What changed in this filing

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Item 1A. Risk Factors

2026-08-04 compared with 2026-05-06 · 57 added, 33 removed, 568 unchanged (14% of the section changed)

19 unchanged sentences

• Our operating results may fluctuate significantly, which could make our future results difficult to predict and could cause our operating results to fall below expectations.

• If we are unable to maintain or develop sales, marketing and distribution capabilities or maintain or develop arrangements with third parties to sell, market and distribute our products, our business may be harmed.

• Our business could be negatively impacted by cyber security incidents or threats, which could lead to data breaches, material interruption to our operations, manufacturing or laboratory systems, clinical trials, and IT systems, and violations of statutory and contractual privacy, confidentiality and data security obligations.

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• our ability to maintain our products at prices and quality that are competitive with those of our competitors, and the potential for new competitors or more aggressive actions by our existing competitors;

• increased availability or customer acceptance of alternative ingredients, including NMN, which could cause customers to reduce purchases from us, shift purchases to competing products or seek more favorable pricing or other commercial terms, and any such reduction by a significant customer could disproportionately affect our ingredient revenue, margins and results of operations;

• our ability to maintain quality levels for our products sufficient to meet the expectations of our customers;

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• our business costs, including increased costs as a result of inflation;

• the expenses we incur in developing and commercializing our products, including the cost of obtaining and maintaining regulatory approvals and developing new distribution channels;

• the expenses we incur in developing and commercializing our products, including research and development and clinical expenses associated with potential pharmaceutical products, the cost of obtaining and maintaining regulatory approvals and developing new distribution channels;

• unanticipated general and administrative expenses.

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For example, we may not be successful in developing our consumer product business for sales of Tru Niagen® products or sales of our Niagen® ingredient products, and our sales may decrease despite us incurring increased costs related to marketing or otherwise developing such products.

We face significant competition, including changes in pricing.

We face significant competition, including from other supplements such as NMN.

The markets for our products and services are both competitive and price-sensitive.

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In September 2025, the FDA determined that nicotinamide mononucleotide (NMN) may be lawfully marketed as a dietary ingredient.

If this determination is not overturned or superseded, it may introduce additional channels of competition in certain product categories.

Additionally, some competitors may engage in misleading marketing practices, including mislabeling their products by overstating ingredient levels or making claims that their products provide benefits similar to ours without scientific support.

The availability of NMN products as dietary supplements has increased competition in the market for NAD precursor and healthy-aging products, including through lower-priced products, products marketed through the same e-commerce, marketplace, retail and practitioner channels through which we sell our products, and products that consumers may perceive as comparable to or interchangeable with our Niagen® and Tru Niagen® products.

The availability of NMN may have a particularly significant competitive impact on our ingredient business, including by causing existing or potential ingredient customers to reduce purchases of our products, purchase alternative ingredients or seek more favorable pricing, volume commitments or other contractual terms from us.

If consumers, retailers, distributors, healthcare providers or other customers choose NMN products instead of our products, or if we are required to increase promotional spending, reduce prices or make commercial concessions in response to such competition, our sales, gross margins, profitability, market share and results of operations could be materially adversely affected.

We have experienced the impacts of this competition in our ingredient business, including on our financial results, since the September 2025 FDA decision.

We have filed a lawsuit challenging the FDA’s interpretation concerning the regulatory status of NMN.

We cannot predict the outcome or timing of that litigation, and NMN products may continue to compete with our products during the pendency of the proceeding or if we do not obtain the relief sought.

If the FDA’s determination is not overturned or superseded, it may continue to introduce additional channels of competition in certain product categories.

Additionally, some competitors, including sellers of NMN, may engage in misleading marketing practices, including mislabeling their products by overstating ingredient levels or making claims that their products provide benefits similar to ours without scientific support.

These practices may mislead consumers into purchasing inferior or ineffective alternatives, thereby eroding our market share and damaging the credibility of the product category as a whole.

If such competitors gain traction in the marketplace, our ability to differentiate our scientifically validated products may be diminished, negatively impacting our sales and overall business.

If such competitors gain traction in the marketplace, our ability to differentiate our scientifically validated products may be diminished, which could adversely affect demand from consumers and ingredient customers, our pricing and contractual terms, our gross margins, and overall business.

Furthermore, the markets for some of our products are also subject to specific competitive risks because these markets are highly price competitive.

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Disputes from time to time with such companies, organizations or individuals are not uncommon, and we cannot assure you that we will always be able to resolve such disputes on terms favorable to us.

We have been, and may in the future be, subject to consumer class actions and other claims challenging the accuracy, substantiation or presentation of our advertising, marketing and product claims.

Refer to Note 8, Commitments and Contingencies, Contingencies in the Notes to the Unaudited Condensed Consolidated Financial Statements, included in Part I, Item 1 of this Quarterly Report on Form 10-Q, for more detail.

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We have a history of operating losses, may need additional financing to meet our future long-term capital requirements and may be unable to raise sufficient capital on favorable terms or at all.

While we have recorded net income in both of the years ended December 31, 2025 and 2024, and have recorded net income of approximately $6.3 million for the three months ended March 31, 2026, we may not be able to sustain profitability in future periods.

While we have recorded net income in both of the years ended December 31, 2025 and 2024, and have recorded net income of approximately $7.3 million for the six months ended June 30, 2026, we may not be able to sustain profitability in future periods.

Our history of net losses and negative cash flow have had, and may continue to have, an adverse effect on our stockholders’ equity and working capital, and if we are not able to sustain profitability in the future, our stock price may be depressed.

We expect to continue to incur increasing expenses as we develop our sales, marketing, distribution and other commercial infrastructure and continue to develop and commercialize our products, including the cost of obtaining and maintaining regulatory approvals, and establishing new distribution channels for pharmaceutical-grade Niagen®.

As of March 31, 2026, our cash and cash equivalents totaled approximately $66.5 million, of which $66.4 million was unrestricted, and we had no borrowings outstanding under our line of credit up to $10.0 million, subject to certain terms and conditions, with Western Alliance Bank.

As of June 30, 2026, our cash and cash equivalents totaled approximately $66.7 million, of which $66.6 million was unrestricted, and we had no borrowings outstanding under our line of credit up to $10.0 million, subject to certain terms and conditions, with Western Alliance Bank.

We believe that our existing cash resources and available borrowings are sufficient to fund our current operating plans for at least the next twelve months.

However, we may require additional funds beyond that period, either through additional equity or debt financings, including pursuant to the At Market Issuance Sales Agreement with Raymond James & Associates, Inc.

and Roth Capital Partners, LLC (ATM Facility), or collaborative agreements, lines of credit from other banks, or other sources.

However, we may require additional funds beyond that period, either through additional equity or debt financings, including pursuant to the Sales Agreement with Canaccord Genuity LLC and Roth Capital Partners, LLC (ATM Facility), or collaborative agreements, lines of credit from other banks, or other sources.

We have no commitments to obtain such additional financing, and we may not be able to obtain any such additional financing on terms favorable to us, or at all.

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• our reliance on third-party partners involved in the development and supply of new or existing products;

• disruptions, suspensions, restrictions or other changes affecting our ability to sell, advertise, fulfill orders or receive payments through third-party e-commerce marketplaces;

• changes in the competitive dynamics of our markets, including new entrants, new products, or discounting of product prices;

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If we are unable to establish and maintain adequate sales, marketing and distribution capabilities, independently or with others, we will not be able to generate product revenue, and may not become profitable.

A portion of our consumer product sales depends on third-party e-commerce marketplaces and platforms.

Our ability to sell products through these channels depends on our continued compliance with marketplace policies, listing requirements, advertising rules, fulfillment standards, intellectual property procedures, customer review practices and other terms and conditions that are established and modified by these marketplaces from time to time.

These marketplaces have broad discretion to interpret and enforce their policies and may suspend, restrict or remove our product listings, limit our advertising or promotional activities, change search rankings or product placement, modify fulfillment or fee structures, impose reserves,

withhold or delay payment of sales proceeds, or take other actions that could adversely affect our sales, cash flows and operating results.

Competitors and other third-parties may also challenge our product listings or advertising claims through marketplace complaint, product-compliance or similar procedures, and marketplaces may restrict or remove a listing while such a challenge is being reviewed.

We have experienced, and may in the future experience, interruptions in our ability to sell products through significant third-party online marketplaces, including temporary suspensions or restrictions of product listings.

Any such interruption, even if temporary or later resolved, could result in lost sales or a material adverse effect on our business, financial condition, results of operations and cash flows.

During the three months ended June 30, 2026, one of our Tru Niagen® product listings was temporarily suspended on a significant third-party e-commerce marketplace through which the product is sold, resulting in lost revenue.

Although the listing was subsequently restored, similar suspensions or restrictions could result in additional lost sales, increased costs and diversion of management resources.

Our business could be negatively impacted by cyber security incidents or threats, which could lead to data breaches, material interruptions to our operations, manufacturing or laboratory systems, clinical trials, and IT systems, and violations of statutory and contractual privacy, confidentiality and data security obligations.

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Our ability to monitor these third-party providers’ information security practices is limited, and these third parties may not have adequate information security measures in place.

Ransomware attacks, including those from organized criminal threat actors, nation-states and nation-state supported actors, are becoming increasingly prevalent and can lead to significant

interruptions, delays, or outages in our operations, loss of data, loss of income, significant extra expenses to restore data or systems, reputational loss and the diversion of funds.

Ransomware attacks, including those from organized criminal threat actors, nation-states and nation-state supported actors, are becoming increasingly prevalent and can lead to significant interruptions, delays, or outages in our operations, loss of data, loss of income, significant extra expenses to restore data or systems, reputational loss and the diversion of funds.

Similarly, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties and infrastructure in our supply chain or our third-party partners’ supply-chains have not been compromised or that they do not contain exploitable defects or bugs that could result in a breach of or disruption to our information technology systems or the third-party information technology systems that support us and our services.

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We may not be able to monetize our products for use in pharmaceuticals through partnerships, licensing, or other arrangements, and we may not receive regulatory approval to commercialize a pharmaceutical product.

As part of our business strategy, we may seek to develop partnerships or licensing arrangements to monetize our proprietary molecules for pharmaceutical applications.

However, there is no guarantee that we will be able to identify suitable partners, negotiate favorable terms, or successfully execute such partnerships.

As part of our business strategy, we are pursuing the development of NAD precursors for potential therapeutic applications, including in advanced aging-related and rare diseases, and may develop partnerships or licensing arrangements to monetize our proprietary molecules for pharmaceutical applications.

To date, these efforts have been limited to research and development activities, including preclinical and clinical studies and regulatory planning, and we do not currently generate revenue from these activities.

Pharmaceutical development is costly, time-consuming and uncertain, and we may incur increasing research and development, clinical, regulatory and other expenses as these activities progress.

There is no guarantee that we will be able to successfully advance any product candidate or identify suitable partners, negotiate favorable terms, or successfully execute such partnerships.

Even if we enter into agreements with third parties, our ability to generate revenue from these arrangements will depend on various factors, including our partners' willingness and ability to invest in research, development, and commercialization efforts.

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There is no guarantee that we will be able to continue to contract with Grace for the supply of NRC, or that such terms will be favorable to us.

Failure by outsourcing facilities that produce pharmaceutical-grade Niagen® and related finish products to adequately perform their obligations could harm our business or financial results.

Failure by outsourcing facilities that produce pharmaceutical-grade Niagen® and related finished products to adequately perform their obligations could harm our business or financial results.

We rely on contract manufacturers to manufacture pharmaceutical-grade Niagen® and 503B outsourcing facilities to compound and distribute pharmaceutical-grade Niagen® into intravenous, injectable and intravenous-push forms and then distribute the same.

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Some of these events could be the basis for FDA action, including injunction, request for recall, seizure, total or partial suspension of production, or issuance of a Form 483 or Warning Letter.

Any failure by clinics administering Niagen Plus products could adversely affect our brand and reputation.

Any failure by clinics, healthcare providers, pharmacies, and other third parties administering Niagen Plus products could adversely affect our brand and reputation.

Although we are independent from the clinics that administer Niagen Plus products, which feature pharmaceutical-grade Niagen®, our brand may be negatively affected by issues arising at the clinic level.

We advertise locations where consumers can receive Niagen Plus products, which may create an association between our brand and the services provided by these third-party clinics.

If clinics administering Niagen Plus products fail to adhere to proper medical protocols, engage in misleading marketing practices, or face regulatory scrutiny, our brand reputation could suffer, even if we are not directly responsible for their actions.

We have limited control over the prices charged by clinics or other third-parties for Niagen Plus products and related services, and efforts to restructure our commercial arrangements may not enable us to achieve desired pricing or consumer accessibility.

If clinics, healthcare providers, pharmacies or other third parties administering Niagen Plus products fail to adhere to proper medical protocols, engage in misleading marketing practices, or face regulatory scrutiny, our brand reputation could suffer, even if we are not directly responsible for their actions.

Additionally, any adverse events or negative customer experiences at these clinics could erode consumer trust in our products and impact demand.

While we seek to partner with reputable clinics, we cannot control their operations, and any issues at the clinic level could have a material adverse effect on our business and reputation.

While we seek to partner with reputable clinics, healthcare providers, pharmacies and other third parties, we cannot control their operations, including their pricing practices, and any issues arising from their activities could have a material adverse effect on our business and reputation.

Unfavorable publicity or consumer perception of our products and any similar products distributed by other companies could have a material adverse effect on our business.

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Future research reports, findings, regulatory proceedings, litigation, media attention or other publicity that are perceived as less favorable than, or that question, such earlier research reports, findings or publicity could have a material adverse effect on the demand for our products and consequently on our business, results of operations, financial condition and cash flows.

Challenges to, or adverse determinations regarding, the substantiation or presentation of our advertising and marketing claims, including by self-regulatory organizations, competitors, marketplaces or plaintiffs, could require us to modify or discontinue claims, result in restrictions on the sale or promotion of our products, expose us to litigation or regulatory scrutiny and adversely affect consumer perception and demand.

Our dependence upon consumer perceptions means that adverse scientific research reports, findings, regulatory proceedings, litigation, media attention or other publicity, if accurate or with merit, could have a material adverse effect on the demand for our products, the availability and pricing of our ingredients, and our business, results of operations, financial condition and cash flows.

For example, negative publicity or consumer concerns regarding competitors’ products — such as nicotinamide mononucleotide (NMN) or similar ingredients — could reduce consumer confidence in dietary supplements generally or in products within the same category, which could in turn adversely affect demand of our products.

For example, negative publicity or consumer concerns regarding competitors’ products — such as NMN or similar ingredients — could reduce consumer confidence in dietary supplements generally or in products within the same category, which could in turn adversely affect demand of our products.

Further, adverse public reports or other media attention regarding the safety, efficacy and quality of dietary supplements in general, or our products specifically, or associating the consumption of dietary supplements with illness, could have such a material adverse effect.

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As a marketer of products manufactured by third parties, we also may be liable for various product liability claims for products we do not manufacture.

We may also be subject to claims arising from products prescribed, compounded, dispensed, sold or administered by independent healthcare providers, pharmacies, clinics or other third parties, particularly where such products bear our name or branding, even if the alleged injury results from conduct or services that we do not control.

We have, and may in the future, be subject to various class action lawsuits and product liability claims, including, among others, that our products include inadequate instructions for use or inadequate warnings concerning possible side effects and interactions with other substances.

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governments, our suppliers and our company.

We may experience delays in the development in, or may never develop, any additional products to commercialize.

We may experience delays in the development of, or may never develop, any additional products to commercialize.

We have invested a substantial amount of our time and resources in developing various new products.

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• our products may not prove to be safe and effective in clinical trials;

• we may experience delays in our development program;

• we may rely on third-parties to develop and produce our products, which could lead to increased costs, unanticipated delays, or other negative impacts;

• we may experience delays in our development program and our pharmaceutical-development efforts, which are at an early stage, may not progress beyond research and development, preclinical or clinical studies or regulatory planning;

• we may rely on third-parties to develop and produce our products, which could lead to increased costs, unanticipated delays, or other negative impacts, and we may be unable to identify or enter into suitable strategic collaborations or licensing agreements;

• any products that are approved may not be accepted in the marketplace;

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• prescriptions for our pharmaceutical-grade products, which require a prescription, may not be available;

• we may not have adequate financial or other resources to complete the development or to commence the commercialization of our products or will not have adequate financial or other resources to achieve significant commercialization of our products;

• we may not have adequate financial or other resources to complete the development or to commence the commercialization of our products or may not have adequate financial or other resources to achieve significant commercialization of our products;

• we may not be able to manufacture any of our products in commercial quantities or at an acceptable cost;

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Product recalls also may lead to increased scrutiny by federal, state or international regulatory agencies of our operations and increased litigation and could have a material adverse effect on our business, results of operations, financial condition and cash flows.

Demand for our products and services are subject to the commercial success of our customers’ products, which may vary for reasons outside our control.

Demand for our products and services is subject to the commercial success of our customers’ products, which may vary for reasons outside our control.

Even if we are successful in securing utilization of our products in a customer’s manufacturing process, sales of many of our products and services remain dependent on the timing and volume of the customer’s production, over which we have no control.

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Furthermore, the laws of foreign countries may not protect our intellectual property rights to the same extent as do the laws of the United States.

Additionally, our patent portfolio may protect both existing and potential commercial opportunities, even if we do not currently commercialize products covered by those patents.

If we are unable to successfully enforce such patents, we may lose competitive or potential future commercialization opportunities.

In the event a competitor infringes our licensed or pending patent or other intellectual property rights, enforcing those rights may be costly, uncertain, difficult and time consuming.

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See Note 8, Commitments and Contingencies , Legal Proceedings in the Notes to the Unaudited Condensed Consolidated Financial Statements, included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

We may not have sufficient resources to enforce our intellectual property rights or to defend our patents rights against a challenge.

We may not have sufficient resources to enforce our intellectual property rights or to defend our patent rights against a challenge.

The failure to obtain patents and/or protect our intellectual property rights could have a material and adverse effect on our business, results of operations and financial condition.

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We do not control the maintenance, prosecution, enforcement or strategy for many of these patents or patent application rights and as such are dependent in part on the owners of the intellectual property rights to maintain their viability.

If any third-party licensor is unable to successfully maintain, prosecute or enforce the licensed patents and/or patent application rights related to our products, we may become subject to infringement or misappropriate claims or lose our competitive advantage.

Without access to these technologies or suitable design-around or alternative technology options, our ability to conduct our business could be impaired significantly.

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Changes in regulation or regulatory priorities, such as a relaxation in regulatory requirements or the introduction of simplified drug approval procedures, or an increase in regulatory requirements that we may have difficulty satisfying or that make our services less competitive, could eliminate or substantially reduce the demand for our services or adversely impact our ability to comply with the new regulations.

For example, recent FDA decisions, including the determination that nicotinamide mononucleotide (NMN) may be lawfully marketed as a dietary ingredient, if not overturned or superseded, may reflect a relaxation of prior regulatory positions and could result in additional competition or reduced demand for our products and services.

For example, recent FDA decisions, including the determination that NMN may be lawfully marketed as a dietary ingredient, if not overturned or superseded, may reflect a relaxation of prior regulatory positions and could result in additional competition or reduced demand for our products and services.

Also, if the government makes efforts to contain drug costs and pharmaceutical and biotechnology company profits from new drugs, or if health insurers were to change their practices with respect to reimbursements for pharmaceutical products, our customers may spend less, or reduce their spending on research and development.

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We may also face enforcement risk where our partners, vendors, or service providers leverage AI in ways that involve personal data, even if we do not control the underlying technology.

We are subject to regulation by various federal, state, and local and foreign agencies that require us to comply with a wide variety of laws and regulations, including those regarding the manufacture of products, advertising and product label claims, the distribution of our products and environmental matters.

We are subject to regulation by various federal, state, local and foreign agencies that require us to comply with a wide variety of laws and regulations, including those regarding the manufacture of products, advertising and product label claims, the distribution of our products and environmental matters.

Failure to comply with these laws and regulations could subject us to fines, penalties and additional costs.

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If the substances used in manufacturing and compounding our products are removed from this interim list or if the FDA determines not to place NRC on the final list of bulk drug substances for which there is a clinical need, it may subject us and our third-party partners to additional regulatory scrutiny.

We are pursuing an investigational new drug (IND) application with the FDA with respect to the potential for one of our patented NAD precursors to be used as a treatment for Ataxia telangiectasia (AT), a rare disease with less than 200,000 cases diagnosed in the U.S.

We are pursuing an investigational new drug (IND) application with the FDA with respect to the potential for one of our patented NAD precursors to be used as a treatment for Ataxia-Telangiectasia (A-T), a rare disease with less than 200,000 cases diagnosed in the U.S.

per year, and have obtained Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) designation from the FDA.

There is no guarantee that our IND application will be successful, or that we will be able to successfully complete clinical trials or a new drug application for FDA approval for the use of our patented NAD precursor as a treatment for AT.

There is no guarantee that our IND application will be successful, or that we will be able to successfully commence or complete clinical trials or obtain FDA approval for the use of our patented NAD precursor as a treatment for AT.

Any delay or failure in advancing the development of our patented NAD precursor as a potential treatment for AT could result in additional costs, and we may not recover the expenses incurred or realize any commercial benefit from these efforts.

We are also subject to various federal, state, local and international laws and regulations that govern the handling, storage, transportation, disposal, manufacture, use and sale of substances that are or could be classified as toxic or hazardous substances.

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• our ability to execute our business plan;

• our operating results are below expectations;

• our operating results falling below expectations;

• our issuance of additional securities, including debt or equity or a combination thereof;

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Future sales of these shares could adversely affect the market price of our common stock.

As of March 31, 2026, we had outstanding options for an aggregate of approximately 9.9 million shares of common stock at a weighted average exercise price of $3.80 per share and unvested restricted stock units and market performance stock units of approximately 0.1 million shares and 1.5 million shares, respectively.

As of June 30, 2026, we had outstanding options for an aggregate of approximately 10.0 million shares of common stock at a weighted average exercise price of $3.82 per share and unvested restricted stock units and market performance stock units of approximately 0.1 million shares and 1.5 million shares, respectively.

Once these awards vest and in the case of stock options, once they are exercised, the resulting shares may be sold in the public market, subject to compliance with our insider trading policies and any applicable requirements under our equity incentive plans.

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New laws and regulations or more stringent interpretations of existing laws and regulations, such as those related to climate change, could affect the operation of our properties or result in significant additional expense and restrictions on our business operations.

If we are unable to satisfy such new criteria, investors may conclude that our policies with respect environmental, social, or corporate responsibility are inadequate.

If we are unable to satisfy such new criteria, investors may conclude that our policies with respect to environmental, social, or corporate responsibility are inadequate.

We risk damage to our brand and reputation in the event that our ESG procedures or standards do not meet or are perceived to not meet the standards set by various constituencies, which could lead to the loss of existing or potential customers and reduced sales.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors