Current shares outstanding 87 mil. Now add 150 million shares. LOL. Maybe the MRI data are positive - large effect size positive :)
In this case, CUR is unlikely to have a viable product following BCLI current success in 2a, and likely future success.
NSI 189 does not have any definitive data demonstrating its efficacy, and the company has mischaracterized the results, IMHO. Garr, once again, guided for MRI results for a year and the held them, and, after a year of calling Fava a consultant, promoted him to co-PI. All slippery PR moves to raise share price, IMHO. It worked, for awhile, and now the company will likely experience a large pull back, IMHO.
The share price, following the dilution, will provide for the company to continue operations for another decade of losses, if ALS is shelved. Or, more succinctly, salaries for staff. As the company became more well known, Garr's manipulation of the press, IMHO, is more widely known. He will now have to dilute prior to BCLI releasing full results for their 2a program. BCLI is also likely to have a compassionate use program putting further pressure on CUR to the downside. BCLI has the limelight.
Anticipate, dilution and further share price erosion.
Company has already indicated that over 50 percent of the patients improved, or had spectacular results in P1/2. Schwartz was on the agenda at the recent ISSCR conference several weeks ago, but did not present his session. This appears to indicate that the company had anticipated the results would have been available by the time of the conference.
It is reasonably probable that the share price will exceed .24 - $30 billion in world-wide potential with no effective treatment for improving dry AMD. 3x bagger on approval.
The spin factor:
1) NSI 189 MRI data promoted for a year and now unavailable
2) NSI 189 shows no statistically significant efficacy on only direct depression scale used in the study - MADRS. Company misleads by promoting the effect size which is not significant
3) NSI cognitive scale results have an unmatched baseline between placebo an active making a comparison invalid IMHO
4) Company promoted Mexican ALS site
5) Majority of patients in P1 trial did not benefit from treatment - Dr. Feldman claims it is too early to tell if treatment is effective yet company promotes otherwise.
6) CUR promotes anecdotal patient blogs for patients claiming positive results, but other patients claim to be worse off -- benefit is not verified yet.
7) CUR promotes right to try in Colorado, but will never treat a patient there. Stunt will backfire severely with the FDA
8) BCLI treatment has a statistically significant result in their 2a interim and full results are do shortly. The therapy does not require surgery or immunosuppression.
9) Large shelf registration was a large miscalculation.
10) STEM is the likely owner of the relevant patents, and has pursued a much more commercially viable clinical pathway with AMD.
11) Repeating STEMS's program in SCI is a waste of funds - success in this area has been fleeting
Conclusions: CUR is likely to be surpassed by BCLI an any effect appears to be neurotrophic rather than related to engraftment. NSI 189 data are inconclusive - no evidence it works. Company also has conspicuously back-tracked on MRI data. Management, time and again, misguides investors and unethically promotes trial results without fair balance IMHO. BCLI is now the company to watch in ALS. SELL.
Sovaldi sales should just exceed $4 billion, and if these two decisions are positive, look for $120 and a stock split after holding above $100 for 60 days.
STEM was upgraded today at Chardan Capital, and the firm issued a price target of $4.0. They have also indicated that STEM will release their AMD data on June 19 prior to the market opening. Depending on how large the efficacy signal is, this has the potential to be transformative for the company.
No oral presentation involved. Typical Neuralstem spin. According to the abstract for June 24 it does not include MRI data, and Garr, despite all his missed guidance on revealing the data, has not indicated that data will include MRI results. Perhaps it will be presented on the 17th - but again - the company does not confirm... Garr misleads - I would wait for actual results before speculating. MRI doesn't appear likely. Original guidance listed Fava as only a consultant, who post study became a co-PI. Is that ethical?
CFO noted on CC that VA/Military channel is not reporting in IMS RX and represents a very large percentage of the pie. Additionally, Europe is also not in this estimate. Revenue estimates based on scripts fall quite short of actuals. 2nd quarter likely $3.4 to $4.0 billion. The CFO comments have sparked the rally.
1) Fiorino introduced - will make the rounds with US bankers
2) Israeli press profiles a 2nd super responder - a soldier. Company considering translating for US news outlets
3) Slides will not be distributed for 2a results due to pending publication of data by PI. Waiting for final 2 patients to complete follow-up in August
4) Company preclinical models of NurOwn in AZ show consistent effects across the board -- nice pipeline expansion for attracting funding
5) Tech transfer completed at 2 additional manufacturing sites - looking to consolidate an approach
6) Publication of 2a results could qualify for FDA breakthrough status - publication to be in major journal
7) Trials moving forward and company believes their technology is better than competitors - working on improvements to share price
8) No discussion of up-listing or reverse stock split
9) No negative news (other than visibility issues being in Israel) - Fiorino thrown in the fire, but performed well
1) No MRI data June 24 - Just a qEEG poster (see actual congress program)
2) 566 eclipsed by BCLI NUROWN with P2a data and potential BT status
3) Garr challenges the FDA - even though he has yet to publish positive efficacy data from any P2 trial
It just occurred to me last night --- wouldn't it make perfect sense for TEVA to partner with BCLI? They are marketers of Copaxone -- exactly the direction BCLI is going with NUROWN following ALS.
xwavve • Sep 14, 2013 12:23 PM
NSI 189 Forecast: Astounding if Successful
Utilizing NIH statistics:
There is approximately a 12 month prevalence of MDD is 13.1-14.2 million in the U.S, and 51.6 percent of cases receive treatment. The average episode duration is 16 weeks, or 4 months. For Rx cost, assume a 10 percent premium per month to Abilify, a cost of $750. Factoring some conservative market shares, the forecast is astounding. It will be difficult for NSI 189 to show efficacy in the 1b, but if there is a signal, the impact on PPS will be astounding. Crunching the number, the first full 12 moths could yield $1.74 billion. Here are some rough calculations:
Year 1: 14M (prevalence) x .52 (% treated) x .08 share x $750/mth x 4 treatment duration = $1.74 billion
Year 2: 14M (prevalence) x .52 (% treated) x .16 share x $750/mth x 4 treatment duration = $3.49 billion
Year 3: 14M (prevalence) x .52 (% treated) x .22 share x $750/mth x 4 treatment duration = $4.80 billion
There should be a press release in the am. Interestingly, Capricor partnered very early with JNJ on their stem cell derivative for repairing MI damage. This may be the case here as the company indicated on their conference call that they had significant company interesest and signed confidentiality agreements (providing data review). Capricor received $12.5 million upfront for JNJ and $375 in milestones + royalties. They are also a penny stock.
Lebovits indicated on the April 28 conference call that they have been contacted by major pharmaceutical companies, signed confidentiality agreements, and had these companies review their data. He was quite confident that they would be able to raise money, and clearly articulated this may non-dilutive from a partnership, or other type of direct investment.
Lebovits also indicated they felt their approach was superior to Neuralstem (but didn't want to speak badly of another company in the ALS field), but that it was far too invasive. It is clear they have results which are consistently positive, but only last for months -- and this is variable from patient to patient.
Their results look superior to Neuralstem, in the few patients they revealed, but this may become more clear June 1, tomorrow, from the release of 2a data.
Visibility is their main issue, and from the clunks asking questions on the CC, this is clear. They hope to hire a US CEO to improve curb appeal.
Bottom-line: BCLI is was extremely confident in their data, and clear that companies were approaching them, signing confidentiality agreements, and reviewing their data. Neuralstem market cap is nearly 10x BCLI, yet BCLI, will quickly move ahead of CUR because patients can be dosed all at once - in fact in several weeks if they are pre-identified. They then stay in the hospital 1-2 days, but this is only mandated by protocol. Looking forward to data release tomorrow.
Patient data will be released mid June for the P1/2 AMD trial. Interim data for the first cohort will be presented, those receiving a transplant of 200k cells each. The second cohort will complete by the end of June for the high dose, 1M cells.
Odds appear good that a positive efficacy signal will be seen at the low dose. The company is heavily communicating in advance of the release, and has announced plans for a P2. This would be a transformative event for the company, as stem cell trial results have been underwhelming based on the original prospects once held for field.
The market for AMD is large, and this would be a tremendous commercial success if the results continue to demonstrate efficacy. Bottom-line: Decent odds for an efficacy signal.