Full Press Release Details
Therapeutics, Inc. Issues Letter to Shareholders
YORK, Sept. 4, 2019 /PRNewswire/ -- Hoth Therapeutics, Inc. (Nasdaq: HOTH), a biopharmaceutical company focused
on unique targeted therapeutics for patients suffering from dermatological indications ranging from atopic dermatitis to chronic
wound disorders, today issued a letter to shareholders.
wanted to take a moment to provide you with a brief update on both the recent achievements and direction at Hoth Therapeutics,
Inc. The Company has made significant strides since its IPO earlier this year. Management has worked diligently to
produce strategic milestones in order to establish a strong foundation capable of supporting long-term growth. We are proud
of our recent accomplishments and excited to leverage the many opportunities that lay ahead.
conjunction with our clinical plan for BioLexa in treating pediatric eczema, Hoth has recently begun its toxicology study and
our female minipigs will be weighed and clipped this Friday in preparation for their first dose on Monday, the 9th of
September. This will begin testing the maximum feasible volume and concentration of the updated BioLexa formulation. The
results of these minipig studies will help guide Hoth in finalizing our clinical trials in humans.
we continue to plan our proposed human trial for atopic dermatitis (Eczema) in Australia. As stated in our press release
dated, June 6, 2019, Hoth has formally set up its Australian subsidiary and has also engaged Novotech as the Company's CRO
in Australia. Novotech, a clinical development program, from project management through to clinical trial monitoring, management
and patient recruitment is widely acclaimed and its expertise will help us expedite our drug development and trial program.
We believe that their experience and knowledge will provide an edge in helping us bring these novel treatments to the worldwide
July, we also announced positive results from our pilot study of BioLexa in treating diabetic wounds. The study, developed
at Massachusetts General Hospital (MGH), was designed to establish foundational protocols for assessing effectiveness of the BioLexa
Platform, for accelerating and improving wound healing in the context of acute and chronic diabetic ulcers, using an animal model
of impaired wound healing developed at MGH. Upon removal of the wound dressings and the obscuring cream, Dr.
Ruxandra Sirbulescu, who designed and conducted the pilot study, observed that the majority of the wounds, treated with either
BioLexa or the carrier base control of BioLexa, were fully closed and re-epithelialized.
Sirbulescu commented, "We observed complete closure in all treated wounds, which is not typical for this experimental model. Moreover,
several parameters associated with the quality of tissue regeneration were significantly improved after treatment of the open
ulcers with Biolexa, including better collagen deposition and increased angiogenesis. Our next studies will aim to confirm
the observed regenerative effects of the Biolexa platform in the context of chronic diabetic ulcers, with and without substantial
initial results represent a critical step in establishing BioLexa within the dermatological treatment sector. The next study
will take place later this year, and into 2020 at MGH and will be a more rigorous examination of the BioLexa platform when it
comes to treating these wounds.
that Hoth maintains exclusive worldwide rights to the BioLexa Platform, our commitment to the commercialization of this drug is
Treatment and Zyl Therapeutics Partnership
20, 2019, Hoth finalized an agreement with Zyl Therapeutics Inc to co-develop a new treatment for patients suffering from
Cutaneous Lupus Erythematosus (CLE). CLE is a chronic autoimmune disease that affects the skin. This
partnership centers around an innovative sustained-release drug-delivery system that uses patented xerogel-derived nanoparticles,
called Z-pods , to deliver-in a sustained and controlled manner-notoriously hard-to-deliver therapeutic agents
through topical administration.
at the Albert Einstein College of Medicine, where the platform technology was originally developed, have demonstrated that
topical administration with AEA-loaded Z-pods inhibits the development of CLE lesions in a well-established animal model of lupus.
This work reinforces and highlights the utility of targeting the endocannabinoid system for autoimmune rheumatic diseases.
plan, along with our partner Zyl Therapeutics, is to undertake an independent confirmation study of prior results later
this year. Hoth also acquired some rights to market the formulation in other countries and to apply it to diseases such
as psoriasis and rheumatoid arthritis.
Licensing Agreements and Strategic Relationships
is committed to working with some of the most well-respected names within the biopharmaceutical market. We recently entered
into an exclusive license option agreement with the George Washington University (GW) pertaining to its intellectual
property on the use of Aprepitant for treating skin-related and other side effects from drugs used to treat cancer.
the terms of the agreement, Hoth has an option to exclusively license two US patents covering methods of using Aprepitant or other
drugs that inhibit neurokinin-1 (NK-1) receptor function. This agreement complements the rights provided to Hoth under
the recently announced research collaboration with inventor William B. Weglicki, M.D.'s laboratory at GW, which includes
an option for Hoth to license any future inventions that may arise from the ongoing Hoth-funded studies at GW.
we aligned ourselves with the University of Maryland, Baltimore and Isoprene Pharmaceuticals Inc., via a Commercial
Evaluation Sublicense and Option Agreement. The agreement grants Hoth complete evaluation and option rights in the Dermatology
Evaluation Field to develop and commercialize therapeutic compounds for the treatment of dermatological conditions in humans.
The licensing agreement for VNLG -152 stems from results reported by UMB relating to the effect Retinoic acid metabolism blocking
agents (RAMBAs) offer in treating cancer and dermatology related issues.
have currently begun the synthesis of VNLG -152 and expect materials by the end of September for a proposed animal study.
we leave summer behind and enter the fall of 2019, Hoth has expanded its pipeline and has established a path for each therapeutic
in our portfolio. Going forward, I will continue to update our shareholders as we continue to execute on our strategic growth
plan. I want to thank you all for your interest and commitment in the company and we look forward to continued success into
Chief Executive Officer
Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc., a Nevada corporation, is a biopharmaceutical company focused on unique targeted therapeutics
for patients suffering from indications such as atopic dermatitis, also known as eczema. Hoth has exclusive worldwide rights to
the BioLexa Platform.
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.
Phone: (646) 756-2997