45 unchanged sentences
Positive results from preclinical or in vitro and in vivo testing of ELX-02 are not necessarily predictive of the results of future clinical trials of ELX-02.
−Removed: If we cannot achieve positive results in our clinical trials for ELX-02, we may be unable to succ essfully develop, obtain regulatory approval for and commercialize ELX-02.
+Added: If we cannot achieve positive results in our clinical trials for ELX-02, we may be unable to successfully develop, obtain regulatory approval for and commercialize ELX-02.
Positive results from our preclinical testing of ELX-02 in vitro and in vivo may not necessarily be predictive of the results from our ongoing and planned clinical trials in humans.
45 unchanged sentences
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: 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: 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 market ed.
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.
18 unchanged sentences
otherwise diminish any competitive advantages that we may have with respect to such product candidate.
−Removed: We may not obtain the necessary FDA, EMA or other worldwide regulatory approvals to commercialize our product candidates in a timely manner, if at all, which would hav e a material adverse effect on our business, results of operations and financial condition.
+Added: We may not obtain the necessary FDA, EMA or other worldwide regulatory approvals to commercialize our product candidates in a timely manner, if at all, which would have a material adverse effect on our business, results of operations and financial conditio n.
We need FDA approval to commercialize our product candidates in the U.S., EMA approval to commercialize our product candidates in the EU and approvals from other foreign regulatory authorities to commercialize our product candidates elsewhere in the world.
24 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 cystinosis as well as for the treatment of MPS I and the treatment of R ett syndrome.
+Added: The FDA has granted orphan drug designation for ELX-02 for the treatment of cystinosis as well as for the treatment of MPS I and the treatment of Rett syndrome.
We may seek orphan drug designation for our other product candidates, and with respect to other indications.
−Removed: Generally, if a drug with an orphan drug designation subsequently receives the first FDA marketing approval for the indication for wh ich it has such designation, the drug is entitled to a period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same drug for the same indication for that time period.
−Removed: The applicable period is seven year s in the U.S.
−Removed: Orphan drug exclusivity may be lost if the FDA or EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.
+Added: Generally, if a drug with an orphan drug designation subsequently receives the first FDA marketing approval for the indication fo r which it has such designation, the drug is entitled to a period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same drug for the same indication for that time period.
+Added: The applicable period is seven years in the U.S.
+Added: Orphan drug exclusivity may be lost if the FDA or EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the r are disease or condition.
Even if we obtain orphan drug exclusivity for a product candidate, that exclusivity may not effectively protect the candidate from competition because different drugs can be approved for the same condition.
30 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 March 31, 2019, had an accumulated deficit of $98.1 million.
+Added: We have a history of net losses and negative cash flows from operating activities since inception, and as of June 30, 2019, had an accumulated deficit of $112.5 million.
Historically, we have financed our operations primarily through equity capital investments, and to a lesser extent from loans and grants from the Israeli Innovation Authority of the Ministry of Economy and Industry, or the IIA.
36 unchanged sentences
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.
−Removed: Accordingly, despite the Public Offering, we will need substantial additional funding in connection with our continuing operations and to achieve our goals.
+Added: Accordingly, despite the public offerings in April 2018 and June 2019, we will need substantial additional funding in connection with our continuing operations and to achieve our goals.
However, our existing cash and cash equivalents may prove to be insufficient for these activities.
34 unchanged sentences
We may also seek to raise funds by selling shares of our capital stock, or securities convertible into our capital stock, which could dilute current stockholders’ ownership interest in our Company.
−Removed: Our business could be affected by litigatio n, government investigations and enforcement actions.
+Added: Our business could be affected by litigation, government investigations and enforcement actions.
We operate in many jurisdictions in a highly regulated industry and we could be subject to litigation, government investigation and enforcement actions on a variety of matters in the U.S.
15 unchanged sentences
Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations.
−Removed: As of March 31, 2019, we had U.S.
+Added: As of June 30, 2019, we had U.S.
federal and state net operating loss, or “NOL”, carry forwards of $89.8 million and $40.0 million, respectively, and federal research tax credit carryforwards of $0.7 million.
13 unchanged sentences
Given the offsetting adjustments to the existing valuation allowance, any ownership change is not expected to have an adverse material effect on our Consolidated Financial Statements.
−Removed: Finally, as of March 31, 2019, we had Israeli NOL carryforwards of $34.6 million, which carry forward indefinitely.
−Removed: Our ability to utilize our NOLs is dependent on attaining profitability sufficient to offset such available NOLs prior to their expiration.
−Removed: In addition, we may not be able to utilize a portion of the NOLs reflec ted on our balance sheet, even if we attain profitability.
+Added: Finally, as of June 30, 2019, we had Israeli NOL carryforwards of $34.6 million, which carry forward indefinitely.
+Added: Our ability to utilize our NOLs is dependent on attaining profitability sufficie nt to offset such available NOLs prior to their expiration.
+Added: In addition, we may not be able to utilize a portion of the NOLs reflected on our balance sheet, even if we attain profitability.
We could be subject to additional tax liabilities.
22 unchanged sentences
The announcement or adoption of regulatory or legislative proposals could delay or prevent our entry into new markets, affect our reimbursement or sales in the markets where we are already selling our approved products, if any, and materially harm our business, financial condition and results of operations.
−Removed: We may be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties and reputational damage.
+Added: We ma y be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties and reputational damage.
We are subject to laws and regulations covering data privacy and the protection of personal information including health information.
25 unchanged sentences
Any one of these events, or similar events occurring through one of our vendors that maintain such information on our behalf, could cause our business to be materially harmed and our results of operations to be adversely impacted.
−Removed: We expect to rely on third parties to conduct some or all aspects of our product manufacturing, protocol development, research and preclinical and clinical testing, and these third parties may not perform satisfactorily.
+Added: We expect to rely on third parties to conduct some or all aspects of our product manufacturing, protocol development, research and preclinical an d clinical testing, and these third parties may not perform satisfactorily.
We do not expect to independently conduct all aspects of our product manufacturing, protocol development, research and preclinical and clinical testing.
1 unchanged sentence
Any of these third parties may terminate their engagements with us at any time.
−Removed: If we need to enter into alternative arrangements, it could delay our product development activitie s.
+Added: If we need to enter into alternative arrangements, it could delay our product development activities.
Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of our responsibility to ensure compliance with all applicable laws and regulations and study protocols.
−Removed: If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our studies in accordance with regulatory requirements or our stated study plans and protocols, we will not be able to complete, or may be delay ed in completing, the preclinical studies and clinical trials required to support future NDA submissions and approval of our product candidates.
+Added: If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our studies in accordance with regulatory requirements or our stated study plans and protocols, we will not be able to complete, or may be delayed in completing, the preclinical studies and clinical trials required to support future NDA submissions and approval of our product candidates.
Reliance on third-party manufacturers, testing sites, and investigators entails risks to which we would not be subject if we developed, researched, tested, and manufactured the product candidates ourselves, including:
20 unchanged sentences
If we fail to attract and retain highly qualified personnel, we may not be able to successfully develop, manufacture or commercialize our product candidates.
−Removed: Risks Related to Intellectual Property
+Added: Risks Related to Int ellectual Property
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.
29 unchanged sentences
If we cannot obtain new patents, maintain our existing patents and protect the confidentiality and proprietary nature of our trade secrets and other intellectual property, our business and competitive position may be harmed.
−Removed: Our success will depend in part on our ability to obtain and maintain patent and regulatory protections for our product candidates, to preserve our t rade secrets and other proprietary rights, to operate without infringing the proprietary rights of third parties, and to prevent third parties from circumventing our rights.
−Removed: Due to the time and expense of bringing new product candidates through development and regulatory approval to the marketplace, there is particular importance in obtaining patent and trade secret protection for significant new technologies, products and processes.
+Added: Our success will d epend in part on our ability to obtain and maintain patent and regulatory protections for our product candidates, to preserve our trade secrets and other proprietary rights, to operate without infringing the proprietary rights of third parties, and to prev ent third parties from circumventing our rights.
+Added: Due to the time and expense of bringing new product candidates through development and regulatory approval to the marketplace, there is particular importance in obtaining patent and trade secret protection f or significant new technologies, products and processes.
We have and may in the future obtain patents or the right to practice patents through ownership or license.
34 unchanged sentences
defend litigation or administrative proceedings that may be costly whether we win or lose, and which could result in a substantial diversion of management resources;
−Removed: Any costs incurred in connection with such events or the inability to develop or sell our products may have a material adverse effect on our busines s, results of operations and financial condition.
+Added: Any costs incurred in connection with such events or the inability to develop or sell our products may have a material adverse effect on our business, results of operations and financial condition.
We rely on confidentiality agreements that could be breached and may be difficult to enforce which could have a material adverse effect on our business and competitive position.
24 unchanged sentences
In addition, since 2010 political uprisings and conflicts in various countries in the Middle East have been affecting the political stability of those countries and the region in general.
−Removed: It is not clear how this instability will develop and how it will affect the political and security situation in the Middle East.
+Added: It is not clear how this instability will develop and how it will affect the political and s ecurity situation in the Middle East.
This instability has raised concerns regarding security in the region and the potential for armed conflict.
1 unchanged sentence
Although these groups’ activities have not directly affected the political and economic conditions in Israel, a stated purpose is to take control of the Middle East, including Israel.
−Removed: The tension between Israel and these other groups may escalate in the future and turn violent, which could affect the Israeli economy in general and us in particular.
+Added: The tension between Israel and these other groups may escalate in the future and turn violent, which could aff ect the Israeli economy in general and us in particular.
Such instability may lead to deterioration in the political and trade relationships that exist between Israel and certain other countries.
−Removed: Any armed conflicts, terrorist
−Removed: activities or political instability in the region could adversely affect business conditions, could harm our results of operations and could make it more difficult for us to raise capital.
−Removed: Several countries, princ ipally in the Middle East, still restrict doing business with Israel and Israeli companies, and additional countries may impose restrictions on doing business with Israel and Israeli companies if hostilities in Israel or political instability in the region continues or increases.
−Removed: Similarly, Israeli companies are limited in conducting business with entities from several countries.
−Removed: In addition, the political and security situation in Israel may result in parties with whom we have agreements involving performa nce in Israel claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions in such agreements.
+Added: Any armed conflicts, terrorist activities or political insta bility in the region could adversely affect business conditions, could harm our results of operations and could make it more difficult for us to raise capital.
+Added: Several countries, principally in the Middle East, still restrict doing business with Israel and Israeli companies, and additional countries may impose restrictions on doing business with Israel and Israeli companies if hostilities in Israel or political instability in the region continues or increases.
+Added: Similarly, Israeli companies are limited in con ducting business with entities from several countries.
+Added: In addition, the political and security situation in Israel may result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their comm itments under those agreements pursuant to force majeure provisions in such agreements.
Our insurance does not cover losses that may occur as a result of an event associated with the security situation in the Middle East or for any resulting disruption in our operations.
32 unchanged sentences
Our research and development efforts have been financed, in part, through royalty-bearing grants from the Israel Innovation Authority, or IIA.
−Removed: To date, we have received the aggregate amount of approximately $2.6 million from the IIA for the development of our technologies.
+Added: To date, we have received the aggregate amount of approximately $2.6 million from the IIA for
+Added: the development of our technologies.
With respect to such grants we are required to pay certain royalties (including accrued LIBOR interest) up to $2.7 million.
We are required to comply with the requirements of the Israeli Encouragement of Research, Development and Technological Innovation in the Industry Law, 5744-1984, as amended, and related regulations, or the R&D Law, with respect to these past grants.
−Removed: If we fail to comply with the R&D Law, we may be required to refund certain grants previously received and/or to pay interest and penalties and we may become subject to criminal charges.
+Added: If we f ail to comply with the R&D Law, we may be required to refund certain grants previously received and/or to pay interest and penalties and we may become subject to criminal charges.
With respect to such grants, we are obligated to pay royalties at a rate of 3% to 6% from the revenue generated from the sale of product (as well as revenue from associated services) developed using IIA grants up to a maximum amount equal to repayment of the grant proceeds received plus accrued interest.
19 unchanged sentences
Our stock price may be volatile and purchasers of our common stock could incur substantial losses.
−Removed: Our common stock began trading on The Nasdaq Global Market on April 26, 2018 under the symbol “ELOX.” On April 30, 2018, we completed a public offering of our common stock, which resulted in gross proceeds to us of approximately $57.5 million.
−Removed: The trading price of our common stock has been volatile and may continue to be volatile and subject to wide fluctuations in the future.
+Added: Our common stock began trading on The Nasdaq Global Market on April 26, 2018 under the symbol “ELOX.” The trading price of our common stock has been volatile and may continue to be volatile and subject to wide fluctuations in the future.
Many factors could have an impact on our stock price, including fluctuations in our or our competitors’ operating results, clinical trial results or adverse events associated with our product candidates, product development by us or our competitors, changes in laws, including healthcare, regulatory, tax or intellectual property laws, intellectual property developments, acquisitions or other strategic transactions, changes in financial or operational estimates or projections and the perceptions of our investors that we are not performing or meeting expectations.
12 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 the 2013 Plan, the 2008 Plan, and the 2018 Plan, our management is authorized to grant share options and other equity-based awards to our employees, directors and consultants.
+Added: Pursuant to the 2018 Plan, our management is authorized to grant share options and other equity-based awards to our employees, directors and consultants.
The 2018 Plan became effective on April 20, 2018.
−Removed: As of March 31, 2019, individuals held share options to purchase an aggregate of 3,921,823 shares of our common stock.
+Added: As of June 30, 2019, individuals held share options to purchase an aggregate of 4,238,027 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.
7 unchanged sentences
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.
−Removed: Unregistered Sales of Equit y Securities and Use of Proceeds
−Removed: Not applicable.
−Removed: Defaults upon Senior Securities
−Removed: Not applicable.
−Removed: Mine Safety Disclosures
−Removed: Not applicable.
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.