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HOTH Successfully Completes Phase 1 Eczema Treatment Study

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NASDAQ:HOTH   Hoth Therapeutics, Inc.
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HOTH (Hoth Therapeutics, Inc.)

Float: 4.16M

Alert Price: $4.1954

Target Price: $8.00
(Diamond Equity Research)

Chart Analysis

Investor Presentation

Website | Recent News
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Members,

Earlier today we promised you an amazing opportunity trading on the Nasdaq exchange.

The Company operates in the highly lucrative biopharmacetical sector, and is making some great strides towards FDA approval.

Please turn your immediate attention to HOTH (Hoth Therapeutics, Inc.)

HOTH is a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis–also known as eczema–as well as dermatological and chronic wound disorders.

On Tuesday, the Company announced that they have completed Phase I of their In-Life dose escalation study. The clinical study was conducted by an independent third party, monitoring the tolerance and toxicity of its proprietary BioLexa Platform on minipigs.

This was just the latest in a long string a milestones for the company.
Recent Milestones

Successfully completed Phase I of In-Life Dose Escalation Study for Treating Eczema
Diamond Equity Research initiated coverage on the Company and slapped on an $8 price target
Received positive results from pilot study of BioLexa on Diabetic Skin Ulcers
Entered into a definitive partnership agreement with Zylö Therapeutics to develop a new treatment for patients suffering from Cutaneous Lupus Erythematosus , a chronic autoimmune disease that affects the skin.
Entered into licensing agreement with the University of Maryland and Isoprene Pharmaceuticals. (March 2019)
Began pilot study in chronic diabetic ulcers at Mass General Vaccine and Immunotherapy Center (March 2019)
Announced Closing of Initial Public Offering.
Here a a few reasons why we believe that HOTH is due for a big move in the near future.
Has a tight float of 4.16M
Operates in the highly volatile biotech sector. (These Stocks Tend to Move Big On News)
Is listed on the Nasdaq Exchange (High Liquidity)
Analysts recently assigned an $8 Price Target, which is an upside of over +90% from today's alert price
Successfully completed Phase I of In-Life Dose Escalation Study for Treating Eczema
Received positive results from pilot study of BioLexa on Diabetic Skin Ulcers
Shortened path towards regulatory approval
Multiple near-term catalysts for value creation.
Peer group valuations are compelling: Pfizer recently paid $4.9 billion for Anacor (lead product, Eucrisa, is a topical treatment for mild to moderate eczema.)
HOTH has been on our radar for quite some time now. After IPO'ing at $5.50, HOTH went on a tear, hitting a 52-week high of $13.88.

HOTH's recent pullback has created the ultimate buy the dip opportunity for traders.

We all know how explosive these small-cap biotech stocks can be...

With HOTH's tiny 4.16M float, any type of market friendly news could send shares soaring.

HOTH also has several bullish catalysts on the horizon that have us confident that its $8.00 price-target is well within reach.

Atopic Dermatitis is a large and growing market

Affects more than 32 million patients in the US
10 20% of all pediatric patients suffer from Atopic Dermatitis
Need for new, differentiated therapies
HOTH's BioLexa Platform offers a non corticosteroid approach to inhibit the formation of biofilms, which increases effectiveness of BioLexa in clearing current symptoms and preventing future flare ups

Phase 2 study is currently being designed by renowned doctors and scientists and on track to start enrollment in Australia by end of 2019
Study will test efficacy, safety, and ease of use
On target to complete Phase 2 clinical trial by end of Q1 2020
As you can see, HOTH is operating in an in-demand market and has several promising products in its pipeline.

Can you imagine how high HOTH shares could go if it were to receive FDA approval?

Based on our research, HOTH appears to be well on its way to becoming our next bio-tech alert to breakout for monster gains.

About HOTH Therapeutics

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.

Hoth owns the exclusive rights to develop the BioLexa Platform for all indications in humans. The BioLexa Platform is a proprietary, patented, drug compound platform developed at the University of Cincinnati. The BioLexa Platform combines an FDA-approved zinc chelator with one or more approved antibiotics in a topical dosage form to address unchecked eczema flare-ups by preventing the formation of infectious biofilms and the resulting clogging of sweat ducts. It is the first product candidate intended to prevent the symptom-triggering flare-ups rather than simply treating symptoms after they occur.

They intend to explore the use of the BioLexa™ Platform for the treatment of atopic dermatitis, or eczema.

They also intend to explore the use of the BioLexa Platform™ in the aesthetic dermatology field to help treat and reduce post-procedure infections, accelerate healing and improve clinical outcomes for patients undergoing procedures. They believe that the BioLexa Platform™s ability to fight bacterial growth will enable the innate immune system to focus on optimal healing rather than fighting post-procedure infection.

Finally, they intend to explore the use of the BioLexa Platform™ in connection with diabetic foot ulcers. We believe that the BioLexa Platform™s ability to fight bacterial growth will help initiate and/or improve chronic diabetic wound healing as well as accelerate the healing of diabetic wounds with S. aureus.

Genetic Marker License

Hoth has also licensed exclusive rights to certain patented technology from the University of Cincinnati for use in determining the risk that a patient will develop allergies to peanuts, milk and other foods as well as predict propensity for eczema. Hoth’s overall goal is to develop and make ready for commercialization a family of genetic screening tests based on the licensed technology.

Company Highlights:

Unique small cap specialty pharma investment opportunity with multiple shots on goal and capital business model.
Multi-billion market opportunity with large unmet need for both the Company’s primary and secondary asset.
Proprietary platform technology which combines two existing approved drugs enabling reliance on existing safety data for those drugs.
Proprietary BioLexa platform technology which combines two existing approved drugs enabling reliance on existing safety data.
VNLG 152 strong pre-clinical data in acne and psoriasis.
Strong IP Portfolio, including licenses to patents and trademarks.
Signed a term sheet with Zylö Therapeutics Inc (Zylö) to co-develop a new treatment for patients suffering from Cutaneous Lupus Erythematosus (CLE). CLE is a chronic autoimmune disease that affects the skin.
Experienced management team, board of directors and scientific advisors with proven drug development experience.
HOTH Is Moving Closer Towards FDA Approval
Hoth Therapeutics Successfully Completes Phase I of In-Life Dose Escalation Study for Treating Eczema
Last Wednesday, HOTH announced that they have completed Phase I of their In-Life dose escalation study. The clinical study was conducted by an independent third party, monitoring the tolerance and toxicity of its proprietary BioLexa Platform on minipigs. There were two phases with the first phase of the study being completed in September of 2019.

Phase I In-Life Dose Escalation Study

Searching for the maximum feasible volume.
Initiated at 0.5 ml/kg, and then increased to 1.0 mg/kg, 1.5 mg/kg, and 2.0 mg/ kg once daily approximately every 18-24 hours.
Found no visible lesions on any of trial patients.
"Management is pleased that our BioLexa Platform continues to demonstrate an impressive safety profile during its testing phase," said, Mr. Robb Knie, Chief Executive Officer of Hoth Therapeutics. "We believe this therapeutic candidate has the potential to provide significant benefits to people afflicted by Atopic Dermatitis. Going forward, we are focused on expanding our clinical efforts into later stage trials."

This stage of the toxicity study was designed to determine dose-limiting adverse events and to define the maximum tolerated dose of the BioLexa Platform. The BioLexa Platform is a proprietary, patented therapeutic designed for the treatment of atopic dermatitis.

Over +90% In Upside Potential From Today's Alert Price

Diamond Equity Research Initiates Coverage on Hoth Therapeutics, Inc. Slaps on $8.00 Price Target

The full research report is available here.

Highlights from the report include:

Large Market Opportunity

Awareness of skin disorders has grown exponentially in recent decades, driving demand for more effective treatments. Eczema is one of the most prevalent skin diseases, with atopic dermatitis (AD) being the most common type affecting a significant portion of the global population. The National Eczema Association estimates conservatively that 31.6 million individuals in the U.S. suffer from eczema, incurring an annual economic burden of around $5.3 billion. The study anticipates that the AD drug sales in the U.S. will grow to $13.6 billion by 2027, which indicates a significant potential market for effective AD treatments.

HOTH’s lead product, BioLexa offers a novel potential therapy to treat AD (eczema). It expects to commence a phase 2 trial with enrollment starting in Australia in the end of 2019, with the company targeting a data readout in 1H 2020. The company expects to file the new drug application from mid- to late 2021, which means HOTH could potentially launch its lead product in the U.S. market in 2023.

Although HOTH’s investment and timeline in getting its drugs to market are relatively small compared to traditional drug development, HOTH’s pipeline is still earlier stage. We believe HOTH is well positioned to provide investors a unique, high risk high reward small-cap specialty pharma investment opportunity, with its multiple differentiated potential treatments under development.

Unique Atopic Dermatitis Treatment Approach

HOTH is an early-clinical-stage biopharmaceutical company developing its lead product BioLexa, a unique potential targeted treatment for mild to moderate atopic dermatitis (AD; also known as eczema). BioLexa is one of the first drug candidates to prevent symptoms triggering eczema rather than simply treating symptoms after they occur. It is differentiated as it combines an FDA-approved zinc chelator with one or more approved antibiotics in a topical dosage form to address unchecked eczema flare-ups by preventing the formation of infectious biofilms; in simpler terms, it targets the bacteria as opposed to other eczema treatments addressing the immune-related and inflammatory factors. Hoth uses approved drugs that would enable it to take the faster 505 (b) (2) route for regulatory approval of BioLexa, if the upcoming clinical studies indicate positive results.The company also working with the George Washington University to counter the dermatological-related side effects of Erlotinib therapy in cancer patients, and is developing VNLG 152 with strong preclinical data in the fields of cancer and dermatology. HOTH has established relationships with renowned doctors and scientists and top medical institutions. It recently signed an exclusive licensing agreement with the University of Cincinnati to obtain a patented new food allergy genetic marker; started a pilot study on diabetic skin disorders with the Massachusetts General Hospital’s Vaccine and Immunology Center; expanded its working relationship and signed an exclusive licensing agreement with George Washington University; and entered into a commercial licensing agreement with the University of Maryland (Baltimore) and Isoprene Pharmaceuticals Inc. We anticipate further licensing agreements and collaborations going forward.

Competition

The global dermatitis drugs market continues to expand, driven by the advancements in numerous drug classes. The AD therapeutics market currently uses conventional forms of therapy such as topical corticosteroids, calcineurin inhibitors, and PDE4 inhibitors to treat patients with mild to moderate AD symptoms.HOTH expects to face significant competition from other current treatments and the development pipelines of large pharmaceutical companies and emerging biotechnology companies. That said, we believe HOTH is well positioned in the industry, with its (1) novel and differentiated potential treatment targeted at preventing the formation of bacterial biofilm and addressing the potential impairment of skin barrier function, (2) patented BioLexa Platform, which combines two existing approved drugs, enabling reliance on existing safety data for those drugs, which could result in faster regulatory approval, (3) strong intellectual property portfolio, including exclusive licenses to patents and trademarks, and (4) additional potential therapies targeting dermatological issues and genetic disorders, including diabetic ulcers, skin aesthetics, psoriasis, and food allergies.

Attractive Valuation

It is very difficult to value Hoth Therapeutics, Inc. given its early stage and the limited number of similar publicly traded dermatology companies. In our comparable company analysis, we screened for small-capitalization companies in the biopharmaceutical industry focused on developing therapeutics for eczema. We used a blend of these companies to arrive at a mean technology value. We also built a discounted cash flow to value HOTH. From our blended valuation models, we found the shares to be undervalued with significant upside from current trading levels. Based on an average of the two methods, we computed a blended valuation of $8 per share, indicating the stock is undervalued relative to current prices.

Market Outlook:

More than $320 billion was spent on prescription drugs in the U.S. in 2016, a figure that's expected to nearly double to $610 billion by 2021, according to IQVIA (formerly QuintilesIMS).

With so much money being spent on necessary medicines, there's serious opportunity for pharmaceutical companies and investors alike.

Atopic dermatitis market predicted to grow $7.2B in 2017 to $24B by end of 2027.

It affects more than 32 million patients in the US.

Diabetic Foot Ulcers affect approximately 9.1-26.1M people worldwide, about 19 34% of people with diabetes are likely to be affected.

Nearly 7.5 million people are affected by psoriasis in the US alone and represent about 2% of the population with approximately 100,000 new cases reported each year.*

60 million people suffering from all grades of acne in the US, 20% of which is severe enough to result in facial scarring.

Technical Analysis

As we stated above, with HOTH's tiny 4.16M float, any type of market friendly news could send its shares soaring.

HOTH has plenty of room to the upside, a move back to its 52-week high of $13.88 would net traders over +230% in profit from today's alert price.

We've done our very own chart analysis, and see the potential for a move of over +18% from here.

Bullish divergence is forming.
HOTH has established strong support at these levels.
We've watch HOTH make several strong bounces off support in the past.
The Bottom-Line

We love these low-float bio-tech alerts.

They have the tendency to breakout faster and bigger than any other sector.

HOTH's management team possesses a wealth of experience, and we believe that they are the right group of individuals to get this game-changer in the pharma space on the right path towards FDA approval

(*Remember to use a Stop-Loss Order or basic Limit Order to protect your gains, as well as limit possible losses.)

Best Regards,

*Past performance is not an indicator of future returns. The publishers of this report are not investment advisors and does not provide investment advice. Always do your own research and make your own investment decisions. This message is not a solicitation or recommendation to buy, sell, or hold securities. The publishers of this report have received compensation from a third party of USD $20,000 cash for a 2-day marketing contract for HOTH. Never make investment decisions based on anything the publisher of this report says. This message is meant for informational and educational purposes only and does not provide investment advice.



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