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New words:
artificial, BID, caficrestat, cardiac, clock, CMT, concomitantly, distinct, dorsiflexion, expert, facilitate, facilitated, fatigue, fine, hospitalization, induced, intelligence, intrinsic, IP, issuable, Lastly, limb, margin, mobility, pain, PDUFA, pre, prespecified, PRV, ratio, RSU, runway, salary, sensory, separate, sit, stabilizing, stable, stair, standalone, subgroup, survival, topline, upper, walk
Removed:
adaptive, amortized, assessed, assessing, award, balance, bank, biomarker, Bipartisan, blinded, Cadillac, closing, CMS, conclusion, concomitant, Cowen, crossed, CTA, device, donut, end, excluding, expensed, explanatory, featuring, format, gap, Goldman, healthy, holdback, hole, incremental, input, insight, institution, invoiced, language, lieu, losing, modification, nineteen, observable, original, paragraph, permitting, progressive, promulgated, quoted, ratable, relied, represented, repriced, repricing, reset, retained, sensitivity, showed, significance, speculative, speed, Spiral, statistical, summarized, suspected, systematic, Trump, unblinded, underlying, unrealized, vesting
Financial report summary
?Risks
- Risks Related to Our Financial Position and Capital Needs
- We have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability.
- We will require substantial additional funding to finance our operations. If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations.
- Raising additional capital may cause dilution to our stockholders and restrict our operations or require us to relinquish rights to our product candidates.
- Risks Related to the Development and Commercialization of Our Product Candidates
- Our future success is substantially dependent on the successful clinical development, regulatory approval and commercialization of our product candidates. If we are not able to obtain required regulatory approvals, we will not be able to commercialize our product candidates and our ability to generate product revenue will be adversely affected.
- The development of additional product candidates is risky and uncertain, and we can provide no assurances that we will be able to replicate our approach to drug development for other disease indications.
- Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials and we cannot assure you that any ongoing, planned or future clinical trials will lead to results sufficient for the necessary regulatory approvals.
- Clinical drug development involves a lengthy and expensive process. We may incur additional costs and encounter substantial delays or difficulties in our clinical trials.
- All of our current product candidates that have proceeded to clinical trials target inhibition of aldose reductase. There can be no assurance that aldose reductase inhibitors will ever receive regulatory approval.
- We may not be able to obtain or maintain rare pediatric disease designation or exclusivity for our product candidates, which could limit the potential profitability of our product candidates.
- A breakthrough therapy designation by the FDA for a product candidate may not lead to a faster development or regulatory review or approval process, and it would not increase the likelihood that the product candidate will receive marketing approval.
- We have sought, and may in the future seek, fast track designation from the FDA for our product candidates. Even if granted, fast track designation may not actually lead to a faster development, regulatory review or approval process.
- Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by multiple factors outside our control.
- Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences following any potential marketing approval.
- Interim, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
- The incidence and prevalence for target patient populations of our product candidates have not been established with precision. If the market opportunities for our product candidates are smaller than we believe they are or any approval we obtain is based on a narrower definition of the patient population, our business may suffer.
- We may face substantial competition, which may result in others developing or commercializing drugs before or more successfully than us.
- We may explore strategic collaborations that may never materialize or we may be required to relinquish important rights to and control over the development and commercialization of our product candidates to any future collaborators.
- Even if any product candidates receive marketing approval, they may fail to achieve market acceptance by physicians, patients, third party payors or others in the medical community necessary for commercial success.
- Even if we obtain regulatory approvals for our product candidates, they will remain subject to ongoing regulatory oversight.
- Even if we obtain and maintain approval for our product candidates from the FDA, we may never obtain approval outside the United States, which would limit our market opportunities.
- If we commercialize our product candidates outside the United States, a variety of risks associated with international operations could harm our business.
- Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop.
- Our insurance policies may be inadequate and potentially expose us to unrecoverable risks.
- Risks Related to Regulatory Compliance
- Our relationships with customers, physicians, and third party payors are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
- Coverage and adequate reimbursement may not be available for our product candidates, which could make it difficult for us to sell profitably, if approved.
- Healthcare reform measures may have a negative impact on our business and results of operations.
- Risks Related to Our Dependence on Third Parties
- We intend to rely on third parties to produce clinical and commercial supplies of our product candidates.
- Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental, health and safety laws and regulations, which can be expensive and restrict how we do, or interrupt our, business.
- We rely on third-parties to conduct, supervise and monitor our preclinical studies and clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
- Risks Related to Our Intellectual Property
- Licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues. If we breach our license agreements with Columbia University or any of the other agreements under which we acquired, or will acquire, the intellectual property rights to our product candidates, we could lose the ability to continue the development and commercialization of the related product.
- If we are unable to obtain and maintain patent protection for our product candidates and technology, or if the scope of the patent protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our product candidates and technology may be adversely affected.
- Obtaining and maintaining our patent rights depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
- Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
- Third-parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a negative impact on the success of our business.
- We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
- We may be involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
- Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our current and any future product candidates.
- We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
- Reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business.
- Intellectual property rights do not necessarily address all potential threats to our business.
- Risks Related to Our Business Operations, Employee Matters and Managing Growth
- We are highly dependent on the services of our Chief Executive Officer and Chairman, Dr. Shoshana Shendelman, and our Chief Medical Officer, Dr. Riccardo Perfetti, and if we are not able to retain these members of our management team or recruit and retain additional management, clinical and scientific personnel, our business will be harmed.
- We expect to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
- Our internal computer systems, or those of our collaborators or other contractors or consultants, may fail or suffer security breaches, which could result in a significant disruption of our product development programs and our ability to operate our business effectively, and adversely affect our business and operating results.
- Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
- Any future acquisitions or strategic collaborations may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and/or subject us to other risks.
- Risks Related to Ownership of Our Common Stock
- The market price of our common stock is volatile and has fluctuated substantially, which could result in substantial losses for purchasers of our common stock.
- Concentration of ownership of our common stock among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions.
- Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
- If research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
- We have broad discretion in the use of our cash and cash equivalents and may use them ineffectively, in ways with which you do not agree or in ways that do not increase the value of your investment.
- We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors.
- We have incurred increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
- Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
- Our governing documents designate certain courts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Management Discussion
- Revenue for the three months ended March 31, 2024, were $0.2 million, compared to $10.7 million for the three months ended March 31, 2023. For the three months ended March 31, 2024, the decrease of $10.5 million was primarily related to:
- Research and development expenses for the three months ended March 31, 2024, were $12.2 million, compared to $15.9 million for the three months ended March 31, 2023. For the three months ended March 31, 2024, the decrease of $3.7 million was primarily related to:
- AT-007.