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RISKS RELATING TO OUR BUSINESS
+Added: There is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.
+Added: Our consolidated unaudited financial statements as of March 31, 2024 have been prepared under the assumption that we will continue as a going concern for the next twelve months.
+Added: Our management concluded that our recurring losses from operations and the fact that as of March 31, 2024 we have an accumulated deficit of approximately $314.5 and working capital of $15.6 million raise substantial doubt about our ability to continue as a going concern for the next twelve months after issuance of our financial statements.
+Added: As of March 31, 2024, we had a cash and cash equivalents and restricted cash balance of approximately $18.4 million.
+Added: At December 31, 2023, we had an accumulated deficit of $309.3 million and working capital of $20.7 million As of December 31, 2023, we had a cash and cash equivalents and restricted cash balance of approximately $23.3 million consisting of cash and investments in highly liquid U.S.
+Added: money market funds.
+Added: We expect to continue to incur losses from expenses related to the development of our product candidates and related administrative activities for the foreseeable future.
+Added: We expect that our current cash will be able to fund operations through the fourth quarter of 2024 and into the first quarter of 2025 but will not be sufficient to fund operations for twelve months from the date of the filing of this Quarterly Report on Form 10-Q and we will need to seek additional capital to fulfill our operating and capital requirement for the next 12 months to advance our clinical development program to later stages of development and commercialize our clinical product candidate.
+Added: In addition, our independent registered public accounting firm has issued a report for the year ended December 31, 2023 that includes an explanatory paragraph referring to our recurring losses from operations (anticipated continued losses in the future) and net capital deficiency that raise substantial doubt in our ability to continue as a going concern without additional capital becoming available.
+Added: Our ability to continue as a going concern is dependent upon our ability to obtain additional equity or debt financing, attain further operating efficiencies, reduce expenditures, and, ultimately, to generate revenue.
+Added: Although management has been successful in raising capital in the past, there can be no assurance that we will be successful or that any needed financing will be available in the future at terms acceptable to us.
+Added: As such, we cannot conclude that such plans will be effectively implemented within one year after the date that the financial statements included in this Quarterly Report on Form 10-Q are filed with the SEC and there is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.
We will need to raise additional capital to operate our business and our failure to obtain funding when needed may force us to delay, reduce or eliminate certain of our development programs or commercialization efforts.
−Removed: During the nine months ended September 30, 2023, our operating activities used net cash of approximately $12.3 million and our cash and cash equivalents were approximately $31.2 million as of September 30, 2023.
+Added: During the three months ended March 31, 2024, our operating activities used net cash of approximately $4.9 million and our cash and cash equivalents were approximately $18.3 million as of March 31, 2024.
With the exception of the three months ended June 30, 2010 and the three months ended December 31, 2017, we have experienced significant losses since inception and have a significant accumulated deficit.
−Removed: As of September 30, 2023, our accumulated deficit totaled approximately $303.8 million on a consolidated basis.
−Removed: Pursuant to the Purchase Agreement, we have agreed to use reasonable efforts to commercialize VCN-01 and we agreed as a post- closing covenant to commit to fund VCN’s research and development programs, including but not limited to VCN-01 PDAC phase 2 clinical trial, VCN-01 RB trial and necessary G&A within a budgetary plan of approximately $27.8 million over the next three years.
+Added: As of March 31, 2024, our accumulated deficit totaled approximately $314.5 million on a consolidated basis.
+Added: Pursuant to the Purchase Agreement, we have agreed to use reasonable efforts to commercialize VCN-01 and we agreed as a post- closing covenant to commit to fund VCN’s research and development programs, including but not limited to VCN-01 PDAC phase 2 clinical trial, VCN-01 RB trial and necessary G&A within a budgetary plan of approximately $27.8 million over three years.
We expect to incur additional operating losses in the future and therefore expect our cumulative losses to increase.
With the exception of the quarter ended June 30, 2010, and limited laboratory revenues from Adeona Clinical Laboratory, which we sold in March 2012, we have generated very minimal revenues.
−Removed: We do not expect to derive revenue from any source in the near future until we or our potential partners successfully commercialize our products.
+Added: We do not expect to derive revenue from any source in the near future until we or our potential
+Added: partners successfully commercialize our products.
We expect our expenses to increase in connection with our anticipated activities, particularly as we continue research and development, initiate and conduct clinical trials, and seek marketing approval for our product candidates.
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We may also enter into strategic transactions, issue equity as consideration for acquisitions or part of license issue fees to our licensors, compensate consultants or settle outstanding payables using equity that may be dilutive.
−Removed: We are authorized to issue 350,000,000 shares of common stock, of which 17,042,765 shares of common stock were outstanding as of September 30, 2023.
−Removed: At September 30, 2023, we had reserved 5,377,777 shares of common stock for issuance upon exercise of our outstanding options, preferred shares and warrants.
+Added: We are authorized to issue 350,000,000 shares of common stock, of which 17,148,049 shares of common stock were outstanding as of March 31, 2024.
+Added: At March 31, 2024, we had reserved 6,834,797 shares of common stock for issuance upon exercise of our outstanding options, and preferred shares.
In addition, at such date, we had 2,822,845 shares of our common stock reserved for future issuance under our equity incentive plans.
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The price per share at which we sell additional shares of our common stock, or securities convertible or exchangeable into common stock, in future transactions may be higher or lower than the price per share paid by existing stockholders.
−Removed: We have identified material weaknesses in our internal controls, and we cannot provide assurances that this weakness will be effectively remediated or that additional material weaknesses will not occur in the future.
−Removed: If our internal control over financial reporting or our disclosure controls and procedures are not effective, we may not be able to accurately report our financial results, prevent fraud, or file our periodic reports in a timely manner, which may cause investors to lose confidence in our reported financial information and may lead to a decline in our stock price.
+Added: We have identified material weaknesses in our internal controls, and we cannot provide assurances that these weaknesses will be effectively remediated or that additional material weaknesses will not occur in the future
+Added: If our internal control over financial reporting or our disclosure controls and procedures are not effective, we may not be able to accurately report our financial results, prevent fraud, or file our periodic reports in a timely manner, which may cause investors to lose
+Added: confidence in our reported financial information and may lead to a decline in our stock price.
Our management is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rule 13a- 15(f) under the Exchange Act.
−Removed: During the preparation of our annual tax provision for the year ended December 31, 2022, we identified a material weakness over non-routine transactions related to the review of internally and externally prepared reports and analysis used in the financial reporting process and the related income tax implication of the non-routine transactions, a material weakness over information technology general controls over logical access and program change management for certain of our key information systems used to support the financial reporting process and a material weakness relating to performance of certain controls not being adequately documented.
−Removed: In addition, during the course of the review for the Quarterly Report for the quarter ended March 31, 2022, we identified a material weakness in our controls relating to accounting and disclosure controls for non-routine transactions.
−Removed: While we are taking and we plan to continue to take remedial action to address the material weaknesses, we cannot provide any assurance that such remedial measures, or any other remedial measures we take, will be effective.
+Added: Based on our assessment, we have concluded that as of March 31, 2024 we did not maintain effective review controls at a sufficient level of precision with certain financial statement areas and over unusual transactions involving complex accounting and related.
+Added: disclosure requirements.
+Added: We also did not maintain effective information technology general controls over user access, program change management, and segregation of duties, within certain key information systems supporting our accounting and financial reporting processes.
+Added: Additionally, many of our business process controls dependent upon the information derived from these information systems were also ineffective, as we did not design and implement controls to validate the completeness and accuracy of underlying data utilized in the operation of those controls.
+Added: While we plan to take remedial action to address the material weaknesses, we cannot provide any assurance that such remedial measures, or any other remedial measures we take, will be effective.
If we fail to maintain effective internal control over financial reporting, we may not be able to accurately report our financial results, detect or prevent fraud, or file our periodic reports in a timely manner, which may, among other adverse consequences, cause investors to lose confidence in our reported financial information and lead to a decline in our stock price.
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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.