UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
FORM 12b-25
NOTIFICATION
OF LATE FILING
(Check one): |
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Form 10-K ☐ Form 20-F
☐ Form 11-K
☒ Form
10-Q ☐ Form 10-D ☐ Form
N-CEN ☐ Form N-CSR |
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For Period Ended: March 31, 2024 |
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Transition Report on Form 10-K |
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Transition Report on Form 20-F |
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Transition Report on Form 11-K |
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Transition Report on Form 10-Q |
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For the Transition Period Ended: |
Nothing
in this Form shall be construed to imply that the Commission has verified any information contained herein. |
If the notification relates to a portion
of the filing checked above, identify the Item(s) to which the notification relates:
PART
I—REGISTRANT INFORMATION
GAMIDA
CELL LTD.
Full
Name of Registrant
N/A
Former
Name if Applicable
116
Huntington Avenue, 7th Floor
Address
of Principal Executive Office (Street and Number)
Boston,
Massachusetts 02116
City,
State and Zip Code
PART II—RULES 12b-25(b)
AND (c)
If
the subject report could not be filed without unreasonable effort or expense and the registrant seeks relief pursuant to Rule 12b-25(b),
the following should be completed. (Check box if appropriate)
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(a) |
The reason described in reasonable detail in Part III of this form could not be eliminated without unreasonable effort or expense;
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(b) |
The subject annual report, semi-annual report, transition report on Form 10-K, Form 20-F, Form 11-K, Form N-CEN or Form N-CSR, or portion thereof, will be filed on or before the fifteenth calendar day following the prescribed due date; or the subject quarterly report or transition report on Form 10-Q or subject distribution report on Form 10-D, or portion thereof, will be filed on or before the fifth calendar day following the prescribed due date; and
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(c) |
The
accountant’s statement or other exhibit required by Rule 12b-25(c) has been attached if applicable. |
PART
III—NARRATIVE
State
below in reasonable detail why Forms 10-K, 20-F, 11-K, 10-Q, 10-D, N-CEN, N-CSR, or the transition report or portion thereof, could not
be filed within the prescribed time period.
Gamida Cell Ltd. (the “Registrant”)
is filing this Notification of Late Filing on Form 12b-25 with respect to its Quarterly Report on Form 10-Q for the fiscal quarter ended
March 31, 2024 (the “Form 10-Q”). As disclosed in the Registrant’s Current Report on Form 8-K (“Form 8-K”)
filed with the Commission on March 27, 2024, the Registrant entered into a Restructuring Support Agreement (the “Support Agreement”)
with Gamida Cell Inc., a Delaware corporation and wholly-owned subsidiary of the Registrant, and certain funds managed by Highbridge Capital
Management LLC, pursuant to which the parties agreed to restructure all of the outstanding equity
and debt of the Registrant and Gamida Cell Inc. in a voluntary restructuring proceeding (the “Debt Arrangement”) in the District
Court of Be’er Sheba, Israel (the “District Court”) that is governed by Israeli law. As disclosed in the Registrant’s
Form 8-K filed with the Commission on May 10, 2024, the District Court approved the Debt Arrangement.
In addition, on April 22,
2024, the Registrant filed a Current Report on Form 8-K reporting the filing of a petition for recognition and enforcement of the Debt
Arrangement in the United States under Chapter 15 of Title 11 of the United States Code in the United States Bankruptcy Court for
the District of Delaware (the “Delaware Bankruptcy Court”). On May 15, 2024, the Delaware Bankruptcy Court entered a final
order granting recognition and enforcement of the Debt Arrangement.
The Registrant was unable
to finalize and file the Form 10-Q within the prescribed time period due to uncertainty related to the timing of closing the transactions
related to Debt Arrangement, and otherwise significant demands related to the Debt
Arrangement that diverted management time and resources from the Registrant’s normal process of preparing and reviewing Quarterly
Reports on Form 10-Q. The Registrant is working expeditiously to prepare and file the Form 10-Q as soon as practicable.
The Registrant cautions that
trading in the Registrant’s securities during the Debt Arrangement is highly speculative
and poses substantial risks. Holders of the ordinary shares may not receive any recovery on account of such securities.
PART
IV—OTHER INFORMATION
| (1) | Name and telephone number of
person to contact in regard to this notification |
Abigail Jenkins |
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617 |
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892-9080 |
(Name) |
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(Area Code) |
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(Telephone Number) |
| (2) | Have all other periodic reports required under Section 13 or 15(d) of
the Securities Exchange Act of 1934 or Section 30 of the Investment Company Act of 1940 during the preceding 12 months or for such
shorter period that the registrant was required to file such report(s) been filed? If answer is no, identify report(s). Yes ☒
No ☐ |
| (3) | Is it anticipated that any
significant change in results of operations from the corresponding period for the last fiscal year will be reflected by the earnings
statements to be included in the subject report or portion thereof? Yes ☒ No ☐ |
If
so, attach an explanation of the anticipated change, both narratively and quantitatively, and, if appropriate, state the reasons why
a reasonable estimate of the results cannot be made.
The Registrant anticipates significant changes in its results of operations
due to (i) the Registrant’s transition from a clinical-development stage company to a commercial stage company and the accompanying
recognition of revenue and costs relating to sales of Omisirge and (ii) the Registrant’s increased expenses related to the Restructuring.
The Registrant’s net revenue was approximately $0.7 million
for the three months ended March 31, 2024, compared to zero in net revenue during the three months ended March 31, 2023.
The Registrant expects cash and cash
equivalents as of March 31, 2024 to be approximately $24.8 million.
The Registrant is still finalizing its
results of operations for the three months ended March 31, 2024; therefore, these are preliminary results based on the Registrant’s
current expectations. These preliminary financial results are subject to change, and the Registrant’s actual results may differ
materially from such estimates.
The Registrant is unable to provide, among other things, a reasonable
estimate of its net revenue, cost of sales and net loss for the three months ended March 31, 2024; thus, a reasonable estimate of the
Registrant’s results of operations cannot be made as indicated in Part III of this Form 12b-25. Furthermore, as discussed above,
on March 27, 2024 the Registrant commenced the Restructuring and subsequently filed to seek relief under Chapter 15 and Chapter 11 of
Title 11 of the United States Bankruptcy Code. The Registrant has not completed its assessment of the effects that the Restructuring has
had on its financial statements, and thus the Registrant cannot provide a reasonable estimate of such effects at this time.
Cautionary Notice Regarding
Forward-Looking Statements
This Form 12b-25 includes information
that constitutes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking
statements are based on the Registrant’s current beliefs, assumptions and expectations regarding future events, which in turn are
based on information currently available to the Registrant. Such forward-looking statements include statements regarding the Registrant’s
expectations with respect to its net revenue for the three months ended March 31, 2024. By their nature, forward-looking statements address
matters that are subject to risks and uncertainties. A variety of factors could cause actual events and results to differ materially from
those expressed in or contemplated by the forward-looking statements. These factors include, without limitation, the risk that additional
or different information may become known prior to the expected filing of the Form 10-Q. Other risks affecting the Registrant
are discussed in the Registrant’s filings with the Securities and Exchange Commission. The Registrant undertakes no obligation to
publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except to
the extent required by applicable laws.
GAMIDA CELL LTD.
(Name of Registrant
as Specified in Charter)
has caused this notification to be signed
on its behalf by the undersigned hereunto duly authorized.
Date: |
May 16, 2024 |
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By: |
/s/ Abigail Jenkins |
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Name: |
Abigail Jenkins |
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Title: |
President, Chief Executive Officer and Director |
INSTRUCTION: The form may be signed
by an executive officer of the registrant or by any other duly authorized representative. The name and title of the person signing the
form shall be typed or printed beneath the signature. If the statement is signed on behalf of the registrant by an authorized representative
(other than an executive officer), evidence of the representative’s authority to sign on behalf of the registrant shall be filed
with the form.
ATTENTION
Intentional
misstatements or omissions of fact constitute Federal Criminal Violations (See 18 U.S.C. 1001). |
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