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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)

April 7, 2022

 

AIM IMMUNOTECH INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-27072   52-0845822
(state or other jurisdiction   (Commission   (I.R.S. Employer
of incorporation)   File Number)   Identification No.)

 

2117 SW Highway 484, Ocala FL   34473
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (352) 448-7797

 

AIM ImmunoTech Inc.

(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))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in 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. ☐

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol   Name of each exchange on which registered
Common Stock, par value $0.001 per share   AIM   NYSE American

 

 

 

 

 

 

Item 1.01 Entry into a Material Definitive Agreement.

 

On April 7, 2022, we executed a work order with Amarex Clinical Research LLC (“Amarex”) our contract research organization, pursuant to which Amarex will manage a Phase 2 clinical trial in advanced pancreatic cancer patients. This AMP-270 clinical trial (the “AMP-270 Study”) is planned to be a randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability. The AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the U.S. and Europe. The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC) and Erasmus MC in the Netherlands are expected to be the primary study sites. We are sponsoring the study. Per the work order, we anticipate that the study will cost approximately $8.2 million which includes pass through costs of approximately $1.0 million and excludes certain third-party costs and escalations. We anticipate that the study will take approximately 4.6 years to complete. A copy of the Amarex work order is filed herewith as Exhibit 10.1.

 

On April 12, 2022, we issued a press release regarding the study. A copy of the press release is furnished herewith as Exhibit 99.1.

 

Item 7.01. Regulation FD Disclosure.

 

On April 12, 2022, we posted an updated Company Presentation to the “Events & Presentations” subsection of the “Investor Relations” tab on the Company’s website at https://AIMImmuno.com.

 

The information in this item and in Exhibits 99.1 and 99.2, are “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Securities Exchange Act of 1934, as amended, or the Securities Act of 1933, as amended, if and to the extent such subsequent filing specifically references the information herein as being incorporated by reference in such filing.

 

Cautionary Statement

 

This Current Report on Form 8-K and the exhibits filed herewith, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. Any forward-looking statements set forth in this presentation speak only as of the date of this presentation. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. We are in various stages of seeking to determine whether Ampligen® will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders and the presentation sets forth our current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen® will be effective in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen® will be efficacious in humans. No assurance can be given as to whether the AMP-270 Study or other current or planned clinical trials will be successful, yield favorable data or not require additional funding, and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Some of the world’s largest pharmaceutical companies and medical institutions are working on a treatment for COVID-19. Even if Ampligen® proves effective in combating the virus, no assurance can be given that our actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive, as multiple vaccines are now available and major pharma companies are working to develop their own disease treatments. We recognize that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing studies. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced in the presentation. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. In addition, many countries, including Argentina, are dealing with COVID-19 outbreaks and have made that their primary focus. We believe that this may be delaying our commercialization of Ampligen® in Argentina until COVID-19 is more under control. We cannot assure that our potential foreign operations will not be adversely affected by these risks.

 

 

 

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
     
10.1   April 7, 2022 Amarex Work Order (portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)).
99.1   Press Release Dated April 12, 2022.
99.2   April 2022 Company Presentation.
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.

 

  AIM IMMUNOTECH INC.
     
April 12, 2022 By: /s/ Thomas K. Equels
    Thomas K. Equels, CEO

 

 

 

 

Exhibit 10.1

 

Response to AIM ImmunoTech’s

Request for Proposal for Trial Services to Support a Phase II Pancreatic Cancer Study

March 30, 2022

 

 

 

 

 

 

 

 

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

Important Information

 

This proposal for a Project Work Order is provided to AIM ImmunoTech Inc (AIM) for the purpose of its evaluation and the information contained herein is not intended to be used by (AIM) for any other purpose than the subject of this proposal. (AIM) agrees not to voluntarily disclose any of the information contained herein to any third party without the prior written consent of Amarex Clinical Research, LLC (Amarex).

 

This proposal document is subject to negotiation and, when the final version is signed by both parties, shall create a Project Work Order with legal obligations on the part of both parties.

 

Proposal Expiration Date: April 8, 2022

 

Prepared for:

 

AIM ImmunoTech Inc

2117 SW Highway 484

Ocala, FL 34473

 

Prepared by:

 

Amarex Clinical Research, LLC

20201 Century Boulevard, Suite 450

Germantown, MD 20874

Phone: (301) 528-7000

Fax: (301) 528-2300

 

Amarex’s Response to AIM’s Request for Proposal

Amarex Clinical Research, LLC Confidential and Proprietary Information

3/30/2022

Page i

 

 

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

Our Understanding of AIM’s Needs

 

Based on our discussions with AIM, Amarex understands that AIM plans to conduct a trial entitled: “A Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Ampligen® Compared to Control Group / No Treatment Following FOLFIRINOX in Subjects with Locally Advanced Pancreatic Adenocarcinoma.” The study will be conducted at up to 30 sites in the United States and Europe. This proposal covers 20 sites in the US. It is assumed that not all 20 sites will start at once, and that as the course of the trial goes on, certain sites will be closed out early if they have no active patients left. Discussions around adding European sites to the project can be addressed in an amendment to this proposal. For the time being, it is assumed one site will be included in the Netherlands. DSMB meetings have been estimated to occur every 4 months. No interim analysis is planned.

 

Study Parameters

 

Following is a list of study parameters Amarex has used in order to prepare this proposal response:

 

Table 1. Study Parameters Used to Prepare This Proposal

 

STUDY PARAMETERS    
Number of US sites   [***]
Number of Dutch sites   [***]
Number of countries participating in study   [***]
Number of subjects randomized/enrolled   [***]
SITE MONITORING AND AUDITING    
Number of qualification sites   [***]
Number of site initiation visits   [***]
Number of interim monitoring sites   [***]
Number of closeout visits   [***]
IRB MANAGEMENT    
Number of Local IRB to manage   [***]
Number of Central IRB to manage   [***]
Number of DSMB meetings to review data   [***]
Number of statistical tables per DSMB   [***]
Number of statistical listings per DSMB   [***]

 

Amarex’s Response to AIM’s Request for Proposal

Amarex Clinical Research, LLC Confidential and Proprietary Information

3/30/2022

Page 1

 

 

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

 

MEDICAL MONITORING    
Estimated number of SAEs   [***]
Estimated number of reportable events   [***]
DATA MANAGEMENT    
Estimated Number of Adverse Events, Concomitant Medications, and Medical Histories to code   [***]
Number of unique pages in eCRF book   [***]
Number of central labs & vendors   [***]
BIOSTATISTICS    
Number of stat. tables for final analysis (uniques/replicates)   [***]
Number of listings for final analysis (uniques/replicates)   [***]
Number of graphs for final analysis (unique/replicate)   [***]
CLINICAL STUDY REPORT WRITING    
Write final clinical trial report     [***]
PROJECT MANAGEMENT    
Number of months for project setup   [***]
Number of months for enrollment   [***]
Number of months for follow-up (treatment period)   [***]
Number of months of active study phase for monitoring   [***]
Number of months for close out   [***]
Number of months of project management (including set up and close out)   [***]

 

Amarex’s Response to AIM’s Request for Proposal

Amarex Clinical Research, LLC Confidential and Proprietary Information

3/30/2022

Page 2

 

 

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

  

Study Tasks

 

Clearly-defined roles are essential to project success, and Amarex will work closely with AIM to make sure all project tasks are covered. It is our current understanding that the tasks associated with this trial are assigned as shown in Table 2, below.

 

Table 2. Study Tasks

 

Service   Not Required   Amarex   AIM
PROJECT MANAGEMENT            
Meetings, Training, and Study Start Up            
Prepare for and Attend Kick-off Meeting & Study Start-Up       X    
Prepare for and Attend Project Team Training       X    
Communication and Tracking            
Coordinate Amarex's Internal Project Team       X    
Communicate with Sponsor (includes standard teleconferences with activities reports, emails, faxes)       X    
Manage Central Labs/Vendors       X    
Tracking Systems Setup       X    
Management of Payments to Sites, IRBs, and/or Vendors       X    
REGULATORY SERVICES   X*        
PRODUCT MANAGEMENT            
Support Initial Drug Shipments       X    
Set up of WebView IRT™ product supply tracking and email alert system.  Track drug shipments to sites, drug supply depots, auto-email requests for resupply based on randomization.  Require acknowledgement email from drug depot.       X    
Maintenance for WebView IRT™ Resupply and Tracking       X    
DATA MANAGEMENT SERVICES            
Data Management            
Develop Data Management Plan       X    
Standard Data Cleaning (Run edit checks; generate, process, and track data queries)       X    
Develop Edit Specifications       X    
Data Operations            

 

Amarex’s Response to AIM’s Request for Proposal

Amarex Clinical Research, LLC Confidential and Proprietary Information

3/30/2022

Page 3

 

 

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

  

Program Edit Checks       X    
Set Up Data Transfer from Vendors       X    
Receive and Reconcile Headers of Clean Data from Vendors       X    

Set Up Transfer of Final SAS Data to Sponsor

(In Amarex's format)

       X    

Perform Data Transfer to Sponsor

(Including export of final SAS Analysis Datasets)

       X    
EDC Support            
Conduct Electronic Data Capture Site Training       X    
Prepare EDC Manual and Completion Instructions (includes up to 1 round of edits)       X    
Prepare User Acceptance Testing (UAT) Management Plan       X    
Conduct QC of EDC Database       X    
Provide Electronic Data Capture Help Desk       X    
WEBVIEW EDC PROGRAMMING            
Development of CRF Screen Shots       X    
EDC Programming       X    
EDC Maintenance       X    
CLINICAL SITE SERVICES            
Site Identification and Contracting            
Prepare Site Identification Plan       X    
Perform Site Identification       X    
Present Sites for Site Qualification Visits       X    
Develop Site Contracts (includes up to 2 rounds of edits)       X    
Negotiate Site Contract CTAs       X    
Negotiate Site Contract Budgets       X    
IRB and Ethics Committee Management            
Submit and Obtain Initial Approval of Local IRB       X    
Submit and Obtain Initial Approval of Central IRB       X    
Obtain Initial Approval for Sites Affiliated with the Central IRB       X    
Review and Approve IRB Informed Consent Comments       X    
Review and Approve Site Informed Consent Prior to IRB Submission       X    
Site Regulatory Document Collection            
Set Up Trial Master File       X    

 

Amarex’s Response to AIM’s Request for Proposal

Amarex Clinical Research, LLC Confidential and Proprietary Information

3/30/2022

Page 4

 

 

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

  

Set Up, File, and Track Investigator/Site Regulatory Files       X    
Conduct Ongoing Regulatory Document Collection, Review, Tracking, and Maintenance of Trial Master File       X    
Monitoring Services            
Prepare Study Operations Manual (includes up to 2 rounds of edits)       X    
Prepare Monitoring Guidelines (includes up to 2 round of edits)       X    
Perform Site Management       X    
Prepare for Site Visit       X    
Prepare Documents for Site Initiation       X    
Conduct Site Qualification Visits       X    
Conduct Study Initiation Visits       X    
Conduct Interim Monitoring Visits       X    
Conduct Close Out Visits       X    
Travel Time for Monitoring Visits       X    
SAFETY            
Set Up Tracking System and SAE Start Up       X    
Prepare Safety Management Plan       X    
Prepare Medical Monitoring Plan       X    
Set Up EDC Safety Reporting Module       X    
Collect, Process, Evaluate SAE or Pregnancy, and Prepare Narrative       X    
Prepare CIOMS or MedWatch Form       X    
Prepare SAE Follow up Reports       X    
Medical Monitoring (24/7)       X    
Distribute SAE "Dear Dr." Letters to Sites       X    
Submit Safety Reports to Regulatory Authorities       X    
Prepare and Submit Full Annual Report for IND (includes TLGs and up to 1 round of edits)       X    
Set Up of Coding System to Code AEs, ConMeds, and Histories       X    
Prepare Medical Coding Plan (includes up to 2 rounds of edits)       X    
Code Adverse Events, Medications, and Histories (Using MedDRA and WHO Drug ATC Level)       X    

 

Amarex’s Response to AIM’s Request for Proposal

Amarex Clinical Research, LLC Confidential and Proprietary Information

3/30/2022

Page 5

 

 

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

DATA SAFETY MONITORING BOARD (DSMB)            
Establish and Manage 3-Member DMC       X    
Develop DSMB Charter (includes up to 1 round of edits)       X    
Organize, Conduct and Participate in DSMB Meetings       X    
Prepare Statistical Analysis Plan for DSMB   X        
Program Tables, Listings and Graphs for DSMB       X    
Prepare Statistical Report for DSMB Meetings       X    
RANDOMIZATION AND ENROLLMENT       X    
Develop WebView IRT™ Enrollment/Randomization Module       X    
Generate WebView IRT™ Randomization Code and Plan       X    
Conduct WebView IRT™ Enrollment/Randomization Maintenance       X    
BIOSTATISTICS            
Prepare Statistical Analysis Plan (includes list of TLGs in Amarex standard format, and data set conventions)       X    
Program Tables, Listings and Graphs for Final Analysis       X    
Conduct QC Audit of Stats       X    
Production and Review of Tables, Listings, and Graphs for Final Analysis (per unique display)       X    
Production and Review of Tables, Listings, and Graphs for Final Analysis (per replicate display)       X    
Base ADaM CDISC Conversion (mapping and programming)       X    
MEDICAL WRITING            

Prepare Interim Clinical Study Report

(non-ICH Format) - includes up to one round of edits

   X        
Prepare Final Clinical Study Report Shell
(ICH Format) - includes up to one round of edits		       X    
Prepare Subject Narratives for CSR       X    
Prepare Final Clinical Study Report (ICH Format) with Appendices - includes up to two rounds of edits       X    
Conduct QC Audit of Clinical Study Report       X    

 

X* - Regulatory work is covered under a separate agreement.

 

Amarex’s Response to AIM’s Request for Proposal

Amarex Clinical Research, LLC Confidential and Proprietary Information

3/30/2022

Page 6

 

 

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

Proposed Amarex Direct Services Budget

(US Dollars)

US

 

AMAREX DIRECT SERVICES FEES                   
Bid ID  Service  Unit Description  Unit Cost $   No.
Units		   Total
Cost $		   Category
Total $		 
B  PROJECT MANAGEMENT                       
   Meetings, Training, and Study Start Up                       
11  Prepare for and Attend Kick-off Meeting & Study Start-Up  per protocol  $[***]    [***]   $[***]      
16  Prepare for and Attend Project Team Training  per day  $[***]    [***]   $[***]      
   Communication and Tracking                       
17  Coordinate Amarex's Internal Project Team  per month  $[***]    [***]   $[***]      
18  Communicate with Sponsor (includes standard teleconferences with activities reports and emails)  per month  $[***]    [***]   $[***]      
19  Manage Central Labs/Vendors  per lab-vendor/per month  $[***]    [***]   $[***]      
20  Tracking Systems Setup  fixed fee  $[***]    [***]   $[***]      
27.1  Management of Payments to Sites, IRBs, Labs, and/or Vendors  per payment / site, IRB or vendor  $[***]    [***]   $[***]   $[***] 
D  PRODUCT MANAGEMENT                       
59  Set up of WebView IRT product supply tracking and email alert system.  Track drug shipments to sites, supply depots, auto-email requests for resupply based on randomization.  Require acknowledgement email from supply depot.  per project  $[***]    [***]   $[***]      
60  Maintenance for WebView IRT Product Resupply and Tracking  per site per month  $[***]    [***]   $[***]      
63  Support Initial Drug Shipments  per site per shipment  $[***]    [***]   $[***]   $[***] 
E  DATA MANAGEMENT SERVICES                       
   Data Management                       
65  Develop Data Management Plan  per project  $[***]    [***]   $[***]      
73  Standard Data Cleaning (Run edit checks; generate, process, and track data queries)  per query  $[***]    [***]   $[***]      
78  Develop Edit Specifications  per project  $[***]    [***]   $[***]      
   Data Operations                       
86  Program Edit Checks  per edit check  $[***]    [***]   $[***]      
88  Set Up Data Transfer from Vendors  fixed cost/per vendor  $[***]    [***]   $[***]      
89  Receive and Reconcile Headers of Clean Data from Vendors  per transfer/per vendor  $[***]    [***]   $[***]      
91  Set Up Transfer of Final SAS Data to Sponsor (in Amarex's format)  per dataset  $[***]    [***]   $[***]      
92  Perform Data Transfer to Sponsor
(Including export of final SAS Analysis Datasets)		  per transfer  $[***]    [***]   $[***]      
   EDC Support                       
95  Conduct Electronic Data Capture Site Training  per training  $[***]    [***]   $[***]      
96  Prepare EDC Manual and Completion Instructions (includes up to 1 round of edits)  per manual  $[***]    [***]   $[***]      
97  Prepare User Acceptance Testing (UAT) Management Plan  per document  $[***]    [***]   $[***]      
98  Conduct QC of EDC Database  per subject enrolled  $[***]    [***]   $[***]      
99  Provide Electronic Data Capture Help Desk  per month  $[***]    [***]   $[***]   $[***] 
   WEBVIEW EDC PROGRAMMING                       
101  Development of CRF Screen Shots  per unique page  $[***]    [***]   $[***]      
102  WebView EDC Programming (Initiation)  per study  $[***]    [***]   $[***]      
103  WebView EDC Programming (UAT 1)  per study  $[***]    [***]   $ [***]    

 

 

 

 
104  WebView EDC Programming (System Activation)  per study  $[***]    [***]   $[***]      
105  WebView EDC Maintenance  per month  $[***]    [***]   $[***]   $[***] 

 

Amarex’s Response to AIM’s Request for Proposal

Amarex Clinical Research, LLC Confidential and Proprietary Information

3/30/2022

Page 7

 

  

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

AMAREX DIRECT SERVICES FEES                   
Bid ID  Service  Unit Description  Unit Cost $   No.
Units		   Total
Cost $		   Category
Total $		 
F  CLINICAL SITE SERVICES                       
   Site Identification and Contracting                       
106  Prepare Site Identification Plan  per plan  $[***]    [***]   $[***]      
107  Perform Site Identification and Present Sites for Site Qualification Visits  per site recommended  $[***]    [***]   $[***]      
108  Develop Site Contracts (includes up to 2 rounds of edits)  per contract  $[***]    [***]   $[***]      
109  Negotiate Site Contract CTAs  per site  $[***]    [***]   $[***]      
110  Negotiate Site Contract Budgets  per site  $[***]    [***]   $[***]      
   IRB and Ethics Committee Management                       
112  Submit and Obtain Initial Approval of Local IRB  per submission per Local IRB  $[***]    [***]   $[***]      
113  Submit and Obtain Initial Approval of Central IRB  per submission per Central IRB  $[***]    [***]   $[***]      
114  Obtain Initial Approval for Sites Affiliated with the Central IRB  per submission per site  $[***]    [***]   $[***]      
116  Review and Approve IRB Informed Consent Comments  per IRB  $[***]    [***]   $[***]      
117  Review and Approve Site Informed Consent Prior to IRB Submission  per site                    
   Site Regulatory Document Collection               $[***]      
120  Set Up Florence Trial Master File  per study  $[***]    [***]   $[***]      
121  Set Up Investigator/Site Regulatory Files  per site  $[***]    [***]   $[***]      
122  Conduct Ongoing Regulatory Document Collection, Review, and Maintenance of eTMF  per site/per month  $[***]    [***]   $[***]      
   Monitoring Services                      
123  Prepare Study Operations Manual (includes up to 2 rounds of edits)  per project  $[***]    [***]   $[***]      
124  Prepare Monitoring Guidelines (includes up to 2 round of edits)  per project  $[***]    [***]   $[***]      
125  Perform Site Management  per site/per month  $[***]    [***]   $[***]      
127  Prepare Documents for Site Initiation  per project  $[***]    [***]   $[***]      
128  Conduct Site Qualification Visits (includes prep and visit report in Amarex format)  per one-day visit  $[***]    [***]   $[***]      
129  Conduct Study Initiation Visits (includes prep and visit report in Amarex format)  per one-day visit  $[***]    [***]   $[***]      
130  Conduct Interim Monitoring Visits (includes prep and visit report in Amarex format)  per one-day visit  $[***]    [***]   $[***]      
131  Conduct Close Out Visits (includes prep and visit report in Amarex format)  per one-day visit  $[***]    [***]   $[***]      
133  Travel Time for Monitoring Visits  per trip  $[***]    [***]   $[***]   $[***] 
G  SAFETY                     
143  SAE Start Up  fixed fee  $[***]    [***]   $[***]      
144  Prepare Safety Management Plan (includes up to 1 round of edits)  per plan  $[***]    [***]   $[***]      
145  Prepare Medical Monitoring Plan (includes up to 1 round of edits)  per plan  $[***]    [***]   $[***]      
146  Set Up WebView EDC Safety Reporting Module  per project  $[***]    [***]   $[***]      
148  Collect, Process, Evaluate SAE/UADE or Pregnancy, and Prepare Narrative  per event  $[***]    [***]   $[***]      
149  Prepare CIOMS or MedWatch Form  per reportable event  $[***]    [***]   $[***]      
150  Prepare SAE/UADE Follow up Reports  per update  $[***]    [***]    [***]      
152  Medical Monitoring Support Line (24/7)  per month  $[***]    [***]   $[***]      
154  Distribute SAE/UADE "Dear Dr." Letters to Sites  per letter per site  $[***]    [***]   $[***]      
155  Submit Safety Reports to Regulatory Authorities  per reportable event per country  $[***]    [***]   $[***]      

 

Amarex’s Response to AIM’s Request for Proposal

Amarex Clinical Research, LLC Confidential and Proprietary Information

3/30/2022

Page 8

 

 

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

 

156  Prepare and Submit Full Annual Report for IDE/IND (includes TLGs and up to 1 round of edits)  per submission  $[***]    [***]   $[***]      
159  Set Up of Coding System to Code AEs, ConMeds, and Histories  fixed cost  $[***]    [***]   $[***]      
160  Prepare Medical Coding Plan (includes up to 2 rounds of edits)  per plan  $[***]    [***]   $[***]      
161  Code Adverse Events, Medications, and Histories (Using MedDRA and WHO Drug ATC Level)  per term  $[***]    [***]   $[***]   $[***] 

AMAREX DIRECT SERVICES FEES                   
Bid ID  Service  Unit Description  Unit Cost $   No.
Units		   Total
Cost $		   Category
Total $		 
H  DATA SAFETY MONITORING BOARD (DSMB)                       
163  Establish and Manage 3-Member DSMB  fixed cost  $[***]    [***]   $ [***]      
164  Develop DSMB Charter (includes up to 1 round of edits)  per project  $[***]    [***]   $ [***]      
165  Organize, Conduct and Participate in DSMB Meetings  per meeting  $[***]    [***]   $ [***]      
167  Program and Produce Unique Tables for DSMB  per unique table  $[***]    [***]   $ [***]      
168  Program and Produce Replicate Tables for DSMB  per replicate table  $[***]    [***]   $ [***]      
169  Program and Produce Unique Listings for DSMB  per unique listing  $[***]    [***]   $ [***]      
170  Program and Produce Replicate Listings for DSMB  per replicate listing  $[***]    [***]   $ [***]      
172  Prepare Statistical Report for DSMB Meeting (open and closed session reports, includes up to 1 round of edits)  per meeting  $[***]    [***]   $[***]   $[***] 
I  RANDOMIZATION AND ENROLLMENT                       
176  Develop WebView IRT Enrollment/Randomization Module  per project  $[***]    [***]   $[***]      
177  Generate WebView IRT Randomization Code and Plan  per project  $[***]    [***]   $[***]      
178  Conduct WebView IRT Enrollment/Randomization Maintenance  per month  $[***]    [***]   $[***]   $[***] 
J  BIOSTATISTICS                      
182  Prepare Statistical Analysis Plan (includes list of TLGs in Amarex standard format, and data set conventions)  per project  $[***]    [***]   $[***]      
189  Program Tables for Final Analysis (unique tables)  per unique table  $[***]    [***]   $[***]      
190  Program Tables for Final Analysis (replicate tables)  per replicate table  $[***]    [***]   $[***]      
191  Program Listings for Final Analysis (unique listings)  per unique listing  $[***]    [***]   $[***]      
192  Program Listings for Final Analysis (replicate listings)  per replicate listing  $[***]    [***]   $[***]      
193  Program Graphs for Final Analysis (unique graph)  per unique graph  $[***]    [***]   $[***]      
195  Conduct QC Audit of Stats  per lock  $[***]    [***]   $[***]      
198  Production and Review of Tables, Listings, and Graphs for Final Analysis (per unique display)  per unique display  $[***]    [***]   $[***]      
199  Production and Review of Tables, Listings, and Graphs for Final Analysis (per replicate display)  per replicate display  $[***]    [***]   $[***]      
   Other                      
202  Base ADaM CDISC Conversion (mapping and programming)  per conversion  $[***]    [***]   $[***]   $$ [***] 
K  MEDICAL WRITING                      
211  Prepare Final Clinical Study Report Shell (ICH Format) - includes up to one round of edits  per report  $[***]    [***]   $[***]      
212  Prepare Subject Narratives for CSR  per narrative  $[***]    [***]   $[***]      
213  Prepare Final Clinical Study Report (ICH Format) with Appendices - includes up to two rounds of edits  per report  $[***]    [***]   $[***]      
214  Conduct QC Audit of Clinical Study Report  per report  $[***]    [***]   $[***]   $[***] 
M  GENERAL & ADMINISTRATIVE EXPENSES                      
221  G&A Expenses  per month  $[***]    [***]   $[***]   $[***] 
N  ADDITIONAL SERVICES                       
253  Identify, Contract, and Setup Vendor  per vendor  $[***]    [***]   $[***]   $[***] 
                           
   Executive Discount ([***]%)               $  ([***]])      
                           
   TOTAL OF ACTIVITY-BASED COSTING               $

[***]

 

      

  

Amarex’s Response to AIM’s Request for Proposal

Amarex Clinical Research, LLC Confidential and Proprietary Information

3/30/2022

Page 9

 

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

Netherlands

 

 

CLINICAL SITE SERVICES
Bid ID  Service  Unit Description    Unit Cost $     No. Units     Total Cost $      Category Total $  
   Study start-up (1 months)                       
1  Study familiarisation  Once  $[***]    [***]   $[***]      
2  Study KO meeting (TC)  Once  $[***]    [***]   $[***]      
3  Preparation of PM Plans  Plans  $[***]    [***]   $[***]      
4  Site initiation  Sites  $[***]    [***]   $[***]      
5  In-house SCRA activities - set up including site communication  Site / months  $[***]    [***]   $[***]      
6  Sponsor TCs - set up  Alternate Weeks  $[***]    [***]   $[***]   $  [***] 
   Conduct (5 months)                       
7  Monitoring Visits  IMV  $[***]    [***]   $[***]      
8  In-house SCRA activities - conduct including site communication  Site / months  $[***]    [***]   $[***]      
9  Sponsor TCs - Conduct  monthly  $[***]    [***]   $[***]   $  [***] 
   Study closure (1 months)                      
10  Close-Out   COVs  $[***]    [***]   $[***]      
11  In-house SCRA activities - closure including site communication  Site / months  $[***]    [***]   $[***]      
12  Sponsor TCs - closure  Alternate Weeks  $[***]    [***]   $[***]   $[***] 
                           
   TOTAL            $  [***]     

 

OPTIONAL SERVICES
Bid ID  Service  Unit Description   Unit Cost $     No.
Units		    Total
Cost $ 		    Category
Total $ 		 
   Study start-up (1 months)                       
13  Backup CRA familiarization and training  per CRA  $[***]    [***]   $[***]      
14  Set up shadow TMF  Sites  $[***]    [***]   $[***]      
15  Set up ISFs  Sites  $[***]    [***]   $[***]   $[***] 
   Conduct(5 months)                       
16  Maintenance of TMF - Conduct  Site / months  $[***]    [***]   $[***]   $[***] 
   Study closure (1 months)                       
17  Return of TMF to sponsor  Sites  $[***]    [***]   $[***]   $[***] 
   Ad Hoc                       
18  Ad hoc project support  per hour  $[***]     TBD     TBD      TBD  

 

The unit costs provided in the budget are discounted according to certain economies of scale. A reduction of tasks or units could result in higher unit costs for remaining tasks or units.

 

Amarex’s Response to AIM’s Request for Proposal

Amarex Clinical Research, LLC Confidential and Proprietary Information

3/30/2022

Page 10

 

 

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

Additional units in excess of those planned above will be billed at the same unit rate as shown above.

 

Amarex budgets services by ‘tasks’ as opposed to by hours. Each task has a fixed unit price associated with it and an estimated number of units proposed for the project. Please examine the estimated number of units for each task carefully to make sure they agree with your expectation. Amarex reserves the right to increase its rates on an annual basis. This increase will not exceed 5% per year.

 

Estimated Pass-Through Costs

 

 

ESTIMATED PASS THROUGH COSTS

Bid ID  Expense  Unit Description   Unit
Cost $		    No.
Units		    Total
Cost $ 		    Category
Total $ 		 
                           
A  TRAVEL AND MEETINGS                       
   US Monitoring Visit Costs (Travel and Living)                       
1  Airfare  per flight  $[***]    [***]   $[***]      
2  Ground Transportation  per day  $[***]    [***]   $[***]      
3  Parking  per trip  $[***]    [***]   $[***]      
4  Hotel Accommodations  per night  $[***]    [***]   $[***]      
5  Meals  per day  $[***]    [***]   $[***]   $[***] 
B  PRINTING & ASSEMBLY OF STUDY MATERIALS                       
36  Miscellaneous Printing/Copying  per site per month  $[***]    [***]   $[***]   $[***] 
C  SHIPPING COSTS (CRFs, Study Binders, etc.)                       
39  Overnight delivery (UPS/FedEx)  per site per month  $[***]    [***]   $[***]   $[***] 
E  MISCELLANEOUS                       
48  DSMB Honorarium  per person per meeting  $[***]    [***]   $[***]      
51  Ad Hoc Electronic Data Transfers Over 12MB  per transfer  $[***]    [***]   $[***]      
53  Florence eTMF Annual Study Fee  per study per year  $[***]    [***]   $[***]      
54  Florence eTMF Annual Entity User Fee  per entity per year  $[***]    [***]   $[***]   $[***] 
                           
  

TOTAL OF ESTIMATED PASS THROUGHS

               $1,027,000.00      

 

Pass-through expenses, such as: approved travel, document shipping and printing, and other project related out-of-pocket expenses incurred by Amarex in the conduct of the study will be invoiced to AIM at the actual cost. These expenses will be supported by acceptable documentation or actual receipts.

 

Amarex’s Response to AIM’s Request for Proposal

Amarex Clinical Research, LLC Confidential and Proprietary Information

3/30/2022

Page 11

 

 

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

Third Party Costs

 

 

Third party costs are not included in this proposal. They can be further discussed with AIM.

 

Amarex’s Response to AIM’s Request for Proposal

Amarex Clinical Research, LLC Confidential and Proprietary Information

3/30/2022

Page 12

 

 

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

Payment Schedule and Terms

Payment Schedule for Services

 

 

The payment terms and obligations for the services outlined in this proposal are as follows:

 

Payment Description  Percentage Due   Amount 
Execution of Project Work Order   [***]%   $[***] 
Monthly Unit-Based Billing   Balance Due   $[***] 
TOTAL       $7,186,493.11 

 

Optional services will be billed on a monthly basis, as needed.

 

The Execution fee will be credited back as follows: $[***] will be credited when the total service invoicing reaches each of the following amounts $[***], $[***], and $[***].

 

Payment Schedule for Pass-Through Expenses

 

 

Pass-through expenses such as approved travel, document shipping and printing, and other reasonable expenses will be invoiced to AIM at cost. These expenses will be supported by acceptable documentation or actual receipts and will be invoiced on a monthly basis.

Payment Terms

 

■Payments are due 30 days after delivery of an invoice.
■Late payment fee: 1% per month interest on all past due, unpaid balances.
■Amarex Clinical Research, LLC Tax ID: [***]
■Please include Invoice numbers on all payments
■Payments will be sent to Amarex’s partner company NSF International
■Payments will be wire transferred to the NSF International bank account at:

JP Morgan Chase

New York, NY, USA

Acct. No.: [***]

ABA No.:  021000021

SWIFT Code: CHASUS33

 

Amarex’s Response to AIM’s Request for Proposal

Amarex Clinical Research, LLC Confidential and Proprietary Information

3/30/2022

Page 13

 

 

EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT

THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL

AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

 

Project Work Order Signatures

 

In Witness Whereof, AIM ImmunoTech Inc. and Amarex Clinical Research, LLC agree to all items and payment terms and conditions presented in this Project Work Order as indicated by the signatures below of their respective duly authorized representatives as of the “Effective Date”, appearing below.

 

ACKNOWLEDGED, ACCEPTED, AND AGREED TO:

 

For and on behalf of AIM ImmunoTech Inc.:   For and on behalf of Amarex Clinical Research, LLC:
     
Print Name: Peter W. Rodino, III   Print Name: Kazem Kazempour
Signature: /s/ Peter W. Rodino   Signature: /s/ Kazem Kazempour
Title: COO & General Counsel   Title: President and CEO (Member)
Effective Date: April 7, 2022   Effective Date: April 7, 2022

 

Amarex’s Response to AIM’s Request for Proposal

Amarex Clinical Research, LLC Confidential and Proprietary Information

3/30/2022

Page 14

 

Exhibit 99.1

 

 

AIM ImmunoTech Provides Progress on Advancement of Ampligen®

Clinical Development Program for the Treatment of Pancreatic Cancer

 

- Ampligen® (rintatolimod) has demonstrated promising activity as a potential maintenance therapy after systemic chemotherapy in patients with advanced pancreatic cancer

 

- Company engages world-renowned CRO, Amarex Clinical Research LLC to conduct upcoming Phase 2 study

 

- Company on track to commence Phase 2 study of Ampligen in advanced pancreatic cancer in Q3 2022

 

OCALA, FL (April 12, 2022) – AIM ImmunoTech Inc. (NYSE: American AIM) (“AIM” or the “Company”), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, today provided an update on its development program evaluating Ampligen® for the treatment of pancreatic cancer.

 

Ampligen is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. Additionally, Ampligen has shown success in increasing survival rates and efficacy in the treatment of animal tumors when used in combination with checkpoint blockade therapies. Ampligen is currently being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the country. Ampligen is also being used as a monotherapy to treat pancreatic cancer patients in a named patient program approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center.

 

“We continue to be encouraged by the progress and data demonstrated by Ampligen for the treatment of pancreatic cancer. Over the past couple of months, we have made noteworthy advancements on multiple fronts, including FDA notice that we are authorized to proceed with our Phase 2 study. Additionally, we continue to amass an encouraging growing body of data that supports our belief in Ampligen to offer an important treatment option to patients living with pancreatic cancer. We are committed to driving this program forward and working hand-in-hand with our CRO, Amarex, to advance our Phase 2 study, which is on track to commence in the third quarter of this year,” commented Thomas Equels, Chief Executive Officer of AIM.

 

The Company recently received notification from the U.S. Food and Drug Administration (“FDA”) that the FDA’s Clinical Hold on AIM’s investigational new drug (“IND”) application for a Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer (AMP-270) has been lifted and the Company may proceed with the study.

 

The AMP-270 clinical trial is planned to be a randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability. The AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the U.S. and Europe. The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC) and Erasmus MC in the Netherlands are expected to be the primary study sites.

 

 

 

 

 

To manage the AIM-sponsored Phase 2 study, on April 7, 2022, the Company engaged Amarex Clinical Research LLC, a CRO with strong track record on advising sponsors through the product development process and providing customized solutions for clinical studies. The AMP-270 clinical trial is on track to commence in Q3 2022.

 

Additionally, recently published data from a single-center named patient program indicated that patients receiving Ampligen had a longer median survival time than matched historical controls. For the study, patients with locally advanced pancreatic cancer (LAPC) or metastatic disease were treated with Ampligen at 2 doses per week with 400 mg per infusion. The manuscript detailing the positive data from the program, titled “Rintatolimod (Ampligen®) enhances numbers of peripheral B cells and is associated with longer survival in patients with locally advanced and metastasized pancreatic cancer pre-treated with FOLFIRINOX: a single-center named patient program1,” was published in March 2022 in the peer-reviewed journal, Cancers Special Issue: Combination and Innovative Therapies for Pancreatic Cancer. Based on these data, the Company believes that Ampligen could prove to be a potential effective maintenance therapy after systemic chemotherapy in patients with advanced pancreatic cancer.

 

About AIM ImmunoTech Inc.

 

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

 

For more information, please visit www.aimimmuno.com.

 

Cautionary Statement

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

 

Investor Relations Contact

 

JTC Team, LLC

Jenene Thomas

833-475-8247

AIM@jtcir.com

 

 

 

1 Cancers 2022, 14(6), 1377; https://doi.org/10.3390/cancers14061377 (registering DOI)

 

 

 

 

Exhibit 99.2