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● Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives relating to the discovery, development and commercialization of our product candidates.
−Removed: ● We will require substantial additional capital to finance our operations.
−Removed: ● Our operations and financial results could be adversely impacted by the novel coronavirus disease (COVID-19) pandemic in the United States and the rest of the world.
−Removed: ● We are substantially dependent on the success of our lead product candidate, EDG-5506, which is currently in a Phase 1 clinical trial.
+Added: ● We will require substantial additional capital to finance our operations before we are able to generate any revenue.
+Added: ● Our operations and financial results could be adversely impacted by the coronavirus disease (COVID-19) pandemic in the United States and the rest of the world.
+Added: ● We are substantially dependent on the success of our lead product candidate, EDG-5506, for which we plan to initiate a Phase 2 clinical trial.
If we are unable to complete development of, obtain approval for and commercialize EDG-5506 for one or more indications in a timely manner, our business will be harmed.
−Removed: ● Our prospects depend in part upon discovering, developing and commercializing product candidates from our EDG-6289, EDG-002 and EDG-003 programs and discovering, developing and commercializing product candidates in future programs.
+Added: ● Our prospects depend in part upon discovering, developing and commercializing product candidates such as EDG-5440 and product candidates from our EDG-002 program and discovering, developing and commercializing product candidates in future programs.
● Clinical drug development involves a lengthy and expensive process with an uncertain outcome.
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As a result, we may fail to capitalize on other indications or product candidates that may ultimately have proven to be more profitable.
−Removed: ● We face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer or less expensive than the product candidates we
−Removed: develop, our commercial opportunities will be negatively impacted.
+Added: ● We face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer or less expensive than the product candidates we develop, our commercial opportunities will be negatively impacted.
In particular, we face competition for patients with DMD from companies that produce corticosteroids and exon skipping drugs, companies that are targeting dystrophin mechanisms and non-dystrophin mechanisms and companies that are developing gene therapies.
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Most of our product candidates are still in preclinical development and have never been tested in human subjects.
−Removed: In October 2020, we initiated our Phase 1 clinical trial for our lead product candidate, EDG-5506, and have not initiated clinical trials for any other product candidate.
−Removed: Since our inception in 2017, we have devoted substantially all of our focus and financial resources to discovering, identifying and developing potential product candidates, including advancing our development programs, conducting preclinical studies of our product candidates and initiating a clinical trial, organizing and staffing our company, business planning, raising capital and securing related intellectual property rights.
−Removed: We have not yet demonstrated our ability to successfully complete any clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a third-party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.
+Added: We plan to initiate Phase 2 clinical trials for our lead product candidate, EDG-5506, and have not initiated clinical trials for any other product candidate.
+Added: Since our inception in 2017, we have devoted substantially all of our focus and financial resources to discovering, identifying and developing potential product candidates, including advancing our development programs, conducting preclinical studies of our product candidates and initiating clinical trials, organizing and staffing our company, business planning, raising capital and securing related intellectual property rights.
+Added: We have not yet demonstrated our ability to obtain marketing approvals, manufacture a commercial-scale product or arrange for a third-party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.
As a result, it may be more difficult for investors to accurately predict our likelihood of success and viability than it could be if we had a longer operating history.
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We have incurred significant net losses since our inception, have not generated any revenue to date and have financed our operations principally through private placements of our convertible preferred stock.
−Removed: Our net loss was $12.9 million and $30.1 million for the three and nine months ended September 30, 2021, respectively.
−Removed: As of September 30, 2021, we had an accumulated deficit of $64.3 million.
−Removed: Our lead product candidate, EDG-5506, is in a Phase 1 clinical trial that commenced in October 2020.
+Added: Our net loss was $14.7 million for the three months ended March 31, 2022.
+Added: As of March 31, 2022, we had an accumulated deficit of $91.6 million.
+Added: Our lead product candidate, EDG-5506, recently completed a Phase 1 clinical trial, and we anticipate initiation of Phase 2 trials in individuals with BMD in the second quarter of 2022 and DMD in the
+Added: second half of 2022.
Our other programs are in preclinical discovery and research stages.
−Removed: As a result, we expect that it will be several years, if ever, before we receive approval to
−Removed: commercialize a product and generate revenue from product sales.
+Added: As a result, we expect that it will be several years, if ever, before we receive approval to commercialize a product and generate revenue from product sales.
Even if we succeed in receiving marketing approval for and commercializing one or more of our approved product candidates, we expect that we will continue to incur substantial research and development and other expenses in order to discover, develop and market additional potential products.
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Our ability to generate revenue and achieve profitability depends significantly on our ability, or any future collaborator’s ability, to achieve several objectives, including:
−Removed: successful and timely completion of preclinical and clinical development of EDG-5506, our EDG-6289, EDG-002 and EDG-003 research programs, and our other future product candidates and programs;
−Removed: establishing and maintaining relationships with CROs and clinical sites for the clinical development of EDG-5506, product candidates in our EDG-6289, EDG-002 and EDG-003 programs and any other future product candidates and programs;
+Added: successful and timely completion of preclinical and clinical development of EDG-5506, EDG-5440 and our EDG-002 research program, and our other future product candidates and programs;
+Added: establishing and maintaining relationships with CROs and clinical sites for the clinical development of EDG-5506, product candidates such as EDG-5440 and product candidates from our EDG-002 program and any other future product candidates and programs;
the initiation and successful patient enrollment and completion of additional clinical trials on a timely basis;
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commercial acceptance of our product candidates by patients, the medical community and third-party payors;
+Added: timely receipt of reimbursement from applicable authorities for any product candidates for which we successfully receive regulatory approval;
satisfying any required post-marketing approval commitments to applicable regulatory authorities;
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addressing any competing therapies and technological and market developments;
−Removed: managing costs, including any unforeseen costs, that we may incur as a result of nonclinical study or clinical trial delays due to COVID-19 or other causes;
+Added: managing costs, including any unforeseen costs, that we may incur as a result of nonclinical study or clinical trial delays due to COVID-19, inflation or other causes;
attracting, hiring and retaining qualified personnel including clinical, scientific, management and administrative personnel.
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If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts.
−Removed: As of September 30, 2021, we had $290.5 million in cash, cash equivalents and marketable securities.
+Added: As of March 31, 2022, we had $265.8 million in cash, cash equivalents and marketable securities.
We expect our current cash and cash equivalents, will be sufficient to fund our current operating plan for at least the next 12 months.
−Removed: Our estimate as to how long we expect our existing cash and cash equivalents, to be able to continue to fund our operations is based on assumptions that may prove to be wrong, and we could use our
−Removed: available capital resources sooner than we currently expect.
+Added: On April 1, 2022, the Company filed:
+Added: (i) a shelf registration statement on Form S-3 with the SEC that became effective on May 5, 2022 and allows us to undertake various equity and debt offerings up to $400,000,000;
+Added: and (ii) a prospectus supplement to the shelf registration statement that covers the offering, issuance and sale of up to $125 million of our common stock from time to time through an “at-the-market” program under the Securities Act.
+Added: Our estimate as to how long we expect our existing cash and cash equivalents, to be able to continue to fund our operations is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.
Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned.
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Our operations and financial results could be adversely impacted by the COVID-19 pandemic in the United States and the rest of the world.
−Removed: In March 2020, the World Health Organization declared the novel coronavirus disease (COVID-19) outbreak a global pandemic.
+Added: In March 2020, the World Health Organization declared the coronavirus disease (COVID-19) outbreak a global pandemic.
To limit the spread of COVID-19, governments have taken various actions including the issuance of stay-at-home orders and physical distancing guidelines.
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Just prior to this planned start, the CRO that operates that trial unit informed us that COVID-19 related issues would delay trial initiation for at least four months, which required us to locate, contract with, and prepare for trial initiation at a new trial site in San Antonio, Texas operated by a different CRO.
−Removed: We have recently switched from an international third-party manufacturer to a third-party manufacturer based in the United States to minimize manufacturing supply chain disruptions as a result of COVID-19.
+Added: In 2020, we switched from an international third-party manufacturer to a third-party manufacturer based in the United States to minimize manufacturing supply chain disruptions as a result of COVID-19.
Changing our third-party manufacturer could result in delays in our manufacturing supply chain which could delay or otherwise impact our development of EDG-5506 and result in increased costs related to EDG-5506.
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It is likely that the disproportionate impact of COVID-19 on hospitals and clinical sites will have an impact on recruitment and retention for our clinical trials.
−Removed: For example, we have experienced delays in enrolling patients for our Phase 1 clinical trial for EDG-5506.
−Removed: In addition, our clinical trial site could experience delays in collecting, receiving and analyzing data from patients enrolled in our clinical trial for EDG-5506 due to limited staff at such sites, limitation or suspension of on-site visits by patients, or patients’ reluctance to visit the clinical trial sites during the pandemic.
−Removed: As a result, research and development expenses and general and administrative expenses may vary significantly if there is an increased impact from COVID-19 on the costs and timing associated with the conduct of our clinical trial and other related business activities.
+Added: For example, we experienced delays in enrolling patients for our Phase 1 clinical trial for EDG-5506.
+Added: In addition, our clinical trial sites could experience delays in collecting, receiving and analyzing data from patients enrolled in our clinical trial for EDG-5506 due to limited staff at such sites, limitation or suspension of on-site visits by patients, or patients’ reluctance to visit the clinical trial sites during the pandemic.
+Added: As a result, research and development expenses and general and administrative
+Added: expenses may vary significantly if there is an increased impact from COVID-19 on the costs and timing associated with the conduct of our clinical trial and other related business activities.
As we continue to actively advance our clinical programs and discovery and research programs, we are assessing the impact of the COVID-19 pandemic on each of our programs, expected timelines and costs on an ongoing basis.
−Removed: In light of ongoing developments relating to the COVID-19 pandemic, the focus of healthcare providers and hospitals on fighting the virus, and consistent with the FDA’s industry guidance for conducting
−Removed: clinical trials during the COVID-19 issued in March 2020, as updated subsequently, as well as other guidance on biopharmaceutical manufacturing and inspections during the pandemic, among others, we and our CROs may be required to implement new clinical trial procedures and policies or make certain adjustments to our clinical trial.
+Added: In light of ongoing developments relating to the COVID-19 pandemic, the focus of healthcare providers and hospitals on fighting the virus, and consistent with the FDA’s industry guidance for conducting clinical trials during the COVID-19 pandemic issued in March 2020, as updated subsequently, as well as other guidance on biopharmaceutical manufacturing and inspections during the pandemic, among others, we and our CROs may be required to implement new clinical trial procedures and policies or make certain adjustments to our clinical trial.
We and our CROs have made certain adjustments to the operation of such trials in an effort to ensure the monitoring and safety of patients and minimize risks to trial integrity during the pandemic in accordance with the guidance issued by the FDA on June 19, 2020 on good manufacturing practice considerations for responding to COVID-19 infection in employees in biopharmaceutical products manufacturing and generally, and may need to make further adjustments in the future.
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Until such time, if ever, as we can generate substantial revenues, we will be required to obtain further funding through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources, which may dilute our stockholders or restrict our operating activities.
−Removed: We do not have any committed external source of funds.
+Added: On April 1, 2022, the Company filed:
+Added: (i) a shelf registration statement on Form S-3 with the SEC that became effective on May 5, 2022 and allows us to undertake various equity and debt offerings up to $400,000,000;
+Added: and (ii) a prospectus supplement to the shelf registration statement that covers the offering, issuance and sale of up to $125 million of our common stock from time to time through an “at-the-market” program under the Securities Act.
+Added: However, we do not have any committed external source of funds.
Adequate additional financing may not be available to us on acceptable terms, or at all.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder.
−Removed: Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions, engaging in acquisition, merger or collaboration transactions, selling or licensing our assets, making capital expenditures, redeeming our stock, making certain investments, declaring dividends or encumbering our assets to secure future indebtedness.
+Added: Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions, engaging in acquisition, merger or collaboration transactions, selling or licensing our assets, making capital expenditures, redeeming our stock, making certain investments, declaring dividends or
+Added: encumbering our assets to secure future indebtedness.
Such restrictions could adversely impact our ability to conduct our operations and execute our business plan.
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Risks Related to the Discovery, Development and Commercialization of Our Product Candidates
−Removed: We are substantially dependent on the success of our lead product candidate, EDG-5506, which is currently in a Phase 1 clinical trial.
−Removed: If we are unable to complete development of, obtain approval for and commercialize EDG-5506 for one or more indications in a timely manner, our business will be harmed.
+Added: We are substantially dependent on the success of our lead product candidate, EDG-5506, which recently completed a Phase 1 clinical trial.
+Added: If we are unable to complete further development of, obtain approval for and commercialize EDG-5506 for one or more indications in a timely manner, our business will be harmed.
Our future success is dependent on our ability to timely and successfully complete clinical trials, obtain marketing approval for and successfully commercialize EDG-5506, our lead product candidate.
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In October 2020, we initiated a Phase 1 clinical trial to evaluate the safety and tolerability of EDG-5506 in HVs.
−Removed: This is our first clinical trial, and EDG-5506 has not previously been tested in humans.
+Added: This was our first clinical trial, and EDG-5506 had not previously been tested in humans.
In addition, we are pursuing EDG-5506 in BMD for which there are no animal models of the human disease and therefore the animal models may not be predictive for human disease outcomes.
−Removed: The Company announced in October 2021 positive topline results from the MAD portion of a first-in-human Phase 1, HV clinical trial.
+Added: We announced in October 2021 positive topline results from the MAD portion of a first-in-human Phase 1, HV clinical trial.
+Added: In addition, we announced in January 2022 positive topline results from the BMD, or Phase 1b, portion of a first-in-human Phase 1 clinical trial assessing the safety, tolerability, PK and PD of EDG-5506.
+Added: We anticipate initiation of Phase 2 trials in individuals with BMD in the second quarter of 2022 and DMD in the second half of 2022.
However, EDG-5506 will require additional clinical development, expansion of manufacturing capabilities, marketing approval from government regulators, substantial investment and significant marketing efforts before we can generate any revenues from product sales.
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the successful and timely completion of our ongoing nonclinical studies and clinical trial of EDG-5506;
−Removed: addressing any delays, necessary adjustments and additional costs in preclinical study and clinical trial resulting from factors related to the COVID-19 pandemic;
+Added: addressing any delays, necessary adjustments and additional costs in nonclinical study and clinical trials resulting from factors related to the COVID-19 pandemic;
the initiation and successful patient enrollment and completion of additional clinical trials of EDG-5506 on a timely basis;
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commercial acceptance by patients, the medical community and third-party payors, particularly since the product candidates we develop may be novel;
−Removed: our ability to compete with other therapies.
+Added: • our ability to compete or combine with other therapies.
We do not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and the manufacturing, marketing, distribution and sales efforts of any future collaborator.
−Removed: If we are not successful with respect to one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize EDG-5506, which would materially harm our business.
+Added: If we are not successful with respect to one or
+Added: more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize EDG-5506, which would materially harm our business.
If we do not receive marketing approvals for EDG-5506, we may not be able to continue our operations.
−Removed: In addition to EDG-5506, our prospects depend in part upon developing and commercializing product candidates from our EDG-6289, EDG-002 and EDG-003 programs and discovering, developing and commercializing product candidates in future programs, which may fail or suffer delays that adversely affect their commercial viability.
−Removed: Our future operating results are dependent on our ability to successfully develop, obtain regulatory approval for and commercialize product candidates from our research programs, including EDG-6289, EDG-002 and EDG-003, in addition to our lead product candidate, EDG-5506.
+Added: In addition to EDG-5506, our prospects depend in part upon developing and commercializing product candidates from our EDG-5440 and EDG-002 programs and discovering, developing and commercializing product candidates in future programs, which may fail or suffer delays that adversely affect their commercial viability.
+Added: Our future operating results are dependent on our ability to successfully develop, obtain regulatory approval for and commercialize product candidates from our research programs, including EDG-5440 and EDG-002, in addition to our lead product candidate, EDG-5506.
However, research and development related to novel therapeutics is inherently risky.
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We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
−Removed: Although the Company announced in October 2021 positive topline results from the MAD portion of a first-in-human Phase 1, HV clinical trial, our lead product candidate, EDG-5506, is in a Phase 1 clinical trial and its risk of failure is high.
+Added: Although we announced in October 2021 positive topline results from the MAD portion of a first-in-human Phase 1, HV clinical trial and we announced in January 2022 positive topline results from the BMD, or Phase 1b, portion of a first-in-human Phase 1 clinical trial assessing the safety, tolerability, PK and PD of EDG-5506, our lead product candidate’s risk of failure is high.
It is impossible to predict when or if EDG-5506 or any other product candidate that we develop will prove effective or safe in humans or will receive marketing approval.
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Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their drugs.
−Removed: Furthermore, the failure of any of our product candidates to demonstrate safety
−Removed: and efficacy in any clinical trial could negatively impact the perception of our other product candidates and/or cause the FDA or other regulatory authorities to require additional testing before approving any of our product candidates.
+Added: Furthermore, the failure of any of our product candidates to demonstrate safety and efficacy in any clinical trial could negatively impact the perception of our other product candidates and/or cause the FDA or other regulatory authorities to require additional testing before approving any of our product candidates.
We have experienced delays in completing our ongoing clinical trial and may experience additional delays in initiating or completing additional clinical trials including delays as a result of COVID-19.
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In addition, our product candidates may be used in combination with certain other therapies, including corticosteroids, which may have undesirable side effects.
−Removed: If our product candidates are associated with undesirable side effects or have unexpected characteristics in preclinical studies or clinical trials when used alone or in combination with other approved products or investigational new drugs we may need to interrupt, delay or abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent,
−Removed: less severe or more acceptable from a risk-benefit perspective.
+Added: If our product candidates are associated with undesirable side effects or have unexpected characteristics in preclinical studies or clinical trials when used alone or in combination with other approved products or investigational new drugs we may need to interrupt, delay or abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.
Treatment-related side effects could also affect patient recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims.
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For example, in the single ascending dose trial for EDG-5506, dose limiting somnolence was observed at the 135 mg level.
−Removed: In addition, in the multiple ascending dose trial for EDG-5506, the most common adverse events were dizziness and somnolence, all of which were mild, transient, and self resolving.
+Added: In addition, in the multiple ascending dose trial for EDG-5506, the most common adverse events were dizziness and somnolence, all of which were mild and transient and in the Phase 1b clinical trial, the most common adverse event was dizziness, which was mild and transient.
EDG-5506 or other product candidates may be used in pediatric populations for which safety concerns may be particularly scrutinized by regulatory agencies.
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Further, if any of our product candidates obtains marketing approval, toxicities associated with such product candidates previously not seen during clinical testing may also develop after such approval and lead to a requirement to conduct additional clinical safety trials, additional contraindications, warnings and precautions being added to the drug label, significant restrictions on the use of the product or the withdrawal of the product from the market.
−Removed: We cannot predict whether our product candidates will cause toxicities in humans that would preclude or lead to the revocation of regulatory approval based on preclinical studies or early stage clinical trials.
+Added: We cannot predict whether our product candidates will cause toxicities in humans that
+Added: would preclude or lead to the revocation of regulatory approval based on preclinical studies or early stage clinical trials.
The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA, EMA or other comparable foreign regulatory authorities.
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Success in preclinical studies and early-stage clinical trials does not mean that future clinical trials will be successful.
−Removed: Although the Company announced in October 2021 positive topline results from the MAD portion of a first-in-human Phase 1, HV clinical trial, we do not know whether EDG-5506 will perform in current or future clinical trials as EDG-5506 has performed in preclinical studies or earlier clinical trials, nor do we know whether any product candidate in our EDG-6289, EDG-002 or EDG-003 programs will perform in current or future preclinical studies or future clinical trials as it has in prior preclinical studies.
+Added: Although we announced in October 2021 positive topline results from the MAD portion of a first-in-human Phase 1, HV clinical trial and we announced in January 2022 positive topline results from the BMD, or Phase 1b, portion of a first-in-human Phase 1 clinical trial assessing the safety, tolerability, PK and PD of EDG-5506 , we do not know whether EDG-5506 will perform in current or future clinical trials as EDG-5506 has performed in preclinical studies or earlier clinical trials, nor do we know whether any product candidate in our EDG-5440 and EDG-002 programs will perform in current or future preclinical studies or future clinical trials as it has in prior preclinical studies.
Product candidates in clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA, EMA and other comparable foreign regulatory authorities despite having progressed through preclinical studies.
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Our ability to enroll eligible patients may be limited or may result in slower enrollment than we anticipate.
−Removed: Currently, we are conducting our Phase 1 clinical trial of EDG-5506 at a single clinical trial site.
−Removed: We may experience delays if our clinical trial site limits their onsite staff or temporarily closes as a result of the COVID-19 pandemic.
+Added: Currently, we are conducting our open-label ARCH study of EDG-5506 at a single clinical trial site.
+Added: Our Phase 2 trials will be conducted at multiple sites.
+Added: We may experience delays if our clinical trial sites limits their onsite staff or temporarily closes as a result of the COVID-19 pandemic.
In addition, patients may not be able to visit clinical trial sites for dosing or data collection purposes due to limitations on travel and physical distancing imposed or recommended by federal or state governments or patients’ reluctance to visit the clinical trial sites during the pandemic.
These factors resulting from the COVID-19 pandemic could delay the anticipated readouts from our EDG-5506 clinical trial and our regulatory submissions.
+Added: We have initiated an industry-sponsored, global, prospective registry investigating the natural history of adults with BMD aged 18 years and older.
+Added: However, we may not be successful in achieving our goal of establishing
+Added: natural history reference data points and identifying future eligibility for recruitment into our planned registrational trial in BMD.
We are developing product candidates for rare muscle disorders with limited patient pools from which to draw for clinical trials.
−Removed: For example, if our Phase 2a clinical trial in BMD is successful and subject to discussion with the FDA and EMA, we plan to pursue a clinical trial in the pediatric DMD population.
−Removed: Such pediatric patients may be difficult to enroll in this trial and the lack of data on these patients may negatively impact the approvability of EDG-5506.
+Added: Such trials may be difficult to enroll and the lack of data on these patients may negatively impact the approvability of EDG-5506.
We also may encounter difficulties in identifying and enrolling subjects with a stage of disease appropriate for our planned clinical trials and monitoring such subjects adequately during and after treatment.
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We are currently focusing the majority of our resources and efforts on developing EDG-5506.
−Removed: As a result, because we have limited resources, we may forgo or delay the pursuit of opportunities for other indications or with other product candidates that may have greater commercial potential including product candidates from our EDG-6289, EDG-002 and EDG-003 programs.
+Added: As a result, because we have limited resources, we may forgo or delay the pursuit of opportunities for other indications or with other product candidates that may have greater commercial potential including product candidates from our EDG-002 program.
In addition, while we currently have multiple compounds in our programs, we are focusing our efforts on select product candidates from each of these programs to develop as lead product candidates in each program.
Our resource allocation decisions may cause us to fail to capitalize on viable commercial drugs or profitable market opportunities.
−Removed: Our spending on current and future research and development activities for EDG-5506 and our EDG-6289, EDG-002 and EDG-003 programs may not yield any commercially viable products.
−Removed: If we do not accurately evaluate the commercial potential or target markets for EDG-5506 or the product candidates we are currently researching in our EDG-6289, EDG-002 and EDG-003 programs, we may relinquish valuable rights to our product candidates or programs through collaboration, licensing or other strategic
−Removed: arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate or program.
+Added: Our spending on current and future research and development activities for EDG-5506, EDG-5440 and our EDG-002 program may not yield any commercially viable products.
+Added: If we do not accurately evaluate the commercial potential or target markets for EDG-5506 or the product candidates we are currently researching, such as EDG-5440 or those from our EDG-002 program, we may relinquish valuable rights to our product candidates or programs through collaboration, licensing or other strategic arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate or program.
We face significant competition and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer or less expensive than the products we develop, our commercial opportunities will be negatively impacted.
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EXONDYS 51 (eteplirsen), AMONDYS 45 (casimersen) and VYONDYS 53 (golodirsen), which are naked PMOs approved for the treatment of DMD patients amenable to Exon 51, Exon 45 and Exon 53 skipping, respectively, and are marketed by Sarepta Therapeutics, Inc., and VILTEPSO (vitolarsen), a naked PMO approved for the treatment of DMD patients amenable to Exon 53 skipping, which is marketed by Nippon Shinyaku Co.
−Removed: Companies focused on developing treatments for DMD that target dystrophin mechanisms include Sarepta Therapeutics with SRP-5051, a peptide-linked PMO currently being evaluated in a Phase 2 clinical trial for patients amenable to Exon 51 skipping, PTC Therapeutics with ataluren, a small molecule targeting nonsense mutations in a Phase 3 clinical trial, Avidity Biosciences, Inc., which is in preclinical development with an antibody oligonucleotide conjugate that targets dystrophin production and Dyne Therapeutics which is also in preclinical development with its proprietary antigen-binding oligonucleotide linker technology that targets dystrophin production.
−Removed: In addition, several companies are developing gene therapies to treat DMD, including Milo Biotechnology (AAV1-FS344), Pfizer Inc.
+Added: Companies focused on developing treatments for DMD that target dystrophin mechanisms include Sarepta Therapeutics with SRP-5051, a peptide-linked PMO currently being evaluated in a Phase 2 clinical trial for patients amenable to Exon 51 skipping, PTC Therapeutics with ataluren, a small molecule targeting nonsense mutations in a Phase 3 clinical trial, Avidity Biosciences, Inc., which is in preclinical development with an antibody oligonucleotide conjugate that targets dystrophin production, Dyne Therapeutics which announced submission of an IND application to initiate a clinical trial with their proprietary antigen-binding oligonucleotide linker technology targeting patients with mutations amenable to skipping Exon 51 and Entrada Therapeutics, Inc.
+Added: which is in preclinical development with oligonucleotides that are designed to promote the skipping of exon mutations associated with DMD.
+Added: In addition, several companies are developing gene therapies to treat DMD, including Genethon Company (GNT-0004), Pfizer Inc.
(PF-06939926), Sarepta Therapeutics (SRP-9001 and Galgt2 gene therapy program), and Solid Biosciences Inc.
Gene editing treatments that are in preclinical development are also being pursued by Vertex and Sarepta Therapeutics.
−Removed: We are also aware of several companies targeting non-dystrophin mechanisms for the treatment of DMD.
+Added: We are also aware of several
+Added: companies targeting non-dystrophin mechanisms for the treatment of DMD.
Moreover, Epirium Bio is developing a synthetic compound that targets cellular energetics and muscle regeneration as a potential therapeutic for BMD.
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These companies also have significantly greater research and marketing capabilities than we do and may also have products that have been approved or are in late stages of development, and collaborative arrangements in our target markets with leading companies and research institutions.
−Removed: Established pharmaceutical and biotechnology companies may also invest
−Removed: heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the product candidates that we develop obsolete.
+Added: Established pharmaceutical and biotechnology companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the product candidates that we develop obsolete.
Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies, as well as in acquiring technologies complementary to, or necessary for, our programs.
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Interim, topline and preliminary data from our clinical trials that we announce or publish may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
−Removed: From time to time, we may publicly disclose preliminary, interim or topline data from our clinical trials, such as the interim data from our Phase 1 clinical trial of EDG-5506.
−Removed: For example, the Company announced in October 2021 positive topline results from the MAD portion of a first-in-human Phase 1, HV clinical trial.
+Added: From time to time, we may publicly disclose preliminary, interim or topline data from our clinical trials, such as the data from our Phase 2 clinical trials of EDG-5506.
These interim updates are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial.
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Further, additional disclosure of interim data by us or by our competitors in the future could result in volatility in the price of our common stock.
−Removed: Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and our company in general.
+Added: Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could
+Added: impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and our company in general.
In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is material or otherwise appropriate information to include in our disclosure.
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In addition, it is possible that existing therapies with which our product candidates are approved for use could themselves fall out of favor.
−Removed: This could result in the need to identify other combination therapies for our product candidates or our own products being removed from the market or being less successful commercially.
+Added: This could result in the need to identify other
+Added: combination therapies for our product candidates or our own products being removed from the market or being less successful commercially.
We may also evaluate our product candidates in combination with one or more other therapies that have not yet been approved for marketing by the FDA, EMA or comparable foreign regulatory authorities.
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As product candidates progress through preclinical and clinical trials to marketing 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 yield and manufacturing batch size, minimize costs and achieve consistent quality and results.
−Removed: For example, we may introduce an alternative formulation of EDG-5506 into the dose expansion phases of our ongoing Phase 1 clinical trial.
+Added: For example, we may introduce an alternative formulation of EDG-5506 of our upcoming Phase 2 clinical trials.
We will also explore alternate formulations for use with pediatric patients, particularly DMD patients, who may have difficulty taking adult formulations.
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The approximate global prevalence of LGMDs as a group is estimated to be from 0.56 to 5.75 per 100,000.
−Removed: Our estimates of the size of these patient populations are based on published studies.
+Added: Our estimates of the size of these patient
+Added: populations are based on published studies.
Given the small number of patients who have the diseases that we are targeting, it is critical to our ability to grow and become profitable that we continue to successfully identify patients with these rare diseases.
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An Ohio newborn screening (NBS) pilot developed a process to determine who should have genetic testing.
−Removed: Currently, a newborn screening pilot program in New York
−Removed: State is testing this and other aspects of a comprehensive newborn screening program at a large scale.
+Added: Currently, a newborn screening pilot program in New York State is testing this and other aspects of a comprehensive newborn screening program at a large scale.
A Steering Committee is compiling other evidence necessary to support a nomination package to the Advisory Committee for Heritable Disorders in Newborns and Children (ACHDNC) to add muscular dystrophies to the RUSP.
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The initial targets in our pipeline are indications with small patient populations.
−Removed: For product candidates that are designed to treat smaller patient populations to be commercially viable, the reimbursement for such product candidates must be higher, on a relative basis, to account for the lack of volume.
+Added: For product candidates that are designed to treat smaller patient populations to be commercially viable, the reimbursement for such product candidates must be
+Added: higher, on a relative basis, to account for the lack of volume.
Accordingly, we will need to implement a coverage and reimbursement strategy for any approved product candidate that accounts for the smaller potential market size.
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There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved products.
−Removed: In the United States, for example, principal decisions about reimbursement for new products are typically
−Removed: made by the Centers for Medicare & Medicaid Services (CMS), an agency within the U.S.
+Added: In the United States, for example, principal decisions about reimbursement for new products are typically made by the Centers for Medicare & Medicaid Services (CMS), an agency within the U.S.
Department of Health and Human Services (HHS).
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If we are unable to establish or sustain coverage and adequate reimbursement for any product candidates from third-party payors, the adoption of those products and sales revenue will be adversely affected, which, in turn, could adversely affect the ability to market or sell those product candidates, if approved.
−Removed: Coverage policies and third-party payor reimbursement rates may change at any time.
+Added: Coverage policies and
+Added: third-party payor reimbursement rates may change at any time.
Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
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As a result, we may be unable to obtain sufficient insurance at a reasonable cost to protect us against losses caused by product liability claims that could have an adverse effect on our business and financial condition.
−Removed: Also, our insurance policies may have various exclusions, and we may be subject to a product liability claim for
−Removed: which we have no coverage.
+Added: Also, our insurance policies may have various exclusions, and we may be subject to a product liability claim for which we have no coverage.
We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.
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In addition, the FDA has the authority to require a Risk Evaluation and Mitigation Strategy (REMS) plan as part of approving an NDA, or after approval, which may impose further requirements or restrictions on the distribution or use of an approved drug.
−Removed: These requirements or restrictions might include limiting prescribing to certain physicians or medical centers that have undergone specialized training, limiting treatment to patients who meet certain safe-use criteria and requiring treated patients
−Removed: to enroll in a registry.
+Added: These requirements or restrictions might include limiting prescribing to certain physicians or medical centers that have undergone specialized training, limiting treatment to patients who meet certain safe-use criteria and requiring treated patients to enroll in a registry.
These limitations and restrictions may significantly limit the size of the market for the drug and affect reimbursement by third-party payors.
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For example, even if the FDA or EMA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion and reimbursement of the product candidate in those countries.
+Added: Complying with new requirements and changes in other foreign regulations that apply to clinical trials and drug development activities can delay our clinical trials and regulatory approval time lines in the EU and other foreign jurisdictions.
+Added: For example, the Clinical Trials Regulation EU No.
+Added: 536/2014 entered into application on January 31, 2022 and is intended to simplify the current rules for clinical trial authorization and standards of performance in EU.
+Added: Complying with such new legislation or changes in healthcare regulation could be time-intensive and expensive, resulting in a material adverse effect on our business.
However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others.
Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions.
−Removed: In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction.
+Added: In many jurisdictions outside the United States, a product candidate must be approved for reimbursement
+Added: before it can be approved for sale in that jurisdiction.
In some cases, the price that we intend to charge for our products is also subject to approval.
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Regulatory authorities in some jurisdictions, including the United States and the EU, may designate drugs for relatively small patient populations as orphan drugs.
−Removed: Under the Orphan Drug Act, the FDA may designate a
−Removed: product as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States.
+Added: Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States.
However, there can be no assurances that we will be able to obtain orphan designations for our product candidates.
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An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.
−Removed: The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage, but is a clinically important
−Removed: improvement from a patient and public health perspective.
+Added: The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage, but is a clinically important improvement from a patient and public health perspective.
If granted, accelerated approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the drug’s clinical benefit.
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For example, certain policies of the current U.S.
−Removed: administration may impact our business and industry, which could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight activities such as implementing statutes through rulemaking, issuance of guidance, and review and approval of marketing applications.
+Added: administration may impact our business and industry, which could impose significant burdens on, or otherwise materially delay, the FDA’s ability to engage in routine regulatory and oversight activities such as
+Added: implementing statutes through rulemaking, issuance of guidance, and review and approval of marketing applications.
It is difficult to predict how current and future legislation, executive actions, and litigation, including the executive orders referenced below, will be implemented, and the extent to which they will impact our business, our clinical development, and the FDA’s and other agencies’ ability to exercise their regulatory authority, including FDA’s pre-approval inspection and timely review of any regulatory filings or applications we submit to the FDA.
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The executive order also instructs certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA.
−Removed: Complying with any new
−Removed: legislation or changes in healthcare regulation could be time-intensive and expensive, resulting in a material adverse effect on our business.
+Added: Complying with any new legislation or changes in healthcare regulation could be time-intensive and expensive, resulting in a material adverse effect on our business.
In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted.
−Removed: These changes included aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, effective April 1, 2013, which will remain in effect through 2030, with the exception of a temporary suspension implemented under various COVID-19 relief legislation from May 1, 2020 through the end of 2021, unless additional congressional action is taken.
+Added: These changes included aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, effective April 1, 2013, which will remain in effect through 2031, with the exception of a temporary suspension implemented under various COVID-19 relief legislation from May 1, 2020 through March 31, 2022, unless additional congressional action is taken.
+Added: Under current legislation, the actual reduction in Medicare payments will vary from 1% in 2022 to up to 4% in the final fiscal year of this sequester.
In January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
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Multiple lawsuits have been brought against the HHS challenging various aspects of the rules.
−Removed: In January 2021, the Biden administration issued a “regulatory freeze” memorandum that directs department and agency heads to review new or pending rules of the prior administration.
The impact of these lawsuits as well as legislative, executive, and administrative actions of the Biden administration on us and the pharmaceutical industry as a whole is unclear.
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We are unable to predict the future course of federal or state healthcare legislation in the United States directed at broadening the availability of healthcare and containing or lowering the cost of healthcare.
−Removed: These and any further changes in the law or regulatory framework that reduce our
−Removed: revenue or increase our costs could also have a material and adverse effect on our business, financial condition and results of operations.
+Added: These and any further changes in the law or regulatory framework that reduce our revenue or increase our costs could also have a material and adverse effect on our business, financial condition and results of operations.
We expect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved product.
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Failure to comply with the GDPR may result in fines up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties.
−Removed: The GDPR may increase our responsibility and liability in relation to personal data that we may process, and we may be required to put in place additional measures in an effort to comply with the GDPR and with other laws and regulations in the EU, including those of EU Member States, relating to privacy and data protection.
−Removed: This may be onerous and if our efforts to comply with GDPR or other applicable EU laws and regulations are not successful, or are perceived to be unsuccessful, it could adversely affect our business in the EU.
+Added: The GDPR may increase our responsibility and liability in relation to personal data that we may process, and we may be required to put in place
+Added: additional measures in an effort to comply with the GDPR and with other laws and regulations in the EU, including those of EU Member States, relating to privacy and data protection.
+Added: This may be onerous and if our efforts to comply with the GDPR or other applicable EU laws and regulations are not successful, or are perceived to be unsuccessful, it could adversely affect our business in the EU.
Further, the European Court of Justice (ECJ) invalidated the EU-U.S.
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Specifically, the UK exited the EU on January 1, 2020, subject to a transition period that ended on December 31, 2020.
−Removed: On June 28, 2021, the European Commission issued an adequacy decision in respect of the UK’s data protection framework, allowing personal data transfers from EU member states to the UK to continue without requiring additional contractual or other measures in order to lawfully
−Removed: transfer personal data between the territories.
+Added: On June 28, 2021, the European Commission issued an adequacy decision in respect of the UK’s data protection framework, allowing personal data transfers from EU member states to the UK to continue without requiring additional contractual or other measures in order to lawfully transfer personal data between the territories.
This decision is subject to renewal after four years, however, and may be revisited by the European Commission at any time.
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In the medium and longer terms, however, the relationship between the UK and EU in relation to aspects of data protection law remains unclear, including with respect to cross-border data transfers and the role of the UK Information Commissioner’s Office with respect to the EU, which exposes us to further compliance risk.
+Added: The UK also has issued its own standard contractual clauses, similar to the SCCs, that are required to be implemented over time.
We may incur liabilities, expenses, costs, and other operational losses relating to the GDPR, the UK GDPR, and other laws and regulations in the EU and UK relating to privacy and data protection, including those of applicable EU Member States in connection with any measures we take to comply with them.
Finally, state and foreign laws may apply generally to the privacy and security of information we maintain, and may differ from each other in significant ways, thus complicating compliance efforts and potentially requiring us to undertake additional measures to comply with them.
−Removed: In the United States, there are a broad variety of data protection laws and regulations that may apply to our activities such as state data breach notification laws, state personal data privacy laws (for example, the California Consumer Privacy Act of 2018 (CCPA)), state health information privacy laws, and federal and state consumer protection laws.
+Added: In the United States, a broad variety of data protection laws and regulations may apply to our activities such as state data breach notification laws, state personal data privacy laws (for example, the California Consumer Privacy Act of 2018 (CCPA)), state health information privacy laws, and federal and state consumer protection laws.
A range of enforcement agencies exist at both the state and federal levels that can enforce these laws and regulations.
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The CPRA will, among other things, give California residents the ability to limit use of certain sensitive personal information, further restrict the use of cross-contextual advertising, establish restrictions on the retention of personal information, expand the types of data breaches subject to the CCPA’s private right of action, provide for increased penalties for CPRA violations concerning California residents under the age of 16, and establish a new California Privacy Protection Agency to implement and enforce the new legislation.
−Removed: Although there are limited exemptions for clinical trial data under the CCPA, the CCPA and other similar laws could impact our business activities, depending on their interpretation.
+Added: Although there are limited exemptions for clinical trial data under the CCPA, the CCPA and other similar laws could impact our business activities,
+Added: depending on their interpretation.
Additionally, other state legislatures have enacted or are currently contemplating, and may pass, their own comprehensive data privacy and security laws, with potentially greater penalties and more rigorous compliance requirements relevant to our business.
For example, in March 2021, Virginia enacted the Virginia Consumer Data Protection Act (CDPA), a comprehensive privacy statute that becomes effective on January 1, 2023 and shares similarities with the CCPA, the CPRA, and legislation proposed in other states.
−Removed: Similarly, in June 2021, Colorado enacted the Colorado Privacy Act (CPA), which takes effect on July 1, 2023.
−Removed: With the GDPR, CCPA, CPRA, CDPA, CPA, and other laws, regulations and other obligations relating to privacy and data protection imposing new and relatively burdensome obligations, and with substantial uncertainty over the interpretation and application of these and other obligations, we may face challenges in addressing their requirements and making necessary changes to our policies and practices, and may incur significant costs and expenses in an effort to do so.
+Added: Similarly, in June 2021, Colorado enacted the Colorado Privacy Act (CPA), which takes effect on July 1, 2023, and in March 2022, Utah enacted the Utah Consumer Privacy Act (UCPA), which takes effect on December 31, 2023.
+Added: With the GDPR, CCPA, CPRA, CDPA, CPA, UCPA, and other laws, regulations and other obligations relating to privacy and data protection imposing new and relatively burdensome obligations, and with substantial uncertainty over the interpretation and application of these and other obligations, we may face challenges in addressing their requirements and making necessary changes to our policies and practices, and may incur significant costs and expenses in an effort to do so.
Additionally, if third parties we work with, such as vendors or service providers, violate applicable laws or regulations or our policies, such violations may also put our or our customers’ data at risk and could in turn have an adverse effect on our business.
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government shut down several times and certain regulatory agencies, such as the FDA and the SEC, had to furlough critical employees and stop critical activities.
−Removed: If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
−Removed: Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
+Added: Separately, in response to the COVID-19 pandemic, since March 2020 when foreign and domestic inspections of facilities were largely placed on hold, the FDA has been working to resume routine surveillance, bioresearch monitoring and pre-approval inspections on a prioritized basis.
+Added: The FDA has developed a rating system to assist in determining when and where it is safest to conduct prioritized domestic inspections.
+Added: In 2020 and 2021, a number of companies announced receipt of complete response letters due to the FDA’s inability to complete required inspections for their applications.
+Added: As of May 2021, the FDA noted it was continuing to ensure timely reviews of applications for medical products during the ongoing COVID-19 pandemic in line with its user fee performance goals and conducting mission critical domestic and foreign inspections to ensure compliance of manufacturing facilities with FDA Good Manufacturing Practices.
+Added: However, the FDA may not be able to continue its current inspection pace, and review timelines could be extended, including where a pre-approval inspection or an inspection of clinical sites is required and due to the ongoing COVID-19 pandemic and travel restrictions, the FDA is unable to complete such required inspections during the review period.
+Added: Regulatory authorities outside the U.S.
+Added: may adopt similar restrictions or other policy measures in response to the COVID-19 pandemic and may experience delays in their regulatory activities.
+Added: If a prolonged government shutdown or disruption occurs, it could significantly impact the ability of the FDA and other regulatory authorities to timely review and process our regulatory submissions and provide feedback on our clinical development plans, which could have a material adverse effect on our business and our anticipated timelines.
+Added: Further, future government shutdowns or disruptions to normal operations could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
Our relationships with healthcare professionals, clinical investigators, CROs and third-party payors in connection with our current and future business activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, government price reporting, and health information privacy and security laws, which could expose us to significant losses, including, among other things, criminal sanctions, civil penalties, contractual damages, exclusion from governmental healthcare programs, reputational harm, administrative burdens and diminished profits and future earnings.
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the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
−Removed: HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH) and their implementing regulations, also imposes obligations, including mandatory contractual terms, on covered entities, which are health plans, healthcare clearinghouses, and certain health care
−Removed: providers, as those terms are defined by HIPAA, and their respective business associates and their subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
−Removed: the federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to CMS information regarding payments and other transfers of value made to covered recipients, including physicians, defined to include doctors, dentists, optometrists, podiatrists and chiropractors, and teaching hospitals as well as information regarding ownership and investment interests held by physicians, as defined by law, and their immediate family members.
−Removed: Beginning with data reported to CMS in 2022, reporting obligations with respect to covered recipients have been expanded to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist assistants, and certified nurse midwives for payments and transfers of value made during the previous year;
+Added: HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH) and their implementing regulations, also imposes obligations, including mandatory contractual terms, on covered entities, which are health plans, healthcare clearinghouses, and certain health care providers, as those terms are defined by HIPAA, and their respective business associates and their subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
+Added: the federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to CMS information regarding payments and other transfers of value made to covered recipients, including physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician healthcare professionals (such as nurse practitioners and physician assistants, among others), and teaching hospitals as well as information regarding ownership and investment interests held by physicians;
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers;
state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance regulations promulgated by the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures, or drug pricing;
−Removed: state and local laws that require the registration of pharmaceutical sales and medical representatives;
+Added: state and local laws that require the
+Added: registration of pharmaceutical sales and medical representatives;
state laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
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Misconduct by these parties could include failures to comply with FDA regulations, provide accurate information to the FDA, comply with federal and state health care fraud and abuse laws and regulations, accurately report financial information or data or disclose unauthorized activities to us.
−Removed: In particular, research, sales, marketing and business arrangements in the health care industry are subject to extensive laws and regulations
−Removed: intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices.
+Added: In particular, research, sales, marketing and business arrangements in the health care industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices.
These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.
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Our operations also produce hazardous waste products.
−Removed: We generally contract with third parties for the disposal of these materials and wastes.
+Added: We generally contract with third parties for the
+Added: disposal of these materials and wastes.
We cannot eliminate the risk of contamination or injury from these materials.
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Responding to any investigation or action will likely result in a materially significant diversion of management’s attention and resources and significant defense costs and other professional fees.
−Removed: As a general matter, investigations, enforcement actions and sanctions could damage our reputation, our brand, our international activities, our ability to attract and retain employees and our business, prospects, operating results and financial condition.
+Added: As a general matter, investigations,
+Added: enforcement actions and sanctions could damage our reputation, our brand, our international activities, our ability to attract and retain employees and our business, prospects, operating results and financial condition.
In addition, our products may be subject to U.S.
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In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.
−Removed: As of September 30, 2021, we had 30 full-time employees.
+Added: As of March 31, 2022, we had 38 full-time employees.
Of these employees, 29 are engaged in research or product development and clinical activities.
−Removed: In order to successfully implement our development and commercialization plans and strategies, and as we begin to operate as a public company, we expect to need additional managerial, operational, sales, marketing, financial and other personnel.
+Added: In order to successfully implement our development and commercialization plans and strategies, we expect to need additional managerial, operational, sales, marketing, financial and other personnel.
Future growth would impose significant added responsibilities on members of management, including:
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To the extent that any disruption or security incident were to result in any loss, destruction, unavailability, alteration, disclosure, or dissemination of, or damage or unauthorized access to, our applications, any other data processed or maintained on our behalf or other assets, or for it to be believed or reported that any of these occurred, we could incur liability, financial harm and reputational damage and the development and commercialization of our product candidates could be delayed.
−Removed: We cannot assure you that our data protection efforts and our investment in information technology, or the efforts or investments of CROs, consultants or other third parties, will prevent significant breakdowns or breaches in systems or other cyber incidents that cause loss, destruction, unavailability, alteration or dissemination of, or damage or unauthorized
−Removed: access to, our data and other data processed or maintained on our behalf or other assets that could have a material adverse effect upon our reputation, business, operations or financial condition.
+Added: We cannot assure you that our data protection efforts and our investment in information technology, or the efforts or investments of CROs, consultants or other third parties, will prevent significant breakdowns or breaches in systems or other cyber incidents that cause loss, destruction, unavailability, alteration or dissemination of, or damage or unauthorized access to, our data and other data processed or maintained on our behalf or other assets that could have a material adverse effect upon our reputation, business, operations or financial condition.
For example, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our programs and the development of our product candidates could be delayed.
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We expect to incur significant costs in an effort to detect and prevent security breaches and incidents, and we may face increased costs and requirements to expend substantial resources in the event of an actual or perceived security breach or incident.
−Removed: We also rely on third parties to manufacture our product candidates, and similar events relating to their computer systems could also have a material adverse effect on our business.
+Added: We also rely on
+Added: third parties to manufacture our product candidates, and similar events relating to their computer systems could also have a material adverse effect on our business.
To the extent that any disruption or security incident were to result in any loss, destruction, or alteration of, unavailability of, or damage or unauthorized access to, our data or other information that is processed or maintained on our behalf, or inappropriate disclosure of or dissemination of any such information, or if any of these were perceived or reported to have occurred, we could be exposed to litigation and governmental investigations, the further development and commercialization of our product candidates could be delayed, and we could be subject to significant fines or penalties for any noncompliance with certain state, federal and/or international privacy and security laws.
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The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses.
+Added: Our business may become subject to economic, political, regulatory and other risks associated with international operations directly or indirectly.
A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
+Added: Our business is subject to risks associated with business operations we conduct internationally, as well as indirect impacts from our relationships with collaborators, partners, or contractors who conduct business internationally.
We may seek regulatory approval of our product candidates outside of the United States and, accordingly, we expect that we will be subject to additional risks related to operating in foreign countries if we obtain the necessary approvals, including:
−Removed: differing regulatory requirements and reimbursement regimes in foreign countries;
+Added: differing regulatory requirements and reimbursement regimes in foreign countries, including changes in existing regulatory requirements and implementation of new regulatory requirements or policies that impact our clinical development and business operations in foreign countries;
+Added: foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials or our interpretation of data from preclinical studies or clinical trials;
+Added: approval policies or regulations of foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval;
unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;
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challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;
−Removed: production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;
−Removed: business interruptions resulting from geo-political actions, including war and terrorism.
+Added: impact of the COVID-19 pandemic or other public health concerns on our ability to produce our product candidates and conduct clinical trials in foreign countries;
+Added: production or supply shortages or other disruptions resulting from any events affecting raw material supply or manufacturing capabilities abroad, including, but not limited to, impacts due to the ongoing Ukraine-Russia war, addition of certain suppliers or companies to the Unverified List or other export restrictions under the Export Administration Regulations, implementation of other export controls, restrictions or sanctions that can impact the supply chain, our business, or business operations of our suppliers, contractors or partners;
+Added: business interruptions resulting from geo-political actions, including war, such as the ongoing war in Ukraine, other regional or geo-political conflicts, and terrorism.
These and other risks associated with our international operations may materially adversely affect our ability to attain or maintain profitable operations.
9 unchanged sentences
Only limited protection may be available and may not adequately protect our rights or permit us to gain or keep any competitive advantage.
−Removed: These uncertainties and/or
−Removed: limitations in our ability to properly protect the intellectual property rights relating to our product candidates could have a material adverse effect on our financial condition and results of operations.
+Added: These uncertainties and/or limitations in our ability to properly protect the intellectual property rights relating to our product candidates could have a material adverse effect on our financial condition and results of operations.
We cannot be certain that the claims in our U.S.
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In addition, although we enter into non-disclosure and confidentiality agreements with parties who have access to patentable aspects of our research and development output, such as our employees, outside scientific collaborators, CROs, third-party manufacturers, consultants, advisors and other third parties, any of these parties may breach such agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection.
−Removed: Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.
+Added: Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are
+Added: commercialized.
As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
68 unchanged sentences
Even if resolved in our favor, these legal proceedings may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities.
−Removed: In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.
+Added: In addition, there could be public announcements of the results of hearings, motions or other
+Added: interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.
Such proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities.
−Removed: We may not have sufficient financial or other resources to conduct such
−Removed: proceedings adequately.
+Added: We may not have sufficient financial or other resources to conduct such proceedings adequately.
Some of these third parties may be able to sustain the costs of such proceedings more effectively than we can because of their greater financial resources.
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With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we, our licensor, and the patent examiners are unaware during prosecution.
−Removed: There is also no assurance that there is not prior art of which we are aware, but which we do not believe affects the validity or enforceability of a claim in our patents and patent applications or the patents and patent applications of our licensor, which may, nonetheless, ultimately be found to affect the validity or enforceability of a claim.
−Removed: If a third-party were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our technology or proprietary drug
−Removed: discovery platform, or any product candidates that we may develop.
+Added: There is also no assurance that there is not prior art of which we are aware, but which we do not believe affects the validity or enforceability of a claim in our patents and patent applications or the
+Added: patents and patent applications of our licensor, which may, nonetheless, ultimately be found to affect the validity or enforceability of a claim.
+Added: If a third-party were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our technology or proprietary drug discovery platform, or any product candidates that we may develop.
Such a loss of patent protection would have a material adverse impact on our business, financial condition, results of operations and prospects.
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Third parties may have blocking patents that could prevent us from marketing our own patented product and practicing our own patented technology.
+Added: No earlier that October 1, 2022, European applications will soon have the option, upon grant of a patent, of becoming a Unitary Patent which will be subject to the jurisdiction of the Unitary Patent Court (“UPC).
+Added: This will be a significant change in European patent practice.
+Added: As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty of any litigation.
Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline.
8 unchanged sentences
Our defense of derivation proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees.
−Removed: In addition, the uncertainties associated with such proceedings could have a material adverse effect on our ability to raise the funds necessary to continue our clinical trials, continue our research programs, license necessary technology from third parties or enter into development or manufacturing partnerships that would help us bring our product candidates to market.
+Added: In addition, the uncertainties associated with such proceedings could have a material adverse effect on our ability to raise the funds necessary to
+Added: continue our clinical trials, continue our research programs, license necessary technology from third parties or enter into development or manufacturing partnerships that would help us bring our product candidates to market.
Changes in U.S.
2 unchanged sentences
Obtaining and enforcing patents in the pharmaceutical industry involve a high degree of technological and legal complexity.
−Removed: Therefore, obtaining and enforcing pharmaceutical patents is costly, time
−Removed: consuming and inherently uncertain.
+Added: Therefore, obtaining and enforcing pharmaceutical patents is costly, time consuming and inherently uncertain.
Changes in either the patent laws or in the interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property and may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents.
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A maximum of one patent may be extended per FDA approved product as compensation for the patent term lost during the FDA regulatory review process.
−Removed: A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only those claims covering such approved drug product, a method for using it or a method for manufacturing it may be extended.
+Added: A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only those claims covering such approved drug product, a method for using it or a method for
+Added: manufacturing it may be extended.
Patent term extension may also be available in certain foreign countries upon regulatory approval of our product candidates.
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If we are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of operations and prospects may be adversely affected.
+Added: Geo-political actions in the United States and in foreign countries could increase the uncertainties and costs surrounding the prosecution or maintenance of our patent applications or those of any current or future licensors and the maintenance, enforcement or defense of our issued patents or those of any current or future licensors.
+Added: For example, the United States and foreign government actions related to Russia’s invasion of Ukraine may limit or prevent filing, prosecution and maintenance of patent applications in Russia.
+Added: Government actions may also prevent maintenance of issued patents in Russia.
+Added: These actions could result in abandonment or lapse of our patents or patent applications, resulting in partial or complete loss of patent rights in Russia.
+Added: If such an event were to occur, it could have a material adverse effect on our business.
+Added: In addition, a decree was adopted by the Russian government in March 2022, allowing Russian companies and individuals to exploit inventions owned by patentees that have citizenship or nationality in, are registered in, or have predominately primary place of business or profit-making activities in the United States and other countries that Russia has deemed unfriendly without consent or compensation.
+Added: Consequently, we would not be able to
+Added: prevent third parties from practicing our inventions in Russia or from selling or importing products made using our inventions in and into Russia.
+Added: Accordingly, our competitive position may be impaired, and our business, financial condition, results of operations and prospects may be adversely affected.
+Added: No earlier that October 1, 2022, European applications will soon have the option, upon grant of a patent, of becoming a Unitary Patent which will be subject to the jurisdiction of the Unitary Patent Court (“UPC).
+Added: This will be a significant change in European patent practice.
+Added: As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty of any litigation.
Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
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We intend to use registered or unregistered trademarks or trade names to brand and market ourselves and our products.
−Removed: Our trademarks or trade names may be challenged, infringed, circumvented or declared generic or
−Removed: determined to be infringing on other marks.
+Added: Our trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks.
We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest.
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Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure.
−Removed: In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise
−Removed: additional funds or otherwise have a material adverse effect on our business, operating results, financial condition and prospects.
+Added: In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise additional funds or otherwise have a material adverse effect on our business, operating results, financial condition and prospects.
We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
8 unchanged sentences
We may enter into additional license agreements in the future with others to advance our research or allow commercialization of product candidates.
−Removed: These and other licenses may not provide exclusive rights to use such intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop or commercialize our technology and products in the future.
+Added: These and other licenses may not provide exclusive
+Added: rights to use such intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop or commercialize our technology and products in the future.
In addition, subject to the terms of any such license agreements, we may not have the right to control the preparation, filing, prosecution, maintenance, enforcement, and defense of patents and patent applications covering the technology that we license from third parties.
19 unchanged sentences
In addition, the agreements under which we license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations.
−Removed: The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations, and prospects.
+Added: The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our
+Added: rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations, and prospects.
Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on our business, financial conditions, results of operations, and prospects.
28 unchanged sentences
This preference for U.S.
−Removed: industry may be waived by the federal agency that provided the funding if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible.
+Added: industry may be waived by the federal agency that provided the funding if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar
+Added: terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible.
This preference for U.S.
16 unchanged sentences
Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, principal investigators and trial sites.
−Removed: If we or any of our CROs fail to comply with
−Removed: applicable GCP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, EMA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications.
+Added: If we or any of our CROs fail to comply with applicable GCP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, EMA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications.
We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials substantially comply with GCP regulations.
39 unchanged sentences
These agreements typically limit the rights of the third parties to use or disclose our confidential information.
−Removed: Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other
−Removed: confidential information increases the risk that such trade secrets become known by our competitors, are intentionally or inadvertently incorporated into the technology of others or are disclosed or used in violation of these agreements.
+Added: Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are intentionally or inadvertently incorporated into the technology of others or are disclosed or used in violation of these agreements.
Given that our proprietary position is based, in part, on our know-how and trade secrets and despite our efforts to protect our trade secrets, a competitor’s discovery of our proprietary technology and confidential information or other unauthorized use or disclosure would impair our competitive position and may have a material adverse effect on our business, financial condition, results of operations and prospects.
18 unchanged sentences
We would face significant competition in seeking appropriate collaborators and the negotiation process is time-consuming and complex.
−Removed: Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the
−Removed: proposed collaboration and the proposed collaborator’s evaluation of a number of factors.
+Added: Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors.
Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA, EMA or comparable foreign regulatory authorities, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing drugs, the existence of uncertainty with respect to our ownership of intellectual property and industry and market conditions generally.
5 unchanged sentences
If we are unable to do so, we may have to curtail the development of a product candidate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.
−Removed: If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all.
+Added: If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional
+Added: capital, which may not be available to us on acceptable terms or at all.
If we do not have sufficient funds, we may not be able to further develop our product candidates or bring them to market and generate product revenue.
14 unchanged sentences
collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all;
−Removed: collaborators may not provide us with timely and accurate information regarding development progress and activities under the collaboration or may limit our ability to share such information, which could adversely impact our ability to report progress to our investors and otherwise plan our own development of our product candidates;
+Added: collaborators may not provide us with timely and accurate information regarding development progress and activities under the collaboration or may limit our ability to share such information, which could
+Added: adversely impact our ability to report progress to our investors and otherwise plan our own development of our product candidates;
collaborators may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property;
8 unchanged sentences
Furthermore, an inactive market may also impair our ability to raise capital by selling shares of our common stock and may impair our ability to enter into strategic collaborations or acquire companies, technologies or other assets by using our shares of common stock as consideration.
−Removed: The price of our stock may be volatile, and you could lose all or part of your investment.
−Removed: The trading price of our common stock is likely to be highly volatile and subject to wide fluctuations in response to various factors, some of which we cannot control.
−Removed: The stock market in general, and pharmaceutical and
−Removed: biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.
+Added: The price of our stock has been and may continue to be volatile, and you could lose all or part of your investment.
+Added: The trading price of our common stock has been and may continue to be highly volatile and subject to wide fluctuations in response to various factors, some of which we cannot control.
+Added: The stock market in general, and pharmaceutical and biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.
Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.
17 unchanged sentences
the availability of fiscal and monetary stimulus measures to counteract the impact of the COVID-19 pandemic;
−Removed: general economic, political, industry and market conditions.
+Added: general economic, political, industry and market conditions including the impact of increasing inflation.
The realization of any of the above risks or any of a broad range of other risks, including those described in this “Risk Factors” section, could have a dramatic and adverse impact on the market price of our common stock.
12 unchanged sentences
the need to conduct unanticipated clinical trials or trials that are larger or more complex than anticipated;
−Removed: competition from existing and potential future products that compete with EDG-5506, our EDG-6289, EDG-002 and EDG-003 research programs and any of our other product candidates or programs, and changes in the competitive landscape of our industry, including consolidation among our competitors or partners;
+Added: competition from existing and potential future products that compete with EDG-5506, our EDG-5440 and EDG-002 research programs and any of our other product candidates or programs, and changes in the competitive landscape of our industry, including consolidation among our competitors or partners;
any delays in regulatory review or approval of EDG-5506 or any of our other product candidates;
15 unchanged sentences
Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
−Removed: As of September 30, 2021, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates beneficially owned approximately 70.1 % of our outstanding common stock.
+Added: As of March 31, 2022, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates beneficially owned approximately 79.3% of our outstanding common stock.
These stockholders, acting together, may be able to control matters requiring stockholder approval.
6 unchanged sentences
Moreover, certain holders of an aggregate of our common stock have rights, subject to certain conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders.
−Removed: Registration of these shares, under the Securities Act of 1933, as amended, would result in the shares becoming freely tradable in the public market, subject to the restrictions of Rule 144 in the case of our affiliates.
+Added: Registration of these shares, under the Securities Act, would result in the shares becoming freely tradable in the public market, subject to the restrictions of Rule 144 in the case of our affiliates.
If any of these additional shares are sold, or if it is perceived that they will be sold, in the public market, the market price of our common stock could decline.
9 unchanged sentences
We have elected to avail ourselves of this exemption from new or revised accounting standards and, therefore, will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
−Removed: As a result, our financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.
+Added: As a result, our financial
+Added: statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.
We will remain an emerging growth company until the earliest to occur of:
12 unchanged sentences
If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
−Removed: We will incur increased costs as a result of operating as a public company, and our management will devote substantial time to related compliance initiatives.
+Added: We incur significantly increased costs and devote substantial management time as a result of operating as a public company.
Additionally, if we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
As a public company, we incur significant legal, accounting and other expenses that we did not incur as a private company, and these expenses may increase even more after we are no longer an “emerging growth company.” We are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Protection Act, as well as rules adopted, and to be adopted, by the SEC and the Nasdaq Stock Market LLC (Nasdaq).
−Removed: Our management and other personnel need to devote a substantial amount of time to these compliance initiatives.
−Removed: Moreover, we expect these rules and regulations to substantially increase our legal and financial compliance costs and to make some activities more time-consuming and costly, which will increase our operating expenses.
−Removed: For example, these rules and regulations make it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial costs to maintain sufficient coverage, particularly in light of recent cost increases related to coverage.
+Added: Our management and other personnel devote a substantial amount of time to these compliance initiatives.
+Added: Moreover, these rules and regulations have substantially increased our legal and financial compliance costs and makes some activities more time-consuming and costly, which has increased our operating expenses.
+Added: For example, these rules and regulations make it more difficult and more expensive for us to obtain director and officer liability insurance and we have been required to incur substantial costs to maintain sufficient coverage, particularly in light of recent cost increases related to coverage.
We cannot accurately predict or estimate the amount or timing of additional costs we may incur to respond to these requirements.
2 unchanged sentences
Under these rules, beginning with our second annual report on Form 10-K after we become a public company, we will be required to make a formal assessment of the effectiveness of our internal control over financial reporting, and once we cease to be an emerging growth company, we will be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm.
−Removed: To achieve compliance with Section 404 within the prescribed period, we will be engaging in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging.
+Added: To achieve compliance with Section 404
+Added: within the prescribed period, we will be engaging in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging.
In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of our internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are designed and operating effectively, and implement a continuous reporting and improvement process for internal control over financial reporting.
19 unchanged sentences
We have never declared or paid any cash dividends on our common stock.
−Removed: We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future.
+Added: We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring
+Added: or paying any cash dividends for the foreseeable future.
Any return to stockholders will therefore be limited to any appreciation in the value of their stock.
16 unchanged sentences
Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America are the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
−Removed: Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, another State court in Delaware or the federal district court for the District of Delaware) is the exclusive forum for the following (except for any claim as to which such court determines that there is an indispensable party not subject to the jurisdiction of such court (and the indispensable party does not consent to the personal jurisdiction of such court within 10 days following such determination), which is vested in the exclusive jurisdiction of a court or forum other than such court or for which such court does not have subject matter jurisdiction):
+Added: Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware (or, if the Court of Chancery does not have jurisdiction, another State court in Delaware or the federal district court for the District of Delaware) is the exclusive forum for the following (except for any claim as to which such court determines that
+Added: there is an indispensable party not subject to the jurisdiction of such court (and the indispensable party does not consent to the personal jurisdiction of such court within 10 days following such determination), which is vested in the exclusive jurisdiction of a court or forum other than such court or for which such court does not have subject matter jurisdiction):
any derivative action or proceeding brought on our behalf;
10 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.