−Removed: in shares of our common stock is very speculative and involves a high degree of risk.
−Removed: You should carefully consider the risks
−Removed: and uncertainties described below, the section of this Annual Report entitled “Management’s Discussion and Analysis of Financial
−Removed: Condition and Results of Operations” and our financial statements and related notes included elsewhere in this Annual Report.
−Removed: risks and uncertainties described below are not the only ones we face.
−Removed: Additional risks and uncertainties that we are unaware of, or
−Removed: that we currently believe are not material, may also become important factors that affect us.
−Removed: If any of the following risks occur, our
−Removed: business, operating results and prospects could be materially harmed.
−Removed: In that event, the price of our common stock could decline, and
−Removed: you could lose part or all of your investment.
−Removed: business is subject to numerous risks and uncertainties that you should consider before investing in our company.
−Removed: You should carefully
−Removed: consider all of the risks described more fully in the section titled “Risk Factors” in this Annual Report on page 19,
−Removed: before deciding to invest in our common stock.
−Removed: If any of these risks actually occurs, our business, financial condition and results of
−Removed: operations would likely be materially adversely affected.
−Removed: factors that could cause actual results or events to differ materially, but are not limited to, the following:
−Removed: Related to Our Intellectual Property
−Removed: depend on rights to Telomir-1 that are or will be licensed to us.
−Removed: may not be able to adequately protect our product candidates or our proprietary technology in the marketplace.
−Removed: third parties claim that our intellectual property, products, processes, or anything else used by us infringes upon their intellectual
−Removed: property, our operating profits could be adversely affected.
−Removed: have been granted a license to the right to develop Telomir-1 in the United States in human and pet application, but we have not been
−Removed: granted a license to the rights to patents covering Telomir-1 in foreign jurisdictions.
−Removed: Related to Our Operations and Financial Condition
−Removed: are an early development-stage company with no revenues and our financial condition raises substantial
−Removed: doubt as to our ability to continue as a going concern .
−Removed: we have a limited operating history, you may not be able to accurately evaluate our operations.
−Removed: will need to raise additional financing for the continuation of our operations.
−Removed: operating results may fluctuate, which could have a negative impact on our ability to grow our client base, establish sustainable revenues
−Removed: and succeed overall.
−Removed: have yet to achieve a profit and will not achieve a profit in the near future, if at all.
−Removed: of our executive officers are not be employed by us on a full-time basis.
−Removed: of interest may arise between us and MIRALOGX.
−Removed: Relating to Our Business and Our Industry
−Removed: future success will largely depend on the success of Telomir-1 and any future product candidates, which development will require significant
−Removed: capital resources and years of clinical development effort.
−Removed: are dependent on our current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized.
−Removed: of pre-clinical studies and earlier clinical trials are not necessarily predictive indicators of future results.
−Removed: have limited marketing experience, and we do not anticipate at this time establishing a sales force or distribution and reimbursement
−Removed: capabilities, and we may not be able to successfully commercialize any of our product candidates if they are approved in the future.
−Removed: will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in managing
−Removed: our growth and executing our growth strategy.
−Removed: expect to face intense competition, often from companies with greater resources and experience than we have.
−Removed: have significant and increasing liquidity needs and may require additional funding.
−Removed: Related to Development and Regulatory Approval of Our Product Candidates
−Removed: trials for our product candidates are expensive, time-consuming, uncertain, and susceptible to change, delay or termination.
−Removed: of clinical trials are open to differing interpretations.
−Removed: failure by us to comply with existing regulations could harm our reputation and operating results.
−Removed: regulatory approval processes with the FDA are lengthy and inherently unpredictable.
−Removed: is a high rate of failure for drug candidates proceeding through clinical trials.
−Removed: Related to Our Reliance Upon Third Parties
−Removed: rely on, and expect to continue to rely on, third parties to conduct clinical trials for our product candidates.
−Removed: existing collaboration arrangements and any that we may enter into in the future may not be successful, which could adversely affect
−Removed: our ability to develop and commercialize our product candidates.
−Removed: Relating to the Ownership of Our Common Stock
−Removed: of the speculative nature of an investment in our company, you may lose your entire investment.
−Removed: of our founding stockholders, plus our existing officers and directors, control a substantial interest in us and thus may influence certain
−Removed: actions requiring stockholder vote.
−Removed: Related to Our Intellectual Property
−Removed: depend on rights to Telomir-1 that are or will be licensed to us.
−Removed: We do not own the intellectual property rights to Telomir-1 and any
−Removed: loss of our rights to it could prevent us from selling our product.
−Removed: our present and future pipeline of treatments, Telomir-1 is in-licensed from another company.
−Removed: We do not currently own any intellectual
−Removed: property rights, including the patent application that underlies this license.
−Removed: Our rights to use Telomir-1 is subject to the negotiation
−Removed: of, continuation of and compliance with the terms of this license.
−Removed: Thus, the non-provisional patent application is not written by us
−Removed: or our attorneys, and we did not have control over the drafting and prosecution.
−Removed: The patent owner and our licensor might not have given
−Removed: the same attention to the drafting and prosecution of these patents and applications as we would have if we had been the owner of the
−Removed: patent application and had control over the drafting.
−Removed: We cannot be certain that drafting of the licensed patent application, or patent
−Removed: prosecution, by the licensor have been or will be conducted in compliance with applicable laws and regulations or will result in valid
−Removed: and enforceable patents and other intellectual property rights.
−Removed: This absence of control over the drafting, prosecution of patent and
−Removed: applications, along with non-compliance with royalty payments and confidentiality breaches are just some of the ways that may result
−Removed: in the Company’s’ loss of the license and inability to continue operations.
−Removed: additional research and development activity, pre-clinical testing, and/or clinical testing Telomir-1 is required before we will have
−Removed: a chance to achieve a viable product for licensing or commercialization.
−Removed: Our business currently depends entirely on the successful development,
−Removed: regulatory approval, and licensing or commercialization of our product candidate, which may never occur.
−Removed: of our licensed patent application or defense of any claims asserting invalidity of these patents is often subject to the control or
−Removed: cooperation of our licensor.
−Removed: Legal action could be initiated against the owners of the intellectual property that we license and an adverse
−Removed: outcome in such legal action could harm our business because it might prevent such companies or institutions from continuing to license
−Removed: intellectual property that we may need to operate our business.
−Removed: In addition, such licensor may resolve such litigation in a way that
−Removed: benefits it but adversely affects our ability to have freedom to operate to develop and commercialize Telomir-1.
−Removed: may not be able to adequately protect our product candidates or our proprietary technology in the marketplace.
−Removed: success will depend, in part, on our ability to obtain patents, protect our trade secrets and operate without infringing on the proprietary
−Removed: rights of others.
−Removed: We may rely upon a combination of patents, trade secret protection (i.e., know-how), trademarks, licenses, and confidentiality
−Removed: agreements to protect the intellectual property of our product candidates.
−Removed: The strengths of patents in the pharmaceutical field involve
−Removed: complex legal and scientific questions and can be uncertain.
−Removed: Where appropriate, we seek patent protection for certain aspects of our
−Removed: products and technology.
−Removed: However, patent protection for naturally occurring compounds is exceedingly difficult to obtain, defend and
−Removed: Filing, prosecuting and defending patents throughout the world would be prohibitively expensive, so our policy is to look to
−Removed: patent technologies with commercial potential in jurisdictions with significant commercial opportunities.
−Removed: However, patent protection
−Removed: may not be available for some of the products or technology we are developing.
−Removed: If we must spend significant time and money protecting,
−Removed: defending, or enforcing our patents, designing around patents held by others or licensing, potentially for large fees, patents or other
−Removed: proprietary rights held by others, our business, results of operations and financial condition may be harmed.
−Removed: We may not develop additional
−Removed: proprietary products that are patentable.
−Removed: patent positions of pharmaceutical products are complex and uncertain.
−Removed: Although we have sought and expect to continue to seek patent
−Removed: protection for our product candidates, their methods of use, and methods of manufacture, any, or all of them may not be subject to effective
−Removed: patent protection.
−Removed: If any of our products are approved and marketed for an indication for which we do not have an issued patent, our
−Removed: ability to use our patents to prevent a competitor from commercializing a non-branded version of our commercial products for that non-patented
−Removed: indication could be significantly impaired or even eliminated.
−Removed: of information related to our product candidates by us, or others may prevent us from obtaining or enforcing patents relating to these
−Removed: products and product candidates.
−Removed: Furthermore, others may independently develop similar products, may duplicate our products, or may design
−Removed: around our patent rights.
−Removed: In addition, any of our issued patents may be opposed and/or declared invalid or unenforceable.
−Removed: to adequately protect our intellectual property, we may face competition from companies who attempt to create a generic product to compete
−Removed: with our product candidates.
−Removed: We may also face competition from companies who develop a substantially similar product to one of our product
−Removed: candidates that is not covered by any of our patents.
−Removed: companies have encountered significant problems in protecting, defending and enforcing intellectual property rights in foreign jurisdictions.
−Removed: The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other
−Removed: intellectual property rights, particularly those relating to pharmaceuticals, which could make it difficult for us to stop the infringement
−Removed: of our patents or marketing of competing products in violation of our proprietary rights generally.
−Removed: Proceedings to enforce our patent
−Removed: rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business.
−Removed: we do not own the rights to the intellectual property and technology that will be used to commercially develop our initial product candidate,
−Removed: MIRALOGX, which is a separate intellectual property development company owned by a trust established by the Company’s
−Removed: founder, holds the patent rights to Telomir-1, which are currently comprised of a pending non-provisional patent application.
−Removed: the issuance of the non-provisional patent application, we will have an exclusive, license from MIRALOGX to develop and commercialize
−Removed: Telomir-1 in the U.S.
+Added: Investing in shares of our common stock
+Added: is very speculative and involves a high degree of risk.
+Added: You should carefully consider the risks and uncertainties described
+Added: below, the section of this Annual Report entitled “Management’s Discussion and Analysis of Financial Condition and Results
+Added: of Operations” and our financial statements and related notes included elsewhere in this Annual Report.
+Added: The risks and uncertainties
+Added: described below are not the only ones we face.
+Added: Additional risks and uncertainties that we are unaware of, or that we currently believe
+Added: are not material, may also become important factors that affect us.
+Added: If any of the following risks occur, our business, operating results
+Added: and prospects could be materially harmed.
+Added: In that event, the price of our common stock could decline, and you could lose part or all
+Added: of your investment.
+Added: Risks Related to Our Intellectual Property
+Added: We depend on rights to Telomir-1 that are
+Added: or will be licensed to us.
+Added: We do not own the intellectual property rights to Telomir-1 and any loss of our rights to it could prevent
+Added: us from selling our product.
+Added: Within our present and future pipeline of treatments,
+Added: Telomir-1 is in-licensed from MIRALOGX.
+Added: We do not currently own any intellectual property rights, including the patent application that
+Added: underlies this license.
+Added: Our rights to use Telomir-1 is subject to the negotiation of, continuation of and compliance with the terms of
+Added: this license.
+Added: Thus, the non-provisional patent application is not written by us or our attorneys, and we did not have control over the
+Added: drafting and prosecution.
+Added: The patent owner and our licensor might not have given the same attention to the drafting and prosecution of
+Added: these patents and applications as we would have if we had been the owner of the patent application and had control over the drafting.
+Added: We cannot be certain that drafting of the licensed patent application, or patent prosecution, by the licensor have been or will be conducted
+Added: in compliance with applicable laws and regulations or will result in valid and enforceable patents and other intellectual property rights.
+Added: This absence of control over the drafting, prosecution of patent and applications, along with non-compliance with royalty payments and
+Added: confidentiality breaches are just some of the ways that may result in the Company’s’ loss of the license and inability to
+Added: continue operations.
+Added: Significant additional research and development
+Added: activity, pre-clinical testing, and/or clinical testing Telomir-1 is required before we will have a chance to achieve a viable product
+Added: for licensing or commercialization.
+Added: Our business currently depends entirely on the successful development, regulatory approval, and licensing
+Added: or commercialization of our product candidate, which may never occur.
+Added: Enforcement of our licensed patent application
+Added: or defense of any claims asserting invalidity of these patents is often subject to the control or cooperation of our licensor.
+Added: action could be initiated against the owners of the intellectual property that we license and an adverse outcome in such legal action
+Added: could harm our business because it might prevent such companies or institutions from continuing to license intellectual property that
+Added: we may need to operate our business.
+Added: In addition, such licensor may resolve such litigation in a way that benefits it but adversely affects
+Added: our ability to have freedom to operate to develop and commercialize Telomir-1.
+Added: We may not be able to adequately protect
+Added: our product candidates or our proprietary technology in the marketplace.
+Added: Our success will depend, in part, on our ability
+Added: to obtain patents, protect our trade secrets and operate without infringing on the proprietary rights of others.
+Added: We may rely upon a combination
+Added: of patents, trade secret protection (i.e., know-how), trademarks, licenses, and confidentiality agreements to protect the intellectual
+Added: property of our product candidates.
+Added: The strengths of patents in the pharmaceutical field involve complex legal and scientific questions
+Added: and can be uncertain.
+Added: Where appropriate, we seek patent protection for certain aspects of our products and technology.
+Added: However, patent
+Added: protection for naturally occurring compounds is exceedingly difficult to obtain, defend and enforce.
+Added: Filing, prosecuting and defending
+Added: patents throughout the world would be prohibitively expensive, so our policy is to look to patent technologies with commercial potential
+Added: in jurisdictions with significant commercial opportunities.
+Added: However, patent protection may not be available for some of the products
+Added: or technology we are developing.
+Added: If we must spend significant time and money protecting, defending, or enforcing our patents, designing
+Added: around patents held by others or licensing, potentially for large fees, patents or other proprietary rights held by others, our business,
+Added: results of operations and financial condition may be harmed.
+Added: We may not develop additional proprietary products that are patentable.
+Added: The patent positions of pharmaceutical products
+Added: are complex and uncertain.
+Added: Although we have sought and expect to continue to seek patent protection for our product candidates, their
+Added: methods of use, and methods of manufacture, any, or all of them may not be subject to effective patent protection.
+Added: If any of our products
+Added: are approved and marketed for an indication for which we do not have an issued patent, our ability to use our patents to prevent a competitor
+Added: from commercializing a non-branded version of our commercial products for that non-patented indication could be significantly impaired
+Added: or even eliminated.
+Added: Publication of information related to our product
+Added: candidates by us, or others may prevent us from obtaining or enforcing patents relating to these products and product candidates.
+Added: others may independently develop similar products, may duplicate our products, or may design around our patent rights.
+Added: In addition, any
+Added: of our issued patents may be opposed and/or declared invalid or unenforceable.
+Added: If we fail to adequately protect our intellectual property,
+Added: we may face competition from companies who attempt to create a generic product to compete with our product candidates.
+Added: We may also face
+Added: competition from companies who develop a substantially similar product to one of our product candidates that is not covered by any of
+Added: Many companies have encountered significant problems
+Added: in protecting, defending and enforcing intellectual property rights in foreign jurisdictions.
+Added: The legal systems of certain countries,
+Added: particularly certain developing countries, do not favor the enforcement of patents and other intellectual property rights, particularly
+Added: those relating to pharmaceuticals, which could make it difficult for us to stop the infringement of our patents or marketing of competing
+Added: products in violation of our proprietary rights generally.
+Added: Proceedings to enforce our patent rights in foreign jurisdictions could result
+Added: in substantial cost and divert our efforts and attention from other aspects of our business.
+Added: Currently, we do not own the rights to the intellectual
+Added: property and technology that will be used to commercially develop our initial product candidate, Telomir-1.
+Added: MIRALOGX, which is a separate
+Added: intellectual property development company owned by a trust established by the Company’s founder, holds the patent rights to Telomir-1,
+Added: which are currently comprised of a pending non-provisional patent application.
+Added: Pending the issuance of the non-provisional patent application,
+Added: we will have an exclusive, license from MIRALOGX to develop and commercialize Telomir-1 in the U.S.
for human and non-human applications.
−Removed: The term of the license will continue through the date of the expiration
−Removed: of the last-to-expire licensed patent or, if later, the date of the expiration of the last strategic partnership/sublicensing agreement
−Removed: covering the licensed products.
−Removed: The licensed patent rights are expected to extend through 2043.
−Removed: We expect additional patent terms may
−Removed: be awarded, including additional patent terms based on the time for regulatory review of drug products.
−Removed: There are no up-front, execution,
−Removed: or milestone payments required under the license agreement.
+Added: The term of the license will continue through the date of the expiration of the last-to-expire licensed patent or, if later, the date
+Added: of the expiration of the last strategic partnership/sublicensing agreement covering the licensed products.
+Added: The licensed patent rights
+Added: are expected to extend through 2043.
+Added: We expect additional patent terms may be awarded, including additional patent terms based on the
+Added: time for regulatory review of drug products.
+Added: There are no up-front, execution, or milestone payments required under the license agreement.
Further, no payments have been made to date under the agreement.
−Removed: required to pay an 8% royalty on net sales or revenue in exchange for an exclusive, worldwide license to patent rights, and we may bring
−Removed: suit in our own name to enforce our patent rights under the license agreement.
−Removed: In the event we are unable to enforce our rights under
−Removed: the agreement or are unable to detect unauthorized use of our intellectual property, we may lose the benefit of the licensed rights used
−Removed: to commercially develop Telomir-1.
−Removed: MIRALOGX will control the prosecution of the patent applications for Telomir-1.
−Removed: third parties claim that our intellectual property, products, processes, or anything else used by us infringes upon their intellectual
−Removed: property, our operating profits could be adversely affected.
−Removed: is a substantial amount of litigation, both within and outside the U.S., involving patent and other intellectual property rights in the
−Removed: pharmaceutical industry.
−Removed: We may, from time to time, be notified of claims that we are infringing upon patents, trademarks, copyrights,
−Removed: or other intellectual property rights owned by third parties, and we cannot provide assurances that other companies will not, in the
−Removed: future, pursue such infringement claims against us, our commercial partners or any third-party proprietary technologies we have licensed.
−Removed: If we were found to infringe upon a patent or other intellectual property right, or if we failed to obtain or renew a license under a
−Removed: patent or other intellectual property right from a third party, or if a third party that we were licensing technologies from was found
−Removed: to infringe upon a patent or other intellectual property rights of another third party, we may be required to pay damages, including
−Removed: damages of up to three times the damages found or assessed, if the infringement is found to be willful, suspend the manufacture of certain
−Removed: products or reengineer or rebrand our products, if feasible, or we may be unable to enter certain new product markets.
−Removed: Any such claims
−Removed: could also be expensive and time consuming to defend and divert management’s attention and resources.
−Removed: Our competitive position
−Removed: could suffer as a result.
−Removed: In addition, if we have declined or failed to enter into a valid non-disclosure or assignment agreement for
−Removed: any reason, we may not own the invention or our intellectual property, and our products may not be adequately protected.
−Removed: Thus, we cannot
−Removed: guarantee that our product candidates, or our commercialization thereof, does not and will not infringe any third party’s intellectual
−Removed: have been granted a license to the right to develop Telomir-1 in the United States in human and pet application, but we have not been
−Removed: granted a license to the rights to patents covering Telomir-1 in foreign jurisdictions.
−Removed: have been granted a license to the right to develop Telomir-1 in the United States but not in countries outside the United States, as
−Removed: MIRALOGX has retained all rights outside the United States and may license such rights to other parties.
−Removed: Accordingly, MIRALOGX potentially
−Removed: could develop a competing product for such jurisdictions outside of the United States.
−Removed: Related to Our Operations and Financial Condition
−Removed: are an early development-stage company with no revenues.
−Removed: very early development-stage enterprise that is focused on the development of a pre-clinical pharmaceutical product, we have generated
−Removed: no revenue and have an accumulated deficit of $30.6 million and $14.1 million as of December 31, 2024 and December 31, 2023, respectively.
−Removed: There can be no assurance that sufficient funds required to pursue our development program will be generated from operations or that
−Removed: funds will be available from external sources, such as debt or equity financings or other potential sources.
−Removed: The lack of additional capital
−Removed: resulting from the inability to generate cash flow from operations, or to raise capital from external sources would force us to substantially
−Removed: curtail or cease operations and would, therefore, have a material adverse effect on business.
−Removed: Furthermore, there can be no assurance
−Removed: that any such required funds, if available, will be available on attractive terms or that they will not have a significant dilutive effect
−Removed: on our existing stockholders.
−Removed: It is for these reasons substantial doubt about our ability to continue as a going concern exists and an
−Removed: explanatory paragraph relating to our ability to continue as a going concern can be found within the report of our independent registered
−Removed: public accounting firm on our audited financial statements for the fiscal year ended December 31, 2024.
−Removed: seek to overcome the circumstances that impact our ability to remain a going concern in the future through the growth of revenues with
−Removed: interim cash flow deficiencies being addressed through additional equity and debt financing.
−Removed: We anticipate raising additional funds through
−Removed: public or private financing, strategic relationships, or other arrangements in the near future to support our business operations;
−Removed: we may not have commitments from third parties for a sufficient amount of additional capital.
−Removed: We cannot be certain that any such financing
−Removed: will be available on acceptable terms, or at all, and our failure to raise capital when needed could limit our ability to continue operations.
−Removed: Our ability to obtain additional funding will determine our ability to continue as a going concern.
−Removed: Failure to secure additional financing
−Removed: in a timely manner and on favorable terms would have a material adverse effect on our financial performance, results of operations and
−Removed: stock price and require us to curtail or cease operations, sell off our assets, seek protection from our creditors through bankruptcy
−Removed: proceedings, or otherwise.
−Removed: Furthermore, additional equity financing may be dilutive to the holders of our common stock, and debt financing,
−Removed: if available, may involve restrictive covenants, and strategic relationships, if necessary, to raise additional funds, and may require
−Removed: that we relinquish valuable rights.
+Added: We are also required to pay an 8% royalty on net sales or revenue in
+Added: exchange for an exclusive, worldwide license to patent rights, and we may bring suit in our own name to enforce our patent rights under
+Added: the license agreement.
+Added: In the event we are unable to enforce our rights under the agreement or are unable to detect unauthorized use
+Added: of our intellectual property, we may lose the benefit of the licensed rights used to commercially develop Telomir-1.
+Added: MIRALOGX will control
+Added: the prosecution of the patent applications for Telomir-1.
+Added: If third parties claim that our intellectual
+Added: property, products, processes, or anything else used by us infringes upon their intellectual property, our operating profits could be
+Added: adversely affected.
+Added: There is a substantial amount of litigation,
+Added: both within and outside the U.S., involving patent and other intellectual property rights in the pharmaceutical industry.
+Added: time to time, be notified of claims that we are infringing upon patents, trademarks, copyrights, or other intellectual property rights
+Added: owned by third parties, and we cannot provide assurances that other companies will not, in the future, pursue such infringement claims
+Added: against us, our commercial partners or any third-party proprietary technologies we have licensed.
+Added: If we were found to infringe upon a
+Added: patent or other intellectual property right, or if we failed to obtain or renew a license under a patent or other intellectual property
+Added: right from a third party, or if a third party that we were licensing technologies from was found to infringe upon a patent or other intellectual
+Added: property rights of another third party, we may be required to pay damages, including damages of up to three times the damages found or
+Added: assessed, if the infringement is found to be willful, suspend the manufacture of certain products or reengineer or rebrand our products,
+Added: if feasible, or we may be unable to enter certain new product markets.
+Added: Any such claims could also be expensive and time consuming to
+Added: defend and divert management’s attention and resources.
+Added: Our competitive position could suffer as a result.
+Added: In addition, if we have
+Added: declined or failed to enter into a valid non-disclosure or assignment agreement for any reason, we may not own the invention or our intellectual
+Added: property, and our products may not be adequately protected.
+Added: Thus, we cannot guarantee that our product candidates, or our commercialization
+Added: thereof, does not and will not infringe any third party’s intellectual property.
+Added: We have been granted a license to the right
+Added: to develop Telomir-1 in the United States in human and pet application, but we have not been granted a license to the rights to patents
+Added: covering Telomir-1 in foreign jurisdictions.
+Added: We have been granted a license to the right to
+Added: develop Telomir-1 in the United States but not in countries outside the United States, as MIRALOGX has retained all rights outside the
+Added: United States and may license such rights to other parties.
+Added: Accordingly, MIRALOGX potentially could develop a competing product for such
+Added: jurisdictions outside of the United States.
+Added: Risks Related to Our Operations and Financial
+Added: We are an early development-stage company
+Added: with no revenues.
+Added: As an early development-stage enterprise that
+Added: is focused on the development of a pre-clinical pharmaceutical product, we have generated no revenue and have an accumulated deficit
+Added: of $41.0 million and $30.6 million as of December 31, 2025 and December 31, 2024, respectively.
+Added: There can be no assurance that sufficient
+Added: funds required to pursue our development program will be generated from operations or that funds will be available from external sources,
+Added: such as debt or equity financings or other potential sources.
+Added: The lack of additional capital resulting from the inability to generate
+Added: cash flow from operations, or to raise capital from external sources would force us to substantially curtail or cease operations and
+Added: would, therefore, have a material adverse effect on business.
+Added: Furthermore, there can be no assurance that any such required funds, if
+Added: available, will be available on attractive terms or that they will not have a significant dilutive effect on our existing stockholders.
+Added: It is for these reasons substantial doubt about our ability to continue as a going concern exists and an explanatory paragraph relating
+Added: to our ability to continue as a going concern can be found within the report of our independent registered public accounting firm on
+Added: our audited financial statements for the fiscal year ended December 31, 2025.
+Added: We seek to overcome the circumstances that impact
+Added: our ability to remain a going concern in the future through the growth of revenues with interim cash flow deficiencies being addressed
+Added: through additional equity and debt financing.
+Added: We anticipate raising additional funds through public or private financing, strategic relationships,
+Added: or other arrangements in the near future to support our business operations;
+Added: however, we may not have commitments from third parties
+Added: for a sufficient amount of additional capital.
+Added: We cannot be certain that any such financing will be available on acceptable terms, or
+Added: at all, and our failure to raise capital when needed could limit our ability to continue operations.
+Added: Our ability to obtain additional
+Added: funding will determine our ability to continue as a going concern.
+Added: Failure to secure additional financing in a timely manner and on favorable
+Added: terms would have a material adverse effect on our financial performance, results of operations and stock price and require us to curtail
+Added: or cease operations, sell off our assets, seek protection from our creditors through bankruptcy proceedings, or otherwise.
+Added: additional equity financing may be dilutive to the holders of our common stock, and debt financing, if available, may involve restrictive
+Added: covenants, and strategic relationships, if necessary, to raise additional funds, and may require that we relinquish valuable rights.
we have a limited operating history, you may not be able to accurately evaluate our operations.
−Removed: have had limited operations to date.
−Removed: Therefore, we have a limited operating history upon which to evaluate the merits of investing in
−Removed: Our stockholders should be aware of the difficulties normally encountered by new companies and the high rate of failure
−Removed: of such enterprises.
−Removed: The likelihood of success must be considered in light of the problems, expenses, difficulties, complications, and
−Removed: delays encountered in connection with the operations that we plan to undertake.
−Removed: These potential problems include, but are not limited
−Removed: to, unanticipated problems relating to the ability to generate sufficient cash flow to operate our business, and additional costs and
−Removed: expenses that may exceed current estimates.
−Removed: We expect to continue to incur significant losses into the foreseeable future.
−Removed: that if the effectiveness of our business plan is not forthcoming, we will not be able to continue business operations.
−Removed: There is no history
−Removed: upon which to base any assumption as to the likelihood that we will prove successful, and it is doubtful that we will generate any operating
−Removed: revenues or ever achieve profitable operations.
+Added: We have had limited operations to date.
+Added: we have a limited operating history upon which to evaluate the merits of investing in our company.
+Added: Our stockholders should be aware of
+Added: the difficulties normally encountered by new companies and the high rate of failure of such enterprises.
+Added: The likelihood of success must
+Added: be considered in light of the problems, expenses, difficulties, complications, and delays encountered in connection with the operations
+Added: that we plan to undertake.
+Added: These potential problems include, but are not limited to, unanticipated problems relating to the ability to
+Added: generate sufficient cash flow to operate our business, and additional costs and expenses that may exceed current estimates.
+Added: to continue to incur significant losses into the foreseeable future.
+Added: We recognize that if the effectiveness of our business plan is not
+Added: forthcoming, we will not be able to continue business operations.
+Added: There is no history upon which to base any assumption as to the likelihood
+Added: that we will prove successful, and it is doubtful that we will generate any operating revenues or ever achieve profitable operations.
If we are unsuccessful in addressing these risks, our business will most likely fail.
−Removed: will need to raise additional financing for the continuation of our operations.
−Removed: we have generated no revenues and currently operate at a loss, we are completely dependent on the continued availability of financing
−Removed: in order to continue our business operations.
−Removed: There can be no assurance that financing sufficient to enable us to continue our operations
−Removed: will be available to us in the future.
−Removed: will need additional funds to complete further development of our business plan to achieve a sustainable level where ongoing operations
−Removed: can be funded out of revenues.
−Removed: We expect that adequate resources are available to fund our operations and initial clinical development
−Removed: programs midway through the first quarter of 2026.
−Removed: We will require further funding to fully implement our business plan
−Removed: to its fullest potential and achieve our growth plans.
−Removed: There is no assurance that any additional financing will be available or if available,
−Removed: on terms that will be acceptable to us.
−Removed: failure to obtain future financing or to produce levels of revenue to meet our financial needs could result in our inability to continue
−Removed: as a going concern and the failure of our business.
−Removed: operating results may fluctuate, which could have a negative impact on our ability to grow our client base, establish sustainable revenues
−Removed: and succeed overall.
−Removed: results of operations may fluctuate as a result of a number of factors, some of which are beyond our control including but not limited
+Added: We will need to raise additional financing
+Added: for the continuation of our operations.
+Added: Because we have generated no revenues and currently
+Added: operate at a loss, we are completely dependent on the continued availability of financing in order to continue our business operations.
+Added: There can be no assurance that financing sufficient to enable us to continue our operations will be available to us in the future.
+Added: We will require additional capital to advance
+Added: our development activities and to achieve a sustainable level at which operations could be supported by revenues, if any.
+Added: current operating plan and available cash resources, we believe that our existing capital will be sufficient to fund operations and planned
+Added: initial clinical development activities into the first quarter of 2027.
+Added: We will require additional financing to continue development
+Added: beyond that period and to fully implement our business strategy.
+Added: There can be no assurance that additional financing will be available
+Added: when needed or, if available, on terms acceptable to us.
+Added: Our failure to obtain future financing or to
+Added: produce levels of revenue to meet our financial needs could result in our inability to continue as a going concern and the failure of
+Added: our business.
+Added: Our operating results may fluctuate, which
+Added: could have a negative impact on our ability to grow our client base, establish sustainable revenues and succeed overall.
+Added: Our results of operations may fluctuate as a
+Added: result of a number of factors, some of which are beyond our control including but not limited to:
economic conditions in the geographies and industries where we sell our services and conduct operations;
12 unchanged sentences
and litigation matters.
−Removed: a result of these factors, we may not succeed in our business, and we could go out of business.
−Removed: have yet to achieve a profit and will not achieve a profit in the near future, if at all.
−Removed: have not yet produced any revenues or profit and will not in the near future, if at all.
−Removed: We cannot be certain that we will be able to
−Removed: realize sufficient revenue to achieve profitability.
−Removed: Further, many of our competitors have a significantly larger industry presence and
−Removed: revenue stream but have yet to achieve profitability.
−Removed: Our ability to continue as a going concern in the future is dependent upon raising
−Removed: capital from financing transactions, increasing revenue and keeping operating expenses below our revenue levels in order to achieve positive
−Removed: cash flows, none of which can be assured.
−Removed: of our executive officers are not employed by us on a full-time basis.
−Removed: Aminov, our Chief Executive Officer and Chairman of our board of directors, is not employed by our company on a full-time basis.
−Removed: to be provided in his employment agreement with our company, he works on a part-time and as-needed basis.
−Removed: Because he does not work full
−Removed: time for our company, instances may occur where he may not be immediately available to provide solutions to problems or address concerns
−Removed: that arise in the course of us conducting our business and thus adversely affect our business.
−Removed: In addition, he can become subject to
−Removed: conflicts of interest because he devotes part of his working time to other business endeavors and may have responsibilities to other
−Removed: Aminov is aware of his duties and accountability to our company and to applicable laws and policies relating to
−Removed: corporate opportunity and conflicts of interest, such conflicts of interest may include deciding how much time to devote to our affairs,
−Removed: as well as what business opportunities should be presented to us.
−Removed: Yanez, our Chief Financial Officer, is not employed by our company on a full-time basis.
−Removed: As intended to be provided in her employment
−Removed: agreement with our company, she works on a part-time and as-needed basis.
−Removed: Because she does not work full time for our company, instances
−Removed: may occur where she may not be immediately available to provide solutions to problems or address concerns that arise in the course of
−Removed: us conducting our business and thus adversely affect our business.
−Removed: In addition, she can become subject to conflicts of interest because
−Removed: she devotes part of her working time to other business endeavors and may have responsibilities to other entities.
−Removed: Although Mrs.
−Removed: is aware of her duties and accountability to our company and to applicable laws and policies relating to corporate opportunity and conflicts
−Removed: of interest, such conflicts of interest may include deciding how much time to devote to our affairs, as well as what business opportunities
−Removed: should be presented to us.
−Removed: of interest may arise between us and MIRALOGX.
−Removed: has a non-provisional patent application to the rights to Telomir-1.
−Removed: MIRALOGX is a separate intellectual property development company
−Removed: owned by the Bay Shore Trust, which is an irrevocable trust established by our founder, Jonnie R.
−Removed: Williams, Sr., and in which Brian McNulty
−Removed: is the trustee.
−Removed: The Bay Shore Trust is also our largest stockholder.
−Removed: We have an exclusive license from MIRALOGX to develop and commercialize
−Removed: Telomir-1 in the U.S.
−Removed: for human and non-human applications.
−Removed: Although the interests of MIRALOGX are 100% owned by the Bay Shore Trust,
−Removed: Williams is not an officer or director of MIRALOGX and Mr.
−Removed: Williams does not have voting or dispositive power over the shares
−Removed: of our company held by Bay Shore Trust, our relationship with the Bay Shore Trust, Mr.
−Removed: Williams may create, or may create the appearance
−Removed: of, conflicts of interest when we are faced with decisions that could have different implications for MIRALOGX than the decisions have
−Removed: Furthermore, in light of the license agreement that we have with MIRALOGX, if a dispute were to arise between MIRALOGX and us
−Removed: relating to our past or future relationship with MIRALOGX or with respect to intellectual property matters, these potential conflicts
−Removed: of interest may make it more difficult for us to favorably resolve such disputes.
−Removed: Relating to Our Business and Our Industry
−Removed: future success will largely depend on the success of Telomir-1 and any future product candidates, which development will require significant
−Removed: capital resources and years of clinical development effort.
−Removed: currently have no drug products on the market, and all of our drug development projects are in a pre-clinical stage of development.
−Removed: business depends almost entirely on the successful pre-clinical and clinical development, FDA regulatory approval, and commercialization
−Removed: of our product candidates, principally Telomir-1.
−Removed: Our stockholders need to be aware that substantial additional investments including
−Removed: pre-clinical and clinical development and FDA regulatory submission and approval efforts will be required before we are permitted to
−Removed: undertake clinical studies and market and commercialize our product candidates, if ever.
−Removed: It may be several years before we can commence
−Removed: clinical trials, if ever.
−Removed: Any clinical trial will be subject to extensive and rigorous review and regulation by numerous government authorities
−Removed: in the United States and other jurisdictions where we intend, if approved, to market our product candidates.
−Removed: Before obtaining regulatory
−Removed: approvals for any of our product candidates, we must demonstrate through pre-clinical testing and clinical trials that the product candidate
−Removed: is safe and effective for its specific application.
−Removed: This process can take many years and may include post- marketing studies and surveillance,
−Removed: which would require the expenditure of substantial resources.
−Removed: Of the large number of drugs in development for approval in the United
−Removed: States (and the rest of the world), only a small percentage will successfully complete the FDA regulatory approval financing to fund
−Removed: our planned research, development, and clinical programs, we cannot assure you that any of our product candidates will be successfully
−Removed: developed or commercialized.
−Removed: may be unable to formulate or scale up any or all of our product candidates.
−Removed: There is no guarantee that any of the product candidates
−Removed: will be or are able to be manufactured or produced in a manner to meet the FDA’s criteria for product stability, content uniformity
−Removed: and all other criteria necessary for product approval in the United States and other markets.
−Removed: Any of our product candidates may fail
−Removed: to achieve their specified endpoints in clinical trials.
−Removed: product candidates may not be approved even if they achieve their specified endpoints in clinical trials.
−Removed: The FDA may disagree with our
−Removed: trial design and our interpretation of data from clinical trials or may change the requirements for approval even after it has reviewed
−Removed: and commented on the design for our clinical trials.
−Removed: The FDA may also approve a drug for fewer or more limited indications than we request
−Removed: or may grant approval contingent on the performance of costly post-approval clinical trials (i.e., Phase IV trials).
−Removed: In addition, the
−Removed: FDA may not approve the labeling claims that we believe are necessary or desirable for the successful commercialization of our product
−Removed: we are unable to expand our pipeline and obtain regulatory approval for our product candidates within the timelines we anticipate, we
−Removed: will not be able to execute our business strategy effectively and our ability to substantially grow our revenues will be limited, which
−Removed: would have a material adverse impact on our long-term business, results of operations, financial condition, and prospects.
−Removed: are dependent on our current and future product candidates, some of which may not receive regulatory approval or be successfully commercialized.
−Removed: ability to progress our plan will depend on our ability to clinically develop, gain regulatory approval for and ultimately commercialize
−Removed: our product candidates.
−Removed: Our ability to successfully commercialize our product candidates will depend on, among other things, our ability
+Added: As a result of these factors, we may not
+Added: succeed in our business, and we could go out of business.
+Added: We have yet to achieve a profit and will
+Added: not achieve a profit in the near future, if at all.
+Added: We have not yet produced any revenues or profit
+Added: and will not in the near future, if at all.
+Added: We cannot be certain that we will be able to realize sufficient revenue to achieve profitability.
+Added: Further, many of our competitors have a significantly larger industry presence and revenue stream but have yet to achieve profitability.
+Added: Our ability to continue as a going concern in the future is dependent upon raising capital from financing transactions, increasing revenue
+Added: and keeping operating expenses below our revenue levels in order to achieve positive cash flows, none of which can be assured.
+Added: Certain of our executive officers are not
+Added: employed by us on a full-time basis.
+Added: Erez Aminov, our Chief Executive Officer and
+Added: Chairman of our board of directors, is not employed by our company on a full-time basis.
+Added: Aminov is the son-in-law of Jonnie R.
+Added: Sr., the founder of the Company.
+Added: As intended to be provided in his employment agreement with our company, he works on a part-time and
+Added: as-needed basis.
+Added: Because he does not work full time for our company, instances may occur where he may not be immediately available to
+Added: provide solutions to problems or address concerns that arise in the course of us conducting our business and thus adversely affect our
+Added: In addition, he can become subject to conflicts of interest because he devotes part of his working time to other business endeavors
+Added: and may have responsibilities to other entities.
+Added: Aminov is aware of his duties and accountability to our company and to
+Added: applicable laws and policies relating to corporate opportunity and conflicts of interest, such conflicts of interest may include deciding
+Added: how much time to devote to our affairs, as well as what business opportunities should be presented to us.
+Added: Alan Weichselbaum, our Chief Financial Officer,
+Added: is not employed by our company on a full-time basis.
+Added: He works on a part-time and as-needed basis.
+Added: Because he does not work full time
+Added: for our company, instances may occur where he may not be immediately available to provide solutions to problems or address concerns that
+Added: arise in the course of us conducting our business and thus adversely affect our business.
+Added: In addition, he can become subject to conflicts
+Added: of interest because he devotes part of her working time to other business endeavors and may have responsibilities to other entities.
+Added: Weichselbaum is aware of his duties and accountability to our company and to applicable laws and policies relating to corporate
+Added: opportunity and conflicts of interest, such conflicts of interest may include deciding how much time to devote to our affairs, as well
+Added: as what business opportunities should be presented to us.
+Added: Conflicts of interest may arise between
+Added: us and MIRALOGX.
+Added: MIRALOGX has a non-provisional patent application
+Added: to the rights to Telomir-1.
+Added: MIRALOGX is a separate intellectual property development company owned by the Bay Shore Trust, which is an
+Added: irrevocable trust established by our founder, Jonnie R.
+Added: Williams, Sr., and in which Brian McNulty is the trustee.
+Added: The Bay Shore Trust
+Added: is also our largest stockholder.
+Added: We have an exclusive license from MIRALOGX to develop and commercialize Telomir-1 in the U.S.
+Added: and non-human applications.
+Added: Although the interests of MIRALOGX are 100% owned by the Bay Shore Trust, and Mr.
+Added: Williams is not an officer
+Added: or director of MIRALOGX and Mr.
+Added: Williams does not have voting or dispositive power over the shares of our company held by Bay Shore Trust,
+Added: our relationship with the Bay Shore Trust, Mr.
+Added: Williams may create, or may create the appearance of, conflicts of interest when we are
+Added: faced with decisions that could have different implications for MIRALOGX than the decisions have for us.
+Added: Furthermore, in light of the
+Added: license agreement that we have with MIRALOGX, if a dispute were to arise between MIRALOGX and us relating to our past or future relationship
+Added: with MIRALOGX or with respect to intellectual property matters, these potential conflicts of interest may make it more difficult for
+Added: us to favorably resolve such disputes.
+Added: Risks Relating to Our Business and Our Industry
+Added: Our future success will largely depend
+Added: on the success of Telomir-1 and any future product candidates, which development will require significant capital resources and years
+Added: of clinical development effort.
+Added: We currently have no drug products on the market,
+Added: and all of our drug development projects are in a pre-clinical stage of development.
+Added: Our business depends almost entirely on the successful
+Added: pre-clinical and clinical development, FDA regulatory approval, and commercialization of our product candidates, principally Telomir-1.
+Added: Our stockholders need to be aware that substantial additional investments including pre-clinical and clinical development and FDA regulatory
+Added: submission and approval efforts will be required before we are permitted to undertake clinical studies and market and commercialize our
+Added: product candidates, if ever.
+Added: It may be several years before we can commence clinical trials, if ever.
+Added: Any clinical trial will be subject
+Added: to extensive and rigorous review and regulation by numerous government authorities in the United States and other jurisdictions where
+Added: we intend, if approved, to market our product candidates.
+Added: Before obtaining regulatory approvals for any of our product candidates, we
+Added: must demonstrate through pre-clinical testing and clinical trials that the product candidate is safe and effective for its specific application.
+Added: This process can take many years and may include post- marketing studies and surveillance, which would require the expenditure of substantial
+Added: Of the large number of drugs in development for approval in the United States (and the rest of the world), only a small percentage
+Added: will successfully complete the FDA regulatory approval financing to fund our planned research, development, and clinical programs, we
+Added: cannot assure you that any of our product candidates will be successfully developed or commercialized.
+Added: We may be unable to formulate or scale up any
+Added: or all of our product candidates.
+Added: There is no guarantee that any of the product candidates will be or are able to be manufactured or
+Added: produced in a manner to meet the FDA’s criteria for product stability, content uniformity and all other criteria necessary for
+Added: product approval in the United States and other markets.
+Added: Any of our product candidates may fail to achieve their specified endpoints
+Added: in clinical trials.
+Added: Furthermore, product candidates may not be approved
+Added: even if they achieve their specified endpoints in clinical trials.
+Added: The FDA may disagree with our trial design and our interpretation
+Added: of data from clinical trials or may change the requirements for approval even after it has reviewed and commented on the design for our
+Added: clinical trials.
+Added: The FDA may also approve a drug for fewer or more limited indications than we request or may grant approval contingent
+Added: on the performance of costly post-approval clinical trials (i.e., Phase IV trials).
+Added: In addition, the FDA may not approve the labeling
+Added: claims that we believe are necessary or desirable for the successful commercialization of our product candidates.
+Added: If we are unable to expand our pipeline and obtain
+Added: regulatory approval for our product candidates within the timelines we anticipate, we will not be able to execute our business strategy
+Added: effectively and our ability to substantially grow our revenues will be limited, which would have a material adverse impact on our long-term
+Added: business, results of operations, financial condition, and prospects.
+Added: We are dependent on our current and future
+Added: product candidates, some of which may not receive regulatory approval or be successfully commercialized.
+Added: Our ability to progress our plan will depend
+Added: on our ability to clinically develop, gain regulatory approval for and ultimately commercialize our product candidates.
+Added: Our ability to
+Added: successfully commercialize our product candidates will depend on, among other things, our ability to:
pre-clinical and other nonclinical studies and clinical trials in a manner that allows us to progress our studies;
7 unchanged sentences
and enforce sufficient intellectual property for our product candidates.
−Removed: failure or delay with respect to any of the factors above could have a material adverse effect on our business, results of operations
−Removed: and financial condition.
−Removed: of pre-clinical studies and earlier clinical trials are not necessarily predictive indicators of future results.
−Removed: positive results from future pre-clinical testing of our product candidates and potential future clinical trials may not necessarily
−Removed: be predictive of the results from Phase I, Phase II or Phase III clinical trials.
−Removed: In addition, our interpretation of results derived
−Removed: from clinical data or our conclusions based on our pre-clinical data may prove inaccurate.
−Removed: Frequently, pharmaceutical and biotechnology
−Removed: companies have suffered significant setbacks in clinical trials after achieving positive results in pre-clinical testing and early phase
−Removed: clinical trials, and we cannot be certain that we will not face similar setbacks.
−Removed: These setbacks may be caused by the fact that pre-clinical
−Removed: and clinical data can be susceptible to varying interpretations and analyses.
−Removed: Furthermore, certain product candidates may perform satisfactorily
−Removed: in pre-clinical studies and clinical trials but nonetheless fail to obtain FDA approval or appropriate approvals by the appropriate regulatory
−Removed: authorities in other countries.
−Removed: If we fail to produce positive results in our clinical trials for our product candidates, the development
−Removed: timeline and regulatory approval and commercialization prospects for them and as a result our business and financial prospects, would
−Removed: be materially adversely affected.
−Removed: have limited marketing experience, and we do not anticipate at this time establishing a sales force or distribution and reimbursement
−Removed: capabilities, and we may not be able to successfully commercialize any of our product candidates if they are approved in the future.
−Removed: ability to generate revenues ultimately depends on our ability to sell our approved products and secure adequate third-party reimbursement.
−Removed: We currently have limited experience in marketing and selling our products.
−Removed: We currently do not have any products approved for sale in
−Removed: the United States or in any other country.
−Removed: commercial success of our product candidates will not happen for the foreseeable future and will depend on a number of factors beyond
−Removed: our control, including the willingness of physicians to prescribe our products to patients, payers’ willingness and ability to
−Removed: pay for the drugs, the level of pricing achieved, patients’ response to our drugs and the ability of our marketing partners to
−Removed: generate sales.
−Removed: There can be no guarantee that we will be able to establish or maintain the personnel, systems, arrangements and capabilities
−Removed: necessary to successfully commercialize Telomir-1 or any product candidate approved by the FDA in the future.
−Removed: If we fail to establish
−Removed: or maintain successful marketing, sales and reimbursement capabilities or fail to enter into successful marketing arrangements with third
−Removed: parties, our product revenues may suffer.
−Removed: will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in managing
−Removed: our growth and executing our growth strategy.
−Removed: management and personnel, systems, and facilities currently in place may not be adequate to support our business plan and future growth.
−Removed: As a result, we may need to further expand certain areas of our organization.
−Removed: need to effectively manage our operations, growth and various projects requires that we:
+Added: Our failure or delay with respect to any of the
+Added: factors above could have a material adverse effect on our business, results of operations and financial condition.
+Added: Results of pre-clinical studies and earlier
+Added: clinical trials are not necessarily predictive indicators of future results.
+Added: Any positive results from future pre-clinical
+Added: testing of our product candidates and potential future clinical trials may not necessarily be predictive of the results from Phase I,
+Added: Phase II or Phase III clinical trials.
+Added: In addition, our interpretation of results derived from clinical data or our conclusions based
+Added: on our pre-clinical data may prove inaccurate.
+Added: Frequently, pharmaceutical and biotechnology companies have suffered significant setbacks
+Added: in clinical trials after achieving positive results in pre-clinical testing and early phase clinical trials, and we cannot be certain
+Added: that we will not face similar setbacks.
+Added: These setbacks may be caused by the fact that pre-clinical and clinical data can be susceptible
+Added: to varying interpretations and analyses.
+Added: Furthermore, certain product candidates may perform satisfactorily in pre-clinical studies and
+Added: clinical trials but nonetheless fail to obtain FDA approval or appropriate approvals by the appropriate regulatory authorities in other
+Added: If we fail to produce positive results in our clinical trials for our product candidates, the development timeline and regulatory
+Added: approval and commercialization prospects for them and as a result our business and financial prospects, would be materially adversely
+Added: We have limited marketing experience, and
+Added: we do not anticipate at this time establishing a sales force or distribution and reimbursement capabilities, and we may not be able to
+Added: successfully commercialize any of our product candidates if they are approved in the future.
+Added: Our ability to generate revenues ultimately depends
+Added: on our ability to sell our approved products and secure adequate third-party reimbursement.
+Added: We currently have limited experience in marketing
+Added: and selling our products.
+Added: We currently do not have any products approved for sale in the United States or in any other country.
+Added: The commercial success of our product candidates
+Added: will not happen for the foreseeable future and will depend on a number of factors beyond our control, including the willingness of physicians
+Added: to prescribe our products to patients, payers’ willingness and ability to pay for the drugs, the level of pricing achieved, patients’
+Added: response to our drugs and the ability of our marketing partners to generate sales.
+Added: There can be no guarantee that we will be able to
+Added: establish or maintain the personnel, systems, arrangements and capabilities necessary to successfully commercialize Telomir-1 or any
+Added: product candidate approved by the FDA in the future.
+Added: If we fail to establish or maintain successful marketing, sales and reimbursement
+Added: capabilities or fail to enter into successful marketing arrangements with third parties, our product revenues may suffer.
+Added: We will need to further increase the size
+Added: and complexity of our organization in the future, and we may experience difficulties in managing our growth and executing our growth
+Added: Our management and personnel, systems, and facilities
+Added: currently in place may not be adequate to support our business plan and future growth.
+Added: As a result, we may need to further expand certain
+Added: areas of our organization.
+Added: Our need to effectively manage our operations,
+Added: growth and various projects requires that we:
to improve our operational, financial, management and regulatory compliance controls and reporting systems and procedures;
3 unchanged sentences
our development efforts effectively while carrying out our contractual obligations to contractors and other third parties;
−Removed: addition, we may utilize the services of part-time outside consultants and contractors to perform several tasks for us, including tasks
−Removed: related to compliance programs, clinical trial management, regulatory affairs, formulation development and other drug development functions.
−Removed: Our growth strategy may entail expanding our use of consultants and contractors to implement these and other tasks going forward.
−Removed: we are not able to effectively expand our organization by hiring new employees and expanding our use of consultants and contractors,
−Removed: we may be unable to successfully implement the tasks necessary to effectively execute on our planned research, development, manufacturing,
−Removed: and commercialization activities and, accordingly, may not achieve our research, development and commercialization goals.
−Removed: expect to face intense competition, often from companies with greater resources and experience than we have.
−Removed: development and commercialization of drugs and medicines is highly competitive.
−Removed: We compete with a variety of multinational pharmaceutical
−Removed: companies and specialized biotechnology companies, as well as products and processes being developed by universities and other research
−Removed: institutions.
−Removed: Many of our competitors have developed, are developing, or will develop drugs and processes which may be competitive with
−Removed: our drug candidates.
−Removed: Competitive products include those that have already been approved by medicines regulators and accepted by the medical
−Removed: community and any new products that may enter the market.
−Removed: For some of our drug development programs / areas of interest, other treatment
−Removed: options or products are currently available, under development, and may become commercially available in the future.
−Removed: If any of our product
−Removed: candidates are approved for the diseases and conditions we are currently pursuing, they may compete with a range of medicines or therapeutic
−Removed: treatments that are either in development, will be developed in the future or currently marketed.
−Removed: companies may have a competitive advantage over us due to their size and experiences, financial resources, and institutional networks.
−Removed: Many of our competitors may have significantly greater financial, technical, and human resources than we do.
−Removed: Due to these factors, our
−Removed: competitors may have an advantage in marketing their approved drugs and may obtain regulatory approval of their drug candidates before
−Removed: we are able to, which may limit our ability to develop or commercialize our drug candidates.
−Removed: Our competitors may also develop drugs or
−Removed: medicines that are safer, more effective, more widely used and less expensive than ours.
−Removed: These advantages could materially impact our
−Removed: ability to develop and, if approved, commercialize our product candidates successfully.
−Removed: Furthermore, some of these competitors may make
−Removed: acquisitions or establish collaborative relationships among themselves or with third parties to increase their ability to rapidly gain
−Removed: market share.
−Removed: interruptions could delay us in the process of developing our product candidates and could disrupt our product sales.
−Removed: research and development activities are conducted through outside contractors and manufacturers.
−Removed: Loss of our contracted manufacturing
−Removed: facilities, stored inventory or laboratory facilities through fire, theft or other causes, or loss of our raw material, could have an
−Removed: adverse effect on our ability to continue product development activities and to conduct our business.
−Removed: Failure to supply our partners
−Removed: with commercial product may lead to adverse consequences, including the right of partners to take over responsibility for product supply.
−Removed: We currently do not have insurance coverage to compensate us for such business interruptions.
−Removed: Our contract manufacturers and suppliers
−Removed: provide that in their separate operations;
−Removed: however, such coverage may prove insufficient to fully compensate us for the damage to our
−Removed: business resulting from any significant property or casualty loss to those facilities.
−Removed: have significant and increasing liquidity needs and may require additional funding.
−Removed: operations have consumed substantial amounts of cash since inception.
−Removed: For the year ended December 31, 2024, we reported a net operating
−Removed: cash outflow of $5.1 million and a net cash inflow from financing activities of $6.3 million.
−Removed: For the year ended December 31, 2023, we
−Removed: reported a net operating cash outflow of $3.9 million and a net cash inflow from financing activities of $3.9 million.
−Removed: and development, and general and administrative expenses, and cash used for operations will continue to be significant and may increase
−Removed: substantially in the future in connection with new research and development initiatives and continued product commercialization efforts.
−Removed: We may need to raise additional capital to fund our operations, continue to conduct clinical trials to support potential regulatory approval
−Removed: of marketing applications and to fund commercialization of our products.
−Removed: amount and timing of our future funding requirements will depend on many factors, including, but not limited to:
+Added: In addition, we may utilize the services of part-time
+Added: outside consultants and contractors to perform several tasks for us, including tasks related to compliance programs, clinical trial management,
+Added: regulatory affairs, formulation development and other drug development functions.
+Added: Our growth strategy may entail expanding our use of
+Added: consultants and contractors to implement these and other tasks going forward.
+Added: If we are not able to effectively expand our organization
+Added: by hiring new employees and expanding our use of consultants and contractors, we may be unable to successfully implement the tasks necessary
+Added: to effectively execute on our planned research, development, manufacturing, and commercialization activities and, accordingly, may not
+Added: achieve our research, development and commercialization goals.
+Added: We expect to face intense competition,
+Added: often from companies with greater resources and experience than we have.
+Added: The development and commercialization of drugs
+Added: and medicines is highly competitive.
+Added: We compete with a variety of multinational pharmaceutical companies and specialized biotechnology
+Added: companies, as well as products and processes being developed by universities and other research institutions.
+Added: Many of our competitors
+Added: have developed, are developing, or will develop drugs and processes which may be competitive with our drug candidates.
+Added: Competitive products
+Added: include those that have already been approved by medicines regulators and accepted by the medical community and any new products that
+Added: may enter the market.
+Added: For some of our drug development programs / areas of interest, other treatment options or products are currently
+Added: available, under development, and may become commercially available in the future.
+Added: If any of our product candidates are approved for
+Added: the diseases and conditions we are currently pursuing, they may compete with a range of medicines or therapeutic treatments that are
+Added: either in development, will be developed in the future or currently marketed.
+Added: Established companies may have a competitive
+Added: advantage over us due to their size and experiences, financial resources, and institutional networks.
+Added: Many of our competitors may have
+Added: significantly greater financial, technical, and human resources than we do.
+Added: Due to these factors, our competitors may have an advantage
+Added: in marketing their approved drugs and may obtain regulatory approval of their drug candidates before we are able to, which may limit
+Added: our ability to develop or commercialize our drug candidates.
+Added: Our competitors may also develop drugs or medicines that are safer, more
+Added: effective, more widely used and less expensive than ours.
+Added: These advantages could materially impact our ability to develop and, if approved,
+Added: commercialize our product candidates successfully.
+Added: Furthermore, some of these competitors may make acquisitions or establish collaborative
+Added: relationships among themselves or with third parties to increase their ability to rapidly gain market share.
+Added: Business interruptions could delay us in
+Added: the process of developing our product candidates and could disrupt our product sales.
+Added: Our research and development activities are conducted
+Added: through outside contractors and manufacturers.
+Added: Loss of our contracted manufacturing facilities, stored inventory or laboratory facilities
+Added: through fire, theft or other causes, or loss of our raw material, could have an adverse effect on our ability to continue product development
+Added: activities and to conduct our business.
+Added: Failure to supply our partners with commercial product may lead to adverse consequences, including
+Added: the right of partners to take over responsibility for product supply.
+Added: We currently do not have insurance coverage to compensate us for
+Added: such business interruptions.
+Added: Our contract manufacturers and suppliers provide that in their separate operations;
+Added: however, such coverage
+Added: may prove insufficient to fully compensate us for the damage to our business resulting from any significant property or casualty loss
+Added: to those facilities.
+Added: We have significant and increasing liquidity
+Added: needs and may require additional funding.
+Added: Our operations have consumed substantial amounts
+Added: of cash since inception.
+Added: For the year ended December 31, 2025, we reported a net operating cash outflow of $3.7 million and a net cash
+Added: inflow from financing activities of $9.7 million.
+Added: For the year ended December 31, 2024, we reported a net operating cash outflow of $5.1
+Added: million and a net cash inflow from financing activities of $6.3 million.
+Added: Research and development, and general and administrative
+Added: expenses, and cash used for operations will continue to be significant and may increase substantially in the future in connection with
+Added: new research and development initiatives and continued product commercialization efforts.
+Added: We may need to raise additional capital to
+Added: fund our operations, continue to conduct clinical trials to support potential regulatory approval of marketing applications and to fund
+Added: commercialization of our products.
+Added: The amount and timing of our future funding requirements
+Added: will depend on many factors, including, but not limited to:
timing of FDA approval, if any, and approvals in international markets of our product candidates, if at all;
8 unchanged sentences
terms and timing of any additional collaborative, licensing, co-promotion, or other arrangements that we may establish.
−Removed: we expect to fund our future capital requirements from several sources including existing cash balances, future cash flows from operations
−Removed: and the proceeds from equity offerings, we cannot assure you that any of these funding sources will be available to us on favorable terms,
−Removed: Further, even if we can raise funds from all of the above sources, the amounts raised may not be sufficient to meet our future
−Removed: capital requirements.
−Removed: results may vary significantly in future periods.
−Removed: expenses and operating results have fluctuated in the past and our revenues, expenses, and operating results are likely to fluctuate
−Removed: significantly in the future.
−Removed: Our financial results are unpredictable and may fluctuate, for among other reasons, due to:
+Added: While we expect to fund our future capital requirements
+Added: from several sources including existing cash balances, future cash flows from operations and the proceeds from equity offerings, we cannot
+Added: assure you that any of these funding sources will be available to us on favorable terms, or at all.
+Added: Further, even if we can raise funds
+Added: from all of the above sources, the amounts raised may not be sufficient to meet our future capital requirements.
+Added: Operating results may vary significantly
+Added: in future periods.
+Added: Our expenses and operating results have fluctuated
+Added: in the past and our revenues, expenses, and operating results are likely to fluctuate significantly in the future.
+Added: Our financial results
+Added: are unpredictable and may fluctuate, for among other reasons, due to:
sales of our products;
8 unchanged sentences
price to decline.
−Removed: depend upon our key personnel and our ability to attract and retain employees.
−Removed: future growth and success depend on our ability to recruit, retain, manage, and motivate our employees.
−Removed: The inability to hire or retain
−Removed: experienced management personnel could adversely affect our ability to execute our business plan and harm our operating results.
−Removed: to the specialized scientific and managerial nature of our business, we rely heavily on our ability to attract and retain qualified scientific,
−Removed: technical, and managerial personnel.
−Removed: The competition for qualified personnel in the pharmaceutical field is intense.
−Removed: Due to this intense
−Removed: competition, we may be unable to continue to attract and retain the qualified personnel necessary for the development of our business
−Removed: or to recruit suitable replacement personnel.
−Removed: proprietary information, or that of our customers, suppliers, and business partners, may be lost or we may suffer security breaches.
−Removed: the ordinary course of our business, we will collect and store sensitive data, including valuable and commercially sensitive intellectual
−Removed: property, clinical trial data, our proprietary business information and that of our customers, suppliers and business partners, and personally
−Removed: identifiable information of our customers, clinical trial subjects and employees, and patients, on our networks, and with our third-party
−Removed: cloud service providers.
−Removed: The secure processing, maintenance and transmission of this information is critical to our operations.
−Removed: our security measures, our information technology and infrastructure, and that of our third parties, may be vulnerable to attacks by
−Removed: hackers or breached due to employee error, malfeasance, or other disruptions.
−Removed: Any breach could compromise our networks and the information
−Removed: stored there could be accessed, publicly disclosed, lost, or stolen.
−Removed: Any such access, disclosure or other loss of information could result
−Removed: in legal claims or proceedings, liability under laws that protect the privacy of personal information, regulatory penalties, disrupt
−Removed: our operations, damage our reputation, and cause a loss of confidence in our products and our ability to conduct clinical trials, which
−Removed: could adversely affect our business and reputation and lead to delays in gaining regulatory approvals for Telomir-1 or other product
−Removed: of our information technology systems, including cybersecurity attacks or other data security incidents, could significantly disrupt
−Removed: the operation of our business.
−Removed: business is increasingly dependent on critical, complex, and interdependent information technology (“IT”) systems, including
−Removed: internet-based systems, some of which are managed or hosted by third parties, to support business processes as well as internal and external
−Removed: communications.
−Removed: The size and complexity of our IT systems make us potentially vulnerable to IT system breakdowns, malicious intrusion,
−Removed: and computer viruses, which may result in the impairment of our ability to operate our business effectively.
−Removed: are continuously evaluating and, where appropriate, enhancing our IT systems to address our planned growth, including to support our
−Removed: planned manufacturing operations.
−Removed: There are inherent costs and risks associated with implementing the enhancements to our IT systems,
−Removed: including potential delays in access to, or errors in, critical business and financial information, substantial capital expenditures,
−Removed: additional administrative time and operating expenses, retention of sufficiently skilled personnel to implement and operate the enhanced
−Removed: systems, demands on management time, and costs of delays or difficulties in transitioning to the enhanced systems, any of which could
−Removed: harm our business and results of operations.
−Removed: In addition, the implementation of enhancements to our IT systems may not result in productivity
−Removed: improvements to a level that outweighs the costs of implementation, or at all.
−Removed: In addition, our systems and the systems of our third-party
−Removed: providers and collaborators are potentially vulnerable to data security breaches which may expose sensitive data to unauthorized persons
−Removed: or to the public.
−Removed: Such data security breaches could lead to the loss of confidential information, trade secrets or other intellectual
−Removed: property, could lead to the public exposure of personal information (including personally identifiable information or individually identifiable
−Removed: health information) of our employees, clinical trial patients, customers, business partners, and others, could lead to potential identity
−Removed: theft, or could lead to reputational harm.
−Removed: Data security breaches could also result in loss of clinical trial data or damage to the integrity
−Removed: of that data.
−Removed: In addition, the increased use of social media by our employees and contractors could result in inadvertent disclosure
−Removed: of sensitive data or personal information, including but not limited to, confidential information, trade secrets and other intellectual
+Added: We depend upon our key personnel and our
+Added: ability to attract and retain employees.
+Added: Our future growth and success depend on our ability
+Added: to recruit, retain, manage, and motivate our employees.
+Added: The inability to hire or retain experienced management personnel could adversely
+Added: affect our ability to execute our business plan and harm our operating results.
+Added: Due to the specialized scientific and managerial nature
+Added: of our business, we rely heavily on our ability to attract and retain qualified scientific, technical, and managerial personnel.
+Added: competition for qualified personnel in the pharmaceutical field is intense.
+Added: Due to this intense competition, we may be unable to continue
+Added: to attract and retain the qualified personnel necessary for the development of our business or to recruit suitable replacement personnel.
+Added: Our proprietary information, or that of
+Added: our customers, suppliers, and business partners, may be lost or we may suffer security breaches.
+Added: In the ordinary course of our business, we will
+Added: collect and store sensitive data, including valuable and commercially sensitive intellectual property, clinical trial data, our proprietary
+Added: business information and that of our customers, suppliers and business partners, and personally identifiable information of our customers,
+Added: clinical trial subjects and employees, and patients, on our networks, and with our third-party cloud service providers.
+Added: The secure processing,
+Added: maintenance and transmission of this information is critical to our operations.
+Added: Despite our security measures, our information technology
+Added: and infrastructure, and that of our third parties, may be vulnerable to attacks by hackers or breached due to employee error, malfeasance,
+Added: or other disruptions.
+Added: Any breach could compromise our networks and the information stored there could be accessed, publicly disclosed,
+Added: lost, or stolen.
+Added: Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under
+Added: laws that protect the privacy of personal information, regulatory penalties, disrupt our operations, damage our reputation, and cause
+Added: a loss of confidence in our products and our ability to conduct clinical trials, which could adversely affect our business and reputation
+Added: and lead to delays in gaining regulatory approvals for Telomir-1 or other product candidates.
+Added: Failure of our information technology systems,
+Added: including cybersecurity attacks or other data security incidents, could significantly disrupt the operation of our business.
+Added: Our business is increasingly dependent on critical,
+Added: complex, and interdependent information technology (“IT”) systems, including internet-based systems, some of which are managed
+Added: or hosted by third parties, to support business processes as well as internal and external communications.
+Added: The size and complexity of
+Added: our IT systems make us potentially vulnerable to IT system breakdowns, malicious intrusion, and computer viruses, which may result in
+Added: the impairment of our ability to operate our business effectively.
+Added: We are continuously evaluating and, where appropriate,
+Added: enhancing our IT systems to address our planned growth, including to support our planned manufacturing operations.
+Added: There are inherent
+Added: costs and risks associated with implementing the enhancements to our IT systems, including potential delays in access to, or errors in,
+Added: critical business and financial information, substantial capital expenditures, additional administrative time and operating expenses,
+Added: retention of sufficiently skilled personnel to implement and operate the enhanced systems, demands on management time, and costs of delays
+Added: or difficulties in transitioning to the enhanced systems, any of which could harm our business and results of operations.
+Added: the implementation of enhancements to our IT systems may not result in productivity improvements to a level that outweighs the costs
+Added: of implementation, or at all.
+Added: In addition, our systems and the systems of our third-party providers and collaborators are potentially
+Added: vulnerable to data security breaches which may expose sensitive data to unauthorized persons or to the public.
+Added: Such data security breaches
+Added: could lead to the loss of confidential information, trade secrets or other intellectual property, could lead to the public exposure of
+Added: personal information (including personally identifiable information or individually identifiable health information) of our employees,
+Added: clinical trial patients, customers, business partners, and others, could lead to potential identity theft, or could lead to reputational
+Added: Data security breaches could also result in loss of clinical trial data or damage to the integrity of that data.
+Added: In addition, the
+Added: increased use of social media by our employees and contractors could result in inadvertent disclosure of sensitive data or personal information,
+Added: including but not limited to, confidential information, trade secrets and other intellectual property.
such disruption or security breach, as well as any action by us or our employees or contractors that might be inconsistent with the rapidly
9 unchanged sentences
threats, our measures to prevent, respond to and minimize such risks may be unsuccessful.
−Removed: breaches, loss of data and other disruptions could compromise sensitive information related to our business, prevent us from accessing
−Removed: critical information or expose us to liability, which could adversely affect our business and our reputation.
−Removed: the ordinary course of our business, we, our vendors, and our third-party cloud service providers may collect and store sensitive data,
−Removed: including legally protected patient health information, credit card information, personally identifiable information about our employees
−Removed: and patients, intellectual property, and proprietary business information.
−Removed: We manage and maintain our applications and data utilizing
−Removed: cloud-based and on-site systems.
−Removed: These applications and data encompass a wide variety of business-critical information including research
−Removed: and development information, commercial information and business and financial information.
−Removed: secure processing, storage, maintenance, and transmission of this critical information is vital to our operations and business strategy,
−Removed: and we devote significant resources to protecting such information.
−Removed: Although we take measures to protect sensitive information from unauthorized
−Removed: access or disclosure, our information technology and infrastructure may be vulnerable to attacks by hackers, or viruses, breaches, or
−Removed: interruptions due to employee error, malfeasance or other disruptions, or lapses in compliance with privacy and security mandates.
−Removed: such virus, breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized parties,
−Removed: publicly disclosed, lost or stolen.
−Removed: We have measures in place that are designed to prevent, and if necessary to detect and respond to
−Removed: such security incidents, breaches of privacy, and security mandates.
−Removed: However, in the future, any such access, disclosure or other loss
−Removed: of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, such
−Removed: as HIPAA in the United States and the General Data Protection Regulation in the European Union, or GDPR, government enforcement actions
−Removed: and regulatory penalties.
−Removed: Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to process
−Removed: samples, provide test results, share and monitor safety data, bill payers or patients, provide customer support services, conduct research
−Removed: and development activities, process and prepare company financial information, manage various general and administrative aspects of our
−Removed: business and may damage our reputation, any of which could adversely affect our business, financial condition and results of operations.
−Removed: events and global economic conditions, such as the Israel-Hamas war may impact the third parties that we engage to supply materials or
−Removed: manufacture any products for our preclinical tests and clinical trials, which increases the risk of potential delay of development efforts,
−Removed: as applicable.
−Removed: the third parties that we engage to supply any materials or manufacture any products for our preclinical tests and clinical trials should
−Removed: cease to continue to do so for any reason, including due to the effects of global economic conditions, including the Hamas-Israel war,
−Removed: we likely would experience delays in advancing these tests and trials while we identify and qualify replacement suppliers or manufacturers,
−Removed: as applicable, and we may be unable to obtain replacement supplies on terms that are favorable to us.
−Removed: In addition, if we are not able
−Removed: to obtain adequate supplies of our product, or the substances used to manufacture them, it will be more difficult for us to develop our
−Removed: product and compete effectively.
+Added: Security breaches, loss of data and other
+Added: disruptions could compromise sensitive information related to our business, prevent us from accessing critical information or expose
+Added: us to liability, which could adversely affect our business and our reputation.
+Added: In the ordinary course of our business, we, our
+Added: vendors, and our third-party cloud service providers may collect and store sensitive data, including legally protected patient health
+Added: information, credit card information, personally identifiable information about our employees and patients, intellectual property, and
+Added: proprietary business information.
+Added: We manage and maintain our applications and data utilizing cloud-based and on-site systems.
+Added: These applications
+Added: and data encompass a wide variety of business-critical information including research and development information, commercial information
+Added: and business and financial information.
+Added: The secure processing, storage, maintenance,
+Added: and transmission of this critical information is vital to our operations and business strategy, and we devote significant resources to
+Added: protecting such information.
+Added: Although we take measures to protect sensitive information from unauthorized access or disclosure, our information
+Added: technology and infrastructure may be vulnerable to attacks by hackers, or viruses, breaches, or interruptions due to employee error,
+Added: malfeasance or other disruptions, or lapses in compliance with privacy and security mandates.
+Added: Any such virus, breach or interruption
+Added: could compromise our networks and the information stored there could be accessed by unauthorized parties, publicly disclosed, lost or
+Added: We have measures in place that are designed to prevent, and if necessary to detect and respond to such security incidents, breaches
+Added: of privacy, and security mandates.
+Added: However, in the future, any such access, disclosure or other loss of information could result in legal
+Added: claims or proceedings, liability under laws that protect the privacy of personal information, such as HIPAA in the United States and
+Added: the General Data Protection Regulation in the European Union, or GDPR, government enforcement actions and regulatory penalties.
+Added: access, loss or dissemination could also disrupt our operations, including our ability to process samples, provide test results, share
+Added: and monitor safety data, bill payers or patients, provide customer support services, conduct research and development activities, process
+Added: and prepare company financial information, manage various general and administrative aspects of our business and may damage our reputation,
+Added: any of which could adversely affect our business, financial condition and results of operations.
+Added: Geopolitical events and global economic
+Added: conditions, such as the Israel-Hamas war may impact the third parties that we engage to supply materials or manufacture any products
+Added: for our preclinical tests and clinical trials, which increases the risk of potential delay of development efforts, as applicable.
+Added: If the third parties that we engage to supply
+Added: any materials or manufacture any products for our preclinical tests and clinical trials should cease to continue to do so for any reason,
+Added: including due to the effects of global economic conditions, including the Hamas-Israel war, we likely would experience delays in advancing
+Added: these tests and trials while we identify and qualify replacement suppliers or manufacturers, as applicable, and we may be unable to obtain
+Added: replacement supplies on terms that are favorable to us.
+Added: In addition, if we are not able to obtain adequate supplies of our product, or
+Added: the substances used to manufacture them, it will be more difficult for us to develop our product and compete effectively.
current and anticipated dependence upon third-party suppliers may adversely affect our ability to develop our product, and product candidates
1 unchanged sentence
such dependence may increase our costs and expenses, and may otherwise harm our operations and financial condition
−Removed: Related to Development and Regulatory Approval of Our Product Candidates
−Removed: trials for our product candidates are expensive, time-consuming, uncertain, and susceptible to change, delay or termination.
−Removed: of clinical trials are open to differing interpretations.
−Removed: trials are expensive, time consuming and difficult to design and implement.
−Removed: Regulatory agencies may analyze or interpret the results
−Removed: differently than us.
−Removed: Even if the results of our clinical trials are favorable, the clinical trials for a number of our product candidates
−Removed: are expected to continue for several years and may take significantly longer to complete.
−Removed: In addition, we, the FDA, or other regulatory
−Removed: authorities, including state and local authorities, or an Institutional Review Board, or IRB, with respect to a trial at its institution,
−Removed: may suspend, delay or terminate our clinical trials at any time, require us to conduct additional clinical trials, require a particular
−Removed: clinical trial to continue for a longer duration than originally planned, require a change to our development plans such that we conduct
−Removed: clinical trials for a product candidate in a different order, e.g., in a step-wise fashion rather than running two trials of the same
−Removed: product candidate in parallel.
+Added: Risks Related to Development and Regulatory
+Added: Approval of Our Product Candidates
+Added: Clinical trials for our product candidates
+Added: are expensive, time-consuming, uncertain, and susceptible to change, delay or termination.
+Added: The results of clinical trials are open to
+Added: differing interpretations.
+Added: Clinical trials are expensive, time consuming
+Added: and difficult to design and implement.
+Added: Regulatory agencies may analyze or interpret the results differently than us.
+Added: Even if the results
+Added: of our clinical trials are favorable, the clinical trials for a number of our product candidates are expected to continue for several
+Added: years and may take significantly longer to complete.
+Added: In addition, we, the FDA, or other regulatory authorities, including state and local
+Added: authorities, or an Institutional Review Board, or IRB, with respect to a trial at its institution, may suspend, delay or terminate our
+Added: clinical trials at any time, require us to conduct additional clinical trials, require a particular clinical trial to continue for a
+Added: longer duration than originally planned, require a change to our development plans such that we conduct clinical trials for a product
+Added: candidate in a different order, e.g., in a step-wise fashion rather than running two trials of the same product candidate in parallel.
The suspension, delay or termination could be for various reasons, including:
23 unchanged sentences
in maintaining contact with patients during or after treatment, which may result in incomplete data.
−Removed: of the foregoing could have a material adverse effect on our business, results of operations and financial condition.
−Removed: failure by us to comply with existing regulations could harm our reputation and operating results.
−Removed: are subject to extensive regulation by U.S.
−Removed: federal and state governments in each of the markets where we have product candidates progressing
−Removed: through the approval process.
−Removed: must also adhere to all regulatory requirements including FDA’s Good Laboratory Practice, Good Clinical Practice, and current Good
−Removed: Manufacturing Practices requirements (“cGMP”) pharmacovigilance requirements, advertising, and promotion restrictions, reporting
−Removed: and recordkeeping requirements.
−Removed: If we or our suppliers fail to comply with applicable regulations, including FDA pre-or post-approval
−Removed: cGMP requirements, then FDA could sanction us.
−Removed: Even if a drug is FDA-approved, regulatory authorities may impose significant restrictions
−Removed: on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-marketing trials.
−Removed: and any of our product candidates that may be approved in the U.S.
−Removed: in the future, will be subject to ongoing regulatory requirements
−Removed: for manufacturing, labeling, packaging, storage, distribution, import, export, advertising, promotion, sampling, recordkeeping and submission
−Removed: of safety and other post-market information, including both federal and state requirements in the U.S.
−Removed: In addition, manufacturers and
−Removed: manufacturers’ facilities are required to comply with extensive FDA requirements, including ensuring that quality control and manufacturing
−Removed: procedures conform to GMP.
−Removed: As such, we, and our contract manufacturers (in the event contract manufacturers are appointed in the future)
−Removed: are subject to continual review and periodic inspections to assess compliance with GMP.
−Removed: Accordingly, we and others with whom we work
−Removed: must continue to spend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, quality control
−Removed: and quality assurance.
−Removed: We will also be required to report certain adverse reactions and production problems, if any, to the FDA, and
−Removed: to comply with requirements concerning advertising and promotion for our products.
−Removed: Promotional communications with respect to prescription
−Removed: drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s
−Removed: approved label.
−Removed: a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency,
−Removed: or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of the product,
−Removed: it may impose restrictions on that product or us, including requiring withdrawal of the product from the market.
−Removed: If we fail to comply
−Removed: with applicable regulatory requirements, a regulatory agency or enforcement authority may:
+Added: Any of the foregoing could have a material adverse
+Added: effect on our business, results of operations and financial condition.
+Added: Any failure by us to comply with existing
+Added: regulations could harm our reputation and operating results.
+Added: We are subject to extensive regulation by U.S.
+Added: federal and state governments in each of the markets where we have product candidates progressing through the approval process.
+Added: We must also adhere to all regulatory requirements
+Added: including FDA’s Good Laboratory Practice, Good Clinical Practice, and current Good Manufacturing Practices requirements (“cGMP”)
+Added: pharmacovigilance requirements, advertising, and promotion restrictions, reporting and recordkeeping requirements.
+Added: If we or our suppliers
+Added: fail to comply with applicable regulations, including FDA pre-or post-approval cGMP requirements, then FDA could sanction us.
+Added: a drug is FDA-approved, regulatory authorities may impose significant restrictions on a product’s indicated uses or marketing or
+Added: impose ongoing requirements for potentially costly post-marketing trials.
+Added: Telomir-1, and any of our product candidates that may be approved
+Added: in the future, will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, distribution,
+Added: import, export, advertising, promotion, sampling, recordkeeping and submission of safety and other post-market information, including
+Added: both federal and state requirements in the U.S.
+Added: In addition, manufacturers and manufacturers’ facilities are required to comply
+Added: with extensive FDA requirements, including ensuring that quality control and manufacturing procedures conform to GMP.
+Added: As such, we, and
+Added: our contract manufacturers (in the event contract manufacturers are appointed in the future) are subject to continual review and periodic
+Added: inspections to assess compliance with GMP.
+Added: Accordingly, we and others with whom we work must continue to spend time, money, and effort
+Added: in all areas of regulatory compliance, including manufacturing, production, quality control and quality assurance.
+Added: We will also be required
+Added: to report certain adverse reactions and production problems, if any, to the FDA, and to comply with requirements concerning advertising
+Added: and promotion for our products.
+Added: Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory
+Added: restrictions and must be consistent with the information in the product’s approved label.
+Added: If a regulatory agency discovers previously unknown
+Added: problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product
+Added: is manufactured, or disagrees with the promotion, marketing or labeling of the product, it may impose restrictions on that product or
+Added: us, including requiring withdrawal of the product from the market.
+Added: If we fail to comply with applicable regulatory requirements, a regulatory
+Added: agency or enforcement authority may:
untitled or warning letters;
13 unchanged sentences
is withdrawn, the value of our business and our operating results may be adversely affected.
−Removed: action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses,
−Removed: divert our management’s attention from the operation of our business and damage our reputation.
−Removed: We expend significant resources
−Removed: on compliance efforts and such expenses are unpredictable and might adversely affect our results.
−Removed: Changing laws, regulations and standards
−Removed: might also create uncertainty, higher expenses and increase insurance costs.
−Removed: As a result, we intend to invest all reasonably necessary
−Removed: resources to comply with evolving standards, and this investment might result in increased management and administrative expenses and
−Removed: a diversion of management time and attention from revenue-generating activities to compliance activities.
−Removed: regulatory approval processes with the FDA are lengthy and inherently unpredictable.
−Removed: are not permitted to market our drug candidates as medicines in the United States or other countries until we receive approval of a New
−Removed: Drug Application (“NDA”) from the FDA or in any foreign countries until we receive the approval from the regulatory authorities
−Removed: of such countries.
−Removed: Prior to submitting an NDA to the FDA for approval of our drug candidates we will need to have completed our pre-clinical
−Removed: studies and clinical trials and demonstrate that our products meet all applicable standards of identity, strength, quality, and purity
−Removed: throughout their expiration date.
−Removed: Successfully completing any clinical program and obtaining approval of an NDA is a complex, lengthy,
−Removed: expensive, and uncertain process, and the FDA (or other country medicines regulatory body) may delay, limit, or deny approval of product
−Removed: candidates for many reasons, including, among others, because:
+Added: Any action against us for violation of these
+Added: laws, even if we successfully defend against it, could cause us to incur significant legal expenses, divert our management’s attention
+Added: from the operation of our business and damage our reputation.
+Added: We expend significant resources on compliance efforts and such expenses
+Added: are unpredictable and might adversely affect our results.
+Added: Changing laws, regulations and standards might also create uncertainty, higher
+Added: expenses and increase insurance costs.
+Added: As a result, we intend to invest all reasonably necessary resources to comply with evolving standards,
+Added: and this investment might result in increased management and administrative expenses and a diversion of management time and attention
+Added: from revenue-generating activities to compliance activities.
+Added: The regulatory approval processes with
+Added: the FDA are lengthy and inherently unpredictable.
+Added: We are not permitted to market our drug candidates
+Added: as medicines in the United States or other countries until we receive approval of a New Drug Application (“NDA”) from the
+Added: FDA or in any foreign countries until we receive the approval from the regulatory authorities of such countries.
+Added: Prior to submitting
+Added: an NDA to the FDA for approval of our drug candidates we will need to have completed our pre-clinical studies and clinical trials and
+Added: demonstrate that our products meet all applicable standards of identity, strength, quality, and purity throughout their expiration date.
+Added: Successfully completing any clinical program and obtaining approval of an NDA is a complex, lengthy, expensive, and uncertain process,
+Added: and the FDA (or other country medicines regulatory body) may delay, limit, or deny approval of product candidates for many reasons, including,
+Added: among others, because:
inability to demonstrate that our product candidates are safe and effective in treating patients to the satisfaction of the FDA;
10 unchanged sentences
regulatory approval for our drug candidates.
−Removed: is a high rate of failure for drug candidates proceeding through clinical trials.
−Removed: there is a high rate of failure for drug candidates proceeding through clinical trials.
−Removed: We may suffer significant setbacks in our clinical
−Removed: trials similar to the experience of a number of other companies in the pharmaceutical and biotechnology industries, even after receiving
−Removed: promising results in earlier trials.
−Removed: Further, even if we view the results of a clinical trial to be positive, FDA may disagree with our
−Removed: interpretation of the data.
−Removed: In the event that we obtain negative results from clinical trials for product candidates or other problems
−Removed: related to potential chemistry, manufacturing and control issues or other hurdles occur and our product candidates are not approved,
−Removed: we may not be able to generate sufficient revenue or obtain financing to continue our operations, our ability to execute on our current
−Removed: business plan may be materially impaired, our reputation in the industry and in the investment community might be significantly damaged
−Removed: and the price of our common stock could decrease significantly.
−Removed: In addition, our inability to properly design, commence and complete
−Removed: clinical trials may negatively impact the timing and results of our clinical trials and ability to seek approvals for our drug candidates.
−Removed: we are found in violation of federal or state “fraud and abuse” laws, we may be required to pay a penalty and/or be suspended
−Removed: from participation in federal or state health care programs, which may adversely affect our business, financial condition, and results
−Removed: of operations.
−Removed: the United States, we are subject to various federal and state health care “fraud and abuse” laws, including anti-kickback
−Removed: laws, false claims laws and other laws intended to reduce fraud and abuse in federal and state health care programs, which could affect
−Removed: us particularly upon successful commercialization of our products in the U.S.
−Removed: The Medicare and Medicaid Patient Protection Act of 1987,
−Removed: or federal Anti-Kickback Statute, makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its
−Removed: behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration that is intended to induce the referral of business,
−Removed: including the purchase, order or prescription of a particular drug for which payment may be made under a federal health care program,
−Removed: such as Medicare or Medicaid.
−Removed: Under federal law, some arrangements, known as safe harbors, are deemed not to violate the federal Anti-Kickback
−Removed: Although we seek to structure our business arrangements in compliance with all applicable requirements, it is often difficult
−Removed: to determine precisely how the law will be applied in specific circumstances.
−Removed: Accordingly, it is possible that our practices may be challenged
−Removed: under the federal Anti-Kickback Statute and Federal False Claims Act.
−Removed: Violations of fraud and abuse laws may be punishable by criminal
−Removed: and/or civil sanctions, including fines and/or exclusion or suspension from federal and state health care programs such as Medicare and
−Removed: Medicaid and debarment from contracting with the U.S.
−Removed: In addition, private individuals have the ability to bring actions
−Removed: on behalf of the government under the federal False Claims Act as well as under the false claims laws of several states.
−Removed: states have adopted laws similar to the federal anti-kickback statute, some of which apply to the referral of patients for health care
−Removed: services reimbursed by any source, not just governmental payers.
−Removed: There are ambiguities as to what is required to comply with these state
−Removed: requirements and if we fail to comply with an applicable state law requirement, we could be subject to penalties.
−Removed: the government nor the courts have provided definitive guidance on the application of fraud and abuse laws to our business.
−Removed: Law enforcement
−Removed: authorities are increasingly focused on enforcing these laws, and it is possible that some of our practices may be challenged under these
−Removed: While we believe we have structured our business arrangements to comply with these laws, it is possible that the government could
−Removed: allege violations of, or convict us of violating, these laws.
−Removed: If we are found in violation of one of these laws, we could be required
−Removed: to pay a penalty and could be suspended or excluded from participation in federal or state health care programs, and our business, results
−Removed: of operations and financial condition may be adversely affected.
−Removed: adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of our product candidates,
−Removed: limit the scope of any approved label or market acceptance, or cause the recall or loss of marketing approval of products that are already
−Removed: any of our product candidates prior to or after any approval for commercial sale, cause serious or unexpected side effects, or are associated
−Removed: with other safety risks such as misuse, abuse or diversion, a number of potentially significant negative consequences could result, including:
+Added: There is a high rate of failure for drug candidates proceeding
+Added: through clinical trials.
+Added: Generally, there is a high rate of failure for
+Added: drug candidates proceeding through clinical trials.
+Added: We may suffer significant setbacks in our clinical trials similar to the experience
+Added: of a number of other companies in the pharmaceutical and biotechnology industries, even after receiving promising results in earlier
+Added: Further, even if we view the results of a clinical trial to be positive, FDA may disagree with our interpretation of the data.
+Added: In the event that we obtain negative results from clinical trials for product candidates or other problems related to potential chemistry,
+Added: manufacturing and control issues or other hurdles occur and our product candidates are not approved, we may not be able to generate sufficient
+Added: revenue or obtain financing to continue our operations, our ability to execute on our current business plan may be materially impaired,
+Added: our reputation in the industry and in the investment community might be significantly damaged and the price of our common stock could
+Added: decrease significantly.
+Added: In addition, our inability to properly design, commence and complete clinical trials may negatively impact the
+Added: timing and results of our clinical trials and ability to seek approvals for our drug candidates.
+Added: If we are found in violation of federal
+Added: or state “fraud and abuse” laws, we may be required to pay a penalty and/or be suspended from participation in federal or
+Added: state health care programs, which may adversely affect our business, financial condition, and results of operations.
+Added: In the United States, we are subject to various
+Added: federal and state health care “fraud and abuse” laws, including anti-kickback laws, false claims laws and other laws intended
+Added: to reduce fraud and abuse in federal and state health care programs, which could affect us particularly upon successful commercialization
+Added: of our products in the U.S.
+Added: The Medicare and Medicaid Patient Protection Act of 1987, or federal Anti-Kickback Statute, makes it illegal
+Added: for any person, including a prescription drug manufacturer (or a party acting on its behalf), to knowingly and willfully solicit, receive,
+Added: offer or pay any remuneration that is intended to induce the referral of business, including the purchase, order or prescription of a
+Added: particular drug for which payment may be made under a federal health care program, such as Medicare or Medicaid.
+Added: Under federal law, some
+Added: arrangements, known as safe harbors, are deemed not to violate the federal Anti-Kickback Statute.
+Added: Although we seek to structure our business
+Added: arrangements in compliance with all applicable requirements, it is often difficult to determine precisely how the law will be applied
+Added: in specific circumstances.
+Added: Accordingly, it is possible that our practices may be challenged under the federal Anti-Kickback Statute and
+Added: Federal False Claims Act.
+Added: Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including fines and/or
+Added: exclusion or suspension from federal and state health care programs such as Medicare and Medicaid and debarment from contracting with
+Added: In addition, private individuals have the ability to bring actions on behalf of the government under the federal
+Added: False Claims Act as well as under the false claims laws of several states.
+Added: Many states have adopted laws similar to the
+Added: federal anti-kickback statute, some of which apply to the referral of patients for health care services reimbursed by any source, not
+Added: just governmental payers.
+Added: There are ambiguities as to what is required to comply with these state requirements and if we fail to comply
+Added: with an applicable state law requirement, we could be subject to penalties.
+Added: Neither the government nor the courts have provided
+Added: definitive guidance on the application of fraud and abuse laws to our business.
+Added: Law enforcement authorities are increasingly focused
+Added: on enforcing these laws, and it is possible that some of our practices may be challenged under these laws.
+Added: While we believe we have structured
+Added: our business arrangements to comply with these laws, it is possible that the government could allege violations of, or convict us of
+Added: violating, these laws.
+Added: If we are found in violation of one of these laws, we could be required to pay a penalty and could be suspended
+Added: or excluded from participation in federal or state health care programs, and our business, results of operations and financial condition
+Added: may be adversely affected.
+Added: Serious adverse events or other safety
+Added: risks could require us to abandon development and preclude, delay or limit approval of our product candidates, limit the scope of any
+Added: approved label or market acceptance, or cause the recall or loss of marketing approval of products that are already marketed.
+Added: If any of our product candidates prior to or
+Added: after any approval for commercial sale, cause serious or unexpected side effects, or are associated with other safety risks such as misuse,
+Added: abuse or diversion, a number of potentially significant negative consequences could result, including:
authorities may interrupt, delay or halt clinical trials;
11 unchanged sentences
for pediatric indications.
−Removed: may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable risk to participants
−Removed: or if preliminary data demonstrate that our product candidates are unlikely to receive regulatory approval or unlikely to be successfully
−Removed: commercialized.
−Removed: Following receipt of approval for commercial sale of a product we may voluntarily withdraw or recall that product from
−Removed: the market if at any time we believe that its use, or a person’s exposure to it, may cause adverse health consequences or death.
−Removed: To date we have not withdrawn, recalled, or taken any other action, voluntary or mandatory, to remove an approved product from the market.
−Removed: In addition, regulatory agencies, IRBs, or data safety monitoring boards may at any time recommend the temporary or permanent discontinuation
−Removed: of our clinical trials or request that we cease using investigators in the clinical trials if they believe that the clinical trials are
−Removed: not being conducted in accordance with applicable regulatory requirements, or that they present an unacceptable safety risk to participants.
−Removed: Although we have never been asked by a regulatory agency, IRB, or data safety monitoring board to discontinue a clinical trial temporarily
−Removed: or permanently, if we elect or are forced to suspend or terminate a clinical trial of any of our product candidates, the commercial prospects
−Removed: for that product will be harmed and our ability to generate product revenue from that product may be delayed or eliminated.
−Removed: any of these events may result in labeling statements such as warnings or contraindications.
−Removed: In addition, such events or labeling could
−Removed: prevent us or our partners from achieving or maintaining market acceptance of the affected product and could substantially increase the
−Removed: costs of commercializing our product candidates and impair our ability to generate revenue from the commercialization of these products
−Removed: either by us or by our collaboration partners.
−Removed: Related to Our Reliance Upon Third Parties
−Removed: rely on, and expect to continue to rely on, third parties to conduct clinical trials for our product candidates.
−Removed: If these third parties
−Removed: do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be
−Removed: able to obtain marketing approval for or commercialize our product candidates, and our business could be substantially harmed.
+Added: We may voluntarily suspend or terminate our clinical
+Added: trials if at any time we believe that they present an unacceptable risk to participants or if preliminary data demonstrate that our product
+Added: candidates are unlikely to receive regulatory approval or unlikely to be successfully commercialized.
+Added: Following receipt of approval for
+Added: commercial sale of a product we may voluntarily withdraw or recall that product from the market if at any time we believe that its use,
+Added: or a person’s exposure to it, may cause adverse health consequences or death.
+Added: To date we have not withdrawn, recalled, or taken
+Added: any other action, voluntary or mandatory, to remove an approved product from the market.
+Added: In addition, regulatory agencies, IRBs, or data
+Added: safety monitoring boards may at any time recommend the temporary or permanent discontinuation of our clinical trials or request that
+Added: we cease using investigators in the clinical trials if they believe that the clinical trials are not being conducted in accordance with
+Added: applicable regulatory requirements, or that they present an unacceptable safety risk to participants.
+Added: Although we have never been asked
+Added: by a regulatory agency, IRB, or data safety monitoring board to discontinue a clinical trial temporarily or permanently, if we elect
+Added: or are forced to suspend or terminate a clinical trial of any of our product candidates, the commercial prospects for that product will
+Added: be harmed and our ability to generate product revenue from that product may be delayed or eliminated.
+Added: Furthermore, any of these events
+Added: may result in labeling statements such as warnings or contraindications.
+Added: In addition, such events or labeling could prevent us or our
+Added: partners from achieving or maintaining market acceptance of the affected product and could substantially increase the costs of commercializing
+Added: our product candidates and impair our ability to generate revenue from the commercialization of these products either by us or by our
+Added: collaboration partners.
+Added: Risks Related to Our Reliance Upon Third Parties
+Added: We rely on, and expect to continue to rely
+Added: on, third parties to conduct clinical trials for our product candidates.
+Added: If these third parties do not successfully carry out their contractual
+Added: duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize
+Added: our product candidates, and our business could be substantially harmed.
are dependent on third parties to conduct our clinical trials and preclinical and nonclinical studies.
23 unchanged sentences
may require us to repeat clinical trials, which would delay the regulatory approval process.
−Removed: is a risk that our CROs, investigators or other third parties will be unable to devote adequate time and resources to such trials or
−Removed: studies or perform as contractually required.
−Removed: If any of these third parties fail to meet expected deadlines, adhere to our clinical protocols
−Removed: or meet regulatory requirements, or otherwise perform in a substandard manner, our clinical trials may be extended, delayed or terminated.
−Removed: In addition, many of the third parties with whom we contract may also have relationships with other commercial entities, including our
−Removed: competitors, for whom they may also be conducting clinical trials or other development activities that could harm our competitive position.
−Removed: In addition, principal investigators for our clinical trials are expected to serve as scientific advisors or consultants to us from time
−Removed: to time and may receive cash or equity compensation in connection with such services.
−Removed: If these relationships and any related compensation
−Removed: result in perceived or actual conflicts of interest, or the FDA concludes that the financial relationship may have affected the interpretation
−Removed: of the study, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical
−Removed: trial itself may be jeopardized, which could result in the delay or rejection by the FDA of any NDA we submit.
−Removed: Any such delay or rejection
−Removed: could prevent us from receiving regulatory approval for, or commercializing, Telomir-1 and any future product candidates.
−Removed: CROs have the right to terminate their agreements with us in the event of an uncured material breach and under other specified circumstances.
−Removed: If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative third
−Removed: parties on commercially reasonable terms, in a timely manner or at all.
−Removed: Switching or adding CROs, investigators and other third parties
−Removed: involves additional cost and requires our management’s time and focus.
−Removed: In addition, there is a natural transition period when a
−Removed: new CRO commences work.
−Removed: As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines.
−Removed: Though we work to carefully manage our relationships with our CROs, investigators and other third parties, there can be no assurance
−Removed: that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact
−Removed: on our business, financial condition and prospects.
−Removed: currently rely on a third party for the manufacture of Telomir-1 for clinical development and expect to continue to rely on third parties
−Removed: for the foreseeable future.
−Removed: This reliance on third parties increases the risk that supplies of our product may not be manufactured in
−Removed: accordance with specifications or that we will not have sufficient quantities of Telomir-1 or such quantities at an acceptable cost,
−Removed: which could delay, prevent or impair our development or potential commercialization efforts.
−Removed: do not own or operate manufacturing facilities and have no plans to develop our own clinical or commercial-scale manufacturing capabilities.
−Removed: We rely on a third party and expect to continue to rely on third parties for the manufacture of Telomir-1 and related raw materials
−Removed: for clinical development, as well as for commercial manufacture if Telomir-1 receives marketing approval.
−Removed: There is a risk that supplies
−Removed: of our product for use in pre-clinical or clinical testing will not be manufactured in accordance with our specifications, which could
−Removed: render our trial data useless or lead to the creation of compounds which are novel and for which we do not have intellectual property
−Removed: Based on the terms of our contracts with our manufacturers, we may have no recourse against them in the case of such errors.
+Added: There is a risk that our CROs, investigators
+Added: or other third parties will be unable to devote adequate time and resources to such trials or studies or perform as contractually required.
+Added: If any of these third parties fail to meet expected deadlines, adhere to our clinical protocols or meet regulatory requirements, or otherwise
+Added: perform in a substandard manner, our clinical trials may be extended, delayed or terminated.
+Added: In addition, many of the third parties with
+Added: whom we contract may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting
+Added: clinical trials or other development activities that could harm our competitive position.
+Added: In addition, principal investigators for our
+Added: clinical trials are expected to serve as scientific advisors or consultants to us from time to time and may receive cash or equity compensation
+Added: in connection with such services.
+Added: If these relationships and any related compensation result in perceived or actual conflicts of interest,
+Added: or the FDA concludes that the financial relationship may have affected the interpretation of the study, the integrity of the data generated
+Added: at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could
+Added: result in the delay or rejection by the FDA of any NDA we submit.
+Added: Any such delay or rejection could prevent us from receiving regulatory
+Added: approval for, or commercializing, Telomir-1 and any future product candidates.
+Added: Our CROs have the right to terminate their agreements
+Added: with us in the event of an uncured material breach and under other specified circumstances.
+Added: If any of our relationships with these third
+Added: parties terminate, we may not be able to enter into arrangements with alternative third parties on commercially reasonable terms, in
+Added: a timely manner or at all.
+Added: Switching or adding CROs, investigators and other third parties involves additional cost and requires our
+Added: management’s time and focus.
+Added: In addition, there is a natural transition period when a new CRO commences work.
+Added: As a result, delays
+Added: occur, which can materially impact our ability to meet our desired clinical development timelines.
+Added: Though we work to carefully manage
+Added: our relationships with our CROs, investigators and other third parties, there can be no assurance that we will not encounter challenges
+Added: or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition
+Added: and prospects.
+Added: We currently rely on a third party for
+Added: the manufacture of Telomir-1 for clinical development and expect to continue to rely on third parties for the foreseeable future.
+Added: reliance on third parties increases the risk that supplies of our product may not be manufactured in accordance with specifications or
+Added: that we will not have sufficient quantities of Telomir-1 or such quantities at an acceptable cost, which could delay, prevent or impair
+Added: our development or potential commercialization efforts.
+Added: We do not own or operate manufacturing facilities
+Added: and have no plans to develop our own clinical or commercial-scale manufacturing capabilities.
+Added: We rely on a third party and expect to
+Added: continue to rely on third parties for the manufacture of Telomir-1 and related raw materials for clinical development, as well as for
+Added: commercial manufacture if Telomir-1 receives marketing approval.
+Added: There is a risk that supplies of our product for use in pre-clinical
+Added: or clinical testing will not be manufactured in accordance with our specifications, which could render our trial data useless or lead
+Added: to the creation of compounds which are novel and for which we do not have intellectual property protection.
+Added: Based on the terms of our
+Added: contracts with our manufacturers, we may have no recourse against them in the case of such errors.
the facilities used by third-party manufacturers to manufacture Telomir-1 must be approved by the FDA and any comparable foreign regulatory
6 unchanged sentences
they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities.
−Removed: addition, we have no control over the ability of third-party manufacturers to maintain adequate quality control, quality assurance and
−Removed: qualified personnel.
−Removed: If the FDA or any comparable foreign regulatory authority does not approve these facilities for the manufacture
−Removed: of Telomir-1 or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would
−Removed: significantly impact our ability to develop, obtain regulatory approval for or market Telomir-1, if approved.
−Removed: Our failure, or the failure
−Removed: of our third-party manufacturers, to comply with applicable regulations also could result in sanctions being imposed on us, including
−Removed: clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures or recalls of Telomir-1
−Removed: or other future products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies
−Removed: of our products and our financial position.
−Removed: or a third party’s failure to execute on our manufacturing requirements on commercially reasonable terms, in a timely manner and
−Removed: in compliance with cGMP or other regulatory requirements could adversely affect our business in a number of ways, including:
+Added: In addition, we have no control over the ability
+Added: of third-party manufacturers to maintain adequate quality control, quality assurance and qualified personnel.
+Added: If the FDA or any comparable
+Added: foreign regulatory authority does not approve these facilities for the manufacture of Telomir-1 or if it withdraws any such approval
+Added: in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain
+Added: regulatory approval for or market Telomir-1, if approved.
+Added: Our failure, or the failure of our third-party manufacturers, to comply with
+Added: applicable regulations also could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties,
+Added: delays, suspension or withdrawal of approvals, seizures or recalls of Telomir-1 or other future products, operating restrictions and
+Added: criminal prosecutions, any of which could significantly and adversely affect supplies of our products and our financial position.
+Added: Our or a third party’s failure to execute
+Added: on our manufacturing requirements on commercially reasonable terms, in a timely manner and in compliance with cGMP or other regulatory
+Added: requirements could adversely affect our business in a number of ways, including:
inability to initiate or complete clinical trials of Telomir-1 or any future product candidates in a timely manner;
4 unchanged sentences
for Telomir-1 or any future product candidates.
−Removed: addition, we do not have any long-term commitments or supply agreements with any third-party manufacturers.
−Removed: We may be unable to establish
−Removed: any long-term supply agreements with third-party manufacturers or to do so on acceptable terms, which increases the risk of failing to
−Removed: timely obtain sufficient quantities of Telomir-1 or such quantities at an acceptable cost.
−Removed: Even if we are able to establish agreements
−Removed: with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:
+Added: In addition, we do not have any long-term commitments
+Added: or supply agreements with any third-party manufacturers.
+Added: We may be unable to establish any long-term supply agreements with third-party
+Added: manufacturers or to do so on acceptable terms, which increases the risk of failing to timely obtain sufficient quantities of Telomir-1
+Added: or such quantities at an acceptable cost.
+Added: Even if we are able to establish agreements with third-party manufacturers, reliance on third-party
+Added: manufacturers entails additional risks, including:
of third-party manufacturers to comply with regulatory requirements and maintain quality assurance;
7 unchanged sentences
or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.
−Removed: performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval or jeopardize
−Removed: our ability to commence or continue commercialization of Telomir-1 or any future product candidates, and any related remedial measures
−Removed: may be costly or time consuming to implement.
−Removed: We do not currently have arrangements in place for redundant supply or a second source
−Removed: for all required raw materials used in the manufacture of our product candidates.
−Removed: If our existing or future third-party manufacturers
−Removed: cannot perform as agreed, we may be required to replace such manufacturers and we may be unable to replace them on a timely basis or
−Removed: Without additional suppliers of required raw materials, we may also be unable to meet the commercial needs of a commercial launch
−Removed: of any future product candidates.
−Removed: addition, our current and anticipated future dependence upon others for the manufacture of Telomir-1 and any future product candidates
−Removed: may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely
−Removed: and competitive basis.
−Removed: expect to rely on third parties to conduct our pre-clinical trials and those third parties may not perform satisfactorily, including
−Removed: failing to meet deadlines for the completion of such trials or failing to comply with regulatory requirements or our pre-clinical protocols.
−Removed: currently rely on Contract Research Organizations (“CROs”) to conduct our pre-clinical trials, as we currently do not plan
−Removed: to independently conduct pre-clinical trials of any of our product candidates.
−Removed: Our agreements with these CROs, and other third parties
−Removed: might terminate for a variety of reasons, including a failure to perform by the third parties to such agreements.
−Removed: If we were ever to
−Removed: need to enter into alternative arrangements or if we were to need to change a CRO for an ongoing pre-clinical trial, we might experience
−Removed: delays in our pre-clinical development activities.
−Removed: existing collaboration arrangements and any that we may enter into in the future may not be successful, which could adversely affect
−Removed: our ability to develop and commercialize our product candidates.
−Removed: have existing, and will likely continue to seek additional collaboration arrangements with pharmaceutical or biotechnology companies
−Removed: for the manufacturing, testing, development or commercialization of our product candidates.
−Removed: We may, with respect to our product candidates,
−Removed: enter into new arrangements on a selective basis depending on the merits of retaining commercialization rights for ourselves as compared
−Removed: to entering into selective collaboration arrangements with leading pharmaceutical or biotechnology companies for each product candidate,
−Removed: both in the U.S.
+Added: Any performance failure on the part of our existing
+Added: or future manufacturers could delay clinical development or marketing approval or jeopardize our ability to commence or continue commercialization
+Added: of Telomir-1 or any future product candidates, and any related remedial measures may be costly or time consuming to implement.
+Added: not currently have arrangements in place for redundant supply or a second source for all required raw materials used in the manufacture
+Added: of our product candidates.
+Added: If our existing or future third-party manufacturers cannot perform as agreed, we may be required to replace
+Added: such manufacturers and we may be unable to replace them on a timely basis or at all.
+Added: Without additional suppliers of required raw materials,
+Added: we may also be unable to meet the commercial needs of a commercial launch of any future product candidates.
+Added: In addition, our current and anticipated future
+Added: dependence upon others for the manufacture of Telomir-1 and any future product candidates may adversely affect our future profit margins
+Added: and our ability to commercialize any products that receive marketing approval on a timely and competitive basis.
+Added: Our existing collaboration arrangements
+Added: and any that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize
+Added: our product candidates.
+Added: We have existing, and will likely continue to
+Added: seek additional collaboration arrangements with pharmaceutical or biotechnology companies for the manufacturing, testing, development
+Added: or commercialization of our product candidates.
+Added: We may, with respect to our product candidates, enter into new arrangements on a selective
+Added: basis depending on the merits of retaining commercialization rights for ourselves as compared to entering into selective collaboration
+Added: arrangements with leading pharmaceutical or biotechnology companies for each product candidate, both in the U.S.
and internationally.
−Removed: To the extent that we decide to enter into collaboration agreements, we will face significant competition
−Removed: in seeking appropriate collaborators and the terms of any collaboration or other arrangements that we may establish may not be favorable
+Added: To the extent that we decide to enter into collaboration agreements, we will face significant competition in seeking appropriate collaborators
+Added: and the terms of any collaboration or other arrangements that we may establish may not be favorable to us.
existing or future collaboration entered into may not allow us to achieve our goals for such collaboration on a timely basis or at all.
7 unchanged sentences
termination or expiration could harm our business reputation and may adversely affect us financially.
−Removed: depend on a limited number of suppliers for materials and components required to manufacture our product candidates.
−Removed: The loss of these
−Removed: suppliers, or their failure to supply us on a timely basis, could cause delays in our current and future capacity and adversely affect
−Removed: our business.
−Removed: depend on a limited number of suppliers for the materials and components required to manufacture our product candidates.
−Removed: we may not be able to obtain sufficient quantities of critical materials and components in the future.
−Removed: A delay or interruption by our
−Removed: suppliers may also harm our business, results of operations and financial condition.
−Removed: In addition, the lead time needed to establish a
−Removed: relationship with a new supplier can be lengthy, and we may experience delays in meeting demand in the event we must switch to a new
−Removed: The time and effort to qualify for and, in some cases, obtain regulatory approval for a new supplier could result in additional
−Removed: costs, diversion of resources or reduced manufacturing yields, any of which would negatively impact our operating results.
−Removed: Our dependence
−Removed: on single-source suppliers exposes us to numerous risks, including the following:
−Removed: our suppliers may cease or reduce production or deliveries,
−Removed: raise prices or renegotiate terms;
−Removed: our suppliers may become insolvent or cease trading;
−Removed: we may be unable to locate a suitable replacement
−Removed: supplier on acceptable terms or on a timely basis, or at all;
−Removed: and delays caused by supply issues may harm our reputation, frustrate our
−Removed: customers and cause them to turn to our competitors for future needs.
−Removed: Relating to the Ownership of Our Common Stock
−Removed: sales of our common stock, or the perception that future sales may occur, may cause the market price of our common stock to decline,
−Removed: even if our business is doing well.
−Removed: of substantial amounts of our common stock in the public market after our IPO, or the perception that these sales may occur, could materially
−Removed: and adversely affect the price of our common stock and could impair our ability to raise capital through the sale of additional equity
−Removed: Those shares of common stock sold in our IPO will be freely tradable, without restriction, in the public market, except for
−Removed: any shares sold to our affiliates.
−Removed: the date of the IPO, when 1,000,000 shares of common stock became publicly tradable, approximately 23,891,902 additional shares of common
−Removed: stock were subject to “lock-up” agreements entered into in connection with the IPO, are or will become eligible to be sold
−Removed: in the public market by existing stockholders by February 9, 2025 as a result of Rule 144 of the Securities Act, subject to volume and
−Removed: other limitations imposed under the federal securities laws.
−Removed: Furthermore, additional shares of our common stock may be publicly tradable
−Removed: as a result of exercises of stock options and restricted stock units (RSUs) under the 2023 Omnibus Incentive Plan.
−Removed: Sales of substantial
−Removed: amounts of our common stock in the public market after the completion of the IPO, or the perception that such sales could occur, could
−Removed: adversely affect the market price of our common stock and could materially impair our ability to raise capital through offerings of our
−Removed: common stock.
−Removed: of the speculative nature of an investment in our company, you may lose your entire investment.
−Removed: investment in our securities carries a high degree of risk and should be considered as a speculative investment.
−Removed: We have a very limited
−Removed: operating history, are in the pre-clinical stage of development of our product candidate, have never generated revenues, have not paid
−Removed: dividends, and are unlikely to pay dividends in the immediate or near future.
−Removed: The likelihood of our being able to achieve our goals and
−Removed: run our business must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered
−Removed: in connection with the establishment of early-stage biotechnology companies.
−Removed: An investment in our securities may result in the loss of
−Removed: the entirety of such investment.
−Removed: Only stockholders and potential stockholders who are experienced in high-risk investments and who can
−Removed: afford to lose their entire investment should consider an investment in our securities.
−Removed: of our founding stockholders, plus our existing officers and directors, control a substantial interest in us and thus may influence certain
+Added: Risks Relating to the Ownership of Our Common
+Added: Future sales of our common stock, or the
+Added: perception that future sales may occur, may cause the market price of our common stock to decline, even if our business is doing well.
+Added: Sales of substantial amounts of our common stock
+Added: in the public market after our IPO, or the perception that these sales may occur, could materially and adversely affect the price of
+Added: our common stock and could impair our ability to raise capital through the sale of additional equity securities.
+Added: Those shares of common
+Added: stock sold in our IPO will be freely tradable, without restriction, in the public market, except for any shares sold to our affiliates.
+Added: Furthermore, additional shares of our common
+Added: stock may be publicly tradable as a result of exercises of stock options and restricted stock units (RSUs) under the 2023 Omnibus Incentive
+Added: Sales of substantial amounts of our common stock in the public market after the completion of the IPO, or the perception that such
+Added: sales could occur, could adversely affect the market price of our common stock and could materially impair our ability to raise capital
+Added: through offerings of our common stock.
+Added: Because of the speculative nature of an
+Added: investment in our company, you may lose your entire investment.
+Added: An investment in our securities carries a high
+Added: degree of risk and should be considered as a speculative investment.
+Added: We have a very limited operating history, are in the pre-clinical
+Added: stage of development of our product candidate, have never generated revenues, have not paid dividends, and are unlikely to pay dividends
+Added: in the immediate or near future.
+Added: The likelihood of our being able to achieve our goals and run our business must be considered in light
+Added: of the problems, expenses, difficulties, complications and delays frequently encountered in connection with the establishment of early-stage
+Added: biotechnology companies.
+Added: An investment in our securities may result in the loss of the entirety of such investment.
+Added: Only stockholders
+Added: and potential stockholders who are experienced in high-risk investments and who can afford to lose their entire investment should consider
+Added: an investment in our securities.
+Added: Certain of our
+Added: founding stockholders, plus our existing officers and directors, control a substantial interest in us and thus may influence certain
actions requiring stockholder vote.
−Removed: founding stockholders, which include five trusts for the benefit of the family of our founder Johnnie R.
−Removed: Williams, Sr., as well as MIRALOGX,
−Removed: collectively own in excess of 70% of our issued and outstanding common stock.
+Added: Our founding stockholders,
+Added: which include five trusts for the benefit of the family of our founder Johnnie R.
+Added: Williams, Sr., as well as MIRALOGX, collectively own
+Added: of our issued and outstanding common stock.
Brian McNulty acts as the trustee for such trusts.
−Removed: officers and directors also own shares of our common stock.
−Removed: Therefore, these entities and individuals could influence the outcome of
−Removed: matters requiring stockholder approval, including the election of directors and approval of significant corporate transactions.
−Removed: of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur, could depress
−Removed: the market price of our common stock.
+Added: Our officers and directors also own shares
+Added: of our common stock.
+Added: Therefore, these entities and individuals could influence the outcome of matters requiring stockholder approval,
+Added: including the election of directors and approval of significant corporate transactions.
+Added: Sales of a significant number of shares
+Added: of our common stock in the public markets, or the perception that such sales could occur, could depress the market price of our common
of a significant number of shares of our common stock in the public markets, or the perception that such sales could occur as a result
6 unchanged sentences
we are permitted to sell a significant number of our securities would have on the market price of our common stock.
−Removed: requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract
−Removed: and retain executive management and qualified board members.
−Removed: a reporting issuer, we are subject to the reporting requirements of applicable securities legislation of the jurisdiction in which it
−Removed: is a reporting issuer, the listing requirements of Nasdaq and other applicable securities rules and regulations.
−Removed: Compliance with these
−Removed: rules and regulations will increase our legal and financial compliance costs, make some activities more difficult, time-consuming or
−Removed: costly and increase demand on its systems and resources.
−Removed: Applicable securities laws will require us to, among other things, file certain
−Removed: annual and quarterly reports with respect to its business and results of operations.
−Removed: In addition, applicable securities laws require
−Removed: us to, among other things, maintain effective disclosure controls and procedures and internal control over financial reporting.
−Removed: order to maintain and, if required, improve its disclosure controls and procedures and internal control over financial reporting to meet
−Removed: this standard, significant resources and management oversight are required.
−Removed: Specifically, due to the increasing complexity of its transactions,
−Removed: it is anticipated that we will improve our disclosure controls and procedures and internal control over financial reporting primarily
−Removed: through the continued development and implementation of formal policies, improved processes and documentation procedures, as well as
−Removed: the continued sourcing of additional finance resources.
−Removed: As a result, management’s attention may be diverted from other business
−Removed: concerns, which could harm our business and results of operations.
−Removed: To comply with these requirements, we may need to hire more employees
−Removed: in the future or engage outside consultants, which will increase costs and expenses.
−Removed: addition, changing laws, regulations and standards relating to corporate governance and public disclosure are creating uncertainty for
−Removed: public companies, increasing legal and financial compliance costs and making some activities more time consuming.
−Removed: These laws, regulations
−Removed: and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application
−Removed: in practice may evolve over time as new guidance is provided by regulatory and governing bodies.
−Removed: This could result in continuing uncertainty
−Removed: regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.
−Removed: continue to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general
−Removed: and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to compliance
−Removed: If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing
−Removed: bodies due to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us,
−Removed: which could adversely affect our business and financial results.
−Removed: a public company subject to these rules and regulations, we may find it more expensive for it to obtain director and officer liability
−Removed: insurance, and it may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.
−Removed: These factors could
−Removed: also make it more difficult for us to attract and retain qualified members of our board of directors, particularly to serve on its Audit
−Removed: Committee and Compensation Committee, and qualified executive officers.
+Added: The requirements of being a public company
+Added: may strain our resources, divert management’s attention and affect our ability to attract and retain executive management and qualified
+Added: board members.
+Added: As a reporting issuer, we are subject to the
+Added: reporting requirements of applicable securities legislation of the jurisdiction in which it is a reporting issuer, the listing requirements
+Added: of Nasdaq and other applicable securities rules and regulations.
+Added: Compliance with these rules and regulations will increase our legal
+Added: and financial compliance costs, make some activities more difficult, time-consuming or costly and increase demand on its systems and
+Added: Applicable securities laws will require us to, among other things, file certain annual and quarterly reports with respect
+Added: to its business and results of operations.
+Added: In addition, applicable securities laws require us to, among other things, maintain effective
+Added: disclosure controls and procedures and internal control over financial reporting.
+Added: In order to maintain and, if required, improve
+Added: its disclosure controls and procedures and internal control over financial reporting to meet this standard, significant resources and
+Added: management oversight are required.
+Added: Specifically, due to the increasing complexity of its transactions, it is anticipated that we will
+Added: improve our disclosure controls and procedures and internal control over financial reporting primarily through the continued development
+Added: and implementation of formal policies, improved processes and documentation procedures, as well as the continued sourcing of additional
+Added: finance resources.
+Added: As a result, management’s attention may be diverted from other business concerns, which could harm our business
+Added: and results of operations.
+Added: To comply with these requirements, we may need to hire more employees in the future or engage outside consultants,
+Added: which will increase costs and expenses.
+Added: In addition, changing laws, regulations and standards
+Added: relating to corporate governance and public disclosure are creating uncertainty for public companies, increasing legal and financial
+Added: compliance costs and making some activities more time consuming.
+Added: These laws, regulations and standards are subject to varying interpretations,
+Added: in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance
+Added: is provided by regulatory and governing bodies.
+Added: This could result in continuing uncertainty regarding compliance matters and higher costs
+Added: necessitated by ongoing revisions to disclosure and governance practices.
+Added: We intend to continue to invest resources to comply with evolving
+Added: laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management’s
+Added: time and attention from revenue-generating activities to compliance activities.
+Added: If our efforts to comply with new laws, regulations and
+Added: standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to their application and practice,
+Added: regulatory authorities may initiate legal proceedings against us, which could adversely affect our business and financial results.
+Added: As a public company subject to these rules and
+Added: regulations, we may find it more expensive for it to obtain director and officer liability insurance, and it may be required to accept
+Added: reduced coverage or incur substantially higher costs to obtain coverage.
+Added: These factors could also make it more difficult for us to attract
+Added: and retain qualified members of our board of directors, particularly to serve on its Audit Committee and Compensation Committee, and
+Added: qualified executive officers.
a result of disclosure of information in filings required of a public company, our business and financial condition will become more
4 unchanged sentences
and results of operations.
−Removed: are an “emerging growth company” and any decision on our part to comply only with certain reduced reporting and disclosure
−Removed: requirements applicable to emerging growth companies could make shares of our common stock less attractive to investors.
−Removed: are an “emerging growth company,” as defined in Section 2(a) of the Securities Act.
−Removed: For as long as we continue to be an emerging
−Removed: growth company, we may choose to take advantage of exemptions from various reporting requirements applicable to other public companies
−Removed: that are not emerging growth companies, including, but not limited to, not being required to have our independent registered public accounting
−Removed: firm audit our internal control over financial reporting under Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations
−Removed: regarding executive compensation in our periodic reports and exemptions from the requirements of holding a nonbinding advisory vote on
−Removed: executive compensation and shareholder approval of any golden parachute payments not previously approved.
−Removed: We could be an emerging growth
−Removed: company until the fifth anniversary of the fiscal year end date following the completion of our initial public offering, however, our
−Removed: status would change more quickly if we have more than US$1.235 billion in annual revenue, if the market value of our shares of common
−Removed: stock held by non-affiliates equals or exceeds US$700 million as of June 30 of any year, or we issue more than US$1.0 billion of non-convertible
−Removed: debt over a three-year period before the end of that period.
−Removed: could find our shares less attractive if we choose to rely on these exemptions.
−Removed: If some investors find shares less attractive as a result
−Removed: of any choice to reduce future disclosure, there may be a less active trading market for our shares and our share price may be more volatile.
−Removed: as long as we are an “emerging growth company”, our independent registered public accounting firm will not be required to
−Removed: attest to the effectiveness of our internal controls over financial reporting pursuant to Section 404.
−Removed: We could be an “emerging
−Removed: growth company” until the fifth anniversary of the fiscal year end date following our initial public offering, which became effective
−Removed: on February 9, 2024.
−Removed: An independent assessment of the effectiveness of our internal controls could detect problems that our management’s
−Removed: assessment might not.
−Removed: Undetected material weaknesses in our internal controls could lead to financial statement restatements and require
−Removed: us to incur the expense of remediation.
−Removed: we identify material weaknesses in our internal control over financial reporting, or if we are unable to comply with the requirements
−Removed: of Section 404 in a timely manner or assert that our internal control over financial reporting is effective, or if our independent registered
−Removed: public accounting firm is unable to express an opinion as to the effectiveness of our internal control over financial reporting when
−Removed: required, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our securities
−Removed: could be negatively affected, and we could become subject to investigations by the stock exchange on which our securities are listed,
−Removed: the SEC, or other regulatory authorities, which could require additional financial and management resources.
−Removed: are a “smaller reporting company” and, even if we no longer qualify as an emerging growth company, we may still be subject
−Removed: to reduced reporting requirements.
−Removed: Additionally,
−Removed: we are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K.
−Removed: Smaller reporting companies may take
−Removed: advantage of certain reduced disclosure obligations, including, among other things, providing only two years of audited financial statements.
−Removed: We will remain a smaller reporting company until the last day of any fiscal year for so long as either:
−Removed: (i) the market value of our shares
−Removed: of common stock held by non-affiliates does not equal or exceed $250 million as of the prior June 30 th ;
−Removed: or (ii) our annual
−Removed: revenues did not equal or exceed $100 million during such completed fiscal year.
−Removed: To the extent we take advantage of such reduced disclosure
−Removed: obligations, it may also make the comparison of our financial statements with other public companies difficult or impossible.
−Removed: we fail to maintain compliance with Nasdaq Listing Rules, our shares may be delisted from Nasdaq, which would result in a limited trading
−Removed: market for our shares and make obtaining future debt or equity financing more difficult for the Company.
−Removed: common stock is listed on the Nasdaq Capital Market under the symbol “TELO”.
−Removed: However, there is no assurance that we will
−Removed: be able to continue to maintain our compliance with the Nasdaq continued listing requirements.
−Removed: If we fail to do so, our securities may
−Removed: be de-listed and cease trading on Nasdaq.
−Removed: As a result, selling our securities could be more difficult because smaller quantities of shares
−Removed: or warrants would likely be bought and sold, transactions could be delayed, and security analysts’ coverage of us may be reduced.
−Removed: In addition, in the event our securities are delisted, broker-dealers would face certain regulatory requirements which may discourage
−Removed: them from effecting transactions in the securities and further limit the liquidity of the securities.
−Removed: These factors could result in lower
−Removed: prices and larger spreads in the bid and ask prices for the securities.
−Removed: Such delisting from Nasdaq and continued or further declines
−Removed: in the share price of the securities could also greatly impair our ability to raise additional necessary capital through equity or debt
−Removed: financing and could significantly increase the ownership dilution to shareholders caused by our issuing equity in financing or other
−Removed: transactions.
−Removed: our shares were to be delisted from Nasdaq, they may become subject to the SEC’s “penny stock” rules.
−Removed: from Nasdaq may cause the securities of the Company to become subject to the SEC’s “penny stock” rules.
−Removed: The SEC generally
−Removed: defines a penny stock as an equity security that has a market price of less than $5.00 per share or an exercise price of less than $5.00
−Removed: per share, and that is not listed on a national securities exchange, such as Nasdaq subject to certain exemptions.
−Removed: Therefore, if shares
−Removed: of our common stock were to be delisted from Nasdaq, the securities of the Company could become subject to the SEC’s “penny
−Removed: stock” rules.
−Removed: These rules require, among other things, that any broker engaging in a purchase or sale of our securities provide
−Removed: its customers with:
−Removed: (i) a risk disclosure document, (ii) disclosure of market quotations, if any, (iii) disclosure of the compensation
−Removed: of the broker and its salespersons in the transaction, and (iv) monthly account statements showing the market values of our securities
−Removed: held in the customer’s accounts.
−Removed: A broker would be required to provide the bid and offer quotations and compensation information
−Removed: before effecting the transaction.
−Removed: This information must be contained in the customer’s confirmation.
−Removed: Generally, brokers are less
−Removed: willing to affect transactions in penny stocks due to these additional delivery requirements.
−Removed: These requirements may make it more difficult
−Removed: for shareholders to purchase or sell the shares of our common stock.
−Removed: Since the broker, not us, prepares this information, we would not
−Removed: be able to assure that such information is accurate, complete or current.
−Removed: provisions of Florida law and our amended and restated articles of incorporation and amended and restated bylaws may have anti-takeover
−Removed: effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our shareholders and may
−Removed: prevent attempts by our shareholders to replace or remove our current management.
−Removed: status as a Florida corporation and the anti-takeover provisions of the Florida Business Corporation Act, which we sometimes refer to
−Removed: as the FBCA, may discourage, delay or prevent a change in control even if a change in control would be beneficial to our shareholders.
−Removed: control share acquisition statute, Section 607.0902 of the FBCA, generally provides that in the event a person acquires voting shares
−Removed: of the company in excess of 20% of the voting power of all of our issued and outstanding shares, such acquired shares will not have any
−Removed: voting rights unless such rights are restored by the holders of a majority of the votes of each class or series entitled to vote separately,
−Removed: excluding shares held by the person acquiring the control shares or any of our officers or employees who are also directors of the company.
−Removed: Certain acquisitions of shares are exempt from these rules, such as shares acquired pursuant to the laws of intestate succession or pursuant
−Removed: to a gift or testamentary transfer, pursuant to a merger or share exchange effected in compliance with the FBCA if we are a party to
−Removed: the agreement, or pursuant to an acquisition of our shares if the acquisition has been approved by our board of directors before the
−Removed: The control share acquisition statute generally applies to any “issuing public corporation,” which means a Florida
−Removed: corporation which has:
+Added: We are an “emerging growth company”
+Added: and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to emerging growth
+Added: companies could make shares of our common stock less attractive to investors.
+Added: We are an “emerging growth company,”
+Added: as defined in Section 2(a) of the Securities Act.
+Added: For as long as we continue to be an emerging growth company, we may choose to take
+Added: advantage of exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies,
+Added: including, but not limited to, not being required to have our independent registered public accounting firm audit our internal control
+Added: over financial reporting under Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation
+Added: in our periodic reports and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder
+Added: approval of any golden parachute payments not previously approved.
+Added: We could be an emerging growth company until the fifth anniversary
+Added: of the fiscal year end date following the completion of our initial public offering, however, our status would change more quickly if
+Added: we have more than US$1.235 billion in annual revenue, if the market value of our shares of common stock held by non-affiliates equals
+Added: or exceeds US$700 million as of June 30 of any year, or we issue more than US$1.0 billion of non-convertible debt over a three-year period
+Added: before the end of that period.
+Added: Investors could find our shares less attractive
+Added: if we choose to rely on these exemptions.
+Added: If some investors find shares less attractive as a result of any choice to reduce future disclosure,
+Added: there may be a less active trading market for our shares and our share price may be more volatile.
+Added: For as long as we are an “emerging growth
+Added: company”, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal
+Added: controls over financial reporting pursuant to Section 404.
+Added: We could be an “emerging growth company” until the fifth anniversary
+Added: of the fiscal year end date following our initial public offering, which became effective on February 9, 2024.
+Added: An independent assessment
+Added: of the effectiveness of our internal controls could detect problems that our management’s assessment might not.
+Added: Undetected material
+Added: weaknesses in our internal controls could lead to financial statement restatements and require us to incur the expense of remediation.
+Added: If we identify material weaknesses in our internal
+Added: control over financial reporting, or if we are unable to comply with the requirements of Section 404 in a timely manner or assert that
+Added: our internal control over financial reporting is effective, or if our independent registered public accounting firm is unable to express
+Added: an opinion as to the effectiveness of our internal control over financial reporting when required, investors may lose confidence in the
+Added: accuracy and completeness of our financial reports and the market price of our securities could be negatively affected, and we could
+Added: become subject to investigations by the stock exchange on which our securities are listed, the SEC, or other regulatory authorities,
+Added: which could require additional financial and management resources.
+Added: We are a “smaller reporting company”
+Added: and, even if we no longer qualify as an emerging growth company, we may still be subject to reduced reporting requirements.
+Added: Additionally, we are a “smaller reporting
+Added: company” as defined in Item 10(f)(1) of Regulation S-K.
+Added: Smaller reporting companies may take advantage of certain reduced disclosure
+Added: obligations, including, among other things, providing only two years of audited financial statements.
+Added: We will remain a smaller reporting
+Added: company until the last day of any fiscal year for so long as either:
+Added: (i) the market value of our shares of common stock held by non-affiliates
+Added: does not equal or exceed $250 million as of the prior June 30th;
+Added: or (ii) our annual revenues did not equal or exceed $100 million during
+Added: such completed fiscal year.
+Added: To the extent we take advantage of such reduced disclosure obligations, it may also make the comparison of
+Added: our financial statements with other public companies difficult or impossible.
+Added: If we fail to maintain compliance with
+Added: Nasdaq Listing Rules, our shares may be delisted from Nasdaq, which would result in a limited trading market for our shares and make
+Added: obtaining future debt or equity financing more difficult for the Company.
+Added: Our common stock is listed on the Nasdaq Capital
+Added: Market under the symbol “TELO”.
+Added: However, there is no assurance that we will be able to continue to maintain our compliance
+Added: with the Nasdaq continued listing requirements.
+Added: If we fail to do so, our securities may be de-listed and cease trading on Nasdaq.
+Added: a result, selling our securities could be more difficult because smaller quantities of shares or warrants would likely be bought and
+Added: sold, transactions could be delayed, and security analysts’ coverage of us may be reduced.
+Added: In addition, in the event our securities
+Added: are delisted, broker-dealers would face certain regulatory requirements which may discourage them from effecting transactions in the
+Added: securities and further limit the liquidity of the securities.
+Added: These factors could result in lower prices and larger spreads in the bid
+Added: and ask prices for the securities.
+Added: Such delisting from Nasdaq and continued or further declines in the share price of the securities
+Added: could also greatly impair our ability to raise additional necessary capital through equity or debt financing and could significantly
+Added: increase the ownership dilution to shareholders caused by our issuing equity in financing or other transactions.
+Added: If our shares were to be delisted from
+Added: Nasdaq, they may become subject to the SEC’s “penny stock” rules.
+Added: Delisting from Nasdaq may cause the securities
+Added: of the Company to become subject to the SEC’s “penny stock” rules.
+Added: The SEC generally defines a penny stock as an equity
+Added: security that has a market price of less than $5.00 per share or an exercise price of less than $5.00 per share, and that is not listed
+Added: on a national securities exchange, such as Nasdaq subject to certain exemptions.
+Added: Therefore, if shares of our common stock were to be
+Added: delisted from Nasdaq, the securities of the Company could become subject to the SEC’s “penny stock” rules.
+Added: require, among other things, that any broker engaging in a purchase or sale of our securities provide its customers with:
+Added: disclosure document, (ii) disclosure of market quotations, if any, (iii) disclosure of the compensation of the broker and its salespersons
+Added: in the transaction, and (iv) monthly account statements showing the market values of our securities held in the customer’s accounts.
+Added: A broker would be required to provide the bid and offer quotations and compensation information before effecting the transaction.
+Added: information must be contained in the customer’s confirmation.
+Added: Generally, brokers are less willing to affect transactions in penny
+Added: stocks due to these additional delivery requirements.
+Added: These requirements may make it more difficult for shareholders to purchase or sell
+Added: the shares of our common stock.
+Added: Since the broker, not us, prepares this information, we would not be able to assure that such information
+Added: is accurate, complete or current.
+Added: Some provisions
+Added: of Florida law and our amended and restated articles of incorporation and amended and restated bylaws may have anti-takeover effects
+Added: that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our shareholders and may prevent
+Added: attempts by our shareholders to replace or remove our current management.
+Added: Our status as a Florida
+Added: corporation and the anti-takeover provisions of the Florida Business Corporation Act, which we sometimes refer to as the FBCA, may discourage,
+Added: delay or prevent a change in control even if a change in control would be beneficial to our shareholders.
+Added: The control share acquisition statute, Section
+Added: 607.0902 of the FBCA, generally provides that in the event a person acquires voting shares of the company in excess of 20% of the voting
+Added: power of all of our issued and outstanding shares, such acquired shares will not have any voting rights unless such rights are restored
+Added: by the holders of a majority of the votes of each class or series entitled to vote separately, excluding shares held by the person acquiring
+Added: the control shares or any of our officers or employees who are also directors of the company.
+Added: Certain acquisitions of shares are exempt
+Added: from these rules, such as shares acquired pursuant to the laws of intestate succession or pursuant to a gift or testamentary transfer,
+Added: pursuant to a merger or share exchange effected in compliance with the FBCA if we are a party to the agreement, or pursuant to an acquisition
+Added: of our shares if the acquisition has been approved by our board of directors before the acquisition.
+Added: The control share acquisition statute
+Added: generally applies to any “issuing public corporation,” which means a Florida corporation which has:
hundred or more shareholders;
3 unchanged sentences
or (iii) one thousand shareholders are resident in Florida.
−Removed: affiliated transaction (or so-called “business combination”) statute, Section 607.0901 of the FBCA, provides that we may
−Removed: not engage in certain mergers, consolidations, sales of assets, issuances of stock, reclassifications, recapitalizations, and other affiliated
−Removed: transactions with any “interested shareholder” for a period of three years following the time that such shareholder became
−Removed: an interested shareholder, unless:
+Added: The affiliated transaction (or so-called “business
+Added: combination”) statute, Section 607.0901 of the FBCA, provides that we may not engage in certain mergers, consolidations, sales
+Added: of assets, issuances of stock, reclassifications, recapitalizations, and other affiliated transactions with any “interested shareholder”
+Added: for a period of three years following the time that such shareholder became an interested shareholder, unless:
to the time that such shareholder became an interested shareholder, our board of directors approved either the affiliated transaction
5 unchanged sentences
of at least two-thirds of the outstanding voting shares which are not owned by the interested shareholder.
−Removed: “interested shareholder” is generally defined as any person who is the beneficial owner of more than 15% of our outstanding
−Removed: voting shares.
−Removed: voting requirements set forth above do not apply to a particular affiliated transaction if one or more conditions are met, including,
−Removed: but not limited to, the following:
−Removed: if the affiliated transaction has been approved by a majority of our disinterested directors;
−Removed: have not had more than 300 shareholders of record at any time during the three years preceding the date the affiliated transaction is
−Removed: if the interested shareholder has been the beneficial owner of at least 80% of our outstanding voting shares for at least
−Removed: three years preceding the date the affiliated transaction is announced;
−Removed: or if the consideration to be paid to the holders of each class
−Removed: or series of voting shares in the affiliated transaction meets certain requirements of the statute with respect to form and amount, among
−Removed: other things.
−Removed: the control share acquisition statute and the affiliated transactions statute may have the effect of discouraging or preventing certain
−Removed: change of control or takeover transactions involving us.
−Removed: addition, our amended and restated articles of incorporation and amended and restated bylaws contain provisions that may make it more
−Removed: difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our shareholders, including
−Removed: transactions in which shareholders might otherwise receive a premium for their shares.
+Added: An “interested shareholder” is generally
+Added: defined as any person who is the beneficial owner of more than 15% of our outstanding voting shares.
+Added: The voting requirements set forth above do not
+Added: apply to a particular affiliated transaction if one or more conditions are met, including, but not limited to, the following:
+Added: affiliated transaction has been approved by a majority of our disinterested directors;
+Added: if we have not had more than 300 shareholders
+Added: of record at any time during the three years preceding the date the affiliated transaction is announced;
+Added: if the interested shareholder
+Added: has been the beneficial owner of at least 80% of our outstanding voting shares for at least three years preceding the date the affiliated
+Added: transaction is announced;
+Added: or if the consideration to be paid to the holders of each class or series of voting shares in the affiliated
+Added: transaction meets certain requirements of the statute with respect to form and amount, among other things.
+Added: Both the control share acquisition statute and
+Added: the affiliated transactions statute may have the effect of discouraging or preventing certain change of control or takeover transactions
+Added: involving us.
+Added: In addition, our amended and restated articles
+Added: of incorporation and amended and restated bylaws contain provisions that may make it more difficult for a third party to acquire us or
+Added: increase the cost of acquiring us, even if doing so would benefit our shareholders, including transactions in which shareholders might
+Added: otherwise receive a premium for their shares.
These provisions include:
9 unchanged sentences
directors will only be able to be removed for cause;
−Removed: amended and restated articles of incorporation authorizes undesignated preferred stock, the terms of which may be established and
+Added: amended and restated articles of incorporation authorize undesignated preferred stock, the terms of which may be established and
shares of which may be issued, without the approval of the holders of our capital stock;
litigation against us can only be brought in Florida.
−Removed: provisions could discourage, delay or prevent a transaction involving a change in control of our company.
−Removed: These provisions could also
−Removed: discourage proxy contests and make it more difficult for you and other shareholders to elect directors of your choosing and cause us
−Removed: to take corporate actions other than those you desire.
+Added: These provisions could discourage, delay or prevent
+Added: a transaction involving a change in control of our company.
+Added: These provisions could also discourage proxy contests and make it more difficult
+Added: for you and other shareholders to elect directors of your choosing and cause us to take corporate actions other than those you desire.
See “Description of Capital Stock.”
−Removed: amended and restated bylaws designates the state courts located within the state of Florida as the exclusive forum for substantially
−Removed: all disputes between us and our shareholders and the federal district courts as the exclusive forum for Securities Act claims, which
−Removed: could limit our shareholders’ ability to obtain a favorable judicial forum for disputes with us.
−Removed: amended and restated bylaws provide that, unless we consent in writing to the selection of an alternative forum, the sole and exclusive
−Removed: forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty
−Removed: owed by any of our current or former directors, officers or other employees to us or our shareholders, (iii) any action arising pursuant
−Removed: to any provision of the FBCA, our amended and restated articles of incorporation or our amended and restated bylaws, or (iv) any other
−Removed: action asserting a claim that is governed by the internal affairs doctrine shall be a state court located within the state of Florida
−Removed: (or, if a state court located within the state of Florida does not have jurisdiction, the federal district court for the Middle District
−Removed: provided that, the exclusive forum provision will not apply to suits brought to enforce any liability or duty created by
−Removed: the Exchange Act, or to any claim for which the federal courts have exclusive jurisdiction.
−Removed: Our amended and restated bylaws also provide
−Removed: that, unless we consent in writing to the selection of an alternative forum, the U.S.
−Removed: federal district courts shall be the exclusive
−Removed: forum for the resolution of any claims arising under the Securities Act.
−Removed: Under the Securities Act, federal and state courts have concurrent
−Removed: jurisdiction over all suits brought to enforce any duty or liability created by the Securities Act, and our stockholders cannot waive
−Removed: compliance with the federal securities laws and the rules and regulations thereunder.
−Removed: Accordingly, there is uncertainty as to whether
−Removed: a court would enforce such a forum selection provision as written in connection with claims arising under the Securities Act.
−Removed: becoming a shareholder in our company, you will be deemed to have notice of and have consented to the provisions of our amended and restated
−Removed: bylaws related to choice of forum.
−Removed: The choice of forum provisions in our amended and restated bylaws may limit our shareholders’
−Removed: ability to obtain a favorable judicial forum for disputes with us.
−Removed: Additionally, the enforceability of choice of forum provisions in
−Removed: other companies’ governing documents has been challenged in legal proceedings, and it is possible that, in connection with any
−Removed: applicable action brought against us, a court could find the choice of forum provisions contained in our amended and restated bylaws
−Removed: to be inapplicable or unenforceable in such action.
−Removed: If so, we may incur additional costs associated with resolving such action in other
−Removed: jurisdictions, which could harm our business, results of operations, and financial condition.
−Removed: or industry analysts may not regularly publish reports on us, which could cause the price of our securities or trading volumes to decline.
−Removed: trading market for our securities could be influenced by research and reports that industry and/or securities analysts may publish us,
−Removed: our business, the market or our competitors.
−Removed: We do not have any control over these analysts and cannot be assured that such analysts
−Removed: will cover us or provide favorable coverage.
−Removed: If any of the analysts who may cover our business change their recommendation regarding
−Removed: our securities adversely, or provide more favorable relative recommendations about our competitors, the price of our securities would
−Removed: likely decline.
−Removed: If any analysts who may cover our business were to cease coverage or fail to regularly publish reports on us, we could
−Removed: lose visibility in the financial markets, which in turn could cause the price of our securities or trading volumes to decline.
−Removed: will likely conduct further offerings of our equity securities in the future, in which case your proportionate interest may become diluted.
+Added: Our amended and
+Added: restated bylaws designate the state courts located within the state of Florida as the exclusive forum for substantially all disputes
+Added: between us and our shareholders and the federal district courts as the exclusive forum for Securities Act claims, which could limit our
+Added: shareholders’ ability to obtain a favorable judicial forum for disputes with us.
+Added: Our amended and restated bylaws provide that,
+Added: unless we consent in writing to the selection of an alternative forum, the sole and exclusive forum for (i) any derivative action or
+Added: proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our current or former
+Added: directors, officers or other employees to us or our shareholders, (iii) any action arising pursuant to any provision of the FBCA, our
+Added: amended and restated articles of incorporation or our amended and restated bylaws, or (iv) any other action asserting a claim that is
+Added: governed by the internal affairs doctrine shall be a state court located within the state of Florida (or, if a state court located within
+Added: the state of Florida does not have jurisdiction, the federal district court for the Middle District of Florida);
+Added: provided that, the exclusive
+Added: forum provision will not apply to suits brought to enforce any liability or duty created by the Exchange Act, or to any claim for which
+Added: the federal courts have exclusive jurisdiction.
+Added: Our amended and restated bylaws also provide that, unless we consent in writing to the
+Added: selection of an alternative forum, the U.S.
+Added: federal district courts shall be the exclusive forum for the resolution of any claims arising
+Added: under the Securities Act.
+Added: Under the Securities Act, federal and state courts have concurrent jurisdiction over all suits brought to enforce
+Added: any duty or liability created by the Securities Act, and our stockholders cannot waive compliance with the federal securities laws and
+Added: the rules and regulations thereunder.
+Added: Accordingly, there is uncertainty as to whether a court would enforce such a forum selection provision
+Added: as written in connection with claims arising under the Securities Act.
+Added: By becoming a shareholder in our company, you
+Added: will be deemed to have notice of and have consented to the provisions of our amended and restated bylaws related to choice of forum.
+Added: The choice of forum provisions in our amended and restated bylaws may limit our shareholders’ ability to obtain a favorable judicial
+Added: forum for disputes with us.
+Added: Additionally, the enforceability of choice of forum provisions in other companies’ governing documents
+Added: has been challenged in legal proceedings, and it is possible that, in connection with any applicable action brought against us, a court
+Added: could find the choice of forum provisions contained in our amended and restated bylaws to be inapplicable or unenforceable in such action.
+Added: If so, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, results
+Added: of operations, and financial condition.
+Added: Securities or industry analysts may not
+Added: regularly publish reports on us, which could cause the price of our securities or trading volumes to decline.
+Added: The trading market for our securities could be
+Added: influenced by research and reports that industry and/or securities analysts may publish about us, our business, the market or our competitors.
+Added: We do not have any control over these analysts and cannot be assured that such analysts will cover us or provide favorable coverage.
+Added: If any of the analysts who may cover our business change their recommendation regarding our securities adversely, or provide more favorable
+Added: relative recommendations about our competitors, the price of our securities would likely decline.
+Added: If any analysts who may cover our business
+Added: were to cease coverage or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could
+Added: cause the price of our securities or trading volumes to decline.
+Added: We will likely conduct further offerings
+Added: of our equity securities in the future, in which case your proportionate interest may become diluted.
will likely be required to conduct equity offerings in the future to finance our current projects or to finance subsequent projects that
6 unchanged sentences
interest in us could become diluted.
−Removed: may issue shares of preferred stock in the future, which could make it difficult for another company to acquire us or could otherwise
−Removed: adversely affect holders of our common stock, which could depress the price of our common stock.
−Removed: certificate of incorporation authorizes us to issue one or more series of preferred stock.
−Removed: Our board of directors will have the authority
−Removed: to determine the preferences, limitations and relative rights of the shares of preferred stock and to fix the number of shares constituting
−Removed: any series and the designation of such series, without any further vote or action by our shareholders.
−Removed: Our preferred stock could be issued
−Removed: with voting, liquidation, dividend and other rights superior to the rights of our common stock.
−Removed: The potential issuance of preferred stock
−Removed: may delay or prevent a change in control of us, discouraging bids for our common stock at a premium to the market price, and materially
−Removed: adversely affect the market price and the voting and other rights of the holders of our common stock.
−Removed: have never declared or paid any cash dividends or distributions on our capital stock.
−Removed: We do not anticipate paying any cash dividends
−Removed: on our common stock in the foreseeable future.
−Removed: have never declared or paid any cash dividends or distributions on our capital stock.
−Removed: We currently intend to retain our future earnings,
−Removed: if any, to support operations and to finance expansion and therefore we do not anticipate paying any cash dividends on our common stock
−Removed: in the foreseeable future.
−Removed: declaration, payment and amount of any future dividends will be made at the discretion of the board of directors, and will depend upon,
−Removed: among other things, the results of our operations, cash flows and financial condition, operating and capital requirements, and other
−Removed: factors as the board of directors considers relevant.
−Removed: There is no assurance that future dividends will be paid, and, if dividends are
−Removed: paid, there is no assurance with respect to the amount of any such dividend.
+Added: We may issue shares of preferred stock
+Added: in the future, which could make it difficult for another company to acquire us or could otherwise adversely affect holders of our common
+Added: stock, which could depress the price of our common stock.
+Added: Our certificate of incorporation authorizes us
+Added: to issue one or more series of preferred stock.
+Added: Our board of directors will have the authority to determine the preferences, limitations
+Added: and relative rights of the shares of preferred stock and to fix the number of shares constituting any series and the designation of such
+Added: series, without any further vote or action by our shareholders.
+Added: Our preferred stock could be issued with voting, liquidation, dividend
+Added: and other rights superior to the rights of our common stock.
+Added: The potential issuance of preferred stock may delay or prevent a change
+Added: in control of us, discouraging bids for our common stock at a premium to the market price, and materially adversely affect the market
+Added: price and the voting and other rights of the holders of our common stock.
+Added: We have never declared or paid any cash
+Added: dividends or distributions on our capital stock.
+Added: We do not anticipate paying any cash dividends on our common stock in the foreseeable
+Added: We have never declared or paid any cash dividends
+Added: or distributions on our capital stock.
+Added: We currently intend to retain our future earnings, if any, to support operations and to finance
+Added: expansion and therefore we do not anticipate paying any cash dividends on our common stock in the foreseeable future.
+Added: The declaration, payment and amount of any future
+Added: dividends will be made at the discretion of the board of directors, and will depend upon, among other things, the results of our operations,
+Added: cash flows and financial condition, operating and capital requirements, and other factors as the board of directors considers relevant.
+Added: There is no assurance that future dividends will be paid, and, if dividends are paid, there is no assurance with respect to the amount
+Added: of any such dividend.
+Added: Risks Related to the planned merger with TELI
+Added: Because TELI has a limited operating history,
+Added: you may not be able to accurately evaluate TELI’s operations.
+Added: TELI has had no operations to date, and therefore,
+Added: TELI has a limited operating history upon which to evaluate the merits of investing in TELI.
+Added: Potential investors should be aware of the
+Added: difficulties normally encountered by new companies and the high rate of failure of such enterprises.
+Added: The likelihood of success must be
+Added: considered in light of the problems, expenses, difficulties, complications, and delays encountered in connection with the operations
+Added: that TELI plans to undertake.
+Added: These potential problems include, but are not limited to, unanticipated problems relating to the ability
+Added: to generate sufficient cash flow to operate TELI’s business, and additional costs and expenses that may exceed current estimates.
+Added: TELI expects to continue to incur significant losses into the foreseeable future.
+Added: TELI recognizes that if the effectiveness of its business
+Added: plan is not forthcoming, it will not be able to continue business operations.
+Added: There is no history upon which to base any assumption as
+Added: to the likelihood that TELI will prove successful, and it is doubtful that TELI will generate any operating revenues or ever achieve
+Added: profitable operations.
+Added: If TELI is unsuccessful in addressing these risks, TELI’s business will most likely fail.
+Added: TELI is an early development-stage company
+Added: with no revenues.
+Added: As a very early development-stage enterprise
+Added: that is focused on the development of a pre-clinical pharmaceutical product, TELI has generated no revenue to date.
+Added: There can be no assurance
+Added: that TELI will be successful in obtaining sufficient funding on terms acceptable to it to fund continuing operations, if at all, identify
+Added: and enter into any strategic transactions that will provide the capital that TELI will require or achieve the other strategies to alleviate
+Added: the conditions that raise substantial doubt about TELI’s ability to continue as a going concern.
+Added: The failure to obtain sufficient
+Added: capital on acceptable terms when needed may require TELI to delay, limit, or eliminate the development of business opportunities and
+Added: TELI’s ability to achieve its business objectives.
+Added: Any of such failures will materially adversely affect TELI’s competitiveness,
+Added: and TELI’s business, financial condition, and results of operations.
+Added: In addition, the perception that TELI may not be able to continue
+Added: as a going concern may cause others to choose not to deal with it due to concerns about TELI’s ability to meet TELI’s contractual
+Added: TELI has significant and increasing liquidity
+Added: needs and will require additional funding.
+Added: Research and development, general and administrative
+Added: expenses and cash used for operations will continue to be significant and may increase substantially in the future in connection with
+Added: new research and development initiatives and continued product commercialization efforts.
+Added: Following the Merger, the combined company
+Added: will need to raise additional capital to fund its operations, continue clinical trials to support potential regulatory approval of marketing
+Added: applications and to fund commercialization of its products.
+Added: Operating results may vary significantly
+Added: in future periods.
+Added: Following the Merger, the combined company’s
+Added: operating and financial results are likely to fluctuate significantly in the future.
+Added: TELI’s operating and financial results are
+Added: unpredictable and may fluctuate, for among other reasons, due to:
+Added: achievement of product development objectives and milestones;
+Added: trial enrollment and expenses;
+Added: and development expenses;
+Added: timing and nature of contract manufacturing and contract research payments.
+Added: In addition, a high portion of TELI’s costs
+Added: are determined on an annual basis, due in part to TELI’s significant research and development costs.
+Added: Thus, increases in TELI’s
+Added: costs could disproportionately affect financial results in a quarter.
+Added: Other factors, including non-cash expenses associated with financing
+Added: activity, could also lead to fluctuations in TELI’s results of operations.
+Added: Because of these factors, TELI’s operating and
+Added: financial results in one or more future quarters may fail to meet the expectations of securities analysts or investors, which could cause
+Added: TELO’s share price to decline.
+Added: TELI has yet to generate revenues or achieve
+Added: a profit and may not generate revenue or achieve a profit for many years, if at all.
+Added: TELI has not yet produced any revenues or profit
+Added: and may not for many years, if at all.
+Added: TELI’s ability to generate revenue is dependent on the receipt of regulatory approval of
+Added: TELI’s product candidates, which will take years to achieve and may not be obtained.
+Added: We therefore cannot assure you TELI will be
+Added: able to ever generate sufficient revenue to pay for TELI’s expenses or achieve profitability.
+Added: TELI’s ability to continue
+Added: as a going concern in the future is dependent upon raising capital from financing transactions and keeping operating expenses below TELI’s
+Added: revenue levels in order to achieve positive cash flows, none of which can be assured.
+Added: TELI does not own rights to Telomir-1
+Added: All of TELI’s rights in Telomir-1 are granted
+Added: to it under a license (“License”) from MIRALOGX LLC, a Florida corporation (“Licensor”), so TELI does not have
+Added: an ownership interest in Telomir-1.
+Added: The License gives TELI the right to make, use and sell Telomir-1 outside the United States.
+Added: If TELI breaches the License or if the Licensor goes
+Added: bankrupt, TELI could lose its rights to Telomir-1 and all of such rights would revert back to the Licensor.
+Added: Further, Licensor will control
+Added: the process of applying for and obtaining any patents or other intellectual property rights in Telomir-1, all at the expense of TELI.
+Added: All of such patents and intellectual rights will be owned by Licensor, subject to TELI’s rights under the License.
+Added: TELI has no control over the patent prosecution strategy, which is fully managed by the Licensor.
+Added: TELI’s rights to Telomir-1 are subject
+Added: to royalties.
+Added: TELI entered into an exclusive licensing agreement
+Added: with MIRALOGX for the licensing by MIRALOGX to TELI the international commercial rights of Telomir-1 (the “Telomir-1 Licensing
+Added: Agreement”) in the United States, Mexico and Canada.
+Added: Under the Telomir-1 Licensing Agreement TELI will owe MIRALOGX a royalty of
+Added: 8% on all revenue it receives from Telomir-1, with a minimum annual royalty of $250,000 that begins in the first year that there is any
+Added: revenue from Telomir-1.
+Added: This $250,000 will be owed even if in any later year there is no revenue from Telomir-1 or if the 8% royalty
+Added: rate on actual revenues yields less than $250,000.
+Added: TELI’s failure to pay minimum royalties in any year would be a breach of the
+Added: Telomir-1 Licensing Agreement and such breach would let the Licensor terminate TELI’s rights to Telomir-1.
+Added: Conflicts of interest may arise between
+Added: TELI and MIRALOGX.
+Added: MIRALOGX is the licensor of TELI’s rights
+Added: to Telomir-1.
+Added: MIRALOGX is a separate intellectual property development company owned by the Bayshore Trust.
+Added: The Bayshore Trust is also
+Added: TELI’s largest stockholder.
+Added: MIRALOGX is 100% owned by the Bayshore Trust.
+Added: TELI’s relationship with MIRALOGX and the Bayshore
+Added: Trust may create, or may create the appearance of, conflicts of interest when TELI is faced with decisions that benefit MIRALOGX but
+Added: do not benefit other holders of TELO Common Stock.
+Added: Furthermore, in light of the license agreement that TELI has with MIRALOGX, if a dispute
+Added: were to arise between MIRALOGX and TELO relating to TELI’s past or future relationship with MIRALOGX or with respect to intellectual
+Added: property matters, there could be a conflict of interest that may make it more difficult for TELI to resolve such disputes on terms that
+Added: are acceptable to TELI.
+Added: TELI’s product candidates, if approved,
+Added: may not achieve the expected market acceptance and, consequently, limit TELI’s ability to generate revenue.
+Added: Even when product development is successful and
+Added: regulatory approval has been obtained, TELI’s ability to generate sufficient revenue depends on the acceptance of its products
+Added: by physicians and patients.
+Added: There is no assurance that TELI’s product candidates will achieve the expected level of market acceptance
+Added: and revenue if and when they obtain the requisite regulatory approvals.
+Added: The market acceptance of any product depends on a number of factors,
+Added: including the indication statement and warnings required by regulatory authorities in the product label.
+Added: Market acceptance can also be
+Added: influenced by continued demonstrations of efficacy and safety in commercial use, physicians’ willingness to prescribe the product,
+Added: reimbursement from third-party payers such as government health care programs and private third-party payers, the price of the product,
+Added: the nature of any post-approval risk management activities mandated by regulatory authorities, competition, and marketing and distribution
+Added: Further, an ineffective or inefficient distribution model at launch may lead to the inability to fulfill demand, and consequently
+Added: a loss of revenue.
+Added: Any factors preventing or limiting the market acceptance of TELI’s products could have a material adverse effect
+Added: on TELI’s business, results of operations and financial condition.
+Added: If the price for any future approved products
+Added: decreases or if government and other third-party payers do not provide coverage and adequate reimbursement levels, TELI’s revenue
+Added: and prospects for profitability will suffer.
+Added: Patients who are prescribed medicine for the
+Added: treatment of their conditions generally rely on third-party payers to reimburse all or part of the costs associated with their prescription
+Added: Reimbursement systems in international markets vary significantly by country and by region, and reimbursement approvals generally
+Added: must be obtained on a country-by-country basis.
+Added: Coverage and adequate reimbursement from governmental healthcare programs, such as Medicare
+Added: and Medicaid, and commercial payers is critical to new product acceptance.
+Added: Coverage decisions may depend upon clinical and economic standards
+Added: that disfavor new drug products when more established or lower-cost therapeutic alternatives are already available or subsequently become
+Added: Even if TELI obtains coverage for products TELI may market, the resulting reimbursement payment rates may require co-payments
+Added: that patients find unacceptably high.
+Added: Patients may not use TELI’s products if coverage is not provided, or reimbursement is inadequate
+Added: to cover a significant portion of their cost.
+Added: In addition, the market for TELI’s products
+Added: will depend significantly on access to third-party payers’ drug formularies or lists of medications for which third-party payers
+Added: provide coverage and reimbursement.
+Added: The industry competition to be included in such formularies often leads to downward pricing pressures
+Added: on pharmaceutical companies.
+Added: Also, third-party payers may refuse to include a particular branded drug in their formularies or otherwise
+Added: restrict patient access to a branded drug when a less costly generic equivalent or other alternative is available, even if not approved
+Added: for the indications for which TELI’s products are approved.
+Added: Third-party payers or governmental or commercial
+Added: entities are developing increasingly sophisticated methods of controlling healthcare costs.
+Added: The current environment is putting pressure
+Added: on companies to price products below what they may feel is appropriate.
+Added: Selling TELI’s products at less than an optimized price
+Added: could impact its revenues and overall success as a company.
+Added: It will be difficult to determine the optimized price for TELI’s products.
+Added: In addition, in the U.S., no uniform policy of coverage and reimbursement for drug products exists among third-party payers.
+Added: coverage and reimbursement for its products may differ significantly from payer to payer.
+Added: As a result, the coverage determination process
+Added: is often a time-consuming and costly process that will require TELI to provide scientific and clinical support for the use of its products
+Added: to each payer separately, with no assurance that coverage will be obtained.
+Added: If TELI is unable to obtain coverage of, and adequate payment
+Added: levels for, products we may market to third-party payers, physicians may limit how much or under what circumstances they will prescribe
+Added: or administer them, and patients may decline to purchase them.
+Added: This in turn could affect TELI’s ability to successfully commercialize
+Added: products we may market, and thereby adversely impact TELI’s profitability, results of operations, financial condition, and future
+Added: In addition, where TELI has chosen to collaborate
+Added: with a third party on product candidate development and commercialization, TELI’s partner may elect to reduce the price of its
+Added: products in order to increase the likelihood of obtaining reimbursement approvals.
+Added: In many countries, products cannot be commercially
+Added: launched until reimbursement is approved and the negotiation process in some countries can exceed 12 months.
+Added: In addition, pricing and
+Added: reimbursement decisions in certain countries can be affected by decisions taken in other countries, which can lead to mandatory price
+Added: reductions and/or additional reimbursement restrictions across a number of other countries, which may thereby adversely affect TELI’s
+Added: sales and profitability.
+Added: In the event that countries impose prices that are not sufficient to allow TELI or its partners to generate
+Added: a profit, TELI’s partners may refuse to launch the product in such countries or withdraw the product from the market, which would
+Added: adversely affect sales and profitability.
+Added: Events, such as price decreases, government mandated rebates or unfavorable reimbursement decisions,
+Added: could affect the pricing and reimbursement of TELI’s products and its other product candidates and could have a material adverse
+Added: effect on TELI’s business, reputation, results of operations and financial condition.
+Added: TELI expects to face intense competition,
+Added: often from companies with greater resources and experience.
+Added: Demand for TELI’s product candidates will
+Added: likely be dependent on a number of social, political, legislative, and economic factors that are beyond its control.
+Added: While we believe
+Added: that there will be a demand for such drugs, and that the demand will grow, there is no assurance that such demand will happen, that we
+Added: will benefit from any demand or that its business, in fact, will ever generate revenues from its drug development programs or become
+Added: The emerging markets for product candidates like
+Added: TELI’s and related medical research and development are and will likely remain competitive.
+Added: The development and commercialization
+Added: of drugs and medicines is highly competitive.
+Added: TELI competes with a variety of multinational pharmaceutical companies and specialized
+Added: biotechnology companies, as well as products and processes being developed by universities and other research institutions.
+Added: Many of TELI’s
+Added: competitors have developed, are developing, or will develop drugs and processes which may be competitive with TELI’s drug candidates.
+Added: Competitive therapeutic treatments include those that have already been approved by medicines regulators and accepted by the medical
+Added: community and any new treatments that may enter the market.
+Added: For some of TELI’s drug development programs / areas of therapeutic
+Added: interest, other treatment options are currently available, under development, and may become commercially available in the future.
+Added: any of TELI’s product candidates are approved for the diseases and conditions TELI is currently pursuing, they may compete with
+Added: a range of medicines or therapeutic treatments that are either in development, will be developed in the future or currently marketed.
+Added: Established companies may have a competitive
+Added: advantage over TELI due to their size and experience, financial resources, and institutional networks.
+Added: Many of TELI’s competitors
+Added: may have significantly greater financial, technical, and human resources than TELI does.
+Added: Due to these factors, TELI’s competitors
+Added: may have an advantage in marketing their approved drugs and may obtain regulatory approval of their drug candidates before TELI is able
+Added: to, which may limit its ability to develop or commercialize TELI’s drug candidates.
+Added: TELI’s competitors may also develop drugs
+Added: / medicines that are safer, more effective, more widely used and less expensive than TELI’s.
+Added: These advantages could materially
+Added: impact TELI’s ability to develop and, if approved, commercialize TELI’s product candidates successfully.
+Added: Furthermore, some
+Added: of these competitors may make acquisitions or establish collaborative relationships among themselves or with third parties to increase
+Added: their ability to rapidly gain market share.
+Added: Moreover, as generic versions of drug products
+Added: enter the market, the price for such medicines may be expected to decline rapidly and substantially.
+Added: Even if Telomir-1 is the first to
+Added: obtain FDA approval of one of its product candidates, the future potential approval of generics could adversely affect the price TELI
+Added: is able to charge, and the profitability of TELI’s product(s) will likely decline.
+Added: Mergers and acquisitions in the pharmaceutical
+Added: and biotechnology industries may result in more resources being concentrated among a smaller number of TELI’s competitors.
+Added: and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large
+Added: and established companies.
+Added: These companies may compete with TELI in recruiting
+Added: and retaining qualified scientific, management and commercial personnel, utilizing contract manufacturing facilities or contract research
+Added: organizations (CROs), or establishing clinical trial sites and subject registration for clinical trials, as well as in acquiring technologies
+Added: complementary to TELI’s research projects.
+Added: There are several conflicts of interests
+Added: inherent in the Merger.
+Added: Several beneficial owners of TELI, are also related
+Added: parties of Telomir.
+Added: For example, our Chief Executive Officer, Erez Aminov, and owner of 5,369,860 shares of Telomir also holds a beneficial
+Added: ownership interest of 7,919,710 shares, or 23%, on a fully diluted basis, of TELI.
+Added: Furthermore, shares of Telomir are held by several
+Added: trusts or individuals, also own shares of TELI.
+Added: Specifically, (i) Bayshore Trust, holders of 5,406,431 shares of TELO, on a fully diluted
+Added: basis, hold 10,798,767 shares of Telomir, or 31.4% on a fully diluted basis, and (ii) the Celeste J Williams Lifetime QTIP Trust holds
+Added: of 1,853,659 shares of TELO and 1,000,000, or 2.9% shares of Telomir.
+Added: Following the Merger, Mr.
+Added: Aminov and Bayshore Trust are expected
+Added: to each beneficially own 13,289,570 and 16,205,198 shares of Telomir, respectively, or 19.32% and 23.56% shares of Telomir respectively.
+Added: Furthermore, several of the parties in the Merger
+Added: are related by marriage.
+Added: For example, Erez Aminov, CEO of each of TELI and Telomir, is the son-in-law of Jonny Williams Sr., the beneficiary
+Added: of the Bayshore Trust, and the largest shareholder of TELO, Telomir and the primary owner of MIRALOGX LLC, the licensor of Telomir-1
+Added: to each of TELI and Telomir.
+Added: Additionally, in connection with the approval
+Added: of the Merger, the Board previously adopted an Executive Compensation Plan that provides for certain performance-based compensation arrangements
+Added: for executive officers, including Erez Aminov, the Chief Executive Officer of TELO.
+Added: These arrangements may be tied to the successful
+Added: completion and overall value of the Merger.
+Added: This would be separate from the shares of TELI Common Stock issued to Mr.
+Added: connection with the Merger.
+Added: Following the Merger, the TELI shareholders
+Added: may potentially own a majority of TELO.
+Added: Following the issuance of the Merger Share Consideration,
+Added: at the Closing, pre-Merger holders of TELI may potentially own a majority of the post-Merger TELO shares.
+Added: Accordingly, after the completion
+Added: of the Merger, the current stockholders of TELI will own a smaller percentage of the post-Merger combined company than their ownership
+Added: of their respective companies prior to the Merger.
+Added: Immediately after the Merger, TELO securityholders as of immediately prior to the
+Added: Merger are currently estimated to own approximately 50% of the outstanding shares of the post-Merger company on a fully-diluted basis
+Added: and former TELI securityholders are currently estimated to own approximately 50% of the outstanding shares of the combined post-Merger
+Added: company on a fully-diluted basis.
+Added: There is no assurance when or if the Merger
+Added: will be completed.
+Added: The completion of the Merger is subject to the
+Added: satisfaction or waiver of a number of conditions as set forth in the Merger Agreement, including, among others, the receipt of the TELO
+Added: Stockholder Approval.
+Added: Further, at the time of the completion of the Merger, under the terms of the Merger Agreement, TELI must have cash
+Added: and marketable securities valued at $1 million.
+Added: There can be no assurance that any conditions, consents, clearances or approvals necessary
+Added: or advisable to be obtained in connection with the Merger will be obtained in a timely manner or at all, or whether they will be subject
+Added: to actions, conditions, limitations or restrictions that may jeopardize or delay the completion of the Transaction, materially reduce
+Added: or delay the anticipated benefits of the Merger or allow the parties to terminate the Merger Agreement.
+Added: The Merger Agreement may be terminated in certain
+Added: circumstances, including, among others, if the Merger has not been completed by the outside date of June 30, 2026 or if a governmental
+Added: entity of competent jurisdiction has issued or granted an order, judgment, decree, ruling or injunction that results in a permanent restraint
+Added: that has become final and nonappealable or imposes, as a final and nonappealable condition.
+Added: See “ The Merger Agreement—Termination.
+Added: The price of TELO’s common stock
+Added: is subject to fluctuations
+Added: The market price of TELO Common Stock is subject
+Added: to general price fluctuations in the market for publicly traded equity securities and has experienced volatility in the past.
+Added: changes may result from a variety of factors, including, among others, general market and economic conditions, changes in the businesses,
+Added: operations and prospects of TELI, and an evolving regulatory landscape.
+Added: Market assessments of the benefits of the Merger and the likelihood
+Added: that the Merger will be completed, as well as general and industry specific market and economic conditions, may also impact the market
+Added: price of TELI Common Stock.
+Added: Many of these factors are beyond TELI’s control.
+Added: You are encouraged to obtain current market price
+Added: quotations for TELO Common Stock before you determine how to vote on the Merger.
+Added: The Merger may be time-consuming to complete
+Added: and may not be completed in a timely manner, or at all, due to pending or potential litigation or regulatory challenges.
+Added: The proposed Merger and related transactions
+Added: may be challenged in court by shareholders or other interested parties.
+Added: While management believes any such claims would be without merit,
+Added: we may be subject to various lawsuits or other legal proceedings, including but not limited to shareholder class action lawsuits alleging
+Added: breaches of fiduciary duties related to the proposed transaction structure, valuation, conflicts of interest or disclosure.
+Added: to and defending against these claims can be time-consuming, expensive, and could divert management’s attention and resources away
+Added: from day-to-day business operations.
+Added: Further, government agencies, including antitrust
+Added: authorities, may seek to block, delay, or impose conditions on the Merger.
+Added: These regulatory reviews and filings are a common aspect of
+Added: mergers and acquisitions and are subject to significant costs, including substantial legal fees and potential judgments or settlements;
+Added: transaction delays or the inability to close the merger on the contemplated terms;
+Added: the imposition of burdensome conditions or restrictions
+Added: on the combined company’s operations;
+Added: or the termination of the Merger agreement altogether, which could have a material adverse
+Added: effect on our business, financial condition, and stock price.
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.