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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): June 3, 2024
LADRX
CORPORATION
(Exact
name of registrant as specified in its charter)
Delaware |
|
000-15327 |
|
58-1642740 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
11726
San Vicente Boulevard, Suite 650
Los
Angeles, California 90049
(Address
of principal executive offices) (Zip Code)
Registrant’s
telephone number, including area code: (310) 826-5648
Former
name or former address, if changed since last report: None
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(g) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.001 per share Series B Junior Participating Preferred Stock Purchase Rights |
|
LADX |
|
OTC
Markets |
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.
Mutual
Termination and Release Agreement
On
June 3, 2024 (the “Effective Date”), LadRx Corporation (the “Company”) entered into
a Mutual Termination and Release Agreement (the “Termination Agreement”) with NantCell, Inc., a Delaware corporation,
and its parent company, ImmunityBio, Inc., a Delaware corporation (collectively, “NantCell”), and XOMA (US)
LLC, a Delaware corporation (“XOMA”). As previously reported, effective July 27, 2017, the Company entered
into an exclusive worldwide license agreement with NantCell, granting to NantCell the exclusive rights to develop, manufacture and commercialize
aldoxorubicin in all indications (the “License Agreement”).
Pursuant
to the Termination Agreement, the License Agreement will terminate automatically on the Effective Date, and neither the Company nor NantCell
will have any continuing obligations to each other than as described in the Termination Agreement. Additionally, except that during the
thirty (30) day period following the Effective Date (the “Discussion Period”), the Company and NantCell shall
engage in good faith discussions regarding the terms of an agreement pursuant to which the Company would have the right to purchase the
inventory of aldoxorubicin (including, without limitation, active pharmaceutical ingredient, WPI and finished dose, the “Inventory”)
and all other materials necessary for the research, development and commercialization, among others, worldwide as of the Effective Date,
at the Company’s expense. If the Company and NantCell are unable to reach an agreement regarding the purchase by the Company and/or
transfer to the Company of the Inventory as of the end of the Discussion Period, then disposition of the Inventory shall be at NantCell’s
sole discretion.
The
Termination Agreement additionally provides for the release of the Company and NantCell from claims, demands and liabilities, among others,
and customary representations and warranties, covenants, and other provisions customary for transactions of this nature.
First
Amendment to Royalty Purchase Agreement
On
June 3, 2024, in consideration for the termination of the License Agreement pursuant to the Termination Agreement, the Company and XOMA
entered into the First Amendment to the Royalty Purchase Agreement (the “First Amendment”). As previously reported,
on June 21, 2023, the Company and XOMA entered into that certain Royalty Purchase Agreement, pursuant to which the Company agreed to
sell, transfer, assign and convey to XOMA, among other payments, all royalty payments and regulatory and commercial milestone payments
payable to the Company pursuant to the License Agreement.
Pursuant
to the First Amendment, if the Company decides to commercialize aldoxorubicin itself, prior to the first commercial sale of aldoxorubicin,
the Company and XOMA shall enter into a synthetic royalty purchase agreement, pursuant to which the Company shall agree to make quarterly
royalty payments to XOMA equal to the amount of all aggregate net sales of aldoxorubicin during each calendar quarter multiplied by 1.5%.
If the Company decides not to commercialize aldoxorubicin itself and instead licenses aldoxorubicin to a third party, upon entry of such
a new license agreement, XOMA shall be entitled to receive (i) royalty payments with respect to net sales of aldoxorubicin payable to
the Company multiplied by 7.5% and (ii) milestone payments of 7.5% of any milestone payable to the Company pursuant to the License Agreement.
The First Amendment contains customary covenants and other provisions customary for transactions of this nature.
The
foregoing descriptions of the Termination Agreement and the First Amendment do not purport to be complete and are qualified in its entirety
by reference to the full text of the Termination Agreement and the First Amendment, copies of which are attached to this Current Report
on Form 8-K as Exhibits 10.1 and 10.2, respectively, and incorporated herein by reference.
Item
1.02 Termination of a Material Definitive Agreement.
The
information required by this Item 1.02 is set forth in Item 1.01, above, and is incorporated herein by reference.
Item
8.01 Other Events.
On
June 3, 2024, the Company issued a press release announcing the Termination Agreement and the First Amendment. A copy of such press release
is attached to this Current Report on Form 8-K as Exhibit 99.1 and incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
Exhibit
Number |
|
Description |
10.1 |
|
Mutual Termination and Release Agreement, dated as of June 3, 2024, by and among LadRx Corporation, NantCell, Inc., ImmunityBio, Inc. and XOMA (US) LLC |
10.2 |
|
First Amendment of Royalty Purchase Agreement, dated as of June 3, 2024, by and between LadRx Corporation and XOMA (US) LLC |
99.1 |
|
Press Release, dated June 3, 2024 |
104 |
|
Cover
Page Interactive Data File (formatted as Inline XBRL) |
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.
|
LADRX
CORPORATION |
|
|
Date:
June 6, 2024 |
/s/
John Y. Caloz |
|
John
Y. Caloz |
|
Chief
Financial Officer |
Exhibit
10.1
Exhibit
10.2
Exhibit 99.1
LadRx and ImmunityBio
Mutually Agree to Terminate Aldoxorubicin License
Aldoxorubicin
Returns to LadRx
Los Angeles, CA, June
3, 2024 – (BUSINESS WIRE) — LadRx Corporation (OTCQB: LADX) (“LadRx” or the “Company”), a biopharmaceutical
innovator focused on research and development of life-saving cancer therapeutics, is pleased to announce that the Company and NantCell,
Inc. (“NantCell”), together with NantCell’s parent company ImmunityBio, Inc. (“ImmunityBio”), have agreed
to a mutual termination of the license of aldoxorubicin entered into in 2017.
With the termination
of the license agreement between LadRx and NantCell, LadRx regains control of aldoxorubicin. In 2023, LadRx transferred the royalty and
milestone rights of arimoclomol and aldoxorubicin to XOMA Corporation (NASDAQ: XOMA) (“XOMA”) in exchange for $5 million
in upfront gross proceeds, up to an additional $2 million for milestones related to arimoclomol and $5 million for milestones related
to aldoxorubicin. XOMA consented to the mutual termination of the LadRx-NantCell agreement in order to facilitate the return of the program
to LadRx. In parallel, LadRx and XOMA have amended their 2023 Royalty Purchase Agreement to provide XOMA with a low-single-digit synthetic
royalty on aldoxorubicin and a mid-single-digit percentage of any economics derived by LadRx from future out-license agreements related
to aldoxorubicin. The agreement between LadRx and XOMA regarding future royalties and milestones associated with arimoclomol is not affected
by the termination of the aldoxorubicin license between LadRx and NantCell.
Stephen Snowdy, PhD,
CEO of LadRx commented, “We are excited to have aldoxorubicin back in-house. Aldoxorubicin is the first LADR-based drug to reach
the clinic and was shown in multiple clinical studies to have lower cardiotoxicity compared to doxorubicin while showing promise of efficacy
in a Phase II trial in advanced soft tissue sarcoma. Aldoxorubicin also proved the premise of LADR-based drugs that targeting chemotoxins
via the LADR backbone allows for several-fold higher dosing of chemotherapeutic drugs.”
Dr. Snowdy continued,
“We congratulate ImmunityBio on their recent successes with their immunity-based products and certainly understand their going-forward
focus on those modalities. Over the coming months, we will be reviewing the pre-clinical and clinical data for aldoxorubicin and plotting
a path forward for its continued clinical development. Meanwhile, we continue to march LADR-7 towards the clinic and remain on track
for filing an IND application for LADR-7 in the third or fourth quarter of 2024.”
Forward-Looking
Statements
This press release
may contain certain statements relating to future results which are forward-looking statements, including whether the company’s
strategic review will be successful and whether the stock split will help the company be more successful in evaluating strategic alternatives.
These statements are not historical facts, but instead represent only LadRx’s belief regarding future events, many of which, by
their nature, are inherently uncertain and outside of LadRx’s control. Such statements involve risks and uncertainties that could
cause actual events or results to differ materially from the events or results described in the forward-looking statements; and other
risks and uncertainties described in the most recent annual and quarterly reports filed by LadRx with the SEC, including disclosures
under the heading “Risk Factors,” and current reports filed since the date of the LadRx’s most recent annual report.
All forward-looking statements are based upon information available to LadRx on the date the statements are first published. LadRx undertakes
no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
About LadRx
LadRx Corporation (OTCQB:
LADX) is a biopharmaceutical company developing new therapeutics to treat patients with cancer. LadRx Corporation’s website is
www.ladrxcorp.com.
Contacts
Longacre Square Partners
Greg Marose / Charlotte
Kiaie
ladrx@longacresquare.com
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