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Except as disclosed below, there have been no material changes from the risk factors disclosed in our 2024 Form 10-K.
−Removed: RISKS RELATING TO OUR BUSINESS
Our auditor’s report on our consolidated financial statements contains an explanatory paragraph regarding our ability to continue as a going concern.
−Removed: Our consolidated unaudited financial statements as of March 31, 2025 have been prepared under the assumption that we will continue as a going concern for the next twelve months.
−Removed: Our management concluded that our recurring losses from operations and the fact that as of March 31, 2025 we have an accumulated deficit of approximately $339.3 and working capital of $4.3 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: Our consolidated unaudited financial statements as of June 30, 2025 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 June 30, 2025 we have an accumulated deficit of approximately $352.4 and working capital of $2.3 million raise substantial doubt about our ability to continue as a going concern for the next twelve months after issuance of our financial statements.
In addition, in connection with the filing of our 2024 Form 10-K our independent registered public accounting firm issued a report that included an explanatory paragraph referring to our recurring losses from operations (anticipated continued losses in the future) and net capital deficiency that, as of the date of such report, raised substantial doubt in our ability to continue as a going concern without additional capital becoming available.
−Removed: As of March 31, 2025, we had a cash and cash equivalents and restricted cash balance of approximately $10.0 million and as of early May, after our receipt of $6.6 million net proceeds from our public offering that was consummated on May 8, 2025, we had cash and cash equivalents of $14.1 million.
+Added: As of June 30, 2025, we had cash and cash equivalents of approximately $12.1 million and as of early August 2025, we had cash and cash equivalents of $9.5 million.
At December 31, 2024, we had an accumulated deficit of $335 million and working capital of $8.7 million.
−Removed: As of December 31, 2024, we had a cash and cash equivalents and restricted cash balance of approximately $11.6 million consisting of cash and investments in highly liquid U.S.
+Added: As of December 31, 2024, we had cash and cash equivalents of approximately $11.6 million consisting of cash and investments in highly liquid U.S.
money market funds.
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.
−Removed: Our consolidated unaudited financial statements as of March 31, 2025 do not include any adjustments that might result from the outcome of this uncertainty.
+Added: Our consolidated unaudited financial statements as of June 30, 2025 do not include any adjustments that might result from the outcome of this uncertainty.
We expect that our current cash will be able to fund operations into the first quarter of 2026 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.
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 three months ended March 31, 2025, our operating activities used net cash of approximately $4.8 million and our cash and cash equivalents were approximately $10.0 million as of March 31, 2025.
+Added: During the six months ended June 30, 2025, our operating activities used net cash of approximately $9.5 million and our cash and cash equivalents were approximately $12.1 million as of June 30, 2025.
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 March 31, 2025, our accumulated deficit totaled approximately $339.3 million on a consolidated basis.
+Added: As of June 30, 2025, our accumulated deficit totaled approximately $352.4 million on a consolidated basis.
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.
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Until such time as we receive approval from the FDA and other regulatory authorities for our product candidates, we will not be permitted to sell our products and therefore will not have product revenues from the sale of products.
−Removed: For the foreseeable future
−Removed: we will have to fund all of our operations and capital expenditures from equity and debt offerings, cash on hand, licensing and collaboration fees and grants, if any.
+Added: For the foreseeable future we will have to fund all of our operations and capital expenditures from equity and debt offerings, cash on hand, licensing and collaboration fees and grants, if any.
We will need to raise additional capital to fund our operations and meet our current timelines and we cannot be certain that funding will be available on acceptable terms on a timely basis, or at all.
The amount of government funding available for grants is dependent upon governmental budgets over which we have no control and which change with new administrations.
−Removed: Based on our current plans, we expect that our current cash will be able to fund operations into the first quarter of 2026 but will not be sufficient to fund our operations for the next twelve months and will only be sufficient to cover overhead costs, manufacturing costs for near-term clinical supply, and limited research efforts, including our ongoing Phase 1 and Phase 2 clinical trials for VCN-01, preclinical studies supporting VCN-01, our ongoing discovery initiatives, and to fund our committed obligations under the terms of the VCN Share Purchase Agreement (the “VCN Purchase Agreement”) related to the VCN Acquisition, but may not be sufficient for additional trials of VCN-01, SYN-020 or SYN-004, or to complete the last cohort of the Phase 1a/2a clinical trial of SYN-004, which are expected to require significant cash expenditures.
+Added: Based on our current plans, we
+Added: expect that our current cash will be able to fund operations into the first quarter of 2026 but will not be sufficient to fund our operations for the next twelve months and will only be sufficient to cover overhead costs, manufacturing costs for near-term clinical supply, and limited research efforts, including our ongoing Phase 1 and Phase 2 clinical trials for VCN-01, preclinical studies supporting VCN-01, our ongoing discovery initiatives, and to fund our committed obligations under the terms of the VCN Share Purchase Agreement (the “VCN Purchase Agreement”) related to the Acquisition, but may not be sufficient for additional trials of VCN-01, SYN-020 or SYN-004, or to complete the last cohort of the Phase 1a/2a clinical trial of SYN-004, which are expected to require significant cash expenditures.
In addition, based on the significant anticipated cost of a Phase 3 clinical program in a broad indication for SYN-004, we expect it will not be feasible for us to initiate and complete this trial at this time without a partner given the capital constraints tied to our current market cap and share 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.