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Category : Testosterone Physicians

Kenergy Scientific, Inc. Announces New Added Location and Telemedicine to Their Florida-Based Men’s Healthcare and Anti-Aging Company – Stockhouse

BAY HARBOR, FL / ACCESSWIRE / September 14, 2020 / Kenergy Scientific, Inc. (OTC PINK:KNSC) is pleased to announce MedSmart Group, Inc's, (MSGI) subsidiary MedSmart Men's Wellness and Antiaging centers is focused on Men's health, and well-being. MedSmart is Well Established in the operations of Clinics from Start up to market dominance. The company has added a new location in Aventura Florida for a brand new 2,000sq ft. state of the art facility. The Center is located a few minutes away from some of the most high-end neighborhoods in South Florida. Coral Gables, Sunny Isles, Golden Beach, Hallandale, to name a few. We are estimating the grand opening by November 2020.

MSGI is progressing extremely well on the integration of Telemedicine and being HIPPA compliant. MedSmart has already contracted for the development of our online presence with some of the top firms in the field, in social marketing, SEO, Google adds, key words, Instagram, and Face book adds.

"In cooperation with our own Compound Pharmacy and our marketing department, we will facilitate direct delivery and prescribing of the necessary medication to our patients. This will intern add to the revenue stream from the Medical Centers" said Calvin Lewis President.

While MedSmart, is continuing to lay the groundwork for expansion in other areas and creating the most exclusive patient Doctor encounter available online today. This will be one of the most impressive sites developed today for Physicians offices, bringing the latest in technology for anti-aging and men's health direct to the patient.

About MedSmart Group, Inc.

MedSmart Group Inc. is a professional network of Medical Centers specializing in "Anti-Aging Treatments" that improve the overall health and quality-of-life of male patients in a comfortable, casual and discreet setting. All of our procedures are administered by licensed physicians and other medical professionals that specialize in the latest treatment options available for the unique needs of men, through our centers along with the availability of face to face visits through Telemedicine, and overnight delivery of Meds.

Our unique Non-invasive treatment plans include: Testosterone Replacement, Erectile Dysfunction (ED), Hypothyroidism, Allergies, High Cholesterol, Hypertension, Diabetes, Physicals Lab on Site - Immediate Results, Hair Loss, Vein Treatment, Cryogen Therapy, Weight loss and Laser Hair Removal. Presently the marketplace for anti-aging products and services is valued at $250 billion, and with an annual growth rate of 9.5%, it is projected to reach $331 billion by 2025. To capture a share of the "Anti-Aging Market", Med Smart Group, Inc. intends to open and operate a nationwide chain of Men's Health and Wellness Centers, along with Telemedicine

Safe Harbor Statement:

The information posted in this release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by use of the words "may," "will," "should," "plans," "explores," "expects," "anticipates," "continue," "estimate," "project," "intend," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, and various other factors beyond the Company's control.

MedSmart Group, Inc. 844 544 4014 info@medsmartgroup.com http://www.medsmartcenters.com http://www.medsmartgroup.com

SOURCE: Kenergy Scientific Inc.

View source version on accesswire.com: https://www.accesswire.com/605909/Kenergy-Scientific-Inc-Announces-New-Added-Location-and-Telemedicine-to-Their-Florida-Based-Mens-Healthcare-and-Anti-Aging-Company

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Kenergy Scientific, Inc. Announces New Added Location and Telemedicine to Their Florida-Based Men's Healthcare and Anti-Aging Company - Stockhouse

Recommendation and review posted by Alexandra Lee Anderson

Testosterone Replacement Therapy Industry Market Current and Future Industry Trends, 2020 ? 2026 – AlgosOnline

The 'Testosterone Replacement Therapy Industry market' research report is latest addition by Market Study Report, LLC, that elucidates relevant market and competitive insights as well as regional and consumer information. In a nutshell, the research study covers every pivotal aspect of this business sphere that influences the existing trends, profitability position, market share, market size, regional valuation, and business expansion plans of key players in the Testosterone Replacement Therapy Industry market.

The Testosterone Replacement Therapy Industry market report provides a broad perspective of this business landscape and elaborates on the various factors that are impacting the revenue generation and growth. The study also enlists exhaustive analysis of the regional landscape as well as regulatory outlook. A detailed SWOT analysis alongside market drivers are analyzed and offered in the document.

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Other details such as challenges & restraints faced by market players as well as new entrants in tandem with their individual impact on the remuneration of companies is highlighted. The study also analyzes the effect of COVID-19 disease outbreak on future remuneration and overall growth of the market.

Underlining the competitive scenario of the Testosterone Replacement Therapy Industry market:

Additional information comprised in the Testosterone Replacement Therapy Industry market report:

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Highlighting the geographical landscape of Testosterone Replacement Therapy Industry market:

TOC of Testosterone Replacement Therapy Industry Market Report Includes:

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Penny Stocks To Watch If You Like Biotech; 1 Up 287% Year To Date – Penny Stocks

Putting Together Your List Of Penny Stocks To Watch?

Do you like biotech penny stocks? Youre likely among a unique group of investors that can handle risk if you said yes. When it comes to these cheap stocks, not only does volatility play a role, so does speculation. Most small-cap biotech stocks tend to experience extremes.

This goes for extreme jumps and extreme drops. It usually involves 1 of a few things. First, when biotech stocks are on the move higher, theres usually a news catalyst to look for. It might stem from something the company just announced. For more info on different ways to trade penny stocks, download our 60+ page eBook for free.

On the flip side biotech companies pre-announce important dates. So it could have something to do with an upcoming announcement. Usually, these entail things like phase trial results, data readouts, or new patient enrollment. You may also see things like PDUFA dates, IND submission or approvals, and NDA submission or approvals. These all have to do with different FDA events. Dont worry if you dont understand what these acronyms mean, Ill explain, briefly.

The FDAs IND or Investigational New Drug program allows pharmaceutical companies permission to begin human clinical trials and ship experimental drugs across state lines before a marketing application for the drug has been approved. Essentially it is a starting point for clinical investigations in the US. The main idea of an initial IND submission is to ensure the safety and rights of clinical trial participants.

In business, you generally see and NDA as a non-disclosure agreement. However, when it comes to biotech, NDA means something completely different. This refers to a New Drug Application. The NDA application sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an IND become part of the NDA.

PDUFA or Prescription Drug User Free Act was passed in the 90s and authorizes the FDA to receive fees from drug manufacturers. These fees are used to fund the drug approval process. The PDUFA date is a deadline for the FDA to review a new drug application. The typical review period can be anywhere from 6-10 months depending on priority.

Read More

Ok, so now youve got a basic understanding of some of the basic FDA forms. As I said above favorable outcomes to data readouts or any of these forms can trigger momentum in the market. On the flip side, if a company isnt granted permissions or misses trial endpoints, then the other side of the coin is a move to the downside. One thing to consider during times of negative readouts is managements commentary.

It can be a big blow to any stock, including penny stocks, but how management reacts is important. Are they fully giving up on the treatment or did they find some positives that suggest that theres still something to build upon? While the road may be long, many biotech penny stocks end up recovering in the end as they rework their trials. With this in mind, here are a few biotech penny stocks to watch right now.

VYNE Therapeutics (VYNE Stock Report) might appear as a new biotech company. However, it is one that weve discussed in the past under the name Menlo Therapeutics. While Menlo had its ups and downs throughout the year, it did experience several bouts of bullishness. This month, the name and symbol changes went into effect and now weve got VYNE stock.

The companys focus remains on dermatology treatments. In light of this, CEO David Domzalski explained, Having achieved FDA approval for our two commercial products AMZEEQ and ZILXI in a period of less than eight months is a testament to the value of our proprietary technology and is aligned to the symbolic meaning behind our new name strength, growth, endurance, and resilience.

Domzalski also filed a Form 4 recently showing the purchase of 75,000 of the companys stock. The average price per share was $1.38. CFO Andrew Saik also picked up a chunk as well. He purchased 40,000 at an average of $1.462. This week, VYNE appointed a new Director to its board, Patrick LePore. Considering the recent activity, will VYNE stock be on your watch list in September?

Unity Biotechnology Inc.(UBX Stock Report) is another one of the trending biotech penny stocks to watch. If youre unfamiliar with the company theres a reason for that. For most of this year, UBX stock rarely came close to penny stock territory. That all came to an end after shares plummeted from around $12.50 to recent lows of $2.72 in August. Remember what I was saying about the outcome of meeting or missing endpoints? In this case, Unity Biotech announced that its UBX0101, osteoarthritis treatment missed its primary endpoint.

After several weeks of sideways trading, volume began picking up this week. Price has also followed. Aside from participating in a few industry conferences this month, Unity also announced new developments. The company announced the initiation of a restructuring. Unity said it is to align programs in ophthalmology and neurology.

[Read More] Should Your List Of Penny Stocks Include These 3 Names?

The company said it will advance its UBX1325 to Phase 1 clinical development in patients with diabetic macular edema. Furthermore, it expects to dose the first patient in the second half of 2020. This corporate restructuring is also said to extend the companys cash runway through mid-2022.

Lipocine Inc. (LPCN Stock Report) is another one of the biotech penny stocks weve watched for months. In fact, year-to-date, LPCN stock is up more than 280%. A lot of the lead-in to the recent price movement came in light of its TLANDO treatment. This is the companys oral testosterone replacement therapy. Lipocine originally had its Prescription Drug User Fee Act goal date ofAugust 28, 2020. However, that was pushed back by the FDA. In light of this extension, the market lost a bit of its thunder and shares have slid nearly $1 a share in the course of about a month.

Although the FDA did not provide a timeline on a new action date, the FDA informed the Company that the review is expected to be completed in the coming weeks. The FDA has not asked for any additional data and the Company has provided the FDA with all information requested to date.

It has now been more than a few weeks since then. The company also just presented at the H.C. Wainwright Investment Conference on Monday. While trading volumes and price have picked up, is this just general speculation on that coming weeks statement? Obviously, well follow this closely, but its also important to note that this could also remain a high-risk situation depending on the PDUFA outcome whenever that may be.

Midam Ventures, LLC | (305) 306-3854 | 1501 Venera Ave, Coral Gables, FL 33146 | news@pennystocks.com

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Testosterone Replacement Therapy Market Size and Share Forecast Analysis, Top Key Players, Latest Developments, Growth Factors till 2020 to 2026 -…

The Testosterone Replacement Therapy Market (2020-2026) Research Report provides key analysis on the market status of the Testosterone Replacement Therapy manufacturers with best facts and figures, meaning, definition, SWOT analysis, expert opinions and the latest developments across the globe. The Report also calculate the market size, Testosterone Replacement Therapy Sales, Price, Revenue, Gross Margin and Market Share, cost structure and growth rate. The report considers the revenue generated from the sales of This Report and technologies by various application segments.

Request a Sample Copy of the Report https://www.marketreportsworld.com/enquiry/request-sample/15985248

Testosterone Replacement Therapy Market 2020 Industry Research Report is a professional and in-depth study on the current state of the Global Testosterone Replacement Therapy industry. Moreover, research report categorizes the global Testosterone Replacement Therapy market by top players/brands, region, type and end user. Testosterone Replacement Therapy Market report also tracks the latest market dynamics, such as driving factors, restraining factors, and industry news like mergers, acquisitions, and investments. It provides market size (value and volume), Testosterone Replacement Therapy market share, growth rate by types, applications, and combines both qualitative and quantitative methods to make micro and macro forecasts in different regions or countries.

This study also contains company profiling, product picture and specifications, sales, market share and contact information of various international, regional, and local vendors of Global Testosterone Replacement Therapy Market. The market competition is constantly growing higher with the rise in technological innovation and M&A activities in the industry.

Major Key Players of Testosterone Replacement Therapy Market:

Moreover, many local and regional vendors are offering specific application products for varied end-users. The new vendor entrants in the market are finding it hard to compete with international vendors based on quality, reliability, and innovations in technology.

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Global Testosterone Replacement Therapy market 2020 research provides a basic overview of the industry including definitions, classifications, applications, and industry chain structure. The Global Testosterone Replacement Therapy market analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status. Development policies and plans are discussed as well as manufacturing processes and cost structures are analyzed. This report also states import/export consumption, supply and demand Figures, cost, price, revenue, and gross margins.

Testosterone Replacement Therapy Market Forecast (2020-2026):

Market Size Forecast:Global Testosterone Replacement Therapy market segmented by overall size, by type/product category, by applications/end users, by regions/geography.

Key Data (Revenue):Market size, market share, growth rate, growth, product sales price, and opportunity.

Trend and forecast analysis:Market trend, forecast and analysis to 2026 by segments and geographical regions.

Segmentation analysis:Global fat burn supplements market size by various applications such as product, material, shape, and end use in terms of value and volume shipment.

Regional analysis:Global Testosterone Replacement Therapy Market Breakdown by North America, Europe, Asia Pacific, And The Rest of the World.

Growth opportunities:Analysis of growth opportunities in different applications and regions in the global Fat Burn Supplements Industry

Strategic analysis:This includes new product development and competitive landscape in the global Fat Burn Supplements

Testosterone Replacement Therapy Market Include the Following Manufacturers Based on Testosterone Replacement Therapy Sales, Revenue, Price and Gross Margin. The analysis of the Testosterone Replacement Therapy Market is a thorough study that offers a select combination of skillful market realities. The study shows changing trends of the market as well as the size of each separate segment in this market. Various product types and application are shown below.

Application of Testosterone Replacement Therapy Market:

Types of Testosterone Replacement Therapy Market:

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In this study, the years considered to estimate the market size of Video Surveillance Storage are as follows:

History Year: 2015-2019

Base Year: 2019

Estimated Year: 2020

Forecast Year: 2020 2026

Key questions answered in the report:

-What will the market growth rate of Testosterone Replacement Therapy market in 2026?

-What are the key factors motivating the global Testosterone Replacement Therapy market?

-Who are the important key players in Testosterone Replacement Therapy market space?

-What are the market opportunities, market risk and market overview of the Testosterone Replacement Therapy market?

-What are sales, revenue, and price analysis by types and applications of Testosterone Replacement Therapy market?

-What are sales, revenue, and price analysis by regions of Testosterone Replacement Therapy industries?

Table of Contents:

1 Report Overview

1.1 Study Scope

1.2 Key Market Segments

1.3 Players Covered

1.4 Market Analysis by Type

1.4.1 Global Testosterone Replacement Therapy Market Size Growth Rate by Type (2020-2026)

1.4.2 Major-Type

1.4.3 Independent-Type

1.4.4 Administrator-Type

1.5 Market by Application

1.5.1 Global Testosterone Replacement Therapy Market Share by Application (2020-2026)

1.5.2 Commercial

1.5.3 Commonweal

1.5.4 Other

1.6 Study Objectives

1.7 Years Considered

2 Global Growth Trends

2.1 Testosterone Replacement Therapy Market Size

2.2 Testosterone Replacement Therapy Growth Trends by Regions

2.2.1 Testosterone Replacement Therapy Market Size by Regions (2020-2026)

2.2.2 Testosterone Replacement Therapy Market Share by Regions (2015-2020)

2.3 Industry Trends

2.3.1 Market Top Trends

2.3.2 Market Drivers

2.3.3 Market Opportunities

3 Market Share by Key Players

3.1 Testosterone Replacement Therapy Market Size by Manufacturers

3.1.1 Global Testosterone Replacement Therapy Revenue by Manufacturers (2014-2020)..

3.4 Date of entering into Testosterone Replacement Therapy Market

3.5 Mergers & Acquisitions, Expansion Plans

4 Breakdown Data by Type and Application

4.1 Global Testosterone Replacement Therapy Market Size by Type (2015-2020)

4.2 Global Testosterone Replacement Therapy Market Size by Application (2015-2020)

Continue..

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Testosterone Replacement Therapy Market Size and Share Forecast Analysis, Top Key Players, Latest Developments, Growth Factors till 2020 to 2026 -...

Recommendation and review posted by Alexandra Lee Anderson

Testosterone Replacement Therapy Sales Market Still Has Room to Grow With Emerging Players 2027 – The Daily Chronicle

(Augest 2020) SMI published a business research report on Testosterone Replacement Therapy Sales Market: Global Industry Analysis, Size, Share, Growth,Trends, and Forecasts 20202027. Research reportwith 110+ pages on market data Tables, Pie Chat, Graphs & Figures spread through Pages and easy to understand detailed analysis. The information is gathered based on modern floats and requests identified with the administrations and items.

Key players are expected to enhance their marketing capabilities over the forecast period owing to certain market conditions. The report presents certain elements that will reflect whats and hows of such changes in the market. Further, the report studies various aspects of the global market such as upstream raw materials, downstream demand, and production value of leading players subject to market growth.

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Geographical segmentation of the Testosterone Replacement Therapy Sales Market involves the regional outlook which further covers the United States, China, Europe, Japan, Southeast Asia and Middle East & Africa. This report categorizes the market based on manufacturers, regions, type and applications.

Testosterone Replacement Therapy Sales Market: Competitive Landscape

Leading players operating in the global Testosterone Replacement Therapy Sales market include AbbVie, Endo International, Eli lilly, Pfizer, Actavis (Allergan), Bayer, Novartis, Teva, Mylan, Upsher-Smith, Ferring Pharmaceuticals, Kyowa Kirin, Acerus Pharmaceuticals.

Scope of the Report:

The key features of the Testosterone Replacement Therapy Sales Market report 2020-2027 are the organization, extensive amount of analysis and data from previous and current years as well as forecast data for the next five years. Most of the report is made up of tables, charts, and figures that give our clients a clear picture of the Testosterone Replacement Therapy Sales Market. The structure of the Testosterone Replacement Therapy Sales Market by identifying its various segments and sub-segments to help to understand the report.

Testosterone Replacement Therapy Sales Market is growing at a High CAGR during the forecast period 2020-2026. The increasing interest of the individuals in this industry is the major reason for the expansion of this market.

As the report proceeds further, it covers the analysis of key market participants paired with development plans and policies, production techniques, price structure of the market. The report also identifies the other essential elements such as product overview, supply chain relationship, raw material supply and demand statistics, expected developments, profit and consumption ratio.

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Important Data Available In This Report:

An Overview of the Impact of COVID-19 on this Market:

The pandemic of COVID-19 continues to expand and impact over 175 countries and territories. Although the outbreak appears to have slowed in China, COVID-19 has impacted globally. The pandemic could affect three main aspects of the global economy: production, supply chain, and firms, and financial markets. National governments have announced largely uncoordinated, country-specific responses to the virus.

Customer Experience Analysis:

The study offers an in-depth assessment of various customers journeys pertinent to the market and its segments. It offers various customer impressions about products and service use. The analysis takes a closer look at their pain points and fears across various customer touchpoints. The consultation and business intelligence solutions will help interested stakeholders, including CXOs, define customer experience maps tailored to their needs. This will help them aim at boosting customer engagement with their brands.

How will the report assist your business to grow?

Do You Have Any Query Or Specific Requirement? Ask Our Industry Expert @ https://www.stratagemmarketinsights.com/quiry/8711

Thanks a million for reading! You can also request custom information like chapter-wise or specific region-wise study as per your interest.

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Testosterone Replacement Therapy Sales Market Still Has Room to Grow With Emerging Players 2027 - The Daily Chronicle

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Global Testosterone Replacement Therapy Market 2020 Growth Analysis, Opportunities, Revenue and sales, Trends and Developments, Forecast by 2025 – Red…

MarketsandResearch.biz has newly added a new research report titled Global Testosterone Replacement Therapy Market 2020 by Manufacturers, Type and Application, Forecast to 2025 which is known to provide comprehensive and detailed information about the market for the projected period from 2020 to 2025. The report inspects the crucial data related to the market. The report focuses on different components of the market including market trends, regional outlook, competitive landscape, key players, business approaches. The report determines the global Testosterone Replacement Therapy market growth and market share for the estimated forecast period. The research report has made through several data exploratory techniques which include primary and secondary research.

The reports objective is to show the development in key regions. The global Testosterone Replacement Therapy market is a database mechanism developed for analysis and access to a large volume of unstructured data. The study analyzes market drivers, challenges, standardization, regulatory landscape, deployment models, operator case studies, opportunities, future roadmap, value chain, player profiles. The research report investigates the whole growth dynamics of the industry as well as market evaluation, manufacturing approach across distinct topologies and competitive landscape analysis.

NOTE: Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

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Market Segmentation:

The global Testosterone Replacement Therapy market is analyzed for different segments to arrive at an insightful analysis. Such segmentation has been done based on type, application, and region.

The study encompasses profiles of major companies operating in the global market. Key players profiled in the report include: AbbVie, Teva, Pfizer, Endo International, Novartis, Eli lilly, Upsher-Smith, Bayer, Actavis (Allergan), Mylan, Ferring Pharmaceuticals, Kyowa Kirin, Acerus Pharmaceuticals

The report provides in-depth comprehensive analysis for regional segments that covers North America (United States, Canada and Mexico), Europe (Germany, France, United Kingdom, Russia and Italy), Asia-Pacific (China, Japan, Korea, India, Southeast Asia and Australia), South America (Brazil, Argentina), Middle East & Africa (Saudi Arabia, UAE, Egypt and South Africa) in the global Testosterone Replacement Therapy report with market definitions, classifications, manufacturing processes, cost structures, development policies, and plans.

Market segment by type, the product can be split into: Gels, Injections, Patches, Other

Market segment by regions/countries, this report covers: Hospitals, Clinics, Others

Moreover in the report, other data models include vendor positioning grid, market timeline analysis, global Testosterone Replacement Therapy market overview, and guide, company positioning grid, company market share analysis, standards of measurement, top to bottom analysis and vendor share analysis. Market players can effortlessly implement strategies with all the data provided to gain a dominant position and beat the competition in the market.

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Questions Answered By The Global Testosterone Replacement Therapy Market Report With Regards To The Geographical Spectrum of The Market:

Customization of the Report:

This report can be customized to meet the clients requirements. Please connect with our sales team (sales@marketsandresearch.biz), who will ensure that you get a report that suits your needs. You can also get in touch with our executives on +1-201-465-4211 to share your research requirements.

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Global Testosterone Replacement Therapy Market 2020 Growth Analysis, Opportunities, Revenue and sales, Trends and Developments, Forecast by 2025 - Red...

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LPCN: Tlando: Target Action Date This Friday – Zacks Small Cap Research

By John Vandermosten

NASDAQ:LPCN

READ THE FULL LPCN RESEARCH REPORT

Up and Coming Milestones

Tlando PDUFA date August 28, 2020

Primary endpoint results for LiFT (LPCN 1144) 4Q:20

Patent Infringement trial February 2021

Complete Phase II LiFT (LPCN 1144) 2Q:21

Second Quarter 2020 Operational and Financial Results

On August 6, 2020 Lipocine (NASDAQ:LPCN) filed its second quarter 2020 10-Q and posted its earnings release for the three month period ending June 30, 2020. The company reported zero revenues and a net loss per share of ($0.13) compared to prior year revenues of zero and loss of ($0.14) per share. Activity during the second quarter revolved around several items including presentation at the American Urological Association (AUA) conference, demonstration of treatment potential for LPCN 1144, investigational new drug clearance for LPCN 1148, affirmation of the USPTO decision and the dismissal of a shareholder lawsuit. The companys shares also exceeded $1.00 in June, and have remained above this level, allowing Lipocine to regain compliance with NASDAQ minimum bid requirements. The most important item on the calendar is the FDAs response to Tlandos NDA submission, which is expected on or before August 28th.

We anticipate that upon approval, Lipocine will find a partner to commercialize Tlando and use associated upfront and milestone payments to further develop the existing portfolio, especially LPCN 1144 and LPCN 1148. Potential licensees are waiting until approval is granted before performing their due diligence. This suggests that a deal would be announced in the fourth quarter of 2020 rather than in the weeks following an assumed approval.

Operational expenses for 2Q:20 were $4.2 million, up 26% and net loss totaled ($6.4) million or ($0.13) per share. Research and development expenses totaled $2.5 million. The 16% rise over prior year amounts reflects increased costs related to the LiFT study and higher personnel expenditures offset by a decrease in amounts related to the ABPM study, lower spend on the Tlando XR program and a fall in manufacturing costs for LPCN 1107. General and administrative costs rose 41% over last years second quarter to $2.0 million on an expansion in legal expenditures related to the Clarus dispute and an increase in personnel costs offset by lower marketing expenses, administrative travel and other expenses. A rise in the share price increased the warrant liability and required the recognition of a $2.1 million non-cash loss in other income.

Cash and marketable securities balance was $18.2 million as of June 30, 2020. There is another $5 million of restricted1 cash which will remain on hold until Tlando is approved. Current and non-current debt is carried on the balance sheet at $6.3 million. Cash burn for 2Q:20 was approximately ($4.1) million and net cash provided by financing was $11.7 million representing a stock offering and warrant proceeds partially offset by a small amount of debt repayment.

Tlando

On November 11 of last year, Lipocine announced that it had received a complete response letter (CRL) for Tlando. The CRL identified one deficiency stating that the trial did not meet one of the three secondary endpoints for maximal testosterone concentrations (Cmax). No deficiencies related to chemistry, manufacturing and controls were noted. FDA guidelines call for 85% of subjects to achieve a Cmax below 1500 ng/dL and no more than 5% of subjects presenting a Cmax between 1800 ng/dL and 2500 ng/dL and 0% above 2500 ng/dL. In the most recent dosing validation (DV) study, 85% of subjects were below 1500 ng/dL and 7% were between 1800 ng/dL and 2500 ng/dL. Although there were small variations from the FDA guidelines in the original SOAR study for subjects above 2500 ng/dL, the FDA did not identify these as a deficiency during the original New Drug Application (NDA) submission.

Following the Post Action meeting with the FDA, Lipocine was advised to address the outstanding deficiencies with a reanalysis of existing data. This recommendation relieved Lipocine of the time and cost of an additional trial and also allowed the resubmission of the Tlando NDA in February. A target action date of August 28th was provided. While the resubmission is a positive, Tlando has faced significant hurdles gaining the favor of the FDA. We published a note on February 25th that discussed details regarding the resubmission.

LPCN 1144

Lipocine announced in August 2018 the pursuit of a new indication in nonalcoholic steatohepatitis (NASH). We discuss the indication and Lipocines efforts in an earlier piece that can be accessed here. Full enrollment of 36 subjects was achieved in November 2018.

In January 2019, Lipocine announced meaningful liver fat reduction in patients participating in its Liver Fat Study and informed investors that the company had filed an investigational new drug (IND) application to begin a Phase II study for NASH. Since LPCN 1144 is the same molecule as TLANDO, for which there were numerous safety studies completed, LPCN was allowed to perform a proof of concept (POC) clinical study under the original IND to assess liver fat changes. This 36-person study was conducted in hypogonadal men at risk of developing non-alcoholic steatohepatitis (NASH) and results were measured using the magnetic resonance imaging proton density fat fraction (MRI-PDFF) technique. Topline results were announced in 1Q:19 demonstrating a 4.0% to 8.2% percentage point reduction in liver fat depending on baseline liver fat category. We discussed the results in further detail in our NASH Topline article.

Lipocine launched its Phase II clinical study for LPCN 1144 and dosed its first patient last September. Prior to the start of the trial, Lipocine announced that the FDA would allow the Phase II LiFT trial to enroll eugonadal patients in addition to the NASH patients that were initially targeted. This expansion was based on research that we discussed in a July 29th note. The study is anticipated to last for 18 months and cost approximately $8 million.

LiFT, an acronym of Liver Fat intervention with oral Testosterone, is a paired biopsy Phase II study in NASH subjects. The study design will employ a three-arm, double-blind, placebo-controlled structure and enroll approximately 75 biopsy confirmed male NASH subjects with a NAS2 score of greater or equal to four. The primary endpoint for the study is 12-week MRI-PDFF liver fat reduction and the first patient was enrolled in 3Q:19. As for the anticipated timeline, Lipocine expects top line liver fat reduction data in 4Q:20 as measured by MRI-PDFF at 12 weeks. Biopsy data at 36 weeks is expected to be available in the second quarter of 2021.

Exhibit I LiFT Study Timeline3

NASH Environment

A lot has happened in the NASH space in 2020. Genfit (GNFT) announced that it will halt development of elafibranor after it failed to distinguish itself compared to placebo earlier this year. CymaBay (CBAY) announced that the FDA had lifted the hold on seladelpars Phase II study last month. No evidence was found for liver injury for the drug and the trial is expected to resume. Intercepts (ICPT) OCA received a complete response letter from the FDA in late June noting that the agency remains uncertain that the benefits of the drug outweigh the risks. Viking (VKTX) is conducting the Phase IIb VOYAGE trial for VK2809 which is still ongoing. A bright spot in the space has been results from Akeros (AKRO) Phase IIb trial for efruxifermin in NASH which were announced June 30. The study found that 48% of patients had fibrosis improvement of at least one stage with a 62% response rate. Fibrosis improved by at least two stages for 28% of the group with a 38% response rate and 48% experienced NASH resolution without worsening of fibrosis across all dose groups.

LPCN 1148

Lipocine is preparing to develop its testosterone molecule to treat NASH cirrhosis patients. While the target market is smaller than that of pre-cirrhotic NASH, there are no other FDA approved products available. The inverse relationship between testosterone and sarcopenia and the increased risks of advancing NASH cirrhosis validates this pursuit. Pending funding, Lipocine plans to initiate a proof of concept trial to evaluate the potential of this candidate. The companys Investigational New Drug (IND) application was cleared by the FDA in May 2020. We anticipate Lipocine will launch the Phase II trial after the start of commercialization of Tlando and upon availability of sufficient capital to fund it. Management has guided to a 4Q:20 or 1Q:21 start.

Exhibit II Lipocine Pipeline4

Markman Hearing

On March 26th, Lipocine announced the outcome of the Markman Hearing, also known as a claim construction hearing. This meeting is an important precursor to a patent infringement lawsuit and provides the definitions of terms critical for a jurys determination on whether or not a patent has value. A patent should not be too specific, as it provides insufficient protection to an invention, or too broad, in which case a court may rule it indefinite. In the hearing order5, Judge Bryson did not agree with most of Clarus claims and sided with Lipocine on the majority of definitions and clarifications. While the terms and definitions are subject to an evolving construction, the order is favorable to Lipocines dispute against Clarus. While this order could be appealed again, it is unlikely in the opinion of Lipocines counsel. Lipocine and Clarus are currently engaged in the fact discovery phase of the lawsuit and the jury trial is anticipated to take place in February 2021. Lipocine need only prevail on one claim to merit damages, which places them in a strong position to succeed in the trial or provide incentive for Clarus to settle.

USPTO Decision Affirmed

The US Court of Appeals affirmed the decision of the USPTO in April 2020 to grant Lipocines Priority Motion in the interference case that cancelled Clarus claims to the 428 patent in January 2019. The USPTO, through its Patent Trial and Appeal Board (PTAB), had granted Lipocines priority motion in the related interference case and entered adverse judgment against Clarus. As we have previously shared, this outcome was expected as it is rare for a federal court to overturn a USPTO ruling. As a reminder, in 2Q:19 Lipocinefiled suitagainst Clarus alleging that Jatenzo infringed on six of Lipocines patents. The injunction filing may slow down commercialization of Jatenzo and force Clarus to come to the table to negotiate a settlement. While the cost of pursuing such legal action could be high, we anticipate by the time the case works its way through the courts, cash flow from Tlando could be sufficient to support the legal efforts.

Publications and Abstracts

Results from Lipocines Liver Fat Study were published in Hepatology Communications in an article entitled LPCN 1144 Resolves Non-Alcoholic Fatty Liver Disease In Hypogonadal Males." The study served to identify the prevalence of non-alcoholic fatty liver disease (NAFLD) in hypogonadal males and quantify the beneficial impact of LPCN 1144 on hypogonadism. 36 hypogonadal males were evaluated using MRI-PDFF measurements for liver fat. 81% of those with baseline liver fat equal to or greater than 5% showed improvement in liver fat content and NAFLD resolved in one-third of the group at six weeks and 48% after 16 weeks. The paper concluded that treatment with LPCN 1144 resolved NAFLD in about half of affected patients without any safety signals.

Lipocine submitted several abstracts to the American Urological Association (AUA) Virtual Experience, which took place from May 15 to 17, 2020. Three titles were presented.

Impact of a new oral testosterone undecanoate on blood pressure and cardiovascular risk was presented by Dr. Mohit Khera which investigated the chronic use of testosterone replacement therapy (TRT) on cardiovascular risk. Jatenzo, Xyosted and Tlando were assessed in their impact on blood pressure and cardiovascular risk in hypogonadal men. Marginal increases in blood pressure were observed and no meaningful impact on cardiovascular risk was noted.

A novel oral testosterone therapy restores testosterone to eugonadal levels without dose titration was presented by Dr. Martin Miner and highlights the shortcomings of dose titration when prescribing TRT. The abstract concluded that fixed dose Tlando normalizes testosterone levels in hypogonadal patients while avoiding the potential problems associated with titrated TRT.

Effects of a new oral testosterone undecanoate (TLANDO) therapy on liver was presented by Dr. Irwin Goldstein and compares oral methyltestosterone (MT) with TRT in males deficient in endogenous testosterone. The study results suggested that unlike MT, Tlando has no adverse effects on liver and can be used for an extended period to potentially reduce liver fat.

Milestones

Tlando CRL November 9, 2019

Tlando FDA post action meeting January 2020

Resubmission of Tlando NDA February 2020

Investigational New Drug (IND) clearance for LPCN 1148 May 2020

Wajda v. Patel shareholder suit dismissed July 2020

Tlando PDUFA date August 28, 2020

Primary endpoint results for LiFT (LPCN 1144) 4Q:20

Patent Infringement trial February 2021

Complete Phase II LiFT (LPCN 1144) 2Q:21

Summary

Since our previous update, Lipocine has participated in scientific conferences, published an article in the journal Hepatology Communications and advanced several months towards the upcoming August 28 PDUFA date for Tlando. Assuming a favorable outcome for the application, Lipocine will seek a commercialization partner and should receive upfront and milestone proceeds in conjunction with a deal. The Phase II LiFT trial continues to be a bright spot for the company and is potentially able to address a large unmet need in NASH patients in contrast to other programs which have met with difficulty. Management has guided towards a year-end readout of LiFT trial results. Lipocine is also developing LPCN 1148 for cirrhosis patients which was recently given clearance to begin a Phase II study. While we do not see this program entering the clinic until sufficient capital is available, we do think it will advance if Phase II data for LPCN 1144 are positive.

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________________________

1. Tlando was not approved by the FDA by May 31, 2018, and therefore Lipocine is required to maintain $5.0 million of cash collateral at Silicon Valley Bank (the lender) until such time as it is approved by the FDA.

2. NAS: NAFLD (Non-alcoholic fatty liver disease) Activity Score. Discussion of the metric can be found here.

3. Source: Lipocine Corporate Presentation May 2020.

4. Source: Lipocine Corporate Presentation July 2020.

5. A link to the Markman Hearing Order can be found on this page: https://ir.lipocine.com/presentations

Link:
LPCN: Tlando: Target Action Date This Friday - Zacks Small Cap Research

Recommendation and review posted by Alexandra Lee Anderson

Testosterone Replacement Therapy Market Size, Analysis, and Forecast Report 2019-2025 – StartupNG

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Testosterone Replacement Therapy Market Size, Analysis, and Forecast Report 2019-2025 - StartupNG

Recommendation and review posted by Alexandra Lee Anderson

Testosterone Replacement Therapy Market Industry: By Type, Application, Regional outlook, Manufactures & Forecast to 2029 – The News Brok

Testosterone Replacement Therapy Market contain SWOT analysis of ramp up growth of industry in supply chain, demand, sales with overall portfolio management along with geographical condition. It also have an investigation on manufactures with vary in trends of market along with future scope by 2020-2029

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This report provides detailed historical analysis of global market for Testosterone Replacement Therapy from 2014-2019, and provides extensive market forecasts from 2020-2029 by region/country and subsectors. It covers the sales volume, price, revenue, gross margin, historical growth and future perspectives in the Testosterone Replacement Therapy market.

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Market segment by Type, the product can be split into

Gels

Injections

Patches

Other

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Hospitals

Clinics

Others

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Direct Channel

Distribution Channel

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North America (United States, Canada and Mexico)

Europe (Germany, UK, France, Italy, Russia and Spain etc.)

Asia-Pacific (China, Japan, Korea, India, Australia and Southeast Asia etc.)

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Chapter 1 Testosterone Replacement Therapy Market Overview

Chapter 2 Testosterone Replacement Therapy Market Segment Analysis by Player

Chapter 3 Testosterone Replacement Therapy Market Segment Analysis by Type

Chapter 4 Testosterone Replacement Therapy Market Segment Analysis by Application

Chapter 5 Testosterone Replacement Therapy Market Segment Analysis by Sales Channel

Chapter 6 Testosterone Replacement Therapy Market Segment Analysis by Region

Chapter 7 Profile of Leading Testosterone Replacement Therapy Players

Chapter 8 Upstream and Downstream Analysis of Testosterone Replacement Therapy

Chapter 9 Development Trend of Testosterone Replacement Therapy (2020-2029)

Chapter 10 Appendix

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Testosterone Replacement Therapy Market Industry: By Type, Application, Regional outlook, Manufactures & Forecast to 2029 - The News Brok

Recommendation and review posted by Alexandra Lee Anderson

UB study finds testosterone therapy can lead to remission in men with Type 2 diabetes – UB Now: News and views for UB faculty and staff – University…

The findings from a recent study by a UB researcher and others could prove to be a game-changer for men with Type 2 diabetes.

The single-site study, conducted over 11 years in Bremerhaven, Germany, found that testosterone therapy reversed Type 2 diabetes in one-third of the study participants.

The occurrence of this syndrome is common, and with appropriate testosterone replacement, obesity insulin resistance and diabetes may be reversible, says Paresh Dandona, SUNY Distinguished Professor in the Department of Medicine in the Jacobs School of Medicine and Biomedical Sciences at UB. He co-authored the study, titled Remission of type 2 diabetes following long-term treatment with injectable testosterone undecanoate in patients with hypogonadism and type 2 diabetes: 11-year data from a real-world registry study.

The prospective, registry-based study was published in June in the online journal Diabetes, Obesity and Metabolism. Dandona also presented the data at the Annual Mohan Diabetes Foundation Symposium in Chennai, India, on July 25, where he was given the organizations Lifetime Achievement Award.

Type 2 diabetes, also known as Type 2 diabetes mellitus, results from a combination of insulin resistance and insufficient production of insulin, causing high blood sugar. The condition is common, with more than 3 million new cases per year in the United States. Reduced testosterone concentrations are found in 33% of men with Type 2 diabetes.

The discovery of this syndrome of hypogonadism in Type 2 diabetes was made by Dandonas group at UB in 2004. This group then extended the prevalence of this syndrome to include 25% of non-diabetic obese men in 2010. Thus, diabetes and obesity became the main cause of male hypogonadism. The group went on to demonstrate that such patients have additional insulin resistance that reverses with testosterone treatment in 2016.

Testosterone deficiency, which is also called male hypogonadism, contributes to reduced response of insulin to glucose, increased insulin resistance and eventually the onset of Type 2 diabetes.

The objective of the researchers study was to determine if men with Type 2 diabetes who also exhibit hypogonadism, when treated with testosterone in addition to their regular diabetes treatment, would demonstrate improved glycemic control and insulin sensitivity, and possibly eventually experience remission of Type 2 diabetes.

The investigators observed 356 men in a single urology practice clinic over 11 years. All patients received standard diabetes treatment, which included mandatory educational courses and materials. In addition, 178 men with a mean age of 62 years received 1,000 milligrams of subcutaneously injected, slow-release testosterone every 12 weeks after an initial six-week interval. The 178 subjects, mean age 64 years, who opted out of the testosterone therapy served as the control group.

The researchers took numerous measurements, including height, weight, waist circumference, blood pressure, hemoglobin, fasting glucose, HbA1c (the average amount of glucose in blood over a six- or 12-week period), insulin, heart rate, lipids, highly sensitive C-reactive protein and total testosterone, among others. They also assessed quality of life using the Aging Males Symptoms scale. Erectile function was also assessed, using the International Index of Erectile Function. Assessment of these clinical metrics was performed at least twice a year, and data over 11 years were analyzed.

The results showed that the men treated with testosterone had significant progressive and sustained reductions in their body weight, fasting glucose, HbA1c and fasting insulin over the treatment period, the authors wrote. In the control group, fasting glucose, HbA1c and fasting insulin increased.

One-third (34.3%) of men treated with testosterone saw remission of their diabetes; almost half (46.6%) achieved normal glucose regulation with antidiabetic treatment and a vast majority (83.1%) reached their target level of HbA1c.

Patients in the control group saw no remission of diabetes or reduction in glucose or HbA1c levels.

In addition, there were fewer deaths, myocardial infarctions, strokes and diabetic complications in the group treated with testosterone.

The research indicates that long-term treatment with testosterone is potentially a novel additional therapy for men with Type 2 diabetes and hypogonadism, the authors wrote.

The clinical significance of these results is further enhanced by the fact that one-third of men with Type 2 diabetes have hypogonadism. Hence, physicians encounter men with hypogonadism and diabetes very frequently. It is remarkable that while Type 2 diabetes mellitus leads to hypogonadism, treatment of hypogonadism results in remission of diabetes itself, the authors wrote.

Going forward, prospective randomized controlled trials are needed to confirm the data. One such trial is currently in progress.

Dandona is one of the worlds leading experts in the treatment of diabetes and vascular disease. He is also the ex-chief of endocrinology at UB and founder of the Diabetes and Endocrinology Center of Western New York, which is sponsored by the Jacobs School and Kaleida Heath. He sees patients at UBMD Internal Medicine.

Dandonas co-authors on the study include Karim Sultan Haider and Ahmad Haider, urologists in Bremerhaven, Germany; Farid Saad, a consultant to Medical Affairs Andrology at Bayer AG in Berlin; Gheorghe Doros from the Department of Epidemiology and Biostatistics at the Boston University School of Public Health; Markolf Hanefeld from GWT-TU Dresden GmbH and Medizinische Klinik, Universittsklinikum Carl Gustav Carus, in Dresden; Sandeep Dhindsa from the Division of Endocrinology, Diabetes and Metabolism at Saint Louis University; and Abdulmaged Traish from the Department of Urology at the Boston University School of Medicine.

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UB study finds testosterone therapy can lead to remission in men with Type 2 diabetes - UB Now: News and views for UB faculty and staff - University...

Recommendation and review posted by Alexandra Lee Anderson


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