The Company operates in a highly regulated and competitive environment. The development, manufacturing and marketing of pharmaceutical products require approval from, and are subject to ongoing oversight by, the Food and Drug Administration (the “FDA”) in the United States, the Therapeutic Goods Administration in Australia, the European Medicines Agency in the European Union, and comparable agencies in other countries. Obtaining approval for a new pharmaceutical product is never certain, may take many years, and is normally expected to involve substantial expenditures.

On March 5, 2024, The Nasdaq Stock Market LLC (“Nasdaq”) notified us that the Nasdaq Hearings Panel (the “Panel”) had determined to delist our Common Stock and trading of our Common Stock was suspended on March 7, 2024. On April 25, 2024, Nasdaq filed a Form 25 Notification of Removal from Listing with the U.S. Securities and Exchange Commission (the “SEC”) and the delisting became effective ten days later. We have applied to list our Common Stock on the US Equity Listings Tier II of the Chicago Board of Options Exchange (“CBOE”). No assurances can be given that we will satisfy the initial listing criteria, the application will be approved, or that a trading market will develop on the CBOE. In the interim, we intend to maintain the existing eligibility for quotation of our Common Stock on the OTCQB under its current symbol, “PBLA.”

We have incurred losses of $132.6 million since our inception in 2011. For the three months ended March 31, 2024, we incurred a net loss of $7.1 million. We also incurred negative cash flows from operating activities of approximately $9.4 million for this period. As we continue to pursue development activities and seek commercialization, we expect to incur substantial losses, which are likely to generate negative net cash flows from operating activities. As of March 31, 2024, we had cash of approximately $300,000, working capital deficit of $8.7 million, (working capital is defined as current assets less current liabilities), and stockholders’ deficit of $3.2 million. The Company’s principal sources of cash have historically included the issuance of convertible debt and equity securities.

Our CRO for the ASPIRE trial has notified the Company of their intent to terminate our relationship, on June 15, 2024, if we are unable to pay the balance due by that time. The balance due is recorded in the Company’s current liabilities. If the CRO terminates the relationship, the trial could be delayed.

The accompanying condensed consolidated financial statements have been prepared assuming that we will continue as a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business. The condensed consolidated financial statements do not include any adjustments relating to the recoverability or classification of assets or the amounts of liabilities that might result from the outcome of these uncertainties. Our current independent registered public accounting firm included a paragraph emphasizing this going concern uncertainty in their audit report regarding our 2023 financial statements dated March 26, 2024. Our ability to continue as a going concern, realize the carrying value of our assets and discharge our liabilities in the ordinary course of business is dependent upon a number of factors, including our ability to obtain additional financing, the success of our development efforts, our ability to obtain marketing approval for our product candidates in the United States, Australia, the European Union or other markets and ultimately our ability to market and sell our product candidates. These factors, among others, raise substantial doubt about our ability to continue operations as a going concern. See Note 4 titled “Liquidity and Business Plan.”

In January of 2022, the Company announced the opening of a global randomized Phase II/III clinical trial, which is being conducted in the United States, Europe and Asia Pacific (APAC). The Company does not expect any disruption to the conduct of this new clinical trial associated with COVID-19. The trial is reliant on adequate supply of gemcitabine and Abraxane (nab-paclitaxel) which can be subject to supply shortages.