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Hoth Therapeutics, Inc. Issues 2019 Shareholder Letter

December 23, 2019 GMT

NEW YORK, Dec. 23, 2019 /PRNewswire/ -- Hoth Therapeutics, Inc. (Nasdaq: HOTH) (“HOTH” or the “Company”), a biopharmaceutical company focused on developing new generation therapies for dermatological and immunological disorders such as atopic dermatitis, psoriasis, asthma and acne, today issued its 2019 Shareholder Letter.

Dear Shareholder,

Looking back on 2019, our first year as a public company, management is pleased with the significant growth initiatives that we have achieved and the strategic relationships that we have built. Hoth has made great strides in developing a robust biopharmaceutical platform, focused on developing next generation therapies for dermatological and immunological disorders. Previously, conventional approaches to skin ailments have provided little benefit, typically only offering relief from the symptoms of disease, rather than targeting underlying disease processes. Our belief is that we can provide better treatments for patients who are suffering from these ailments by harnessing the power of our pipeline. Our product pipeline currently includes several treatments, pertaining to diverse dermatological and immunological conditions and encompassing a large addressable market. In an effort to maintain a transparency and rapport with our investors, we have comprised a summary of Hoth’s corporate developments for the current year.

BioLexa Platform:
HOTH’s lead drug candidate platform BioLexa, targets millions of patients, suffering from eczema or atopic dermatitis. Early this year we began testing of the BioLexa platform with our partners at Mass General Hospital. Following the initial study, we resynthesized our vehicle and formulation to bring a more robust form of BioLexa to the lab for further toxicology studies. With our partner Particle Sciences, we began production of GLP materials which were sent for our escalating maximum dose study. Upon successful completion of the dose escalation study we undertook a seven-day toxicology study which showed no-ill effects. We are currently in the midst of our 28-day toxicology study, which we will end in early 2020. In addition to possessing exclusive worldwide rights to the BioLexa Platform, we also maintain a licensing deal with the University of Cincinnati to utilize the innovative BioLexa Platform. Our plan is to begin clinical trials in humans in Australia during 2020.

VNLG-152:
We have an exclusive Commercial Licensing Agreement with University of Maryland, Baltimore and Isoprene Pharmaceuticals Inc. for the compound VNLG-152 for dermatological use, which has shown strong preclinical results, and we are working to develop for treatment in psoriasis and acne patients. Acne is the result, in part, of Propionibacterium acnes or ‘P. acnes’ growth in hair follicles, which leads to a defined set of pathogenic gene expression changes.

This Fall, Hoth began the synthesis of VNLG -152 and received materials for a proposed animal study. Just last week we announced entering into a research collaboration agreement with Weill Cornell Medicine to examine the ability of retinoic acid metabolism blocking agents (RAMBA) to block acne pathogenic gene expression in human keratinocytes, mouse skin, and carcinogenesis in mice. The research collaboration will be conducted in three phases for a period of one year. Dr. Jonathan Zippin, M.D., Ph.D., FAAD, Associate Professor of Dermatology at Weill Cornell Medicine and Hoth’s Senior Scientific Advisor, will be the Principal Investigator for the research collaboration.

Aprepitant:
In July 2019, Hoth and GW announced its working relationship and entering into an exclusive license option agreement pertaining to its intellectual property on the use of Aprepitant in treating skin-related and other side effects from drugs used to treat cancer. This fall, Hoth announced that it has entered into a sponsored research agreement with the George Washington University (GW) and began the SRA to explore the potential use of Aprepitant for topical and/or systemic therapy to counter the dermatological related side-effects of Erlotinib therapy in cancer patients. Erlotinib is a drug that is used to combat various cancers and has been known to cause varying degrees of skin rashes, lesions, hair loss and nail changes to patients. These side-effects can negatively impact the patient’s quality of life and even cause usage interruption, jeopardizing the overall success of the treatment.

The research agreement intends to explore whether other chronic conditions that also display dermatitis may benefit from this novel therapeutic approach. Overseeing this collaboration will be William B. Weglicki, MD, professor of biochemistry and molecular medicine and professor of medicine at the GW School of Medicine and Health Sciences. Dr. William Wegliki recently submitted his manuscript based on his team’s findings highlighting the positive dermatological effects of Aprepitant. I’m also pleased to note that just last week, we officially appointed Dr. Weglicki, M.D. to our Scientific Advisory Board, where we will have even greater access to his expertise.

Gene Therapy
In November Hoth announced it entered into a licensing agreement with North Carolina State University (NC State) to study its exon skipping approach for treating allergic diseases. Earlier this month, Hoth announced the initiation of a preclinical study for the treatment of asthma and allergic inflammation in collaboration with North Carolina State University which will begin in early 2020.

The study centers around NC State’s exon skipping approach for treating allergic Diseases. The exon skipping approach was developed by Dr. Glenn Cruse, Principal Investigator and Assistant Professor in the Department of Molecular Biomedical Sciences at the NC State College of Veterinary Medicine. These findings set a breakthrough for allergic diseases as they are driven by the activation of mast cells and the release of mediators in response to IgE-directed antigens.

This collaboration will allow us to leverage this invention from the renowned expertise of Dr. Glenn Cruse and his scientific team at North Carolina State University. We look forward to seeing how their work advances and what this might mean for patients suffering from undesirable steroid side effects who need an alternate treatment for asthma and other allergic diseases.

Z-Pods:
The Company is co-developing with Zylö Therapeutics, a patented technology delivery system for drugs treating Cutaneous Lupus Erythematosus (CLE), a chronic autoimmune disease that affects the skin, by using patented xerogel-derived nanoparticles, called Z-pods™. Hoth secured an exclusive license to the Anandamide-loaded Z-pods™ for the treatment of CLE in North America. Anandamide, generally referred to as AEA, is one of the cannabinoids that the human body makes naturally. The topical administration supplies—in a sustained and controlled manner—notoriously hard-to-deliver therapeutic agents, hence improving overall outcome.

During initial studies, it was reported Z-Pods™ has the capacity to improve drug skin penetration, reduces the expected inflammatory cytokine secretion by keratinocytes when exposed to ultraviolet radiation, prevents the development of CLE skin lesions, improves skin histopathology, prevents inflammation and structural damage on histology and reduces macrophages and C3 accumulation. Zyl has initiated an independent confirmation study to provide a critical point of validation for this proprietary topical solution. In November we announced initiating a confirmatory study and look forward to those results in 2020.

Genetic Marker:
The Company secured an exclusive license from the University of Cincinnati using its patented technology to determine a person’s propensity to suffer an allergic reaction to certain types of food. We believe this Genetic Marker may lead to the reduction of children undergoing risky food challenge treatments. Hoth looks to leverage this marker in relation to the cause of eczema and food allergy.

In closing, 2019 served as a monumental first year for us. The Company bolstered its balance sheet and fortified its industry affiliations with some of the most influential and respected leaders in the field of healthcare. I’m confident that the aforementioned updates in this letter will serve as validation that we are well-positioned to leverage the numerous opportunities that lay ahead of us in order to achieve our primary goal of improved shareholder value.

I want to thank you all for your interest and commitment in the company and we look forward to continued success into 2020 and beyond.

Sincerely yours,

Mr. Robb Knie, Chief Executive Officer

About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for dermatological disorders. HOTH’s pipeline has the potential to improve the quality of life for patients suffering from indications including atopic dermatitis, chronic wounds, psoriasis, and acne. HOTH has the exclusive worldwide rights to BioLexa, the company’s proprietary lead drug candidate topical platform that uniquely combines two FDA approved compounds to fight bacterial infections across multiple indications. HOTH is preparing to launch its clinical trial for the treatment of adolescent subjects, 2-17 years of age, with mild to moderate atopic dermatitis during 2020. To learn more, please visit www.hoththerapeutics.com.

Forward Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements that relate to the advancement and development of the BioLexa Platform, the commencement of clinical trials, the availability of data from clinical trials and other information that is not historical information. When used herein, words such as “anticipate”, “being”, “will”, “plan”, “may”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Hoth’s current expectations and various assumptions. Hoth believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described under the caption “Risk Factors” in Hoth’s Form 10K for the period ending December 31, 2018, and Hoth’s other filings made with the Securities and Exchange Commission. 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 law.

Contacts
Investor Relations Contact:
Phone: (646) 756-2997
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com

KCSA Strategic Communications
Valter Pinto / Daniela Guerrero
(212) 896-1254 / (212) 682-6300
Hoth@kcsa.com

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SOURCE Hoth Therapeutics, Inc.