54 unchanged sentences
The extent to which the ongoing COVID-19 pandemic will continue to impact our business is uncertain and cannot be predicted.
−Removed: The pandemic’s impact on our business will depend on a variety of factors, including the timing, extent, effectiveness and durability of vaccine programs or other treatments, new or continuing travel and other restrictions and public health measures, such as social distancing, business closures or disruptions.
+Added: The pandemic’s impact on our business will depend on a variety of factors, including the timing, extent, effectiveness and durability of vaccine programs or other treatments, new or continuing travel and other restrictions and public health measures, such as social distancing, business closures or disruptions, and the development and spread of COVID-19 variants.
The effectiveness of actions taken in the United States and other countries to contain, ameliorate the impact of and treat the disease and to address its impact, is not yet known.
12 unchanged sentences
In addition, since March 2020, Alameda County, California, where our headquarters are located, has been subject to various “shelter-in-place” regulations and guidance related to the pandemic.
+Added: While the “shelter-in-place” orders have terminated or been phased out along with the reopening of businesses in Alameda County, California, we may continue to be subject to capacity restrictions and health and safety recommendations that encourage continued social distancing and remote work, limiting or ability to return to pre-pandemic levels of activity.
Our laboratory facilities currently remain open for research activities that cannot be conducted remotely, with heightened safety measures designed to minimize occupational exposure and reduce transmission of COVID-19 within our workplace.
14 unchanged sentences
We expect that our financial condition and operating results will fluctuate significantly from period to period due to a variety of factors, many of which are beyond our control, including the success of our programs, decisions by regulatory bodies, actions taken by competitors and other factors identified in these risk factors.
−Removed: Accordingly, the likelihood of our success must be evaluated in light of many potential challenges and variables associated with a clinical-stage biopharmaceutical company, many of which are outside of our control, and past results, including operating or financial results, should not be relied on as an indication of future results.
+Added: Accordingly, the likelihood of our success must be evaluated in light of many potential challenges and variables associated with a
+Added: clinical-stage biopharmaceutical company, many of which are outside of our control, and past results, including operating or financial results, should not be relied on as an indication of future results.
We are heavily dependent on the success of our product candidates in clinical development, and if any of these products fail to receive regulatory approval or are not successfully commercialized, our business would be adversely affected.
27 unchanged sentences
We may experience delays in ongoing clinical trials, and we do not know whether planned clinical trials will begin on time, need to be redesigned, enroll patients on time or be completed on schedule, if at all.
−Removed: Clinical trials can be
−Removed: delayed for a variety of reasons, including if a clinical trial is modified, suspended or terminated by us, by the institutional review boards or ethics committees of the institutions in which such clinical trials are being conducted, by a Data Safety Monitoring Board, for such trial or by the FDA or other regulatory authorities.
+Added: Clinical trials can be delayed for a variety of reasons, including if a clinical trial is modified, suspended or terminated by us, by the institutional review boards or ethics committees of the institutions in which such clinical trials are being conducted, by a Data Safety Monitoring Board, for such trial or by the FDA or other regulatory authorities.
Such authorities may impose a modification, suspension or termination due to a number of factors.
28 unchanged sentences
We have incurred significant operating losses every year since inception and expect to continue to incur operating losses for the foreseeable future.
−Removed: As of March 31, 2021, we had an accumulated deficit of $307.8 million.
+Added: As of June 30, 2021, we had an accumulated deficit of $338.7 million.
We expect to continue to incur significant research, development and other expenses related to our ongoing operations and product development.
10 unchanged sentences
Absent the funding support from this agreement, our further development of the collaboration product candidates would require significant additional capital from us, or the establishment of alternative collaborations with third parties, which may not be possible.
−Removed: As of March 31, 2021, we had cash, cash equivalents and marketable securities of $279.7 million.
+Added: As of June 30, 2021, we had cash, cash equivalents and marketable securities of $380.4 million.
Based upon our current operating plan and expected expenditures, we believe that our existing cash, cash equivalents, and marketable securities and proceeds from our debt facility will be sufficient to fund our operations for at least the next 12 months.
28 unchanged sentences
Even if we establish other collaboration arrangements, any such collaboration may not ultimately be successful, which could have a negative impact on our business, results of operations, financial condition and growth prospects.
−Removed: If we enter into collaborations limited to certain territories, we may not maintain significant rights or control of future development and commercialization of any product candidate subject to the collaboration and potential disputes could develop in the future over the terms of the collaboration and the respective rights of the parties, such as our ongoing dispute with Zealand Pharma related to our collaboration that ended in 2014.
+Added: If we enter into collaborations limited to certain territories, we may not maintain significant rights or control of future development and commercialization of any product candidate subject to the collaboration and potential disputes could develop in the future over the terms of the collaboration and the respective rights of the parties, such as our ongoing dispute with Zealand related to our collaboration that ended in 2014.
We rely on third parties to conduct our pre-clinical studies and clinical trials.
162 unchanged sentences
We expect to expand the size of our organization, and we may experience difficulties in managing this growth.
−Removed: As of March 31, 2021, we had 83 full-time equivalent employees, including 63 full-time equivalent employees engaged in research and development.
+Added: As of June 30, 2021, we had 101 full-time equivalent employees, including 81 full-time equivalent employees engaged in research and development.
As our development and commercialization plans and strategies develop, we expect to need additional managerial, operational, scientific, sales, marketing, research, development, regulatory, manufacturing, financial and other resources.
5 unchanged sentences
The size and complexity of our internal computer systems and those of our CROs, contract manufacturers, collaboration partner, and other third parties on which we rely may make them potentially vulnerable to breakdown, telecommunications and electrical failures, malicious intrusion such as ransomware and computer viruses that may result in the impairment of key business processes.
−Removed: Those systems and processes require appropriate training and adherence to security protocols by our personnel and third parties personnel.
+Added: Those systems and processes require appropriate training and adherence to security protocols by our personnel and third-party personnel.
In addition, our systems are potentially vulnerable to data security breaches, by employees or others, that may expose sensitive data to unauthorized persons.
212 unchanged sentences
Our stock price has fluctuated in the past and is likely to be volatile in the future.
−Removed: From January 1, 2020 through March 31, 2021, the reported sale price of our common stock has fluctuated between $5.30 and $32.10 per share.
+Added: From January 1, 2020 through June 30, 2021, the reported sale price of our common stock has fluctuated between $5.30 and $45.93 per share.
The stock market in general and the market for biotechnology companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies.
6 unchanged sentences
This assessment needs to include disclosure of any material weaknesses identified by our management in our internal control over financial reporting.
−Removed: In addition, if our public float on June 30, 2021 is greater than or equal to $700.0 million, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting beginning with our Annual Report required to be filed with the SEC for the fiscal year ending December 31, 2021.
+Added: Our public float on June 30, 2021 was greater than $700.0 million, and our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting beginning with our Annual Report required to be filed with the SEC for the fiscal year ending December 31, 2021.
At that time, if we have a material weakness, we would receive an adverse opinion regarding our internal control over financial reporting from our independent registered accounting firm.
35 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.