Item 5. Other Information
ITEM 5.
OTHER INFORMATION
During the three months ended
March 31, 2024, no director or officer of the Company adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule
10b5-1 trading arrangement, as each term is defined in Item 408(a) of Regulation S-K.
Termination of Clinical Co-Development Agreement with AgonOx
On May 8, 2024, we notified
AgonOx, Inc. (“ AgonOx ”) of our election to terminate the Clinical Co-Development Agreement, dated February 26, 2021,
by and between the Company and AgonOx (the “ Clinical Co-Development Agreement ”), effective immediately. We elected
to terminate the Clinical Co-Development Agreement pursuant to Section 12.2.3.3 of the Clinical Co-Development Agreement due to enrollment
delays in the Phase 1 clinical trial described below.
On February 26, 2021, we entered
into the Clinical Co-Development Agreement with AgonOx to develop a T cell-based therapy using our lead product candidate, PH-762, and
AgonOx’s “double positive” tumor infiltrating lymphocytes (“ DP TIL ”) technology. Per the terms of
the Clinical Co-Development Agreement, we agreed to reimburse AgonOx up to $4,000,000 in expenses incurred to conduct a Phase 1 clinical
trial of PH-762 treated DP TIL in patients with advanced melanoma and other advanced solid tumors. We were also eligible to receive certain
future development milestones and low single-digit sales-based royalty payments from AgonOx’s licensing of its DP TIL technology.
Prior to the termination of
the Clinical Co-Development Agreement with AgonOx, PH-762 treated DP TIL was being evaluated in a Phase 1 clinical trial in the United
States with up to 18 patients with advanced melanoma and other advanced solid tumors by AgonOx. The primary trial objectives were to evaluate
the safety and to study the potential for enhanced therapeutic benefit from the administration of PH-762 treated DP TIL. As of the effective
date of the termination, AgonOx had treated three patients. The first two patients were treated with DP TIL only and the third patient
was treated with a combination of DP TIL and PH-762.
Effective as of the date of
termination, the Clinical Co-Development Agreement and our continuing obligations and those of AgonOx thereunder will be terminated in
their entirety. We will no longer be required to provide financial support for the development costs incurred under the Clinical Co-Development
Agreement or entitled to certain future development milestones and low single-digit sales-based royalty payments from AgonOx’s licensing
of its DP TIL technology. We will pay to AgonOx all payment obligations that have accrued prior to the termination of the Clinical Co-Development
Agreement. We intend to pay to AgonOx future fees to be incurred for patients that were treated in the Phase 1 clinical trial as of the
date of termination. We estimate that such payments will amount to approximately $388,000, which primarily relate to the Company’s
accrued obligations under the Clinical Co-Development Agreement as of March 31, 2024, as well as future fees to be incurred for patients
that were being treated in the Phase 1 clinical trial and other miscellaneous costs as of the date of termination.
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Pursuant to the terms of the
Clinical Co-Development Agreement, we and AgonOx shall meet and discuss the orderly wind-down of the Phase 1 clinical trial. Each of us
and AgonOx shall be responsible for its own costs and expenses incurred in connection with the wind-down of the Phase 1 clinical trial.
The foregoing summary of the
Clinical Co-Development Agreement does not purport to be complete and is subject to, and qualified in its entirety by, reference to the
full text of the Clinical Co-Development Agreement, a copy of which is filed as Exhibit 10.2 to our Form 10-K for the year ended December
31, 2023 and incorporated herein by reference.
ITEM 6.
EXHIBITS
EXHIBIT INDEX
Incorporated by Reference Herein
Exhibit
Number
Description
Form
Date
31.1
Sarbanes-Oxley Act Section 302 Certification of Principal Executive Officer and Principal Financial Officer. *
32.1
Sarbanes-Oxley Act Section 906 Certification of Principal Executive Officer and Principal Financial Officer. **
101.INS
Inline XBRL Instance Document.*
101.SCH
Inline XBRL Taxonomy Extension Schema Document.*
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document.*
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document.*
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document.*
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document.*
104
The cover page for this report, formatted in Inline XBRL (included in Exhibit 101).*
_________________
*
Filed herewith.
**
Furnished herewith and not deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section or incorporated by reference into any filing under the Securities Act or the Exchange Act.
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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 thereunto duly authorized.
Phio Pharmaceuticals Corp.
By:
/s/ Robert J. Bitterman
Robert J. Bitterman
President and Chief Executive Officer
(as Principal Executive and Financial Officer)
Date: May 9, 2024
23
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.