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Busy Day. BTX takes out partners (Hadasit HBL) in Israely CellCure Neuroscience (OpRegen® Clinical Trial, PI/IIa, encouraging results) @ 60 million valuation for the business. HBL gets to book an exit, and BTX gets to consolidate as subsidiary a significant strategic business, at very atractive price, selling shares.
As part of the transaction, HBL, which owns 21% of Cellcure's share capital, will sell its entire holdings to BioTime, Inc., In exchange, BioTime will pay $12.75 million in Biotime shares to HBL
JERUSALEM, June 19, 2017 /PRNewswire/ --
Hadasit Bio-Holdings Ltd. ("HBL") (TASE: HDST) announced that it has completed a share swap transaction with BioTime, Inc., ("BioTime") (TASE: BTX.TA) in their joint portfolio company Cell Cure Neurosciences ("Cell Cure").
The transaction is the first exit event to HBL since its establishment in 2006.
Cell Cure is a privately held company held by HBL (approximately 21%) with the majority of the shares held by BioTime. Under the terms of the transaction, HBL will sell its entire holdings in Cellcure to BioTime, as well as its interest in certain convertible loans provided by HBL to Cell Cure.
The consideration provided by BioTime in exchange of its Cell Cure shares and loans is approximately $12.75 million, payable by issuance of BioTime shares to HBL at the transaction's closing date.
BioTtime committed to file with the Securities and Exchange Commission (the "SEC") a registration statement to register the shares issued by it to HBL as part of the transaction.
HBL reserves the right to buy back up to approximately 5% of Cell Cure shares for a period of five years at a price of $40.5356 per share, so as to benefit from future upside. In addition, If Cell Cure consummates a financing through the issuance of shares during the five year period following closing of the transaction, BioTime committed to ensure that Cell Cure provide HBL with a warrant, to purchase shares of the same type and class as issued in such financing, in an amount equal to 5% of the aggregate amount of Cell Cure's securities issued thereunder, on the same terms of the financing, exercisable during a period of five years commencing on the closing. In the event that Cell Cure fails to issue HBL such warrant(s), BioTime will grant HBL an option to purchase shares of Cell Cure held by it, on the same terms as those mentioned above.
At the closing, the directors appointed to the Board of Directors of Cell Cure by HBL will resign and HBL will be entitled to appoint an observer to Cell Cure's Board of Directors.
HBL expects to reflect in its 2017 financial statements an accounting revenue of approximately $ 9 million (before tax calculation) for the transaction, subject to the completion date thereof.
HBL largest shareholders are Centaurus Investment Ltd and Hadasit, the technology transfer company of the Hadassah Medical Center.
HBL Chairman, Baruch Halpert, commented, "We are pleased to enter into a share swap agreement with BioTime, our partner for the past several years. We have full confidence in BioTime's management and its expertise in stem cells technology to succeed in commercializing the breakthrough science of the stem cell therapy developed by Prof. Benjamin Reubinoff and Dr. Eyal Banin from Hadassah Medical Center."
Mr. Vincent Tchenguiz on behalf of Consensus Business Group ("CBG") advising Centaurus Investment Ltd, said, "After many years of supporting the company, we are very delighted that HBL has reached this significant milestone with the completion of this transaction. Centaurus has identified the potential of HBL early on and we plan to continue investing in biomed companies in Israel.
Dr. Tamar Raz, CEO of Hadasit, said, "CellCure is the perfect example of breakthrough science developed at Hadassah by Profs. Benjamin Reubinoff and Eyal Banin from the Hadassah Medical Center, that reached advanced stages of development following a successful technology transfer. Hadasit will remain involved with CellCure through its collaboration and licensing agreement with the Company."
HBL - Hadasit Bio-Holdings Ltd. is a holding company with holdings in life sciences companies involved in medical and biotechnological research and development. HBL was founded and listed on the Tel Aviv Stock Exchange to allow the public to have a share in the biotechnological field. Most of HBL portfolio companies originate in knowhow developed at the Hadassah Medical Center in Jerusalem.
"Centaurus Investment Ltd (a BVI Company) is wholly owned by the trustees of a discretionary family trust, which is advised by CBG.
CBG, chaired by Mr Vincent Tchenguiz, is a business group with diversified investment portfolio that includes structured financial instruments and purchase, management and development of commercial and residential real estate properties. CBG is strategically focused on the biotech industry but it is active also in renewable energy, infrastructures, cyber, enterprise software and digital media. To date, CBG has participated in over $400 million of private equity, venture capital infrastructure and funds investment. CBG advises Centaurus on its investments in Israel.
Hadasit is the technology transfer company of the Hadassah Medical Center, established 100 years ago and considered one of Israel's major medical centers. The combination of practical experience, the ability to pinpoint medical needs and research at the forefront of science has yielded a broad potential of ideas, innovation and developments in all aspects of medicine, including pharmaceuticals, diagnostics and medical devices. Hadasit was founded in 1986 as a tool for commercializing medical technologies developed in the hospitals and invested in turning ideas into existing products and services for the benefit of humanity. Hadasit cooperates with leading international companies and research institutes as well as incubatorsand venture capital groups
CellCure Neuroscience is a a biotechnological company focusing on developing cell therapy for degenerative retinal and macular diseases. CellCure's technology is based on human embryonic stem cells (hESC) which can be produced on a mass scale for any cell of the human body.
BioTime is a clinical-stage biotechnology company focused on developing and commercializing novel therapies developed from what the company believes to be the world's premier collection of pluripotent cell assets. The foundation of BioTime's core therapeutic technology platform is pluripotent cells that are capable of becoming any of the cell types in the human body. Pluripotent cells have potential application in many areas of medicine with large unmet patient needs, including various age-related degenerative diseases and degenerative conditions for which there presently are no cures. Unlike pharmaceuticals that require a molecular target, therapeutic strategies based on the use of pluripotent cells are generally aimed at regenerating or replacing affected cells and tissues, and therefore may have broader applicability than pharmaceutical products. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. and OncoCyte Corporation, which BioTime founded and which, until recently, were majority-owned consolidated subsidiaries of BioTime. BioTime also has a significant ownership interest in HBL at 14%.
Biotime Expands & Advances Ophthalmology Portfolio
Date(s): 19-Jun-2017 7:00 AM
• Expanded Exclusive, Global License to RPE and Photoreceptor Cells for Use in All Eye Disorders
• Data Presented at International Society for Stem Cell Research (ISSCR) Conference
• Translational Vision Sciences & Technology (TVST) Journal Publishes OpRegen® Data
ALAMEDA, Calif.--(BUSINESS WIRE)--Jun. 19, 2017-- BioTime, Inc. (NYSE MKT: BTX), a clinical-stage biotechnology company developing and commercializing products addressing degenerative diseases, today reported several developments for its ophthalmology portfolio including:
• Signing a new and expanded licensing agreement with Hadassah Medical Organization of Jerusalem, Israel
• Presentation of data from its Phase 1/2a Dose Escalation Study of OpRegen® at ISSCR
• Presentation of the similarities between human retinal tissue and 3D retinal tissue derived using BioTime's proprietary methodology and pluripotent cells at ISSCR
• Publication of preclinical data forming the foundation of the OpRegen® IND submission with the U.S. Food & Drug Administration in TVST
• Complete control of OpRegen® development program through consolidation of ownership in Cell Cure NeuroSciences
"OpRegen is making great progress in the clinic," said Adi Mohanty, co-CEO of BioTime. "Data from the Phase 1/IIa trial was presented this past weekend at the International Society of Stem Cell Research (ISSCR) conference.
As OpRegen® continues to show encouraging results, we are leveraging our expertise in ophthalmology to build a leading pipeline of cell therapy products in ophthalmology. The technology for OpRegen for dry AMD was originally licensed from Hadassah. The new license increases our field of use for RPE cells to all eye disorders, and adds photoreceptor cells, for all eye disorders. As part of this process, we have consolidated our ownership of Cell Cure Neurosciences providing BioTime with complete control of the OpRegen® development program while at the same time building momentum in developing innovative cell therapies to address ophthalmic conditions with unmet needs," concluded Mr. Mohanty.
ISSCR Presentations
A poster demonstrating similarities between normal human retinal tissue and laboratory grown 3D retinal tissue derived using BioTime's proprietary methodology with pluripotent cells (hPSC) was presented during ISSCR. The study compared normal human retinal cells with the BioTime's proprietary hPSC-derived 3D retinal tissue for the potential use in helping to restore vision for blind people with advanced stages of retinal degeneration. The results presented demonstrated high correlation in gene expression profiles, between the various cellular components of normal human retinal tissue and the hPSC-derived tissue, including retinal pigment epithelium, retinal progenitor, photoreceptor, amacrine and ganglion cells.
In addition, the most recent data from the ongoing Phase I/II clinical trial of the lead product, OpRegen®, for the treatment of dry age-related macular degeneration was presented during the conference. The Phase I/IIa dose-escalation study evaluating the safety and efficacy of three different dose regimens of the company's investigational product, OpRegen®. OpRegen® has received Fast Track designation from the FDA for treatment of the advanced form of dry-AMD. Details of the trial and about a patient's eligibility are available at https://clinicaltrials.gov/ with the following Identifier: NCT02286089 (dry-AMD).
TVST Journal Publication
The TVST Journal article is titled "Long-Term Efficacy of GMP Grade Xeno-Free hESC-derived RPE Cells Following Transplantation" and Trevor J. McGill was the lead author. The article concluded OpRegen® RPE cells survived, rescued vision function, preserved rod and cone photoreceptors long term in the Royal College of Surgeons rat. These data were key elements in support of the potential clinical utility for the use of OpRegen® RPE cells for the treatment of human RPE cell disorders including AMD.
"These studies continue to leverage and expand our proprietary approaches utilizing hPSCs for a broad range of ocular diseases associated with cellular and tissue degeneration that other therapeutic approaches can't address effectively," said Oscar Cuzzani, M.D., Ph.D., BioTime's Vice President of Clinical Development. "As ophthalmology remains among BioTime's core areas of focus, we are uniquely positioned with our broad expertise, capabilities and IP portfolio in regenerative ophthalmology, creating a stronger pipeline to address problems of degenerative diseases of the eye."
“… there are wolves out there that love to eat unwary dreamers”
Indeed, there have always been and always will be. This is the reason one conducts a DD on businesses before investment to establish the facts and seperate them from the "Dream".
Now, in the case of BTX – some of the best minds in the field pour in their collective wit to generate progress in the field. There are Peer Reviews to support it and, more importantly there are mid stage clinical trials clearly showing the incredible benefits of the treatments, such as the Spinal cord paralyzed patients regaining uses of hands (AST-OPC-1), Cancer blood tests showing incredible accuracy (Oncocyte tests) being prepared to commercial launch, Aesthetic products lasting over 6 and 12 months in the face of very sick patients (Renevia), and much more.
Current income is very low, and none of it is connected to these products, yet.
This is the heart of the investment thesis. Within one or two years, a steady increase in Revenue will begin as novel products will reach approvals and meet desperate clients and physicians. With it will come margin expansion when the market realizes this is powerhouse of I/P and generator of clinically safe and effective novel therapies in a field that is yet to get approved by the mainstream.
There are ALWAYS RISKS. (risk of failure, of delays, of dilution, etc. Read the risk factors in the 10Ks). Heck, Research and development are very risky investments! Do not invest more than you can comfortably lose! But investing is mainly about finding cheap assets compared to their future earning power/Assets, either today (“left for dead” value investing ) or in the future (“yet unrecognized” Growth stocks).
I remember buying Activision Blizzard when everyone and their sister avoided gaming stocks “because of piracy”. I got to buy at 9$ per share because I recognized the Digitalization of the business, its online nature – safe from piracy and its future earning power. It is close to 60$ today, and barely getting started, with many future years of growth ahead. When you recognize explosive earning power before it is booked in sales, you are in for a treat!
About BioTime - I did the work. I think the tradeoff between risk and price/return is very good now. I voted with my money. There is steady progress made. Within 5 years, I estimate 3$ per share will be but a far memory, similar to $ATVI. I may be wrong. Have been wrong before. But I feel very confident the value is there and it is going to explode for many, many years.
I am very sure you will be able to tell your grandkids how you came across BTX. I hope you will be able to tell them much of the family wealth was generated by the decision to study the business deeper.
Its very easy to be weary of risk and so become paralyzed. It is the way not to generate wealth.
Investing in BTX sue to dream is not the right motivation, which is studying the business carefully, doing the work and investing the time it takes, building confidence and putting the resources there to back your work when you become confident in the future of the business
I found you can make millions that way.
Now, do YOUR Work and decide.
I leave this here to help others see what I see and perhaps build their confidence and understanding about this unfollowed little gem.
The Investment Thesis for Biotime $BTX:
What you get for Biotime at 330 million Dollar Market Cap (June 2017):
1) 7 Clinical Trials, of which 2 at later Stage Pivotal Trials.
2) 2 Product nearing launch aimed at >Billion $ TAM, One Aesthetics and one Cancer Diagnostics (launched at 2H2017).
3) 2 Subsidiaries trading separately worth about 147 M$ at market (valuing the rest of which one product – Renevia, launched at 2018 is targeting a 7 billion Dollar market) at less than 200 million$.
4) Several promising early stage Programs.
5) Many proprietary Assets (in the shape of Pluripotent Stem Cells lines I/P – more discovered every day).
6) Large Stable of IP dominating Embryonic and Pluripotent Stem Cells – close to complete chokehold on the field of Stem Cell Regenerative medical therapies -possibly the main disruptor of Healthcare in the next 20 years.
7) Large Shareholders as Board of Directors.
8) Superior financial acumen by insider owner Board– ridiculous Dilution incurred in developing the business.
9) Imminent Catalysts – 1 Product to be launched 2H2017, another one during 2018.
10) Science led by the Father of Stem Cell Medicine– Dr. Michael West.
11) Medical therapeutics possessing powerful moat – virtually protected from the threat of Generics (you cant “copy” a cell – one must walk through the full, expensive, journey leading to approval) – highly desirable.
12) Infinite possibilities for reinvestment of cash into highly profitable products for many years (production of on the shelf stem cell medicine very profitable business).
13) Little to no Street coverage because the business rarely taps Wall Street for funds (hence no Sell Side Analyst coverage) – Stocks are usually bought directly by large insiders, and Held, not Traded.
In terms of investor narrative: BioTime group of companies increasingly look like the Intel of Stem Cells, The Tesla/Musk of future disruption and possibilities, at dirt cheap prices today.
Business Overview (recent S-3 Form):
We are a clinical-stage biotechnology company focused on developing and commercializing products addressing degenerative diseases. Our clinical programs are based on two platform technologies: pluripotent stem cells and cell and drug delivery platform technologies. The foundation of our core therapeutic technology platform is pluripotent cells that are capable of becoming any of the cell types in the human body.
The foundation of our cell delivery platform is our HyStem® cell and drug delivery matrix technology.
Our current clinical programs are targeting three primary sectors: aesthetics, ophthalmology and cell and drug delivery.
We also have significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc., or Asterias, and OncoCyte Corporation, or OncoCyte, which we founded and which, until recently, were our majority-owned consolidated subsidiaries.
Asterias (NYSE MKT: AST) is presently focused on advancing three clinical-stage programs that have the potential to address areas of very high unmet medical need in the fields of neurology (spinal cord injury) and oncology (Acute Myeloid Leukemia, or AML, and lung cancer).
OncoCyte (NYSE MKT: OCX) is developing confirmatory diagnostic tests for lung cancer, breast cancer, and bladder cancer utilizing novel liquid biopsy technology.
The combined market value of our holdings in Asterias and OncoCyte was about $147.69 million as of June 15, 2017.
We are also enabling early-stage programs in new technologies through our own research programs as well as through our subsidiaries and affiliates. These technologies have the potential to improve the treatment of diseases associated with aging, including diseases such as diabetes, and cardiovascular and metabolic disorders that affect large numbers of people. We are also researching other novel technologies that may help the body regenerate certain types of degenerated cells and tissues.
Together with our subsidiaries and affiliates, we currently have seven product candidates in human clinical trials, one of which is in a late-stage, pivotal study in Europe, one cancer diagnostic that is expected to be commercially launched in the U.S. during the second half of 2017 and several early stage programs that may help address some of the biggest unmet medical needs faced by our aging population.
In addition, we have obtained a collection of pluripotent stem cell assets and a proprietary therapeutic delivery platform with many potential uses.
Pluripotent stem cells are capable of becoming any of the cell types in the human body. Cell types derived from pluripotent stem cells have potential applications in many areas of medicine with large unmet patient needs, including various tissue injuries and age-related degenerative diseases and degenerative conditions for which there presently are no cures.
Unlike pharmaceuticals which almost always require a molecular target, cell therapy strategies use cell types derived from pluripotent stem cells to regenerate, replace or augment affected cells and tissues, and therefore may have broader applicability and impact than traditional pharmaceutical products.
Our pluripotent stem cell technology is complemented by our HyStem® technology, which includes a family of unique, biocompatible resorbable hydrogels to deliver bioactive compositions for therapeutic benefit.
HyStem® was designed to enable the effective transfer, engraftment and metabolic support for cells, whether derived from pluripotent stem cells or from a patient’s own somatic or adult stem cells. The flexibility of the HyStem® technology also allows for direct therapeutic use and the sustained delivery of therapeutics.
Our near term therapeutic focus is in three core areas of aesthetics, ophthalmology, and cell and drug delivery.
In addition, we, through our subsidiaries and affiliates, also focus on therapeutic products in neurology and oncology and liquid biopsies for diagnosis of cancer.
Facial Aesthetics Renevia®, our lead facial aesthetics product, is a potential treatment for facial lipoatrophy. “Lipoatrophy” is another word for “fat loss or deficiency.” It is currently in a pivotal clinical trial in Europe to assess its safety and efficacy in restoring normal skin contours in patients whose subcutaneous fat, or adipose tissue, has been lost due to the use of certain drugs often used to treat patients with HIV. While this pivotal trial, if successful, is expected to enable a filing for marketing authorization in the European Union, we see this trial as supportive of U.S. development of Renevia®, for a much larger market opportunity, for treating additional forms of facial volume restorations, whether from drugs, trauma or aging. Renevia® consists of our cell-transplantation delivery matrix (HyStem®) combined with the patient’s own adipose progenitor cells. Developed as an alternative for traditional fat transfer procedures, Renevia® is designed to mimic the naturally-occurring extracellular matrix and provide a 3-D scaffold that enables effective cell transplant, engraftment and proliferation. Renevia®, is being developed with the goal of providing a natural, long-lasting improvement to the patient’s skin contouring.
Ophthalmology OpRegen® is our lead product for ophthalmological disorders. It is a suspension of retinal pigment epithelial, or RPE, cells that are derived from pluripotent stem cells. RPE cells form the back lining of the retina, and support the function of photoreceptors (rods and cones). RPE cells can be damaged and lost in various forms of retinal degeneration. The OpRegen® therapeutic approach is to replace damaged or lost RPE cells and possibly slow disease progression and/or preserve or restore visual function. It is currently in a Phase I/IIa clinical trial for the treatment of the dry form of age-related macular degeneration, or AMD. AMD affects approximately 1.6 million newly diagnosed people annually in the U.S. and is the leading cause of blindness in people over the age of 60. Approximately 90 percent of AMD patients suffer from the dry form, for which the U.S. Food and Drug Administration, or FDA, has not approved any therapies. In February 2017, we expanded our ophthalmology portfolio through the acquisition of exclusive global rights to technology from University of Pittsburgh through the execution of an exclusive license agreement. This technology allows the generation of three-dimensional laminated human retinal tissue derived from human pluripotent stem cells. This tissue contains all the cell types and layers of the human retina and has shown evidence of functional integration in proof of concept animal models for advanced retinal degeneration. The technology is being developed for implantation in patients to potentially treat or prevent a variety of retinal degenerative diseases.
Cell and Drug Delivery In addition to Renevia®, we have two additional primary programs utilizing our proprietary HyStem® technology. HyStem®-BDNF is a preclinical development program for the delivery of recombinant human brain-derived neurotrophic factor, or BDNF, directly into the stroke cavity of patients with the goal of aiding in tissue repair and functional recovery.
ReGlyde™ is in preclinical development as a device for viscosupplementation and a combination product for drug delivery in osteoarthritis, or OA. The viscosupplementation device program aims to administer ReGlyde™ directly into affected OA joints provide joint lubrication to reduce pain and improve quality of life. The drug delivery programs seek to enable the sustained release of therapeutics in affected OA joints to slow or reverse disease progression, in addition to improving pain and joint function.
Also, included in our delivery platform is Premvia™, which is a HyStem® hydrogel formulation for the management of wounds including partial and full-thickness wounds, ulcers, tunneled/undermined wounds, surgical wounds, and burns. Premvia™ was cleared by the FDA via a 510(k) device approval pathway.
In addition to these programs, we are developing HyStem® product enhancements. Current efforts are focused on the development of a frozen liquid product format, which, if successful, will make significant improvements in end-user convenience.
Therapeutic Products in Neurology and Oncology Asterias is presently focused on advancing three clinical-stage programs, which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. Asterias’ lead products are:
· AST-OPC1, a therapy derived from pluripotent stem cells that is currently in a Phase I/IIa clinical trial for spinal cord injuries, with positive early efficacy data reported in September 2016;
· AST-VAC1, a patient-specific cancer immunotherapy with promising Phase II clinical trial data in AML; and
· AST-VAC2, a non-patient specific cancer immunotherapy for which the initiation of a Phase I/IIa clinical trial in non-small cell lung cancer is planned for the first half of 2017.
Liquid Biopsies for Diagnosis of Cancer OncoCyte is developing confirmatory diagnostic tests for lung cancer, breast cancer, and bladder cancer utilizing novel liquid biopsy technology. While current biopsy tests use invasive surgical procedures to provide tissue samples to determine if a tumor is benign or malignant, OncoCyte is developing a next generation of diagnostic tests that will be based on liquid biopsies using blood or urine samples. OncoCyte recently conducted a 300- patient study of its lung cancer test. On March 6, 2017, OncoCyte announced the successful completion of the study.
Our Subsidiaries and Our Affiliates
The following table shows our subsidiaries and affiliates, their respective principal fields of business, our percentage ownership, directly and through subsidiaries, as of June 15, 2017, and the country where their principal business is located:
Cell Cure Neurosciences Ltd. Products to treat age-related macular degeneration 62.53%(1)
Israel ES Cell International Pte. Ltd. Stem cell products for research, including clinical grade cell lines produced under cGMP 100% Singapore
LifeMap Sciences, Inc. Biomedical, gene, disease, and stem cell databases and tools 81.74% USA
OncoCyte Corporation(2) Cancer diagnostics 49.84% USA
OrthoCyte Corporation Developing bone grafting products for orthopedic diseases and injuries 99.76% USA
ReCyte Therapeutics, Inc. Research and development involved in stem cell-derived endothelial and cardiovascular related progenitor cells for the treatment of vascular disorders, ischemic conditions and brown adipocytes for type-2 diabetes and obesity 94.84% USA
Asterias Biotherapeutics, Inc.(3) Therapeutic products derived from pluripotent stem cells, and immunotherapy products. Clinical programs include: ASTOPC1 for spinal cord injury, AST-VAC1 for acute myelogenous leukemia, and AST-VAC2 for non-small cell lung cancer 43.90% USA
(1) Includes shares owned by us and ES Cell International Pte. Ltd. Does not include shares that would be owned by us, if we were to convert certain convertible debt into Cell Cure Neurosciences Ltd., or Cell Cure, ordinary shares. In June 2017, we entered into agreements to acquire 168,800 ordinary shares of Cell Cure from the selling shareholders. As a result, we will own 99.79% of Cell Cure upon completion of the transactions.
(2) As of February 17, 2017, we deconsolidated OncoCyte and OncoCyte is no longer a subsidiary of ours as of that date, but remains an affiliate and significant investee of our company.
(3) Since the deconsolidation of Asterias in May 2016, Asterias is an affiliate and significant investee of our company. We will continue to work on simplifying our corporate, financial and organizational structure to allow us to execute our objectives more efficiently, while also making it much easier for investors, and other external stakeholders, to better understand our company. Our purpose is to deliver therapies for significant unmet, or under-met, needs to patients, while creating value for our investors. We believe that we have several valuable assets within our company, our subsidiaries and our affiliates.
This is a non profit development corp.
Currently, mostly played by day traders on a short term trading. Most likely a case of buy the rumor, sell the news.
It will be a year before revenues start to flow and some kind of valuation can be formed, other than very speculative.
Anything below 3$ is usually a great buying opportunity or has been up to now.
Business/development wise no news other than constant steps forward by very savvy management.
Cosmetics, for non medical applications is rarely covered by insurance. And that's the beauty. Have you ever seen Botox party? You should to appreciate that cost is NOT an issue.
I can easily see Renevia displace current therapies very very fast.
It's a cash business and the distribution is done by countless nurses and doctors that work on assembly line like offices: a new client gets in gets injection and leaves paying hundreds of dollars.
A thing of beauty.
There is some minor trading going on with BTX by day traders: which provides liquidity to an utherwise unknown micro-small cap (good for Investors).
BTX is a very Long term position for me. It will take time to fully develop the products to get the business to CF positive, so many investors stay away for now.
I fully expect the change to arrive abruptly and suddenly, probably when new CF streams turn on and some validation is given to the Stem Cell, Regenerative medicine. Very rapidly this business could be worth over 1 Billion $ and perhaps multiples thereof.
Having an unlinited highly profitable reinvestment opportunities and buying cheap is the "rocket fuel" of 100 Baggers. BTX has a good chance of being such a rocket, when they turn CF positive.
There are not so many business with such unlimited future ahead of them, at this price.
Good luck.
Notes of $BTX Renevia Pivotal Data Conference Call 14.6.2017
Patient’s own fat cells transplanted with Renevia.
26 – 21 control group.
5CC in each side. 5.1 CC after 6 months found. Very High statistical proof of efficacy. 6m- 95%, 12m 93% volume retention. May be better in Non HIV patients.
Well position to compete in facial aesthetics (fat transfer lasts 6 – 12 months then need again).
File CE up to end of year, then available commercially in Europe in 2018.
1Million HIV in Europe, ~ 300 with facial atrophy.
Dr. Ramon – the treating doctor practice in Palma de Mallorca – Stem Europe Center.
Excited about the results. High volume retention rate is compelling. Also safe and well tolerated in sick patients.
Unmet clinical need. Effective transfer of adult fat stem cells. Combined with Renevia, enabled effective delivery.
Positive finding that we may be adding new cells !
Applicable to other practices (breast reconstruction, for eg).
Plastic surgeons might be able to use this.
Implants loaded with cells is very large use probability.
Plan to develop Renevia.
Working on Flexible Platform to allow surgeons to use it in many ways.
PT additional trial: Larger volume of Revenia.
Expects Revenue in 2018 with long runway of growth, additional uses, TAM multi Billion $ market.
Q&A:
1. Patients: First time and recurrent (fillers) and dissatisfied from it. Very homogenous sample of patients.
2. Bar for EU approval what is required & how long?
a. Data today is all needed to file and sufficient for approval (no need for more data), just wait for full data (this is top line results). Couple of months. Efficacy and safety is done.
b. Timeline: CE Mark process (3-6M), depends on agency overload. 1H2018 is a not unreasonable expectation to get CE approval.
3. Potential partnering: Several ways to commercialize. Discussions progressing. Remain open for everything. For EU (Non US) Commercializing via partner seems like the best way. Partner with capabilities in plastic surgery arena minimizing investment in global infrastructure at this point, keeps us heavily involved in development and evolution of this product. Renevia might be able to do lots of things and shortly more data will be added supporting “so many other possible uses of Renevia”. Several conversation with partners (Asia, Europe). Hope to move this along faster. More in the coming months.
4. What more clinical trials are needed:
a. We have a US clinical trial in Non HIV Renivia with fat cells (Patients will get whatever size / shape transplant/implant they what to satisfy aesthetic needs) . Starts this month – data soon.
b. This Data is good not only for EU but with the Non HIV patients results and with some more data from Dr Ramon additional studies soon to generate data: That will be supportive of (1) planned conversation with FDA about A General Facial Fat Loss Indication trial, (2) Additional indications we want (informed by real life use of the product in the market – the Drs will provide knowledge and feedback to expand label as well as possible uses identified by the company).
c. Partnering Opps. Asia: Will you need more clinical trials there?
i. This data is sufficient for Serious Partnership conversation worldwide. Substantial Trial.
ii. (didn’t want to answer about more trial elsewhere at this time).
d. 3D scanner – how accurate to assess the volume gain?
i. There was published study about it. It demonstrated statistical significance between CT scans, MRI and 3D scanners. It is a standard accepted to prove change in volume (FDA).
ii. Further validated it with additional studies until confidant of the appropriateness of this technology. 0.2CC accuracy.
e. How to assess new tissue growth?
i. In vitro conditions we saw the cells were very happy: three dimensional existence of cells.
ii. The cells are not disappearing, but volume is retained – although the scaffold is disappearing!
iii. Homogeneous, well vascularized tissue exists.
iv. One biopsy supported the assumption that this is a new live, tissue.
v. Implantation site hardens then softens, and it feels there is real tissue there. Ultrasound should there is no foreign body there but natural tissue vascularized – very probable.
f. End of Q3 data?
i. Full report, Secondary endpoint (Aesthetics Score – anecdotal not significance), 12 months follow up, correlation to BMI.
g. Reconstructive procedures for Renevia:
i. It’s a significant platform – plastic, breast, body contouring, facial, orthopedic surgeries are candidates.
ii. Trauma uses (Orthopedic), muscle, tendon, joint disease are candidates.
iii. In next studies – will pursue these thing: Step 1: Non HIV patients (validates that Renevia works better in healthy patient), Step 2: long list of possible uses – Seems like the medical doctors have more Ideas than the company – great sign.
h. EU Partnership: candidates? Initiated discussion.
i. Completed conversations, advanced conversations – guidance pretty soon.
Possessing an approved, validated therapeutics that does much better than current standard of care, with a Massive TAM is a huge deal. BTX is significantly de-risked today. Not long to wait for the Therapeutic to start generating cash flows. Good Day.
Renevia is Done. CE mark 2017, marketing starts 2018. Congrats.
BioTime's Renevia® Achieves Primary Endpoint in European Pivotal Trial
Date(s): 14-Jun-2017 7:00 AM
* Data Reinforce Renevia's Potential in Multi-Billion Dollar Facial Aesthetics Market
* BioTime on Track to File for Renevia CE Mark by End of 2017
* Conference Call Today with Lead Investigator at 4:30 p.m. ET
ALAMEDA, Calif.--(BUSINESS WIRE)--Jun. 14, 2017-- BioTime, Inc. (NYSE MKT:BTX), a clinical-stage biotechnology company developing and commercializing products addressing degenerative diseases, today reported that, based on the analysis of top line data, the Renevia® pivotal trial in Europe has met its primary endpoint. The primary endpoint was the change in hemifacial volume at six months in the treated patients compared to patients in the delayed treatment arm as measured by 3D photographic volumetric assessment. Treated patients received approximately 5cc of Renevia in each side of the face (hemifacial). On average, 5.1cc of hemifacial volume was measured after six months, which represents an approximate 100% retention of transplanted volume. Untreated patients had no incremental hemifacial volume after six months. Comparison of the two trial arms had a statistical p value <.001. All Renevia transplants were shown to be safe and well tolerated. There were no serious adverse events during the trial.
"In the Renevia pivotal trial, we studied patients with HIV-associated facial lipoatrophy, which is a very severe form of facial volume loss," stated Adi Mohanty, Co-CEO of BioTime. "In this clinical study, Renevia has proven to be safe and effective in these patients. We believe the data announced today, positions us to proceed with our planned CE mark filing."
"There were further encouraging data at the 12-month time-points for seven of the trial's run-in patients, which followed the exact same clinical trial protocol as enrolled patients, but were considered training patients for the clinical sites," continued Mr. Mohanty. "This run-in group, on average, had 96% volume retention at six months and 93% volume retention at 12 months, which suggests the potential of even longer lasting volume retention in this patient population. Additional data from the pivotal trial, including 12-month performance and secondary endpoints, should be received in the third quarter of 2017."
"Renevia was used to enable the transfer of a patient's own autologous fat precursor cells as a means of possibly creating a sustained volume. The retention of the transfer volume after six months in patients is quite impressive and we look forward to evaluating the 12-month data," said Ramon Llull, MD, PhD, Director of Stem Europe Mallorca Center, Mallorca, Spain and the primary investigator of the Renevia trial. "Given the compromised tissue of the patients participating in this study, I believe it is possible that Renevia could perform even better in patients without HIV, and I am beginning studies now with this larger population to test this theory."
About the Trial
The current Renevia Pivotal Trial was designed to demonstrate the safety and efficacy of Renevia for treating facial lipoatrophy (abnormal fat loss in the face) in HIV patients. The pivotal trial was a multi-center, randomized, evaluator-blinded, delayed-treatment-controlled study of the effectiveness and safety of Renevia. Renevia was used to deliver the subject's own fat-derived cells harvested via liposuction and implanted under the skin (subcutaneously) into areas of the patient's face where there has been a loss of fat (lipoatrophy).
The study enrolled nine run-in patients and an additional 47 patients have completed their six months follow up. Of these 47 trial patients, 26 were in the treated arm and 21 were in the delayed treatment, control arm. The primary endpoint was the change in hemifacial volume at six months in treated patients compared to patients in the delayed treatment arm as measured by 3D photographic volumetric assessment. Participants in the delayed treatment group are being offered treatment after an evaluation at six months.
Renevia Program Next Steps
The next steps for the Renevia program include submission of an application for CE mark by the end of the year and conclusion of partner selection to begin preparing for European commercial launch next year. At the same time, BioTime will initiate additional pilot trials studying various dosages of Renevia by itself, Renevia in combination with autologous fat, and Renevia in combination with stromal vascular fraction cells (SVF) for any facial volume loss. Besides the studies mentioned by Dr. Llull, during the third quarter, BioTime will support a U.S. investigator initiated study by a leading plastic surgeon who will treat patients in need of facial volume restoration without underlying HIV disease. These patients will be treated with larger volumes of Renevia than in the European pivotal trial in combination with their own fat precursor cells obtained from a liposuction procedure. Successful results from this as well as additional trials with Renevia would position BioTime to quickly enter the global facial aesthetics market which is estimated to be $7 billion annually.
"There are approximately 350,000 HIV patients in Europe suffering from significant facial lipoatrophy and our objective is to make Renevia available to these patients next year," said Mr. Mohanty. "If we achieve our goals, then we should be helping these patients and generating revenue in 2018, while at the same time working to expand Renevia's addressable markets."
Conference Call Information
BioTime is hosting a conference call and webcast today, Wednesday, June 14, at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss the top line data from the Company's Renevia European pivotal trial. The conference call dial-in number in the U.S./Canada is 1-877-407-0784. For international participants outside the U.S./Canada, the dial-in number is 1-201-689-8560. For all callers, please refer to the "BioTime, Inc. Conference Call." The live webcast can be accessed on the "Events & Presentations" page of the "Investors & Media" section on the company's website at http://www.biotimeinc.com/.
A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling toll-free from U.S./Canada: 1-844-512-2921; international callers dial 1-412-317-6671. Use the Conference ID 13664249. Additionally, the archived webcast will be available on the "Events & Presentations" page of the "Investors & Media" section on the company's website at http://www.biotimeinc.com/.
About Renevia®
Renevia is an investigational medical device that is being developed as a replacement for whole adipose tissue in cell assisted lipotransfer (CAL) procedures. Renevia's hydrogel polymer network provides the requisite amino acid sequences for adipose stromal vascular cell attachment and may support proliferation, localization and adipogenic differentiation. Renevia is part of the HyStem hydrogel family of proprietary injectable matrices, which are designed to facilitate the survival and growth of transplanted cells. To learn more about Renevia, click here. To learn more about the HyStem hydrogel technology, click here.
About BioTime, Inc.
BioTime, Inc. is a clinical-stage biotechnology company focused on developing and commercializing novel therapies developed from what the company believes to be the world's premier collection of pluripotent cell assets. The foundation of BioTime's core therapeutic technology platform is pluripotent cells that are capable of becoming any of the cell types in the human body. Pluripotent cells have potential application in many areas of medicine with large unmet patient needs, including various age-related degenerative diseases and degenerative conditions for which there presently are no cures. Unlike pharmaceuticals that require a molecular target, therapeutic strategies based on the use of pluripotent cells are generally aimed at regenerating or replacing affected cells and tissues, and therefore may have broader applicability than pharmaceutical products. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. and OncoCyte Corporation, which BioTime founded and which, until recently, were majority-owned consolidated subsidiaries of BioTime.
BioTime common stock is traded on the NYSE MKT and TASE under the symbol BTX. For more information, please visit www.biotimeinc.com or connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+.
To receive ongoing BioTime corporate communications, please click on the following link to join the Company's email alert list: http://news.biotimeinc.com.
Forward-Looking Statements
Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime, Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates" should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the "Risk Factors" section of its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. BioTime specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.
Renevia's Pivotal trial results are successful! CE mark 2017, marketing starts 2018. Congrats.
BioTime's Renevia® Achieves Primary Endpoint in European Pivotal Trial
Date(s): 14-Jun-2017 7:00 AM
* Data Reinforce Renevia's Potential in Multi-Billion Dollar Facial Aesthetics Market
* BioTime on Track to File for Renevia CE Mark by End of 2017
* Conference Call Today with Lead Investigator at 4:30 p.m. ET
ALAMEDA, Calif.--(BUSINESS WIRE)--Jun. 14, 2017-- BioTime, Inc. (NYSE MKT:BTX), a clinical-stage biotechnology company developing and commercializing products addressing degenerative diseases, today reported that, based on the analysis of top line data, the Renevia® pivotal trial in Europe has met its primary endpoint. The primary endpoint was the change in hemifacial volume at six months in the treated patients compared to patients in the delayed treatment arm as measured by 3D photographic volumetric assessment. Treated patients received approximately 5cc of Renevia in each side of the face (hemifacial). On average, 5.1cc of hemifacial volume was measured after six months, which represents an approximate 100% retention of transplanted volume. Untreated patients had no incremental hemifacial volume after six months. Comparison of the two trial arms had a statistical p value <.001. All Renevia transplants were shown to be safe and well tolerated. There were no serious adverse events during the trial.
"In the Renevia pivotal trial, we studied patients with HIV-associated facial lipoatrophy, which is a very severe form of facial volume loss," stated Adi Mohanty, Co-CEO of BioTime. "In this clinical study, Renevia has proven to be safe and effective in these patients. We believe the data announced today, positions us to proceed with our planned CE mark filing."
"There were further encouraging data at the 12-month time-points for seven of the trial's run-in patients, which followed the exact same clinical trial protocol as enrolled patients, but were considered training patients for the clinical sites," continued Mr. Mohanty. "This run-in group, on average, had 96% volume retention at six months and 93% volume retention at 12 months, which suggests the potential of even longer lasting volume retention in this patient population. Additional data from the pivotal trial, including 12-month performance and secondary endpoints, should be received in the third quarter of 2017."
"Renevia was used to enable the transfer of a patient's own autologous fat precursor cells as a means of possibly creating a sustained volume. The retention of the transfer volume after six months in patients is quite impressive and we look forward to evaluating the 12-month data," said Ramon Llull, MD, PhD, Director of Stem Europe Mallorca Center, Mallorca, Spain and the primary investigator of the Renevia trial. "Given the compromised tissue of the patients participating in this study, I believe it is possible that Renevia could perform even better in patients without HIV, and I am beginning studies now with this larger population to test this theory."
About the Trial
The current Renevia Pivotal Trial was designed to demonstrate the safety and efficacy of Renevia for treating facial lipoatrophy (abnormal fat loss in the face) in HIV patients. The pivotal trial was a multi-center, randomized, evaluator-blinded, delayed-treatment-controlled study of the effectiveness and safety of Renevia. Renevia was used to deliver the subject's own fat-derived cells harvested via liposuction and implanted under the skin (subcutaneously) into areas of the patient's face where there has been a loss of fat (lipoatrophy).
The study enrolled nine run-in patients and an additional 47 patients have completed their six months follow up. Of these 47 trial patients, 26 were in the treated arm and 21 were in the delayed treatment, control arm. The primary endpoint was the change in hemifacial volume at six months in treated patients compared to patients in the delayed treatment arm as measured by 3D photographic volumetric assessment. Participants in the delayed treatment group are being offered treatment after an evaluation at six months.
Renevia Program Next Steps
The next steps for the Renevia program include submission of an application for CE mark by the end of the year and conclusion of partner selection to begin preparing for European commercial launch next year. At the same time, BioTime will initiate additional pilot trials studying various dosages of Renevia by itself, Renevia in combination with autologous fat, and Renevia in combination with stromal vascular fraction cells (SVF) for any facial volume loss. Besides the studies mentioned by Dr. Llull, during the third quarter, BioTime will support a U.S. investigator initiated study by a leading plastic surgeon who will treat patients in need of facial volume restoration without underlying HIV disease. These patients will be treated with larger volumes of Renevia than in the European pivotal trial in combination with their own fat precursor cells obtained from a liposuction procedure. Successful results from this as well as additional trials with Renevia would position BioTime to quickly enter the global facial aesthetics market which is estimated to be $7 billion annually.
"There are approximately 350,000 HIV patients in Europe suffering from significant facial lipoatrophy and our objective is to make Renevia available to these patients next year," said Mr. Mohanty. "If we achieve our goals, then we should be helping these patients and generating revenue in 2018, while at the same time working to expand Renevia's addressable markets."
Conference Call Information
BioTime is hosting a conference call and webcast today, Wednesday, June 14, at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss the top line data from the Company's Renevia European pivotal trial. The conference call dial-in number in the U.S./Canada is 1-877-407-0784. For international participants outside the U.S./Canada, the dial-in number is 1-201-689-8560. For all callers, please refer to the "BioTime, Inc. Conference Call." The live webcast can be accessed on the "Events & Presentations" page of the "Investors & Media" section on the company's website at http://www.biotimeinc.com/.
A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling toll-free from U.S./Canada: 1-844-512-2921; international callers dial 1-412-317-6671. Use the Conference ID 13664249. Additionally, the archived webcast will be available on the "Events & Presentations" page of the "Investors & Media" section on the company's website at http://www.biotimeinc.com/.
About Renevia®
Renevia is an investigational medical device that is being developed as a replacement for whole adipose tissue in cell assisted lipotransfer (CAL) procedures. Renevia's hydrogel polymer network provides the requisite amino acid sequences for adipose stromal vascular cell attachment and may support proliferation, localization and adipogenic differentiation. Renevia is part of the HyStem hydrogel family of proprietary injectable matrices, which are designed to facilitate the survival and growth of transplanted cells. To learn more about Renevia, click here. To learn more about the HyStem hydrogel technology, click here.
About BioTime, Inc.
BioTime, Inc. is a clinical-stage biotechnology company focused on developing and commercializing novel therapies developed from what the company believes to be the world's premier collection of pluripotent cell assets. The foundation of BioTime's core therapeutic technology platform is pluripotent cells that are capable of becoming any of the cell types in the human body. Pluripotent cells have potential application in many areas of medicine with large unmet patient needs, including various age-related degenerative diseases and degenerative conditions for which there presently are no cures. Unlike pharmaceuticals that require a molecular target, therapeutic strategies based on the use of pluripotent cells are generally aimed at regenerating or replacing affected cells and tissues, and therefore may have broader applicability than pharmaceutical products. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. and OncoCyte Corporation, which BioTime founded and which, until recently, were majority-owned consolidated subsidiaries of BioTime.
BioTime common stock is traded on the NYSE MKT and TASE under the symbol BTX. For more information, please visit www.biotimeinc.com or connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+.
To receive ongoing BioTime corporate communications, please click on the following link to join the Company's email alert list: http://news.biotimeinc.com.
Forward-Looking Statements
Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime, Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates" should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the "Risk Factors" section of its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. BioTime specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.
Renevia is Done. CE mark 2017, marketing starts 2018. Congrats.
BioTime's Renevia® Achieves Primary Endpoint in European Pivotal Trial
Date(s): 14-Jun-2017 7:00 AM
* Data Reinforce Renevia's Potential in Multi-Billion Dollar Facial Aesthetics Market
* BioTime on Track to File for Renevia CE Mark by End of 2017
* Conference Call Today with Lead Investigator at 4:30 p.m. ET
ALAMEDA, Calif.--(BUSINESS WIRE)--Jun. 14, 2017-- BioTime, Inc. (NYSE MKT:BTX), a clinical-stage biotechnology company developing and commercializing products addressing degenerative diseases, today reported that, based on the analysis of top line data, the Renevia® pivotal trial in Europe has met its primary endpoint. The primary endpoint was the change in hemifacial volume at six months in the treated patients compared to patients in the delayed treatment arm as measured by 3D photographic volumetric assessment. Treated patients received approximately 5cc of Renevia in each side of the face (hemifacial). On average, 5.1cc of hemifacial volume was measured after six months, which represents an approximate 100% retention of transplanted volume. Untreated patients had no incremental hemifacial volume after six months. Comparison of the two trial arms had a statistical p value <.001. All Renevia transplants were shown to be safe and well tolerated. There were no serious adverse events during the trial.
"In the Renevia pivotal trial, we studied patients with HIV-associated facial lipoatrophy, which is a very severe form of facial volume loss," stated Adi Mohanty, Co-CEO of BioTime. "In this clinical study, Renevia has proven to be safe and effective in these patients. We believe the data announced today, positions us to proceed with our planned CE mark filing."
"There were further encouraging data at the 12-month time-points for seven of the trial's run-in patients, which followed the exact same clinical trial protocol as enrolled patients, but were considered training patients for the clinical sites," continued Mr. Mohanty. "This run-in group, on average, had 96% volume retention at six months and 93% volume retention at 12 months, which suggests the potential of even longer lasting volume retention in this patient population. Additional data from the pivotal trial, including 12-month performance and secondary endpoints, should be received in the third quarter of 2017."
"Renevia was used to enable the transfer of a patient's own autologous fat precursor cells as a means of possibly creating a sustained volume. The retention of the transfer volume after six months in patients is quite impressive and we look forward to evaluating the 12-month data," said Ramon Llull, MD, PhD, Director of Stem Europe Mallorca Center, Mallorca, Spain and the primary investigator of the Renevia trial. "Given the compromised tissue of the patients participating in this study, I believe it is possible that Renevia could perform even better in patients without HIV, and I am beginning studies now with this larger population to test this theory."
About the Trial
The current Renevia Pivotal Trial was designed to demonstrate the safety and efficacy of Renevia for treating facial lipoatrophy (abnormal fat loss in the face) in HIV patients. The pivotal trial was a multi-center, randomized, evaluator-blinded, delayed-treatment-controlled study of the effectiveness and safety of Renevia. Renevia was used to deliver the subject's own fat-derived cells harvested via liposuction and implanted under the skin (subcutaneously) into areas of the patient's face where there has been a loss of fat (lipoatrophy).
The study enrolled nine run-in patients and an additional 47 patients have completed their six months follow up. Of these 47 trial patients, 26 were in the treated arm and 21 were in the delayed treatment, control arm. The primary endpoint was the change in hemifacial volume at six months in treated patients compared to patients in the delayed treatment arm as measured by 3D photographic volumetric assessment. Participants in the delayed treatment group are being offered treatment after an evaluation at six months.
Renevia Program Next Steps
The next steps for the Renevia program include submission of an application for CE mark by the end of the year and conclusion of partner selection to begin preparing for European commercial launch next year. At the same time, BioTime will initiate additional pilot trials studying various dosages of Renevia by itself, Renevia in combination with autologous fat, and Renevia in combination with stromal vascular fraction cells (SVF) for any facial volume loss. Besides the studies mentioned by Dr. Llull, during the third quarter, BioTime will support a U.S. investigator initiated study by a leading plastic surgeon who will treat patients in need of facial volume restoration without underlying HIV disease. These patients will be treated with larger volumes of Renevia than in the European pivotal trial in combination with their own fat precursor cells obtained from a liposuction procedure. Successful results from this as well as additional trials with Renevia would position BioTime to quickly enter the global facial aesthetics market which is estimated to be $7 billion annually.
"There are approximately 350,000 HIV patients in Europe suffering from significant facial lipoatrophy and our objective is to make Renevia available to these patients next year," said Mr. Mohanty. "If we achieve our goals, then we should be helping these patients and generating revenue in 2018, while at the same time working to expand Renevia's addressable markets."
Conference Call Information
BioTime is hosting a conference call and webcast today, Wednesday, June 14, at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss the top line data from the Company's Renevia European pivotal trial. The conference call dial-in number in the U.S./Canada is 1-877-407-0784. For international participants outside the U.S./Canada, the dial-in number is 1-201-689-8560. For all callers, please refer to the "BioTime, Inc. Conference Call." The live webcast can be accessed on the "Events & Presentations" page of the "Investors & Media" section on the company's website at http://www.biotimeinc.com/.
A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling toll-free from U.S./Canada: 1-844-512-2921; international callers dial 1-412-317-6671. Use the Conference ID 13664249. Additionally, the archived webcast will be available on the "Events & Presentations" page of the "Investors & Media" section on the company's website at http://www.biotimeinc.com/.
About Renevia®
Renevia is an investigational medical device that is being developed as a replacement for whole adipose tissue in cell assisted lipotransfer (CAL) procedures. Renevia's hydrogel polymer network provides the requisite amino acid sequences for adipose stromal vascular cell attachment and may support proliferation, localization and adipogenic differentiation. Renevia is part of the HyStem hydrogel family of proprietary injectable matrices, which are designed to facilitate the survival and growth of transplanted cells. To learn more about Renevia, click here. To learn more about the HyStem hydrogel technology, click here.
About BioTime, Inc.
BioTime, Inc. is a clinical-stage biotechnology company focused on developing and commercializing novel therapies developed from what the company believes to be the world's premier collection of pluripotent cell assets. The foundation of BioTime's core therapeutic technology platform is pluripotent cells that are capable of becoming any of the cell types in the human body. Pluripotent cells have potential application in many areas of medicine with large unmet patient needs, including various age-related degenerative diseases and degenerative conditions for which there presently are no cures. Unlike pharmaceuticals that require a molecular target, therapeutic strategies based on the use of pluripotent cells are generally aimed at regenerating or replacing affected cells and tissues, and therefore may have broader applicability than pharmaceutical products. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. and OncoCyte Corporation, which BioTime founded and which, until recently, were majority-owned consolidated subsidiaries of BioTime.
BioTime common stock is traded on the NYSE MKT and TASE under the symbol BTX. For more information, please visit www.biotimeinc.com or connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+.
To receive ongoing BioTime corporate communications, please click on the following link to join the Company's email alert list: http://news.biotimeinc.com.
Forward-Looking Statements
Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime, Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates" should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the "Risk Factors" section of its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. BioTime specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.
These things are material information and need to be disclosed pretty fast. Companies tend to disclose terrible news on a Friday evening in a press release.
They want to hold a webcast with the researchers and this takes some scheduling. These are busy people.
The news up to on the trial now were terrific no reason to suspect anything bad. Listen to the recent Q webcast.
It would be a small step forward- no reason to expect any major motion up until cash starts to flow in from sales.
But when the market catches up to the billions of potential, 3$ is going to be a very distant memory.
Don't Worry. When the time comes there are some super loyal shareholders willing to be dilluted and unwilling to check their basic assumptions. (been one for 2 years).
Dr S (the face) and his Operator will drag this on as far as possible.
TOX is just around the corner.
I read the 10K for laughs. I think they deserve an oscar on vaugness and generaly evesive language.
funny how people have difficulty reassessing data and keeping a position after they are invested in terms of support of management.
Where is the red line?
Correct, they speak of 4+ billion TAM , plus further research into developing better accuracy (even thought high now) and additional testing using the same tech.
These are the very first Stem Cell Medicine applications coming to market. Soon the valuations will reflect real value of so many different treatments in the BTX portfolio.
Hi P, and welcome to the board, pretty deserted place, for the time being.
The visionary and leading scientist behind Ocata, Geron and almost all IP concerning Stem Cell Regenerative Medicine is Dr. Michael D. West.
https://en.m.wikipedia.org/wiki/Michael_D._West
Dr West was the CEO at Ocata, and developed or guided the main IP concerning embryonic stem cells (@Geron) and pluripotent stem cells at Btx.
Geron abandoned the mission of Regenerative Medicine and Dr west managed to get the whole IP for peanuts and it is now controlled and developed by Asterias a publicly listed not consolidated subsidiary. Check out their incredible Clinical trials AST-OPC1, Geron stared and abandoned. Amazing results.
At Biotime, Dr Michael continues innovating and expanding the range of Stem Cell medicine while medium to short term catalysts (Renevia for Cosmetic 7bill$ market) are one the horizon. You may want to look at the Biotime Site - there is an abundance of materials there, and sign up for email updates while you are there.
There is OncoCyte, listed subsidiary with its cancer blood test, at the final steps pre marketing. Check out that site for updates.
Investing wise, most Stem Cell companies are just disastrous businesses, with insane dilution and almost zero insider holdings.
@ Biotime, the lessons of past mistakes was learned. With minimal dilution massive progress is made and soon revenues will start flowing. The Board is composed of very large investors so the interests are aligned.
I believe Biotime' subsidiary Israeli CellCure - developing and clinically testing its RPE Stem Cell AMD therapeutic is superior to Ocata, you will find information on BTX's site.
Investing in BTX is buying a mutual fund of stem cell with INTEL INSIDE like IP. At the end, I believe, any therapeutic outside of Adult Stem Cell is going to be using this IP.
This is very early yet. One day, and not in the far future, there will be a mad rush to invest in Stem Cell businesses, probably after the FDA will start authorizing the first therapeutics. As I see it, the Top Dog is BTX.
I hope this helps.
Good luck!
Adi
BTX Conf call notes 1Q2017.
Great Progress. This is a very long term play and only for those with patience. At this time I look for owner-operator culture, strong financial capabilities and execution - All exist in Spades. I do believe that Dr West is as high caliber entrepreneur as Elon Musk, but Investing In BTX today could be ten times more rewarding.
Clinical Progress:
1. Ophthalmology. Cohort 1+2 Opregen. PI/IIa. No adverse events. Transplant rather than therapeutic (transplant works, high success rate 80-90%). If safely engraft and remain live, higher probability it will work Vs small/large molecule therapeutics. If so, Should be valued higher earlier than molecular drug treatment with only 1 in 10 drugs make to commercialization (9 failed), for side effect. Transplant 90% range success. Early signals of biological activity. 50K, 200K cells: imagining – engrafted in the eye including in scar area – completely depleted of RPE cells. The thin area of cells above the scar increased in thickness indicating structural improvement. Mean – not only enrapt but likely functioning as intended. No sign of deterioration (no loss of RPE cells). Next step – Cohort 3 (US and Israel).
2. Ophthalmology. Retinal restoration: 3 D tissue – retinal implant. Lab manufactured, containing all cell types that needed. Tissue may repair vision to blind.
3. Renevia: Pivotal clinical trial. no safety issues. Top line June. New indication for facial esthetics market – 7 Bill$. Natural long lasting. Result suggest achieving Volumetric improvement may be for over 1 year (vs 6 months alternative). Self Pay market. Possible US trial.
4. Asterias – Spinal Cord OPC-1 – more data for Cohort 2,3,4 later year. Several year’s data continue to look good.
5. Oncocyte – on track to commercialize test. Test May 22.
6. AgeX – Innovation by leader. 90’s cell aging 2010, possible to reverse aging in lab dish. Provocative, now common. Can generate young cells to be used in regen. Medicine. An ENTIERLY NEW CLASS of therapies directly targeting some of the largest market opportunities associated with human aging. In our minds, these new technologies are the most powerful we have even invented. 3 New Programs for development: 1) type 2 diabetics, 2) age related ischemic disease, 3) scoreless tissue regeneration. Induced Tissue Regeneration (ITR) is we believe a means to unlocking the body’s ability to regenerate and repair tissue scarelessly. AgeX will develop it, and will accept sub’s Life map sciences, recite therapeutics – turn to a leader in the biotechnology of aging and unlock value.
Q&A
1. Presentation reaction: “the data is remarkable”. Very possible. “Never seen RPE cells attach to the injury”. Structural recovery can raise hope to visual recovery.
2. 12 – 3 months of immunosuppression shortening means easier to get participants.
3. Renevia is going very well. US: interested in approaching the FDA about Non HIV patient with larger volume of Renevia. In Asia and Latin America – already engaging with authorities.
4. HIV patients – if does well here under medication, will be better in healthy. Trial demands 6 months. (Current treatment is 5CC – 2CC retention 6-9 months. Anything better than 50% retention. Longer duration – better retention will be a great sign).
5. AgeX – planning the Capitalization of AgeX which will determine timelines and milestones – preclinical studies and IND.
Incredible business, with so many irons in the fire that in the long run there is plenty of growth. Very soon I will be taking a 10X victory round and I solidly expect it to become 20, 30X.
The bigger it becomes, the more resources it has to develop its incredibly rich high return business opportunity.
Expect more games, Esport & advert income that will put it with google and Facebook avert. Income
BTW. No CEO who is personally well invested dilutes herself by holding a PP @ sub 10 cents after the stock was way higher.
Check out the last PP.
But for someone who works there, it's just not important, as the upside comes form paycheck rather than stock appreciation.
All of this is investing 101.
I have seen many microcap with amazing ideas fail. They all had one thing in common: Terrible Incentive System - read: no owner operator at the helm.
Perhaps it will change.
LOOK, DON'T LISTEN!
A. 29G stock is Ridiculous amount in real $. She should own 1% of the outstanding stock to be able to say she has skin in the game with straight face, and no less than 200,000$ worth of stock, at this size.
B. The argument that Options & Stock provides "skin in the game" is ridiculous insufficient. Why? Because IT LACKS DOWNSIDE. Without downside risk an Exec IS AND WILL NEVER BE TRUELY ACCOUNTABLE. It is a "Heads - I win, Tail - you lose" situation.
C. The CFO, I believe and suspect is connected with the guys who funded the failed business before Lisa, and most likely hired, brought in and control Lisa and the business. They are so deep in losses, they have no choice but to keep funding the business if they ever want to recoup their losses.
I would not give much weight to that debt.
Once again,
Where are the 3 new leaders of the business in terms of real stock holding? Close to Zero.
Sorry, that's reality.
They can change it any time!
;)
Yes, it could.
The translation of profits to pps is not very attractive, and, eventually, this is what will drive Your Capital Gains.
The Incentive Structure is Terrible, and as Charlie Munger (BRK) says: Incentives are Everything.
These two factors might improve, and when they do, we might establish a significant position.
Until that time, we're doing what the insiders are doing! ;)
Calculate the FD including all the warrants and options.
Then, go compare with Constellation Software, whose CEO is an owner operator, to gain perspective how an OWNER treats issuing shares.
Check out how what is his FD outstanding figure and study what is the impact of every Cent of earning on the share price.
Check out how well or be did the investors do there...
Then you will be able to tell if $RHT.v is shareholder friendly or well managed.
Yes, and until I see here building a sizable % above 1, she has the burden of proof to show otherwise.
Why she is there?
Better Salary as a public company CEO than private?
Hope to achieve something great?
To be clear, not saying she is a crook. I don't believe she is.
But there is a VAST difference between being a hired gun and drawing large salaries and being AN OWNER OPERATOR GETTING RICH FROM SHARE OWNERSHIP WITH INVESTORS,
Even if she is as great as we think she is, whose interests does she promote?
Yours and mines?
Or the person who hired her and will fire her?
What his/their interest and objectives? So far, NOT in building a successful business, as the past track shows.
It's as simple as that.
She must, by here actions show investors she is NOT a pawn but rather someone with power to decide.
How will she do that with close to ZERO holding?
She can't.
Worse, she is not the source of the Tech!
And those that are, own even less.
WATCH the BOARD,
WATCH the INSIDER FILINGS
WATCH the 3 key personas holdings.
WATCH the ratio between cash compensation and % holdings.
When she will know she stands to make 10X here cash income by rise in pps, that's when she will be focused on Investors interests.
Lisa is the one good thing about this company. As an executive.
But to make it a great investment, she would have to think and treat it as here business. She must be an owner.
Having 20kCAD invested will not make it.
The owner calls the shots.
So far, they've been disastrous, as the OS shares will attest.
Will Lisa grow up to be an owner?
I don't know,
She was brought in by the owner, presumably to solve his problems.
She is a good talker.
But her actions tell the tale.
What I don't like about reliq health technologies inc. $RHT.V - 2017 version.
1. Lisa makes a point of NOT Building an equity position, and only buying the least amount when pressured. She says options give her exposure, carefully avoiding mentioning the protect her downside.
2. The Technical Brains carefully hide from talking to investors. They make a point to have ZERO ownership. They prefer cash. That's zero trust in their work.
3. The filling suggests this company's board is bigger than Google. Although I talked with Lisa, this is not solved. It means the control of this business is out of her hand.
4. I can't establish who is the decision maker in the business, as he hides himself. I guess it's the PR/Financial backer who ousted the lady CEO. They never built IMHO a real successful business. It seems Lise is their "front".
5. The share structure is a disaster. With so many shares out, shareholders will see very little upside from pilot wins. They should have a massive reverse split, take FD share count under 10 millions and then start posting revenues.
Then again, perhaps that's what they are aiming at and that's why no insider establishes position.
6. Old CEO position overhang is providing a constant selling pressure.
Otherwise, the strategy is ok and the product is interesting.
Telemedicine is HOT. they need to execute, well, fast, or be left behind.
There are many ugly hairs on this one. Don't mistake it for great company. It's still shady little micro, and the CEO doesn't want or CANT resolve it.
When she straightens up the Board, when the she buys 1% of the business herself, when she demands all Board members to be owners or replaces them, when the other 2 key tech terminals start to buy significant stock at the market, these will be the signed Lisa wants to be a businesswoman and not "for hire" CEO, puppet for the financial predator firm that gave too much money to a failing CEO and just want to pump the stock high enough to be made whole on their failed involvement.
Remember, Lisa has GREAT reasons not to own 1%. If she know this is the chance of her live, she would invest at these low prices in a heartbeat! By here actions we know she is of firm opinion she doesn't think so.
As they say: Look, don't listen!
GLTA
The Stem Cell sector is, still considered a voodoo medicine by Investors. Indeed, it has failed to generate even one credible treatment, although it did generate some mind boggling value destruction for investors.
But this is about to change.
Within 2 years I believe we will see some actual Stem Cell Regenerative treatments reaching P.3, resolving crippling conditions and pulling in massive revenues.
At that time credibility will return. The best companies will see a lot of demand for shares.
Biotime, IMHO, is the top asset in the whole field. It controls a ton of IP and has its fingers in many pies.
I like to think of BTX as the Intel of Stem Cell.
The CEO practically pioneered the research into Stem Cell.
It's miles ahead of everyone else, and it's financing record, for non profit corp. are second to none.
The Board is practically majority shareholders.
But there is still some time to the big changes.
So, this is a ten year game. Buy now and you will be considered a genius in 10 years.
But you'll have to wait.
Waiting is hard, even when value is created every quarter in the lab.
That why most people don't do well in the stock exchange.
Btx can easily be a large cap company. There is so much to do in this sector, and so little doing it.
Heck. Asterias (sub) is practically turning fully crippled people to people who can be self reliant. That has never occurred before.
Sit tight and observe the building of a industry titan.
Before a serious phase 2, a drug will not generate serious value. Add in the lack of credibility of people that never brought a drug to market in this corp. + pumping by people like Agora and you get no interest from serious players. This might change if they cross P.2 with similar results.
Long.
Ad
Cancer drugs chances of clearing phase 3 from 1 are ~4%. This is preclinical work. Hence the market yawn.
No. Have to confess I never did.
On the other hand, did manage to generate 100 times as much buy going long in under the radar, under valued super companies.
But than again, what do I know...
;)
Hedge fund mainly profit from ripping investors 2&20 and most trail the market heavily.
You might want to look https://www.google.co.il/amp/amp.timeinc.net/fortune/2016/05/11/warren-buffett-hedge-fund-bet/%3Fsource%3Ddam?client=safari
Again, I have never seen a billionaire that became so from trading options, and until I see audited traded records, talk is just -- talk...
The after tax mathematics, if one cares to do the work, are against heavy duty compounding on this path.
Now, YOU may be a planetary genius.
I would argue if you were you would be making millions from 2& 20...
I may be in error but statistics says I'm not..,
I don't know anyone who ever became a billionaire trading options...
I do know of billionaires who bought and held great companies for the long haul.
I am still waiting for the person who can submit his 20 year trading history for inspection...
But to each his own.
I bought it @ 12$, when no one understood the stock. It's a seven figure position now.
Nothing unpredictable about the business. It just improves.
The rest is just noise.
Buy and hold great businesses, if you want to become rich
Care to provide a detailed explanation, backed by fundamentals?
Way higher?
Have a look at recent presentation on the company's web site.
While commercialization is still down the road, these are some major therapeutics suggesting market cap of multiples from here.
I believe the safer way to own $AST is via $BTX, it's holding company. You get more diversification
Encouraging.
Still way to go to 50m.
A new interesting development is farmers coming and asking INP to handle their Canola sales, since they get better prices, and share the upside.
Since INP gets only 20-30% of the Canola with any farmer, the upside from this additional business can nice addition.
Brad et al are working to get the service known and to become valuable to the farmers.
Small contracts means easier transactions and more exposure.
Good quarter in my book.
Input Capital's value is going to be driven, short term (next few years) by its growth rates (book value; OCF; EPS).
Bulls/INP says - value using CFO multiples, like streaming companies.
Bears says - value as alternates lender, max 1.5 per book value, not streaming as only 6 year contract then need to 'refill' book, like lender.
The one KEY variable underpinning the two is growth.
Growth is slow.
Why? A. Either new/green sales team (solvable) or
B. Market less warm to the idea = smaller opportunity than thought.
Div says we have more capital than we can deploy (sales are not expected to go into hyperdrive mode).
Pay close attention to management coming up with creative but less profitable ways to grow as another Tell the thesis has changed.
This deployment season will tell us a lot about what to expect and how to modify the thesis.
An upside from these prices is reasonable to expect, but right now, there are way better growth stories out there.
Must watch for anyone who does DD on Biotime $BTX.
The Fault with this logic is pretty strightforward.
The comparable for buying Prurisol is ~ 600 millions - sale.
Lets assume the market shares your exhiliration and enthusiasm, and offers a double (!) unheared of price for a PII Psoriasis drug, with all the risks of PII drug. That would be spactacular.
When such a sale is done, the buyer buys all the upside, of course, so what he can do with Prurisol is really not interesting to the seller.
a 1.2$ billion sale offer, which I would argue Leo would take and run, will only translate to -- 1.2 billion $ or about 7.2$ FD.
no where near 10 billion.
Now I don't see ANY big pharma CEO paying anywhere NEAR that sum. If Prurisol was an approved drug with 2 billion sales, sure. But the fact is -- its not, and if it will - the Per Share aspect of the cash is going to take a massive hit.
I believe best case is 500-800 million cash deal, and if Leo wants exposure to the upside in the form of partnership, perhaps slivers of that sum.
Which brings us back a full circle: It seems the posters on this board are very enthused and on a long positive feedback loop, which is always bad for investors.
When and if a deal DOES come around, with 4$ cash per share, and no where near the 10 billion fantasy for Prurisol (a solid deal), people are going to be disappionted.
CTIX MAY hit the coveted 10 Billion $ in the FUTURE, but that would necessitate developing and generating alone blockbuster compounds - which may or may not be Brilacidine or Kevetrine.
While I approve of management and investment of capital, we are still long ways away from that day.
Keep your expectations reasonable and achievable. Its a zero sum game: less money for current OS or more money for smaller part of an OS figure.
And you are all invited to show me 10 billion $ in market cap - I will not be resent it at all ... ;) It just I would not hold my breath waiting for it to happen in the next 5 years...
See you in another year, folks.
About the 10 Bill - The company itself cites full sale transactions on comparables in the range of 500-600 million for the whole business (sometimes including other IP than Psoriasis). Thats about $3 FD per share.
Otzela does about 1 bill in sales (albeit modeled to do 2 next year). At 5 times sales you do get 10 bill, although its unreasonable to expect Otzela goes to 0 once Prurisol launches so again 10 is very very optimistically rich.
If the company seeks partner, rather than a buyer, and they were constantly using this term "partner", the cash part of the transaction would be significatly lower than the 500-600 millions.
So, while I have never been more optimistic about this company, I realistically see a deal with up to 4$ per share (in sale) or in case of partnership, perhaps 1$ per share + 15-25% revenues, which in time could translate to another 3$ per share and more importantly, no more dillution.
That would allow for Uplist and comfortablly advancing Brilacidin and Kevetrin forward, and in time, pave the way to another bump up in share price when more drugs or indications are achieved.
Alternatly, they decide to go at it alone, but then dillution is going to be a bummer and shareholders will still see just a sliver of all the benefits.
Either way, while I am very optimistic we see progress in the medium future and my holding is in six figures (stock), 10 bill strikes me as somewhat premature or hyperbole.
Now, if anyone can show his work to educate me how CTIX can develop Prurisol to reach 10 billion M. Cap while maitaining my % stake in the new wealth, or otherwise how 60$ PPS is around the corner, I would be a very happy camper!
They have an awesome competitive advantage with this IP. They built fantastically involved audience. They are very good at what they do. This company is like DIS in the 60's, with all this massive IP, and check out how DIS did since. I've been an owner since 25$, and nothing changed really, other than more IP and more dominating of video game industry.
Buy and hold for dear life.
I have been a long time shareholder, but am no longer. I just do not trust management decisions and professionalism. Too many stupid errors and terrible judgement.
CX May turn up a fantastic success. If so, good for all the sick people. I just can not hold asset when Management is not trust worthy.
The new posters lack the history with this management team, and that's fine, GLTA.