CONTINGENT LIABILITIES AND COMMITMENTS |
6 Months Ended | ||||||||||||||||||||
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Jun. 30, 2026 | |||||||||||||||||||||
| Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||
| CONTINGENT LIABILITIES AND COMMITMENTS |
Litigation
Commitments
In June 2019, the Company entered into a service agreement with Formulex, as subsequently amended in March 2020 (the “2019 Formulex Service Agreement”), to facilitate the flow of information and know how, as well as help develop the Company products. The Company agreed to pay a monthly fee of $5 under this agreement. The 2019 Formulex Service Agreement renewed every year for a period of one year, unless terminated by either party upon 30 days’ written notice, in accordance with the terms and conditions set forth therein. In December 2025, the Company and Formulex agreed on the termination of the 2019 Formulex Service Agreement and to forfeiture of prior obligations under that agreement.
On September 8, 2025, the Company entered into a services agreement with Formulex where the Company would pay a monthly fee of $10 for research and development services. The term of the service agreement is 36 months and the Company has the right to terminate it with 30 days notice.
In connection with the same, Formulex provided the Company with non-recurring development services in the six months ended June 30, 2026 and 2025 for additional fees of $114 and $76, respectively.
On March 23, 2026, the Company entered into a services agreement with Formulex for the formulation, development, analytical method qualification, GMP manufacturing, batch release, and stability testing services for the Company’s Ondansetron Nasal Powder. Under the agreement, Formulex will manufacture up to 200 investigational drug product devices and perform related analytical and stability services in accordance with the agreed scope of work. The Company will compensate Formulex based on the agreed project milestones and payment schedule set forth in the agreement. An amount of $7 is recorded in the consolidated statements of operations in research and development expenses during the six month period ended June 30, 2026.
NASUS PHARMA LTD. AND ITS SUBSIDIARY NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Amounts in U.S. dollars in thousands, except share and per share amounts)
The 2019 Aptar Agreement had an early termination fee in case the Company terminate NS001 or NS002 programs for whatever reason, other than a breach of the agreement by Aptar, of $450 for each product.
In April 2021, the Company entered into an agreement with Aptar’s subdivision, NextBreath, which was subject to terms and conditions of the 2019 Aptar Agreements, to perform laboratory and development services in connection with NS001. For the services received under the 2019 Aptar Agreement by April 2022, there was an amount of $529 outstanding payable to Aptar.
On June 15, 2022, Aptar sent Nasus a Notice of Default Letter, which followed by Notice of Termination Letter sent on October 5, 2022, in which Aptar claimed for alleged breach of the contractual obligations of the Aptar Agreement made by Nasus and stated the outstanding amounts of $529 and in addition a termination fee of $450 related to NS001. The Company did not agree with the alleged breach made by Aptar and the existence of any grounds for termination of the Aptar’s Agreement. As of June 30, 2025 and December 31, 2024, a liability of $529 was recorded as accounts payable within the consolidated balance sheets. The Company has not recorded a liability for the termination fees of $900 ($450 for NS001 and $450 for NS002). The Company settled all outstanding disputes relating to the 2019 Aptar Agreement as further noted below.
In October 2025, the Company and Aptar entered into a Termination and Settlement Agreement (the “Termination Agreement”) pursuant to which the Company and Aptar agreed to (i) terminate the 2019 Aptar Agreements, and (ii) fully and finally resolve and settle all outstanding disputes relating to the 2019 Aptar Agreements. Pursuant to the Termination Agreement, the Company paid Aptar $75 in 2025 and $225 in May 2026, for a total settlement of $300 (the “Settlement Amount”), in full and final settlement of all outstanding disputes relating to the 2019 Aptar Agreements, including the $529 claimed by Aptar and any future claims for termination fees. As of June 30, 2026 and December 31, 2025, a liability of $0 and $225, respectively, is recorded as accounts payable within the consolidated balance sheets.
In October 2025, the Company and Aptar concurrently entered into a new master service agreement and schedules of work (the “New Aptar Agreement”) in which Aptar granted the Company technology access to co-development and support for the development and submissions to regulatory bodies of intranasal to deliver NS002 using Aptar’s technology. In connection with the New Aptar Agreement, the Company is required to pay Aptar up to $1,000 in the aggregate comprising of $600 to be paid in three annual instalments, milestone payments of $200 upon submission of New Drug Application (“NDA”) with the U.S. Food and Drug Administration (or equivalent body outside the U.S) (“FDA”) and additional $200 upon approval of the NDA with the FDA, and royalty payments based on sales of the intranasal Epinephrine product for a period of seven years commencing on the date of first commercial sale. The Company paid $200 to Aptar to date under the New Aptar Agreement. The New Aptar Agreement has an early termination fee in case the Company terminates NS002 program for whatever reason, other than a breach of the agreement by Aptar, of up to $160 based on termination date.
In addition, in October 2025, the Company entered into a short-form supply agreement (the “Supply Agreement”) with Aptar relating to NS002. Pursuant to the Supply Agreement, and subject to approval of the underlying product by the FDA, Aptar will serve as the Company’s exclusive supplier of unit dose powder nasal delivery system devices, and the Company has agreed to purchase 100% of its requirements for such devices from Aptar for use in the Company’s Epinephrine products. The Supply Agreement has an initial term of five years and is renewable for an additional two-year period. The Supply Agreement also sets forth pricing on a per-component basis. Initial payment of $95 was made on May 20, 2026 and was booked as prepaid expense, as the related materials had not yet been received as of June 30, 2026.
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