57 unchanged sentences
We have incurred significant net losses in each period since our inception and anticipate that we will continue to incur net losses for the foreseeable future and may never achieve or maintain profitability .
−Removed: We are not profitable and have incurred significant losses in each period since our inception, including net losses of $4.4 million for the six months ended June 30, 2025 and $14.1 million for the year ended December 31, 2024.
+Added: We are not profitable and have incurred significant losses in each period since our inception, including net losses of $6.4 million for the nine months ended September 30, 2025 and $14.1 million for the year ended December 31, 2024.
We have not commercialized any products and have never generated any revenue from product sales.
24 unchanged sentences
If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts.
−Removed: As of June 30, 2025, we had approximately $6.1 million in cash.
+Added: As of September 30, 2025, we had approximately $5.9 million in cash.
In June 2021, we completed the IPO for net proceeds of $14.8 million after deducting underwriting discounts and commissions and offering expenses.
2 unchanged sentences
In November 2023, we entered into a Sales Agreement and established an ATM Program, pursuant to which we may offer and sell, from time to time through A.G.P./Alliance Global Partners, as sales agent, shares of our common stock having an aggregate offering price of up to $17.0 million.
−Removed: As of the period ended June 30, 2025, we sold a total of 145,516 shares of our common stock under the ATM Program, at a weighted-average price of $65.20 per share, raising $9.2 million of gross proceeds and net proceeds of $8.8 million after deducting commissions to the sales agent and other ATM Program related expenses.
+Added: As of the period ended September 30, 2025, we sold a total of 145,516 shares of our common stock under the ATM Program, at a weighted-average price of $65.20 per share, raising $9.2 million of gross proceeds and net proceeds of $8.8 million after deducting commissions to the sales agent and other ATM Program related expenses.
There remains approximately $7.8 million available for future sales of shares of common stock under the Sales Agreement.
3 unchanged sentences
On May 8, 2025, we entered into the ELOC with Lincoln Park, pursuant to which Lincoln Park committed to purchase up to $12.0 million in shares of our common stock, $0.001 par value per share.
−Removed: Under the ELOC, we raised net proceeds of approximately $0.6 million after deducting related fees and expenses.
+Added: Under the ELOC, we raised net proceeds of approximately $2.3 million after deducting related fees and expenses as of September 30, 2025.
On June 17, 2025, we entered into a warrant inducement agreement with existing warrant holders, receiving net proceeds of approximately $2.5 million after deducting fees and transaction expenses.
−Removed: We believe that, based upon our current operating plan, our existing capital resources will not be sufficient to fund our anticipated operations for at least 12 months from the issuance of our condensed interim financial statements for the period ended June 30, 2025.
+Added: We believe that, based upon our current operating plan, our existing capital resources will not be sufficient to fund our anticipated operations for at least 12 months from the issuance of our condensed interim financial statements for the period ended September 30, 2025.
Our future capital requirements and the period for which we expect our existing resources to support our operations may vary significantly from what we expect.
233 unchanged sentences
Any delay or failure in obtaining required approvals could adversely affect our ability to generate revenues from the particular product candidate for which we are seeking approval.
−Removed: Furthermore, any regulatory approval to market a product may be
−Removed: subject to limitations on the approved uses for which we may market the product or the labeling or other restrictions.
−Removed: In addition, the FDA has the authority to require a risk evaluation and mitigation strategy (“REMS”) as a condition of approval, which may impose further requirements or restrictions on the distribution or safe use of an approved drug, such as limiting prescribing rights to certain physicians or medical centers that have undergone specialized training, limiting treatment to patients as specially defined by the indication statement or who meet certain safe-use criteria, and requiring treated patients to enroll in a registry, among other requirements.
+Added: Furthermore, any regulatory approval to market a product may be subject to limitations on the approved uses for which we may market the product or the labeling or other restrictions.
+Added: In addition, the FDA has the authority to require a risk evaluation and mitigation strategy (“REMS”) as a condition of approval, which may impose
+Added: further requirements or restrictions on the distribution or safe use of an approved drug, such as limiting prescribing rights to certain physicians or medical centers that have undergone specialized training, limiting treatment to patients as specially defined by the indication statement or who meet certain safe-use criteria, and requiring treated patients to enroll in a registry, among other requirements.
These limitations and restrictions may limit the size of the market for the product and affect reimbursement by third-party payors.
322 unchanged sentences
Our largest stockholders will exercise significant influence over our company for the foreseeable future, including the outcome of matters requiring stockholder approval.
−Removed: Our officers, directors and their affiliates currently collectively own 319,545 shares of our common stock (on an as-converted basis) or approximately 19% of our outstanding shares of common stock (on an as-converted basis) as of June 30, 2025.
−Removed: Accordingly, if these stockholders were to choose to act together, they could have a significant influence over all matters requiring stockholder
−Removed: approval, including the election of directors and approval of significant corporate transactions, such as a merger or other sale of our company or all or a significant percentage of our assets.
+Added: Our officers, directors and their affiliates currently collectively own 323,629 shares of our common stock (on an as-converted basis) or approximately 16% of our outstanding shares of common stock (on an as-converted basis) as of September 30, 2025.
+Added: Accordingly, if these stockholders were to choose to act together, they could have a significant influence over all matters requiring
+Added: stockholder approval, including the election of directors and approval of significant corporate transactions, such as a merger or other sale of our company or all or a significant percentage of our assets.
This concentration of ownership could limit your ability to influence corporate matters and may have the effect of delaying or preventing a third party from acquiring control over us.
12 unchanged sentences
At that time, we may appeal the Staff’s determination to a Nasdaq Hearing Panel.
+Added: On August 26, 2025, we received a letter from Nasdaq notifying us that we regained compliance with Nasdaq Listing Rule 5550(b)(1).
On February 24, 2025, we received a letter from The Nasdaq Stock Market (“Nasdaq”) notifying us that for the preceding 31 consecutive business days our common stock did not maintain a minimum closing bid price of $1.00 per share as required by Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).
5 unchanged sentences
We would then be entitled to appeal that determination to a Nasdaq Hearing Panel.
+Added: On August 26, 2025, we received a letter from Nasdaq notifying us that we regained compliance with Nasdaq Listing Rule 5550(a)(2).
Should we fail to satisfy additional continued listing requirements, such as the corporate governance requirements, Stockholders’ Equity Requirement, or the Minimum Bid Price Requirement, Nasdaq may take steps to delist our common stock.
Such a delisting would likely 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.
−Removed: In the event of a delisting, we would take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below Nasdaq’s Minimum Bid Price Requirement or prevent future non-compliance with the Nasdaq’s listing requirements.
+Added: In the event of a delisting, we would take actions to restore our compliance with Nasdaq’s
+Added: listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below Nasdaq’s Minimum Bid Price Requirement or prevent future non-compliance with the Nasdaq’s listing requirements.
If Nasdaq does not maintain the listing of our securities for trading on its exchange, we could face significant material adverse consequences, including:
23 unchanged sentences
We cannot assure you that our data protection efforts will prevent significant breakdowns, data leakages, breaches in our systems, or those of our third-party vendors and other contractors and consultants, or other cyber incidents that could have a material adverse effect upon our reputation, business, operations, or financial condition.
−Removed: For example, if such an event were to occur and cause
−Removed: interruptions in our operations, or those of our third-party vendors and other contractors and consultants, it could result in a material disruption of our programs and the development of our services and technologies could be delayed.
+Added: For example, if such an event were to occur and cause interruptions in our operations, or those of our third-party vendors and other contractors and consultants, it could result in a material disruption of our programs and the development of our services and technologies could be delayed.
Furthermore, significant disruptions of our internal information technology systems or those of our third-party vendors and other contractors and consultants, or security breaches could result in the loss, misappropriation, and/or unauthorized access, use, or disclosure of, or the prevention of access to, confidential information (including trade secrets or other intellectual property, proprietary business information, and personal information), which could result in financial, legal, business, and reputational harm to us.
196 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.