Natty Greene

Long only
Natty Greene
Long only
Contributor since: 2011
You state that,
"Drug launches can be slow and this might especially be true for Relypsa, which has no other products on the market and no prior experience."
You must remember that the Veltassa sales force does have great experience because of the co-detailing agreement with Sanofi. Sanofi's renal sales force is very experienced and serves as a tremendous asset in the field generating sales for Veltassa.
"No prior experience" is not accurate. Kudos to management for bringing in experienced Sanofi sales team to compliment 120 RLYP reps in the beginning of launch to take advantage of lead time over unapproved FDA competitor ZS-9.
Red Acre,
When do you forecast next PH3 results to be released for second CIC trial?
Anyone hear what I heard at UBS last week; CEO could not be more clearly teeing up PH3 results PR...
As expected and commented on above in my 1/30/15 comment...Zogenix CFO Ann Rhoads confirmed yesterday at Leerink Global Healthcare Conference that since the recent sNDA approval of Zohydro ER with AD tech, Zogenix has received:
"Additional interest from companies that have morphed into more strategic dialogue around Zohydro ER."
Strategic dialogue = buyout discussions of Zohydro ER asset
ZGNX sold Sumavel for 4X sales run rate in 2014 for $105M but I think the market opportunity for Zohydro ER is much larger and the asset is much more valuable. At a current $23M sales run rate, Zohydro ER could fetch 5-7X sales for an asset value of $115M - $165M.
If Cam & company's ongoing "strategic dialogue" can get the bidding up to 7X range ($165M), I would expect them to sell Zohydro ER and use $ to focus on valuable pipeline.
Yes, Cam & Co. were successful in getting FDA approval for Zohydro and the stock want to $5+ on this success. What caused the major drop is the extraordinary attempt by MA Governor Patrick to ban the drug in his state. I explain this in details here, .
Cam & Co. were successful again in MA court by beating back the Governor's assault on Zogenix and their FDA-approved drug, Zohydro. I explain the victory here, .
This assault on a private company by Governor Patrick did some damage to Zohydro's launch and early adoption. Cam & Co. are finally gaining some steam in Zohydro sales and today's AD formulation approval (95% chance IMO) will dramatically expand sales and blunt the criticism of Zohydro for good.
If the entire company does not get bought out after approval, at the least I would expect there to be a bidding war for Zohydro ER franchise from Purdue and Teva. Zogenix has already inked small deals re: Zohydro with Teva and Purdue. This is a clue that the lines of communication are open and the companies are in discussions.
Cam & Co. like to exit their investments when the price is right. His successful track record is legendary. I expect nothing less from ZGNX when the price of the Zohydro franchise dramatically increases with the expected approval today.
Video released today (1/13/15) of NVIV's pilot study first patient walking in the water....and moving legs beneath knee while seated. This video evidence of efficacy of the first in human implanted Neural Spinal Scaffold (NSS) to treat spinal cord injury should be very encouraging for NVIV investors, not to mention the fans of Jordan's recovery.
This video is more powerful and more illustrative of the success to date of the first in human procedure than any PR would have been to outline Jordan's progress to date.
I agree with you 100% on NVIV as having the potential to be a major mover in 2015. You mention the NVIV share price in 2013 of $6.20/share. Based on OS at that time, the market cap rose to $487 million. This rise was on the FDA news of approval of human trials and the hope of safety/efficacy once device was in human trials.
Today, patient #1 according to "the interview" you have authenticated has progressed positively from ASIA A to ASIA B in the impairment scale. Yet, the share price is now at $1.30, or a market cap of $121 million.
There is a major disconnect and massive undervaluation based on what is actually happening in this human trial.
With the company being divorced to date in contact directly with Jordan or in the assessment of current data on him, we are approaching the critical 90-day assessment next Monday (January 12) where NVIV will get a full assessment report on Jordan's progress since October 14.
I am under the assumption that this 90-day progress will rise to the level of "dramatically positive results" which the NVIV CEO said on October 15 would result in NVIV communicating the progress outside of standard medical and scientific forums.
This leads to a major catalyst next week post the 90-day assessment report provided to the company. I think the company has to follow their 10/15/14 guidance and inform shareholders and public of what you have authenticated as "dramatically positive results."
Thanks for your research...always enjoy reading your material.
Bottom line is this:
$39M market cap
$32M in cash
These drug assets are worth much more than $7 million.
Strong buy at these levels ($1.90s)!
The October 7-9 COMP meeting report is out (
The application, EMA/OD/117/14- For treatment of acute peripheral arterial occlusion - was not one of the 29 applications on the list which received a positive orphan status opinion.
According to EMA, application EMA/OD/117/14 has been withdrawn.
Therefore, the basis for the near term catalyst mentioned in this article is not happening. This was unexpected considering the MST-188 for treatment of ALI has already received orphan status in the US.
When the full meeting minutes are published in about 60 days, we should know more details on what led to this application withdrawal decision.
MSTX announced that EU orphan application (MST-188/ALI) was filed in Q2 - 2014. Now that application has been withdrawn. Now the company needs to provide an update on the timing of this application going forward. When will they reapply?
Looking ahead, the following is still on the horizon for MSTX despite this EU orphan development which include:
Phase 2 Study (heart failure): agreement with FDA on protocol
Q4 2014
Nonclinical Study (heart failure): data
Q1 2015
Nonclinical Study (embolic stroke): data
Q2 2015
Phase 2 Study (heart failure): initiate enrollment
1H 2015
Phase 2 Study (acute limb ischemia): complete enrollment
Q4 2015
EPIC Study (sickle cell disease): complete enrollment
Q4 2015
Phase 2 Study (WHO Group 2 pulmonary hypertension): data
2H 2015
Phase 2 Study (heart failure): data (interim analysis)
2H 2015
Patience on this many catalysts are on the horizon. This current valuation of $75M very much undervalues the company's drug asset potential.
The EMA's Committee on Orphan Medicinal Products (COMP) is meeting as I type to give an opinion on MST-188 (ALI). With orphan status designation expected, this would give MSTX orphan status for MST-188 in US and in EU for two different indications (sickle cell & acute limb ischemia).
The COMP meeting ends on Thursday, October 9, and they will issue a meeting report a few days after with their opinions on orphan status. The average time for this monthly report to be released in 2014 is 6 days after COMP meeting ends (October 15 in this case), but they have also issued report as soon as 2 days after meeting ends. Therefore, we could know as early as Monday, October 13.
To inform your opinion of why "GSK dumped this", here is the full history of what is now known as MST-188. You'll notice that the new formulation is a second generation "purified" version....NOT the "unpurified" version used by GSK sub:
RheothRx – A first-generation product with unpurified, excipient-grade poloxamer 188 as the active ingredient. Associated with elevated serum creatinine.
MST-188 (formerly known as ANX-188, FLOCOR and CRL-5861) – A second-generation product with purified poloxamer 188 as the active ingredient. Certain low molecular weight substances present in excipient-grade poloxamer 188 that are associated with elevated serum creatinine are not present in MST-188. No clinically significant elevations in creatinine have been observed in clinical studies conducted with the purified material (>300 administrations).
Early Development: The CytRx Corporation/Burroughs Wellcome Alliance
Poloxamer 188 is a well studied compound. It was originally used as an emulsifying agent in topical wound cleansers and parenteral nutrition products. However, the therapeutic use of poloxamer 188 was largely conceived by Dr. Robert Hunter, MD, PhD (Distinguished Professor and Chairman, Department of Pathology and Laboratory Medicine, University of Texas Medical School at Houston). Dr. Hunter (then at Emory University) identified the compound’s rheologic, cytoprotective and antithrombotic activities through an extensive series of laboratory studies. His work led to the formation of CytRx Corporation, a start-up company that licensed Dr. Hunter’s inventions from Emory. CytRx conducted a wide range of pre-clinical and clinical studies with first-generation poloxamer 188, then known as RheothRx. These studies led to a major alliance with Burroughs Wellcome (today, GSK). Burroughs also performed an extensive series of nonclinical studies and 8 clinical trials, primarily focused on acute myocardial infarction (AMI). Early studies investigating RheothRx were promising. The largest AMI trial planned to enroll approximately 20,000 patients. However, during the 3,000-patient lead-in phase of this study, elevations in serum creatinine were observed, particularly in those patients aged 65 years and older and in subjects with elevated creatinine at baseline. This phenomenon was referred to as “acute renal dysfunction” and resulted in the discontinuation of the program by Glaxo, which had recently merged with Burroughs Wellcome.
Addressing Renal Toxicity and Pursuing Sickle Cell Disease
After Glaxo returned the RheothRx program, CytRx investigated the source of the renal dysfunction and determined the elevation in serum creatinine was attributable to preferential absorption of certain low molecular weight substances by the proximal tubule epithelial cells in the kidney. CytRx developed a proprietary method of manufacture based on supercritical fluid chromatography that reduced the level of these low molecular weight substances present in poloxamer 188, creating what is now known as purified poloxamer 188. Nonclinical testing of purified poloxamer 188 (now known as MST-188), demonstrated less accumulation in kidney tissue, less pronounced vacuolization of proximal tubular epithelium, more rapid recovery from vacuolar lesions, and less effect on serum creatinine. A full report of the differential effects of commercial-grade and purified poloxamer 188 on renal function has been published.1
Subsequently, CytRx sought to re-introduce MST-188 into the clinic. However, CytRx lacked the resources to conduct a 20,000-patient heart attack study. Instead, they focused the development of MST-188 in sickle cell disease (SCD), a rare disease with a huge unmet need and in which RheothRx had demonstrated positive results in a pilot Phase 2 study conducted by Burroughs Wellcome. In that Phase 2 study (n=50), RheothRx significantly reduced the duration of crisis, pain intensity, and total analgesic use and showed trends to shorter days of hospitalization in the subgroup of patients who received the full dose of study drug (n=31). These data were reported more fully by Adams-Graves et al.2 Notably, CytRx conducted safety studies in both adult and pediatric sickle cell patients and, even at significantly higher levels of exposure than anticipated therapeutic doses, there were no clinically significant changes in serum creatinine observed and no acute kidney failure reported. Based on these promising Phase 1 and 2 results, CytRx subsequently launched a randomized, double-blind, placebo-controlled Phase 3 study of MST-188 in 350 patients with sickle cell disease. The primary endpoint was a reduction in the duration of a painful crisis. However, CytRx concluded the study at 255 patients, in part due to capital constraints. Nonetheless, the study demonstrated treatment benefits in favor of MST-188. However, it did not achieve statistical significance in the primary study endpoint (p=0.07). Mast believes that enrolling fewer than the originally-planned number of patients and key features of the study’s design negatively affected the outcome of the primary endpoint. In particular, the study assumed that most patients would resolve their crisis within one week (168 hours). However, a substantial number of patients did not achieve crisis resolution within 168 hours and were assigned a “default” value of 168 hours, which had a potentially significant effect on the primary endpoint. Notably, in a post hoc “responder’s analysis” of the intent-to-treat population (n=249), which analyzed the proportion of patients who achieved crisis resolution at 168 hours (excluding those who had been assigned the default of 168 hours), over 50% of subjects receiving MST-188 achieved crisis resolution within 168 hours, compared to 37% in the control group (p=0.02). Data from the Phase 3 study are reported more fully by Orringer et al.3 Following conclusion of the Phase 3 study, CytRx merged with a private company and modified its business strategy by discontinuing development of all of its existing programs (including MST-188) to focus on assets held by the private company with which it merged.
After the corporate reorganization at CytRx, a group of individuals, including Dr. Hunter, formed a private entity, which they named SynthRx, Inc., to acquire rights to the data, know-how, and extensive clinical and pre-clinical and manufacturing information necessary to continue development of MST-188. SynthRx developed new intellectual property and conducted additional analyses of the existing data. However, they were unable to raise capital to fund development of MST-188 during the “great recession.”
Mast Therapeutics
In 2010, Mast Therapeutics met with Dr. Hunter and his colleagues to negotiate the acquisition of SynthRx and continue the development of MST-188. The merger was finalized in April 2011.
Since April 2011, Mast Therapeutics has re-established the unique manufacturing process through a partnership with Pierre Fabre (FRA) and met with the FDA multiple times to discuss a pivotal study protocol for MST-188 in sickle cell disease. In 2013, Mast initiated the EPIC study, a 388-patient pivotal Phase 3 trial of MST-188 in sickle cell disease, and, in 2014, Mast initiated its second MST-188 clinical program with a Phase 2, proof-of-concept study of MST-188 in combination with rt-PA in patients with acute limb ischemia. In addition, based on recent nonclinical study data showing improvements in cardiac ejection fraction and key biomarkers and prior studies showing MST-188 improved cardiac function without increasing cardiac energy requirements, Mast has announced its intent to pursue clinical development of MST-188 in heart failure.
1. Emanuele, M. and Balasubramaniam, B. Differential Effects of Commercial-Grade and Purified Poloxamer 188 on Renal Function. Drugs in R&D April 2014. Available at
2. Adams-Graves P, Kedar A, Koshy M, et al. RheothRx (Poloxamer 188) Injection for the Acute Painful Episode of Sickle Cell Disease: A Pilot Study. Blood 1997;90:2041-6
3. Orringer EP, Casella JF, Ataga KI, et al. Purified poloxamer 188 for treatment of acute vaso-occlusive crisis of sickle cell disease: A randomized controlled trial. JAMA 2001;286(17):2099-106
Yes, good day for GLYC, but still down 16% from intraday high just a week ago at $8.82 prior to news that Pfizer significantly delayed their PH3 trial.
You are correct, it is PFE. I have submitted that edit the editors and it should be changed in article copy soon. Thank you.
Congrats on those picks. I agree on Franklin and also like that Baker Bros are involved (3M share position) in MSTX too. Definitely smart money there!
Glad you enjoyed the read. Not covered in the article is my opinion that significant institutional $ will begin to move into stock post EU orphan status opinion next week. With only 17% institutional ownership, there is a long runway of growth in that department. That expected wave of buying will be what really pushes the stock much higher in Q4.
Judge Zobel rules exactly as I predicted in this article. The only problem for Zogenix and the reason the stock is not moving up on this news is that Purdue news (competitive Hydrocodone ER given priority review by FDA) was released this morning too. ZGNX just can't catch a break!
A 30,000 share buy on the open market is an insider buy in my book and even more notable because of who made the buy, Zogenix founder and chairman Cam Garner.
This is very helpful for Zogenix too with physicians....a supportive Zohydro statement from the American Academy of Pain Management,
Agreed Rick.....this goes to $3 on favorable ruling by Zobel. Today's move (18%) is minor compared to what a favorable, precedent-setting ruling by the U.S. District Court would do.
I am always bothered by insider selling and this is no exception. I put much weight in my investment decisions based on insider buying and that was stressed in this article regarding Hawkins and Hyde. You'll just have to weigh whether you think this dump of 72K shares discounts the purchase of nearly 12M shares purchased at $1.78 mentioned in this article.
Yes, that is correct...PH2 breast cancer data is the key catalyst here.
Thank you for this correction. You are correct, GTXI is based in Memphis. I have had ZGNX on my mind lately as I prepare to write an article on them, and ZGNX is based in San Diego. Thanks for correcting this mistake.
You ever heard of activist investors? I would not be surprised that after positive Phase 2 results are announced, big Pharma would come bidding.
As you may have noticed, in my articles I like to point out things in a company that the average observer may have missed (like a Form 4 filing, or institutional ownership increase, or like in this case the chain that is now carrying NEXAFED). I never claim to be the omniscient expert on any stock I write about. Just pointing out some things to add to the free discussion of stock ideas.
You do raise some good questions on stocking and reorders which I hope management will be explain more clearly on the next CC.
My points in this article are simply:
1. I was amazed that the stock did not react (as it has historically done to positive PRs) to the 85% rise in pharmacies carrying NEXAFED. This struck me as very positive news. I came to the conclusion it was because the new chain was not named (unlike when they named Kerr Drugs) in the 9/18 PR.
2. As an ACUR investor, I was curious which chain was now carrying NEXAFED, so I researched and found that there are only two large regional supermarkets based in FL. A few simple phone calls verified that Publix stores in five states had NEXAFED available (as of yesterday).
(Regarding your question on orders....all I know is what the company has released in PRs or in conference calls....and they say that revenue from NEXAFED is being deferred in recognition until the return period is over.....this could be 30 days, 60 days, or longer depending on what the terms of sale were.....therefore we really will not know how well NEXAFED is doing in these expanded pharmacies until a few more quarters....the verdict is still out on adoption of this Sudafed alternative and whether folks will buy it time and time again)
3. Regarding OXECTA, any longtime ACUR follower knows of the delays in OXECTA rollout and marketing. Acura's success/royalties ($$) with OXECTA all depends on Pfizer's sales efforts. I found it significant that Pfizer will ramp its communication with health care providers regarding OXECTA in Q4 2013 according to Acura.
Perhaps someone can do a followup to this piece and actually estimate sales #s for NEXAFED, but that was not something I covered here. Just sharing my thoughts on Acura, folks must decide for themselves whether they want to invest in the company. Biotech investing is always speculative and risky.
I added at 1.50 based on these developments covered in my article. Time will tell if that was a good investment or not.
APPY has named its French distributor/partner, Nephrotek,
When the MoU Agreement is signed, I would expect a PR from company.
Also, UK and Germany distributors to be announced in next 45 days too.
Great opportunity to add today at $1.40
APPY has named its French distributor/partner, Nephrotek,
When the MoU Agreement is signed, I would expect a PR from company.
Also, UK and Germany distributors to be announced in next 45 days too.
Great opportunity to add today at $1.40
The reason I expect this stock to see $2 range if trials fail to meet both primary endpoints is mostly supported by technical action of stock on past disappointing news.
You will notice that when Capesaris clinical trials were put on hold in January 2012, ,the stock went from $6.55 to $2.61 shortly following this news.
Further back, you will notice that when GTx had their last secondary offering (10M shares @ $4.75) in June 2011, the stock went from $6.86 to $2.67 in short order.
I have no doubt that if current Phase III trials are unsuccessful, the stock will perform similarly based on past technicals and the assumption that another capital raise would be forthcoming.
Cora Schlesinger,
Excellent article on GTXI,
I skipped the "flawed data" debate details because others (you, Choi, & now Schlesinger) have all effectively covered those points in your public postings.
In my articles, I always try to provide an analysis not yet reported in public forums to add to the discussion and due diligence on a particular stock.
Agreed on the risk/reward profile and not for faint of heart. Let's be honest, if trials fail to meet both primary endpoints, the stock gets hit hard. That is why this is considered highly speculative investing. I, too, have been given greater confidence in GTXI due to massive insider buying and ownership (Schuller, Hyde). We'll know soon enough.