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New words:
abstention, acknowledge, adequacy, allegedly, Analyst, Andrev, Antonio, Arbor, attack, audience, Australian, Axogen, banker, Becerra, binding, biometric, Bob, border, Breakthrough, Brexit, Burlington, cabinet, calendar, campaign, Carolina, causal, CBO, chat, civilian, clash, classified, complaint, conclusion, confounding, conscripted, cybersecurity, Dagher, deadline, Dec, delist, delisted, delisting, dental, destination, Diaz, Diez, dismutase, disproportionate, divergence, driven, email, endemic, exceed, exposure, faith, fiduciary, fireside, Gaza, geopolitical, Germany, Gordon, Hamburg, headcount, Hezbollah, Hierarchical, hierarchy, HMNC, Holtzman, hostile, hub, IDF, illustrating, IMD, infrastructure, Iran, kidnapping, latitude, lawyer, Lebanon, Les, lessor, lingering, Main, marker, Maxim, mismanagement, missile, mobilization, Molnlycke, multimodal, Naor, neighboring, Neuro, neurodegeneration, neutralizing, Nevada, NfL, Nir, noncash, nonperformance, orderly, organizational, Orlando, outlined, overtime, parallel, plaintiff, pledged, predecessor, prejudice, premodification, proactive, prognostic, proportionally, proportionate, prudent, purported, Qalsody, quotation, quote, quoted, QuVa, realignment, reconciling, refocused, regain, remeasured, rocket, safeguard, segment, send, shareholder, shortage, southern, SPA, Sporn, streamlining, stricter, Strip, Superoxide, Switzerland, Syria, talk, terrorist, till, Trejo, trust, UCB, unadjusted, unjust, unobservable, uphold, Usawa, vigorously, war, Weizman, writing, Zurich
Removed:
abstract, accredited, acted, advisor, antisense, army, AstraZeneca, authorize, automatic, Bayshore, biopharma, Bipartisan, branded, Brooklyn, chaired, China, combat, commandeered, Consortium, continuity, David, Davidoff, dependence, Devereux, dialog, diligently, Duke, enactment, FACP, faculty, Fellow, FL, franchise, Furiex, Gateway, GDOR, GlaxoSmithKline, Glenholme, graduated, Harrington, hedge, Hutcher, Icahn, Ichilov, implanted, imposing, infused, inhaled, injected, instilled, Island, Kurome, leased, Likewise, LLP, Malito, Manhattan, Marymount, methodology, MHSc, Miami, molecule, Monumental, motoneuron, Mt, NDA, Northeast, nurse, Obama, oligonucleotide, outbreak, overturned, pace, philanthropy, plc, Portugal, posed, poverty, practiced, proceed, qui, RDD, RedHill, remotely, removing, repealed, resistance, Safer, Sankesh, SAP, scaling, sequester, Setboun, Shot, simplify, Simplifying, Sinai, slight, Smith, Stanford, step, subset, surfaced, tam, tampering, targeting, TIG, Tigenix, Trump, Trustee, unclear, undermine, vast, VP, vulnerable, WAVE, workforce, Wuhan, XI
Financial report summary
?Competition
Biogen • Cytokinetics • Medicinova • Palisade Bio • Athersys, Inc / New • Longeveron Inc - Ordinary Shares • NeuroSense TherapeuticsRisks
- We need to raise additional capital. If we are unable to raise additional capital in favorable terms and a timely manner, we will not be able to execute our business plan and we could be forced to restrict or cease our operations.
- We have a history of losses and we expect to incur losses for the foreseeable future.
- We are exposed to fluctuations in currency exchange rates.
- The dollar cost of our operations in Israel will increase to the extent increases in the rate of inflation in Israel are not offset by a devaluation of the NIS in relation to the dollar, which would harm our results of operations.
- If our NurOwn® stem cell therapy does not demonstrate safety and efficacy sufficient to obtain regulatory approval, it may not receive regulatory approval and we will be unable to market it.
- Our product development programs are based on novel technologies and are inherently risky.
- We may not be able to secure and maintain research institutions to conduct our clinical trials.
- The field of stem cell therapy is relatively new and our development efforts may not yield an effective treatment of human diseases.
- Our NurOwn® stem cell therapy, even if approved, may not be accepted in the marketplace; therefore, we may not be able to generate significant revenue, if any.
- Adoption of our NurOwn® stem cell therapy for the treatment of patients with ALS, PMS, AD or other neurodegenerative diseases, even if approved, may be slow or limited. If our NurOwn® stem cell therapy does not achieve broad acceptance as a treatment option for ALS, PMS, AD or other neurodegenerative diseases, our business would be negatively impact our revenue forecast.
- Our success will depend in part on establishing and maintaining effective strategic partnerships and collaborations, which may impose restrictions on our business and subject us to additional regulation.
- We will need to develop or acquire additional capabilities in order to commercialize our NurOwn® stem cell therapy, if approved for sale, and we may encounter unexpected costs or difficulties in doing so.
- We expect to expand our development, regulatory, manufacturing and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
- We have never manufactured our NurOwn® stem cell therapy at commercial scale and there can be no assurance that it can be manufactured in compliance with regulations at a cost or in quantities necessary to make it commercially viable.
- Lack of coordination internally among our employees and externally with physicians, hospitals and third-party suppliers and carriers, could cause manufacturing difficulties, disruptions or delays and cause us to not meet our expected clinical trial requirements or potential commercial requirements.
- We face competition in our efforts to develop cell therapies for ALS and other neurodegenerative diseases.
- The trend towards consolidation in the pharmaceutical and biotechnology industries may adversely affect us.
- There is a scarcity of experienced professionals in the field of cell therapy and we may not be able to retain key personnel or hire new key personnel needed to implement our business strategy and develop our products and businesses. If we are unable to retain or hire key personnel, we may be unable to continue to grow our business or to implement our business strategy, and our business may be materially and adversely affected.
- Technological and medical developments or improvements in conventional therapies could render the use of stem cells and our services and planned products obsolete.
- We may expend our limited resources to pursue our NurOwn® stem cell therapy or a specific indication for its use and fail to capitalize on stem cell therapies or indications that may be more profitable or for which there is a greater likelihood of success.
- Our NurOwn® stem cell therapy is based on a novel technology, which may raise development issues that we may not be able to resolve, regulatory issues that could delay or prevent approval or personnel issues that may keep us from being able to develop our treatments.
- We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws health information privacy and security laws, and other health care laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
- It is uncertain to what extent the government, private health insurers and third-party payors will approve coverage or provide reimbursement for the therapies and products to which our services relate. Availability for such reimbursement may be further limited by an increasing uninsured population and reductions in Medicare and Medicaid funding in the United States.
- Unintended consequences of recently adopted health reform legislation in the U.S. may adversely affect our business.
- Ethical and other concerns surrounding the use of stem cell therapy may negatively impact the public perception of our stem cell services, thereby suppressing demand for our services.
- We may be subject to significant product liability claims and litigation which could adversely affect our future earnings and financial condition.
- Our business could be adversely affected by the effects of health epidemics, including any ongoing public health crises, in regions where we operate.
- Political, economic and military instability in Israel may impede our ability to execute our plan of operations.
- We are subject to a strict regulatory environment. If we fail to obtain and maintain required regulatory approvals for our potential cell therapy products, our ability to commercialize our potential cell therapy products will be severely limited.
- Even if regulatory approvals are obtained for our stem cell therapies, we will be subject to ongoing government regulation. If we or one or more of our partners or collaborators fail to comply with applicable current and future laws and government regulations, our business and financial results could be adversely affected.
- We are subject to environmental, health and safety laws.
- We are subject to significant regulation with respect to manufacturing of our NurOwn® stem cell therapy.
- Part of our business in the foreseeable future will be based on technology licensed from Ramot and if this license were to be terminated upon failure to make required royalty payments in the future, we would need to change our business strategy and we may be forced to cease our operations.
- If Ramot is unable to obtain patents on the patent applications and technology licensed to our Israeli Subsidiary or if patents are obtained but do not provide meaningful protection, we may not be able to successfully market our proposed products.
- We may be unable to protect our intellectual property from infringement by third parties.
- As a result of our reliance on consultants, we may not be able to protect the confidentiality of our technology, which, if disseminated, could negatively impact our plan of operations.
- We received grants from the Israel Innovation Authority, or IIA, we are subject to on-going restrictions.
- If we fail to regain compliance with the continued listing requirements of Nasdaq, our Common Stock may be delisted and the price and liquidity of our common stock may be negatively impacted.
- We are and could be further subject to securities class action litigation and other types of stockholder litigation.
- The price and trading volume of our stock is expected to be volatile.
- Your percentage ownership will be diluted by future issuances of our securities.
- ACCBT holds equity participation rights and other rights that could affect our ability to raise funds.
- You may experience difficulties in attempting to enforce liabilities based upon U.S. federal securities laws against us and our non-U.S. resident directors and officers.
- If we fail to implement and maintain an effective system of internal controls, we may be unable to accurately report our results of operations or prevent fraud, and investor confidence and the market price of our Common Stock may be materially and adversely affected.
- Delaware law could discourage a change in control, or an acquisition of us by a third party, even if the acquisition would be favorable to you, and thereby adversely affect existing stockholders.
- We do not expect to pay dividends in the foreseeable future, and accordingly you must rely on stock appreciation for any return on your investment.
Management Discussion
- For the period from inception (September 22, 2000) until December 31, 2023, we did not generate any revenues from operations. In addition, we incurred operating costs and expenses of approximately $17,192,000 during the year ended December 31, 2023.
- Our business model calls for significant investments in research and development. Our research and development expenditures, net in the year ended December 31, 2023 were $10,746,000, a decrease of $3,210,000 compared to $13,956,000 for the year ended December 31, 2022.
- This decrease is due to: (i) a decrease of $2,204,000 in connection with costs related to the Phase 3 Clinical Trials; (ii) a decrease of $1,146,000 for costs related to payroll expenses and (iii) a decrease of $841,000 in connection with materials, depreciation and rent and other costs. This decrease was partially offset by (i) an increase of $726,000 for costs related to stock-based compensation expenses; (ii) a decrease of $200,000 in participation under various awarded grants in 2022 and (iii) an increase of $55,000 for costs related to travel and depreciation.