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Risk Factors" in our Annual Report, there are a number of risks and uncertainties that may have a material effect on the operating results of our business and our financial condition.
−Removed: There are no additional material updates or changes to our risk factors since the filing of our Annual Report, except as discussed below.
+Added: There are no additional material updates or changes to our risk factors since the filing of our Annual Report, and our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024 filed with the SEC on August 14, 2024, except as discussed below.
In evaluating our risks, readers also should carefully consider the risk factors discussed in our Annual Report, which could materially affect our business, financial condition, or operating results, in addition to the other information set forth in this report and in our other filings with the SEC.
−Removed: Risks related to our business, financial position and capital needs
−Removed: Our strategic prioritization and streamlining of resources undertaken to extend our cash runway and focus more of our capital resources on PRGN-2012 might not achieve our intended outcome.
−Removed: On August 6, 2024, we publicly announced a strategic prioritization of our clinical portfolio and streamlining of resources, including a reduction of over 20% of our work force, to focus on potential commercialization of PRGN-2012 for the treatment of RRP.
−Removed: In connection with the implementation of our strategic prioritization and streamlining of resources, we recorded non-cash impairment charges to goodwill and other assets of approximately $32.9 million, net of tax, in the second quarter of 2024 and also estimate we will record severance costs of approximately $3.0 million in the aggregate between the second and third quarters of 2024, of which $2.1 million was recorded in the second quarter of 2024.
−Removed: We may incur additional expenses not currently contemplated due to events associated with strategic prioritization and streamlining of resources;
−Removed: for example, the reduction in force may have a future impact on other areas of our liabilities and obligations, which could result in losses in future periods.
−Removed: The reduction in force may result in unintended consequences and costs, such as the loss of institutional knowledge and expertise, attrition beyond the intended number of employees, and decreased morale among our remaining employees.
−Removed: In addition, while positions have been eliminated, certain functions necessary to our operations remain, and we might not successfully distribute the duties and obligations of our terminated employees among our remaining employees.
−Removed: The reduction in workforce could also make it difficult for us to pursue, or prevent us from pursuing, new opportunities and initiatives due to insufficient personnel, or require us to incur additional and unanticipated costs to hire new personnel to pursue such opportunities or initiatives.
−Removed: Moreover, we may not realize, in full or in part, the anticipated benefits and savings from this strategic prioritization and streamlining of resources due to unforeseen difficulties, delays or unexpected costs.
−Removed: If we are unable to realize the anticipated benefits from the strategic prioritization and streamlining of resources, or if we experience significant adverse consequences from such actions, our business, financial condition and results of operations may be materially adversely affected.
−Removed: In addition, we may need to undertake additional workforce reductions or restructuring activities in the future.
−Removed: Despite the proceeds received from our August 2024 public offering, we will still require significant additional capital funding and such capital may not be available to us.
−Removed: We recently raised approximately $31.4 million in net proceeds in an offering of equity securities in August 2024.
−Removed: The net proceeds of the offering, together with our recently announced strategic prioritization and streamlining of resources and cash on hand, are expected to fund our operations into early 2025.
−Removed: This projection is based on our current expectations regarding cost structure, cost savings from the strategic prioritization and streamlining of resources, cash burn rate and other operating assumptions.
−Removed: In the event that our operating expenses are higher than anticipated, or our cost savings from the strategic prioritization and streamlining of resources are less than we anticipate, we may be required to implement contingency plans within our control to conserve and/or enhance our liquidity to meet operating needs, including potential financings.
−Removed: We have no additional committed external sources of funds and there can be no assurance that new financings or other transactions will be available to us on commercially acceptable terms, or at all, and such financings may adversely affect the holdings or rights of our stockholders and may cause significant dilution to existing stockholders.
−Removed: If additional financing is not available when required or is not available on acceptable terms, we may need to delay, modify or abandon our plans for our product candidates,
−Removed: which could have a material adverse effect on our business, results of operations and financial condition.
−Removed: If we are unable to fund our operations without additional external financing and therefore cannot sustain future operations, we may be required to delay, reduce and/or cease our operations and/or seek bankruptcy protection.
+Added: Risks related to our common stock
+Added: We are required to meet the Nasdaq Global Select Market’s continued listing requirements and other Nasdaq rules, or we may risk delisting.
+Added: Delisting could negatively affect the price of our common stock which, could make it more difficult for us to sell securities in a future financing or for you to sell our common stock.
+Added: Our common stock is currently listed on the Nasdaq Global Select Market of The Nasdaq Stock Market, LLC (“Nasdaq”), which has qualitative and quantitative continued listing criteria.
+Added: However, we cannot assure you that our common stock will continue to be listed on Nasdaq in the future.
+Added: In order to continue listing our common stock on Nasdaq, we are required to meet the continued listing requirements of Nasdaq and other Nasdaq rules, including those regarding director independence and independent committee requirements, minimum stockholders’ equity, minimum share price and certain other corporate governance requirements.
+Added: In particular, we are required to maintain a minimum bid price for our listed common stock of $1.00 per share.
+Added: If we do not meet these continued listing requirements, our common stock could be delisted.
+Added: On November 1, 2024, we received a deficiency letter (the “Deficiency Letter”) from the Listing Qualifications Department (the “Staff”) of Nasdaq indicating that, for the last thirty consecutive business days, the bid price for our common stock had closed below the minimum $1.00 per share requirement for continued listing on Nasdaq under Nasdaq Listing Rule 5450(a)(1) (the “Bid Price Rule”).
+Added: In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we were provided an initial period of 180 calendar days, or until April 30, 2025, to regain compliance.
+Added: To regain compliance, the bid price of our common stock must close at $1.00 per share or more for a minimum of ten consecutive business days during such 180-day compliance period.
+Added: The Deficiency Letter had no immediate effect on the listing or trading of our common stock.
+Added: We have not yet regained compliance with the Bid Price Rule.
+Added: If we do not regain compliance with the Bid Price Rule by April 30, 2025, we may be eligible for an additional 180 calendar day compliance period.
+Added: To qualify, we would be required to transfer the listing of our common stock to the Nasdaq Capital Market, provided that we meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide written notice of our intention to cure the deficiency during the second compliance period, including by effecting a reverse stock split, if necessary.
+Added: However, if it appears to the Staff that we will not be able to cure the deficiency, or if we are otherwise not eligible, Nasdaq would notify us that our securities would be subject to delisting.
+Added: In the event of such a notification, we may appeal the Staff’s determination to delist our securities.
+Added: There can be no assurance that we will be eligible for the additional 180 calendar day compliance period, if applicable, or that the Staff would grant our request for continued listing subsequent to any delisting notification.
+Added: If Nasdaq delists our common stock from trading on its exchange and we are not able to list our securities on another national securities exchange, we expect our securities could be quoted on an over-the-counter market.
+Added: In such case, our stockholders’ ability to trade, or obtain quotations of the market value of our common stock would be severely limited because of lower trading volumes and transaction delays.
+Added: These factors could contribute to lower prices and larger spreads in the bid and ask
+Added: prices of these securities.
+Added: In addition, delisting could also result in a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities.
+Added: There can be no assurance that our securities, if delisted from Nasdaq in the future, would be listed on a national securities exchange, a national quotation service, the over-the-counter markets or the pink sheets.
+Added: Delisting from Nasdaq, or even the issuance of a notice of potential delisting, would also result in negative publicity, make it more difficult for us to raise additional capital, adversely affect the market liquidity of our securities, decrease securities analysts’ coverage of us or diminish investor, supplier and employee confidence, any or all of which could material adversely affect our business and results of operations.
Unregistered Sales of Equity Securities and Use of Proceeds
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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.