Mast-Cell Sarcoma

Algorithm for Use on Eight Types of Cancer Trained on Seven Scanner Models SPOKANE, Wash., Sept. 19, 2023 /PRNewswire/ -- Gestalt Diagnostics is proud to announce our latest release – an AI algorithm for use on one of the broadest trained environments for commercial or research use. The Mitotic Counting algorithm was trained on over 100,000 individual mitosis and across seven scanner models. The algorithm boasts an F1-Score of 0.74, which is tantamount to the best state-of-the-art methods. This algorithm is available today in the Gestalt AI Studio™ and for use on - Cutaneous mast cell tumor, breast cancer, lymphoma, lung cancer, melanoma, neuroendocrine, colon cancer, and bladder carcinoma. It has been trained on various models of Hamamatsu, Leica, 3D Histech and Aperio scanners. The defining factor for the broad applicability of deep learning models is their capability to generalize to unseen scanners and tissue types; a comprehensive dataset is essential to achieving this goal. The data set we employed covers seven tissue types spanning eight tumors and is digitized with seven scanners. Lisa-Jean Clifford, Gestalt COO & Chief Strategy Officer, asks: "What does this mean for our customers? Confidence. Gestalt is focused on providing solutions that provide a foundation of confidence in use as this industry continues to evolve, innovate, and incorporate products that are meant to enhance a pathologist's or scientist's daily life." "We are extremely proud of the comprehensive approach we take to AI development as an organization. Our position is to not only look at development and training with a small subset of images or on one or two scanners, that would not prove as effective or accurate as we feel our customers and the industry require. Therefore, we train on tens of thousands images, tumors cells, or in this case, mitosis and multiple scanner models across several scanner vendors to ensure the most accurate, clinically usable options for our customers," says Brian Napora, Gestalt VP, AI Solutions. Gestalt Diagnostics, Inc. Gestalt Diagnostics transforms pathology through an intelligent, configurable, vendor-neutral, and AI-driven digital workflow that provides true interoperability enabling pathologists to diagnose* diseases faster and more efficiently. Our PathFlow solution is a cloud-based digital pathology enterprise platform that can easily be customized based on your specific preferences. Our platform consists of professional, education, and research modules for ease of mixing and matching the digital needs of your facility in a single solution, freeing pathologists from tedious, repetitive, and manual tasks allowing them to focus on their expertise, providing invaluable expertise where it matters most. To learn more, visit and follow Gestalt on LinkedIn and @Gestalt122 on Twitter. Research Use Only (RUO) unless following CAP guidelines for LDT. SOURCE Gestalt Diagnostics

Gastrointestinal Stromal Tumors Cells Rapidly Died Between 48 and 72 Hours After Exposure to HT-KIT. HT-KIT Shows Positive Results in AML Positive Preclinical Results of Novel HT-KIT Therapeutic Performed at NC State University NEW YORK, Sept. 13, 2023 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced that HT-KIT, a new molecular entity, for the treatment of advance systemic mastocytosis (AdvSM) achieved positive preclinical results in a study sponsored by Hoth. HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT by inducing mRNA frame shifting and already has Orphan Drug Designation from the FDA. The sponsored preclinical research was conducted at NC State University ("NCSU") over the past two years. The aim of the initial studies was to assess how long HT-KIT was functional in cancerous and non-cancerous mast cells, and to determine whether the cells could develop resistance to HT-KIT. Key findings from initial studies in the mouse model show: HT-KIT effectively kills human mast cells that rely on signaling through the KIT receptor to survive. The effects of a single dose of HT-KIT lasted for about 2 weeks. HT-KIT efficacy at reducing KIT expression lasted for 7 days Additional studies were then performed to assess whether HT-KIT had potential applications further to the mastocytosis indication. Gastrointestinal stromal tumors (GISTs) are also associated with activating KIT mutations. Key findings from these studies show: HT-KIT potently reduced KIT expression using GIST cells and that GIST cells rapidly died between 48 and 72 hours after exposure to HT-KIT. Further, we also examined the effects of HT-KIT on a cell line that represents acute myeloid leukemia (AML) cells, and found KIT expression was lower in the AML cells compared to either the mastocytosis or GIST cells, but was effectively and dose-dependently reduced with HT-KIT treatment over 72 hours. Overall, these data provide strong support for potential applications of HT-KIT outside of mastocytosis and mast cell leukemia where KIT may be expressed and could play a role in disease aggression. Further in vivo and mechanistic studies are underway at NCSU in these diseases. "The results from our HT-KIT preclinical trial further reinforces our belief that targeting mutations in the KIT pathway could be the answer for patients living with mast cell-derived cancers and related conditions," stated Robb Knie, Chairman and CEO of Hoth Therapeutics. "We look forward to leveraging these results in our program development as we prepare to meet with the FDA before year end." About HT-KIT HT-KIT is a new molecular entity (NME) under development for treatment of mast cell derived cancers and anaphylaxis. HT-KIT was developed Dr. Glenn Cruse, Assistant Professor at North Carolina State University and shares the same molecular class as Hoth's current HT-004 drug. The HT-KIT drug is designed to more specifically target the receptor tyrosine kinase KIT in mast cells, which is required for the proliferation, survival and differentiation of bone marrow-derived hematopoietic stem cells. Mutations in the KIT pathway have been associated with several human cancers, such as gastrointestinal stromal tumors and mast cell-derived cancers (mast cell leukemia and mast cell sarcoma). Based on the initial proof-of-concept success, Hoth intends to initially target mast cell neoplasms for development of HT-KIT, which is a rare, aggressive cancer with poor prognosis. HT-KIT has Orphan Drug Designation from the FDA. FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity. About Hoth Therapeutics, Inc. Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to develop 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, the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current Coronavirus pandemic, or any other 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, 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 entitled "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 LLC Email: investorrelations@hoththerapeutics.com Phone: (678) 570-6791 Company Codes: NASDAQ-NMS:HOTH

HT-KIT received Orphan Drug Designation from FDA for its mRNA Frame Shifting Cancer Therapeutic Hoth intends to initially target mast cell neoplasms for development of HT-KIT, which is a rare, aggressive cancer with poor prognosis NEW YORK, Sept. 11, 2023 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced it has submitted a request for a Pre-Investigational New Drug (IND) meeting to the U.S. Food and Drug Administration (FDA) to discuss the proposed drug development program for HT-KIT, a new molecular entity, for the treatment of advance systemic mastocytosis (AdvSM). HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT by inducing mRNA frame shifting and already has Orphan Drug Designation from the FDA. Currently in the preclinical stage of development of HT-KIT, Hoth anticipates a meeting with the FDA to be scheduled during the fourth quarter of 2023. During the pre-IND meeting with the FDA, Hoth Therapeutics plans to discuss the overall proposed drug development program for HT-KIT including requirements for nonclinical, clinical pharmacology, clinical, chemistry, and manufacturing controls. Hoth also plans to present clinical trial designs for the IND-opening, phase 1 dose ranging and dose extension studies as well as a proposed follow-up phase 2 safety and efficacy study; both studies will be conducted in adult patients with advanced systemic mastocytosis (AdvSM). AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SMAHN), and mast cell leukemia (MCL). "Today's FDA submission brings us one step closer to advancing HT-KIT for patients who are suffering with a rare aggressive form of cancer," stated Robb Knie, Chairman and CEO of Hoth Therapeutics. "We look forward to working closely with the FDA and advancing HT-KIT through the IND-enabling and clinical phases of development." About HT-KIT HT-KIT is a new molecular entity (NME) under development for treatment of mast cell derived cancers and anaphylaxis. HT-KIT was developed Dr. Glenn Cruse, Assistant Professor at North Carolina State University and shares the same molecular class as Hoth's current HT-004 drug. The HT-KIT drug is designed to more specifically target the receptor tyrosine kinase KIT in mast cells, which is required for the proliferation, survival and differentiation of bone marrow-derived hematopoietic stem cells. Mutations in the KIT pathway have been associated with several human cancers, such as gastrointestinal stromal tumors and mast cell-derived cancers (mast cell leukemia and mast cell sarcoma). Based on the initial proof-of-concept success, Hoth intends to initially target mast cell neoplasms for development of HT-KIT, which is a rare, aggressive cancer with poor prognosis. HT-KIT has Orphan Drug Designation from the FDA. FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity. About Hoth Therapeutics, Inc. Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to develop 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, the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current Coronavirus pandemic, or any other 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, 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 entitled "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 LLC Email: [email protected] Phone: (678) 570-6791 SOURCE Hoth Therapeutics, Inc.