What the changes say
- Spruce Biosciences faces substantial financial losses and relies heavily on ongoing clinical development of TA-ERT and tildacerfont.
- New debt covenants and international trade disruptions add strict financial and operational constraints.
- Commercial viability depends heavily on third-party payor reimbursement and avoiding off-label promotion penalties.
What changed since the prior 10-K
New
- NewRisks Related to Our Business and Industry
Changing circumstances may cause us to consume capital significantly faster than we currently anticipate, and we may need to spend more money than currently expected because of circumstances beyond our control
Geopolitical uncertainty and macroeconomic events could restrict our access to credit markets and increase our capital needs for TA-ERT.
- NewRisks Related to Our Business and Industry
biopharmaceutical area. Consequently, any predictions about our future performance may not be as accurate as they would be if we had a history of successfully developing and commercializing biopharmaceutical products
We have no approved products, reported net losses of $39.0 million for 2025, and an accumulated deficit of $289.2 million.
- NewRisks Related to Our Business and Industry
experience delays in completing, or ultimately be unable to complete, the development and commercialization of TA-ERT and our other current and future product candidates
Our preclinical studies and early trials for TA-ERT, tildacerfont, and SPR202 may fail to predict the success or safe dosage in later trials.
- NewRisks Related to Our Business and Industry
trial protocol, as part of an IND or similar regulatory filing under which we must receive authorization to proceed with clinical development
We rely on third-party CROs for clinical data and regulatory submissions, and their poor performance could delay our development programs.
- NewRisks Related to Our Business and Industry
International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects
U.S. and foreign tariffs and trade barriers on pharmaceutical products may adversely affect our international supply chain and operations.
- NewRisks Related to Our Business and Industry
at the authorities have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable
Government shutdowns, such as the one on October 1, 2025, can furlough FDA staff and delay our regulatory submissions.
- NewRisks Related to Our Business and Industry
and any other current or future product candidates, significant fines, penalties, sanctions, or product liability claims, and our image and reputation within the industry and marketplace could be harmed
Off-label promotion of TA-ERT by physicians could result in warning letters, government fines, and product liability claims.
- NewRisks Related to Our Business and Industry
reimbursement of our future products are unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitability
Third-party payors may restrict access to our products on their formularies or set reimbursement rates at unsatisfactory levels.
- NewRisks Related to Our Business and Industry
On January 7, 2026, we entered into the Loan Agreement with Avenue Capital. For a description of our Loan Agreement, see Note 15, “Loan Agreement with Avenue Capital”, to the consolidated financial statements included elsewhere in this Annual Report
Our January 7, 2026 Loan Agreement with Avenue Capital imposes restrictive covenants that could trigger immediate repayment upon default.
- NewRisks Related to Our Business and Industry
integrated entities, and it may be difficult to integrate companies into our information technology environment and security program
Our reliance on third-party cloud infrastructure and research collaborators introduces supply-chain cybersecurity risks and vulnerabilities.
- NewRisks Related to Our Business and Industry
arbitration demands. Some of these claims allow for the recovery of statutory damages on a per violation basis, and, if viable, carry the potential for monumental statutory damages, depending on the volume of data and the number of violations
Data privacy violations could lead to statutory damages, business interruptions, and reputational harm.
- NewRisks Related to Our Business and Industry
a decline in the price of our common stock
Inadequate product liability insurance coverage for commercial launches could expose us to uninsurable court judgments.
- NewRisks Related to Ownership of Our Common Stock
On April 26, 2024, we received a letter from Nasdaq Listing Qualifications, notifying us that, for the previous 30 consecutive business day period prior to the date of the letter, the closing bid price for our common stock was below $1.00 (the “Minimum Bid Price Requirement”)
- NewRisks Related to Our Reliance on Third Parties
materials relating to certain compounds developed by HBM (the “HBM License Agreement”)
- NewRisks Related to Our Intellectual Property
license are deemed invalid and unenforceable, our ability to commercialize or license our technology could be adversely affected
Dropped
- DroppedRisks Related to Our Business and Industry
We will need substantial additional financing to develop our product candidates and implement our operating plan. If we fail to obtain additional financing, we may be forced to delay, reduce or eliminate our product development programs or commercialization efforts
Need substantial financing to develop tralesinidase alfa and tildacerfont.
- DroppedRisks Related to Our Business and Industry
We will require additional capital for the further development and commercialization of tralesinidase alfa, tildacerfont and our other current and future product candidates and may need to raise additional funds sooner if we choose to expand more rapidly than we presently anticipate
Capital requirements for tralesinidase alfa and SVB exposure risk.
- DroppedRisks Related to Our Business and Industry
and placebo. Cortibon stratifies the patient sample with a sensitivity and specificity above 80% and post-hoc analysis suggests treatment benefit of a CRF1receptor antagonist in the Cortibon-positive population
- DroppedRisks Related to Our Business and Industry
foreign regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of tildacerfont
- DroppedRisks Related to Our Business and Industry
the EU, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our product candidates is also subject to approval
Collaboration with HMNC for Phase 2 trial TAMARIND of tildacerfont.
- DroppedRisks Related to Our Business and Industry
or reproduce the data, and subsequently commercialize the product. Additionally, theft of our intellectual property or proprietary business information could require substantial expenditures to remedy
- DroppedRisks Related to Our Business and Industry
global revenue, whichever is greater; or private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests
- DroppedRisks Related to Our Business and Industry
a decline in our share price
- DroppedRisks Related to Our Reliance on Third Parties
commercial prospects for tralesinidase alfa, tildacerfont and any future product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed
- DroppedRisks Related to Our Intellectual Property
or we are subject to a bankruptcy, the license agreements may be terminated, in which event we would not be able to develop, commercialize or market our product candidates
- DroppedRisks Related to Our Intellectual Property
have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations
- DroppedRisks Related to Ownership of Our Common Stock
prevent our common stock from dropping below the Nasdaq Minimum Bid Price Requirement or prevent future non-compliance with the listing requirements of Nasdaq Listing Qualifications
- DroppedRisks Related to Ownership of Our Common Stock
An active, liquid and orderly trading market for our common stock may not be sustained
Delays or termination of tralesinidase alfa trials harming commercial prospects.
- DroppedRisks Related to Ownership of Our Common Stock
Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to the Shelf Registration, Sales Agreement and our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall
Reworded
- 100% rewrittenRisks Related to Our Business and Industry
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
Updated from detailing specific past trials of tralesinidase alfa by Allievex to listing general factors for clinical success of TA-ERT.
- 100% rewrittenRisks Related to Ownership of Our Common Stock
If we are unable to maintain compliance with all applicable requirements of the Nasdaq Capital Market (“Nasdaq”), our common stock could be subject to delisting which would adversely affect the market liquidity of our common stock and the market price of our common stock could decrease
Removed the specific April 2024 Nasdaq deficiency notice details regarding the $1.00 minimum bid price.
Was: If we fail to meet all applicable requirements of the Nasdaq Capital Market (“Nasdaq") and Nasdaq determines to delist our common stock, the delisting could adversely affect the market liquidity of our common stock and the market price of our common stock could decrease
- 95% rewrittenRisks Related to Our Business and Industry
Any delays in the commencement or completion, or termination or suspension, of our clinical trials could result in increased costs to us, delay or limit our ability to generate revenue, and adversely affect our commercial prospects
Shortened the description of preclinical filing and IND requirements before initiating clinical trials.
- 78% rewrittenRisks Related to Our Business and Industry
Obtaining and maintaining regulatory approval for a product candidate in one jurisdiction does not mean that we will be successful in obtaining regulatory approval for that product candidate in other jurisdictions
Retained the core message on multi-jurisdictional regulatory approvals with minor stylistic phrasing adjustments.
- 77% rewrittenRisks Related to Our Business and Industry
neither experimental nor investigational
Replaced references to tralesinidase alfa with TA-ERT and added a note about approved label impacts on reimbursement.
- 74% rewrittenRisks Related to Our Business and Industry
Current and future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize TA-ERT and any other current or future product candidates and may affect the prices we may set
Added a mention of executive, judicial, and Congressional challenges to the Affordable Care Act.
Was: Current and future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize tralesinidase alfa, tildacerfont and any other current or future product candidates and may affect the prices we may set
- 72% rewrittenRisks Related to Our Business and Industry
improving our operational, financial and management controls, reporting systems and procedures
Retained management growth and vendor utilization risks with identical core text.
- 72% rewrittenRisks Related to Our Business and Industry
the effectiveness of our sales and marketing efforts and those of any collaboration or distribution partner on whom we rely for sales in foreign jurisdictions
Replaced tralesinidase alfa with TA-ERT and added a warning that target indication markets may be smaller than estimated.
- 70% rewrittenRisks Related to Our Business and Industry
the impacts of contagious disease outbreaks on our ongoing and planned clinical trials
- 70% rewrittenRisks Related to Our Reliance on Third Parties
We rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize TA-ERT and our other current and future product candidates
Was: We rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize tralesinidase alfa, tildacerfont, and our other product candidates
- 69% rewrittenRisks Related to Our Business and Industry
intellectual property protection
- 68% rewrittenRisks Related to Ownership of Our Common Stock
We are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors
Was: We are an emerging growth company and a smaller reporting company, and the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors
- 66% rewrittenRisks Related to Our Business and Industry
If we do not achieve one or more of these factors, many of which are beyond our control, in a timely manner or at all, we could experience significant delays or an inability to obtain regulatory approvals or commercialize our product candidates, if approved
Was: If we do not achieve one or more of these factors, many of which are beyond our control, in a timely manner or at all, we could experience significant delays or an inability to obtain regulatory approvals or commercialize our product candidates
- 64% rewrittenRisks Related to Our Business and Industry
We do not currently have sufficient working capital to fund our planned operations for the next twelve months and substantial doubt exists as to our ability to continue as a going concern
- 62% rewrittenRisks Related to Our Business and Industry
Raising additional capital may cause dilution to our existing stockholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates
- 61% rewrittenRisks Related to Ownership of Our Common Stock
Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall
- 56% rewrittenRisks Related to Our Business and Industry
Unfavorable U.S. and global economic and geopolitical conditions could adversely affect our business, financial condition, results of operations and prospects
Was: Unfavorable U.S. and global economic and geopolitical conditions could adversely affect our business, financial condition or results of operations
- 50% rewrittenRisks Related to Our Business and Industry
Additionally, we may be subject to federal consumer protection and unfair competition laws, and equivalent foreign laws, which broadly regulate marketplace activities and activities that potentially harm consumers
- 50% rewrittenRisks Related to Our Reliance on Third Parties
We depend on intellectual property licensed from others, the termination of which could result in the loss of significant rights, which would harm our business
- 49% rewrittenRisks Related to Our Business and Industry
Use of TA-ERT and our other current and future product candidates could be associated with side effects, adverse events or other properties that could delay or prevent regulatory approval or result in significant negative consequences following marketing approval, if any
Was: Use of tralesinidase alfa, tildacerfont or our other current and future product candidates could be associated with side effects, adverse events or other properties that could delay or prevent regulatory approval or result in significant negative consequences following marketing approval, if any
- 35% rewrittenRisks Related to Our Intellectual Property
If we do not obtain patent term extension for our product candidates, our business may be materially harmed
- 32% rewrittenRisks Related to Ownership of Our Common Stock
The trading price of our common stock has been, and may continue to be volatile, and you could lose all or part of your investment
- 30% rewrittenRisks Related to Our Business and Industry
Our clinical trials may fail to adequately demonstrate that our product candidates are well tolerated and provide sufficient clinical benefits for patients, which could prevent or delay regulatory approval and commercialization
- 30% rewrittenRisks Related to Our Business and Industry
Changes in tax laws or regulations that are applied adversely to us may have a material adverse effect on our business, cash flow, financial condition or results of operations
- 28% rewrittenRisks Related to Our Business and Industry
The occurrence of any event or penalty described above may inhibit our ability to commercialize, if approved, TA-ERT and our other current and future product candidates and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity
Was: The occurrence of any event or penalty described above may inhibit our ability to commercialize tralesinidase alfa, tildacerfont and our other current and future product candidates and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity
- 28% rewrittenRisks Related to Our Business and Industry
If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of TA-ERT and any other current or future product candidates
Was: If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of tralesinidase alfa, tildacerfont and any future product candidates
- 24% rewrittenRisks Related to Our Business and Industry
If the market opportunities for TA-ERT and our other current and future product candidates are smaller than we believe they are, our future revenue, if any, may be adversely affected, and our business may suffer
Was: If the market opportunities for tralesinidase alfa, tildacerfont and our other current and future product candidates are smaller than we believe they are, our future revenue may be adversely affected, and our business may suffer
- 21% rewrittenRisks Related to Our Intellectual Property
Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad
All 87 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Business and Industry
- 01We do not currently have sufficient working capital to fund our planned operations for the next twelve months and substantial doubt exists as to our ability to continue as a going concern64% rewritten
- 02Changing circumstances may cause us to consume capital significantly faster than we currently anticipate, and we may need to spend more money than currently expected because of circumstances beyond our controlNew
- 03Raising additional capital may cause dilution to our existing stockholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates62% rewritten
- 04biopharmaceutical area. Consequently, any predictions about our future performance may not be as accurate as they would be if we had a history of successfully developing and commercializing biopharmaceutical productsNew
- 05If 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 harmed100% rewritten
- 06If we do not achieve one or more of these factors, many of which are beyond our control, in a timely manner or at all, we could experience significant delays or an inability to obtain regulatory approvals or commercialize our product candidates, if approved66% rewritten
- 07Our clinical trials may fail to adequately demonstrate that our product candidates are well tolerated and provide sufficient clinical benefits for patients, which could prevent or delay regulatory approval and commercialization30% rewritten
- 08We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively
- 09intellectual property protection69% rewritten
- 10experience delays in completing, or ultimately be unable to complete, the development and commercialization of TA-ERT and our other current and future product candidatesNew
- 11If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
- 12Any delays in the commencement or completion, or termination or suspension, of our clinical trials could result in increased costs to us, delay or limit our ability to generate revenue, and adversely affect our commercial prospects95% rewritten
- 13trial protocol, as part of an IND or similar regulatory filing under which we must receive authorization to proceed with clinical developmentNew
- 14the impacts of contagious disease outbreaks on our ongoing and planned clinical trials70% rewritten
- 15the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval
- 16Interim, topline, and preliminary data from our clinical trials 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
- 17If the market opportunities for TA-ERT and our other current and future product candidates are smaller than we believe they are, our future revenue, if any, may be adversely affected, and our business may suffer24% rewritten
- 18Obtaining and maintaining regulatory approval for a product candidate in one jurisdiction does not mean that we will be successful in obtaining regulatory approval for that product candidate in other jurisdictions78% rewritten
- 19Unfavorable U.S. and global economic and geopolitical conditions could adversely affect our business, financial condition, results of operations and prospects56% rewritten
- 20International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospectsNew
- 21We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy
- 22Use of TA-ERT and our other current and future product candidates could be associated with side effects, adverse events or other properties that could delay or prevent regulatory approval or result in significant negative consequences following marketing approval, if any49% rewritten
- 23Any of these events could prevent us from achieving or maintaining market acceptance of TA-ERT and our other current and future product candidates, if approved, and could significantly harm our business, financial condition, results of operations and prospects
- 24The occurrence of any event or penalty described above may inhibit our ability to commercialize, if approved, TA-ERT and our other current and future product candidates and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity28% rewritten
- 25at the authorities have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictableNew
- 26Even if we obtain regulatory approval for TA-ERT and our other current and future product candidates, they may not gain market acceptance among physicians, patients, healthcare payors and others in the medical community
- 27the effectiveness of our sales and marketing efforts and those of any collaboration or distribution partner on whom we rely for sales in foreign jurisdictions72% rewritten
- 28and any other current or future product candidates, significant fines, penalties, sanctions, or product liability claims, and our image and reputation within the industry and marketplace could be harmedNew
- 29Coverage and reimbursement may be limited or unavailable in certain market segments for TA-ERT and our other current or future product candidates, which could make it difficult for us to sell TA-ERT and our other current or future product candidates profitably
- 30neither experimental nor investigational77% rewritten
- 31reimbursement of our future products are unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitabilityNew
- 32Current and future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize TA-ERT and any other current or future product candidates and may affect the prices we may set74% rewritten
- 33Our failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our product candidates internationally
- 34Even if we obtain the necessary regulatory approvals, a variety of risks associated with marketing TA-ERT and any other current or future product candidates internationally could materially adversely affect our business
- 35If we fail to develop and commercialize additional product candidates, we may be unable to grow our business
- 36We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements
- 37We will need to grow the size of our organization, and we may experience difficulties in managing this growth
- 38improving our operational, financial and management controls, reporting systems and procedures72% rewritten
- 39On January 7, 2026, we entered into the Loan Agreement with Avenue Capital. For a description of our Loan Agreement, see Note 15, “Loan Agreement with Avenue Capital”, to the consolidated financial statements included elsewhere in this Annual ReportNew
- 40Business disruptions could seriously harm our future revenues and financial condition and increase our costs and expenses
- 41Our employees, independent contractors, principal investigators, CROs, consultants, strategic partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
- 42Additionally, we may be subject to federal consumer protection and unfair competition laws, and equivalent foreign laws, which broadly regulate marketplace activities and activities that potentially harm consumers50% rewritten
- 43integrated entities, and it may be difficult to integrate companies into our information technology environment and security programNew
- 44arbitration demands. Some of these claims allow for the recovery of statutory damages on a per violation basis, and, if viable, carry the potential for monumental statutory damages, depending on the volume of data and the number of violationsNew
- 45If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of TA-ERT and any other current or future product candidates28% rewritten
- 46a decline in the price of our common stockNew
- 47Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited
- 48Changes in tax laws or regulations that are applied adversely to us may have a material adverse effect on our business, cash flow, financial condition or results of operations30% rewritten
Risks Related to Ownership of Our Common Stock
- 49If we are unable to maintain compliance with all applicable requirements of the Nasdaq Capital Market (“Nasdaq”), our common stock could be subject to delisting which would adversely affect the market liquidity of our common stock and the market price of our common stock could decrease100% rewritten
- 50On April 26, 2024, we received a letter from Nasdaq Listing Qualifications, notifying us that, for the previous 30 consecutive business day period prior to the date of the letter, the closing bid price for our common stock was below $1.00 (the “Minimum Bid Price Requirement”)New
- 51The trading price of our common stock has been, and may continue to be volatile, and you could lose all or part of your investment32% rewritten
- 52other events or factors discussed in this “Risk Factors” section and elsewhere in this Annual Report, many of which are beyond our control
- 53We could be subject to securities class action litigation
- 54If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline
- 55We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock
- 56Our principal stockholders and management own a significant percentage of our stock and are able to exert significant control over matters subject to stockholder approval
- 57We are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors68% rewritten
- 58As a result of being a public company, we are obligated to develop and maintain proper and effective internal control over financial reporting, and any failure to maintain the adequacy of these internal controls may adversely affect investor confidence in our company and, as a result, the value of our common stock
- 59We have incurred and will continue to incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives
- 60Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall61% rewritten
- 61sales. Such sales may also result in material dilution to our existing stockholders, and new investors could gain rights, preferences and privileges senior to the holders of our common stock
- 62Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove our current management
- 63the authority of the board of directors to issue preferred stock on terms determined by the board of directors without stockholder approval and which preferred stock may include rights superior to the rights of the holders of common stock
Risks Related to Our Reliance on Third Parties
- 64We depend on intellectual property licensed from others, the termination of which could result in the loss of significant rights, which would harm our business50% rewritten
- 65materials relating to certain compounds developed by HBM (the “HBM License Agreement”)New
- 66We rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize TA-ERT and our other current and future product candidates70% rewritten
- 67If we or our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages
- 68Social media platforms and AI-based platforms present new risks and challenges to our business
Risks Related to Our Intellectual Property
- 69license are deemed invalid and unenforceable, our ability to commercialize or license our technology could be adversely affectedNew
- 70countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop, and market competing product candidates in those countries
- 71the patents of others may have an adverse effect on our business
- 72Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time
- 73If we do not obtain patent term extension for our product candidates, our business may be materially harmed35% rewritten
- 74the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners
- 75Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
- 76Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
- 77We may not be able to protect our intellectual property rights throughout the world
- 78We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property
- 79We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses
- 80Third-party claims alleging intellectual property infringement may prevent or delay our drug discovery and development efforts
- 81publications in the scientific literature often lag behind actual discoveries
- 82require us to enter into royalty or license agreements, which may not be available on commercially reasonable terms, or at all
- 83We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees or consultants have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers
- 84Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad21% rewritten
- 85Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties
- 86If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected
- 87Any collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our products
Other Spruce Biosciences 10-Ks
- FY2024 10-K risk factors86 risks
Spruce Biosciences faces substantial going concern doubt with only $38.8 million in cash as of December 31, 2024.
Filed Apr 15, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.