v3.26.1
Commitments and Contingencies
6 Months Ended
Jun. 30, 2026
Commitments and Contingencies.  
Commitments and Contingencies

(12)   Commitments and Contingencies

(a)   Leases

From February 1, 2023, to January 31, 2025, the Company subleased 4,837 square feet of laboratory and office space in Newton, Massachusetts, which it accounted for in accordance with to ASU 842. Upon termination of this sublease on January 31, 2025, the Company relocated its business operations to another location under a six-month agreement for $3,520 per month with options to renew semi-annually.

Prior to February 1, 2023, and subsequent to January 31, 2025, the Company had no operating leases with maturities greater than one year.

Rent expense for the three months ended June 30, 2026 and 2025, was $20,922 and $11,715, respectively, and $38,514 and $57,278, respectively, for the six months ended June 30, 2026 and 2025.

(b)   License Agreements

License One. In November 2018, the Company licensed the exclusive rights to certain intellectual property to support development of its therapeutic candidates (“License”). The intellectual property licensed by the Company is owned by The General Hospital Corporation, d/b/a Massachusetts General Hospital, (“Licensor”). Payments by the Company under the license agreement included a one-time non-refundable fee of $50,000 paid after execution of the License; reimbursement of Licensor’s patent costs which, at execution of the License, were approximately $145,000; a minimum annual license fee of $25,000 payable within 60 days of each anniversary of the effective date of the License prior to the first commercial sale of a product or process covered by the License; milestone payments upon attainment of certain milestone events; royalties based on net sales of products covered by the patent-related rights; and a portion of any sublicense income received by the Company. The Company is responsible for the development and commercialization of the licensed assets and for meeting certain milestones set forth in the License.

The Company has the right to terminate the License at any time by giving 90 days’ advance notice subject to the payment of any amounts due under the License at that time. The License may also be terminated for cause by either party upon the breach of the material obligations of the other party or the bankruptcy or liquidation of the other party. If the Company does not terminate the License, the term of the License shall continue until the latest of (i) the date on which all issued patents and filed patent applications subject to the License have expired or been abandoned; (ii) expiration of the last to expire regulatory exclusivity covering a covered product or process; or (iii) 10 years after the first commercial sale. The License requires the Company to make royalty payments beyond the term of the License at 1.5%.

(12)   Commitments and Contingencies (continued)

Milestone payments payable by the Company are summarized below. (Amounts shown as “[**]” are confidential.)

Milestone Event

  ​ ​ ​

Amount

1. Enrollment of first patient in a phase II clinical trial of a therapeutic product or process

$

[**]

2. Enrollment of first patient in a phase III clinical trial of a therapeutic product or process

$

[**]

3. First commercial sale of a therapeutic product or process

$

[**]

4. Filing of an application for regulatory approval of a clinical diagnostic product or process

$

100,000

5. First regulatory approval of a clinical diagnostic product or process

$

150,000

6. Change of Control Liquidity Event:

a. between $50 million and $100 million, or

$

[**]

b. greater than $100 million

$

[**]

Royalties to be paid to Licensor shall be assessed on net sales of licensed products on a country-by-country basis in an amount equal to 3.0% for therapeutic products or processes, and 6.0% for clinical diagnostic products and processes. The Company shall pay Licensor 30% of any and all sublicense income.

In November 2020, the Company and Licensor amended the License. Under the amendment, the intellectual property licensed in 2018 was categorized as “Patent Family 1” and a provisional patent filing related to the Company’s nanoparticle technology was added to Patent Family 1. A second patent family (“Patent Family 2”) was created which includes Licensor intellectual property targeting PD-L1. The minimum annual license fee prior to the first commercial sale of a product or process covered by the License was increased from $25,000 per year to $30,000 per year for Patent Family 1, and a minimum annual license fee of $10,000 per year was added related to Patent Family 2. All other terms of the License including milestone payments, royalties and payment terms related to sublicense income received by the Company remain the same as in the original License.

Effective August 15, 2025, the Company and Licensor further amended the License (the “Second Amendment”) to revise the diligence requirements and milestone payments. In connection with the Second Amendment, the Company paid the Licensor a license

amendment fee of $75,000. The Second Amendment revised certain one-time milestone payments to be made by the Company to the Licensor for Products and Processes covered by the License as follows:

(i) a certain dollar amount within sixty (60) days following dosing of the first patient in the first phase II clinical trial for a Therapeutic Product or Therapeutic Process for each Patent Family;

(ii) a certain dollar amount within sixty (60) days following dosing of the first patient in the first phase III clinical trial for a Therapeutic Product or Therapeutic Process for each Patent Family; and

(iii) a certain dollar amount within sixty (60) days following the First Commercial Sale of a Therapeutic Product or Therapeutic Process for each Patent Family.

In addition, upon the occurrence of a Change of Control Liquidity Event (as defined in the Second Amendment), the Company shall pay Licensor up to a certain dollar amount.

The License One milestone payments the Company shall pay to Licensor shall not exceed $2,950,000 based upon and subject to the attainment of each milestone event. These payments are generally due within 60 days of achievement of the milestone.

As of June 30, 2026 and December 31, 2025, no License One milestone events had been achieved.

(12)   Commitments and Contingencies (continued)

License Two. The Company’s second license is between Polynoma, LLC and Sloan Kettering Institute (“SKI”) For Cancer Research (the “SKI License”). The SKI License was entered into on April 12, 2006, by SKI and MAANEX LLC, a predecessor of Polynoma. The SKI License includes the following Milestone Events (excluding milestones that occurred prior to the Company’s acquisition of Polynoma which prior milestones were previously paid):

Milestone Event

  ​ ​ ​

Amount

1. Upon filing of a New Drug Application with the FDA for a product(s) subject to the SKI License

$

50,000

2. Enrollment of first patient in a phase III clinical trial of a therapeutic product or process

$

125,000

As of June 30, 2026, and December 31, 2025, no License Two milestone events had been achieved.

Accrued License Obligations. At June 30, 2026, and December 31, 2025, the Company had accrued $25,473 and $0, respectively, in license payments under the foregoing arrangements included in accounts payable and accrued expenses.

(c)   Collaboration Agreements

On December 11, 2025, the Company announced a collaboration to evaluate TTX-MC138 as part of the PRE-I-SPY clinical trial platform operated by Quantum Leap Health Care Collaborative (“Quantum Leap”). The PRE-I-SPY program will incorporate TTX-MC138 into a Phase IIa clinical trial designed as a multicenter, open-label, one-year treatment duration with one-year follow up, dose-expansion trial. The trial will evaluate event-free survival, ctDNA dynamics and pharmacokinetics of TTX-MC138 in up to 45 patients (i) with stage I-III adenocarcinoma of the colon or rectum who are ctDNA positive with minimal residual disease detected by tumor-informed ctDNA assays, (ii) who have completed standard curative-intent therapy, and (iii) who show no radiographic evidence of recurrence or metastasis. This trial was initiated in the second quarter 2026 with initial patient enrollments expected in the third quarter 2026. Dr. Paula Pohlmann of the MD Anderson Cancer Center is the Principal Investigator. The study is being conducted under a Quantum Leap IND and cross-referenced to the Company’s IND. The total amount of the Quantum Leap agreement is approximately $7.3 million payable against milestones tied to Quantum Leap’s performance under the terms of the collaboration agreement.

On July 29, 2022, the Company signed a five-year strategic collaboration agreement with The University of Texas M. D. Anderson Cancer Center (“MD Anderson”). Under the collaboration, the Company anticipated making certain expenditures with respect to Phase I and Phase II clinical trials which it expected to be conducted in part through MD Anderson as a primary investigator site. MD Anderson was also to provide preclinical work under the collaboration. The details of clinical and preclinical work were to be mutually agreed by the parties prior to commencing work. The Company committed to fund up to $10 million over the term of the collaboration. Of this amount, the initial payment schedule called for $500,000 to be paid within the first year in two installments. The $250,000 first payment made by the Company to MD Anderson in January 2023 was recorded as a Prepaid Expense pending such time as payments under the collaboration were due. In late 2024, the Company and MD Anderson agreed to amend the collaboration agreement in favor of MD Anderson focusing solely on participation in the Company’s Phase I/II clinical trial. This amendment relieved the Company from the obligation to make up to $10 million of collaboration payments. The Company is obligated to pay charges incurred by MD Anderson in connection with clinical trial services. Initial expenses of the clinical trial were charged against the initial payment made to MD Anderson. For the six months ended June 30, 2026 and 2025, these charges were $15,866 and $138,439, respectively.

(d)   Employment Agreements and Severance

The Company has entered into employment agreements with its executive officers which provide the employee with, among other things, severance payments upon termination of the agreement by the Company for any reason other than for cause, death or disability, or by the employee for good reason. The maximum aggregate severance payments under current agreements, which arise in the event of termination involving a Change of Control (as defined in the agreements), are approximately $2,436,750.

(12)   Commitments and Contingencies (continued)

(e)   Litigation

The Company may from time to time be subject to claims by others under various legal disputes. The defense of such claims, or any adverse outcome relating to any such claims, could have a material adverse effect on the Company’s liquidity, consolidated financial condition, and consolidated cash flows. At the balance sheet dates herein, the Company did not know of any claims or actions pending against it or threatened, the ultimate disposition of which could have a material adverse effect on its consolidated results of operations or consolidated financial condition except (i) claims by an investment bank that it is entitled to fees, claims which the Company rigorously disputes; and (ii) a complaint filed by Wheeler Bio, Inc. (“Wheeler”) on April 24, 2026, in the Supreme Court of the State of New York, County of New York, captioned Wheeler Bio, Inc. v. Polynoma LLC, et al., No. 652458/2026 against Polynoma and TransCode (the “Wheeler Action”). The Wheeler Action asserts two causes of action: breach of contract against Polynoma and intentional interference with contractual relations against TransCode. The claims arise out of an agreement between Wheeler and Polynoma for certain contract development and manufacturing services offered by Wheeler (the “Wheeler Agreement”). Wheeler alleges that, on October 1, 2025, Polynoma terminated a Statement of Work and a Change Order effective immediately without advance notice required by the Wheeler Agreement, and has failed to pay certain delay fees, cancellation fees, and invoices generated in connection with the Wheeler Agreement. Wheeler further alleges that TransCode caused Polynoma to terminate the Wheeler Agreement and to refuse to pay the fees at issue. The Wheeler Action seeks various amounts for compensatory and punitive damages, restitution, pre- and post-judgment interest, and attorneys’ fees and costs involving as much as approximately $9.2 million. The Company disputes the claims in the Wheeler Action and intends to defend vigorously against this litigation. Under the Wheeler Agreement, the parties agreed that any disputes regarding Wheeler’s performance would be resolved by arbitration.  The Company filed a motion to compel arbitration and to stay the litigation pending the outcome of arbitration. On July 30, 2026, the Court entered an order compelling the dispute to arbitration and staying the litigation pending a final decision in that arbitration.

(f)   Indemnification Agreements

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with the members of its Board and executive officers that require the Company, among other things, to indemnify the parties against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any costs as a result of payments required by such indemnifications. The Company is not aware of any indemnification arrangements that could have a material adverse effect on its consolidated financial position, consolidated results of operations or consolidated cash flows, and it has not accrued any liabilities related to such obligations in its consolidated financial statements, as of the balance sheet dates herein.

(g)   Risks and Uncertainties

As geopolitical events such as wars in the Ukraine and the Middle East and major health issues such as SARS-CoV-2, or the coronavirus, continue to evolve, the extent to which they affect the Company’s operations directly or through parties on whom the Company depends is highly uncertain and cannot be predicted with confidence. Outcomes resulting from these events could delay the Company’s plans, increase its operating expenses and have a material adverse effect on its consolidated financial condition, consolidated results of operations or consolidated cash flows.

(12)   Commitments and Contingencies (continued)

(h)  Contingent Value Rights Agreement

Concurrent with the Closing of the Acquisition, the Company entered into a contingent value rights agreement (the “CVR Agreement”) with a rights agent (the “Rights Agent”), pursuant to which each holder of Common Stock as of October 20, 2025, including those holders receiving shares of Common Stock in connection with the Acquisition, was entitled to one contractual contingent value right (each, a “CVR”) issued by the Company, subject to and in accordance with the terms and conditions of the CVR Agreement. The CVR Agreement has a term of seven years.

Each CVR entitles the holders thereof (each a “CVR Holder”), in the aggregate, to 50% of the Net Proceeds (as defined in the CVR Agreement) from any Upfront Payment (as defined in the CVR Agreement) or Milestone Payment (as defined in the CVR Agreement) received by the Company in a given calendar quarter. Distributions in respect of the CVRs that become payable will be made on a quarterly basis less deductions specified in the CVR Agreement, subject to certain exceptions or limitations, including but not limited to for certain taxes and certain out-of-pocket expenses incurred by the Company.

Under the CVR Agreement, the Rights Agent has, and CVR Holders of at least 30% of the CVRs then-outstanding have, certain rights to audit and enforcement on behalf of all CVR Holders. The CVRs may not be sold, assigned, pledged, encumbered or in any other manner transferred or disposed of, in whole or in part, other than as permitted pursuant to the CVR Agreement. By virtue of holding CVRs, a CVR Holder does not have the rights of a stockholder including the ability to vote, rights to dividends, or other interests. The CVRs also establish certain restrictions on mergers and change in control activities, as defined in the CVR Agreement.

As no transaction was deemed probable as of the date of the latest consolidated balance sheet included in this Quarterly Report on Form 10-Q, the Company has not recorded any potential liability related to the CVRs.