Hoth Therapeutics Announces New Pipeline Asset, HT-TBI for Stroke and Traumatic Brain Injury

HT-TBI is a novel, point-of-care drug-device combination product under development for acute treatment of secondary brain injury resulting from ischemic stroke and traumatic brain injury

NEW YORK, April 19, 2022 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced the company is adding a new asset to its pipeline portfolio, HT-TBI, which is based on scientific research performed by Hoth. HT-TBI is being developed as a novel, point-of-care therapy for the treatment of secondary brain injury (e.g., brain edema and inflammation) resulting from ischemic stroke and traumatic brain injury ("TBI"). HT-TBI will be developed as a ready-to-use drug-device combination product for use in non-healthcare settings by patients and caregivers at risk for stroke/TBI, emergency healthcare professionals, and military personnel.

Stroke and TBIs are leading causes of death and disability globally. Ischemic stroke results from the obstruction to the brain blood supply, resulting in cell death and secondary brain injury (e.g., fluid/swelling, inflammation, oxidative stress, cell death) triggered as a result of the cellular stress that, together, leads to long-term functional deficits. TBIs occur due to physical or mechanical trauma to the brain but are also associated with secondary brain injury (e.g., fluid/swelling, inflammation, oxidative damage, etc.).

The common underlying treatment issue for all cases of TBI and stroke is the substantial delay in medical treatment measures that could reduce the severity of the injury and improve the overall patient outcome. For both TBI and stroke, studies have shown better treatment outcomes for patients (such as decrease in disability) that experienced stroke and TBI if treatment is initiated within 3 hours of stroke or within 4-7 hours post-TBI. However, this window of opportunity can be limited by logistical issues, especially in rural areas and for military field personnel.

"HT-TBI is being developed as a paradigm shift in patient care – faster treatment to achieve better outcomes," stated Dr. Stefanie Johns, Chief Scientific Officer. "Emergencies like stroke and TBI are unpredictable and can lead to long-term burden on patients of all ages and their families. By providing HT-TBI as a ready-to-use therapy to emergency healthcare responders, sports coaches, and military personnel, there is potential to prevent these severe neurological effects by reducing the degree of secondary brain injury. The statistics of patients permanently impacted by stroke and TBI is astounding and Hoth is driven to reduce that burden."

HT-TBI is the second drug in the Hoth Pipeline to target neurological disorders; HT-ALZ, another Hoth central nervous system asset, is under development for the treatment of Alzheimer's disease.

Stroke and TBI Statistics:

• There are over 12.2 million new strokes each year. Globally, one in four people over age 25 will have a stroke in their lifetime.
• There are over 7.6 million new ischemic strokes each year. Globally, over 62% of all incident strokes are ischemic strokes.
• Over 63 million years of healthy life is lost each year due to ischemic stroke-related death and disability. 41% of healthy life lost due to ischemic stroke-related death and disability affects people under the age of 70 years.
• More than 2.8 million people experience a TBI each year in the US; there were 61,000 TBI related deaths in 2019 in the US alone.
• For patients that survive a moderate to severe TBI, the burden on patient quality of life is severe: 57% are moderately to severely disabled, 55% are unemployed, 50% require hospital readmission, and 33% are dependent on others for their activities of daily living.

Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs. Hoth's pipeline development is focused to improve the quality of life for patients suffering from skin toxicities associated with cancer therapy, mast-cell derived cancers and anaphylaxis, Alzheimer's Disease, atopic dermatitis and other indications. To learn more, please visit https://ir.hoththerapeutics.com/.

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 Hoth may develop, and the labeling under any approval Hoth may obtain; the timing and costs of clinical trials; the timing and costs of other expenses; market acceptance of Hoth's products; the ultimate impact of the current Coronavirus pandemic, or any other health epidemic, on Hoth's business, its clinical trials, its research programs, healthcare systems or the global economy as a whole; Hoth's intellectual property; Hoth's reliance on third party organizations; Hoth's competitive position; Hoth's industry environment; Hoth's anticipated financial and operating results, including anticipated sources of revenues; Hoth's assumptions regarding the size of the available market, benefits of Hoth's products, product pricing and timing of product launches; management's expectation with respect to future acquisitions; statements regarding Hoth's goals, intentions, plans and expectations, including the introduction of new products and markets; and Hoth's 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 undue 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 Hoth believes that the expectations reflected in the forward-looking statements are reasonable, Hoth 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 of this press release. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update 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
www.hoththerapeutics.com
Phone: (678) 570-6791

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SOURCE Hoth Therapeutics, Inc.