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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): August 7, 2024
Conduit
Pharmaceuticals Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-41245 |
|
87-3272543 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
No.) |
4995
Murphy Canyon Road, Suite 300
San
Diego, California |
|
92123 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (760) 471-8536
Not
Applicable
(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 (see General Instruction A.2. below):
☐ |
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 |
Common
Stock, $0.0001 par value per share |
|
CDT |
|
The
Nasdaq Stock Market LLC |
Redeemable
Warrants, each whole warrant exercisable for one share of Common Stock at an exercise price of $11.50 |
|
CDTTW |
|
The
Nasdaq Stock Market LLC |
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
August 7, 2024, Conduit Pharmaceuticals Inc. (the “Company”) and AstraZeneca AB (PUBL)
(“AstraZeneca”) entered into a License Agreement, dated August 7, 2024 (the “License Agreement”). Pursuant
to such License Agreement, AstraZeneca agreed to grant a license to the Company under certain intellectual property rights
controlled by AstraZeneca related to HK-4 Glucokinase activators AZD1656 and AZD5658 in all indications and myeloperoxidase
inhibitor AZD5904 for the treatment, prevention, and prophylaxis of idiopathic male infertility. The Company will be responsible for
the development and commercialization of the relevant products licensed under the License Agreement (the “Licensed
Products”).
As
consideration for the grant of the license, the Company (i) has agreed to grant AstraZeneca common stock pursuant to a Stock Issuance
Agreement (as further set out below), (ii) has paid AstraZeneca an up-front payment of $1.5 million, and (iii) will pay AstraZeneca a
percentage (on a tiered basis) of any amounts it may receive in connection with a grant of a sublicense (subject to various customary
exceptions).
AstraZeneca
has been granted a right of first negotiation to develop, manufacture, and commercialize a Licensed Product if Conduit receives an offer
for, or solicits, a transaction where a third party would obtain the right to develop, manufacture, or commercialize a Licensed Product.
If AstraZeneca exercises such right, the parties would negotiate in good faith for an agreed period of time on an exclusive basis.
Either
party may terminate the License Agreement for material breach (subject to a cure period) or insolvency of the other party. The Company
may terminate the License Agreement for convenience (in its entirety or on a Licensed Product-by-Licensed Product basis). In addition,
AstraZeneca may terminate the License Agreement in certain circumstances, including (but not limited to) the Company ceasing development
of all Licensed Products (subject to certain exceptions for normal pauses or gaps between clinical studies).
In
addition, in connection with the execution of the License Agreement, the Company and AstraZeneca entered into a Stock Issuance Agreement,
dated August 7, 2024 (the “Issuance Agreement”), whereby the Company has agreed to issue AstraZeneca 9,504,465 shares (the
“Shares”) of the Company’s common stock. The Issuance Agreement provides AstraZeneca with resale registration rights
for the Shares.
The
Shares were not registered under the Securities Act of 1933, as amended (the “Securities Act”) in reliance on the exemption
from registration provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder. The issuance of the Shares
did not involve any public offering, were made without general solicitation or advertising, and AstraZeneca represented to the Company
that they were “accredited investors” as defined under the Securities Act with access to information about the Company and
its financial condition, results of operations, business, properties, management and prospects sufficient to enable AstraZeneca to evaluate
an investment in the Shares.
As
a result of the above, the Company will no longer fund the development of AZD1656 or AZD5904 under the terms of the Exclusive Funding
Agreement, dated March 26, 2021 (the “Funding Agreement”) with St George Street Capital (“SGSC”). In this regard,
the Company previously entered into a deed of amendment (the “Amendment”) amending the Funding Agreement. The parties agreed
that the project funding provisions of the Funding Agreement whereby the Company had the right to fund a project or refer other funders
to SGSC, but not the obligation to fund any project, are hereby amended to provide that SGSC must still include the Company in any project
funding opportunities and requests but may now seek other third party project funders in addition to the Company.
The
foregoing description of the License Agreement and the Issuance Agreement do not purport to be complete and are qualified in their entirety
by reference to the full text of such agreements, which will be filed with the U.S. Securities and Exchange Commission as exhibits to
the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2024.
Item
3.02 |
Unregistered
Sales of Equity Securities. |
The
disclosure set forth under Item 1.01 above is hereby incorporated into this Item 3.02 by reference.
Item
9.01 |
Financial
Statements and Exhibits. |
(d)
Exhibits.
Exhibit
No. |
|
Description |
99.1 |
|
Press Release dated August 8, 2024 |
104 |
|
Cover
Page Interactive Data File (the cover page XBRL tags are 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.
Date:
August 8, 2024 |
CONDUIT
PHARMACEUTICALS INC. |
|
|
|
|
By: |
/s/
Dr. David Tapolczay |
|
Name: |
Dr.
David Tapolczay |
|
Title: |
Chief
Executive Officer |
Exhibit
99.1
Conduit
Pharmaceuticals Enters into Exclusive License Agreement with AstraZeneca for Multiple Assets to Advance Potential First-in-Class Treatments
| ● | Conduit
Pharmaceuticals enters into exclusive license agreement with AstraZeneca for HK-4 Glucokinase
activators AZD1656 and AZD5658 targeting autoimmune indications and myeloperoxidase inhibitor
AZD5904 targeting idiopathic male infertility |
| | |
| ● | Assets
have shown favorable preclinical and Phase I data. Conduit to initiate Phase II clinical
trials |
SAN
DIEGO and LONDON, August 8, 2024 (GLOBE NEWSWIRE)— Conduit Pharmaceuticals Inc. (Nasdaq: CDT) (“Conduit”
or the “Company”), today announced that the Company has entered into an agreement with AstraZeneca to exclusively license
rights to develop AZD1656 and AZD5658, both HK-4 glucokinase activators, and AZD5904, a myeloperoxidase inhibitor (MPO). AstraZeneca
had progressed AZD1656 and AZD5904 through Phase 1 clinical trials.
Conduit
initially intends to conduct Phase II clinical trials on clinical candidates AZD1656 and AZD5658 in 2024 for applications in autoimmune
disorders, a category which affect an estimated 10% of the population1.
Under
the terms of the License Agreement, AstraZeneca will grant Conduit an exclusive license to both AZD1656 and AZD5658 for all human indications,
as well as an exclusive license to AZD5904 for use in Idiopathic Male Infertility.
As
part of the License Agreement, AstraZeneca will be issued shares of common stock in Conduit, and Conduit will also pay AstraZeneca a
share of sublicense revenues, including upfront payments, milestones, and royalties received from future partners.
AstraZeneca
will share pre-clinical and clinical data on the assets and supply Conduit with certain quantities of AZD1656, AZD5904, and AZD5658 from
its inventory. The License Agreement also includes provisions for the transfer of know-how related to AZD1656, AZD5658 and AZD5904 from
AstraZeneca to Conduit. AstraZeneca has been granted a right of first negotiation to develop, manufacture, and commercialize the licensed
compounds if Conduit seeks to assign, license, or grant such rights to a third party.
Through
the License Agreement, Conduit will analyze existing clinical data and initiate Phase II trials. Conduit believes this will fast-track
the development of these compounds and bring innovative new medicines to patients facing substantial unmet needs.
“We
are delighted to have entered into an agreement with AstraZeneca to secure the rights to develop AZD1656, AZD5658, and AZD5904. The potential
of these assets to become important first-in-class medicines for patients is promising. Given the data from AstraZeneca’s clinical
trials, we believe there is a strong rationale to initiate Phase II studies in multiple indications to progress to commercialization
of these assets,” said Dr. David Tapolczay, Chief Executive Officer of Conduit.”
1
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00457-9/abstract
Conduit
departs from the traditional business model of shepherding assets through an entire commercial lifecycle by acquiring assets that have
already undergone pre-clinical and clinical testing. The Company works towards accelerating the assets through Phase II trials and, if
successful, intends to seek exits through third-party license opportunities.
About
Conduit Pharmaceuticals
Conduit
is a multi-asset, clinical stage, disease-agnostic life science company delivering an efficient model for compound development. Conduit
both acquires and funds the development of Phase II-ready assets and then seeks an exit through third-party license deals following successful
clinical trials. Led by a highly experienced team of pharmaceutical executives including Dr. David Tapolczay and Dr. Freda Lewis-Hall,
this novel approach is a departure from the traditional pharma/biotech business model of taking assets through regulatory approval.
Forward-Looking
Statements
This
press release contains certain forward-looking statements within the meaning of the federal securities laws. All statements other than
statements of historical facts contained in this press release, including statements regarding Conduit’s future results of operations
and financial position, Conduit’s business strategy, prospective product candidates, product approvals, research and development
costs, timing and likelihood of success, plans and objectives of management for future operations, future results of current and anticipated
studies and business endeavors with third parties, and future results of current and anticipated product candidates, are forward-looking
statements. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,”
“anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,”
“plan,” “may,” “should,” “will,” “would,” “will be,” “will
continue,” “will likely result,” and similar expressions. These forward-looking statements are subject to a number
of risks, uncertainties and assumptions, including, but not limited to; the inability to maintain the listing of Conduit’s securities
on Nasdaq; the ability to recognize the anticipated benefits of the business combination completed in September 2023, which may be affected
by, among other things, competition; the ability of the combined company to grow and manage growth economically and hire and retain key
employees; the risks that Conduit’s product candidates in development fail clinical trials or are not approved by the U.S. Food
and Drug Administration or other applicable authorities on a timely basis or at all; changes in applicable laws or regulations; the possibility
that Conduit may be adversely affected by other economic, business, and/or competitive factors; and other risks as identified in filings
made by Conduit with the U.S. Securities and Exchange Commission. Moreover, Conduit operates in a very competitive and rapidly changing
environment. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted
or quantified and some of which are beyond Conduit’s control, you should not rely on these forward-looking statements as predictions
of future events. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance
on forward-looking statements, and except as required by law, Conduit assumes no obligation and does not intend to update or revise these
forward-looking statements, whether as a result of new information, future events, or otherwise. Conduit gives no assurance that it will
achieve its expectations.
Media
Sean
Leous
ICR
Westwicke
Sean.Leous@westwicke.com
+1.646.866.4012
Investors
Bill
Begien
Conduit
Pharmaceuticals Inc.
bb@conduitpharma.com
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