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Commitments and Contingencies
12 Months Ended
Dec. 31, 2021
Commitments And Contingencies Disclosure [Abstract]  
Commitments and Contingencies

7.

Commitments and Contingencies

Leases

At the inception of a contractual arrangement, the Company determines whether the contract contains a lease by assessing whether there is an identified asset and whether the contract conveys the right to control the use of the identified asset in exchange for consideration over a period of time. If both criteria are met, the Company calculates the associated lease liability and corresponding right-of-use asset upon lease commencement using a discount rate based on the rate implicit in the lease or an incremental borrowing rate commensurate with the term of the lease. Lease renewable options are included in the estimation of lease term when it is reasonably certain that the Company will exercise such options.  

The Company records lease liabilities within current liabilities or long-term liabilities based upon the length of time associated with the lease payments. The Company records its operating lease right-of-use assets as long-term assets. Right-of-use assets for financing leases are recorded within property and equipment, net in the Balance Sheet. Leases with an initial term of 12 months or less are not recorded on the Balance Sheet. Instead, the Company recognizes lease expense for these leases on a straight-line basis over the lease term.

The Company leases laboratory, office and storage facilities in San Antonio, Texas, under operating lease agreements that expire in 2025. The Company also leases certain office space in Austin, Texas under a month-to-month operating lease agreement.

On March 1, 2021, the Company entered into a lease agreement for office space in Charlottesville, Virginia (the “Charlottesville Lease”). The Charlottesville Lease has a term of 12 months and is renewable for four additional one-year periods. The minimum lease payment is $30,000 for the first twelve months, subject to a 3% annual increase if and when the lease is renewed. The lease commencement date is April 1, 2021. The Company measured the operating lease right-of-use asset and related lease liability related to the Charlottesville Lease as of the lease commencement date.  

In addition, the Company has entered into leases for certain equipment under various operating and finance leases. The lease agreements generally provide for periodic rent increases, and renewal and termination options. The Company’s lease agreements do not contain any material variable lease payments, residual value guarantees or material restrictive covenants.

During 2021, contractual terms of all finance leases had expired and the Company did not have any right-of-use assets or lease liabilities relating to finance leases as of December 31, 2021.  The lease agreements generally provide for periodic rent increases, and renewal and termination options. The Company’s lease agreements do not contain any material variable lease payments, residual value guarantees or material restrictive covenants.

Certain leases require the Company to pay taxes, insurance, and maintenance. Payments for the transfer of goods or services such as common area maintenance and utilities represent non-lease components. The Company elected the package of practical expedients and therefore does not separate non-lease components from lease components.

The table below summarizes the Company’s lease liabilities and corresponding right-of-use assets (in thousands, except years and rates):

 

 

2021

 

 

2020

 

Assets

 

 

 

 

 

 

Operating

$

341

 

$

636

 

Financing

 

 

 

7

 

Total leased assets

$

341

 

$

643

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

Current:

 

 

 

 

 

 

Operating

$

111

 

$

123

 

Financing

 

10

 

Noncurrent:

 

 

 

 

 

 

Operating

269

 

528

 

Total lease liabilities

$

380

 

$

661

 

 

 

 

 

 

 

 

Weighted-average remaining lease term (years) - operating leases

2.86

 

6.57

 

Weighted-average remaining lease term (years) - finance leases

 

0.42

 

Weighted-average discount rate - operating leases

 

9.00

%

 

7.79

%

Weighted-average discount rate - finance leases

 

N/A

 

 

5.00

%

 

 

The table below summarizes the Company’s lease costs from its consolidated statements of operations, and cash payments from its consolidated statements of cash flows.

 

 

 

Year Ended December 31,

 

 

 

 

2021

 

 

2020

 

Lease expense:

 

 

 

 

 

 

 

Operating lease expense

 

$

211

 

$

210

 

Finance lease expense:

 

 

 

 

 

 

 

Depreciation of right-of-use assets

 

 

7

 

127

 

Interest expense on lease liabilities

 

 

4

 

Total lease expense

 

$

218

 

$

341

 

 

 

 

 

 

 

 

 

Cash payment information:

 

 

 

 

 

 

 

Operating cash used for operating leases

 

$

206

 

$

204

 

Financing cash used for financing leases

 

8

 

117

 

Total cash paid for amounts included in the measurement of lease liabilities

 

$

214

 

$

321

 

 

Total rent expenses for each of the years ended December 31, 2021 and 2020 was $0.2 million, which includes leases in the table above, month-to-month operating leases, and common area maintenance charges.

 

The Company’s future minimum annual lease payments under operating and financing leases at December 31, 2021 are as follows (in thousands):

 

 

 

 

 

 

 

 

Operating Leases

 

2022

$

159

 

2023

 

137

 

2024

 

113

 

2025

 

18

 

Thereafter

 

 

 

Total minimum lease payments

$

 

427

 

Less: amount representing interest

 

 

(47

)

Present value of obligations under leases

 

 

380

 

Less: current portion

 

 

(111

)

Noncurrent lease obligations

$

 

269

 

       

Piramal Master Services Agreement

OJanuary 8, 2021, the Company entered into a Master Services Agreement (the “MSA”) with Piramal Pharma Solutions, Inc. (“Piramal”), for Piramal to perform certain services related to the development, manufacture, and supply of the Company’s 186RNL-Liposome Intermediate Drug Product. The MSA includes the transfer of analytical methods, development of microbiological methods, process transfer and optimization, intermediate drug product manufacturing, and stability studies for the Company, which has been initiated at Piramal’s facility located in Lexington, Kentucky. 

 

The MSA has a term of five years and will automatically renew for successive one-year terms unless either party notifies the other no later than six months prior to the original term or any additional terms of its intention to not renew the MSA.  The Company has the right to terminate the MSA for convenience upon thirty days’ prior written notice.  Either party may terminate the MSA upon an uncured material breach by the other party or upon the bankruptcy or insolvency of the other party.

Other Commitments and Contingencies

The Company has entered into agreements with various research organizations for pre-clinical and clinical development studies, which have provisions for cancellation. Under the terms of these agreements, the vendors provide a variety of services including conducting research, recruiting and enrolling patients, monitoring studies and data analysis. Payments under these agreements typically include fees for services and reimbursement of expenses. The timing of payments due under these agreements is

estimated based on current study progress.  As of December 31, 2021, the Company did not have any clinical research study obligations.   

Legal proceedings

On June 22, 2021, the Company was named as a defendant in an action brought by Lorem Vascular, Pte. Ltd. (“Lorem”) in the District Court for the District of Delaware. The complaint alleges false representations were made to Lorem regarding the manufacturing facility in the United Kingdom (the “UK Facility”) that Lorem purchased from the Company under the Equity Purchase Agreement, dated March 29, 2019, between the Company and Lorem (the “Lorem Agreement”). Lorem also claims that false representations were made regarding the UK Facility’s certification to sell and distribute devices in the European Union and export such devices to China. In connection with these allegations, Lorem claims entitlement to at least $6,000,000 in compensatory damages and operational costs and expenses (collectively, the “Lorem Claim”). The Company believes that the claims from Lorem are without merit and intends to vigorously defend the case and on August 12, 2021, the Company filed a Motion to Dismiss asking the District Court to dismiss the Lorem Claim. Lorem filed an opposition on September 9, 2021, which the Company responded to on September 30, 2021. On February 7, 2022, a hearing was held on the Company’s Motion to Dismiss and the presiding judge ruled against the Motion to Dismiss.  The Company is moving forward with discovery in this case.

 

 

 

The Company is subject to various claims and contingencies related to legal proceedings.  Due to their nature, such legal proceedings involve inherent uncertainties including, but not limited to, court rulings, negotiations between affected parties and governmental actions.  Management assesses the probability of loss for such contingencies and accrues a liability and/or discloses the relevant circumstances, as appropriate.