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COMMITMENTS AND CONTINGENCIES
9 Months Ended
Jun. 30, 2021
Commitments and Contingencies  
F. COMMITMENTS AND CONTINGENCIES

F. COMMITMENTS AND CONTINGENCIES

 

Clinical Research Agreements

 

Under co-development and revenue sharing agreements with Ergomed, Ergomed agreed to contribute up to $12 million towards the Company’s Phase 3 Clinical Trial in the form of discounted clinical services in exchange for a single digit percentage of milestone and royalty payments, up to a specific maximum amount. The Company accounted for the co-development and revenue sharing agreements in accordance with ASC 808 “Collaborative Arrangements.” The Company determined the payments to Ergomed are within the scope of ASC 730 “Research and Development.” Therefore, the Company records the discount on the clinical services as a credit to research and development expense on its Statements of Operations. Since the inception of the agreement with Ergomed, the Company has incurred research and development expenses of approximately $34.8 million for Ergomed’s services. This amount is net of Ergomed’s discount of approximately $11.7 million. During the nine months ended June 30, 2021 and 2020, the Company recorded, net of Ergomed’s discount, approximately $1.4 million and $1.3 million, respectively, as research and development expense related to Ergomed’s services.

 

Lease Agreements

 

The Company leases a manufacturing facility near Baltimore, Maryland (the San Tomas lease). The building was remodeled in accordance with the Company’s specifications so that it can be used by the Company to manufacture Multikine for the Company’s Phase 3 clinical trial and sales of the drug if approved by the FDA. The lease is for a term of twenty years and requires annual base rent to escalate each year at 3%. The Company is required to pay all real estate and personal property taxes, insurance premiums, maintenance expenses, repair costs and utilities. The lease allows the Company, at its election, to extend the lease for two ten-year periods or to purchase the building at the end of the 20-year lease, which expires in October 2028.

 

In August 2020, the Company entered into an amendment to the San Tomas lease agreement under which the landlord agreed to allow the Company to substantially upgrade the manufacturing facility in preparation for the potential commercial production of Multikine. The estimated cost of the upgrades is $10.7 million, of which approximately $10.5 million has been incurred as of June 30, 2021. The landlord agreed to finance the final $2.4 million of the costs incurred which will be repaid through increased lease payments over the remaining lease term starting on March 1, 2021. The repayment will include a base rent which escalates at 3% each year plus interest that accrues at 13.75% per year. The Company remeasured the right of use liability to account for the modified payments using a 8.45% implicit interest rate. Additionally, this financing is considered to be a lease incentive from the landlord and has been included in the calculation of the lease liability as it is realized. Approximately $1.6 million was received as of June 30, 2021. The total value of the leasehold improvements will be recorded in property and equipment and will be amortized over the remaining lease term when the assets are placed in service.

During June 2021, CEL-SCI determined that it used an incorrect discount rate to calculate the opening ROU asset and lease liability balances upon adoption of ASC 842. In addition, CEL-SCI determined that the discount rate used to calculate the modification of a finance lease during the quarter ended March 31, 2021 was also incorrect. CEL-SCI engaged an outside valuation specialist to perform a synthetic credit rating analysis to determine an appropriate rate for both the discount rate upon adoption, and the rate used for the lease modification. The revised rate upon adoption of ASC 842 was calculated to be 10.19% compared to the previously used rate of 8.80%, and the revised rate for the lease modification was calculated to be 8.45% compared to the previous rate of 10.00%. CEL-SCI performed an assessment and determined that the impact in the change of interest rates at September 30, 2020 is not material and would have decreased the right of use assets by $712,000 and the related lease liability by $683,000 and increased the net loss by $29,000. As a result, the error was corrected in the quarterly period ended June 30, 2021 as an out of period adjustment.

 

The net impact of correcting these errors resulted in an increase of approximately $0.5 million to the right of use assets and lease liabilities as of June 30, 2021. For the nine months ended June 30, 2021, this resulted in an increase of expense of approximately $27,000, which is recorded as expense in the nine and three months ended June 30, 2021. There is no impact to the Company’s cash flows as a result of the adjustment.

 

At June 30, 2021 and September 30, 2020, the net book value of the finance lease right of use asset is approximately $13.1 million and $13.8 million, respectively and the balance of the finance lease liability is approximately $14.1 million and $12.7 million, respectively, of which approximately $0.5 million and $0.9 million is current as of June 30, 2021, and September 30, 2020, respectively. These amounts include the San Tomas lease as well as several other smaller finance leases for office equipment. The finance right of use assets are being depreciated using a straight-line method over the underlying lease terms. Total cash paid related to finance leases during the nine months ended June 30, 2021 and 2020 was approximately $1.6 million, of which approximately $0.9 million was for interest. The weighted average discount rate of the Company’s finance leases is 8.45% and the weighted average time to maturity is 7.3 years.

 

The Company was required to deposit the equivalent of one year of base rent in accordance with the original lease. Under the landlord’s $2.4 million financing arrangement, the Company was required to deposit an additional $0.2 million during the quarter ended June 30, 2021. As of June 30, 2021 and September 30, 2020, respectively, the approximate $1.9 million and $1.7 million deposit is included in non-current assets.

 

Approximate future minimum lease payments under finance leases as of June 30, 2021 are as follows:

 

Nine months ending September 30, 2021 (1)

 

$(182,000)

Years ending September 30,

 

 

 

 

2022

 

 

2,486,000

 

2023

 

 

2,569,000

 

2024

 

 

2,648,000

 

2025

 

 

2,733,000

 

2026

 

 

2,824,000

 

Thereafter

 

 

6,186,000

 

Total future minimum finance lease obligation

 

 

19,264,000

 

Less: imputed interest on financing lease obligation

 

 

(5,126,000)

Net present value of financing lease obligation

 

$14,138,000

 

 

 

 

 

 

(1) Amount is net of landlord incentive of $0.8 million expected to be received in 2021

Effective April 30, 2020, the Company terminated a month-to-month arrangement with a sub-lessee as the sub-leased space is needed to prepare the facility to produce Multikine for commercial purposes and before the Company’s Biologics License Application (BLA) can be submitted to the FDA. The sublease rental income for the nine and three months ended June 30, 2020 was approximately $39,000 and $2,000, respectively.

 

The Company leases two facilities under 60-month operating leases. The lease for its research and development laboratory expires February 28, 2022 and the lease for its office headquarters expires on November 30, 2025. The operating leases include escalating rental payments. The Company is recognizing the related rent expense on a straight-line basis over the full 60-month terms of the leases. As of June 30, 2021 and September 30, 2020, the net book value of the operating lease right of use assets is approximately $1.0 million and $1.2 million, respectively. As of June 30, 2021 and September 30, 2020, the balance of the operating lease liabilities is approximately $1.1 million and $1.3 million, of which approximately $200,000 and $100,000, respectively, is current. The Company incurred lease expense for operating leases of approximately $0.2 million for the nine months ended June 30, 2021 and 2020. The Company incurred lease expense for operating leases of approximately $66,000 and $67,000, respectively, for the three months ended June 30, 2021 and 2020. Total cash paid related to operating leases during the nine months ended June 30, 2021 and 2020 was approximately $176,000 and $198,000 respectively. Total cash paid related to operating leases during the three months ended June 30, 2021 and 2020 was approximately $64,000 and $66,000 respectively. The weighted average discount rate of the Company’s operating leases is 10.2% and the weighted average time to maturity is 5.9 years.

 

As of June 30, 2021, future minimum lease payments on operating leases are as follows:

 

Three months ending September 30, 2021

 

$66,000

 

Year ending September 30,

 

 

 

 

2022

 

 

267,000

 

2022

 

 

275,000

 

2024

 

 

281,000

 

2025

 

 

288,000

 

2026

 

 

207,000

 

Thereafter

 

 

80,000

 

Total future minimum lease obligation

 

 

1,464,000

 

Less imputed interest on operating lease obligation

 

 

(344,000)

Net present value of operating lease obligation

 

$1,120,000