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Commitments and Contingencies
9 Months Ended
Sep. 30, 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.

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 2028. On October 1, 2021, the operating lease in San Antonio, Texas was amended so that the lease would expire in February 2025, with a 3% increase to the previously agreed-on annual minimum lease payments. 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”). In addition, the Company has entered into leases for certain equipment under various operating and finance leases. As of September 30, 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. The Company’s existing operating 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.

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 was April 1, 2021. At lease inception, the Company believed that it was reasonably certain that it would renew the Charlottesville Lease beyond its initial 12 months term to 36 months in total. As a result, the Company recorded the operating lease right-of-use asset and related lease liability related to the Charlottesville Lease as of the lease commencement date, using the applicable discount rate of 8.95%.

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 operating lease liabilities and corresponding right-of-use assets (in thousands, except years and rates):

 

September 30, 2021

 

Assets

 

 

 

Operating

$

559

 

Total leased assets

$

559

 

Liabilities

 

 

 

Current:

 

 

 

Operating

$

106

 

Noncurrent:

 

 

 

Operating

504

 

Total lease liabilities

$

610

 

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

5.97

 

Weighted-average discount rate - operating leases

 

7.0

%

 

The table below summarizes the Company’s lease costs from its unaudited consolidated condensed statement of operations, and cash payments from its unaudited consolidated condensed statement of cash flows during the three and nine months ended September 30, 2021 and 2020 (in thousands):

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30, 2021

 

September 30, 2020

 

 

September 30, 2021

 

September 30, 2020

 

Lease expense:

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating lease expense

$

58

 

$

52

 

 

$

166

 

$

160

 

Finance lease expense:

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation of right-of-use assets

 

 

32

 

 

7

 

95

 

Interest expense on lease liabilities

 

 

1

 

 

 

 

4

 

Total lease expense

$

58

 

$

85

 

 

$

173

 

$

259

 

Cash payment information:

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating cash used for operating leases

$

56

 

$

56

 

 

$

162

 

$

155

 

Financing cash used for financing leases

 

 

 

42

 

 

 

8

 

 

93

 

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

$

56

 

$

98

 

 

$

170

 

$

248

 

 

 

Total rent expenses for the nine months ended September 30, 2021 and 2020 was $170,000 and $177,000, respectively, 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 September 30, 2021 are as follows (in thousands):

 

 

Operating Leases

 

 

 

 

 

Remaining 2021

$

44

 

2022

154

 

2023

131

 

2024

114

 

2025

108

 

Thereafter

234

 

Total minimum lease payments

$

785

 

Less: amount representing interest

 

(175

)

Present value of obligations under leases

$

610

 

Less: current portion

 

(106

)

Noncurrent lease obligations

$

504

 

 

 

        Piramal Master Services Agreement

On January 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 RNL-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 parties contemplate that the MSA will lead to clinical and commercial supply agreements between the Company and Piramal.

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 September 30, 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 we responded to on September 30, 2021. As of October 21, 2021, the Company is waiting for the District Court’s decision on our motion. No liability was accrued as of September 30, 2021.

 

 

 

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.