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Post by jckrdu on Sept 9, 2014 12:36:14 GMT
Hi Jck, Since July 18ths low of 2.65 the sp has crept up about 10%. Ok, not earth shaking, but I am hoping this is the beginning of a nice, long climb. I wonder if our new CFO had anything to do with restructuring of deal. Just speculating but I can't help to think there will be some significant news in the coming weeks. Things in India have been quiet. Agree this is near the bottom.... hopefully an uptrend continues. I sold a bunch of ADXS to buy more ACTC on the recent move down. Will look to re-establish a position in ADXS after ACTC recovers. Potential ADXS catalysts include: 1) News on the "end of Phase 2 meeting" with the FDA on how the HPV trials will move forward in Phase 3 in the US, 2) partnership(s) sometime before the end of 2014 (HPV Phase 3 in US, prostate, breast, and PD-1 combination deal), and 3) approval to commercialize HPV in India (via Biocon deal) after Phase 2 results. Potential ADXS risks include: 1) if HPV Phase 3 is not approved in US (based on Phase 2 results in India) until ADXS does more testing required by the FDA, and 2) if HPV is not approved for commercialization in India based on Phase 2 results - in that case ADXS would need to conduct and fund a Phase 3 HPV trial in India. While the risks are real, I believe at least 1 of the potential catalysts will hit before any risks manifest... if they do at all. New PR out this morning on HPV Phase 3 trial plans. Not sure how the market will take this news, as previous guidance was HPV Phase 3 initiating in 2014 and this PR states 2015 which is a slip. SEC quarterly filing also released today, with several statements indicating more dilution "may" be coming to fund the "significant" increases in operating expenses due to all the new trials starting. As we know, recently announced trials/collaborations with Merck and Astrazeneca did not include any upfront cash and ADXS is on the hook to fund the trials. ADXS ended July 31, 3014 with about $20 million cash. Quarterly burn rate is $6 million. The SEC filing says they project they have enough cash to last until October 2015, or about 1 year (some minimal amount of revenue'licensing from Aratana/PETX must be included in that cash projection.) Looking ahead: IMO, more dilution is likely sometime over the next 6 months, as ADXS won't wait until October 2015 to secure more funding. Non-dilutive capital is also still possible coming from either 1) breast, 2) HPV Phase 3, or 3) revenue from India via the Biocon deal. However, recent ADXS deals with no upfront cash do not get me overly optimistic about a pile of non-dilutive capital coming soon, but its certainly possible. Disclosure: I own no shares of ADXS at the moment. Looking for ACTC to pop on data news, and will be considering starting an ADXS position after they do their next round of dilutive funding which I expect over the next 6 months. Perhaps ADXS looks to get the pps higher by announcing a deal with some non-dilutive capital first, and then raise additional funds on the back of that good news. So, it is possible that pps heads higher before lower.... let's see what the market thinks of today's news. finance.yahoo.com/news/advaxis-provides-clinical-development-immunotherapy-113000345.html
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Post by lcd on Sept 9, 2014 12:48:14 GMT
Thanks jckrdu. When they didn't get any upfront money in their JVs, I sold all my ADXS shares too. I think waiting until the next round of dilution is the way to go on this one.
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Post by jckrdu on Sept 10, 2014 2:28:53 GMT
Agree this is near the bottom.... hopefully an uptrend continues. I sold a bunch of ADXS to buy more ACTC on the recent move down. Will look to re-establish a position in ADXS after ACTC recovers. Potential ADXS catalysts include: 1) News on the "end of Phase 2 meeting" with the FDA on how the HPV trials will move forward in Phase 3 in the US, 2) partnership(s) sometime before the end of 2014 (HPV Phase 3 in US, prostate, breast, and PD-1 combination deal), and 3) approval to commercialize HPV in India (via Biocon deal) after Phase 2 results. Potential ADXS risks include: 1) if HPV Phase 3 is not approved in US (based on Phase 2 results in India) until ADXS does more testing required by the FDA, and 2) if HPV is not approved for commercialization in India based on Phase 2 results - in that case ADXS would need to conduct and fund a Phase 3 HPV trial in India. While the risks are real, I believe at least 1 of the potential catalysts will hit before any risks manifest... if they do at all. New PR out this morning on HPV Phase 3 trial plans. Not sure how the market will take this news, as previous guidance was HPV Phase 3 initiating in 2014 and this PR states 2015 which is a slip. SEC quarterly filing also released today, with several statements indicating more dilution "may" be coming to fund the "significant" increases in operating expenses due to all the new trials starting. As we know, recently announced trials/collaborations with Merck and Astrazeneca did not include any upfront cash and ADXS is on the hook to fund the trials. ADXS ended July 31, 3014 with about $20 million cash. Quarterly burn rate is $6 million. The SEC filing says they project they have enough cash to last until October 2015, or about 1 year (some minimal amount of revenue'licensing from Aratana/PETX must be included in that cash projection.) Looking ahead: IMO, more dilution is likely sometime over the next 6 months, as ADXS won't wait until October 2015 to secure more funding. Non-dilutive capital is also still possible coming from either 1) breast, 2) HPV Phase 3, or 3) revenue from India via the Biocon deal. However, recent ADXS deals with no upfront cash do not get me overly optimistic about a pile of non-dilutive capital coming soon, but its certainly possible. Disclosure: I own no shares of ADXS at the moment. Looking for ACTC to pop on data news, and will be considering starting an ADXS position after they do their next round of dilutive funding which I expect over the next 6 months. Perhaps ADXS looks to get the pps higher by announcing a deal with some non-dilutive capital first, and then raise additional funds on the back of that good news. So, it is possible that pps heads higher before lower.... let's see what the market thinks of today's news. finance.yahoo.com/news/advaxis-provides-clinical-development-immunotherapy-113000345.htmlWell, the market didn't really like the news above. Link below to ADXS webcast/presenation at the Rodman/Renshaw conference today (9/9 @ 3:45 PM EST). Good presentation, but no major new news to move the pps, IMO. Strategy on the no cash up-front deals with Merck and Astrazeneca was explained; playing for the long term... strategy is to produce data and and have the data drive the value of the subsequent licensing deals. Good long-term strategy to maximize value, but leaves questions open on mid-term cash needs. With burn rate increasing per the recent 10Q, the market is going to want to see clarity on how all the trials will be paid for, and will assume dilution forthcoming (IMO) if ADXS doesn't announce a deal with some upfront cash fairly soon. Deals on HPV Phase 3, breast and Biocon license revenue are possible, but no strong indicators in this presentation of anything imminent on those fronts. ir.advaxis.com/ir-calendar
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Post by jckrdu on Sept 10, 2014 11:16:10 GMT
Some additional information and thoughts on ADXS via a discussion with Fbg on Yahoo:
FBG's Post: Surprised About Two Things
1) the market reaction today given the news on the FDA meeting on cervical cancer. It's great news and a big deal IMO that the FDA is not requiring ADXS to conduct another Phase 2. My understanding is that it is not uncommon for the FDA to require an additional Phase 2 before giving the green light on a Phase 3. To all who have claimed that the ADXS India Phase 2 trial was worthless, apparently the FDA doesn't think so.
2) That ADXS has not gotten a partnership for the cervical cancer Phase 3 trial. Maybe there is a partner about to be announced or maybe potential partners have been waiting until the FDA meeting to ensure that another Phase 2 does not have to be done before they step forward to partner with ADXS. At this point, we need a partnership with some kind of upfront non-dilutive cash to raise investor confidence and take us to a valuation in line with the company's pipeline (+$200 million).
My Response:
Fbg - Very good points. As a former large block owner that recently sold ADXS, I'll confirm that fear of more dilution was a major factor in my decision (and higher reward / lower risk opportunity elsewhere IMO) after the 1st two pharma deals were executed with no upfront cash.
On why the market reacted the way it did on what I agree was good news of HPV moving to Phase 3 in the US, I think the slip from "initiating in 2014" (prior guidance) to "initiating in 2015" (new guidance) is what carried the day and caused the negative reaction. Really no clarity on when treatments are projected to start in 2015 for HPV? Early 2015? Mid 2015? Late 2015?
Last point I'll make is on the updated milestone slide in the new deck. Not one bullet on when any data/results will be announced from any trials. Pretty much all the milestones in 2014 and 2015 are about initiating new trials... which translates to cash needs and a higher burn rate.
ADXS needs non-dilutive capital or remaining gaps are likely to fill, IMO ($3.25 to $3.32 and $2.78 to $3.00). All prior gaps have filled in the 2+ years I've been watching this stock. GLTA. (Disclosure: I have no position in ADXS).
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Post by jckrdu on Sept 17, 2014 19:44:27 GMT
Some additional information and thoughts on ADXS via a discussion with Fbg on Yahoo: FBG's Post: Surprised About Two Things 1) the market reaction today given the news on the FDA meeting on cervical cancer. It's great news and a big deal IMO that the FDA is not requiring ADXS to conduct another Phase 2. My understanding is that it is not uncommon for the FDA to require an additional Phase 2 before giving the green light on a Phase 3. To all who have claimed that the ADXS India Phase 2 trial was worthless, apparently the FDA doesn't think so. 2) That ADXS has not gotten a partnership for the cervical cancer Phase 3 trial. Maybe there is a partner about to be announced or maybe potential partners have been waiting until the FDA meeting to ensure that another Phase 2 does not have to be done before they step forward to partner with ADXS. At this point, we need a partnership with some kind of upfront non-dilutive cash to raise investor confidence and take us to a valuation in line with the company's pipeline (+$200 million). My Response: Fbg - Very good points. As a former large block owner that recently sold ADXS, I'll confirm that fear of more dilution was a major factor in my decision (and higher reward / lower risk opportunity elsewhere IMO) after the 1st two pharma deals were executed with no upfront cash. On why the market reacted the way it did on what I agree was good news of HPV moving to Phase 3 in the US, I think the slip from "initiating in 2014" (prior guidance) to "initiating in 2015" (new guidance) is what carried the day and caused the negative reaction. Really no clarity on when treatments are projected to start in 2015 for HPV? Early 2015? Mid 2015? Late 2015? Last point I'll make is on the updated milestone slide in the new deck. Not one bullet on when any data/results will be announced from any trials. Pretty much all the milestones in 2014 and 2015 are about initiating new trials... which translates to cash needs and a higher burn rate. ADXS needs non-dilutive capital or remaining gaps are likely to fill, IMO ($3.25 to $3.32 and $2.78 to $3.00). All prior gaps have filled in the 2+ years I've been watching this stock. GLTA. (Disclosure: I have no position in ADXS). Gap from $3.25 to $3.32 filled today.
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Post by selluwud on Oct 10, 2014 14:36:03 GMT
I had a price alert set up for pps movement below 2.78 that just hit. Does anyone know what's coming up next? I know we may be looking at a raise of some type in the near future, but at what pps??? I am just keeping an eye on this for picking some up somewhere near the bottom as it may seem.
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Post by jckrdu on Oct 24, 2014 13:51:51 GMT
I had a price alert set up for pps movement below 2.78 that just hit. Does anyone know what's coming up next? I know we may be looking at a raise of some type in the near future, but at what pps??? I am just keeping an eye on this for picking some up somewhere near the bottom as it may seem. Some updates on ADXS... First, they're going to run out of cash by mid next year. IMO, they won't wait to replenish cash on the balance sheet until the last minute... something will happen (dilutive event most likely) before the end of 2014. Second, they recently hired the former head of Merck's cancer clinical trials. Pretty bold move for that guy to leave Merck and head to ADXS. You'll recall that ADXS signed a deal with Merck to evaluate Merck's PD-1 inhibitor in combination with ADXS' listeria based immunotherapy. Things are brewing between ADXS and Merck. Third, Wainwright upgraded ADXS to a "buy" rating with an $8 pps target yesterday. Wainwright specializes in doing PIPEs (private investments in public equities). Speculation is that Wainwright may be arranging a PIPE for Advaxis, where Merck makes an investment in Advaxis. The net effect is that Advaxis would get $$$ from Merck, and Merck would get ADXS shares. I have no idea what pps the transaction would be done at, but even if its done at around $3.00 pps, it'll be good news as the news will be that Merck is investing in ADXS. This is all speculation.... but given the recent collaboration between Merck and ADXS, the Merck guy joining ADXS, the fact that ADXS needs cash, and now the emergence of Wainwright touting Advaxis via a buy rating.... something seems to be up. Fourth, J&J just closed another huge deal with Auduro (private company) taking the milestone payments from J&J to Auduro to over $1 billion for Auduro's listeria based immunotherapy. So, J&J has locked up Auduro. It looks like Merck is working towards securing Advaxis as a partner, as Auduro and Advaxis are the only 2 listeria based cancer immunotherapies out there. It looks like Advaxis is working to close a big partnership deal with Merck, but only after Phase 1 data is out... which will be late 2015 at the earliest. I don't hold any ADXS shares at this time. I intend to keep an eye on things and may re-establish a position after they raise some cash (maybe thru a PIPE with Merck), which IMO will happen before the end of 2014. Jck A private investment in public equity, often called a PIPE deal, involves the selling of publicly traded common shares or some form of preferred stock or convertible security to private investors. It is an allocation of shares in a public company not through a public offering in a stock exchange. PIPE deals are part of the primary market. In the U.S., a PIPE offering may be registered with the Securities and Exchange Commission on a registration statement or may be completed as an unregistered private placement.
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Post by terrible on Oct 25, 2014 15:41:35 GMT
JCK...thanks for the updates. I continue to be fairly heavy in ADXS. I agree with your analysis that dillutive funding is coming by the end of the year in the form of a PIPE. I think this could be viewed positively with Merck making an investment.
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Post by selluwud on Oct 29, 2014 12:09:32 GMT
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Post by selluwud on Nov 6, 2014 14:35:33 GMT
ADXS is falling this AM, must be some type of dilution/financing deal that has been done. Looking for news anytime.
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Post by jckrdu on Nov 6, 2014 19:13:19 GMT
ADXS is falling this AM, must be some type of dilution/financing deal that has been done. Looking for news anytime. Yeah, they PR'd news yesterday that the Prostate IND was filed with the FDA (good news), but the pps is dropping because investors don't have clarity on how that trial and others will be paid for. ADXS is on my watch list. Will take a position after I see news on the funding.
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Post by Jimmywho on Jan 21, 2015 0:32:06 GMT
O U C H ! ! !
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Post by iamaverb on Jan 21, 2015 15:44:05 GMT
I sold 80% of my shares this morning when it appeared the drop would continue. I'll be back I am sure.
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Post by RLC on Jan 21, 2015 15:59:13 GMT
I sold 80% of my shares this morning when it appeared the drop would continue. I'll be back I am sure. Congrats verb!
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Post by selluwud on Jan 21, 2015 16:12:22 GMT
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Post by RLC on Jan 21, 2015 16:43:57 GMT
Wow... talk about a brutal piece. Saying this guy was hard on ADXS is a huge understatement...
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Post by stemwinder on Jan 21, 2015 16:52:23 GMT
Wow... talk about a brutal piece. Saying this guy was hard on ADXS is a huge understatement... He is good, I like his articles. Unfortunately the biotech space is filled with these crummy little scam outfits.
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Post by RLC on Jan 21, 2015 17:25:14 GMT
Wow... talk about a brutal piece. Saying this guy was hard on ADXS is a huge understatement... He is good, I like his articles. Unfortunately the biotech space is filled with these crummy little scam outfits. ADXS is far from a "crummy little scam outfit"... The article wasn't about BHRT. IMO, the recent rise in PPS is primarily due to the company's change in focus. They realize that their platform as a mono-therapy isn't going to cut it, but see great potential in combining it with other products (i.e. checkpoint inhibitors). This is obviously a very hot space right now. The fact that they were able to score partnerships with Merck and Medimmune to go forward with combo studies bodes very well for long shareholders. IMO, the stock was clearly overbought and due for a massive correction.
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Post by stemwinder on Jan 21, 2015 18:37:02 GMT
He is good, I like his articles. Unfortunately the biotech space is filled with these crummy little scam outfits. ADXS is far from a "crummy little scam outfit"... The article wasn't about BHRT. IMO, the recent rise in PPS is primarily due to the company's change in focus. They realize that their platform as a mono-therapy isn't going to cut it, but see great potential in combining it with other products (i.e. checkpoint inhibitors). This is obviously a very hot space right now. The fact that they were able to score partnerships with Merck and Medimmune to go forward with combo studies bodes very well for long shareholders. IMO, the stock was clearly overbought and due for a massive correction. I'm not impressed. PII with one site in India! Management with dubious history of promotion. Poor data. These combo trials with big pharma should not be taken as endorsements. BP looks at them like lottery tickets. They have a draw full.
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Post by RLC on Jan 21, 2015 18:50:00 GMT
ADXS is far from a "crummy little scam outfit"... The article wasn't about BHRT. IMO, the recent rise in PPS is primarily due to the company's change in focus. They realize that their platform as a mono-therapy isn't going to cut it, but see great potential in combining it with other products (i.e. checkpoint inhibitors). This is obviously a very hot space right now. The fact that they were able to score partnerships with Merck and Medimmune to go forward with combo studies bodes very well for long shareholders. IMO, the stock was clearly overbought and due for a massive correction. I'm not impressed. PII with one site in India! Management with dubious history of promotion. Poor data. These combo trials with big pharma should not be taken as endorsements. BP looks at them like lottery tickets. They have a draw full.If this were true, I'd be very concerned for OCAT as BP doesn't even think they're "lottery ticket" worthy...
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