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Globe and Mail
an hour ago
- Health
- Globe and Mail
Obesity Clinical Trials Appears Robust With 80+ Key Pharma Companies Actively Working in the Therapeutics Segment
DelveInsight's, ' Obesity Pipeline Insigh t 2025 ' report provides comprehensive insights about 80+ companies and 100+ pipeline drugs in Obesity pipeline landscape. It covers the Obesity pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Obesity therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive Obesity pipeline products in this space. Stay ahead with the latest insights! Download DelveInsight's comprehensive Obesity Pipeline Report to explore emerging therapies, key Obesity Companies, and future Obesity treatment landscapes @ Obesity Pipeline Outlook Report Key Takeaways from the Obesity Pipeline Report In June 2025, Carmot Therapeutics Inc. announced a Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Weekly CT-388 Administered Subcutaneously for 48 Weeks to Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus. In June 2025, Zomagen Biosciences Ltd. conducted a study to understand if taking VTX3232 alone or in combination with semaglutide is safe in participants diagnosed with Obesity. Approximately 160 patients will take VTX3232 Dose A, Placebo, VTX3232 Dose A in combination with semaglutide, or Placebo in combination with semaglutide. In June 2025, Boehringer Ingelheim organized a study is to find out whether a medicine called survodutide (BI 456906) helps people living with obesity disease to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. In June 2025, Novo Nordisk A/S announced a study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term. The study has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'. In the main study participants will either get CagriSema (a study medicine) or placebo (a dummy medicine that looks like CagriSema but has no active ingredient). Which treatment participants get is decided by chance. Participants are two times more likely to get CagriSema than placebo. If participants get CagriSema in the main study, participants will continue on CagriSema in the extension study. In June 2025, Hanmi Pharmaceutical Company Limited conducted a phase 3 study to evaluate efficacy and safety of HM11260C in adult obesity patients without diabetes mellitus. DelveInsight's Obesity pipeline report depicts a robust space with 80+ active players working to develop 100+ pipeline therapies for Obesity treatment. The leading Obesity Companies such as Zealand Pharma, Sciwind Biosciences, Genexine, Sirnaomics, Sparrow Pharmaceuticals, Shionogi, Regor Pharmaceuticals, Innovent Biologics, Pfizer, NodThera Limited, Boehringer Ingelheim, Fractyl Health, TransThera, Clearmind Medicine, PegBio, Biolingus, and others. Promising Obesity Therapies such as APHD-012, Bimagrumab, Semaglutide, CT-868, GLY-200, Bremelanotide, and others. Discover how the Obesity treatment paradigm is evolving. Access DelveInsight's in-depth Obesity Pipeline Analysis for a closer look at promising breakthroughs @ Obesity Clinical Trials and Studies Obesity Emerging Drugs Survodutide: Zealand Pharma Survodutide (BI 456906) is a long-acting glucagon/GLP-1 receptor dual agonist for once-weekly subcutaneous administration that activates two key gut hormone receptors simultaneously and may offer better efficacy than current single-hormone receptor agonist treatments. Survodutide is targeting the treatment of obesity and nonalcoholic steatohepatitis (NASH). Boehringer Ingelheim is advancing survodutide into three global Phase III trials in people living with overweight or obesity. Ecnoglutide: Sciwind Biosciences Glucagon-like peptide-1 (GLP-1) analogs are effective therapies in managing type 2 diabetes, obesity, and have demonstrated clinical potential as a treatment for NASH. Ecnoglutide (XW003) is a novel, cAMP signaling biased, long-acting GLP-1 analogue optimized for improved biological activity, cost-effective manufacturing, and once weekly dosing. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Obesity. CT-868: Carmot Therapeutics CT-868 is a dual GLP-1 and GIP receptor modulator with a unique pharmacological profile optimized for improved tolerability at the GLP-1 receptor. The combined action of GLP-1 and GIP results in greater body weight loss and glucose control. CT-868 is dosed once daily to maximize efficacy and tolerability. CT-868 dual agonist candidate was discovered using the chemotype evolution technology as a peptide-small molecule hybrid compound, able to mimic the native GLP-1 hormone. In the Phase I trial, CT-868 demonstrated compelling pharmacodynamic activity across several clinical measures in overweight and obese healthy individuals a safe and generally well-tolerated profile. Carmot Therapeutics is now expanding the observations in overweight and obese patients with type 2 diabetes to demonstrate CT-868's effects on glycemic control, weight loss, and tolerability. Currently, the drug is in the Phase II stage of development to treat obesity. DD01: D&D Pharmatech DD01 is a proprietary, imbalanced dual agonist of GLP-1 and glucagon receptors with a half-life of 11 days in non-human primates. DD01 is being developed as a potential disease-modifying agent for obesity and liver fatty disease. Treatment with DD01 caused weight loss, reduced liver fat, and improved glucose tolerance in preclinical obesity, diabetes, and fatty liver models. In preclinical models of diabetes and nonalcoholic fatty liver disease (NAFLD), DD01 could reduce weight and blood sugar and improve insulin sensitivity and lipid and fat metabolism, which could ameliorate NASH. DD01 demonstrated greater efficacy in preclinical models than semaglutide, an approved GLP-1R receptor agonist; from a mechanical perspective, the effect of DD01 persisted after cessation of treatment. It is currently being evaluated in Phase I clinical trial to investigate the safety, tolerability, PK, and PD of DD01 administered by subcutaneous (SC) injection in overweight/obese subjects with type 2 diabetes mellitus and nonalcoholic fatty liver disease (NAFLD). The Obesity pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Obesity with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Obesity Treatment. Obesity Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Obesity Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Obesity market. Get a detailed analysis of the latest innovations in the Obesity pipeline. Explore DelveInsight's expert-driven report today! @ Obesity Unmet Needs Obesity Companies Zealand Pharma, Sciwind Biosciences, Genexine, Sirnaomics, Sparrow Pharmaceuticals, Shionogi, Regor Pharmaceuticals, Innovent Biologics, Pfizer, NodThera Limited, Boehringer Ingelheim, Fractyl Health, TransThera, Clearmind Medicine, PegBio, Biolingus, and others. Obesity pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Obesity Products have been categorized under various ROAs such as Oral Parenteral Intravenous Subcutaneous Topical Obesity Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Download DelveInsight's latest report to gain strategic insights into upcoming Obesity Therapies and key Obesity Developments @ Obesity Market Drivers and Barriers, and Future Perspectives Scope of the Obesity Pipeline Report Coverage- Global Obesity Companies- Zealand Pharma, Sciwind Biosciences, Genexine, Sirnaomics, Sparrow Pharmaceuticals, Shionogi, Regor Pharmaceuticals, Innovent Biologics, Pfizer, NodThera Limited, Boehringer Ingelheim, Fractyl Health, TransThera, Clearmind Medicine, PegBio, Biolingus, and others. Obesity Therapies- APHD-012, Bimagrumab, Semaglutide, CT-868, GLY-200, Bremelanotide, and others. Obesity Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Obesity Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Which companies are leading the race in Obesity drug development? Find out in DelveInsight's exclusive Obesity Pipeline Report—access it now! @ Obesity Emerging Drugs and Major Companies Table of Contents Introduction Executive Summary Obesity Overview Obesity Pipeline Therapeutics Obesity Therapeutic Assessment Late Stage Products (Phase III) Survodutide: Zealand Pharma Drug profiles in the detailed report….. Mid Stage Products (Phase II) CT-868: Carmot Therapeutics Drug profiles in the detailed report….. Early Stage Products (Phase I) DD01: D&D Pharmatech Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Drug name: Company name Drug profiles in the detailed report….. Inactive Obesity Products Obesity Key Companies Obesity Key Products Obesity Unmet Needs Obesity Market Drivers Obesity Market Barriers Obesity Future Perspectives and Conclusion Obesity Analyst Views Obesity Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
Yahoo
16 hours ago
- Business
- Yahoo
Addex Therapeutics Ltd (ADXN) Q1 2025 Earnings Call Highlights: Strategic Advances and ...
Cash Balance: CHF2.8 million as of March 31, 2025. Cash Runway: Expected to last through mid-2026. Continuing R&D Expenses: CHF0.1 million, primarily related to the GABAB PAM program. Continuing G&A Expenses: CHF0.5 million, primarily related to corporate loan activities. Net Loss from Discontinued Operations: Specific line item due to divested business. Current Liabilities: CHF1.1 million as of March 31, 2025. Non-Current Liabilities: CHF0.1 million as of March 31, 2025. Equity Interest: 20% equity interest in a divested business, recorded under non-current assets. Warning! GuruFocus has detected 6 Warning Signs with ADXN. Release Date: June 19, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Addex Therapeutics Ltd (NASDAQ:ADXN) has made significant progress in its GABAB positive allosteric modulator program with partner Indivior, completing IND-enabling studies for substance use disorders. The company regained rights to its mGluR2 positive allosteric modulator program from Johnson & Johnson, opening new therapeutic opportunities. Addex Therapeutics Ltd (NASDAQ:ADXN) has repositioned its mGluR5 negative allosteric modulator program for brain injury recovery, with promising preclinical data supporting its potential. The company has a strong cash position with CHF2.8 million, providing a runway through mid-2026, and has reduced cash burn following the Neurosterix spinout. Addex Therapeutics Ltd (NASDAQ:ADXN) has a robust pipeline with multiple programs advancing, including a promising candidate for chronic cough with favorable preclinical efficacy and tolerability. The current cash position does not fund the progression of unpartnered programs into the clinic, indicating potential future financing needs. Revenue decreased compared to the previous year due to the completion of the funded research phase with Indivior, impacting financial performance. The company faces competition in the chronic cough market, with existing compounds showing promising efficacy but challenging tolerability profiles. There is uncertainty regarding the clinical development pathway and competitive landscape for the chronic cough program, which could impact future success. Addex Therapeutics Ltd (NASDAQ:ADXN) needs to conduct further studies to optimize the use of dipraglurant in post-stroke rehabilitation, indicating a longer timeline before potential market entry. Q: Can you provide your updated thoughts on the current competitive landscape in chronic cough and the relevance of proceeding programs for your clinical development pathway? A: Mikhail Kalinichev, Head of Translational Science, explained that there are several compounds in development, such as now roofing, which has shown promising efficacy but with tolerability challenges. Addex aims to deliver similar efficacy with improved tolerability, targeting both IPF-related and refractory chronic cough. The development plan includes studies in healthy volunteers and a challenge study in chronic cough patients, followed by a Phase 2 study with advanced monitoring technologies. Q: Can you comment on the potential applicability of your agent for chronic painful cough in indications outside of IPF, like pulmonary sarcoidosis? A: Mikhail Kalinichev noted that chronic painful cough could be a suitable indication due to the sustained activation of GABAB across multiple conditions, including chronic cough. Tim Dyer, CEO, added that they are considering this indication for Phase 2 development. Q: Regarding dipraglurant in post-stroke rehabilitation, what would an appropriate control arm look like in a registration-quality study, and what is the efficacy bar in this indication? A: Mikhail Kalinichev stated that dipraglurant would be used alongside physiotherapy due to its short half-life and good tolerability. They plan to conduct clinical pharmacology studies to understand its modulation effects better, which will inform the design of a Phase 2 study. The efficacy bar is challenging as no pharmacotherapies are currently approved in this context. Q: Can you elaborate on the strategic importance of your GABAB positive allosteric modulator program with Indivior? A: Tim Dyer highlighted the program's potential to deliver a better baclofen for substance use disorders, with a longer half-life and improved side effect profile. The partnership with Indivior is crucial, as it allows Addex to advance its own independent GABAB PAM program for chronic cough, leveraging the strong rationale for GABAB PAMs in this area. Q: What are the financial implications of your recent achievements and strategic partnerships? A: Tim Dyer reported that Addex completed Q1 2025 with CHF2.8 million in cash, providing a runway through mid-2026. The cash burn has been reduced following the Neurosterix spinout, and the company is well-positioned to deliver on strategic objectives, including advancing their pipeline and exploring new partnerships. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
a day ago
- Business
- Yahoo
Actio gains $66m to advance small molecule therapeutics pipeline
US-based Actio Biosciences has closed a Series B financing round, raising $66m to advance the genetics-driven small molecule therapeutics pipeline aimed at rare and common diseases. The funding will primarily be used to propel the development of the company's lead oral programmes, ABS-1230 and ABS-0871. The round was jointly led by new investor Regeneron Ventures and current investor Deerfield Management. Other participants were current investors Canaan, Euclidean Capital and Droia Ventures. ABS-1230 is a selective potassium channel subfamily T member 1 (KCNT1) inhibitor designed to address KCNT1-related epilepsy, a severe paediatric epileptic encephalopathy. The company is preparing to launch the healthy volunteer segment of a Phase I trial of the therapy in the second half of 2025. The company then plans to expand into a Phase Ib proof-of-concept trial in patients with KCNT1-related epilepsy in early 2026. The US Food and Drug Administration (FDA) has awarded ABS-1230 both orphan drug and rare paediatric designations. ABS-0871, another small molecule in Actio's pipeline, inhibits transient receptor potential vanilloid 4 (TRPV4) and is being developed for the treatment of the rare inherited neurological disorder, Charcot-Marie-Tooth disease type 2C (CMT2C). Actio is progressing this therapy through the healthy volunteer phase of a Phase I trial and aims to move into a Phase Ib trial in individuals with TRPV4+ CMT2C in 2026. The US regulator has granted orphan drug, fast track and rare paediatric drug designations to the therapy. Actio Biosciences CEO and co-founder David Goldstein stated: 'We have made tremendous progress across our pipeline – executing a precision medicine strategy that targets the root causes of disease through genetically informed drug development. 'ABS-1230 and ABS-0871 have the potential to be transformative disease-modifying therapies in their respective rare indications, and growing evidence supports expansion into broader indications. This new funding from industry-leading investors speaks to the value of our approach and provides us with important resources to continue advancing our programmes.' "Actio gains $66m to advance small molecule therapeutics pipeline" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
National Post
2 days ago
- Business
- National Post
Satellos Bioscience Shareholders Elect Two New Board Members
Article content TORONTO — Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) (' Satellos ' or the ' Company '), a biotech company developing new small molecule therapeutic approaches to improve the treatment of muscle diseases and disorders, today announced the election of Iris Loew-Friedrich, M.D., Ph.D., and Selwyn Ho, MBBS, to its Board of Directors. Article content 'I am so excited to welcome Dr. Loew-Friedrich and Dr. Ho to our Board at this pivotal time,' said Frank Gleeson, Satellos co-founder and CEO. 'We believe their deep expertise in global clinical and commercial development will be invaluable to Satellos as we advance SAT-3247 and realize our technology's transformative potential for the treatment of people living with Duchenne muscular dystrophy and other degenerative conditions. We look forward to drawing on their proven expertise in positioning Satellos for future partnerships and development strategies focused on delivering optimal value for shareholders.' Article content A highly accomplished biotech and pharmaceutical executive, Dr. Loew-Friedrich is recognized as the senior clinical leader who shaped UCB into a global powerhouse in neurology and immunology. Serving as executive vice president and chief medical officer until 2024, she led UCB's worldwide development and regulatory strategy for over two decades, overseeing the global approvals of multiple blockbuster therapies, including Cimzia, Briviact, Evenity, Rystiggo, Zilbrysq, and Bimzelx. Her leadership was instrumental in advancing both common and rare disease treatments, with a deep and sustained commitment to improving outcomes for underserved patient populations. Prior to UCB, Loew-Friedrich held senior R&D roles at Schwarz Pharma, BASF Pharma, and Hoechst/Aventis, where she contributed to the development and success of market-leading drugs such as Humira, Arava, Actonel, Vimpat, and Neupro. Article content Dr. Ho is a seasoned pharmaceutical and biotech executive with broad leadership experience across commercial strategy, business development, financing, and board governance. He has held senior roles at global companies including Dermira (Eli Lilly), UCB, Allergan (AbbVie), Novartis, and AstraZeneca, with expertise spanning ophthalmology, immunology, oncology, and dermatology. As CEO of Medigene AG, he led a strategic transformation and established and extended key partnerships with BioNTech, Regeneron, WuXi Biologics and EpimAb Biotherapeutics. Previously, as EVP & chief business officer at Connect Biopharma, he was instrumental in raising over $350 million through IPO and private funding. He also serves on the boards of Antennova Inc. and Peptomyc S.L., and as executive-in-residence at New Rhein Healthcare Investors. Article content As part of the Annual General Meeting, Rima Al-awar, Ph.D., William Jarosz, J.D., and William McVicar, Ph.D., did not stand for reelection. Article content 'I want to personally thank Rima, Bill and Bill for their dedicated service, thoughtful leadership and support,' said Gleeson. 'Their guidance helped position Satellos for continued progress, and we wish them all the best in their future endeavors.' Article content About Satellos Bioscience Inc. Article content Satellos is a clinical-stage drug development company focused on restoring natural muscle repair and regeneration in degenerative muscle diseases. Through its research, Satellos has developed SAT-3247, a first-of-its-kind, orally administered small molecule drug designed to address deficits in muscle repair and regeneration. SAT-3247 targets AAK1, a key protein that Satellos has identified as capable of replacing the signal normally provided by dystrophin in muscle stem cells to effect repair and regeneration. By restoring this missing dystrophin signal in DMD, SAT-3247 enables muscle stem cells to divide properly and more efficiently, promoting natural muscle repair and regeneration. SAT-3247 is currently in clinical development as a potential disease-modifying treatment initially for DMD. Satellos also is leveraging its proprietary discovery platform MyoReGenX™ to identify additional muscle diseases or injury conditions where restoring muscle repair and regeneration may have therapeutic benefit and represent future clinical development opportunities. For more information, visit Article content . Article content This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding Satellos and its business, which may include, but are not limited to, statements regarding the potential for SAT-3247 to represent a disease modifying approach to the therapeutic treatment of people living with Duchenne; anticipated benefits to patients from a small molecule treatment for Duchenne; the advancement SAT-3247 through clinical trials; the pharmacodynamic properties and mechanism-of-action of SAT-3247; the potential of our approach in other degenerative muscle diseases; its/their prospective impact on Duchenne patients, patients with other degenerative muscle disease or muscle injury or trauma, and on muscle regeneration generally; and Satellos' technologies and drug development plans. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, occurrences or developments, are 'forward-looking information or statements.' Often but not always, forward-looking information or statements can be identified by the use of words such as 'shall', 'intends', 'believe', 'plan', 'expect', 'intend', 'estimate', 'anticipate', 'potential', 'prospective' , 'assert' or any variations (including negative or plural variations) of such words and phrases, or state that certain actions, events or results 'may', 'might', 'can', 'could', 'would' or 'will' be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, risks relating to the pharmaceutical and bioscience industry (including the risks associated with preclinical and clinical trials and regulatory approvals), and the research and development of therapeutics, the results of preclinical and clinical trials, general market conditions and equity markets, economic factors and management's ability to manage and to operate the business of the Company generally, including inflation and the costs of operating a biopharma business, and those risks listed in the 'Risk Factors' section of Satellos' Annual Information Form dated March 26, 2025 (which is located on Satellos' profile at Article content Article content ). Although Satellos has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Satellos does not undertake any obligation to publicly update or revise any forward-looking statement, whether resulting from new information, future events, or otherwise. Article content Article content Article content Article content Article content Contacts Article content Investors: Article content Liz Williams, CFO, Article content Article content
Yahoo
2 days ago
- Business
- Yahoo
Hoth Therapeutics Reports Positive Preclinical Safety Data for Cancer Fighting HT-KIT -- Dose-Dependent Liver Activity with No Observed Toxicity Supports IND Pathway
HOTH ALERT: Hoth Therapeutics Reports Positive Preclinical Safety Data for HT-KIT — Dose-Dependent Activity, No Toxicity, IND on Deck HOTH announces strong preclinical data for HT-KIT showing dose-dependent liver activity with zero observed toxicity – key milestone as the company prepares for IND filing. Study Results: Liver weight increased from 1.11g → 1.32g across 0 → 3.0 mg/kg No adverse effects on kidney, spleen, or thymus 100% clean safety profile — no visible lesions or gross pathology Validates safety of HT-KIT in vivo Robb Knie, CEO: "These results strengthen our confidence in HT-KIT as we advance toward clinical trials. A strong safety signal with dose responsiveness and no toxicity gives us a clear path forward." NEW YORK, June 18, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company developing innovative therapeutics for rare and inflammatory diseases, today announced encouraging preclinical results from a multi-dose study of HT-KIT, its investigational oncology candidate targeting the c-KIT pathway. The study demonstrated a clear dose-responsive effect on liver mass with no observable toxicity or organ pathology, reinforcing the favorable safety profile of HT-KIT as the Company prepares for further toxicology studies and regulatory advancement. Key Preclinical Findings (HT-KIT): Liver weight increased from 1.11g at 0 mg/kg to 1.32g at 3.0 mg/kg, consistent with pharmacological engagement. Kidney and spleen weights remained stable, indicating no off-target or systemic toxicity. Thymus and other critical organ weights were within normal range across all groups. No gross pathology or visible lesions observed in any treated animal. "These clean and compelling safety results validate our confidence in HT-KIT," said Robb Knie, CEO of Hoth Therapeutics. "A dose-dependent biological signal without organ damage strongly supports our plan to move forward with GLP studies and an IND submission." Hoth Therapeutics expects to initiate GLP toxicology studies, with plans to submit an Investigational New Drug (IND) application soon after. About Hoth Therapeutics, Inc. Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit . Forward-Looking Statement This press release includes forward-looking statements based upon Hoth's current expectations, which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties, and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, and the timing and costs of other expenses; market acceptance of our products; the ultimate impact of any health epidemic, on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; our intellectual property; our reliance on third-party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, and timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans, and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms, or the negative of those terms. Although the company believes that the expectations reflected in the forward-looking statements are reasonable, the company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section titled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance, or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. Investor Contact:LR Advisors LLCEmail: investorrelations@ (678) 570-6791 View original content to download multimedia: SOURCE Hoth Therapeutics, Inc.
