FBIOP — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-13

• ●For the three months ended June 30, 2026, net revenue included $0.7 million related to Journey’s supply of Amzeeq to Cutia Therapeutics (HK) Limited (“Cutia”), and $0.2 million in Cyprium’s royalty revenue from ZYCUBO. Other revenue for the three months ended June 30, 2025 consists of revenue recog…

• ●For the six months ended June 30, 2026 and 2025, net revenue was $34.8 million and $29.6 million, respectively, and is primarily related to the sale of Journey’s marketed products.

• ●For the six months ended June 30, 2026, net revenue included $0.7 million in royalties related to Journey’s supply of Amzeeq to Cutia, and $0.3 million in Cyprium’s royalty revenue from sales of ZYCUBO. Other revenue for the six months ended June 30, 2025 consists of revenue recognized by Avenue re…

• ●Cyprium is eligible to receive up to $128 million in aggregate sales milestones and tiered royalties on net sales of ZYCUBO ranging from 3% to 12.5% on annual net sales. For the six months ended June 30, 2026, Cyprium recognized $0.3 million in royalty revenue on net sales of ZYCUBO.

• ●Sun Pharma pays Fortress a 2.5% royalty on net sales of UNLOXCYT. For the six months ended June 30, 2026, Fortress recognized $0.1 million in royalty income on net sales of UNLOXCYT.

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• ●For the three months ended March 31, 2026, net revenue included $0.1 million in royalties related to Journey’s supply of Amzeeq to Cutia Therapeutics (HK) Limited (“Cutia”) and Cyprium’s royalty revenue from ZYCUBO.

• ●Previously, in October 2025, Cyprium announced that the FDA had issued a complete response letter (“CRL”) to Sentynl for CUTX-101 (copper histidinate for Menkes disease). The CRL noted cGMP deficiencies had been observed at the facility where CUTX-101 is manufactured and did not cite any other appr…

• ●Cyprium is eligible to receive up to $128 million in aggregate sales milestones and royalties on net sales of ZYCUBO ranging from 3% to 12.5% on tiered annual net sales. For the quarter ending March 31, 2026, Cyprium recognized $0.1 million in royalty revenue on net sales of ZYCUBO.

• ●On December 13, 2024, Checkpoint received approval from the FDA for UNLOXCYT (cosibelimab-ipdl), for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”) in adults who are not candidates for curative surgery or radiation.

• ●Also in October 2025, Urica announced the first patients were dosed in two randomized, double-blind, multicenter global Phase 3 trials, (ClinicalTrials.gov identifiers: the RUBY study (NCT07089875) and the TOPAZ study (NCT07089888)) evaluating dotinurad, a next-generation, once daily oral, URAT1 in…

Text added vs the prior filing · source: 10-Q · 2026-08-13

• ●one or more of our development-stage product candidates is approved for commercial sale and we decide to commercialize such product(s) ourselves, due to the need to establish the necessary commercial infrastructure to launch and commercialize this product without substantial delays, including hirin…

• If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations, and could result in financial, legal, business, and reputational harm to us. For example, in 2021, our partner company Journey w…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• for our product candidates and the ability to produce and distribute our products in the volume needed to both meet commercial demand and build inventory to mitigate possible supply disruptions.

• and prospects. Even if we are allowed to pursue the Section 505(b)(2) regulatory pathway, we cannot assure you that our product candidates will receive the requisite approvals for commercialization in a timely manner, or at all.

• ●one or more of our development-stage product candidates is approved for commercial sale and we decide to commercialize such product(s) ourselves, due to the need to establish the necessary commercial infrastructure to launch and commercialize

• this product without substantial delays, including hiring sales and marketing personnel and contracting with third parties for manufacturing, testing, warehousing, distribution, cash collection and related commercial activities;

• If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations, and could result in financial, legal, business, and reputational harm to us. For example, in 2021,