XML 18 R10.htm IDEA: XBRL DOCUMENT v3.23.3
Balance Sheet Components
9 Months Ended
Sep. 30, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Balance Sheet Components

4. Balance Sheet Components

 

Property and Equipment, net

 

Property and equipment, net consist of the following (in thousands):

 

   September 30,   December 31, 
   2023   2022 
   (unaudited)     
Lab equipment  $2,232   $2,246 
Leasehold improvements   527    527 
Total property and equipment   2,759    2,773 
Less: Accumulated depreciation   (2,248)   (2,043)
Property and equipment, net  $511   $730 

 

Depreciation expense was approximately $58,000 and $123,000 for the three months ended September 30, 2023 and 2022, respectively, and approximately $205,000 and $383,000 for the nine months ended September 30, 2023 and 2022, respectively.

 

Intangible Assets, net

 

Intangible assets, net consist of the following (in thousands):

 

   September 30,   December 31, 
   2023   2022 
   (unaudited)     
Licenses  $81   $81 
Less: Accumulated amortization   (68)   (64)
Intangible assets, net  $13   $17 

 

Amortization expense was approximately $1,000 for each of the three month periods ended September 30, 2023 and 2022, and approximately $4,000 for each of the nine month periods ended September 30, 2023 and 2022.

 

Licenses

 

Broad Institute of MIT and Harvard — Non-Exclusive Manufacturing License Agreement

 

In January 2021, we entered into a non-exclusive manufacturing licensing agreement with the Broad Institute of MIT and Harvard (the “Broad Institute”) to make and manufacture CRISPR Modified Cell Lines, CRISPR Modified Animals and CRISPR Modified Plants. These license rights permit the non-exclusive use of the CRISPR Technology for the creation of and improvement of yield from protein and mAb production cell lines, which is one of the core components of the APEXTM mAb discovery and manufacturing production technology.

 

 

Pursuant to this agreement, the Company is obligated to pay to the Broad Institute an issue fee of $25,000, an annual license maintenance fee of $50,000 in 2022, and fees of $100,000 in December 2023 and each year thereafter. Additionally, the Company is obligated to pay a royalty of 7% of all service income received from a customer for the manufacture, sale or transfer of CRISPR modified cell line, CRISPR Modified Animals and CRISPR Modified Plants or end products, as well as 0.5% of end product net sales from use of any commercialized product that contains any small or large molecule made through the use of a CRISPR modified cell line, CRISPR Modified Animals and CRISPR Modified Plants. The term of the license agreement continues until all patents and filed patent applications, included within the licensed Broad Institute patents, have expired or been abandoned.

 

MedImmune Limited — License Agreement

 

In July 2021, the Company executed a license agreement effective July 12, 2021 and entered into an amendment to the license agreement on August 9, 2021 (collectively the “MedImmune License Agreement”) with MedImmune Limited (“MedImmune”), pursuant to which MedImmune granted the Company an exclusive worldwide license for the development and commercialization of suvratoxumab, a Phase 3 ready fully human monoclonal antibody targeting the Staphylococcus aureus alpha toxin (the “Licensed Product”). As consideration for the MedImmune License Agreement, the Company issued 884,956 shares of its common stock to MedImmune and a $5.0 million cash payment is due to MedImmune upon the earlier of (i) a registered direct offering in which the Company receives third-party funding or (ii) December 31, 2021. The $5.0 million liability has not been paid and therefore has been included in accrued liabilities within the Company’s consolidated balance sheet at December 31, 2022 and September 30, 2023.

 

As additional consideration, the Company will pay MedImmune milestone payments upon the achievement of certain regulatory approvals for one licensed product, up to a total aggregate amount of $30.0 million and sales related milestone payments of up to $85.0 million. To date, no milestones have been achieved and no milestone payments have been made pursuant to this agreement. MedImmune is entitled to royalty payments based on aggregate net sales ranging from 12.5% to 15% dependent on net sales volume. Further, until delivery of an interim data readout, or an interim futility analysis, from the first Phase 3 clinical study for any indication, MedImmune has a right of first negotiation regarding any commercial rights that the Company intends to sub-license. The term of the MedImmune License Agreement continues until the expiration of the last royalty term for the last licensed product as defined in the license agreement.

 

On March 20th, 2023, the Company received a written notice from MedImmune that it has terminated that certain License Agreement by and between MedImmune and the Company dated as of July 12, 2021, and as amended by Amendment No. 1 to License Agreement, dated as of August 9, 2021 (the “License Agreement”), pursuant to Section 9.2.1 of the License Agreement for non-payment of the Upfront Cash Payment which was due on December 31, 2021. The notice states that such termination shall be effective on March 30, 2023. As a result of the termination, the on-going AR-320-003 Phase 3 clinical study has been put on hold. The Company does not agree that it is in material breach of the License Agreement. Based on the failure of MedImmune to assist in the necessary technology transfer pursuant to Section 3.5.2 of the License Agreement. The Company notified MedImmune on March 24, 2023 that it was in material breach of Section 3.5.2 and requested that the material breach be cured as soon as possible.

 

Accrued Liabilities

 

Accrued liabilities consist of the following (in thousands):

 

   September 30,   December 31, 
   2023   2022 
   (unaudited)     
Research and development services  $7,215   $9,000 
Payroll related expenses   435    456 
Professional services and other   41    108 
Accrued liabilities  $7,691   $9,564