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Jason Napodano, CFA ?@JNapodano 4h4 hours ago
Early-stage diabetes company $ANTB raised $7M through a PIPE at $1.85 this morning. Stock is $1.28. Interesting they got funds to over pay.
$ANTB...Plan of Operation
In first half of calendar 2014, we successfully raised more than $11 million to fund our operations including hiring and retaining qualified
staff, leasing a manufacture and research facility and engaging third party advisors to assist in the AB101 development efforts. As of
September 30, 2014, we had $4.3 million cash on hand. Our general operating expenses average $350-$500 thousand per month and we
anticipate that our current cash would be sufficient to fund our operations well into 2
nd half of calendar 2015. However, our current cash is not
sufficient to fund the production of cGMP material required for AB101 clinical studies and it is insufficient to pay for our planned clinical
study in 2
nd half of 2015. In order to advance our clinical program for AB101, we believe that we require at least an additional $10 million of
cash.
Specifically, in order to produce cGMP material in our facility we will need to construct a manufacturing suite which we estimate will cost at
least $2.5 million and we expect that our first clinical study in 2
nd half of calendar 2015 will cost approximately $4 million. In addition,
following the move into our Louisville facility we discovered that some of the equipment required for the production of microspheres on our
platform is missing, broken or was managed by software which is outdated and unsupported and consequently we anticipate acquiring or
leasing additional equipment which may cost approximately $1 million.
17We believe that our current cash is sufficient to support the manufacture of fresh GLP AB101 material as well as to conduct studies in support
of our IND, including acute and sub-acute toxicity studies in at least two species (which are likely to be rodents and dogs), safety
pharmacology, and mutagenicity/genotoxicity studies.
We are also planning to conduct additional in vitro and in vivo pharmacology in the animal to demonstrate the promise of once weekly dosing
of basal insulin.
In our clinical studies our objective is to demonstrate that AB101 is safe and effective at the intended once weekly subcutaneous dosing
frequency and that it is non-inferior to current standard of care basal insulin therapies in controlling blood glucose without an undue risk of
hypoglycemia. After completion of additional IND-enabling work, we plan on filing an IND with the FDA in 2015, folowed by the initiation
of a clinical trial in the second half of 2015. The objectives of the Phase 1 program will be to assess the single and repeat (once weekly)
ascending dose safety, pharmacokinetics (PK), and pharmacodynamics (PD) in the target population with type 1 and type 2 diabetes, including
confirmation of the time action profile for glucose lowering (Phase 2a data). Following successful completion of the Phase 1/2a program,
Phase 2b trials in both populations will be conducted to obtain proof-of-concept for the intended once weekly dosing regimen, using the
accepted biomarker for glucose efficacy (hemoglobin A1c; HbA1c), compared to a standard of care basal insulin such as Lantus.
If proof-of-concept trials are successful, we would expand our clinical program to include Phase 3 registration trials in various jurisdictions
including the US and Europe, to obtain regulatory and marketing approval. The Phase 3 program would include studies in combination with
other injectable and oral glucose lowering therapies, and would be designed to meet regulatory guidelines for the development of therapies for
diabetes, while achieving an expanded label at the time of product launch.
$ANTB...ANTRIABIO ANNOUNCES $7 MILLION PRIVATE PLACEMENT
Download PDF
LOUISVILLE, CO -- (Marketwired) -- 01/05/15 -- AntriaBio, Inc. ("Company") (OTCQB: ANTB), a biopharmaceutical corporation focused on developing novel extended release therapies, announced today that it has successfully raised approximately $7 million in a private placement transaction. At $1.85 per unit, institutions and accredited investors were issued one share of common stock and one warrant exercisable for three years at $2.50 for one share of common stock. Notably, the Company was successful in raising over $18 million through equity financings in 2014.
AntriaBio will use the proceeds from its most recent financing for general corporate purposes including the production of cGMP material and initiation of Phase 1 clinical studies for AB101, a basal insulin with potential for once-weekly dosing for patients with type 1 and type 2 diabetes.
Nevan Elam, Chairman and Chief Executive Officer stated, "Our fundraising efforts in 2014 were instrumental in advancing our clinical program for AB101. The confidence that our investors have shown in us is a testament to our extended release platform and the potential of AB101 to transform the $10 billion basal insulin market."
The securities sold in the financing have not been registered under the United States Securities Act of 1933, as amended ("Securities Act"), and may not be offered or sold in the US absent registration or an applicable exemption from registration requirements. As part of the financing, the Company has agreed to file a resale registration statement on Form S-1 with the United States Securities and Exchange Commission within 90 days of the closing of the financing for purposes of registering the resale of the shares of common stock issued or issuable in connection with the financing.
This press release is being issued pursuant to Rule 135c under the Securities Act and does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.
About AntriaBio, Inc.
AntriaBio is a biopharmaceutical company that develops novel extended release therapies by combining proprietary formulation and manufacturing capabilities with well-known molecules to significantly improve standards of care. For more information visit: www.antriabio.com.
Forward-Looking Statements
This release, like many written and oral communications presented by AntriaBio, Inc., and our authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of the Company, are generally identified by use of words "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "seek," "strive," "try," or future or conditional verbs such as "could," "may," "should," "will," "would," or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, AntriaBio undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made.
AntriaBio, Inc. Contact:
Noopur Liffick
VP of Corporate Development
(650) 549-4175
Email Contact
Source: AntriaBio Inc.
ANTB...AntriaBio’s lead diabetes product candidate, AB101, is a once-a-week injectable basal insulin that is currently in preclinical development. AB101 is to be administered by subcutaneous injection and is intended for use in patients with Type 1 and Type 2 diabetes who require basal insulin for the control of hyperglycemia.
The formulation has been designed to release human insulin slowly and uniformly over a period of approximately one week without an adverse initial burst of insulin. The release profile results in a sustained and near peak-less insulin level over the intended treatment period, which supplements the effects of endogenous and exogenous insulin and complements the effects of orally administered hypoglycemic agents. AB101 has the potential to be a clearly differentiated product which would represent a significant advance in basal insulin therapy.
Unlike existing basal insulin replacement therapies which use synthetic insulin analogues, AB101 is formulated from human recombinant insulin. The extended duration of action is the result of the PEGylation (PEG) of human insulin which is then encapsulated into poly-lactic, poly-glycolic (PLGA) microspheres. Typically, PEGylated biomolecules use large molecular weight PEG chains to decrease clearance and therefore reduce injection frequency. However, in our patented formulation we use a very small molecular weight PEG for AB101 to modify the solubility of insulin, permitting encapsulation of the drug into a biodegradable polymer which determines the extended release profile.
After injection, the PEGylated insulin is slowly released at the injection site as the polymer microspheres are broken down by simple hydrolysis. As a result of our unique formulation capabilities, AB101 extends the duration of action of human insulin without the use of any new excipients. Regulatory authorities have already approved numerous products using PEG or biodegradable polymers such as PLGA.
In addition to the proprietary technology for PEGylation of insulin and incorporation of the PEGylated insulin, we use a proprietary microparticle manufacturing technology which ensures production of a very tight particle size distribution with uniformly small microparticles. Our efficient manufacturing capability allows us to maintain high yields as well as to facilitate patient comfort by producing microspheres that can be injected through 25 gauge or smaller needles.
ATHX...took profit..20%..still holding 1100 shares..hog
$MSTX...MSTX to Provide Updates on EPIC Study & 2015 Events
- Conference Call Scheduled for 8:00am ET / 5:00am PT on Tuesday January 6th, 2015
SAN DIEGO, Dec. 30, 2014 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage biopharmaceutical company, today announced that it will hold a conference call at 8am Eastern Time, 5am Pacific Time on Tuesday, January 6, 2015. The Company intends to provide an update on EPIC, its pivotal phase 3 study of its lead product candidate vepoloxamer (MST-188) in sickle cell disease, which the Company continues to expect will complete enrollment by the end of 2015, and anticipated clinical and business milestones for 2015.
$ZGNX...strong buy rec from analysts...hog
http://www.nasdaq.com/symbol/zgnx/analyst-research
$ZGNX...Zogenix Inc. (web site) is a pharmaceutical company which develops and commercializes medications for central nervous system disorders and pain. Zogenix has commercialized Zohydro, an extended-release hydrocodone for the treatment of moderate to severe chronic pain. The company is currently developing Relday, which is in Phase I clinical trials to treat schizophrenia and bipolar disorder in adults and teenagers 13 years of age and older. The company was founded in 2006, is headquartered in San Diego, and has approximately 110 employees.
Current Market Cap: ~ $210 million
Share Structure
Zogenix ownership summary
Shares short:
Zogenix shares held short
Source: Nasdaq.com
Why Zogenix Shares Were Beat Down in 2014
Zogenix shares were hit hard in 2014, closing the year down 73% from the high of $5.19 made in February. While shares were making this precipitous drop, revenue for the nine months ended September 30, 2014 was $25.6 million, an 11% increase from the $23.1 million in sales during the first 9 months of 2013. In Q3 the company also trimmed losses from .10/share to .09/share.
Despite these positives, shares were under pressure from dilution with approximately 40 million new shares hitting the market in 2014. More significantly, both the FDA and Zogenix received a torrent of negative publicity over the FDA’s approval of, and the company’s commercialization of Zohydro ER.
Zohydro ER is an extended-release form of hydrocodone used for around-the-clock treatment of severe pain. Like any narcotic, Zohydro can be addictive and has the potential for misuse by substance abusers. Even before the drug was launched in March, a group called “Fed UP!” (a coalition to end the opioid epidemic) sent this letter to FDA commissioner Margaret Hamburg imploring her to re-write policies regarding FDA approval of all narcotics and that “the very last thing the country needs is another dangerous, high-dose opioid.”
With 2014 being an election year, some politicians couldn’t help themselves in what I believe was an attempt to win a few votes with the “Act to Ban Zohydro” in March. The lead on this bill was Sen. Joe Manchin (D-W.Va.). His daughter is the CEO of competing drug company Mylan Inc. which was also a major contributor to his campaign. This is a severe conflict of interest if ever there was one.
The media picked up on the Zohydro story with gusto, with multiple outlets parroting false claims such as:
Zohydro will kill people as soon as it is released (nobody has died)
Zohydro is 10 times stronger than Vicodin (it is the same strength)
It only takes 1 or 2 tablets to kill a patient (untrue)
Children who take 1 pill will die (unlikely, and how will a child have access?)
This is the worst decision by the FDA, a disaster and tragedy for this country (it was the right decision)
Zohydro is more powerful than anything on the market (it is actually the least powerful opioid in its class, when compared to oxycodone or morphine)
Zogenix tried to correct the misinformation spread by the media and politicians in Let’s Get the Facts Straight About Zohydro in May, as did the FDA in this update, but much of the damage to shares had already been done. Never letting facts get in the way of improving their ratings, media outlets continued to perpetuate false claims about Zohydro and shares continued to slide to a low of $1.07 made two weeks ago.
Personally, I trust the judgment of noted pain management specialist Dr. Lawrence Robbins who wrote “Zohydro Debate: Drug Hysteria or True Concern” and FDA Commissioner Margaret Hamburg who discusses the safety and efficacy of Zohydro in this video over a politician with a clear conflict of interest and the media’s perpetuation of falsehoods to boost ratings.
The “Act to Ban Zohydro” is one of over 10,600 bills and resolutions currently before Congress and of those, only about 5% will become law. The web site GovTrack.us gives the Zohydro ban a 0% chance of being enacted. GoveTrack.us is one of the world’s most visited government transparency websites and their embeddable widgets are deployed on more than 80 official websites of Members of Congress.
However, due to the unwarranted controversy and continued misinformation surrounding Zohydro ER, Zogenix shares were sold and shorted throughout 2014. Shares are just now coming off their lows while at the same time 25 million shares are held short.
At MicrocapResearch.com, we like this setup when combined with near-term events in January that we believe will lead to an appreciable recovery.
Why Zogenix Shares Will Recover- PDUFA January 30th
Zogenix submitted a supplemental New Drug Application (sNDA) to the FDA for a new formulation of Zohydro, “Zohydro AD” (Abuse Deterrent). Zohydro AD is more difficult to abuse by injection or nasal insufflation and the FDA’s decision is expected on January 30th. Having already refused to cave in to pressure from a politician who received large campaign contributions from a competitor (and whose daughter is the CEO of that same competitor), the odds of the FDA approving the same drug in a safer formulation that’s harder to abuse appear excellent.
Zogenix - ReldayIn addition to the likely approval of Zohydro AD on January 30th by the FDA, Zogenix will be initiating the next phase of studies for Relday, a once/month subcutaneous injection for persons suffering from schizophrenia in Q1 of this year.
Phase I trials of Relday were positive and if approved, Relday will be the first subcutaneous antipsychotic product that allows for once-monthly dosing. Non-compliance by patients taking antipsychotics is common and well documented. A once-monthly subcutaneous dose would have obvious advantages for both clinicians and their patients. This is truly a potential blockbuster drug in the Zogenix pipeline- note that sales of the antipsychotic drug Abilify alone were some $5.4 billion in 2011-2012.
Also in development is Brabafen for the treatment a catastrophic form of epilepsy (Dravet Syndrome) for which there is currently no cure. Treatment options are “extremely limited” according to this Dravet Syndrome Foundation Scientific Advisory Board publication. Brabafen had dramatic results in a Belgian study where 70% of patients taking the drug were seizure-free for at least 1 year. Phase 3 clinical trials are expected to begin in Q2.
Technically Speaking…
Shares are now approaching a resistance level around $1.50 that they failed to break for months as shown on the weekly chart below.
Zogenix weekly chart - resistance levels
We believe shares will break above resistance due to forward events and recent activity in the stock. On December 30th, shares crossed the 100 day moving average on heavy volume, prompting us to make this tweet to notify subscribers we entered the stock at $1.30. Zogenix is one of many high-potential, “best microcaps” we’ve identified, and the volume in crossing the 100 dma is convincing, as was the New Year’s Eve follow-thru on lower, but still respectable volume.
Zogenix 100 dma breakout
Finally, the odds of a golden crossover look good in Q1…and possibly in the next 2-3 weeks.
The 200 dma will continue a rapid decent for the next month while the 50 dma should begin to slope up given last week’s rise off the bottom. Something to watch for!
Zogenix golden cross
The Bottom Line
Shares of Zogenix have been oversold and over-shorted, due in large part to media misinformation re: Zohydro ER that fueled investor fear
With year-end tax loss selling over, the January 30th PDUFA date for Zohydro AD, the Q1 pharmacokinetics study of Relday, and sizable short interest in the stock, we believe shares of Zogenix are on the verge of an appreciable move to the upside in January
Risk of near term share dilution appears mitigated by the company’s $50 million cash balance reported at the end of Q3 combined with the December 31st filing of a credit facility of up to $20 million
Traders may wish to hold off for a break above $1.50-$1.55 resistance- which we believe will take place soon.
We recommend the use of stop-loss orders to preserve capital in all trades.
Supplemental: Zogenix December 2014 Investor Presentation
Follow MicrocapResearch.com on Twitter:
http://microcapresearch.com/zogenix/
$RMTI...Rockwell Medical (RMTI) Speculative Buy as January PDUFA Date Nears
Posted on December 12, 2014 by Gary Anderson | Leave a reply
Rockwell Medical (RMTI) Speculative Buy as January PDUFA Date Nears
January 24 PDUFA date set for patented, drug with large market potential = near term catalyst
Shares may be coming off double bottom formation
Completed capital raise in November by BofA Merrill Lynch at 9:00/share for net proceeds of $54.7 million
$53 million in ttm revenue from existing operations
Overview/Share Structure
Rockwell Medical logoRockwell Medical, Inc. (RMTI) is a biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with products and services for the treatment of iron deficiency anemia, secondary hyperparathyroidism and hemodialysis.
Founded in 1995 and headquartered in Wixom, MI, Rockwell Medical has 286 full time employees.
Shares outstanding: 46.6 million (following November capital raise)
Insider ownership: 18.6% with 420,000 shares purchased in last 4 months and zero insider sells
Institutional ownership: 22-28% (depending on source)
January 24 PDUFA Date for New Drug, “Triferic”
For those new to pharma/biotech stocks, a critically important day is the PDUFA date (pronounced puh-doo-fuh). It stands for “Prescription Drug User Fee Act” and the trading leading up to the PDUFA date is typically volatile.
What’s at stake is huge, as the PDUFA date is the day the FDA votes to approve or reject a new drug. Sometimes, the FDA will rule before the announced PDUFA date, but it’s the day by which a decision is expected.
Triferic is Rockwell’s late-stage investigational iron maintenance therapy for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis, and the PDUFA date set for approval or rejection by the FDA is January 24.
While this may not be as exciting as a cure for cancer, the market/revenue implications for Rockwell are big. End Stage Renal Disease (ESRD) is the condition where a patient’s kidneys have completely failed. As a result, patients with ESRD require dialysis treatments several times/week (or a kidney transplant) to survive. There is no cure. Unfortunately, ESRD affects 2.52 million patients globally and is growing 6-8% annually, exceeding population growth rates in much of the world.
The key to understanding Triferic’s potential is that these 2.5 million dialysis patients also suffer from chronic anemia (low hemoglobin levels) and serious (sometimes life-threatening) liver failure. Liver failure in this patient population is most often caused by iron toxicity resulting from the iron replacement therapies currently used to treat the underlying anemia. It’s a real (and expensive) problem for hospitals and renal physicians to manage hemoglobin and iron levels in these patients, and Triferic addresses the problem.
Triferic is administered during the patient’s dialysis treatment and in positive clinical trials has shown to be efficacious in preventing anemia and high iron levels that can lead to liver failure. There were no adverse effects from the drug reported in the studies. Should the FDA approve Trifecta for use in ESRD patients, then I can see widespread use of by physicians to more easily manage their patients.
Moreover, hospitals nationwide have an increasing role in patient treatment modalities. Hospitals nationwide must be accredited by and follow “best practice standards” set by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). The JCAHO has enormous power in healthcare administration nationwide. If a hospital loses accreditation from JCAHO, they lose their Medicare funding…a devastating blow. While JCAHO may not literally “prescribe” a drug, they can strongly influence its use by making hospitals prove they are using “disease-specific best practices” to lower cost and reduce the average patient length of stay. So a drug like Triferic can become a best practice protocol used by hospitals to demonstrate to JCAHO what they are proactive in reducing patient length of stay limiting expensive complications of anemia and liver toxicity in ESRD patients. These protocols become part of a standard set of orders that physicians who are authorized to practice at a particular hospital must follow.
Existing Operations
Risk in RMTI is somewhat mitigated in the fact the company has a 20 year operating history and ttm revenues of $53 million from sales of various solutions and products for dialysis. In October 2014, the company entered into an exclusive licensing agreement with Baxter Healthcare, a $40 billion industry giant, to market their dialysis solutions (listen to conference call). So, unlike a pharma microcap with one product that’s make or break leading up to the PDUFA date, RMIT has several irons in the fire for future revenue expansion.
Possible Double Bottom
RMTI shares are volatile and might be making a double bottom formation. With end of year tax-loss sales, support could be broken with new lows made between now and eoy, so caution is advised. In fact it’s possible that RMTI may have broken to new lows by the time this is published.
Rockwell Medical chart
Analyst Estimates
For those who follow analyst estimates, there are 5 currently covering Rockwell Medical. Their average estimate for 2014 is for a loss of .46/share, improving (dramatically) to positive earnings of .24/share for 2015.
Suggested Trade
I believe shares have a reasonably strong chance of coming off the bottom here and are likely to move up rapidly by January as the 1/24/2015 PDUFA date nears.
Buy RMTI shares above recent $8.10 low and below $9 with a tight stop loss. Should shares be under $8.10 by the time you read this- you might consider holding off for even lower prices as the year winds down and tax loss sellers complete their exit.
Disclosure: I am long RMTI @ $8.14
Rockwell Medical
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Posted in Biotech, Pharmaceutical.
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RMTI...RSI says overbought...buying back in 9.80 range...hog
$MEIP...2015 Small-Cap Biotech Watchlist Announced
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Source: Staff of The Life Sciences Report (12/18/14)
In its third year, The Life Sciences Report's 2015 Small-Cap Biotech Watchlist currently includes 12 drug development companies selected by leading analysts in the sector. With catalysts on the horizon and pipelines that encompass a variety of indications and innovative platforms, these biotechs are primed to return multiples on investment.
http://www.thelifesciencesreport.com/pub/na/16417
$MEIP..."Based on these encouraging data and recent discussions with the U.S. Food and Drug Administration, we are now actively preparing for a Phase III registration study using CR as the primary endpoint to support accelerated approval for this indication and overall survival as the endpoint for full approval," said Robert D. Mass, MD, Chief Medical Officer of MEI Pharma. "Meanwhile, we look forward to unblinding our randomized, placebo-controlled Phase II study of Pracinostat and azacitidine in front line myelodysplastic syndrome and reporting top line data in March 2015."
$CUR...Neuralstem Inc.
TICKER: CUR:NYSE.MKT
Neuralstem Inc. is focused on developing and commercializing treatments for central nervous system diseases based on transplanting human neural stem cells and small molecule drugs. The company has developed and maintains a portfolio of patents and patent applications that form the base of its research and development efforts in neural stem cell research, small molecule research and related technologies. Neuralstem has also developed and patented a series of small molecule compounds (low molecular weight organic compounds) that can efficiently cross the blood/brain barrier. hide
The information provided below is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.
Expert Comments:
Larry Smith, SmithOnStocks (12/18/14) "Neuralstem Inc. has noted in response to questions that it appears to be seeing encouraging signs in the patients initially treated in the Chinese ischemic stroke trial; however, this is the very early 'dose up' part of the trial. In the U.S., this would be called a Phase 1b trial that treats patients suffering from the disease state as opposed to healthy volunteers."
Jason Napodano, Zacks Small-Cap Research (11/7/14) "The last patient has been treated in Neuralstem Inc.'s Phase 2 amyotrophic lateral sclerosis study, and data are expected during Q1/15. The first patient in the spinal cord injury study has been treated, and we expect continued enrollment of this trial in 2015." -Zacks Small-Cap Research
Jason Napodano, Seeking Alpha (10/15/14) "For the purpose of our financial model, we assume that if Neuralstem Inc.'s NSI-566 works, regardless of the entry criteria for the Phase 1 trial, neurosurgeons will use it in all patients and all areas of injury. . .as for the price of the surgery, we believe $150K is realistic. . .if we apply these data in a detailed epidemiology and pricing model, with 5% U.S. market share, NSI-566 is a potential $500M drug."
Reni Benjamin, H.C. Wainwright & Co. (10/13/14) "Last Thursday, Neuralstem Inc. announced that the first of four chronic spinal cord injury patients in a Phase 1 trial of NSI-566 was recently treated at the University of California, San Diego School of Medicine. . .we view the forward progress of the trial as welcome news for investors; it marks a foray into an indication area with a potentially addressable patient population nearly 10 times that of amyotrophic lateral sclerosis."
Ram Selvaraju, Aegis Capital (10/9/14) "This morning, Neuralstem Inc. announced that the first patient was treated last week in the firm's Phase 1 trial testing NSI-566. . .we are encouraged to see the initiation of this important clinical program, and believe that preclinical evidence of NSI-566 therapeutic efficacy is particularly strong in the context of spinal cord injury."
fewer comments
Reni Benjamin, H.C. Wainwright & Co. (9/23/14) "Dr. Glass of Emory University presented positive long-term follow-up data of a subset of patients from the Phase 1 trial of NSI-566 testing Neuralstem Inc.'s human neural stem cells in Amyotrophic Lateral Sclerosis (ALS). . .together, the data continue to suggest that NSI-566 treatment can slow the progression of the disease for over three years in ambulatory patients given bilateral injections of NSI-566 cells in the lumbar and cervical spine. . .if the above results are successfully replicated in the ongoing Phase 2 trial in ALS, we believe NSI-566 could represent a treatment capable of producing long lasting and durable responses in this progressive and invariably fatal neurological disease."
Larry Smith, SmithOnStocks (9/23/14) "The key investigators for the treatment of amyotrophic lateral sclerosis (ALS) with Neuralstem Inc.'s NSI-566 neural stem cells have been extremely positive in public statements; they are Dr. Eva Feldman, the lead investigator for the trial, and Dr. Jonathan Glass. Feldman is professor of medicine at the University of Michigan Health Care System and past president of the American Neurological Association; Glass is director of the Emory ALS Center at Emory University."
Reni Benjamin, H.C. Wainwright & Co. (9/8/14) "We are initiating coverage on Neuralstem Inc. . .the major investment pros are: a lead product that potentially addresses unmet global medical needs, orphan drug status in amyotrophic lateral sclerosis, a pipeline with multiple products in various stages of early clinical development and an excellent safety profile based on multiple Phase 1 and 2 studies."
The Life Sciences Report Interview with Raghuram Selvaraju (8/13/14) "Neuralstem Inc. has been in the process of running a Phase 2 proof-of-concept study in amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease. It's an orphan disease. There is no effective therapy, and after diagnosis, patients typically die within three to six years.
Neuralstem's stem cell-based solution, NSI-566 (human fetal spinal cord-derived stem cells), has been widely anticipated. The Phase 1/2 data, published in the peer-reviewed journal Annals of Neurology, showed anecdotal evidence of efficacy, which was encouraging. If these Phase 2 data, expected from all cohorts in early 2015, show signs of the same kind of efficacy, that would go a long way toward convincing the FDA that NSI-566 should receive breakthrough therapy designation. NSI-566 could then be fast-tracked toward approval. . ." More >
Ram Selvaraju, Aegis Capital (8/8/14) "Neuralstem Inc. reported financial results for Q2/14, ending the period with $30.2M in cash. We expect this to be sufficient to fund operations through 2015. . .the company essentially delivered an in line quarter."
Jason Napodano, Zacks Small-Cap Research (8/8/14) "Neuralstem Inc. exited Q2/14 ending June 30, 2014 with $30.2M in cash and investments. Based on the current quarterly burn rate, less debt repayments, we believe this is enough cash to fund operations into the middle of 2016." -Zacks Small-Cap Research
Ram Selvaraju, Aegis Capital (8/4/14) "This morning, Neuralstem Inc. announced that the final patient had been treated in its Phase 2 study of NSI-566, a novel stem cell-based therapeutic agent, assessing individuals with amyotrophic lateral sclerosis. . .the trial will continue until six months past the final surgery, at which point the data will be evaluated. In anticipation of favorable efficacy results from this Phase 2 trial of NSI-566, we reiterate our Buy rating and 12-month price target of $7/share."
Jason Napodano, Zacks Small-Cap Research (6/25/14) "Data from Neuralstem Inc.'s Phase 1b, randomized, double-blind, placebo-controlled, multiple-dose escalation study evaluating the effects of NSI-189 in patients with major depressive disorder was presented via an oral presentation and poster at two major neuropharmacology meetings earlier this month. . .in terms of a Phase 1b study, [data] looks very good. Safety was confirmed and there are clear trends toward efficacy. . .we continue to be optimistic on the future of Neuralstem."
Ram Selvaraju, Aegis Capital (6/25/14) "We are raising our price objective on Neuralstem Inc. in the wake of favorable safety and efficacy data. . .these data validate the company's hypothesis that NSI-189 has activity as both a cognitive function enhancer and an antidepressant. . .we reiterate our Buy rating and raise our 12-month price target from $6 to $7/per share."
http://www.thelifesciencesreport.com/pub/co/4857
$CUR...Press Releases
Neuralstem ALS Investigator Presents Long-Term Follow Up Phase I Data
Some Patients Continue to Show Slowed Disease Progression or Improvement Three Years Post-Transplant
09/22/2014
Photos(1)
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GERMANTOWN, Md., Sept. 22, 2014 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced that Jonathan D. Glass, MD, site investigator at Emory University, presented long-term follow up data on the Phase I trial testing NSI-566 human neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The presentation, which occurred at the Annual Symposium on ALS of the Foundation Andre-Delambre, in Montreal, Canada, on Friday, and was not open to the public, covered data up to approximately 1200 days post the stem cell treatment.
Dr. Glass reported that patients in the last safety cohort (n=3), who received treatments in both the lumbar and the cervical region with the highest number of cells per injection, all showed significant slowing of the progression of the disease. One patient showed functional improvement from pre-treatment baseline, which is maintained to present day. The other two patients are maintaining the same level of functionality as they had at the baseline for over three years since the stem cell treatment.
"The long-term follow up data is very encouraging," said Karl Johe, PhD, Neuralstem's Chairman and Chief Scientific Officer. "In Phase I, patients 10, 11, and 12 each received 10 lumbar and five cervical injections, of 100,000 cells each, which was far below the safe maximal dose. Even so, the data shows a significant slowing of the disease progression for over three years. If replicated on a larger scale, this could represent meaningful improvement in quality of life, and lifespan, compared to untreated patients. In our Phase II dose escalation trial, we successfully reached the maximal dose planned, which consisted of 20 lumbar and 20 cervical injections of 400,000 cells each, more than ten times the number of stem cells delivered in the highest dose cohort of the Phase I trial."
"The progress in this trial is truly groundbreaking," said Dr. Glass, who is Director of the Emory ALS Center at Emory University, the first site in the trial. "It has provided data on the safety of multiple injections and multiple transplantation surgeries in ALS patients, as well as the long- term survival of the transplanted cells in the human spinal cord. This provides a strong foundation for moving ahead with more definitive trials focused on the potential therapeutic efficacy of spinal cord transplantation of neural stem cells for ALS."
- See more at: http://investor.neuralstem.com/2014-09-22-Neuralstem-ALS-Investigator-Presents-Long-Term-Follow-Up-Phase-I-Data#sthash.ggPbyYSG.dpuf
Guided Therapeutics : Nigerian Clinical Studies Demonstrate Advantages of LuViva® Advanced Cervical Scan for Screening and Detecting Cervical Pre-Cancer in Africa
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11/26/2014 | 07:14pm US/Eastern
By a News Reporter-Staff News Editor at Cancer Weekly -- Results of two clinical studies of the LuViva® Advanced Cervical Scan showed the versatility of the technology in its ability to screen the general population for cervical cancer and to eliminate unnecessary testing for women who are screened by other methods. The studies were presented at the Society of Gynecology and Obstetrics of Nigeria 2014 conference in Asaba, Nigeria, this week (see also Guided Therapeutics, Inc.).
The LuViva, developed by Guided Therapeutics, Inc. (OTCBB:GTHP) (OTCQB:GTHP), is designed to eliminate costly, painful and unnecessary follow up testing following a positive Pap, human papillomavirus (HPV) or other screening test.
In a 100-patient study led by Professor Issac Adewole, MD, Principal Investigator for cervical cancer for Nigeria, and conducted at University Teaching Hospital, Ibadan, Nigeria, it was concluded that LuViva was able to detect 100% of serious pre-cancer (Cervical intraepithelial neoplasia 2+, CIN2+) while eliminating up to 40% of false positive results, or women who were actually disease free, from further testing. These results are consistent with other published studies conducted in North America. Three of the CIN2+ cases correctly identified by LuViva tested negative for HPV at the time of the study.
"These results are encouraging and demonstrate the value of LuViva as a means to detect cervical disease, even in the absence of a positive human papillomavirus result, while also providing a means to reduce unnecessary additional testing," said Professor Adewole. "In addition to the accuracy displayed in the study, LuViva is painless and results are immediate, important attributes for the patient and healthcare provider, particularly in rural communities."
The second study looked at LuViva as a tool for primary screening where Pap tests are not available. The study enrolled 254 women and was led by Professor B. Olusola Fasubaa, Commissioner of the State Ministry of Health, Ekiti State, Nigeria. In the study, LuViva classified 13% of the women as having a greater than normal likelihood of cervical disease. These results are similar to those presented in 2012 at the American Society of Colposcopy and Cervical Pathology and with other to be published screening studies and support the potential of LuViva as a primary screening modality.
Keywords for this news article include: Cancer, Oncology, Guided Therapeutics Inc..
Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx
$GTHP...The LuViva® Advanced Cervical Scan continues to demonstrate the capability to screen the general population for cervical cancer and to eliminate unnecessary testing for women who are screened by other methods, according to recent studies presented at the 25th Turkish Society of Gynecology Oncology Congress.
The LuViva, developed by Guided Therapeutics, Inc. (OTCBB:GTHP) (OTCQB:GTHP), is designed to eliminate costly, painful and unnecessary follow up testing following a positive Pap, human papillomavirus (HPV) or other screening test. It has also been used in clinical studies in Turkey and Nigeria as a means to screen women for cervical cancer where the availability of infrastructure necessary for Pap and HPV testing is restricted.
Results of the most recent Turkish screening study were presented by Professor Dr. Ali Ayhan of Baskent University in Ankara and President of the Turkish Society of Gynecologic Oncology. Dr. Ayhan concluded that the performance of LuViva for primary screening was comparable to that of HPV and Pap screening, and that LuViva also had the added advantage of providing an immediate result.
“These results support our marketing efforts from North Africa to Southwest Asia that LuViva is a solution to the widespread problem of lack of proper medical facilities to screen for cervical cancer,” said Zafer Yazici, CEO and President of I.T.E.M. Medical Technologies Group in Turkey. “As a result, in 2015 we expect to place between 50 and 100 LuViva devices in clinics to improve early detection of cervical cancer, and to build upon those numbers in the following years.”
Dr. Leo B. Twiggs, of the Miller School of Medicine at the University of Miami, reported on new results from international evaluations that supported the use of LuViva as an effective triage test in countries with established screening programs. Specifically, evaluations at five international centers and one U.S. center, involving 287 women referred to colposcopy and biopsy, showed that LuViva's sensitivity ranged from 91% to 100% and specificity ranged from 33% to 46%.
“These results further indicate a successful transition of LuViva from controlled clinical trials to postmarket evaluations in a wide range of clinical environments around the world,” said Gene Cartwright, CEO and President of Guided Therapeutics. “Results of these studies confirm recently published studies from Nigeria, the U.S. and Canada, which support our sales and marketing efforts throughout the world.”
Published studies of the LuViva are available at http://www.guidedinc.com/publications/.
About LuViva® Advanced Cervical Scan
LuViva is a technologically advanced diagnostic device that scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of precancer that may be below the surface of the cervix or misdiagnosed as benign. This technique is called biophotonics. Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which may result in eliminating costly, painful and unnecessary additional testing. LuViva is intended for use with women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases, involves taking a biopsy of the cervix. The device is used in conjunction with the LuViva® Cervical Guide single-use patient interface and calibration disposable.
http://preview.irdirect.net/pr/release/id/1030426
$ATHX...Athersys Inc. is a clinical-stage biotechnology company developing MultiStem, a patented, adult-derived "off-the-shelf" stem cell product platform for the cardiovascular, neurological, inflammatory and immune disease areas. The company currently has five clinical stage programs involving MultiStem, including those for treating inflammatory bowel disease (partnered with Pfizer Inc.), ischemic stroke, damage caused by myocardial infarction and for the prevention of graft-versus-host disease. Athersys has additional pharmaceutical programs in the metabolic and neurological areas, and a broad international network of collaborations with leading clinical and research institutions. hide
The information provided below is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.
Expert Comments:
Jason Kolbert, Maxim Group (12/29/14) "Athersys Inc. is closing in on a major milestone. . .the company announced that it has concluded enrollment of its Phase 2 (~N=140) control versus active stroke trial. . .our research and channel checks leave us enthused about stroke data in Q1/15. We believe the probability skew is positive for Athersys, and the outcome has the potential to be transformative for both the company and patients."
Wall Street Titan, Seeking Alpha (11/26/14) "Athersys Inc. is doing everything within its power to position itself to grab a Japanese revenue opportunity that would place an entirely new valuation on the company. The beauty of this legislation, from a risk perspective, is that Athersys does not need a home run from its stroke data to start earning substantial revenues in Japan. The company has already demonstrated safety. . .with an enterprise value of only $78M it certainly seems that Athersys shares have substantial room for upside, based on the stroke opportunity and their other programs entering phase 2 shortly, including graft-versus-host disease and acute myocardial infarction."
Christian Glennie, Edison Investment Research (11/24/14) "Athersys Inc. is developing MultiStem, an allogeneic stem cell product (bone marrow-derived, multipotent adult progenitor cells or MAPCs). Results from a 140-patient Phase 2 study in ischaemic stroke are expected in Q1/15, with recruitment to complete in Q4/14. Positive results could be transformational for the treatment of stroke patients and for Athersys' market valuation. . .the company is well positioned in terms of its stage of development and the profile of its MAPCs, in terms of safety, high dose (>1 billion cells), and convenient mode of delivery. The MAPCs appear to be substantially differentiated from other MSCs."
Jason Kolbert, Maxim Group (11/10/14) "Athersys Inc.ended Q3/14 with $32M in cash, plenty of capital to fund the company through its next major catalyst, results of the Phase 2 stroke trial, where enrollment is almost complete. . .we are excited for results from its Phase 2 stroke trial. We are hopeful of good data (positive bias) and believe good data will be transformational to Athersys and the field."
The Life Sciences Report Interview with R. Lee Buckler (10/22/14) "Athersys Inc. has announced a desire to move into Japan, and I know it is putting boots on the ground in the country to develop a strategy there. Back in January, the company announced some new Japanese patents in graft-versus-host disease and autoimmune diseases, such as inflammatory bowel diseases." More >
more comments
http://www.thelifesciencesreport.com/pub/co/4435
ATHX...12/29/2014 | Press release
Athersys Finishes Enrollment of Phase 2 Study of MultiStem(R) Cell Therapy for Ischemic Stroke
distributed by noodls on 12/29/2014 11:45
0 0 0
CLEVELAND, Dec. 29, 2014 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) today announced that it has concluded patient enrollment of its Phase 2 clinical study involving administration of Athersys' MultiStem® cell therapy to ischemic stroke patients. The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating the safety and efficacy of MultiStem therapy in subjects suffering moderate to moderate-severe ischemic strokes. Athersys expects initial results from the study to be disclosed around the end of the first quarter of 2015.
"With enrollment now finished, we look forward to the initial 90-day results from this study," commented Dr. Gil Van Bokkelen, Chief Executive Officer at Athersys. "An ischemic stroke can be a devastating event for a patient, and effective treatments for stroke are limited, resulting in substantial opportunities for new therapies. Based upon MultiStem's preclinical efficacy profile, its novel mechanisms of action, and a favorable safety profile demonstrated in preclinical and clinical settings, we believe that MultiStem could provide meaningful benefit to these patients. The results from this study are expected to provide significant insight into the potential for MultiStem therapy for the treatment of ischemic stroke."
Ischemic stroke is caused by a blockage of blood flow to the brain. A leading cause of death and disability globally, each year more than 15 million people are estimated to suffer a stroke, including more than two million people in the United States, Japan and European Union, combined. According to the American Heart Association, ischemic strokes comprise more than 85% of all strokes. Current standard of care for ischemic stroke involves the administration of a thrombolytic (clot dissolving) agent within three to four hours after a stroke has occurred, a narrow window that results in only a small percentage of patients receiving such treatment.
In this Phase 2 trial, stroke victims were administered MultiStem cells or placebo intravenously one to two days after the stroke had occurred. If this study shows that MultiStem treatment is both safe and effective following such administration, as was demonstrated in non-clinical studies, the treatment window could be expanded significantly, from hours to days, providing an important new therapeutic option for stroke patients. Based on preclinical studies, Athersys believes that MultiStem treatment has the potential to substantially improve neurological and functional recovery following stroke by attenuating the inflammatory activity that follows the stroke, accelerating the return to immune system homeostasis, supporting protection of at-risk neurons, and by supporting conditions for neuronal recovery and growth, thereby enhancing repair and patient recovery. The MultiStem treatment's potential multidimensional impact distinguishes the cell therapy from other pharmaceutical therapies focused on a single mechanism of benefit.
The randomized, double-blind, placebo-controlled Phase 2 clinical trial is being conducted by Athersys at sites in the United States and United Kingdom, and has enrolled subjects who received either MultiStem treatment or placebo one to two days following the stroke. The primary endpoints for the study include safety over the first seven days following treatment and global stroke recovery at day 90, which assesses global disability (modified Rankin Score), neurological deficit (NIH stroke scale) and activities of daily living (Barthel Index). Additionally, there are multiple secondary and exploratory endpoints evaluating multiple elements of recovery and dysfunction, including biomarkers associated with the condition and recovery, and safety variables over the study period.
About MultiStem
MultiStem cell therapy is a patented regenerative medicine product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage. MultiStem has demonstrated therapeutic potential for the treatment of inflammatory and immune disorders, neurological conditions, and cardiovascular disease, as well as other areas. It represents a unique "off-the-shelf" stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. The product is extensively characterized for safety, consistency and potency.
About Athersys
Athersys is a clinical stage biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product platform for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas. The Company currently has several clinical stage programs involving MultiStem, including for treating inflammatory bowel disease, ischemic stroke, damage caused by myocardial infarction, and for the prevention of graft-versus-host disease. Athersys has also developed a diverse portfolio that includes other technologies and product development opportunities, and has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions in the United States and Europe to further develop its platform and products. More information is available at www.athersys.com.
The Athersys, Inc. logo is available at: http://www.globenewswire.com/newsroom/prs/?pkgid=4548
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "intends," "may," "plans," "potential," "should," "suggest," "will," or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face that could cause actual results to differ materially from those implied by forward-looking statements are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as human therapeutics, such as the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem for the treatment of inflammatory bowel disease, acute myocardial infarction, stroke and other disease indications, including lysosomal storage disorders, and the prevention of graft-versus-host disease. These risks may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. Other important factors to consider in evaluating our forward-looking statements include: our ability to raise additional capital; final results from our MultiStem clinical trials; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials; changes in external market factors; changes in our industry's overall performance; changes in our business strategy; our ability to protect our intellectual property portfolio; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our ability to meet milestones under our collaboration agreements; our collaborators' ability to continue to fulfill their obligations under the terms of our collaboration agreements; the success of our efforts to enter into new strategic partnerships and advance our programs; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; and the success of our competitors and the emergence of new competitors. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: William (B.J.) Lehmann, J.D.
President and Chief Operating Officer
Tel: (216) 431-9900
bjlehmann@athersys.com
Investor Relations:
Lisa M. WilsonIn-Site Communications
Tel: (917) 543-9932
lwilson@insitecony.com
Source: Athersys, Inc.
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- See more at: http://www.noodls.com/view/113FC15E10FF86E8C6E0CF0A80BB948A1E710752#sthash.d2rAvf3o.dpuf
http://www.noodls.com/view/113FC15E10FF86E8C6E0CF0A80BB948A1E710752
$RNN...http://www.thelifesciencesreport.com/pub/co/5343
CJ: We like Rexahn Pharmaceuticals Inc. (RNN:NYSE.MKT), and we think there's a big disconnect between the current valuation of about $1.15/share and our $3/share target price.
It is rare to see an actual pipeline of proposed products in clinical trials in the small-cap space. Rexahn's focal point is oncology, but it is focused diversely. You have lots of shots on goal with this name. You have Archexin, which is an RNA-based therapeutic—an antisense compound—as well as a two small molecule approaches with differing mechanisms of action. In addition to that, the company has a platform.
"The most important near-term catalyst in most of these growth names is going to be data."
Last year was tough for the stock because of the lack of catalysts, but the company has a number of significant drivers coming in Q1/15. We will see Phase 1 data from Supinoxin (RX-5902) in solid tumors in patients who previously failed other regimens. Also in early 2015, we will see Phase 2 proof-of-concept data from Archexin (Akt-1 antisense oligonucleotide inhibitor) in metastatic renal cell carcinoma. That's a program we're very excited about, and probably the most significant near-term growth driver for the stock. Then, possibly in late in Q1/15, we could see data from RX-3117 (fluorocyclopentenylcytosine) in patients with solid tumors. I think 2015 will shape up to be much more meaningful for Rexahn than 2014.
There are lots of ways to create value with Rexahn. Once we start to see some data—some hints of efficacy—early next year, I think the discussion around partnership should pick up. That could be a significant driver as well.
$EAPH. Read the latest PR and look at the two week chart. Room to run with the low float.
PXYN chart....
from drugdoctor
PXYN.053-Praxsyn-Pharmas'-RISE-to-NET-PROFITS-Incredible-Reverse-Merger-Story
About once every year, a tiny company will go public, and have an amazing growth in revenues and profits, and the stock price will go up 1000% or more, and people will say.... if only I had known then what I know now.
In my opinion, Praxsyn Pharmaceuticals is that company for 2014-2015. At only .053 per share the stock has not yet shown the appreciation that the turnaround in it's financials since going public have warranted, but it should began to rise now, and continue throughout 2015, and here's why...
First, a little background on Praxsyn Pharmaceuticals
PXYN is a REVERSE MERGER company that just went public this year. Pharmacy Development Company (PDC) and Mesa Pharmacy, used the old PAWS shell to accomplish this going public, and in order to comply with SEC rules and FINRA rules, it took over 8 months for the company to accomplish updated 10K annual reports and accomplish the name change and updated symbol change to Praxsyn Pharmaceuticals PXYN.
Also with the old shell came some convertible debt and the PDC company also had some debts and it appears that some of those debts were exchanged for shares, and many of those were diluted into the markets over the summer and drove the stock price down from the .20 area to the .03 area in early fall. However, that selling appears to be done and the stock now has recently traded as high as .08 but fell back on the "sell on the news" reaction that many microcap stock have, as momentum traders leave a stock after anticipated NEWS or Earnings is posted. So that leaves us now with a NET PROFITABLE company as reported in the third quarter, with the prospects for much larger revenues and NET PROFITS in the fourth quarter, and then huge growth, and I am not hyping, HUGE GROWTH in 2015 in both Revenues and NET PROFITS.
There is a huge wealth of information in the 2014 SEC 10Q - 3rd quarter earnings report about what Praxsyn is doing, and I encourage all investors and potential investors to take about 30 minutes to read this document in its entirety. Here is a link:
https://www.sec.gov/Archives/edgar/data/1346973/000149315214003857/form10q.htm
For the purposes of this discussion, I will first post a table of side by side quarterly results from the 10Q SEC filings for 2014, then I will discuss the results and will include some results from posters on the I-hub board that were prepared using the SEC filings. I have not had the time to independently verify all of their data, so if you find any errors or inconsistencies with their information, please post those here for correction in the comments below this blog. Here's the table:
To analyze this table you first need to know that for 2013 as a private company, the gross billings were: 3 months ending 9/30/2014 vs 9/30/2013- Net billing revenues $ 22,895,889 vs $ 403,315. That's not a misprint folks, the gross billings are up 5000% in one year. WHY?
During the three and nine months ended September 30, 2014 and 2013, revenues generated from sales of compounding pharmaceutical products primarily to worker’s compensation patients located throughout Southern California represented 100% of total revenues. At times the collection on these receivables can take in excess of one year, during which we may attend legal hearings, file liens to securitize claims, negotiate before worker’s compensation administrative judges, resolve liens with stipulations and orders for defendants to pay, and transmit demands to settle liens filed with the adjuster or defense attorneys.
During the nine months ended September 30, 2014 and 2013, we retained principal consultants to help us market with customers for our products. The terms of the consulting agreements entitled the consultants to receive amounts ranging from 13% to 17.5% of the gross prescription sales generated. We estimate that these two consultants’ marketing efforts generated almost 100% of the revenue for each period presented. Fees for these two consultants represented nearly all of our selling and marketing expense. In addition, on March 31, 2014, we added one of these consultants to our Board of Directors. Management believes the loss of these consultants to our Company would have a material adverse impact on our consolidated financial position, results of operations, and cash flows. For the nine months ended September 30, 2014 the consultants earned the following:
Nine Months Ended: September 30, 2014 - @29,134,507 Includes stock-based compensation of $11,391,301.
Read the full consulting agreement with Trestles Pain Specialists (TPS) and John Garbino here.
https://www.sec.gov/Archives/edgar/data/1346973/000149315214003857/ex10-1.htm
Selling and Marketing Expense
Our selling and marketing expense for the three months ended September 30, 2014 was $9,057,171, $2,612,051 of which was stock-based. For the comparable period in 2013, selling and marketing expense was $185,544, none of which was stock-based. The stock-based expense results mainly from the issuance of Series D Preferred shares to TPS under our January 23, 2014 agreement with them. See Note 1 to the accompanying consolidated financial statements. The remaining increase of $6,259,576 results from increased qualified prescription referral fees, mainly payable to TPS, on significantly higher net revenues.
So as you can see from the information above, the addition of TPS and John Garbino to the board of directors has caused explosion in revenues and gross profits for the company. In my opinion, the 13 to 17% gross billing revenues charged by TPS are excessive, and are slowing the profit growth of the company, but they are subject to re-negotiation in 2015 upon renewal of the contract, imo. Since TPS now owns preferred shares worth 160 million common shares, John Garbino has every reason to want to ensure the company grows fast and profitable and that share value is indeed increased!
Now I'm going to use some data from posts on the Investorshub board that have been presented. I have not verified this data, but the posters are reputable and I have linked to the posts..
Poster Lighthouse points out that the company continues to manage and clean up it's convertible debts by using a combination of new notes, shares, and CASH PAYOFFS to manage the debts. It appears they have embarked on a debt elimination plan as the company becomes profitable and is able to use cash no only to finance accounts receivable collections, but also to pay off old debts.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=108402344
On September 19, 2014, we repaid principal and interest on notes in this category with face value totaling $95,000. In connection with this transaction, we recorded a gain on extinguishment of debt of $182. On September 30, 2014, we entered into a Settlement Agreement and Mutual Release with the related party note holder referred to above. Under the agreement, we settled notes in this category with face value totaling $152,500 along with a 2012 Convertible Promissory note (see below) with a face value of $150,000. Under the settlement agreement, we paid the note holder $302,500 in full settlement of the notes, including accrued interest, and recorded a gain on extinguishment of debt in the amount of $99,704 and eliminated $143,517 in derivative liability, which was recorded to additional paid-in capital upon extinguishment.
Forte Capital
This obligation was assumed March 31, 2014 in the amount of $289,398 as a result of the Merger discussed in Note 1. The obligation arose from a March 2014 agreement with Forte Capital Partners, LLC under which we agreed to repay amounts outstanding under a 14% convertible debenture with a total of 14,351,322 shares of our common stock, issuable in six monthly installments of 2,391,887 shares beginning in March 2014. 2,391,887 shares were issued prior to the merger discussed in Note 1 and 11,959,435 were issued post-merger. As of September 30, 2014, we have issued all shares required under the agreement with Forte Capital and no further amounts are owed.
AATV
As discussed in Note 5, on May 1, 2014, we finalized a settlement agreement with AATV. Under the finalized agreement, we agreed to pay AATV $1,100,000 for the following:
$600,000 for the full repayment of principal and accrued interest on a Profit Sharing Note, $100,000 of which was paid in March 2014 (see Note 5).
$500,000 for the repurchase of 7,504 Series D Preferred shares, representing the amount of AATV’s original investment (see Note 8).
As of September 30, 2014, we had paid all amounts owed under our obligation to AATV.
looks like there is a possibility of putting 60 million shares back into treasury... THEY HAD BETTER COME UP WITH THE $961,000 OR THEIR SHARES ARE GONE
Liabilities of discontinued operations totaling $961,831 represent the liabilities of our interest in our subsidiary Pet Airways, Inc. On March 26, 2014, we issued 60,000,000 common shares to a company controlled by two former officers of our Company in exchange for the former officers’ agreement to purchase our interest in Pet Airways and to forgive their unpaid wages. The former officers’ agreement to purchase our interest in Pet Airways was meant to relieve us of these debts. As of September 30, 2014, the former officers had not fulfilled their obligation to purchase our interest in Pet Airways, and other matters between the parties are in dispute.
We have endeavored to resolve our disputes with the former officers, including their fulfillment of their obligation to purchase the interest in Pet Airways, but to date have been unsuccessful. Subsequent to September 30, 2014 we agreed to participate in non-binding mediation for the matters in dispute. If we are unable to come to a satisfactory resolution through this process, we will likely pursue litigation.
Myhill
On August 28, 2012, we received a claim from Roger Saxton, Loren Myhill, Lucas Myhill, Beryl Myhill, and Ann Marie Kaumo (collectively the “Myhill Litigants”) seeking $358,433 for delayed public entry and illiquidity stemming from an investment made by the Myhill Litigants. On January 6, 2014, we entered into a Settlement and Mutual General Release Agreement with the Myhill Litigants under which they agreed to release all claims against us and relinquish all shares of PDC they owned in exchange for $200,000, $20,000 of which was payable on execution of the settlement agreement and the remainder payable at $10,000 per month over the following 18 months. In connection with this transaction, the $200,000 has been recorded as Treasury Stock.
The settlement agreement requires Counsel for the Plaintiffs to hold the PDC stock certificates during pendency of the payout period. During such period, Plaintiffs shall have no right to vote such shares, transfer such shares, or encumber such shares, and will not be entitled to receive cash dividends or stock dividends or any distributions based on ownership of such shares. The Plaintiffs shall return each of their stock certificates to the Company with a full executed stock power sufficient to transfer such shares. In the event of any transaction by the Company, including merger or buyout, that results in Plaintiffs’ shares of PDC to be converted to shares of another entity, such obligations and restrictions stated herein shall apply to such new or different shares.
Primary Care
In December 2009, we entered into an agreement with Primary Care Management Services (“Primary Care”) under which Primary Care would provide services consisting of billing to and collection from various insurance carriers for our products. Primary Care was to be compensated by a rate equaling two percent of the amounts billed on our behalf. In April 2012, we entered into a settlement agreement with Primary Care, who by that time had billed in excess of $10 million which it had been unable to collect. Under the settlement agreement, we agreed to pay Primary Care $92,000, $20,000 of which was payable immediately and the remainder payable at $2,000 per month over the following 36 months.
On May 15, 2014 we entered into a new settlement agreement with Primary Care under which we paid them $40,000 in full satisfaction of all remaining amounts owed them. In connection with this new settlement agreement, we recorded a gain on extinguishment of debt in the amount of $8,000 during the three and nine months ended September 30, 2014.
More highlights from Q3 from Lighthouse:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=108363453
Here are just a few highlights from the Q for starters and you can see why the buyers are back today
Q2 vs Q3
Cash on hand $518k $593K
Acct receivable $8.5M $11M
Inventory $78K $105k
Acct Recievable Longterm $3M $4.5M
Acct Payable $607k $453k
Notes payable $5.3M $3.1M
Settlement Liab $700k $100k
Total shareholder
Equity $-3.5M $+70K
Expenses
Q2 vs Q3
Selling and Marketing
12.7M vs 9M
Operating income
8.5M vs 12M
Loss on extinguishment of debt (a good thing)
0 Vs (231K)
If you wonder how sales are doing so far in Q4, look what I found...
Pharmaceutical compounding material purchases
to the end of Q1 = $272,090
to the end of Q2 = $952,813 ( a $680,000 increase over Q1)
To the end of Q3 = $1,714,679 ( an additional $762,000 increase over Q2) NICE TREND
MORE VERY EXCITING THINGS I FOUND
1. The Q2 10Q shows nothing for unaccounted accounts receivable yet Q3 10Q has a whole section. It shows accounts receivable gross of $35.7M minus $20M in allowance for doubtful accounts and another $4.4M for the long term portion. That leaves just under $11 Million that could be coming to the bottom line for Q4...??
2. Gross billing sold to factoring for the Q were $40 Million yet the gross billings were $49.6 Million. That looks to me like they are in house collecting approx. $9.6 million so far.
THIS IS HUGE FOR Q4... TPS share issuance now complete and this cash can go on the bottom line if pxyn just does the same in sales they will have a bottom line of almost $12 Million profit due to not having the $11.3 Million in TPS shares...
Quote:
Our selling and marketing expense for the nine months ended September 30, 2014 was $29,134,507, $11,391,301 of which was stock-based. For the comparable period in 2013, selling and marketing expense was $945,000, none of which was stock-based. The stock-based expense results mainly from the issuance of Series D Preferred shares to TPS under our January 23, 2014 agreement with them( which is now complete)
More....
Lease is now 6000 sq ft
Leasehold improvements
Q2 = $24.7K when they did their lab expansion
Q3 = $39.4K...Looks like they may have expanded more??
Computer equipment went up by almost $5000 as well
Q2 = 26.8K
Q3 = 31.4K
(This likely due to in house billing)
Net profit also up Q3 to %531K when interest from notes are included
OhManIDied - has a lot of nice Due diligence links and interesting reading..
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=108368576
Additional Praxsyn-DD (10-q analysis)
-- Don't forget to checkout the ibox!
Ihubber, cdhames, visits the facility in California, on June 20th, 2014.
Here is his report:
https://docs.google.com/document/d/1fk2C0s75Lbn6iGbH1ybAXBYvOotT9npWYoh-QIrJoPE/edit
Summary of Year-to-date (10-31-14) progress:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=107676593
Highlights from the 10-Q (released 11-19-14):
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=108363453
-- Quarter 2 vs Quarter 3 (oh, how things have changed)
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=108366143
-- Factoring "kickbacks", what!?!
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=108321047
-- A handful of nice developments..
Estimated earnings potential of the PXYN within the medium term:
-- Does not account for freshly discovered factoring "kickbacks"
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=108193142
CA WC-Study Supports Recent PXYN Moves
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=108237899
Workers Comp total Medical Expenses by State in 2012 (in $Millions):
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=107958833
PXYN
In conclusion, looking forward to 2015, the PLAN OF OPERATIONS from the CEO and the company from the 10Q says it best:
Management’s Plan of Operations
There are two significant influences to the losses we have reported in 2014. First, our revenue recognition, as discussed in Note 2, is based on our estimate of the net realizable value of each of our customer billings. We invoice our customers, which are insurance companies for workers compensation cases, in accordance with the fees permitted according to the State of California fee schedule. This is our gross billing. Given the nature of our industry and the reimbursement environment in which we operate, our estimate of the net realizable value of our billings is often less than the gross billing we are allowed to charge. We have recorded our revenue based on historical collection trends. Second, we have had to finance our operations by selling our accounts receivable (recorded at net realizable value) to a number of factors. The cost of factoring, which we record as interest expense, can be quite high – anywhere from 70% to 75% of the recorded accounts receivable.
These two influences have had a material impact on our operating results, but also offer a major opportunity for profit growth as we move forward. We have recently formed a subsidiary named NexGen Med Solutions, LLC, which will allow us to greatly expand our accounts receivables collection effort. We believe this will allow us to improve our collections, increase the net realizable value of our gross billing revenues, and reduce our dependency on factoring. In addition we continue to seek more conventional financing which will allow us to further move away from factoring and reduce our interest expense. Finally, we continue to seek new markets for our transdermal creams which will diversify our business, increase profitability and improve shareholder value. While there is no certainty that we will be able to achieve these goals, Management is hopeful we will be successful.
------------------------------------
There you have it folks - the company has completed it's Reverse Merger and reported NET PROFITS in just 3 quarters of operation as a public company. It has experienced tremendous growth, and has announced licenses to operation in 11 more states. They also have a Toxicology testing business also set to roll out. In house collections and internal financing of accounts receivable and continued growth of revenues promises a bright future for investors in PXYN as the chart link shows, the stock is still way off the 2014 highs and imo, should be trading in the .25 to .50 per share range at this time... Now you know....
ETRM DD from $heff...
$ETRM..Key Info (DD) Post on Conf Call Today w/ key highlights into their PMA Approval for YE 14.
http://ir.enteromedics.com/eventdetail.cfm?EventID=152936
-"We are literally waiting for FDA Approval any day now." (1:30)
-Key Highlights
FDA Dialogue Has Specific Requests from it: (3:45 min mark-FDA Feedback)
*Company has been in continued active dialogue with the FDA. The FDA has asked the company 3 specific questions regarding their PMA.
(6:30 FDA Dialogue Questions)
#1) With Approval what would a post-approval registry look like.
#2) What would the ETRM labeling look like & how should it be worded.
#3) What Instructions for use of the Maestro should look like.
-Believe they have closed on all of the items the FDA has asked for and waiting for review to complete.
---------------------------------------------------------------
-Just hired a Chief Commercial Officer.
-Company already has CAT 3 codes. Will apply for CAT 1 code on approval.
Where will provider place the MAESTRO in the treatment paradigm (22m)
Looking for partners for distribution outside the U.S. & for exploring indications (24min)
Financing 26min. Largest batch or warrants are $2.19 or less. Expect for shareholders to exercise them on approval to lock in their financing. That way they won't have to do any additional dilution.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=108381519&txt2find=etrm
KBIO audio from $heff back in 11/14...good stuff..
http://screencast-o-matic.com/watch/c2XliKeDxg
KB001-A is an anti-PcrV mAb fragment being developed for the prevention and treatment of Pseudomonas aeruginosa (Pa) infection. KaloBios is conducting a 180 patient Phase 2 study in cystic fibrosis (CF) subjects with chronic Pa lung infection. KaloBios has received Orphan Drug designation from both the U.S. FDA and the European Medicines Agency for KB001-A for the treatment of Pa lung infection in CF patients. KB001-A has also received Fast Track Status from the U.S. FDA for the prevention of ventilator associated pneumonia. KaloBios is planning to seek a partner to help accelerate the development of this program.
@IPCI...Mega Product Pipeline:
http://www.intellipharmaceutics.com/common/download/download.cfm?companyid=ABEA-43EQSZ&fileid=686834&filekey=f6735dd6-88b5-4f50-91d9-7ffe4df4168c&filename=IPCI_pipeline.png
$IPCI...this is a 7 month old sticky...we have got to be close...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=101290569
Updated dozen pending IPCI pipeline catalysts/valuation drivers to consider that could easily hit at any given time now forward>>>
1. FDA approval of Effexor which has already surpassed 3 and a half years of the FDA's ANDA timeline to approval process
2. FDA approval of Protonix which has already surpassed 3 and a half years of the FDA's ANDA timeline to approval process
3. FDA approval of Glucophage which has already surpassed 3 and a half years of the FDA's ANDA timeline to approval process
4. FDA approval of Seroquel which has already surpassed 3+ years of the FDA's ANDA timeline to approval process
5. Positive Rexista study update and movement towards Phase 3 this calendar year(Regabatin trial updates and movement towards Phase 3 as well)
6. Potential new partnership/licensing agreement on Effexor with large up front payment and large milestone payments.
7. Potential new partnership/licensing agreement on Protonix with large up front payment and large milestone payments.
8. Potential new partnership/licensing agreement on Glucophage with large up front payment and large milestone payments.
9. Potential new partnership/licensing agreement on Seroquel with large up front payment and large milestone payments.
10. Strong expectation that IPCI will soon be ringing the Nasdaq Opening Bell once again...as already promised by IPCI themselves on 1 of their next milestone achievements.
11. IPCI expects to have 2 new ANDA's filed this calendar year...with their stated goal being up to four ANDA Filings per year.
12. IPCI may also choose to proceed with developing the value of any 1 of their next pipeline of ANDA's in house...and then license them out for full commercialization for even more lucrative returns than partnership/licensing agreements...as alluded to as a strong possibility at the most recent Roth Conference
hog
$CUR...http://www.thelifesciencesreport.com/pub/co/4857#quote
Neuralstem Inc. is focused on developing and commercializing treatments for central nervous system diseases based on transplanting human neural stem cells and small molecule drugs. The company has developed and maintains a portfolio of patents and patent applications that … read more
The information provided below is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.
Expert Comments:
Larry Smith, SmithOnStocks (12/18/14) "Neuralstem Inc. has noted in response to questions that it appears to be seeing encouraging signs in the patients initially treated in the Chinese ischemic stroke trial; however, this is the very early 'dose up' part of the trial. In the U.S., this would be called a Phase 1b trial that treats patients suffering from the disease state as opposed to healthy volunteers."
Jason Napodano, Zacks Small-Cap Research (11/7/14) "The last patient has been treated in Neuralstem Inc.'s Phase 2 amyotrophic lateral sclerosis study, and data are expected during Q1/15. The first patient in the spinal cord injury study has been treated, and we expect continued enrollment of this trial in 2015." -Zacks Small-Cap Research
Jason Napodano, Seeking Alpha (10/15/14) "For the purpose of our financial model, we assume that if Neuralstem Inc.'s NSI-566 works, regardless of the entry criteria for the Phase 1 trial, neurosurgeons will use it in all patients and all areas of injury. . .as for the price of the surgery, we believe $150K is realistic. . .if we apply these data in a detailed epidemiology and pricing model, with 5% U.S. market share, NSI-566 is a potential $500M drug."
Reni Benjamin, H.C. Wainwright & Co. (10/13/14) "Last Thursday, Neuralstem Inc. announced that the first of four chronic spinal cord injury patients in a Phase 1 trial of NSI-566 was recently treated at the University of California, San Diego School of Medicine. . .we view the forward progress of the trial as welcome news for investors; it marks a foray into an indication area with a potentially addressable patient population nearly 10 times that of amyotrophic lateral sclerosis."
Ram Selvaraju, Aegis Capital (10/9/14) "This morning, Neuralstem Inc. announced that the first patient was treated last week in the firm's Phase 1 trial testing NSI-566. . .we are encouraged to see the initiation of this important clinical program, and believe that preclinical evidence of NSI-566 therapeutic efficacy is particularly strong in the context of spinal cord injury."
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$CTIX...hope you made bank hound...hog
What up hog! Check out CTIX!
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