AVBP

The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that affect us.
See “Special Note Regarding Forward-Looking Statements.” Our actual results could differ materially and adversely from those anticipated in these forward-looking statements as a result of certain factors, including those set forth below. Summary of Risk Factors Our business is subject to numerous risks and uncertainties, including those highlighted in this section below, that represent challenges that we face in connection with the successful implementation of our strategy.
If we are unable to achieve or sustain profitability, the market value of our common stock will likely decline. ● We have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability. ● Operating our business requires substantial additional capital to finance our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations. ● We currently depend significantly on the success of firmonertinib.
If we are unable to advance firmonertinib in clinical development, obtain regulatory approval and ultimately commercialize firmonertinib, or experience significant delays in doing so, our business will be materially harmed. ● Clinical and preclinical development of new biopharmaceutical products involves a lengthy and expensive process with uncertain timelines and outcomes, and results of prior clinical trials and studies our current product candidates are not necessarily predictive of future results.
Our other product candidates may not achieve favorable results in our clinical trials or receive regulatory approval on a timely basis, if at all. ● Any difficulties or delays in the commencement or completion, or the termination or suspension, of our current or planned clinical trials or nonclinical studies could result in increased costs to us, delay or limit our ability to generate revenue or adversely affect our commercial prospects. ● Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control, which could adversely affect our business, operating results and prospects. ● Use of our current or future product candidates could be associated with adverse side effects, adverse events or other safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials, abandon a product candidate, limit the commercial profile of an approved drug label or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition. ● Several of the ongoing clinical trials for our lead product candidate, firmonertinib, and an ongoing trial for ARR-217, are being conducted outside the United States, including in China.
However, the FDA and foreign regulatory equivalents may not accept data from such trials, or may expect proportionately more data from subjects in the United States, in which case our development plans will be delayed, which could materially harm our business. ● Interim, topline and preliminary data from our clinical trials and nonclinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data. ● The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to timely submit for and obtain regulatory approval for our product candidates, our business will be substantially harmed. ● Firmonertinib has been granted Breakthrough Therapy Designation for the treatment of first-line patients with locally advanced or metastatic EGFRm NSCLC with exon 20 insertion mutations from the FDA and we may seek Breakthrough Therapy Designation for other product candidates in the future.
Even if we apply for Breakthrough Therapy Designation in the future, we might not receive such designation, and even if received, such designation FDA may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval. ● Firmonertinib has been granted Fast Track Designation by the FDA for the treatment of patients with NSCLC harboring activating EGFR or HER2 kinase domain mutations, including exon 20 insertion mutations and we may seek Fast Track Designation for other product candidates in the future.
Further, such designation could be withdrawn by the FDA. ● We heavily rely on our exclusive licenses with our partners to provide us with intellectual property rights to develop and commercialize our product candidates.
Any termination or loss of significant rights under our agreements with our partners would adversely affect our development or commercialization of our product candidates. ● We currently rely on Chinese third parties for the manufacture of firmonertinib, ARR-217, and ARR-002 for clinical development, expect to rely on such manufacturers for potential future commercial supply of firmonertinib, ARR-217, and ARR-002, and expect to continue to rely on third parties for the foreseeable future.
This reliance on third parties increases the risk that we will not have sufficient quantities for clinical development of firmonertinib, ARR-217, or ARR-002, or for commercialization of firmonertinib in such quantities at an acceptable cost, which could delay, prevent or impair our development or potential commercialization efforts. ● Even if we receive regulatory approval for any of our current or future product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense.
Additionally, our current and any future product candidates, if approved, could be subject to labeling and other restrictions on marketing or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, if any of them are approved. ● We face significant competition, and if our competitors develop and commercialize technologies or product candidates more rapidly than we do, or their technologies or product candidates are more effective, safer, or less expensive than our current and any future product candidates we develop, our business and our ability to develop and successfully commercialize products will be adversely affected. ● We are subject to various U.S. federal, state and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could expose us to criminal sanctions, civil and administrative penalties, contractual damages, reputational harm and diminished profits and future earnings, among other penalties, any of which could harm our results of operations and financial condition. ● If our internal information technology systems, or those used by our CROs, clinical sites, or other contractors or consultants upon which we rely, are or were compromised, become unavailable or suffer security breaches, loss or leakage of data or other disruptions, we could suffer material adverse consequences resulting from such compromise, including but not limited to, operational or service interruption, harm to our reputation, litigation, fines, penalties and liability, compromise of sensitive information related our business, and other adverse consequences. ● We depend heavily on intellectual property licensed from third parties, and our licensors may not always act in our best interest.
If our product candidates are not successfully developed, approved and commercialized, we may never generate significant revenue, if we generate any revenue at all.
Our net losses were $166.3 million and $80.5 million for the years ended December 31, 2025 and 2024, respectively.
As of December 31, 2025, we had an accumulated deficit of $404.6 million.
Substantially all of our losses have resulted from expenses incurred in connection with in-licensing intellectual property related to, and developing, our product candidates and from general and administrative costs associated with our operations.
Our current product candidates, and any future product candidates will require substantial additional development time and resources before we would be able to apply for or receive regulatory approvals and begin generating revenue from product sales.
We expect to continue to incur losses for the foreseeable future, and we anticipate these losses will increase substantially as we continue our development of, seek regulatory approval for and potentially commercialize our product candidates, seek to identify, assess, acquire, in-license intellectual property related to or develop additional product candidates and operate as a public company.
In addition, we are obligated to pay Aarvik regulatory and sales milestone payments up to an aggregate not to exceed $98.0 million upon the achievement of certain development, regulatory and sales milestone events as set forth in the Aarvik Collaboration Agreement, as defined herein, tiered royalties on aggregate net sales of products developed under the Aarvik Collaboration and commercialized by us or on our behalf at royalty rates in the mid-single digits.
See “Business — Licenses, Partnerships and Collaborations — Aarvik Research Collaboration Agreement” .
This will require us to be successful in a range of challenging activities, including completing clinical trials of our current product candidates and any future product candidates, acquiring additional product candidates, obtaining regulatory approvals for our current and any future product candidates, and manufacturing, marketing, and selling any products for which we may obtain regulatory approvals.
We commenced operations in April 2021 and, to date, we have focused primarily on organizing and staffing our company, business planning, raising capital, in-licensing our product candidates, establishing our intellectual property portfolio and conducting research, preclinical studies, and clinical trials.
We expect our expenses to substantially increase in connection with our ongoing activities, particularly as we conduct our ongoing and planned clinical trials for our product candidates, and potentially seek regulatory approval for our current and any future product candidates we may develop, acquire or in-license additional product candidates and operate as a public company.
In addition, if we are able to progress our product candidates through development and commercialization, we will be required to make milestone and royalty payments to our licensors from whom we have in-licensed intellectual property related to our product candidates.
If we obtain regulatory approvals for our current or future product candidates, we also expect to incur significant commercialization expenses related to product manufacturing, marketing, sales, and distribution.
Because the outcome of any clinical trial or preclinical study is highly uncertain, we cannot reliably estimate the actual amount of financing necessary to successfully complete the development and commercialization of our current or future product candidates.
Our existing cash and cash equivalents, may not be sufficient to complete development of our current product candidates, or any future product candidate, and we will require substantial capital in order to advance our current product candidates, and any future product candidates through clinical trials, regulatory approval and commercialization.
Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from factors that include but are not limited to, change in inflation rates, trade sanctions, tariffs, the conflicts in the Middle East, between Russia and Ukraine, potential future U.S. action in Venezuela, and other factors, diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability.
Attempting to secure additional financing may divert our management from our day-to-day activities, which may adversely affect our ability to develop our current product candidates and any future product candidates.
Our future capital requirements, both near and long-term, will depend on many factors, including, but not limited to: ● the initiation, type, number, scope, progress, expansions, results, costs and timing of clinical trials and studies of our current product candidates, and any future product candidates we may choose to pursue, including any modifications to clinical development plans based on feedback that we may receive from regulatory authorities; ● the costs and timing of manufacturing for our current product candidates, or any future product candidate, including commercial manufacture at sufficient scale, if any product candidate is approved, including as a result of inflation, any supply chain issues or component shortages; ● requirements of regulatory authorities in any jurisdictions in which we may seek approval for our current product candidates, and any future product candidates and our anticipated timing for seeking approval in such jurisdictions; ● the costs, timing and outcome of regulatory meetings and reviews of our current product candidates or future product candidates; ● any delays and cost increases that may result from any health epidemics and outbreaks, including COVID- 19 or measles; ● the costs of obtaining, maintaining, enforcing and protecting our patents and other intellectual property and proprietary rights; ● our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal control over financial reporting; ● the costs associated with hiring additional personnel and consultants as our business grows, including additional executive officers and clinical development, regulatory, Chemistry, Manufacturing, and Controls (CMC), quality, compliance, and commercial personnel; ● the timing and amount of the milestone, royalty or other payments we must make to our licensors, from whom we have in-licensed our current product candidates, or any future licensors; ● the costs and timing of establishing or securing sales and marketing capabilities if any current or future product candidate is approved; ● our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; ● our ability and strategic decision to acquire or develop future product candidates other than our current product candidates, and the timing of such development, if any; ● patients’ willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors; ● the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; and ● costs associated with any products or technologies that we may in-license or acquire. Conducting clinical trials and nonclinical studies and potentially identifying future product candidates is a time consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and commercialize our current or future product candidates.
If approved, our current product candidates, and any future product candidates may not achieve commercial success.
Risks Related to the Development and Regulatory Approval of Our Product Candidates We currently depend significantly on the success of our product candidates If we are unable to advance our product candidates in clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
We currently have two product candidates in clinical development, firmonertinib and ARR-217, the intellectual property for which we have individually in-licensed.
Firmonertinib is in Phase 3 clinical development and ARR-217, which is in Phase 1 clinical development.
Our business presently depends significantly on our ability to successfully develop, obtain regulatory approval for, and commercialize firmonertinib and our other product candidates in a timely manner.
This may make an investment in our company riskier than similar companies that have more product candidates in active development and may be able to better sustain the delay or failure of a lead product candidate.
In addition, our assumptions about our product candidates’ development potential are partially based on the data generated from preclinical studies and clinical trials conducted by our licensors and we may observe materially and adversely different results as we continue to conduct our clinical trials.
The success of our product candidates will depend on several factors, including the following: ● successful initiation, enrollment and completion of ongoing and future clinical trials with favorable results in accordance with good clinical practice (GCP) requirements and other applicable rules and regulations; ● acceptance of regulatory submissions by the FDA or comparable foreign regulatory authorities for the conduct of nonclinical studies and clinical trials of our product candidates, including clinical trials conducted outside the United States, including China, and our proposed design of planned nonclinical studies and clinical trials of our product candidates; ● the frequency, severity, and types of adverse events observed, or that we may observe, in nonclinical studies and clinical trials; ● maintaining relationships with contract research organizations (CROs) and clinical sites for the clinical development of our product candidates, and ability of such CROs and clinical sites to comply with clinical trial protocols, current GCP and other applicable requirements; ● demonstrating the safety and efficacy of our product candidates to the satisfaction of applicable regulatory authorities, including by establishing a safety database of a size satisfactory to regulatory authorities; ● receipt and maintenance of marketing approvals from applicable regulatory authorities for the initial indication for use and any additional indications, including approvals of NDAs from the FDA, and maintaining any such approvals; ● maintain relationships with our third-party manufacturers and their ability to comply with current Good Manufacturing Practice (cGMP) requirements as well as making arrangements with our third-party manufacturers for, or establishing our own, clinical or commercial manufacturing capabilities at a cost and scale sufficient to support commercialization; ● establishing commercial capabilities and launching commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others; ● obtaining, establishing, maintaining and enforcing patent and any potential trade secret protection or regulatory exclusivity for our product candidates; ● maintaining an acceptable safety profile of our product candidates following regulatory approval, if any; ● maintaining and growing an organization of people who can develop and, if approved, commercialize our product candidates, if approved; and ● acceptance of our product candidates, if approved, by patients, the medical community and third-party payors. If we are unable to develop, receive marketing approval for and successfully commercialize our product candidates, or if we experience delays as a result of any of the above factors or otherwise, our business would be significantly harmed.
Clinical and preclinical development of new biopharmaceutical products involves a lengthy and expensive process with uncertain timelines and outcomes, and results of prior clinical trials and studies of our product candidates are not necessarily predictive of future results.
Our product candidates may not achieve favorable results in our clinical trials or receive regulatory approval on a timely basis, if at all.
We do not know how our product candidates will perform in on-going and future clinical trials.

and 200 more.

Gone since FY2024

The risks and uncertainties described below are not the only ones we face.
Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that affect us.
See “Special Note Regarding Forward-Looking Statements.” Our actual results could differ materially and adversely from those anticipated in these forward-looking statements as a result of certain factors, including those set forth below.
Summary of Risk Factors Our business is subject to numerous risks and uncertainties, including those highlighted in this section below, that represent challenges that we face in connection with the successful implementation of our strategy.
If we are unable to achieve or sustain profitability, the market value of our common stock will likely decline. ● We have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability. ● Operating our business requires substantial additional capital to finance our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations. ● We currently depend significantly on the success of firmonertinib, which is our only product candidate in clinical development.
If we are unable to advance firmonertinib in clinical development, obtain regulatory approval and ultimately commercialize firmonertinib, or experience significant delays in doing so, our business will be materially harmed. ● Clinical and preclinical development of new biopharmaceutical products involves a lengthy and expensive process with uncertain timelines and outcomes, and results of prior clinical trials and studies of firmonertinib and our other product candidates are not necessarily predictive of future results.
Firmonertinib and our other product candidates may not achieve favorable results in our clinical trials or receive regulatory approval on a timely basis, if at all. ● Any difficulties or delays in the commencement or completion, or the termination or suspension, of our current or planned clinical trials or nonclinical studies could result in increased costs to us, delay or limit our ability to generate revenue or adversely affect our commercial prospects. ● Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control, which could adversely affect our business, operating results and prospects. ● Use of firmonertinib or any other current or future product candidates could be associated with adverse side effects, adverse events or other safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials, abandon a product candidate, limit the commercial profile of an approved drug label or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition. ● Several of the ongoing clinical trials for our lead product candidate, firmonertinib, are being conducted outside the United States, including in China.
However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business. ● Interim, topline and preliminary data from our clinical trials and nonclinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data. ● The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed. ● Firmonertinib has been granted Breakthrough Therapy Designation for the treatment of first-line patients with locally advanced or metastatic EGFRm NSCLC with exon 20 insertion mutations from the FDA and we may seek Breakthrough Therapy Designation for other product candidates in the future.
Even if we apply for Breakthrough Therapy Designation in the future, we might not receive such designation, and even if received, such designation FDA may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval. ● Furmonertinib has been granted Fast Track Designation by the FDA for the treatment of patients with NSCLC harboring activating EGFR or HER2 kinase domain mutations, including exon 20 insertion mutations and we may seek Fast Track Designation for other product candidates in the future.
Further, such designation could be withdrawn by the FDA. ● We heavily rely on our exclusive license with Allist to provide us with intellectual property rights to develop and commercialize firmonertinib.
Any termination or loss of significant rights under our agreements with Allist would adversely affect our development or commercialization of firmonertinib. ● We currently rely on a Chinese third party for the manufacture of firmonertinib and other product candidates for clinical development, and potential future commercial supply of firmonertinib, and expect to continue to rely on third parties for the foreseeable future.
We expect to rely on a Chinese third party for the manufacture of ARR-217 for clinical development.
This reliance on third parties increases the risk that we will not have sufficient quantities of firmonertinib or ARR-217 or such quantities at an acceptable cost, which could delay, prevent or impair our development or potential commercialization efforts. ● Even if we receive regulatory approval for firmonertinib or any other current or future product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense.
Additionally, firmonertinib and any future product candidates, if approved, could be subject to labeling and other restrictions on marketing or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, if any of them are approved. ● We face significant competition, and if our competitors develop and commercialize technologies or product candidates more rapidly than we do, or their technologies or product candidates are more effective, safer, or less expensive than firmonertinib and any future product candidates we develop, our business and our ability to develop and successfully commercialize products will be adversely affected. ● We are subject to various U.S. federal, state and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could expose us to criminal sanctions, civil and administrative penalties, contractual damages, reputational harm and diminished profits and future earnings, among other penalties, any of which could harm our results of operations and financial condition. ● If our internal information technology systems, or those used by our CROs, clinical sites, or other contractors or consultants upon which we rely, are or were compromised, become unavailable or suffer security breaches, loss or leakage of data or other disruptions, we could suffer material adverse consequences resulting from such compromise, including but not limited to, operational or service interruption, harm to our reputation, litigation, fines, penalties and liability, compromise of sensitive information related our business, and other adverse consequences. ● We depend heavily on intellectual property licensed from third parties, and our licensors may not always act in our best interest.
If firmonertinib is not successfully developed, approved and commercialized, we may never generate significant revenue, if we generate any revenue at all.
Our net losses were $80.5 million and $69.3 million for the years ended December 31, 2024 and 2023, respectively.
As of December 31, 2024, we had an accumulated deficit of $238.3 million.
Substantially all of our losses have resulted from expenses incurred in connection with in-licensing intellectual property related to, and developing, firmonertinib and from general and administrative costs associated with our operations.
Firmonertinib, our other product candidates, and any future product candidates will require substantial additional development time and resources before we would be able to apply for or receive regulatory approvals and begin generating revenue from product sales.
We expect to continue to incur losses for the foreseeable future, and we anticipate these losses will increase substantially as we continue our development of, seek regulatory approval for and potentially commercialize firmonertinib and our other product candidates, seek to identify, assess, acquire, in-license intellectual property related to or develop additional product candidates and operate as a public company.
See “Business — Licenses, Partnerships and Collaborations — .
This will require us to be successful in a range of challenging activities, including completing clinical trials of firmonertinib, our other product candidates, and any future product candidates, acquiring additional product candidates, obtaining regulatory approval for firmonertinib and any future product candidates, and manufacturing, marketing, and selling any products for which we may obtain regulatory approval.
We commenced operations in April 2021 and, to date, we have focused primarily on organizing and staffing our company, business planning, raising capital, in-licensing our product candidates, firmonertinib, and our other product candidates, establishing our intellectual property portfolio and conducting research, preclinical studies, and clinical trials.
We expect our expenses to substantially increase in connection with our ongoing activities, particularly as we conduct our ongoing and planned clinical trials for firmonertinib, our other product candidates, and potentially seek regulatory approval for firmonertinib and our other current and any future product candidates we may develop, acquire or in-license additional product candidates and operate as a public company.
In addition, if we are able to progress firmonertinib and our other product candidates through development and commercialization, we will be required to make milestone and royalty payments to our licensors from whom we have in-licensed intellectual property related to our product candidates.
If we obtain regulatory approval for firmonertinib or any other current or future product candidates, we also expect to incur significant commercialization expenses related to product manufacturing, marketing, sales, and distribution.
Because the outcome of any clinical trial or preclinical study is highly uncertain, we cannot reliably estimate the actual amount of financing necessary to successfully complete the development and commercialization of firmonertinib or any other current or future product candidates.
Our existing cash and cash equivalents, may not be sufficient to complete development of firmonertinib, our other product candidates, or any future product candidate, and we will require substantial capital in order to advance firmonertinib, our other product candidates,and any future product candidates through clinical trials, regulatory approval and commercialization.
Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from factors that include but are not limited to, change in inflation rates, trade sanctions, tariffs the conflicts in the Middle East and between Russia and Ukraine and other factors, diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability.
Attempting to secure additional financing may divert our management from our day-to-day activities, which may adversely affect our ability to develop firmonertinib, our other product candidates and any future product candidates.
Our future capital requirements, both near and long-term, will depend on many factors, including, but not limited to: ● the initiation, type, number, scope, progress, expansions, results, costs and timing of clinical trials and studies of firmonertinib, our other product candidates, and any future product candidates we may choose to pursue, including any modifications to clinical development plans based on feedback that we may receive from regulatory authorities; ● the costs and timing of manufacturing for firmonertinib, our other product candidates, or any future product candidate, including commercial manufacture at sufficient scale, if any product candidate is approved, including as a result of inflation, any supply chain issues or component shortages; ● requirements of regulatory authorities in any jurisdictions in which we may seek approval for firmonertinib, our other product candidates, and any future product candidates and our anticipated timing for seeking approval in such jurisdictions; ● the costs, timing and outcome of regulatory meetings and reviews of firmonertinib or any other current or future product candidates; ● any delays and cost increases that may result from any health epidemics and outbreaks, including COVID-19; ● the costs of obtaining, maintaining, enforcing and protecting our patents and other intellectual property and proprietary rights; ● our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal control over financial reporting; ● the costs associated with hiring additional personnel and consultants as our business grows, including additional executive officers and clinical development, regulatory, Chemistry, Manufacturing, and Controls (CMC) quality and commercial personnel; ● the timing and amount of the milestone, royalty or other payments we must make to our licensors, from whom we have in-licensed our current product candidates, or any future licensors; ● the costs and timing of establishing or securing sales and marketing capabilities if firmonertinib or any other current or future product candidate is approved; ● our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; ● our ability and strategic decision to acquire or develop future product candidates other than firmonertinib, and the timing of such development, if any; ● patients’ willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors; ● the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; and ● costs associated with any products or technologies that we may in-license or acquire.
Conducting clinical trials and nonclinical studies and potentially identifying future product candidates is a time consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and commercialize firmonertinib or any other current or future product candidates.
If approved, firmonertinib, our other product candidates, and any future product candidates may not achieve commercial success.
Risks Related to the Development and Regulatory Approval of Our Product Candidates We currently depend significantly on the success of firmonertinib, which is our only product candidate in clinical development.
If we are unable to advance firmonertinib in clinical development, obtain regulatory approval and ultimately commercialize firmonertinib, or experience significant delays in doing so, our business will be materially harmed.
We currently only have one product candidate in clinical development, firmonertinib, the intellectual property for which we have in-licensed and which is in Phase 3 clinical development.
Our business presently depends significantly on our ability to successfully develop, obtain regulatory approval for, and commercialize firmonertinib in a timely manner.
This may make an investment in our company riskier than similar companies that have multiple product candidates in active development and may be able to better sustain the delay or failure of a lead product candidate.
In addition, our assumptions about firmonertinib’s development potential are partially based on the data generated from preclinical studies and clinical trials conducted by our licensor and we may observe materially and adversely different results as we continue to conduct our clinical trials.
The success of firmonertinib will depend on several factors, including the following: ● successful initiation, enrollment and completion of ongoing and future clinical trials with favorable results in accordance with good clinical practice (GCP) requirements and other applicable rules and regulations; ● acceptance of regulatory submissions by the FDA or comparable foreign regulatory authorities for the conduct of nonclinical studies and clinical trials of firmonertinib, including clinical trials conducted outside the United States, including China, and our proposed design of planned nonclinical studies and clinical trials of firmonertinib; ● the frequency, severity, and types of adverse events observed, or that we may observe, in nonclinical studies and clinical trials; ● maintaining relationships with contract research organizations (CROs) and clinical sites for the clinical development of firmonertinib, and ability of such CROs and clinical sites to comply with clinical trial protocols, current GCP and other applicable requirements; ● demonstrating the safety and efficacy of firmonertinib to the satisfaction of applicable regulatory authorities, including by establishing a safety database of a size satisfactory to regulatory authorities; ● receipt and maintenance of marketing approvals from applicable regulatory authorities for the initial indication for use and any additional indications, including approvals of NDAs from the FDA, and maintaining any such approvals; ● maintain relationships with our third-party manufacturers and their ability to comply with current Good Manufacturing Practice (cGMP) requirements as well as making arrangements with our third-party manufacturers for, or establishing our own, clinical or commercial manufacturing capabilities at a cost and scale sufficient to support commercialization; ● establishing sales, marketing and distribution capabilities and launching commercial sales of firmonertinib, if and when approved, whether alone or in collaboration with others; ● obtaining, establishing, maintaining and enforcing patent and any potential trade secret protection or regulatory exclusivity for firmonertinib; ● maintaining an acceptable safety profile of firmonertinib following regulatory approval, if any; ● maintaining and growing an organization of people who can develop and, if approved, commercialize, market and sell firmonertinib, if approved; and ● acceptance of firmonertinib, if approved, by patients, the medical community and third-party payors.

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