18 unchanged sentences
• our competitive position, and developments and projections relating to our competitors and our industry;
−Removed: • the impact of the COVID-19 coronavirus, or COVID-19, as a global pandemic and related public health issues.
+Added: • the impact of the COVID-19 coronavirus, or COVID-19, as a global pandemic and related public health issues, including potential material supplies and supply chain disruptions, hiring and retaining talent, and global or national economic impacts such as inflation.
Risks related to product development
24 unchanged sentences
We may also experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive marketing approval or commercialize our product candidates, including:
−Removed: • the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials or be lost to follow-up at a higher rate than we anticipate, or may elect to participate in alternative clinical trials sponsored by our competitors with product candidates that treat the same indications as our product candidates;
+Added: • the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials or be lost to follow-up at a higher rate than we anticipate, or may elect to participate in alternative clinical
+Added: trials sponsored by our competitors with product candidates that treat the same indications as our product candidates;
• regulators or institutional review boards, or IRBs, may not authorize us or our investigators to commence a clinical trial, conduct a clinical trial at a prospective trial site, or amend trial protocols, or may require that we modify or amend our clinical trial protocols;
91 unchanged sentences
Changes in product candidate manufacturing or formulation may result in additional costs or delay.
−Removed: As product candidates are developed through preclinical studies to later stage clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results.
+Added: As product candidates are developed through preclinical studies to later stage clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods, facilities, equipment and formulation, are altered along the way in an effort to optimize processes and results.
Any of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered materials.
205 unchanged sentences
We are not profitable and have incurred losses in each period since our inception.
−Removed: For the three months ended June 30, 2021 and 2020, we reported a net loss of $27.3 million and $17.5 million, respectively.
−Removed: At June 30, 2021, we had an accumulated deficit of $220.5 million.
+Added: For the six months ended September 30, 2021 and 2020, we reported a net loss of $56.7 million and $37.6 million, respectively.
+Added: At September 30, 2021, we had an accumulated deficit of $249.8 million.
We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek marketing approvals for, RP1, our other product candidates and any additional product candidates we may develop.
23 unchanged sentences
Our operations have consumed substantial amounts of cash since inception.
−Removed: At June 30, 2021, our cash and cash equivalents and short-term investments were $458.3 million.
+Added: At September 30, 2021, our cash and cash equivalents and short-term investments were $435.8 million.
We expect to continue to spend substantial amounts to continue the clinical and preclinical development of RP1 and our other product candidates.
267 unchanged sentences
The virus continues to spread globally, including the United States, the United Kingdom and other countries in which we conduct clinical trials, and has been declared a pandemic by the World Health Organization.
−Removed: The impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world.
+Added: The impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy and supply chains, as well as businesses and capital markets around the world.
In an effort to halt the outbreak of COVID-19, many countries, including the United States, the United Kingdom and certain other countries in which we conduct clinical trials, placed significant restrictions on travel and business operations or issued shelter-in-place orders.
89 unchanged sentences
• general economic, industry and market conditions;
−Removed: • political and economic instability, including the impact of COVID-19, the possibility of an economic recession, international hostilities, acts of terrorism and governmental restrictions, inflation, trade relationships and military and political alliances;
+Added: • political and economic instability, including the impact of COVID-19, the possibility of an economic recession, international hostilities, acts of terrorism and governmental restrictions, inflation, trade relationships, supply chain disruptions and military and political alliances;
• the other factors described in this “Risk factors” section.
22 unchanged sentences
• potential unforeseen business disruptions that increase our costs or expenses;
−Removed: • political and economic instability, including the impact of COVID-19, the possibility of an economic recession, international hostilities, acts of terrorism and governmental restrictions, inflation, trade relationships and military and political alliances;
+Added: • political and economic instability, including the impact of COVID-19, the possibility of an economic recession, international hostilities, acts of terrorism and governmental restrictions, inflation, trade relationships, supply chain disruptions and military and political alliances;
• future accounting pronouncements or changes in our accounting policies;
17 unchanged sentences
Our executive officers, directors, and stockholders and their affiliates who beneficially own more than 5% of our common stock exercise significant influence over our company, which limits your ability to influence corporate matters and could delay or prevent a change in corporate control.
−Removed: Based on the number of shares outstanding as of June 30, 2021, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates beneficially owned a significant portion of our voting stock and, accordingly, these stockholders will continue to have significant influence over matters requiring stockholder approval.
+Added: Based on the number of shares outstanding as of September 30, 2021, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates beneficially owned a significant portion of our voting stock and, accordingly, these stockholders will continue to have significant influence over matters requiring stockholder approval.
For example, these stockholders will continue to significantly influence elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction.
58 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.