10 unchanged sentences
Failure to close the transaction could adversely impact the market price of our shares as well as our business and operating results, cash flows and results of operations.
−Removed: The closing of the transaction is contingent on completion of the successful reviews under antitrust laws in the United States, Australia, and the United Kingdom, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
−Removed: We cannot make any assurances that the transaction will be closed on the timeline currently contemplated or at all, or that, as part of the regulatory review process, that additional conditions or terms may be required.
−Removed: While we and CSL Behring intend to pursue vigorously all required governmental clearances, the requirement to receive these clearances before the closing of the transaction could delay the transaction or result in an inability to complete the transaction.
+Added: The closing of the transaction contemplated by the CSL Behring Agreement is contingent on completion of the successful reviews under antitrust laws in the United States, Australia, and the United Kingdom, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
+Added: We cannot make any assurances that the transaction will be closed at all, or that, as part of the regulatory review process, that additional conditions or terms may be required.
+Added: The requirement to receive these clearances before the closing of the transaction could delay the transaction or result in an inability to complete the transaction.
Any delay in the completion of the transaction could diminish anticipated benefits of the transaction, including realization of expected benefits of partnering, result in additional transaction costs, loss of revenue or other effects associated with uncertainty about the transaction.
3 unchanged sentences
These factors could adversely impact the cash flows and results that we are able to generate in relation to etranacogene dezaparvovec.
−Removed: To the extent that the market price of the ordinary shares of our common stock reflects positive market assumptions that the transaction will close or that the transaction is advantageous to us, the price of such shares may decline if the transaction does not close for any reason or in a timely manner.
+Added: To the extent that the market price of our ordinary shares reflects positive market assumptions that the transaction will close or that the transaction is advantageous to us, the price of such shares may decline if the transaction does not close for any reason or in a timely manner.
The announcement and pendency of the transaction with CSL Behring could adversely affect our business and operations.
16 unchanged sentences
Further, while the potential economic impact brought by, and the duration of, the COVID-19 pandemic is difficult to assess or predict, the impact of the COVID-19 pandemic on the global financial markets may reduce our ability to access capital, which could negatively impact our short-term and long-term liquidity.
−Removed: Additionally, the stock market has been unusually volatile during the COVID-19 outbreak and such volatility may continue.
−Removed: To date, during certain periods of the COVID-19 pandemic, our stock price fluctuated significantly, and such fluctuation may continue to occur.
The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change.
107 unchanged sentences
In addition, there is the potential risk of delayed adverse events following exposure to gene therapy products due to persistent biological activity of the genetic material or other components of products used to carry the genetic material.
−Removed: As of June 30, 2020, a total of three patients reported serious adverse events related to the treatment of AMT-060, our first generation hemophilia B gene therapy, in our Phase I/II trial, including one patient with a short, self-limiting fever in the first 24 hours after treatment and two patients with mild, asymptomatic elevations in liver transaminases.
−Removed: Additionally, one patient in our ongoing Phase IIb study of etranacogene dezaparvovec underwent hip surgery due to a pre-existing condition and was treated perioperatively with short-acting factor replacement.
−Removed: This was reported by the investigator as a serious adverse event unrelated to etranacogene dezaparvovec.
−Removed: Adverse events in our clinical trials or those conducted by other parties (even if not ultimately attributable to our product candidates), and the resulting publicity, could result in increased governmental regulation, unfavorable public perception, failure of the medical community to accept and prescribe gene therapy treatments, potential regulatory delays in the testing or approval of our product candidates, stricter labeling requirements for those product candidates that are approved and a decrease in demand for any such product candidates.
+Added: A small number of patients have experienced serious adverse events during our clinical trials of either AMT-060 (our first-generation hemophilia B gene therapy) or etranacogene dezaparvovec.
+Added: In each instance of a serious adverse event, whether or not attributed to one of our product candidates, the issues resolved without delay in the respective clinical trial.
+Added: However, adverse events in our clinical trials or those conducted by other parties (even if not ultimately attributable to our product candidates), and the resulting publicity, could result in delay, a hold or termination of our clinical trials, increased governmental regulation, unfavorable public perception, failure of the medical community to accept and prescribe gene therapy treatments, potential regulatory delays in the testing or approval of our product candidates, stricter labeling requirements for those product candidates that are approved and a decrease in demand for any such product candidates.
If any of these events should occur, it may have a material adverse effect on our business, financial condition and results of operations.
332 unchanged sentences
We have incurred significant losses to date, expect to incur losses over the next several years and may never achieve or maintain profitability.
−Removed: We had a net loss of $70.6 million in the six months ended June 30, 2020, $124.2 million in the full year 2019 and $83.3 million in the full year 2018.
−Removed: As of June 30, 2020, we had an accumulated deficit of $730.3 million.
+Added: We had a net loss of $124.3 million in the nine months ended September 30, 2020, $124.2 million in the full year 2019 and $83.3 million in the full year 2018.
+Added: As of September 30, 2020, we had an accumulated deficit of $784.0 million.
To date, we have financed our operations primarily through the sale of equity securities and convertible debt, venture loans, through upfront payments from our collaboration partners and, to a lesser extent, subsidies and grants from governmental agencies and fees for services.
1 unchanged sentence
We expect to continue to incur significant expenses and losses over the next several years, and our net losses may fluctuate significantly from quarter to quarter and year to year.
−Removed: Our losses will be materially impacted by the amount of license revenue that we will recognize in accordance with ASC 606 following the potential closing of our collaboration and license agreement with CSL Behring.
+Added: Our losses will be materially impacted by the amount of license revenue that we will recognize in accordance with ASC 606 in the event of the closing of the transactions contemplated by the CSL Behring Agreement.
We anticipate that our expenses will increase substantially as we:
● Advance the clinical development of AMT-130, our Huntington’s disease gene therapy program;
−Removed: ● Build-out our commercial and medical affairs infrastructure and seek marketing approval for any product candidates (including etranacogene dezaparvovec in case our collaboration and license agreement with CSL Behring would not close) that successfully complete clinical trials;
+Added: ● Build-out our commercial and medical affairs infrastructure and seek marketing approval for any product candidates (including etranacogene dezaparvovec in the event that the transactions contemplated by the CSL Behring Agreement do not close) that successfully complete clinical trials;
● Advance multiple research programs related to gene therapy candidates targeting liver-directed and CNS diseases;
16 unchanged sentences
Our existing and any future indebtedness could adversely affect our ability to operate our business.
−Removed: As of June 30, 2020, we had $35.0 million of outstanding principal of borrowings under the 2018 Amended Facility, which we are required to repay in monthly principal installments from January 2022 through June 2023.
+Added: As of September 30, 2020, we had $35.0 million of outstanding principal of borrowings under the 2018 Amended Facility, which we are required to repay in monthly principal installments from January 2022 through June 2023.
We could in the future incur additional debt obligations beyond our borrowings from Hercules.
98 unchanged sentences
Our share price has been and may in the future be volatile.
−Removed: From the start of trading of our ordinary shares on the Nasdaq Global Select Market on February 4, 2014 through July 28, 2020, the sale price of our ordinary shares ranged from a high of $82.49 to a low of $4.72.
−Removed: The closing price on July 28, 2020, was $39.52 per ordinary share.
+Added: From the start of trading of our ordinary shares on the Nasdaq Global Select Market on February 4, 2014 through October 22, 2020, the sale price of our ordinary shares ranged from a high of $82.49 to a low of $4.72.
+Added: The closing price on October 22, 2020, was $41.26 per ordinary share.
The stock market in general and the market for smaller biopharmaceutical companies in particular, have experienced extreme volatility that has often been unrelated to the operating performance of particular companies.
20 unchanged sentences
Our directors, executive officers and major shareholders, if they choose to act together, will continue to have a significant degree of control with respect to matters submitted to shareholders for approval.
−Removed: Our directors, executive officers and major shareholders holding more than 5% of our outstanding ordinary shares, in the aggregate, beneficially own approximately 46.0% of our issued shares (including such shares to be issued in relation to exercisable options to purchase ordinary shares) as at June 30, 2020.
+Added: Our directors, executive officers and major shareholders holding more than 5% of our outstanding ordinary shares, in the aggregate, beneficially own approximately 45.5% of our issued shares (including such shares to be issued in relation to exercisable options to purchase ordinary shares) as at September 30, 2020.
As a result, if these shareholders were to choose to act together, they may be able, as a practical matter, to control many matters submitted to our shareholders for approval, as well as our management and affairs.
83 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.