4 unchanged sentences
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, 2022, our operating activities used net cash of approximately $13.7 million and our cash and cash equivalents were approximately 48.2 million as of November 1, 2022.
+Added: During the three months ended March 31, 2023, our operating activities used net cash of approximately $5.6 million and our cash and cash equivalents were approximately $35 million through early May.
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, 2022, our accumulated deficit totaled approximately $285.4 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 retinoblastoma trial and necessary G&A within a budgetary plan of approximately $27.8 million over the next three years.
+Added: As of March 31, 2023, our accumulated deficit totaled approximately $295.4 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 the next three years.
We expect to incur additional operating losses in the future and therefore expect our cumulative losses to increase.
1 unchanged sentence
We do not expect to derive revenue from any source in the near future until we or our potential partners successfully commercialize our products.
−Removed: 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
−Removed: product candidates.
+Added: 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.
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.
1 unchanged sentence
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.
−Removed: Based on our current plans, our cash and cash equivalents will be sufficient to complete our planned later stage clinical trials of VCN-01 (our proposed clinical trials in PDAC and retinoblastoma), Phase 1a/2a clinical trial of SYN-004, our Phase 1 multiple-ascending dose clinical trials of SYN-020, but may not be sufficient additional trials of SYN-020 or SYN-004, which are expected to require significant cash expenditures.
+Added: Based on our current plans, our cash and cash equivalents will be sufficient to complete our planned later stage clinical trials of VCN-01 (our proposed clinical trials in PDAC and retinoblastoma), Phase 1a/2a clinical trial of SYN-004, but may not be sufficient for additional trials of SYN-020 or 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.
4 unchanged sentences
In addition, we could be forced to delay, discontinue or curtail product development, forego sales and marketing efforts, and forego licensing in attractive business opportunities.
−Removed: Our ability to raise capital through the sale of securities may be limited by number of shares we have available for issuance and the rules of the SEC and NYSE American that place limits on the number and dollar amount of securities that may be sold.
+Added: Our ability to raise capital through the sale of securities may be limited by the rules of the SEC and NYSE American that place limits on the number and dollar amount of securities that may be sold.
There can be no assurances that we will be able to raise the funds needed, especially in light of the fact that our ability to sell securities registered on our registration statement on Form S-3 will be limited until such time the market value of our voting securities held by non-affiliates is $75 million or more.
4 unchanged sentences
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 15,844,061 shares of common stock were issued and outstanding as of September 30, 2022.
−Removed: At September 30, 2022, we had reserved 3,700,847 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 15,124,061 shares of common stock were issued and outstanding as of March 31, 2023.
+Added: At March 31, 2023, we had reserved 5,388,910 shares of common stock for issuance upon exercise of our outstanding options, preferred shares and warrants.
In addition, at such date, we had 4,906,998 shares of our common stock reserved for future issuance under our equity incentive plans.
5 unchanged sentences
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: If our acquired intangible assets become impaired, we may be required to record a significant charge to earnings.
−Removed: We regularly review acquired intangible assets for impairment when events or changes in circumstances indicate that the carrying value may not be recoverable.
−Removed: We test goodwill and indefinite-lived intangible assets for impairment at least annually.
−Removed: Factors that may be considered a change in circumstances, indicating that the carrying value of the intangible assets may not be recoverable, include:
−Removed: macroeconomic conditions, such as deterioration in general economic conditions;
−Removed: industry and market considerations, such as deterioration in the environment in which we operate;
−Removed: cost factors, such as increases in labor or other costs that have a negative effect on earnings and cash flows;
−Removed: our financial performance, such as negative or declining cash flows or a decline in actual or planned revenue or earnings compared with actual and projected results of relevant prior periods;
−Removed: other relevant entity-specific events, such as changes in management, key personnel, strategy, or customers;
−Removed: and sustained decreases in share price.
−Removed: Unfavorable U.S.
−Removed: or global economic conditions could adversely affect our business, financial condition or results of operations.
−Removed: Our results of operations could be adversely affected by general conditions in the global economy and financial markets.
−Removed: A severe or prolonged economic downturn could result in a variety of risks to our business, including weakened demand for our technologies and our ability to raise additional capital when needed on favorable terms, if at all.
−Removed: Recently, the rate of inflation has increased throughout the U.S.
−Removed: Inflation may adversely affect us by increasing the costs associated with performing research and development on internal research initiatives and partnered programs.
−Removed: We may experience significant increases in the prices of labor, consumables, and other costs of doing business.
−Removed: In an inflationary environment, such cost increases may outpace our expectations, causing us to use cash faster than forecasted.
−Removed: A weak or declining economy may also strain our partners, possibly resulting in supply disruption, or cause delays in their payments to us.
−Removed: Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.
−Removed: We have identified a material weakness 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: In addition, we are not yet required to perform an assessment of internal controls for VCN.
+Added: 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.
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.
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 first quarter of 2022, we identified a material weakness in our controls over financial reporting related to the accounting for non-routine transactions.
−Removed: Specifically, the controls related to the review of internal and externally prepared reports and analysis utilized in the financial reporting process and the related income tax implication of the non-routine transactions.
−Removed: Although management believes that the control deficiencies will be remediated by the end of the fiscal year there can be no assurance that the deficiency will be remediated at such time or that the internal control over financial reporting, as modified, will enable us to identify or avoid material weaknesses in the future.
−Removed: In addition, the material weakness will not be considered remediated until the applicable controls operate for a sufficient period of time and management has concluded, through testing, that these controls are designed and operating effectively.
−Removed: As permitted by the SEC, we have elected to exclude VCN from the assessment of internal control over financial reporting the year ending December 31, 2022.
−Removed: In conjunction with the acquisition of VCN, we are currently in the process of integrating VCN’s policies, processes, people, technology, and operations into the consolidated company, and integrating VCN’s operations into our system of internal control over financial reporting;
−Removed: however, we cannot assure you that such integration will be successful to enable us to identify or avoid material weaknesses in the future.
+Added: 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 over certain controls not being adequately documented.
+Added: 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.
+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.
+Added: 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.
+Added: In addition, a material weakness will not be considered remediated until the applicable controls operate for a sufficient period of time and management has concluded, through testing, that these controls are designed and operating effectively.
+Added: Although management believes that the material weaknesses will be remediated by the end of the fiscal year there can be no assurance that the deficiencies will be remediated at such time or that the internal control over financial reporting, as modified, will enable us to identify or avoid material weaknesses in the future.
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.