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● Our business and operations have been, and may continue to be, materially and adversely affected by the ongoing Covid pandemic.
+Added: ● We cannot predict when or if we will obtain marketing approval to commercialize any of our product candidates, or whether they will be commercially successful once approved.
● We may not be successful in our efforts to use our gene therapy technology platform to build a pipeline of additional product candidates.
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● Our resources might be adversely affected if we are unable to meet our product development and supply needs and obligations, including our ability to complete the validation of our existing manufacturing processes as well as to develop larger scale manufacturing processes, which could adversely affect our ability to sufficiently meet our future production needs or regulatory filing timelines.
−Removed: ● We cannot predict when or if we will obtain marketing approval to commercialize a product candidate.
● We are exposed to a number of external factors such as competition, insurance coverage of and pricing and reimbursement for our product candidates that may adversely affect our product revenue and that may cause our business to suffer.
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As evidenced by the postponement of procedures for two patients in our Phase I/II clinical study of AMT-130, the evolving Covid pandemic has impacted the pace of enrollment and procedures in our clinical trials, as well as caused challenges in scheduling follow-up visits and managing other aspects of our clinical trials.
−Removed: We may be affected by similar delays as patients may avoid or may not be able to travel to healthcare facilities and physicians’ offices unless due to a health emergency and clinical trial staff can no longer get to the clinic.
+Added: We may in the future be affected by similar delays as patients may avoid or may not be able to travel to healthcare facilities and physicians’ offices unless due to a health emergency and clinical trial staff can no longer get to the clinic.
Such facilities and offices have been and may continue to be required to focus limited resources on non-clinical trial matters, including treatment of Covid patients, thereby decreasing availability, in whole or in part, for clinical trial services.
In addition, employee disruptions and remote working environments related to the Covid pandemic, and federal, state, and local public health measures designed to mitigate the spread of the virus, have impacted, and could continue to negatively impact the efficiency and pace with which we work and develop our product candidates and our manufacturing capabilities.
−Removed: Further, while the potential economic impact brought by, and the duration of, the Covid pandemic is difficult to assess or predict, the impact of the Covid pandemic on global financial markets may reduce our ability to access capital, which could negatively impact our short-term and long-term liquidity.
+Added: Further, while the potential economic impact brought by, and the duration of, the Covid pandemic is difficult to assess or predict, the impact of the Covid pandemic on global financial markets may reduce our ability to access capital, which could negatively impact our long-term liquidity.
The ultimate impact of the Covid pandemic is highly uncertain and subject to change.
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We have never generated any significant revenue from product sales and may never be profitable.
−Removed: All our product candidates are in research or development.
+Added: All of our product candidates are in research or development.
We have not generated any revenues from the sale of products or manufacturing of our product for a licensee and do not expect to generate any such revenue before 2022.
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Even if our clinical development efforts result in positive data, our product candidates may not receive regulatory approval or be successfully introduced and marketed at prices that would permit us to operate profitably.
−Removed: We may encounter substantial delays in and impediments to the progress of our clinical trials or fail to demonstrate the safety and efficacy of our product candidates.
+Added: We have encountered and may encounter future delays in and impediments to the progress of our clinical trials or fail to demonstrate the safety and efficacy of our product candidates.
Clinical and non-clinical development is expensive, time-consuming, and uncertain as to outcome.
Our product candidates are in different stages of clinical or preclinical development, and there is a significant risk of failure or delay in each of these programs.
+Added: For example, we experienced an immaterial but unexpected delay when our clinical trials of etranacogene dezaparvovec were placed on clinical hold by the FDA from December 2020 to April 2021, following a preliminary diagnosis of hepatocellular carcinoma in one patient.
We cannot guarantee that any preclinical tests or clinical trials will be completed as planned or completed on schedule, if at all.
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Failure to confirm favorable results from earlier trials by demonstrating the safety and effectiveness of our products in later-stage clinical trials with larger patient populations could have a material adverse effect on our business, financial condition, and results of operations.
−Removed: Additionally, where there are differences in the early-stage and late-stage trials, such as the differences between AMT-060 and AMT-061, regulatory authorities may require additional or longer-term data in late-stage trials, which may delay regulatory submissions or approvals and which the regulatory authorities may ultimately not accept or approve.
+Added: Additionally, where there are differences in the early-stage and late-stage trials, such as the differences between AMT-060 and AMT-061, regulatory authorities may require additional or longer-term data in late-stage trials as compared to early-stage trials, which may delay regulatory submissions or approvals and which the regulatory authorities may ultimately not accept or approve.
Fast track product, breakthrough therapy, priority review, or Regenerative Medicine Advanced Therapy (“RMAT”) designation by the FDA, or access to the PRIME scheme by the EMA, for our product candidates may not lead to faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.
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If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those with whom they communicate, from using that technology or information to compete with us.
+Added: Risks Related to Acquisitions
+Added: Our acquisition strategy may not produce the cash flows expected or could result in additional costs and challenges.
+Added: Any acquisition, including the recent acquisition of Corlieve Therapeutics, could expose us to unknown liabilities and risks, and we may incur additional costs and expenses necessary to address an acquired company’s failure to comply with laws and governmental rules and regulations.
+Added: We could incur additional costs related to resources to align our business practices and operations.
+Added: Moreover, we cannot assure that the anticipated benefits of any acquisition would be realized in a timely manner, if at all.
+Added: In addition, the finalization of the valuation of the identifiable assets acquired in connection with the Corlieve Transaction could require us to expense all identifiable intangible assets without an alternative future use if we would determine that substantially all of the gross value of the assets is concentrated in a single identifiable asset or group of similar identifiable assets.
+Added: Additionally, the product candidate and intellectual property rights that we acquired in the Corlieve Transaction were developed and owned by Corlieve and its licensors and we have not yet demonstrated an ability to develop, advance, or run clinical trials with this product candidate.
+Added: As a result, we cannot ensure that we will be able to successfully advance this product candidate going forward.
Risks Related to Pricing and Reimbursement
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We have incurred significant losses in prior years and expect to incur losses over the next several years and may never achieve or maintain profitability.
−Removed: We had a net gain of $357.9 million in the six months ended June 30, 2021, and a net loss of $125.0 in the full year 2020 and $124.2 million in the full year 2019.
−Removed: As of June 30, 2021, we had an accumulated deficit of $426.8 million.
+Added: We had a net gain of $321.4 million in the nine months ended September 30, 2021, and a net loss of $125.0 million in the full year 2020 and $124.2 million in the full year 2019.
+Added: As of September 30, 2021, we had an accumulated deficit of $463.4 million.
In the past, we have financed our operations primarily through the sale of equity securities and convertible debt, venture loans, upfront payments from our collaboration partners and, to a lesser extent, subsidies and grants from governmental agencies and fees for services.
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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 profit in the three and six months ended June 30, 2021 was materially impacted by the amount of license revenue that we recognized as a result of the Closing of the transaction under the CSL Behring Agreement.
+Added: Our profit in the three and nine months ended September 30, 2021, was materially impacted by the amount of license revenue that we recognized as a result of the Closing of the transaction under the CSL Behring Agreement.
We anticipate that our expenses will increase substantially as we:
● advance the clinical development of AMT-130 for our Huntington’s disease gene therapy program;
−Removed: ● Advance multiple research programs related to gene therapy candidates targeting liver-directed and CNS diseases;
+Added: ● advance multiple research programs related to gene therapy candidates targeting liver-directed and central nervous system (“CNS”) diseases;
● continue to expand our employee base to support research and development, as well as general and administrative functions;
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● maintain, expand, and protect our intellectual property portfolio, including in-licensing additional intellectual property rights from third parties;
+Added: ● make potential future milestone payments related to the acquisition of Corlieve, if any.
We may never succeed in these activities and, even if we do, may never generate revenues that are sufficient to achieve or sustain profitability.
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Our existing and any future indebtedness could adversely affect our ability to operate our business.
−Removed: As of June 30, 2021, we had $70.0 million of outstanding principal of borrowings under the 2018 Amended Facility and 2021 Amended Facility, which following our January 2021 amendment we are required to repay in June 2023.
+Added: As of September 30, 2021, we had $70.0 million of outstanding principal of borrowings under the 2018 Amended Facility and 2021 Amended Facility, which following our January 2021 amendment we are required to repay in June 2023.
We could in the future incur additional debt obligations beyond our borrowings from Hercules.
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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 22, 2021, 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 22, 2021, was $26.49 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 21, 2021, 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 21, 2021, was $28.24 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.
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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 54.9% of our issued shares (including such shares to be issued in relation to exercisable options to purchase ordinary shares) as at June 30, 2021.
+Added: Our directors, executive officers and major shareholders holding more than 5% of our outstanding ordinary shares, in the aggregate, beneficially own approximately 54.8% of our issued shares (including such shares to be issued in relation to exercisable options to purchase ordinary shares) as at September 30, 2021.
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.
75 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.