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Our consolidated financial statements have been prepared assuming that we will continue as a going concern.
−Removed: Our consolidated unaudited financial statements as of March 31, 2026 have been prepared under the assumption that we will continue as a going concern for the next twelve months.
+Added: Our consolidated unaudited financial statements as of June 30, 2026 have been prepared under the assumption that we will continue as a going concern for the next twelve months.
Our management concluded that our recurring losses from operations and the fact that we will require additional financing as we continue to execute our business strategy, including the need for additional funds for the commencement of our planned clinical trials, 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 2025 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, 2026 we had cash and cash equivalents of approximately $14.4 million and as of early May 2026, we had cash and cash equivalents of $13.1 million.
−Removed: At December 31, 2025, we had an accumulated deficit of $358.7 million and working capital of $7.5 million.
+Added: As of June 30, 2026 we had cash and cash equivalents of approximately $11.3 million and as of early August 2026, we had cash and cash equivalents of $9.6 million.
+Added: At June 30, 2026, we had an accumulated deficit of $364 million and working capital of $1.6 million.
+Added: December 31, 2025, we had an accumulated deficit of $358.7 million and working capital of $7.5 million.
As of December 31, 2025, we had cash and cash equivalents of approximately $13.1 million consisting of cash and investments in highly liquid U.S.
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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, 2026 do not include any adjustments that might result from the outcome of this uncertainty.
+Added: Our consolidated unaudited financial statements as of June 30, 2026 do not include any adjustments that might result from the outcome of this uncertainty.
Based upon the Company’s current business plans, we expect that our current cash will be able to fund operations into the first quarter of 2027.
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, 2026, our operating activities used net cash of approximately $2.5 million and our cash and cash equivalents were approximately $14.4 million as of March 31, 2026.
+Added: During the six months ended June 30, 2026, our operating activities used net cash of approximately $5.5 million and our cash and cash equivalents were approximately $11.3 million as of June 30, 2026.
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, 2026, our accumulated deficit totaled approximately $360.7 million on a consolidated basis.
+Added: As of June 30, 2026, our accumulated deficit totaled approximately $364 million on a consolidated basis.
Pursuant to the Purchase Agreement entered into in connection with the Acquisition, we have agreed to use reasonable efforts to commercialize VCN-01.
Additionally, pursuant to the Purchase Agreement, we agreed to pay up to $70.2 million in contingent consideration upon the achievement of certain milestones, including regulatory filings, of which to date $7.3 million has been paid and an additional $5.0 million has been earned but deferred pending ongoing discussion with Grifols.
−Removed: If we are required to make the deferred $5.0 million milestone payment to Grifols, it will significantly deplete our cash and cash equivalents, which could materially and adversely affect our liquidity and limit our ability to fund operations or meet other financial obligations.
+Added: If we are required to make the deferred $5.0 million milestone payment to Grifols, it will significantly deplete our cash and cash equivalents, which could materially and adversely affect our liquidity and limit our ability to fund operations, continue clinical research and development activities or meet other financial obligations.
We expect to incur additional operating losses in the future and therefore expect our cumulative losses to increase.
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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 sufficient to fund operations into the first quarter of 2027 and will only be sufficient to cover overhead costs, commence a proposed Phase 2a study in metastatic PDAC patients evaluating more frequent VCN-01 dosing for a longer period, exploratory VCN-01 manufacturing scale-up activities, regulatory interactions regarding a proposed pivotal clinical trial of VCN-01 in retinoblastoma, and limited preclinical studies supporting VCN-01 and VCN-12, the first candidate from our VCN-X discovery program.
−Removed: We believe our cash will also be sufficient to fund our committed obligations under the terms of the Purchase Agreement related to the Acquisition, but may not be sufficient for additional trials of VCN-01 (other than the planned Phase 2a study evaluating more frequent VCN-01 dosing for a longer period), 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 expect that our current cash will be sufficient to fund operations into the first quarter of 2027 and will only be sufficient to cover overhead costs, commence an approved Phase 2a study in metastatic PDAC patients evaluating more frequent VCN-01 dosing for a longer period, conduct exploratory VCN-01 manufacturing scale-up activities, complete regulatory interactions regarding a proposed pivotal clinical trial of VCN-01 in retinoblastoma, and undertake limited preclinical studies supporting VCN-01 and VCN-12, the first candidate from our VCN-X discovery program.
+Added: We believe our cash will also be sufficient to fund our committed obligations under the terms of the Purchase Agreement related to the Acquisition, but may not be sufficient for additional trials of VCN-01 (other than the Phase 2a study evaluating more frequent VCN-01 dosing for a longer period), 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.
−Removed: We intend to focus our capital on our VCN-01 clinical trials and do not intend to provide further funding for our development of SYN-004 internally but intend to out-license or partner further development of SYN-004.
+Added: We intend to focus our capital on our VCN-01 clinical trials and do not intend to provide further funding for our development of SYN-004 internally.
+Added: Any future development of SYN-004 is expected to be funded from out-licensing or partnering for which there can be no assurance.
Further development of VCN’s product candidates will require additional funding.
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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.