v3.26.1
Commitments and Contingencies
3 Months Ended
Mar. 31, 2026
Commitments and Contingencies [Abstract]  
COMMITMENTS AND CONTINGENCIES

NOTE 6 — COMMITMENTS AND CONTINGENCIES

 

Employee Commitments

 

There are no employee commitments as the Company operates on an at-will employment basis.

 

Rental Agreement

 

The Company rents a virtual office on a month-to-month basis at JLabs in New York, New York, a facility owned by Johnson & Johnson. The current monthly rent is $811. Rent expense for the three months ended March 31, 2026 and 2025 was $2,433 and $3,150, respectively.

 

License Obligation and Manufacturing Agreements

 

Advaxis (now Ayala)

 

In September 2018, the Company entered into an exclusive license agreement with Advaxis, Inc., as amended, under which it acquired the rights to develop and commercialize the Advaxis HER2 Construct, including related patents.

 

Under the agreement, all milestone payments were non-refundable, non-creditable and payable only once upon the achievement of the corresponding milestone. As of December 31, 2020, the first milestone was achieved and paid ($1,550,000) in January 2021. The second milestone was completed and paid ($1,375,000) in May 2021. No milestone payments were made for the three months ended March 31, 2026 or March 31, 2025. The license agreement was terminated upon the Company’s purchase of the HER2 Assets from Ayala on April 9, 2025, which included a payment of $400,000 and the issuance of common stock and pre-funded warrants as consideration. All common stock and pre-funded warrants were issued to Ayala in 2025.

BlinkBio

 

In July 2020, the Company entered into a Licensing Agreement with BlinkBio, Inc., to utilize their proprietary technology. As of August 2020, the $300,000 License fee was fully paid and recorded in license expense. These payments have been recorded in the Licensing expenses of the accompanying statement of operations. No payments were due or made in the three months ended March 31, 2026 and 2025. The Company is currently conducting early-stage research on the licensed drug, including studies to support future toxicology evaluations. A payment schedule for future milestones is summarized below.

 

Milestone Bearing Event  Milestone
Payment
 
1.  License Fee to utilize proprietary technology (paid)   $300,000 + $2.4 million Convertible Note 
2.  Commencement of a toxicology study commented pursuant to Good Laboratory Practices (per 21 CFR Part 58) such that any resulting positive data would be admissible to applicable Regulatory Authorities to support an IND (commonly referred to as “GLP-Tox”)  $375,000 
3.  Completion of a Phase I Clinical Trial  $1,500,000 
4.  Completion of a Phase II Clinical Trial  $2,500,000 
5.  Filing of an NDA, BLA or MAA registration (or the equivalent in any other territory around the world)  $6,000,000 
6.  Regulatory Approval in the first of the United States, within the EU or within the UK  $12,000,000 

 

The Company will make the cash payments set forth in the table above by wire transfer of immediately available funds, to BlinkBio within 30 days of the occurrence of each milestone set forth with respect to the first Product to attain each such milestone, except that the first Milestone above will apply with respect to The Company’s first product candidate. During the Royalty Term, the Company will pay BlinkBio a royalty of 6% on Net Sales on a Product-by-Product and country-by-country basis during the Royalty Term, in a country in which no Valid Claim Covers the manufacture, use, or sale of a Product, the royalty on Net Sales of such Product in such country will be reduced to 3%. No royalties were due in the three months ended March 31, 2026 and 2025.

 

For the avoidance of doubt, each milestone payment will be payable only once, and the aggregate amount of Milestone payments payable hereunder will not exceed $22,375,000. A Milestone may be achieved by the Company or a Commercial Sublicensee.

George Clinical Inc.

 

In June 2020, the Company entered into a Research Service Agreement, as amended, with George Clinical Inc., to use their clinical research services for the Company’s study: “An Open Label, Phase 2 Study of Maintenance Therapy with OST-HER2 after Resection of Recurrent Osteosarcoma”. Under the terms of the agreement, the Company was required to pay to George Clinical certain fees described in the fee schedule below. The total budget under the agreement was approximately $2,436,928. For the three months ended March 31, 2026 and 2025, the total research and development expenses recorded in the statement of operations were $0 and $0, respectively. The fee schedule for certain fees and corresponding payment amounts is set forth below.

 

George Clinical Payment Schedule   Payment
Amount
 
1.   Service Fee Advance (paid)   $ 49,989  
2.   Service Fee Advance of $212,335 minus the amount already paid, plus PTC Fee Advance of $31,325 (paid)   $ 193,671  
3.   Statistics Fees – 35% on Electronic Data Capture (EDC) Go Live Date   $ 47,740  
4.   Statistics Fees – 35% on Development of SAP tables   $ 47,740  
5.   Statistics Fees – 30% on Final Analysis   $ 40,920  
6.   Service Fees – Remainder Due     Split monthly over course of study  

 

George Clinical tracked and invoiced the Company for the number of task units completed and pass-through costs were invoiced each month in arrears based on actual costs without mark-up. The PTC Advance Fee was used to offset final pass-through fees payable. As of March 31, 2026, the balance payable to George Clinical was $0, and the services agreement has terminated in accordance with its terms. All fees due under the agreement have been satisfied, and no further obligations to the vendor remain.

 

Biolacuna Ltd

 

The Company has contracted with Biolacuna Ltd, a global life sciences advisory firm, to assist with the following agencies requirements to register OST-HER2 and gain approval of its use in the respective regions:

 

European Medicines Agency (EMA, Europe);

 

Medicines Evaluation Board (MEB, Netherlands);

 

Medicines and Healthcare products Regulatory Agency (MHRA, United Kingdom); and

 

U.S. Food and Drug Administration (FDA, United States).

 

For the three months ended March 31, 2026, the Company paid $6,515,059 in consulting fees, which includes refundable value-added tax (VAT) expenses. As of March 31, 2026 and December 31, 2025, accounts payable related to consulting fees and VAT totaled $9,943,617 and $7,323,386, respectively.

Trustees for the University of Pennsylvania

 

On April 9, 2025, the Company acquired from Ayala the HER2 Assets. Pursuant to the terms of the HER2 Purchase Agreement, the amended and restated development, license and supply agreement with Advaxis terminated. In connection with the acquisition of the HER2 Assets, the Company was assigned by Ayala a license agreement with the Trustees of the University of Pennsylvania covering the use of HER2 construct patents. Under the terms of the license agreement, the Company is required to pay an annual license fee to the Trustees of the University of Pennsylvania. In April 2025, the Company paid a fee of $266,317. In addition, the Company is obligated to pay a royalty equal to 1.5% of net sales related to:

 

OST-HER2-related sales;

 

ADXS-503-related sales;

 

ADXS-504-related sales; and

 

Sales related to any new immunotherapy drug candidates created from the Lm platform during the term of such licensing agreement.

 

Legal Proceedings

 

From time to time, the Company may be involved in disputes, including litigation, relating to claims arising out of operations in the normal course of business. Any of these claims could subject the Company to costly legal expenses and, while management generally believes that there will be adequate insurance to cover different liabilities at such time the Company becomes a public company and commences clinical trials, the Company’s future insurance carriers may deny coverage or policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on the results of operations and financial position. Additionally, any such claims, whether or not successful, could damage the Company’s reputation and business. The Company is currently not a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, could have a material adverse effect on the Company’s results of operations or financial position. The Company recently participated in an arbitration hearing related to a claim brought by its former investment advisor concerning underwriter compensation for the Company’s initial public offering in August 2024 and any subsequent equity offerings during the following 12 months. The hearing concluded on November 7, 2025, and the arbitrators issued a ruling on January 28, 2026, awarding the former investment advisor $1,055,428 and their attorneys $308,805. The Company also incurred $15,128 in arbitration-related fees.

 

The total amount of $1,379,361 has been accrued in the Company’s financial statements as of March 31, 2026 and December 31, 2025 and is recorded within accrued expenses. The Company does not intend to challenge the ruling. In accordance with ASC 450, the obligation is considered both probable and reasonably estimable.