’ equity rule during the one-year monitoring period.

Current report

On July 13, 2026, we received a delisting determination letter from the Staff in accordance Nasdaq Listing Rule 5815(d)(4)(B) informing us that because our Quarterly Report on Form 10-Q for the period ended March 31, 2026 reported stockholders’ equity of less than $2.5 million and, as of July 13, 2026, we did not meet the alternative requirements of $35 million in market value of listed securities or $500,000 in net income from continuing operations, we no longer complied with Nasdaq Listing Rule 5550(b). Pursuant to Nasdaq Listing Rule 5815, we were permitted to request an appeal of the Staff’s delisting determination and a hearing to address the listing deficiency before the Panel. We timely submitted the hearing request, which stayed the suspension and delisting of our common stock at least pending the issuance of the Panel’s decision following the hearing and the expiration of any extension period that may be granted by the Panel. The hearing has been scheduled for late August 2026. Pursuant to published Nasdaq guidance, the Panel typically issues its decision within 30 days of the hearing.

Current report

Following the hearing, the Panel may, as it deems appropriate, grant an extension period not to exceed 180 days from the date of the Staff’s delisting determination letter for us to evidence compliance with Nasdaq Listing Rule 5550(b), suspend and delist our common stock from The Nasdaq Capital Market, or find us in compliance with all applicable listing standards. There can be no assurance that our hearing before the Panel will result in a favorable outcome or, if any extension period is granted, that we will regain compliance with Nasdaq Listing Rule 5550(b) within such extension period or that we will be successful in otherwise maintaining the listing of our common stock on the Nasdaq Capital Market. If the Panel issues a decision to delist our common stock, unless the Panel’s decision specifies to the contrary, Nasdaq will immediately take action to suspend trading of our common stock. If the Panel issues a delisting decision, we will have an opportunity to appeal the decision to the Nasdaq Listing and Hearing Review Council (the “Listing Council”). If the Panel issues a delisting decision and we do not appeal the decision or if the Listing Council does not call the matter for review or withdraws its call for review, Nasdaq will follow the procedures described in Nasdaq Listing Rule 5830 to submit an application on Form 25 to the SEC to delist our common stock.

Current report

The suspension or delisting of our common stock, or the commencement of delisting proceedings, for whatever reason, including the ongoing process that began with the July 13, 2026 Staff delisting determination letter, could, among other things, substantially impair our ability to raise additional capital; result in the loss of interest from institutional investors, the loss of confidence in our company by investors and employees, and in fewer financing, strategic and business development opportunities; and result in potential breaches of agreements under which we made representations or covenants relating to our compliance with applicable listing requirements. Claims related to any such breaches, with or without merit, could result in costly litigation, significant liabilities and diversion of our management’s time and attention and could have a material adverse effect on our financial condition, business and results of operations. In addition, the suspension or delisting of our common stock, or the commencement of delisting proceedings, for whatever reason, may materially impair our stockholders’ ability to buy and sell shares of our common stock and could have an adverse effect on the market price of, and the efficiency of the trading market for, our common stock.

Current report

We may not enroll a sufficient number of subjects in our ongoing Phase 3 clinical study to support an FDA determination of an adequate benefit-risk profile for Ovaprene.

Current report

Our pivotal clinical trial for Ovaprene is being conducted under an Investigational Device Exemption (IDE). The study protocol currently calls for at least 2,500 menstrual cycles of exposure to Ovaprene and expects that at least 250 subjects would complete 13 menstrual cycles of use, whom we refer to as completers. In July 2026, we submitted a protocol amendment to the FDA that proposed to remove the specific expectation of at least 250 completers, which number the FDA had originally requested, instead targeting solely approximately 2,500 total menstrual cycles of use across all enrolled subjects, which we believe will be achieved with less than 250 completers. In August 2026, the FDA approved this protocol amendment. However, in its approval letter, the FDA stated that the data we submitted in support of removing the target number of completers was insufficient and cautioned that it believes implementing the proposed modification would result in a study that is not able to generate sufficient evidence of Ovaprene’s safety profile to support a favorable premarket approval (PMA) decision.

Current report

Additionally, the sample size for the study was calculated based on an identified Pearl Index performance goal. The FDA also cautioned that the performance goal may not be sufficient to support a favorable benefit-risk determination for Ovaprene in a future marketing application based on its product profile and novelty as compared to contraceptive products that guided selection of the performance goal. If the FDA ultimately does not agree that this performance goal is adequate, our current trial, regardless of the number of completers, may not generate sufficient data to support FDA approval of Ovaprene.

Current report

We currently expect to proceed to amend the protocol to eliminate the 250 completer expectation and we do not currently plan to modify the performance goal. We intend to continue engagement with the FDA on the recommendations and considerations it provided in its August 2026 letter, including with respect to the study’s minimum number of completers and performance goal. Based on the interim safety data reviewed by the study’s DSMB in May 2026, including the absence of new types of adverse events or increased frequency of adverse events with prolonged use of Ovaprene in the study, and the study’s expected achievement of at least 2,500 menstrual cycles of exposure, we believe the amended study design will generate sufficient safety data to support a PMA application to the FDA. However, there is no assurance that the FDA will agree, and data generated from fewer than 250 completers, or from our current trial design more generally, may not be sufficient to support FDA approval of Ovaprene. The FDA's approval of our proposed protocol amendment does not mean that the FDA has determined, or will determine, that the resulting data package from our ongoing study will be adequate to support FDA approval. If the FDA determines that our data are insufficient, whether due to the number of completers, the statistical basis for our study design, or other considerations, we may be required to enroll additional subjects, conduct additional clinical studies, generate additional data, or otherwise delay, limit, or restructure our development and regulatory strategy for Ovaprene. We may lack the financial resources, the number of available investigational devices, or sufficient time to satisfy any such additional FDA requirements, and we may determine to allocate our limited resources to other development programs or initiatives. Any of the foregoing could significantly delay or prevent FDA approval of Ovaprene and have a material adverse effect on our business, financial condition, and results of operations.