Climb Bio Inc
For the period ended Sep 30, 2024. Filed Nov 12, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 12, 2024
CLYM$10.29+16.0%Stored close · as of Nov 6, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-14.
0000950170-24-096626
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsDefaults Upon Senior SecuritiesMine Safety DisclosuresOther InformationCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0000950170-24-125294
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsDefaults Upon Senior SecuritiesMine Safety DisclosuresOther InformationThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 433 previous paragraphs and 475 current paragraphs.
279 unchanged; 151 reworded; 27 added; 3 removed; 0 previous and 18 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (27)
Current report
conduct clinical trials of budoprutug and any product candidates we may develop;
Current report
the terms of any collaborations and/or research and development agreements we may enter into, which may impact the cost, timing and development plans of budoprutug or any product candidate programs;
Current report
the costs of manufacturing budoprutug or any product candidates we may develop by third parties;
Current report
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies, budoprutug or any product candidates we may develop.
Current report
the cost of clinical trials of budoprutug or any product candidates we may develop being greater than we anticipate;
Current report
clinical trials of budoprutug or any product candidates we may develop producing negative or inconclusive results, which may result in our deciding, or regulators requiring us, to conduct additional clinical trials or abandon development of such product candidate;
Current report
Moreover, principal investigators for our future clinical trials may serve as scientific advisors or consultants to us and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities. The FDA or a comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected the interpretation of the study. The FDA or a comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDA or a comparable foreign regulatory authority, as applicable, and may ultimately lead to the denial of marketing approval of budoprutug or any product candidates we may develop.
Current report
Companies developing biologics and other modalities targeting CD19 for immune-mediated diseases, including naked monoclonal antibodies, include Amgen Inc. (UPLINZA (inebilizumab), which is approved for the treatment of neuromyelitis optica spectrum disorder), bispecific T-cell engagers such as Cullinan Therapeutics, Inc. (CLN-978), and companies developing CD19 bifunctional monoclonal antibodies, including Zenas BioPharma, Inc. (obexelimab).
Current report
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 budoprutug or any product candidates we may develop, restrict or regulate post-approval activities and affect our ability to profitably sell any product for which we obtain marketing approval.
Current report
At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In addition, regional healthcare organizations and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. These measures could reduce the ultimate demand for budoprutug, if and when approved, and any other products we may develop, or put pressure on our product pricing. We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for budoprutug or any product candidates we may develop or additional pricing pressures.
Current report
The FDA may also use such procedures to withdraw an accelerated approval if a sponsor fails to conduct any required post-approval study of the product with due diligence. The new procedures include the provision of due notice and an explanation for a proposed withdrawal, and opportunities for a meeting with the FDA and a written appeal, among other things. We will need to fully comply with these and other requirements in connection with the development and approval of budoprutug or any product candidates we may develop that qualify for accelerated approval.
Current report
The FDA and Congress may further reevaluate the Orphan Drug Act and its regulations and policies. This may be particularly true in light of a decision from the Court of Appeals for the 11th Circuit in September 2021 finding that, for the purpose of determining the scope of exclusivity, the term “same disease or condition” means the designated “rare disease or condition” and could not be interpreted by the FDA to mean the “indication or use.” Although there have been legislative proposals to overrule this decision, they have not been enacted into law. On January 23, 2023, the FDA announced that, in matters beyond the scope of that court order, the FDA will continue to apply its existing regulations tying orphan-drug exclusivity to the uses or indications for which the orphan drug was approved.
Current report
We do not know if, when, or how the FDA may change the orphan drug regulations and policies in the future or whether Congress will take legislative action, and it is uncertain how any changes might affect our business. Depending on what changes the FDA or Congress may make to orphan drug regulations and policies, our business could be adversely impacted.
Current report
Patent terms may be inadequate to protect our competitive position on budoprutug or any product candidates we may develop for an adequate amount of time.
Current report
any delay in our regulatory filings for budoprutug or any product candidates we may develop and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information;
Current report
unanticipated serious safety concerns related to the use of budoprutug or any product candidates we may develop;
Current report
On August 16, 2024, Adam Rosenberg, adirector of our company, entered into a Rule 10b5-1 trading arrangement for the sale of our common stock that is intended to satisfy the affirmative defense conditions of the Exchange Act Rule 10b5-1(c) (Rule 10b5-1 Trading Plan). Mr. Rosenberg's Rule 10b5-1 Trading Plan provides for the sale of up to 40,000 shares of common stock. The estimated selling start date is January 1, 2025, and Mr. Rosenberg’s Rule 10b5-1 Trading Plan will terminate on June 30, 2025 or such earlier date upon which all transactions are completed or expire without execution.
Current report
August 30, 2024 -Aoife Brennan, Chief Executive Officer
Current report
August 30, 2024 -Brett Kaplan, Chief Operating Officer
Current report
On November 7, 2024, Liam Ratcliffe, M.D., Ph.D., notified us of his decision to resign as a member of our board of directors, which resignation was effective on November 8, 2024 (the Effective Date). With the resignation, Dr. Ratcliffe also resigned as Chair of the compensation committee of our board of directors and as a member of the nominating and corporate governance committee of our board of directors. Dr. Ratcliffe informed us that his resignation was not related to any disagreement with our company on any matter relating to our operations, policies or practices.
Current report
On the Effective Date, our board of directors, upon the recommendation of the nominating and corporate governance committee of our board of directors, appointed Douglas E. Williams, Ph.D., as a director to serve until our 2026 annual meeting of stockholders and thereafter until his successor has been duly appointed and qualified or until his earlier death, resignation or removal. As of the Effective Date, Dr. Williams will also serve as the chair of our board of directors, as the chair of the compensation committee of our board of directors, and as a member of the nominating and corporate governance committee of our board of directors.
Current report
Dr. Williams will receive compensation for his service as a non-employee director in accordance with our non-employee director compensation program, which is described in the definitive proxy statement for our 2024 annual meeting of stockholders that was filed with the SEC on June 4, 2024, including a grant to him on November 11, 2024 (the Grant Date) of an option to purchase 26,291 shares of our common stock at an exercise price equal to $4.06 per share, the closing price of our common stock on the Grant Date, which option will vest (i) with respect to 20,000 shares underlying the option, in equal monthly installments from November 8, 2024 (the Vesting Commencement Date) until the third anniversary of the Vesting Commencement Date, and (ii) with respect to 6,291 shares underlying the option, on the earlier of (a) June 26, 2025 or (b) the day immediately prior to our 2025 annual meeting of stockholders, in each case, subject to his continued service. Dr. Williams will also be entitled to receive annual cash retainers for his service as a director, plus additional cash compensation for his service as the chair of our board of directors, as the chair of our compensation committee, and as a member of our nominating and corporate governance committee, and annual equity grants in accordance with our non-employee director compensation program.
Current report
There are no arrangements or understandings between Dr. Williams and other persons pursuant to which he was appointed as a director. Dr. Williams has no family relationships with any of our directors or executive officers. There are no related-party transactions and no proposed transactions between Dr. Williams or us that would require disclosure under Item 404(a) of Regulation S-K.
Current report
In connection with his appointment as a director, Dr. Williams will enter into an indemnification agreement with us, pursuant to which we may be required, among other things, to indemnify Dr. Williams for certain expenses (including attorneys’ fees), judgments, penalties, fines and amounts paid in settlement actually and reasonably incurred by Dr. Williams in any action or proceeding arising out of his service to and activities on behalf of our company.
Removed paragraphs (3)
Previous report
conduct clinical trials of budoprutug and any future product candidates we may develop;
Previous report
Companies developing biologics and other modalities include Roche Holding AG (currently markets Rituxan (rituximab), which is used for a broad number of autoimmune diseases), Amgen (UPLINZA (inebilizumab) for the treatment of neuromyelitis optica spectrum disorder) and Ocrevus (ocrelizumab for the treatment of multiple sclerosis), each of which target CD20 on B cells, and others who have biologics aimed at other targets relevant to autoimmune diseases, including, for example, AbbVie Inc., Johnson & Johnson, Bristol-Myers Squibb Company and Novartis AG.
Previous report
We have broad discretion in the use of our cash and cash equivalents and may not use them effectively.
Reworded paragraphs (151)
Previous wording
We are a biotechnology company with a limited operating history. Our efforts are focused primarily on the treatment of unmet needs in autoantibody-mediated diseases, in particular the clinical development of budoprutug. To date, we have not received regulatory approvals for any of our product candidates or generated any revenue from the sale of products, and we do not expect to generate any revenue in the foreseeable future. Budoprutug is in early stages of research and development. As a result, we are not profitable, and we have incurred significant operating losses since inception. Our net losses were $56.6 million and $27.5 million for the six months ended June 30, 2024 and 2023, respectively. We had an accumulated deficit of $212.6 million and $156.0 million as of June 30, 2024 and December 31, 2023, respectively. We expect to continue to incur substantial expenses and operating losses for the foreseeable future as we continue to develop budoprutug and any future product candidates we may develop. As a result, we expect to continue to incur significant losses for the foreseeable future as we:
Current wording
We are a clinical-stage biotechnology company with a limited operating history. Our efforts are focused primarily on the treatment of unmet needs in immune-mediated diseases, in particular the development of budoprutug. To date, we have not received regulatory approvals for budoprutug or any other product candidate or generated any revenue from the sale of products, and we do not expect to generate any revenue for the foreseeable future. Budoprutug is in early stages of research and development. As a result, we are not profitable, and we have incurred significant operating losses since inception. Our net losses were $65.5 million and $31.5 million for the nine months ended September 30, 2024 and 2023, respectively. We had an accumulated deficit of $221.5 million and $156.0 million as of September 30, 2024 and December 31, 2023, respectively. We expect to continue to incur substantial expenses and operating losses for the foreseeable future as we continue to develop budoprutug and any product candidates we may develop. As a result, we expect to continue to incur significant losses for the foreseeable future as we:
Previous wording
continue development of budoprutug and any future product candidates we may develop;
Current wording
continue development of budoprutug and any product candidates we may develop;
Previous wording
initiate and continue research and development, including preclinical, clinical and discovery efforts for any future product candidates we may develop;
Current wording
initiate and continue research and development, including preclinical, clinical and discovery efforts for any product candidates we may develop;
Previous wording
seek regulatory approvals for budoprutug or any future product candidates we may develop that successfully complete clinical development;
Current wording
seek regulatory approvals for budoprutug or any product candidates we may develop that successfully complete clinical development;
Previous wording
We had cash and cash equivalents of $223.1 million and cash, cash equivalents, and marketable securities of $106.8 million at June 30, 2024 and December 31, 2023, respectively.
Current wording
We had cash, cash equivalents and marketable securities of $217.9 million and $106.8 million at September 30, 2024 and December 31, 2023, respectively.
Previous wording
Based upon our current operating plan and assumptions, we believe that our existing cash and cash equivalents will be sufficient to fund our operations into 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. In addition, we will need additional capital to advance and expand our research pipeline, conduct preclinical studies, proceed to develop and commercialize any approved products, and explore other pipeline opportunities. Our estimates of the sufficiency of our cash and cash equivalents are based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we expect. Further, changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned.
Current wording
Based upon our current operating plan and assumptions, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operations through 2027. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. In addition, we will need additional capital to advance and expand our research pipeline, conduct preclinical studies and clinical trials, proceed to develop and commercialize any approved products, and explore other pipeline opportunities. Our estimates of the sufficiency of our cash, cash equivalents and marketable securities are based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we expect. Further, changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned.
Previous wording
Conducting preclinical studies, conducting clinical trials, pursuing regulatory approvals, establishing outsourced manufacturing relationships and successfully manufacturing and commercializing our product candidates is, and will be, very time-consuming, expensive and an uncertain process that takes years to complete. Our future need for additional funding depends on many factors, including:
Current wording
Conducting preclinical studies, conducting clinical trials, pursuing regulatory approvals, establishing outsourced manufacturing relationships and successfully manufacturing and commercializing budoprutug or any product candidates we may develop is, and will be, very time-consuming, expensive and an uncertain process that takes years to complete. Our future need for additional funding depends on many factors, including:
Previous wording
We cannot be certain that additional funding will be available on acceptable terms, or at all. Our ability to raise additional capital may be adversely impacted by disruptions to, or continuing volatility in, the credit and financial markets in the United States and worldwide, including increased volatility in the trading prices for shares of public companies in the biopharmaceutical sector, actual and perceived changes in interest rates and inflation, macroeconomic uncertainties, or otherwise. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of our product candidates or other research and development initiatives.
Current wording
We cannot be certain that additional funding will be available on acceptable terms, or at all. Our ability to raise additional capital may be adversely impacted by disruptions to, or continuing volatility in, the credit and financial markets in the United States and worldwide, including increased volatility in the trading prices for shares of public companies in the biopharmaceutical sector, actual and perceived changes in interest rates and inflation, macroeconomic uncertainties, or otherwise. We have no committed source of additional capital and if we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of budoprutug or product candidates we may develop or other research and development initiatives.
Previous wording
Until such time, if ever, as we can generate substantial revenues from product sales, we may need or may seek to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of common stock, convertible securities or other equity securities, your ownership interest may be diluted, and the terms of these securities could include liquidation or other preferences and anti-dilution protections that could adversely affect your rights as a common stockholder. In addition, debt financing, if available, may result in fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures, creating liens, redeeming stock or declaring dividends, that could adversely impact our ability to conduct our business. Further, securing financing could require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development of our product candidates.
Current wording
Until such time, if ever, as we can generate substantial revenues from product sales, we may need or may seek to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of common stock, convertible securities or other equity securities, your ownership interest may be diluted, and the terms of these securities could include liquidation or other preferences and anti-dilution protections that could adversely affect your rights as a common stockholder. In addition, debt financing, if available, may result in fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures, creating liens, redeeming stock or declaring dividends, that could adversely impact our ability to conduct our business. Further, securing financing could require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development of budoprutug or any product candidates we may develop.
Previous wording
Further, we have issued, and may in the future issue additional, equity securities as consideration for business development transactions, which may also dilute our existing stockholders’ ownership interests. For example, we issued additional shares of our common stock in connection with the Acquisition, as well as in the concurrent private placement of shares of our common stock to certain institutional investors.
Current wording
Further, we have issued, and may in the future issue additional, equity securities as consideration for business development transactions, which may also dilute our existing stockholders’ ownership interests. For example, we issued additional shares of our common stock in connection with our acquisition of Tenet Medicines, Inc. (the Acquisition), as well as in the concurrent private placement of shares of our common stock to certain institutional investors.
Previous wording
If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Current wording
If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market budoprutug or any product candidates that we would otherwise prefer to develop and market ourselves.
Previous wording
Drug development is highly uncertain, and if we are unable to successfully develop and commercialize product candidates or experience significant delays in doing so, our business may be harmed.
Current wording
Drug development is highly uncertain, and if we are unable to successfully develop and commercialize budoprutug or experience significant delays in doing so, our business may be harmed.
Previous wording
Drug development is a highly uncertain undertaking and involves a substantial degree of risk. For example, previously we paused or discontinued the development of all of our product candidates for the treatment of neuronal excitability disorders, including ETX-155 and Kv7, which were still in drug discovery stages, and we may not ever obtain regulatory approval for budoprutug or any future product candidates we may develop. In addition, as a company, we have not developed any product candidates for the autoimmune diseases, and following the closing of the Acquisition, we are focused on the clinical development of our lead product candidate, budoprutug, for systemic lupus erythematosus and lupus nephritis (SLE/LN), immune thrombocytopenia (ITP). We also have no prior experience developing biological product candidates. As such, we may encounter delays or difficulties in our efforts to develop and commercialize budoprutug.
Current wording
Drug development is a highly uncertain undertaking and involves a substantial degree of risk. For example, previously we paused or discontinued the development of all of our product candidates for the treatment of neuronal excitability disorders, including ETX-155 and Kv7, which were still in drug discovery stages, and we may not ever obtain regulatory approval for budoprutug or any product candidates we may develop. In addition, as a company, we have not developed any product candidates for the immune-mediated diseases, and following the closing of the Acquisition, we are focused on the clinical development of our lead product candidate, budoprutug, for primary membranous nephropathy (pMN), immune thrombocytopenia (ITP) and systemic lupus erythematosus (SLE). We also have no prior experience developing biological product candidates. As such, we may encounter delays or difficulties in our efforts to develop and commercialize budoprutug.
Previous wording
To date, we have not initiated or completed a pivotal clinical trial, obtained marketing approval for any product candidates, manufactured a commercial scale product or arranged for a third party to do so on our behalf, or conducted the sales and marketing activities necessary for successful product commercialization. Our short operating history as a company makes any assessment of our future success and viability subject to significant uncertainty. We will encounter risks and difficulties frequently experienced by early-stage biotechnology companies in rapidly evolving fields, and we have not yet demonstrated an ability to successfully overcome such risks and difficulties. If we do not address these risks and difficulties successfully, our business may be harmed.
Current wording
To date, we have not initiated or completed a pivotal clinical trial, obtained marketing approval for any product candidate, manufactured a commercial scale product or arranged for a third party to do so on our behalf, or conducted the sales and marketing activities necessary for successful product commercialization. Our short operating history as a company makes any assessment of our future success and viability subject to significant uncertainty. We will encounter risks and difficulties frequently experienced by early-stage biotechnology companies in rapidly evolving fields, and we have not yet demonstrated an ability to successfully overcome such risks and difficulties. If we do not address these risks and difficulties successfully, our business may be harmed.
Previous wording
We have never commercialized a product or generated any revenues from commercial product sales, or otherwise, and we may never become profitable. Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a time-consuming, expensive and uncertain process that takes years to complete. We may never generate the necessary data or results required to obtain marketing approval for budoprutug or any other product candidates or generate revenue from the sale of budoprutug any products for which we may obtain marketing approval. Our ability to generate revenue from product sales or achieve profitability will depend upon our ability, alone or with any future collaborators, to successfully commercialize budoprutug or any products that we may develop, in-license or acquire in the future. Even if we are able to successfully achieve regulatory approval for budoprutug or any other product candidate, we do not know when budoprutug or any other product candidate will generate revenue from product sales for us, if at all. Our ability to generate revenue from budoprutug or any future product candidates we may develop also depends on a number of additional factors, including our or any future collaborators’ ability to:
Current wording
We have never commercialized a product or generated any revenues from commercial product sales, or otherwise, and we may never become profitable. Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a time-consuming, expensive and uncertain process that takes years to complete. We may never generate the necessary data or results required to obtain marketing approval for budoprutug or any product candidates we may develop or generate revenue from the sale of budoprutug or any products for which we may obtain marketing approval. Our ability to generate revenue from product sales or achieve profitability will depend upon our ability, alone or with any future collaborators, to successfully commercialize budoprutug or any products that we may develop, in-license or acquire in the future. Even if we are able to successfully achieve regulatory approval for budoprutug or any product candidate we may develop, we do not know when budoprutug or any such product candidate will generate revenue from product sales for us, if at all. Our ability to generate revenue from budoprutug or any product candidates we may develop also depend on a number of additional factors, including our or any future collaborators’ ability to:
Previous wording
complete and submit investigational new drug applications (INDs) to the U.S Food and Drug Administration (the FDA) that allow commencement of our planned clinical trials or future clinical trials for our product candidates;
Current wording
complete and submit investigational new drug applications (INDs) to the U.S Food and Drug Administration (the FDA) that allow commencement of our planned clinical trials or future clinical trials for budoprutug or any product candidates we may develop;
Previous wording
set a commercially viable price for our products;
Current wording
set a commercially viable price for any products;
Previous wording
achieve market acceptance for our products, if any;
Previous wording
In addition, because of the numerous risks and uncertainties associated with pharmaceutical product development, budoprutug or any future product candidates we may develop may not advance through development or achieve the endpoints of applicable clinical trials, we are unable to predict the timing or amount of increased expenses, or when or if we will be able to achieve or maintain profitability. In addition, our expenses could increase beyond expectations if we decide, or are required by the FDA or foreign regulatory authorities, to perform studies or trials in addition to those that we currently anticipate. Even if we can complete the development and regulatory process for budoprutug or any future product candidates we may develop, we anticipate incurring significant costs associated with commercializing these products.
Current wording
In addition, because of the numerous risks and uncertainties associated with pharmaceutical product development, budoprutug or any product candidates we may develop may not advance through development or achieve the endpoints of applicable clinical trials. We are unable to predict the timing or amount of increased expenses, or when or if we will be able to achieve or maintain profitability. In addition, our expenses could increase beyond expectations if we decide, or are required by the FDA or foreign regulatory authorities, to perform studies or trials in addition to those that we currently anticipate. Even if we can complete the development and regulatory process for budoprutug or any product candidates we may develop, we anticipate incurring significant costs associated with commercializing any such products.
Previous wording
Even if we can generate revenues from the sale of budoprutug or any future product candidates we may develop that may be approved, we may not become profitable and may need to obtain additional funding to continue operations. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce our operations.
Current wording
Even if we can generate revenues from the sale of budoprutug or any product candidates we may develop that may be approved, we may not become profitable and may need to obtain additional funding to continue operations. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce our operations.
Previous wording
Our future success is dependent primarily on the regulatory approval and commercialization of budoprutug and any future product candidates we may develop.
Current wording
Our future success is dependent primarily on the regulatory approval and commercialization of budoprutug and any product candidates we may develop.
Previous wording
We do not have any product candidates that have gained regulatory approval, and we are substantially dependent on the success of budoprutug and any other product candidates we may develop in the future. As a result, our prospects, including our ability to finance our operations and generate revenue, are substantially dependent on our ability to obtain regulatory approval for budoprutug, and, if approved, to successfully commercialize budoprutug and any future product candidates we may develop. We cannot commercialize budoprutug or any future product candidates we may develop in the United States without first obtaining regulatory approval for the product from the FDA; similarly, we cannot commercialize budoprutug or any future product candidates we may develop outside of the United States without obtaining regulatory approval from comparable foreign regulatory authorities. The FDA review process for a BLA typically takes more than a year to complete and approval is never guaranteed. Before obtaining regulatory approvals for the commercial sale of budoprutug or any future product candidates we may develop for a target indication, we must demonstrate with substantial evidence gathered in preclinical and well-controlled clinical trials, generally including at least two well-controlled Phase 3 trials, and, with respect to approval in the United States, to the satisfaction of the FDA, that the product candidate is potent, safe and pure for use for that target indication and that the manufacturing facilities, processes and controls are adequate. If budoprutug encounters undesirable safety signals, insufficient efficacy results, development delays, regulatory issues or other problems, our development plans and business would be significantly harmed.
Current wording
We do not have any product candidates that have gained regulatory approval, and we are substantially dependent on the success of budoprutug and any product candidates we may develop in the future. As a result, our prospects, including our ability to finance our operations and generate revenue, are substantially dependent on our ability to obtain regulatory approval for budoprutug, and, if approved, to successfully commercialize budoprutug and any product candidates we may develop. We cannot commercialize budoprutug or any product candidates we may develop in the United States without first obtaining regulatory approval for the product from the FDA; similarly, we cannot commercialize budoprutug or any product candidates we may develop outside of the United States without obtaining regulatory approval from comparable foreign regulatory authorities. Under the Prescription Drug User Fee Act, the FDA’s standard review process for a BLA is meant to take 10 months from the date a BLA is accepted for filing, but that process may take longer to complete and FDA approval is never guaranteed. Before obtaining regulatory approvals for the commercial sale of budoprutug or any product candidates we may develop for a target indication, we must demonstrate with substantial evidence gathered in preclinical and well-controlled clinical trials, generally including at least two well-controlled Phase 3 trials, and, with respect to approval in the United States, to the satisfaction of the FDA, that the product candidate is potent, safe and pure for use for that target indication and that the manufacturing facilities, processes and controls are adequate. If budoprutug encounters undesirable safety signals, insufficient efficacy results, development delays, regulatory issues or other problems, our development plans and business would be significantly harmed.
Previous wording
Further, under the Pediatric Research Equity Act, a BLA or supplement to a BLA for certain biological products must contain data to assess the safety, potency and purity of the biological product in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe, potent and pure, unless the sponsor receives a deferral or waiver from the FDA. A deferral may be granted for several reasons, including a finding that the product or therapeutic candidate is ready for approval for use in adults before pediatric trials are complete or that additional safety, potency and purity data need to be collected before the pediatric trials begin. The applicable legislation in the European Union also requires sponsors to either conduct clinical trials in a pediatric population in accordance with a Pediatric Investigation Plan approved by the Pediatric Committee of the European Medicines Agency (EMA) or to obtain a waiver or deferral from the conduct of these studies by this Committee. For any of our product candidates for which we are seeking regulatory approval in the United States or the European Union, we cannot guarantee that we will be able to obtain a waiver or alternatively complete any required studies and other requirements in a timely manner, or at all, which could result in associated reputational harm and subject us to enforcement action.
Current wording
Further, under the Pediatric Research Equity Act, a BLA or supplement to a BLA for certain biological products must contain data to assess the safety, potency and purity of the biological product in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe, potent and pure, unless the sponsor receives a deferral or waiver from the FDA. A deferral may be granted for several reasons, including a finding that the product or therapeutic candidate is ready for approval for use in adults before pediatric trials are complete or that additional safety, potency and purity data need to be collected before the pediatric trials begin.
Previous wording
Obtaining regulatory approval for marketing of budoprutug or any future product candidates we may develop in one country does not ensure we will be able to obtain regulatory approval in other countries, but a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in other countries.
Current wording
Obtaining regulatory approval for marketing of budoprutug or any product candidates we may develop in one country does not ensure we will be able to obtain regulatory approval in other countries, but a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in other countries.
Previous wording
Even if budoprutug or future product candidates we may develop were to successfully obtain approval from the FDA and comparable foreign regulatory authorities, any approval might contain significant limitations related to use restrictions for specified age groups, gender or subpopulation of target indication, warnings, precautions or contraindications, or may be subject to burdensome post-approval study or risk management requirements. If we are unable to obtain regulatory approval for one or more jurisdictions, or any approval contains significant limitations, we may not be able to obtain sufficient funding or generate sufficient revenue to continue the development of any of budoprutug or any of our future product candidate that we may discover, in-license, develop or acquire in the future. Also, any regulatory approval of budoprutug or any future product candidates we may develop, once obtained, may be withdrawn. Furthermore, even if we obtain regulatory approval for budoprutug or any future product candidates we may develop, such product’s commercial success will depend on a number of factors, including the following:
Current wording
Even if budoprutug or product candidates we may develop were to successfully obtain approval from the FDA and comparable foreign regulatory authorities, any approval might contain significant limitations related to use restrictions for specified age groups, gender or subpopulation of target indication, warnings, precautions or contraindications, or may be subject to burdensome post-approval study or risk management requirements. If we are unable to obtain regulatory approval for one or more jurisdictions, or any approval contains significant limitations, we may not be able to obtain sufficient funding or generate sufficient revenue to continue the development of budoprutug or any product candidate that we may discover, in-license, develop or acquire. Also, any regulatory approval of budoprutug or any product candidates we may develop, once obtained, may be withdrawn. Furthermore, even if we obtain regulatory approval for budoprutug or any product candidates we may develop, such product’s commercial success will depend on a number of factors, including the following:
Previous wording
the ability of our third-party manufacturers to manufacture quantities of our products in commercially sufficient processes and at a scale sufficient to meet anticipated demand and enable us to reduce our cost of manufacturing;
Current wording
the ability of our third-party manufacturers to manufacture quantities of such product in commercially sufficient processes and at a scale sufficient to meet anticipated demand and enable us to reduce our cost of manufacturing;
Previous wording
our success in educating physicians and patients about the benefits, administration and use of our products;
Current wording
our success in educating physicians and patients about the benefits, administration and use of such products;
Previous wording
acceptance of our products as potent, safe and pure by patients and the medical community; and
Current wording
acceptance of such product as potent, safe and pure by patients and the medical community; and
Previous wording
a continued acceptable safety profile of our products following approval.
Current wording
a continued acceptable safety profile of such product following approval.
Previous wording
Many of these factors are beyond our control. If we, or our potential commercialization collaborators, are unable to successfully commercialize budoprutug or any future product candidates we may develop, we may not be able to earn sufficient revenues to continue our business.
Current wording
Many of these factors are beyond our control. If we, or our potential commercialization collaborators, are unable to successfully commercialize budoprutug or any product candidates we may develop, we may not be able to earn sufficient revenues to continue our business.
Previous wording
Even if budoprutug or any future product candidates we may develop receive regulatory approval, they may still face future development and regulatory difficulties.
Current wording
Even if budoprutug or any product candidates we may develop receive regulatory approval, they may still face future development and regulatory difficulties.
Previous wording
Even if we obtain regulatory approval for budoprutug or a future product candidate, it would be subject to ongoing requirements by the FDA and comparable foreign regulatory authorities governing the manufacture, quality control, further development, labeling, packaging, storage, distribution, safety surveillance, import, export, advertising, promotion, recordkeeping and reporting of safety and other post-market information. The safety profile of any product will continue to be closely monitored by the FDA and comparable foreign regulatory authorities after approval. If the FDA or comparable foreign regulatory authorities become aware of new safety information after approval of budoprutug or any future product candidate, they may require labeling changes or establishment of a Risk Evaluation and Mitigation Strategy (REMS) or similar strategy, impose significant restrictions on a product’s indicated uses or marketing, or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance.
Current wording
Even if we obtain regulatory approval for budoprutug or any product candidate we may develop, it would be subject to ongoing requirements by the FDA and comparable foreign regulatory authorities governing the manufacture, quality control, further development, labeling, packaging, storage, distribution, safety surveillance, import, export, advertising, promotion, recordkeeping and reporting of safety and other post-market information. The safety profile of any product will continue to be closely monitored by the FDA and comparable foreign regulatory authorities after approval. If the FDA or comparable foreign regulatory authorities become aware of new safety information after approval of budoprutug or any product candidate, they may require labeling changes or establishment of a Risk Evaluation and Mitigation Strategy (REMS) or similar strategy, impose significant restrictions on a product’s indicated uses or marketing, or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance.
Previous wording
In addition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current good manufacturing practice (cGMP) requirements and other regulations. If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. If we, our product candidates or the manufacturing facilities for our product candidates, fail to comply with applicable regulatory requirements, a regulatory agency may:
Current wording
If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. If we, budoprutug or any product candidates we may develop or the manufacturing facilities for such product candidates, fail to comply with applicable regulatory requirements, a regulatory agency may:
Previous wording
impose restrictions on the marketing or manufacturing of the product candidates;
Current wording
impose restrictions on the marketing or manufacturing of such product candidate;
Previous wording
The occurrence of any event or penalty described above may inhibit our ability to commercialize budoprutug or any future product candidates we may develop and generate revenue.
Current wording
The occurrence of any event or penalty described above may inhibit our ability to commercialize budoprutug or any product candidates we may develop and generate revenue.
Previous wording
The FDA strictly regulates the advertising and promotion of drug products, and drug products may only be marketed or promoted for their FDA approved uses, consistent with the product’s approved labeling. Advertising and promotion of any product candidate that obtains approval in the United States will be heavily scrutinized by the FDA, the Department of Justice, the Office of Inspector General of the U.S. Department of Health and Human Services (HHS) state attorneys general, members of Congress and the public. Violations, including promotion of our products for unapproved or off-label uses, are subject to enforcement letters, inquiries and investigations, and civil, criminal and/or administrative sanctions by the FDA and other enforcement authorities. Additionally, advertising and promotion of any product candidate that obtains approval outside of the United States will be heavily scrutinized by relevant foreign regulatory authorities.
Current wording
The FDA strictly regulates the advertising and promotion of drug products, and drug products may only be marketed or promoted for their FDA approved uses, consistent with the product’s approved labeling. Advertising and promotion of any product candidate that obtains approval in the United States will be heavily scrutinized by the FDA, the Department of Justice, the Office of Inspector General of the U.S. Department of Health and Human Services (HHS) state attorneys general, members of Congress and the public. Violations, including promotion of any products for unapproved or off-label uses, are subject to enforcement letters, inquiries and investigations, and civil, criminal and/or administrative sanctions by the FDA and other enforcement authorities. Additionally, advertising and promotion of any product candidate that obtains approval outside of the United States will be heavily scrutinized by relevant foreign regulatory authorities.
Previous wording
Existing government regulations may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of budoprutug or any future product candidates we may develop. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and/or be subject to fines or enhanced government oversight and reporting obligations, which would adversely affect our business, prospects and ability to achieve or sustain profitability.
Current wording
Existing government regulations may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of budoprutug or any product candidates we may develop. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and/or be subject to fines or enhanced government oversight and reporting obligations, which would adversely affect our business, prospects and ability to achieve or sustain profitability.
Previous wording
Our ability to develop and market new drug products may be impacted if litigation challenging the FDA’s approval of another company’s drug continues. In April 2023, the U.S. District Court for the Northern District of Texas invalidated the approval by the FDA of mifepristone, a drug product, which was originally approved in 2000, and whose distribution is governed by various measures adopted under a REMS. The Court of Appeals for the Fifth Circuit declined to order the removal of mifepristone from the market but did hold that plaintiffs were likely to prevail in their claim that changes allowing for expanded access of mifepristone, which the FDA authorized in 2016 and 2021, were arbitrary and capricious. In June 2024, the Supreme Court reversed and remanded that decision after unanimously finding that the plaintiffs did not have standing to bring this legal action against the FDA. Depending on the outcome of this litigation, if it continues, our ability to develop budoprutug or future product candidates we may develop may be at risk and could be delayed, undermined or subject to protracted litigation.
Current wording
In April 2023, the U.S. District Court for the Northern District of Texas invalidated the approval by the FDA of mifepristone, a drug product, which was originally approved in 2000, and whose distribution is governed by various measures adopted under a REMS. The Court of Appeals for the Fifth Circuit declined to order the removal of mifepristone from the market but did hold that plaintiffs were likely to prevail in their claim that changes allowing for expanded access of mifepristone, which the FDA authorized in 2016 and 2021, were arbitrary and capricious. In June 2024, the Supreme Court reversed and remanded that decision after unanimously finding that the plaintiffs (anti-abortion doctors and organizations) did not have standing to bring this legal action against the FDA. On October 11, 2024, the Attorneys General of three states (Missouri, Idaho and Kansas) filed an amended complaint in the district court in Texas challenging the FDA’s actions. Depending on the outcome of this litigation, our ability to develop budoprutug or any product candidates we may develop may be at risk and could be delayed, undermined or subject to protracted litigation.
Previous wording
Finally, we could be adversely affected by several significant administrative law cases decided by the U.S. Supreme Court in 2024. In Loper Bright Enterprises v. Raimondo, for example, the court overruled Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., which for 40 years required federal courts to defer to permissible agency interpretations of statutes that are silent or ambiguous on a particular topic. The Supreme Court stripped federal agencies of this presumptive deference and held that courts must exercise their independent judgment when deciding whether an agency such as FDA acted within its statutory authority under the Administrative Procedure Act (APA). Additionally, in Corner Post, Inc. v. Board of Governors of the Federal Reserve System, the court held that actions to challenge a federal regulation under the APA can be initiated within six years of the date of injury to the plaintiff, rather than the date the rule is finalized. The decision appears to give prospective plaintiffs a personal statute of limitations to challenge longstanding agency regulations. These decisions could introduce additional uncertainty into the regulatory process and may result in additional legal challenges to actions taken by federal regulatory agencies, including the FDA and the Centers for Medicare & Medicaid Services (CMS) that we rely on. In addition to potential changes to regulations as a result of legal challenges, these decisions may result in increased regulatory uncertainty and delays and other impacts, any of which could adversely impact our business and operations.
Current wording
Finally, we could be adversely affected by several significant administrative law cases decided by the U.S. Supreme Court in 2024. In Loper Bright Enterprises v. Raimondo, for example, the court overruled Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., which for 40 years required federal courts to defer to permissible agency interpretations of statutes that are silent or ambiguous on a particular topic. The Supreme Court stripped federal agencies of this presumptive deference and held that courts must exercise their independent judgment when deciding whether an agency such as FDA acted within its statutory authority under the Administrative Procedure Act (APA). Additionally, in Corner Post, Inc. v. Board of Governors of the Federal Reserve System, the court held that actions to challenge a federal regulation under the APA can be initiated within six years of the date of injury to the plaintiff, rather than the date the rule is finalized. The decision appears to give prospective plaintiffs a personal statute of limitations to challenge longstanding agency regulations. Another decision, Securities and Exchange Commission v. Jarkesy, overturned regulatory agencies’ ability to impose civil penalties in administrative proceedings. These decisions could introduce additional uncertainty into the regulatory process and may result in additional legal challenges to actions taken by federal regulatory agencies, including the FDA and the Centers for Medicare & Medicaid Services (CMS) that we rely on. In addition to potential changes to regulations as a result of legal challenges, these decisions may result in increased regulatory uncertainty and delays and other impacts, any of which could adversely impact our business and operations.
Previous wording
From time to time, we may announce, present or publish preliminary, initial, or interim data or other information from our clinical trials, such as the preliminary data from the Phase 1b clinical trial of budoprutug for the treatment of membranous nephropathy (MN). Any such data and other results from our clinical trials may materially change as more patient data and information become available. Such data and information may also undergo significant change following subsequent auditing, validation and/or verification procedures that are commonly conducted in clinical trials. Thus, any preliminary, initial, or interim data or other information may not be predictive of final results from the clinical trial and should be viewed with caution until the final data are available. We may also arrive at different conclusions, or other determinations that may qualify such results, once we have received and fully evaluated the additional data. Differences between preliminary, initial or interim results and final results could lead to significantly different interpretations or conclusions of the trial outcomes.
Current wording
From time to time, we may announce, present or publish preliminary, initial, or interim data or other information from our clinical trials, such as the preliminary data from the Phase 1b clinical trial of budoprutug for the treatment of pMN. Any such data and other results from our clinical trials may materially change as more patient data and information become available. Such data and information may also undergo significant change following subsequent auditing, validation and/or verification procedures that are commonly conducted in clinical trials. Thus, any preliminary, initial, or interim data or other information may not be predictive of final results from the clinical trial and should be viewed with caution until the final data are available. We may also arrive at different conclusions, or other determinations that may qualify such results, once we have received and fully evaluated the additional data. Differences between preliminary, initial or interim results and final results could lead to significantly different interpretations or conclusions of the trial outcomes.
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Current report — wording carried from elsewhere
The applicable legislation in the European Union also requires sponsors to either conduct clinical trials in a pediatric population in accordance with a Pediatric Investigation Plan approved by the Pediatric Committee of the European Medicines Agency (EMA) or to obtain a waiver or deferral from the conduct of these studies by this Committee. For any product candidates for which we seek regulatory approval in the United States or the European Union, we cannot guarantee that we will be able to obtain a waiver or alternatively complete any required studies and other requirements in a timely manner, or at all, which could result in associated reputational harm and subject us to enforcement action.
Current report — wording carried from elsewhere
In addition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with current good manufacturing practice (cGMP) requirements and other regulations.
Current report — wording carried from elsewhere
Our ability to develop and market new drug products may be impacted if litigation challenging the FDA’s approval of another company’s drug product continues.
Current report — wording carried from elsewhere
To obtain the requisite regulatory approvals to commercialize budoprutug or any product candidates we may develop, we must demonstrate through extensive preclinical studies and clinical trials that such product candidates are potent, safe and pure in humans to the satisfaction of FDA. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain.
Current report — wording carried from elsewhere
Our market opportunity estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates which may not prove to be accurate. We currently focus our research and product development on budoprutug for the treatment of pMN, ITP and SLE. Our understanding of the patient populations with these diseases is based on estimates in published literature.
Current report — wording carried from elsewhere
Specifically, with respect to price negotiations, Congress authorized Medicare to negotiate lower prices for certain costly single-source drug and biologic products that do not have competing generics or biosimilars and are reimbursed under Medicare Part B and Part D. CMS may negotiate prices for ten high-cost drugs paid for by Medicare Part D starting in 2026, followed by 15 additional Medicare Part D drugs in 2027, 15 additional Medicare Part B or Part D drugs in 2028, and 20 additional Medicare Part B or Part D drugs per year in 2029 and beyond.
Current report — wording carried from elsewhere
To obtain reimbursement or pricing approval in some countries, we or our collaborators may be required to conduct a clinical trial that compares the cost-effectiveness of our product to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount or if pricing is set at unsatisfactory levels, our business could be materially harmed.
Current report — wording carried from elsewhere
In addition, if we fail to obtain the non-U.S. approvals required to market budoprutug or any product candidates we may develop outside the United States or if we fail to comply with applicable non-U.S. regulatory requirements, our target markets will be reduced and our ability to realize the full market potential of such product candidate will be harmed and our business, financial condition, results of operations and prospects may be adversely affected.
Current report — wording carried from elsewhere
Like our information security systems, those of our third-party service providers are vulnerable to compromise, damage, loss or exfiltration from cyber-attacks, computer viruses, unauthorized access and other causes. Our third-party service providers may not anticipate or immediately detect such incidents and the damage caused by such incidents or notify us in a timely or complete manner.
Current report — wording carried from elsewhere
We rely heavily on patents, know-how and other intellectual property licensed from others. We are party to a license agreement with Cancer Research Technology Limited (CRH) under which we are granted rights to intellectual property that are important to our business.
Current report — wording carried from elsewhere
Our success depends in significant part on our ability and the ability of our licensors, or future licensors, licensees or collaborators to obtain, maintain, enforce and defend patents and other intellectual property rights with respect to budoprutug or any product candidates we may develop and technology and to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of others.
Current report — wording carried from elsewhere
We cannot be certain that such activities by third parties have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents or other intellectual property rights.
Current report — wording carried from elsewhere
We obtained our right to a number of existing license agreements pursuant to an asset purchase agreement with Acelyrin, Inc., or Acelyrin, which imposes on us various development, regulatory and/or commercial diligence obligations, payment of milestones and/or royalties and other obligations.
Current report — wording carried from elsewhere
Additionally, the issued patents, or patents that may be issued from the pending patent applications that we exclusively in-licenses from CRH are expected to expire in 2026, excluding any patent term adjustment that might be available following the grant of the patent and any patent term extensions that might be available following the grant of marketing authorizations. In each instance of the above, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to budoprutug.
Current report — wording carried from elsewhere
As is common in the biopharmaceutical industry, we engage the services of consultants to assist us in the development of budoprutug. Many of these consultants were previously employed at, or may have previously provided or may be currently providing consulting services to, other biopharmaceutical companies including our competitors or potential competitors.
Current report — wording carried from elsewhere
The global credit and financial markets have experienced extreme volatility and disruptions (including as a result of actual or perceived changes in interest rates, inflation and macroeconomic uncertainties), which has included severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, high inflation, uncertainty about economic stability, and increases in unemployment rates.
Current report — wording carried from elsewhere
During times of war and other major conflicts, we, and the third parties upon which we rely, may be vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks, that could materially disrupt our systems and operations, supply chain, and harm our business.
Current report — wording carried from elsewhere
We are also a “smaller reporting company,” as defined in the Exchange Act. Even after we no longer qualify as an “emerging growth company,” we may still qualify as a “smaller reporting company,” which would allow us to continue to take advantage of many of the same exemptions from disclosure requirements. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and the price of our common stock may be more volatile.