Technically, Huck, he is weighing whether Dr. Tetzlaf is a co-inventor on the (now) StemCell Inc. patents. Neuralstem has a world wide license from Dr. Tetzlaf, meaning Stem's infringement claim would fail and be dismissed. The Judge owes the parties a decision. I think a Friday afternoon before a 3-day weekend would be a good time to drop a decision on two publicly traded companies. They would have the long weekend to sort through and have their spin in order by Tuesday.
As an aside, that's $0.31 in cash per share, meaning, the market is currently valuing everything else at bupkiss. Ridiculous.
CUR is fine. They finished the first quarter with more cash ($28.6 million) than they entered it with ($27.5 million at December 31) due to some warrant exercises. The burn rate is $4-5 million / quarter. One analyst stated they were fine on cash until late 2016. No need for any raises at these levels.
From a February SEC filing: "Dr. Johe received 1,200,000 options on July 28, 2005 with a term of 10 years and an exercise price of $0.50 per share." (It's unclear if these were any of the options/shares he had to sell periodically to pay his divorce settlement). So, unless the good Doctor has $600,000 lying around, he will have to do a "cashless exercise" (i.e., sell enough shares to exercise the options on the rest), or let his options expire. So, he has every incentive to ensure the stock price is as high as possible in 2.5 months so he has to sell as few as possible to exercise the rest of the options. (Although, no matter how few or many he sells we'll be bombarded with "Insider's Selling!" when, in fact, they are exercising options.) At any rate, that's a lot of dough at stake, and clearly we are nearing a time when management's personal financial goals should be nicely aligned with shareholders.
Ziggy: I found an even worse Yahoo! Message Board. Yes. It's true. VICL. One guys posts so incessantly that even when you have him on ignore you have to dig to 2-3 tabs into the messages to find one that he hasn't posted. Makes Karen look like she's asleep at the switch. More prolific than even Dogface.
The big news in the 10Q (as always): cash and clinical trials. The company ended Q1 with more cash than it entered ($28.63 million v. $27.0 million), which is simply amazing. In the rest of 2015 it will conclude a Phase I (SCI), begin three (3) Phase II's (ALS, Stroke, MDD), and will commence a Phase I(b) (Schizoprenia). Those two things should drive everything else. But, I also noticed this:
Full time and contract employees 3/31/14 v. 3/31/15: Grew from 16 to 25. Burn rate will go up, but a positive sign that the company is growing, and has confidence.
Manufacturing: they moved their HQ to a new facility and intend to bring the stem cell manufacturing in-house. Another positive sign supporting planned growth.
Insurance proceeds: "This was coupled with a decrease of approximately $0.5 million in legal fees resulting from insurance claims related to litigation expense." Now, I happen to know something about insurance coverage, and I was speculating that the libel claims from STEM might have triggered some insurance coverage for CUR. It's very helpful when your CGL carrier is paying for part of your defense.
Ischemic Stroke (Beijing): I did not realize that this trial was approved by the FDA in 2012, even though it's taking place in China. I tried to find it on clinical trials gov. Although I did not find it, I found 40 other trials involving stroke taking place in Beijing. So, rather than being a rogue trial that some critics have alleged, it appears that US-driven trials are fairly common in China. As Garr said to the question "why are you in China?", "How can we not be in China?" Over a billion people, and a middle class larger than the US population. How can you not be in China?
As a get rich quick scheme of mine, CUR has not been a success (holding since 2011). But, continued patience should reap some big benefits into 2015-2017. IMHO.
A development stage biotech finishes the quarter with more cash than it started (thanks to warrant exercises), and is on the cusp of about 3-4 Phase II's and Ib's, and the A/P Headline: "Neuralstem reports Q1 Loss." And water is wet . . .
Talk about a rigged game. The Soros investment is announced on Monday, and 2 days later a major acquisition is announced. Soros buys in below $3, and it went over $10 today (before settling back).
Not "tsunami." I believe you mean "tuna season" at the tip of Baja. Also, we caught 5 marlin in one day at about this time 2 years ago. We released 4 healthy ones, but 1 was in distress, foul-hooked, and wrapped in the line as we reeled him in, and our boat captain mentioned that his village and family would appreciate the meat . . .
Yesterday, you posted a link to a blog called Translate ALS by Steve Perrin. Today, your post is gone. Did you delete? Or, Yahoo!? A very interesting analysis of Genervon, and how not to deal with the FDA. From CUR's perspective, abiding by protocol and moving forward with peer-reviewed data is superior long-term. You implied that more news was coming on this blog. What do you know?
Huck: You have been very consistent in your position that no MRI data is coming. So, I went back and tried to determine where the idea of pending MRI data came from. I looked at some old investor presentations. Frankly, I can't find where the idea came from. So, your position is looking pretty strong unless another Board member can identify the source of our belief.
There is a very strong San Diego connection: the SCI Trial at UCSD; Dr. Eva Feldman did a sabbatical with Martin Marsala at UCSD; CIRM hosts a gathering there; Neuralstem has an office there; and I believe I was told last year that Dr. Johe is spending the majority of his time in San Diego (although, if I were him, I'd keep the Miami residency for tax reasons). I believe some of the Board members are West Coasters. The Board is a mature bunch; they are not whooping it up at the Lodge. Neuralstem has just about the lowest G&A of any company around. I went last year, but I plan to be fishing in Mexico this year. Anyone who can make it, should. (You have to have your proxy and prove you are a shareholder to get in). Mr. Garr was very approachable, and the Board members very friendly and candid.
We are hereby pleased to invite you to the 2015 annual meeting of shareholders (the “Annual Meeting”) of Neuralstem Inc., a Delaware corporation (the “Company”), which will be held on June 19, 2015 at 11:00 a.m. PDT at The Lodge at Torrey Pines, 11480 North Torrey Pines Road, La Jolla, California 92037. Details regarding the business to be conducted at the Annual Meeting are described in the Notice of Internet Availability of Proxy Materials (“Notice”) you received in the mail and in this proxy statement (the “Proxy Statement”). The following summarizes the matters to be voted upon at the Annual Meeting:
1. Election of (3) members to Class I of the Board of Directors to serve for the following three years or until their respective successors are elected and qualified;
2. Ratification of Stegman & Company as the Company’s independent registered public accounting firm for 2015; and
3. To transact such other business as may properly come before the Annual Meeting and any postponement(s) or adjournment(s) thereof.
Only shareholders of record as of the close of business on April 22, 2015 are entitled to receive notice of, to attend, and to vote at, the Annual Meeting.
We have elected to utilize the Securities and Exchange Commission’s “notice and access” rules that allow issuers to furnish proxy materials to their shareholders on the Internet. The Company believes the “notice and access rules” allow it to provide you with the information you need while lowering the costs of delivery and reducing the environmental impact of the Annual Meeting. For further information please see the Questions and Answers section of this proxy statement.
Your vote is important. Whether or not you plan to attend the Annual Meeting, we hope you will vote as soon as possible. You may vote over the internet, as well as by telephone, or, if you requested to receive printed proxy materials, by mailing a proxy or voting instruction card.
All great questions; similar to those raised by Huck_Taylor in a similar thread. I'm just curious, can someone compile your comments and Huck's and ask Jason Napodano while he was so hard on Neuralstem with its 47% responder rate, while giving a free pass to this BCLI shoddiness? If he has any integrity, he'll revist one or both of his analyses. I can't find an e-mail for the guy.
Search: The flimsy case for a miracle ALS drug collapses under expert scrutiny April 15, 2015 By John Carroll
Napodano (Zach's) is out with a pretty positive analysis of BCLI's Phase 2a study (the market is less impressed). I went back and read his post-top-line results article on CUR to see if he was holding CUR to a higher standard, and I think he is. In his March CU article he said, "Top-line data from Neuralstem’s Phase 2a study looked at patients at nine months. Brainstorm’s stopped at six months! The graph below is taken from Leuven University Hospital and shows the outcome of 30 randomly selected ALS patients in Belgium. We draw several conclusions from this graph: 1) ALS patient outcome is highly variable, 2) bulbar patients decline rapidly once their ALSFRS score drops below 30, 3) nine months is not an acceptable endpoint to determine efficacy for any ALS treatment, 4) some patients experience months (or even years) or disease stabilization while others decline rapidly for no apparent reason."
So, he admits CUR followed the patients 3 months longer than BCLI, and states that he doesn't even think 9 months is enough, but today he gives a thumbs-up to BCLI's data (which, frankly, I don't see as better than the CUR responder data). Like CUR, BCLI had 15 patients in its study. What am I missing?
And, I forgot, Judge Titus ruling on the 3-day bench trial (now over 4 months ago). Issue was motion to dismiss Stem's suit. I've read the transcript from the last day, and I like Edit's theory that the good judge is looking for away to add Dr. Tetzlaff as an inventor on the patents, thus mooting the entire case. That way, he doesn't have to really rule on the merits, and he doesn't have to invalidate STEM's patents. Or, he could rule against Neuralstem and things could drag on. His opinion could come out today, tomorrow, next week, next month, next year . . .
Hopefully, Eva Feldman's analysis of the Phase II ALS Results will reverse any misconceptions. No idea when that will come out. She speaks next week, but she's part of a panel, and it seems like a poor venue to release the complete findings. I see these catalysts:
- ALS Phase II full results (end of Q2--just my WAG).
- Fava releases MRI / hypocampal growth results from NSI-189 Phase I (Q2). (This hunch is based on his KOL event on March 5 that is on the Neuralstem website where he says, "Next Steps: Hypocampal Volume Analyses."
-NSI-189 Phase II for MDD, start Q2 of 2015*
-NSI-189 Phase Ib for Schizoprenia starts Q2/Q3 of 2015.*
- NSI-566 ALS Phase IIb or III starts Q3/4 of 2015.
- NSI-566 SCI Phase Ib data Q4 2015.*
-NSI-566 Ischemic Stroke China / Results Q3/Q4 2015?
-China Stroke Phase II starts 2015.*
Awaiting approval or in animal studies: South Korea acute spinal cord, and NSI-523.IGF Alzheimer's Disease.*
* = straight from presentation on company website. Rest is my informed speculation.
Throw in, potential new partners, new research papers, on-going collaborations that we don't know about.