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Item 5. Other Information

2024-08-14 compared with 2024-05-09 · 29 added, 46 removed, 20 unchanged (79% of the section changed)

1 unchanged sentence

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

June 30, 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 ”) 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.

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

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.

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.

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.

EXHIBIT INDEX

Incorporated by Reference Herein

Sarbanes-Oxley Act Section 302 Certification of Principal Executive Officer and Principal Financial Officer.

Sarbanes-Oxley Act Section 906 Certification of Principal Executive Officer and Principal Financial Officer.

Amended and Restated Certificate of Incorporation of Phio Pharmaceuticals Corp.