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>>> ProNAi Reports 2015 Year-End Financial and Operational Results
http://pronai.investorroom.com/2016-03-03-ProNAi-Reports-2015-Year-End-Financial-and-Operational-Results
VANCOUVER, March 3, 2016 /CNW/- ProNAi Therapeutics, Inc. (NASDAQ: DNAI), a clinical-stage oncology company advancing novel therapeutics for patients with cancer and hematological diseases, today reported its financial and operational results for the year ended December 31, 2015.
"During 2015, we continued to transform ProNAi into a world-class oncology drug development company, securing both the talent and capital required to pursue our vision of developing and commercializing a pipeline of promising clinical-stage oncology assets with the potential to provide meaningful therapeutic outcomes to patients with cancer," said Dr. Nick Glover, President and CEO of ProNAi Therapeutics. "Concurrent with building our company, we continued to advance our lead asset PNT2258, operationalizing two Phase 2 trials in 2015, Wolverine and Brighton, that are at the forefront of a concerted registration-oriented clinical development program planned for the drug. In addition to PNT2258, during 2015 we began evaluating novel product candidates available for licensing or acquisition, with the goal of maximizing our clinical development capabilities and leveraging the full potential of our team by advancing a broad and diversified pipeline of assets."
"We anticipate reporting initial interim data from the Wolverine trial in third-line DLBCL in the second quarter of 2016. This trial has been designed to identify and characterize patient populations who respond to PNT2258 on the basis of their genetics and disease characteristics and will be essential to determining potential paths to registration for the drug," added Dr. Glover. "We recently started enrolling the Brighton trial in Richter's transformation and expect to report interim data from this trial before the end of 2016. We are also designing a number of additional Phase 2 trials that could support the registration and commercialization strategies for PNT2258. Two planned trials, Cypress and Granite, will evaluate PNT2258 in combination with standard-of-care treatment regimens for the treatment of second-line DLBCL in the "transplant eligible" and "transplant ineligible" patient populations respectively. We are also designing trials evaluating PNT2258's potential in DLBCL in combination with a targeted anti-cancer drug, and in other hematological malignancies as well. Although we maintain a strong balance sheet, we are carefully considering the timing of these additional trials with a view to maximizing PNT2258's potential while deploying our capital prudently."
2015 Operational Highlights:
•Operationalized the Wolverine Phase 2 trial evaluating single-agent PNT2258 in third-line relapsed or refractory DLBCL, opening more than 20 clinical sites during 2015 that are now actively recruiting patients.
•Initiated the Brighton Phase 2 trial evaluating single-agent PNT2258 in Richter's transformed CLL.
•Completed a successful IPO in July 2015, raising more than $158 million in gross proceeds. ProNAi shares began trading on the NASDAQ Global Market on July 16, 2015 under the symbol "DNAI."
•Strengthened the ProNAi management team, appointing six additional experienced senior executives including Dr. Barbara Klencke, M.D., as Chief Development Officer. Dr. Klencke is an accomplished oncology drug developer with a demonstrable track record of success, having made substantial contributions to the development and approval of several important oncology products including Kyprolis, Kadcyla, Avastin and Tarceva.
•Expanded the company from approximately 25 employees to more than 50 employees and opened our corporate headquarters in Vancouver, Canada.
•ProNAi (NASDAQ:DNAI) was selected for addition to the NASDAQ Biotechnology Index (NASDAQ:NBI)
2015 Financial Results (all amounts reported in U.S. currency)
Total operating expenses for the year ended December 31, 2015 were $35.8 million compared to $22.6 million for the year ended December 31, 2014. Total operating expenses include non-cash stock based compensation of $3.2 million and $0.3 million for the years ended December 31, 2015 and 2014, respectively.
Research and development expenses increased to $26.4 million for the year ended December 31, 2015 from $19.1 million for the year ended December 31, 2014. These increases were primarily due to expenses related to the continuation of our PNT2258 clinical trials, the manufacture of PNT2258 and an increase in personnel-related costs. Expenses for the year ended December 31, 2014 include a one-time $11.0 million milestone payment that was made to Novosom AG during the second quarter of 2014.
General and administrative expenses increased to $9.5 million for the year ended December 31, 2015 from $3.5 million for the year ended December 31, 2014. These increases were primarily due to increased personnel-related costs and professional fees incurred in support of activities as a public company and corporate growth.
For the year ended December 31, 2015, ProNAi incurred a net loss of $53.3 million compared to a net loss of $23.9 million for the year ended December 31, 2014. The net loss includes a non-cash charge related to the change in fair value of preferred stock warrants of $17.4 million and $1.4 million for the years ended December 31, 2015 and 2014, respectively.
At December 31, 2015, ProNAi had $150.2 million in cash and cash equivalents compared to $39.2 million in cash, cash equivalents and short-term investments at December 31, 2014.
At December 31, 2015, there were approximately 30,058,105 shares of common stock issued and outstanding and 3,522,813 options issued and outstanding.
About ProNAi Therapeutics
ProNAi Therapeutics is a clinical-stage oncology company advancing novel therapeutics for patients with cancer and hematological diseases. ProNAi's lead product candidate, PNT2258, is based on the company's pioneering and proprietary DNAi technology platform. PNT2258 is designed to target cancers that overexpress BCL2, an important and validated oncogene known to be dysregulated in many types of cancer. ProNAi is pursuing a multi-faceted clinical development strategy designed to efficiently achieve regulatory approval and maximize the commercial opportunity of PNT2258. ProNAi is actively enrolling patients in "Wolverine", a Phase 2 trial evaluating PNT2258 for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and in "Brighton", a Phase 2 trial evaluating PNT2258 for the treatment of Richter's transformation. For more information, please visit www.pronai.com.
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Valeant Pharma (VRX) - bottom play, soap opera stock -
>>> Valeant Pharmaceuticals International, Inc. develops, manufactures, and markets pharmaceuticals, over-the-counter products, and medical devices worldwide. The company offers Solodyn to treat red and pus-filled pimples of acne in patients, as well as Ziana, Acanya, Atralin, Retin- A Micro, and ONEXTON gel; Wellbutrin XL for major depressive disorder in adults; Jublia for onychomycosis of the toenails; Xenazine for chorea; Targretin for Cutaneous T-Cell Lymphoma; Arestin, a subgingival sustained-release antibiotic; and PROVENGE for the treatment of prostate cancer. It also provides Zovirax, an antiviral for recurrent herpes labialis and initial genital herpes; Syprine to treat patients with Wilson's disease; Elidel to treat atopic dermatitis; Prolensa for inflammation and pain following cataract surgery; Duromine, a weight loss drug; and Lotemax gel for post-operative inflammation and pain. In addition, the company offers PreserVision, an antioxidant eye vitamin and mineral supplement; CeraVe to rebuild and repair the skin barrier; ReNu Multiplus to lubricate and rewet soft contact lenses; Biotrue for healthy contact lens wear; Ocuvite, a lutein eye vitamin and mineral supplement; Boston, a cleansing solution for gas permeable contact lenses; Artelac to treat dry eyes; AntiGrippin for acute respiratory and respiratory viral diseases, and influenza; and Bedoyecta, a vitamin B complex product. Further, it provides SofLens daily disposable contact lenses; PureVision, a contact lens; various ophthalmic surgical products; Biotrue ONEday lens; medical device systems for aesthetic applications; and Bausch + Lomb Ultra, a contact lens. Additionally, the company offers Tobramycin and Dexamethasone ophthalmic suspension for steroid responsive inflammatory ocular conditions; Cardizem CD to treat hypertension and angina; and Latanoprost for the treatment of glaucoma. Valeant Pharmaceuticals International, Inc. was founded in 1983 and is headquartered in Laval, Canada. <<<
Peregrine Pharma (PPHM) - bottom play, may require patience but eventual recovery is possible -
>>> Peregrine Pharmaceuticals, Inc., a biopharmaceutical company, researches and develops monoclonal antibodies for the treatment and diagnosis of cancer in the United States and internationally. The company?s lead immunotherapy candidate, bavituximab, which is in Phase III development stage for the treatment of previously-treated non-small cell lung cancer along with various investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. It is also involved in the development of molecular imaging agent, 124I-PGN650, which is in exploratory clinical trial for the imaging of various solid tumor types. The company provides current good manufacturing practice services from cell line development to commercial biomanufacturing for its third-party customers. It has license agreements with the University of Texas Southwestern Medical Center at Dallas; Genentech, Inc.; Avanir Pharmaceuticals, Inc.; Lonza Biologics; Affitech A/S; and Merck KGaA.; and collaboration agreement with AstraZeneca PLC for immuno-oncology combination clinical trial, as well as with the National Comprehensive Cancer Network. Peregrine Pharmaceuticals, Inc. was founded in 1981 and is headquartered in Tustin, California. <<<
Primo Water (PRMW) - had formed an ascending triangle over the past 6 months and broke out strongly this week -
>>> Primo Water Corporation, together with its subsidiaries, provides multi-gallon purified bottled water, self-service refill water, and water dispensers in the United States and Canada. The company operates in two segments, Primo Water and Primo Dispensers. The Primo Water segment offers exchange and refill products through point of purchase display racks, or self-serve filtered water displays and recycling centers. The Primo Dispensers segment sells water dispensers that are designed to dispense Primo and other dispenser-compatible bottled water. As of December 31, 2015, the company?s products and services were offered at approximately 25,700 combined retail locations. Primo Water Corporation was founded in 2004 and is headquartered in Winston-Salem, North Carolina. <<<
Cablela's (CAB) - has formed a bullish inverted head + shoulders formation over the last 8 months. It's sitting right at key resistance and is poised for a possible breakout. The chart should also have golden cross over the next several weeks. If it breaks out it should move up into the previous trading range (50-58). Currently at 49.5 -
>>> Cabela's Incorporated operates as a specialty retailer and direct marketer of hunting, fishing, camping, and related outdoor merchandise. The company operates through Retail, Direct, and Financial Services segments. The Retail segment sells products and services through its retail stores The Direct segment sells products through its e-commerce websites, including Cabelas.com and Cabelas.ca; and direct mail catalogs. The Financial Services segment issues Cabela's CLUB Visa credit card, a rewards based credit card program; and certificates of deposit, as well as underwrites credit statistics. This segment offers its Cabela's CLUB Visa credit card through various channels, including retail stores, Website, inbound telemarketing, and catalogs. The company?s product assortment includes hunting equipment, such as firearms, ammunition, optics, archery products, and related accessories and supplies; and field wear apparel and footwear, sportswear apparel and footwear, casual apparel and footwear, and workwear products. Its product assortment also comprises equipment and accessories for various outdoor activities, including fishing and tackle products; boats, electronics, and marine accessories and equipment; camping gear and equipment; food preparation and outdoor cooking products; all-terrain vehicles and accessories; and gifts and home furnishings. The company operates 77 retail stores, including 68 stores in the United States; and 9 stores in Canada. Cabela's Incorporated was founded in 1961 and is headquartered in Sidney, Nebraska. <<<
>>> Oil might have hit the bottom: Analyst
CNBC
By Alexandra Gibbs
http://finance.yahoo.com/news/oil-might-hit-bottom-analyst-160422065.html#
As oil prices struggled to hold onto this week's gains, investors are obsessed with pinpointing crude's next move—and there's hopes the worst might be over.
"We might have hit the bottom," Neil Atkinson, head of analysis at Lloyd's List Intelligence, told CNBC Wednesday. "Simply because the Brent and WTI price have both been stuck in the mid to upper $40s since about the beginning of August (aside from Black Monday period). They haven't really gone anywhere, a little bit up, a bit down."
Both Brent crude and WTI Crude remain below $50 per barrel, sharply below the levels above $100 seen prior to the slump that began in June 2014.
At the end of 2015's third quarter, WTI crude closed down over 24 percent, with ongoing supply and demand imbalances worsened by the economic slowdown in China and accompanying financial markets fears. The three months from July to September marked WTI's worst quarterly performance since 2014's fourth quarter, when it lost over 40 percent.
However, Atkinson forecast that the supply-demand imbalance would soften during the remainder of 2015.
On the supply side, he said that U.S. oil production seemed to have peaked in June at 9.6 million barrels a day. Since then, production has come down slightly, with the U.S government announcing Wednesday that oil production was now just over 9 million barrels.
Meanwhile, global demand growth prospects are being revised upwards, which Atkinson attributed partly to investors' reaction to the lower prices seen during the past year.
"We've got falling supply from the non-OPEC group of countries, rising demand growth from around the world, not least of course from the United States – bit of uncertainty about China," he said.
"So we may well see this rebalancing of the oil market, which people have been looking forward to for some time, might now finally be underway."
Atkinson added that OPEC (the Organization of the Petroleum Exporting Countries) members were "hanging in there for better days," waiting for when the market rebalanced and demand growth picked up.
On Wednesday, Russia launched its first round of air strikes on Syria, leading to debate as whether or not this might impact oil prices .
"Russia's military intervention in the Syrian conflict has increased the geopolitical risks, which is giving tailwind to the prices," Carsten Fritsch, a Commerzbank analyst, told Reuters.
However, Atkinson argued that oil prices had been barely affected by the multi-year long Syrian conflict.
"Throughout the whole of the Syrian conflict – which has been going on for five years now – it's influence on the oil markets has actually been essentially zero," he said.
"Syria was a significant oil producer but not that important, and I don't think today's rise in the oil price has got that much to do with the Russian actions. Perhaps a little bit, yes."
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If you get a chance listen to this week's conference call. Goal posts keep getting moved.TSLA loses about 10K on every car they sell. They have a distribution problem (no dealership sales model illegal in many states), resale value problems due to high cost of replacement batteries, 150 cars sold in all of China last year, and BMW, Toyota, Mercedes all getting electric car religion.
On the positive side Musk is a messianic figure for many investors. Their product is truly awesome to drive (muscle car e.t.s without the guilt.)
But then so was the DeLorean.
Re: Apple. All the negatives about Apple you pointed out are true, BUT I think activists like Carl Ichan will eventually win out and force APPL to do bigger stock repurchases and maybe even dividends, so the S.P. will be bolstered by those moves in the short term. As a rule I never bet against Ichan, he makes more trading in a few seconds than I'll ever make in a lifetime.
Drfreely, I haven't followed Tesla that closely, but chartwise it does look like it could be starting to roll over. $25 bil market cap, and the chart has been sideways for a year. Looks like a big short position is in place, approx 25% of the float. Key support looks like 180-185 area (May and Jan lows), so the official signal to short would come if it breaks below there. Then next key support looks like 140 and 120 (Jan '14 and Nov '13 lows).
Speaking of Apple, could it be the first $1 Tril company? Possibly, but while it's minting gobs of money at the moment, I still feel queasy about tech companies like Apple. There's a big trendiness/fad element to their products, and there is the problem of commoditization eventually eating into their rich profit margins, plus the loss of their visionary leader. The stock looked like it had run out of gas until they did their split. Can't argue with that monster chart though.
re: gfp post #5, tsla "death cross." Sounded like Musk used the conference call to drive that death cross right through the shareholders heart. He sounded like he was one toke over the line.
The boast about besting AAPLs market cap: pure hubris. He'd be lucky to end up as a low octane Richard Branson. Wish I was short. Hope you are. Damn good call!
Re: ILMN. First read about them in "Wired" on a plane to Vegas in 2000 right after their IPO. I bought some that fall that I've held on to. Wish I'd spent more on ILMN and less at the Blackjack Table. They sure were right to turn down Roches' offers in the 40's. Every now and then I think of selling the stock but they seem destined for ever-increasing sp as medicine is moving more towards individualized medicine. They have competition, but now have the best, most affordable mouse-trap.
I'm nibbling at some SLB, and glad to see Lippa and Margolis at the helm of poor old CORX.
>>> Father of the Country
February 5, 2 BC
By Zachary Beasley
Father of the Country”
The title of Pater Patriae, or Father of the Country, was first given to a Roman general – Marcus Furius Camillus, in 386 BC. It was an honorary title conferred by the Senate, and in the case of Camillus, it was given because of his role after the siege of Rome in the Battle of the Allia by Gallic invaders, when he routed the Senones and was determined to be the second founder of the city, after Romulus.
The title would not be used again for over three hundred years, when the Senate would confer it to consul Marcus Tullius Cicero in 63 BC, for his role in the exposing the Second Catalinarian Conspiracy to overthrow the Roman Republic by senator Lucius Sergius Catalina and various members of the senate and equestrian ranks. Cicero intercepted letters the conspirators sent to the Allobroges, a Gallic tribe, about the plot, read them to the Senate, and the Senate condemned the conspirators to death without a trial.
For having ended the civil wars, and declaring himself dictator and the de facto ruler of the Republic, the Senate next awarded the honor to Gaius Julius Caesar in 45 BC. This was made possible by Caesar’s move in 46 BC to give himself the title Praefectura Morum, or “Prefect of the Morals”, allowing him to have the powers of a censor, but not subjecting himself to their checks and balances. As such, he was able to fill the Senate with allies, who then bestowed numerous honors and titles to him.
On February 5, 2 BC, the senate offered the title of Pater Patriae to Augustus. Since the title didn’t bring with it any additional powers, and wasn’t needed to legitimize his position as Roman emperor, it wasn’t used regularly in his list of titles. When it was used on coins, it was fully spelled out PATER PATRIAE. The coins stuck posthumously to honor Augustus often simply list the title as PATER.
The title would be offered to many subsequent rulers, some of which would accept the honor, but the tradition was to decline the offer initially out of humility, until the Senate would offer it again in the future. Tiberius declined the honor all-together and Nero declined it the first time. Hadrian deferred for eleven years, until finally accepting it in 128 AD. Many of the emperors with short reigns did not have the chance to prove themselves worthy to the Senate to have the title offered to them, but those that did would simply abbreviate it as P P on their coinage.
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Hi Athero, Illumina has a monster chart, and looks poised to go even higher. I remember the company when it was much smaller, but lost track of it, and now it's a $25 Bil company. Looks very interesting -
>>> Illumina, Inc. develops, manufactures, and markets life science tools and integrated systems for the analysis of genetic variation and function in North America, Europe, Latin America, the Asia-Pacific, the Middle East, and South Africa. The company?s products include sequencing platforms that are based on its SBS technology are designed to meet the various demands of a range of sequencing applications; and array platforms consist of HiScan and iScan systems that are array scanners, which support the imaging of array-based genetic analysis products. It also offers various sample preparation and sequencing kits to simplify workflows and accelerate analysis. In addition, the company provides genotyping and whole genome sequencing services. It serves genomic research centers, academic institutions, government laboratories, hospitals, and reference laboratories, as well as pharmaceutical, biotechnology, agrigenomics, commercial molecular diagnostic, and consumer genomics companies. The company sells its products directly, as well as through distributors. It has strategic partnerships with AstraZeneca PLC; Janssen Biotech, Inc.; and Sanofi to focus on the transition from single-analyte companion diagnostics to panel-based assays that select for companion therapeutics. Illumina, Inc. was founded in 1998 and is headquartered in San Diego, California. <<<
Hay, I think you found another scary stock, but here is Aetna's take.
I would be concerned about the profit per insertion of device and what might be the competition?
I only have one patient on gastric pacing (for gastroparesis) not morbid obesity.
http://www.aetna.com/cpb/medical/data/600_699/0678.html
ILMN (Illumina Inc), is interesting, at a new high and reporting tommorrow.
The trend toward personalized medicine is clear, as opposed to a generic or poly pill (one size fits all, third world approach). Even SOTU endorsed the approach, despite the headwinds of cost.
If ILMN can maintain its leadership as Murphy's law plays out, genetic analysis before prescription selection and dosing will be key driver of utilization.
GFP, thanks for keeping us informed on the bottom dwelling CORX.OB
CHM, >> CTIX <<
I'm not that familiar with their previous financing arrangements with Aspire. It could be that additional financing is already pre-arranged and CTIX can just get the money when they want, but it's generally not a great idea for a bio stock to let the cash get this low.
I have no position in the company and am just following it loosely to see what happens with the defensin mimetics platform. After Polymedix's icy brush with bankruptcy, I figure these bio stocks are best left in the 'entertainment' category, lol.
Good morning, gfp... CTIX had better get that financing done soon, because investors are starting to realize that the string of PR releases touting "future" news are mere fluff, triggering selling instead of the desired buying.
Hoping that it holds $3...
CBMX is another interesting bottom play chart. It formed a double bottom over the past 3-4 months, and now is near breakout territory (1.70), with the 200 MA as next resistance (1.84).
THLD chart starting to look interesting. Currently at 3.56, and if it can work its way back to the 200 MA (3.80) it could be set up for a breakout. But still early.
It has formed a 'Rounded Bottom' which is a bullish reversal pattern, and if it gets to 3.80 it will then be similar to a Cup + Handle, also bullish (though technically a Cup + Handle is a continuation pattern not a reversal pattern).
Stay short Euro, long dollar -- >>> Draghi Delivers: ECB To Spend At Least 1.1 Trillion Euro Fighting Deflation <<<
Note - Draghi was vice chairman and managing director of Goldman Sachs International.
>>> Draghi Delivers: ECB To Spend At Least 1.1 Trillion Euro Fighting Deflation
Forbes
http://www.forbes.com/sites/steveschaefer/2015/01/22/draghi-delivers-ecb-to-spend-at-least-1-1-trillion-euro-fighting-deflation/?partner=yahootix
The European Central Bank launched an expanded asset purchase program of 60 billion euro a month that will last from March 2015 until September 2016. In aggregate, the ECB’s asset purchasing program will be over 1.1 trillion euro, the high end of analyst expectations. The euro/U.S. dollar exchange rate is at $1.1530 (down 0.73%) on the news Thursday.
More Downside for Euro
The euro is at the lowest level it has been in the last 11 years after Draghi’s announcement. With the ECB essentially printing 60 billion euro each month, the value of the Euro is expected to depreciate further, potentially hitting parity levels not seen since 2002.
A weaker euro is in the EU’s best interest as it helps spur growth the Eurozone desperately needs. The ECB has already taken stimulative growth measures before this latest action by cutting interest rates to record lows, buying private sector assets and funneling cheap loans to banks. However, as seen below, GDP growth remains stagnant.
ECB1
Running out of options, the ECB followed policies that the U.S. Federal Reserve, Bank of Japan and Bank of England have already used to revive growth. A depreciated euro should be helpful for Eurozone exporters, since European goods would be cheaper relative to other currencies, most notably the Japanese Yen and U.S. dollar. The ECB is also banking on the quantitative easing (QE) program to raise the inflation rate on the continent.
Meanwhile, the U.S. economy added 1.7 million jobs in 2014 and is expected to expand by 2.6 percent during the year. This initial economic traction has influenced the Federal Reserve to potentially consider raising rates in 2015, making the U.S. the only major economy to consider such conduct. With the majority of developed economies struggling to find their footing, the greenback remains the safest bet in the currency market. Due to this, the dollar is expected to continue its ascent against weakening pairs, most notably the euro.
Writing on the Wall
Market participants were expecting this bond buying program and many took action to prepare. Last week the Swiss National Bank eliminated its euro floor on the Swiss franc, sending a panic across markets. Denmark, the last major currency to peg its currency to the Euro, saw its national bank cut interest rates deeper into negative territory (from -0.05% to -0.2%). Similar to the franc, investors have been attracted to the perceived safe assets, such as the Danish krone, to avoid the depreciating Euro currency.
Companies Impacted by Potential Parity
Any American multinational that has a significant portion of revenues derived from European operations will be a victim of a stronger dollar. International operations are translated back to U.S. currency, meaning the dollar’s appreciated value converts foreign currencies at a lower rate. For example, American cigarette manufacturer Philip Morris International PM +0.15% has about 35% of its $30B in revenues coming from the European Union. When calculating earnings, Philip Morris must account for the currency loss of exchanging the depreciated Euro into the stronger USD. Other notable companies with significant European sales include McDonald's MCD -0.12% and Coca-Cola KO +0.39%.
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CTIX - 2 oral presentations and a poster presentation, not too shabby. I'm impressed :o)
Now, how in the world did CTIX get a totally off topic mention by this Marijuana stock pump outfit?? Obviously someone somewhere paid for it, Weird -
>>> Will Cannabis Be The Biggest Thing In Biotech For 2015?
http://finance.yahoo.com/news/cannabis-biggest-thing-biotech-2015-135600900.html
CORAL GABLES, FL / ACCESSWIRE / January 22, 2015 / Attention on marijuana stocks has increased since Colorado legalized it for recreational use in 2014. With larger institutional investment flowing into the industry, there's no doubt that this may be just the beginning for stocks in this sector. With 2016 slated as the next vote for more states to come online for legalization of medical and recreational licensing, much speculation has given rise to where to invest as it would appear not many new developments may come about until more states can come online. Biotech has been one of the identified target markets as regulation does not limit these organizations to particular state laws but more on the Federal side, specifically the FDA. From prescription sprays to cannabinoid oils, the biotech space may offer potential investment opportunity prior to the next vote.
Oxis International Inc. (OXIS) CEO, Tony Cataldo, was recently featured in an interview with The Wolf of Weedstreet where they discussed plans for future growth in the company. Mr. Cataldo previously helped build another small cap biotech company (at the time) into a much larger organization by the time he had moved onto his next project. In the interim, the company, under Cataldo's watch, has begun to build a stronger Scientific Advisory Board which will initially focus on the application of CBD's for those who suffer from multiple myeloma. After seeing highs near $0.04 over the last few weeks, investors are finding support levels and heavy accumulation at $0.025.
Peak Pharmaceuticals, Inc. (CTCO) recently signed a worldwide license agreement with Canna-Pet LLC and a cultivation agreement with a Colorado-based hemp farm. The stock has enjoyed a surge of buying volume which sent prices up by as much as 120% during the month. According to the American Pet Products Association, the U.S. pet industry has grown at an 8% CAGR to reach $58.51 billion by 2014 which puts Peak in position to capitalize on a fairly untapped niche through its focus on cannabis application for pets.
But just because cannabinoids are gaining mass appeal does not mean traditional biotechs are loosing their luster. Cellceutix Corporation (CTIX) has seen an incredibly volatile and volume filled market recently. This week the stock has rebounded by as much as 57% from Tuesday lows. Wednesday's late afternoon trading saw a pullback in the stock to close at $3.69. Today Cellceutix announced results of its recently completed phase 2b clinical trial will be given in an oral presentation at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) to be held in Copenhagen, Denmark from April 25-28, 2015.
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gfp927z: No consensus about anything on the CTIX board that I've seen. Most of the posters there are expecting a partnership or additional financing through Aspire. I don't think most of them realize the costs involved with running a Phase 3 trial.
I'd agree with your guesstimate of $3 - $3.25 per share if the shelf were to be accessed today. Company may try to put it off as long as possible to keep the good news flowing and get the stock price back up above $4 before diluting.
My guess is that once a financing is finalized, there are a lot of people waiting on the sidelines that will be eager to become shareholders once the unknown becomes known, so I think the share price will recover quickly.
And, a partnership is still a possibility.... as you say, antibiotics have become a hot sector. Today's press release announcing the oral presentation at ECCMID hopefully helps build their credibility, in my opinion.
Cellceutix Phase 2b Clinical Trial of Brilacidin Accepted for Oral Presentation at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)
Company to Give Three Presentations Highlighting Its Novel Antibiotics
BEVERLY, MA--(Marketwired - Jan 22, 2015) - Cellceutix Corporation (OTC: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, is pleased to report that results of its recently completed phase 2b clinical trial "A Randomized, Double-Blind Study Comparing Single-Dose and Short-Course Brilacidin to Daptomycin in the Treatment of Acute Bacterial Skin & Skin Structure Infections (ABSSSI)" will be given in an oral presentation at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) to be held in Copenhagen, Denmark from April 25-28, 2015. ECCMID is one of the largest annual gatherings of infectious disease experts in the world, and an ideal forum to present the results of a clinical trial. Dr. Daniel Jorgensen, Cellceutix's Chief Medical Officer, will give the presentation during a session entitled "New Antibacterial Agents - Phase 2 and Phase 3 Clinical Trials."
"We worked with the FDA in designing the recent phase 2b study," said Dr. Jorgensen. "As predicted, a lower total dose of Brilacidin, given as a single-dose regimen, was well tolerated and efficacy was comparable to that of the 7-day regimen of the active control, daptomycin."
"It's important to note that a single-dose regimen has benefits beyond safety and efficacy," Dr. Jorgensen added. "It can maximize patient compliance and thereby reduce the potential for the development of antibiotic resistance. Of course, Brilacidin's unique mechanism of action to penetrate the bacterial cell wall to eradicate bacteria is another reason why resistance is unlikely to develop. Further, Brilacidin has anti-inflammatory and anti-biofilm properties. When considering all these factors, Brilacidin has the potential to transform the way we treat infectious diseases."
In addition to the clinical data from the ABSSSI trial, Cellceutix will also present important preclinical data. The abstract entitled Synthetic Novel Host Defense Protein Mimetics for the Treatment of Gram-Negative Bacterial Infections has been accepted for oral presentation in the session entitled Drug Discovery. "This is an opportunity for experts to hear about the other promising defensin-mimetics -- not just Brilacidin," said Dr. Jorgensen. "These compounds have potential to treat serious Gram-negative infections, including those identified by CDC as 'antibiotic resistance threats.' "
The final presentation, a poster entitled Brilacidin, Host Defense Peptide Mimetic, One of a New Class of Immunomodulatory Agents that can Target Multiple Disease Indications, will be given in the category of New Antimicrobials. "This is an important poster, as it highlights the immunomodulatory properties of Brilacidin, in addition to its antimicrobial properties," Dr. Jorgensen added. "These animal data support the use of topical Brilacidin in humans to prevent or ameliorate oral mucositis, a painful condition in cancer patients undergoing chemoradiation therapy. A phase 2 clinical trial is about to begin."
Dr. Jorgensen concluded, "There is an urgent need for new classes of antibiotics that are effective in this era of increasing drug resistance. We believe our defensin-mimetics, including Brilacidin, can address this need and that these compounds will also play an important role in the management of inflammatory diseases of the skin and mucous membranes. The laboratory and clinical data we have collected to date support the exciting promise of this class of compounds. We look forward to sharing these data at the ECCMID meeting."
About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix will soon begin a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol has recently completed a Phase 1 clinical trial and is being readied for a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
CHM, Any consensus over on the CTIX board concerning the financing? I've been thinking they would do a 15 mil share deal at $3, netting $45 mil range, but that's just a guess. A partnership would be another possibility, though probably less likely.
Cempra (CEMP) and Tetraphase (TTPH) are also good looking stocks in the antibiotic sector. There's been a lot of acquisitions in the sector over the past year or so, including Trius and Optimer gobbled up by Cubist, and Durata by Actavis, and now Cubist by Merck. So antibiotics have become one of the hotter sectors in biotech.
I'm assuming you mean "Biotech Values" when you bring up Dew's board? I've posted a couple of CTIX items there, but no replies until Dew's non-reply of this morning.
Agree that the CTIX board is congested. I finally coughed up for a paid subscription after 9 years, just so I could get through the posts faster.
A fellow called slcimmuno is worth following there... a medical researcher by trade, he finds all kinds of interesting things to post.
If I see anything earth shattering, would you like for me to cross-post it here?
CHM, >> CTIX on Dew's board <<
You might get some valuable input over there. I think Biomaven once followed Polymedix, and others may have some insights. The CTIX board looks too congested to sift through, so may not be especially useful.
For myself I only follow CTIX loosely for the Brilacidin / defensin mimetics angle, so am far from an expert on the company. Just glad to see the technology moving ahead.
I guess it was a mistake to post anything about CTIX on Dew's board. His negative comments are being picked up on Twitter now.
I know nothing about charts, LOL. MARA is one of my largest holdings. I started buying them in 2013 at $0.43 (before the reverse split and uplisting, obviously) and have been more than happy with my ROI. I consider it a hedge against my mostly biotech portfolio.
There is a very good MARA board on iHub with knowledgeable posters. I am not one of them...
I just recently got into Cynapsus (in a very small way). I found their presentation at Monday's Noble Financial Conference very interesting... not sure I can still find the link; perhaps you already have it?
CHM, Marathon Patent (MARA) also has a nice looking chart. I'll have to check them out -
>>> Marathon Patent Group, Inc. is a patent acquisition and monetization company. It acquires patents from various patent holders ranging from individual inventors to Fortune 500 companies. The company provides its clients advice and services that enable them to realize financial and strategic returns on their intellectual property rights. Marathon Patent Group monetizes patent portfolios through actively managed patent licensing campaigns. It has a portfolio of 124 patents, as well as contract rights related to revenue generated from approximately 50 patent assets. The company was formerly known as American Strategic Minerals Corporation and changed its name to Marathon Patent Group, Inc. in February 2013. Marathon Patent Group, Inc. was incorporated in 2010 and is based in Alexandria, Virginia. <<<
CHM, Yes, CTIX shouldn't have let the cash level get this low, considering the stock has tripled since Summer.
Btw, I see you follow Cynapsus. I had never heard of the company, but it looks interesting and the stock chart looks promising -
>>> Cynapsus Set For Major Revaluation On Positive Phase 2 Data
By Zacks Small Cap Research
November 19, 2014
By Jason Napodano, CFA
OTC:CYNAF
TSXV:CTH
http://finance.yahoo.com/news/cynapsus-set-major-revaluation-positive-150000982.html
APL-130277 Shows Clear Proof-of-Concept In Phase 2 Trial
On November 19, 2014, Cynapsus Therapeutics Inc. (CYNAF) (CTH.V) announced what looks to be a clear demonstration of proof-of-concept via positive top-line results from the CTH-105 Phase 2 clinical trial. The CTH-105 study was the first to test Cynapsus APL-130277, a fast-acting, sublingual, thin filmstrip formulation of apomorphine in Parkinson’s patient for the management of “off” motor symptoms. We believe these data set the stage for a significant re-valuation of the shares to meaningfully higher levels. Our target is $2.75 per share, offering 250% upside.
…Quick Highlight Of The Data…
The primary objective of CTH-105 (NCT02228590) was to evaluate the efficacy, tolerability and safety of single treatments of APL-130277 in 16 patients with Parkinson's Disease (PD). The primary endpoint was the efficacy based on “time to on” using the percent change in UPDRS. Safety and tolerability, as well as frequency of adverse events, were also primary and secondary outcome measures in the study. In the trial, patients were then given escalating doses of APL-130277 (at a minimum of three hours between doses) until “on” was achieved. UPDRS III score was measured at 15, 30, 45, 60 and 90 minutes. Pooled data from 16 patients was released this morning, with management noting that three additional patients are continuing dosing.
According to management, all five doses of APL-130277 used in the study (10, 15, 20, 25, 30 mg) resulted in patients moving from “off” to “on”. We are encouraged by the fact that even the lowest dose showed efficacy, with 3 of the 16 patients (~19%) moving to “on”. Out of 16 patients treated with APL-130277, 14 converted from “off” to “on” time. Study investigators hypothesized that the two patients (~13%) that did not convert to “on” probably need more drug, as their baseline UPDRS scores were significantly higher than the mean for the other 14 patients. This is consistent with prescribing label for subcutaneous apomorphine were approximately 20% of PD patients require the highest dose. We suspect that management can dose 35 or 40 mg in the upcoming Phase 3 trial.
Mean baseline UPDRS III scores for the pool group was 41.4. The maximum mean change from baseline was 18.4. This data compares well with published literature for subcutaneous apomorphine. Cynapsus reported that onset to clinically meaningful improvement was seen in as early as 10 minutes and last up to 90 minutes (the last measured time point). Mean “time to on” was 22 minutes. Below is a graph showing the mean change in UPDRS Part III from baseline over the study period for patients converting from “off” to “on” time. Take note, even at 90 minutes patients were still “on”, suggesting that APL-130277 could act as a bridge between regular oral levodopa dosing (typically 4x daily).
Cynapsus reported that treatment with APL-130277 was safe and well tolerated. Nausea, reported by three subjects at doses of 10, 15 and 20 mg, looked to be the most common side effect. One of these patients also experienced a mild episode of vomiting. There were no reports of nausea at higher doses of 25 and 30 mg. There were no reports of local irritation or hypotension in any subject treated. A total of 60 doses of APL-130277 were administered to the 16 patients who completed dosing in the CTH-105 study. Additional safety data will be presented with all 19 patients complete dosing. We expect to see individual patient data at an upcoming medical meeting or when the results are published by study investigators.
Acorda Acquires Civitas And Validates The Market
We have been saying that the market opportunity for an effective rescue medication to treat off episodes in Parkinson’s patients in a potential multi-hundred million-dollar opportunity. In fact, in our most recent Zacks report on Cynapsus Therapeutics, we estimated the peak U.S. sales for APL-130277 were $387 million. And we believe this estimate includes conservative forecasts on both pricing and market penetration (see below). It also does not include forecasts for sales in Europe or Asia.
On September 24, 2014, Acorda Therapeutics (ACOR) announced it had made an offer to acquire privately-held Civitas Therapeutics for $525 million in cash. The impetus of the acquisition by Acorda was to get CVT-301, a Phase 3 inhaled formulation of levodopa for the treatment of off episodes in Parkinson’s patients. With CVT-301, Acorda believes it has an attractive late-stage asset to add to the company’s CNS-focused pipeline. The CVT-301 Phase 3 study is expected to begin enrollment in early 2015, with a new drug application (NDA) planned for 2016. Acorda estimates the market opportunity for CVT-301 is in excess of $500 million. Civitas had been previously planning an initial public offering, but the $525 million all-cash offer from Acorda was simply too attractive to pass up.
Civitas’ CVT-301 looks only a few months ahead of Cynapsus’ APL-130277. Cynapsus just recently completed the CTH-105 study discussed above. The next step is a bridging study, dubbed CTH-200, designed to be a single dose, crossover comparative bioavailability and pharmacokinetic study in healthy volunteers. This study is designed to provide the clinical “bridge” to the FDA’s finding of safety and efficacy for the reference-listed drug (Apokyn®) – a necessary step to file an application via the 505(b)(2) pathway. The CTH-200 Bridging Study is expected to begin shortly. Meanwhile, Cynapsus has already schedule an “End of Phase 2” meeting with the U.S. FDA to discuss the Phase 3 program. This meeting is expected to take place in early February 2015. As such, we expect the Phase 3 program for APL-130277 to begin during the second quarter of 2015. Again, based on the recent positive data from CTH-105, we estimated CVT-301 is only a few months ahead of APL-130277.
…And We Think Cynapsus Drug Is Clearly Better…
Ever since the announced acquisition of Civitas, investors have been asking, “Why Civitas and not Cynapsus?” and “What does the added competition do to our forecasts?” The answer is simple – We think Acorda bought the wrong drug and that APL-130277 clearly has better attributes than CVT-301.
Specifically, CVT-301 is an inhaled formulation of levodopa. Levodopa is the most common form of dopamine replacement therapy, a backbone regimen and standard of care for the treatment of Parkinson’s disease. Parkinson’s disease is a slowly progressing neurological disorder characterized by tremor, stiffness and decreased movement. The decreased movement is a direct result of the lack of dopamine in the brain. Levodopa, when taken orally, is converted into dopamine in the substantia nigra by dopa decarboxylase. The administration of levodopa temporarily diminishes the motor symptoms associated with the lack dopamine in the substantia nigra. Carbidopa, a dopa decarboxylase inhibitor, is commonly dosed with levodopa to prevent L-DOPA metabolism before it reaches the blood-brain barrier. In fact, co-formulations of levodopa/carbidopa (Sinemet-CR) are available. Civitas’ formulation of levodopa bypasses the gut metabolism through inhalation, a pathway known to for rapid uptake and onset of action.
There are, however, major limitations to the use of levodopa as a treatment for Parkinson’s disease. Mainly, the patient must have substantial remaining dopaminergic neurons in the substantia nigra to metabolize the drug. However, according to research published in the Journal of Neural Transmission by P. Riederer et al in 1976, pathological studies of Parkinson’s disease show at least 70-80% of the dopaminergic neurons are lost before the onset of symptoms. This work was confirmed byK. Yoshikawa et al, 2004. This explains why levodopa is very effective for a period of time, then wanes with disease progression. A newly diagnosed Parkinson’s patient has the capacity to process levodopa. As the patient loses this capacity, the therapeutic window for levodopa therapy begins to narrow. Levodopa also has a relatively short half-life of only 60-90 minutes. The drugs effect, even in the mild Parkinson’s patient, only lasts for 1.5 to 2.0 hours post dose (Brooks, D, 2008).
Work done by Olanow et al, 2006 shows that a therapeutic window for Parkinson’s disease patients rapidly closes (narrows) as patients gain experience with Levodopa use. This is due to a combination of disease progression, loss of dopaminergic neurons in the substantial nigra, and the short half-life of the drug.
As such, dosing dynamics for levodopa are challenging (Schapira et al, 2009). Too much drug (or too frequent dosing) leads to leads to dyskinesia, a direct result of excess dopamine in the brain. Too little drug leads to increase “off” time (bradykinesia / akinesia), the specific condition that both Civitas and Cynapsus are aiming to treat.
We question the concept of treating “off” episodes in Parkinson’s patients with more levodopa. Many neurologists and movement disorder doctors will delay the use of levodopa in newly diagnosed Parkinson’s patients specifically to avoid the narrowing of the therapeutic window and the risks of complications such as dyskinesia (see this YouTube video from the MJFF talking about Levodopa and Off/On time). We believe CVT-301 complicates the dosing regimen for the Parkinson’s patient taking a drug like Sinemet-CR. We suspect substantial acceleration of the narrowing of the therapeutic window and dyskinesia with the drugs use. And as the Parkinson’s patient progresses from mild to moderate or severe disease, we suspect that CVT-301 will become a less effective drug. We also strongly question the approvability of an inhaled drug, with chronic use, in an elderly population for a non-pulmonary disease. The pathway to approval for CVT-301 seems arduous.
Apomorphine, the active drug in the only currently approved rescue medication for the treatment of off episodes in the U.S. in Apokyn®, is not a dopamine replacement therapy. Apomorphine is a dopamine agonist, and acts directly at the post-synaptic dopamine receptor, thus bypassing the need for dopamine and dopaminergic neurons in the substantial nigra. Instead, apomorphine can act directly on the gabaergic neurons that are not impacted by Parkinson’s disease, and provide an effective treatment option as a rescue medication to patients at all stages of disease progression.
The knock on apomorphine is that because the drug is rapidly metabolized by the liver, it must be administered by a route that bypasses the gut. As such, the currently approved formulation of apomorphine in the U.S. is a subcutaneous injection. Subcutaneous injectable apomorphine, sold in the U.S. as Apokyn®, is a horrible impractical and inefficient drug, flawed by its delivery system and quick peak-to-trough pharmacokinetic profile. Apomorphine is highly lipid soluble and quickly crosses the blood-brain barrier. Onset of action is as little as five minutes, but only lasts for 60-90 minutes. Under QID dosing for levodopa, patients with advanced disease may still experience off episodes.
Self-administration of subcutaneous Apokyn is next to impossible for the akinetic (or dyskinetic) Parkinson’s patient. For example, the Instructions For Use for Apokyn® is 27 pages long, and consists of steps that logically seem impossible for the frozen or rigid Parkinson’s patient to complete. Because self-administration of Apokyn® is nearly impossible, the treatment of off episodes requires direct caregiver support, likely from a skilled nurse. This places undue burden on the healthcare system.
The above inhibiting attributes greatly limit sales of Apokyn in the U.S. Cynapsus’ APL-130277 is a sublingual formulation of apomorphine, with each thin film strip found inside an easy to open non-superimposable die cut peelable foil laminate pouch. The product can be self-administered, under the tongue, and is designed to be used anywhere, anytime, with little or no assistance required. The comparable dose strength of Apokyn® sells for $13-15 per injection. We believe Cynapsus APL-130277, with a far more convenient administration and lack of skilled caregiver requirement, will see sizable market shares gains and expansion over the current Apokyn market.
For example, Cynapsus sponsored neurologist surgery (n=500) with data conclusions suggesting a 7.5-fold increase in penetration across the board for mild, moderate, and severe Parkinson’s patients. It is for these reasons that we believe APL-130277 has peak U.S. sales far in excess of Apokyn, or Acorda’s newly acquired CVT-301.
Conclusion, Valuation & Recommendation
Off time is a significant problem for patients with advanced Parkinson’s disease. In the U.S., there are an estimated one million PD patients (4-6 million globally). According to a recent survey by the Michael J. Fox Foundation, more than 90% of PD patients report having “off” episodes each day. Roughly two-thirds have “off” time greater than two hours, with 20% experiencing “off” time of greater than four hours. This is a significant problem for PD patients and an enormous unmet medical need.
Data from the recently completed CTH-105 study clearly validates the proof-of-concept for APL-130277. The drug demonstrated substantial signs of efficacy for all doses (10, 15, 20, 25, and 30 mg). Onset of action was as soon as ten minutes for some patients, with mean “time to on” of 22 minutes – admittedly not as rapid as CVT-301 but still well within the reasonable range for a rescue medication. More importantly, duration of effect was still evident at 90 minutes, exceeding what has been demonstrated with Apokyn or what we suspect will be shown in the CVT-301 Phase 3 trial given the half-life of levodopa has been documented to be less than 90 minutes.
In conclusion, we see APl-130277 as an easier-to-use and more effective drug than CVT-301, along with a better mechanism of action and pathway to approval. Data from CTH-105 de-risks the story and Cynapsus has enough cash to fund all necessary clinical trials prior to the U.S. NDA filing (see our quick review of the Q3 financial results). A recent paper published by researchers out of the UK on behalf of EUROPAR and EPDA confirms our belief that this is a potential enormous market. The paper concludes that early-morning “off” episodes are a significantly larger problem than believed even five years ago, with nearly two-thirds of all PD patients suffering across all stages of the disease (Rizos et al, 2012).
We do not know whether or not Acorda approached Cynapsus with a potential buy-out to acquire APL-130277 prior to its decision to scoop-up Civitas for $525 million. What we do know is that Cynapsus, on a fully-diluted basis, is currently worth only $75 million. If Civitas was worth $525 million, Cynapsus is worth more. As such, we could be looking at a ten-fold increase in valuation for Cynapsus over the next 2 years.
<<<
Ah, I didn't realize baystreet.ca was a paid promotion media house. No disclaimer on their article... my bad.
I agree that CTIX is headed for a financing... and surprised that they haven't accessed the shelf as of this date. They may be waiting for the Brilacidin-OM trial to get started; if it is truly being held at MDA, it should get some positive press.
CHM, >> CTIX <<
Today's article from 'Company Spotlight' (Baystreet.ca) appears to mainly be a paid for promotional piece, coordinated to come out the day after the CTIX press release. The article does contain some other useful info on other programs beyond CTIX's, but CTIX management have historically been on the hypey side of the spectrum, compared to say Cortex. But they're not as bad as some other small bios. Most likely these recent press releases are setting up a financing.
>>> p53, Immunology and Antibody Drug Conjugate Therapies Bringing More Powerful Weapons to Battlefield in the War on Cancer
January 21,2015
http://ir.baystreet.ca/article.aspx?id=57&1421840000
War has been declared on a great many things: a war on poverty, a war on illegal drugs, a war on terrorism, etc. It has been about four and a half decades since President Richard Nixon and Congress declared war on cancer with the National Cancer Act of 1971. Hundreds of billions of dollars in government and privately-funded research later, there have been significant improvements in some treatments, diagnostics and prophylactics, but cancer is closing the gap with heart disease and held as the number two cause of death in the U.S. as reported by the CDC. Backstopped by a library of data collected over decades, scientists are making advancements with understanding the mechanics of what causes some cancers at a molecular level and slowly addressing the grand challenge of developing new treatments used in combination or independent of legacy therapies (i.e. surgery, chemo, radiation). While a “cure” for cancer is likely off on the horizon, there is a great deal of hope for more efficacious, less toxic treatments in the near term with strides being made in the areas of p53, immunotherapy and antibody-drug conjugates. In war-speak, these therapies are entering the battlefield, bringing boots on the ground, smart weapons and a general to lead an assault on tumors.
A long-heralded area of interest in oncology is p53, a tumor suppressor protein encoded by the gene TP53 coined the “Guardian of the Genome” because of its role in controlling cell cycles by enabling the repair of damaged cells or triggering their death (apoptosis). Cancer cells proliferate in part because they block or trick the body’s immune system from recognizing and attacking them, forming the foundation of immuno-oncology. They also affect p53, abrogating the pathway (wild type p53) or causing mutations (mutant type p53) in nearly every form of solid or liquid tumors so the key protein doesn’t perform its duties as commander sitting atop the cell cycle defense hierarchy. With that enormous potential patient population, p53 has for years been one of the most well known, but largely untouchable, targets in oncology. There’s been limited progress since a wider knowledge base of p53 started being constructed in the late-1980’s, but advancements seem to be accelerating in recent years.
Two notable leaders in this space are smaller companies by Wall Street standards. Privately held Aileron Therapeutics is hoping to advance its ALRN-6924, a stapled peptide believed to target the p53 tumor suppressor proteins MDM2 and MDMX, into the clinic this year. Cellceutix Corp. (OTC: CTIX) (the Company announced it intends to uplist to NASDAQ) is nearing the completion of a Phase 1 trial against solid tumors for Kevetrin, a novel small molecule shown in extensive pre-clinical research to promote p53 activation in a lengthy list of tumor types. The trials are being hosted at the venerable cancer hospitals Harvard Cancer Center’s Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. Elsewhere, the University of Bologna is waiting for the trial to determine the maximum tolerated dose of Kevetrin before setting its dosing protocol and commencing a Phase 1/2 trial of Kevetrin in combination with cytarabine in patients with acute myelogenous leukemia (AML).
Reports from the trial have been impressive, showing Kevetrin to be well tolerated and non-genotoxic (doesn’t damage healthy DNA). Importantly, news this week detailed a dose-dependent increase in the p21 biomarker and a metastatic lesion in the spleen of a stage 4 ovarian cancer that has “disappeared,” an almost unheard of event in an early trial of such a hard-to-treat cancer.
Breakthroughs in immunotherapy go back more than 50 years with research on the cytokine interleukin-2 serving as part of a foundation for the potential to find an answer to cancer. A narrow therapeutic window and toxic side effects slowed development of immunotherapies to a certain extent, but advanced research and a better understanding of the mechanisms of cancer have it once again in the forefront of scientists and investors alike as companies compete to bring new products to market. The list of headliners in this space include those with FDA-approved drugs like Bristol-Myers Squibb (NYSE: BMY) with its immune checkpoint inhibitor Opdivo (nivolumab), which was recently approved for melanoma and demonstrated a survival advantage over the chemotherapy docetaxe in a pivotal lung cancer trial, and Merck (NYSE: MRK), who already has its PD-1 inhibitor Keytruda approved for melanoma and intends to file with the FDA later this year for expanded use of the drug in lung cancer.
While these companies are targeting PD-1, a protein that prevents the body's immune system from attacking cancer cells, smaller companies like Kite Pharma (NASDAQ: KITE) and newly-public Juno Therapeutics (NASDAQ: JUNO) are seeing significant increases in valuation due to holding a leadership position with novel chimeric antigen receptors (CAR)-T therapies. In fact, Credit Suisse this month maintained its “outperform” rating on Kite and boosted its price target from $34 to $71, citing the successful Juno IPO and Kite’s strong showing at the American Society of Hematology (ASH) conference as signs of “sustained investor and physician enthusiasm for new immune-based and personalized therapies.” Coupling the excitement with Kite planning to move into multiple late-stage trials this year, Credit Suisse thinks that a “lucrative ex-US partner is likely.”
A promising area of immunotherapy is called adoptive cell transfer, which involves engineering a patient’s own immune cells to recognize antigens and attack tumor cells. In Kite’s platform technology, dubbed eACT (engineered Autologous Cell Therapy), a patient’s peripheral blood T cells, the killer cells of the immune system, are manufactured ex vivo and infused back into the patient, essentially sending an expanded army after tumors. The re-administered cells are genetically engineered to produce special receptors on the surface called either T cell receptors (TCR) or CARs, which recognize target antigens on cancerous tumors and become activated upon engagement to selectively eradicate the tumor cells.
Kite’s therapy is showing its potential in several clinical trials being conducted by its collaborator, the Surgery Branch of the National Cancer Institute, and has attracted the attention of big pharma, including a partnership earlier this month with Amgen that entitles Kite to an upfront payment of $60 million, R&D funding and eligibility for up to $525 million in milestone payments. Already with $195.4 million in corporate coffers at the end of the third quarter, Kite is in an optimum position to advance its pipeline. The lead CAR program is a mid-stage trial of KTE-C19 for treatment of B-cell Lymphoma. There is a great deal of interest in this indication because Kite’s modified T cells are homing in on CD19, a hallmark protein expressed on the cell surface of B cell lymphomas and leukemias where there are currently very few effective therapeutic options. Elsewhere in the pipeline, data from a Phase 1 clinical trial showed that administration of anti-CD19 CAR T cells resulted in a 70% complete response rate in 20 pediatric or young adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL). This year, Kite says it plans to advance KTE-C19 into pivotal trial for the above indications as well chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) in addition to therapies in its TCR eACT program for various cancers.
Another area of significant interest is the antibody-drug conjugate (ADC) business, where scientists are coupling a monoclonal antibody with cytotoxic drug and unleashing the lethal combo to seek and destroy tumors with the hope of little collateral damage to healthy tissue, a smart bomb of sorts. Wyeth, who was later acquired by Pfizer (NYSE: PFE), brought the first ADC drug to market in 2001 with Mylotarg for AML, but it was removed from marketing in 2010 due to increased risk of death and non-superior results to other AML drugs. As it stands today, only two FDA-approved ADC drugs are on the market: Seattle Genetics’ (NASDAQ: SGEN) Adcetris for both Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL) was approved in 2011; and Roche (OTC:RHHBY)/Genentech’s Kadcyla for HER2-positive breast cancer who fail to respond to some other treatments was approved in early 2013. Both drugs have black box warnings in the U.S.
At the backbone of Seattle Genetics’ (or “Seagen” for short) ADC technology are linkers that have been shown in lab work to be up to 10 times more stable in the blood than conventional methods for attaching cytotoxic agents to antibodies. A key for the company is going to be expanding the approved indications for Adcetris, something that Roche just struggled to do with Kadcyla in partnership with ImmunoGen (NASDAQ: IMGN). Positive data from several studies were disclosed recently by Seagen, including results from a Phase 3 study on Adcetris, which targets the CD30 protein for treating Hodgkin lymphoma patients at risk of disease progression following autologous stem cell transplantation. Adcetris-treated patients had an “unprecedented” 50% higher chance of progression-free survival at two years compared to placebo. Separately, follow-up data from a Phase 2 trial presented at the ASH meeting showed Adcetris-treated patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) had a four-year survival rate of 64%, progression-free survival of 20 months and a median overall survival of 55.1 months. Seagen is also targeting B-cell malignancies (a la Kite in one trial, pointing its antibody at CD19).
Through its partnership with Takeda to develop and market Adcetris, Adcetris is sold in 47 countries (SGEN in the US and Canada, Takeda in the rest of the world). Through the third quarter of 2014, Seagen sales of Adcetris were up to $131.7 million from $106.1 million in the year prior period. For the full year, SGEN raised its US and Canadian sales outlook for Adcetris to a range of $172 million to $177 million. Like so many young companies, Seagen is still operating in the red, with a net loss through Q3 of $49.5 million.
Sales and $339 million in the bank are helping SGEN develop the most robust ADC drug pipeline in biotech with an array of antigen targets and synthetic cytotoxins being bound together for treating a spectrum of disease. The company has partnerships with many top pharmas, including AbbVie (NASDAQ: ABBV), Genentech, Bayer, Pfizer, GlaxoSmithKline (NYSE: GSK) and now Bristol-Myers Squibb, which will combine Adcetris with Opdivo. These collaborations put $4.5 billion on the table in potential milestone payments for Seagen if they can successfully move products forward. Insiders have made large buys recently and some analysts with much higher price targets are saying the shares of SGEN are at an unwarranted year-and-a-half low due in part to perceived competition from drugs, such as PD-1 inhibitors.
Finding a single silver bullet to destroy cancer is a misconception; it’s going to take an arsenal. More fighters moving trench to trench with smarter weapons to flesh out the enemy under the order of a fully functioning commander are substantial steps in the right direction to win this so-called war on cancer. It’s already clear that companies are quickly joining forces with the combination of their therapies as the competition is heating up, underscored by the incredible revenue potential for successful, next generation technologies. It’s been said that there is no real winner in a war, but in this case there can be many, including companies, shareholders, the scientific community and certainly cancer patients. We’re not there, but let’s hope we are moving a little closer to that horizon with these new approaches.
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You might want to read this blog entry about Kevetrin:
http://blogs.shu.edu/cancer/2015/01/17/kevetrin-p53-inducer-by-cellceutix/
Some of the earliest replies were by MD's who seemed rather enthused...
CHM, I've noticed CTIX has a tendency toward that type of breathless headline. It's good timing if they're about to raise some cash, but I don't like seeing a company use hype routinely.
But perhaps this really is a significant development(?) I haven't researched their non-Brilacidin programs much since they're so early stage, but I'll be curious to read any comments over on Dew's board. Someone just posted the CTIX press release over there -
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=110082534
To be honest, I wasn't too crazy about the Kevetrin PR this morning.. but 20% later, how can I really complain?
I'm also not too sure about the wording of "the Principal Investigators for the Kevetrin trial have requested that the Company start preparing a presentation to be used for an article on the safety and pharmacological effect of Kevetrin on multiple cancer lines as demonstrated in the clinical trial". In my experience, the principal investigators would want to release any data in a peer-reviewed journal, and not a "presentation" or an "article".
I guess I'm just being too judgmental, but have been burned before by small biotechs getting ahead of themselves on releasing anecdotal results.
CTIX making a nice rebound. I'm still expecting a financing announcement fairly soon though. They only had $7 mil in cash as of Sept, and have a full schedule of clinical trials planned and ongoing, so something has to happen on the cash front soon.
The overall market not looking too hot at the moment. Chart-wise it's been looking choppy/toppy since Oct. The main indices have formed a bearish near term Head + Shoulders, so will see if the Fed/PPT can step in with more juice to reaffirm the uptrend. But after 6 years it's looking long in the tooth.
The QQQ never did make a new high in late Dec (unlike the SPY and DIA), so it's formed a bearish near term descending triangle.
Gold breakout continues - having cleared the Dec high (1235), Oct high (1255), and the 200 MA (1255), it's entering the lower end of the Summer trading range (1280-1335), all in spite of the still rising dollar.
One would expect Gold to do some re-testing of the 200 MA in the days/weeks ahead, but all in all a pretty impressive move so far.
Silver is not as far along, but has cleared its Oct high (17.60), though still under the 200 MA (18.50). The Summer trading range was 18.80-21.50.
Nice moves so far.
Thanks for sharing your PYMX data and thoughts with me, it's much appreciated.
I remember your detailed analysis back in the early COR days, so I have great respect for your thought processes. But, as you say, we all were "humbled" by that particular biotech and I can list several more that I have personally been humbled by.
Regardless of those experiences, I am drawn to biotech like a moth to flame. It's just so darn interesting!
Best regards,
CHM
CHM, Polymedix showed an unusual amount of detail on those slides for an investment presentation. But Cellceutix has gone to the other extreme, with only sparce data, which is more typical. But expecting complete efficacy from a single dosing of an antibiotic is so unheard of that it's only natural to want to see the full unambiguous proof of efficacy, not just a vague 20% reduction in 2-3 days.
Most of my detailed biotech notes were thrown out several years ago when I decided to stop investing in biotech and just follow it 'for fun', so to remember all the details I'd have to refer back to some of the old I-Hub posts.
Biotech is so complex and difficult, trying to microanalyze every bit of info may be futile in the end anyway, since even a PhD will likely draw inaccurate conclusions. Instead, having modest positions in 6 or 8 promising companies to spread the risk is probably a better strategy. Much smarter investors than us have been humbled time and again by this sector.
Thanks for the PYMX slide deck.. I had seen an earlier version of it, but this one had better numbers.
How can CTIX provide the same data as the Polymedix trial when the FDA has changed trial design guidance? Are you expecting CTIX to present results for the post-treatment evaluation period out to 28 days?
Thank you for providing additional historical information for me to absorb... but I need to warn you at this point that most of this discussion about trial design is way over my head...
CHM, Here are the Phase 2 presentation slides from 2012 (Polymedix). They used 3 dose levels of Brilacidin (PMX-30063), see slide 8, and dosed for 5 days (7 days for Daptomycin/Cubicin), then evaluated efficacy out to day 28. This is the type of complete data I'd like to see made available for Cellceutix's Phase 2 -
http://files.shareholder.com/downloads/ABEA-4ITCYZ/1877348381x0x561958/968184e3-1d80-40b0-b850-9516be738d22/PMX-30063%20Phase%202%20Full%20DataWebcast%204-23-12%20(final).pdf
Misc discussion of the Polymedix Phase 2 results -
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=75515171
(continued)
CTIX: I've spent some time trying to educate myself on the newer FDA guidance for ABSSSI trials. I found this paper, which helped me to better understand the difference between the primary endpoints for the Polymedix and the Cellceutix Phase 2 trials.
http://paperity.org/p/42787973/fda-guidance-for-absssi-trials-implications-for-conducting-and-interpreting-clinical
Although the paper indicates that the >20% lesion reduction standard is less subjective than the old guidelines, I now understand your comments about the shorter treatment period. That won't fly with the EMA apparently. However, don't the new FDA guidelines include much stricter enrollment criteria?
Also, the TRSAE reported in the Phase 2a trial done by Polymedix were only at the highest doses, correct? I'm hoping that the "lack of transparency" in releasing the full Phase 2b data is due to CTIX saving it for release directly to the scientific community via poster presentation at ECCMID in April or via publication in a peer-reviewed journal.
One comment you made earlier was your concern that the FDA would try to "deep six" the defensin mimetics technology for antibiotic use. Without going into why you've had such a concern in the past, wouldn't the new QIDP designation allay those concerns?
The "Motif Investing" does seem interesting; I remember seeing it about a year ago (perhaps on the CORX board, posted by you?) and will have to re-familiarize myself with it.
You've brought up several issues with Brilacidin that I was not aware of, so I am going to have to do some additional research before I can intelligently discuss it with you. Of particular interest/concern is the "20% criteria" that you mention for the latest comparison of Brilacidin to Daptomycin.
It looks like you've given me some "homework" to do on our stock market holiday tomorrow! But for now, football is the name of the game.
Best regards!
CHM, These days I follow biotech mainly out of general interest. To invest again I'd probably do it via 'Motif Investing', which allows you to create your own ETF of up to 30 stocks for a single $9.95 trade. I mainly prefer other safer sectors, but biotech is fun to follow.
While antibiotics are the main focus, the Oral Mucositis indication by itself is enough to justify interest in Cellceutix from a commercial standpoint. But defensin mimetics is such a huge breakthrough, it's easy to get all gaga and be blinded by the cool science, ala Cortex.
CTIX's cash level at the end of Q3 was only $7 mil, so they need some type of financing soon. Other potential problems lurking include getting the Phase 3 approved. In the recent investor presentation they said the FDA requested some additional data analysis from the Phase 2. For various reasons, I've always worried that the FDA would try to 'deep six' the defensin mimetics technology as it relates to antibiotics.
Another source of worry is the new FDA clinical trial guideline that emphasizes a mere 20% reduction in symptoms after 2-3 days. That seems like a really low barrier, so when CTIX says they had similar efficacy to Cubicin in the Phase 2 using only a single dose, they're using that weak 20% criteria.
Back in the previous Phase 2 done by Polymedix, we saw the data for the entire treatment period out to a month post-treatment. That trial had a longer dosing period, and Brilacidin showed excellent efficacy, but had some side effects including the paresthesia and cardio effects. Now they're proposing a single dose for the Phase 3, but between the low 20% criteria and the lack of transparency in showing us the full data, there is significant room to worry. Once the FDA approves the Phase 3 I'll feel a lot better.
I've been a holder since under $2 last summer. I'm also waiting for P3 Brilacidin to get a go-ahead before adding substantially to my holdings, although I did snatch a few shares on the dip last week.
I'm also excited for the Brilacidin-OM trial for oral mucositis to start. That indication is for an un-met need and the trial site has been announced as being MD Anderson, which may bring some much-needed credibility to the company.
I remember back in the gloomiest COR days your saying that you were no longer going to do cash investments in biotech, just "on paper" investments. Is that still the case?
Hi Haysaw, >> Enteromedics <<
Looks interesting, though probably will need to see how fast the revenues ramp up this year and whether insurances will cover it. But at least it got approval, so that's a key milestone. Looks like a sizable short position, so some of the pop on the approval may have been short covering.
>>> Enteromedics Garners FDA Approval For Obesity Device: What's Next
Jan. 16, 2015
http://seekingalpha.com/article/2826806-enteromedics-garners-fda-approval-for-obesity-device-whats-next
Summary
•Maestro device is pacemaker type device for obesity.
•FDA approved device for people with BMI of 35 or more with co-morbid condition.
•Device slated to cost about $15,000.
Enteromedics (NASDAQ:ETRM) has finally received the long awaited FDA approval for its VBLOC anti-obesity device, the company announced this past Wednesday. Many retail investors felt that FDA approval would be a catalyst that sent the stock skyward. Unfortunately, the pop was very short lived and the stock currently trades in the same area it did throughout the last several months. I was personally invested in the company for the purpose of playing the approval, and due the fact that I was in meetings could not participate in the approval news pop in the stock. That leaves the equity trading where it has been. What is next, and is there a play in this equity?
Enteromedics is in a much better place today than it was 2 weeks ago. It now has an FDA approved device for obesity. With that news, why is the equity seeming to languish? There could be several answers to that question, but in my opinion the main thing holding the company back was contained in the press release announcing the approval
"EnteroMedics anticipates that the device will be available, on a limited basis, at select Bariatric Centers of Excellence in the U.S. this year."
The use of the term limited puts a ceiling on things. Simply stated, do not expect many procedures to transpire in 2015. Some investors are looking for over 10,000 procedures in short order. In my opinion such thinking is more of a dream than a reality. This device could eventually get there, but it will take quite some time to build up to that type of pace.
The second big hurdle is cost and insurance. It is estimated that the cost of the VBLOC device will be about $15,000. This is not something that people will simply run out and do. A $15,000 lump sum is not something that most people have simply sitting in their checking account. Until insurance steps up to the plate, it will be challenging getting people to buy into the idea of VBLOC. That being said, someone that has been saving up for a procedure such as full blown lap band surgery may find the idea of VBLOC and a much less invasive surgery quite appealing.
With these types of hurdles, what can drive this equity? One simple answer is that, with an FDA approved device, Enteromedics becomes a much more attractive company. Could a potential suitor be waiting in the wings? It is certainly a possibility. Enteromedics did the grunt work of getting this device approved. Now a potential buyer, or even a partner, could be in the cards. If Enteromedics was worth about $1.30 prior to approval, it is certainly worth a bit more with approval.
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CHM, Yes, I've been following the Brilacidin saga since the Polymedix days. No position, but defensin mimetics seem like a major breakthrough in antibiotics, and the other indications like oral mucositis and diabetic foot ulcers also look extremely promising.
CTIX needs to raise money soon, so that might be a good time to enter the stock. But biotech is full of landmines, so I'll feel better once the FDA has given the OK for the ABSSSI Phase 3 to start.
Gfp old chap, how do you be? How is our resident science nerd, conspiracy theorist, and gun enthusiast doing (and fellow music appreciator)? Glad to see you keeping up with things.
My latest venture is etrm. They just got fda approval for a novel medical device to treat obesity. The device (the "Maestro", in part) is placed in the abdomen and has electrodes which send nerve impulses to your brain to tell you that you're full. With pills and riskier invasive surgeries the primary medical options, this could really find a niche. I bought at 1.38, after it spiked to 2.04 on the approval, and now it is practically trading at the pre-approval price. The stock has mostly been a dog for years. The market is underwhelmed, but I think they could be a sleeper.
My handle is haysaw, and I too, am a cortex loser :)
We are the Confederacy of Dunces, welcome...
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