OS Therapies Inc

Previous wording

Our ability to become profitable depends upon our ability to generate revenue. To date, while we have generated significant interest in various research collaboration revenue, we have not generated any commercial revenue from our current core product candidates, including our lead core product candidate OST-HER2 and our other core product candidate OST-tADC, and we do not know and do not expect to generate any revenue from the sale of drugs in the near future. We do not expect to generate revenue unless and until we complete the development of, obtain marketing approval for, and begin to sell, OST-HER2, which is being evaluated in a Phase IIb clinical trial, or OST-tADC, which is still being evaluated at the preclinical stage. We are also unable to predict when, if ever, we will be able to generate revenue from such product candidates due to the numerous risks and uncertainties associated with drug development, including the uncertainty of:

Current wording

Our ability to achieve profitability depends on our ability to generate revenue from product sales. To date, while we have generated interest in potential research collaborations, we have not generated any commercial revenue from our product candidates, including our lead product candidate OST-HER2 and our OST-tADC platform. We do not expect to generate revenue from drug sales in the near future. We will not generate revenue unless and until we successfully complete the development of, obtain regulatory approval for, and commercialize one or more of our product candidates. Our lead product candidate, OST-HER2, has completed a Phase IIb clinical trial in patients with recurrent, fully resected pulmonary metastatic Osteosarcoma and we are currently pursuing regulatory interactions with the FDA and regulatory authorities in the United Kingdom and European Union regarding potential approval pathways. These pathways may include the FDA’s Accelerated Approval Program and conditional approval pathways in other jurisdictions. However, there can be no assurance that any such approvals will be granted, that confirmatory trials will be successful or that we will ultimately be able to commercialize OST-HER2. Our OST-tADC platform remains in the preclinical stage of development.

Previous wording

Since inception, we have focused substantially all of our efforts on the development of OST-HER2 and OST-tADC and our other clinical developments. To date, we have financed our operations primarily through the sale of convertible notes and other securities to outside investors. From July 2018 to April 2024, we raised an aggregate of approximately $19.2 million in gross proceeds from sales of our convertible notes. On July 31, 2024, we completed our initial public offering, raising $6.4 million in gross offering proceeds. From December 2024 through January 2025, we raised an aggregate of $7.1 million in gross proceeds from the Private Placement. Due to our significant research and development expenditures, we have experienced negative cash flows from operations, even in periods of operating income. For each of the years ended December 31, 2024 and 2023, we incurred a loss from operations and negative cash flows from operations. We expect to continue to incur significant expenses and operating losses over the next several years and for the foreseeable future. Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity and working capital. We expect our expenses to significantly increase in connection with our ongoing activities, as we:

Current wording

Since our inception, we have devoted substantially all of our resources to the research and development of our product candidates, including OST-HER2 and our OST-tADC platform. As a result, we have incurred significant operating losses and negative cash flows from operations. For each of the years ended December 31, 2025 and 2024, we incurred operating losses and negative cash flows from operations. Since July 2018, we have financed our operations primarily through public and private offerings of our securities, from which we have raised aggregate gross proceeds of approximately $41.1 million. We have not generated any revenue from product sales and do not expect to do so unless and until one or more of our product candidates receives regulatory approval and is successfully commercialized. We expect to continue to incur significant expenses and operating losses for the foreseeable future. Our historical losses, together with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity and working capital. Our expenses are expected to increase substantially as we:

Previous wording

We may seek additional capital through a combination of public and private equity offerings, including our Equity Line of Credit as well as other debt financings, strategic collaborations and alliances and licensing arrangements. The terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline. The sale of additional equity or convertible securities would dilute all of our stockholders. The incurrence of indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required to seek funds through arrangements with collaborators or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or current or future product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.

Current wording

We may seek additional capital through a combination of public and private securities offerings, including our at-the-market offering program, as well as other debt financings, strategic collaborations and alliances and licensing arrangements. The terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline. The sale of additional equity or convertible securities would dilute all of our stockholders. The incurrence of indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required to seek funds through arrangements with collaborators or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or current or future product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.

Previous wording

Our financial statements do not include any adjustments that might result from the outcome of this uncertainty. We will need to raise additional capital to fund our future operations and remain a going concern. However, we cannot guarantee that we will be able to obtain sufficient additional funding or that such funding, if available, will be obtainable on terms favorable to us. In the event that we are unable to obtain sufficient additional funding, there can be no assurance that we will be able to continue as a going concern.

Current wording

We will need to raise substantial additional capital to fund our operations and remain a going concern. However, we cannot guarantee that we will be able to obtain sufficient additional funding or that such funding, if available, will be obtainable on acceptable terms. If we are unable to raise additional capital or otherwise address our liquidity needs, we may be required to significantly delay, scale back or discontinue the development of our product candidates, including OST-HER2, or otherwise curtail our operations. In such case, there can be no assurance that we will be able to continue as a going concern. In addition, the inclusion of a going concern explanatory paragraph in our auditor’s report may adversely affect our ability to obtain financing on acceptable terms, or at all, and could negatively impact the market price of our common stock.

Previous wording

Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an “ownership change” (generally defined as a greater than 50 percentage points (by value) in the ownership of its equity over a three-year period), the corporation’s ability to use its pre-change tax attributes to offset its post-change income may be limited. We have experienced such ownership changes in the past, and we may experience ownership changes in the future as a result of this offering or subsequent shifts in our stock ownership, some of which are outside our control. As of December 31, 2024 and 2023, we had federal and state NOLs of approximately $22,236,580 and $16,269,893, respectively, federal and state research and development tax credits of $268,568 and $268,568, respectively, and general business credit carryforwards of approximately $1,672,876 and $1,408,963, respectively. Our ability to utilize these NOLs and tax credit carryforwards may be limited by an “ownership change.” If we undergo future ownership changes, many of which may be outside of our control, our ability to utilize our NOLs and tax credit carryforwards could be further limited by Sections 382 and 383 of the Code. There is also a risk that due to regulatory changes, such as suspensions on the use of NOLs, or other unforeseen reasons, our existing NOLs could expire or otherwise become unavailable to offset future income tax liabilities. Additionally, our NOLs and tax credit carryforwards could be limited under state law. For these reasons, even if we attain profitability, we may be unable to use a material portion of our NOLs and other tax attributes.

Current wording

Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an “ownership change” (generally defined as a greater than 50 percentage points (by value) in the ownership of its equity over a three-year period), the corporation’s ability to use its pre-change tax attributes to offset its post-change income may be limited. We have experienced such ownership changes in the past, and we may experience ownership changes in the future as a result of this offering or subsequent shifts in our stock ownership, some of which are outside our control. As of December 31, 2025 and 2024, we had federal and state NOLs of approximately $33,561,091 and $22,236,580, respectively, federal and state research and development tax credits of $268,568 and $268,568, respectively, and general business credit carryforwards of approximately $3,492,199 and $1,672,876, respectively. Our ability to utilize these NOLs and tax credit carryforwards may be limited by an “ownership change.” If we undergo future ownership changes, many of which may be outside of our control, our ability to utilize our NOLs and tax credit carryforwards could be further limited by Sections 382 and 383 of the Code. There is also a risk that due to regulatory changes, such as suspensions on the use of NOLs, or other unforeseen reasons, our existing NOLs could expire or otherwise become unavailable to offset future income tax liabilities. Additionally, our NOLs and tax credit carryforwards could be limited under state law. For these reasons, even if we attain profitability, we may be unable to use a material portion of our NOLs and other tax attributes.

Previous wording

We currently have no product candidates approved for sale and may never be able to develop marketable product candidates. Our business depends heavily on the successful development, regulatory approval and commercialization of the current or future immunotherapy for Osteosarcoma product candidates, of which our lead product candidate, OST-HER2, is in Phase IIb clinical development. OST-tADC will require additional preclinical development and substantial clinical development, testing and regulatory approval before we are permitted to commence its commercialization. The preclinical studies and clinical trials of our current or future product candidates are, and the manufacturing and marketing of our current or future product candidates will be, subject to extensive and rigorous review and regulation by numerous government authorities in the United States and in other countries where we intend to test or, if approved, market any of our current or future product candidates. Before obtaining regulatory approvals for the commercial sale of any of our current or future product candidates, we must demonstrate through preclinical studies and clinical trials that each product candidate is safe and effective for use in each target indication. Drug development is a long, expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical trials. This process can take many years and may include post-marketing studies and surveillance, which will require the expenditure of substantial resources beyond the proceeds we raise in this offering. Of the large number of drugs in development in the United States, only a small percentage will successfully complete the FDA regulatory approval process and will be commercialized, with similarly low rates of success for drugs in development in the European Union obtaining regulatory approval from the European Medicines Agency (EMA). Accordingly, even if we are able to obtain the requisite financing to continue to fund our development and preclinical studies and clinical trials, we cannot assure you that any of our current or future product candidates will be successfully developed and commercialized.

Current wording

We currently have no products approved for sale and may never successfully develop marketable product candidates. Our business depends heavily on the successful development, regulatory approval, and commercialization of our current and future immunotherapy product candidates for Osteosarcoma, of which our lead candidate, OST-HER2, is in Phase IIb clinical development. OST-tADC remains in preclinical development and will require substantial additional preclinical and clinical testing, as well as regulatory approvals, before we may commercialize it. The preclinical studies and clinical trials of our product candidates, as well as the manufacturing and marketing of any approved product, are subject to extensive and rigorous regulation by government authorities in the United States, the European Economic Area (EEA), and other jurisdictions in which we intend to test or market our product candidates. Before obtaining regulatory approvals, we must demonstrate through preclinical studies and clinical trials that each product candidate is safe and effective for its intended indication. Drug development is a lengthy, expensive, and uncertain process, and delay or failure can occur at any stage. Even with sufficient funding, there can be no assurance that any of our product candidates will be successfully developed, approved, or commercialized.

Previous wording

We are not permitted to market our current or future product candidates in the United States until we receive approval of a BLA from the FDA CBER, in the European Economic Area (EEA) until we receive approval of a marketing authorization applications (MAA) from the EMA, or in any other foreign countries until we receive the requisite approval from such countries. Obtaining approval of a BLA or MAA is a complex, lengthy, expensive and uncertain process, and the FDA or EMA may delay, limit or deny approval of any of our current or future product candidates for many reasons, including, among others:

Current wording

We cannot market our product candidates in the United States without approval of a BLA from the FDA, in the EEA without approval of a MAA from the EMA, or in other foreign jurisdictions without the requisite approvals. Obtaining regulatory approval is complex, time-consuming, costly, and uncertain, and the FDA, EMA, or other foreign authorities may delay, limit, or deny approval for many reasons, including but not limited to:

Previous wording

We may not be able to initiate or continue clinical trials for our current or future product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or similar regulatory authorities outside the United States. In particular, because we are focused on patients with rare Osteosarcoma, our ability to enroll eligible patients may be limited or may result in slower enrollment than we anticipate. Some of our competitors have ongoing clinical trials for current or future product candidates that treat the same patient populations as our current or future product candidates, and patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ current or future product candidates.

Current wording

We may not be able to initiate or continue clinical trials for our current or future product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or similar regulatory authorities outside the United States. This challenge is particularly significant because we are focused on patients with rare Osteosarcoma, which has a relatively low prevalence, with an incident rate of approximately 1,000 individuals affected per year in the United States. Identifying patients who meet our eligibility criteria, including those with specific molecular or driver gene profiles, may be difficult and could lead to slower-than-expected enrollment. Some of our competitors have ongoing clinical trials for current or future product candidates that treat the same patient populations as our current or future product candidates, and patients who would otherwise be eligible for our clinical trials may instead enroll in clinical trials of our competitors’ current or future product candidates.

Previous wording

If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals both for our current or future product candidates, we will not be able to commercialize, or will be delayed in commercializing, our current or future product candidates, and our ability to generate revenue will be materially impaired.

Current wording

If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for both our current or future product candidates, we will not be able to commercialize, or will be delayed in commercializing, our current or future product candidates, and our ability to generate revenue will be materially impaired.

Previous wording

The process of obtaining regulatory approvals, both in the United States and abroad, is expensive, may take many years if additional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the current or future product candidates involved. Changes in marketing approval requirements or policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted NDA or BLA. The FDA and comparable authorities in other countries have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies. Our current or future product candidates could be delayed in receiving, or fail to receive, regulatory approval for many reasons, including the following:

Current wording

The process of obtaining regulatory approvals, both in the United States and abroad, is expensive, may take many years if additional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the current or future product candidates involved. Changes in marketing approval requirements or policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted NDA or BLA. The FDA and comparable authorities in other countries have substantial discretion in the approval process and may refuse to accept any application or may decide that our data is insufficient for approval and require additional preclinical, clinical or other studies. Our current or future product candidates could be delayed in receiving, or fail to receive, regulatory approval for many reasons, including the following:

Previous wording

We may not be able to obtain or maintain orphan drug designation or exclusivity for any product candidates and, even if we do, that exclusivity may not prevent the FDA or EMA from approving other competing products.

Current wording

We may not be able to obtain or maintain orphan drug designation or exclusivity for any product candidates and, even if we do, that exclusivity may not prevent the FDA, EMA or other regulatory authorities from approving other competing products.

Previous wording

OST-HER2 received orphan drug designation for Osteosarcoma in the United States, and we may seek orphan drug designation (“ODD”) for other current or future product candidates. We are currently preparing to submit required information to the FDA in order to re-establish ODD for OST-HER2 in the first half of 2025. Regulatory authorities in some jurisdictions, including the United States and the European Union, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act of 1983, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States.

Current wording

OST-HER2 received orphan drug designation for Osteosarcoma in the United States, and we may seek orphan drug designation (“ODD”) for other current or future product candidates. We have submitted the required information to the FDA in order to re-establish ODD for OST-HER2 in 2026. Regulatory authorities in some jurisdictions, including the United States and the European Union, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act of 1983, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States.

Previous wording

Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the FDA or EMA from approving another marketing application for the same drug for that time period. The applicable period is seven years in the United States and ten years in the European Union. The exclusivity period in the European Union can be reduced to six years if a drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified. Orphan drug exclusivity may be lost if the FDA or EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.

Current wording

Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product may be entitled to a period of marketing exclusivity, during which the FDA or EMA generally cannot approve another marketing application for the same active ingredient for the same indication. The applicable period is seven years in the United States and ten years in the European Union, although EU exclusivity may be reduced to six years if a drug no longer meets the orphan criteria or is considered sufficiently profitable. Orphan drug exclusivity may be lost if the FDA or EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient drug supply to meet patient needs.

Previous wording

Even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because competing drugs containing a different active ingredient can be approved for the same condition. In addition, even after an orphan drug is approved, the FDA can subsequently approve the same drug for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care. Further, we may not be the first to obtain marketing approval for any particular orphan indication due to the uncertainties associated with developing pharmaceutical products, and thus, for example, approval of our product candidates could be blocked for seven years if another company previously obtained approval and orphan drug exclusivity in the United States for the same drug and same condition.

Current wording

Even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition. Drugs with different active ingredients can be approved for the same condition, and the FDA or EMA may approve the same drug for the same condition if a later product demonstrates clinical superiority, such as being safer, more effective, or making a major contribution to patient care. In addition, we may not be the first to obtain marketing approval for a particular orphan indication. Approval of another product for the same active ingredient and indication could prevent or delay our ability to obtain orphan drug exclusivity, materially affecting our competitive position.

Previous wording

Although we have obtained rare pediatric disease designation for OST-HER2 for Osteosarcoma patients, we may not be eligible to receive a priority review voucher in the event that FDA approval does not occur prior to September 30, 2026.

Current wording

Although we have obtained rare pediatric disease designation for OST-HER2 for Osteosarcoma patients, we may not be eligible to receive a priority review voucher in the event that FDA approval does not occur within the timeframe required by the applicable statutory provisions or if future law changes eliminate or further modify the PRV Program.

Previous wording

The Rare Pediatric Disease Priority Review Voucher Program (“PRV Program”) is intended to incentivize pharmaceutical sponsors to develop drugs for rare diseases. A sponsor who obtains approval of an NDA or BLA for a rare disease may be eligible for a Priority Review Voucher (“PRV”) under this program, which may be redeemed by the owner of such PRV to obtain priority review for a marketing application. A PRV is fully transferrable and can be sold to any sponsor, who in turn can redeem the PRV for priority review of a marketing application in six months, compared to the standard timeframe of approximately ten months. Under the 21 st Century Cures Act, a drug that receives rare disease designation before September 30, 2024, will continue to be eligible for a PRV if the drug is approved before September 30, 2026. If we do not obtain approval of a BLA for OST-HER2 in patients with Osteosarcoma, and if the PRV Program is not extended by Congressional action, we may not receive a PRV.

Current wording

The Rare Pediatric Disease Priority Review Voucher Program (“PRV Program”) is intended to incentivize pharmaceutical sponsors to develop drugs for rare diseases. A sponsor who obtains approval of an NDA or BLA for a rare disease may be eligible for a Priority Review Voucher (“PRV”) under this program, which may be redeemed by the owner of such PRV to obtain priority review for a marketing application. A PRV is fully transferrable and can be sold to any sponsor, who in turn can redeem the PRV for priority review of a marketing application in six months, compared to the standard timeframe of approximately ten months. Under current law, as amended by the Consolidated Appropriations Act, 2026, the PRV Program is authorized through September 30, 2029. The FDA may not award PRVs under this program after that date. Eligibility for a PRV generally requires both rare pediatric disease designation and approval of a marketing application for the designated rare pediatric disease. Even if OST-HER2 receives rare pediatric disease designation and is ultimately approved, we may not receive a PRV if the BLA is not approved in time to meet statutory requirements or if the PRV Program is subsequently modified or allowed to expire. In addition, even if we are eligible for and obtain a PRV, there can be no assurance that we will be able to realize significant value from the voucher, as the market for PRVs and their perceived value may vary over time and may be affected by changes in regulatory policies, business conditions or the supply of available PRVs.

Previous wording

If the FDA or a comparable foreign regulatory authority approves any of our current or future product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping for the drug will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs and Good Clinical Practices, or GCPs, for any clinical trials that we conduct post-approval. Any regulatory approvals that we receive for our current or future product candidates may also be subject to limitations on the approved indicated uses for which the drug may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase IV clinical trials, and surveillance to monitor the safety and efficacy of the drug. Later discovery of previously unknown problems with a drug, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

Current wording

If the FDA or a comparable foreign regulatory authority approves any of our current or future product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping for the drug will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs and GCPs for any clinical trials that we conduct post-approval. Any regulatory approvals that we receive for our current or future product candidates may also be subject to limitations on the approved indicated uses for which the drug may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase IV clinical trials, and surveillance to monitor the safety and efficacy of the drug. Later discovery of previously unknown problems with a drug, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

Previous wording

Positive results from our preclinical studies of our current or future product candidates, and any positive results we may obtain from our early clinical trials of our current or future product candidates, may not necessarily be predictive of the results from required later preclinical studies and clinical trials. Similarly, even if we are able to complete our planned preclinical studies or clinical trials of our current or future product candidates according to our current development timeline, the positive results from our preclinical studies and clinical trials of our current or future product candidates may not be replicated in subsequent preclinical studies or clinical trial results. For example, our later-stage clinical trials could differ in significant ways from our ongoing Phase IIb clinical trial of OST-HER2, which could cause the outcome of these later-stage trials to differ from our earlier-stage clinical trials. For example, these differences may include changes to inclusion and exclusion criteria, final dosage formulation, efficacy endpoints and statistical design.

Current wording

Positive results from our preclinical studies of our current or future product candidates, and any positive results we may obtain from our early clinical trials of our current or future product candidates, may not necessarily be predictive of the results from required later preclinical studies and clinical trials. Similarly, even if we are able to complete our planned preclinical studies or clinical trials of our current or future product candidates according to our current development timeline, the positive results from our preclinical studies and clinical trials of our current or future product candidates may not be replicated in subsequent preclinical studies or clinical trial results. For example, our later-stage clinical trials could differ in significant ways from our Phase IIb clinical trial of OST-HER2, which could cause the outcome of these later-stage trials to differ from our earlier-stage clinical trials. For example, these differences may include changes to inclusion and exclusion criteria, final dosage formulation, efficacy endpoints and statistical design.

Previous wording

Because we have limited financial and management resources, we focus on a limited number of research programs and product candidates and are currently focused on our core programs, including our lead core product candidate OST-HER2 for the treatment of Osteosarcoma and our other core product candidate OST-tADC for the treatment of Osteosarcoma. As a result, we may forego or delay pursuit of opportunities with other current or future product candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial drugs or profitable market opportunities. Our spending on current and future research and development programs and current or future product candidates for specific indications may not yield any commercially viable drugs. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through future collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.

Current wording

Because we have limited financial and management resources, we focus on a limited number of research programs and product candidates and are currently focused on our lead core product candidate OST-HER2 and our other core product candidate OST-tADC, both targeting the treatment of Osteosarcoma. As a result, we may forego or delay pursuit of opportunities with other current or future product candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial drugs or profitable market opportunities. Our spending on current and future research and development programs and current or future product candidates for specific indications may not yield any commercially viable drugs. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through future collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.

Previous wording

The incidence of new cases of Osteosarcoma is approximately 1,000 individuals in the United States annually and approximately 20,000 individuals globally. In some countries, particularly in the European Union, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a drug. To obtain coverage and reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. In addition, many countries outside the United States have limited government support programs that provide for reimbursement of drugs such as are product candidates, with an emphasis on private payors for access to commercial products. If reimbursement of our product candidates is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially, based, in part, on the larger population of patients with Osteosarcoma who reside in foreign countries. In parts of Africa and certain countries in the Middle East, the lack of healthcare infrastructure to help adequately diagnose and treat patients may limit our business potential in those otherwise viable markets. Finally, there is a remote possibility that price controls may be enacted in the United States.

Current wording

The incidence of new cases of Osteosarcoma is approximately 1,000 individuals annually in the United States and approximately 20,000 globally. Although the global patient population is larger, our ability to generate revenues outside the United States may be limited by pricing regulations, reimbursement restrictions, and market access barriers. In many countries, particularly in the European Union and other developed markets, the pricing of prescription pharmaceuticals is subject to governmental control, and pricing and reimbursement approvals may be required prior to or following marketing authorization. Pricing negotiations with governmental authorities can be lengthy and may delay the commercial launch of a product candidate. In some jurisdictions, obtaining reimbursement or pricing approval may require the submission of health economic data or the conduct of additional clinical studies to demonstrate cost-effectiveness relative to existing therapies. If reimbursement for our product candidates is unavailable, limited in scope, or subject to significant restrictions, or if pricing is set at unsatisfactory levels, our ability to generate revenues in those markets may be materially adversely affected. In addition, in certain regions, including parts of Africa and the Middle East, limited healthcare infrastructure and diagnostic capabilities may constrain our ability to identify and treat patients, thereby limiting commercial opportunities. In the United States, there have been significant efforts to control drug pricing. For example, the Inflation Reduction Act of 2022 introduced measures that allow the federal government to negotiate prices for certain drugs under Medicare and impose rebates tied to inflation. These and other pricing reforms may reduce the prices we are able to charge for any approved products and adversely affect our revenues.

Previous wording

The development and commercialization of new drugs is highly competitive. We face competition with respect to our current product candidates and will face competition with respect to any product candidates that we may seek to develop or commercialize in the future from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. There are a number of large pharmaceutical and biotechnology companies that currently market and sell drugs or are pursuing the development of therapies for rare diseases and cancers, including Osteosarcoma. Some of these competitive drugs and therapies are based on scientific approaches that are similar to our approach, and others are based on entirely different approaches. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

Current wording

The development and commercialization of new drugs is highly competitive and constantly evolving. We face competition with respect to our current product candidates and will face competition with respect to any product candidates that we may seek to develop or commercialize in the future from major pharmaceutical companies, specialty pharmaceutical companies, biotechnology companies, academic institutions, government agencies and other public and private research organizations worldwide. Some of these competitors currently market or are actively developing therapies for rare diseases and cancers, including Osteosarcoma, and some programs may be based on scientific approaches that are similar to ours, while others may employ entirely different approaches.

Previous wording

Specifically, there are a large number of companies developing or marketing treatments for rare diseases and cancers, including many major pharmaceutical and biotechnology companies. If OST-HER2 receives marketing approval for the treatment of Osteosarcoma, it may face competition from other product candidates in development for these indications, including product candidates in development from AstraZeneca, Y-mAbs Therapeutics and MD Anderson Cancer Center, among others.

Current wording

Specifically, if OST-HER2 receives marketing approval for the treatment of Osteosarcoma, it may face competition from other product candidates in development for these indications, including programs from AstraZeneca, Y-mAbs Therapeutics, MD Anderson Cancer Center and others. The competitive landscape is dynamic: competitors’ programs may advance or be discontinued, and new entrants may emerge, which could materially affect our ability to capture or maintain market share.

Previous wording

Many of the companies against which we are competing or against which we may compete in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and reimbursement and marketing approved drugs than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific, sales, marketing and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

Current wording

Many of the companies against which we are competing or may compete in the future have significantly greater financial, technical, regulatory and commercial resources than we do, including greater expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and reimbursement, and marketing approved drugs. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in further consolidation and concentration of resources among a smaller number of competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors may also compete with us in recruiting and retaining qualified scientific, sales, marketing, and management personnel, establishing clinical trial sites and enrolling patients in clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

Previous wording

The regulations that govern regulatory approvals, pricing and reimbursement for new drugs vary widely from country to country. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after marketing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain marketing approval for a product candidate in a particular country, but then be subject to price regulations that delay our commercial launch of the product candidate, possibly for lengthy time periods, and negatively impact the revenues we are able to generate from the sale of the product candidate in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more current or future product candidates, even if our current or future product candidates obtain marketing approval.

Current wording

The regulations that govern regulatory approvals, pricing, and reimbursement for new drugs vary widely from country to country. Some countries require approval of the sale price of a drug before it can be marketed, and in many countries, the pricing review period begins after marketing approval is granted. In certain markets, including the European Union, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval. As a result, we may obtain marketing approval for a product candidate in a particular country but be subject to price regulations that delay commercial launch or limit the revenues we are able to generate from the sale of the product candidate in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more current or future product candidates, even if approved.

Previous wording

Our ability to commercialize any current or future product candidates successfully also will depend in part on the extent to which coverage and reimbursement for these current or future product candidates and related treatments will be available from government authorities, private health insurers and other organizations. Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for (i.e., cover) and establish reimbursement levels. Factors payors consider in determining reimbursement are based on whether the product is:

Current wording

Our ability to successfully commercialize any current or future product candidates will depend in part on the extent to which coverage and reimbursement for these product candidates and related treatments are available from government authorities, private health insurers, and other organizations. Government authorities and other third-party payors decide which medications they will cover and establish reimbursement levels. Factors payors consider in determining reimbursement include whether the product is a covered benefit, safe and effective, medically necessary, appropriate for the patient, and cost-effective, and whether it is considered experimental or investigational.

Previous wording

A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and other third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular drugs. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for drugs. We cannot be sure that coverage will be available for any product candidate that we commercialize and, if coverage is available, the level of reimbursement. Reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval. If reimbursement is not available or is available only to limited levels, we may not be able to successfully commercialize any product candidate for which we obtain marketing approval.

Current wording

A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and third-party payors have sought to control costs by limiting coverage, setting reimbursement levels, requiring rebates and discounts, and challenging the prices charged for drugs. We cannot be sure that coverage will be available for any product candidate that we commercialize or, if coverage is available, the level of reimbursement. Reimbursement levels may impact the demand for, or the price of, any product candidate for which we obtain marketing approval.

Previous wording

There may be significant delays in obtaining reimbursement for newly approved drugs, and coverage may be more limited than the purposes for which the drug is approved by the FDA or similar regulatory authorities outside the United States. Moreover, eligibility for reimbursement does not imply that any drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. In the United States, decisions as to coverage and reimbursement by the Medicare program are typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency within the U.S. Department of Health and Human Services, or HHS. CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. Our inability to promptly obtain coverage and profitable payment rates from both government-funded and private payors for any approved drugs that we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize drugs and our overall financial condition.

Current wording

There may be significant delays in obtaining reimbursement for newly approved drugs, and coverage may be more limited than the purposes for which the drug is approved by the FDA or comparable foreign regulatory authorities. Moreover, eligibility for reimbursement does not imply that any drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacturing, and distribution. Reimbursement rates may vary based on the use of the drug, the clinical setting, and comparisons to lower-cost therapies, and may be incorporated into bundled payments for other services. Net prices for drugs may also be reduced by mandatory discounts or rebates required by government healthcare programs or private payors. In the United States, coverage and reimbursement decisions for Medicare are made by CMS, and private payors often follow Medicare coverage policies and payment limitations in setting their own reimbursement practices. Our inability to obtain timely and adequate coverage and reimbursement for any approved products could have a material adverse effect on our business, financial condition, and results of operations.

Previous wording

The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that could prevent or delay marketing approval of our current or future product candidates or any future product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell a product for which we obtain marketing approval. Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example: (i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of our products; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business.

Current wording

The United States and many foreign jurisdictions have enacted and continue to consider legislative and regulatory changes affecting the healthcare system that could prevent or delay marketing approval of our current or future product candidates, restrict or regulate post-approval activities, and affect our ability to profitably commercialize any products for which we obtain marketing approval. Changes in regulations, statutes, or the interpretation of existing requirements could require, among other things: (i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling; (iii) the recall or discontinuation of products; or (iv) additional recordkeeping, reporting, or compliance obligations. Any such changes could adversely affect our operations and increase our costs.

Previous wording

Our revenue prospects could be affected by changes in healthcare spending and policy in the United States and abroad. We operate in a highly regulated industry and new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations or decisions, related to healthcare availability, the method of delivery or payment for healthcare products and services could negatively impact our business, operations and financial condition. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action in the United States or any other jurisdiction. It is possible that additional governmental action is taken to address the Covid-19 pandemic. If we or any third parties we may engage are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or such third parties are not able to maintain regulatory compliance, our product candidates may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.

Current wording

Our revenue prospects may also be affected by changes in healthcare spending and policy in the United States and abroad. We operate in a highly regulated industry, and new laws, regulations, or judicial decisions, or new interpretations of existing laws, regulations, or decisions, related to healthcare availability, pricing, coverage, or reimbursement may negatively impact our business, financial condition, and results of operations. We cannot predict the likelihood, nature, or extent of future healthcare reform measures or their potential impact on our business. If we or any third parties we engage are unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or such third parties fail to maintain regulatory compliance, we may lose any regulatory approvals that we may obtain and may not achieve or sustain profitability.

Previous wording

Our relationships with prescribers, customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm and diminished profits and future earnings.

Current wording

Our relationships with prescribers, customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to significant penalties and adversely affect our business.

Previous wording

Although we do not currently have any drugs on the market, if we begin commercializing our current or future product candidates, we will be subject to additional healthcare statutory and regulatory requirements and enforcement by the federal government and the states and foreign governments in which we conduct our business. Healthcare providers, including physicians, play a primary role in the recommendation and prescription of any current or future product candidates for which we obtain marketing approval. Our future arrangements with healthcare providers, as well as third-party payors and customers, will expose us to broadly applicable fraud and abuse and other healthcare laws and regulations will constrain the business and/or financial arrangements and relationships through which we market, sell and distribute our current or future product candidates for which we obtain marketing approval. Restrictions under applicable federal and state healthcare laws and regulations, include the following:

Current wording

Although we do not currently have any products on the market, if we begin commercializing our current or future product candidates, we will become subject to additional healthcare statutory and regulatory requirements and enforcement by federal, state, and foreign governmental authorities. Healthcare providers, including physicians, play a primary role in the recommendation and prescription of any products for which we obtain marketing approval. Our arrangements with healthcare providers, third-party payors, and customers will expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that constrain the business and financial relationships through which we market, sell, and distribute our products. Restrictions under applicable federal and state healthcare laws and regulations include, among others, the following:

Previous wording

Ensuring that our future business arrangements with third parties comply with applicable healthcare laws and regulations could involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations were to be found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, exclusion from government funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations. If any of the physicians or other providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

Current wording

Ensuring that our business arrangements with third parties comply with applicable healthcare laws and regulations could involve substantial costs. The regulatory and enforcement environment in the healthcare industry remains active, and governmental authorities have increased their focus on compliance with these laws. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, or case law. If our operations are found to be in violation of any of these laws or any other applicable regulations, we may be subject to significant civil, criminal, and administrative penalties, including damages, fines, exclusion from government-funded healthcare programs such as Medicare and Medicaid, and the curtailment or restructuring of our operations. In addition, if any of the physicians or other providers or entities with whom we do business are found to be non-compliant, they may be subject to sanctions, which could also adversely affect our business.

Previous wording

We focus our research and product development on treatments for Osteosarcoma. The incidence of new cases of Osteosarcoma is approximately 1,000 individuals in the United States annually and approximately 20,000 individuals globally. Given the smaller number of patients who have the diseases that we are targeting, it is critical to our ability to grow and become profitable that we continue to successfully identify patients with these rare diseases. Our projections of both the number of people who have these diseases, are based on our beliefs and estimates. These estimates have been derived from a variety of sources, including the scientific literature, surveys of clinics, patient foundations or market research that we conducted, and may prove to be incorrect or contain errors. New studies may change the estimated incidence or prevalence of these diseases. The number of patients may turn out to be lower than expected. The effort to identify patients with diseases we seek to treat is in early stages, and we cannot accurately predict the number of patients for whom treatment might be possible. Further, even if we obtain significant market share for OST-HER2 and any of our other current or future product candidates, because the potential target populations are very small, we may never achieve profitability despite obtaining such significant market share.

Current wording

We focus our research and product development on treatments for osteosarcoma, a rare disease. The incidence of new cases of Osteosarcoma is approximately 1,000 individuals in the United States annually and approximately 20,000 individuals globally. Given the limited number of patients with the diseases we are targeting, our ability to achieve meaningful revenue will depend on our ability to accurately identify eligible patients, successfully commercialize our product candidates, and capture a significant share of the addressable market. Our estimates of the number of patients who may be eligible for treatment with OST-HER2 or any of our other current or future product candidates are based on a variety of sources, including published literature, clinical experience, and internal analyses, and may prove to be inaccurate. Although we have completed enrollment in our Phase IIb clinical trial for OST-HER2, which enrolled a limited number of patients consistent with the rare nature of the disease, our understanding of the addressable patient population remains subject to significant uncertainty. New studies or real-world data may change the estimated incidence, prevalence, or treatable population for osteosarcoma, and the number of patients ultimately eligible for our therapies may be lower than expected. In addition, identifying, diagnosing, and referring patients with osteosarcoma, particularly in earlier stages or in certain geographic regions, can be challenging, and we may not be successful in reaching all patients who could potentially benefit from our therapies. Even if we obtain regulatory approval and achieve meaningful market penetration, the small size of the target patient population may limit our ability to generate sufficient revenue to achieve or sustain profitability.

Previous wording

Our target patient populations are relatively small, and there are currently limited standard of care treatments directed at Osteosarcoma. As a result, the pricing and reimbursement of OST-HER2 and any other product candidates we may develop, if approved, is uncertain, but must be adequate to support commercial infrastructure. If we are unable to obtain adequate levels of reimbursement, our ability to successfully market and sell OST-HER2 and any of our other current or future product candidates will be adversely affected.

Current wording

Furthermore, because there are limited standard-of-care treatments specifically directed at Osteosarcoma, the pricing and reimbursement landscape for OST-HER2 and any other product candidates we may develop is uncertain. While therapies for rare diseases may in some cases support premium pricing, there can be significant variability in reimbursement decisions by governmental authorities and third-party payors. If we are unable to obtain adequate reimbursement at levels sufficient to support our anticipated commercial infrastructure, our ability to successfully market and sell OST-HER2 and any of our other current or future product candidates would be adversely affected.

Previous wording

Although we intend to design the clinical trials for our current or future product candidates, or be involved in the design when other parties sponsor the trials, we anticipate that third parties will conduct all of our clinical trials. As a result, many important aspects of our clinical development, including their conduct, timing and response to the ongoing Covid-19 pandemic, will be outside of our direct control. Our reliance on third parties to conduct future clinical trials will also result in less direct control over the management of data developed through clinical trials than would be the case if we were relying entirely upon our own staff. Communicating with outside parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities.

Current wording

Although we intend to design the clinical trials for our current or future product candidates, or be involved in the design when other parties sponsor the trials, we anticipate that third parties will conduct all of our clinical trials. As a result, many important aspects of our clinical development, including their conduct and timing, will be outside of our direct control. Our reliance on third parties to conduct future clinical trials will also result in less direct control over the management of data developed through clinical trials than would be the case if we were relying entirely upon our own staff. Communicating with outside parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities.

Previous wording

We have entered into licensing arrangements with Advaxis, Inc. (now Ayala Pharmaceuticals, Inc.) and BlinkBio, Inc. and a Research Service Agreement with George Clinical, Inc., and may in the future form or seek strategic alliances or acquisitions, create joint ventures, or enter into additional collaboration and licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to our current product candidates and any future product candidates that we may develop.

Current wording

We are party to licensing arrangements with the Trustees of the University of Pennsylvania and BlinkBio, Inc., and may in the future form or seek strategic alliances or acquisitions, create joint ventures, or enter into additional collaboration and licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to our current product candidates and any future product candidates that we may develop.

Previous wording

Going forward, we are seeking strategic partners for the further development and potential commercialization of our non-core and out-licensed programs, including OST-tADC. Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our management and business.

Current wording

Going forward, we are seeking strategic partners for the further development and potential commercialization of our non-core and out-licensed programs, including OST-tADC. However, identifying appropriate partners is competitive, and the negotiation of these arrangements is complex, time-consuming, and resource-intensive. Potential partners may be unwilling to commit to such transactions on acceptable terms, or at all, particularly if they determine that our product candidates do not have sufficient clinical validation, commercial potential, or likelihood of regulatory approval. Even if we are successful in entering into such arrangements, we may not realize the anticipated benefits. Strategic transactions typically involve significant risks, including the potential for loss of control over certain development or commercialization activities, reliance on third parties to meet development, regulatory and commercialization milestones, disagreements or disputes with partners, which could delay or terminate development programs, reduced economic returns as a result of profit-sharing, milestone payments or royalties, and the diversion of management attention and internal resources.

Previous wording

As a result, we may not be able to realize the benefit of our existing collaboration and licensing arrangements or any future strategic partnerships or acquisitions, license arrangements we may enter, if we are unable to successfully integrate them with our existing operations and company culture, which could delay our timelines or otherwise adversely affect our business. We also cannot be certain that, following a strategic transaction, license, collaboration or other business development partnership, we will achieve the revenue or specific net income that justifies such transaction. Any delays in entering into new collaborations or strategic partnership agreements related to our current or future product candidates could delay the development and commercialization of our current or future product candidates in certain geographies for certain indications, which would harm our business prospects, financial condition and results of operations.

Current wording

As a result, we may not realize the anticipated benefits of our existing collaboration and licensing arrangements or any future strategic transactions, including partnerships, acquisitions, or licensing arrangements, particularly if we are unable to effectively integrate such arrangements with our existing operations and company culture. Any such failure could delay development timelines, disrupt our business, or otherwise adversely affect our results of operations. In addition, we cannot assure that any strategic transaction or collaboration will generate the expected revenues, cost savings, or other anticipated benefits that justified our entry into such arrangement. Further, delays in identifying or entering into new collaboration or strategic partnership agreements with respect to our current or future product candidates may delay or limit the development and commercialization of such product candidates, including in specific geographies or for particular indications, which could materially harm our business prospects, financial condition and results of operations.

Previous wording

If we and those third parties from whom we in-license patents are unable to obtain and maintain patent and other intellectual property protection for our technology and product candidates or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and drugs similar or identical to ours, and our ability to successfully commercialize our technology and drugs may be impaired.

Current wording

If we and the third parties from whom we in-license intellectual property are unable to obtain, maintain, protect, or enforce patent and other intellectual property rights for our technology and product candidates, or if the scope of such protection is not sufficiently broad, our competitors could develop and commercialize similar or identical technologies and products, and our ability to successfully commercialize our product candidates may be impaired.

Previous wording

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. Our commercial success depends in part on our ability and the ability of those third parties from whom we in-license patents to obtain and maintain intellectual property protection in the United States and other countries for our current or future product candidates, including our lead core product candidate OST-HER2, our other core product candidate OST-tADC, our non-core product candidates, our proprietary compound library and other know-how. We seek to protect our proprietary and intellectual property position by, among other methods, in-licensing patents and patent applications in the United States and abroad related to our proprietary technology, inventions and improvements that are important to the development and implementation of our business.

Current wording

The patent position of biotechnology and pharmaceutical companies is highly uncertain and involves complex legal and factual questions, and has been the subject of extensive litigation in recent years. Our commercial success depends in part on our ability, and the ability of our licensors and other partners, to obtain, maintain, protect, and enforce intellectual property rights in the United States and other jurisdictions for our current and future product candidates, including OST-HER2, OST-tADC, our non-core programs, and our proprietary technologies and know-how.