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Posting link to BIOMM English version of their recent 2Q investor presentation & formal filing.
Cytodyn is mentioned prominently and appears to be a welcomed source of future revenue for them.
Scroll down first page to CVM filing presentation. Hope it takes-
http://ri.biomm.com/default_en.asp?idioma=1&conta=44#
Lets look on the bright side, the last time they unjustly enriched themselves they worked like gangbusters to pump the PPS!
I've been a vocal critic of NP- Would like to see him removed along with Naydenov-- Just not with the players submitted as replacements-
While I do endorse some management changes, just noticed that ticker symbol ECOR is
run by Errico & Staats - and has dived from opening IPO price of $18 to $1.18 - So maybe these guys aren't the captains were looking for either
https://finance.yahoo.com/quote/ECOR/profile?p=ECOR
Grip:
Been waiting for this day for far too long. What a deceitful POS Pourhassan is-
The new group has all my ( and remaining group) votes- Send this guy & useless crony BOD packing-
Are you kidding me? I've been here 4yrs.+ and the one constant shareholders can count on is Pourhassan's broken promises. His ethics, competency and credibility amount to zero. If he actually cared about investors ( and patients) instead of feeding his immature insecure ego, he'd never set foot in front of a microphone again.
A complete train wreck of a CEO- The one thing that would assuredly give the PPS a pop tomorrow is if he announced he was stepping down.
AbbiVie would seem more plausible as they're already in line to receive 3.5% of net sales for at least 10 years via a royalty/DLA license agreement through Progenics. They have international reach and shouldn't be all that difficult for the parties to come together on a mutually beneficial partnership.
AbbiVie is going to face tremendous competition for Humira sales in 2023 as that's when patent protection finally expires and already six bio similars have been approved by FDA. Facing potential huge loss of revenue-
Your wrong- Per the recent 10k they had $18 million as of 8/31- and burning $10 million+ monthly and actively hiring. So unless you know of warrant exercises that the rest of us don't -
As our grand leader instructs, see the filings if want accurate information-
Sums it up beautifully- The great fundraiser has taken us back to the point & position of having to find money under PPS with warrants- Awful-
Howard:
Gilead has now partnered with Humanigen so they'll be pushing hard to see that particular trial to finish line ASAP- not to mention their are at least 300+ CV-19 trials underway around the globe, many in the U.S.- However we do have one advantage as many of them are focused on non-hospitalized moderately sick patients.
I think Regeneron will be the next to be approved, likely Lenzilumab soon because of NIH/Gilead connections. And Red Hill/Opaganib & Kiniksa/Mavrilimumab are also making strides- and a few others are moving along ( Anakinra, Gimsliumab, Mesoblast, Acalabrutinib) but trailing Leronlimab at this time.
I'm not as sold on Aviptadil ( due to management) as others
Current reports say 250k-300k new infections daily worldwide so the patient population requires that a multitude of effective therapies be found. More than enough need to feed all the hungry pharmas
Lawman:
I agree with you regarding NP - and todays interview only cemented those feelings. How dare he take obscene amounts of shares to enrich himself when the company is burning $10million+ per month - and right about now very low on funds-
But more than that he refuses to accept any blame for the current share price, instead telling loyal investors who've propped up the company for years to sell if they don't like it. Anyone with an inkling of foresight would've had the NASDAQ up listing application prepared and submitted in early June anticipating a rise in PPS. Their was a seven week window from 6/21 to 8/13 where we traded above $4.00 and likely could have completed the jump.
And that would have cured both our public relations & money problems- Where's the funding going to come from now? They need at least $120+ million for twelve months operations- and another $60 million minimum to Samsung- A huge and costly error not to be on the big board-
I've been buying/selling for nearly four years and often a critic of NP's management style and shortcomings - HOWEVER - enough already with the threat of lawsuits, investor uprisings and storming the castle with pitchforks & torches.
Any experienced investor would know well ahead of placing a bet that in and of itself a small start up biotech company pumping one drug with limited capital is an inherently risky proposition and should be prepared for a wild long term ride to the finish line- and pray that you even see a profit. So all the crap your whining about comes with the territory. Get over it or get out.
NP certainly isn't perfect, nor a true visionary ( even high profile leaders like Jobs, Musks, etc have many detractors) - but to his credit when presented an opportunity he works tirelessly to find if their might be a favorable outcome for investors. And for those crying foul, he's not the autocrat you paint him out to be. He's surrounded and advised by an ever expanding seasoned team ( excluding Mulholland) of medical, scientific, drug trial, legal and general business professionals.
I'm bullish, optimistic and looking forward to next twelve months. The keys are unchanged for me;
1) Up List 2) FDA approval of ANYTHING - Off to the races. And for those still frightened by the thought of jumping to the NASDAQ without approval or revenue, don't be. At least 50%+ of the 380 companies listed in Barcharts biomedical sector have zero revenue or negative earnings and often trade at $20+ -
Lastly, I appreciate and admire that NP works as long & hard as he does for investors- And lets not forget that right now he's doing so in very unsafe hellish conditions. The fires that have torn through Washington & Oregon have devastated entire communities and he's living/working right in the heart of that tragedy and threat- GLTA
I've been here nearly four years and still waiting for the two things most important to drive PPS;
1) Uplist
2) The FDA approval of ANYTHING
Pretty simple formula - get it done-
Jay:
The company does not have 12 months of operating capital- they had approximately $44 million at beginning of August and they burn at least $7 million monthly- So possibly six months - and they have hefty lump sum payments to Samsung and royalty fees to a number of parties upon certain milestones met-
Unless many of the remaining warrants are exercised, they'll be scrambling for cash at Thanksgiving-
Be easy to sell 10 million shares at hopefully $6+ to get to HIV revenue- Who knows? So many balls in the air-
Grip:
The bottom line hasn't changed with this bet, it's now and has always been, can the science outrun the shortcomings of management? And it's still a dead heat-
Thanks go to Pestell, Patterson, etc who are credited with "waking" sleepy original management to the news that PRO-140 was much more than a one trick pony and fortunately for we early investors be given the opportunity to suddenly be holding a ticket at 10 to 1 odds - and cash in accordingly -
Howard;
As has been the nature of this ride for my forty+ months on board, it's never been subject to more potential scenarios - and wild speculation than it is today. However one thing that is easy and true to measure is the burn rate. The 10K reveals the company running trough approximately $8 million monthly, the YOY increase appropriately so given the increase in open trials, manufacturing, employee hiring and additional consultants.
What we seem to have in the bank ( without knowledge of any near term warrant conversion) as of 8/1 is $44 million or approximately six months of OI. Reality is we'll need $150 million in coming twelve months to cover operating expenses, myriad of royalty payments & hefty lump sums to Samsung & other manufacturers.
It's reasonable to assume we won't see any HIV revenue for twelve months, so If we're unable to garner FDA approval for CV-19 or forge a meaningful news worthy partnership for CV-19, Cancer, NASH, etc-- not a huge concern ( but would be a big investor & PPS letdown) just sell shares at $10-$12 ( here's the guessing game) as needed.
As I've seen in my 30yr+ investing, the general rule of pre-revenue bio-tach stocks has been that they can hold water & appreciate when having a "compelling" story to tell/sell and able to easily fund operations until revenue kicks in or partnership/acquisition occurs. - I know we're a solid bet at $3 to $4 - growth potential is enormous- GLTA
Their are vastly different conductors driving the trains- One has traveled to the depths of space and back, the other can't find his way to Hussongs Cantina-
Hello Misui:
Hope your well & healthy knowing CV-19 is tearing through Florida. I believe we have a fighting chance for approval in MM with just the 86 patient data sitting in FDA/CDER's lap. Once the findings are unveiled & published they'll be under tremendous pressure & scrutiny from citizenry & physicians clamoring for ANYTHING that proves it can slow/stop the rampaging virus and save lives.
In 2019 the FDA approved 48 "novel" drugs and we certainly meet that definition, especially the "first-in-class" category which is the "drugs indicator for strong positive impact on the health of American people and OFTEN having "mechanisms of action" different than those of existing therapies"- And frankly we meet the definition for Priority Review, BTD & Accelerated Approval.
On top of that we have a science advisor ( Dr. BP) who on June 18th shared he'd " SEEN data from two FDA trials on HUNDREDS of patients over multiple, multiple weeks of therapy and was excited & hopeful about the possibility the drug can keep patients from transitioning from mild/moderate to severe disease
state & for those in critical condition saving lives" --
https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2019
Those HIV drugs are like comparing apples to donuts - or maybe a cough to cancer. We're lightyears superior to them in every aspect. IMO the CV-19 treatment field has been whittled down to eight or nine others along with Leronlimab;
1) Mesoblast- Ryoncil - Showed great promise, been aggressive with trials, has a 300 patient PH III underway. NCT 04371393
2) Kiniksa - Mavrilimumab - Also showed promise, has two FDA trials underway- PH II with 60 patients, another is PH III 160 to 420 patients.
3) Humanigen - Lenzulimab - Another with encouraging early results- Have PH III trial planned, not sure it's recruiting yet
4) Anakinra - Also encouraging early results- Has aggressive PH III trial underway throughout Belgium.
Likely not the "broad" spectrum cure Leronlimab might be.
5) Acalabrutinib- Calquence- The CALAVI worldwide trial has been slow to start I believe
6) Red Hill- Opaganib/Yeliva - Have Phase II/III trials in United Kingdom with 270+ patients and smaller 40 patient trial in America
7) Incyte has the 400+ patient "RUXCOVID" worldwide study slowly ramping up -
8) Regeneron also just starting PH III study of it's "two-fisted" antibody drug.
I think Cytodyn might have a leg up on the field with respect to unblinding trial results in the coming weeks- Most of these competitors have a longer road ahead - Although we don't have much or any lead time in relation to a couple of these companies that are conducting parallel PH III trials with severe patients
Daemon57:
Thanks for sharing this link and news. Appears these results are from a 19 patient trial, would expect them to ask FDA for new Ph III protocol. The Calquence/Acalabrutinib results are certainly most similar to ours, however that BK-Inhibitor carries many more potentially harmful side effects.
What I love about the story is that Aztra Zeneca bought the rights to Calquence in 2015 for essentially $7 BILLION dollars- The drug was finally approved for one use in 2017 and first year sales 2018/19 were only $108 million--
Now that's a partnership deal we all could embrace-
That was the most forceful, informative and compelling interview to date. He seems utterly confident in the trial outcomes and we should see results in five weeks or so- Wish he could be the permanent voice & face of the company-
Yes, I was invested in Cytosorbents ( Novel Blood Filter to Reduce Cytokine Storm) CTSO from 2012-2015. They traded between .08cts-30cts for years and as they're we're nearing EU approval, primarily in German hospitals, they effected a 25 to 1 spilt- My 450,000 shares at .12cts became 18,000 at $3.00.
I & most investors very much welcomed the move as they were loaded down with 650 million shares that suddenly became a very tight 26,000,000 - they crossed over on Dec. 1st 2014 at .21cts or $5.25 and held there for thirty days then gradually over the next 60 days ran to $13.00
So my one/only experience with R/S was very favorable- They've bounced around in past five years from $3.00 to $15.00 -- Cytodyn has a universe of possibilities compared to CTSO, that's why it's my repeated hope they will find the way/huevos to crossover at $4.00 minimum, or $5.00 preferred to give every institutional investor, hedge fund, etc the opportunity to push us much much higher--
I concur with those that see this insert news as a positive sign, FDA reviewed and responded to the submittal quickly. I expect approval within four months of a formal PDUFA date. This week the FDA granted Novartis accelerated approval for their lung cancer drug Capmatinib in three months stating they " are keeping the trend of approving cancer/other therapies ahead of schedule" - especially with a rolling review-
Also noticed that Leronlimab was mentioned along with a host of other therapies as a possible answer to Covid-19 in the very thorough abstract linked below - GLTA
https://www.nature.com/articles/s41577-020-0331-4.pdf
In the event anyone wants to send information to many of these partners I'll post the Scientists to Stop Covid-19 manifesto ( signed) below in PDF attachment.
For example, Dr. Stuart Schreiber is Stuart_schreiber@harvard.edu
Dr. Michael Lin. is mzlin@stanford.edu.
Hit them with relevant Cytodyn news & information
https://static1.squarespace.com/static/5bbd597c34c4e25c7a1fe46f/t/5ea9ec739d6bf9244ec0dce3/1588194420398/Scientists_to_Stop_COVID19_2020_04_23_FINAL.pdf
Hello Bulldog:
Apologize if this is redundant information, passing along link to full PDF Patterson paper
https://www.medrxiv.org/content/10.1101/2020.05.02.20084673v1.full.pdf
Thanks for posting link
Too many posts for me to review, just leaving link to the full PDF at MedRxIV.org
https://www.medrxiv.org/content/10.1101/2020.05.02.20084673v1.full.pdf
Hope this takes- GLTA
They need more than warrant money to hit the big time- and by that I mean the NASDAQ at $4.00+
They're burning $7 million+ monthly in current operations and will owe Samsung $60+ million ten months from now--
So government and/or foundation loans/investment will be necessary to pay manufacturing cost as it's unlikely we'll see much revenue ( more manufacturing) from HIV combo sales- And they've got milestone & royalty payments due to others as well.
They need a partnership(s) with at least $50 million in upfront cash to properly fund operations and up list without a reverse split-
Agree with all you said, however the BIGGEST problem is being stuck on the OTC- we suffer from a glaringly lack of credibility, major media & analyst coverage, and of course the ocean of institutional investment that would flow our way-
These daily 10%-15% PPS declines will remain commonplace until we're playing in the big leagues-
Great call, incredible story unfolding- And to reinforce the RANTES discovery here's a link to article published today about Regeneron AND Sanofi showing poor CV-19 results when hitching their wagon to IL-6 --
And please send a thank you to Dr. Pourhassan/Team for their around the clock efforts to bring Leronlimab to as many patients as possible, and this amazing drug to the forefront of scientific and public consciousness.
https://endpts.com/covid-19-roundup-nih-remdesivir-data-in-next-one-or-two-weeks-chinese-vaccine-candidate-comes-to-canada/
And their's the rub, we're still groveling in the minor leagues. The Toledo Mud Hens of the OTC- Can hit sixty home runs, still only going to get paid $7k per month-- Trust me, I'm thrilled with the formal BLA filing and progress in other indications, however we're seeing diminishing PPS returns because of where we play--
On the NASDAQ be $10+ easily and could shed all the BS & flies that call OTC home-
BTW- Feel free to send Kush Dhody a note of thanks, a generally unrecognized crucial part of CYDY's success. kushd@amarexcro.com.
Thanks for sharing the link
Actually the lowest warrants/options price was .19cts-- No matter the figure, enough of them we're converted during the third quarter & thirty five days afterwards to help fund operations. Dr. NP has publicly stated often he hopes to continue funding the company in tis manner. Believe their is approximately 140 million left at .60ct-.65ct average- or approximately $85 million-
I don't think anyone can know what the holder of a .25ct warrant/option might do. What is certain is that the company has approximately $31 million in the bank which gets them to end of June or early July, and hopefully can raise another $15 million through additional conversions to carry them through August.
Attaching two articles. One a dual authored paper published in Science Magazine regarding the Cytokine release syndrome in severe CV-19 patients and the authors opinions of best drug therapy - and another from Endpoints newsletter that speaks to the FDA approving a couple of drugs early, prior to PDUFA dates.
If the BLA is finally submitted by end of April I think we stand a decent chance of approval in four months- The FDA is very familiar with the efficacy & safety and should have already reviewed first portion-- No reason they can't stamp it approved in four months- And I hope we're on the NASDAQ prior to then to really watch the PPS take off
https://science.sciencemag.org/content/early/2020/04/16/science.abb8925.full
https://endpts.com/with-third-fda-approval-seattle-genetics-plans-virtual-launch-of-metastatic-breast-cancer-drug-amid-coronavirus-pandemic/
Not sure how much is panic selling or just the conversion of warrants & options- Per the 10K- Forgetting the most recent quarter that ended Feb. 29th, subsequently from March 1st to April 6, 29,357,527 shares were issued in connection to the exercise of warrants/options resulting in proceeds of $7.4 million- Or approximately .25cts per conversion- Thats a sweetheart deal, quick 10 bagger
Over on Happy Hangout board they're is a mildly heated debate about future PPS & buy-out numbers - of course ranging from $5/8 to $100 -- Regardless of the figure mentioned, nobody took into consideration that the most important factor to valuation is simply BEING on the NASDAQ.
For biotech stocks you can throw out any conventional valuation methodologies as it's truly a future "story" that's being sold. However two things that nearly every pre-revenue company have ( priced over $30) is a healthy relationship of cash on hand in relation to shares outstanding. It's uncommon the see these companies with less than $100 million in cash and more than 40 million in OS--
So along with up listing we have to somehow flip the numbers we're now saddled with - Hate to see us crossover with 600+ O/S. - but another partnership and the conversion of many of the remaining 140 million or so warrants/options would pad the account by $100 million+-- Which we'll need since we're now burning $7 million monthly and have substantial payments due to Samsung
Our story is still early & unfolding, so dream on-
I already sent it to you, quit wasting everyones time with your BS
Here's the contact info- he'll usually respond ASAP to text, email or phone call-
https://www.cytodyn.com/contact
Good luck
Yes, of course we have a CHANCE- they should be able to enroll 75 patients in the mild to moderate trial AND the NIH announced today that they've formed a public-private partnership to speed up COVID-19 vaccine & TREATMENT options. Of course we're not on the early sixteen person invitation list.
However I did send a message & link to NP regarding the NIH's strong desire to find Three or Four treatment options by June or July- If Dr. Patterson or Dr. Lalezari would contact NIH with the data they have in hand ( and with HIV data NIH is considering as relevant) we are very deserving of making that list
https://www.nih.gov/news-events/news-releases/nih-launch-public-private-partnership-speed-covid-19-vaccine-treatment-options
Chump:
I fired off another 30+ messages to reporters in Denver. Atlanta, Miami, Philly & Chicago, who knows , maybe one of them will take the bait and run with it.
Also sent a message to NP ( knowing he's busy 24/7) about the continued rise in positive CV-19 tested sailors on the hospital ship Mercy docked at LA harbor- Believe the seventh was reported today and hoped he might be able to find where their being held/treated - and offer Leronlimab under EIND or other use protocol
Curing our Naval soldiers, especially in LA market, would be another big boost in exposure-- BTA
Chump:
You triple down on the nitroglycerin today? Really bringing the heat STRONG!
Here's what I sent out today to approximately fifteen reporters at LA Times & Seattle Times. Who knows, it's worth a shot , and certainly the story has a Washington & California flavor( Patterson & Lalezari )to it. May not be everyones idea of journalism, but if you want/can copy/paste - or send me contacts & I'll forward the message - Best to all--
Sharing that Washington based biotech, Cytodyn,Inc, and it’s novel monoclonal antibody Leronlimab are now saving the lives of critically ill Coronavirus patients in ICU’s across America. FDA approved for Coronavirus use, first patients were treated in March at Montefiore-Einstein hospital under the guidance of Dr. Harish Seethamraju ( A true hero in fight against the virus).
After seeing astonishing early patient response ( 100% of patients benefitted) often in 1 to 7 days, the FDA quickly granted expanded access being very familiar with Leronlimab’s impressive safety/efficacy having data on 850+ HIV, Cancer & GVHD clinical trial patients. As with other indications, Leronlimab has consistently shown superb results slowing/stopping Coronavirus spread with NO side effects. Safe & tolerable - just ONE 700mg shot per week.
Doctors are clamoring for the drug, as example, Cytodyn, Inc partnered with Novant Health care systems bringing treatment to hospitals in the Carolinas, Georgia & Virginia. Further, the FDA quickly blessed TWO Ph II/III Coronavirus trials along with continuing original EIND protocol.This is the ONLY DRUG making a meaningful life saving difference in ICU's.
Leronlimab is the FUTURE of HIV, certain cancers, GVHD & now Coronavirus. Attached within is a video clip from Seal Beach California woman saved by Leronlimab as well as many of the recent press releases posted at company website. Cytodyn management & lead scientists (Dr. Nadar Pourhassan, Dr. Jacob Lalezari & Dr. Bruce Patterson) have moved with lightening speed to work with the FDA to get it’s life saving drug into the hands of doctors, saving countless lives and certainly is worthy of recognition as being on the frontlines of the fight against Coronavirus.
www.cytodyn.com CEO Dr. Nadar Pourhassan. npourhassan@cytodyn.com.
https://losangeles.cbslocal.com/2020/04/10/coronavirus-survivor-leronlimab/
https://content.equisolve.net/_db373f8119150c85817ed8f616297d92/cytodyn/news/2020-04-09_Blood_Samples_at_Day_0_3_and_7_for_Severely_Ill_413.pdf
https://content.equisolve.net/_db373f8119150c85817ed8f616297d92/cytodyn/news/2020-04-07_Novant_Health_Initiates_Phase_2_COVID_19_Trial_411.pdf
https://www.montefiore.org/body_mobile.cfm?id=1743&action=detail&ref=18574
https://content.equisolve.net/_db373f8119150c85817ed8f616297d92/cytodyn/news/2020-04-09_Severely_Ill_COVID_19_Patient_at_Leading_Southern__412.pdf