9 unchanged sentences
To date, we have invested substantial efforts and financial resources in the research and development of ELX-02, which is currently our only product candidate in clinical development.
−Removed: We have increased investment in our pre-clinical candidate portfolio but have yet to advance other molecules into clinical development.
+Added: We have increased investment in our preclinical candidate portfolio but have yet to advance other molecules into clinical development.
Our ability to achieve and sustain profitability depends on obtaining regulatory approvals for, and successfully commercializing ELX-02 and any future product candidates, either alone or with third parties.
30 unchanged sentences
On March 25, 2020, we announced that enrollment in our clinical trials had been paused temporarily in response to the COVID-19 pandemic in order to avoid unnecessary exposure in at-risk populations, to maintain the integrity of our study data and to support global healthcare providers in their commitment to ensure patient safety.
−Removed: On June 17, 2020, we announced that enrollment in our Phase 2 clinical trial in cystic fibrosis has been resumed in Israel and Europe, and that our U.S.
−Removed: trial remains temporarily paused due to the COVID-19 pandemic.
−Removed: COVID-19 is rapidly evolving and we continue to work closely with our clinical sites and investigators.
−Removed: While we remain committed to completing enrollment in these Phase 2 proof of concept clinical trials and reporting top line data as soon as feasible, we cannot provide assurances as to when this will be accomplished or whether we will incur significant additional costs, expend additional resources or be subject to additional regulatory requirements, any of which may have a material adverse impact on our financial condition and results of operations.
+Added: On June 17, 2020, we announced that enrollment in our Phase 2 clinical trial in cystic fibrosis had resumed in Israel and Europe, and on August 12, 2020, we announced that enrollment in our Phase 2 clinical trial in cystic fibrosis had resumed in the U.S.
+Added: COVID-19 is continuing to evolve and we continue to work closely with our clinical trial sites and investigators.
+Added: While we remain committed to completing enrollment in these Phase 2 proof of concept clinical trials and reporting top line data in the first half of 2021 , we cannot provide assurances as to when this will be accomplished or whether we will incur significant additional costs, expend additional resources or be subject to additional regulatory requirements, including COVID-19 related disruptions, any of which may have a material adverse impact on our financial condition and results of operations.
We could encounter delays if prescribing physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of our product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles.
−Removed: Further, a clinical trial may be suspended or terminated by us, our collaborators, the IRB of the institutions in which such trials are being conducted, the Data Safety Monitoring Board, or DSMB, for such trial, or by the FDA or other regulatory authorities due to a number of factors, including:
+Added: Further, a clinical trial may be suspended or terminated by us, our collaborators, the IRB of the institutions in which such trials are being conducted, the Data Safety Monitoring Board (“DSMB”) for such trial, or by the FDA or other regulatory authorities due to a number of factors, including:
failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
4 unchanged sentences
lack of adequate funding to continue the clinical trial.
−Removed: In addition, significant adverse events with respect to individuals who are not enrolled in any of our clinical trials but who receive our drug candidate under our compassionate use policy (typically under a single-patient IND (investigational new drug application) administered by the individual’s treating physician) may result in a partial or full clinical hold on our on-going clinical trials.
−Removed: A clinical hold may result in the inability to enroll new patients in our studies until the hold is removed and make it more difficult to enroll patients thereafter.
+Added: In addition, significant adverse events with respect to individuals who are not enrolled in any of our clinical trials but who receive our drug candidate under our compassionate use policy (typically under a single-patient investigational new drug application (“IND”) administered by the individual’s treating physician) may result in a partial or full clinical hold on our ongoing clinical trials.
+Added: A clinical hold may result in the inability to enroll new patients in our studies until the hold is removed and may make it more difficult to enroll patients thereafter.
Additionally, a clinical hold may also result in, among other things, protocol redesign, changes in eligibility criteria and increased costs, any of which could adversely affect our projected development timelines and jeopardize successful completion of our clinical programs.
46 unchanged sentences
Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations and prospects.
−Removed: Our clinical trials may be costly and lengthy, time-consuming and difficult to design and implement, may result in unforeseen costs and could be delayed or terminated, which may have a material adverse effect on our business, results of operations and financial condition.
+Added: Our clinical trials may be costly, lengthy, time-consuming and difficult to design and implement, may result in unforeseen costs and could be delayed or terminated, which may have a material adverse effect on our business, results of operations and financial condition.
For human trials, patients must be recruited, and each product candidate must be tested at various doses and formulations for each clinical indication.
16 unchanged sentences
In addition, the protocol for our clinical trials generally mandates that a patient cannot be involved in more than one clinical trial for the same indication.
−Removed: Therefore, subjects that participate in ongoing clinical trials for products that are competitive with our product candidates are not available to participate in our clinical trials.
+Added: Therefore, subjects that participate in ongoing clinical trials for products that are competitive with our product candidates are not eligible to participate in our clinical trials.
We cannot guarantee that any of our programs will identify a sufficient number of patients to complete clinical development, pursue regulatory approval and market our product candidates, if approved.
3 unchanged sentences
On June 17, 2020, we
−Removed: announced that enrollment in our Phase 2 clinical trial in cystic fibrosis has been resumed in Israel and Europe, and that our U.S.
−Removed: trial remains temporarily paused due to the COVID-19 pandemic.
−Removed: COVID-19 is rapidly evolving and we continue to work closely with our clinical sites and investigators to ensure that patient enrollment will continue as soon as feasible in a safe environment for our patients .
+Added: announced that enrollment in our Phase 2 clinical trial in cystic fibrosis ha d resumed in Israel and Europe, and on August 12, 2020 , we announced that enrollment in our Phase 2 clinical trial in cystic fibrosis ha d resumed in the U.S.
+Added: COVID-19 is continuing to evolve and we continue to work closely with our clinical trial sites and investigators to ensure that patient enrollment will continue as quickly as is feasible in a safe environment for our patients .
+Added: We are also evaluating additional clinical sites in other countries where patient enrollment may be feasible.
Additionally, significant additional costs as a result of this delay in enrollment or failure to complete enrollment in accordance with our objectives may have a material adverse impact on our financial condition and results of operations.
4 unchanged sentences
We cannot control the amount or timing of resources that they devote to our preclinical and or clinical development programs and they may not assign as great a priority to our preclinical or clinical development programs or pursue them as diligently as we would if we were undertaking such programs directly.
−Removed: If outside collaborators fail to devote sufficient time and resources to our preclinical and clinical development programs, or if their performance is substandard, the authorization of investigational new drug applications (“INDs”) and pre-clinical trial applications (“CTAs”) and the approval of anticipated new drug applications (“NDAs”) and other marketing applications, and our introduction of new drugs, if any, may be delayed or impeded, which could impair our clinical development programs and would have a material adverse effect on our business and results of operations.
+Added: If outside collaborators fail to devote sufficient time and resources to our preclinical and clinical development programs, or if their performance is substandard, the authorization of INDs and clinical trial applications (“CTAs”) and the approval of anticipated new drug applications (“NDAs”) and other marketing applications, and our introduction of new drugs, if any, may be delayed or impeded, which could impair our clinical development programs and would have a material adverse effect on our business and results of operations.
These collaborators may also have relationships with other commercial entities, some of whom may compete with us and we may be unable to prevent them from establishing competing businesses or developing competing products.
−Removed: The extent to which the COVID-19 pandemic and municipalities’ efforts to combat it through temporary quarantines, containment zones and limitations on travel, as well as other restrictions, may create business disruptions within the organizations of our third-party researchers, scientists and consultants, as well as CROs, clinical sites and patient assistance groups, that result in the unavailability of personnel needed to successfully conduct and complete our clinical trials, may have a material adverse impact on our business and financial condition.
−Removed: We are subject to extensive governmental regulation including the requirements of FDA and comparable foreign regulatory authorities for development and approval of our product candidates before they can be marketed.
+Added: The extent to which the COVID-19 pandemic and municipalities’ efforts to combat it through temporary quarantines, containment zones and limitations on travel, as well as other restrictions, may create business disruptions within the organizations of our third-party researchers, scientists and consultants, as well as CROs, clinical trial sites and patient assistance groups, that result in the unavailability of personnel needed to successfully conduct and complete our clinical trials, may have a material adverse impact on our business and financial condition.
+Added: We are subject to extensive governmental regulation including the requirements of the FDA and comparable foreign regulatory authorities for development and approval of our product candidates before they can be marketed.
We, our product candidates, our suppliers, our contract manufacturers, our contract testing laboratories and our clinical trial sites and clinical trial researchers are subject to extensive regulation by the FDA and comparable foreign regulatory authorities.
23 unchanged sentences
In the EU, we must submit a Marketing Authorization Application, or MAA, to the EMA.
−Removed: Satisfaction of the FDA’s, the EMA’s and other foreign regulatory authorities’ regulatory requirements typically takes many years, depends upon the type, complexity and novelty of the product candidate and requires substantial resources for research, development and testing.
+Added: Satisfaction of the regulatory requirements of the FDA, the EMA and other foreign regulatory authorities typically takes many years, depends upon the type, complexity and novelty of the product candidate and requires substantial resources for research, development and testing.
Even if we comply with all the requests of regulatory authorities, they may ultimately reject any marketing applications that we file for our product candidates, or we might not obtain regulatory clearance in a timely manner if at all.
19 unchanged sentences
Moreover, in order to obtain orphan designation in the EU, it is necessary to demonstrate that there exists no satisfactory method of diagnosis, prevention or treatment of the condition authorized for marketing in the EU, or if such a method exists, that the product will be of significant benefit to those affected by the condition.
−Removed: The FDA has granted orphan drug designation for ELX-02 for the treatment of cystic fibrosis as well as for the treatment of cystic fibrosis, MPS I and the treatment of Rett syndrome.
+Added: The FDA has granted orphan drug designation for ELX-02 for the treatment of cystic fibrosis, MPS I and Rett syndrome.
We may seek orphan drug designation for our other product candidates, and with respect to other indications.
18 unchanged sentences
launching, marketing and selling drugs.
−Removed: These organizations also compete with us to attract qualified personnel, acquisitions and joint ventures candidates and for other collaborations.
+Added: These organizations also compete with us to attract qualified personnel, for acquisitions and joint venture candidates and for other collaborations.
Efforts to compete and the pursuit of activities of our competitors may impose unanticipated costs on our business, which would have a material adverse effect on our business, results of operations and financial condition.
13 unchanged sentences
We may never achieve or maintain profitability.
−Removed: We have a history of net losses and negative cash flows from operating activities since inception, and as of June 30, 2020, had an accumulated deficit of $(158.9) million.
+Added: We have a history of net losses and negative cash flows from operating activities since inception, and as of September 30, 2020, had an accumulated deficit of $(165.5) million.
Historically, we have financed our operations primarily through equity capital investments, and to a lesser extent from loans and grants.
20 unchanged sentences
Our failure to become and remain profitable would decrease the value of the company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations.
−Removed: A decline in the value of our Company could also cause investors to lose all or part of their investment.
+Added: A decline in the value of the company could also cause investors to lose all or part of their investment.
We will need substantial additional funding.
1 unchanged sentence
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, continue and initiate clinical trials of, and seek marketing approval for ELX-02, and as we become obligated to make milestone payments pursuant to our outstanding license agreements.
−Removed: In addition, if we obtain marketing approval for any of our current or future product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution of the approved product.
+Added: In addition, if we obtain marketing approval for any of our current or future product candidates, we expect to incur significant commercialization expenses related to sales, marketing, manufacturing and distribution of the approved product.
Our future capital requirements will depend on many factors, including:
8 unchanged sentences
In addition, our product candidates, if approved, may not achieve commercial success.
−Removed: Our commercial revenue, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if at all.
+Added: Our commercial revenue, if any, will be derived from sales of products that we do not expect to be commercially available for several years, if at all.
Accordingly, despite our prior public equity offerings and debt financing, we will need substantial additional funding in connection with our continuing operations and to achieve our goals.
52 unchanged sentences
tax on foreign earnings (subject to certain important exceptions), immediate deductions for certain new investments instead of deductions for depreciation expense over time, and modifying or repealing many business deductions and credits.
−Removed: In response to the COVID-19 pandemic, CARES Act was signed into law in March 2020.
+Added: In response to the COVID-19 pandemic, the CARES Act was signed into law in March 2020.
The CARES Act lifts certain deduction limitations originally imposed by the TCJA.
−Removed: Corporate taxpayers may carryback net operating losses (NOLs) originating during 2018 through 2020 for up to five years, which was not previously allowed.
+Added: Corporate taxpayers may carry back net operating losses (NOLs) originating during 2018 through 2020 for up to five years, which was not previously allowed.
The CARES Act also eliminates the 80% of taxable income limitations by allowing corporate entities to fully utilize
47 unchanged sentences
Legislative changes to the PPACA also remain possible and appear likely under the current administration.
−Removed: The issuance of regulations and coverage expansion by various governmental agencies relating to the Medicaid Drug Rebate Program has and will continue to increase our costs and the complexity of compliance, has been and will be time-consuming, and could have a material adverse effect on our results of operations.
+Added: The issuance of regulations and coverage expansion by various governmental agencies relating to the Medicaid Drug Rebate Program has increased and will continue to increase our costs and the complexity of compliance, has been and will be time-consuming, and could have a material adverse effect on our results of operations.
Governments in countries where we operate have adopted or have shown significant interest in pursuing legislative initiatives to reduce costs of healthcare.
8 unchanged sentences
On March 25, 2020, we announced that enrollment in our clinical trials had been paused temporarily in response to the COVID-19 pandemic in order to avoid unnecessary exposure in at-risk populations, to maintain the integrity of our study data and to support global healthcare providers in their commitment to ensure patient safety.
−Removed: On June 17, 2020, we announced that enrollment in our Phase 2 clinical trial in cystic fibrosis has been resumed in Israel and Europe, and that our U.S.
−Removed: trial remains temporarily paused due to the COVID-19 pandemic.
−Removed: COVID-19 is rapidly evolving and we continue to work closely with our clinical sites and investigators.
−Removed: While we remain committed to completing enrollment in these Phase 2 proof of concept clinical trials and reporting top line data as soon as feasible, we cannot provide assurances as to when this will be accomplished or whether we will incur significant additional costs, expend additional resources or be subject to additional regulatory requirements, any of which may have a material adverse impact on our financial condition and results of operations.
+Added: On June 17, 2020, we announced that enrollment in our Phase 2 clinical trial in cystic fibrosis had resumed in Israel and Europe, and on August 12, 2020, we announced that enrollment in our Phase 2 clinical trial in cystic fibrosis had resumed in the U.S.
+Added: COVID-19 is continuing to evolve and we continue to work closely with our clinical sites and investigators.
+Added: While we remain committed to completing enrollment in these Phase 2 proof of concept clinical trials and reporting top line data in the first half of 2021 , we cannot provide assurances as to when this will be accomplished or whether we will incur significant additional costs, expend additional resources or be subject to additional regulatory requirements, including COVID-19 related disruptions, any of which may have a material adverse impact on our financial condition and results of operations.
We may be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties and reputational damage.
4 unchanged sentences
If we fail to comply with applicable laws and regulations, we could be subject to penalties or sanctions, including criminal penalties if we knowingly obtain individually identifiable health information from a covered entity in a manner that is not authorized or permitted by HIPAA or for aiding and abetting the violation of HIPAA.
−Removed: Numerous other countries have, or are developing, laws governing the collection, use and transmission of personal information as well.
+Added: Numerous other countries have also developed, or are developing, laws governing the collection, use and transmission of personal information.
EU member states and other jurisdictions have adopted data protection laws and regulations, which impose significant compliance obligations.
9 unchanged sentences
The secure maintenance of this information is critical to our operations and business strategy.
−Removed: Some of this information could be an attractive target of criminal attack by third parties with a wide range of motives and expertise, including organized criminal groups, “hacktivists,” patient groups, disgruntled current or former employees, and others.
−Removed: Cyber-attacks are of ever-increasing levels of sophistication, and despite our security
−Removed: measures, our information technology and infrastructure may be vulnerable to such attacks or may be breached, including due to employee error or malfeasance.
+Added: Some of this information could be an attractive target of criminal attack by third parties with a wide range of motives and expertise, including organized criminal groups, “hacktivists,” patient groups, disgruntled current or
+Added: former employees, and others.
+Added: Cyber-attacks are of ever-increasing levels of sophistication, and despite our security measures, our information technology and infrastructure may be vulnerable to such attacks or may be breached, including due to employee error or malfeasance.
We have also implemented information security measures to protect patients’ personal information against the risk of inappropriate and unauthorized external use and disclosure.
46 unchanged sentences
If we fail to adequately protect or enforce our intellectual property rights or secure rights to third party patents, the value of our intellectual property rights would diminish, and our business, competitive position and results of operations would suffer.
−Removed: As of June 30, 2020, we owned or licensed 22 issued patents and 54 pending patent applications in the U.S.
+Added: As of September 30, 2020, we owned or licensed 22 issued patents and 54 pending patent applications in the U.S.
and abroad, not including U.S.
13 unchanged sentences
Thus, any patents we own or license from or to third parties may not provide any protection against our competitors and those who infringe upon our patents.
−Removed: Furthermore, the life of our patents is limited.
+Added: Furthermore, the lives of our patents are limited.
With regard to our lead compound ELX-02, patents that have issued or that may issue in the future from our primary composition of matter patent family are currently set to expire in 2031.
121 unchanged sentences
If we sell common stock, convertible securities or other equity securities in one or more transactions, existing investors may be materially diluted by subsequent sales, and new investors could gain rights superior to our existing stockholders.
−Removed: Pursuant to our 2018 Equity Incentive Plan, or the 2018 Plan, our management is authorized to grant stock options and other equity-based awards to our employees, directors and consultants.
−Removed: As of June 30, 2020, individuals held share awards to purchase or receive an aggregate of 5,643,291 shares of our common stock.
+Added: Pursuant to our 2018 Equity Incentive Plan, our management is authorized to grant stock options and other equity-based awards to our employees, directors and consultants.
+Added: As of September 30, 2020, individuals held share awards to purchase or receive an aggregate of 5,635,904 shares of our common stock.
If our board of directors elects to increase the number of shares available for future grant by the maximum amount each year, our stockholders may experience additional dilution, which could have a negative effect on our share price.
6 unchanged sentences
Further, we do not have rights of indemnification against the pre-transaction stockholders of Sevion.
−Removed: We may not be able to contain or control the costs or liabilities associated with Sevion’s historic business, which could materially and
−Removed: adversely affect our business, liquidity, capital resources or results of operation, and may divert management’s time and attention from conducting the business of the Company.
+Added: We may not be able to contain or control the costs or liabilities associated with Sevion’s historic business, which could materially and adversely affect our business, liquidity, capital resources or results of operation, and may divert management’s time and attention from conducting the business of the Company.
The following is a list of exhibits filed as part of this Report.
21 unchanged sentences
ELOXX PHARMACEUTICALS, INC.
−Removed: August 7, 2020
+Added: November 6, 2020
/s/ Stephen G.
2 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.