Category Archives: Testosterone Replacement Therapy

This past spring, a small group of women gathered at the Beaverbrook estate in Surrey, England, a 470-acre country idyll outside London that once received guests including Elizabeth Taylor and Ian Fleming. The sprawling property, which has become a destination for wellness programs featuring everything from lectures on traditional Chinese massage to Wim Hofs cold plunges, had lured attendees for a womens health retreat. The topics included abdominal massage therapy and guided talks on depleted estrogen. This is the first time there have been so many of us, gut-health expert Amanda Porter relayed to the group, adding the staggering statistic that nearly 1 billion women are projected to experience the onset of symptoms including hot flashes and brain fog by 2025. They are the many, the confused, the perimenopausal.

Think of it like puberty, says Jen Gunter, MD, a Canadian American gynecologist and the author of The Menopause Manifesto. There isnt really a hard start date, and you dont know that youre in it until youre really in it. She goes on to describe an often undiagnosed panoply of symptoms associated with perimenopause, which precedes menopause (when youve gone 12 consecutive months without menstruating) and can start as early as our mid-30s: cycle irregularities, increased anxiety and depression, insomnia, night sweats, weight gain, a decimated sex drive. A lack of visibility doesnt help. When I turned 43, feeling wholly unequipped for my own experience with mood swings and spontaneously heavy periodsand with no guidance from my doctorI found myself googling flash periods after an episode of And Just Like That (the one where Charlotte memorably bleeds through a white jumpsuit at a charity paint party). There was just this lack of information and support, agrees the actor Naomi Watts when we spoke about the topic earlier this year. Id had enough. This September, Watts will join an increasingly vocal group of entrepreneurs, celebrities, and medical providers determined to change that dynamic when she launches a new perimenopause- and menopause-focused wellness brand with Bay Area biotech company Amyris.

Its true that hormonestheir unpredictability, and their ripple effect on how we look and feelare increasingly part of the beauty conversation. The first part of perimenopause is typically characterized by estrogen levels that fluctuate, but are still pretty high, and decreasing progesterone levels. And then the second part has to do with very rapidly declining estrogen, explains Anna Barbieri, MD, an ob-gyn at New Yorks Mount Sinai Hospital. Hormone replacement therapy (HRT), in which synthetic versions of these hormones can bolster dwindling supplies, remains a tried-and-true course of treatment. Every single one of us whos entering this transition or going through it should know about the option of hormone therapy and its risks and benefits, says Barbieri, who is also the founding physician of Elektra Health, a digital womens health platform offering virtual one-on-one menopause care with accredited providers and accountability counselors known as menopause doulas. But now there are also products such as Kindras hot flash and night sweatmitigating Cool Down Mist; Wiles Drinking Your Feelings, a stress-reducing adaptogen powder that can be mixed into your daily matcha; and the skin-calming Meditation Gel Cream from Knours, an entire skin-care range tailored to fluctuating cycles. Veracity, a six-piece skin-care line formulated to support tangential issues, including excess oil production and thinning skin, recently inspired a Hormone Balancing Facial at The Well, Manhattans buzzy destination for mindful beauty. A 60-minute treatment left my skin far less inflamed than usual, and my soul soothed.

Despite an uptick in home diagnostic tests from Thriva and Everlywell, there is no clinically proven way to test for perimenopause. Somebody who tells you we can just measure your estrogen and progesterone is bullshitting you, says Alicia Jackson, PhD, the founder of Evernow, a telehealth company that aims to provide patients with 24/7 online perimenopause support as well as virtual hormone therapy plans. Thats because our hormone levels during this transition vary wildly from day to day, so testing them to get a quantifiable diagnosis isnt reliable. Theres no established value for them, agrees Barbieri. What hormone testing can help with, she says, is to rule out other conditions (like thyroid abnormalities, for instance) that can often pose as perimenopause. Somi Javaid, MD, a Cincinnati-based ob-gyn, uses hormone tests at HerMD, the medical practice she runs in Ohio and Kentucky, for a different reason: If women see that their FSH [follicle-stimulating hormone], which is responsible for controlling our menstrual cycles, is going up and their estrogen and testosterone are going down, I may not be able to tell them theyre perimenopausal, but it helps them understand that somethings going on, says Javaid, adding that this kind of validation is extremely important: So many women who complain about perimenopause symptoms are being dismissed.

According to a recent report published in The New York Times, female patientsand particularly women of colorare far more likely than men to experience a kind of medical gaslighting (in which legitimate symptoms are invalidated by doctors); when it comes to perimenopause, that brush-off may be even more widespread. Stacy London experienced this firsthand. The longtime fashion stylists hormonal transition at age 46 had a number of typical markers. I started to feel anxiety all the time, my skin got worse, my joints felt sore, I had insomnia and terrible brain fog, says London. I thought my brain was short-circuiting, because I couldnt remember words. Londons doctor recognized her symptoms but provided little recourse for treatment. She said, Its just menopause, youll get through it, London recalls. The experience compelled her to join State Of, a skin- and body-care line that she became the CEO of in 2021, which aims to give the menopause transition a makeover, one cheerily packaged tube of joint cream at a time.

Excerpt from:
Once a Taboo Topic, Menopause Is (Finally) Having Its Wellness Moment - Vogue

Shares of Clarus Therapeutics Holdings, Inc. (NASDAQ:CRXT Get Rating) have been assigned an average recommendation of Buy from the six ratings firms that are presently covering the company, MarketBeat Ratings reports. Four analysts have rated the stock with a buy recommendation. The average 1-year price objective among analysts that have covered the stock in the last year is $6.88.

A number of brokerages have issued reports on CRXT. Maxim Group decreased their price objective on Clarus Therapeutics to $1.50 in a research report on Thursday. Zacks Investment Research raised Clarus Therapeutics from a hold rating to a buy rating and set a $1.75 target price on the stock in a research note on Monday, April 4th. Needham & Company LLC dropped their price objective on Clarus Therapeutics to $3.00 and set a buy rating on the stock in a research note on Tuesday, May 17th. Finally, Truist Financial dropped their target price on Clarus Therapeutics from $7.00 to $3.00 and set a na rating on the stock in a research report on Tuesday, May 17th.

A number of hedge funds have recently modified their holdings of CRXT. Verition Fund Management LLC acquired a new stake in Clarus Therapeutics during the 3rd quarter worth about $160,000. UBS Group AG acquired a new stake in Clarus Therapeutics during the 3rd quarter worth about $206,000. Telemetry Investments L.L.C. acquired a new stake in Clarus Therapeutics during the 3rd quarter worth about $240,000. Powell Investment Advisors LLC grew its position in Clarus Therapeutics by 48.8% during the 4th quarter. Powell Investment Advisors LLC now owns 64,000 shares of the companys stock worth $156,000 after purchasing an additional 21,000 shares during the period. Finally, Citadel Advisors LLC acquired a new stake in Clarus Therapeutics during the 4th quarter worth about $31,000. Institutional investors own 19.50% of the companys stock.

Clarus Therapeutics (NASDAQ:CRXT Get Rating) last posted its earnings results on Monday, May 16th. The company reported ($0.61) EPS for the quarter. The company had revenue of $4.01 million during the quarter. On average, equities research analysts anticipate that Clarus Therapeutics will post -1.22 EPS for the current year.

Clarus Therapeutics Company Profile (Get Rating)

Clarus Therapeutics Holdings, Inc, a pharmaceutical company, focuses on the development and commercialization of oral testosterone replacement therapy in the United States. It offers JATENZO, a soft gel oral formulation of testosterone undecanoate for treating hypogonadal men. The company has a licensing agreement with HavaH Therapeutics for product to treat androgen therapies for inflammatory breast disease and certain forms of breast cancer; and license agreement with The Royal Institution for the Advancement of Learning/McGill University to develop and commercialize McGill's proprietary technology designed to treat conditions associated with CoQ10 deficiencies in humans.

Further Reading

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Clarus Therapeutics Holdings, Inc. (NASDAQ:CRXT) Receives $6.88 Consensus PT from Analysts - Defense World

Juvenile Macular Degeneration Treatment: Introduction

Juvenile macular dystrophy, also known as juvenile macular degeneration, refers collectively to a group of rare and genetic inherited eye disorders that can affect children and young adults. Juvenile macular dystrophy involves the deterioration of the eyes macula; however, it is different from age-related macular degeneration (AMD).

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AMD occurs as part of the bodys natural aging process and affects older adults; however, juvenile macular dystrophy is an inherited condition, which primarily targets the vision of children, teens, and young adults.

Key Drivers and Restraints of Global Juvenile Macular Degeneration Treatment Market

Increase in R&D activities, rise in number of patients suffering from diseases, and rapid expansion of health care and biopharmaceutical industries in developed and developing countries are anticipated to propel the global advancements in therapies in the juvenile macular degeneration treatment market during the forecast period. In June 2018, Lin BioScience granted orphan drug designation to LBS-008, a first-in-class oral therapy, for the treatment of Stargardt Disease by the European Medicines Agency.

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Juvenile macular degeneration is currently an untreatable inherited condition that causes permanent vision loss in children during childhood and adolescence. Stargardt disease is the most common form of juvenile macular degeneration that affects approximately 37,000 individuals in the U.S. and 66,000 in the EU. Currently, there is no approved treatment for Stargardt patients. The disease is caused due accelerated formation and accumulation of toxic vitamin A dimers in the retina caused due mutation in the ABCA4 gene, which cause progressive retinal cell death. Consequently, this process eventually leads to legal blindness with only peripheral vision remaining.

Increase in the number of eye care centers has been recorded, since primary eye care is presently taken care of in optical shops. New optical shops have the latest technological devices that improve user friendliness. Rise in the number of optical shops, eye care centers, and hospitals has increased the availability of treatment.

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In terms of end-user, the global juvenile macular degeneration treatment market can be categorized into hospitals, ophthalmic clinics, and ambulatory surgical centers. The hospitals segment accounted for a major share of the global macular degeneration treatment market. The segment is likely to maintain its leading position during the forecast period. A large population prefers to visit a hospital first rather than an ophthalmic clinic for treatment, as the cost of therapy at a hospital is lower. An ambulatory surgical center is a relatively less preferred option for the treatment of AMD.

Asia Pacific to Lead Global Juvenile Macular Degeneration Treatment Market

In terms of geography, the global juvenile macular degeneration treatment market can be segmented into five key regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America and Europe are expected to hold major share of the global juvenile macular degeneration treatment market during the forecast period, owing to developed health care infrastructure and large patient population along with increasing technological development in these regions.

Increase in government intervention in emerging markets has led to a rise in awareness about diseases and improvement in health care infrastructure. Additionally, socioeconomic development has been observed in emerging economies such as Asia, Africa, and Latin America. These factors contribute to the overall increase in spending capacity of the population. Moreover, an increase in the foreign direct investment has been observed in these countries. This has led to various international players who are presently entering into these markets.

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Key Players Operating in Global Juvenile Macular Degeneration Treatment Market

Manufacturers in the global juvenile macular degeneration treatment market are increasingly investing in research & development of new and innovative drugs such as Alkeus Pharmas lead compound, ALK-001; Katairo GmbH lead product, Remofuscin; Gene Therapy to Activate ABCA4 for Stargardt Disease and Recombinant Enzyme for Age Related Macular Degeneration and Stargardt Disease. These players are also focused on offering highly efficient and patient compliant products.

Leading companies operating in the global juvenile macular degeneration treatment market are:

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Juvenile Macular Degeneration Treatment Market Set to Grow According to Forecasts 2020 2030 Industrial IT - Industrial IT

The primary research analysis labelled Global Testosterone Replacement Therapy Market from 2022 to 2028, initially provided by MarketsandResearch.biz, is created with an excellent blend of operating characteristics, inventive solutions, possible solutions, and cutting-edge technology to provide a better user experience. The Testosterone Replacement Therapy market report covers a portfolio and performance comparison of the economys major companies, as well as commercial surveys, segment market share, geographic presence, planning processes, advancements, expansions, and technological developments.

The Testosterone Replacement Therapy Market research report keeps a close eye on crucial competitors through strategic analysis, internal and external market trends, pricing analysis, a full assessment of market circumstances, and the Testosterone Replacement Therapy Market research report keep a close watch on prominent competitors. A comprehensive study focuses on primary and secondary characteristics, market share, leading sectors, and regional analyses.

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The Testosterone Replacement Therapy market research also includes a feasibility analysis of all segments and geographies, calculated based on their market size, growth rate, and attractiveness to present and prospective opportunists to forecast the future market growth.

Market segmentation based on the geographical boundaries:

The market has been reduced depending on

The market has been reduced as a result of

Market segmentation based on dominant players:

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The Testosterone Replacement Therapy Market research report closely monitors crucial competitors through corporate strategy, micro and macro market trends, pricing analysis, and a complete evaluation of market circumstances. The Testosterone Replacement Therapy Market research report keeps a close eye on crucial competitors.

The report offers thorough information on essential aspects impacting the growth of the global Testosterone Replacement Therapy market, such as drivers, constraints, opportunities, and industry-specific problems. This study aids in analyzing and projecting market size in terms of value and volume. The analysis forecasts the size of market segments in terms of value for the major geographies.

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Testosterone Replacement Therapy Market 2022 to 2028 Global Industry Analysis, Growth, Trends and Forecast Queen Anne and Mangolia News - Queen Anne...

As of today, April 7, 2022, I have started on my journey for Hormone Replacement Therapy. I have thought long and hard about this decision for months now, and to overcome my body dysphoria I have decided that this is the best choice for me, personally.

That said, there is no right or wrong way to be transgender. You dont need surgery or HRT to feel happy as you are, and anyone who thinks different has a problem. Trans people do not need politicians, peers, or family speaking for what their experience should be or what it is, because thats our decision. Whether you wear a binder, walk around in a dress with a full beard, or dont really show the label, I stand by you.

Gender is a nuanced topic that no cis person can touch upon to the extent that a trans person could, and gender is not as simple as pink or blue, XX or XY chromosomes, penis or vagina. For the cis people that read this and feel like Im rehashing things thatve already been said, then get ready to hear it again because the world discriminating against us is very real and very lethal, and Im not going to stop advocating for trans rights even if I die at the hands of someone who sees me as a threat.

Im no threat, and I think theres much worse in the world than a person changing their gender, a choice that in no way affects another persons function.

Today, my doctors have prescribed me Estradiol in a 2-milligram pill to take daily. What I can expect from this is enlarged breasts, shrunken testicles, fewer erections, lower sex drives, mood swings, changes in fat distribution, and less muscle tone. These are all things I look forward to and accept; however, there is risk. These include threats to the cardiovascular system,

liver failure, and potential stroke. All of these are mitigated by the cessation of tobacco, exercise, and cardio which I do consistently enough for this to not be an issue.

Along with Estradiol, if I choose, I can also seek hormone blockers to make it so testosterone is not produced in my system. I have not thought about seeking these yet, because Id rather start slow.

All of this to say that this is my way of being trans. I am nonbinary, meaning I exist outside the spectrum of man or woman. Right now, I look like a man to those who arent in the know, and growing up this way made me uncomfortable in my own body. I take pride in my appearance and its hard to have pride when I look in the mirror and feel as though I am not within this skin that holds me.

Estradiol may change that to the point of people thinking I am a woman, and thats fine to me. Id rather look the way I chose to look, just as cis people would. Just because I have different genitals means nothing: There are women with penises and men with vaginas, and if people really want to try and define gender by genitals, then they need to talk to actual, modern biologists rather than relying on simple biology from high school textbooks desperately in need of being updated. Not only this, but there are intersex people to combat this idea persons born with varied anatomy so if we were really to link gender only to genitalia, then people wouldnt know where to put this differing factor.

NOT AN ENEMY

Although I may now hold the privilege to be proudly out of the closet and seeking medical transitioning, the current state of America is one of disarray, over deciding whether or not peoples decisions are their own to make, yet again.

As the powerful few try to talk over experiences theyve never had, people find themselves entrapped into calling LGBT people groomers or pedophiles, despite the fact that any person in the LGBT community will tell you that we dont align with these sickening criminals. This ideology is just spat out for the sake of creating enemies out of the people you likely share your work, classrooms, or home, with.

Whats more, the banning of gender affirmation therapy will not stop people from being trans, but could lead to a higher suicide rate and deterioration of mental health because gender affirmation therapy is the therapy needed for transgender people. And by that I dont mean that we stop being trans, but rather that we accept ourselves and feel brighter about our own future.

Im not going to stop being trans because a person tells me to, even if I got painful shocks into my head. This doesnt stop something that is completely natural. Thats a fact, even if it only antagonizes further the people in power who try to talk over us and mitigate our chances of life.

Even within our blue state here in Oregon, there is still ignorance we need to combat, as too many people still fear their own children coming out of the closet as something awful. Too many parents refuse to do basic research on the subject and instead let FOX News or Newsmax do the talking for them.

Alongside this, some people like to give money to media that are often aligned against trans people such as the work of famous author, known bigot, and loud voice in the fight to kill transgender people, J.K. Rowling. Rowling has been an advocate for trans exclusionary radical feminism, a flawed ideology that has played a key role in the passing of anti-trans and anti-LGBT legislation that seeks to define a woman solely by her reproductive property and nothing else, an ideology that many have described as hypocritical to feminism itself.

Within this realm of media that secretly punish LGBT youth comes Disney, which has been caught donating to several anti-trans and anti-LGBT legislators and lawmakers in Florida. These transactions have caused outrage among Disney consumers and Disney workers that has led to various strikes at Disney parks. Theres even been the advocation by Disney higher-ups demanding that workers remove any LGBT pins sold in their own stores and, in some cases, the termination of employees who have spoken against the companys terrible sense of decision-making.

Trans and LGBT rights have yet to finish coming, because until we are safe to walk in every state as open as we want to be without a bigot killing us, we are not safe. Neither are we some scary boogeyman thatll go away if you kill enough of us. Were people that you likely have a lot in common with, and maybe instead, you should listen to us.

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Being trans and starting HRT - The Advocate

Toronto, Ontario

Toronto Functional Medicine Centre in Toronto, ON, Canada, has recently released a blog post that explains that the functional medicine approach to fertility in women is to check on DHEA levels. This is because DHEA is a hormone that plays a significant role in a science-based, patient-centered and individualized approach to fertility. It has been noted that DHEA levels decrease as women age and this can result in fertility issues. Women who have low ovarian reserve usually have low DHEA levels and research has revealed that DHEA supplementation may enhance fertility rates for these women. Furthermore, DHEA may help in boosting egg quality and boost the chances of successful pregnancy.

In functional medicine DHEA levels are indicative of a womans fertility. DHEA has been found to support fertility by helping with egg quality and enhancing pregnancy rates in women with diminished ovarian reserve (DOR). DOR is characterized by smaller follicles and a decline in ovarian follicular pool size at a particular age. Women with DOR typically produce a low optimal number of eggs, plus they also have poor quality embryos, with the result that they have decreased rates of implantation and pregnancy. An Anti-Mullerian Hormone (AMH) blood test must be performed to determine whether a woman has a low ovarian reserve.

Women with DOR typically have lower DHEA levels, which may be a significant factor in their poor response to fertility treatment. However, studies have shown that fertility treatments tend to be effective for women with low ovarian reserve if DHEA is used. This is because DHEA may help in enhancing egg quality through the promotion of follicular steroidogenesis. It increases IGF-1, which functions as a pre-hormone for follicular testosterone, decreasing aneuploidy while increasing the AMH and antral follicle count.

At the Toronto Functional Medicine Centre, their goal is to help patients boost their chances of getting pregnant and also to help them achieve optimal wellness. This is because they offer an integrative approach to functional medicine programs, which focus on traditional Chinese medicine, Western medicine/allopathic medicine, naturopathic medicine, bioidentical hormone replacement therapy, acupuncture, and herbal medicine. The philosophical basis of functional medicine is that every patient is a unique entity and functional medicine must address fertility by personalizing treatment plans for the patients specific biology only. Functional medicine testing may be used, including fertility-specific treatments with regards to lifestyle changes, nutritional deficiencies, chronic diseases, hormone imbalances, disease prevention, and more.

Toronto Functional Medicine Centre treats each patient as a unique whole person and their treatment methods are designed to restore cellular functioning and energy levels, while managing both the symptoms and the root cause of the health issue. They can address a broad variety of health problems, such as: brain health, adrenal fatigue, immunity, menopause, inflammation, chronic conditions, digestive health, detoxification, mold toxicity, hormone imbalances, nutritional deficiencies, food allergies or intolerance, thyroid malfunction, infertility, and more. Additionally, those interested can learn about the functional medicine approach to pcos from a previous article the clinic published.

The integrative care they provide to patients may include different strategies, including: traditional Chinese medicine, acupuncture for pain relief, naturopathic and herbal medicine, allopathic/western medicine, and medically-supervised IV therapy. And it should be pointed out that naturopathy integrates the traditional and natural forms of medicine with the latest scientific knowledge.

People who are interested in using DHEA for their fertility goals, should speak to their nurse practitioner and or medical doctor about functional medicine fertility support in Toronto. Those interested can also visit the Toronto Functional Medicine Centre website, or contact them on the phone (416) 968-6961 or through email at [emailprotected]. They are conveniently located at the heart of downtown Toronto.

###

For more information about Toronto Functional Medicine Centre, contact the company here:

Toronto Functional Medicine Centre(416) 968-6961[emailprotected]Toronto Functional Medicine Centre162 Cumberland St 222 AToronto, ON M5R 1A8

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DHEA Levels and Their Role in Fertility for Functional Medicine Patients - Digital Journal

By John Vandermosten, CFA

NASDAQ:LPCN

READ THE FULL LPCN RESEARCH REPORT

On May 9, 2022 Lipocine LPCN filed its Form 10-Q and posted its earnings release for the quarter ending March 31, 2022.

Highlights for the first quarter 2022 and to-date include:

TLANDO US commercialization licensing agreement with Antares Pharma - October 2021

FDA grants Fast Track Designation to LPCN 1144 - November 2021

First patient dosed in Phase II, LPCN 1148 in liver cirrhosis - December 2021

Presentations at 2022 NASH-TAG Conference - January 2022

Publication of Phase III results for TLANDO - January 2022

Licensee Antares TLANDO NDA resubmission accepted - February 2022

Regulatory guidance on LPCN 1144 in non-cirrhotic NASH - March 2022

Lipocine generated no revenues in the first quarter. It reported net loss of ($3.5) million, or ($0.04) per diluted share.

For the quarter ending March 31, 2022 and versus the same ending March 31, 2021:

Revenues were zero in both periods;

Research & Development expense totaled $1.9 million, up 19% from $1.6 million, driven by higher contract research organization (CRO) expenses for LPCN 1148, pharmacokinetic and food effect studies for LPCN 1107 and 1154, greater manufacturing scale-up costs for LPCN 1111 and higher personnel expenses;

General & Administrative expenses were $1.2 million, falling 19% from $1.5 million primarily due to lower legal costs relating to the Clarus lawsuit, and lower personnel costs, partially offset by higher professional fees, consulting fees, proxy solicitation expenses and corporate insurance costs;

Total other net expense was ($0.4) million, compared to ($0.3) million, as increases in interest and investment income were more than offset by an increase in unrealized loss on the warrant liability;

Net loss was ($3.5) million or ($0.04) per share compared with net loss of ($3.4) million or ($0.04) per share, respectively.

At quarter's end, marketable securities, cash and equivalents totaled $42.0 million. Cash burn for 1Q:22 was ($3.9) million, compared with ($4.1) million in 1Q:21. During the three month period, Lipocine repaid $0.8 million of debt and received $0.2 million from option exercises for a net cash change vs. year end 2021 of ($2.8) million.

TLANDO Licensing Agreement with Antares Pharma

On October 18th of last year Lipocine announced that it had entered into a licensing agreement with Antares Pharma. The agreement is for commercialization of TLANDO in the US and includes the following terms:

Up to $21 million in licensing fees;

$11 million payable immediately;

$10 million in future payments subject to certain conditions;

Commercial sales payments based on milestones up to $160 million;

Tiered royalties on net sales from mid-teens up to 20%;

Antares responsible for all commercialization, post-marketing studies, and sourcing of TLANDO in US;

Also included is Antares option to license TLANDO XR; if exercised

Antares gains license to develop and commercialize TLANDO XR in the US;

Lipocine would receive $4 million in license fees;

Up to $35 million in clinical and regulatory milestone payments;

Tiered royalties on net sales from mid-teens to 20%

Antares responsible for all clinical development costs, regulatory filings, commercialization and post-marketing activities.

On April 1, 2022, Lipocine and Antares amended the Tlando XR option agreement, extending it by three months to June 30, 2022 from the original March 31 date. Tlando XR is the next generation of Tlando which allows for once daily dosing for the TRT therapy. In return for the extension, Antares paid Lipocine $500,000 which will be credited towards the $4 million license fee required if Antares wishes to execute the license.

Lipocine retains all rights to rest of world and non-testosterone replacement therapy indications for both TLANDO and TLANDO XR. We update our model to reflect the terms of this arrangement and assume that Antares will exercise its option to advance TLANDO XR.

LPCN 1144 for Treatment of Non-Cirrhotic NASH

With the commercialization of TLANDO underway with Antares, LPCN 1144 moves into pole position at Lipocine. The company will shift its primary attention towards LPCN 1144 and an upcoming End of Phase II (EoP2) meeting with the FDA to determine trial design. We anticipate that a clear path forward for LPCN 1144 will be provided to stakeholders later this year.

Regulatory Guidance on LPCN 1144

On March 1, 2022, Lipocine provided an update on its Type C meeting with the FDA regarding LPCN 1144's development. The FDA provided written response acknowledging that LPCN 1144's NDA would be submitted via 505(b)(2) regulatory pathway, that no additional nonclinical studies are needed to support the submission, and that Lipocine's Phase II LiFT study's multicomponent primary surrogate endpoint is acceptable for seeking approval under accelerated approval. The FDA recommended Lipocine either conduct a separate dose-ranging study prior to Phase III or evaluate multiple doses in the Phase III study and that the aforementioned multicomponent primary surrogate endpoint is acceptable. The FDA recommended Phase III study duration of 72 weeks. The FDA also recommended that Lipocine submit an updated Phase III protocol and discuss details further in an EoP2 which is expected to take place in 3Q:22.

Next Steps

Now that selected 36-week biopsy data has been presented to stakeholders and with the Fast Track Designation in its back pocket, Lipocine's next steps are to prepare a presentation for a scientific and medical conference and complete the extension study. With feedback from its Type C meeting with the FDA, Lipocine is now charged with redesigning and submitting an updated Phase III protocol to the FDA, and scheduling an EoP2 meeting with the FDA. In response to FDA guidance, Lipocine must decide whether it wishes to conduct a preliminary dose-ranging study, or to incorporate dose-ranging into the design of its Phase III trial. Management has voiced its desire to seek a partner to advance LPCN 1144 into a registrational study.

Clarus Settlement

In mid-2021, Lipocine settled its claims related to the patent infringement litigation with Clarus for $4.0 million as described in our August 6, 2021 report. $2.5 million was paid immediately, followed by a promised $1.0 million payment in July 2022 and $500,000 in July 2023. On April 29, 2022, Lipocine modified the agreement in its favor by consenting to pay Clarus $1.25 million in May 2022, with no additional payments required thereafter. This provides non-discounted savings of $250,000 over the original agreement and settles the financial aspect of this matter.

Milestones

TLANDO

NDA filed for TLANDO - February 2020

Tentative approval of TLANDO - December 2020

TLANDO licensing agreement with Antares - October 2021

TLANDO full approval - March 28, 2022

First sales late 2Q:22

LPCN 1144

Presentation of 36-week LiFT study, biopsy data to investors - August 2021

End of Phase II meeting with FDA - 2H:21

Grant of Fast Track Designation for LPCN 1144 - November 2021

Type C meeting results for LPCN 1144 - March 2022

LPCN 1144 End-of-Phase II meeting request - April 2022

Open Label Extension (OLE) topline results May 2022

LPCN 1144 End-of-Phase II meeting - 3Q:22

Explore business development partnering 2022/2023

LPCN 1148

IND clearance for Phase II study of LPCN 1148 - May 2020

Male cirrhosis trial first subject dosed for LPCN 1148 - 4Q:21

Enrollment completion - 3Q:22

Topline 24-week results - 1Q:23

LPCN 2101 IND in epilepsy - 2022

Topline announcement for PK study for LPCN 1154 - 4Q:21/1Q:22

Launch Phase IIa proof of concept Post-Partum Depression (PPD) trial - 4Q:21

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1. Lipocine Corporate Presentation January 2022

Read this article:
LPCN: First Quarter 2022 Financial and Operational Results - Benzinga

The following discussion of our financial condition and results of operationsshould be read in conjunction with our unaudited condensed consolidatedfinancial statements and the related notes thereto and other financialinformation included elsewhere in this report. For additional context with whichto understand our financial condition and results of operations, see themanagement's discussion and analysis included in our Form 10-K, filed with theSEC on March 9, 2022 as well as the financial statements and related notescontained therein.

As used in the discussion below, "we," "our," and "us" refers to Lipocine.

This section and other parts of this report contain forward-looking statementswithin the meaning of Section 27A of the Securities Act of 1933, as amended, andSection 21E of the Securities Exchange Act of 1934, as amended, that involverisks and uncertainties. Forward-looking statements provide current expectationsof future events based on certain assumptions and include any statement thatdoes not directly relate to any historical or current fact. Forward-lookingstatements may refer to such matters as products, product benefits, pre-clinicaland clinical development timelines, clinical and regulatory expectations andplans, expected responses to regulatory actions, anticipated financialperformance, future revenues or earnings, business prospects, projectedventures, new products and services, anticipated market performance, expectedresearch and development and other expenses, future expectations for liquidityand capital resources needs and similar matters. Such words as "may", "will","expect", "continue", "estimate", "project", and "intend" and similar terms andexpressions are intended to identify forward looking statements. Forward-lookingstatements are not guarantees of future performance and our actual results maydiffer significantly from the results discussed in the forward-lookingstatements. Factors that might cause such differences include, but are notlimited to, those discussed in Part II, Item 1A (Risk Factors) of this Form10-Q, or in Part I, Item 1A (Risk Factors) of our Form 10-K filed with the SECon March 9, 2022. Except as required by applicable law, we assume no obligationto revise or update any forward-looking statements for any reason.

We are a clinical-stage biopharmaceutical company focused on neuroendocrine andmetabolic disorders using our proprietary oral drug delivery technology. Ourproprietary delivery technologies are designed to improve patient compliance andsafety through orally available treatment options. Our primary developmentprograms are based on oral delivery solutions for poorly bioavailable drugs. Wehave a portfolio of differentiated innovative product candidates that targethigh unmet needs for neurological and psychiatric CNS disorders, liver diseases,and hormone supplementation for men and women.

We entered into a license agreement for the development and commercializationour product candidate, TLANDO, an oral testosterone replacement therapy ("TRT")comprised of testosterone undecanoate ("TU"). TLANDO is a registered trademarkassigned to Antares. On October 14, 2021, we entered into a license agreement(the "Antares License Agreement") with Antares Pharma, Inc. ("Antares" or our"Licensee"), pursuant to which we granted to Antares an exclusive,royalty-bearing, sublicensable right and license to develop and commercialize,upon final approval of TLANDO from the United States Food and DrugAdministration ("FDA"), the TLANDO product for TRT in the U.S. Any FDA requiredpost-marketing studies will also be the responsibility of our licensee, Antares.On March 28, 2022, Antares received approval from the FDA for TLANDO as a TRT inadult males for conditions associated with a deficiency of endogenoustestosterone, also known as hypogonadism.

Additional pipeline candidates include: LPCN 1148 comprising a novel prodrug oftestosterone, testosterone laurate ("TL"), for the management of decompensatedcirrhosis; LPCN 1144, an oral prodrug of androgen receptor modulator for thetreatment of non-cirrhotic non-alcoholic steatohepatitis ("NASH") which hascompleted phase 2 testing; LPCN 1111 (TLANDO XR), a next generation oral TRTproduct comprised of testosterone tridecanoate ("TT") with the potential foronce daily dosing which has completed Phase 2 testing; ; LPCN 1107, potentiallythe first oral hydroxy progesterone caproate ("HPC") product indicated for theprevention of recurrent preterm birth ("PTB"), which has completed a dosefinding clinical study in pregnant women and has been granted orphan drugdesignation by the FDA; and neuroactive steroids (NAS) including LPCN 1154 forpostpartum depression (PPD) and LPCN 2101 for epilepsy.

The following chart summarizes the status of our product candidate developmentprograms:

To date, we have funded our operations primarily through the sale of equitysecurities, debt and convertible debt and through up-front payments, researchfunding and royalty and milestone payments from our license and collaborationarrangements. We have not generated any revenues from product sales and we donot expect to generate revenue other than TLANDO royalties and license fees fromproduct sales by Antares unless and until we obtain regulatory approval of ourproduct candidates.

We have incurred losses in most years since our inception. As of March 31, 2022,we had an accumulated deficit of $176.2 million. Income and losses fluctuateyear to year, primarily depending on the nature and timing of research anddevelopment occurring on our product candidates. Our net loss was $3.5 millionfor the three months ended March 31, 2022, compared to $3.4 million for thethree months ended March 31, 2021. Substantially all of our operating lossesresulted from expenses incurred in connection with our product candidatedevelopment programs, our research activities and general and administrativecosts associated with our operations.

We expect to continue to incur significant expenses and operating losses for theforeseeable future as we:

To fund future long-term operations, including the potential commercializationof any of our product candidates, we will need to raise additional capital. Theamount and timing of future funding requirements will depend on many factors,including capital market conditions, the commercial success of TLANDO,regulatory requirements related to our other product development programs, thetiming and results of our ongoing development efforts, the potential expansionof our current development programs, potential new development programs, ourability to license our products to third parties, the pursuit of variouspotential commercial activities and strategies associated with our developmentprograms and related general and administrative support. We anticipate that wewill seek to fund our operations through public or private equity or debtfinancings or other sources, such as potential license, partnering andcollaboration agreements. We cannot be certain that anticipated additionalfinancing will be available to us on favorable terms, in amounts sufficient tofund our operations, or at all. Although we have previously been successful inobtaining financing through public and private equity securities offerings andour license and collaboration agreements, there can be no assurance that we willbe able to do so in the future.

Our goal is to become a leading biopharmaceutical company focused on applyingour proprietary drug delivery technology for the development of pharmaceuticalproducts focusing on neuroendocrine and metabolic disorders. The key componentsof our strategy are to:

Build a diversified multi-asset pipeline of novel therapies. We intend to employa value-driven strategy based on our proprietary technology platform to identifyand develop product candidates for neuroendocrine and metabolic disordersincluding Central Nervous System (CNS) disorders and end stage diseases such asdecompensated cirrhosis. We intend to focus on product candidates that webelieve are differentiated, have attractive profiles, and address a clear unmetmedical need that we can advance quickly and efficiently into late-stagedevelopment.

Advance LPCN 1148, a unique prodrug of androgen receptor agonist to manage endstage (decompensated) liver cirrhosis disease. We believe LPCN 1148, a novelprodrug of testosterone, could address a significant unmet medical need inpatients with decompensated liver cirrhosis accompanied with muscle disordersuch as secondary sarcopenia. Sarcopenia in male cirrhotic patients is known tobe independently associated with poor outcomes including quality of life,increased decompensation events such as hepatic encephalopathy, increasedhospital admissions, and increased mortality rate. We believe LPCN 1148 may beeligible for an orphan drug designation. Enrollment in a multi-centerplacebo-controlled phase 2 trial is currently ongoing.

Support our licensee in commercialization of our licensed oral TRT option. Webelieve the TRT market needs a differentiated, convenient oral option. We haveexclusively licensed rights to TLANDO to Antares for commercialization of TLANDOin the US. We plan to support our licensee's efforts to effectively enable theavailability of TLANDO to patients in a timely manner, in addition to receivingmilestone and royalty payments associated with TLANDO commercialization asagreed to in the Antares License Agreement.

Develop partnership(s) to continue the advancement of pipeline assets. Wecontinuously strive to prioritize our resources in seeking co-developmentpartnerships of our pipeline assets. We currently plan to explore partnering ofLPCN 1144, our candidate for treatment of non-cirrhotic NASH, LPCN 1107, ourcandidate for prevention of pre-term birth, and LPCN 1111, a once-a-day therapycandidate for TRT.

Our pipeline of clinical candidates including LPCN 1148, an androgen therapy forthe management of cirrhosis, LPCN 1144, an oral androgen therapy for thetreatment of non-cirrhotic NASH, LPCN 1111, a next-generation potential oncedaily oral TRT, LPCN 1107, an oral therapy for the prevention of PTB, and NASincluding LPCN 1154 for postpartum depression (PPD) and LPCN 2101 for epilepsy.We will continue to explore other product candidates targeting indications witha significant unmet need.

Our products are based on our proprietary Lip'ral drug delivery technologyplatform. Lip'ral based TLANDO was approved in March 2022. Lip'ral technology isa patented technology based on lipidic compositions which form an optimaldispersed phase in the gastrointestinal environment for improved absorption ofinsoluble drugs. The drug loaded dispersed phase presents the solubilized drugefficiently at the absorption site (gastrointestinal tract membrane) thusimproving the absorption process and making the drug less dependent onphysiological variables such as dilution, gastro-intestinal pH, and food effectsfor absorption. Lip'ral based formulation enables improved solubilization andhigher drug-loading capacity, which can lead to improved bioavailability,reduced dose, faster and more consistent absorption, reduced variability,reduced sensitivity to food effects, improved patient compliance, and targetedlymphatic delivery where appropriate.

LPCN 1148: Oral Product Candidate for the Management of Decompensated Cirrhosis

We are currently evaluating LPCN 1148 comprising testosterone laurate (TL) forthe management of decompensated cirrhosis. We believe LPCN 1148 targets unmetneeds for cirrhosis subjects including improvement in the quality of life ofpatients while on the liver transplant waiting list, prevention or reduction inthe occurrence of new decompensation events, and improvement in post livertransplant survival, including outcomes and costs.

We are currently conducting a Phase 2 POC study (NCT04874350) in male cirrhoticsubjects to evaluate the therapeutic potential of LPCN 1148 for the managementof sarcopenia. The ongoing Phase 2 POC study is a prospective, multi-center,randomized, placebo-controlled study in male sarcopenic cirrhotic patients.Subjects will be randomized 1:1 to one of two arms. The treatment arm is an oraldose of LPCN 1148, and the second arm is a matching placebo. The primaryendpoint is change in skeletal muscle index at week 24 with key secondaryendpoints including change in liver frailty index, rates of breakthrough hepaticencephalopathy, and number of waitlist events, including all-cause mortality.Total treatment is expected to be 52 weeks. We currently expect enrollment inthe Phase 2 study to be complete by the end of the third quarter of 2022 andtop-line 24-week results by the end of the first quarter of 2023.

Possible outcomes of interest from the Phase 2 study include clinical outcomessuch as overall survival and new decompensation events (including hepaticencephalopathy and/or ascites occurrences), rates of survival to transplant,rates of hospitalizations, infections, etc., muscle changes such as muscle mass,body composition, myosteatosis (muscle fat), functional capacity changes such asliver frailty index (LFI), patient reported outcomes (PROs), and biochemicalmarkers including hematocrit for anemia status, albumin, creatinine/kidneyfunction, etc.

Disease Overview - Cirrhosis

There are over 2 million cases of cirrhosis worldwide, with over 500,000 peopleliving with decompensated cirrhosis in the U.S. and nonalcoholic fatty liverdisease is the most rapidly increasing indication for liver transplant. 62% ofthose on the liver transplant ("LT") waitlist are male. The economic burden(approximately $812,500/transplant) is high and continues to increase. Each yearabout half of the approximately 17,000 people in U.S. on the LT waitlist undergotransplant, while nearly 3,000 patients either die or are removed from the listbecause they were "too sick to transplant."

Liver cirrhosis is defined as the histological development of regenerativenodules surrounded by fibrous bands. Cirrhotic patients typically have ayears-long silent, asymptomatic phase (compensated cirrhosis) until decreasingliver function and increasing portal pressure move the patient into thesymptomatic phase (decompensated cirrhosis). Transition to decompensatedcirrhosis is marked by clinical events including ascites, encephalopathy,jaundice, and/or variceal hemorrhage. Decompensated subjects survive on averageless than 2 years. Common causes of liver cirrhosis include alcoholic liverdisease, nonalcoholic fatty liver disease (NAFLD), chronic hepatitis B and C,primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC) andcryptogenic.

Common complications in cirrhotic patients may include: compromised liverfunction, portal hypertension, varices in GI tract with internal bleeding,edema, ascites, hepatic encephalopathy, compromised immunity withpost-transplant acute rejection risk, high sodium levels, increased bilirubin,low albumin level, insulin resistance with impaired peripheral uptake ofglucose, depression, accelerated muscle disorder in the form of sarcopenia,myosteotosis, and frailty with compromised energetics, bone diseases (e.g.,osteoporosis), high alkaline phosphatase (ALP), cachexia, malnutrition, weightloss (>5%), symptoms of hypogonadism such as abnormal hair distribution, anemia,sexual dysfunction, testicular atrophy, muscle wasting, fatigue, osteoporosis,gynecomastia, inflammation with elevated cytokines, and infection risk leadingto hospital admissions and possibly death.

Hepatic encephalopathy ("HE"), a significant decompensation event in patientwith cirrhosis, is a brain dysfunction caused by liver insufficiency and/orportal systemic shunting. Because the damaged liver cannot function normally (asin cirrhosis), neurotoxins such as ammonia are inadequately removed fromsystemic circulation and travel to the brain, where they affectneurotransmission. This can cause episodes of HE, which may present asalterations in consciousness, cognition, and behavior that range from minimal tosevere. Overt HE occurs in 30% to 40% of patients with cirrhosis at some pointduring the clinical course of their disease. As the burden of chronic liverdisease and cirrhosis is increasing, the frequency of HE is also increasing.

Muscle Disorders and Cirrhosis

Muscle disorders secondary to cirrhosis could be manifested in the form ofseveral inter-related characteristics such as sarcopenia, myosteotosis, andfrailty impacting muscle mass, strength, quality, and function. Chronicinflammation and oxidative stress have also been reported to accelerate musclewasting. Muscle also plays a significant compensatory role in detoxifyingammonia, a neurotoxin and a myotoxin implicated in precipitation of HE incirrhosis patients.

Sarcopenia and associated frailty affect up to 70% of cirrhotic men and are aleading cause of patients being removed from the LT wait list. Due to the lackof available organs and aging demographics of those on the waitlist, patientsthat do receive a transplant are "increasingly being described as frail". Thepresence of sarcopenia or frailty is associated with increased risk ofhospitalization and hepatic decompensation, a two-fold increase in waitlistmortality, poor post-transplant outcomes, and reportedly is equivalent to adding9-10 points to the Model for End-Stage Liver Disease (MELD) score.

Sarcopenia is typically associated with body composition changes with decreasedmuscle mass and/or low skeletal muscle index. Change in one or more ofappendicular lean mass, total lean mass, fat mass, high VAT (visceral adiposetissue), waist circumference, weight, and/or BMI are notable features.Myosteotosis (fat infiltration in muscles) is indicative of poor muscle quality.Frailty is a state of low energetics accompanied with low physicalperformance/mobility probably because of poor muscle strength/function and isassessed via various measures such as decreased gait speed, weak hand grip; slowrising from a chair, balance, isometric knee extension peak torque or acomposite measure such as liver frailty index (LFI).

Reportedly, as shown in the figure below, muscle disorder such as sarcopenia andmyosteotosis in cirrhosis could be a clinically meaningful predictor of survivaland mortality with lower survival in cirrhotic patients with accompanying muscledisorders.

Muscle Disorders and Mortality in Liver Cirrhosis

Sarcopenia develops in the majority of male cirrhosis patients. The mainmechanisms associated with sarcopenia and decompensated cirrhosis include acatabolic state, progressive immobility, imbalance between muscle breakdown andformation, and hormonal changes. Patients are typically diagnosed withdecompensated cirrhosis upon development of cirrhotic symptoms (e.g., jaundice,HE), and the diagnosis is confirmed via various liver function/imaging tests(e.g., MELD score, liver biopsy, CT scan). A variety of clinical evaluations formuscle mass, strength, and function are typically used to diagnose sarcopenia.Sarcopenia in cirrhosis also correlates with decompensation events, particularlyHE (sarcopenia is about 2-fold more prevalent in overt HE patients than thosewithout overt HE). Notably, low testosterone in males is associated withsarcopenia, severity of cirrhosis, and mortality.

Reportedly, as shown in figure below, sarcopenia is a predictor for increasedmortality in cirrhosis (about 2-fold higher compared to no sarcopenia).

Reportedly, as shown in figure below, pre transplant sarcopenia in livercirrhosis often produces poor post-transplant outcomes with higher mortalityrates. Longer post-transplant hospitalization and rehabilitation can bedemanding on the individual, both physically and financially.

Myosteatosis, fat infiltration in muscles, has been found in many cirrhoticpatients undergoing liver transplant evaluation, and studies have associated itwith more complications and poor survival. Myosteatosis is characteristicallyassociated with liver steatosis in NAFLD, resulting from ectopic fataccumulation in skeletal muscle. Myosteatosis may affect many individuals who donot meet the anthropometric criteria for sarcopenia or obesity. The accumulationof excess fat in extramyocellular compartments is mostly pathologic. It can bedefined as intramuscular (between muscle fibers) or intermuscular (betweenmuscle fascicles) and is associated with lower muscle function and strength,muscle atrophy, and physical disabilities.

Frailty is a state of low energetics accompanied with low physicalperformance/mobility, usually as a result of poor muscle strength/function andits presence is assessed via various measures such as decreased gait speed, weakhand grip, slow rising from a chair, poor balance, low isometric knee extensionpeak torque or a composite measure such as liver frailty index (LFI).

Reportedly, as shown in figure below, frailty predicts LT waitlist mortalityamong outpatients with cirrhosis regardless of the MELD score.

The presence of frailty is associated with increased waitlist death/delisting

Moreover, it has also been reported, as shown in figure below, that there is ahigher incidence of waitlist mortality as the frailty worsened.

Trajectory of liver frailty and mortality

Currently, there are no FDA approved drugs to treat secondary sarcopenia incirrhosis. We believe we are the only clinical-stage company pursuingdecompensation in sarcopenic cirrhotic patients, and no regulatory precedentcurrently exists for the approval of decompensation or sarcopenia-targetedtherapies. We believe LPCN 1148 has the potential to aid the management ofdecompensation events in male sarcopenic cirrhotic patients through thefollowing possible mechanisms of action: myo-augmentation (impact muscle massand/or quality and/or function) via myostatin inhibition, myosteatosisreduction, anti-catabolic effect, changes in body composition (increase leanmass and/or reduce fat mass) and slowing muscle autophagy; inducinghepato-effective actions with improved key liver injury markers; increaseprotein synthesis; improve anemia, induce immunomodulation with improvement ofimmuno-dysregulation, and lower infection rates; anti-inflammatory/antioxidanteffects by lowering undesirable cytokines such as IL-1, IL-6, and TNF-?; andimprove mitochondrial function.(1)

(1) Ref: Leise. Mayo Clin Proc. 2014.; Hudson. Eur J Gastroenterol. 2019.; Bajaj.

LPCN 1144: An Oral Prodrug of Bioidentical Testosterone Product Candidate forthe Treatment of NASH

We are currently evaluating LPCN 1144, an oral prodrug of bioidenticaltestosterone comprised of TU, for the treatment of non-cirrhotic NASH.

NASH is a more advanced state of non-alcoholic fatty liver disease ("NAFLD") andcan progress to a cirrhotic liver or liver failure, require liver transplant,and can result in hepatocellular carcinoma/ liver cancer, and death. Progressionof NASH to end stage liver disease will soon surpass all other causes of liverfailure requiring liver transplantation. Importantly, beyond these criticalconditions, NASH and NAFLD patients additionally suffer heightenedcardiovascular risk and, in fact, die more frequently from cardiovascular eventsthan from liver disease. NAFLD/NASH is becoming more common due to its strongcorrelation with obesity and metabolic syndrome, including components ofmetabolic syndrome such as diabetes, cardiovascular disease and high bloodpressure. Twenty to thirty percent of the U.S. population is estimated to sufferfrom NAFLD and fifteen to twenty percent of this group progresses to NASH, whichis a substantially large population that lacks an effective therapy. NASH is asilent killer that affects millions in the U.S. Diagnoses have been on the riseand are expected to increase dramatically in the next decade. Approximately 50%of NASH patients are in adult males. In men, especially with comorbiditiesassociated with NAFLD/NASH, testosterone deficiency has been associated with anincreased visceral adipose tissue and insulin resistance, which could be factorscontributing to NAFLD/NASH. There is currently no approved therapy for thetreatment of NASH although there are several drug candidates currently underdevelopment with many clinical failures to date.

The critical pathophysiologic mechanisms underlying the development andprogression of NASH include reduced ability to handle lipids, increased insulinresistance, injury to hepatocytes and liver fibrosis in response to hepatocyteinjury. NASH patients have an excessive accumulation of fat in the liverresulting primarily from a caloric intake above and beyond energy needs. Ahealthy liver contains less than 5% fat, but a liver in someone with NASH cancontain more than 20% fat. This abnormal liver fat contributes to theprogression to NASH, a liver necro-inflammatory state that can lead to scarring,also known as fibrosis, and, for some, can progress to cirrhosis and liverfailure.

Alanine aminotransferase ("ALT") is an enzyme that is produced in liver cellsand is naturally found in the blood of healthy individuals. In liver disease,liver cells are damaged and, as a consequence, ALT is released into the blood,increasing ALT levels above the normal range. Physicians routinely test bloodlevels of ALT to monitor the health of a patient's liver. ALT level is aclinically important biochemical marker of the severity of liver inflammationand ongoing liver disease. Elevated levels of ALT represent general markers ofliver cell death and inflammation without regard to any specific mechanism.Aspartate aminotransferase ("AST") is a second enzyme found in the blood that isproduced in the liver and routinely measured by physicians along with ALT. Aswith ALT, AST is often elevated in liver disease and, like ALT, is considered anoverall marker of liver inflammation.

Most people with NASH are asymptomatic and their disease is often discoveredincidentally following a liver imaging procedure, such as an ultrasound,prescribed for other reasons or as part of an investigation for elevated liverenzymes. Once suspected clinically, a liver biopsy is required to definitivelydiagnose NASH, which necessitates the joint presence of steatosis, ballooningand lobular inflammation. Once pathologically confirmed, the severity of NAFLDand NASH is determined using the histologically validated NAFLD activity score,which grades disease activity on a scale of 0 to 8. The NAFLD activity score isthe sum of the individual scores for steatosis (0 to 3), lobular inflammation (0to 3), and hepatocellular ballooning (0 to 2) but does not include a score forfibrosis. Fibrosis staging (F0-F4) relies on the NASH CRN classification (F0 =no fibrosis; F1 = perisinusoidal or portal/periportal fibrosis (not both); F2 =both perisinusoidal and portal/periportal fibrosis; F3 = bridging fibrosis; F4 =cirrhosis).

Histological diagnosis remains the gold standard for assessment of NASH andfibrosis. However, given that liver biopsy is associated with risks of pain,bleeding and other morbidity, as well as significant cost, the procedure is notpractical for general patient screening. Several non-invasive tools such asclinical risk scores and imaging techniques are increasingly used to assesspotential NASH patients. Clinical risk scores such as the NAFLD fibrosis score,Fibrosis-4 index, the Enhanced Liver Fibrosis score and vibration-controlledtransient elastography ("VCTE"), have been validated and are increasingly used.These tools have an excellent negative predictive value and an acceptablepositive predictive value for detection of advanced (? F3) fibrosis and areincreasingly used in clinical settings. Extensive efforts are also under way todevelop non-invasive means to identify patients with NAS ? 4 or fibrosis ? F2without a liver biopsy. In draft guidance, the FDA encouraged sponsors toidentify biochemical or noninvasive imaging biomarkers that, once characterizedand agreed by the FDA, could replace liver biopsies for patient selection andefficacy assessment in clinical trials.

We expect that the validation and subsequent adoption of these new tools willresult in an increase in the diagnosis and treatment rates for NASH in thefuture.

We have recently completed the LiFT Phase 2 clinical study in biopsy-confirmednon-cirrhotic NASH subjects. The LiFT clinical study was a prospective,multi-center, randomized, double-blind, placebo-controlled multiple-arm study inbiopsy-confirmed hypogonadal and eugonadal male NASH subjects with grade F1-F3fibrosis and a target NAFLD Activity Score ? 4 with a 36-week treatment period.The LiFT clinical study enrolled 56 biopsy confirmed NASH male subjects.Subjects were randomized 1:1:1 to one of three arms (Treatment A is a twicedaily oral dose of 142 mg testosterone equivalent, Treatment B is a twice dailyoral dose of 142 mg testosterone equivalent formulated with 217 mg of d-alphatocopherol equivalent, and the third arm is twice daily matching placebo).

The primary endpoint of the LiFT clinical study was change in hepatic fatfraction via MRI-PDFF and exploratory liver fat/marker end points post 12 weeksof treatment. Additionally, key secondary endpoints post 36 weeks of treatmentincluded assessment of histological change for NASH resolution and/or fibrosisimprovement (biopsy) as well as liver fat data (MRI-PDFF). The LiFT clinicalstudy was not powered to assess statistical significance of any of the secondaryendpoints. Other important endpoints included the following: change in liverinjury markers, anthropomorphic measurements, lipids, insulin resistance andinflammatory/fibrosis markers; as well as patient reported outcomes.

Additionally, subjects have access to LPCN 1144 through an open label extension("OLE") study. The extension study will enable the collection of additional dataon LPCN 1144 for up to a total of 72 weeks of therapy, as well as data for 36weeks of therapy for those subjects on placebo in the LiFT study. The OLE hasbeen completed and we expect topline results from the study in May 2022.

Treatments with LPCN 1144 post 12 weeks of treatment resulted in robust liverfat reduction, assessed by MRI-PDFF, and showed improvement of liver injurymarkers with no observed tolerability issues.

Liver biopsies were performed at baseline ("BL") and after 36 weeks of treatment("EOS"). Prespecified biopsy analyses included NASH Clinical Research Network("CRN") scoring as well as a continuous paired ("Paired Technique") and digitaltechnique ("Digital Technique-Fibronest"). All biopsy analyses were performed onthe same slides and the reads for the three techniques were done independently.Analysis sets included the NASH Resolution Set (all subjects that have BL andEOS biopsy with NASH at BL [NAS ?4 with lobular inflammation score ? 1 andhepatocyte ballooning score ?1 at BL] (n=37)), the Biopsy Set (all subjects withbaseline and EOS biopsies (n=44)), and the Safety Set (all randomized subjects(n=56)).

Both LPCN 1144 treatment arms met with statistical significance thepre-specified accelerated approval regulatory endpoint of NASH resolution withno worsening of fibrosis based on NASH CRN scoring. Additionally, both treatmentarms showed substantial improvement of the observed NASH activity in steatosis,inflammation, and ballooning.

Key results from the LiFT clinical study are presented in the following tablesand figures:

In both treatment arms, substantial reductions in markers of liver injurycompared to placebo were observed post four weeks of treatment and weresustained through EOS. Using all available Safety Set data, ALT decreased up toa mean of 23.4 U/L at EOS from all group mean baseline of 51.5 U/L and ASTdecreased up to a mean of 13.3 U/L at EOS from all group mean baseline of 31.9U/L.

Positive effects in appendicular lean mass and whole-body fat mass, an indicatorof overall tissue quality, based on dual-energy X-ray absorptiometry scans, werenoted in both LPCN 1144 treatment arms.

Finding on liver injury marker and positive effects on body composition can beseen in the following table:

During the 36 weeks of treatment, LPCN 1144 was well tolerated with an overallsafety profile comparable to placebo.

In November 2021, the FDA granted Fast Track Designation to LPCN 1144 as atreatment for non-cirrhotic NASH. The Fast Track program is designed toaccelerate the development and expedite the review of products, such as LPCN1144, which are intended to treat serious diseases and for which there is anunmet medical need.

We had a written only response from FDA for a LPCN 1144 Type C meeting with theFDA in January 2022 to discuss the development path forward with LPCN 1144. TheFDA acknowledged that the NDA submission of LPCN 1144 would be via 505(b)2regulatory pathway and agreed that no additional non-clinical studies are neededto support an NDA submission. The FDA recommended to request an end-of-phase 2(EOP2) meeting. The FDA acknowledged that in the LiFT study subjects achievedimprovements in key components associated with NASH histopathology after36-weeks of treatment with LPCN 1144 in adult males and agreed that the proposedmulticomponent primary surrogate endpoint is acceptable for seeking approvalunder the accelerated approval pathway. The FDA also recommended eitherconducting a separate dose-ranging study prior to phase 3 or evaluating multipledoses in phase 3. The FDA agreed that the proposed primary multicomponentsurrogate endpoint, NASH resolution with no worsening of fibrosis, is acceptablefor seeking approval under the accelerated approval pathway and the FDArecommended a phase 3 trial with a study duration of 72 weeks. The FDA hasrequested that Lipocine submit an updated Phase 3 protocol for FDA feedback onthe study design and we have requested an EOP2 meeting to discuss the phase 3and confirmatory trial designs.

We are exploring the possibility of licensing LPCN 1144 to a third party,although no licensing agreement has been entered into by the Company. Noassurance can be given that any license agreement will be completed, or, if anagreement is completed, that such an agreement would be on acceptable terms.

TLANDO: An Oral Product Candidate for Testosterone Replacement Therapy

As previously described, under the Antares License Agreement, we granted toAntares an exclusive, royalty-bearing, sublicensable right and license todevelop and commercialize, upon final approval of TLANDO from the FDA, ourTLANDO product for TRT in the U.S. On December 8, 2020, the FDA providedtentative approval for TLANDO as a TRT in adult males for conditions associatedwith a deficiency of endogenous testosterone, also known as hypogonadism. TheFDA provided final approval of TLANDO on March 28, 2022. Any FDA requirement toconduct certain post-marketing studies will be the responsibility of ourlicensee, Antares.

Proof-of-concept for TLANDO was initially established in 2006, and subsequentlyTLANDO was licensed in 2009 to Solvay Pharmaceuticals, Inc. which was thenacquired by Abbott Products, Inc. ("Abbott"). Following a portfolio reviewassociated with the spin-off of AbbVie Inc. by Abbott in 2011, the rights toTLANDO were reacquired by us. All obligations under the prior license agreementhave been completed except that Lipocine will owe Abbott a perpetual 1% royaltyon net sales. Such royalties are limited to $1 million in the first two calendaryears following product launch, after which period there is not a cap onroyalties and no maximum aggregate amount. If generic versions of any suchproduct are introduced, then royalties are reduced by 50%.

Under the Pediatric Research Equity Act ("PREA"), since TLANDO received full FDAapproval, under the Antares Licensing Agreement, Antares will need to addressthe PREA requirement to assess the safety and effectiveness of TLANDO inpediatric patients. The FDA may also require certain post-marketing studies tobe conducted which will also be the responsibility of our licensee, Antares.

Upon execution of the Antares License Agreement, Antares paid to us an initialpayment of $11.0 million. Antares will also make additional payments of $5.0million to us on each of January 1, 2025, and January 1, 2026, provided thatcertain conditions are satisfied. We are also eligible to receive milestonepayments of up to $160.0 million in the aggregate, depending on the achievementof certain sales milestones in a single calendar year with respect to allproducts licensed by Antares under the Antares License Agreement. In addition,upon commercialization, we will receive tiered royalty payments at rates rangingfrom percentages in the mid-teens to up to 20% of net sales of TLANDO in theUnited States, subject to certain minimum royalty obligations. Further, onOctober 14, 2021, we assigned our Manufacturing Agreement, dated August 27,2013, by and between the Company and Encap Drug Delivery (the "ManufacturingAgreement") to Antares as part of the Antares License Agreement.

We are exploring the possibility of licensing LPCN 1021 (known as TLANDO in theUnited States) to third parties outside the United States, although no licensingagreement has been entered into by the Company. If and when an agreement is madewith a partner, such arrangement would likely be contingent upon obtainingacceptable cost of goods by securing an agreement with a new manufacturer inaddition to obtaining local regulatory approval. No assurance can be given thatany license agreement will be completed, or, if an agreement is completed, thatsuch an agreement would be on terms favorable to us.

LPCN 1111: A Next-Generation Long-Acting Oral Product Candidate for TRT

LPCN 1111: is a next-generation, novel ester prodrug of testosterone comprisedof testosterone tridecanoate (TT) which uses the proprietary delivery technologyto enhance solubility and improve systemic absorption. We completed a Phase 2bdose finding study in hypogonadal men in the third quarter of 2016. The primaryobjectives of the Phase 2b clinical study were to determine the starting Phase 3dose of LPCN 1111 along with safety and tolerability of LPCN 1111 and itsmetabolites following oral administration of single and multiple doses inhypogonadal men. Good dose-response relationship was observed over the testeddose range in the Phase 2b study. Additionally, the target Phase 3 dose metprimary and secondary end points. Overall, LPCN 1111 was well tolerated with nodrug-related severe or serious adverse events reported in the Phase 2b study.

In February 2018 we had a meeting with the FDA to discuss these pre-clinicalresults and to discuss the Phase 3 clinical study and path forward for LPCN1111. Based on the results of the FDA meeting and additional pre-clinicalstudies conducted after the FDA meeting, we have proposed a Phase 3 protocol forLPCN 1111 and have solicited FDA feedback. Based on initial FDA feedback, weexpect the Phase 3 clinical trial design to follow the International Council forHarmonisation of Technical Requirements for Pharmaceuticals for Human Use("ICH") guidelines and we expect the trial will include at least a three-monthefficacy treatment period and a one-year safety component for approximately 100subjects. We are currently seeking further clarification from FDA with respectto the total subject LPCN 1111 exposure information needed for an NDA filing. Wecontinue to refine the Phase 3 protocol and plan to request FDA approval of theprotocol once it is finalized. Additionally, the FDA previously requested that afood effect and a phlebotomy study be completed, and that ambulatory bloodpressure monitoring ("ABPM") be included as part of the Phase 3 clinical study.We are currently transferring the manufacturing of LPCN 1111 to a third-partycontract manufacturer and scaling up the formulation after which we anticipatethe next steps in developing LPCN 1111 may be to conduct a foodeffect/phlebotomy study with LPCN 1111. Under the terms of the Antares LicenseAgreement, Antares has been granted an option to license LPCN 1111, exercisableon or before March 31, 2022, for further development and, should LPCN 1111receive FDA approval, commercialization. On April 1, 2022, the Company enteredinto the First Amendment to the License Agreement (the "Amendment"), pursuant towhich the License Agreement was amended to extend the deadline by which Antaresshall exercise its option to license LPCN 1111 to June 30, 2022. Asconsideration for the Company agreeing to enter into the Amendment, Antares paidthe Company a non-refundable cash fee of $500,000 in April 2022.If Antaresexercises its option to license LPCN 1111, we will be entitled to an additionalpayment of $3.5 million, as well as development milestone payments of up to$35.0 million in the aggregate and tiered royalty payments at rates ranging frompercentages in the mid-teens to 20% of net sales of LPCN 1111 in the UnitedStates. We are currently in the process of scaling up manufacturing productionof clinical supplies for a Phase 3 clinical trial.

LPCN 1107: An Oral Product Candidate for the Prevention of Preterm Birth

We believe LPCN 1107 has the potential to become the first oralhydroxyprogesterone caproate ("HPC") product indicated for the reduction of riskof PTB (delivery less than 37 weeks) in women with singleton pregnancy who havea history of singleton spontaneous PTB. Prevention of PTB is a significant unmetneed as approximately 11.7% of all U.S. pregnancies result in PTB, a leadingcause of neonatal mortality and morbidity.

We have completed a multi-dose PK dose selection study in pregnant women. Theobjective of the multi-dose PK selection study was to assess HPC blood levels inorder to identify the appropriate LPCN 1107 Phase 3 dose. The multi-dose PK doseselection study was an open-label, four-period, four-treatment, randomized,single and multiple dose PK study in pregnant women with three dose levels ofLPCN 1107 and the IM HPC (Makena). The study enrolled 12 healthy pregnant women(average age of 27 years) with a gestational age of approximately 16 to 19weeks. Subjects received three dose levels of LPCN 1107 (400 mg BID, 600 mg BID,or 800 mg BID) in a randomized, crossover manner during the first threetreatment periods and then received five weekly injections of HPC during thefourth treatment period. During each of the LPCN 1107 treatment periods,subjects received a single dose of LPCN 1107 on Day 1 followed by twice dailyadministration from Day 2 to Day 8. Following completion of the three LPCN 1107treatment periods and a washout period, all subjects received five weeklyinjections of HPC. Results from this study demonstrated that average steadystate HPC levels (Cavg0-24) were comparable or higher for all three LPCN 1107doses than for injectable HPC. Additionally, HPC levels as a function of dailydose were linear for the three LPCN 1107 doses. Also, unlike the injectable HPC,steady state exposure was achieved for all three LPCN 1107 doses within sevendays.

A traditional PK/PD based Phase 2 clinical study in the intended patientpopulation is not expected to be required prior to entering into Phase 3.Therefore, based on the results of our multi-dose PK study we had anEnd-of-Phase 2 meeting and subsequent guidance meetings with the FDA to define apivotal Phase 2b/3 development plan for LPCN 1107. However, these discussionswill need to be updated based on recent developments with Covis' Makena. Weplan to resume our interactions with the FDA to discuss our pivotal clinicaltrial design and better understand next steps to advance LPCN 1107

We are exploring the possibility of licensing LPCN 1107 to a third party,although no licensing agreement has been entered into by the Company. Noassurance can be given that any license agreement will be completed, or, if anagreement is completed, that such an agreement would be on acceptable terms.

The FDA has granted orphan drug designation to LPCN 1107 based on a majorcontribution to patient care. Orphan designation qualifies Lipocine for variousdevelopment incentives, including tax credits for qualified clinical testing,and a waiver of the prescription drug user fee when we file our NDA.

On October 5, 2020, the FDA's Center for Drug Evaluation and Research ("CDER")proposed that Makena be withdrawn from the market because the PROLONG trialfailed to verify the clinical benefit of Makena and concluded that the availableevidence does not show Makena is effective for its approved use.

CDER issued AMAG Pharmaceuticals, the NDA holder at the time, a Notice ofOpportunity for Hearing to withdraw approval of Makena, for which AMAGPharmaceuticals responded by requesting a hearing and providing detail on thecompany's position, recognizing clinicians' decade-long use of Makena'streatment and the public health implications of withdrawing approval. The FDACommissioner has recently granted Covis a public hearing although the date ofthat hearing is not publicly known. During this time, Makena and the approvedgenerics of Makena will remain on the market until the FDA makes a finaldecision about these products.

Currently, Makena and the approved generics of Makena are the only productsapproved for the prevention of recurrent preterm birth.

The FDA also indicated that it intends to hold a meeting with experts inobstetrics, neonatal care, and clinical trial design to discuss how tofacilitate development of effective and safe therapies to treat preterm birth.

Oral NAS Programs for CNS Disorders

Some preferred endogenous or naturally occurring NAS present in central nervoussystem (CNS) act as positive allosteric modulators (PAM) of the GABAA receptor,the major biological target of the inhibitory neurotransmitter ?-aminobutyricacid (GABAA). To improve oral delivery of these modulators, several syntheticNAS derivatives of endogenous GABAA receptor PAMs, have been developed fortherapeutic use in the past few decades.

We believe through utilization of our proprietary technology we may have theability to enable effective oral delivery of endogenous GABAA receptor PAMswhich historically had been challenging to deliver orally as they were deemed tobe not orally bioavailable. We believe these endogenous GABAA receptor PAMsprovide opportunity as a differentiated NAS for treatment of various CNSdisorders via the preferred and convenient oral route.

LPCN 1154: Product Candidate for PPD

We are currently evaluating LPCN 1154 comprising an endogenous NAS for PPD. FDAhas cleared LPCN 1154 IND (investigational new drug) application to conduct aphase 2 study in PPD. We have completed a PK study with LPCN 1154 post oraladministration in which we believe clinically relevant levels of the active wereobserved. We are currently conducting a food effect PK study.

PPD (Postpartum depression), a type of major depressive disorder with onseteither during pregnancy or within four weeks of delivery, refers to depressionpersisting up to 12 months after childbirth. PPD can be clinically segmented bythe severity of symptoms and presence of a comorbidity, including epilepsy.Approximately 1 in 9 mothers suffers from PPD in the United States alone; thisequates to approximately 500,000 women being affected by PPD annually.

Approximately, 1 in 9 mothers suffer from PPD in the United States alone, whichequates to approximately 500,000 women affected by PPD annually. We believethere is considerable unmet need within women with PPD due to lack of convenientand fast-acting oral therapies. Selective Serotonin Reuptake Inhibitors (SSRIs)have been the traditional first-line choice for women with severe PPD requiringweeks for onset of efficacy; therefore, a need for a faster onset of actionremains a significant unmet need in treating PPD, especially in women withepilepsy risk wherein psychiatric comorbidity is common and PPD rates are higherthan the general population.

Injectable brexanolone (ZulressoTM, Sage Therapeutics) became the firstFDA-approved treatment for postpartum depression. However, numerous factorslimit the utilization of injectable brexanolone such as method ofadministration, cost, and safety concerns. Administration of injectablebrexanolone requires a 60-hour continuous infusion in a supervised medicalsetting, a demanding ask for a mother with a newborn. Besides associated privacyconcerns and social stigma, hospitalization may also require separation of themother and child for a few days, which may be difficult to the already strainedmother-infant bond and may present breast feeding challenges. Moreover, thepharmacotherapy costs coupled with hospitalization/childcare costs limits itsaccessibility and affordability to women most in need of the therapy. Finally,due to concerns about the safety of injectable ZulressoTM including excessivesedation or loss of consciousness, Zulresso has a Black Box Warning in its labeland is only available through a restricted distribution program (REMS), andsites need significant time to become treatment ready.

We believe the need for a convenient, at-home treatment with faster onset ofaction which could offer privacy and affordability, independent ofsocio-economic status, for women with PPD is a significant unmet need. LPCN 1154targets this unmet need with affordable NAS.

LPCN 2101: NAS for epilepsy

We are currently evaluating an additional NAS candidate, LPCN 2101, for womenwith epilepsy ("WWE"). We have completed a pre-clinical study for LPCN 2101. Weplan to file an IND with the U.S. FDA for LPCN 2101 to conduct aproof-of-concept study for the evaluation of safety, tolerability, and efficacyin adult female subjects of childbearing age diagnosed with epilepsy.

Disease Overview - Epilepsy

Epilepsy is defined by the 1) occurrence of at least two unprovoked seizuresmore than 24 hours apart, 2) occurrence of one unprovoked seizure and aprobability of further seizures occurring over the next 10 years, and/or 3)diagnosis of an epilepsy syndrome. Patients with epilepsy are more likely to becomorbid with other conditions, including depression and anxiety.

Patients with epilepsy have increased risk of mortality due to direct effects ofseizures (e.g., status epilepticus, car accidents) and indirect effects ofseizures (e.g., suicide, cardiovascular effects.)

Epilepsy is a disorder of the brain that causes seizures, affecting thephysical, mental, and social well-being of persons, and is associated with a 2to 3 times greater mortality rate compared with the general population. About60-65% of epilepsy is idiopathic and about 30% of patients are refractory (i.e.,epilepsy not well managed with currently available antiepileptic drugs("AEDs")). Epilepsy is the most common neurological disorder during pregnancy.

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LIPOCINE INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) - Marketscreener.com

Red light therapy, mentioned by Fox News host Tucker Carlson as a way to increase testosterone levels in men, is not medically approved for that purpose.

Fox News host Tucker Carlson recently interviewed personal trainer Andrew McGovern, who advocates for the use of red light therapy to increase testosterone levels in men as part of his Tucker Carlson Originals series.

During the interview, Carlson refers to red light therapy as testicle tanning, a phraseshared widely on social media platforms like Twitter. This comes as Carlson is promoting his documentary The End of Men, which states that decreasing testosterone levels in men is a problem in the U.S.

A urologist said later in a viral tweet that there is absolutely no data on testicle tanning, adding that it doesnt stimulate the production of testosterone.

THE QUESTION

Is red light therapy a medically approved treatment for increasing testosterone levels?

THE SOURCES

THE ANSWER

No, red light therapy isnt a medically approved treatment for increasing testosterone levels.

WHAT WE FOUND

Red light therapy is often promoted as a treatment for common skin woes, such as stretch marks, scars, acne and others, along with improving hair growth and reducing inflammation. Cleveland Clinic says red light therapy, which is also known as low-level laser light therapy and low-power laser therapy among other names, is an emerging therapy but holds a lot of promise.

During red light therapy, you expose your skin to a lamp, device or laser with a red light. Its thought to work by acting on the power plant in your bodys cells called mitochondria. With more energy, cells can work more efficiently to do things like repairing a persons skin.

But red light therapy isnt approved as a medical treatment for increasing testosterone levels and many experts dont recommend it.

The U.S. Food and Drug Administration (FDA) has approved oral testosterone capsules like Jatenzo as a treatment for men with low testosterone levels due to certain medical conditions.

According to mens health website prostate.net, the FDA hasnt approved any light therapy devices to increase testosterone production. There are red light therapy devices available online that dont need FDA clearance, but they arent meant for raising testosterone.

One medical professional who spoke to VERIFY said red light therapy could do more harm to testosterone levels than good.

The risks of it come with temperature changes as you elevate the temperature of the scrotum. If there is a temperature increase, sperm production will diminish, testosterone production will diminish, so there's that potential, said Amin Herati, M.D., director of male infertility and mens health at Johns Hopkins School of Medicine.

Additionally, there is absolutely no controlled study that proves red light therapy increases testosterone, Adam Friedman, M.D., professor and chair of dermatology at The George Washington School of Medicine and Health Sciences, said. The science is just simply not there.

There are some studies that show low-level light therapy or low intensity red light could increase testosterone levels. But they were conducted on animals like rats and birds not humans.

A 2013 study on 30 six-week-old rats found that low-level light therapy might be an alternative treatment modality to the conventional types of testosterone replacement therapy.

Some proponents of red light therapy also point to a 2016 study conducted by researchers at the University of Siena in Italy that focuses on a lack of interest in sex being remedied by exposure to bright light. But those researchers studied a relatively small group of only 38 men.

One group received regular treatment with a specially adapted light box, while the control group received treatment with a light box that gave out significantly less light, researchers said. After two weeks of treatment or placebo, researchers found that those who received treatment through higher levels of light had increased testosterone levels and reported greater levels of sexual satisfaction.

One reason could be that light therapy inhibits the pineal gland in the center of the brain, which may allow the production of testosterone, researchers said.

Though the study found some indication the treatment might increase testosterone, the researchers still said they could not yet recommend light therapy as a clinical treatment. It may be a viable solution to a lack of interest in sex if its shown to work in a larger study, they added.

Many published studies looking into red light therapy for a variety of uses apart from testosterone production have only included a small number of people, were absent a placebo group, or were limited to animals as well, Cleveland Clinic says.

Testicle tanning is a misnomer for red light therapy

The way Carlson referred to red light therapy as testicle tanning is also a misnomer.

Red light therapy uses low wavelength red light, Cleveland Clinic explains, unlike cancer-causing UV rays from the sun or tanning booths. Thats why medical professionals say it appears to be safe for treating certain skin conditions.

Theres no such thing as a safe tan, since its actually the way skin responds to being injured or harmed by ultraviolet radiation in an effort to limit further damage, Friedman said. Exposure to UV rays can also lead to painful sunburns and increase the risk of developing skin cancer.

Its unlikely that a tanning bed or direct exposure to sunlight will increase testosterone production in the testicles, either, according to Herati.

For the light to be able to reach the testicles, it has to penetrate through multiple layers of tissue has to go through the skin, the layer muscle under the skin, a couple other layers of fascia before it reaches the lining of the testicle and it has to penetrate within the testicle, he said. So the likelihood that the UV would be able to penetrate would be unlikely in that situation, or to have an effect.

Some natural ways that men can boost their testosterone include a healthy diet, an exercise routine that incorporates cardio and strength training, and getting enough sleep, experts say.

The VERIFY team works to separate fact from fiction so that you can understand what is true and false. Please consider subscribing to our daily newsletter, text alerts and our YouTube channel. You can also follow us on Snapchat, Twitter, Instagram, Facebook and TikTok. Learn More

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No, red light therapy isnt a medically approved treatment for increasing testosterone - ABC10.com KXTV

Are there three words in the English language that can strike quite as much trepidation into the hearts of the sane and rational person as Tucker Carlson original? Yes, the documentary strand that brought you such titles as Hungary vs Soros: The Fight for Civilization and Patriot Purge, a BS-laden fantasy about the January 6 riots that contained so many bonkers claims about false-flag operations that it forced a tranche of Fox News veterans to quit the network, has returned.

The latest addition to the Carlson oeuvre is called The End of Men and its Magic Mike-style trailer just dropped.

It begins with a familiar Make America Great Again-style montage, centering on a John F Kennedy speech in which he extols the virtues of strength and exercise and berates Americas soft, chubby fat-looking children. Quickly, Kennedys reasonable-for-the-time approach to childhood obesity is equated with a precipitous decline in sperm counts and testosterone over the last 50 years.

And then what could only be described as a series of money shots. As the booming timpanis of a Richard Strauss piece from 2001: A Space Odyssey swell we see huge buff topless men, cutting wood, milking cows, firing guns, barbecuing, fighting, drinking egg yolks and most strikingly, tanning their genitals. This supposed sequence of real red-blooded males is perhaps the campest thing Fox News has aired since Glenn Beck doused a handsome model in gasoline.

Carlsons deeply homoerotic version of real men looks more xVideos than ex-mining town but the testosterone-based view of masculinity hes pushing has been a common theme for Fox News over the past decade, and a profitable one.

The testicle tanning, or red-light therapy, shown in the video is explained further in an interview Carlson does with a self-proclaimed bromeotherapy expert. He claims that by dousing your balls in red LEDs, you can create higher levels of testosterone.

The potential for UV or red light to increase testosterone levels has been quite well documented but there are no peer-reviewed double-blind studies that are able to prove these claims. Testosterone levels also change dramatically throughout the day, and also see dramatic increases from exercise, new sexual partners and changes to diet.

Its no surprise to see Fox News suggest that the answer to all of mankinds problems are testosterone related. The channel is heavily invested in the idea that a decrease in testosterone is making men more liberal and less masculine, and many of its remaining advertisers sell pills that promise to increase mens testosterones levels.

I spent some time reporting this story three years ago, that testosterone was becoming heavily politicised, particularly by Trump-supporting radio hosts who equated liberalism to having low T (one rightwing radio doctor even offered a free testosterone test to any listener thinking about voting for Hillary Clinton). The US is awash with ads for testosterone supplements that make a similar claim, many of them airing on Fox News. Trump himself used to insinuate that his opponents were tired and had low T.

Many men are injecting themselves with testosterone with political motivations but in reality the idea that testosterone is the male hormone and oestrogen is the female one is wrong. Both men and women have both hormones, at highly varied levels, and most men have far more testosterone than they need (indeed, testosterone, which is critical to heart function, is often converted into oestrogen, which means that people who routinely inject testosterone often end up growing breasts). Low testosterone can make some men feel tired and impotent and they need replacement therapy, but others get by on low levels of blood testosterone just fine.

Carlson is right that sperm counts and overall testosterone have been decreasing over the last 50 years due to lifestyle changes including rising obesity. But the idea that this in some way is a problem of manliness, and that if only we tanned our balls men would become happier, is patently untrue.

The show is also a reflection of how far Carlson has shifted into the world of pseudo-scientific and bezerk solutions in the past few years. Just four years ago he was still talking about falling testosterone levels but as part of a wider soul-searching about men in America, doing pieces about why men were more likely to kill themselves, commit mass shootings, be incarcerated, be medicated as children and are performing worse by some educational measures. In the video above, Carlson takes a rightwing anti-feminist position but at least makes some reasonable points about the problems facing American men.

Since then Carlson has fallen off a deep end of trolling and insanity and would rather entertain wild medical interventions than political change. Perhaps hed be happier doing some red light therapy instead of his nightly red face therapy.

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Tucker Carlsons answer to masculinitys supposed crisis? Testicle tanning - The Guardian