Latest 10-Q filed 11/14/2024 · Compared against 8/13/2024
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Item 1A.
Risk Factors.
In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the factors discussed in Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2023 (the Form 10-K), which could materially affect our business, financial condition or future results.
There have been no material changes in the risk factors disclosed in the Form 10-K, except the following risk associated with our common stock has been updated as follows:
Failure to obtain or maintain a listing of our common stock on a national securities exchange could seriously harm the liquidity of our stock and our ability to raise capital.
Nasdaq completed the delisting of our common stock by filing a Form 25 Notification of Delisting with the SEC on April 24, 2024. Our common stock became eligible for quotation on the OTCQB market starting on April 16, 2024, under the symbol PBLA. We have applied to relist our common stock on the Nasdaq. No assurances can be given that we will satisfy the listing criteria, our application will be approved, or that a trading market will develop or be maintained. Our share price on the OTCQB may not be indicative of the market price on Nasdaq if we become listed.
If, for any reason, we were unable to obtain listing on Nasdaq or another reputable national securities exchange, a reduction in some or all of the following may occur, each of which could materially adversely affect our stockholders:
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| the liquidity and marketability of our common stock; |
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| the market price of our common stock; |
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| our ability to obtain financing for the continuation of our operations; |
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| the number of institutional and general investors that will consider investing in our common stock; |
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| the number of market makers in our common stock; |
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| the availability of information concerning the trading prices and volume of our common stock; and |
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| the number of broker-dealers willing to execute trades in shares of our common stock. |
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In addition, if we cannot obtain or maintain a listing on a national securities exchange, we may have to continue trading on a less recognized or accepted market, such as the OTCQB, our stock would continue to be traded as a penny stock, which would make transactions in our stock more difficult and cumbersome, and we may be unable to access capital on favorable terms or at all, as companies trading on alternative markets may be viewed as less attractive investments with higher associated risks, such that existing or prospective institutional investors may be less interested in, or prohibited from, investing in our common stock. This may also cause the market price of our common stock to decline further.
The protection provided by the federal securities laws relating to forward-looking statements may not apply to us. The lack of this protection could harm us in the event of an adverse outcome in a legal proceeding relating to forward-looking statements made by us.
Although federal securities laws provide a safe harbor for forward-looking statements made by a public company that files reports under the federal securities laws, this safe harbor is not available to certain issuers, including penny stock issuers. If we are determined to have issued a penny stock, we will not have the benefit of this statutory safe harbor protection in the event of certain legal actions based upon forward-looking statements. The lack of this protection in a contested proceeding could harm our financial condition and, ultimately, the value of our common stock.
Our common stock is eligible for quotation on the over-the-counter-market but not listed on any national securities exchange.
Our shares of common stock are eligible for quotation on the OTCQB tier of the over-the-counter markets. Despite eligibility for quotation, no assurance can be given that any market for our common stock will be maintained for any period of time. Quotation on the over-the-counter markets is generally understood to be a less active, and therefore less liquid, trading market than other types of markets such as a national securities exchange. In comparison to a listing on a national securities exchange, quotation on the over-the-counter markets is expected to have an adverse effect on the liquidity of shares of our common stock, both in terms of the number of shares that can be bought and sold at a given price, but also through delays in the timing of transactions and reduction in analyst and media coverage. This may result in lower prices for our common stock than might otherwise be obtained and could also result in a larger spread between the bid and ask prices for our common stock.
Due to our reliance on third parties to conduct our clinical trials, we are unable to directly control the timing, conduct, expense and quality of our clinical trials, which could adversely affect our clinical data and results and related regulatory approvals.
We rely on independent third-party CROs to conduct many of our clinical trials, including document preparation, site identification, screening and preparation, pre-study visits, training, program management and bio-analytical analysis. Many important aspects of the services performed for us by the CROs are out of our direct control. Due to recent cash constraints, we have been unable to stay current with payments to the CRO for the ASPIRE trial. In May 2024, we were notified by the CRO of their intent to terminate their relationship with us if we were unable to pay the balances due in a satisfactory timeframe. In exchange for a $1.5 million payment made on July 26, 2024, our CRO for the ASPIRE trial has provided an extension of their intent to terminate our relationship to August 19, 2024. The payment to that CRO was funded by proceeds from the USWM Loan. If we are unable to pay On August 19, 2024, the balance due, or unable to negotiatCRO began termination our contract with them, and the Company at that time an extension, by August 16, 2024, tssumed direct responsibility for the conduct of the trial. The CRO hasompany is also indicated that i contract negotiation with a new CRO to assist will begin teth the completion of the study. The termination procedures as of August 19, 2024. Tof the contract with the previous CRO and the balance due totaled $9.7 millionassociated transfer of all aspects of August 7, 2024, and is the trial, either direcorded in tly to the Companys current liabilities If the or a new CRO terminates, is expected to cause the relacompletionship, of the ASPIRE trial couldto be delayed.
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