What changed in this filing

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Item 1A. Risk Factors

2025-11-12 compared with 2025-08-14 · 34 added, 2 removed, 8 unchanged (82% of the section changed)

2 unchanged sentences

For a discussion of these potential risks and uncertainties, see Part I, Item 1A.

“Risk Factors” of our Annual Report.

“Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2024.

Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, operating results and the price of our common stock.

There have been no material changes in our risk factors to those included in our Annual Report.

Except as set forth below, there have been no material changes in our risk factors to those included in our Annual Report.

Our future results largely depend upon our ability to successfully develop, commercialize, market and sell breast reconstruction biologic products.

The Company has focused much of its attention recently on EluPro, which was cleared for marketing by the U.S.

Food and Drug Administration (“ FDA ”) in June 2024 and was indicated for use with implantable electronic devices including cardiac and neurostimulator devices.

As previously reported, on October 1, 2025, Elutia and its subsidiary completed the sale of all of its assets related to its business of researching, developing, administering, operating, commercializing, manufacturing, selling and marketing cardiac implantable electronic device (“ CIED ”) products, including its CanGaroo, CanGaroo RM, EluPro and CIED envelope products, including next generation CIED envelope products (collectively the “ CIED Business ”).

The assets of the CIED Business constituted substantially all of the assets of Elutia’s former Device Protection segment.

Our future results consequently depend on the success of our Women’s Health and Cardiovascular businesses.

There can be no guarantee, however, that we will be able to increase the sales or profitability of the remaining businesses sufficiently to replace or exceed the financial contribution, or potential financial contribution, from the sold CIED Business.

Elutia’s current strategy principally focuses on applying the Company’s drug-eluting biologics platform to advancing NXT-41x, a biomatrix that seeks to ameliorate breast reconstruction infections following mastectomy.

We believe the development, commercialization and marketing efforts with respect to NXT-41x will require significant investments in time and resources.

Although the sale of the CIED Business has resulted in significant cash net proceeds to the Company, there can be no assurance that these resources, or other resources we may raise or have access to in the future, will be sufficient to make the necessary investments in order to develop and commercially exploit NXT-41x, or that if made, such investments will yield the results sought.

Moreover, development or marketing of NXT-41x may require further approvals or action from the FDA, and there can be no guarantee that the Company will be able to obtain such approvals on a timely basis, or at all.

If we fail to successfully develop, commercialize, market and sell NXT-41x, the Company’s business and financial condition may be materially adversely affected.

Our enhanced reliance in the wake of the disposition of the CIED Business on a smaller suite of existing products and on future products poses risks to the Company’s growth.

If the financial contribution from remaining legacy products and NXT-41x and other potential future drug-eluting biomatrix products fail to replace lost contribution from the CIED Business, or otherwise fail to meet expectations, the Company’s business and financial condition may be materially adversely affected.

We may not be able to maintian a listing of our Class A common stock on the Nasdaq Capital Market.

Because our Class A common stock is listed on the Nasdaq Capital Market, we must meet certain financial and liquidity criteria to maintain such listing.

On November 7, 2025, we received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”), notifying us that, for the last 30 consecutive business days, the closing bid price for our Class A common stock, par value $0.001 per share (the “Common Stock”), was below $1.00 per share, which is the minimum closing bid price (the “Minimum Bid Price”) required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Notice”).

We were provided a compliance period of 180 calendar days from the date of the Notice, or until May 6, 2026 (the “Compliance Period”), to regain compliance with the Minimum Bid Price requirement.

As of the date of this filing, we have not had a closing bid price over $1.00 and there can be no assurance that we will regain compliance with the Minimum Bid Price requirement prior to the end of the Compliance Period or that we will otherwise maintain compliance with any of the other Nasdaq listing requirements.

If we do not regain compliance during the Compliance Period, we may be eligible for an additional 180-calendar day period to regain compliance with the Minimum Bid Price, provided that we meet the applicable market value of publicly held shares requirement for continued listing and all other applicable standards for initial listing on The Nasdaq Capital Market (except the Minimum Bid Price requirement), and notify Nasdaq of our intent to cure the deficiency by effecting a reverse stock split of our Common Stock, if necessary.

If Nasdaq determines that we are not

eligible for an additional 180 calendar days compliance period or we will not be able to cure the deficiency with the Minimum Bid Price requirement within the allotted compliance period, the Common Sock will be subject to delisting.

We will continue to actively monitor the closing bid price of our Common Stock and will evaluate available options, including, without limitation, seeking to effect a reverse stock split, in order to resolve the deficiency and regain compliance with Minimum Bid Price requirement.

We are also subject to continued listing requirements under Nasdaq Listing Rule 5550(b) for the Nasdaq Capital Market.

Rule 5550(b) requires that a listed company must satisfy one of the following three standards:

(1) stockholders’ equity of at least $2.5 million;

(2) market value of listed securities of at least $35 million;

or (3) net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the three most recently completed fiscal years.

Although we believe we are currently in compliance with this standard based on our market capitalization, there is no guarantee that we will be able to maintain compliance with this standard, particularly in view of the recent decline in our prevailing stock price and our history of net losses and stockholders’ deficits.

If we fail to regain compliance with the Minimum Bid Price requirement, or otherwise violate or fail to meet any Nasdaq listing requirements, our Common Stock may be delisted.

A delisting of our Common Stock stock from Nasdaq may materially impair our stockholders’ ability to buy and sell our Common Stock and could have an adverse effect on the market price of, and the efficiency of the trading market for, our Common Stock.

In the event our Common Stock is delisted from Nasdaq, the delisting of our Common Stock could significantly impair our ability to raise capital and stockholder value.

Unregistered Sales of Equity Securities and Use of Proceeds.

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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