UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
(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:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
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.
On January 31, 2023, Karuna Therapeutics, Inc. (the “Company”) entered into a license agreement (the “Agreement”) with GFB (ABC), LLC (“GFB”), assignee of the assignment estate of Goldfinch Bio, Inc., pursuant to which GFB granted to the Company an exclusive (even as to GFB and its affiliates), worldwide, and sublicensable right and license to certain patent rights and related know-how (the “Licensed Intellectual Property”) to develop, manufacture, and commercialize GFB’s investigational transient receptor potential canonical 4 and 5 (TRPC4/5) channel candidates, including the lead clinical-stage candidate known as GFB-887 (collectively, the “Licensed Compounds”). The Company agreed to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize at least one product that contains or comprises a Licensed Compound (a “Licensed Product”) in at least two indications in the United States.
Under the terms of the Agreement, the Company is obligated to pay to GFB a $15.0 million upfront payment, and a total of up to $520.0 million for each Licensed Compound upon the achievement of certain development, regulatory and commercial milestones with respect to such Licensed Compound, of which $410.0 million are related to regulatory approval and commercial sales milestones. The Company is also obligated to pay GFB a flat low-single-digit royalty on aggregate net sales of each Licensed Product on a country-by-country basis until the later of: (i) the expiration date of the last valid claim covering the Licensed Product in such country; (ii) the expiration date of regulatory exclusivity with respect to such Licensed Product in such country; and (iii) the date that is a specific period after the first commercial sale of such Licensed Product in such country (collectively, the “Royalty Term”). The royalty rate is subject to reduction on a Licensed Product-by-Licensed Product and country-by-country basis under certain circumstances. In the event that the Company sublicenses to a third party any of the rights to the Licensed Intellectual Property granted under the Agreement, the Company will be obligated to pay GFB royalties within the range of 25% to 35% on any consideration the Company receives from the sublicensee, excluding royalties and certain other payments.
Unless earlier terminated, the Agreement will expire on the expiration of the last to expire Royalty Term. Unless the Agreement is earlier terminated, on expiration of each applicable Royalty Term, the Company will have a fully paid-up, irrevocable and perpetual license under the Licensed Intellectual Property to develop, manufacture and commercialize each applicable Licensed Product in the applicable country. Either party may terminate the Agreement for the other party’s material breach, following a customary notice and cure period, or insolvency, other than an insolvency proceeding related to the administration of the assignment estate of Goldfinch Bio, Inc. The Company may terminate the Agreement for any reason upon 90 days written notice to GFB.
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, a copy of which the Company intends to file with the Securities and Exchange Commission, with confidential terms redacted, as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.
Item 7.01 Regulation FD Disclosure.
On February 2, 2023, the Company and GFB issued a joint press release regarding the Agreement. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated into this Item 7.01 by reference. The information contained in Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be 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 incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 |
|
Joint press release issued by Karuna Therapeutics, Inc. and GFB (ABC), LLC, dated February 2, 2023 |
|
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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.
|
|
|
KARUNA THERAPEUTICS, INC. |
|
|
|
|
Date: |
February 2, 2023 |
By: |
/s/ Troy Ignelzi |
|
|
|
Troy Ignelzi |
Exhibit 99.1
Karuna Therapeutics Announces Exclusive Global License Agreement for Goldfinch Bio’s Investigational TRPC4/5 Product Candidates
Karuna to obtain exclusive global license to develop, manufacture, and commercialize multiple TRPC4/5 candidates, including lead clinical-stage candidate GFB-887
Goldfinch Bio assignment estate to receive $15 million upfront payment and up to $520 million in potential milestone payments plus royalties for each TRPC4/5 candidate
Karuna to share details on the planned development of GFB-887 for the treatment of mood and anxiety disorders in the second half of 2023
BOSTON, Mass.– February 2, 2023 -- Karuna Therapeutics, Inc. (NASDAQ: KRTX) and GFB (ABC), LLC, assignee of the Goldfinch Bio assignment estate, today announced their entry into an exclusive license agreement under which Karuna will obtain global development, manufacturing, and commercialization rights to Goldfinch Bio’s investigational transient receptor potential canonical 4 and 5 (TRPC4/5) channel candidates, including lead clinical-stage candidate GFB-887. Karuna intends to evaluate these candidates as potential treatments for various psychiatric and neurological conditions, starting with GFB-887 for the treatment of mood and anxiety disorders. Karuna expects to share details on the planned development of GFB-887 in the second half of 2023.
“We are focused on addressing the substantial need for new and better treatments in psychiatry through identifying and developing mechanistically novel and distinct medicines,” said Bill Meury, president and chief executive officer of Karuna. “We believe that the TRPC4/5 mechanism could represent a completely novel approach to treating mood and anxiety disorders and complements our existing pipeline of differentiated potential medicines. This agreement aligns with our strategic goal to become a fully integrated neuroscience company with treatments that could offer much more than just incremental benefits to patients, and we look forward to sharing next steps for the program later this year.”
“We are incredibly excited to expand and diversify our development efforts and are encouraged about the potential of TRPC4/5 inhibitors to treat both mood and anxiety disorders based on pre-clinical and clinical data demonstrating anxiolytic and antidepressant properties of these inhibitors,” said Steve Paul, M.D., president of research & development and chief scientific officer. “Our lead candidate in the TRPC4/5 program, GFB-887, has already demonstrated a compelling safety profile in non-clinical and clinical studies. We are fortunate to have found as advanced a clinical stage drug candidate directed
against these important CNS targets and we will now study GFB-887 in various mood and anxiety disorders where there remains a significant unmet medical need for mechanistically novel medicines.”
Under the terms of the agreement, the assignment estate of Goldfinch Bio will receive a $15 million upfront payment and is eligible to receive up to $520 million in milestone payments for each licensed TRPC4/5 candidate, of which $410 million are related to regulatory approval and commercial sales milestones, as well as a flat low-single-digit royalty on any potential global net sales of each licensed product.
“GFB-887 demonstrated compelling benefits in preclinical models of mood and anxiety disorders, and we are delighted that Karuna will leverage its well-established expertise in developing medicines for psychiatric disorders to advance our TRPC4/5 candidates,” commented Anthony Johnson, M.D., president and chief executive officer of Goldfinch Bio. “I am tremendously grateful to all the patients and investigators, and Goldfinch Bio employees, advisors and investors who contributed to progressing GFB-887 and our other TRPC4/5 candidates to this point. It’s my sincere hope that these important contributions will lead to innovative new medicines for patients in need.”
Goldman Sachs & Co. LLC and Cowen served as financial advisors, and Ropes & Gray provided legal counsel to Goldfinch Bio.
About Karuna
Karuna Therapeutics is a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions. At Karuna, we understand there is a need for differentiated and more effective treatments that can help patients navigate the challenges presented by these severe and disabling disorders. Utilizing our extensive knowledge of neuroscience, we are harnessing the untapped potential of the brain in pursuit of novel pathways to develop medicines that make meaningful differences in peoples’ lives. For more information, please visit www.karunatx.com.
Karuna Therapeutics 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, including statements regarding the potential of the TRPC4/5 program, including GFB-887, to treat mood and anxiety disorders, our goals to develop and commercialize our product candidates and
other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our ability to generate positive clinical trial results for our product candidates and other risks inherent in clinical development, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, and other risks set forth under the heading “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2021. Our actual results could differ materially from the results described in or implied by such forward looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
Karuna Therapeutics Contacts:
Investors:
Alexis Smith
518-338-8990
asmith@karunatx.com
Media:
Bob Josefsberg
bjosefsberg@karunatx.com
646-734-3584
Goldfinch Bio Contact:
Kyle Kuvalanka
kkuvalanka@goldfinchbio.com