Summary of Risk Factors
−Removed: We are providing the following summary of the risk factors contained in this Annual Report on Form 10-K to enhance the readability and accessibility of our risk factor disclosures.
+Added: We are providing the following summary of the risk factors contained in this annual report to enhance the readability and accessibility of our risk factor disclosures.
This summary does not address all of the risks that we face.
10 unchanged sentences
We may not achieve our publicly announced milestones on time, or at all.
−Removed: We are heavily dependent on the success of our lead drug candidates, GTX-104, GTX-102 and GTX-101.
−Removed: Our future results will suffer if we do not effectively manage our expanded operations.
−Removed: We may not be able to maintain our operations and advance our research and development and commercialization of our lead drug candidates without additional funding.
+Added: We are heavily dependent on the success of our lead drug candidate.
+Added: We may not be able to maximize value from our de-prioritized drug candidates, GTX-102 and GTX-101, through either development, out-licensing or sale.
+Added: We may not be able to maintain our operations and advance our research and development and commercialization of our lead drug candidate, GTX-104 without additional funding.
Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
1 unchanged sentence
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline.
−Removed: Lawsuits have been filed, and other lawsuits may be filed, against us and members of our board of directors challenging the Grace merger, and an adverse ruling in any such lawsuit may result in an award of damages against us.
Risk Factors Relating to our Business
17 unchanged sentences
If the FDA does not conclude that our drug candidates satisfy the requirements for the 505(b)(2) regulatory approval pathway, or if the requirements for approval of any of our drug candidates under Section 505(b)(2) are not as we expect, the approval pathway for our drug candidates will likely take significantly longer, cost significantly more and encounter significantly greater complications and risks than anticipated, and in any case may not be successful.
−Removed: An NDA submitted under Section 505(b)(2) subjects us to the risk that we may be subject to a patent infringement lawsuit that would delay or prevent the review or approval of our drug candidate.
−Removed: The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
Clinical development is a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
4 unchanged sentences
The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our drug candidates, our business will be substantially harmed.
+Added: An NDA submitted under Section 505(b)(2) subjects us to the risk that we may be subject to a patent infringement lawsuit that would delay or prevent the review or approval of our drug candidate.
+Added: The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
+Added: Our drug development strategy relies heavily upon the 505(b)(2) regulatory pathway, which requires us to certify that we do not infringe upon third-party patents covering approved drugs.
+Added: Such certifications often result in third-party claims of intellectual property infringement, the defense of which can be costly and time consuming, and an unfavorable outcome in any such litigation may prevent or delay our development and commercialization efforts, which would harm our business.
Our business is subject to extensive regulatory requirements and our drug candidates that obtain regulatory approval will be subject to ongoing and continued regulatory review, which may result in significant expense and limit our ability to commercialize such products.
6 unchanged sentences
We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed alleged confidential information or trade secrets of their other clients or former employers to us.
−Removed: Our success depends in part upon our ability to protect our intellectual property for our branded drug products and drug candidates, such as GTX-104, GTX-102 and GTX-101.
−Removed: Our drug development strategy relies heavily upon the 505(b)(2) regulatory pathway, which requires us to certify that we do not infringe upon third-party patents covering approved drugs.
−Removed: Such certifications often result in third-party claims of intellectual property infringement, the defense of which will be costly and time consuming, and an unfavorable outcome in any litigation may prevent or delay our development and commercialization efforts which would harm our business.
+Added: Our success depends in part upon our ability to protect our intellectual property for our branded drug products and drug candidates.
If we fail to comply with our obligations in the agreements under which we license rights to technology from third parties, or if the license agreements are terminated for other reasons, we could lose license rights that are important to our business.
4 unchanged sentences
We may not be able to protect our intellectual property rights throughout the world.
−Removed: If our estimates or judgments relating to our critical accounting policies for intangible assets prove to be incorrect, impairment charges could result.
+Added: If our estimates or judgments relating to our critical accounting policies for intangible assets prove to be incorrect, further impairment charges could result.
Risks Related to Our Dependence on Third Parties
1 unchanged sentence
Our contract manufacturers may encounter manufacturing failures that could delay the clinical development or regulatory approval of our drug candidates, or their commercial production, if approved.
−Removed: We rely on third parties to conduct our preclinical studies and clinical trials.
+Added: We rely on third parties to conduct our pre-clinical studies and clinical trials.
If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our drug candidates and our business could be substantially harmed.
9 unchanged sentences
federal income tax purposes.
−Removed: The IRS may not agree that we should be treated as a foreign corporation for U.S.
+Added: The Internal Revenue Service (“IRS”) may not agree that we should be treated as a foreign corporation for U.S.
federal tax purposes.
5 unchanged sentences
There can be no assurance that an active market for our common shares will be sustained.
−Removed: If we fail to meet applicable listing requirements, the NASDAQ Stock Market or the TSX Venture Exchange may delist our common shares from trading, in which case the liquidity and market price of our common shares could decline.
+Added: If we fail to meet applicable listing requirements, the Nasdaq Stock Market may delist our common shares from trading, in which case the liquidity and market price of our common shares could decline.
We may pursue opportunities or transactions that adversely affect our business and financial condition.
−Removed: We are a “smaller reporting company”
−Removed: under the SEC’s disclosure rules and have elected to comply with the reduced disclosure requirements applicable to smaller reporting companies.
−Removed: As a non-accelerated filer, we are not required to comply with the auditor attestation requirements of the Sarbanes-Oxley Act.
We are a Québec incorporated company headquartered in Canada, and U.S.
1 unchanged sentence
Any investment in our common shares involves a high degree of risk.
−Removed: The following risk factors and other information included in this annual report on Form 10-K should be carefully considered.
+Added: The following risk factors and other information included in this annual report should be carefully considered.
If any of these risks actually occur, our business, financial condition, prospects, results of operations or cash flow could be materially and adversely affected, and you could lose all or a part of the value of your investment.
6 unchanged sentences
The timing of events such as completion of a clinical trial, discovery of a new product candidate, filing of an application to obtain regulatory approval, beginning of commercialization of products, completion of a strategic partnership, or announcement of additional clinical trials for a product candidate may ultimately vary from what is publicly disclosed.
−Removed: These variations in timing may occur as a result
−Removed: of different events, including the nature of the results obtained during a clinical trial or during a research phase, problems with a supplier or a distribution partner or any other event having the effect of delaying the publicly announced timeline.
+Added: These variations in timing may occur as a result of different events, including the nature of the results obtained during a clinical trial or during a research phase, problems with a supplier or a distribution partner or any other event having the effect of delaying the publicly announced timeline.
We undertake no obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as otherwise required by law.
Any variation in the timing of previously announced milestones could have a material adverse effect on our business, financial condition or operating results and the trading price of our common shares.
−Removed: We are heavily dependent on the success of our lead drug candidates, GTX-104, GTX-102 and GTX-101.
+Added: We are heavily dependent on the success of our lead drug candidate, GTX-104
Our business and future success are substantially dependent on our ability to successfully and timely develop, obtain regulatory approval for, and commercialize our lead product candidate, GTX-104.
1 unchanged sentence
Our planned development, approval and commercialization of GTX-104 may fail to be completed in a timely manner or at all.
−Removed: Our other product candidates, GTX-102 and GTX-101, are at an earlier development stage and we will require additional time and resources to develop and seek regulatory approval for such drug candidates and, if we are successful, to proceed with commercialization.
−Removed: We cannot provide assurance that we will be able to obtain approval for any of our drug candidates from the FDA or any foreign regulatory authority or that we will obtain such approval in a timely manner.
−Removed: We may not be able to maintain our operations and advance our research and development and commercialization of our lead drug candidates without additional funding.
+Added: As part of our recent strategic realignment plan, we determined to focus primarily on the development of GTX-104, which concentrates the level of our drug development risk on one drug candidate.
+Added: We cannot provide assurance that we will be able to obtain approval for GTX-104 or any other of our drug candidates from the FDA or any foreign regulatory authority or that we will obtain such approval in a timely manner.
+Added: We may not be able to maximize value from our de-prioritized drug candidates, GTX-102 and GTX-101, through either development, out-licensing or sale.
+Added: Our GTX-102 and GTX-101 drug candidates are at an earlier development stage than GTX-104 and will require additional time and resources to develop.
+Added: As part of our recent strategic realignment plan, we determined to focus primarily on the development of GTX-104 and to de-emphasize the development of GTX-102 and GTX-101.
+Added: While we will continue to seek ways to maximize the value of GTX-102 and GTX-101, including through subsequent development, out-licensing or sale, we may not be successful in doing so.
+Added: We may not be able to maintain our operations and advance our research and development and commercialization of our GTX-104 lead drug candidate without additional funding.
We have incurred operating losses and negative cash flows from operations since our inception.
To date, we have financed our operations through public offerings and private placements of securities, proceeds from exercises of warrants, rights and options, and receipt of research tax credits and research grant programs.
−Removed: Our cash and cash equivalents and short-term investments (including restricted investments) were $43.7 million as of March 31, 2022 and $60.7 million as of March 31, 2021.
+Added: Our cash and cash equivalents and short-term investments were $27.9 million as of March 31, 2023 and $43.7 million as of March 31, 2022.
Our current assets, as of March 31, 2023, are projected to support our current liabilities as at that date when combined with the projected level of our expenses for the next twelve months, including fully funding the completion of our Phase 3 program for GTX-104.
1 unchanged sentence
Consequently, we expect to require additional capital to fund our daily operating needs beyond the next twelve months.
−Removed: Based on a conservative estimate, we believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements beyond the completion of our Phase 3 trials for GTX-104.
+Added: Based on the steps we are taking in our strategic realignment plan to focus primarily on the development of GTX-104 and to de-emphasize the development of GTX-102 and GTX-101, we believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements beyond the completion of our Phase 3 trials for GTX-104.
To fully execute our business plan, we plan to raise the necessary capital primarily through additional securities offerings and multiple sources of non-dilutive capital, such as grants or loans and strategic alliances.
−Removed: If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay the research and development and commercial launch of our lead drug candidates.
−Removed: Unexpected negative results in our clinical programs for our lead drug candidates may affect our ability to raise additional capital and/or complete strategic development and/or distribution partnerships to support the commercial launch of our drug candidates.
−Removed: Additional funding from third parties may not be available on acceptable terms or at all to enable us to continue with the research and development and commercialization of our lead drug candidates.
−Removed: Our future results will suffer if we do not effectively manage our expanded operations.
−Removed: As a result of the merger, we have become a larger company than either of Acasti or Grace prior to the merger, and our business has become more complex.
−Removed: There can be no assurance that we will effectively manage the increased complexity without experiencing operating inefficiencies or control deficiencies.
−Removed: Significant management time and effort is required to effectively manage the increased complexity of the larger organization and if we fail to successfully do so it could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
−Removed: In addition, as a result of the merger, our financial statements and results of operations in prior years may not provide meaningful guidance to form an assessment of our prospects or the potential success of our future business operations.
+Added: If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay the research and development and commercial launch of our GTX-104.
+Added: If we determine to continue development of GTX-102 and GTX-101, significant additional funding will be needed.
+Added: Unexpected negative results in our clinical programs for our lead drug candidate may affect our ability to raise additional capital and/or complete strategic development and/or distribution partnerships to support the commercial launch of our drug candidate.
+Added: Additional funding from third parties may not be available on acceptable terms or at all to enable us to continue with the research and development and commercialization of our lead drug candidate.
Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
1 unchanged sentence
The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increase our costs and expenses.
−Removed: We rely on third-party manufacturers to manufacture our products.
−Removed: Our ability to obtain supplies of candidate products could be disrupted if the operations of our manufacturers and suppliers are affected by a man-made or natural disaster or other business interruption.
+Added: We rely on third-party manufacturers to manufacture our drug candidate products.
+Added: Our ability to obtain supplies of drug candidate products could be disrupted if the operations of our manufacturers and suppliers are affected by a man-made or natural disaster or other business interruption.
We may be subject to foreign exchange rate fluctuations.
−Removed: Our reporting currency is the U.S.
+Added: Our functional currency is the U.S.
However, many of our expenses currently are and/or are expected to be, denominated in foreign currencies, including Canadian dollars.
6 unchanged sentences
The trading market for our common shares will depend in part on the research and reports that securities or industry analysts publish about us or our business.
−Removed: We do not currently have limited research coverage by securities and industry analysts.
−Removed: If few or no securities or industry analysts commence coverage of our company, the trading price for our common shares could be negatively impacted.
−Removed: If one or more of the analysts who covers us downgrades our common shares or publishes inaccurate or unfavorable research about our business, our share price would likely decline.
+Added: We currently have limited research coverage by securities and industry analysts.
+Added: If few or no securities or industry analysts cover our company, the trading price for our common shares could be negatively impacted.
+Added: If one or more of the analysts who covers us downgrades our common shares or publishes inaccurate or unfavorable research about our
+Added: business, our share price would likely decline.
If one or more of these analysts ceases coverage of us or fails to publish reports on us regularly, demand for our common shares could decrease, which could cause our share price and trading volume to decline.
−Removed: Lawsuits have been filed, and other lawsuits may be filed, against us and members of our board of directors challenging the Grace merger, and an adverse ruling in any such lawsuit may result in an award of damages against us.
−Removed: In connection with the Grace merger, four shareholder lawsuits were filed.
−Removed: Two of the lawsuits have been voluntarily dismissed without prejudice and the remaining two have been consolidated.
−Removed: The lawsuits generally allege that our public disclosures pertaining to the Grace merger omit material facts in purported violation of Section 14(a) of the Exchange Act and Rule 14a-9 promulgated thereunder, and that members of our board of directors are liable for those purported omissions under Section 20(a) of the Exchange Act.
−Removed: The relief sought in the lawsuits includes, among other things, to enjoin the consummation of the merger, to award damages purportedly caused by the alleged omissions, and to award plaintiffs’
−Removed: attorneys’
−Removed: fees and other costs.
−Removed: It is possible that additional lawsuits asserting similar claims could be filed.
−Removed: We strongly believe the allegations in the lawsuits are frivolous and without merit, and are vigorously defending against them.
−Removed: The results of complex legal proceedings are difficult to predict.
−Removed: Moreover, the pending litigation is, and any future additional litigation could be, time consuming and expensive and could divert management’s attention away from its regular business.
Risk Factors Relating to our Business
Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
−Removed: We are highly dependent on the principal members of our executive team.
+Added: We recently appointed several new members to our executive team and are highly dependent on the principal members of our executive team.
+Added: While members of our executive team have significant industry experience, they have not been with our company for long.
Any of our executive officers could leave our employment at any time, as all of our employees are “at will”
−Removed: Recruiting and retaining other qualified employees for our business, including scientific and technical personnel, will also be critical to our success.
+Added: Also, as part of our strategic realignment, we have significantly reduced the number of our employees while we shift the base of our operations from Canada to the United States.
+Added: As a result, in the process of shifting the base of our operations to the United States, we will have to recruit employees from the industry employment market in the United States.
+Added: Recruiting and retaining qualified employees for our business, including scientific and technical personnel, will also be critical to our success.
There is currently a shortage of skilled executives and other personnel in our industry, which is likely to continue.
As a result, competition for skilled personnel is intense and the turnover rate can be high.
−Removed: We may not be able to attract and retain personnel on acceptable terms given the competition among numerous pharmaceutical companies for individuals with similar skill sets.
+Added: As we rebuild our organization in accordance with our strategic realignment, we may not be able to attract and retain personnel on acceptable terms given the competition among numerous pharmaceutical companies for individuals with similar skill sets.
In addition, failure to succeed in clinical studies may make it more challenging to recruit and retain qualified personnel.
The inability to recruit key executives or the loss of the services of any executive or key employee might impede the progress of our development and commercialization objectives.
−Removed: We will need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations and our ability to compete.
−Removed: As our company matures, we expect to expand our employee base to increase our managerial, scientific, engineering, operational, sales, marketing, financial and other resources and to hire more consultants and contractors.
+Added: We may need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations and our ability to compete.
+Added: If our drug development efforts are successful, we expect to expand our employee base to increase our managerial, scientific, engineering, operational, sales, marketing, financial and other resources and to hire more consultants and contractors.
Future growth would impose significant additional responsibilities on our management, including the need to identify, recruit, maintain, motivate, and integrate additional employees, consultants and contractors.
23 unchanged sentences
Even if our drug candidates receive regulatory approval in the United States, we may never obtain regulatory approval or successfully commercialize our products outside of the United States.
−Removed: Our business plan is highly dependent upon our ability to obtain regulatory approval to market and commercialize our lead drug candidates, GTX-104, GTX-102 and GTX-101 in the United States.
−Removed: The failure to do so would have a material adverse effect on our ability to execute on our business plan and generate revenue.
+Added: Our business plan is highly dependent upon our ability to obtain regulatory approval to market and commercialize our lead drug candidate, GTX-104in the United States.
+Added: As GTX-104 is currently the focus of our drug development program, the failure to commercialize it would have a material adverse effect on our ability to execute on our business plan and generate revenue.
In addition, even if we obtain U.S.
−Removed: regulatory approvals to commercialize GTX-104, GTX-102 and GTX-101, we may not be able to do so in other international jurisdictions.
+Added: regulatory approvals to commercialize GTX-104, we may not be able to do so in other international jurisdictions.
We are subject to uncertainty relating to healthcare reform measures and reimbursement policies which, if not favorable to our drug candidates, could hinder or prevent our drug candidates ’
2 unchanged sentences
As a threshold for coverage and reimbursement, third-party payors generally require that drug products have been approved for marketing by the FDA.
−Removed: Third-party payors are increasingly imposing additional
−Removed: requirements and restrictions on coverage and limiting reimbursement levels for medical products.
+Added: Third-party payors are increasingly imposing additional requirements and restrictions on coverage and limiting reimbursement levels for medical products.
These restrictions and limitations influence the purchase of healthcare services and products.
33 unchanged sentences
If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our drug candidates, we may be unable to generate any revenue.
−Removed: Although we intend to establish a small, focused, specialty sales and marketing organization to promote GTX-104 and GTX-102, if approved for marketing in the United States, we currently have no such organization and the cost of establishing and maintaining such an organization may exceed the benefit of doing so.
−Removed: Given the size of its potential market, we anticipate that to commercialize GTX-101, we would seek to enter into a strategic partnership with a larger marketing partner, if GTX-101 is approved by the FDA for marketing, and we may not be successful in doing so.
+Added: Although we intend to establish a small, focused, specialty sales and marketing organization to promote GTX-104, if approved for marketing in the United States, we currently have no such organization and the cost of establishing and maintaining such an organization may exceed the benefit of doing so.
+Added: We believe that GTX-102 could also be marketed by a small, focused, specialty sales and marketing organization if and when we decide to resume development of GTX-102.
+Added: Given the size of its potential market, we anticipate that commercializing GTX-101 would require entering into a strategic partnership with a larger marketing partner, if GTX-101 is approved by the
+Added: FDA for marketing, and the ability to find any such strategic partnership would be uncertain.
If we are unable to establish adequate sales, marketing and distribution capabilities, whether independently or with third parties, we may not be able to generate sufficient product revenue and may not become profitable.
40 unchanged sentences
Furthermore, an adverse outcome of a dispute may require us:
−Removed: to pay damages, potentially including treble damages and attorneys’
+Added: to pay damages, potentially
+Added: including treble damages and attorneys’
fees, if we are found to have willfully infringed a party’s patent or other intellectual property rights;
8 unchanged sentences
Additionally, timely enrollment in planned clinical trials is dependent upon clinical trial sites which could be adversely affected by global health matters, such as pandemics.
−Removed: We plan to conduct clinical trials for our drug candidates in geographies which are currently being affected by the COVID-19 pandemic.
−Removed: Some factors from the COVID-19 pandemic that could delay or otherwise adversely affect enrollment in the clinical trials of our drug candidates, as well as our business generally, include:
−Removed: the potential diversion of healthcare resources away from the conduct of clinical trials to focus on pandemic concerns, including the attention of physicians serving as our clinical trial investigators, hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our prospective clinical trials;
−Removed: limitations on travel that could interrupt key trial and business activities, such as clinical trial site initiations and monitoring, domestic and international travel by employees, contractors or patients to clinical trial sites, including any government-imposed travel restrictions or quarantines that will impact the ability or willingness of patients, employees or contractors to travel to our clinical trial sites or secure visas or entry permissions, a loss of face-to-face meetings and other interactions with potential partners, any of which could delay or adversely impact the conduct or progress of our prospective clinical trials;
−Removed: the potential negative affect on the operations of our third-party manufacturers;
−Removed: interruption in global shipping affecting the transport of clinical trial materials, such as patient samples, investigational drug product and conditioning drugs and other supplies used in our prospective clinical trials;
−Removed: disruptions caused by potential workplace, laboratory and office closures and an increased reliance on employees working from home, disruptions to or delays in ongoing laboratory experiments;
−Removed: operations, staffing shortages, travel limitations or mass transit disruptions, any of which could adversely impact our business operations or delay necessary interactions with local regulators, ethics committees and other important agencies and contractors;
−Removed: changes in local regulations as part of a response to the COVID-19 pandemic, which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue such clinical trials altogether;
−Removed: interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines.
−Removed: These factors arising from COVID-19 could worsen in countries that are already afflicted with COVID-19 or could continue to spread to additional countries.
−Removed: Any of these factors, and other factors related to any such disruptions that are unforeseen, could have a material adverse effect on our business and our results of operation and financial condition.
−Removed: Further, uncertainty around these and related issues could lead to adverse effects on the economy of the United States and other economies, which could impact our ability to raise the necessary capital needed to develop and commercialize our programs and drug candidates.
We are subject to numerous complex regulatory requirements and failure to comply with these regulations, or the cost of compliance with these regulations, may harm our business.
5 unchanged sentences
If the FDA does not conclude that our drug candidates satisfy the requirements for the 505(b)(2) regulatory approval pathway, or if the requirements for approval of any of our drug candidates under Section 505(b)(2) are not as we expect, the approval pathway for our drug candidates will likely take significantly longer, cost significantly more and encounter significantly greater complications and risks than anticipated, and in any case may not be successful.
−Removed: We intend to seek FDA approval through the 505(b)(2) regulatory pathway for GTX-104, GTX-101 and GTX-102.
+Added: We intend to seek FDA approval through the 505(b)(2) regulatory pathway for our lead drug candidate GTX-104.
The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, added Section 505(b)(2) to the Federal Food, Drug and Cosmetic Act (“FDCA”).
Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies that were not conducted by or for the applicant.
−Removed: If the FDA does not allow us to pursue the 505(b)(2) regulatory pathway for GTX-104, GTX-101 or GTX-102 as anticipated, we may need to conduct additional clinical trials, provide additional data and information and meet additional standards for regulatory approval.
+Added: If the FDA does not allow us to pursue the 505(b)(2) regulatory pathway for GTX-104, we may need to conduct additional clinical trials, provide additional data and information and meet additional standards for regulatory approval.
If this were to occur, the time and financial resources required to obtain FDA approval for our drug candidates would likely substantially increase.
8 unchanged sentences
Failure can occur at any time during the clinical trial process, even with active ingredients that have previously been approved by the FDA as safe and effective.
−Removed: The results of preclinical studies and early clinical trials of our drug candidates may not be predictive of the results of later stage clinical trials.
+Added: The results of pre-clinical studies and early clinical trials of our drug candidates may not be predictive of the results of later stage clinical trials.
A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials.
1 unchanged sentence
Clinical trial failures may occur at any stage and may result from a multitude of factors both within and outside our control, including flaws in formulation, adverse safety or efficacy profile and flaws in trial design, among others.
−Removed: If the trials result in negative or inconclusive results, we or our collaborators may decide, or regulators may require us, to discontinue trials of our drug candidates or conduct additional clinical trials or preclinical studies.
+Added: If the trials result in negative or inconclusive results, we or our collaborators may decide, or regulators may require us, to discontinue trials of our drug candidates or conduct additional clinical trials or pre-clinical studies.
In addition, data obtained from trials and studies are susceptible to varying interpretations, and regulators may not interpret our data as favorably as we do, which may delay, limit or prevent regulatory approval.
70 unchanged sentences
In the United States, pediatric exclusivity adds six months to any existing exclusivity period.
+Added: Our drug development strategy relies heavily upon the 505(b)(2) regulatory pathway, which requires us to certify that we do not infringe upon third-party patents covering approved drugs.
+Added: Such certifications often result in third-party claims of intellectual property infringement, the defense of which will be costly and time consuming, and an unfavorable outcome in any litigation may prevent or delay our development and commercialization efforts which would harm our business.
+Added: Litigation or other proceedings to enforce or defend intellectual property rights are often complex in nature, may be very expensive and time-consuming, may divert our management’s attention from other aspects of our business and may result in unfavorable outcomes that could adversely impact our ability to launch and market our drug candidates, or to prevent third parties from competing with our drug products and drug candidates.
+Added: In particular, our commercial success depends in large part on our avoiding infringement of the patents and proprietary rights of third parties for existing approved drug products.
+Added: Because we intend to utilize the 505(b)(2) regulatory pathway for the approval of our drug products and drug candidates, we rely in whole or in part on studies conducted by third parties related to those approved drug products.
+Added: Because patent applications can take many years to issue, there may be currently pending or subsequently filed patent applications which may later result in issued patents that may be infringed by our drug products or drug candidates.
+Added: If any third-party patents were held by a court of competent jurisdiction to cover aspects of our drug candidates, including the formulation, method of use, any method or process involved in the manufacture of any of our drug candidates, any molecules or intermediates formed during such manufacturing process or any other attribute of the final product itself, the holders of any such patents may be able to block our ability to commercialize our drug candidates unless we obtain a license under the applicable patents, or until such patents expire.
+Added: In either case, such a license may not be available on commercially reasonable terms or at all.
+Added: Parties making claims against us may request and/or obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our drug candidates on a temporary or permanent basis.
+Added: Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.
+Added: In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’
+Added: fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products or manufacturing processes, which may be impossible or require substantial time and monetary expenditure.
+Added: We cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms.
+Added: Furthermore, even in the absence of litigation, we may need to obtain licenses from third parties to advance our research, manufacture clinical trial supplies or allow commercialization of our drug candidates.
+Added: We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all.
+Added: In that event, we would be unable to further develop and commercialize one or more of our drug candidates, which could harm our business significantly.
+Added: We cannot provide any assurances that third-party patents do not exist which might be enforced against our products, resulting in either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of compensation to third parties.
Our business is subject to extensive regulatory requirements and our drug candidates that obtain regulatory approval will be subject to ongoing and continued regulatory review, which may result in significant expense and limit our ability to commercialize such products.
28 unchanged sentences
the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;
−Removed: HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, (“HITECH”), and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information without appropriate authorization;
+Added: HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the iprivacy, security and transmission of individually identifiable health information without appropriate authorization;
the federal Physician Payment Sunshine Act, created under Section 6002 of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, (collectively, “ACA,”), and its implementing regulations requires manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the United States Department of Health and Human Services, or HHS, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) (and beginning on January 1, 2021 this also includes Physician Assistants, Nurse Practitioners, Clinical Nurse Specialists, Certified Registered Nurse Anesthetists, and Certified Nurse Midwives (CNM) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members, with data collection required beginning August 1, 2013 and reporting to the Centers for Medicare & Medicaid Services required by March 31, 2014 and by the 90th day of each subsequent calendar year;
39 unchanged sentences
Any such litigation would be protracted, expensive, and potentially subject to an unfavorable outcome.
−Removed: Our success depends in part upon our ability to protect our intellectual property for our branded products and drug candidates, such as GTX-104, GTX-102 and GTX-101.
−Removed: Our commercial success with respect to our drug products and drug candidates, including GTX-104, GTX-102 and GTX-101, depends on obtaining and maintaining patent protection in the United States and in other countries and trade secret protection for our drug candidates, proprietary technologies and their uses.
+Added: Our success depends in part upon our ability to protect our intellectual property for our branded products and drug candidates.
+Added: Our commercial success with respect to our drug products and drug candidates, depends on obtaining and maintaining patent protection in the United States and in other countries and trade secret protection for our drug candidates, proprietary technologies and their uses.
Our ability to protect our drug products from unauthorized or infringing use by third parties depends in substantial part on our ability to obtain and maintain valid and enforceable patents.
19 unchanged sentences
Moreover, our competitors may independently develop equivalent knowledge, methods, and know-how, and we would not be able to prevent their use.
−Removed: Our drug development strategy relies heavily upon the 505(b)(2) regulatory pathway, which requires us to certify that we do not infringe upon third-party patents covering approved drugs.
−Removed: Such certifications often result in third-party claims of intellectual property infringement, the defense of which will be costly and time consuming, and an unfavorable outcome in any litigation may prevent or delay our development and commercialization efforts which would harm our business.
−Removed: Litigation or other proceedings to enforce or defend intellectual property rights are often complex in nature, may be very expensive and time-consuming, may divert our management’s attention from other aspects of our business and may result in unfavorable outcomes that could adversely impact our ability to launch and market our drug candidates, or to prevent third parties from competing with our drug products and drug candidates.
−Removed: In particular, our commercial success depends in large part on our avoiding infringement of the patents and proprietary rights of third parties for existing approved drug products.
−Removed: Because we intend to utilize the 505(b)(2) regulatory pathway for the approval of our drug products and drug candidates, we rely in whole or in part on studies conducted by third parties related to those approved drug products.
−Removed: Because patent applications can take many years to issue, there may be currently pending or subsequently filed patent applications which may later result in issued patents that may be infringed by our drug products or drug candidates.
−Removed: If any third-party patents were held by a court of competent jurisdiction to cover aspects of our drug candidates, including the formulation, method of use, any method or process involved in the manufacture of any of our drug candidates, any molecules or intermediates formed during such manufacturing process or any other attribute of the final product itself, the holders of any such patents may be able to block our ability to commercialize our drug candidates unless we obtain a license under the applicable patents, or until such patents expire.
−Removed: In either case, such a license may not be available on commercially reasonable terms or at all.
−Removed: Parties making claims against us may request and/or obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our drug candidates on a temporary or permanent basis.
−Removed: Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.
−Removed: In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’
−Removed: fees for wilful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products or manufacturing processes, which may be impossible or require substantial time and monetary expenditure.
−Removed: We cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms.
−Removed: Furthermore, even in the absence of litigation, we may need to obtain licenses from third parties to advance our research, manufacture clinical trial supplies or allow commercialization of our drug candidates.
−Removed: We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all.
−Removed: In that event, we would be unable to further develop and commercialize one or more of our drug candidates, which could harm our business significantly.
−Removed: We cannot provide any assurances that third party patents do not exist which might be enforced against our products, resulting in either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of compensation to third parties.
If we fail to comply with our obligations in the agreements under which we license rights to technology from third parties, or if the license agreements are terminated for other reasons, we could lose license rights that are important to our business.
11 unchanged sentences
We may also be subject to claims that former employers or other third parties have an ownership interest in our patents.
−Removed: Litigation may be necessary to defend against these claims.
+Added: Litigation may be necessary to defend
+Added: against these claims.
There is no guarantee of success in defending these claims, and if we are successful, litigation could result in substantial cost and be a distraction to our management and other employees.
31 unchanged sentences
Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.
−Removed: If our estimates or judgments relating to our critical accounting policies for intangible assets prove to be incorrect, impairment charges could result.
+Added: If our estimates or judgments relating to our critical accounting policies for intangible assets prove to be incorrect, further impairment charges could result.
We carry a significant amount of intangible assets on our consolidated balance sheet, associated with acquired in process research and development.
−Removed: In the ordinary course of business, circumstances may arise, including manifestation of any of the risks identified in this section, that could result in recognition that the carrying values of our assets may not be recovered from future operations.
−Removed: Under such circumstances, it is possible we may be required to impair our asset values to the extent that their remaining value after any such impairment can be recovered by our business going forward.
+Added: In the ordinary course of business, circumstances may arise, including manifestation of any of the risks identified in this section, that could result in further recognition that the carrying values of our assets may not be recovered from future operations.
+Added: Under such circumstances, it is possible we may be required to further impair our asset values to the extent that their remaining value after any such impairment can be recovered by our business going forward.
Intangible assets with an indefinite useful life are subject to an impairment review at least annually.
15 unchanged sentences
This review may be costly and time-consuming and could delay or prevent the launch of a drug candidate.
−Removed: We rely on third parties to conduct our preclinical studies and clinical trials.
+Added: We rely on third parties to conduct our pre-clinical studies and clinical trials.
If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our drug candidates and our business could be substantially harmed.
−Removed: We have relied upon and plan to continue to rely upon third party CROs to monitor and manage data for our preclinical and clinical programs.
−Removed: We rely on these parties for execution of our preclinical studies and clinical trials, and control only certain aspects of their activities.
+Added: We have relied upon and plan to continue to rely upon third-party CROs to monitor and manage data for our pre-clinical and clinical programs.
+Added: We rely on these parties for execution of our pre-clinical studies and clinical trials, and control only certain aspects of their activities.
Nevertheless, we are responsible for ensuring that each of our trials is conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards and our reliance on the CROs does not relieve us of our regulatory responsibilities.
91 unchanged sentences
The extent to which we can utilize any or all of our NOLs will depend on many factors, including the jurisdiction applicable to any of our future taxable revenue.
+Added: In connection with our planned shift of our operations to the United States, we may not be able to justify the allocation of revenue to Canada sufficient to recover the tax benefits arising from NOLs and other tax credits.
Our ability to use NOLs will also depend on the amount of taxable income generated in future periods.
2 unchanged sentences
federal tax purposes.
−Removed: Although we are incorporated in Quebec, Canada, the Internal Revenue Service (the "IRS") may assert that we should be treated as a U.S.
+Added: Although we are incorporated in Quebec, Canada, the IRS may assert that we should be treated as a U.S.
corporation (and, therefore, a U.S.
9 unchanged sentences
federal tax purposes.
−Removed: Under Section 7874, if (1) former Grace shareholders owned (within the meaning of Section 7874) 80% or more (by vote or value) of our ordinary shares after the merger by reason of holding Grace common stock (such ownership percentage, the "Section 7874 ownership percentage"), and (2) our "expanded affiliated group" did not have "substantial business activities" in Canada ("the substantial business activities test"), we will be treated as a U.S.
+Added: Under Section 7874, if (1) former Grace Therapeutics shareholders owned (within the meaning of Section 7874) 80% or more (by vote or value) of our ordinary shares after the merger by reason of holding Grace Therapeutics common stock (such ownership percentage, the "Section 7874 ownership percentage"), and (2) our "expanded affiliated group" did not have "substantial business activities" in Canada ("the substantial business activities test"), we will be treated as a U.S.
corporation for U.S.
federal tax purposes.
−Removed: If the Section 7874 ownership percentage of the former Grace shareholders after the merger was less than 80% but greater than or equal to 60%, and the substantial business activities test was not met, we and our U.S.
+Added: If the Section 7874 ownership percentage of the former Grace Therapeutics shareholders after the merger was less than 80% but greater than or equal to 60%, and the substantial business activities test was not met, we and our U.S.
affiliates may, in some circumstances, be subject to certain adverse U.S.
6 unchanged sentences
tax liabilities.
−Removed: Based on the terms of the merger, the rules for determining share ownership under Section 7874 and certain factual assumptions, we believe that former Grace shareholders owned (within the meaning of Section 7874) less than 60% (by both vote and value) of our ordinary shares after the merger by reason of holding shares of Grace common stock.
+Added: Based on the terms of the merger, the rules for determining share ownership under Section 7874 and certain factual assumptions, we believe that former Grace Therapeutics shareholders owned (within the meaning of Section 7874) less than 60% (by both vote and value) of our ordinary shares after the merger by reason of holding shares of Grace common stock.
Therefore, under current law, we believe that we should not be treated as a U.S.
corporation for U.S.
−Removed: federal tax purposes and that Section 7874 should otherwise not apply to us or our affiliates as a result of the merger with Grace.
+Added: federal tax purposes and that Section 7874 should otherwise not apply to us or our affiliates as a result of the merger with Grace Therapeutics .
Risks Relating to Our Common Shares
35 unchanged sentences
We have in place an “at-the-market”
−Removed: sales agreement where we may issue and sell from time-to-time common shares having an aggregate offering price of up to $75,000,000.
+Added: sales agreement where we may issue and sell from time-to-time common shares having an aggregate offering price of up to $75,000,000, but due to our market capitalization, under applicable SEC rules, the availability of our access to this program is currently significantly limited.
The incurrence of indebtedness by us would result in increased fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.
5 unchanged sentences
Some of the factors that could cause the market price for our common shares to fluctuate include the following:
−Removed: results of preclinical studies and clinical trials, or the addition or termination of preclinical studies, clinical trials or funding support;
−Removed: the fluctuations in valuation of our derivative warrant liabilities;
−Removed: the timing of the release of results from any preclinical studies and clinical trials;
+Added: results of pre-clinical studies and clinical trials, or the addition or termination of pre-clinical studies, clinical trials or funding support;
+Added: the timing of the release of results from any pre-clinical studies and clinical trials;
an inability to complete drug product development in a timely manner that results in a failure or delay in receiving the required regulatory responses, approvals, or allowances to commercialize drug candidates;
27 unchanged sentences
and any event resulting in a delisting of our common shares.
−Removed: If we fail to meet applicable listing requirements, the NASDAQ Stock Market or the TSX Venture Exchange ( “
−Removed: TSXV ”
−Removed: ) may delist our common shares from trading, in which case the liquidity and market price of our common shares could decline.
−Removed: Our common shares are currently listed on the NASDAQ Stock Market and the TSXV, but we cannot assure you that our securities will continue to be listed on the NASDAQ Stock Market and the TSXV in the future.
−Removed: In the past, we have received notices from the NASDAQ Stock Market that we have not been in compliance with its continued listing standards, and we have taken responsive actions and regained compliance.
−Removed: If we fail to comply with listing standards and the NASDAQ Stock Market or TSXV delists our common shares, we and our shareholders could face significant material adverse consequences, including:
+Added: If we fail to meet applicable listing requirements, the Nasdaq Stock Market may delist our common shares from trading, in which case the liquidity and market price of our common shares could decline.
+Added: Our common shares are currently listed on the Nasdaq Stock Market, but we cannot assure you that our securities will continue to be listed on the Nasdaq Stock Market in the future.
+Added: On July 27, 2022, we received written notification from the Nasdaq Listing Qualifications Department for failing to maintain a minimum bid price of $1.00
+Added: per common share for the last 30 consecutive business days, as required by Nasdaq Listing Rule 5550(a)(2) - bid price (the “Minimum Bid Price Rule”).
+Added: The Nasdaq notification had no immediate effect on the listing of our common shares, and we had 180 calendar days, or until January 23, 2023, to regain compliance.
+Added: On January 24, 2023, we received notification from Nasdaq that we are eligible for an additional 180 calendar days, or until July 24, 2023, to regain compliance with the Minimum Bid Price Rule.
+Added: We were granted the second extension because we meet the continued listing requirements for the market value of publicly held shares and all other initial listing standards for Nasdaq Capital Market, except for the bid price requirement.
+Added: If at any time over this additional 180 calendar day period the bid price of our common shares closes at $1.00 per share or more for at least a minimum of ten consecutive business days, Nasdaq will provide written confirmation of compliance and the matter will be closed.
+Added: We intend to monitor the closing bid price of our common shares and, if necessary, evaluate all available options to resolve the deficiency and regain compliance with the Minimum Bid Price Rule.
+Added: If we fail to comply with listing standards and the Nasdaq Stock Market delists our common shares, we and our shareholders could face significant material adverse consequences, including:
a limited availability of market quotations for our common shares;
10 unchanged sentences
We may not be able to successfully overcome these risks and other problems associated with any future acquisitions and this may adversely affect our business and financial condition.
−Removed: We are a “
−Removed: smaller reporting company ”
−Removed: under the SEC ’
−Removed: s disclosure rules and have elected to comply with the reduced disclosure requirements applicable to smaller reporting companies.
−Removed: We are a “smaller reporting company”
−Removed: under the SEC’s disclosure rules, meaning that we have either:
−Removed: a public float of less than $250 million;
−Removed: annual revenues of less than $100 million during the most recently completed fiscal year;
−Removed: no public float;
−Removed: a public float of less than $700 million.
−Removed: As a smaller reporting company, we are permitted to comply with scaled-back disclosure obligations in our SEC filings compared to other issuers, including with respect to disclosure obligations regarding executive compensation in our periodic reports and proxy statements.
−Removed: We have elected to adopt the accommodations available to smaller reporting companies.
−Removed: Until we cease to be a smaller reporting company, the scaled-back disclosure in our SEC filings will result in less information about our company being available than for other public companies that are not smaller reporting companies.
−Removed: If investors consider our common shares less attractive as a result of our election to use the scaled-back disclosure permitted for smaller reporting companies, there may be a less active trading market for our common shares and our share price may be more volatile.
−Removed: As a non-accelerated filer, we are not required to comply with the auditor attestation requirements of the Sarbanes-Oxley Act.
−Removed: We are a non-accelerated filer under the Exchange Act and we are not required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002.
−Removed: Therefore, our internal controls over financial reporting will not receive the level of review provided by the process relating to the auditor attestation included in annual reports of issuers that are subject to the auditor attestation requirements.
−Removed: In addition, we cannot predict if investors will find our common shares less attractive because we are not required to comply with the auditor attestation requirements.
−Removed: If some investors find our common shares less attractive as a result, there may be a less active trading market for our common shares and the trading price for our common shares may be negatively affected.
We are a Qu é
16 unchanged sentences
Not applicable.
+Added: Our head office and operations are located at 3009 boul.
+Added: de la Concorde East, Suite 102, Laval, Québec, Canada H7E 2B5 and our research and development and quality control laboratories are located at Espace Lab, 2650 Maximilien-Chagnon, Sherbrooke, Québec, Canada, J1E 0M8.
+Added: We currently lease our office and laboratory space.
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.