What changed in this filing

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Item 1A. Risk Factors

2025-11-13 compared with 2025-08-13 · 72 added, 54 removed, 84 unchanged (60% of the section changed)

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Quarterly Report on Form 10-Q, including our unaudited interim Condensed Consolidated Financial Statements and accompanying notes, our Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 27, 2025, including the risk factors

and our financial statements and related notes contained therein, and the additional information in the other reports we file with the Securities and Exchange Commission, including, without limitation, the risk factors previously disclosed in our

prior quarterly reports on Form 10-Q filed during this fiscal year.

quarterly reports on Form 10-Q filed during this fiscal year.

These risks may result in material harm to our business and our financial condition and results of operations.

In this event, the market price of our common stock may decline and you

could lose part or all of your investment.

In this event, the market price of our common stock may decline and you could

lose part or all of your investment.

Additional risks that we currently believe are immaterial may also impair our business operations.

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We have incurred net losses and utilized cash in operations since inception.

We believe that with the receipt of the net proceeds from

the transactions contemplated by that certain securities purchase agreement dated April 30, 2025, between us and certain accredited investors and JGB Collateral LLC, as collateral agent for the investors, or the JGB Purchase Agreement, together with

our existing cash and cash equivalents, and after taking into account the minimum cash covenant pursuant to the terms of the JGB Purchase Agreement, based on our current business plan we will be able to fund our operating expenses and capital

expenditure requirements into the fourth quarter of 2025.

Based on recurring losses from operations incurred since inception, the expectation of continued operating losses and the need to raise additional capital to finance our future operations, we

have determined that there is substantial doubt about our ability to continue as a going concern within 12 months from the date of this Quarterly Report.

We will continue to seek to raise additional capital, but without additional financing we may

not be able to continue as a going concern.

We believe that with the receipt of the net proceeds from the

transactions contemplated by that certain securities purchase agreement dated April 30, 2025, between us and certain accredited investors and JGB Collateral LLC, as collateral agent for the investors, or the JGB Purchase Agreement, together with our

existing cash and cash equivalents, and after taking into account the minimum cash covenant pursuant to the terms of the JGB Purchase Agreement, based on our current business plan we will be able to fund our operating expenses and capital expenditure

requirements into the first quarter of 2026.

Based on recurring losses from operations incurred since inception, the expectation of continued operating losses and the need to raise additional capital to finance our future operations, we have determined

that there is substantial doubt about our ability to continue as a going concern within 12 months from the date of this Quarterly Report.

We will continue to seek to raise additional capital, but without additional financing we may not be able to

continue as a going concern.

Our future operations are dependent upon the successful entry into collaborations, strategic alliances, or license agreements with third

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The perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.

If we are unable to continue as a

going concern, you could lose all or part of your investment.

If we are unable to continue as a going

concern, you could lose all or part of your investment.

Our operating activities may be restricted as a result of covenants related to the outstanding indebtedness issued

pursuant to the transactions contemplated by that certain securities purchase agreement with JGB, and we may be required to repay the outstanding indebtedness in an event of default, which could have a materially adverse effect on our business.

In April 2025, we entered into the JGB Purchase Agreement for the sale of (i) Senior Secured Convertible Debentures, or the Debentures,

in an aggregate principal amount of $22,222,222 and (ii) warrants to purchase up to 1,000,000 shares of our common stock, for an exercise price of $2.52 per share.

Beginning on August 28, 2025, the holders of Debentures may require us to redeem a

pursuant to the transactions contemplated by the securities purchase agreement with JGB, and we may be required to repay the outstanding indebtedness in an event of default, which could have a materially adverse effect on our business.

In April 2025, we entered into the JGB Purchase Agreement for the sale of (i) Senior Secured Convertible Debentures, or the Debentures, in

an aggregate principal amount of $22,222,222 and (ii) warrants to purchase up to 1,000,000 shares of our common stock, for an exercise price of $2.52 per share.

Effective as of August 28, 2025, the holders of Debentures may require us to redeem a

portion of the Debentures of up to $500,000 in the aggregate per calendar month by providing written notice to us.

To secure our obligations under the JGB Purchase Agreement and the Debentures, we granted the investors a first priority lien on

substantially all of our assets, including intellectual property, or the Collateral.

During the three months ended September 30,2025, we redeemed an aggregate of $1,000,000 of the principal amount of the Debentures.

secure our obligations under the JGB Purchase Agreement and the Debentures, we granted the investors a first priority lien on substantially all of our assets, including intellectual property, or the Collateral.

Under the Debentures, we must at all times maintain a cash balance equal to the lesser of (a) $15.0 million and (b) the then-outstanding

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default under the Debentures, the investors could elect to declare all amounts outstanding, if any, to be immediately due and payable.

If there are any amounts outstanding that we are unable to repay, the investors could proceed against the

Collateral granted to it to secure such indebtedness.

If there are any amounts outstanding that we are unable to repay, the investors could proceed against the Collateral

granted to it to secure such indebtedness.

We are currently operating in a period of global economic uncertainty and capital markets disruption, which has been

significantly impacted by geopolitical conflicts, natural and man-made disasters, global health emergencies and uncertainties in regulatory developments and legislative actions, which could adversely affect our business, financial condition and

results of operations.

of operations.

Our results of operations could be adversely affected by general conditions in the global economy, uncertainty from political conditions

and changing regulations, and disruption of global financial markets that may result in a recession or market correction.

The financial markets and the global economy may be adversely affected by the current or anticipated impact of war, terrorism

and geopolitical conflicts, including in Russia and Ukraine, the Middle East and other areas.

Sanctions and enhanced export controls imposed by the United States and other countries in response to such conflicts may also adversely impact the

financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability.

The financial markets and the global economy may be adversely affected by the current or anticipated impact of war, terrorism and

geopolitical conflicts, including in Russia and Ukraine, the Middle East and other areas.

Sanctions and enhanced export controls imposed by the United States and other countries in response to such conflicts may also adversely impact the financial

markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability.

Changes in regulations and policies by the new U.S.

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administration has recently issued regulations to restrict direct and indirect investment by U.S.

companies with specified connections to China that use specific technologies of concern.

persons into companies

with specified connections to China that use specific technologies of concern.

Such changes in the regulations and policies by the current U.S.

administration and the resulting political and economic uncertainty materially impact our

operations and those of our third-party service providers and reduce our ability to access capital, which could negatively affect our liquidity and adversely affect our business and the value of our common stock.

administration may also

enact other new regulations or policies that affect trade with China or otherwise impact the pharmaceutical industry by enacting laws to restrict U.S.

pharmaceutical companies from contracting with Chinese companies on the development, research or

manufacturing of pharmaceutical products.

administration and the resulting political and economic uncertainty materially impact our operations and

those of our third-party service providers and reduce our ability to access capital, which could negatively affect our liquidity and adversely affect our business and the value of our common stock.

administration may also enact other new

regulations or policies that affect trade with China or otherwise impact the pharmaceutical industry by enacting laws to restrict U.S.

pharmaceutical companies from contracting with Chinese companies on the development, research or manufacturing of

pharmaceutical products.

In April 2025, the U.S.

Department of Commerce initiated national security investigations into the importation of pharmaceuticals and pharmaceutical ingredients pursuant to Section 232 of the Trade Expansion

Act of 1962, which could result in the imposition of new tariffs on imports within the pharmaceutical industry.

Department of Commerce initiated national security investigations into the importation of pharmaceuticals and pharmaceutical ingredients pursuant to Section 232 of the Trade Expansion Act of 1962, which

could result in the imposition of new tariffs on imports within the pharmaceutical industry.

Further, in April 2025, an executive order to lower prescription drug prices was signed.

The details of such proposed regulations and

policies are unclear and the final terms and impact remain uncertain, and may pose long-term risks to our business.

The details of such proposed regulations and policies are unclear and

the final terms and impact remain uncertain, and may pose long-term risks to our business.

In addition, natural and man-made disasters and global health emergencies, including pandemics and epidemics, may adversely affect the

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inventory or equipment, which could disrupt, delay or curtail our operations.

Such business disruptions may also heighten the risk of power outages, telecommunications, transportation or other infrastructure failure, cybersecurity incidents or

physical security breaches.

The cost of insurance has increase significantly, including as a result of the impact of climate change and inflation, and we may not be able to obtain sufficient coverage at a reasonable cost to protect us against losses

from such disasters and unforeseen events.

Such business disruptions may also heighten the risk of power outages, telecommunications, transportation or other infrastructure failure, cybersecurity incidents or physical

security breaches.

disasters and unforeseen events.

The volatile business environment or continued unpredictable and unstable market conditions may result in further deterioration of the

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presidential administration may directly affect us and the global economy.

The political and economic environment in the United States and elsewhere has resulted in and will continue to result in some

Changing regulatory policies because of the changing political environment could impact our regulatory and compliance costs and future revenues, all of which could materially and adversely affect our business, financial condition and

operating results.

The political and economic environment in the United States and elsewhere has resulted in and will continue to result in some uncertainty.

For example, significant layoffs or turnover at FDA could affect the FDA’s ability to respond to regulatory filings.

Failure to adapt to or comply with evolving regulatory requirements or investor or stakeholder expectations and

standards could negatively impact our reputation, ability to do business with certain partners, access to capital and our stock price.

Failure to adapt to or comply with evolving regulatory requirements or investor or stakeholder expectations and standards could

negatively impact our reputation, ability to do business with certain partners, access to capital and our stock price.

Further, the new U.S.

administration and congressional seat turnover may result in increased regulatory and economic uncertainty.

Changes in federal policy by the executive branch and regulatory agencies may occur over time through the new presidential administration’s and/or Congress’s policy and personnel changes, which could lead to changes involving the level of oversight

and focus on the pharmaceutical industry;

in federal policy by the executive branch and regulatory agencies may occur over time through the new presidential administration’s and/or Congress’s policy and personnel changes, which could lead to changes involving the level of oversight and focus

on the pharmaceutical industry;

however, the nature, timing and economic and political effects of such potential changes remain highly uncertain.

Any future changes in federal and state laws and regulations, as well as the interpretation

and implementation of such laws and regulations, could affect us in substantial and unpredictable ways.

At this time, it is unclear what laws, regulations and policies may change and whether future changes or uncertainty surrounding future changes

will adversely affect our operating environment and therefore our business, financial condition and results of operations.

Any future changes in federal and state laws and regulations, as well as the interpretation and

implementation of such laws and regulations, could affect us in substantial and unpredictable ways.

At this time, it is unclear what laws, regulations and policies may change and whether future changes or uncertainty surrounding future changes will

adversely affect our operating environment and therefore our business, financial condition and results of operations.

Artificial intelligence presents risks and challenges that can impact our business including by posing security risks

to our confidential information, proprietary information and personal data.

Issues in the use of artificial intelligence, combined with an uncertain regulatory environment, may result in reputational harm,

liability or other adverse consequences to our business operations.

As with many technological innovations, artificial intelligence presents risks and challenges that could impact our business.

Our vendors may incorporate generative artificial

intelligence tools into their offerings without disclosing this use to us, and the providers of these generative artificial intelligence tools may not meet existing or rapidly evolving regulatory or industry standards with respect to privacy and data

protection and may inhibit our or our vendors’ ability to maintain an adequate level of service and experience.

If any of our vendors experience an actual or perceived breach or privacy or security incident because of the use of generative artificial

intelligence, we may lose valuable intellectual property and confidential information and our reputation and the public perception of the effectiveness of our security measures could be harmed.

Further, bad actors around the world use increasingly

sophisticated methods, including the use of artificial intelligence, to engage in illegal activities involving the theft and misuse of personal information, confidential information and intellectual property.

Any of these outcomes could damage our

reputation, result in the loss of valuable property and information, and adversely impact our business.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

DEFAULTS UPON SENIOR SECURITIES

MINE SAFETY DISCLOSURES

Not applicable.

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