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This is just the beginning...
Can a sponsor submit a request for breakthrough therapy designation for multiple indications of the same drug? A breakthrough therapy designation applies to a combination of a drug (either alone or in combination with other drugs) and the specific use for which it is being studied. A separate breakthrough designation request must be submitted for each proposed development program (i.e., each indication for a drug (or drug combination)).
http://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/frequently-asked-questions-breakthrough-therapies
PRESS RELEASE:
“Our collective team of key opinion leaders believes that all patients with similar cancers in regards to CCR5 expression may also benefit from the use of leronlimab, including melanoma, brain, throat, lung, stomach, breast, ovarian, uterine, pancreatic, bladder, and thyroid cancer patients. We also believe the mechanism of action for leronlimab may have potential indications in autoimmune diseases such as multiple sclerosis, polymyolitis, Crohn’s disease, inflammatory bowel syndrome and psoriasis.”
http://empoweredpatientradio.com/monoclonal-antibody-treatments-shown-safe-for-hiv-and-other-indications-with-dr-nader-pourhassan-cytodyn
Monoclonal Antibody Treatments Shown Safe for HIV and Other Indications with Dr. Nader Pourhassan CytoDyn
January 6,2020
CYDY: OTCMarkets
https://www.otcmarkets.com/stock/CYDY/quote#trade-data
Overall small trading volumes on this New Year’s Eve but holding steady.
Have a safe and happy NY.
Listing requirements NASDAQ/NYSE
For those that are unaware...General requirements...
NYSE requires firms to already have 1.1 million publicly-traded shares outstanding with a collective market value of at least $100 million; the Nasdaq requires firms to already have 1.25 million publicly-traded shares with a collective market value of $45 million. Both the NYSE and the Nasdaq require a minimum security listing price of $4 per share.
NASDAQ
Listing Requirements for All Companies
Each company must have a minimum of 1,250,000 publicly traded shares upon listing, excluding those held by officers, directors or any beneficial owners of more than 10% of the company.
Also, the regular bid price at the time of listing must be $4.00, and there must be at least three market makers for the stock.
However, a company may qualify under a closing price alternative of $3.00 or $2.00 if the company meets varying requirements.
Each listing firm is also required to follow NASDAQ corporate governance rules 4350, 4351 and 4360.
Companies must also have at least 450 round lot (100 shares) shareholders, 2,200 total shareholders, or 550 total shareholders with 1.1 million average trading volume over the past 12 months.
https://www.investopedia.com/ask/answers/nasdaq-listing-requirements/
NYSE
The company is required to meet the following guidelines:
Must issue at least 1.1 million shares to at least 400 shareholders.
Market value of public shares must be at least $40 million, with a minimum share price of $4.
Must have $10 million in aggregate pre-tax earnings for the last three fiscal years, including $2 million in most recent year. If this requirement cannot be met, the companycan also apply based on a global market capitalization of at least $500 million, with revenues of at least $100 million in the last year, and no negative cash flow in the three most recent years. The company can also be listed based on revenues of at least $75 million in the last fiscal year.
https://www.diffen.com/difference/NASDAQ_vs_NYSE
Antibodies to watch in 2020
https://www.tandfonline.com/doi/full/10.1080/19420862.2019.1703531?scroll=top&needAccess=true
The CYDY world is about to get a lot brighter
$140 million market cap
$87.5 million UPFRONT payments
Eventually, ‘the universe will serve it’
Averill Powers - CEO
Averill Powers, CEO of Phoenixus AG, Vyera’s parent company, noted: “Vyera’s collaboration with CytoDyn demonstrates our commitment to address the needs of significant patient populations across our group companies generally and, in particular, a new level of our commitment to supporting patients living with HIV.”
https://www.linkedin.com/in/averill-powers-a1a6574
The MOST important aspect...
Of the press release is that it only involves the US market!
In exchange for the exclusive right to market and distribute leronlimab in the U.S. for HIV-related indications, Vyera will pay upfront and regulatory and sales-based milestone payments of up to $87.5 million, as well as a royalty of 50 percent on net sales. Vyera will also make an investment in CytoDyn of $4 million in the form of registered CytoDyn common stock
————————
Poised to reach over US$10.4 Billion by the year 2025, Multi-Class Combination Drugs will bring in healthy gains adding significant momentum to global growth.
Representing the developed world, the United States will maintain a 2.8% growth momentum. Within Europe, which continues to remain an important element in the world economy, Germany will add over US$229.7 Million to the region's size and clout in the next 5 to 6 years. Over US$185.9 Million worth of projected demand in the region will come from the rest of the European markets. In Japan, Multi-Class Combination Drugs will reach a market size of US$549.9 Million by the close of the analysis period.
As the world's second largest economy and the new game changer in global markets, China exhibits the potential to grow at 5.7% over the next couple of years and add approximately US$1.8 Billion in terms of addressable opportunity for the picking by aspiring businesses and their astute leaders.
https://www.ptcommunity.com/wire/global-hiv-drugs-market-report-2019-2025-market-projected-grow-63-billion
FDA Is Green-Lighting Drugs at Breakneck Speed and Raising Alarm
https://www.bloomberg.com/news/articles/2019-12-06/fda-is-green-lighting-drugs-at-breakneck-speed-and-raising-alarm
Richard Pestell keynote: ‘Breast cancer and therapeutic targeting via CCR5”
https://www.facebook.com/KomenPhilly/photos/presenting-our-keynote-address-promising-research-and-what-it-means-for-you-as-a/10156813707028325/
Nov. 16, 2019
CROI submission dates
Late-Breaking Abstract Submission
Late abstract submission opens December 2, 2019, 9:00 AM Eastern Time.
Deadline for submitting late-breaking abstracts: January 15, 2020, 5:00 PM Pacific Time
Tick Tok
Quote: Last slide
‘Sometimes it is the people no one imagines anything of who do the things that no one can imagine.’
Alan Turing
New proactive video
Dr. Milana Dolezal
https://www.cytodyn.com/clinical-trial-enrollment
Assistant Medical Director/Clinical Scientist in BioOncology Therapeutics
Genentech
https://phoamd.com/dr-dolezal
Recent Advances in Targeting CCR5 for Cancer
https://cancerres.aacrjournals.org/content/canres/79/19/4801.full.pdf
HIV HOPE HIV cure is step closer as scientists discover ‘kill switch’ that stops virus reproducing
https://www.thesun.co.uk/news/10008045/hiv-cure-kill-switch-cells-reproducing/
And again...This time 10 million shares7.5 million warrants
https://sec.report/Document/0001193125-19-234045/
5,639,500 Shares of Common Stock
Warrants to Purchase up to 2,819,750 Shares of Common Stock
https://www.streetinsider.com/dr/news.php?id=15865412&gfv=1
Annual shareholders meeting
https://ih.advfn.com/p.php?pid=nmona&article=80581920
New proactive interview.
Trump Brings Hope to Black America With Bold Measures to End AIDS
https://www.newsmax.com/jackbrewer/hiv-aids-trump-black-america/2019/08/02/id/927030/
“There just may be a very innovative healthcare solution recently developed by CytoDyn. The company is one of only a few firms to be given “fast track” approval from the FDA, meaning their new drug, Leronlimab (PRO 140) could be approved by the end of this year. Leronlimab is the first self-administered therapy for HIV that has reached late-stage clinical development. It’s a major game changer for those living with HIV, because unlike most current therapies, it doesn’t require any pills.
“We have patients who have gone 18 months without any pills,” says Dr. Nader Pourhassan, CytoDyn CEO. “Some patients had up to seven pills a day, they put all of it away, and we are very proud of those results.” Recent clinical trials have shown that Leronlimab does not negatively affect normal immune functions, but it does block the HIV co-receptor on T-cells. These trials also found that using Leronlimab can significantly reduce viral burden in people infected with HIV.
CytoDyn and Leronlimab have been garnering major buzz in the news, they’ve even been noticed by actor Charlie Sheen, who was recently diagnosed with HIV, and has applied to be a part of CytoDyn’s trials. With blacks representing nearly half of the Americans infected with HIV, I am reaching out to the company to ensure that they have an accurate representation of African Americans in their upcoming trial.”
CytoDyn to apply to enter phase 2 for colon cancer
Another interview.
CytoDyn Inc. (OTC: CYDY) HIV therapy nearing FDA approval + drug pipeline with blockbuster potential
https://shows.pippa.io/wall-street-reporter/episodes/cytodyn-inc-otc-cydy-hiv-therapy-nearing-fda-approval-drug-p
CEORoadshow Interview with CEO of CytoDyn, Inc. (CYDY)
The new HIV treatment that Charlie Sheen wants to try
The full Yahoo Finance video has this as a title. Strange as Charlie sheen was already receiving leronlimab (Pro140).
Charlie Sheen: https://abcnews.go.com/GMA/video/charlie-sheen-life-revealing-hiv-diagnosis-44701826
Full video: https://finance.yahoo.com/video/hiv-treatment-charlie-sheen-wants-163449846.html
Recent Advances targeting CCR5 for Cancer and its Role in Immuno-Oncology
http://cancerres.aacrjournals.org/content/early/2019/07/10/0008-5472.CAN-19-1167
AIDS drug accelerates stroke recovery
In a study in Tel Aviv, stroke survivors without a functioning CCR5 gene showed significantly better improvements in motor skills, language, sensory function, memory and attention.
The drug maraviroc blocks CCR5 and slows HIV progression. Carmichael hopes the same mechanism will accelerate stroke recovery.
https://www.wndu.com/content/news/AIDS-drug-accelerates-stroke-recovery-511793761.html
The cat out of the bag?
Each diagnostic test may use 20 micro mg of PRO 140, implying significant revenue opportunity for CytoDyn, since any use of leronlimab for commercial purposes will require this diagnostic test,” said Dr Pourhassan. “Bottom line, this is a small first step in realizing full value from PRO 140.”
“We are excited about the potential to utilize the PA-14 and/or PRO 140 diagnostic test throughout our franchise, including in diagnostic tests that we will be conducting for major pharmaceutical and life science companies,” said IncellDx CEO Bruce Patterson. “It is important to note that the diagnostic test using PA-14 and/or PRO 140 is performed in vitro.”
1. Leronlimab diagnostic test to determine efficacy potential of leronlimab and to customize dosing based on CCR5 receptor density.
2. Use of leronlimab will require this diagnostic test
3. Only one company developing leronlimab
4. ‘Life sciences’ company = cydy
5. Major pharmaceutical company = ?
Thoughts?
Check that: Looks like Pinot Noir (1.5 liter)
Check out OPENED champagne bottle. Top right.
Premarket Notification 510(k)
https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k
Worcester news
Final results and key points
1. Mean baseline viral load was 21,104 copies/mL
2. After @6 months of therapy, 81% had viral load <50 c/mL
3. After @6 months of therapy, 92% had viral load <400 c/mL
4. No serious adverse events reported during this period
5. No discontinuation of therapy reported during this period
6. Patients enrolled had documented resistance to >9 ART drugs
POSTER PRESENTATION: Final Results of Pivotal Study of PRO 140 SC in Heavily Treatment-Experienced HIV Pts
https://eventpilotadmin.com/web/page.php?page=IntHtml&project=ASM19&id=191
ASM Microbe conference on June 21, 2019
Following FDA approval, ReWalk commercializing stroke device
In the U.S., I describe this as a Main Street product. There’s about 1,00 Tier 1 centers that will be candidates initially. Behind that, there’s 10s of thousands of smaller centers. There will be typically multiple devices per center at this price point.
https://www.wbjournal.com/article/following-fda-approval-rewalk-commercializing-stroke-device
CytoDyn stock jumps as investor focus shifts to leronlimab as CymaBay flames out
https://www.proactiveinvestors.com/companies/news/221916/cytodyn-stock-jumps-as-investor-focus-shifts-to-leronlimab-as-cymabay-flames-out-221916.html
Humanigen teams up with Kite Pharma (Gilead)