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If we are unable to raise such financing or complete such a transaction, we may not be able to continue operations.
−Removed: In light of the expected development timeline to potentially obtain FDA approval for rNAPc2 or Gencaro, if at all, the substantial additional costs associated with the development of our product candidates, including the costs associated with clinical trials related thereto, and the substantial cost of commercializing rNAPc2 or Gencaro, if approved, we will need to raise substantial additional funding through public or private equity or debt transactions or a strategic combination or partnership.
+Added: As a result of the expected development timeline to potentially obtain FDA approval for rNAPc2 or Gencaro, if at all, the substantial additional costs associated with the development of our product candidates, including the costs associated with clinical trials related thereto, and the substantial cost of commercializing rNAPc2 or Gencaro, if approved, we will need to raise substantial additional funding through public or private equity or debt transactions or a strategic combination or partnership.
If we are delayed in obtaining funding or are unable to complete a strategic transaction, we may discontinue our development activities on rNAPc2, Gencaro and our other product candidates or discontinue our operations.
Even if we are able to fund continued development of rNAPc2, Gencaro or any of our other product candidates is approved, we expect that we will need to complete a strategic transaction or raise substantial additional funding through public or private equity or debt securities to successfully commercialize rNAPc2, Gencaro or any other product candidate.
−Removed: We believe our cash and cash equivalents as of March 31, 2021 will be sufficient to fund our operations through the end of fiscal year 2022.
+Added: We believe our cash and cash equivalents as of June 30, 2021 will be sufficient to fund our operations through the end of fiscal year 2022.
Conducting a Phase 3 rNAPc2 clinical trial or the Phase 3 PRECISION-AF trial would likely require additional financing .
−Removed: On July 22, 2020, we entered into a new sales agreement with a placement agent to sell, from time to time, our common stock having an aggregate offering price of up to $54.0 million, in an “at the market offering.” As of March 31, 2021, we sold an aggregate of 9,928,272 shares of our common stock pursuant to the terms of such sales agreement for aggregate gross proceeds of approximately $54.0 million.
+Added: On July 22, 2020, we entered into a new sales agreement with a placement agent to sell, from time to time, our common stock having an aggregate offering price of up to $54.0 million, in an “at the market offering.” As of June 30, 2021, we sold an aggregate of 9,928,272 shares of our common stock pursuant to the terms of such sales agreement for aggregate gross proceeds of approximately $54.0 million.
Net proceeds received in this offering were approximately $52.2 million, after deducting expenses for executing the “at the market offering” and commissions paid to the placement agent.
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In future periods, if we do not meet the minimum stockholders’ equity, minimum closing bid price requirements, or any other listing requirements, we would be subject to delisting from the Nasdaq Capital Market.
−Removed: As of May 10, 2021, the closing price of our common stock was $3.06 per share, and the total market value of our listed securities was approximately $44.1 million.
−Removed: As of March 31, 2021, we had stockholders’ equity of $65.9 million.
−Removed: Our financial statements for the quarter ended March 31, 2021 were prepared assuming that we will continue as a going concern.
+Added: As of August 3, 2021, the closing price of our common stock was $3.02 per share, and the total market value of our listed securities was approximately $43.5 million.
+Added: As of June 30, 2021, we had stockholders’ equity of $61.2 million.
+Added: Our financial statements for the quarter ended June 30, 2021 were prepared assuming that we will continue as a going concern.
Our management has concluded that due to our need for additional capital, and the uncertainties surrounding our ability to raise such funding, there may be uncertainty about our ability to continue as a going concern in future years.
−Removed: Our financial statements for the quarter ended March 31, 2021 were prepared assuming that we will continue as a going concern.
+Added: Our financial statements for the quarter ended June 30, 2021 were prepared assuming that we will continue as a going concern.
The going concern basis of presentation assumes that we will continue in operation for the foreseeable future and will be able to realize our assets and discharge our liabilities and commitments in the normal course of business and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from our inability to continue as a going concern.
As of December 31, 2019, our management and our independent registered public accounting firm concluded that, due to our need for additional capital and the uncertainties surrounding our ability to raise such funding, substantial doubt existed as to our ability to continue as a going concern for a period from one year after our annual financial statements had been issued.
−Removed: We believe our cash and cash equivalents as of March 31, 2021 will be sufficient to fund our operations through the end of fiscal year 2022.
+Added: We believe our cash and cash equivalents as of June 30, 2021 will be sufficient to fund our operations through the end of fiscal year 2022.
Conducting a Phase 3 rNAPc2 clinical trial or the Phase 3 PRECISION-AF trial would likely require additional financing .
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As a result, our business could be materially harmed.
−Removed: We will need to establish a collaborative arrangement with a third-party diagnostics services provider to obtain marketing clearance or approval of the companion genetic test.
+Added: We will need to establish a collaborative arrangement with a third-party diagnostics services provider to obtain marketing clearance or approval of the companion genetic test for Gencaro.
There is no guarantee that the FDA will grant timely clearance or approval of the genetic test, if at all, and failure to obtain such timely clearance or approval would adversely affect our ability to market Gencaro.
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Moreover, such delays or increased costs or failures could adversely affect our business, operating results and prospects for commercializing the genetic test.
−Removed: If a third-party diagnostics provider responsible for the genetic test or certain of its third-party suppliers fails to comply with ongoing FDA or other foreign regulatory authority requirements, or if there are unanticipated problems with the genetic test, these products could be subject to restrictions or withdrawal from use in a trial or from the market.
+Added: If a third-party diagnostics provider responsible for the genetic test associated with Gencarp or certain of its third-party suppliers fails to comply with ongoing FDA or other foreign regulatory authority requirements, or if there are unanticipated problems with the genetic test, these products could be subject to restrictions or withdrawal from use in a trial or from the market.
Any diagnostic for which a third-party diagnostics provider obtains clearance or approval, and the manufacturing processes, reporting requirements, post-approval clinical data and promotional activities for such product, will be subject to continued regulatory review, oversight and periodic inspections by the FDA and other domestic and foreign regulatory bodies.
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Sales in the public market of substantial amounts of our common stock could depress prevailing market prices of our common stock.
−Removed: As of March 31, 2021, approximately 14.4 million shares of common stock were outstanding, and all of these shares are freely transferable without restriction or further registration under the Securities Act of 1933, as amended, or the Securities Act, except for shares held by our directors, officers and other affiliates and unregistered shares held by non-affiliates.
+Added: As of June 30, 2021, approximately 14.4 million shares of common stock were outstanding, and all of these shares are freely transferable without restriction or further registration under the Securities Act of 1933, as amended, or the Securities Act, except for shares held by our directors, officers and other affiliates and unregistered shares held by non-affiliates.
The sale of these additional shares, or the perception that such sales may occur, could depress the market price of our common stock.
−Removed: As of March 3 1 , 202 1 , approximately 133,000 shares of our common stock were issuable upon the exercise of outstanding warrants.
+Added: As of June 30 , 202 1 , approximately 133,000 shares of our common stock were issuable upon the exercise of outstanding warrants.
Once a warrant is exercised, if the shares of our common stock issued upon the exercise of any such warrant are not available for sale in the open market without further registration under the Securities Act, then the holder can arrange for the resale of shares either by invoking any applicable registration rights, causing the shares to be registered under the Securities Act and thus freely transferable, or by relying on an exemption to the Securities Act.
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If these registration rights, or similar registration rights that may apply to securities we may issue in the future, are exercised, it could result in additional sales of our common stock in the market, which may have an adverse effect on our stock price.
−Removed: As of March 31, 2021, there were approximately 596,000 shares of our common stock which may be issued upon the exercise of outstanding stock options, and we anticipate that we will continue to issue stock option awards to our employees and consultants in the fiscal year ended December 31, 2021 and thereafter.
+Added: As of June 30, 2021, there were approximately 625,000 shares of our common stock which may be issued upon the exercise of outstanding stock options, and we anticipate that we will continue to issue stock option awards to our employees and consultants in the fiscal year ended December 31, 2021 and thereafter.
If and when these options are exercised, such shares will be available for sale in the open market without further registration under the Securities Act.
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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.