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RALEIGH, N.C., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a pharmaceutical company focused on developing innovative therapies for testosterone deficiency, is proud to announce the expansion of access to its FDA-approved oral testosterone therapy, KYZATREX™, to the Department of Veteran Affairs (VA). This initiative is a significant milestone in Marius Pharmaceutical’s ongoing mission to provide accessible and life-enhancing therapies to focused communities. Military personnel face an array of physical and psychological health challenges, including but not limited to stress, insomnia, emotional distress, and physical injuries. Veterans often endure unresolved health implications, including mental health conditions, that are frequently linked to low testosterone. A lack of awareness about the impacts of military service on both hormone health and symptom stigma makes it difficult for veterans to confront low testosterone. Studies have shown that the stress associated with intense military field training can result in up to a 47% decrease in testosterone levels. With increased education and awareness about this connection, veteran mental and physical health can be addressed. Marius Pharmaceuticals is committed to offering a safe and accessible oral solution with KYZATREX™. By providing a trusted therapy like KYZATREX™, Marius aims to not only enhance the long-term quality of life for these individuals but also contribute to the savings to the U.S. Healthcare system. “At Marius Pharmaceuticals, we are proud to offer a treatment option to our veterans who have suffered from the physical and mental conditions associated with Low T, while bringing awareness of their plight to countless others who might not have realized the connection. Early diagnosis and treatment can reduce or eliminate downstream expenses freeing up budget dollars to help more veterans obtain the help they deserve,” shared Rich Callaghan, SVP, Operations at Marius Pharmaceuticals. As part of its comprehensive effort to raise awareness about testosterone deficiency or hypogonadism, Marius Pharmaceuticals has launched the ReThink Testosterone disease state awareness initiative and website. ReThink Testosterone is committed to educating individuals, including veterans and active-duty service members, about the impact of low testosterone on overall health and well-being. The initiative will continue to expand its content and resources to provide valuable information on this critical topic. About KYZATREX™: KYZATREX™ is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX™ was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX™ achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX™ reported improvements in quality of life, energy/fatigue, erectile function, intercourse satisfaction, and positive mood. The most common side effect reported in ≥ 2 percent of KYZATREX™ patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX™ in males less than 18 years old have not been established. Please see additional Important Safety Information below, including Boxed Warning for potential increased blood pressure, for KYZATREX™ or visit . About Marius Pharmaceuticals: Marius Pharmaceuticals strives to better the lives of men and women by focusing on therapies designed for hypogonadism or Testosterone Deficiency. Their vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit . About ReThink Testosterone: ReThink Testosterone is a disease state awareness campaign that aims to transform lives through education and support for individuals affected by low testosterone or Low T (male hypogonadism). Its mission is to enhance understanding of the symptoms, impact, and available treatment options for this condition, empowering men to make informed decisions about their health and well-being. For more information, please visit . Important Safety Information for KYZATREX™ (testosterone undecanoate) Use KYZATREX™ (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions. KYZATREX™ is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX™ is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX™ is not meant for use by women. Important Safety Information for KYZATREX™ KYZATREX™ can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. If your blood pressure increases while on KYZATREX™, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure. If your blood pressure cannot be controlled, KYZATREX™ may need to be stopped. Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX™. Do not take KYZATREX™ if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX™ may harm your unborn baby); are allergic to KYZATREX™ or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX™ if you have low testosterone due to age). Before you take KYZATREX™, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea). Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX™ with certain other medicines can affect each other. Especially, tell your healthcare provider if you take: insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines. KYZATREX™ may cause other serious side effects including: Increase in red blood cell count (hematocrit) or hemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX™ if your red blood cell count increases. If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX™. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow. Increased risk of prostate cancer. Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain. Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects. In large doses, KYZATREX™ may lower your sperm count. Liver problems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain). Swelling of your ankles, feet, or body (edema), with or without heart failure. Enlarged or painful breasts. Breathing problems while you sleep (sleep apnea). Call your healthcare provider right away if you have any of the serious side effects listed above. The most common side effect of KYZATREX™ is high blood pressure. Other side effects may include headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels. These are not all the possible side effects of KYZATREX™. For more information, ask your healthcare provider or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Marius by calling 1-833-949-5040. Keep KYZATREX™ and all medicines out of the reach of children. See Full Prescribing Information and Medication Guide for KYZATREX™. Media Contact: Lilly Washburn 336-404-9622 lilly@mariuspharma.com

RALEIGH, N.C., July 24, 2023 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a patient-centric healthcare company specializing in therapies for hypogonadism or Testosterone Deficiency, is proud to announce the launch of their disease state awareness website, ReThink Testosterone. With the aim of changing the narrative surrounding testosterone and testosterone therapy, ReThink Testosterone seeks to empower men dealing with Low T to advocate for their health by providing valuable education and debunking long-standing myths. Low testosterone, also known as male hypogonadism, affects millions of men worldwide, often impacting their overall health and well-being. However, misconceptions and stigma have created barriers to understanding and seeking appropriate treatment. ReThink Testosterone is a comprehensive online resource designed to address this gap, equipping men with knowledge to make informed decisions about their health. "At Marius Pharmaceuticals, we believe in empowering individuals to take control of their health," said Shalin Shah, CEO of Marius Pharmaceuticals. "Our goal with the launch of ReThink Testosterone is to provide a platform where men with low testosterone can better understand the symptoms, impacts, and treatment options available to them." ReThink Testosterone offers a wealth of information and resources, including informative videos, insightful podcasts, and relevant studies, all focused on testosterone and testosterone therapy. By debunking prevalent myths and misconceptions, the website aims to alleviate confusion and provide clarity on the benefits and potential risks associated with testosterone therapy. Additionally, visitors can access information about symptoms, diagnosis, and various treatment options. The website goes beyond just discussing low testosterone itself. It aims to educate visitors about the relationship between Low T and various comorbidities, such as type 2 diabetes, obesity, cardiovascular disease, and more. By highlighting the potential links between low testosterone and these conditions, ReThink Testosterone provides a holistic view of hormonal health and its impact on overall well-being. ReThink Testosterone caters to men who are experiencing low testosterone or those who have an interest in understanding testosterone and its implications. The website serves as a valuable resource to facilitate open conversations between patients and healthcare providers, promoting proactive engagement in managing hormonal health. Dispelling common myths is a key focus of ReThink Testosterone. Misconceptions such as testosterone therapy causing serious adverse cardiovascular events, being solely a hormone for sexual and muscular purposes, or leading to aggression will be addressed through evidence-based information and expert insights. Other myths, including claims that testosterone therapy causes prostate cancer, will also be refuted, ensuring that visitors have accurate and reliable information at their fingertips. By visiting ReThink Testosterone at www.rethinktestosterone.com or following on Instagram (@rethinktestosterone), individuals can embark on a journey of understanding and empowerment. The website will serve as a trusted resource, enabling men to recognize the symptoms of Low T, take proactive steps towards diagnosis and treatment, and ultimately improve their overall quality of life. About Marius Pharmaceuticals: Marius Pharmaceuticals is a patient-centric healthcare company focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company’s mission is to improve the functional lives of patients by reducing the downstream effects of Testosterone Deficiency, which include multiple comorbidities, such as type 2 diabetes and obesity. For more information, please visit www.mariuspharma.com. About ReThink Testosterone: ReThink Testosterone is a disease state awareness campaign that aims to transform lives through education and support for individuals affected by low testosterone or Low-T (male hypogonadism). Its mission is to enhance understanding of the symptoms, impact, and available treatment options for this condition, empowering men to make informed decisions about their health and well-being. Media Contact: Lilly Washburn 336-404-9622 lilly@mariuspharma.com

SALT LAKE CITY, March 10, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS") disorders by leveraging its proprietary platform to develop differentiated products, today announced financial results for the year ended December 31, 2022 and provided a corporate update. In 2022, Lipocine announced a new strategic direction, focusing on the development of endogenous neuroactive steroids which have broad applicability in treating various CNS conditions. The Company is currently exploring partnering non-core assets including LPCN 1107, for prevention of pre-term birth, LPCN 1148, for the management of decompensated cirrhosis, LPCN 1144, for treatment of non-cirrhotic NASH, LPCN 1111, a once-a-day therapy candidate for TRT and LPCN 1021 (TLANDO in the U.S.) outside of the U.S. Clinical Program Highlights Neuroactive Steroids The Company completed an oral PK study and a food effect study with LPCN 1154 demonstrating the first enablement of effective oral delivery of brexanalone, a bioidentical neuroactive steroid. A pilot PK bridge study of LPCN 1154, an oral neuroactive steroid ("NAS") product candidate, in postpartum depression ("PPD") has been initiated. Results are expected in the first half of the year. The FDA has agreed with Lipocine's proposal for establishing the efficacy of LPCN 1154 via the 505(b)(2) pathway. The proof-of-concept study is a prelude to a pivotal study required for NDA filing. LPCN 1148 in liver cirrhosis Enrollment has been completed in a Phase 2 proof-of-concept ("POC") study evaluating the therapeutic potential of LPCN 1148 for the management of decompensated cirrhosis of various etiologies. Topline results on the primary endpoint (change in skeletal muscle index at Week 24) are expected mid-2023. TLANDO® for hypogonadism TLANDO™ was approved and granted Market Exclusivity by the U.S. Food and Drug Administration ("FDA") for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary or hypogonadotropic hypogonadism). TLANDO™ has been licensed to Antares and was launched commercially in the U.S. in June 2022. Year Ended December 31, 2022 Financial Results Lipocine reported a net loss of $10.8 million, or ($0.13) per diluted share, for the year ended December 31, 2022, compared with a net loss of $634,399, or ($0.01) per diluted share, for the year ended December 31, 2021. Lipocine recognized license revenue of $500,000 during the year ended December 31, 2022, compared to $16.1 million during the year ended December 31, 2021. License revenue in 2022 was related to a non-refundable cash fee of $500,000 received from Antares for consideration of a 90-day extension to exercise its option to license LPCN 1111. License revenue in 2021 primarily related to the Antares Licensing Agreement for TLANDO which was signed in October 2021 and was comprised of licensing fees, minimum royalties and the sale of finished goods inventory. Research and development expenses were $8.6 million and $7.7 million, respectively, for the years ended December 31, 2022, and 2021. The increase in research and development expenses during the year ended December 31, 2022 was primarily due to an increase in contract research organization expense related to the Phase 2 POC study in male cirrhotic subjects with LPCN 1148, an increase in manufacturing scale up costs, an increase in personnel expense primarily resulting from additional headcount, and an increase in other R&D expenses. These increases were offset by decreases in costs related to LPCN 1144, LPCN 1107, and LPCN 1154. General and administrative expenses were $4.1 million and $5.3 million, respectively, for the years ended December 31, 2022, and 2021. The decrease in general and administrative expenses during the year ended December 31, 2022 was primarily due to a decrease in legal fees, a decrease in personnel related costs and a decrease in other general and administrative expenses. These decreases were offset by an increase in costs related to the recruitment and compensation for two additional directors, an increase in other various professional fees, an increase in strategic advisory services, an increase related to proxy solicitation services, and an increase in travel related costs. As of December 31, 2022, Lipocine had $32.5 million of unrestricted cash, cash equivalents and marketable investment securities compared to $46.6 million at December 31, 2021. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop products for CNS disorders. Lipocine has candidates in development as well as candidates for which we are exploring partnering. Our candidates represent enablement of patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs. Lipocine clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy and LPCN 1148, an oral prodrug of bioidentical testosterone targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of pre-term birth, LPCN 1148, for the management of decompensated cirrhosis, LPCN 1144, our candidate for treatment of non-cirrhotic NASH, and LPCN 1111, a once-a-day therapy candidate for testosterone replacement therapy (TRT). TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit . Forward-Looking Statements This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product development efforts, our strategic plans for developing products to treat CNS disorders, our ability to monetize non-core product candidates, including through entering into partnering arrangements, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, the achievement of milestones within and completion of clinical trials, the timing and completion of regulatory reviews, outcomes of clinical trials of our product candidates, and the potential uses and benefits of our product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates to treat CNS disorders, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc.