| Item 1.01 |
Entry Into a Material Definitive Agreement.
|
On October 7, 2022, Cabaletta Bio, Inc. (the “Company”)
entered into an Exclusive License Agreement (the “Agreement”) with
Nanjing IASO Biotherapeutics Co., Ltd. (“IASO”). Pursuant to the
Agreement, the Company received an exclusive, worldwide license
under certain IASO intellectual property to use a novel
clinical-stage anti-CD19 binder to develop, manufacture,
commercialize and otherwise exploit T cell products directed to
CD19 for the purpose of diagnosis, prevention or treatment of any
autoimmune or alloimmune indications in humans. As partial
consideration for the exclusive license, IASO will receive an
upfront payment of $2.5 million. IASO is also eligible to
receive up to mid double digit millions in milestone payments based
upon the achievement of specified pre-clinical, development and
regulatory milestones, and up to an additional low triple digit
millions in milestone payments based upon achievement of specified
sales milestones, for a total consideration, inclusive of the
upfront payment, of up to $162 million, along with tiered
mid-single digit royalties
on future net sales for licensed products that may result from the
Agreement. IASO has the right of first negotiation if the Company
desires to grant a third party an exclusive license to develop,
manufacture, commercialize or otherwise exploit the licensed
products in the Greater China region. Pursuant to the Agreement,
each of IASO and the Company have agreed, subject to certain
exceptions, to refrain from engaging in certain competitive
activities with respect to certain programs. The Company also may
sublicense through multiple tiers the rights granted to it by IASO
under the Agreement at any time and, however, it must pay IASO a
low double-digit percentage of any revenue obtained from
sublicenses or options to third parties, subject to certain
customary exclusions. The Agreement will continue on a country-by-country, licensed
product-by-licensed product
basis until the expiration of the royalty term as identified in the
Agreement, unless earlier terminated. Each of the Company and IASO
may terminate the Agreement for a material, uncured breach or
insolvency of the other party. The Company may also terminate the
Agreement at will upon advance written notice and in the event IASO
rejects the Agreement due to bankruptcy-related matters. IASO may
also terminate the Agreement if the Company fails to achieve
certain specified diligence milestones in a timely manner and/or if
the Company commences any patent challenges with respect to the
patents and patent applications relating to the licensed sequence,
in each case upon advance written notice.
The foregoing description of the terms of the Agreement does not
purport to be complete and is qualified in its entirety by
reference to the full text of the Agreement which will be filed
with the Company’s Quarterly Report on Form 10-Q for the quarter
ended September 30, 2022.
| Item 7.01 |
Regulation FD Disclosure.
|
On October 11, 2022, the Company posted to the
“Investors & Media” section of the Company’s website at
www.cabalettabio.com an
updated corporate presentation providing a corporate overview and
updated development plan (the “Corporate Presentation”). A copy of
the Corporate Presentation is attached hereto as Exhibit 99.1 and
is incorporated by reference into this Item 7.01 of this Current
Report on Form 8-K.
On October 11, 2022, IASO issued a press release announcing
the exclusive license granted to the Company (the “IASO Press
Release”). A copy of the IASO Press Release is attached hereto as
Exhibit 99.2 and is incorporated by reference into this Item 7.01
of this Current Report on Form 8-K.
The information contained in Item 7.01 of this Current Report on
Form 8-K is being furnished
and shall not be deemed to be “filed” for the 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 and shall not be incorporated by reference in any
filing under the Securities Act of 1933, as amended, or the
Exchange Act, except as shall be expressly set forth by specific
reference in such filing.
On October 11, 2022, the Company issued a press release
announcing CABA-201, a
newly designed product candidate, which is a fully-human CD19
chimeric antigen receptor containing a 4-1BB co-stimulatory domain. The Company has
obtained an exclusive, worldwide license for the CD19 binder in
CABA-201, in-licensed from IASO pursuant to the
Agreement described in Item 1.01. In addition, the Company
announced that it has established an exclusive translational
research partnership with Professor Georg Schett, a global leader
in the application of CD19-targeting cell therapies in
autoimmunity, to generate additional translational data and
clinical insights from his ongoing clinical studies. A copy of the
full text of the press release referenced above is filed as Exhibit
99.3 to this Current Report on Form 8-K and is
incorporated herein by reference into this Item 8.01 of this
Current Report on Form 8-K.
On October 7, 2022 the U.S. Food and Drug Administration
granted Orphan Drug Designation for MuSK-CAART, or muscle-specific
kinase (“MuSK”) chimeric autoantibody receptor T (“MuSK-CAART”)
cells, for the treatment of MuSK myasthenia gravis.