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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): July 20, 2026 (
July 16, 2026)
ELUTIA INC.
(Exact name of registrant as specified in its
charter)
| Delaware |
|
001-39577 |
|
47-4790334 |
(State
or other jurisdiction of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
20
Firstfield Road, Gaithersburg,
MD 20878
(Address
of principal executive offices) (Zip Code)
(240)
247-1170
(Registrant’s
telephone number, including area code)
N/A
(Former
name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
| Class A
Common Stock, $0.001 par value per share |
|
ELUT |
|
The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate
by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 1.01
Entry into a Material Definitive Agreement.
Agreement to Sell SimpliDerm Business
On July 16, 2026, Elutia Inc., a Delaware corporation (the “Company”
or “Elutia”), entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Cellution Biologics Inc.
, a Delaware corporation (“Cellution Biologics”). Subject to the terms and conditions of the Purchase Agreement, at the closing
(the “Closing”) of the transactions contemplated by the Purchase Agreement (collectively, such transactions, the “Asset
Purchase”), Cellution Biologics will purchase from the Company substantially all of the assets related to the Company’s business
of commercializing, manufacturing, distributing, selling and/or marketing human acellular dermis (hADM) products for use in the field
of breast reconstruction under the SimpliDerm® brand (the “SimpliDerm Business”). The assets of the SimpliDerm Business
constitute substantially all of the assets currently held in Elutia’s Women’s Health segment. Cellution Biologics is only
assuming certain liabilities related to performance of the contracts transferred in the Asset Purchase (such liabilities, the “Assumed
Liabilities”).
The
Purchase Agreement provides for aggregate consideration payable to the Company of up to $11 million, consisting of: (i) a base purchase
price of $8 million in cash, payable at Closing, subject to adjustment for any inventory shortfall; (ii) a contingent payment of
up to $2 million, payable upon completion of certain technology transfer and manufacturing transition milestones within an 18-month
period following the Closing, subject to reduction for sales shortfalls against monthly SimpliDerm sales targets during such transition
period; and (iii) contingent payments of up to $1 million, in the aggregate, in the form of earn-out payments, payable for any four
of the first five quarters following the Closing in which SimpliDerm sales exceed a specified quarterly revenue target (collectively,
the “Purchase Price”).
In connection with the Purchase Agreement, the
Company has agreed, for a five-year period following the Closing, to be subject to certain non-competition restrictions in the business
of manufacturing, marketing, distributing or selling human acellular dermis products. The Company has also agreed not to solicit Cellution
Biologics’ employees and independent contractors for a period of five years following the Closing.
The Company and Cellution Biologics have also
negotiated a transition services agreement, to be entered into at Closing, pursuant to which the Company will agree to perform certain
transition services for a period of time following the Closing with respect to Cellution Biologics’ use and operation of the assets
purchased in the Asset Purchase.
The Purchase Agreement contains customary representations, warranties
and covenants of the parties. The Company and Cellution Biologics have agreed to indemnify each other from and against losses the respective
parties may incur arising out of breaches of the other party’s representations, warranties and covenants contained in the Purchase
Agreement. In addition, Cellution Biologics has agreed to indemnify the Company for losses relating to the Assumed Liabilities (as defined
in the Purchase Agreement), and the Company has agreed to indemnify Cellution Biologics for losses relating to the Excluded Assets and
Excluded Liabilities (each as defined in the Purchase Agreement). The Company has also agreed to indemnify Cellution Biologics for losses
related to the operation of the SimpliDerm Business prior to Closing, certain transaction expenses, certain successor-liability matters,
and certain specified litigation matters. Certain of the indemnification obligations of the parties under the Purchase Agreement are subject
to specified survival limitations, including an 18-month general survival period, a three-year survival period for certain special representations,
and a six-year or longer survival period for certain fundamental representations. The Company’s liability under the Purchase Agreement
is subject to a deductible amount equal to 10% of the Purchase Price, overall cap amounts ranging from 10% to 100% of the Purchase Price
depending on the nature of the representations, and other customary exceptions and limitations. The remedies provided under the Purchase
Agreement’s indemnification provisions are the parties’ sole and exclusive remedies, subject to customary carve-outs for fraud
and specific performance.
The Closing is subject to customary closing conditions, including,
among others, (i) the accuracy of representations and warranties set forth in the Purchase Agreement (subject to customary materiality
qualifiers), (ii) the absence of any Material Adverse Effect (as defined in the Purchase Agreement) with respect to the SimpliDerm Business,
(iii) material compliance with covenants set forth in the Purchase Agreement, (iv) the execution and delivery of certain related ancillary
documents, (v) no termination or material impairment of assumed or shared contracts, (vi) resolution of certain supply related matters,
and (vii) certain other conditions set forth in the Purchase Agreement. Subject to the satisfaction or waiver of the conditions to Closing,
the Company expects the Closing to occur in the second half of 2026.
The Company and Cellution Biologics are each permitted under certain
circumstances to terminate the Purchase Agreement, including in the event that (i) the Closing has not occurred by January 16, 2027, (ii)
any final and nonappealable order is issued and effective or a law is enacted that prohibits or makes illegal the Asset Purchase, or (iii)
if the other party to the Purchase Agreement has breached any representation, warranty, covenant or other agreement such that the closing
conditions relating to either the accuracy of representations or the satisfaction of covenants by the other party are not met and cannot
be cured as provided in the Purchase Agreement.
The foregoing description of the Purchase Agreement and the Asset Purchase
does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the Purchase Agreement, which is
filed as Exhibit 10.1 to this Current Report on Form 8-K (this “Form 8-K”) and is incorporated herein by reference. The Purchase
Agreement is not intended to provide any other factual information about the Company, Cellution Biologics, or their respective owners,
subsidiaries and affiliates. The representations, warranties and covenants contained in the Purchase Agreement (i) were made solely for
purposes of the Purchase Agreement and as of the date of the Purchase Agreement, (ii) were solely for the benefit of the parties to the
Purchase Agreement, (iii) may be subject to qualifications and limitations agreed upon by the parties to the Purchase Agreement, including
being qualified by confidential disclosures made for the purposes of allocating contractual risk among the parties to the Purchase Agreement
instead of establishing these matters as facts and (iv) may be subject to standards of materiality applicable to the contracting parties
that differ from those applicable to security holders of the Company. Investors and security holders of the Company should not rely on
the representations, warranties and covenants or any description thereof as characterizations of the actual state of facts or condition
of the Company. Moreover, information concerning the subject matter of the representations, warranties and covenants may change after
the date of the Purchase Agreement, which subsequent information may or may not be fully reflected in public disclosures by the Company.
Item 7.01
Regulation FD Disclosure.
On July 16, 2026, Elutia issued a press release announcing the Purchase
Agreement, a copy of which is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 (including Exhibit 99.1) of this
Current Report on Form 8-K is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall
it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange
Act, except as expressly set forth by specific reference in such filing.
Forward-Looking Statements
This report contains “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,”
“would,” “should,” “believes,” “expects,” “anticipates,” “estimates,”
“intends,” “plans,” “potential,” “promise” or similar references to future periods. All
statements contained in this report that do not relate to matters of historical fact should be considered forward-looking statements,
including any statements and information concerning the Company’s plans for the closing of the sale of the SimpliDerm Business,
which is subject to customary closing conditions, including if and when the Asset Purchase will be consummated, and any statements regarding
the maximum of up to $3 million in contingent technology transfer and commercial milestone and earn-out payments, which if earned, shall
form part of the consideration and are conditioned upon satisfaction of certain milestones and metrics.
Forward-looking statements are based on management’s current
assumptions and expectations of future events and trends, which affect or may affect our business, strategy, operations or financial performance,
and actual results may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking
statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, and other important factors
that may cause actual results, performance or achievements to differ materially from those contemplated or implied in this report, including,
but not limited to: the occurrence of any event, change or circumstance that could delay the Asset Purchase or give rise to termination
of the Purchase Agreement; the risk that the technology transfer and commercial milestone payments are reduced, delayed, or not earned
or received; the outcome of any legal proceedings instituted against the Company following announcement of the Asset Purchase; the inability
to consummate the Asset Purchase due to failure to satisfy closing conditions; the risk that the Asset Purchase disrupts Elutia’s
current plans and operations, including distraction of management and employees; costs related to the Asset Purchase; changes in applicable
laws or regulations; and other risks and uncertainties which can be found in the “Risk Factors” section of Elutia’s
public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for
the year ended December 31, 2025, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including
Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of
Elutia’s website at https://investors.elutia.com.
Because forward-looking statements are inherently subject to risks
and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement
made by Elutia in this report is based only on information currently available and speaks only as of the date on which it is made. Except
as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written
or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Item 9.01
Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description |
| 10.1*† |
Asset Purchase Agreement, dated July 16, 2026, by and between Cellution Biologics Inc. and Elutia Inc. |
| 99.1 |
Press release of Elutia Inc., dated July 16, 2026 |
| 104 |
Cover Page Interactive Data File (formatted as Inline XBRL document) |
*Certain confidential information contained in this Exhibit, marked
in brackets, has been omitted, because it is both not material and of the type of information that the registrant treats as private or
confidential.
† Schedules have been omitted pursuant to Item 601(a)(5) of
Regulation S-K. The Company undertakes to furnish supplemental copies of any of the omitted schedules upon request by the SEC.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
ELUTIA INC. |
| |
(Registrant) |
| |
|
| Date: July 20, 2026 |
By: |
/s/
Matthew Ferguson |
| |
Matthew Ferguson |
| |
Chief Financial Officer |
Exhibit 99.1
Elutia
Signs Definitive Agreement to Sell SimpliDerm® in Transaction Valued at up to $11 Million, Strengthening Balance Sheet
Ahead of NXT-41x Launch
| · | Transaction
provides $8 million in cash at closing and up to $3 million in technology transfer and commercial
milestone payments over the next 18 months |
| · | Proceeds
provide additional non-dilutive capital to advance NXT-41x toward anticipated clearance and
targeted commercial launch in 2027 |
| · | Divestiture
sharpens Elutia’s focus on NXT-41x and the $1.5 billion plastic and reconstructive
surgery opportunity |
GAITHERSBURG, Md., July 16, 2026 (GLOBE NEWSWIRE) -- Elutia Inc.
(Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today announced
the signing of a definitive agreement to sell its SimpliDerm® human acellular dermal matrix business to Cellution Biologics Inc.
for total consideration of up to $11 million. Elutia will receive $8 million in cash at closing, along with up to $3 million in technology
transfer and commercial milestone payments over the next 18 months. Closing is expected to occur in the second half of 2026, subject
to customary closing conditions.
The divestiture completes Elutia’s previously announced strategic
process for SimpliDerm and focuses the Company’s resources on NXT-41x, its next-generation antibiotic-eluting biomatrix for plastic
and reconstructive surgery. The proceeds further strengthen Elutia’s balance sheet without equity dilution and provide additional
capital to support its planned commercial launch in 2027.
“This transaction is another decisive step in fortifying Elutia’s
balance sheet with non-dilutive capital and sharpening our focus on NXT-41x,” said Dr. Randy Mills, Chief Executive Officer
of Elutia. “SimpliDerm is a well-established regenerative solution developed by Elutia, and this transaction places the business
with an organization committed to its continued success. Looking ahead, we believe NXT-41x has the potential to redefine soft tissue
reinforcement for women undergoing surgery after breast cancer, a setting in which serious complications still affect as many as 1 in
3 patients. We are committed to changing that.”
Under the terms of the agreement, Elutia will receive $8 million in
cash at closing, along with up to an additional $3 million in technology transfer and commercial milestone payments payable over the
next 18 months.
NXT-41x is being developed for the approximately $1.5 billion U.S.
plastic and reconstructive surgery market, where Elutia believes antibiotic-eluting biomatrix technologies fulfill a significant unmet
need in soft tissue reinforcement.
About Elutia
Elutia
develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need
them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive
without compromise. For more information, visit www.Elutia.com.
SimpliDerm® is a registered trademark of Elutia Inc.
Forward-Looking Statements
This press release contains “forward-looking statements”
within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,”
“could,” “would,” “should,” “believes,” “expects,” “anticipates,”
“estimates,” “intends,” “plans,” “potential,” “promise” or similar references
to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered
forward-looking statements, including any statements and information regarding whether or when the sale of the SimpliDerm® human
acellular dermal matrix business (the “Transaction”) will be consummated; the total consideration to be received by the Company
in the Transaction, including whether any of the technology transfer and commercial milestones will be achieved or any of the related
milestone payments will be received; the application of the anticipated proceeds of the Transaction; and the size of the U.S. breast
reconstruction market and the potential of the Company’s next-generation drug-eluting biomatrix pipeline to compete in that market,
including the timing and success of NXT-41 and NXT-41x. These forward-looking statements are based on our management’s beliefs
and assumptions and on information currently available to us. Additionally, such forward-looking statements are subject to a number of
known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to
be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements,
including, but not limited to the following: (i) the occurrence of any event, change or other circumstance that could delay the
Transaction or give rise to the termination of the agreement related thereto; (ii) the risk that the technology transfer and commercial
milestone payments are reduced, delayed, or not earned or received; (iii) the outcome of any legal proceedings that may be instituted
against the Company following announcement of the Transaction; (iv) the inability to consummate the Transaction due to the failure
to satisfy the conditions to closing in the agreement related thereto; (v) the risk that the proposed Transaction disrupts the Company’s
current plans and operations as a result of the announcement of the Transaction, including the distraction of management and the Company’s
employees; (v) costs related to the Transaction; (vi) changes in applicable laws or regulations; and (vii) the other risks
discussed in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”),
including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from
time to time in Elutia’s other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the Investor Relations
page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks
and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement
made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made.
Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether
written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Investors:
Elutia Investor Relations
ir@elutia.com
