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Post by selluwud on Nov 6, 2015 16:37:08 GMT
Last years Q3 call was on Monday, Nov 10th, FWIW. Do you think think climb is due to people hedging on news from the expected call? I don't know KIP, maybe it's just trying to equalize in value to what the institutional investors paid in the last raise. As far as news, I don't see much being revealed in the Qtrly statement but the guided information about a non-core JV before the year end may perk things up a bit when released. Hopefully the pack of rabid shorts that were circling us have moved on to other prey. |
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Post by jckrdu on Nov 6, 2015 17:14:54 GMT
Last years Q3 call was on Monday, Nov 10th, FWIW. Do you think think climb is due to people hedging on news from the expected call? OCAT has been trading pretty much in line with the IBB index in the absence of news. IBB was down early today and then reversed back up. OCAT continues to follow the IBB.
There also could be some new buying (I started a new position this morning) on expectations of 4th QTR news, which includes the following potential news items...
- SMD trial initiation - SMD SPA update - Photoreceptor pre-clinical paper - Non core JV
I don't expect any of those news items to dramatically increase the pps. I'm still seeing the $4-$6 range until enrollment for Dry AMD cohort-1 is announced sometime early in 2016.
Also, be prepared for a "sell the news" reaction if the non-core JV is announced and comes with no upfront cash and is just more of a research collaboration (most likely scenario) with no money coming into OCAT.
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Post by ignorantsilver on Nov 6, 2015 20:42:09 GMT
Opening a short position prior to any ocat conference call is a pretty safe bet.
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Post by iamaverb on Nov 7, 2015 22:50:06 GMT
Opening a short position prior to any ocat conference call is a pretty safe bet. I counter, based on the timing of the CC announcement and the actual call, it may prove to be a risky bet. |
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Post by ignorantsilver on Nov 7, 2015 22:59:27 GMT
Seriously doubt it. If there were any actual news they'd have PRed something in order to get folks to tune in and listen. More likely just scheduled early because weren't able to do it in the afternoon.
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Post by Whidbeygal CM 20/20 on Nov 9, 2015 3:34:54 GMT
I find it interesting that 'MakoResearch' is again tweeting about OCAT. The twitter feed was silent for over a month.
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Post by jckrdu on Nov 9, 2015 14:18:19 GMT
Do you think think climb is due to people hedging on news from the expected call? OCAT has been trading pretty much in line with the IBB index in the absence of news. IBB was down early today and then reversed back up. OCAT continues to follow the IBB.
There also could be some new buying (I started a new position this morning) on expectations of 4th QTR news, which includes the following potential news items...
- SMD trial initiation - SMD SPA update - Photoreceptor pre-clinical paper - Non core JV
I don't expect any of those news items to dramatically increase the pps. I'm still seeing the $4-$6 range until enrollment for Dry AMD cohort-1 is announced sometime early in 2016.
Also, be prepared for a "sell the news" reaction if the non-core JV is announced and comes with no upfront cash and is just more of a research collaboration (most likely scenario) with no money coming into OCAT.
Very bad update this morning from OCAT. I sold my small position in pre-market at $4.50. Below is the message I sent to family and friends this morning. The schedule risk I've posted about (bolded above) turned into an issue this morning... ________________________
OCAT - OCAT held their quarterly call this morning. Not good, as they announced delays with both the Dry AMD and SMD trials...
Dry AMD - While they reported high interest in the trials and solid enrollment, the patients enrolling are having trouble meeting the entry criteria. Essentially, because the patients are mostly elderly and have to undergo ummunosupressants prior to getting treated (thus compromising their immune systems) they're not able to meet the strict entry criteria where they have to be in pristine health. Essentially, OCAT needs to find elderly adults who are otherwise in excellent health, with the exception of their eyes. Patients are being screened out because of things like high blood pressure. So, what's next? They'll still try to enroll patients using the existing criteria with the high bar, but they're also in the process of adjusting the entry criteria with the FDA to a lower entry bar. No guidance given on when that lower bar will be in place. The CEO stated that they still intend to release the first set of results from cohort-1 "next summer", which is a delay from past guidance of "2nd quarter 2016". Per my past messages, I'm not planning to take a significant position in OCAT until I see that "cohort-1 enrollment completion" PR sometime next year, as that schedule risk was always out there, and turned into an issue today.
SMD - More bad news on this trial. Prior guidance was that this trial would start before the end of 2015. That timeline in unlikely as - in my opinion - the same entry criteria change that is being made for Dry AMD is also likely to be made for SMD. In any case, the updated guidance is that they plan to start enrolling patients in this trial at the end of the 1st quarter or beginning of the 2nd quarter 2016.
As a results of the above, I sold my small OCAT position in pre-market trading, and will stay on the sidelines until I see the entry criteria modified with the FDA and see the PR that they've treated all Dry AMD cohort-1 patients, as only that PR will take the schedule risk off the table.
Note... we still could see news before the end of the year about a non-core JV, but I'm not expecting any major announcement or major deal with any upfront cash, which is what's needed to move the stock, IMO.
Wish I had better news.
Jim
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Post by ignorantsilver on Nov 9, 2015 14:24:04 GMT
Well that was unexpected.... Lol.
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Post by actcfan on Nov 9, 2015 14:51:58 GMT
OCAT has been trading pretty much in line with the IBB index in the absence of news. IBB was down early today and then reversed back up. OCAT continues to follow the IBB.
There also could be some new buying (I started a new position this morning) on expectations of 4th QTR news, which includes the following potential news items...
- SMD trial initiation - SMD SPA update - Photoreceptor pre-clinical paper - Non core JV
I don't expect any of those news items to dramatically increase the pps. I'm still seeing the $4-$6 range until enrollment for Dry AMD cohort-1 is announced sometime early in 2016.
Also, be prepared for a "sell the news" reaction if the non-core JV is announced and comes with no upfront cash and is just more of a research collaboration (most likely scenario) with no money coming into OCAT.
Very bad update this morning from OCAT. I sold my small position in pre-market at $4.50. Below is the message I sent to family and friends this morning. The schedule risk I've posted about (bolded above) turned into an issue this morning... ________________________
OCAT - OCAT held their quarterly call this morning. Not good, as they announced delays with both the Dry AMD and SMD trials...
Dry AMD - While they reported high interest in the trials and solid enrollment, the patients enrolling are having trouble meeting the entry criteria. Essentially, because the patients are mostly elderly and have to undergo ummunosupressants prior to getting treated (thus compromising their immune systems) they're not able to meet the strict entry criteria where they have to be in pristine health. Essentially, OCAT needs to find elderly adults who are otherwise in excellent health, with the exception of their eyes. Patients are being screened out because of things like high blood pressure. So, what's next? They'll still try to enroll patients using the existing criteria with the high bar, but they're also in the process of adjusting the entry criteria with the FDA to a lower entry bar. No guidance given on when that lower bar will be in place. The CEO stated that they still intend to release the first set of results from cohort-1 "next summer", which is a delay from past guidance of "2nd quarter 2016". Per my past messages, I'm not planning to take a significant position in OCAT until I see that "cohort-1 enrollment completion" PR sometime next year, as that schedule risk was always out there, and turned into an issue today.
SMD - More bad news on this trial. Prior guidance was that this trial would start before the end of 2015. That timeline in unlikely as - in my opinion - the same entry criteria change that is being made for Dry AMD is also likely to be made for SMD. In any case, the updated guidance is that they plan to start enrolling patients in this trial at the end of the 1st quarter or beginning of the 2nd quarter 2016.
As a results of the above, I sold my small OCAT position in pre-market trading, and will stay on the sidelines until I see the entry criteria modified with the FDA and see the PR that they've treated all Dry AMD cohort-1 patients, as only that PR will take the schedule risk off the table.
Note... we still could see news before the end of the year about a non-core JV, but I'm not expecting any major announcement or major deal with any upfront cash, which is what's needed to move the stock, IMO.
Wish I had better news.
Jim
Haven't listened yet but sounds like it was pretty awful.. I also have a very small position at the moment and won't add until it either presents a real value (i.e. mid/low $3s) or something changes. I still think that US SMD SPA is off the table for now but guess we will see. Not sure why they wouldn't press forward in UK even if it is. |
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Post by actcfan on Nov 9, 2015 15:01:26 GMT
Q3 10Q highlights:
1) No Lincoln draws in Q3:
Q2 10Q: During the six months ended June 30, 2015, Lincoln Park purchased 2,022,996 shares of common stock pursuant to the 2014 Purchase
Agreement for cash proceeds of $12,797,047.
Q3 10Q: During the nine months ended September 30, 2015, we received $12,797,047 from the issuance of 2,022,996
shares to Lincoln Park as part of the 2014 Purchase Agreement
2) Additional warrants purchased after offering:
In addition, the Underwriting Agreement provided the underwriters a 30-day option to purchase up to an additional 825,000 shares
and/or warrants to purchase an additional 412,500 shares of common stock from the Company (of which 242,500 Warrants were purchased
immediately in connection with the Offering’s closing on June 22, 2015).
3) Cash position:
As of September 30, 2015, we have $32,137,535 in cash.
As of September 30, 2015, $5,822,405 is available to us through the Lincoln Park financing arrangement.
As of September 30, 2015, an additional term loan totaling $4,000,000 is available to us subject to the terms and conditions of the
Loan and Security Agreement.
We believe that our current cash balance, and the $5,822,405 available to us under the Lincoln Park financing arrangement as of
September 30, 2015, will be sufficient to fund our operations into the second half of 2016
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Post by jckrdu on Nov 9, 2015 15:24:49 GMT
Thanks Actc_Fan.
The bolded below means - IMO - they'll need to secure more funds (bank loan, Lincoln, capital raise) before the interim Dry AMD Phase 2 results are available sometime "next summer". IMO, PW is not going to want to negotiate with pharma on a RPE licensing deal when they are running low on cash.
_______________________
We believe that our current cash balance, and the $5,822,405 available to us under the Lincoln Park financing arrangement as of
September 30, 2015, will be sufficient to fund our operations into the second half of 2016.
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Post by Wallace907 on Nov 9, 2015 15:52:42 GMT
Thanks Actc_Fan. The bolded below means - IMO - they'll need to secure more funds (bank loan, Lincoln, capital raise) before the interim Dry AMD Phase 2 results are available sometime "next summer". IMO, PW is not going to want to negotiate with pharma on a RPE licensing deal when they are running low on cash. _______________________ We believe that our current cash balance, and the $5,822,405 available to us under the Lincoln Park financing arrangement as of September 30, 2015, will be sufficient to fund our operations into the second half of 2016. its likely they will do this by EOY. I think that 30mm ATM is required for the additional 4mm from SVB. I seen that those interest only payments can be extended for another 6 months as well. |
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Post by JHam on Nov 9, 2015 16:54:19 GMT
I have not been following this one very much, but after a look at the transcript and the recaps by those here and at iCell, it really just seems like same ole same ole. New management, same old unmet promises and missed timelines. I can't believe they still haven't treated one patient. Hopefully there will be some kind of good news in the near future for those who are underwater in this one.
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Post by jckrdu on Nov 9, 2015 17:16:37 GMT
I have not been following this one very much, but after a look at the transcript and the recaps by those here and at iCell, it really just seems like same ole same ole. New management, same old unmet promises and missed timelines. I can't believe they still haven't treated one patient. Hopefully there will be some kind of good news in the near future for those who are underwater in this one. They took 4 years with the Phase 1 trial. Phase 1 experienced many delays due to the trial entrance criteria and patients getting screened out at the last minute. GR explained that in detail.
One would think that with all that time and experience during Phase 1, they would have been able to define appropriate entrance criteria for Phase 2. Nope.
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Post by actcfan on Nov 9, 2015 18:16:08 GMT
Wow, yeah that call was pretty bad.
How many years have they been designing Phase 2, and they can't get the exclusion criteria right to get even one patient treated? I can find you quotes from Rabin back in Jan 2013.. and from the current management almost 2 years ago.
Remember the meeting in October 2013 where the OAB designed the Phase 2 study.. yet here they sit with no P2 patient treated.
Anglade has been at Ocata since Jan 2014, P2 being his number 1 priority, and here they sit with no P2 patient being treated.
Wooton said the following in August 2014.. still nothing. It is amazing that this company can't get out of its own way.
"Our number one corporate objective, following good discussion with the FDA, is to initiate the Phase II clinical trials of these important programs by the end of 2014."
I feel really bad for Dr. Lanza, and for shareholders who have been mislead so many times.
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Post by jckrdu on Nov 9, 2015 18:37:16 GMT
Wow, yeah that call was pretty bad. How many years have they been designing Phase 2, and they can't get the exclusion criteria right to get even one patient treated? I can find you quotes from Rabin back in Jan 2013.. and from the current management almost 2 years ago. Remember the meeting in October 2013 where the OAB designed the Phase 2 study.. yet here they sit with no P2 patient treated. Anglade has been at Ocata since Jan 2014, P2 being his number 1 priority, and here they sit with no P2 patient being treated. Wooton said the following in August 2014.. still nothing. It is amazing that this company can't get out of its own way. "Our number one corporate objective, following good discussion with the FDA, is to initiate the Phase II clinical trials of these important programs by the end of 2014."I feel really bad for Dr. Lanza, and for shareholders who have been mislead so many times. Pathetic performance. Now they most likely need to go back to the FDA to get the entry criteria modified, and then back thru the IRBs at each site. Who knows how long that takes. PW gave very loose guidance on when injections are likely to happen and when interim results would be out. |
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Post by actcfan on Nov 9, 2015 18:50:24 GMT
My take on SMD is that they are delaying UK SMD because the FDA said they needed more from the for SPA in the US. Sounds like they are going to hold up the UK trial until they can figure out what the FDA wants for SPA. Another missed timeline, by a lot.
Wotton, May 2015: [Blue is my comment]
"Later this quarter we plan to submit the Pivotal Protocol Design to the FDA under Special Protocol Assessment [Still hasn't happened 6 months later..], which will serve to further solidify this strategy. Although this would involve a slight delay to the start of the clinical trial itself, experience shows that it is better to ensure that clinical programs are designed correctly and in partnership with regulatory authorities, rather than rushing ahead with an ambiguous plan. [So basically Anglade "rushed ahead with an ambguous plan" from Jan 2014 until May 2015 and now you have figured this out?] Overall we are pleased with the guidance and the level of interaction that we have received from the EMA and the FDA. Assuming these results replicate the data published in the Lancet, we believe that we will be in a position to apply for marketing authorization following the completion of this study. This harmonization of the clinical plan with guidance from both major regulatory agencies should result in a very effective development program. Also as a reminder, Ocata has been granted Advanced Therapy Medical Product, or ATMP designation for this RPE therapy for macular degeneration. This designation is an essential step in allowing companies to commercialize products effectively across the European Union. We interpret this designation as a favorable indication of how the European regulators view our therapy. The SMD program also has orphan status, both in the US and in Europe. We also intend to request Breakthrough status from the FDA in the near future. [Must have the same definition of "near future" that Rabin did?]"
I know how frustrated I am, can't imagine how frustrated people are who still own a lot of shares.
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Post by vzveteran on Nov 9, 2015 18:59:28 GMT
Given the current state of our finances, coupled with the stated delays;Does anyone think we will see another proxy next fall?
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Post by selluwud on Nov 9, 2015 20:06:01 GMT
As in most companies, the buck stops with the CEO. PW is near failing. He must take corrective measures (people or processes) and get on track or be labeled incompetent by the institutions. We're not quite ready for an onsides kick yet, but the game is getting shorter.
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Post by perrinmosca on Nov 9, 2015 20:50:54 GMT
I sold at 430 after a long time holding probably why we are going back up! I just couldnt deal with the missed timelines any longer. Lets see how this plays out. Good luck to the rest of you still holding.
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