Litigation

As previously disclosed, on April 26, 2024, the Company received a notice of a demand for arbitration with the American Arbitration Association from Pivot Holding LLC (“Pivot”), a successor in interest to Sphaera Pharma Pte. Ltd. (“Sphaera”), in connection with the Collaborative Research and Development Agreement dated February 29, 2012, as amended, between the Company and Sphaera (the “Collaboration Agreement”), alleging breach of contract by the Company for failure to pay certain milestone payments under the Collaboration Agreement and seeking damages. Also as previously disclosed, on June 17, 2024, the Company filed an answering statement and counterclaim denying that it had breached the Collaboration Agreement and counterclaiming. On September 30, 2024, following a non-binding confidential mediation, the Company and Pivot entered into a settlement agreement (the “Settlement Agreement”) pursuant to which the Company agreed to pay to Pivot a total sum of $500,000, which Pivot agreed shall constitute full and complete payment for, and shall fully satisfy, any and all amounts for any and all project milestone payments owed or that may be owed to Sphaera and/or Pivot by the Company under the Collaboration Agreement for: (i) “First dosing of patient in US phase 1 trial”; (ii) “US Phase 1 trial completion with endpoints met”; and (iii) “US Phase 2 trial completion with endpoints met” (each as described in the Collaboration Agreement) which payments would have totaled $1.625 million in the event Pivot were to be successful in claiming that the Company conducted Phase 1 and Phase 2 trials or that would be due upon successful milestones in the future. The Company also agreed to pay to Pivot a one-time payment of $4.4 million, increased from $4.0 million, upon FDA Approval (as described in the Collaboration Agreement) and the parties agreed that no further FDA Approval milestone payment(s) shall be due to Pivot in the event that the Company receives additional FDA Approval(s). The Settlement Agreement contains customary mutual releases and covenants not to sue. Except as otherwise provided in the Settlement Agreement, all terms in the Collaboration Agreement shall remain in full force and effect.

Lease

On April 18, 2022, the Company entered into an operating lease agreement for office space at its new location in Lexington, Massachusetts (the "Office Lease"). On August 8, 2022, the Company commenced occupancy of the leased space. The lease runs through September 30, 2025. We have an option to extend the lease term for an additional three (3) years thereafter.

The Company accounts for the Office Lease under the provisions of ASC 842. We recorded a right-of-use asset and a corresponding operating lease liability on the Company's condensed consolidated balance sheets upon the accounting commencement date in August 2022. The lease liability was measured at the accounting commencement date utilizing a 12% discount rate. The right-of-use asset had a balance of $133,105 at September 30, 2024. The operating lease obligations totaled $145,210 at September 30, 2024, all of which is included under current liabilities. The Company recorded lease expense of $35,296 and $105,887 and other short-term payments of $5,521 and $16,827 for the three and nine months ended September 30, 2024, respectively, in selling, general and administrative expenses and lease expense relating to the Office Lease of $35,296 and $105,887 and other short-term payments of $5,788 and $17,364 for the three and nine months ended September 30, 2023, respectively, in selling, general and administrative expenses.

The Office Lease contains escalating payments during the lease period. Upon execution of the Office Lease, the Company prepaid one month of rent and a security deposit, one of which will be held in escrow and credited at the termination of the lease and the other of which will be applied to the first month’s rent.

As of September 30, 2024, a security deposit of approximately $25,000 was included in prepaid expenses and other current assets on the Company’s condensed consolidated balance sheet related to the Office Lease.