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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): November 9, 2023
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.) |
12510
Prosperity Drive, Suite 370,
Silver Spring, MD
20904
(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 x
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 7.01 | Regulation FD Disclosure. |
On November 8, 2023, Elutia Inc. (the “Company” or “Elutia”)
closed its previously announced sale of substantially all of the assets of its Orthobiologics business to Berkeley Biologics, LLC (the
“Closing”).
On November 9, 2023, Elutia issued a press
release announcing the Closing, a copy of which is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated
herein by reference.
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 our expectations for receiving the upfront and earnout payments under our agreement with Berkeley Biologics,
LLC. 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 press release,
including, but not limited to: risks associated with shifting focus to our drug-eluting biomatrix solutions in the cardiovascular
and breast reconstruction areas and away from our Orthobiologics business; risks regarding the ability to successfully execute or
realize the anticipated benefits under our distribution arrangements with LeMaitre Vascular and Sientra; risks relating to the
potential removal of our securities from listing and registration on the Nasdaq Capital Market; our inability to generate sufficient
revenue to achieve or sustain profitability; adverse changes in economic conditions and instability and disruption of credit
markets; our ability to continue as a going concern; our ability to successfully achieve expected benefits from the divestiture of
our Orthobiologics business; our products and our ability to enhance, expand, develop and commercialize our product offerings; the
impact on our business of the recall of a single lot of our FiberCel product and the discontinuation of its sales by our
distribution partner; consequences of our recall of a single lot of one of our viable bone matrix products and market withdrawal of
all of our viable bone matrix products; our dependence on our commercial partners; the impact of the bankruptcy of Surgalign
Holdings, Inc., a significant customer of the Company, on our future revenues; physician awareness of the distinctive
characteristics, and acceptance by the medical community, of our products; the ability to obtain regulatory approval or other
marketing authorizations; our intellectual property rights, and risks that the requirements for any or all of the Earn Out Payments
might not be achieved and that any or all of the additional consideration tied to the Earn Out Payments might not be received by the
Company, and other important factors 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, 2022, 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 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.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
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: November 9, 2023 |
By: |
/s/ Matthew Ferguson |
|
Matthew Ferguson |
|
Chief Financial Officer |
Exhibit 99.1
Elutia Completes Divestiture of Orthobiologics
Business Unit for Cash Proceeds of Up to $35 Million
- Company Now Focused on Proprietary Drug-Eluting
Biomatrix Platform -
SILVER
SPRING, Md., Nov. 9, 2023 — Elutia Inc. (Nasdaq: ELUT) (“Elutia”), a company pioneering drug-eluting biomatrix
products, today announced it completed the divestiture of its Orthobiologics business unit to Berkeley Biologics LLC, a wholly owned subsidiary
of GNI Group Ltd.
The transaction enables Elutia to
strategically focus on its proprietary drug-eluting biomatrix platform and provides the Company with cash proceeds of up to $35
million, comprised of upfront payments no later than November 17, 2023 of $15 million plus potential earnout payments of up to $20
million over a five-year period. Combined proceeds with the previously announced September 2023 private placement potentially top
$60 million.
“With the closing of this transaction, Elutia
is now fully focused on our high-growth biomatrix product platforms, including our near-term blockbuster opportunity with CanGaroo®RM,”
said Dr. Randy Mills, President and Chief Executive Officer of Elutia. “The proceeds from this transaction, coupled with
the September financing, should have us well-capitalized to advance our proprietary drug-eluting biomatrix platform. And all of this is made
possible by the outstanding work of our team, which continues to execute the Elutia plan with relentless drive and focus.”
Mizuho Securities USA LLC acted as financial advisor
and Kilpatrick Townsend & Stockton LLP acted as legal advisor to Elutia in connection with this transaction.
About Elutia
Elutia develops and commercializes biologic 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.
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 concerning our expectations for receiving the upfront and earnout payments under our
agreement with Berkeley Biologics LLC, the potential success of our CanGaroo®RM biomatrix product platform, and the sufficiency
of our capitalization to advance our proprietary drug-eluting biomatrix platform. 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 press release, including, but not limited to: risks
associated with shifting focus to our drug-eluting biomatrix solutions in the cardiovascular and breast reconstruction areas and
away from our Orthobiologics business; risks regarding the ability to successfully execute or realize the anticipated benefits under
our distribution arrangements with LeMaitre Vascular and Sientra; risks relating to the potential removal of our securities from
listing and registration on the Nasdaq Capital Market; our inability to generate sufficient revenue to achieve or sustain
profitability; adverse changes in economic conditions and instability and disruption of credit markets; our ability to continue as a
going concern; our ability to successfully achieve expected benefits from the divestiture of our Orthobiologics business; our
products and our ability to enhance, expand, develop and commercialize our product offerings; the impact on our business of the
recall of a single lot of our FiberCel product and the discontinuation of its sales by our distribution partner; consequences of our
recall of a single lot of one of our viable bone matrix products and market withdrawal of all of our viable bone matrix products;
our dependence on our commercial partners; the impact of the bankruptcy of Surgalign Holdings, Inc., a significant customer of the
Company, on our future revenues; physician awareness of the distinctive characteristics, and acceptance by the medical community, of
our products; the ability to obtain regulatory approval or other marketing authorizations; and our intellectual property rights, and
other important factors 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, 2022, 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 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:
Matt Steinberg
FINN Partners
matt.steinberg@finnpartners.com
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Elutia (NASDAQ:ELUT)
過去 株価チャート
から 8 2024 まで 9 2024
Elutia (NASDAQ:ELUT)
過去 株価チャート
から 9 2023 まで 9 2024