9 unchanged sentences
• Our prospects were highly dependent on a single product candidate, ADAIR.
−Removed: As the SEAL study of ADAIR did not meet its predefined clinical endpoint, we are currently assessing the best path forward for ADAIR and have been evaluating other strategic alternatives to maximize stockholder value, which we may not be successful in.
+Added: As the SEAL study of ADAIR did not meet its predefined clinical endpoint, we are currently assessing the best path forward for ADAIR and have been evaluating other strategic alternatives to maximize stockholder value, which may not be successful.
• We have no approved products and a limited operating history, which may make it difficult to evaluate our technology and product development capabilities and predict our future performance.
10 unchanged sentences
We have significantly reduced our research and development activities to reduce operating expenses while we evaluate these opportunities.
−Removed: We expect to devote significant time and resources to identifying and evaluating strategic transactions;
+Added: We expect to devote significant time and
+Added: resources to identifying and evaluating strategic transactions;
however, there can be no assurance that such activities will result in any agreements or transactions that will enhance stockholder value.
−Removed: In addition, potential strategic transactions that require stockholder
−Removed: approval may not be approved by our stockholders or a counterparty’s stockholders.
+Added: In addition, potential strategic transactions that require stockholder approval may not be approved by our stockholders or a counterparty’s stockholders.
Further, any strategic transaction that is completed ultimately may not deliver the anticipated benefits or enhance stockholder value.
25 unchanged sentences
In addition, we may be subject to litigation or other claims related to a dissolution and liquidation of the Company.
−Removed: If a dissolution and liquidation were pursued, our board of directors, in consultation with our advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve.
+Added: If a dissolution and liquidation were pursued, our board of directors, in consultation with our advisors, would need to evaluate these matters and make a determination about a
+Added: reasonable amount to reserve.
Accordingly, holders of our common stock could lose all or a significant portion of their investment in the event of a liquidation, dissolution or winding up of the Company.
19 unchanged sentences
Our ability to generate product revenue or profits was dependent on the successful development and eventual commercialization of ADAIR.
−Removed: Given that the topline data from our SEAL study of ADAIR for the treatment of ADHD failed to meet statistical significance for the primary endpoint of E max Drug Liking ad we are assessing the best path forward for the ADAIR program, we may never be able to develop or commercialize a marketable product.
+Added: Given that the topline data from our SEAL study of ADAIR for the treatment of ADHD failed to meet statistical significance for the primary endpoint of E max Drug Liking and we are assessing the best path forward for the ADAIR program, we may never be able to develop or commercialize a marketable product.
Our current and future programs and product candidates will require additional discovery research, preclinical development, clinical development, regulatory approval to commercialize the product, manufacturing validation, obtaining manufacturing supply, capacity and expertise, building of a commercial and distribution organization, substantial investment and significant marketing efforts before we generate any revenue from product sales.
1 unchanged sentence
Our limited operating history may make it difficult to evaluate our, or any new, technology and industry and predict its future performance.
−Removed: Our short history as an operating company makes any assessment of our future success or viability subject to significant uncertainty.
+Added: Our short history as an operating company makes any assessment of our future success or viability subject to significant
We will encounter risks and difficulties frequently experienced by early-stage companies in evolving fields.
If we do not address these risks successfully, our business will suffer.
−Removed: Similarly, we expect that our financial condition and operating results will
−Removed: fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control.
+Added: Similarly, we expect that our financial condition and operating results will fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control.
As a result, our stockholders should not rely upon the results of any quarterly or annual period as an indicator of future operating performance.
4 unchanged sentences
As a result, we are not profitable and have incurred losses in each period since our inception.
−Removed: For the three months ended March 31, 2022, we reported a net loss of $2.6 million.
−Removed: As of March 31, 2022, we had an accumulated deficit of $24.5 million.
+Added: For the six months ended June 30, 2022, we reported a net loss of $4.4 million.
+Added: As of June 30, 2022, we had an accumulated deficit of 26.3 million.
To become and remain profitable, we or any potential future collaborator must develop and eventually commercialize products with significant market potential at an adequate profit margin after cost of goods sold and other expenses.
10 unchanged sentences
While we plan to significantly decrease our research and development expenses as we assess the best path forward for ADAIR, we expect to continue to spend a considerable amount of resources on pursuing strategic opportunities.
−Removed: Furthermore, to further the development of ADAIR or any other product candidates, we would be required to spend substantial amounts to conduct clinical trials of such programs, to validate the manufacturing process and specifications for any such product candidate, to seek regulatory approvals for such product candidate and to launch and commercialize any products for which we receive regulatory approval, including potentially building our own commercial organization.
−Removed: As of March 31, 2022, we had $5.2 million of cash, cash equivalents and marketable securities on hand.
+Added: Furthermore, to move forward with the development of ADAIR or any other product candidates, we would be required to spend substantial amounts to conduct clinical trials of such programs, to validate the manufacturing process and specifications for any such product candidate, to seek regulatory approvals for such product candidate and to launch and commercialize any products for which we receive regulatory approval, including potentially building our own commercial organization.
+Added: As of June 30, 2022, we had $7.0 million of cash, cash equivalents and marketable securities on hand.
Our future capital requirements and the period for which our existing resources will support our operations may vary significantly from what we currently expect and may change if our business plan changes from our current expected operating plan.
9 unchanged sentences
• undertaking and completing additional pre-clinical studies to generate data required to support the clinical development of a product candidate;
−Removed: • inability to enroll sufficient patients to complete a protocol;
+Added: • inability to enroll sufficient patients to complete clinical trials;
• difficulty in having patients complete a trial or return for post-treatment follow-up;
15 unchanged sentences
If we raise additional capital through debt financing, we would be subject to fixed payment obligations and may be subject to covenants limiting or restricting its ability to take specific actions, such as incurring additional debt, making capital expenditures, declaring dividends or acquiring or licensing intellectual property rights.
−Removed: If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to its product candidate, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us.
−Removed: We also could be required to seek collaborators for one or more of our current or future
−Removed: product candidates at an earlier stage than otherwise would be desirable or relinquish our rights to product candidates or technologies that we otherwise would seek to develop or commercialize ourself.
+Added: If we raise additional capital through marketing
+Added: and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to its product candidate, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us.
+Added: We also could be required to seek collaborators for one or more of our current or future product candidates at an earlier stage than otherwise would be desirable or relinquish our rights to product candidates or technologies that we otherwise would seek to develop or commercialize ourself.
If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of our other research and development initiatives.
4 unchanged sentences
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.