LPCN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-07

• On January 12, 2024, we entered into the Verity License Agreement with Verity, pursuant to which we granted to Verity an exclusive, royalty-bearing, sublicensable right and license to develop and commercialize the TLANDO product for TRT in the Licensed Verity Territory. Any FDA post-marketing studie…

• In September 2024, we entered into the SPC License Agreement (the “SPC License Agreement”) for the development and commercialization of TLANDO with SPC Korea Limited (“SPC”), pursuant to which the Company granted to SPC a non-transferable, exclusive, royalty-bearing license to commercialize our TLAN…

• Additional clinical development pipeline candidates include: LPCN 1154 for postpartum depression (“PPD”); LPCN 2201 for major depressive disorder (“MDD”); LPCN 2203 for essential tremor; LPCN 2101 for epilepsy; LPCN 2401 for improved body composition in obesity management. In addition to our clinica…

• The following chart summarizes the status of our product candidate development programs:

• Our goal is to become a leading biopharmaceutical company focused on leveraging our proprietary drug delivery technology platform to develop differentiated products through oral delivery of previously difficult to deliver molecules. The key components of our corporate strategy are to:

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• We entered into our first license agreement for the development and commercialization of our product, TLANDO®, an oral testosterone replacement therapy comprised of testosterone undecanoate in October 2021. On March 28, 2022, the FDA approved TLANDO as a testosterone replacement therapy (“TRT”) in a…

• On January 12, 2024, we entered into the Verity License Agreement with Verity Pharma, pursuant to which we granted to Verity Pharma an exclusive, royalty-bearing, sublicensable right and license to develop and commercialize the TLANDO product for TRT in the Licensed Verity Territory. Any FDA post-ma…

• In September 2024, we entered into the SPC License Agreement for the development and commercialization of TLANDO with SPC, pursuant to which the Company granted to SPC a non-transferable, exclusive, royalty-bearing license to commercialize our TLANDO product for TRT in the SPC Territory. In October …

• Additional clinical development pipeline candidates include: LPCN 1154 for postpartum depression (“PPD”); LPCN 2401 for improved body composition in GLP-1 agonist use such as obesity management; LPCN 2101 for epilepsy; and LPCN 2203 for essential tremor. In addition to our clinical development produ…

• The following chart summarizes the status of our product candidate development and partnering programs:

Text added vs the prior filing · source: 10-Q · 2026-05-07

• As a “smaller reporting company,” this item is not required.

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• We are exposed to various market risks, which include potential losses arising from adverse changes in market rates and prices, such as interest rates. We do not enter into derivatives or other financial instruments for trading or speculative purposes.

• There have been no material changes to the Company’s market risk during the first nine months of 2025. For a discussion of the Company’s exposure to market risk, refer to the Company’s market risk disclosures set forth in Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk”…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• LPCN 1154 is in development and an NDA submission may not be filed, or if filed, may not be accepted by the FDA.

• LPCN 1154 is currently in development. There can be no assurance as to whether the results of the clinical trials in LPCN 1154 for postpartum depression will support an NDA submission or whether an NDA submission will be accepted for review or approved by the FDA, including the oral route related br…

• LPCN 1154 may not achieve planned commercialization or commercialization objectives for a variety of reasons.

• Commercialization of LPCN 1154 is likely dependent on us finding a partner to market and sell LPCN 1154, if approved. We are exploring the possibility of partnering LPCN 1154 to a third party for commercialization, however we may not be able to identify potential partners or successfully enter into …

• There can be no assurance there will not be any third-party patent infringement proceedings against us. Such proceedings could delay or prevent further development of LPCN 1154.