What changed in this filing

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Item 1A. Risk Factors

2025-11-12 compared with 2025-08-11 · 45 added, 10 removed, 42 unchanged (57% of the section changed)

3 unchanged sentences

Our auditor’s report on our consolidated financial statements contains an explanatory paragraph regarding our ability to continue as a going concern.

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.

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.

Our consolidated unaudited financial statements as of September 30, 2025 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 as of September 30, 2025 we have an accumulated deficit of approximately $356.7 and working capital of $(1.1 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.

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.

As of September 30, 2025, we had cash and cash equivalents of approximately $7.5 million and as of early November 2025, we had cash and cash equivalents of $15.5 million.

At December 31, 2024, we had an accumulated deficit of $335 million and working capital of $8.7 million.

2 unchanged sentences

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.

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.

Our consolidated unaudited financial statements as of September 30, 2025 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.

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.

During the nine months ended September 30, 2025, our operating activities used net cash of approximately $13.8 million and our cash and cash equivalents were approximately $7.5 million as of September 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.

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.

As of September 30, 2025, our accumulated deficit totaled approximately $356.7 million on a consolidated basis.

Pursuant to the VCN 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 retinoblastoma trial and necessary general and administrative expenses within a budgetary plan of approximately $27.

8 million over three years.

If we are required to make the $5 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.

We expect to incur additional operating losses in the future and therefore expect our cumulative losses to increase.

6 unchanged sentences

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.

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 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.

Based on our current plans, we expect that our current cash will be able to fund operations into the first quarter of 2027 but will not be sufficient to fund our operations for the next twelve months and will only be sufficient to cover overhead costs, close out of the VIRAGE Phase 2b clinical trial;

exploratory VCN-01 manufacturing scale-up activities, regulatory interactions regarding proposed VCN-01 clinical trials in PDAC and retinoblastoma, preclinical studies supporting VCN-01 and VCN-12, the first candidate from our VCN-X discovery program.

The cash is also sufficient to fund our committed obligations under the terms of 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.

20 unchanged sentences

economy or certain sectors thereof, the global economy, and our industry, and as a result, could have a material adverse effect on our business, financial condition and results of operations.

The shutdown of the U.S.

federal government may adversely affect our business.

A prolonged or recurring shutdown of the U.S.

federal government may adversely affect our business operations and regulatory compliance.

During such shutdowns, while the SEC’s EDGAR system remains operational, the unavailability of SEC staff to review filings, issue comments, or declare registration statements effective may delay our ability to complete public offerings, respond to comment letters, or obtain timely regulatory approvals.

These delays could impact our access to capital markets, hinder strategic transactions, and create uncertainty around our disclosure obligations.

Additionally, the lack of interpretive guidance or exemptive relief during a shutdown may increase legal and compliance risks.

We continue to monitor developments and adjust our regulatory strategies accordingly, but there can be no assurance that future shutdowns will not materially affect our operations or financial condition.

Inadequate funding for the FDA, the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’ staffing and operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

Currently, federal agencies in the United States are operating under a federal government shutdown due to the expiration of the continuing resolution that expired on September 30, 2025.

The duration of the current government shutdown is unknown.

In addition, the current U.S.

administration is focused on reducing costs of the federal government generally, including significantly reducing the number of government employees.

Without appropriation of additional funding to federal agencies, our business operations related to our product development activities for the U.S.

market could be impacted.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, the ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes.

Average review times at the agency have fluctuated in recent years as a result.

In addition, government funding of the SEC and other government agencies on which our operations may rely is subject to the political process, which is inherently fluid and unpredictable.

Our business depends on timely interactions with the FDA, including the review of regulatory submissions, scheduling of formal meetings, and oversight of clinical trials.

Disruptions at the FDA and other federal agencies, including substantial leadership departures, personnel cuts, policy changes and those related to the federal government shutdown, may result in reduced staffing or suspension of non-essential FDA operations, which could delay or cancel meetings with the FDA, including our upcoming meetings with the FDA for planned clinical trials in patients with mPDAC and retinoblastoma, hinder regulatory guidance, cause delays in the implementation or enforcement of regulatory requirements in a timely fashion or at all, and postpone the review of IND applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs).

These disruptions may also affect the initiation, conduct, and monitoring of clinical trials, particularly those requiring FDA authorization or ongoing regulatory engagement.

Interruptions in FDA activities could materially delay our development timelines, increase operational costs, and adversely impact our ability to complete our ongoing and planned clinical trials and to advance product candidates toward approval and commercialization.

Any such delays or uncertainties may have a significant negative effect on our business, financial condition, and results of operations.

If the current U.S.

federal government shutdown is prolonged or if the FDA, National Institutes of Health (“NIH”), SEC or the United States Patent and Trademark Office (“USPTO”) experiences significant decreases in funding or personnel, it could significantly impact the ability of the FDA to issue licenses needed for conduct of our clinical trials, the NIH to conduct research or provide grants, and the abilities of the FDA and the USPTO to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Certain of our clinical trials are dependent on federal grant funding.

A lapse in appropriations resulting in a government shutdown could materially disrupt the timing and availability of these funds.

During such shutdowns, federal agencies may suspend the processing of new grant applications, delay reimbursements, or pause disbursements for existing awards.

These interruptions could adversely affect our ability to commence enrollment for the third cohort of our Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (“HCT”) recipients for the prevention of acute graft-versus-host-disease because we cannot fund the SYN-004 development program unless we receive grant funding.

If federal funding continues to be delayed, reduced or canceled, we may need to seek alternative sources of financing, scale back research efforts, or defer planned initiatives, any of which could have a material adverse effect on our financial condition and results of operations.

There is substantial uncertainty as to whether and how the new administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates and any products for which we obtain approval.

Additionally, the new administration could also issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new therapeutic candidates.

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.

What changed 10-Q

Item 1A. Risk Factors