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• 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;
−Removed: • the ongoing military conflict between Russia and Ukraine and the impact on the global economy and related governmental imposed sanctions and potential material supplies and supply chain disruptions and global or national economic impacts such as inflation.
+Added: • the ongoing Russian-Ukrainian and Israel-Hamas military conflicts, and their impact on the global economy and related governmental imposed sanctions and potential material supplies and supply chain disruptions and global or national economic impacts such as inflation.
Risks related to product development
383 unchanged sentences
We are not profitable and have incurred losses in each period since our inception.
−Removed: For the three months ended June 30, 2023 and 2022, we reported a net loss of $49.6 million and $42.3 million, respectively.
−Removed: At June 30, 2023, we had an accumulated deficit of $535.0 million.
+Added: For the three months ended September 30, 2023 and 2022, we reported a net loss of $60.0 million and $43.1 million, respectively.
+Added: At September 30, 2023, we had an accumulated deficit of $595.1 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.
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Our operations have consumed substantial amounts of cash since inception.
−Removed: At June 30, 2023, our cash and cash equivalents and short-term investments were $539.1 million.
+Added: At September 30, 2023, our cash and cash equivalents and short-term investments were $496.8 million.
We expect to continue to spend substantial amounts to continue the clinical and preclinical development of RP1 and our other product candidates.
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Until we can generate sufficient product revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements.
−Removed: Based on our current operating plan, we expect that our existing cash and cash equivalents and short-term investments,as of June 30, 2023 will enable us to fund operations into the second half of calendar 2025.
+Added: Based on our current operating plan, we expect that our existing cash and cash equivalents and short-term investments, as of September 30, 2023 will enable us to fund operations into the second half of calendar 2025.
We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
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and (ii) a herpes simplex virus, wherein the herpes simplex virus lacks a functional ICP34.5 encoding gene and a functional ICP47 encoding gene, and comprises a gene encoding human GM-CSF.
−Removed: We believe the USPTO erred in its issuance of the ‘938 Patent for at least the reason that the invention covered by the claims of the ‘938 Patent was in the public domain prior to the filing date of the '938 Patent, and accordingly on November 2, 2022, we filed a petition for inter partes review with the Patent Trial and Appeal Board (PTAB) of the USPTO, seeking to invalidate certain claims of United States Patent 10,034,938 (the ‘938 Patent).
+Added: On November 2, 2022, we filed a petition for inter partes review with the Patent Trial and Appeal Board (PTAB) of the USPTO, seeking to invalidate certain claims of United States Patent 10,034,938 (the ‘938 Patent).
+Added: In August 2023 we entered into a Settlement Agreement with Amgen and mutually agreed to terminate our challenges to their patents.
+Added: In connection with the Settlement Agreement, we entered into a License and Covenant Agreement with Amgen in which we agreed to pay Amgen low single-digit royalty payments on net sales of our products that, but for the license, could be found to infringe a valid Amgen patent on a country-by-country and product-by-product basis.
Third parties may assert infringement or other intellectual property claims against us based on existing patents or patents that may be filed and/or granted in the future.
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In addition, we are developing certain of our product candidates in combination with nivolumab and cemiplimab, which are covered by patents or licenses held by BMS and Regeneron, respectively, to which we do not have a license other than for use in connection with the applicable clinical trial.
−Removed: We also may develop our product candidates in combination with products developed by additional companies that are covered by patents or licenses held by those entities to which we do not have a license.
−Removed: In the event that a labeling instruction is required in product packaging recommending that combination, we
−Removed: could be accused of, or held liable for, infringement of the third-party patents covering the product candidate or product recommended for administration with RP1 or our other product candidates.
+Added: We also may develop our product candidates in combination with
+Added: products developed by additional companies that are covered by patents or licenses held by those entities to which we do not have a license.
+Added: In the event that a labeling instruction is required in product packaging recommending that combination, we could be accused of, or held liable for, infringement of the third-party patents covering the product candidate or product recommended for administration with RP1 or our other product candidates.
In such a case, we could be required to obtain a license from the other company or institution to use the required or desired package labeling, which license may not be available on commercially reasonable terms, or at all.
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We may in the future seek collaboration arrangements with other parties for the development or commercialization of our product candidates.
−Removed: The success of any collaboration arrangements may depend on the efforts and activities of our collaborators.
+Added: The success of any collaboration arrangements may depend on the efforts and activities of our
+Added: collaborators.
Collaborators generally have significant discretion in determining the efforts and resources that they will apply to these arrangements.
−Removed: Disagreements between parties to a collaboration arrangement regarding clinical development and
−Removed: commercialization matters can lead to delays in the development process or commercializing the applicable product candidate and, in some cases, termination of the collaboration arrangement.
+Added: Disagreements between parties to a collaboration arrangement regarding clinical development and commercialization matters can lead to delays in the development process or commercializing the applicable product candidate and, in some cases, termination of the collaboration arrangement.
Collaborations with biopharmaceutical companies and other third parties often are terminated or allowed to expire by the other party.
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Additionally, if any future collaborator of ours is involved in a business combination, the collaborator might de-emphasize or terminate development or commercialization of any product candidate it licenses to us.
−Removed: If one of our collaborators
−Removed: terminates its agreement with us, we may find it more difficult to attract new collaborators and our reputation in the business and financial communities could be adversely affected.
+Added: If one of our collaborators terminates its agreement with us, we may find it more difficult to attract new collaborators and our reputation in the business and financial communities could be adversely affected.
We face significant competition in seeking appropriate collaborators.
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we may not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates;
−Removed: we may not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates, or we or they may be subject to regulatory enforcement actions.
+Added: we may not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates, or we or they may be subject to regulatory
+Added: enforcement actions.
As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed.
−Removed: To the extent we are unable to
−Removed: successfully identify and manage the performance of third-party service providers in the future, our business, financial condition, results of operations, stock price and prospects may be materially harmed.
+Added: To the extent we are unable to successfully identify and manage the performance of third-party service providers in the future, our business, financial condition, results of operations, stock price and prospects may be materially harmed.
If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative providers or to do so on commercially reasonable terms.
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If the manufacturers upon which we rely fail to produce our raw materials or process consumables in the volumes that we require on a timely basis, or fail to comply with stringent regulations applicable to biopharmaceutical manufacturers, we may face delays in the development and commercialization of, or be unable to meet demand for, our product candidates and may lose potential revenues.
−Removed: We continue to rely on third-party contract manufacturers to manufacture our raw materials and clinical trial product supplies until our in-house manufactured clinical trial product supplies are qualified for use in our clinical trials.
+Added: We continue to rely on third-party contract manufacturers to manufacture our raw materials and certain clinical trial product supplies.
As a result, there can be no assurance that our clinical development or commercial supplies will not be limited, interrupted, or of satisfactory quality or continue to be available at acceptable prices.
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We also may participate in collaborations and relationships with third parties whose actions, if noncompliant, could potentially subject us to liability under the FCPA, Bribery Act or local anticorruption laws.
−Removed: We are also subject to other laws and regulations governing our international operations, including regulations administered by the governments of the United States and the United Kingdom and authorities in the European Union, including applicable import and export control regulations, economic sanctions on countries and persons, anti-money laundering laws, customs requirements and currency exchange regulations, collectively referred to as the trade control laws.
+Added: We are also subject to other laws and regulations governing our international operations, including regulations administered by the governments of the United States and the United Kingdom and authorities in the European Union, including applicable import and export control regulations, economic
+Added: sanctions on countries and persons, anti-money laundering laws, customs requirements and currency exchange regulations, collectively referred to as the trade control laws.
We can provide no assurance that we will be completely effective in ensuring our compliance with all applicable anticorruption laws or other legal requirements, including trade control laws.
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Changes in our management team resulting from the hiring or departure of executives and key employees from time to time could disrupt our business.
−Removed: For example, in May 2023, we announced Jean Franchi, our Chief Financial Officer notified us of her resignation from the Company effective June 2, 2023.
These changes and any future significant leadership changes or senior management transitions involve inherent risk.
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There can be no assurance that our security efforts and measures will be effective or that attempted security breaches or disruptions would not be successful or damaging.
−Removed: Our internal computer systems and those of our contractors and consultants are vulnerable to damage or interruption from computer viruses, unauthorized or inappropriate access or use, natural disasters, pandemics (including COVID-19), terrorism, war (including the ongoing conflict in Ukraine), and telecommunication and electrical failures.
+Added: Our internal computer systems and those of our contractors and consultants are vulnerable to damage or interruption from computer viruses, unauthorized or inappropriate access or use, natural disasters, pandemics (including COVID-19), terrorism, war (including the ongoing conflicts in Ukraine and Israel), and telecommunication and electrical failures.
Such events could cause interruption of our operations.
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• 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 including, but not limited to, the ongoing military conflict between Russia and Ukraine, acts of terrorism, governmental restrictions and sanctions, inflation, global supply chain disruptions, 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 including, but not limited to, the ongoing Russian-Ukrainian and Israel-Hamas military conflicts, acts of terrorism, governmental restrictions and sanctions, inflation, global supply chain disruptions, trade relationships 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, including, but not limited to, those resulting from the ongoing military conflict between Russia and Ukraine, acts of terrorism, governmental restrictions and sanctions, inflation, global supply chain disruptions, 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, including, but not limited to, those resulting from the ongoing Russian-Ukrainian and Israel-Hamas military conflicts, acts of terrorism, governmental restrictions and sanctions, inflation, global supply chain disruptions, trade relationships and military and political alliances;
• future accounting pronouncements or changes in our accounting policies;
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Any sales of securities by these stockholders could have a material adverse effect on the market price of our common stock.
−Removed: We may sell up to $93.3 million of shares of our common stock in “at-the-market” offerings pursuant to a Sales Agreement entered into on June 23, 2022 with SVB Leerink LLC, or the 2022 Sales Agreement.
+Added: We may sell up to $250.0 million of shares of our common stock in “at-the-market” offerings pursuant to a Sales Agreement entered into on August 3, 2023 with Leerink Partners LLC, or the 2023 Sales Agreement.
The sale of a substantial number of shares of our common stock pursuant to the 2023 Sales Agreement, or anticipation of such sales, could cause the trading price of our common stock to decline or make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise desire.
38 unchanged sentences
Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets.
−Removed: The financial markets and the global economy may also be adversely affected by the current or anticipated impact of military conflict, including the ongoing conflict between Russia and Ukraine, terrorism or other geopolitical events.
+Added: The financial markets and the global economy may also be adversely affected by the current or anticipated impact of military conflict, including the ongoing Russian-Ukrainian and Israel-Hamas military conflicts, terrorism or other geopolitical events.
Sanctions imposed by the United States and other countries in response to such conflicts may also adversely impact our clinical trials, the financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability.
A weak or declining economy or political disruption, including any international trade disputes, could disrupt or otherwise adversely impact our operations and those of third parties upon which we rely.
−Removed: Although we do not currently operate in Russia or Ukraine, if the conflict broadens it may impact countries or territories in which we do operate or intend to operate, which could have a negative impact on our ability to achieve our objectives or timelines.
+Added: Although we do not currently operate in Russia, Ukraine, Israel or territories under Hamas control, if these conflicts broaden it may impact countries or territories in which we do operate or intend to operate, which could have a negative impact on our ability to achieve our objectives or timelines.
The increasing focus on environmental sustainability and social initiatives could increase our costs, harm our reputation and adversely impact our financial results.
11 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.