Calliditas Therapeutics AB

SALT LAKE CITY, Nov. 7, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the third quarter and nine months ended September 30, 2024 and provided a corporate update. Neuroactive Steroids LPCN 1154, oral brexanolone, is being developed as a treatment for postpartum depression (PPD). It is targeted to be a highly effective, oral, fast-acting and short duration treatment option. The Company has completed labeling studies such as a food effect study and PK profiling in women with PPD, and is targeting NDA submission for LPCN 1154 by the end of 2024. In October, Lipocine announced positive results from a quantitative electroencephalogram (qEEG) study conducted in healthy subjects administered single doses of LPCN 1154. The results indicated robust central nervous system (CNS) activity of LPCN 1154, with concentration- and time-dependent post-dose changes in qEEG. The study confirmed GABAA positive allosteric modulation and supports future development of LPCN 1154 in neuropsychiatric indications. LPCN 2401 for obesity management LPCN 2401 is an oral formulation comprised of a proprietary anabolic androgen receptor agonist targeted for once daily regimen. In October, Lipocine hosted a virtual key opinion leader (KOL) event on LPCN 2401. The event highlighted positive data from the Phase 2 study of LPCN 2401 and the data support the potential for the product to be used as an adjunct with incretin mimetics (GLP-1/GIP agonists) or as a monotherapy, including post incretin mimetic discontinuation. Frank Greenway, MD (Professor and Chief Medical Officer at Pennington Biomedical Research Center) discussed the unmet needs and current treatment landscape in obesity management with a focus on fat loss and lean muscle mass preservation for patients on incretin therapies. A poster "Oral LPCN 2401 Reduces Fat Mass and Increases Lean Mass in Men With Obesity" featuring the Phase 2 data was presented by Dr. Greenway at the Obesity Society's Annual ObesityWeek® conference on November 5, 2024 in San Antonio, TX. Lipocine plans to meet with the FDA to discuss the study design for a proof-of-concept Phase 2 study for LPCN 2401 and expansion to the female population. LPCN 1148 Management of Cirrhosis Lipocine is evaluating LPCN 1148 for the management of decompensated cirrhosis and has conducted a successful Phase 2 study that met its primary endpoint. The Company plans to request a Type C meeting with the FDA to discuss the clinical development plan for LPCN 1148. TLANDO® In October, Lipocine signed an exclusive supply and distribution agreement with Pharmalink to commercialize TLANDO, its oral testosterone replacement therapy, in the Gulf Cooperation Council (GCC) countries consisting of Saudi Arabia, Kuwait, the United Arab Emirates (UAE), Qatar, Bahrain, and Oman. In September, Lipocine signed an exclusive distribution and license agreement with SPC Korea to commercialize TLANDO in South Korea. The company continues to pursue opportunities for partnering and/or development arrangements for the continued development and/or marketing of our remaining pipeline candidates. Third Quarter Ended September 30, 2024 Financial Results Lipocine reported a net loss of $2.2 million, or ($0.44) per diluted share, for the third quarter ended September 30, 2024, compared with a net loss of $6.7 million, or ($1.27) per diluted share, for the quarter ended September 30, 2023. There were no revenues recorded during the third quarter ended September 30, 2024. In the third quarter of 2023, the company recorded a non-cash revenue reversal of variable consideration for minimum guaranteed royalties of $3.1 million related to the termination of the Antares License Agreement. Research and development expenses were $1.6 million and $2.9 million, respectively, for the quarters ended September 30, 2024 and 2023. The decrease was a result of a decrease in TLANDO related costs, a decrease in contract research organization expense and outside consulting costs related to the wind down of the LPCN 1148 study in 2024, and a decrease in costs related to LPCN 1154 clinical studies, offset by increases in personnel related costs and other research and development related costs and supplies. General and administrative expenses were $1.0 million in each of the quarters ended September 30, 2024 and 2023. As of September 30, 2024, Lipocine had $19.8 million of unrestricted cash, cash equivalents and marketable investment securities compared to $22.0 million at December 31, 2023. Nine Months Ended, September 30 2024, Financial Results Lipocine reported a net loss of $1.8 million, or ($0.33) per diluted share, for the nine months ended September 30, 2024, compared with a net loss of $14.1 million, or ($2.72) per diluted share, for the nine months ended September 30, 2023. Revenues for the nine-month period ended September 30, 2024 were $7.7 million, primarily consisting of licensing revenue received from our Verity License Agreement, in addition to TLANDO royalty revenue of $206,000. During the nine months ended September 30, 2023, the company recognized a non-cash revenue reversal of variable consideration for minimum guaranteed royalties of $3.1 million relating to the termination of the Antares License Agreement offset by licensing revenue of approximately $55,000 for payments received related to the Spriaso license agreement. Research and development expenses were $6.3 million and $8.5 million, respectively, for the nine months ended September 30, 2024 and 2023. The decrease was a result of a decrease in contract research organization expense and outside consulting costs related to the wind down of the LPCN 1148 study in 2024, a decrease in TLANDO related costs, a decrease in personnel related costs, and a decrease in other research and development related costs. These decreases were offset an increase in costs related to the LPCN 1154 clinical studies. General administrative expenses were $4.1 million and $3.8 million respectively, for the nine months ended September 30, 2024 and 2023. The increase in general and administrative expenses was a result of increases in business development expenses, corporate legal fees and director fees, offset by decreases in corporate insurance expense, professional fees, other administrative consulting fees, personnel related costs, and travel related costs. For more information on Lipocine's financial results, refer to Form 10-Q filed by the Company with the SEC. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnerships. 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 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in obesity management 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, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for obesity management, 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 development and commercialization of TLANDO and TLANDO XR by our licensees, the amount of the license fee, milestone payments, and royalty payments we will ultimately receive, the ability of our licensees to grow the TLANDO franchise, our product development efforts, the application of our proprietary platform in developing new treatments for CNS disorders, our product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1148 and LPCN 2401, the timing of our submission of a NDA with the FDA for LPCN 1154, 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. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Dive Brief:Jade Biosciences, a privately held developer of immune disease drugs, will combine with Aerovate Therapeutics in a reverse merger that gives Jade a fast pass to trade on public markets.Prior to the merger, which the companies announced Thursday, Jade expects to raise $300 million via a private financing involving more than a dozen life sciences investors, among them Fairmount, Venrock Healthcare Capital Partners, RA Capital Management and Samsara BioCapital.The combined company, which will be almost entirely owned by pre-merger Jade stockholders, will operate with Jades name and trade on the Nasdaq under the ticker JBIO. The deal is expected to close in the first half of 2025.Dive Insight:Jade is the fourth spinout of Paragon Therapeutics to go public via a reverse merger and the third this year, following Oruka Therapeutics and Crescent BioPharma. (A fifth, Apogee Therapeutics, conducted an initial public offering last year.)Founded by Fairmount in 2021, Paragon specializes in discovering promising new antibody drugs, which it then licenses to newly created companies to advance their development.In Jades case, Paragon designed an antibody the companies believe could be a best-in-class treatment for a kidney disease called IgA nephropathy. The drug targets a protein known as APRIL thats thought to play a major role in the development of the disease, which over time erodes kidney function.JADE-001 is engineered to deliver superior potency and an extended half-life compared to other anti-APRIL monoclonal antibodies in development, optimizing efficacy with convenient, infrequent dosing, Andrew King, Jades chief scientific officer, said in a Thursday statement.Specifically, Jade aims to dose its drug every two months, compared to anti-APRIL antibodies being developed by Otsuka and Novartis that are dosed once per month or once every two weeks. (Otsuka last week said its antibody, sibeprenlimab, succeeded in a Phase 3 trial, while Novartis expects data for its drug, zigakibart, in 2026.)More broadly, IgAN has become a competitive area of drug development. Along with zigakibart, Novartis acquired another treatment for the disease in its acquisition of Chinook Therapeutics last year. Biogen and Vertex Pharmaceuticals bought IgAN developers in deals of their own this year. Travere Therapeutics and Calliditas Therapeutics have both launched new therapies for the disease in the U.S.Jade is much further behind. Its lead asset is set to enter the clinic in the second half of next year, with results to follow in 2026.But it will be well-funded, with enough cash from its pre-merger financing to run operations through 2027. Prior to closing the merger, Aerovate intends to distribute a cash dividend of $65 million to its pre-merger shareholders; the company had $99 million in funds available to it as of March 31 and raised $24 million in April.Aerovates fortunes nosedived in June, however, when a Phase 2 study of its experimental therapy for pulmonary arterial hypertension missed its main goal. The companys share price collapsed and, in July, it announced plans to consider strategic alternatives, like a sale or reverse merger.Pre-merger Jade shareholders will own just over 98% of the combined company, while pre-merger Aerovate stockholders will own 1.6%.Tom Frohlich, currently CEO of Jade, will lead the combined company, which will be advised by a board of directors that includes representatives from Samsara BioCapital, Oruka Therapeutics and Fairmount, among others. '

An experimental medicine Otsuka Pharmaceutical acquired in a buyout six years ago has succeeded in a Phase 3 trial in a rare kidney disease, the company said Tuesday.The drug, called sibeprenlimab, met its main goal in a study in IgA nephropathy, or IgAN, a chronic condition that can lead to kidney failure. Upon a pre-specified, interim analysis after nine months of treatment, the company said sibeprenlimab therapy was associated with a statistically significant and clinically meaningful reduction, versus placebo, in the amount of protein in participants urine a marker of kidney health.Otsuka didnt provide specifics, making the magnitude of the drugs effects unclear. It also said, without details, that the drugs safety profile was consistent with previously reported data. But the company intends to discuss with the Food and Drug Administration the possibility of an accelerated approval filing while the study continues. The trial is expected to wrap up in early 2026.For Otsuka, the results are a measure of validation for its bet on Visterra, a Waltham, Massachusetts-based biotechnology startup and sibeprenlimabs developer. Visterra was founded in 2008 around a type of antibody drug discovery technology that originated at MIT. The company initially used that technology to develop drugs for infectious diseases before broadening its therapeutic scope, and tried, unsuccessfully, to go public in 2017.Otsuka stepped in a year later and acquired the company for $430 million in upfront cash. Visterra has since operated as a wholly owned subsidiary of Otsuka and has still been run by its longtime CEO, Brian Pereira. The company now has a pipeline of drugs mostly for immune diseases and led by sibeprenlimab, which, following Tuesdays study results, could become the first treatment of its kind for IgAN.Some estimates hold that upwards of 130,000 people in the U.S. have IgAN, a progressive autoimmune condition that damages the kidneys. While several therapies are available, there remains room for improvement, as patients with the disease still see their kidney function decline.The need for better therapies, along with a growing understanding of the diseases underlying biology, has made IgAN a focus of an increasing number of drug companies. Since 2023, Novartis, Biogenand Vertex Pharmaceuticals have all acquired biotechs with IgAN drugs in testing. Travere Therapeutics and Calliditas Therapeutics have recently launched IgAN medicines. Others, including Q32 Bio and Vera Therapeutics, are advancing would-be therapies as well.These emerging medicines are more commonly aimed at immune-mediated drivers of the disease, analysts at the investment bank Piper Sandler wrote in a recent report. Sibeprenlimab targets a protein dubbed APRIL thats implicated in the progression of IgAN. The drug Vertex acquired in a buyout of Alpine Immune Sciences aims at APRIL and a second protein called BAFF. Felzartamab, which Biogen acquired in its acquisition of HI-Bio, blocks the protein CD38.Otsukas trial results suggest that by targeting APRIL, we could provide a new therapeutic strategy for people living with this progressive kidney disease,“ said John Kraus, the executive vice president and chief medical officer of Otsukas pharmaceutical development and commercialization division, in a statement. '