UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q/A
(Amendment No. 1)
(Mark One)
| x | QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended April 30, 2012
| ¨ | TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT |
For the transition period from to ________________ to ________________
Commission file number 000-28489
ADVAXIS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 02-0563870 | |
| (State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
305 College Road East, Princeton, NJ 08540
(Address of principal executive offices)
(609) 452-9813
(Registrant’s telephone number)
(Former name, former address and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ¨ | Accelerated filer ¨ | Non-accelerated filer ¨ | Smaller Reporting Company x |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
The number of shares of the registrant's common stock, $0.001 par value, outstanding as of June 11, 2012 was 363,451,168
EXPLANATORY NOTE
This Amendment No. 1 to the Quarterly Report on Form 10-Q for the quarterly period ended April 30, 2012 (the “Form 10-Q”), originally filed by Advaxis, Inc. on June 14, 2012, is being filed solely for the purpose of amending and restating Exhibit 10.3 of the Form 10-Q.
The Form of Project Agreement by and between Numoda Corporation and Advaxis, Inc. filed as Exhibit 10.3 to the Form 10-Q is being replaced with the executed version of the Project Agreement by and between Numoda Corporation and Advaxis, Inc., dated as of July 1, 2009. Part II, Item 6 is being amended and restated to reflect that Exhibit 10.3 is filed herewith.
Except as described above, no other changes have been made to the Form 10-Q. This Amendment does not amend, update or change the financial statements or disclosures in the Form 10-Q and does not reflect events occurring after the filing of the Form 10-Q.
PART II - OTHER INFORMATION
Item 6. Exhibits.
| 10.3* | Project Agreement, dated as of July 1, 2009, by and between Numoda Corporation and Advaxis, Inc. | |
| 31.1* | Certification of Chief Executive Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002 | |
| 31.2* | Certification of Chief Financial Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002 | |
| 32.1* | Certification of Chief Executive Officer pursuant to section 906 of the Sarbanes-Oxley Act of 2002 | |
| 32.2* | Certification of Chief Financial Officer pursuant to section 906 of the Sarbanes-Oxley Act of 2002 |
* Filed herewith
SIGNATURES
In accordance with the requirements of the Securities Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| ADVAXIS, INC. | ||
| Registrant | ||
| Date: June 26, 2012 | By: | /s/ Thomas Moore |
| Thomas Moore | ||
| Chief Executive Officer and Chairman of the Board | ||
| By: | /s/ Mark J. Rosenblum | |
| Mark J. Rosenblum | ||
| Chief Financial Officer, Senior Vice President and Secretary | ||
EXHIBIT INDEX
| Exhibit No. | Document Description | |
| 10.3* | Project Agreement, dated as of July 1, 2009, by and between Numoda Corporation and Advaxis, Inc. | |
| 31.1* | Certification of Chief Executive Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002 | |
| 31.2* | Certification of Chief Financial Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002 | |
| 32.1* | Certification of Chief Executive Officer pursuant to section 906 of the Sarbanes-Oxley Act of 2002 | |
| 32.2* | Certification of Chief Financial Officer pursuant to section 906 of the Sarbanes-Oxley Act of 2002 |
* Filed herewith
Exhibit 10.3
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
NUMODA
PROJECT AGREEMENT FOR PROTOCOL #'s:
Lm-LLO-E7-15 and Lm-LLO-E7-07
(Two Trials — TRIAL 1 in India, and TRIAL 2 in the U.S.
|
Protocol Number: Lm-LLO-E7-15 (conducted in India) Protocol Title: A Randomized, Active Therapy Controlled Phase
2 Study to Assess the Safety and |
|
Protocol Number : Lm-LLO-E7-07 (conducted in the United States) Protocol Title: A Randomized, Single Blind, Placebo Controlled
Phase 2 Study to Assess the Safety |
Pursuant to the Master Agreement entered into by Advaxis, Inc. ("ADVAXIS") and Numoda Corporation ("Numoda") on June 19, 2009 ("MA"), this Project Agreement (PA) and attachments, including:
| A. | Description of Services — Project Specifications |
| B. | Integration Assumptions; Systems, and Reporting Tools |
| C. | Project Budget |
| D. | Payment Schedule/Terms |
| E. | Transfer of Regulatory Obligations |
is entered into and is effective on the Effective Date shown below. Only when specified in the MA, the parties agree that Numoda shall perform the Project Agreement in accordance with and is subject to all the terms and conditions of the MA. The Project Agreement is Incorporated in and made a part of the MA. In the event that a discrepancy exists between the terms of the MA and this PA, this PA shall supersede.
Effective Date: July 1, 2009
The parties agree as follows:
| 1. | Scope of Work: Numoda agrees to provide services for this Study ("Project") as outlined in Attachment A (Description of Services — Project Specifications). The Parties understand Attachments A, B, C and D may need some adjustments after the date of signing this Project Agreement, in order to reflect any material differences between the protocol provided to Numoda and the final protocol. ADVAXIS transfers to Numoda the obligations listed in Attachment E in accordance with 21 CFR §312.52. |
| 2. | Payment: Payments will be made in accordance with Attachment D. Upon final reconciliation, additional services not included in the scope of work, that was mutually agreed to in writing; and having been done, will be billed to ADVAXIS, and any overpayment attributable to services not rendered or costs not incurred, will be refunded to ADVAXIS. |
| 3. | Term: The term of this Project Agreement shall commence on the Effective Date and shall continue until the Project as described in this Project Agreement is completed, unless this Project Agreement is terminated earlier in accordance with the MA. |
| 4. | Contact: Until further notice and for the purpose of this Project Agreement, Numoda's contact within ADVAXIS will be John Rothman, and ADVAXIS' contact within Numoda will be Mike Dempsey, the Project Controller. |
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
| For ADVAXIS: | For Numoda Corporation: | |||
| Sign: | /s/ John Rothman | Sign: | /s/ Ann Vurimindi | |
| Print: | John Rothman | Print: | Ann Vurimindi | |
| Title: | EVP: Science & Operations | Title: | COO | |
| Date: | July 8, 2009 | Date: | July 8, 2009 | |
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
Attachment A:
DESCRIPTION OF SERVICES - PROJECT SPECIFICATIONS
| Overall Assumptions | India Trial | US Trial | ||
| Protocol Number | Lm-LLO-E7-15 | Lm-LLO-E7-07 | ||
| Study Phase | Phase II, India | Phase II, U.S. | ||
| Compound | ADXS11-001 | ADXS11-0011 | ||
| Number of Sites | 12 | 20 | ||
| Number of Patients Screened | 122 | 88 | ||
| Number of Patients Enrolled | 110 | 80 | ||
| Number of Patients Completed | 110 | 80 | ||
| Country | India Only | USA Only | ||
| Startup (Number of Weeks) From signed PA to FPFV Recruitment (Number of Weeks) (Tria1 #2 totals 36 months for | 13 | 8.5 | ||
| Treatment (Number of Weeks) Recruitment + Treatment) | 13 | 26 | ||
| Closeout (Number of Weeks) | 52 | 130 | ||
| 13 | 8.5 | |||
| Total Project Duration (Weeks) | 91 (21 Mo's) | 173 (40 Mo's) | ||
| GC Project Management Assumptions | ||||
| Number of Status Reports | Unlimited within the | Unlimited within the | ||
| Number of Kick Off Meetings | scope | scope | ||
| Number of Investigator Meetings | 1 | 1 | ||
| Number of Newsletters | 1 | 0 | ||
| Number of Teleconferences (1 Hour Calls) | 21 | 36 | ||
| 91 | 173 | |||
| Monitoring Assumptions | ||||
| Qualification Visits | 12 | 22 | ||
| Site Initiation Visits | 12 | 20 | ||
| Interim Monitoring Visits | 97 | 312 | ||
| Closeout Visits | 12 | 20 | ||
| Information/Data Management Assumptions | ||||
| Total Number of CRF Pages per Patient | 100 | 90 | ||
| Number of Unique CRF Pages per Patient | 20 | 22 | ||
| Total Number of CRF Pages | 11,904 | 11,688 | ||
| Unlimited within the | Unlimited within the | |||
| Total Number of Queries | scope | scope | ||
| Total Number of Users | 30 | 50 | ||
| Number of Interim Analyses | 1 | 2 | ||
| Con Meds per Patient | 10 | 10 | ||
| Diseases per Patient | 10 | 10 | ||
| AE’s per Patient | 10 | 10 | ||
| Biostats Assumptions | ||||
| Statistical Analysis Plan | 1 | 1 | ||
| Tables | 24 | 24 | ||
| Listings | 30 | 30 | ||
| Figures | 6 | 6 | ||
| Final Study Report | 1 | 1 |
| Safety Assumptions | ||||
| SAE’s | 40 | 15 | ||
| Safety Database | 1 | 1 | ||
| Estimated Timeline | ||||
| Contract Signed | Jul-09 | Jul-09 | ||
| First Patient Enrolled | Oct-09 | Sep-09 | ||
| Last Patient Enrolled | Jan-10 | Mar-10 | ||
| Last Patient Out | Jan-11 | Sep-12 | ||
| Final Clinical Study Report | Apr-11 | Nov-12 |
Note: The Project Budget in Attachment C is based on the specifications and integration assumptions listed here on Attachment A, and in Attachment B.
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
Attachment B:
INTEGRATION ASSUMPTIONS
| Numoda | |||
| Integrations Assumptions | |||
| Single Integrated Portal | 1 | ||
| Custom Integration and Interoperability | 3 | ||
| Ongoing Consolidation & Reconciliation | 1 | ||
| Clinical Project Accounting, Contracting (Vendor Negotiation, Documentation, Monitoring) | 1 | ||
| Systems and Reporting Tools | |||
| Start-up & Regulatory Administration (4 Tool Sets) | 1 | ||
| Project Timelines | |||
| Site Launch Logistics System (SLLS) | |||
| Communication Plan | |||
| Roles and Responsibilities | |||
| Clinical Project Accounting Systems (3 Tool Sets) | 1 | ||
| Key Value Tracking | |||
| Percentage of Completion Reporting | |||
| CPA Procedures | |||
| Planning, Procurement, Contracting (4 Tool Sets) | 1 | ||
| Vendor Contract Status | |||
| Business Analysis Report | |||
| Key Value Points | |||
| Business Integration | |||
| Screening and Enrollment Reporting Tools (9 Tool Sets) | 1 | ||
| Executive Summary | |||
| Enrollment Status | |||
| Subject Status | |||
| Early Termination | |||
| Screen Failure | |||
| Enrollment by Site | |||
| Patient Source Summary | |||
| Site Info | |||
| Team Contact Info | |||
| Document Management System (7 Tool Sets) | 1 | ||
| Protocol and Amendments | |||
| Newsletters | |||
| Training Materials | |||
| Project Management | |||
| Waivers | |||
| Upload | |||
| Remove File | |||
| Monitoring Systems (7 Tool Sets) | 1 | ||
| Data View | |||
| Monitoring Summary | |||
| Query Tracking | |||
| Comments | |||
| Supplies Status For Monitors | |||
| Sync Status Report | |||
| Trip Report Management | |||
| Data Management and Integrations (17 Tool Sets) | 1 | ||
| Data View | |||
| IVR Reconciliation | |||
| Data Extractor | |||
| Edit Checks | |||
| Query Frequency | |||
| Edit Check Frequency | |||
| Query Status Summary | |||
| Coding System | |||
| PI Sign-Off | |||
| AE/Cmed/Med HX Summary | |||
| Various Lab Reconciliation Tools (7) | |||
| Early Safety Signal Detection System (5 Tool Sets) | 1 | ||
| AE/SAE | |||
| Subject Safety Reports | |||
| Subject Status | |||
| Early Terminators | |||
| Site Info | |||
| Supplies Management System (3 Tool Sets) | 1 | ||
| Site Supplies Status | |||
| Site Transaction History | |||
| Site Supplies Summary | |||
| Project Management Administration Tools (11 Tool Sets) | 1 | ||
| User Management | |||
| Login History | |||
| Failed Logins | |||
| Database SQL Tools | |||
| IVR Database View | |||
| Team Contact Management | |||
| Message System Management | |||
| Shipment Address Management | |||
| Document Group Management | |||
| Trip Report Administration | |||
| IVRS Administration | |||
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
Attachment C:
| India Trial | US Trial | |||||||
| Standardized Professional Fees | ||||||||
| Start Up, Regulatory & Sites Management | $ | 122,362 | $ | 250,604 | ||||
| Monitoring | $ | 254,613 | $ | 1,268,014 | ||||
| Project Management | $ | 151,469 | $ | 396,950 | ||||
| Data Management | $ | 226,063 | $ | 289,759 | ||||
| Safety, Medical & Scientific Services | $ | 79,898 | $ | 183,446 | ||||
| Biostatistics | $ | 145,460 | $ | 167,804 | ||||
| Medical Writing | $ | 45,000 | $ | 60,000 | ||||
| Total Standardized Professional Fees | $ | 1,024,885 | $ | 2,616,577 | ||||
| Efficiency Credit | $ | (96,848 | ) | |||||
| sub-total | $ | 928,037 | ||||||
| Products | ||||||||
| Role-Based Portals Connecting to Interoperable Neural Network | $ | 30,457 | $ | 55,404 | ||||
| All Custom Complete Integration and Interoperability | $ | 45,943 | $ | 83,323 | ||||
| Ongoing Consolidation and Reconciliation | $ | 21,003 | $ | 37,493 | ||||
| Clinical Project Accounting Vendor Management & Financial Reconciliation | $ | 55,498 | $ | 98,046 | ||||
| Screening and Enrollment System | $ | 16,858 | $ | 25,359 | ||||
| Site Compliance Tools | $ | 34,659 | $ | 55,548 | ||||
| Real Time Reporting Tools (with Document Management System) | $ | 27,202 | $ | 57,072 | ||||
| Integrated, Web-Based Monitoring system (with Centralized Trip Reports) | $ | 28,945 | $ | 68,814 | ||||
| Early Safety Signal Detection System | $ | 32,053 | $ | 57,294 | ||||
| Clinical Project Accounting System | $ | 35,819 | $ | 90,508 | ||||
| Interoperable System for Supplies and Re-Supply Logistics Management | $ | 19,192 | $ | 33,353 | ||||
| IVRS System | $ | 60,264 | $ | 122,963 | ||||
| IVRS Diary Activities | $ | - | $ | - | ||||
| Total Products | $ | 407,891 | $ | 783,176 | ||||
| Efficiency Credit | $ | (113,749 | ) | |||||
| sub-total | $ | 294,142 | ||||||
| Pass-Through Expenses (Estimated) | ||||||||
| EDC | Free | Free | ||||||
| Investigator Fees | $ | 496,650 | $ | 1,002,560 | ||||
| Investigator Meeting Organization | $ | 21,000 | $ | 21,000 | ||||
| Investigator Meeting Travel | $ | 47,565 | $ | 49,350 | ||||
| Monitor Travel | $ | 84,058 | $ | 370,448 | ||||
| Travel to Training Meetings | $ | 2,310 | $ | 34,150 | ||||
| Travel to Client Meetings | $ | 1,050 | $ | 1,050 | ||||
| Travel for Audit Visits | $ | 1,260 | $ | 2,100 | ||||
| Meetings and Teleconferences | $ | 4,778 | $ | 18,199 | ||||
| IVRS Expenses | $ | 22,680 | $ | 57,456 | ||||
| Printing, Shipping and Other | $ | 7,749 | $ | 18,900 | ||||
| Regulatory and EC Fees | $ | 6,300 | $ | 10,500 | ||||
| Translation | $ | 12,600 | $ | 55,260 | ||||
| Lab Fees | $ | 207,900 | $ | 533,845 | ||||
| Drug Supply | $ | - | $ | 124,960 | ||||
| Specialty Lab/ECG | $ | 103,950 | $ | - | ||||
| Central Pathologists | $ | - | $ | 25,200 | ||||
| Other | $ | - | $ | 15,750 | ||||
| Total Pass-Through Expenses | $ | 1,019,850 | $ | 2,340,728 | ||||
| Total Project Cost | $ | 2,242,029 | $ | 5,740,480 | ||||
| Less: Numoda Investment | $ | (250,000 | ) | $ | (100,000 | ) | ||
| Net Total Due from Advaxis | $ | 1,992,029 | $ | 5,640,480 | ||||
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
| Trial Pricing - Advaxis (Two Trial Scenario) | INDIA Trial | Efficiencies from US Trial | Discounted India Trial | US Trial | Grand Total- Both Trials | |||||||||||||||
| Budget Summary | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | |||||||||||||||
| NUMODA GENERAL CONTRACTOR AND INTEGRATION SERVICES: | ||||||||||||||||||||
| Role-Based Portals Connecting to Interoperable Neural Network | $ | 30,457 | $ | (9,359 | ) | $ | 21,098 | $ | 55,404 | $ | 76,502 | |||||||||
| All Custom Complete Integration and Interoperability | $ | 45,943 | $ | (12,673 | ) | $ | 33,270 | $ | 63,323 | $ | 116,593 | |||||||||
| Ongoing Consolidation and Reconciliation | $ | 21,003 | $ | (6,376 | ) | $ | 14,627 | $ | 37,493 | $ | 52,120 | |||||||||
| Planning, Procurement & Contracting | $ | 27,748 | $ | (8,753 | ) | $ | 18,995 | $ | 47,552 | $ | 56,547 | |||||||||
| Clinical Project Accounting Vendor Management, Documentation, Monitoring & Financial Reconciliation | $ | 27,748 | $ | (9,073 | ) | $ | 18,675 | $ | 50,494 | $ | 69,169 | |||||||||
| CLINICAL PROFESSIONAL SERVICES: | ||||||||||||||||||||
| Start Up, Regulatory & Site Management | $ | 122,362 | $ | 0 | $ | 122,362 | $ | 250,604 | $ | 372,966 | ||||||||||
| Monitoring | $ | 254,613 | $ | 0 | $ | 254,613 | $ | 1,288,014 | $ | 1,522,627 | ||||||||||
| Project Management | $ | 151,489 | $ | (49,908 | ) | $ | 101,581 | $ | 396,950 | $ | 498,531 | |||||||||
| Data Management | $ | 226,063 | $ | (46,940 | ) | $ | 179,123 | $ | 289,759 | $ | 468,882 | |||||||||
| Safety, Medical & Scientific Services | $ | 79,898 | $ | 0 | $ | 79,898 | $ | 183,446 | $ | 283,344 | ||||||||||
| Biostatistics & Medical Writing | $ | 190,460 | $ | 0 | $ | 190,460 | $ | 227,804 | $ | 418,264 | ||||||||||
| SUBTOTAL PROFESSIONAL FEES | $ | 1,177,784 | $ | (143,082 | ) | $ | 1,034,702 | $ | 2,890,843 | $ | 3,935,545 | |||||||||
| Budget Summary | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | |||||||||||||||
| NUMODA SYSTEMS AND REPORTING TOOLS: | ||||||||||||||||||||
| Screening and Enrollment systems | $ | 16,858 | $ | (3,804 | ) | $ | 13,054 | $ | 25,359 | $ | 38,413 | |||||||||
| Site compliance Tools | $ | 34,659 | $ | (7,554 | ) | $ | 27,105 | $ | 55,546 | $ | 82,651 | |||||||||
| Real Time Reporting Tools (with Document Management system) | $ | 27,202 | $ | (7,762 | ) | $ | 19,440 | $ | 57,072 | $ | 76,512 | |||||||||
| Integrated, Web-Based Monitoring system (with Centralized Trip Reports) | $ | 28,945 | $ | (9,087 | ) | $ | 19,858 | $ | 66,814 | $ | 86,672 | |||||||||
| Early Safety Signal Detection System | $ | 32,053 | $ | (7,094 | ) | $ | 24,959 | $ | 57,294 | $ | 82,253 | |||||||||
| Clinical Project Accounting System | $ | 35,819 | $ | (10,955 | ) | $ | 24,864 | $ | 90,508 | $ | 115,372 | |||||||||
| Interoperable system for Supplies and Re-Supply Logistics Management | $ | 19,192 | $ | (4,536 | ) | $ | 14,656 | $ | 33,353 | $ | 48,009 | |||||||||
| IVRS System | $ | 60,264 | $ | (16,723 | ) | $ | 43,541 | $ | 122,963 | $ | 156,504 | |||||||||
| IVRS Diary Activities | $ | 0 | $ | 0 | $ | 0 | $ | 0 | $ | 0 | ||||||||||
| SUBTOTAL NUMODA SYSTEMS AND REPORTING TOOLS | $ | 254,992 | $ | (67,515 | ) | $ | 187,477 | $ | 508,909 | $ | 686,386 | |||||||||
| TOTAL GENERAL CONTRACTOR SERVICES, INTEGRATIONS, PROFESSIONAL FEES, AND SYSTEMS AND TOOLS | $ | 1,432,776 | $ | (210,596 | ) | $ | 1,222,180 | $ | 3,399,752 | $ | 4,621,932 | |||||||||
| Budget Summary | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | |||||||||||||||
| VALUE ADDED SUPPLIER ITEMS (Estimated) | ||||||||||||||||||||
| EDC | $ | 0 | $ | 0 | $ | 0 | $ | 0 | $ | 0 | ||||||||||
| Investigator Fees | $ | 496,650 | $ | 0 | $ | 496,650 | $ | 1,002,560 | $ | 1,499,210 | ||||||||||
| Investigator Meeting Organization | $ | 21,000 | $ | 0 | $ | 21,000 | $ | 21,000 | $ | 42,000 | ||||||||||
| Investigator Meeting Travel | $ | 47,665 | $ | 0 | $ | 47,565 | $ | 49,350 | $ | 96,915 | ||||||||||
| Monitor Travel | $ | 84,058 | $ | 0 | $ | 84,058 | $ | 370,448 | $ | 454,506 | ||||||||||
| Travel to Training Meetings | $ | 2,310 | $ | 0 | $ | 2,310 | $ | 34,150 | $ | 36,460 | ||||||||||
| Travel to Client Meetings | $ | 1,050 | $ | 0 | $ | 1,050 | $ | 1,050 | $ | 2,100 | ||||||||||
| Travel for Audit Visits | $ | 1,260 | $ | 0 | $ | 1,260 | $ | 2,100 | $ | 3,360 | ||||||||||
| Meetings and Teleconferences | $ | 4,778 | $ | 0 | $ | 4,778 | $ | 18,199 | $ | 22,977 | ||||||||||
| IVRS Expenses | $ | 22,680 | $ | 0 | $ | 22,680 | $ | 57,456 | $ | 80,136 | ||||||||||
| Printing, Shipping and Other | $ | 7,749 | $ | 0 | $ | 7,749 | $ | 18,900 | $ | 26,649 | ||||||||||
| Regulatory and EC Fees | $ | 6,300 | $ | 0 | $ | 6,300 | $ | 10,500 | $ | 16,800 | ||||||||||
| Translation | $ | 12,600 | $ | 0 | $ | 12,600 | $ | 55,260 | $ | 67,850 | ||||||||||
| Lab Fees | $ | 207,900 | $ | 0 | $ | 207,900 | $ | 533,845 | $ | 741,745 | ||||||||||
| Drug Supply | $ | 0 | $ | 0 | $ | 0 | $ | 124,960 | $ | 124,960 | ||||||||||
| Specialty Lab/ECG | $ | 103,850 | $ | 0 | $ | 103,950 | $ | 0 | $ | 103,950 | ||||||||||
| Central Pathologists | $ | 0 | $ | 0 | $ | 0 | $ | 25,200 | $ | 25,200 | ||||||||||
| Other | $ | 0 | $ | 0 | $ | 0 | $ | 15,750 | $ | 15,760 | ||||||||||
| TOTAL ESTIMATED PASS THROUGH COSTS | $ | 1,019,850 | $ | 0 | $ | 1,019,850 | $ | 2,340,728 | $ | 3,360,578 | ||||||||||
| TOTAL PROJECT BUDGET | $ | 2,452,626 | $ | (210,597 | ) | $ | 2,242,029 | $ | 5,740,480 | $ | 7,982,509 | |||||||||
| LESS: NUMODA INVESTMENT | $ | (250,000 | ) | $ | 0 | $ | (250,000 | ) | $ | (100,000 | ) | $ | (350,000 | ) | ||||||
| NET TOTAL DUE from ADVAXIS | $ | 2,202,626 | $ | (210,597 | ) | $ | 1,992,029 | $ | 5,640,480 | $ | 7,632,509 | |||||||||
| -9.56 | % | -10.57 | % | |||||||||||||||||
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
Notes TO PROJECT BUDGET:
| (A) | Budget for Trial 1 includes an Efficiency Credit of $210,597 that is given with the understanding that Numoda will be providing services to Advaxis for two trials, as long as Numoda's work on the first Trial has been satisfactory. The actual, final scope of the second trial is yet to be determined, therefore prices for Trial 2 shown above, may be adjusted, if the scope is changed .. |
| (B) | Budget for Trial 1 is based on the protocol dated May 30, 2009. Budget for Trial 2 is based on protocol dated December 3, 2008. |
| (C) | Per the Master Agreement, paragraph 7.0 Change Orders, it is understood that Advaxis may seek to materially change the scope of Services and/or project assumptions agreed upon in the Project Agreement for either trial, such as can occur when there are amendments to the Protocol. Both parties agree to negotiate in good faith to reach an agreement on a budget and assumptions for such changes. |
| (D) | The $350,000 Numoda Investment (which includes the $150,000 Investment committed in previously executed LOI documents between the parties) is payable to Numoda in Advaxis common stock, based on the average of the five (5) days stock price, prior to the execution of a Stock Purchase Agreement. |
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
Attachment D:
PAYMENT SCHEDULE
| Start-Up Payment (July 15, 2009) | $ | 212,029 |
Trial 1 Lm-LLO-E7-15 (110 patients/12 sites, in India)
| Easy Level Monthly Payment Plan assumes 20 monthly installments of $89,000 each | ||||||
| 2009 – 4 months | $ | 356,000 | ||||
| Beginning Sept. 2009 thru April, 2011 | ||||||
| 2010 – 12 months | $ | 1,068,000 | ||||
| 2011 – 4 months | $ | 356,000 | ||||
| Sub-total Monthly Payments (20) | $ | 1,780,000 | ||||
| TOTAL TRIAL 1 -India | $ | 1,992,029 | ||||
| Start-Up Payment (August 15, 2009) | $ | 564,480 |
Trial 2 Lm-LLO-E7-07 (80 patients/20 sites, in USA)
| 2009 – 3 Months | $ | 423,000 | ||||||
| 2010 – 12 months | Easy Level Monthly Payment Plan assumes 36 monthly installments of $141,000 each | $ | 1,692,000 | |||||
| 2011 – 12 months | Beginning Sept, 2009 thru August, 2012 | $ | 1,692,000 | |||||
| 2012 – 9 months | $ | 1,269,000 | ||||||
| Sub-total Monthly Payments (36) | $ | 5,076,000 | ||||||
| TOTAL TRIAL 2 – US | $ | 5,640,480 |
Notes to Payment Schedule:
| (a) | Monthly Payments are due an the 15th of each month. |
| (b) | Numoda shall mail and/or email invoices to Advaxis per Advaxis' instructions. |
| (c) | Advaxis shall make all payments payable to Numoda Corporation, by wire transfer, EFT, or ACH. Advaxis shall send funds to Harleysville National Bank, as follows: |
| Bank: Harleysville National Bank | |
| ABA Number | - xxxxxxxxx |
| Account Name | - Numoda Corporation |
| Account Number | - xxxxxxxxxx |
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
Attachment E:
Transfer of Regulatory Obligations
1.0 Numode will retain records and reports associated with the Project in accordance with 21 CFR 312.57(b)
2.0 Numoda will conduct the services set forth in this Project Agreement in accordance with Clinical Protocols, Lm-LLO-E7-15 and Lm-LLO-E7-07.
EXHIBIT 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO 18.U.S.C. 7350
(SECTION 302 OF THE SARBANES OXLEY ACT OF 2002)
I, Thomas Moore, certify that:
| 1. | I have reviewed this report on Form 10-Q/A for the quarter ended April 30, 2012 of Advaxis, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| June 26, 2012 | |
| /s/ Thomas Moore | |
| Name: Thomas Moore | |
| Title: Chief Executive Officer |
EXHIBIT 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO 18.U.S.C. 7350
(SECTION 302 OF THE SARBANES OXLEY ACT OF 2002)
I, Mark J. Rosenblum, certify that:
| 1. | I have reviewed this report on Form 10-Q/A for the quarter ended April 30, 2012 of Advaxis, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| June 26, 2012 | |
| /s / Mark J. Rosenblum | |
| Name: Mark J. Rosenblum | |
| Title: Chief Financial Officer |
EXHIBIT 32.1
CERTIFICATION-PURSUANT TO SECTION 906 OF THE SARBANES OXLEY ACT OF 2002
The undersigned as Chief Executive Officer of Advaxis, Inc. (the “Company”), does hereby certify that the foregoing Amendment No. 1 to Quarterly Report on Form 10-Q/A of the Company for the quarter ended April 30, 2012:
| (1) | Fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
| (2) | Fairly presents, in all material respects, the financial condition and result of operations of the Company. |
| June 26, 2012 | |
| /s/ Thomas Moore | |
| Thomas Moore | |
| Chief Executive Officer |
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
EXHIBIT 32.2
CERTIFICATION-PURSUANT TO SECTION 906 OF THE SARBANES OXLEY ACT OF 2002
The undersigned as the Chief Financial Officer of Advaxis, Inc. (the “Company”), does hereby certify that the foregoing Amendment No. 1 to Quarterly Report on Form 10-Q/A of the Company for the quarter ended April 30, 2012:
| (1) | Fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
| (2) | Fairly presents, in all material respects, the financial condition and result of operations of the Company. |
| June 26, 2012 | |
| /s/ Mark J. Rosenblum | |
| Mark J. Rosenblum | |
| Chief Financial Officer |
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.