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What changed in Lipocine Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Lipocine Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+412 added−432 removedSource: 10-K (2026-03-10) vs 10-K (2024-12-31)

Top changes in Lipocine Inc.'s 2025 10-K

412 paragraphs added · 432 removed · 317 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

100 edited+44 added−65 removed150 unchanged
Biggest changeIn addition to our clinical development product candidates, we have assets for which we expect to seek partnerships to enable further development including TLANDO for territories outside of the United States, South Korea, and the GCC, LPCN 1148 comprising a novel prodrug of testosterone and testosterone laurate (“ testosterone laurate” or “TL”), for the management of cirrhosis, LPCN 1144, an oral prodrug of androgen receptor modulator for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), formerly referred to as non-cirrhotic non-alcoholic steatohepatitis (“MASH”), which has completed Phase 2 testing; and LPCN 1107, potentially the first oral hydroxy progesterone caproate (“HPC”) product indicated for the prevention of recurrent PTB, which has completed a dose finding clinical study in pregnant women and has been granted orphan drug designation by the FDA. 4 The following chart summarizes the status of our product candidate development programs: Corporate Strategy Our goal is to become a leading biopharmaceutical company focused on leveraging our proprietary Lip’ral drug delivery technology platform to develop differentiated products through oral delivery of previously difficult to deliver molecules.
Biggest changeIn addition to our clinical development product candidates, we have assets for which we expect to seek partnerships to enable further development including TLANDO for territories outside of the United States, South Korea, the GCC, and Brazil, LPCN 1148 comprising a novel prodrug of testosterone and testosterone laurate (“testosterone laurate” or “TL”), for the management of decompensated cirrhosis, and LPCN 1107, potentially the first oral hydroxy progesterone caproate (“HPC”) product indicated for the prevention of recurrent PTB, which has completed a dose finding clinical study in pregnant women and has been granted orphan drug designation by the FDA.
Each year about half of the approximately 17,000 people in U.S. on the LT waitlist undergo transplant, while nearly 3,000 patients either die or are removed from the list because they were “too sick to transplant.” Liver cirrhosis is defined as the histological development of regenerative nodules surrounded by fibrous bands.
Each year about half of the approximately 17,000 people in the U.S. on the LT waitlist undergo transplant, while nearly 3,000 patients either die or are removed from the list because they were “too sick to transplant.” Liver cirrhosis is defined as the histological development of regenerative nodules surrounded by fibrous bands.
The FDA stated that in light of the unmet need for a treatment for preventing preterm birth and improving neonatal outcomes, it is imperative that the medical and scientific communities increase their efforts to find effective treatments and stated their hope that the decision to withdraw Makena will help galvanize further research.
The FDA stated that in light of the unmet need for a treatment preventing preterm birth and improving neonatal outcomes, it is imperative that the medical and scientific communities increase their efforts to find effective treatments and stated their hope that the decision to withdraw Makena will help galvanize further research.
In October 2024, we announced positive data from our qEEG study of our oral brexanolone with results indicating robust central nervous system activity of oral brexanolone, with concentration- and time-dependent post-dose changes in qEEG as follows: ● Quantitative Electroencephalogram (“qEEG”) in healthy subjects administered single doses of oral brexanolone, a neuroactive steroid, confirmed GABAA modulation ● Rapid and durable CNS target engagement confirms effective oral delivery of bioidentical brexanolone ● Promising results support continued development of oral brexanolone for the treatment of neuropsychiatric disorders We believe through utilization of our proprietary technology we may have the ability to enable effective oral delivery of endogenous GABA A receptor PAMs which historically had been deemed to be not orally bioavailable.
In October 2024, we announced positive data from our qEEG study of our oral brexanolone with results indicating robust central nervous system activity of oral brexanolone, with concentration- and time-dependent post-dose changes in qEEG as follows: ● Quantitative Electroencephalogram (“qEEG”) in healthy subjects administered single doses of oral brexanolone, a neuroactive steroid, confirmed GABA A modulation ● Rapid and durable CNS target engagement confirms effective oral delivery of bioidentical brexanolone ● Promising results support continued development of oral brexanolone for the treatment of neuropsychiatric disorders We believe through utilization of our proprietary technology we may have the ability to enable effective oral delivery of endogenous GABA A receptor PAMs which historically had been deemed to be not orally bioavailable.
This in turn could affect our ability to successfully commercialize our products and impact our profitability, results of operations, financial condition, and future success. 22 Related Party Transaction On July 23, 2013, we entered into assignment/license and services agreements with Spriaso, an entity that is majority-owned by Mahesh V. Patel, Gordhan Patel, John W. Higuchi, the late Dr. William I.
This in turn could affect our ability to successfully commercialize our products and impact our profitability, results of operations, financial condition, and future success. Related Party Transaction On July 23, 2013, we entered into assignment/license and services agreements with Spriaso, an entity that is majority-owned by Mahesh V. Patel, Gordhan Patel, John W. Higuchi, the late Dr. William I.
There remains an unmet need for an ASM without the aforementioned downsides, with no to low fetal-neonatal toxicity and without any breast-feeding concerns, as well as the potential to treat associated comorbidities. While over 30 molecules have been approved for the treatment of epilepsy in the U.S., no epilepsy drug has been specifically approved for WWE of CB age.
There remains an unmet need for an ASM without the aforementioned downsides, with no to low fetal-neonatal toxicity and without breast-feeding concerns, as well as the potential to treat associated comorbidities. While over 30 molecules have been approved for the treatment of epilepsy in the U.S., no epilepsy drug has been specifically approved for WWE of CB age.
No assurance can be given that any partnering agreement will be completed, or, if an agreement is completed, that such an agreement would be on terms favorable to us. 7 PPD PPD, a type of major depressive disorder with onset either during pregnancy or within four weeks of delivery, refers to depression persisting up to 12 months after childbirth.
No assurance can be given that any partnering agreement will be completed, or, if an agreement is completed, that such an agreement would be on terms favorable to us. PPD PPD, a type of major depressive disorder with onset either during pregnancy or within four weeks of delivery, refers to depression persisting up to 12 months after childbirth.
This includes a requirement that the Department of Health and Human Services negotiate a “maximum fair price” with drug manufacturers for certain single-source brand drugs or biologics without generic or biosimilar competitors that are covered under Medicare Part D and Part B. This pricing will begin in 2026 for Medicare Part D and 2028 for Medicare Part B.
This includes a requirement that the Department of Health and Human Services negotiate a “maximum fair price” with drug manufacturers for certain single-source brand drugs or biologics without generic or biosimilar competitors that are covered under Medicare Part D and Part B. This pricing began in 2026 for Medicare Part D and will begin in 2028 for Medicare Part B.
Other Pipeline Candidates We continue to pursue opportunities for partnering and/or development arrangements for the continued development and/or marketing of LPCN 2401, LPCN 1148, LPCN 1144, and LPCN 1107. We do not currently anticipate conducting any further significant development activities with respect to these products and product candidates without the participation of a partner.
Other Pipeline Candidates We continue to pursue opportunities for partnering and/or development arrangements for the continued development and/or marketing of LPCN 2401, LPCN 1148, and LPCN 1107. We do not currently anticipate conducting any further significant development activities with respect to these products and product candidates without the participation of a partner.
In addition, we will receive tiered royalty payments at rates ranging from 12% up to 18% of net sales of all products licensed under the Verity License Agreement in the Licensed Verity Territory. SPC paid us a non-refundable, non-creditable upfront fee in October 2024.
In addition, we will receive tiered royalty payments at rates ranging from 12% up to 18% of net sales of all products licensed under the Verity License Agreement in the Licensed Verity Territory. 5 SPC paid us a non-refundable, non-creditable upfront fee in October 2024.
Prevention of PTB is a significant unmet need as approximately 11% of all U.S. pregnancies result in PTB, a leading cause of neonatal mortality and morbidity. Current Status We have completed a multi-dose PK dose selection study in pregnant women.
Prevention of PTB is a significant unmet need as approximately 11% of all U.S. pregnancies result in PTB, a leading cause of neonatal mortality and morbidity. 13 Current Status We have completed a multi-dose PK dose selection study in pregnant women.
We have the right to terminate the assignment agreement upon the complete liquidation or dissolution of Spriaso, unless the assignment agreement is assigned to an affiliate or successor of Spriaso. Under the services agreement, we agreed to provide facilities and up to 10% of the services of certain employees to Spriaso for a period of time.
We have the right to terminate the assignment agreement upon the complete liquidation or dissolution of Spriaso, unless the assignment agreement is assigned to an affiliate or successor of Spriaso. 20 Under the services agreement, we agreed to provide facilities and up to 10% of the services of certain employees to Spriaso for a period of time.
Phase 2 clinical trials sometimes include randomization of patients. 19 Phase 3 Clinical Trials : Phase 3 clinical trials take approximately 2 to 5 years to complete and involve tests on a much larger population of patients (several hundred to several thousand patients) suffering from the targeted condition or disease.
Phase 2 clinical trials sometimes include randomization of patients. Phase 3 Clinical Trials : Phase 3 clinical trials take approximately 2 to 5 years to complete and involve tests on a much larger population of patients (several hundred to several thousand patients) suffering from the targeted condition or disease.
Generally, 2 adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of an NDA or foreign authorities for approval of NDAs. Post-approval studies, or Phase 4 clinical trials, may be conducted after initial marketing approval.
Generally, 2 adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of an NDA or foreign authorities for approval of NDAs. 17 Post-approval studies, or Phase 4 clinical trials, may be conducted after initial marketing approval.
Any agency or judicial enforcement action could have a material adverse effect on us. 18 It takes many years for a typical experimental drug to go from concept to approval. The process required by the FDA before a pharmaceutical product may be marketed in the United States generally includes the following: ● Completion of preclinical laboratory tests and animal studies.
Any agency or judicial enforcement action could have a material adverse effect on us. 16 It takes many years for a typical experimental drug to go from concept to approval. The process required by the FDA before a pharmaceutical product may be marketed in the United States generally includes the following: ● Completion of preclinical laboratory tests and animal studies.
Our proprietary delivery technologies are designed to improve patient compliance and safety through orally available treatment options. Our primary development programs are based on oral delivery solutions for poorly bioavailable drugs. We have a portfolio of differentiated innovative product candidates that target high unmet needs for neurological and psychiatric CNS disorders, liver diseases, and hormone supplementation for men and women.
Our proprietary delivery technologies are designed to improve patient compliance and safety through orally available treatment options. Our primary development programs are based on oral delivery solutions for poorly bioavailable drugs. We have a portfolio of differentiated innovative product candidates that target high unmet needs for neurological and psychiatric CNS disorders, liver disease, and hormone supplementation for men and women.
All obligations under the prior license agreement have been completed except that Lipocine will owe Abbott a perpetual 1% royalty on net sales of TLANDO. Such royalties are limited to $1 million in the first two calendar years following product launch, after which period there is no cap on royalties and no maximum aggregate amount.
All obligations under the prior license agreement have been completed except that Lipocine will owe Abbott a perpetual 1% royalty on net sales of TLANDO. Such royalties were limited to $1 million in the first two calendar years following product launch, after which period there is no cap on royalties and no maximum aggregate amount.
If we or our Licensee are marketing the TLANDO product at the time the patents expire and have no other issued U.S. patents covering the product, then we will lose certain advantages that come with FDA Orange Book listing of patents and will no longer be able to prevent others in the U.S. from practicing the inventions claimed by the 13 patents.
If we or our Licensee are marketing the TLANDO product at the time the patents expire and have no other issued U.S. patents covering the product, then we will lose certain advantages that come with FDA Orange Book listing of patents and will no longer be able to prevent others in the U.S. from practicing the inventions claimed by the 14 patents.
We have exclusively licensed rights to TLANDO to Verity for commercialization of TLANDO in the Licensed Verity Territory, to SPC for commercialization in the SPC Territory, and to Pharmalink in the Pharmalink Territory (together, the “Currently Licensed TLANDO Territories”).
We have exclusively licensed rights to TLANDO to Verity for commercialization of TLANDO in the Licensed Verity Territory, to SPC for commercialization in the SPC Territory, to Pharmalink in the Pharmalink Territory, and to Aché in the Aché Territory (together, the “Currently Licensed TLANDO Territories”).
We plan to support Verity’s, SPC’s and Pharmalink’s efforts to effectively enable the availability of TLANDO to patients in a timely manner, in addition to receiving milestone payments, royalty payments, and/or payments for product sales associated with TLANDO commercialization as agreed to in the Verity License Agreement, the SPC License Agreement and the Pharmalink Distribution Agreement.
We plan to support Verity’s, SPC’s, Pharmalink’s, and Aché’s efforts to effectively enable the availability of TLANDO to patients in a timely manner, in addition to receiving milestone payments, royalty payments, and/or payments for product sales associated with TLANDO commercialization as agreed to in the Verity License Agreement, the SPC License Agreement, the Pharmalink Distribution Agreement and the Aché License Agreement.
LPCN 1154: Product Candidate for PPD Our most advanced NAS candidate is LPCN 1154, a non-invasive, rapid onset, oral formulation of the neuroactive steroid brexanolone which we are developing for the treatment of PPD. We have completed clinical oral PK studies including a pilot food effect study and a pilot PK bridge study.
LPCN 1154: Product Candidate for PPD Our most advanced NAS candidate is LPCN 1154, a rapid onset, oral formulation of the neuroactive steroid brexanolone which we are developing for the treatment of PPD. We have completed clinical oral PK studies including a pilot food effect study and a pilot PK bridge study.
The drug loaded dispersed phase presents the solubilized drug efficiently at the absorption site (gastrointestinal tract membrane) thus improving the absorption process and making the drug less dependent on physiological variables such as dilution, gastro-intestinal pH and food effects for absorption.
The drug loaded dispersed phase presents the solubilized drug efficiently at the absorption site (gastrointestinal tract membrane) thus improving the absorption process and making the drug less dependent on physiological variables such as dilution, gastrointestinal pH and food effects for absorption.
Common causes of liver cirrhosis include alcoholic liver disease, non-alcoholic fatty liver disease (“NAFLD”), chronic hepatitis B and C, primary biliary cirrhosis (“PBC”), and primary sclerosing cholangitis (“PSC”) and some patients have liver disease of unknown cause (cryptogenic).
Common causes of liver cirrhosis include alcoholic liver disease, non-alcoholic fatty liver disease (“NAFLD”), chronic hepatitis B and C, primary biliary cirrhosis, and primary sclerosing cholangitis and some patients have liver disease of unknown cause (cryptogenic).
Our priority is on the development of LPCN 1154, a fast-acting oral antidepressant for PPD with potential for outpatient use. Support our Licensees, Verity, SPC, and Pharmalink, in commercialization of our licensed oral TRT product . We believe the TRT market needs a differentiated, convenient oral option.
Our priority is the development of LPCN 1154, a fast-acting oral antidepressant for PPD with potential for outpatient use. 4 Support our Licensees, Verity, SPC, Pharmalink, and Aché in commercialization of our licensed oral TRT product . We believe the TRT market needs a differentiated, convenient oral option.
Additionally, we have 13 U.S. patents that are listed in the FDA Orange Book for TLANDO that are expected to expire between 2029 and 2041.
Additionally, we have 14 U.S. patents that are listed in the FDA Orange Book for TLANDO that are expected to expire between 2029 and 2041.
In July 2014, the FDA granted the AB rating to Perrigo’s 1% testosterone gel drug product (NDA 203098) approved in January 2013, and a BX rating to Teva’s 1% gel drug product (NDA 202763) approved in February 2012. Each are versions of AbbVie’s AndroGel 1.0% and employed 505(b)(2) submissions citing AndroGel as their reference listed drugs.
In July 2014, the FDA granted the AB rating to Perrigo’s 1% testosterone gel drug product (NDA 203098) approved in January 2013, and a BX rating to Teva’s 1% gel drug product (NDA 202763) approved in February 2012. Each is a version of AbbVie’s AndroGel 1.0% and employed 505(b)(2) submissions citing AndroGel as their reference listed drugs.
The Company also received an additional payment for a non-refundable, non-creditable prepayment in consideration for TLANDO product inventory, and is eligible to receive additional payments for various marketing authorization and sales milestones, and the Company will supply TLANDO to SPC and receive a supply price.
We also received an additional payment for a non-refundable, non-creditable prepayment in consideration for TLANDO product inventory, and we are eligible to receive additional payments for various marketing authorization and sales milestones, and the Company will supply TLANDO to SPC and receive a supply price.
Lip’ral-based formulation enables improved solubilization and higher drug-loading capacity, which can lead to improved bioavailability, reduced dose, faster and more consistent absorption, reduced variability, reduced sensitivity to food effects, improved patient compliance, and targeted lymphatic delivery where appropriate.
Our formulation enables improved solubilization and higher drug-loading capacity, which can lead to improved bioavailability, reduced dose, faster and more consistent absorption, reduced variability, reduced sensitivity to food effects, improved patient compliance, and targeted lymphatic delivery where appropriate.
In the meeting, we were advised that the FDA believes, in addition to the previously completed PK bridge data, an efficacy and safety study of oral LPCN 1154 in the target population will be required for 505(b)(2) NDA submission.
In the meeting, we were advised that the FDA believes, in addition to the previously completed PK dosing regimen confirmation data, an efficacy and safety study of oral LPCN 1154 in the target population will be required for 505(b)(2) NDA submission.
As of March 13, 2025, our intellectual property patent portfolio consists of various issued patents and patent applications related to Oral TU, LPCN 1111, LPCN 1107, LPCN 1144/1148, LPCN 1154, and LPCN 2401 both in the U.S. and in multiple countries outside of the U.S.
As of March 10, 2026, our intellectual property patent portfolio consists of various issued patents and patent applications related to Oral TU, LPCN 1111, LPCN 1107, LPCN 1144/1148, LPCN 1154, and LPCN 2401 both in the U.S. and in multiple countries outside of the U.S.
In 2024 and 2023, we spent $7.4 million and $10.2 million, respectively, on research and development. Competition Neuroactive Steroids Market overview The unique potential mechanism of action (“MOA”) of NAS presents an opportunity to treat a variety of CNS disorders. Accordingly, multiple NASs as GABA A receptor PAMs are in active development for varied indications.
In 2025 and 2024, we spent $8.6 million and $7.4 million, respectively, on research and development. Competition Neuroactive Steroids Market overview The unique potential mechanism of action (“MOA”) of NAS presents an opportunity to treat a variety of CNS disorders. Accordingly, multiple NASs as GABA A receptor PAMs are in active development for varied indications.
Proof-of-concept for TLANDO was initially established in 2006, and TLANDO was subsequently licensed in 2009 to Solvay Pharmaceuticals, Inc., which was then acquired by Abbott Products, Inc. (“Abbott”). Following a portfolio review associated with the spin-off of AbbVie Inc. by Abbott in 2011, the rights to TLANDO were reacquired by us.
Proof-of-concept for TLANDO was initially established in 2006, and TLANDO was subsequently licensed in 2009 to Solvay Pharmaceuticals, Inc., which was then acquired by Abbott Products, Inc. (“Abbott”). Following a portfolio review associated with the spin-off of AbbVie Inc. by Abbott in 2011, we re-acquired the rights to TLANDO.
If generic versions of any such product are introduced, then royalties are reduced by 50%. TLANDO was commercially launched on June 7, 2022. During the years ended December 31, 2024 and 2023, we incurred royalty expense of approximately $24,000 and $34,000, respectively.
If generic versions of any such product are introduced, then royalties will be reduced by 50%. TLANDO was commercially launched on June 7, 2022. During the years ended December 31, 2025 and 2024, we incurred royalty expense of approximately $40,000 and $24,000, respectively.
Employees As of December 31, 2024, we had 16 full time employees, and we also utilize the services of consultants on a regular basis. Eleven employees are engaged in drug development activities and five are in general and administration functions and the majority of our employees work out of our Salt Lake City facility.
Employees As of December 31, 2025, we had 14 full-time employees, and we also utilize the services of consultants on a regular basis. Nine employees are engaged in drug development activities and five are in general and administration functions and the majority of our employees work out of our Salt Lake City facility.
ITEM 1. BUSINESS General Lipocine Inc. (“Lipocine” or the “Company”) is incorporated under the laws of the State of Delaware. We are a biopharmaceutical company focused on leveraging our proprietary Lip’ral platform to develop differentiated products through the oral delivery of previously difficult to deliver molecules.
ITEM 1. BUSINESS General Lipocine Inc. (“Lipocine” or the “Company”) is incorporated under the laws of the State of Delaware. We are a biopharmaceutical company focused on leveraging our proprietary technology platform to develop innovative products with effective oral delivery of previously difficult to deliver molecules.
LPCN 2401 is expected to have a favorable benefit to risk profile as a non-invasive option for use as an adjunct to GLP-1 receptor agonist chronic weight management therapies and/or as a monotherapy post cessation of GLP-1 receptor agonist chronic weight management therapies with demonstrated benefits to the liver.
LPCN 2401 is expected to have a favorable benefit to risk profile as a non-invasive option for use as an adjunct to GLP-1 chronic weight management therapies for quality weight loss and/or as a monotherapy post cessation of GLP-1 chronic weight management therapies for weight and glycemic status maintenance with demonstrated benefits to the liver.
Additional clinical development pipeline candidates include: LPCN 1154 for postpartum depression (“PPD”); LPCN 2101 for epilepsy; LPCN 2203 for essential tremor and LPCN 2401 for improved body composition in obesity management.
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; and LPCN 2401 for improved body composition in obesity management.
In June 2024, we announced results from the PK bridge study which demonstrated LPCN 1154 meets bioequivalence with comparator, IV brexanolone, meeting standard bioequivalence criteria and C trough criteria. LPCN 1154 treatment was well-tolerated with no sedation nor somnolence events observed in the pivotal study.
In June 2024, we announced results from a dosing regimen confirmation study which demonstrated LPCN 1154 meets bioequivalence with comparator, IV brexanolone, meeting standard bioequivalence criteria and C trough criteria. LPCN 1154 treatment was well-tolerated with no sedation nor somnolence events observed in the dosing regimen confirmation study.
We will also continue efforts to enter into partnership arrangements for the continued development and/or marketing of LPCN 1144, LPCN 1148, LPCN 2401, LPCN 1107 as well as for the TRT Assets outside of the Currently Licensed TLANDO Territories. 5 Our products are based on our proprietary Lip’ral drug delivery technology platform.
We will also continue efforts to enter into partnership arrangements for the continued development and/or marketing of LPCN 1144, LPCN 1148, LPCN 2401, LPCN 1107 as well as for the TRT Assets outside of the Currently Licensed TLANDO Territories. Our products are based on our proprietary drug delivery technology platform. TLANDO was approved by the FDA in March 2022.
Accelerated Approval Accelerated Approval or Subpart H Approval is a program described in the NDA regulations that is intended to make promising products for life threatening diseases available on the basis of evidence of effect on a surrogate endpoint prior to formal demonstration of patient benefit.
A Priority designation is intended for those products that address unmet medical needs. 18 Accelerated Approval Accelerated Approval or Subpart H Approval is a program described in the NDA regulations that is intended to make promising products for life threatening diseases available on the basis of evidence of effect on a surrogate endpoint prior to formal demonstration of patient benefit.
Moreover, discontinuation of these therapies frequently results in a rapid regain in weight. Loss of lean mass has multiple negative health implications including weakness/fatigue and lowered metabolism which can cause a regain in fat mass, declines in neuromuscular function, potential effects on emotion and psychological states, and increased risk of injury.
Loss of lean mass has multiple negative health implications including weakness/fatigue, lowered metabolism which can cause a regain in fat mass, declines in neuromuscular function, potential effects on emotion and psychological states, and increased risk of injury.
The only FDA approved pharmacological treatment for ET was approved more than 50 years ago, and the majority of patients with ET experience a sub-optimal response with standard-of-care treatments, highlighting numerous and compelling unmet needs in care such as daytime efficacy and improved tolerability, a PRN (pro re nata) or “as needed” option, and a superior benefit-to-risk profile.
Overall, 90% of participants noted the emotional impact of ET, with 75% reporting tremor-related worry or anxiety. 10 The only FDA approved pharmacological treatment for ET was approved more than 50 years ago, and the majority of patients with ET experience a sub-optimal response with standard-of-care treatments, highlighting numerous and compelling unmet needs in care such as daytime efficacy and improved tolerability, a PRN (pro re nata) or “as needed” option, and a superior benefit-to-risk profile.
We are currently exploring partnerships for our liver programs LPCN 1144, our candidate for treatment of MASH and LPCN 1148 for the management of cirrhosis including prevention of the recurrence of overt hepatic encephalopathy (“overt hepatic encephalopathy” or “OHE”); LPCN 2401 for improved body composition in obesity management as adjunct therapy as an adjunct therapy to or as a monotherapy post cessation of incretin mimetics use; and LPCN 1107, our candidate for prevention of pre-term birth.
We are currently exploring partnerships for our liver program LPCN 1148 for the management of decompensated cirrhosis including prevention of the recurrence of overt hepatic encephalopathy (“overt hepatic encephalopathy” or “OHE”); LPCN 2401 for improved body composition as adjunct therapy to incretin mimetics use in obesity management; and LPCN 1107, our candidate for prevention of pre-term birth.
Often, these women experience hormonal and endogenous NAS imbalances, coupled with fluctuations in the blood levels of ASMs that impact control of seizures, efficacy of oral contraceptives, any coexisting anxiety and/or depression and any associated sleep impairment. Epileptic patients are 5-20 times more likely to develop depression. Clinical segmentation can be categorized by epilepsy type, comorbidities and patient subgroups.
Often, these women experience hormonal and endogenous NAS imbalances, coupled with fluctuations in the blood levels of ASMs that impact control of seizures, efficacy of oral contraceptives, any coexisting anxiety and/or depression and any associated sleep impairment. Epileptic patients are 5-20 times more likely to develop depression.
Orphan drug exclusivity, however, could also block the approval of one of our products for seven years if a competitor obtains approval of the same drug as defined by the FDA or if our drug candidate is determined to be contained within the competitor’s product for the same indication or disease. 20 Priority Review Priority Review is a designation for an NDA after it has been submitted to the FDA for review.
Orphan drug exclusivity, however, could also block the approval of one of our products for seven years if a competitor obtains approval of the same drug as defined by the FDA or if our drug candidate is determined to be contained within the competitor’s product for the same indication or disease.
Antares Pharma, Inc. markets a sub-cutaneous weekly auto-injector testosterone therapy, Xyosted®. Acerus Pharmaceuticals markets an intranasal testosterone therapy, NATESTO®. Finally, Tolmar Pharmaceuticals markets an oral TRT, JATENZO®, which received FDA approval in March 2019 and Marius Pharmaceuticals markets an oral TU, KYZATREX®, which received FDA approval for treatment of those with Klinefelter’s Syndrome in August 2022.
Acerus Pharmaceuticals markets an intranasal testosterone therapy, NATESTO®. Finally, Tolmar Pharmaceuticals markets an oral TRT, JATENZO®, which received FDA approval in March 2019 and Marius Pharmaceuticals markets an oral TU, KYZATREX®, which received FDA approval for treatment of those with Klinefelter’s Syndrome in August 2022.
LPCN 1107: An Oral Product Candidate for the Prevention of Preterm Birth (“PTB”) We are exploring the possibility of partnering with a third party for the development and/or marketing of LPCN 1107, although no partnering agreement has been entered into by us.
As the burden of chronic liver disease and cirrhosis is increasing, the frequency of HE is also increasing. LPCN 1107: An Oral Product Candidate for the Prevention of Preterm Birth (“PTB”) We are exploring the possibility of partnering with a third party for the development and/or marketing of LPCN 1107, although no partnering agreement has been entered into by us.
Unmet Medical Need We believe there is considerable unmet need within women with PPD due to lack of convenient and fast-acting oral therapies.
Unmet Medical Need We believe there is considerable unmet need within women with PPD due to lack of convenient and fast-acting oral therapies with good tolerability, especially with respect to CNS depressant effects.
Currently, there are no FDA approved drugs to treat secondary sarcopenia in decompensated cirrhosis beyond treatment of the underlying conditions. Lipocine is a leader in pursuing treatment for subjects with decompensated cirrhosis with sarcopenia, however, there are candidates known to be under development for cirrhosis related indication(s).
Reportedly, Xifaxan sales for the 12-month period ending November 2024 totaled ~ $2.5B. Currently, there are no FDA approved drugs to treat secondary sarcopenia in decompensated cirrhosis beyond treatment of the underlying conditions. Lipocine is a leader in pursuing treatment for subjects with decompensated cirrhosis with sarcopenia, however, there are candidates known to be under development for cirrhosis related indication(s).
Selective Serotonin Reuptake Inhibitors (“SSRIs”) have been the traditional first-line choice for women with severe PPD and require weeks for onset of efficacy; therefore, a need for an oral treatment option with a faster onset of action remains a significant unmet need in treating PPD, especially in mothers with moderate to severe depression prone to harmful actions.
Selective Serotonin Reuptake Inhibitors (“SSRIs”) have been the traditional first-line choice for women with severe PPD and require weeks for onset of efficacy; therefore, a need for an oral treatment option with a faster onset of action, short treatment duration, and improved tolerability remains a significant unmet need in treating PPD, especially in mothers with moderate to severe depression prone to harmful actions. 7 Injectable brexanolone (Zulresso™, SAGE Therapeutics (“Sage”)) became the first FDA-approved treatment for postpartum depression.
A Priority designation sets the target date for the FDA action on 90% of applications at eight months after submission for drugs considered new molecular entities and at 6 months after submission for drugs considered non-new molecular entities. A Priority designation is intended for those products that address unmet medical needs.
A Priority designation sets the target date for the FDA action on 90% of applications at eight months after submission for drugs considered new molecular entities and at 6 months after submission for drugs considered non-new molecular entities.
Verity also made an additional payment of $2.5 million to us on December 30, 2024, and is required to make an additional payment of $1 million to us before January 1, 2026.
Verity also made an additional payment of $2.5 million to us on December 30, 2024, and made the final license payment of $1 million to us on January 5, 2026.
Our Pipeline Product Candidates Our pipeline of clinical development candidates includes LPCN 1154 for PPD, LPCN 2101 for epilepsy, LPCN 2203 for essential tremor, and LPCN 2401 as an aid for improved body composition in obesity management. We will continue to explore other product development candidates targeting CNS indications with a significant unmet need.
Our Pipeline Product Candidates Our pipeline of clinical development candidates includes LPCN 1154 for PPD, LPCN 2201 for MDD, LPCN 2101 for epilepsy, and LPCN 2203 for essential tremor. We will continue to explore other product development candidates targeting CNS indications with a significant unmet need.
We believe LPCN 1154 targets the unmet need for robust, rapid relief of PPD symptoms with a 48-hour dosing duration through a convenient oral therapy candidate comprising bioidentical NASs with good tolerability. LPCN 2101: NAS for Epilepsy We are currently evaluating an additional NAS candidate, LPCN 2101, for women with epilepsy (“WWE”).
We believe LPCN 1154 targets the unmet need for robust, rapid relief of PPD symptoms with a 48-hour dosing duration through a convenient oral therapy candidate comprising bioidentical NASs with improved tolerability.
LPCN 2401 has potential for use as an adjunct to incretin mimetics (GLP-1/GIP agonists) including amplification of GLP-1 insulinotropic actions which is supported by studies demonstrating the role of androgen receptor agonist in regulation of GLP-1 through: ● Enhancement of GLP-1-mediated insulin release from β cells through genomic- and non-genomic mechanisms ● Increase in GLP-1 Receptor Expression in diabetics and non-diabetics ● Promoting proliferation of β cells and improving insulin sensitivity Target benefits of LPCN 2401 in combination with GLP-1 agonists include improved body composition with quality weight loss while attenuating lean mass loss, a serious unmet need, in addition to quality fat loss through appreciable abdominal fat loss.
LPCN 2401 has potential for use as an adjunct to incretin mimetics (GLP-1/GIP agonists) including amplification of GLP-1 insulinotropic actions which is supported by studies demonstrating the role of androgen receptor agonist in regulation of GLP-1 through: ● Enhancement of GLP-1-mediated insulin release from β cells through genomic- and non-genomic mechanisms ● Increase in GLP-1 Receptor Expression in diabetics and non-diabetics ● Promoting proliferation of β cells and improving insulin sensitivity Target benefits of LPCN 2401 in combination with GLP-1 agonists include inducing quality weight loss by attenuation of functionality and activities of daily life while lessening lean mass loss, a serious unmet need, especially for elderly and sarcopenic adult GLP-1 agonist users who are most vulnerable to accelerated lean mass loss and functional decline.
Transdermal patches include Allergan’s Androderm®. Intramuscular forms of testosterone also exist although commercialized mostly in generic forms by multiple companies and in branded form as Aveed® by Endo. Additionally, Endo markets the buccal testosterone replacement therapy Striant® and the Testopel® implantable testosterone pellets, which it acquired from Auxillium in 2015.
Intramuscular forms of testosterone also exist although commercialized mostly in generic forms by multiple companies and in branded form as Aveed® by Endo. Additionally, Endo markets the buccal testosterone replacement therapy Striant® and the Testopel® implantable testosterone pellets, which it acquired from Auxillium in 2015. Antares Pharma, Inc. markets a sub-cutaneous weekly auto-injector testosterone therapy, Xyosted®.
If drug products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements may apply. 21 Additionally, to the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post-marketing requirements, including fraud and abuse, privacy and transparency laws.
Additionally, to the extent that any of our products are sold in a foreign country, we may be subject to similar foreign laws and regulations, which may include, for instance, applicable post-marketing requirements, including fraud and abuse, privacy and transparency laws.
(1) Bank of American Global Reseach, Pharmaceutical Scripts/sales Data Report, Jan 21, 2025 Testosterone Replacement Therapy Market Overview The gel-based testosterone replacement products that are currently available include AbbVie’s AndroGel®, Lilly and Company’s Axiron® Topical Solution and Endo ’ s Testim® and Fortesta® along with their respective authorized generics as well as the equivalent generic versions of each.
Testosterone Replacement Therapy Market Overview The gel-based testosterone replacement products that are currently available include AbbVie’s AndroGel®, Lilly and Company’s Axiron® Topical Solution and Endo ’ s Testim® and Fortesta® along with their respective authorized generics as well as the equivalent generic versions of each. Transdermal patches include Allergan’s Androderm®.
Postpartum Depression SAGE Therapeutics’ product ZURZUVAE (zuranolone), an oral, once-daily, 14-day treatment for PPD was approved by the FDA in August 2023. ZURZUVAE became commercially available in December 2023.
Some companies engaged in development/commercialization include Seaport Therapeutics and Praxis Precision Medicines. Postpartum Depression SAGE Therapeutics’ product ZURZUVAE (zuranolone), an oral, once-daily, 14-day treatment for PPD was approved by the FDA in August 2023. ZURZUVAE became commercially available in December 2023.
Lip’ral-based TLANDO was approved by the FDA in March 2022. Lip’ral technology is a patented technology based on lipidic compositions which form an optimal dispersed phase in the gastrointestinal environment for improved absorption of insoluble drugs.
Our patented technology is based on lipidic compositions which form an optimal dispersed phase in the gastrointestinal environment for improved absorption of insoluble drugs.
In an interview study of ET patients and care partners, the most common impacts on activities of daily living are pouring liquids and writing/typing (100%) and grooming/hygiene, drinking, dressing, eating, and reading (80-85%). Overall, 90% of participants noted the emotional impact of ET, with 75% reporting tremor-related worry or anxiety.
In an interview study of ET patients and care partners, the most common impacts on activities of daily living are pouring liquids and writing/typing (100%) and grooming/hygiene, drinking, dressing, eating, and reading (80-85%).
Caregivers for WWE in the preconception phase either intending to start a family (planning pregnancy) or using contraception to prevent an unplanned pregnancy face significant challenges to balance seizure control efficacy with the selection and dosage of ASMs and ASM-related risks such as, among other risks, fetal-neonatal toxicity, contraception failure, and psychiatric side effects.
Caregivers for WWE in the preconception phase either intending to start a family (planning pregnancy) or using contraception to prevent an unplanned pregnancy face significant challenges to balance seizure control efficacy with the selection and dosage of ASMs and ASM-related risks such as, among other risks, fetal-neonatal toxicity, contraception failure, and psychiatric side effects. 9 Several ASMs are known to have teratogenic effects on the developing fetus (converging evidence from registry studies indicates that teratogenic risks are highest with valproate, followed by carbamazepine and topiramate).
As a result, coverage and adequate third-party reimbursement may not be available for our products to enable us to realize an appropriate return on our investment in research and product development. The Inflation Reduction Act of 2022 (Pub. L.
As a result, coverage and adequate third-party reimbursement may not be available for our products to enable us to realize an appropriate return on our investment in research and product development. 19 The Inflation Reduction Act of 2022 (Pub. L. No. 117-169) includes a number of provisions aimed at lowering prescription drug costs and reducing government spending on drugs.
(“Antares”), was terminated and the transition of the U.S. commercial rights for TLANDO from Antares to Verity was completed on February 1, 2024, for the distribution, marketing and sale of TLANDO.
On January 31, 2024, our license agreement with the former licensee (the “Antares License Agreement”), Antares Pharma, Inc. (“Antares”), was terminated and the transition of the U.S. commercial rights for TLANDO from Antares to Verity was completed on February 1, 2024, for the distribution, marketing and sale of TLANDO.
In April 2024, Lipocine announced results from a multi-center prospective, blinded Phase 2 study, which demonstrated placebo-adjusted increase in lean mass of 4.4%, decrease in fat mass of 6.7%, reduction in trunk fat mass of 2.5%, and increased bone mineral content of 2.8% with LPCN 2401+E in a population consistent with FDA guidance for developing products for weight management.
In April 2024, Lipocine announced results from a multi-center prospective, blinded Phase 2 study, which demonstrated increases in lean mass of 4.4%, decreases in fat mass of 6.7%, reduction android fat 4.1%, and increased bone mineral content of 2.8% in a population consistent with GLP-1 use for weight management.
Disease Overview – Cirrhosis There are over two million cases of cirrhosis worldwide, with over 500,000 people living with decompensated cirrhosis in the U.S. Non-alcoholic fatty liver disease is the most rapidly increasing indication for liver transplant. 62% of those on the liver transplant (“LT”) waitlist are male and the economic burden (approximately $812,500/transplant) is high and continues to increase.
Non-alcoholic fatty liver disease is the most rapidly increasing indication for liver transplant. 62% of those on the liver transplant (“LT”) waitlist are male and the economic burden (approximately $812,500/transplant) is high and continues to increase.
Patients with epilepsy have increased risk of mortality due to direct effects of seizures (e.g., status epilepticus, car accidents) and indirect effects of seizures (e.g., suicide, cardiovascular effects.) Epilepsy is a disorder of the brain that causes seizures, affecting the physical, mental, and social well-being of persons, and is associated with a 2 to 3 times greater mortality rate compared with the general population.
Epilepsy is a disorder of the brain that causes seizures, affecting the physical, mental, and social well-being of persons, and is associated with a 2 to 3 times greater mortality rate compared with the general population.
In October 2024, SAGE Therapeutics announced plans to discontinue marketing their injectable version of an endogenous neuroactive steroid, brexanolone, ZULRESSO™, for treatment in PPD in order to focus their commercial efforts on ZURZUVAE. Cirrhosis/MASH Market Overview Decompensated cirrhosis patients with sarcopenia exhibit significantly shorter overall survival than those without sarcopenia.
In October 2024, SAGE Therapeutics announced plans to discontinue marketing their injectable version of an endogenous neuroactive steroid, brexanolone, ZULRESSO™, for treatment in PPD in order to focus their commercial efforts on ZURZUVAE.
(1) Ref: Caterson and Hubbard et al. 2004; Calle and Thun et al. 1999 (2) https://news.harvard.edu/gazette/story/2012/03/the-big-setup/ (3) https://www.ncbi.nlm.nih.gov/books/NBK305895/ (4) https://pmc.ncbi.nlm.nih.gov/articles/PMC6316192/#sec3-nutrients-10-01976 (5) https://www.jpmorgan.com/insights/global-research/current-events/obesity-drugs (6 ) Ref: Flynn et al. Morgan Stanley, February 27, 2024 https://www.cdc.gov/nchs/products/databriefs/db360.htm (7) J. Gerontol. A Biol. Sci. Med.
(1) Ref: Caterson and Hubbard et al. 2004; Calle and Thun et al. 1999 (2) https://news.harvard.edu/gazette/story/2012/03/the-big-setup/ (3) https://www.ncbi.nlm.nih.gov/books/NBK305895/ (4) https://pmc.ncbi.nlm.nih.gov/articles/PMC6316192/#sec3-nutrients-10-01976 (5) https://www.jpmorgan.com/insights/global-research/current-events/obesity-drugs (6) Ref: Flynn et al. Morgan Stanley, February 27, 2024 LPCN 1148: Oral Product Candidate for the Management of Decompensated Cirrhosis We are currently evaluating LPCN 1148 comprising testosterone laurate (“TL”) for the management of decompensated cirrhosis.
The FDA concluded that the available evidence does not show Makena is effective for its approved use and withdrew its approval of Makena and ordered the immediate withdrawal of Makena and several approved generic versions of the drug, making it unlawful for the drug to be distributed in the U.S.
The FDA concluded that the available evidence does not show Makena is effective for its approved use and withdrew its approval of Makena and ordered the immediate withdrawal of Makena and several approved generic versions of the drug, making it unlawful for the drug to be distributed in the U.S. 15 Intellectual Property Drug Delivery Technologies for Lipophilic Drug Substances Our patent portfolio is directed to various types of compositions and methods for delivery of lipophilic drugs, which are drugs that are soluble in lipids.
There may continue to be additional proposals relating to the reform of the U.S. healthcare system, in the future, some of which could further limit coverage and reimbursement of drug products.
There may continue to be additional proposals relating to the reform of the U.S. healthcare system, in the future, some of which could further limit coverage and reimbursement of drug products. If drug products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements may apply.
We entered into a license agreement for the development and commercialization of our product candidate, TLANDO®, an oral treatment indicated for testosterone replacement therapy (“testosterone replacement therapy” or “TRT”) in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadotropic hypogonadism) comprised of testosterone undecanoate (“testosterone undecanoate” or “TU”).
The license agreement is for the development and commercialization of our product, TLANDO, an oral treatment indicated for testosterone replacement therapy (“testosterone replacement therapy” or “TRT”) in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadotropic hypogonadism) comprised of testosterone undecanoate (“testosterone undecanoate” or “TU”) and any post-marketing studies required by the United States Food and Drug Administration (“FDA”) will also be the responsibility of Verity.
There can be no guarantee that we will be able to identify or enter into partnering arrangements on terms that are beneficial to us or at all.
There can be no guarantee that we will be able to identify or enter into partnering arrangements on terms that are beneficial to us or at all. Even if we do enter into partnering arrangements, such arrangements may not be sufficient to successfully develop and commercialize these products.
The Inflation Reduction Act of 2022 signals an increased desire to control the prices and costs associated with pharmaceutical products. In recent years, state laws have been enacted to lower prescription drug costs and prices.
The Inflation Reduction Act of 2022 signals an increased desire to control the prices and costs associated with pharmaceutical products.
Similarly, SPC and Pharmalink are responsible for obtaining any regulatory/marketing approvals for TLANDO required for the SPC Territory and the Pharmalink Territory, respectively. Upon execution of the Verity License Agreement, Verity paid us an initial payment of $2.5 million which was received on signing of the License Agreement and $5 million which was received on February 1, 2024.
Upon execution of the Verity License Agreement, Verity paid us an initial payment of $2.5 million which was received on signing of the License Agreement and $5 million which was received on February 1, 2024.
There is a significant unmet need for an oral, efficacious, muscle preserving/gaining option for chronic obesity/weight management that ameliorates the loss of lean mass associated with GLP-1/GIP agonist treatment, resulting in a higher quality weight loss and improved functionality, especially in elderly obese and sarcopenic obese patients.
Therefore, a focus on body composition in obesity management to sustainably lose fat mass while maintaining lean mass should be an essential goal. There is a significant unmet need for an oral, efficacious, muscle preserving/gaining option for chronic obesity/weight management that ameliorates the loss of lean mass associated with GLP-1/GIP agonist treatment, resulting in a higher quality weight loss.
Moreover, as an adjunct to incretin mimetics, LPCN 2401 may increase weight loss, particularly in diabetics, through increased expression activity of GLP1R and increased effectiveness of GIP1 therapies secondary to actions at GLP1R (glucose lowering). LPCN 2401 could also be potentially used as monotherapy post discontinuation of GLP-1 agonist to manage weight/fat regain and durability of diabetes remission.
Moreover, as an adjunct to incretin mimetics, LPCN 2401 may help maintain or increase weight loss, particularly in diabetics, through increased expression activity of GLP1R and increased effectiveness of GIP1 therapies secondary to actions at GLP1R (glucose lowering).
Women of CB age with epilepsy face many additional challenges such as hormonal influences on seizure activity and endocrine function throughout the different phases of their reproductive cycles, and approximately 30% of patients with epilepsy cannot efficiently control their seizures with available ASMs, making consideration of newer pharmacological treatment development options important. 9 Managing uncontrolled seizures in WWE of CB age is the primary aim during preconception, pregnancy, and postpartum phases.
Unmet need to treat WWE in CB age Approximately 30% of patients with epilepsy cannot efficiently control their condition with available ASMs, making consideration of newer pharmacological treatment development options important, and managing uncontrolled seizures in WWE of CB age is the primary aim during preconception, pregnancy, and postpartum phases.
In addition to approval for Zulresso, SAGE Therapeutics received FDA approval for zuranolone (brand name ZURZUVAE™) in August 2023 and ZURZUVAE was launched commercially in December 2023. Zuranolone, a synthetic neuroactive steroid derivative, is an oral, once daily 14-day treatment for postpartum depression and is the first oral medication approved by the FDA for the treatment of postpartum depression.
Zuranolone, a synthetic neuroactive steroid derivative, is an oral, once daily 14-day treatment for postpartum depression and is the first oral medication approved by the FDA for the treatment of postpartum depression.
Acrux also confirmed the availability of an authorized generic version of Axiron in the United States, through a marketing and distribution agreement between Lilly and Company and a leading authorized generics company.
Acrux also confirmed the availability of an authorized generic version of Axiron in the United States, through a marketing and distribution agreement between Lilly and Company and a leading authorized generics company. Hydroxyprogesterone caproate, or HPC, Preterm Birth, or PTB, Market Overview PTB is defined as delivery before 37 weeks of gestation.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIn recent years, the stock of other biotechnology and biopharmaceutical companies has experienced extreme price fluctuations that have been unrelated to the operating performance of the affected companies. There can be no assurance that the market price of our shares of common stock will not experience significant fluctuations in the future, including fluctuations that are unrelated to our performance.
Biggest changeThere can be no assurance that the market price of our shares of common stock will not experience significant fluctuations in the future, including fluctuations that are unrelated to our performance. These fluctuations may result due to macroeconomic and world events, national or local events, general perception of the biotechnology industry or to a lack of liquidity.
The ramifications of the results of these studies conducted by Verity, or the ramifications of Verity’s inability or unwillingness to conduct these studies, are unknown to us and would be the between Verity and the FDA.
The ramifications of the results of these studies conducted by Verity, or the ramifications of Verity’s inability or unwillingness to conduct these studies, are unknown to us and would be between Verity and the FDA.
Moreover, any regulatory approval of a drug which is eventually obtained may entail limitations on the indicated uses for which that drug may be marketed. Furthermore, product approvals may be withdrawn or limited in some way if problems occur following initial marketing or if compliance with regulatory standards is not maintained.
Moreover, any regulatory approval of a drug which is eventually obtained may entail limitations on the indicated uses for which that drug may be marketed. Furthermore, product approvals may be withdrawn or limited in some way if problems occur following initial marketing or if compliance with regulatory standards is not maintained.
The proposal reflects a clear intent to substantially alter many of the current drug discount and services compensation practices among pharmaceutical manufacturers and Medicare and Medicaid managed care organizations and their pharmacy benefit managers.
The proposal reflects a clear intent to substantially alter many of the current drug discount and services compensation practices among pharmaceutical manufacturers and Medicare and Medicaid managed care organizations and their pharmacy benefit managers.
The proposal also reflects a skepticism that current drug discount and compensation practices among manufacturers and pharmacy benefit managers are sufficiently transparent to health plans to ensure that all appropriate cost reductions and value is passed through to health plans and reflected in lower health plans costs and lower premiums for beneficiaries.
The proposal also reflects a skepticism that current drug discount and compensation practices among manufacturers and pharmacy benefit managers are sufficiently transparent to health plans to ensure that all appropriate cost reductions and value is passed through to health plans and reflected in lower health plans costs and lower premiums for beneficiaries.
If we elect to increase our expenditures to fund development or commercialization activities either inside or outside of the United States on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms, or at all.
If we elect to increase our expenditures to fund development or commercialization activities either inside or outside of the United States on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms, or at all.
If a third-party claims that we or our collaborators infringe its intellectual property rights, we may face a number of issues, including, but not limited to: ● infringement and other intellectual property claims which, regardless of merit, may be expensive and time-consuming to litigate and may divert our management’s attention from our core business; 50 ● substantial damages for infringement, which we may have to pay if a court decides that the product at issue infringes on or violates the third party’s rights, and if the court finds that the infringement was willful, we could be ordered to pay treble damages and the patent owner’s attorneys’ fees; ● a court prohibiting us from selling or licensing the product unless the third-party licenses its product rights to us, which it is not required to do; ● if a license is available from a third party, we may have to pay substantial royalties, upfront fees and/or grant cross-licenses to intellectual property rights for our products; and ● redesigning our products or processes so they do not infringe, which may not be possible or may require substantial monetary expenditures and time.
If a third-party claims that we or our collaborators infringe its intellectual property rights, we may face a number of issues, including, but not limited to: ● infringement and other intellectual property claims which, regardless of merit, may be expensive and time-consuming to litigate and may divert our management’s attention from our core business; ● substantial damages for infringement, which we may have to pay if a court decides that the product at issue infringes on or violates the third party’s rights, and if the court finds that the infringement was willful, we could be ordered to pay treble damages and the patent owner’s attorneys’ fees; ● a court prohibiting us from selling or licensing the product unless the third-party licenses its product rights to us, which it is not required to do; ● if a license is available from a third party, we may have to pay substantial royalties, upfront fees and/or grant cross-licenses to intellectual property rights for our products; and ● redesigning our products or processes so they do not infringe, which may not be possible or may require substantial monetary expenditures and time.
Obtaining approval of any of our product candidates is an extensive, lengthy, expensive and uncertain process, and the FDA may delay, limit or deny approval for many reasons, including: ● we may not be able to demonstrate that the product candidate is safe and effective to the satisfaction of the FDA; ● the results of our clinical trials may not meet the level of statistical or clinical significance required by the FDA for marketing approval; ● the FDA may disagree with the number, design, size, conduct or implementation of our clinical trials; ● the contract research organization that we retain to manage our clinical trials may take actions outside of our control that materially adversely impact our clinical trials; ● the FDA may not find the data from preclinical studies and clinical trials sufficient to demonstrate that a particular product candidate’s clinical and other benefits outweigh its safety risks; ● the FDA may disagree with our interpretation of data from our preclinical studies and/or clinical trials or may require that we conduct additional trials; ● the FDA may not accept data generated at our clinical trial sites; ● if an NDA, once submitted, is reviewed by an Advisory Committee, the FDA may have difficulties scheduling an Advisory Committee meeting in a timely manner or the Advisory Committee may recommend against approval of our application or may recommend that the FDA require, as a condition of approval, additional preclinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions; ● the FDA may require development of a REMS as a condition of approval; ● the FDA may require longer or additional duration of stability data on the clinical lots prior to initiation of further clinical trials; and ● the FDA may identify deficiencies in the formulation or stability of our product candidates or products, or relating to our manufacturing processes or facilities, or in the processes and facilities of the contract manufacturing organization (“CMO”), our suppliers, or other third parties that may be utilized in the production supply chain of our products.
Obtaining approval of any of our product candidates is an extensive, lengthy, expensive and uncertain process, and the FDA may delay, limit or deny approval for many reasons, including: ● we may not be able to demonstrate that the product candidate is safe and effective to the satisfaction of the FDA; ● the results of our clinical trials may not meet the level of statistical or clinical significance required by the FDA for marketing approval; ● the FDA may disagree with the number, design, size, conduct or implementation of our clinical trials; ● the contract research organizations that we retain to manage our clinical trials may take actions outside of our control that materially adversely impact our clinical trials; ● the FDA may not find the data from preclinical studies and clinical trials sufficient to demonstrate that a particular product candidate’s clinical and other benefits outweigh its safety risks; ● the FDA may disagree with our interpretation of data from our preclinical studies and/or clinical trials or may require that we conduct additional trials; ● the FDA may not accept data generated at our clinical trial sites; ● if an NDA, once submitted, is reviewed by an Advisory Committee, the FDA may have difficulties scheduling an Advisory Committee meeting in a timely manner or the Advisory Committee may recommend against approval of our application or may recommend that the FDA require, as a condition of approval, additional preclinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions; ● the FDA may require development of a REMS as a condition of approval; ● the FDA may require longer or additional duration of stability data on the clinical lots prior to initiation of further clinical trials; and ● the FDA may identify deficiencies in the formulation or stability of our product candidates or products, or relating to our manufacturing processes or facilities, or in the processes and facilities of the contract manufacturing organizations (“CMO”), our suppliers, or other third parties that may be utilized in the production supply chain of our products.
Risks Related to Our Dependence on Third Parties ● our reliance on third-party contractors and service providers for the execution of some aspects of our development programs; ● our reliance on contract research organizations or other third parties to assist us in conducting clinical trials; ● our reliance on suppliers for the active and inactive ingredients for our products; and ● our ability to establish successful collaborations for our products. 24 Risks Related to Ownership of Our Common Stock ● our stock price’s reaction to the results and timing of clinical trials, regulatory and other decisions; ● the effectiveness of our internal control over financial reporting; ● the cost and expense to comply with the requirements of being a public company; ● the volatility of our share price; ● the possibility of delisting of our securities from the Nasdaq Capital Market; ● anti-takeover provisions in our amended and restated certificate of incorporation and our amended and restated bylaws, as well as provisions of Delaware law and our stockholder rights plan; ● our decision not to pay dividends on our common stock; ● our management and directors’ ability to exert influence over our affairs; ● volatility in the trading price of our common stock; and ● any failure of securities or industry analysts to publish accurate research about our business.
Risks Related to Our Dependence on Third Parties ● our reliance on third-party contractors and service providers for the execution of some aspects of our development programs; ● our reliance on contract research organizations or other third parties to assist us in conducting clinical trials; ● our reliance on suppliers for the active and inactive ingredients for our products; and ● our ability to establish successful collaborations for our products. 22 Risks Related to Ownership of Our Common Stock ● our stock price’s reaction to the results and timing of clinical trials, regulatory and other decisions; ● the effectiveness of our internal control over financial reporting; ● the cost and expense to comply with the requirements of being a public company; ● the volatility of our share price; ● the possibility of delisting of our securities from the Nasdaq Capital Market; ● anti-takeover provisions in our amended and restated certificate of incorporation and our amended and restated bylaws, as well as provisions of Delaware law and our stockholder rights plan; ● our decision not to pay dividends on our common stock; ● our management and directors’ ability to exert influence over our affairs; ● volatility in the trading price of our common stock; and ● any failure of securities or industry analysts to publish accurate research about our business.
Risks Relating to Our Intellectual Property ● our ability to protect our intellectual property; ● our ability to obtain additional protection under the Drug Price Competition and Patent Term Restoration Act; ● the possibility of incurring substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, or our inability to protect our rights to our products and technology; ● the cost and expense, and any unfavorable outcomes, resulting from any claims for infringing intellectual property rights of third parties; ● the fact that we do not have patent protection for our product candidates in a significant number of countries; ● our ability to comply with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies; and ● the possibility that we may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers. 25 Risks Relating to Our Business and Industry The timelines and costs of our clinical trials may be impacted by numerous factors and any delays may adversely affect our ability to execute our current business strategy.
Risks Relating to Our Intellectual Property ● our ability to protect our intellectual property; ● our ability to obtain additional protection under the Drug Price Competition and Patent Term Restoration Act; ● the possibility of incurring substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, or our inability to protect our rights to our products and technology; ● the cost and expense, and any unfavorable outcomes, resulting from any claims for infringing intellectual property rights of third parties; ● the fact that we do not have patent protection for our product candidates in a significant number of countries; ● our ability to comply with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies; and ● the possibility that we may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers. 23 Risks Relating to Our Business and Industry The timelines and costs of our clinical trials may be impacted by numerous factors and any delays may adversely affect our ability to execute our current business strategy.
For example, all regular Schedule III drug prescriptions must be signed by a physician and may not be refilled more than six months after the date of the original prescription or more than five times unless renewed by the physician. 37 Entities must register annually with the DEA to manufacture, distribute, dispense, import, export and conduct research using controlled substances.
For example, all regular Schedule III drug prescriptions must be signed by a physician and may not be refilled more than six months after the date of the original prescription or more than five times unless renewed by the physician. Entities must register annually with the DEA to manufacture, distribute, dispense, import, export and conduct research using controlled substances.
If we raise additional funds through collaboration, strategic alliance and licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, our intellectual property, future revenue streams or grant licenses on terms that are not favorable to us. 46 We cannot predict when we will generate product revenues and may never achieve or maintain profitability.
If we raise additional funds through collaboration, strategic alliance and licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, our intellectual property, future revenue streams or grant licenses on terms that are not favorable to us. We cannot predict when we will generate product revenues and may never achieve or maintain profitability.
Our future capital requirements may be substantial and will depend on many factors including: ● market conditions for raising capital, particularly for life science companies; 45 ● current and future clinical trials for our product candidates, including for LPCN 1154, LPCN 2401, LPCN 2101, LPCN 2203 and LPCN 1148; ● regulatory actions of the FDA; ● the scope, size, rate of progress, results and costs of completing ongoing clinical trials and development plans with our product candidates; ● the cost, timing and outcomes of our efforts to obtain marketing approval for our product candidates in the United States; ● payments received under any current or future license agreements, strategic partnerships or collaborations; ● the cost of filing, prosecuting and enforcing patent claims; ● the costs associated with commercializing our product candidates if we receive marketing approval for product candidates other than TLANDO, including the cost and timing of developing internal sales and marketing capabilities or entering into strategic collaborations to market and sell our products; ● the costs of on-going and future litigation; and ● funding additional product line expansions.
Our future capital requirements may be substantial and will depend on many factors including: ● market conditions for raising capital, particularly for life science companies; ● current and future clinical trials for our product candidates, including for LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401 and LPCN 1148; ● regulatory actions of the FDA; ● the scope, size, rate of progress, results and costs of completing ongoing clinical trials and development plans with our product candidates; ● the cost, timing and outcomes of our efforts to obtain marketing approval for our product candidates in the United States; ● payments received under any current or future license agreements, strategic partnerships or collaborations; ● the cost of filing, prosecuting and enforcing patent claims; ● the costs associated with commercializing our product candidates if we receive marketing approval for product candidates other than TLANDO, including the cost and timing of developing internal sales and marketing capabilities or entering into strategic collaborations to market and sell our products; ● the costs of on-going and future litigation; and ● funding additional product line expansions.
Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to predict the timing or amount of expenses and when we will be able to achieve or maintain profitability, if ever. We have incurred significant operating losses in most years since our inception and anticipate that we will incur continued losses for the foreseeable future.
Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to predict the timing or amount of expenses and when we will be able to achieve or maintain profitability, if ever. 43 We have incurred significant operating losses in most years since our inception and anticipate that we will incur continued losses for the foreseeable future.
This includes a requirement that the Department of Health and Human Services negotiate a “maximum fair price” with drug manufacturers for certain single-source brand drugs or biologics without generic or biosimilar competitors that are covered under Medicare Part D and Part B. This pricing will begin in 2026 for Medicare Part D and 2028 for Medicare Part B.
This includes a requirement that the Department of Health and Human Services negotiate a “maximum fair price” with drug manufacturers for certain single-source brand drugs or biologics without generic or biosimilar competitors that are covered under Medicare Part D and Part B. This pricing began in 2026 for Medicare Part D and will begin in 2028 for Medicare Part B.
We may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. For example, to our knowledge, HPC has not been administered orally in a published clinical trial in any pregnant woman for the prevention of PTB.
We may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. 34 For example, to our knowledge, HPC has not been administered orally in a published clinical trial in any pregnant woman for the prevention of PTB.
If the regulation becomes effective, it could result in lower prices for pharmaceutical products in general. Any further legislative or administrative action to reduce reimbursement or health benefits to beneficiaries under the Medicare or Medicaid program could affect the payment we could collect from sale of any product in the United States.
If the regulation becomes effective, it could result in lower prices for pharmaceutical products in general. 33 Any further legislative or administrative action to reduce reimbursement or health benefits to beneficiaries under the Medicare or Medicaid program could affect the payment we could collect from sale of any product in the United States.
On November 14, 2019, the Company and certain of its officers were named as defendants in a purported shareholder class action lawsuit, Solomon Abady v. Lipocine Inc. et al ., 2:19-cv-00906-PMW, filed in the United District Court for the District of Utah.
On November 14, 2019, the Company and certain of its officers were named as defendants in a purported shareholder class action lawsuit, Solomon Abady v. Lipocine Inc. et al ., 2:19-cv-00906-PMW, filed in the United States District Court for the District of Utah.
Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. 40 Problems with the timeliness or quality of the work of a CRO may lead us to seek to terminate the relationship and use an alternative service provider.
Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. Problems with the timeliness or quality of the work of a CRO may lead us to seek to terminate the relationship and use an alternative service provider.
Conversely, our capital resources could last longer if we reduce expenses, reduce the number of activities currently contemplated under our operating plan or if we terminate or suspend on-going clinical studies. Funding may not be available to us on favorable terms, or at all.
Conversely, our capital resources could last longer if we reduce expenses, reduce the number of activities currently contemplated under our operating plan or if we terminate or suspend on-going clinical studies. 42 Funding may not be available to us on favorable terms, or at all.
If our confidential or proprietary information is divulged to or acquired by third parties, including our competitors, our competitive position in the marketplace will be harmed and our ability to successfully generate revenues from our product candidates, if approved by the FDA or other regulatory authorities, could be adversely affected.
If our confidential or proprietary information is divulged to or acquired by third parties, including our competitors, our competitive position in the marketplace could be harmed and our ability to successfully generate revenues from our product candidates, if approved by the FDA or other regulatory authorities, could be adversely affected.
Our management and other personnel will need to devote a substantial amount of time to compliance with these laws and regulations. These requirements have increased and will continue to increase our legal, accounting, and financial compliance costs and have made and will continue to make some activities more time-consuming and costly.
Our management and other personnel will need to devote a substantial amount of time to compliance with these laws and regulations. These requirements have increased and could continue to increase our legal, accounting, and financial compliance costs and have made and will continue to make some activities more time-consuming and costly.
Such legislation and regulation bears upon, among other things, the approval of protocols and human testing, the approval of manufacturing facilities, safety of the product candidates, testing procedures and controlled research, review and approval of manufacturing, preclinical and clinical data prior to marketing approval including adherence to cGMP during production and storage as well as regulation of marketing activities including advertising and labeling. 28 In order to obtain regulatory clearance for the commercial sale of any of our product candidates, we must demonstrate through preclinical studies and clinical trials that the potential product is safe and efficacious for use in humans for each target indication.
Such legislation and regulation bears upon, among other things, the approval of protocols and human testing, the approval of manufacturing facilities, safety of the product candidates, testing procedures and controlled research, review and approval of manufacturing, preclinical and clinical data prior to marketing approval including adherence to cGMP during production and storage as well as regulation of marketing activities including advertising and labeling. 26 In order to obtain regulatory clearance for the commercial sale of any of our product candidates, we must demonstrate through preclinical studies and clinical trials that the potential product is safe and efficacious for use in humans for each target indication.
We engaged a CRO to conduct our SOAR, DV and DF Phase 3 clinical studies for TLANDO, as well as the ABPM study for TLANDO. Additionally, we utilized a CRO for the Phase 2 LiFT clinical study for LPCN 1144, the Phase 2 clinical study for LPCN 1148 and the pilot, pivotal and future studies for LPCN 1154.
We engaged a CRO to conduct our SOAR, DV and DF Phase 3 clinical studies for TLANDO, as well as the ABPM study for TLANDO. Additionally, we utilized a CRO for the Phase 2 LiFT clinical study for LPCN 1144, the Phase 2 clinical study for LPCN 1148 and the pilot, pivotal and Phase 3 studies for LPCN 1154.
For example: ● others may be able to make or use compounds that are the same or similar to the pharmaceutical compounds used in our product candidates but that are not covered by the claims of our patents; ● the Active Pharmaceutical Ingredients (“APIs”) in our licensed product TLANDO and current product candidates LPCN 1154, LPCN 2401, LPCN 1148, LPCN 1144, LPCN 1111, and LPCN 1107 are, or may soon become, commercially available in generic drug products, and no patent protection may be available without regard to formulation or method of use; ● we may not be able to detect infringement against our owned or licensed patents, which may be especially difficult for manufacturing processes or formulation patents; ● we might not have been the first to make the inventions covered by our issued patents or pending patent applications or those we license; ● we might not have been the first to file patent applications for these inventions; ● others may independently develop similar or alternative technologies or duplicate any of our technologies; ● it is possible that our pending patent applications or those of our licensor will not result in issued patents; ● it is possible that there are dominating patents to any of our product candidates of which we are not aware; ● it is possible that there are prior public disclosures that could invalidate our patents, or parts of our patents, of which we are not aware; ● it is possible that others may circumvent our owned or licensed patents; ● it is possible that there are unpublished applications or other patent applications maintained in secrecy that may issue later than our patents/applications but may have priority dates that are earlier than our priority dates and may have claims covering our products or technology similar to ours; ● the laws of foreign countries may not protect our proprietary rights to the same extent as the laws of the United States; ● the claims of our owned or licensed issued patents or patent applications, if and when issued, may not cover our product candidates; ● our issued patents or those of our licensor may not provide us with any competitive advantages, or may be narrowed in scope, be held invalid or unenforceable as a result of legal challenges by third parties; ● our licensor or licensees as the case may be, who have access to our patents, may attempt to enforce our owned or licensed patents, which if unsuccessful, may result in narrower scope of protection of our owned or licensed patents or our owned or licensed patents becoming invalid or unenforceable; ● we may not develop additional proprietary technologies for which we can obtain patent protection; or ● the patents of others may have an adverse effect on our business.
For example: ● others may be able to make or use compounds that are the same or similar to the pharmaceutical compounds used in our product candidates but that are not covered by the claims of our patents; ● the Active Pharmaceutical Ingredients (“APIs”) in our licensed product TLANDO and current product candidates LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401, LPCN 1148, and LPCN 1107 are, or may soon become, commercially available in generic drug products, and no patent protection may be available without regard to formulation or method of use; ● we may not be able to detect infringement against our owned or licensed patents, which may be especially difficult for manufacturing processes or formulation patents; ● we might not have been the first to make the inventions covered by our issued patents or pending patent applications or those we license; ● we might not have been the first to file patent applications for these inventions; ● others may independently develop similar or alternative technologies or duplicate any of our technologies; ● it is possible that our pending patent applications or those of our licensor will not result in issued patents; ● it is possible that there are dominating patents to any of our product candidates of which we are not aware; ● it is possible that there are prior public disclosures that could invalidate our patents, or parts of our patents, of which we are not aware; ● it is possible that others may circumvent our owned or licensed patents; ● it is possible that there are unpublished applications or other patent applications maintained in secrecy that may issue later than our patents/applications but may have priority dates that are earlier than our priority dates and may have claims covering our products or technology similar to ours; ● the laws of foreign countries may not protect our proprietary rights to the same extent as the laws of the United States; ● the claims of our owned or licensed issued patents or patent applications, if and when issued, may not cover our product candidates; ● our issued patents or those of our licensor may not provide us with any competitive advantages, or may be narrowed in scope, be held invalid or unenforceable as a result of legal challenges by third parties; ● our licensor or licensees as the case may be, who have access to our patents, may attempt to enforce our owned or licensed patents, which if unsuccessful, may result in narrower scope of protection of our owned or licensed patents or our owned or licensed patents becoming invalid or unenforceable; ● we may not develop additional proprietary technologies for which we can obtain patent protection; or ● the patents of others may have an adverse effect on our business.
Our ability to generate revenues from this and other collaborative arrangements, including with SPC and Pharmalink, will depend on our collaborators’ abilities and efforts to successfully perform the functions agreed to with them in these arrangements.
Our ability to generate revenues from this and other collaborative arrangements, including with SPC, Pharmalink, and Aché will depend on our collaborators’ abilities and efforts to successfully perform the functions agreed to with them in these arrangements.
While we believe we have sufficient liquidity and capital resources to fund our projected operating requirements through at least March 31, 2026, we will need to raise additional capital at some point through the equity or debt markets or through out-licensing activities, either before or after March 31, 2026, to support our operations, the on-going clinical development of our product candidates, and compliance with regulatory requirements.
While we believe we have sufficient liquidity and capital resources to fund our projected operating requirements through at least March 31, 2027, we will need to raise additional capital at some point through the equity or debt markets or through out-licensing activities, either before or after March 31, 2027, to support our operations, the on-going clinical development of our product candidates, and compliance with regulatory requirements.
In such an event, our competitors might be able to enter the market and this circumstance would have a material adverse effect on our business. We also may rely on trade secrets and confidentiality agreements to protect our technology and know-how, especially where we do not believe patent protection is appropriate or obtainable.
In such an event, our competitors might be able to enter the market and this circumstance could have a material adverse effect on our business. We also may rely on trade secrets and confidentiality agreements to protect our technology and know-how, especially where we do not believe patent protection is appropriate or obtainable.
Payers may require a more arduous prior authorization process as a condition to payment for TRT therapy. This could adversely affect the market for TRT products. 30 In the United States and in many other countries, pricing and/or profitability of some or all prescription pharmaceuticals and biopharmaceuticals are subject to varying degrees of government control.
Payers may require a more arduous prior authorization process as a condition to payment for TRT therapy. This could adversely affect the market for TRT products. 28 In the United States and in many other countries, pricing and/or profitability of some or all prescription pharmaceuticals and biopharmaceuticals are subject to varying degrees of government control.
Furthermore, the limited number of suppliers of testosterone esters may provide such companies with greater opportunity to raise their prices. If we or our Licensees are unable to obtain testosterone esters in a timely manner and/or in sufficient quantities, our ability to develop, and potentially commercialize, LPCN 1111, LPCN 1148, and LPCN 1144 may be adversely affected.
Furthermore, the limited number of suppliers of testosterone esters may provide such companies with greater opportunity to raise their prices. If we or our Licensees are unable to obtain testosterone esters in a timely manner and/or in sufficient quantities, our ability to develop, and potentially commercialize, LPCN 1111, LPCN 2401, and LPCN 1148, may be adversely affected.
Additionally, regulatory approval of TLANDO may be withdrawn and the failure to maintain regulatory approvals would prevent TLANDO from being marketed and could have a material adverse effect on our business. 29 Under the PREA, our licensing partner, Verity, will need to address the PREA requirement to assess the safety and effectiveness of TLANDO in pediatric patients.
Additionally, regulatory approval of TLANDO may be withdrawn and the failure to maintain regulatory approvals would prevent TLANDO from being marketed and could have a material adverse effect on our business. 27 Under the PREA, our licensing partner, Verity, will need to address the PREA requirement to assess the safety and effectiveness of TLANDO in pediatric patients.
In assessing these risks, you should also refer to the other information contained in this Annual Report, including our consolidated financial statements and related notes. 23 Risk Factors Summary Our business operations are subject to numerous risks, factors and uncertainties, including those outside of our control, that could cause our actual results to be harmed, including risks regarding the following: Risks Relating to Our Business and Industry ● the timelines of our clinical trials; ● the early stage of development of LPCN 1154, LPCN 2401, LPCN 2101, LPCN 2203, LPCN 1148, LPCN 1144, LPCN 1111 and LPCN 1107; ● the early stage of development of our research and development programs and processes and the risk of competition; ● the regulatory requirements for our product candidates and the possibility that regulatory approval will not be received; ● the commercial success of our licensed product candidate, TLANDO; ● the possibility that T-replacement therapies could be found to create, or could be perceived to create, health risks; ● any possible failure to obtain adequate healthcare reimbursement for our products; ● competition in the TRT market, including the entrance of generic TRTs into the market; ● our Licensee’s ability to commercialize TLANDO may be limited; ● successful commercialization of our product candidates internally or through collaborators; ● the possibility that we may never receive regulatory approval to market our products outside the United States; ● the stringent government regulations concerning the clinical testing of our products; ● the market’s acceptance of our products; ● physicians and patients using other products may not switch to our product; ● the possibility that regulatory agencies could find that we have improperly promoted off-label uses; ● any possible failure to comply with federal and state healthcare laws; ● our ability to retain our chief executive officer and other key executives and to attract, retain and motivate qualified personnel; ● difficulties in managing the growth of the Company; ● re-importation of drugs from foreign countries into the United States by our competitors; ● any product liability claims; ● any failure to comply with the Controlled Substances Act; ● the defense and resolution of any litigation; and ● cyber security risks.
In assessing these risks, you should also refer to the other information contained in this Annual Report, including our consolidated financial statements and related notes. 21 Risk Factors Summary Our business operations are subject to numerous risks, factors and uncertainties, including those outside of our control, that could cause our actual results to be harmed, including risks regarding the following: Risks Relating to Our Business and Industry ● the timelines of our clinical trials; ● the early stage of development of LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401, LPCN 1148, and LPCN 1107; ● the early stage of development of our research and development programs and processes and the risk of competition; ● the regulatory requirements for our product candidates and the possibility that regulatory approval will not be received; ● the commercial success of our licensed product candidate, TLANDO; ● the possibility that T-replacement therapies could be found to create, or could be perceived to create, health risks; ● any possible failure to obtain adequate healthcare reimbursement for our products; ● competition in the TRT market; ● our Licensee’s ability to commercialize TLANDO may be limited; ● successful commercialization of our product candidates internally or through collaborators; ● the possibility that we may never receive regulatory approval to market our products outside the United States; ● the stringent government regulations concerning the clinical testing of our products; ● the market’s acceptance of our products; ● physicians and patients using other products may not switch to our product; ● the possibility that regulatory agencies could find that we have improperly promoted off-label uses; ● any possible failure to comply with federal and state healthcare laws; ● our ability to retain our chief executive officer and other key executives and to attract, retain and motivate qualified personnel; ● difficulties in managing the growth of the Company; ● re-importation of drugs from foreign countries into the United States by our competitors; ● any product liability claims; ● any failure to comply with the Controlled Substances Act; ● the defense and resolution of any litigation; and ● cyber security risks.
All of our clinical candidates will be subject to extensive regulation which can be costly and time consuming, cause delays or prevent approval of the products for commercialization. Our clinical development of LPCN 1154, LPCN 2401, LPCN 2101, LPCN 2203, LPCN 1148, LPCN 1144, and LPCN 1107 and any future product candidates is subject to extensive regulations by the FDA.
All of our clinical candidates will be subject to extensive regulation which can be costly and time consuming, cause delays or prevent approval of the products for commercialization. Our clinical development of LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401, LPCN 1148, and LPCN 1107 and any future product candidates is subject to extensive regulations by the FDA.
We believe that our existing capital resources, together with interest thereon, will be sufficient to meet our projected operating requirements through at least March 31, 2026. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.
We believe that our existing capital resources, together with interest thereon, will be sufficient to meet our projected operating requirements through at least March 31, 2027. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.
The lawsuit seeks certification as a class action (for a purported class of purchasers of the Company’s securities from March 27, 2019 through November 8, 2019), compensatory damages in an unspecified amount, and unspecified equitable or injunctive relief. The Company filed a motion to dismiss the class action lawsuit on July 24, 2020.
The lawsuit sought certification as a class action (for a purported class of purchasers of the Company’s securities from March 27, 2019 through November 8, 2019), compensatory damages in an unspecified amount, and unspecified equitable or injunctive relief. The Company filed a motion to dismiss the class action lawsuit on July 24, 2020.
In addition, there can be no assurance that we will not experience similar claims in the future. Cyber security risks and the failure to maintain the integrity of company, employee or guest data could expose us to data loss, litigation and liability, and our reputation could be significantly harmed.
In addition, there can be no assurance that we will not experience similar claims in the future. Cyber security risks and the failure to maintain the integrity of company, employee or clinical data could expose us to data loss, litigation and liability, and our reputation could be significantly harmed.
Our Licensee’s ability to successfully commercialize TLANDO is contingent upon numerous factors including, among other things, the completion of post-marketing studies, the availability of supplies, commercial acceptance by patients, the medical community, and third-party payors, and the resources that our Licensee devotes to the commercialization of TLANDO.
Our Licensees’ ability to successfully commercialize TLANDO is contingent upon numerous factors including, among other things, the completion of post-marketing studies, the availability of supplies, commercial acceptance by patients, the medical community, and third-party payors, and the resources that our Licensee devotes to the commercialization of TLANDO.
The complaint alleges that the defendants made false and/or misleading statements and/or failed to disclose that our filing of the NDA for TLANDO to the FDA contained deficiencies and as a result the defendants’ statements about our business and operations were false and misleading and/or lacked a reasonable basis in violation of federal securities laws.
The complaint alleged that the defendants made false and/or misleading statements and/or failed to disclose that our filing of the NDA for TLANDO to the FDA contained deficiencies and as a result the defendants’ statements about our business and operations were false and misleading and/or lacked a reasonable basis in violation of federal securities laws.
The existence of either or both of physician or patient reluctance in switching to our products would have an adverse effect on our operating results and financial condition. The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
The existence of either or both of physician or patient reluctance in switching to our products could have an adverse effect on our operating results and financial condition. The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management, which would adversely affect our financial condition. 51 ITEM 1B. UNRESOLVED STAFF COMMENTS None.
Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management, which could adversely affect our financial condition. ITEM 1B. UNRESOLVED STAFF COMMENTS None.
In addition, any increase in price for testosterone esters will likely reduce our potential gross margins for LPCN 1148 and LPCN 1144. We rely on limited suppliers for our supply of NAS, the active pharmaceutical ingredients of LPCN 1154, LPCN 2101, and LPCN 2203 and the loss of these limited suppliers could harm our business.
In addition, any increase in price for testosterone esters will likely reduce our potential gross margins for LPCN 2401 and LPCN 1148. We rely on limited suppliers for our supply of NAS, the active pharmaceutical ingredients of LPCN 1154, LPCN 2201, LPCN 2101, and LPCN 2203 and the loss of these limited suppliers could harm our business.
We and our Licensees rely/will rely on a single third-party supplier for our supply of testosterone esters, the active pharmaceutical ingredient of TLANDO, LPCN 1111, LPCN 1148, and LPCN 1144.
We and our Licensees rely/will rely on a single third-party supplier for our supply of testosterone esters, the active pharmaceutical ingredient of TLANDO, LPCN 1111, LPCN 2401, and LPCN 1148.
In addition, our capital resources may be consumed more rapidly if we pursue additional clinical studies for LPCN 1154, LPCN 2401, LPCN 2101, LPCN 2203, LPCN 1148, LPCN 1144, and LPCN 1107.
In addition, our capital resources may be consumed more rapidly if we pursue additional clinical studies for LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401, LPCN 1148, and LPCN 1107.
License agreements and/or collaborations involving our drug candidates, such as our agreement with Verity, pose numerous risks to us, including the following: ● partners have significant discretion in determining the efforts and resources that they will apply to these efforts and may not perform their obligations as expected; ● partners may de-emphasize or not pursue development and commercialization of our drug candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the partners’ strategic focus, including as a result of a sale or disposition of a business unit or development function, or available funding or external factors such as an acquisition that diverts resources or creates competing priorities; ● partners may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a drug candidate, repeat or conduct new clinical trials or require a new formulation of a drug candidate for clinical testing; ● partners could independently develop, or develop with third parties, products that compete directly or indirectly with our products or drug candidates if the partners believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; ● partners may not be able to acquire and maintain supplier and manufacturer relationships necessary to successfully commercialize our products; ● a partner with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and distribution of our product relative to other products; 39 ● partners may not properly obtain, maintain, defend or enforce our intellectual property rights or may use our proprietary information and intellectual property in such a way as to invite litigation or other intellectual property related proceedings that could jeopardize or invalidate our proprietary information and intellectual property or expose us to potential litigation or other intellectual property related proceedings; ● disputes may arise between our partners and us that result in the delay or termination of the research, development or commercialization of our products or drug candidates or that result in costly litigation or arbitration that diverts management attention and resources; ● agreements may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable drug candidates; ● agreements may not lead to development or commercialization of drug candidates in the most efficient manner or at all; and ● if a partner of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program could be delayed, diminished or terminated.
License agreements and/or collaborations involving our drug candidates, such as our agreement with Verity, pose numerous risks to us, including the following: ● partners have significant discretion in determining the efforts and resources that they will apply to these efforts and may not perform their obligations as expected; ● partners may de-emphasize or not pursue development and commercialization of our drug candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the partners’ strategic focus, including as a result of a sale or disposition of a business unit or development function, or available funding or external factors such as an acquisition that diverts resources or creates competing priorities; ● partners may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a drug candidate, repeat or conduct new clinical trials or require a new formulation of a drug candidate for clinical testing; ● partners could independently develop, or develop with third parties, products that compete directly or indirectly with our products or drug candidates if the partners believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; ● partners may not be able to acquire and maintain supplier and manufacturer relationships necessary to successfully commercialize our products; ● a partner with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and distribution of our product relative to other products; ● partners may not properly obtain, maintain, defend or enforce our intellectual property rights or may use our proprietary information and intellectual property in such a way as to invite litigation or other intellectual property related proceedings that could jeopardize or invalidate our proprietary information and intellectual property or expose us to potential litigation or other intellectual property related proceedings; ● disputes may arise between our partners and us that result in the delay or termination of the research, development or commercialization of our products or drug candidates or that result in costly litigation or arbitration that diverts management attention and resources; ● agreements may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable drug candidates; ● agreements may not lead to development or commercialization of drug candidates in the most efficient manner or at all; and ● if a partner of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program could be delayed, diminished or terminated. 37 If our license arrangements with Verity, or any other or future license or collaboration we may enter into, if any, are not successful, our business, financial condition, results of operations, prospects and development and commercialization efforts may be adversely affected.
Our drug development programs for our product candidates will require substantial additional cash to fund expenses. We have not yet established any collaborative arrangements relating to the development or commercialization of LPCN 1154, LPCN 2401, LPCN 2101, LPCN 2203, LPCN 1144, LPCN 1148, or LPCN 1107.
Our drug development programs for our product candidates will require substantial additional cash to fund expenses. We have not yet established any collaborative arrangements relating to the development or commercialization of LPCN 1154, LPCN 2401, LPCN 1148, or LPCN 1107.
In order to market any products outside of the United States including South Korea and the GCC countries, we must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy. Approval procedures vary among countries and can involve additional product candidate testing and additional administrative review periods.
In order to market any products outside of the United States including South Korea, the GCC countries, and Brazil, our licensees must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy. Approval procedures vary among countries and can involve additional product candidate testing and additional administrative review periods.
The market price of our common stock may fluctuate significantly in response to a number of factors, most of which we cannot control, including: ● the success of the commercialization of TLANDO; ● plans for, costs of, progress of and results from clinical trials of our product candidates; ● the failure of our product candidates to receive FDA approval; ● regulatory uncertainty in the TRT class; ● FDA Advisory Committee meetings and related recommendations; ● product approval and potential FDA required labeling language and/or Phase 4 study commitments; ● announcements of new products, technologies, commercial relationships, acquisitions or other events by us or our competitors; ● our ability to license our products to third parties; 42 ● failure to engage with collaborators or build an internal sales force to commercialize our products should a product candidate other than TLANDO receive FDA approval; ● the success or failure of other TRT products or non-testosterone based testosterone therapy products; ● failure of our products, if approved, to achieve commercial success; ● fluctuations in stock market prices and trading volumes of similar companies; ● general market conditions and overall fluctuations in U.S. equity markets; ● variations in our quarterly operating results; ● changes in our financial guidance or securities analysts’ estimates of our financial performance; ● changes in accounting principles; ● sales of large blocks of our common stock, including sales by our executive officers, directors and significant stockholders; ● additions or departures of key personnel; ● discussion of us or our stock price by the press and by online investor communities; ● our cash balance; and ● other risks and uncertainties described in these risk factors.
The market price of our common stock may fluctuate significantly in response to a number of factors, most of which we cannot control, including: ● the success of the commercialization of TLANDO; ● plans for, costs of, progress of and results from clinical trials of our product candidates; ● the failure of our product candidates to receive FDA approval; ● regulatory uncertainty in the TRT class; ● FDA Advisory Committee meetings and related recommendations; ● product approval and potential FDA required labeling language and/or Phase 4 study commitments; ● announcements of new products, technologies, commercial relationships, acquisitions or other events by us or our competitors; ● our ability to license our products to third parties; ● failure to engage with collaborators or build an internal sales force to commercialize our products should a product candidate other than TLANDO receive FDA approval; ● the success or failure of other TRT products or non-testosterone based testosterone therapy products; ● failure of our products, if approved, to achieve commercial success; ● fluctuations in stock market prices and trading volumes of similar companies; ● general market conditions and overall fluctuations in U.S. equity markets; ● variations in our quarterly operating results; ● changes in our financial guidance or securities analysts’ estimates of our financial performance; ● changes in accounting principles; ● sales of large blocks of our common stock, including sales by our executive officers, directors and significant stockholders; ● additions or departures of key personnel; ● discussion of us or our stock price by the press and by online investor communities; ● our cash balance; and ● other risks and uncertainties described in these risk factors. 40 In recent years, the stock of other biotechnology and biopharmaceutical companies has experienced extreme price fluctuations that have been unrelated to the operating performance of the affected companies.
The laws that may affect our ability to operate include: ● the federal Anti-Kickback Statute, which constrains our marketing practices, educational programs, pricing policies, and relationships with healthcare providers or other entities, by prohibiting, among other things, soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, either the referral of an individual or the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs; ● federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent; ● HIPAA, which among other things created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; ● the federal Physician Payments Sunshine Act, which, among other things, requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under certain federal healthcare programs to report annually information related to “payments or other transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and ownership and investment interests held by certain healthcare professionals and their immediate family members; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and its implementing regulations, which imposes certain requirements relating to the privacy, security, breach notification, and transmission of individually identifiable health information; and ● state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. 35 Because of the breadth of these laws and the narrowness of available statutory and regulatory exceptions, it is possible that some of our business activities could be subject to challenge under one or more such laws.
The laws that may affect our ability to operate include: ● the federal Anti-Kickback Statute, which constrains our marketing practices, educational programs, pricing policies, and relationships with healthcare providers or other entities, by prohibiting, among other things, soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, either the referral of an individual or the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs; ● federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent; ● HIPAA, which among other things created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; ● the federal Physician Payments Sunshine Act, which, among other things, requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under certain federal healthcare programs to report annually information related to “payments or other transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and ownership and investment interests held by certain healthcare professionals and their immediate family members; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and its implementing regulations, which imposes certain requirements relating to the privacy, security, breach notification, and transmission of individually identifiable health information; and ● state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
These losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity and working capital.
These losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity.
Therefore, at this stage, our ability to realize revenue depends on TLANDO’s successful commercialization. The commercial success of TLANDO depends almost entirely on Verity’s commercialization efforts and we have very limited ability to influence Verity’s efforts, including the amount and timing of resources they devote, if any, to the commercialization of TLANDO.
Therefore, at this stage, our ability to realize revenue depends on TLANDO’s successful commercialization. The commercial success of TLANDO in the U.S. and Canada depends almost entirely on Verity’s commercialization efforts and we have very limited ability to influence Verity’s efforts, including the amount and timing of resources they devote, if any, to the commercialization of TLANDO.
LPCN 2203 is in an early stage of development and may not be further developed for a variety of reasons. Our oral NAS comprising programs (including LPCN 2203) are in a very early stage of development and consequently the risk that we may fail to commercialize LPCN 2203 and related products is high.
LPCN 2203 is in an early stage of development and may not be further developed for a variety of reasons. Our oral NAS comprising program LPCN 2203 is in a very early stage of development and consequently the risk that we may fail to commercialize LPCN 2203 and related products is high.
Pending resource availability, we may expend significant resources before determining that this program is not a viable candidate for regulatory approval and commercialization. 26 LPCN 2101 is in a very early stage of development and may not be further developed for a variety of reasons.
We may expend significant resources before determining that this program is not a viable candidate for regulatory approval and commercialization. LPCN 2101 is in a very early stage of development and may not be further developed for a variety of reasons.
The Centers for Medicare and Medicaid Services issued an interim final rule on November 20, 2020, that would tie prices for certain drugs under Medicare Part B to the lowest price for those drugs available in certain countries that are members of the Organization for Economic Co-operation and Development. This rule was rescinded in December 2021.
The Centers for Medicare and Medicaid Services issued an interim final rule on November 20, 2020, that would tie prices for certain drugs under Medicare Part B to the lowest price for those drugs available in certain countries that are members of the Organization for Economic Co-operation and Development.
In particular, TLANDO competes in the T-replacement therapies market, which is competitive and currently dominated by the sale of T-gels and T-injectables. Receipt of future potential payments under our licensing agreement will depend, in large part, on our licensing partner’s ability to obtain an adequate share of the market.
TLANDO competes in the T-replacement therapies market, which is competitive and currently dominated by the sale of T-gels and T-injectables. Receipt of future potential payments under our licensing agreements will depend, in large part, on our licensing partners’ ability to obtain an adequate share of the market.
If we, or any future marketing collaborators or CMOs, fail to comply with applicable regulatory requirements, we may be subject to sanctions including fines, product recalls or seizures and related publicity requirements, injunctions, total or partial suspension of production, civil penalties, suspension or withdrawals of previously granted regulatory approvals, warning or untitled letters, refusal to approve pending applications for marketing approval of new products or of supplements to approved applications, import or export bans or restrictions, and criminal prosecution and penalties.
This could result in a product not being approved. 31 If we, or any future marketing collaborators or CMOs, fail to comply with applicable regulatory requirements, we may be subject to sanctions including fines, product recalls or seizures and related publicity requirements, injunctions, total or partial suspension of production, civil penalties, suspension or withdrawals of previously granted regulatory approvals, warning or untitled letters, refusal to approve pending applications for marketing approval of new products or of supplements to approved applications, import or export bans or restrictions, and criminal prosecution and penalties.
We have only conducted Phase 1 clinical studies with the active pharmaceutical ingredient in LPCN 2203 and the ultimate regulatory or technical success of the neuroactive steroids under investigation in these programs is uncertain. The current limited pre-clinical and Phase 1 results we have observed may not be replicated in larger studies, future PK, Phase 2, or pivotal studies.
We have only conducted Phase 1 clinical studies with the active pharmaceutical ingredient in LPCN 2203 and the ultimate regulatory or technical success of the neuroactive steroid under investigation in this program is uncertain. The current limited pre-clinical and Phase 1 results we have observed may not be replicated in larger studies, future PK, Phase 2, or pivotal studies.
The FDA could become more risk averse to any side effects or set higher standards of safety and efficacy prior to reviewing or approving a product. This could result in a product not being approved. We are dependent on the commercial success of our licensed product, TLANDO, for royalty revenue and potential milestone payments.
The FDA could become more risk averse to any side effects or set higher standards of safety and efficacy prior to reviewing or approving a product. This could result in a product not being approved. Our business depends, in part, on the commercial success of our licensed product, TLANDO, for royalty revenue and potential milestone payments.
As a result, we expect to continue to incur significant operating losses for the foreseeable future as we evaluate further clinical development of LPCN 1154, LPCN 2401, LPCN 2101, LPCN 2203, and LPCN 1148 and our other programs and continued research efforts.
As a result, we expect to continue to incur significant operating losses for the foreseeable future as we evaluate further clinical development of LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401, and possibly LPCN 1148 and LPCN 1107, in addition to our other programs and continued research efforts.
As of December 31, 2024, our executive officers and directors beneficially owned approximately 6.3% of our common stock. These stockholders, if they act together, may be able to influence our management and affairs and all matters requiring stockholder approval, including significant corporate transactions.
As of December 31, 2025, our executive officers and directors beneficially owned approximately 5.7% of our common stock. These stockholders, if they act together, may be able to influence our management and affairs and all matters requiring stockholder approval, including significant corporate transactions.
The provisions of ACA of importance to our potential product candidates include the following: ● an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents; ● an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program; ● expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance; ● a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; ● extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; ● expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals beginning in 2014 and by adding new mandatory eligibility categories for certain individuals with specified income levels, thereby potentially increasing manufacturers’ Medicaid rebate liability; ● expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; ● new requirements to report annually certain financial arrangements with physicians, certain other healthcare professionals, and teaching hospitals; ● a new requirement to annually report drug samples that manufacturers and distributors provide to licensed practitioners, pharmacies of hospitals and other healthcare entities; and ● a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
The provisions of ACA of importance to our potential product candidates include the following: ● an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents; ● an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program; ● expansion of healthcare fraud and abuse laws, including the False Claims Act and the Anti-Kickback Statute, new government investigative powers, and enhanced penalties for noncompliance; ● extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations; ● expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals beginning in 2014 and by adding new mandatory eligibility categories for certain individuals with specified income levels, thereby potentially increasing manufacturers’ Medicaid rebate liability; ● expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; ● new requirements to report annually certain financial arrangements with physicians, certain other healthcare professionals, and teaching hospitals; ● a new requirement to annually report drug samples that manufacturers and distributors provide to licensed practitioners, pharmacies of hospitals and other healthcare entities; and ● a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
As such, our product development processes for LPCN 1154, LPCN 2401, LPCN 2101, LPCN 2203, and LPCN 1148, in addition to LPCN 1111, LPCN 1144, and LPCN 1107 are very risky and uncertain, and our product candidates may fail to advance beyond the current study.
As such, our product development processes for LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401, LPCN 1148, and LPCN 1107 are very risky and uncertain, and our product candidates may fail to advance beyond the current study.
The covered technology and the scope of coverage varies from country to country. For those countries where we do not have granted patents, we have no ability to prevent the unauthorized use of our intellectual property, and third parties in those countries may be able to make, use, or sell products identical to, or substantially similar to our product candidates.
For those countries where we do not have granted patents, we have no ability to prevent the unauthorized use of our intellectual property, and third parties in those countries may be able to make, use, or sell products identical to, or substantially similar to our product candidates.
LPCN 1144 is in a very early stage of development and may not be further developed for a variety of reasons. LPCN 1144 is in a very early stage of development and consequently the risk that we fail to commercialize LPCN 1144 and related products is high.
LPCN 2201 is in a very early stage of development and may not be further developed for a variety of reasons. Our oral NAS comprising program LPCN 2201 is in a very early stage of development and consequently the risk that we may fail to commercialize LPCN 2201 and related products is high.
We have only conducted Phase 1 clinical studies of LPCN 2101 and the ultimate regulatory or technical success of the neuroactive steroids under investigation in these programs is uncertain.
We have only conducted Phase 1 clinical studies of LPCN 2101 and the ultimate regulatory or technical success of the neuroactive steroid under investigation in this program is uncertain.
Regulatory agencies could become more risk adverse to any side effects or set higher standards of safety and efficacy prior to reviewing or approving a product. This could result in a product not being approved.
Regulatory agencies could become more risk adverse to any side effects or set higher standards of safety and efficacy prior to reviewing or approving a product.
The degree of market acceptance for our products, if approved, will depend on a number of factors, including: ● the relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; ● the prevalence and severity of any adverse side effects; ● limitations or warnings contained in the labeling approved by the FDA; ● availability of alternative treatments, including a number of competitive therapies already approved or expected to be commercially launched in the near future; ● distribution and use restrictions imposed by the FDA or agreed to by us as part of a mandatory REMS or voluntary risk management plan; ● pricing and cost effectiveness; ● the effectiveness of our or any future collaborators’ sales and marketing strategies; ● our ability to increase awareness of our products through marketing efforts; ● our ability to obtain sufficient third-party coverage or reimbursement; and ● the willingness of patients to pay out-of-pocket in the absence of third-party coverage. 34 If our product candidates are approved but do not achieve an adequate level of acceptance by physicians, healthcare payors and patients, we may not generate sufficient revenue from our products and we may never become or remain profitable.
The degree of market acceptance for our products, if approved, will depend on a number of factors, including: ● the relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; ● the prevalence and severity of any adverse side effects; ● limitations or warnings contained in the labeling approved by the FDA; ● availability of alternative treatments, including a number of competitive therapies already approved or expected to be commercially launched in the near future; ● distribution and use restrictions imposed by the FDA or agreed to by us as part of a mandatory REMS or voluntary risk management plan; ● pricing and cost effectiveness; ● the effectiveness of our or any future collaborators’ sales and marketing strategies; ● our ability to increase awareness of our products through marketing efforts; ● our ability to obtain sufficient third-party coverage or reimbursement; and ● the willingness of patients to pay out-of-pocket in the absence of third-party coverage.
If those collaborations, including, without limitation, our license arrangement with Verity for the development and commercialization of TLANDO, are not successful, we may not be able to capitalize on the market potential of these drug candidates and may have to alter our development and commercialization plans for our products.
If those collaborations, including, without limitation, our license arrangement with Verity for the development and commercialization of TLANDO, are not successful, we may not be able to capitalize on the market potential of these drug candidates and may have to alter our development and commercialization plans for our products. 36 Our drug development programs for our product candidates will require substantial additional cash to fund expenses.
The market price and trading volume of our common stock has been volatile over the past year, and it may continue to be volatile. During 2024, our common stock has traded as low as $2.83 and as high as $10.69 per share.
The market price and trading volume of our common stock has been volatile over the past year, and it may continue to be volatile. During 2025, our common stock has traded as low as $2.53 and as high as $8.03 per share.
Commercialization of LPCN 1154 is likely highly 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 partnership arrangements on terms favorable to us, if at all.
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 partnership arrangements on terms favorable to us, if at all.
Any future class action litigation that may be initiated against us may result in us incurring substantial costs and our management’s attention may be diverted from our operations, which could significantly harm our business.
Any future class action litigation that may be initiated against us may result in us incurring substantial costs and our management’s attention may be diverted from our operations, which could significantly harm our business. In addition, such litigation could lead to increased volatility in our share price.
This legislation, as well as any future statutes or regulations at the federal or state level, may impact reimbursement for our product candidates and may challenge our ability to realize an appropriate return on our investment in research and product development.
The expansion of these federal and state pricing controls could significantly reduce our revenue potential. This legislation, as well as any future statutes or regulations at the federal or state level, may impact reimbursement for our product candidates and may challenge our ability to realize an appropriate return on our investment in research and product development.
While we believe there is a potential to gain Orphan Drug Designation for an indication or condition in male liver cirrhosis, the FDA may not grant such designation which could adversely impact development or the commercial potential of LPCN 1148.
While we believe there is a potential to gain Orphan Drug Designation for an indication or condition in male liver cirrhosis, the FDA may not grant such designation which could adversely impact development or the commercial potential of LPCN 1148. 25 LPCN 1107 is in a very early stage of development and may not be further developed for a variety of reasons.
Our completed Phase 1 clinical studies may not be predictive of safety concerns that may arise in pregnant women or demonstrate that LPCN 1107 has an adequate safety profile to warrant further development.
Our completed Phase 1 clinical studies may not be predictive of safety concerns that may arise in pregnant women or demonstrate that LPCN 1107 has an adequate safety profile to warrant further development. These factors can impact the timing of and our ability to continue development or partner LPCN 1107.
If resurrected, any similar proposal could result in lower prices for pharmaceutical products in general. The Inflation Reduction Act of 2022 (Pub. L. No. 117-169) was signed into law on August 16, 2022 and includes a number of provisions aimed at lowering prescription drug costs and reducing government spending on drugs.
This rule was rescinded in December 2021, but a similar rule was reproposed on December 23, 2025. If resurrected, any similar proposal could result in lower prices for pharmaceutical products in general. The Inflation Reduction Act of 2022 (Pub. L. No. 117-169) includes a number of provisions aimed at lowering prescription drug costs and reducing government spending on drugs.
There can be no assurance as to whether the results of the clinical trials will support an NDA submission or whether an NDA submission will be accepted for review or approved by the FDA for postpartum depression, including the oral route related brexanolone or its metabolites exposure profile relative to the reference injectable brexanolone.
There can be no assurance as to whether the results of the clinical trials in LPCN 1154 for postpartum depression will support a 505(b)2 NDA submission, whether a paragraph IV patent certification will be required or whether an NDA submission will be accepted for review, or approved by the FDA, including the oral route related brexanolone or its metabolites exposure profile relative to injectable brexanolone.
In September 2024, we entered into a distribution and license agreement for the development and commercialization of TLANDO in South Korea with SPC and in October 2024, we entered into a distribution and supply agreement for TLANDO in the GCC countries with Pharmalink Markets for TLANDO outside the United States, including Canada, South Korea and the GCC countries.
In September 2024, we entered into a distribution and license agreement for the development and commercialization of TLANDO in South Korea with SPC, in October 2024, we entered into a distribution and supply agreement for TLANDO in the GCC countries with Pharmalink, and in April 2025 we entered into a distribution and license agreement for the development and commercialization of TLANDO in Brazil.
We have incurred losses in most years since our inception. As of December 31, 2024, we had an accumulated deficit of $199.8 million. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations.
As of December 31, 2025, we had an accumulated deficit of $209.4 million. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations.
Our corporate governance documents include provisions: ● limiting the ability of our stockholders to call and bring business before special meetings and to take action by written consent in lieu of a meeting; ● requiring advance notice of stockholder proposals for business to be conducted at meetings of our stockholders and for nominations of candidates for election to our Board of Directors; ● authorizing blank check preferred stock, which could be issued with voting, liquidation, dividend and other rights superior to our common stock; and ● limiting the liability of, and providing indemnification to, our directors and officers.
Our corporate governance documents include provisions: ● limiting the ability of our stockholders to call and bring business before special meetings and to take action by written consent in lieu of a meeting; ● requiring advance notice of stockholder proposals for business to be conducted at meetings of our stockholders and for nominations of candidates for election to our Board of Directors; ● authorizing blank check preferred stock, which could be issued with voting, liquidation, dividend and other rights superior to our common stock; and ● limiting the liability of, and providing indemnification to, our directors and officers. 41 As a Delaware corporation, we are also subject to provisions of Delaware law, including Section 203 of the Delaware General Corporation Law, which limits the ability of stockholders owning in excess of 15% of our outstanding voting stock from engaging in certain business combinations with us.
We have focused a significant portion of our efforts on developing TLANDO and more recently on our oral neuroactive steroids LPCN 1154, LPCN 2101, and LPCN 2203, in addition to LPCN 2401, and LPCN 1148. We have funded our operations to date through sales of our equity securities, debt, and payments received under our license and collaboration arrangements.
We have focused a significant portion of our efforts on developing TLANDO and more recently on LPCN 1154, LPCN 1148 and LPCN 1144. We have funded our operations to date through sales of our equity securities, debt, and payments received under our license and collaboration arrangements. We have incurred losses in most years since our inception.
Human therapeutic products involve the risk of product liability claims and associated adverse publicity. Currently, the principal risks we face relate to patients in our clinical trials, who may suffer unintended consequences. Claims might be made by patients, healthcare providers or pharmaceutical companies or others.
Currently, the principal risks we face relate to patients in our clinical trials, who may suffer unintended consequences. Claims might be made by patients, healthcare providers or pharmaceutical companies or others.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeGovernance Our board of directors oversees our risk management process, including as it pertains to cybersecurity risks, which focuses on the most significant risks we face in the short-, intermediate-, and long-term timeframe.
Biggest change“Risk Factors” for additional details regarding cybersecurity risks and potential impacts on our business. 48 Governance Our board of directors oversees our risk management process, including as it pertains to cybersecurity risks, which focuses on the most significant risks we face in the short-, intermediate-, and long-term timeframe .
Refer to the risk factor captioned “ Cyber security risks and the failure to maintain the integrity of company, employee or guest data could expose us to data loss, litigation and liability, and our reputation could be significantly harmed ” in Part I, Item 1A. “Risk Factors” for additional details regarding cybersecurity risks and potential impacts on our business.
Refer to the risk factor captioned “ Cyber security risks and the failure to maintain the integrity of company, employee or clinical data could expose us to data loss, litigation and liability, and our reputation could be significantly harmed ” in Part I, Item 1A.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeITEM 2. PROPERTIES Our corporate headquarters are located in a leased facility in Salt Lake City, Utah. Our lease expires on February 28, 2026. We believe that our existing facility is suitable and adequate and that we have sufficient capacity to meet our current anticipated needs.
Biggest changeITEM 2. PROPERTIES Our corporate headquarters are located in a leased facility in Salt Lake City, Utah. Our lease expires on February 28, 2027. We believe that our existing facility is suitable and adequate and that we have sufficient capacity to meet our current anticipated needs.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeWe may, from time to time, be involved in various legal proceedings arising from the normal course of business activities, and, while the Company has insurance that covers claims of this nature, unfavorable resolution of any of these matters could materially affect our future results of operations, cash flows, or financial position. ITEM 4.
Biggest changeWe may, from time to time, be involved in various legal proceedings arising from the normal course of business activities, and, while the Company has insurance that covers claims of this nature, unfavorable resolution of any of these matters could materially affect our future results of operations, cash flows, or financial position.
ITEM 3. LEGAL PROCEEDINGS On November 14, 2019, we and certain of our officers were named as defendants in a purported shareholder class action lawsuit, Solomon Abady v. Lipocine Inc. et al ., 2:19-cv-00906-PMW, filed in the United District Court for the District of Utah.
ITEM 3. LEGAL PROCEEDINGS On November 14, 2019, we and certain of our officers were named as defendants in a purported shareholder class action lawsuit, Solomon Abady v. Lipocine Inc. et al ., 2:19-cv-00906-PMW, filed in the United States District Court for the District of Utah.
Removed
MINE SAFETY DISCLOSURES Not Applicable. 52 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeITEM 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock is quoted on The Nasdaq Capital Market under the symbol “LPCN.” Holders As of March 11, 2025, there were approximately 87 holders of record of our common stock.
Biggest changeITEM 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock is quoted on The Nasdaq Capital Market under the symbol “LPCN.” Holders As of March 9, 2026, there were approximately 86 holders of record of our common stock.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeWe have entered into the Verity License Agreement, the SPC License Agreement and the Pharmalink Distribution Agreement with the potential for revenue from future milestones, royalties, and/or product sales, but we may never generate revenues from any of our clinical or preclinical development programs or licensed products as we may never succeed in obtaining regulatory approval or commercializing any of these product candidates.
Biggest changeWe have entered into the Verity License Agreement, the SPC License Agreement, the Pharmalink Distribution Agreement, and the Aché License Agreement with the potential for revenue from future milestones, royalties, and/or product sales, but we may never generate revenues from any of our clinical or preclinical development programs or licensed products as we may never succeed in obtaining regulatory approval or commercializing any of these product candidates. 52 Research and Development Expenses Research and development expenses consist primarily of salaries, benefits, stock-based compensation and related personnel costs, fees paid to external service providers such as contract research organizations and contract manufacturing organizations, contractual obligations for clinical development, clinical sites, manufacturing and scale-up for late stage clinical trials, formulation of clinical drug supplies, and expenses associated with regulatory submissions.
Future research and development expenditures are subject to numerous uncertainties regarding timing and cost to completion, including, among others: ● the timing and outcome of regulatory filings and FDA reviews and actions for product candidates; ● our dependence on third-party manufacturers for the production of satisfactory finished product for registration and launch should regulatory approval be obtained on any of our product candidates; ● the potential for future license or co-promote arrangements for our product candidates, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our future plans and capital requirements; and ● the effect on our product development activities of actions taken by the FDA or other regulatory authorities.
Future research and development expenditures are subject to numerous uncertainties regarding timing and cost to completion, including, among others: ● the timing and outcome of regulatory filings and FDA reviews and actions for product candidates; ● our dependence on third-party manufacturers for the production of satisfactory finished products for registration and launch should regulatory approval be obtained on any of our product candidates; ● the potential for future license or co-promote arrangements for our product candidates, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our future plans and capital requirements; and ● the effect on our product development activities of actions taken by the FDA or other regulatory authorities.
We concluded that licensing revenue recognized in conjunction with the Verity License Agreement, the SPC License Agreement and the Pharmalink Distribution Agreement met the requirements under ASC 606, Revenue from Contracts with Customers. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
We concluded that licensing revenue recognized in conjunction with the Verity License Agreement, the SPC License Agreement, the Pharmalink Distribution Agreement and the Aché License Agreement met the requirements under ASC 606, Revenue from Contracts with Customers. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
We are also eligible to receive milestone payments of up to $259 million in the aggregate, depending on the achievement of certain development milestones and sales milestones in a single calendar year with respect to all products licensed by Verity under the Verity License Agreement.
We are also eligible to receive milestone payments of up to $259 million in the aggregate, depending on the achievement of certain development milestones and sales milestones in a single calendar year with respect to all products licensed by Verity Pharma under the Verity License Agreement.
Liquidity and Capital Resources Since our inception, our operations have been primarily financed through sales of our equity securities, debt and payments received under our license and collaboration arrangements. We have devoted our resources to funding research and development programs, including discovery research, preclinical and clinical development activities.
Liquidity and Capital Resources Since our inception, our operations have been primarily financed through sales of our equity securities, issuances of debt and payments received under our license and collaboration arrangements. We have devoted our resources to funding research and development programs, including discovery research, preclinical and clinical development activities.
To fund future operations, we will need to ultimately raise additional capital and our requirements will depend on many factors, including the following: 59 ● the scope, rate of progress, results and cost of our clinical studies, pre-clinical testing and other related activities for all of our product candidates including LPCN 1154, LPCN 2401, LPCN 2101, LPCN 2203, LPCN 1148, LPCN 1144, and LPCN 1107; ● the cost of manufacturing clinical supplies, and establishing commercial supplies, of our product candidates and any products that we may develop; ● the cost and timing of establishing sales, marketing and distribution capabilities, if any; ● the terms and timing of any collaborative, licensing, settlement and other arrangements that we may establish; ● the number and characteristics of product candidates that we pursue; ● the cost, timing and outcomes of regulatory approvals; ● the timing, receipt and amount of sales, profit sharing or royalties, if any, from our potential products; ● the cost of preparing, filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; ● the extent to which we acquire or invest in businesses, products or technologies, although we currently have no commitments or agreements relating to any of these types of transactions; and ● the extent to which we grow significantly in the number of employees or the scope of our operations.
To fund future operations, we will need to ultimately raise additional capital and our requirements will depend on many factors, including the following: ● the scope, rate of progress, results and cost of our clinical studies, pre-clinical testing and other related activities for all of our product candidates including LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401, LPCN 1148, and LPCN 1107; ● the cost of manufacturing clinical supplies, and establishing commercial supplies, of our product candidates and any products that we may develop; 56 ● the cost and timing of establishing sales, marketing and distribution capabilities, if any; ● the terms and timing of any collaborative, licensing, settlement and other arrangements that we may establish; ● the number and characteristics of product candidates that we pursue; ● the cost, timing and outcomes of regulatory approvals; ● the timing, receipt and amount of sales, profit sharing or royalties, if any, from our potential products; ● the cost of preparing, filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; ● the extent to which we acquire or invest in businesses, products or technologies, although we currently have no commitments or agreements relating to any of these types of transactions; and ● the extent to which we grow significantly in the number of employees or the scope of our operations.
If we are unable to raise additional capital or obtain non-dilutive financing, we may need to reduce research and development expenses in order to extend our ability to continue as a going concern. 56 General and Administrative Expenses General and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation and outside consulting services related to our executive, finance, business development, and administrative support functions.
If we are unable to raise additional capital or obtain non-dilutive financing, we may need to reduce research and development expenses in order to extend our ability to continue as a going concern. 53 General and Administrative Expenses General and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation, and outside consulting services related to our executive, finance, business development, and administrative support functions.
Clinical development timelines, the probability of success and development costs can differ materially from expectations and results from our clinical trials may not be favorable. If we are successful in progressing LPCN 1154, LPCN 2401, LPCN 2101, LPCN 2203 or other future product candidates into later stage development, we will require additional capital.
Clinical development timelines, the probability of success, and development costs can differ materially from expectations and results from our clinical trials may not be favorable. If we are successful in progressing LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, or other future product candidates into later stage development, we will require additional capital.
Sales Agreement”) with A.G.P./Alliance Global Partners (“A.G.P.”) pursuant to which we may issue and sell, from time to time, shares of our common stock having an aggregate offering price of up to the amount we registered on an effective registration statement pursuant to which the offering is being made.
Sales Agreement”) with A.G.P./Alliance Global Partners (“A.G.P.”) pursuant to which we could issue and sell, from time to time, shares of our common stock having an aggregate offering price of up to the amount we registered on an effective registration statement pursuant to which the offering is being made.
While we believe we have sufficient liquidity and capital resources to fund our projected operating requirements through at least March 31, 2026, we will need to raise additional capital at some point through the equity or debt markets or through additional out-licensing activities, either before or after March 31, 2026, to support our operations.
While we believe we have sufficient liquidity and capital resources to fund our projected operating requirements through at least March 31, 2027, we will need to raise additional capital at some point through the equity or debt markets or through additional out-licensing activities, either before or after March 31, 2027, to support our operations.
Given the stage of clinical development and the significant risks and uncertainties inherent in the clinical development, manufacturing and regulatory approval process, we are unable to estimate with any certainty the time or cost to complete the development of LPCN 1154, LPCN 2401, LPCN 2101, LPCN 2203, LPCN 1148, LPCN 1144, LPCN 1107 and other product candidates.
Given the stage of clinical development and the significant risks and uncertainties inherent in the clinical development, manufacturing, and regulatory approval process, we are unable to estimate with any certainty the time or cost to complete the development of LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401, LPCN 1148, LPCN 1107 and other product candidates.
In addition, we receive tiered royalty payments at rates ranging from percentages of 12% up to 18% of net sales of all products licensed to Verity in the Licensed Verity Territory. Our ability to realize benefits from the Verity License Agreement, including milestone and royalty payments, is subject to a number of risks.
In addition, we receive tiered royalty payments at rates ranging from 12% up to 18% of net sales of all products licensed to Verity Pharma in the Licensed Verity Territory. Our ability to realize benefits from the Verity License Agreement, including milestone and royalty payments, is subject to a number of risks.
License revenue from payments to be received in the future will be recognized when it is probable that we will receive license payments under the terms of the Verity License Agreement, the SPC License Agreement or the Pharmalink Distribution Agreement. 61 We have identified the following accounting policies that we believe require application of management’s most subjective judgments, often requiring the need to make estimates about the effect of matters that are inherently uncertain and may change in subsequent periods.
License revenue from payments to be received in the future will be recognized when it is probable that we will receive license payments under the terms of the Verity License Agreement, the SPC License Agreement, the Pharmalink Distribution Agreement or the Aché License Agreement . 58 We have identified the following accounting policies that we believe require application of management’s most subjective judgments, often requiring the need to make estimates about the effect of matters that are inherently uncertain and may change in subsequent periods.
We may provide research and development services under collaboration arrangements to advance the development of jointly owned products. We record the expenses incurred and reimbursed on a net basis in research and development expense. As of December 31, 2024, we do not have any active collaboration agreements.
We may provide research and development services under collaboration arrangements to advance the development of jointly owned products. We record the expenses incurred and reimbursed on a net basis in research and development expense. As of December 31, 2025, we do not have any active collaboration agreements.
Contractual Commitments and Contingencies Purchase Obligations We enter into contracts and issue purchase orders in the normal course of business with clinical research organizations for clinical trials and clinical and commercial supply manufacturing and with vendors for preclinical research studies, research supplies and other services and products for operating purposes.
Contractual Commitments and Contingencies Purchase Obligations We enter into contracts and issue purchase orders in the normal course of business with clinical research organizations for clinical trials and clinical and commercial supply manufacturing and with vendors for pre-clinical research studies, research supplies and other services and products for operating purposes.
We have not generated any revenues from product sales and while we expect to generate royalties from our Licensee’s sales of TLANDO, we do not expect to generate revenue from product sales from our other product candidates unless and until approval. We have incurred losses in most years since our inception.
We have not generated any revenues from product sales and while we expect to generate royalties from our Licensees’ sales of TLANDO, we do not expect to generate revenue from product sales from our other product candidates unless and until approval. We have incurred losses in most years since our inception.
Any FDA post-marketing studies required will also be the responsibility of our Licensee, Verity. 53 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 in the SPC Territory.
Any FDA post-marketing studies required will also be the responsibility of our Licensee, Verity Pharma. 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.
We may not realize milestone, product sale or royalty payments in anticipated amounts, or at all. 58 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 our TLANDO product with respect to TRT in the Licensed Verity Territory.
We may not realize milestone, product sale or royalty payments in anticipated amounts, or at all. 55 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 our TLANDO product with respect to TRT in the Licensed Verity Territory.
We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect if additional activities are performed by us including new clinical studies for LPCN 2401, LPCN 2101, LPCN 1148, LPCN 1144, and/or LPCN 1107.
We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect if additional activities are performed by us including new clinical studies for LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401, LPCN 1148, and/or LPCN 1107.
In addition, our capital resources may be consumed more rapidly if we pursue additional clinical studies for LPCN 1154, LPCN 2401, LPCN 2101, LPCN 2203, LPCN 1148, LPCN 1144, and/or LPCN 1107.
In addition, our capital resources may be consumed more rapidly if we pursue additional clinical studies for LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401, LPCN 1148, and/or LPCN 1107.
Research and development expenses also include an allocation of indirect costs, such as those for facilities, office expense, and depreciation of equipment based on the ratio of direct labor hours for research and development personnel. We expense research and development expenses as incurred.
Research and development expenses also include an allocation of indirect costs, such as those for facilities, office expense, and depreciation of equipment based on the ratio of direct labor hours for research and development personnel to total direct labor hours for all personnel. We expense research and development expenses as incurred.
During the year ended December 31, 2024, we sold 32,110 shares of our common stock under the Cantor Sales Agreement at a weighted-average sales price of $6.77 per share, resulting in net proceeds of approximately $209,000, which is net of approximately $8,000 in expenses.
During the year ended December 31, 2024, we sold 32,110 shares of our common stock under the Cantor Sales Agreement at a weighted-average sales price of $6.77 per share, resulting in net proceeds of approximately $209,000, which is net of approximately $8,000 in expenses. On April 24, 2024, we terminated the Cantor Sales Agreement.
Sources and Uses of Cash The following table provides a summary of our cash flows for the years ended December 31, 2024 and 2023.
Sources and Uses of Cash The following table provides a summary of our cash flows for the years ended December 31, 2025 and 2024.
Forward Looking Statements This section and other parts of this report contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risks and uncertainties.
Forward Looking Statements This section and other parts of this report contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that involve risks and uncertainties.
We have incurred operating losses in most years since our inception and we expect to continue to incur operating losses into the foreseeable future as we advance clinical development of LPCN 1154, LPCN 2101, LPCN 2203, LPCN 2401 and any other product candidate, including continued research efforts.
We have incurred operating losses in most years since our inception and we expect to continue to incur operating losses into the foreseeable future as we advance clinical development of LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, and any other future product candidates, including continued research efforts.
We have exclusively licensed rights to TLANDO to Verity for commercialization of TLANDO in the Licensed Verity Territory, to SPC for commercialization in the SPC Territory, and to Pharmalink in the Pharmalink Territory.
We have exclusively licensed rights to TLANDO to Verity Pharma for commercialization of TLANDO in the Licensed Verity Territory, to SPC for commercialization in the SPC Territory, to Pharmalink in the Pharmalink Territory, and to Aché in the Aché Territory.
Revenues to date have been generated substantially from license fees, royalty and milestone payments and research support from our licensees. Since our inception through December 31, 2024, we have generated $53.1 million in revenue under our various license and collaboration arrangements and from government grants.
Revenues to date have been generated substantially from license fees, royalty and milestone payments and research support from our licensees. Since our inception through December 31, 2025, we have generated $55.1 million in revenue under our various license and collaboration arrangements and from government grants.
These contracts generally provide for termination on notice and are cancellable obligations. Operating Leases In August 2004, we entered into an agreement to lease our facility in Salt Lake City, Utah consisting of office and laboratory space which serves as our corporate headquarters. On December 2, 2024, we modified and extended the lease through February 28, 2026.
These contracts generally provide for termination on notice and are cancellable obligations. Operating Leases In August 2004, we entered into an agreement to lease our facility in Salt Lake City, Utah, consisting of office and laboratory space which serves as our corporate headquarters. On December 12, 2025, we modified and extended the lease through February 28, 2027.
We will continue efforts to enter into partnership arrangements for the continued development and/or marketing of LPCN 1144, LPCN 1148, LPCN 2401, LPCN 1107, for the development and commercialization of TLANDO outside of the United States, Canada, South Korea, and the GCC countries and LPCN 1111 outside of the United States and Canada.
We will continue efforts to enter into partnership arrangements for the continued development and/or marketing of LPCN 1154, LPCN 2401, LPCN 1148, LPCN 1107, and for the development and commercialization of TLANDO outside of the United States, Canada, South Korea, the GCC countries and Brazil.
As of December 31, 2024, there was $440,000 of total unrecognized compensation cost related to unvested share-based compensation arrangements granted under the Company’s stock option plan. Warrant Liability In connection with the November 2019 public offering, we issued warrants to purchase common stock.
As of December 31, 2025, there was $473,000 of total unrecognized compensation cost related to unvested share-based compensation arrangements granted under the Company’s stock option plan. 59 Warrant Liability In connection with the November 2019 public offering, we issued warrants to purchase common stock.
Our estimates of the number of performance-based options that will vest will be revised, if necessary, in subsequent periods. 62 We use the Black-Scholes model to compute the estimated fair value of stock option awards.
Our estimates of the number of performance-based awards that are expected to vest will be revised, if necessary, in subsequent periods. We use the Black-Scholes model to compute the estimated fair value of stock option awards.
Forward-looking statements may refer to such matters as products, product benefits, pre-clinical and clinical development timelines, clinical and regulatory expectations and plans, anticipated financial performance, future revenues or earnings, business prospects, projected ventures, new products and services, anticipated market performance, future expectations for liquidity and capital resources needs and similar matters.
Forward-looking statements may refer to such matters as products, product benefits, pre-clinical and clinical development timelines, clinical and regulatory expectations and plans, expected responses to regulatory actions, anticipated financial performance, future revenues or earnings, business prospects, projected ventures, new products and services, anticipated market performance, expected research and development and other expenses, future expectations for liquidity and capital resources needs and similar matters.
Potential compensation cost, measured on the grant date, related to these performance options will be recognized only if, and when, we estimate that these options will vest, which is based on whether we consider the options’ performance conditions to be probable of attainment.
Potential compensation cost, measured on the grant date, related to these performance options or stock grants will be recognized only if, and when, we estimate that these options or stock grants will vest, which is based on whether we consider the awards’ performance conditions to be probable of attainment.
We plan to support Verity’s, SPC’s and Pharmalink’s efforts to effectively enable the availability of TLANDO to patients in a timely manner, in addition to receiving milestone payments, royalty payments, and/or payments for product sales associated with TLANDO commercialization as agreed to in the Verity License Agreement, the SPC License Agreement and the Pharmalink Distribution Agreement.
We plan to support Verity’s, SPC’s, Pharmalink’s, and Aché’s efforts to effectively enable the availability of TLANDO to patients in a timely manner, in addition to receiving milestone payments and royalty payments associated with TLANDO commercialization as agreed to in the Verity License Agreement, the SPC License Agreement, the Pharmalink Distribution Agreement, and the Aché License Agreement.
Our net income was approximately $8,000 for the year ended December 31, 2024, compared to approximately $16.4 million for the year ended December 31, 2023. Substantially all of our operating losses resulted from expenses incurred in connection with our product candidate development programs, our research activities and general and administrative costs associated with our operations.
Our net loss was approximately $9.6 million for the year ended December 31, 2025, compared to net income of $8,000 for the year ended December 31, 2024. Substantially all of our operating losses resulted from expenses incurred in connection with our product candidate development programs, our research activities and general and administrative costs associated with our operations.
Upon execution of the Verity License Agreement in January 2024 and upon transition of the commercialization of TLANDO from Antares to Verity in February 2024, Verity paid to us an initial payment of $2.5 million, and subsequent payments of $5 million and $2.5 million in February 2024 and December 2024, respectively.
Upon execution of the Verity License Agreement in January 2024 and upon transition of the commercialization of TLANDO from Antares to Verity Pharma in February 2024, Verity Pharma paid to us initial payments of $2.5 million and $5 million, respectively.
As of December 31, 2024, we had an accumulated deficit of approximately $199.8 million. Income and losses fluctuate year to year, primarily depending on the nature and timing of research and development occurring on our product candidates.
As of December 31, 2025, we had an accumulated deficit of approximately $209.4 million. Income and losses fluctuate year to year, primarily depending on the nature and timing of research and development occurring on our product candidates.
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.
On January 12, 2024, we entered into the Verity License Agreement with Verity, 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 and Verity Pharma filed a NDS for TLANDO in Canada in June 2025.
Interest and Investment Income The decrease in interest and investment income of approximately $220,000 during the year ended December 31, 2024 was due to declining cash and marketable investment securities balances in fiscal year ended December 31, 2024 compared to 2023.
Interest and Investment Income The decrease in interest and investment income of approximately $403,000 during the year ended December 31, 2025 was mainly due to declining cash and marketable investment securities balances in the year ended December 31, 2025 compared to 2024.
We are also exploring the possibility of licensing LPCN 1144, LPCN 1148, LPCN 2401 and LPCN 1107, although we have not entered into a licensing agreement and no assurance can be given that any license agreement will be completed, or, if an agreement is completed, that such an agreement would be on terms favorable to us.
We are also exploring the possibility of licensing all of our product candidates, although we have not entered into a licensing agreement and no assurance can be given that any license agreement will be completed, or, if an agreement is completed, that such an agreement would be on terms favorable to us.
We believe that our existing capital resources, together with interest thereon, will be sufficient to meet our projected operating requirements through at least March 31, 2026 which include a clinical study for LPCN 1154, research and development activities and compliance with regulatory requirements.
We believe that our existing capital resources, together with interest thereon, will be sufficient to meet our projected operating requirements through at least March 31, 2027 which include research and development activities and compliance with regulatory requirements.
We currently have registered up to $10,616,169 of shares of common shares for sale under the A.G.P. Sales Agreement, pursuant to the Registration Statement on Form S-3, as amended (File No. 333-275716) (the “Form S-3”), through A.G.P. as sales agent.
As of February 26, 2026, we have registered up to $50,000,000 of common shares for sale under the A.G.P. Sales Agreement, pursuant to the Registration Statement on Form S-3, as amended (File No. 333-275716) (the “Form S-3”), through A.G.P. as sales agent.
The offering of common stock pursuant to the A.G.P. Sales Agreement will terminate upon the termination of the A.G.P. Sales Agreement as permitted therein. We and A.G.P. may each terminate the A.G.P. Sales Agreement at any time upon ten days’ prior notice. As of December 31, 2024, we had not sold any shares under the A.G.P. Sales Agreement.
The offering of common stock pursuant to the A.G.P. Sales Agreement will terminate upon the termination of the A.G.P. Sales Agreement as permitted therein. We and A.G.P. may each terminate the A.G.P. Sales Agreement at any time upon ten days’ prior notice.
We expect to continue to incur significant expenses and operating losses for the foreseeable future as we: ● subject to resource availability, conduct further development of our other product candidates, including LPCN 1154, LPCN 2101, LPCN 2203, and LPCN 2401; ● continue our research efforts; ● research new products or new uses for our existing products; ● maintain, expand and protect our intellectual property portfolio; and ● provide general and administrative support for our operations.
We expect to continue to incur significant expenses and operating losses for the foreseeable future as we: ● subject to resource availability, conduct further development of our other product candidates, including LPCN 1154, LPCN 2201, LPCN 2101, and LPCN 2203; ● continue our research efforts; ● research new products or new uses for our existing products; ● maintain, expand and protect our intellectual property portfolio; and ● provide general and administrative support for our operations. 51 To fund future long-term operations, including the potential commercialization of any of our product candidates, we will need to raise additional capital.
Financial Operations Overview Revenue To date, we have not generated any revenues from product sales and do not expect to do so until our FDA approved product receives regulatory approval in the SPC Territory or the Pharmalink Territory or until one of our other product candidates receives approval from the FDA.
Financial Operations Overview Revenue To date, we have not generated any revenues from product sales and do not expect to do so until our FDA approved product receives regulatory approval outside the U.S. and Canada or until one of our product candidates receives approval from the FDA.
Pharmalink paid us a one-time non-refundable, non-creditable upfront fee. We are eligible to receive additional payments in regulatory authorization milestones related to the marketing approval in countries in the Pharmalink Territory under the Pharmalink Distribution Agreement and we have agreed to supply TLANDO to Pharmalink at a specified transfer price.
We are eligible to receive additional payments in regulatory authorization milestones related to the marketing approval in countries in the Pharmalink Territory under the Pharmalink Distribution Agreement and we have agreed to supply TLANDO to Pharmalink at a specified transfer price.
The warrants issued under the November 2019 public offering expired in November 2024, and there were no warrants from the November 2019 offering outstanding as of December 31, 2024. As of December 31, 2024 and 2023, the warrant liability was $0 and $17,000, respectively.
The warrants issued under the November 2019 public offering expired in November 2024, and there were no warrants from the November 2019 offering outstanding as of December 31, 2024, and the warrant liability was fully extinguished.
Our primary development programs are based on oral delivery solutions for poorly bioavailable drugs. We have a portfolio of differentiated innovative product candidates that target high unmet needs for neurological and psychiatric CNS disorders, liver diseases, and hormone supplementation for men and women.
Our proprietary delivery technologies are designed to improve patient compliance and safety through orally available treatment options. Our primary development programs are based on oral delivery solutions for poorly bioavailable drugs. We have a portfolio of differentiated innovative product candidates that target high unmet needs for neurological and psychiatric CNS disorders, liver diseases, and hormone supplementation for men and women.
Research and Development Expenses We recorded research and development expenses of $7.4 million and $10.2 million, respectively, for the years ended December 31, 2024 and 2023.
Research and Development Expenses We recorded research and development expenses of $8.6 million and $7.4 million, respectively, for the years ended December 31, 2025 and 2024.
The key components of our strategy are to: Advance LPCN 1154 and other CNS product candidates. We intend to focus on the development of NASs which have broad applicability in treating various CNS conditions where we can leverage our technology platform to develop highly differentiated oral therapeutics.
Advance LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203 and other CNS product candidates. We intend to focus on the development of endogenous neuroactive steroids (“NASs”) which have broad applicability in treating various CNS conditions where we can leverage our technology platform to develop highly differentiated oral therapeutics.
Unrealized Gain on Warrant Liability We recorded gains of $17,000 and $213,000, respectively, on warrant liability during the fiscal years ended December 31, 2024 and 2023 related to the change in the fair value of outstanding common stock warrants issued in November 2019.
We recorded a non-cash gain of approximately $17,000 on warrant liability during the fiscal years ended December 31, 2024 related to the change in the fair value of outstanding common stock warrants issued in November 2019 as of December 31, 2024 as compared to December 31, 2023.
Since our inception, we have spent approximately $154.6 million in research and development expenses through December 31, 2024. 55 We expect to continue to incur significant costs in the development of future pipeline product candidates.
Since our inception, we have spent approximately $163.2 million in research and development expenses through December 31, 2025. We expect to continue to incur significant costs as we develop our product candidates, including our CNS product candidates, as well as the development of future pipeline product candidates.
We expect to incur significant research and development expenses in the future as we conduct future clinical studies, including when and if we conduct Phase 2 clinical studies with our development product candidates and when and if we conduct Phase 3 clinical studies with LPCN 1144, LPCN 1148, and LPCN 1107.
We expect to incur significant research and development expenses in the future as we complete on-going clinical studies, including studies for CNS product candidates, and as we conduct future clinical studies, including when and if we conduct Phase 2 clinical studies with LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401, and/or Phase 3 clinical studies with LPCN 1148, and/or LPCN 1107.
Our ability to realize benefits from the SPC License Agreement, including milestone, product sale and royalty payments, is subject to a number of risks.
In addition, we will receive royalties on net sales in the SPC Territory under the SPC License Agreement. Our ability to realize benefits from the SPC License Agreement, including milestone, product sale and royalty payments, is subject to a number of risks.
The gain in fiscal year ended December 31, 2024 was attributable to the expiration in November 2024 of the warrant issued in the November 2019 Offering.
The gain in fiscal year ended December 31, 2024 was attributable to the November 2024 expiration of the warrants issued in the November 2019 Offering. There were no common stock warrants exercised during 2024.
Net cash provided by financing activities during the year ended December 31, 2024 and 2023, was related to the sale of 32,110 shares of our common stock for net proceeds of $209,000 and 81,000 shares of our common stock for net proceeds of $405,000, respectively, under the Cantor Sales Agreement, less associated costs.
Net cash provided by financing activities in 2024 was related to the sale of 32,110 shares of our common stock for net proceeds of $209,000 under the Cantor Sales Agreement.
The guidance also requires disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. We adopted this pronouncement effective January 1, 2017.
The guidance also requires disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. We adopted this pronouncement effective January 1, 2017. We recognized license and royalty revenue of $2.0 million and $11.2 million during the years ended December 31, 2025 and 2024, respectively.
Net Cash Provided by Financing Activities During the years ended December 31, 2024 and 2023, net cash provided by financing activities was $209,000 and $405,000, respectively, and was the result of proceeds from the sales of our common stock under the Cantor Sales Agreement.
Capital expenditures during the year ended December 31, 2024 were $90,000. Net Cash Provided by Financing Activities During the years ended December 31, 2025 and 2024, net cash provided by financing activities was $2.9 million and $209,000, respectively, and the result of proceeds from the sales of our common stock under the ATM sales agreements.
We also received an additional payment for a non-refundable, non-creditable prepayment in consideration for TLANDO product inventory, and are eligible to receive additional payments for various marketing authorization and sales milestones and will supply TLANDO to SPC and receive a supply price. In addition, we will receive royalties on net sales in the SPC Territory under the SPC License Agreement.
We also received a non-refundable payment in consideration for certain TLANDO product inventory, and are eligible to receive additional payments upon the receipt of marketing authorization and achievement of sales milestones, and we will supply TLANDO to SPC and receive a supply price.
Although we have previously been successful in obtaining financing through public and private equity securities offerings and our license and collaboration agreements, there can be no assurance that we will be able to do so in the future. 54 Corporate Strategy Our goal is to become a leading biopharmaceutical company focused on leveraging our proprietary Lip’ral drug delivery technology platform to develop differentiated products through oral delivery of previously difficult to deliver molecules.
Although we have previously been successful in obtaining financing through public and private equity securities offerings and our license and collaboration agreements, there can be no assurance that we will be able to do so in the future. Corporate Strategy The key components of our strategy are to: Continue to leverage our drug delivery technology platform .
Years Ended December 31, 2024 2023 Cash used in operating activities $ (1,221,233 ) $ (11,865,991 ) Cash provided by investing activities 2,446,061 13,084,686 Cash provided by financing activities 209,340 404,567 60 Net Cash Used in Operating Activities During each of the years ended December 31, 2024 and 2023, net cash used in operating activities was $1.2 million and $11.9 million, respectively.
Years Ended December 31, 2025 2024 Cash used in operating activities $ (9,760,721 ) $ (1,221,233 ) Cash provided by investing activities 5,891,085 2,446,061 Cash provided by financing activities 2,869,552 209,340 57 Net Cash Used in Operating Activities During each of the years ended December 31, 2025 and 2024, net cash used in operating activities was $9.8 million and $1.2 million, respectively.
In September 2024, we entered into the SPC License Agreement with SPC. Under the terms of the SPC License Agreement, SPC paid us a non-refundable, non-creditable upfront fee in October 2024.
In September 2024, we entered into the SPC License Agreement with SPC, pursuant to which we granted to SPC a non-transferable, non-creditable upfront fee in October 2024.
We are exploring the possibility of licensing TLANDO to third parties outside of the Currently Licensed TLANDO Territories, although as of the date of this Annual Report, no additional licensing agreements have been entered into by the Company in any other territories.
We are also exploring the possibility of licensing LPCN 1021 (known as TLANDO in the United States) to third parties outside of the Licensed Verity Territory, the SPC Territory, the Pharmalink Territory and the Aché Territory, although as of the date of this report, no licensing agreement has been entered into by the Company in any other territories.
To date, we have funded our operations primarily through the sale of equity securities, debt and convertible debt and through up-front payments, research funding and royalty and milestone payments from our license and collaboration arrangements.
To date, we have funded our operations primarily through sales of equity securities, debt and payments received under our license and collaboration arrangements.
In addition to our clinical development product candidates, we have assets for which we expect to seek partnerships to enable further development including TLANDO for territories outside of North America, South Korea, and the GCC, LPCN 1148 comprising a novel prodrug of testosterone, and TL, for the management of cirrhosis, LPCN 1144, an oral prodrug of androgen receptor modulator for the treatment of non-cirrhotic MASH which has completed Phase 2 testing, and LPCN 1107, potentially the first oral HPC product indicated for the prevention of recurrent PTB, which has completed a dose finding clinical study in pregnant women and has been granted orphan drug designation by the FDA.
In addition to our clinical development product candidates, we have assets for which we expect to seek partnerships to enable further development including TLANDO for territories outside of the United States, Canada, South Korea, the GCC, and Brazil, LPCN 2401 for improved body composition in GLP-1 agonist use such as obesity management, LPCN 1148 comprising a novel prodrug of testosterone, testosterone laurate (“TL”), for the management of decompensated cirrhosis, and LPCN 1107, potentially the first oral hydroxy progesterone caproate (“HPC”) product indicated for the prevention of recurrent preterm birth (“PTB”), which has completed a dose finding clinical study in pregnant women and has been granted orphan drug designation by the FDA.
Net cash provided by investing activities during 2024 and 2023 was primarily the result of the maturity of marketable investment securities of $35.4 million and $36.0 million, respectively offset by the purchase of marketable investment securities of $32.9 million and $22.9 million, respectively.
Net cash provided by investing activities during 2025 and 2024 was primarily the result of the maturity of marketable investment securities of $20.6 million and of $35.4 million, respectively offset by the purchase of marketable investment securities of $14.7 million and $32.9 million, respectively. There were no capital expenditures for the year ended December 31, 2025.
Factors that might cause such differences include, but are not limited to, those discussed in Part I, Item 1A (Risk Factors) of this Form 10-K. Except as required by applicable law, we assume no obligation to revise or update any forward-looking statements for any reason.
Factors that might cause such differences include, but are not limited to, those discussed in Part I, Item 1A (Risk Factors) of this Form 10-K.
Our priority is on the development of LPCN 1154, a fast-acting oral antidepressant for PPD with potential for outpatient use. Support our licensees, Verity, SPC, and Pharmalink in commercialization and/or of our licensed oral TRT product . We believe the TRT market needs a differentiated, convenient oral option.
Support our partners, Verity, SPC, Pharmalink and Aché, in commercialization and/or development of our licensed oral TRT option . We believe the TRT market needs a differentiated, convenient oral option.
Verity has also agreed to make an additional payment to us of $1 million before January 1, 2026. The Verity License Agreement also provides Verity with a license to develop and commercialize TLANDO XR (“LPCN 1111”), our potential next generation, once daily oral product candidate for testosterone replacement therapy comprised of testosterone tridecanoate, in the Licensed Verity Territory.
The Verity License Agreement also provides Verity Pharma with a license to develop and commercialize TLANDO XR (LPCN 1111), our potential next generation, once daily oral product candidate for testosterone replacement therapy comprised of TT in the U.S. and Canada.
We are currently exploring partnerships for our liver programs LPCN 1144, our candidate for treatment of non-cirrhotic MASH and LPCN 1148 for the management of cirrhosis including prevention of the recurrence of overt hepatic encephalopathy; LPCN 2401 for improved body composition in obesity management as an adjunct therapy to or as a monotherapy post cessation of incretin mimetics use; and LPCN 1107, our candidate for prevention of pre-term birth.
We are currently exploring partnerships for LPCN 1148 for the management of decompensated cirrhosis including prevention of the recurrence of overt hepatic encephalopathy (“OHE”), and we are also exploring partnerships for LPCN 2401 for management of incretin mimetics use and LPCN 1107, our candidate for prevention of pre-term birth.
Other Income and Expense Other income and expense consists primarily of interest income earned on our cash, cash equivalents and marketable investment securities, imputed interest on minimum royalties under the Antares Licensing Agreement in 2023, and gains on our warrant liability.
Other Income and Expense Other income and expense consists primarily of interest income earned on our cash, cash equivalents and marketable investment securities, and, in 2024, included a gain on our warrant liability resulting from the expiration of the underlying warrants.
Results of Operations Comparison of the Years Ended December 31, 2024, and 2023 The following table summarizes our results of operations for the years ended December 31, 2024 and 2023: Years Ended December 31, 2024 2023 Variance Revenue $ 11,198,144 $ (2,850,818 ) $ 14,048,962 Research and development expenses 7,351,753 10,175,251 (2,823,498 ) General and administrative expenses 5,001,426 4,904,888 96,538 Interest and investment income 1,146,902 1,366,940 (220,038 ) Unrealized gain on warrant liability 17,166 212,690 (195,524 ) Income tax expense (681 ) (755 ) 74 Revenue We recognized revenue of $11.2 million during the year ended December 31, 2024, compared to a net reversal of variable consideration revenue of $2.9 million during the year ended December 31, 2023.
Results of Operations Comparison of the Years Ended December 31, 2025, and 2024 The following table summarizes our results of operations for the years ended December 31, 2025, and 2024: Years Ended December 31, 2025 2024 Variance Revenue $ 1,976,677 $ 11,198,144 $ (9,221,467 ) Research and development expenses 8,583,919 7,351,753 1,232,166 General and administrative expenses 3,764,137 5,001,426 (1,237,289 ) Interest and investment income 744,074 1,146,902 (402,828 ) Unrealized gain on warrant liability - 17,166 (17,166 ) Income tax expense (200 ) (681 ) 481 Revenue We recognized revenue of $2.0 million during the year ended December 31, 2025, compared to revenue of $11.2 million during the year ended December 31, 2024.
Revenue in 2024 primarily consisted of revenue from our licensees, Verity, SPC and Pharmalink and royalty revenue from TLANDO sales.
Revenue in 2025 primarily consisted of license revenue from our licenses, Verity and Aché of $1.5 million, and royalty revenue from TLANDO sales of $480,000. Revenue in 2024 primarily consisted of $10.9 million in upfront, one-time, license revenue from our licensees, Verity, SPC and Pharmalink and royalty revenue from TLANDO sales of $298,000.
We entered into a license agreement for the development and commercialization our product candidate, TLANDO®, an oral testosterone replacement therapy comprised of testosterone undecanoate. On March 28, 2022, the FDA approved TLANDO as a TRT in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
On March 28, 2022, the FDA approved TLANDO as a testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism and on June 7, 2022, our former commercial partner Antares (a wholly owned subsidiary of Halozyme) announced the commercial launch of TLANDO.
Additional clinical development pipeline candidates include: LPCN 1154 for PPD, LPCN 2101 for epilepsy, LPCN 2203 for essential tremor and LPCN 2401 for improved body composition in obesity management.
Additional clinical development pipeline candidates include: LPCN 1154 for postpartum depression (“PPD”), LPCN 2201 for Major Depressive Disorder (“MDD”), LPCN 2101 for epilepsy, and LPCN 2203 for essential tremor.
The increase in general and administrative expenses during the year ended December 31, 2024 was primarily due to a $800,000 increase in business development and strategic advisory services related expenses and a $53,000 increase in intellectual property and patent expenses, offset by a $222,000 decrease in corporate insurance expense, a $208,000 decrease in personnel related costs, a $161,000 decrease in professional fees relating to our annual shareholder’s meeting and subsequent decision to enact a reverse stock split, a $146,000 decrease in other various consulting and professional fees, and a $20,000 decrease in other general and administrative expenses.
The decrease in general and administrative expenses during the year ended December 31, 2025 was primarily due to approximately a $1.3 million decrease in business development, strategic advisory services, and corporate legal fees incurred in connection with our various license agreements in 2024, a $121,000 decrease in estimated franchise taxes, a $55,000 decrease in other various professional fees, and a $47,000 decrease in corporate insurance expense, offset by an increase of $165,000 in personnel related expenses, a $104,000 increase in patent related fees and a $25,000 increase in other general and administrative expenses.
In October 2024, we entered into the Pharmalink Distribution Agreement with Pharmalink granting a non-transferable, exclusive, license to commercialize our TLANDO product in the Pharmalink Territory. Our ex-U.S. commercialization partners are planning to file marketing approval applications in Canada, the GCC countries, and South Korea in 2025.
In October 2024, we entered into the Pharmalink Distribution Agreement with Pharmalink granting a non-transferable, exclusive, license to commercialize our TLANDO product specific to the GCC, including Saudi Arabia, Kuwait, UAE, Qatar, Bahrain, and Oman (the “Pharmalink Territory”).
Overview of Our Business We are a biopharmaceutical company focused on leveraging our proprietary Lip’ral platform to develop differentiated products through the oral delivery of previously difficult to deliver molecules. Our proprietary delivery technologies are designed to improve patient compliance and safety through orally available treatment options.
Except as required by applicable law, we assume no obligation to revise or update any forward-looking statements for any reason. 50 Overview of Our Business We are a biopharmaceutical company focused on leveraging our proprietary drug delivery technology platform to develop differentiated products through the oral delivery of previously difficult to deliver molecules.
These decreases were offset by a $996,000 increase in LPCN 1154 clinical studies, a $188,000 increase in other lab supplies and research costs, and a $46,000 increase in LPCN 2401 costs. 57 General and Administrative Expenses We recorded general and administrative expenses of $5.0 million and $4.9 million, respectively, for the years ended December 31, 2024 and 2023.
The increase in research and development expenses during the year ended December 31, 2025 primarily relates to an $894,000 increase in our clinical study costs, a $174,000 increase in other supplies and research costs and a $164,000 increase in personnel-related costs 54 General and Administrative Expenses We recorded general and administrative expenses of $3.8 million and $5.0 million, respectively, for the years ended December 31, 2025 and 2024.
As of December 31, 2024, we had $21.6 million of unrestricted cash, cash equivalents and marketable investment securities compared to $22.0 million as of December 31, 2023. In October 2024, we entered into the Pharmalink Distribution Agreement with Pharmalink, pursuant to which we granted to Pharmalink a non-transferable, exclusive, license to commercialize our TLANDO product in the Pharmalink Territory.
As of December 31, 2025, we had $14.9 million of unrestricted cash, cash equivalents and marketable investment securities compared to $21.6 million as of December 31, 2024.

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