Sarcopenia

SALT LAKE CITY, March 7, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System ("CNS") disorders, today announced financial results for the year ended December 31, 2023 and provided a corporate update. Neuroactive Steroids Lipocine announced positive topline results from a pharmacokinetics ("PK") pilot bridge study of LPCN 1154 (oral brexanolone). Lipocine is developing LPCN 1154 for postpartum depression ("PPD") The bridge study results demonstrated comparative pharmacokinetics of LPCN 1154 to an approved IV infusion brexanolone The study identified a dosing regimen of LPCN 1154 to be tested in a single confirmatory pivotal PK study required for NDA filing LPCN 1154 treatment was well-tolerated with no hypoxia or sedation-related adverse events The Company completed a successful meeting with the U.S. Food and Drug Administration ("FDA") during which it confirmed with the FDA its proposal for a 505(b)(2) NDA filing based on a single pivotal study comparing exposure of LPCN 1154 with the approved IV infusion of brexanolone. The use of exposure parameters and criteria to assess comparable exposure to IV infusion brexanolone was also agreed upon In January 2024, Lipocine completed a single arm PK study (N=8) utilizing the "to be marketed" LPCN 1154 formulation and target dosing regimen. PK exposure results of the scaled-up formulation were consistent with the PK performance of the formulation evaluated in the pilot study. The study results confirm the 48-hour dosing regimen for the planned pivotal PK study The company anticipates beginning the LPCN 1154 pivotal study in Q1 '24. Top line results from the study are expected by the end of Q2 '24. Assuming the study meets expectations, the company plans to file an NDA at the end of Q4 '24 Lipocine has identified a lead neuroactive steroid candidate for the management of essential tremor and is planning to submit a protocol for a proof-of-concept phase 2 study for Essential Tremor ("ET") in the first half of 2024 LPCN 1148 Lipocine announced positive topline results from its Phase 2 proof-of-concept ("POC") study evaluating LPCN 1148 for the management of decompensated cirrhosis The study met the primary endpoint: treatment with LPCN 1148 increased L3 skeletal muscle index (L3-SMI) relative to placebo (P <0.01) Fewer hepatic encephalopathy (HE) events of grade >1 were observed in the LPCN 1148 treatment arm relative to placebo (P < 0.05) More patients on LPCN 1148 reported symptom improvement compared to those on placebo (P < 0.05) LPCN 1148 was well-tolerated, with AE rates and severities similar to placebo Posters on LPCN 1148 and LPCN 1144 were presented at the European Association for the Study of the Liver (EASL) Congress 2023, in Vienna, Austria, June 21 – 24, 2023 Updated results from the Phase 2 POC study were presented at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2023, in Boston, MA, November 2023 After week 24, all patients in the study entered into a single arm open-label extension ("OLE") stage and received LPCN 1148. Patients converting from placebo to LPCN 1148 in this OLE showed improvement in sarcopenia End of study results from the POC study are expected by the end of Q2 '24 TLANDO™ In January 2024, Lipocine and Verity Pharma entered into an exclusive License Agreement under which Verity Pharma will market TLANDO in the United States and, if approved, in Canada Verity Pharma is responsible for regulatory and marketing obligations in the U.S. and Canada, and for all further development of TLANDO and TLANDO XR Verity Pharma agreed to pay Lipocine a license fee totaling $11 million. Upon execution of the agreement and upon transition of the commercialization of TLANDO to Verity, Lipocine received initial payments of $2.5 million and $5 million. Further payments of $2.5 million and $1 million are due from Verity Pharma no later than January 1, 2025, and January 1, 2026, respectively Lipocine is entitled to receive up to $259 million in development and sales-based commercial milestone payments, as well as tiered royalty payments ranging from 12% up to 18% on net sales of TLANDO franchise products Year Ended December 31, 2023 Financial Results Lipocine reported a net loss of $16.4 million, or ($3.14) per diluted share, for the year ended December 31, 2023, compared with a net loss of $10.8 million, or ($2.15) per diluted share, for the year ended December 31, 2022. During 2023 Lipocine recognized a non-cash minimum guaranteed royalties reversal of variable consideration revenue of $2.9 million related to the termination of the Antares License Agreement. The reversal of revenue is due to the fact that, as a result of the termination of the license agreement, the Company will not receive anticipated minimum royalties that were previously recorded for the Antares License Agreement. In 2022, the Company recorded revenue of $500,000 related to a non-refundable cash fee received from Antares. Research and development expenses were $10.2 million and $8.6 million, respectively, for the years ended December 31, 2023 and 2022. The increase in research and development expenses was primarily due to an increase in contract research organization expense related to the LPCN 1154 clinical studies, an increase in TLANDO manufacturing related costs, an increase related to the LPCN 1148 Phase 2 POC study in male patients with cirrhosis, and an increase in personnel expense. These increases were offset by a decrease related to expenses incurred in 2022 for LPCN 1111 scale up costs, LPCN 1107 clinical study costs, and other research and development activities. General and administrative expenses were $4.9 million and $4.1 million, respectively, for the years ended December 31, 2023 and 2022. The increase in general and administrative expenses was primarily due to an increase in business development and strategic advisory services expenses, an increase in legal fees, an increase in personnel related costs, an increase in franchise taxes, an increase in director fees, and an increase in other general and administrative expenses. These increases were offset by a decrease in corporate insurance expense, a decrease related to 2022 expenses for the recruitment of two additional directors, and a decrease in various consulting and professional fees. As of December 31, 2023, Lipocine had $22.0 million of unrestricted cash, cash equivalents and marketable investment securities compared to $32.5 million at December 31, 2022. Subsequent to year end, Lipocine received payments of $2.5 million and $5 million as part of the initial license fee from Verity Pharma in connection with the agreement entered into in January 2024 whereby Verity will take over commercialization of TLANDO, as described above. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products for CNS disorders. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnering. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs. Lipocine's clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy, LPCN 2203 for the potential treatment of essential tremor and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN1154, for rapid relief of postpartum depression, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of non-cirrhotic NASH. 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, the application of our proprietary platform in developing new treatments for CNS disorders, our lead neuroactive steroid candidate for the management of essential tremor, the timing of studies and clinical trials, our product candidates and related clinical trials, our development of and filing of a NDA with the FDA for LPCN 1154, the receipt of license fees, milestone payments and royalty payments under our license agreement with Verity Pharma, 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 have sufficient capital to complete the development processes for our product candidates, 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 and our ability to utilize a streamlined approval pathway for LPCN 1154, 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.

BOSTON--( BUSINESS WIRE )-- Lincoln Property Company ("Lincoln"), Cresa Boston , and BPGbio, Inc. , a leading biology-first AI-powered biopharma that focuses on oncology, neurology, and rare diseases, today announced that BPGbio has leased approx. 70,000 sq. ft. of lab and office space at 300 Third Avenue in Waltham, Mass. The company plans to relocate its headquarters from Framingham and expand into two full floors of the new space circa June 2025, significantly increasing its footprint in the Boston region. The property is co-owned by a MetLife Investment Management client. “The move to the vibrant culture and biotech talent pool in and around Waltham positions BPGbio onto a successful growth trajectory to serve patients. Our employees are excited with the additional space which enables BPGbio to accelerate development of therapeutics and diagnostics in our pipeline,” said Niven R. Narain, Ph.D. , CEO of BPGbio. “Our new facility will also house our 100,000+ sample rich biobank, which forms the basis of our unique biology-first, AI-powered drug development, and fuel successful partnerships with pharma, academic, and government partners.” “We are excited to welcome BPGbio to 300 Third and to help expand Waltham’s flourishing biotech community,” said Scott Faber, Senior Vice President of Investments and Acquisitions at Lincoln. 300 Third Avenue is a 143,533-sq.-ft. purpose-built life science building with four stories of laboratory space and 441 on-site parking spaces. The project is LEED Gold and WiredScore Gold certified, providing best-in-class connectivity, infrastructure, and technology readiness. On-site amenities include a roof deck, fitness center, grab & go café, and free shuttle to Alewife (MBTA Red Line to Cambridge). The high-visibility building is located on Route 128 in one of Greater Boston’s largest life science clusters. 300 Third is nearly fully leased, with Lincoln now marketing the last remaining floor. BPGbio’s therapeutic pipeline , developed from the company’s Bayesian-AI powered NAi Interrogative Biology Platform , includes therapeutic candidates being studied for glioblastoma multiforme (GBM) in active phase 2b trials, pancreatic cancer , having recently completed a phase 2a trial, epidermolysis bullosa (EB), squamous cell carcinoma (SCC), sarcopenia , solid and liquid tumors, Huntington’s disease, Parkinson’s disease, and diabetes type II. The company’s diagnostic pipeline includes its prostate diagnostic panel pstateDx , as well as tests being developed and validated for the detection of Parkinson’s disease , pancreatic cancer , breast cancer , and liver disease. Lincoln’s Tim Latham, Christopher Scott and Chris Devaux represented ownership in the transaction. Cresa Boston's Paul Delaney, Adam Subber, and Nate Heilbron represented the tenant. BPGbio joins another biotech company, Biocytogen, in the building. About Lincoln Property Company Lincoln Property Company (“Lincoln”) is one of the largest diversified real estate services companies with 35 offices across the United States the United Kingdom and Europe. Offering a comprehensive suite of real estate solutions, Lincoln manages, leases, develops, and provides advisory services to owners and occupiers of office, life science, retail, industrial, data center, production studio, and mixed-used properties. Lincoln's combined management and leasing portfolio on behalf of institutional clients includes approximately 500 million square feet of commercial space. In addition to providing third party real estate services, Lincoln, which was founded in 1965, has principally acquired and developed more than $24 billion and 62 million square feet of commercial projects since 2018. For more information, visit: www.lpc.com . About BPGbio, Inc. BPGbio is a leading AI-powered clinical stage biopharma and diagnostics company focused on oncology, neurology, and rare diseases. The company has a deep portfolio of AI-developed therapeutics, including several in late stage development. BPGbio’s novel approach is underpinned by NAi, its proprietary Interrogative Biology Platform, protected by over 400 US and international patents; the world’s largest clinically annotated non-governmental biobank; and exclusive access to the most powerful supercomputer in the world. With these tools, BPGbio is redefining how patient biology can be modeled using unbiased AI. Headquartered in Boston, the company is at the forefront of a new era in medicine, combining biology, data, and AI to transform the way disease is diagnosed and treated. For more information, visit bpgbio.com About Cresa Cresa is the world's only global commercial real estate advisory firm that exclusively represents occupiers and specializes in the delivery of fully integrated real estate solutions. Cresa’s purpose is to think beyond space, strengthening those we serve and enhancing the quality of life for our clients. Delivered across every industry, Cresa's services include Transaction Management, Workplace Solutions, Project Management, Consulting, Lease Administration, Technology, Investment Banking & Capital Markets, and Portfolio Solutions. In partnership with London-based Knight Frank, Cresa provides service through 16,000 people, across 380 offices in 51 territories. For more information, please visit www.cresa.com .

Cutting-edge therapy shows meaningful improvements in muscle strength, function and fatigue resistance, offering hope for millions suffering from sarcopenia DIEPENBEEK, Belgium, Feb. 21, 2024 /PRNewswire/ -- Rejuvenate Biomed NV ("Rejuvenate Biomed"), a pioneering clinical-stage platform and pipeline company committed to enhancing lifelong health through innovative therapeutics, today announces breakthrough functional outcome results from its Phase 1b trial of lead candidate RJx-01 for the treatment of sarcopenia. Sarcopenia, a condition affecting up to 22% of 65-year-olds and 50% of 80-year-olds, is characterized by the progressive loss of muscle strength and physical performance. This decline not only impacts the quality of life but also elevates the risk of falls, disability, and mortality, particularly among the older population. RJx-01 is a proprietary combination drug that was identified by the Company's in-house drug discovery platform and has shown to have beneficial effects on various preclinical models of sarcopenia[1]. The recent exploratory clinical trial results, which follow earlier confirmation of safety and tolerability and pharmacokinetics[2], highlight the potential of RJx-01 in addressing the unmet need for effective sarcopenia treatments. The key findings of the Phase 1b trial with RJx-01 reveal promising functional outcomes: Improved strength: Participants with disuse-induced sarcopenia treated with RJx-01 exhibited a promising improvement in muscle strength recovery compared to the placebo group. This beneficial effect, assessed through isometric dynamometry, underscores the ability of RJx-01 to promote muscle strength improvement, an outcome that would support the daily activities of sarcopenia patients. Improved muscle function: Treatment with RJx-01 led to an important improvement of leg acceleration, assessed through isokinetic dynamometry. The ability to accelerate the limb rapidly is important for functional movement in daily activities and is pivotal in mitigating fall risks – a critical consideration for sarcopenia patients. Improved fatigue resistance: Neuromuscular fatigue was assessed by monitoring muscle parameters during a series of leg exercises. Participants receiving RJx-01 showed a reduced propensity for fatigue indicating that RJx-01 can promote physical activities such as walking, a performance improvement that is important for sarcopenia patients. Dr. Ann Beliën, Founder and Chief Executive Officer of Rejuvenate Biomed, expressed her enthusiasm, stating: "Today marks a pivotal moment in our journey to address age-related diseases, most notably sarcopenia – a condition affecting up to 1 in 5 individuals over 65 years. The impact demonstrated by RJx-01 offers great potential to make a substantial difference for individuals with sarcopenia or muscle strength loss due to other underlying factors. We eagerly anticipate advancing our Phase 2 program later this year, aiming to substantiate RJx-01's therapeutic potential in addressing sarcopenia and osteoporosis." Prof. Dr. Jean-Yves Reginster, Chair of Rejuvenate Biomed's Clinical Advisory Board, added: "These compelling data confirm RJx-01's promise to improve physical performance and muscle strength. With aging populations, it is inevitable that the number of people living with long-term health conditions will rise, challenging ones functional abilities and overall physical performance. Thus, it is crucial that companies like Rejuvenate Biomed work towards the goal of treating and even preventing the development of age-related diseases such as sarcopenia." Prof. Dr. Roger Fielding, Clinical Advisory Board member of Rejuvenate Biomed, echoed his resounding endorsement: "The number of people living with muscle-related conditions is increasing, emphasizing the urgent need for viable solutions to improve the age-related decline in muscle performance. The new data announced today by Rejuvenate Biomed regarding RJx-01 are very promising for patients with sarcopenia, as well as for those experiencing a loss of muscle function due to other causes." Rejuvenate Biomed will commence a Phase 2 study evaluating RJx-01's effect on sarcopenia and osteoporosis, as these two diseases often co-exist, so frequently that "osteosarcopenia" has recently been described in medical literature as a distinct syndrome. Additionally, the Company is actively exploring partnership opportunities to investigate RJx-01 in combination with GLP-1 drugs, that are marketed for obesity and diabetes type 2. The positive outcomes from the Phase 1b trial validate the predictive power of Rejuvenate Biomed's proprietary drug discovery platforms CombinAge™ and CelegAge™, which efficiently screen small molecules to identify promising therapeutics targeting age-related pathways. Rejuvenate Biomed intends to make these platforms available to third parties through strategic partnerships or licensing agreements. 1. Tezze C, et al. JCI Insight 2023; 8(15):e168787. . 2. . About Rejuvenate Biomed Rejuvenate Biomed is a clinical-stage platform and pipeline company dedicated to redefining the aging process. The Company leverages validated platform technology to develop innovative therapeutics targeting the root causes of age-related diseases. With two distinct drug discovery platforms – AI-enabled in silico CombinAge™ and in vivo CelegAge™ – Rejuvenate Biomed has demonstrated the predictive power of this approach, resulting in a pipeline of five unique combination drugs targeting various age-related diseases, including neuromuscular, musculoskeletal, metabolic, cardiovascular, nephrological, and neurodegenerative indications. Headquartered in Belgium, Rejuvenate Biomed is committed to promoting healthy aging. Visit for more information. About the RJx-01-101 study RJx-01-101 is a randomized, double-blind, placebo-controlled clinical trial that successfully met primary and secondary endpoints, demonstrating positive clinical outcome data. Involving 42 healthy male subjects aged 65 to 75 with disuse-induced sarcopenia, the trial confirmed the safety, tolerability, and bioavailability of RJx-01 after 6 weeks of treatment. The Phase 1b study explored RJx-01's impact on various pharmacodynamic parameters, paving the way for further investigations in sarcopenia and related conditions. Following the trial, participants underwent a personalized rehabilitation program. SOURCE Rejuvenate Biomed