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I think these shelf offerings are usually intentionally vague, as they don't know if or when they may need to access it, or what the CP will be when they do. But I don't think it's sleazy. I think it's an overreaction what is going on AH here. As mentioned, we don't know how much of this shelf they will end up using, or at what share prices. The fact they have $42M in the bank as of 3/31 (guessing maybe $35M at end of Q2), means they don't have to access it right now when SP is $1.50. As we approach end of year, and more is known about BLA filing, I think SP will pick up based on Accelerated Approval and Rolling Review, and then they can access shares at a higher price (at least that's the hope).
Agree with you BT - short term traders with long positions looking for a bump on yesterday's news had a bad day, but as a sesn investor, yesterday's call was very good news actually - FDA recommending Accelerated Approval (don't companies usually ask for AA, not the FDA?) and a Rolling Review of BLA submission were both new and should cut time to approval. It's pretty clear FDA wants this out in the market for this terrible disease and it seems like they are doing all they can to assist pushing this to the finish line. I also am selling a couple other things to load up. I think a year from now (or less), we will be looking at a double digit SP.
I am long sesn so I want to hear good news Monday, but I am trying to think of scenarios where the news is not so good and am having a hard time. If there was something wrong, or the FDA needed clarification on something, I would think the company would work on that prior to having a CC, not with only one business day in between. They did announce results of the meeting would be presented within 30 days, so if something needed fixing, I would think they would take as much time as possible to work on a solution so that could be also presented at a CC. Other reasons I am optimistic:
- Yesterday was the 6th Type B meeting company has had with FDA. They have been working closely with FDA over this time and designed their trials to maximize probability of approval. Oncology products that make it through BLA submission have an 82% chance of approval.
- FDA approval is based on favorable risk / benefit assessment. Responders with Vicinium are 15 time more likely than non-responders to remain cystecomy-free at 2.5 years. This is a huge quality of life issue for a terrible disease. Competition Valstar was approved in the 90's and hurts healthy cells as well as cancer cells. Vicinium only kills cancer cells.
- BCG is in short supply shortages are expected to continue at least through 2019.
- Safety profile is excellent and FDA has already granted fast-track designation.
- No further clinical studies required.
- Satisfactory meeting with FDA on production on May 21.
- Institutions own almost half the company (not a driver for FDA approval, but they clearly see something they like).
I have been burned before but to me, this sounds like a positive Monday am.
Agree - buyers are getting in here at low $2's in anticipation of favorable FDA meeting on the 6th. Waiting until after that may result in much higher prices as all signs point to positive news - Vicinium is safe and effective (Responders are approximately 15 times more likely than non-responders to remain cystectomy-free at 2.5 years, an important stat for FDA), it's simple to produce with high reliability, BCG is in short supply and expected to stay that way throughout 2019, Valstar was approved over 20 years ago and hurts good cells along with cancer cells (Vicinium only kills cancer cells), addresses serious disease with huge quality of life issues (if cystectomy has to be done). Granted fast-track designation. Nice TAM of about $750M in US and about $2B outside US. Institutions own about half the company.
About 80 million shares @ $35 / share = $2.8 billion - not sure where you are getting $37B from.....I agree $37B is not reasonable, but $2.8B could be with approval....
Very positive Business update (link below). Some pretty exciting and transforming catalysts upcoming later this year. If they can partner or sell PortIO and / or NextFlo (which they are trying to do), that would take care of any cash requirements to get their two main devices, CarpX and EsoCheck / EsoGuard, to market without further dilution. Second half of year could (and should) see dramatic increase in SP with total addressable markets for CarpX and EsoCheck over $3B ($1B for CarpX and $2B for EsoCheck), and these are domestic only, not outside US. A little patience may be very well rewarded here over the next 2-4 quarters, notwithstanding my colleague elcheepo who bashes the company at every turn but provides no justification for the negative outlook.
https://finance.yahoo.com/news/pavmed-reports-first-quarter-2019-133000952.html
Haha - you added good info about a possible timeline for approval which is consistent with DD I have read - especially with the shortage of BCG. I keep trying to find a reason why FDA would not approve, but am having a hard time - efficacy and safety are better than BCG, definite need for a serious disease which would improve quality of life and delay surgery (responders are approximately 15 times more likely than non-responders to remain cystectomy-free at 2.5 years, an important stat for FDA), likely partnerships in discussion, significant institutional ownership (almost 50%).
Today's meeting is about manufacturing, the June 6 meeting is about the BLA submission. From a Friday afternoon SA article:
"A Type C CMC meeting is scheduled for May 20 to discuss the best path for the transfer of technology to Fujifilm to ensure that product quality and integrity are maintained. Per the press release, the recently completed full-scale GMP manufacturing run at Fujifilm’s facility yielded “encouraging preliminary results”. The June 6 pre-BLA meeting’s primary objective is to obtain feedback from the agency as to whether the efficacy and safety data, benefit-risk profile and overall information that has been compiled is adequate for BLA submission. Among oncology products reviewed by the FDA between 2006 and 2015, the approval rate for those that get through BLA filing is 82%, significantly higher than the 33% that get through Phase 3. (bold highlight is mine)
Link to full article:
https://seekingalpha.com/article/4264984-sesen-bio-looks-better-ever-update
Looking very positive based on reward / risk of Vicinium.
You must have had your calendar flipped to next week. Earnings are after bell next Thursday the 9th....
https://finance.yahoo.com/news/verastem-oncology-announce-first-quarter-110000023.html
More good progress keeps emerging. Report-out below indicates benefits they weren't even looking for. They have a lot of shots on goal here and could see some real appreciation in SP by late this year with EsoCheck (and EsoGuard), CarpX, DisappEar, and PortIO all humming along in variance stages of delivery. A little patience may pay off very handsomely.
https://finance.yahoo.com/news/pavmed-reports-excellent-disappear-animal-133000595.html
Personally, I am watching for a break out to the upside confirmed by the Ralph Kramden "To The Moon" Oscillator Band Envelope. Or, you can always go with the Inverted Cattywampus Nincompoop Trailing Momentum Stochastic. Both are predicting a $15 - $20 share price in 12 months.
Waking up from a long winter hibernation......and the links below are two of their secondary products. Very positive advancements on both. Future looks bright, but patience is required (2-3 quarters). Everything they are doing seems to be on the right track now (after the delay in CarpX approval) with real paths for approval for both CarpX and EsoCheck. My only concern is they may be running a little low on cash but hopefully they will address that at next CC and not have to dilute. With market cap at $29M today (they do have 17M warrants out with a strike of $1.60 expiring 2024) and total potential market of $3B (with just CarpX and EsoCheck), reward to risk is very outsized here with multiple shots on goal this year. Very long and adding. GL
https://seekingalpha.com/pr/17449710-pavmed-announces-nextflo-breakthrough
https://seekingalpha.com/pr/17442613-pavmed-announces-portio-breakthrough
Yep - appears a bit over-bought here though and am hoping it consolidates a little before earnings 3/12 so I can buy more. Great prospects.
Thanks for posting the article. I follow vstm pretty closely but hadn't seen it. Possible expanded use of duvelicib very positive.
Still time to get in on this before fireworks start soon. Very upbeat and positive business update this am:
https://finance.yahoo.com/news/pavmed-provides-business-123000591.html
This is one of my favorite small companies with the likelihood of impending device approvals, potential market opportunities, improvement over existing processes / technology, cash on hand, diversification, ownership / management. As of 2018 proxy statement, CEO owns 26.6% of stock himself and controls another 22.8% through Pavilion Venture Partners (just under 50% total) so he has a huge vested interest in making this all work. Two business updates already this year indicate things are on the move and more news is forthcoming soon. While taking longer to get approvals from FDA on CarpX and EsoCheck, they seem to be working closely with them on formulating a game plan that will ensure approval. I'm willing to wait it out as I think they will ultimately be successful.
I agree, tech. Great company with super prospects I think, but it already has a $300M market cap at today's share price. With $20M revenue this year, MC of 15x today's revenues. Yes, it should continue to keep growing rapidly over next few years, but I think slow / steady share price gains would be more the expectation as opposed to quick gains to $100 - which would be a $1.8B MC on probably $35M - $40M revenues in '19 (75% - 100% increase from '18).
Heard back from IR within an hour of e-mailing Mike Havrilla asking if the company would be providing an update on the pre-submission meeting with the FDA yesterday on CarpX. His response:
"PAVmed plans to issue a comprehensive business update press release by the end of this week which will include the outcome of the FDA pre-submission meeting and the next steps for CarpX in addition to providing updates for our other product pipeline devices."
Looking forward to what they have to say as it will hopefully provide a clear and fast track to CarpX approval.
Hoping to hear an update on the pre-submission meeting for CarpX with the FDA scheduled for today. After the lack of action by the consulting branch in August (lead branch recommended approval), the company was putting all their ducks in a row to push this forward, starting today with the FDA meeting. Feedback as to how it went would be helpful. I will be writing IR to see if there is any comment.
Totally agree DC. Pre-submission meeting with FDA 1/7 for CarpX. After not receiving concurrence from consulting branch in August, company seems to be getting all its ducks lined up and trying to take any doubt for approval out with new experts, lawyers with FDA experience, etc. EsoCheck has been accepted for 510(k) by FDA end of November. It's safe and effective and per CEO - "optimistic that EsoCheck CCD will be cleared expeditiously and available for clinical use in early 2019." Also working with investment bank to partner or sell one or more other devices. I think '19 is the year of Pavmed. I have been loading up on PAVMZ warrants with a 2024 expi date at $.30 - $.33 too. GLTA.
It is basically the same price it was 6 months ago in anticipation of CarpX approval which didn't come as planned in August. I don't expect it to go up or down much until word comes out from FDA meeting on CarpX Jan 7 and 510(k) submission of EsoCheck (FDA acknowledged receipt 11/29). There is also the possibility of news surrounding the investment bank shopping around PortIO or one of their other more minor devices. News is coming soon and I keep adding little chunks to my main position when I can as I think the next 3-6 months could bring significant SP increase (assuming good news on CarpX and EsoCheck).
Nice overview of company and prospects in SA:
https://seekingalpha.com/article/4227752-biolife-solutions-stellar-pick-shovel-play
Solid investment here IMO. GL
Agree bUrRp......I have been picking up a few thousand warrants every week or so here in anticipation of a nice move up over the next few quarters. Am very patient with the company as they have several key catalysts upcoming soon with CarpX, EsoCheck, and other devices. Management is excellent and they are funded through commercialization. 2019 could be a VERY good year for PAVM SP. GL.
Agree - several catalysts coming up very shortly - FDA meeting on re-submission of CarpX January 7, approval anytime to allow first-in-human CarpX clinical series in New Zealand in December, submission of EsoCheck CCD for 510(k) clearance by end of November, major investment bank exploring potential strategic partnerships including acquisition of PortIO. 2019 could be PAVM's year. Approval of CarpX and EsoCheck would, I think, result in SP being significantly higher next year. GL.
I did buy them for my ROTH..... my employer offers both a taxable and a Roth 401k. I put the vast majority in taxable to get the tax break now and some in the Roth that I consider more speculative. Am more conservative in the taxable one and more aggressive in the ROTH for the reason you mentioned - hoping for a nice tax free return in the ROTH, but it won't kill me if it doesn't work out. GL.
Picked up 25,000 PAVMZ yesterday and today at $.30-$.32. With 6 years to expi, am definitely willing to pay the time premium today to get 3x more shares with the warrants as compared to the common based on the prospects they have ahead of them. Assuming approval even of only one of CarpX and EsoCheck, my feeling is this goes to $10 over the next 2-3 years with the size of those potential markets (company would still be only a $430M market cap after all warrants exercised). No doubt this is speculative but to me reward / risk here is justified on the verge of several catalysts coming up soon. GL!
Nice on the warrants. When do they expire? Even a SP of $4.1 or so gives you a 10-bagger as warrants would be worth $2.50. GL to us all!
Let's look at facts. This is a $28M company on the verge of getting approvals to access $3B in potential market opportunities ($1B for CarpX and $2B for EsoCheck). The probability is very high both their main devices get approved next year. They have 3 other minor devices they are making progress on. They have a year's worth of cash. Yes, they may need to do a small raise to see these to finish but maybe not if they get a partner or sell on one of the minor devices, or upcoming catalysts push the price over $1.60 and warrants start cashing in, or they add to their existing debt and not dilute.
The company expects to secure Ethics Committee approval by end of November which would allow first-in-human CarpX clinical series in New Zealand in December. Esocheck was highlighted as one of the year’s significant advances in cancer prevention by the National Cancer Institute. They expect to submit EsoCheck CCD for 510(k) clearance by end of November. They have engaged a major investment bank to explore potential strategic partnerships including acquisition of PortIO. I continue to buy at these levels and look forward to multi-bagger returns in '19. GL.
This company could have a tremendous 2019 with everything they have going on with CarpX and EsoCheck, not to mention their other more minor devices. At a SP just over $1 with a $28M MC (plus 17M warrants at $1.60), this company is addressing potential markets of about $3B for their 2 main products. Even getting a small percentage of those markets could propel SP much much higher. Plus both appear to be be definite improvements on existing care.
Yes, consensus could not be reached by the consulting branch in August for CarpX (lead branch wanted approval) but it sounds like the company is doing everything right for their Jan 7 pre-submission meeting with FDA - pulling together significant data, bringing in outside expertise, requesting senior FDA decision makers attend, etc. so hopefully they will push it over the goal line this time. If they get their two products approved and in the market, I see a multi-bagger by this time next year. Of course there could be unforeseen issues, but having gone through this process once, I think they are dotting every "i" and crossing every "t" to get this approved. And I think they will be successful in both cases. GLTA.
That would be one way for it to disappear. The other way is if the Closing Indicative Value (as found on the VelocityChares DGAZ site) has a 85% or more drop from the previous day (NG futures in the index go up 28.33%) - the fund could be accelerated and you get paid the Intrinsic value and the fund shuts down after 5 business days. While you would get paid something back, you don't have much of a chance for the price to rebound.....take it from a former XIV holder.
From page 7 of the prospectus:
Acceleration Event: As discussed in more detail under “Specific Terms of the ETNs—Acceleration at Our Option or Upon an Acceleration Event” in this pricing supplement, an Acceleration Event includes any event that adversely affects our ability to hedge our obligations in connection
with the ETNs, including, but not limited to, if the Intraday Indicative Value for any series of ETNs is equal to or less than 15% of the prior day’s Closing Indicative Value for such series of ETNs.
https://www.velocityshares.com/etns/product/dgaz/
Good news just before CC tomorrow....hope to hear more about the deal then. Still in early innings here but I don't feel there is much downside risk as they are trading for less than cash on balance sheet. Low float, with multiple catalysts. Have to be patient though. 2019 could be a tipping point year, in a good way. Adding below $5 when I can as I don't think it will stay there long.
https://seekingalpha.com/pr/17324112-arcadia-biosciences-ardent-mills-announce-collaboration-develop-commercialize-wheat
Been watching this closely and pulled the trigger today at $3.88, way under cash value. Assuming cash usage in Q3 of $4.5M, that would leave approx $24M in cash on balance sheet as of 9/30, or $5/share. That $24M also equates to about 6 qtrs of cash usage, which I am hoping is more than enough time to start monetizing some of these patents and assets. With a MC of only $19M, if they start generating some decent revenues and EBITDA, the low float could send this skyrocketing (see March of this year). GLTA.
Haven't heard anything from management since the Aug 22 CC. Now I am thinking if it was just an easy fix or data submission, company would have announced something by now. I have lightened up my position considerably thinking the next news we hear now will not be good since it has taken so long to hear anything. Depending on the news and the probable outcome for CarpX, I will reconsider adding back at that time, but right now there is too much uncertainty for me. Any delay may send the price down in the $.80 - $.90 range, but if it looks like they can still bring this across the finish line in a reasonable time frame, I may reconsider getting back in. They have several good devices in development, experienced management, and I think the company will succeed in the long run, but there may be some short term pain. Am happy to be on the sidelines here waiting to hear how it plays out. My personal opinion is that after all this time, the probability of the company coming back any time soon and saying the consulting branch is ready to approve is relatively small, but that's just me. GLTA.
I think it's a high-level, but accurate representation of what's going on. I do consider prices down here very attractive and will add on as I can.
Also, more good news just came out this afternoon comparing COPIKTRA to Novartis' ARZERRA:
https://seekingalpha.com/news/3395293-verastems-duvelisib-beats-novartis-arzerra-late-stage-blood-cancer-study-shares-1-percent
Not sure why you are saying the company will never be profitable or why doctors won't prescribe the drug. The Stocktwits report you mention may indeed be compelling and I would love to read it and have others comment on it, but the company's actions tell another story (rapid ramp-up of sales force, immediate agreement with China), at least right now. There are no other alternatives for these relapsed patients. If there is a proven drug out there that can extend life when the alternative is to do nothing, why would it not be prescribed?
In terms of institutional ownership, you're right - they have resources and knowledge we don't. I'm not talking short term traders, but institutional investors who put their money into companies based on long term fundamental factors and projected future revenues / profits. As of 6/30/2018, BlackRock tripled their position to 3.5 million shares and Fidelity started a new 4 million share position. Consonance Capital, a fund specializing in pharma and managed by MDs, bought 7.16 million (approx. 10% of current outstanding shares) shares in a direct offering in June for $6 - at a price 10% over the market price at the time. Time will tell whether it will be prescribed or not, and I am willing to give this strong management team the benefit of the doubt for now.
Needed this good news after price action today. The first of multiple agreements outside the US hopefully.
https://finance.yahoo.com/news/cspc-pharmaceutical-group-limited-verastem-202000683.html
Added to position this morning and staying long. I don't think management is getting any credit for being able to market this, but certainly this agreement they had in pocket, just waiting for US approval, shows they are rapidly working behind the scenes. Very positive within 24 hours after approval.
Nice price action today. Hoping to hear something on CarpX by end of next week (45 days from Aug 22 is Oct 5) so we can get a sense as to what is expected to move this forward. Still very positive on this company with other devices in progress. A positive resolution with the consulting branch would lead to greatly increased SP IMO. GLTA.
I respectfully disagree that VSTM is a waste. This is not a first line drug. Duvelisib is for patients where there are no other options and they have been through at least two other treatments per the FDA Full Prescribing paper (see page 2):
www.accessdata.fda.gov/
Yes, there are BB warnings, and the company also made those clear in the press release. The drug successfully works in the population for which it was intended. It was approved ahead of the PDUFA date with no delays or CRLs. It was common knowledge the warnings would be present and was never thought there would be none. I guess insurance and cost have to play out but the alternative to this drug is nothing for the people who need it. They also have a couple of other drugs in the pipeline, top shelf management, ramped-up sales force, and adequate funding. SP may flounder a bit here as people digest the facts, but it just gives those of us who are positive on the company more opportunity to buy. GLTA.
DUVELISIB APPROVED! Trading halted by NASDAQ. Great news for longs as well as patients.
https://seekingalpha.com/news/3392533-fda-oks-verastems-duvelisib-shares-3-percent-trade-halt
Been 3 weeks today since CC announced consulting branch was holding up CarpX approval (lead branch wants approval and is willing to help company get there). Hoping we hear something soon as to what they are looking for so they can get this approved. I am still very high on this company and its prospects but would like to hear what is necessary for this approval and how soon company feels they can comply. They also plan on a 510(k) submission on EsoCheck by year end. These two, plus other devices in development, plus potential ex-US agreements could provide positive SP catalysts over the next few months. Only 26M shares outstanding (plus 17M warrants at $1.60) so if receive approval on those two devices, plenty of upside potential IMO. GL
New CFO hired - "VSTM today announced the appointment of Robert E. Gagnon, an experienced financial executive, as Chief Financial Officer, effective August 28, 2018. Mr. Gagnon was most recently Chief Financial Officer at Harvard Bioscience, Inc., a global developer, manufacturer, and marketer of a broad range of tools to advance life science research and regenerative medicine."
Clearly he thinks Duvelicib will be approved since 100,000 of his options are dependent on hitting certain sales figures for the drug. I take this executive hire as another positive sign of approval.
(highlights are mine)
"In connection with the hiring of Mr. Gagnon, effective August 28, Verastem Oncology granted to Mr. Gagnon stock options to purchase an aggregate of 450,000 shares of Verastem Oncology’s common stock and 50,000 restricted stock units (RSUs) pursuant to the Nasdaq inducement grant exception as an inducement material to Mr. Gagnon’s acceptance of employment with Verastem Oncology in accordance with Nasdaq Listing Rule 5635(c)(4). A stock option to purchase 350,000 shares of Verastem Oncology’s common stock will vest as to 25% of the shares on the first anniversary of the date of hire and as to an additional 6.25% of the shares at the end of each successive three-month period following the first anniversary of the date of hire, provided that Mr. Gagnon continues to serve as an employee of or other service provider to Verastem Oncology on each such vesting date. A stock option to purchase 100,000 shares will vest in full upon achievement of certain net sales targets of duvelisib, provided that Mr. Gagnon continues to serve as an employee of or other service provider to Verastem Oncology on the vesting date. Both stock options have an exercise price equal to $9.43, the closing price of Verastem Oncology's common stock as reported by Nasdaq on August 28, 2018 . The RSUs will vest as to 100% of the shares on the first anniversary of the date of hire."