Item 1.01Item 1.01 - Entry into Material Agreement
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 7.01Item 7.01 - Regulation FD Disclosure
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.