TheraCryf Plc

This week, financing came in the form of loans, private placements and a Series B, throwing support behind an injectable heart failure drug, oral immunology therapies and an ASD treatment. This week, financing came in the form of loans, private placements and a Series B, throwing support behind an injectable heart failure drug, oral immunology therapies and cell-based treatments. Vita Therapeutics Earns $31M in Series B Cell engineering company Vita Therapeutics closed its Series B financing round Wednesday, counting $31 million in earnings. The Baltimore biotech plans to use these proceeds to advance VTA-100, its lead pre-clinical asset for limb-girdle muscular dystrophy. The money will also help support Vita’s newest program, VTA-120, which is being investigated as a potential treatment for facioscapulohumeral muscular dystrophy. Series B earnings will also help the company further deepen its discovery pipeline. The funding round was led by Cambrian BioPharma and a new investor Solve FSHD. During the Series B, Vita found new supporters in Cedars Sinai and Riptide Ventures. The company has raised a total of $66 million since it was established in 2019. scPharmaceuticals Enters $100M Debt Agreement On Monday, scPharmaceuticals announced a binding term sheet agreement for $100 million in a secured debt facility, with the financing managed by Oaktree Capital Management. The partners expect to ink the deal in mid-October, subject to each party’s execution of the definitive agreements and customary closing conditions. The deal will see scPharmaceuticals get $50 million upon signing and remain eligible for two $25 million tranches based on commercial milestones. The Massachusetts pharma will use the proceeds, along with remaining cash on hand, to pay out existing loans and security agreements and support the launch of its chronic heart failure therapy Furoscix (furosemide injection). Alongside the announcement of its debt financing, scPharmaceuticals also revealed Monday the FDA has also approved Furoscix for the treatment of congestion in adults due to fluid overload. Furoscix contains a proprietary furosemide formulation, self-administered using a delivery device attached to the patient’s abdomen. Andera Raises $442M for New Fund Life science venture capital firm Andera Partners announced Monday that it had raised around $442 million for the sixth generation of its BioDiscovery fund. The money will be used to build the venture’s portfolio of biopharma companies working on innovative treatments and medical technologies across all stages of development. So far, BioDiscovery 6 has already invested in Imcheck, Mineralys, Tubulus, TargED, Amolyt and Evommune. The BioDiscovery family of funds has raised nearly $1.1 billion since it was established and has helped finance more than 80 companies across North America and Europe. Its portfolio includes over 40 exits with around 20 companies sold, such as Arvelle, Sanifit and ReViral. BioDiscovery has also supported some twenty firms that have had their initial public offerings, including Axonics and LogicBio. Private Financing Wins Immunic $60M Immunic, Inc. recently closed its private investment in public equity (PIPE) financing round, expecting around $60 million in gross earnings before offering-related expenses are deducted. The agreement saw the New York biopharma sell a total of 8,696,552 shares of its common stock at a 10% premium, corresponding to a price of $4.35 per share. The proceeds will help Immunic fund its current clinical development projects, particularly its three lead oral immunology candidates: IMU-838 (vidofludimus calcium) for multiple sclerosis, IMU-935 for psoriasis and castration-resistant prostate cancer and IMU-856 for conditions associated with bowel barrier dysfunction. The PIPE money, together with current cash, cash equivalents and marketable securities, will see Immunic through the fourth quarter of 2024. Evgen, STALICLA Ink $160.5M In-Licensing Deal in ASD Precision neuroscience biotec h STALICLA SA announced Monday that it was in-licensing Evgen Pharma’s SFX-01, a candidate for a biologically-characterized subgroup of people with autism spectrum disorder (ASD). The deal will see STALICLA make a $0.5 million upfront payment. Evgen will remain eligible for up to $160.5 million in cumulative milestones in relation to the candidate’s first indication, as well as to low-to-medium double-digit percentage royalties on SFX-01 sales. STALICLA is adding SFX-01 to its pipeline of precision medicine treatments for neurodevelopmental disorders. Monday’s in-licensing deals follows the successful completion of a Phase 1b trial for STP1 early this year. STP1 is its lead candidate and is being investigated in a different biological subtype of ASD.

SFX-01 will strengthen STALICLA's pipeline to advance precision medicine for a new subgroup of patient with Autism Spectrum Disorder GENEVA, Oct. 10, 2022 /PRNewswire/ -- STALICLA S.A., a precision neuroscience clinical stage biotech, advancing the first precision medicine platform (DEPI) for patients with Neurodevelopmental Disorders (NDDs), today announced the worldwide in-licensing of SFX-01 from Evgen Pharma plc (Evgen) in neurodevelopmental disorders and schizophrenia, with a first indication for a biologically-characterized subgroup of patients with Autism Spectrum Disorder (ASD). STALICLA's unique approach addresses a major weakness in the drug development process for NDDs and neuropsychiatric disorders: behaviour is a terrible biomarker. Thanks to DEPI, a proprietary platform aggregating molecular data and human genetic information, STALICLA pushes the frontier of precision medicine further into precision NDDs. DEPI has already reached validation through the clinical identification of biologically defined subgroups of patients with ASD, and their respective candidate treatments. SFX-01 will strengthen STALICLA's pipeline to advance precision medicine for a new subgroup of patient with Autism Spectrum Disorder. SFX-01 is a patented composition of sulforaphane and alpha cyclodextrin, and the only grade of sulforaphane suitable for clinical research and possible approval as medicine. Thanks to DEPI, STALICLA identified SFX-01 as the best treatment candidate for its second subgroup of patients, ASD-Phenotype 2. SFX-01 in-licensing follows the completion, in early 2022, of Phase 1b for STP1, Stalicla's lead candidate tailored to ASD-Phenotype1, a first subgroup of patients identified by DEPI. Lynn Durham, STALICLA CEO & Founder commented: "There are no current approved treatments for ASD. Bringing precision treatments to patients such as SFX-01 could radically alter this landscape thanks to an effective oral option for a subgroup of ASD patients. This agreement with Evgen to advance SFX-01 expands STALICLA's option to improve the quality of life of a biologically defined subgroup of patients with ASD". Dr Huw Jones, Evgen CEO, added: "Stalicla is a unique partner in the ASD space, with its proprietary technology for screening those patients who are most likely to respond to SFX-01. This recognition of SFX-01 as a potential treatment for a major neuropsychiatric condition, demonstrates the variety of potential uses of our Sulforadex® stabilising platform, along with our ability to execute on our business model." Pursuant to the terms of the agreement, STALICLA will be responsible for the clinical development in the NDD field, and the parties will cooperate on regulatory activities to secure approval of the product. Key financial terms: $0.5m upfront payment Total cumulated milestones of up to $160.5m in relation to the first indication under the license. Low to medium double digit percentage royalties on sales of SFX-01 About STALICLA STALICLA is a precision molecular neuroscience clinical stage biotech company, advancing the first precision medicine platform (DEPI) for patients with Neurodevelopmental Disorders (NDDs), and neuropsychiatric disorders. STALICLA's unique approach is addressing the poor construct validity of behaviourally defined disorders through its unique platform integrating molecular data with human genetic information to create testable clinical hypotheses in psychiatry / neuroscience. With multiple clinical proof of concepts, DEPI has allowed for the identification of two distinct subgroups of patients with Autism Spectrum Disorder and their tailored treatment STP1 and STP2 both planned to enter clinical Phase 2 in 2023. STP1 and STP2 hold a multi-billion market potential. The DEPI platform has been validated in clinical setting showing high specificity, sensitivity and positive predictive value in prospectively designed trials recalling of "high" responder patients to previously failed drug candidates. STALICLA is currently engaged in preparing its next stage of growth to advance its pipelines and to scale its platform towards revenue generation. For further information, please visit: About Evgen Evgen Pharma is a clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases. The Company's core technology is Sulforadex®, a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane.  The Company's lead asset, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin and has completed, with a positive outcome, a Phase 2a clinical trial for oestrogen-positive (ER+) metastatic breast cancer. In September 2021 the FDA granted Orphan Drug status to SFX-01 in malignant glioma. The Company also has a wide number of collaborations with leading academic centres in the UK, Europe and AsiaPac as part of the continuing strategy to build the data set of safety and efficacy around the compound. With respect to non-core areas, Evgen signed an out-licensing deal with JuvLife, the dietary products and functional foods division of Juvenescence Ltd, for the development of a naturally sourced sulforaphane nutritional health supplement, stabilised using Evgen's Sulforadex® technology. The Company has its headquarters and registered office at Alderley Park, Cheshire.  It joined the AIM market of the London Stock Exchange in October 2015 and trades under the ticker symbol EVG.  For further information, please visit:  Logo:

UK-based Evgen Pharma has announced that it has now recruited a total of 102 patients into a trial investigating its lead asset SFX-01 in COVID-19. The Phase II/III STAR trial is investigating if SFX-01 can reduce the severity or prevent the onset of acute respiratory distress syndrome (ARDS) in patients with suspected COVID-19. The trial is including patients if they are infected with the SARS-CoV-2 virus, which causes COVID-19, or other respiratory infections causing community-acquired pneumonia. The study is sponsored by the University of Dundee and funded by the UK-based charity LifeArc. Evgen is expecting recruitment to the STAR trial to be completed at the end of 2021 or the first quarter of 2022. “We are pleased with the recruitment progress in this trial and would again like to thank professor James Chalmers and his colleagues at Dundee for their considerable efforts in a very challenging clinical environment,” said Huw Jones, chief executive officer of Evgen. “Randomising over 100 patients is an important milestone in this trial and takes us a step closer to receiving the initial data from the study. We look forward to further updating the market as we progress through this important trial,” he added.