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$land is definitely a possibility. 2 things gotta happen to get there. 1. Company continues to execute their plan without delay. 2. You buy your tickets!
Good luck!
Should be interesting to watch for sure. Good luck!
WE GOT IT!
Profound Medical Receives U.S. FDA 510(k) Clearance for TULSA-PRO®
U.S. Commercial Launch Expected in the 4th Quarter of 2019
August 16, 2019 07:00 ET | Source:Profound Medical Corp.
TORONTO, Aug. 16, 2019 (GLOBE NEWSWIRE) -- Profound Medical Corp. (TSX:PRN; OTCQX:PRFMF) (“Profound” or the “Company today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market TULSA-PRO® for ablation of prostate tissue.
TULSA-PRO® is a transurethral prostate tissue ablation system that combines real-time Magnetic Resonance Imaging (“MRI”) with robotically-driven directional thermal ultrasound and closed-loop temperature feedback control software to deliver predictable physician prescribed ablation of whole-gland or partial prostate tissue. The TULSA-PRO® system is designed to provide customizable and predictable, incision-free and radiation-free prostate ablation while actively protecting the urethra and rectum with water cooling to preserve men’s functional abilities.
The FDA’s clearance of TULSA-PRO® was based on the Company’s TACT pivotal clinical trial, which met all of its primary and secondary efficacy and safety endpoints. TACT enrolled 115 patients across the United States, Canada and Europe with biopsy-proven, organ-confined prostate cancer (67% and 33% of subjects had NCCN intermediate and low risk disease, respectively). All patients received primary treatment of whole-gland prostate ablation with sparing of the urethra and urinary sphincter. TACT demonstrated that the TULSA-PRO® provides safe and effective prostate tissue ablation, with minimal adverse events, significant prostate volume and PSA reduction, and low rates of residual prostate disease. The favorable safety profile offered by the TULSA-PRO contrasts with radical prostatectomy and radiation therapy that can leave many men with permanent erectile dysfunction, urinary incontinence and bowel dysfunction. The TACT study also demonstrated a favorable risk-benefit profile in the context of other ablative approaches, including whole-gland HIFU and cryotherapy.
The FDA label for TULSA-PRO® will allow U.S. surgeons to perform prostate tissue ablation procedures indiscriminate of tissue type, including malignant and benign.
“We are pleased with the FDA’s expeditious review of our application,” said Arun Menawat, Profound’s CEO. “We believe this, combined with the label that the Agency approved for TULSA-PRO®, serves as a testament to our technology’s strong clinical profile.”
“While we have been conducting a limited commercial launch of TULSA-PRO® in select CE mark jurisdictions over the past few quarters, in many respects, we only just crossed the starting line following the recent reporting of the positive TACT trial clinical results and today’s announcement of FDA 510(k) clearance,” continued Dr. Menawat. “The feedback from physicians using the system in Europe, and from key opinion leaders in the United States who have first-hand experience with the technology as TACT trial investigators, has been very positive, particularly regarding the ease-of-use, efficiency and flexibility based on patient needs; in addition to its excellent patient tolerability and short recovery periods. Given this interest and feedback, we are very much looking forward to working with our strategic partners, Philips and Siemens Healthcare, in concert with our direct sales and marketing teams, to prepare for the U.S. commercial launch of TULSA-PRO® in Q4-2019.”
About Profound Medical Corp.
Profound develops and markets customizable, incision-free therapies for the ablation of diseased tissue.
Profound is commercializing TULSA-PRO®, a novel technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO® is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient’s natural functional abilities. TULSA-PRO® is demonstrating to be a flexible technology in customizable prostate ablation, including intermediate stage cancer, localized radio-recurrent cancer, retention and hematuria palliation in locally advanced prostate cancer, and the transition zone in large volume benign prostatic hyperplasia (BPH). TULSA-PRO® is CE marked and received 510(k) clearance from the U.S. Food and Drug Administration in August 2019.
Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve® has also been approved by the China Food and Drug Administration for the non-invasive treatment of uterine fibroids. The Company is in the early stages of exploring additional potential treatment markets for Sonalleve® where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.
Forward-Looking Statements
This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, uterine fibroids and palliative pain treatment. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the pharmaceutical industry, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.
For further information, please contact:
Stephen Kilmer
Investor Relations
skilmer@profoundmedical.com
T: 647.872.4849
Finally had a chance to listen to their quarterly CC. Nothing is ever a sure thing but I really like what I hear from these guys. Very interesting call.....the prepared remarks were only about 20 minutes with about 30 minutes of Q&A. They made it seem as though they have aspirations of an FDA approval sometime in Q3. Great questions and worth a listen if you have time. Further reinforced my bullish stance. Good luck to all. Link to call below.
https://profoundmedical.com/investors/#webcasts
News out - New Board Member. They really seem to stress his experience with being a part of several companies that were bought out. I am not implying that a BO is likely, just stating that the co. seemed to imply that is the expertise the new board member gives to the company.
TORONTO, Aug. 15, 2019 (GLOBE NEWSWIRE) -- Profound Medical Corp. (TSX:PRN; OTCQX:PRFMF) (“Profound” or the “Company”), the only company to provide customizable, incision-free therapies which combine real-time Magnetic Resonance Imaging (“MRI”), thermal ultrasound and closed-loop temperature feedback control for the radiation-free ablation of diseased tissue, today announced the appointment of Steve Forte to its Board of Directors. The appointment of Mr. Forte, who will serve on the Board's Audit Committee, increases the size of the Board to seven members.
Mr. Forte is a senior finance leader with broad experience managing complex, large-scale finance environments. Most recently, he served as Chief Financial Officer at Clementia Pharmaceuticals Inc. (NASDAQ:CMTA), which was acquired by Ispen S.A. for approximately US$1.3 billion in April 2019. Before joining Clementia, Mr. Forte was CFO of Thinking Capital Financial Corporation, a leading financial technology firm, which he helped lead through rapid growth and ultimately to a successful sale of the company to Purpose Investments. Prior to that, Mr. Forte’s experience includes nearly a decade at Aptalis Pharma Inc., where he was responsible for the overall corporate controllership function of a multinational pharmaceutical company with approximately $700 million in annual revenue, six operating companies, five manufacturing sites and 40 subsidiaries. Mr. Forte led Aptalis’ preparations for a U.S. IPO prior to the successful sale of the company to Forest Labs for US$2.9 billion. Mr. Forte received his Bachelor of Commerce in Accountancy from Concordia University and is a CPA/CMA.
“On behalf of everyone at Profound, I am very pleased to welcome Steve to our team,” commented Brian Ellacott, Independent Lead Director of the Company’s Board. “Steve is not only an experienced financial executive in the life science industry, but also has a breadth of relevant NASDAQ listing and M&A experience that could prove to be invaluable as Profound executes the next stages of its growth strategy. I am confident that his expertise and guidance will be of significant benefit to the Company and its shareholders.”
About Profound Medical Corp.
Profound develops and markets customizable, incision-free therapies for the ablation of diseased tissue.
Profound is commercializing TULSA-PRO®, a novel technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO® is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient’s natural functional abilities.
TULSA-PRO® is CE marked and commercially launched in key European and other CE mark jurisdictions. TULSA-PRO® is demonstrating to be a flexible technology in customizable prostate ablation, including intermediate stage cancer, localized radio-recurrent cancer, retention and hematuria palliation in locally advanced prostate cancer, and the transition zone in large volume benign prostatic hyperplasia (BPH).
In April 2019, Profound announced positive topline results from a multicenter, prospective clinical trial, TACT, which is expected to support its recent application to the FDA for 510(k) clearance to market TULSA-PRO® in the United States.
Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve® has also been approved by the China Food and Drug Administration for the non-invasive treatment of uterine fibroids. The Company is in the early stages of exploring additional potential treatment markets for Sonalleve® where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.
Forward-Looking Statements
This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, uterine fibroids and palliative pain treatment. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the pharmaceutical industry, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.
For further information, please contact:
Stephen Kilmer
Investor Relations
skilmer@profoundmedical.com
T: 647.872.4849
Janey - I don't agree but many do seem to have that opinion. Good luck to you!
My quick take on yesterday's call:
Perfect call for institutions IMO. Retail hears a year before NDA, tutes hear very high likelihood of success with no need to raise capital.
No comparison whatsoever, but think Tesla or Beyond meat. Yes they have revenue, but they loose cash consistently. Tutes are heavy here cause they know (or have a great expectation anyway) that the future is bright. When do the huge drops happen.....capital raises. Tutes are going to be more than happy to let retail panic, day traders do their thing, and let shorts play while they steadily accumulate. I really believe we are heading into a new territory in the next 6-9 months (maybe sooner) when tutes will determine the stock volatility and not retail. Does that mean we get rich today or tomorrow...no. The PPS can go way up or way down....if I had to guess, I would bet it will do both at some point. Perfect for day traders..... that's just not my game and I won't try to guess near term fluctuations.
But what I do think.
1. CRMD is highly confident, that is obvious.
2. Why the little anecdote about bringing in a more experienced, BF type player to partner with oncology? I think they have a plan in process.
3. My valuation has only increased. Just the 40M hd locks is huge.
I am, have been, and remain bullish. Everything above are my opinions only. Notice I said "think or believe" a lot as I don't know anything!!!
Good luck all!
Short answer is no, but things to consider about Cormedix and other similar companies. There is a relatively high retail investor presence with high expectations of what is going to happen tomorrow or today or in the next hour. Many are playing with scared money and sell when they start seeing a down trend or start Cadillac shopping when there is an uptrend. This makes the stock prone for big swings inviting day traders to the party. This creates great opportunities for shorts to play the game. Most wild pre and post movement swings are on a few shares. Is this MM sending signals to each other, a retail investor scared and dumping his/her 50 shares, or a retail investor buying way to high cause sticktwits says it's going to the moon? Who knows, but I don't care about meaningless swings myself. This type of movement will only stop once the volatility slows or there is a much higher institutional stake. Tutes seem to be buying in Q2. If their holdings can eventually get to 50% or so, the games you see will slow. Right now, I think everyone can make money here.....traders, shorts, and longs......pick your poison. I am staying long cause that is all I do. All just my opinions. Good luck to you.
Regardless of market reaction that I won't even try to guess, I thought this was a very positive call and am pleased with the update. The most important thing to me is their current cash position. If a buyout is going to happen, will be in next 12 months.....If not, seems we have a clear path to US distribution. Almost makes me want to buy more! Just my opinions! Good luck all!
Saw this in another board for BGSM compliments of Rob Cos. But I thought it was very interesting and pertinent to our Profound investment and shows the possible value being placed on non invasive use of robotics to perform certain procedures. Totally different type of condition being treated but interesting none the less.
Germany's Siemens Healthineers to buy U.S. firm Corindus for $1.1 billion Germany's Siemens Healthineers to buy U.S. firm Corindus for $1.1 billion
Healthineers is paying $4.28 per share for Massachusetts-based Corindus, which develops robotic systems for minimally invasive vascular therapy procedures, a 77% premium to the U.S. company’s closing price on Wednesday.
Systems produced by Corindus, which has approximately 100 employees, allow doctors to guide catheters and stent implants with controlling modules.
Corindus made a loss of $35 million last year on revenue of $10.8 million. But Jochen Schmitz, Healthineers’ finance chief, told analysts on Thursday he expected the unit to post a profit in 2023.
Corindus’ board has approved the deal, Corindus said in a statement, but the deal is still subject to shareholder agreement.
“We believe the transaction will deliver immediate, compelling and certain value to all Corindus stockholders,” Corindus Chief Executive Mark Toland said.
Rival Philips (PHG.AS) is the second-largest shareholder in Corindus with a 12.8% stake, according to Refinitiv data. Healthineers’ Schmitz said he doesn’t expect a counter bid from the Dutch company.
A Philips spokesman said the company was reviewing the announcement and wouldn’t comment further
In 2015, Philips bought U.S. medical equipment maker Volcano, specialized in equipment for minimally invasive surgery, for $1.2 billion, strengthening its position in image-guided therapies.
Siemens and Corindus said the deal is expected to close by the end of the year.
Reporting by Alexander Huebner in Munich; Additional reporting by Bart Meijer in Amsterdam Writing by Tom Sims; Editing by Michelle Martin and David Holmes
Our Standards:The Thomson Reuters Trust Principles.
And we find ourselves once again at one of the the most overhyped yet underwhelming days of the year.....the quarterly update. The day where it is revealed that some random small cap company ( in this case, Cormedix) has been keeping huge secrets of success waiting for this very day to announce stock spiking FDA or buyout news. Anyone who knows me knows I am a CRMD bull, but big spikes on earnings day is generally for companies with earnings! Yes, I hope some big reveal will come forth and push the PPS to $50, but my expectations are tempered. Let's hope the cash burn hasn't exploded while they work through FDA approval, let's hope for a little more clarity on already known FDA approval guidance, and let's hope they don't need cash in the forseeable future.....but I am not going to assume they are withholding information to reveal today. That's how shorts win after most small cap quarterly updates. Preying on the vulnerable hoping for a miracle. Good things are coming and I am long and bullish here! If you are a trader, then yes, you should pay attention.....if you are long, relax and enjoy the ride on the longest bumpiest road in the word in our Cormedix bus with no shocks!! I know there is no real pertinent info in this post and everything is just my opinion.....just had to get this off my chest. Good luck to all!
Thanks Janey. I just try to be careful when talking number of shares or $$$. $10k for example can be chump change to some and a fortune for others. Bashfulness aside, I'd say my trigger is bigger than average.....
Mrdecember - I certainly don't want to mess with any good mojo so I promise anything said that was a secret is safe with me! I completely agree with your patience strategy here. If everything works out, could be a very nice long term reward. Emphasis on the "if" cause nothing is a sure thing....but I do like what I see here a lot. Have a great weekend and good luck to you with all your investments.....even the secret ones!
Hey Chilar - Thanks and I agree that's what I should and probably will do when ready to pull the big trigger....well, at least as big of a trigger as I've got anyway. I was able to add some today albeit not a huge amount. Kinda want to see how the CC goes and how the share price reacts - if it reacts at all - before I free up some more substantial powder to put into this. Good luck and I appreciate the feedback!
Appreciate the tip and added confidence. I too have recurring unfilled bids but have gotten lucky a couple times over the last week. Very thinly traded makes you have to go get them which is a little outside my comfort zone, but alas...I am usually only a penny or 2 under the ask so I really should just man up and go get them. Appreciate the feedback! Good luck to you!
Hey Chilar! Full transparency, I would consider myself a newcomer to PRFMF. But when in, I tend to get as much info as possible and follow as much as possible, especially with these small nano and small cap ventures. There is a lot to like here and I really am excited about the future. Disclaimer on the above: Just my opinions and I am no professional. Congrats to you PAYS folks out there. Wish I had a piece of that over the past year or two. Haven't finished looking into them fo an entry now (obviously I am late) but certainly looks good and has definitely performed well for you guys. Good luck to you!
The presentation they gave yesterday is up on their website. A lot of the same info we have seen in the past, but there was some good info during the short Q&A period. They seem pretty bullish on FDA approval and they also seemed a little more clear on their proposed US rollout than I remember hearing them discuss in prior presentations. Just my opinion about the webinar. If you have 25 minutes, I think it is worth a look. Looking forward to next week's quarterly update! Good luck everyone!
Sounds like a plan. Work had me glued to my desk today and I just checked today's action. Can't say I wasn't expecting it, but I got slaughtered on the broader market today. Let's see how it shakes out.....a lot of international and geopolitical turbulence right now. After a quick look, I think the only sector I own that is up is crypto.....and I hate crpto cause I have no idea how it works....lol! Changes nothing with my current outlook for PRFMF. I continue to be bullish. No opportunity to buy today for me, but I think we have a little time. I am really interested to see what comes of the quarterly call next week. This could be really good with continued revenue growth, or somewhat bad with some kind of approval delay. I honestly have no clue what to expect, but I will be listening for:
1. Q2 revenue....does it grow from Q1?
2. FDA approval update/ clearer timeline
3. Asia focus: how is it looking....any color to sales progression, leads, overall update.
4. Cash burn, cash on hand....are we still in good shape?
5. Do they share info in their aspiration to get listened on NASDAQ? This was mentioned in PR and annual shareholder meeting voting. This is where big money comes in if they can get listed.
I see more positive catalysts than negative to be discussed during the conference call. Looking forward to it.
Finally, I own shares, looking to add more. I am bullish on this company but am not a professional and could be totally wrong. Everything above is just my opinion. Good luck to all!
Totally agree. The non invasiveness and predictability of their procedures and seemingly the only game in town with this type of procedure has me bullish. I am also reading the tea leaves here....prostate cancer, while a large market in its own right seems like it is more of a proof of concept than anything. If and when this gets approved, I can see them taking this tech to the next level with other indications. For now, their focus is on Asia sales and U.S. approval. Your 6-8 months seems fair for their current focus, but I think it could be much bigger than that in 2 - 3 years. I also think anything under a MC of $125M is a great price.....mainly cause I think they need to be at $160M just to make it to NASDAQ with seems like a goal. I think they could be profitable if Asia sales go well and US gets approved pretty quick. NASDAQ listing thereafter and they self fund future trials and indications and grow their business into something real special without dilution. Basically, I see a long list of bullish catalysts for the next couple years.......and not typical small bio catalysts like phase 1 trials and pre nda meetings......i see a long list of revenue generating and profit driving catalysts. Of course I could also see someone in this space buying them out at some point too during this period. Finally, and to be transparent, I could see bumps in the road too and I could easily be missing something. I am not a professional medical device guy or anything..... unfortunately failure could happen as always.....but I remail bullish. These are all my opinions only. Good luck to all!
Well I don't post much cause too many mean people, but this board seems pretty cordial and I really appreciate that. First, thanks to mrdecember. I saw a post on another board from him and started looking here. DD is never complete, but I have been researching and have found myself quite bullish. The last Investors call gave me some confidence and I like the current tried and true slow approach they discussed on the call. I also listened to the investors day (or whatever that was called). Hearing Doc's from John Hopkins, UCLA, etc only enhanced my positive view......these guys are the real deal! Going through the past few years PR's shows a steady progression with very few bumps along the way. Sure I got some unresolved issues. Not a fan of the share structure, and it is very thinly traded. Hard to buy and hard to sell. Thinly traded I can deal with as I am just stashing shares now anyway for a longer term hold....but most of the time you have to go get them. I am also having a hard time putting together a timetable to profitability or understanding expected revenue growth quarter by quarter going forward. I will keep working on that. I think it is good they are looking at getting a NASDAQ listing, but will be interested to see how they can accomplish it. Need to grow the MC and might need a split to get to $4 for a new listing. But this doesn't concern me at all and will be a good move if they can get this goal accomplished. Seem to have plenty of cash on hand though Q4 costs should rise as principal payments come due on their loan in October....still see no reason for a raise in quite some time (in my opinion) and I do think sales will increase. Questions aside, the tech seems pretty legit, they have a clear plan, and I think that obviously a lot is riding on their 510K which I do think will get approved. Not sure if I will get rich tommorow, but I do see, in my opinion, a multi bagger. I am very excited about these guys and their future, but I am still going to keep digging into the few questions I still have. If anyone has any insight into these, it would be greatly appreciated! FYI: Established a small long position last week and will continue to add at this point. Thanks to all who read my babbling, and good luck to everyone!
Thanks Rap! Hadn't seen that article. GLTU
Not that I am anything special, but I did take an entry position today so there is at least one new retail investor involved in today's action. GL
I am pretty sure Pietro is wrong. This is just his already owned shares. The 13G shows Soon and all of his affiliates own these shares which means no other shares are owned. Here is what the 13G says about who owns it shares:
"Patrick Soon-Shiong, M.D. and ImmunityBio, Inc. (“IB”). Dr. Soon-Shiong, through affiliated entities (Cambridge Equities, LP, MP 13 Ventures, LLC, California Capital Equity, LLC, Nantworks, LLC, and NantBio, Inc.) indirectly owns a majority-in-interest of the voting and dispositive power of IB. Dr. Soon-Shiong is also the sole member of the board of directors of IB. Each of IB and Dr. Soon-Shiong may be referred to herein as a “Reporting Person."
I don't have a crystal ball, so if you think buying is good then please do. I get a lot wrong and am no professional. My take though is that it will probably get to a markecap of at or under $5M. That is where I would consider buying. There are so many variables though being OTC. I would be surprised if they don't try to register more shares with some kind of excuse of continuing clinical trials or possibly venturing into another field. Management has a lot more flexibility now which is scary IMO. The best thing they could do is nothing and hope Alox comes through as proof of concept for LADR.....but that means a slow bleed for 2 years. All just my opinions and I sincerely hope I am wrong! Good luck to you!
I could be wrong, but I do think you have plenty of time to get cheapies. In my opinion, yesterday seemed ok, but I think it is a false read. Going OTC doesn't create some unknown optimism to generate all those buys. I think shorts we're waiting for this to plummet from going OTC, which it did, then covered giving the false signal of buying interest. Just my opinion, but I think the PPS goes down.....way down. Just my opinion and I may even look to re-enter at some point (even though my brain says run). I am not a professional, but I am not going to rush to buy anything thinking it is a bargain until it shakes way down.....cause I think it could go much much lower.
Just my opinions, still hoping for the best! Good luck!
Hope all is going well Knox! For what it's worth, and this is by no means advice to anyone, I am not buying here. I am out.....again with the exception of my soon to expire worthless call options. If, and that is a big if, anything good happens, I think we have plenty of time to pick up shares at probably a huge discount to today's price.....yes, may sound crazy to many bulls, but I think this is going into OTC purgatory and could fall to a MC of as low as $5M. If there was really hope for some fancy magic deal, they would have stayed on NASDAQ. But no one is buying this company soon.....heck, no one of any importance would even buy a share of this company at .5... No institutional Investors to speak of, no BP taking an equity stake..... nothing. I feel bad for bulls, and of course I could be wrong, but I think continued trouble is in store. Good luck everyone. I will keep monitoring but no buys for me at this time. All just my opinions.
When an extension of delisting is requested by a company, a clear plan must be in the request for how the company plans to regain compliance within the extension period. I fear that CYTR sees no path to get above $1 in the next 180 days which is why CYTRX chose not to submit it.
I also think (hope I am wrong with this one) that a buyout is not in the near term based on their chosen course of action.
Just my opinions. Good luck!
Knox - Good luck with your sale. I am sure there are a lot of memories in the things you are going through and what you are doing is no easy task. I wish you the best this weekend.
As far as CYTR goes, I am going to have to admit that it looks like I was wrong. Can't see a RM happening now. Gotta be an out right sale or we could really be in trouble. They seem content to go OTC (of which there are multiple exchanges each with their own set of rules and variables). Their recent filling stated that very clearly. I really gotta think this through as I have no clue what to expect. I would assume they are content to just ride it out as a shell company on OTC and hope aldox comes through as a proof of concept in a couple years. Not prepared to make any opinion or prediction at this point. Again, I wish you well this weekend! Good luck to all!
Well, today's big headliner is not good. I hope it is wrong....OTC is not the way to go. Would be real bad for all except management.
Forgot to add that these are my opinions only.
Below is from page 33/34 of last 10K. Institutional Investors don't buy biotech companies that are closing and selling furniture. They may play a little, but no real investments will happen. I still think a RM is out there to be had, but CYTRX has turned themselves into a shell company. Hard to get good value from a yard sale. I still hope for the best, but man is it hard to see. Good luck!
Discontinued Operations
On December 21, 2018, the Company announced that its pre-clinical lab operations had successfully completed its objectives – namely, it has developed four lead compounds, LADR 7, LADR-8, LADR-9 and LADR 10 along with a companion diagnostic (ACDx). Accordingly, the Company terminated the contracts of all its employees at this location and closed the lab at the end of January 2019.
33
The Company currently has a lease expiring in September 2020 at a cost of 10,070 Euros ($11,377) monthly. However it is currently negotiating with a third party to sub-lease the premises or take over the entire liability of the lease. The Company sold its analytical equipment in March 2019 and accordingly has classified these assets as current assets held for sale and has written down these assets by $0.2 million. In addition, it plans on selling the office and lab furniture along with the leasehold improvements to a third party. The Company estimates the value of these assets are greater than their net book value and so no write-down has been recorded. The results of these discontinued operations are presented separately on the Company’s Consolidated Statement of Operations.
My take: Majority of volume occurred in 20-25 minutes. About 525k or so. Signals 1 big player followed by immediate fall off in volume, though slightly higher than usual which signals retail getting excited about "today being the day" because of the 1 player so they start buying - albeit not nearly as significant as the large volume 20 minute push. No Spidey senses yet from me. If I had to guess:
1. Maybe 1 buyer took a stake.
2. Maybe just an existing tute like Sabby washing shares back and forth, and then retail thinking something big is happening so they started buying.
Regardless, my Spidey senses need sustained pressure, not 20 minutes for me to start getting excited, and I rarely see publicly traded company (outside of pink sheets) get excited or pop over a patent. If it's a true NASDAQ company, partents should be a forgone conclusion, not a catalyst.
Maybe I am wrong, but I am just not feeling it yet. Just my opinions. Good luck to all.
But - until sustained buying is noted, I am not getting excited. Still is nice to see and I am hoping for the best. Good luck all and these are just my opinions.
Carried away is a good way to describe Pietro, but I do hope the best for him. I don't think there will be dilution cause no shares on the shelf....maybe a few, but not many. Don't think r/s cause not enough votes and it would put the share count in crazy territory unless a/s stays the same. Problem with his thinking is that he is focused on how downside and risk is limited......that is not how to invest....we need upside potential. Orphan and Aldox mean nothing to big money. If they really do work, they will invest in the companies developing the drug, not a company with 10%. CYTR hopes rest on LADR, which still need developed. The core issue is that retail sees value, CYTRX sees value, but no one else seems to see the value or the share price would reflect such. SK's biggest failure as a CEO is his inability to bring in hedge funds except notoriously bad ones like Sabby. Regardless of the company, with no hedge support, companies are forced to crush retail to fund operations. I do think there is value, but what I think is irrelevant cause the facts are, we are valued at less than $20M with our only hope for success resting in the negotiating skills of EC and SK, which to date, appear futile. Gosh I feel bad for a lot of the longs. There is still hope. You all know where I think this is headed. Good luck to all if us! All of the above are just my opinions.
I am also from farm country and your analogy fits the bill well.
I am not offering advice, just saying what I am doing which isn't always right. In the end, we are all making our bets one way or another.
I will certainly let you know if my Spidey senses start to perk up.
I do wish everyone the best of luck.
Still here Knox and I try to follow as much as I can, just not much to say that hasn't been said. I am no expert and hate giving advice, but one piece of investing advice I was given that has really helped me is that is is always better to average up than to average down. Totally counter to nano biotech investing I know, but in general, If averaging up, stock is doing well, averaging down, stock is doing bad.
1. Sabby still has their 5%. If anything changes we will know by 5/15. They may be lending them to short (probably to their own subsidiary), but they still retain ownership.
2. No, Spidey senses not going off right now.
3. CYTR is currently in no man's land. Hopefully a deal comes through, but no insider or hedge fund buys says otherwise.....these guys always know before retail does.
4. I don't see any reason for a significant PPS drop, but also don't see a reason for a significant raise in PPS. No shares on shelf for offering (gotta keep enough on shelf to cover fully diluted shares). No real catalysts except the hope of other companies coming through or CYTR sale. CYTR is basically doing nothing as a company. Sure it could flex between .38 and .7 if someone wants to manipulate it to make a few bucks.
5. Kman is trying to sell a company with a $20M valuation for $1B. Seems hedge funds aren't buying it.
6. Eventually time will run out and his hand will be forced into either a bad deal or as I have said before, a reverse merger with a private biotech.
I am still hoping for the best and there is a chance....I just don't see it right now.
My plan is to stand Pat and IF the big deal every one hopes for happens, I will chase. Unless of course the Spidey senses start tingling. This is the only time I would ever recommend chasing.....I just see better places to put my money right now. All just my opinions and is in no way meant to be advice to you or anyone. Not a bear or a bull, just calling it as I see it. Good luck!
Haven't posted much cause I don't have much to say.....Nothing good anyway. What I think is highly likely is a bad deal unfortunately. CYTR is by all (my) standards a done company hoping for a strategic transaction to bring this three ring circus to an end. That however requires intense negotiations to work. When negotiating, you need to be in a position of power. IE:. We don't need you but if the price is right....sure. The problem is, they do need someone. And every month $500K comes off the books they need someone worse. They don't have the money to run trials, they don't have shares on the shelf to raise money. Basically, the end has to be near ( less than 2 years) cause then they run out of money. SK has managed this into a crisis from a business prospective from what I can tell. I have no idea where this is going, but I find it hard to believe that it will be good. Hope I am wrong....a lot of good people in this - I am still in this. Still wishing for the best! Good luck all.
My work has me traveling a lot lately so haven't been around but I have been watching. Unfortunately I don't have a lot of confidence here. I really hope longs (including myself) make out okay, but outside of scalpers, not much going on. And will someone tell the twits that Soon doesn't manage CYTRX. He doesn't care about CYTR nor should he. And all the talk on Aldox......all they talk about is Soon and Aldox. Should just move their investment to one of the Nants who are actually managed by Soon and have the development rights and a 90% interest in Aldox. Just venting a little....but every day that goes by and the MC remains this low, the more likely a negative outcome will occur. I really hope SK has something up his sleeve! Best to all and the above are only my opinions! Good luck!
Thanks Rap. I took a big loss here and came back recently. They got some good science, but I don't have a single good thing I can say about management. They have destroyed shareholder value. With that said, based in last 12 months moves by the company, it seems the end is near. I really hope the end is a big payday for legacy longs. A lot of good people, including Rodin and Knox on this board have been here for years and their faith and support should be rewarded. No doubt the company has value and good science, now to see if management can work a deal to capture that value for all shareholders....not just Sabby and management! I am not really bearish or bullish....I think I am more opportunistic at this point if that makes any sense. All just my opinions. Good luck Rap with your new positions and good luck to all CYTR longs!
Rap - Welcome to CYTR land.
I hope those buys work out for you! And I don't mean to harp on CRMD, I only invest in a few small bios with a portion of my portfolio. Currently, CRMD is my largest small biotech which is why it is an easy reference for me! Good luck to you!
I am gonna respectfully disagree a portion of your post. Yes I agree with standard practice of giving shares and options as awards. This is common with all companies big and small. But with small biotechs it is common for insider buys. I could give a bunch of examples, but I will stick with CRMD. Look at all the Form 4's over the past 24 months including yesterday. A lot of awarded stock and options, but almost just as many buys at the market from insiders. Just yesterday, and insider at CRMD submitted a form 4 showing a healthy buy at 1.66. These moves always increase shareholder sentiment. If an insider sees value, so will outsiders. This is just my opinion. Volume is picking up some, but for me to think something is up, I would like a much higher uptick. Still think something is happening, but I really have no indicators at the moment to support this feeling. Good luck! All just my opinions, I am long, and I do hope for a very positive near term catalyst!