5 unchanged sentences
Currently, federal agencies in the U.S.
−Removed: are operating under a continuing resolution that is set to expire on September 30, 2025.
+Added: are operating under federal government shutdown due to expiration of the a continuing resolution on September 30, 2025.
+Added: The duration of the current government shutdown is unknown.
Without appropriation of additional funding to federal agencies, our business operations related to our product development activities for the U.S.
4 unchanged sentences
Disruptions at the FDA and other federal agencies, including substantial leadership departures, personnel cuts, and policy changes, may also slow the time necessary for new drugs to be reviewed and/or approved, which would harm our business.
−Removed: Changes and cuts in FDA staffing have been reported within the pharmaceutical industry as creating instrances of delays in the FDA’s responsiveness or in its ability to review IND submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all.
+Added: Changes and cuts in FDA staffing have been reported within the pharmaceutical industry as creating instances of delays in the FDA’s responsiveness or in its ability to review IND submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all.
A prolonged government shutdown or significant leadership, personnel, and/or policy changes, or other substantial modification in agency activities (including due to global health concerns or geopolitical factors) could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
4 unchanged sentences
presidential administration in 2025, there is substantial uncertainty as to whether and how the Trump administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates and any products for which we obtain approval.
−Removed: This uncertainty could
−Removed: present new challenges and/or opportunities as we navigate development and approval of our product candidates.
+Added: This uncertainty could present new challenges and/or opportunities as we navigate development and approval of our product candidates.
Additionally, the new administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new therapeutic candidates.
−Removed: If we fail to comply or regain compliance with the continued listing standards of the Nasdaq Capital Market, or Nasdaq, we may be delisted and the price of our common stock, or ability to access the capital markets and our financial condition could be negatively impacted.
−Removed: Our common stock is currently listed on the Nasdaq Stock Market LLC, which has minimum requirements that a company must meet in order to remain listed.
−Removed: These requirements include maintaining a minimum closing bid price of $1.00 per share, which closing bid cannot fall below $1.00 per share for a period of more than 30 consecutive trading days.
−Removed: On September 12, 2024, we received a deficiency letter from the Staff of the Nasdaq Stock Market LLC notifying us that, for the last 30 consecutive business days, the closing bid price for our common stock has been below the minimum $1.00 per share required for continued listing on The Nasdaq Global Market pursuant to Rule 5450(a)(1).
−Removed: In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were given 180 calendar days, or until March 11, 2025, to regain compliance with Rule 5450(a)(1).
−Removed: We did not come into compliance by March 11, 2025.
−Removed: On March 12, 2025, we received approval from the Listing Qualifications Department of Nasdaq Stock Market LLC to transfer the listing of our stock to the Nasdaq Capital Market.
−Removed: Following the transfer of the listing, we have been granted an additional 180 calendar day period to regain compliance with Nasdaq's $1.00 minimum bid price requirement.
−Removed: The additional 180-day grace period will end on September 8, 2025.
−Removed: If we do not regain compliance within the allotted compliance period(s), including any extensions that may be granted by Nasdaq, Nasdaq will provide notice that our common stock will be subject to delisting.
−Removed: At that time, we may appeal the Nasdaq staff's determination to a Hearings Panel.
−Removed: We intend to actively monitor the closing bid price for our common stock and will consider available options to resolve the deficiency and regain compliance with Rule 5450(a)(1).
−Removed: However, there can be no assurance that the Company will regain compliance with the minimum bid price requirement.
−Removed: If Nasdaq delists our securities from trading on its exchange for failure to meet the listing standards, we and our stockholders could face negative consequences including the reduction of liquidity and market price of our common stock, our ability to obtain sufficient additional capital to fund our operations, and our ability to operate as a going concern would be substantially impaired.
Unregistered Sales of Equity Securities and Use of Proceeds
Recent Sales of Unregistered Securities
−Removed: There were no unregistered sales of our equity securities during the fiscal quarter ended June 30, 2025.
+Added: There were no unregistered sales of our equity securities during the fiscal quarter ended September 30, 2025.
Repurchase of Shares of Company Equity Securities
3 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.