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Valuation Sept 2017:
Oncocyte’s part is valued at 98M$
Asterias – 68M$
Agex (last funding) 58M$
BTX – 323M$
Hence Internal value is 99M$, buys you: OpRegen + Renevia and anything else in the future for free.
Let's say Opregen fails (we already have evidence it engrafts and is working).
Renevia has been proven to work clinically and will be selling by the end of 2018, into a massive market with no competition in the natural fat transfer universe. For 100M$ it is a steal.
Do your own DD… It is getting very simple to understand when to add...
Notes about Renevia & Facial cosmetics treatments.
5-600$ per CC. 10CC will get you to 5-6K$, many times more needed.
Will last 12-14 months.
Not natural: “Kiss factor” – when you kiss it you FEEL it isn’t natural.
Clients want natural solution – therefore the Fat Transplant procedures Plastic Surgeons do.
With the current treatment, at 6 months, 50%+ of the fat is gone.
With Renevia, at 6 months – 100% retention, at 12m – 70% and 5 patients suggest at 18m – over 60%.
This with very sick patients. Perhaps healthy patients will fare better?
This was beyond what the company expected. They though 70% at 6 m is a winner.
Plastic Surgeons will market it. For them, a patient is worth 100,000$ over the lifetime: facial treatment has upsell such as hand and other treatments. But since the natural treatment is not good, they lose the patients because they are unhappy with results. Plastic Surgeons want the patients coming back again and again over as long as possible, in a typical treatment cycle of 2-year.
Natural fat transfer costs about 8-10K$ today (with these poor results).
If Plastic Surgeons get over 60% retention after 18 months, this brings them to good results over 2-year cycle and increases customer retention.
On the verge of starting new trials with healthy patients. They see many opportunity for off-label expansion.
Notes from BioTime, Inc. Ladenburg Thalmann 2017 Healthcare Conference New York, NY September 26, 2017 2:00 p.m. (ET).
Unsure, immaterial.
What these distributions do is to make the valuation of BTX less complicated and more understandable to the investing community.
Each time BTX's holding goes below 50%, the position is registered on the balance sheet as an asset (market value). above - the subsidiary needs to be consolidated which muddles the picture and hides the real value.
The main catalysts now are Renevia, the blood test (Oncocyte) and later, Opragen.
2018 will be a year with revenue growth when the market will realize the value and scope of BTX's (and Subs) technology and potential earning power.
Nothing will happen next month, but that's fine.
Patient investors who understand the vast platform this business is developing get a chance to build a position sub 2.5$ from time to time and will realize massive returns in the coming years.
GL
$BTX's #Renevia filing for CE mark, results @ 18 months surpass expectations (though small sample). Live WebCast today.
Title: BioTime Announces Positive Secondary and Additional Positive Long-Term Data from the Renevia® Pivotal Trial
Date(s): 26-Sep-2017
For a complete listing of our news releases, please click here
• Filing for Renevia® CE mark by the end of 2017
• Positive long-term data in HIV-associated lipoatrophy reinforces Renevia's® potential in multibillion-dollar global facial aesthetics market
ALAMEDA, Calif.--(BUSINESS WIRE)--Sep. 26, 2017-- BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology company focused on developing and commercializing products addressing degenerative diseases, today announced that treated patients from the Renevia® pivotal trial in Europe retained an average of 70% of the transplanted volume at 12 months. Additionally, preliminary data for five patients indicates an average retention of 64% of the transplanted volume at 18 months. These data exceed management expectations for long-term performance of the Renevia® transplant. BioTime remains on track to file Renevia® for CE mark approval by the end of the year.
The Renevia® trial data will be further discussed at the BioTime presentation at the Ladenburg Thalmann 2017 Healthcare Conference in New York. The presentation is scheduled for 2:00 pm ET/11:00 am PT today, September 26, 2017. A live webcast and subsequent archived replay of the BioTime's presentation may be accessed via the investor relations section of the BioTime's website at www.investor.biotimeinc.com/phoenix.zhtml?c=83805&p=irol-EventDetails&EventId=5263572.
"These additional positive data further support our confidence that Renevia® may soon become an important, stable long-term solution, not only for people with HIV-associated lipoatrophy, but for people with any facial fat loss, whether caused by pharmaceuticals, trauma or aging," said BioTime's Co-Chief Executive Officer, Adi Mohanty. "We are moving quickly to submit an application for a CE mark to the European regulatory agency, with a possible approval and commercial launch in 2018."
BioTime previously reported meeting the primary endpoint of this pivotal trial and now has the remaining required data, secondary endpoints and safety report to complete the clinical data package necessary to file for a CE mark in Europe. The secondary endpoints, such as qualitative improvements, trended positive and support the statistically significant primary endpoint. Secondary data points were not powered for statistical significance, but positive trends were seen in both the Mid-Face Volume Deficit Scale and Body Image Quality of Life Inventory. BioTime remains on track for filing the CE mark application by the end of this year with possible approval and launch next year.
In this pivotal trial, BioTime studied patients with HIV-associated lipoatrophy, which is a severe form of lipoatrophy characterized by the pathological loss of body fat from under the skin. All Renevia® transplants were well tolerated and there were no device-related serious adverse events noted in this pivotal trial. 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 3-D photographic volumetric assessment. The 3-D volumetric endpoint directly measures retained volume over time.
The additional data were encouraging as further supporting the commercial prospects of Renevia®, and its potential for label expansion into other indications, such as cosmetic facial aesthetics. The facial aesthetics market is estimated to be over 5 billion dollars and growing at or near double digits.
Treated patients received approximately 5cc of Renevia® in each side of the face (hemifacial) and the following table details the average (mean) volume measured through 18 months.
6 Months 9 Months 12 Months 18 Months
Patients 28 21 15 5
Mean volume measured (cc) 5.1 4.1 3.5 3.2
Percent of retention 100% 82% 70% 64%
While only a small number of patients have been observed through 18 months, the results thus far are encouraging.
This positive data, along with the secondary endpoints and full safety report, will be presented at the upcoming International Federation for Adipose Therapeutics and Science (IFATS) conference. The IFATS conference will be held in Miami, FL. from November 30th through December 3rd of this year.
About Renevia®
Renevia® is an investigational medical device that is being developed as an alternative for whole adipose tissue transfer (fat grafting) 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.
AgeX is going to be distributed.
ALAMEDA, Calif.--(BUSINESS WIRE)--Sep. 25, 2017-- BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology company focused on developing and commercializing products addressing degenerative diseases, announced today that its Board of Directors has approved a distribution of some or all of the shares of AgeX Therapeutics, Inc. owned by BioTime to BioTime's shareholders.
The Board also authorized management to work with investment banks and other financial institutions to finalize and implement the strategy for taking AgeX public, which may include a tax-free distribution.
"Asterias BioTherapeutics and OncoCyte Corporation, two companies founded by BioTime, were successfully transitioned into independent, publicly-traded companies that created significant value for BioTime and its shareholders," said Alfred Kingsley, BioTime's Chairman of the Board. "We believe the formation and independent funding of AgeX, and a subsequent distribution to BioTime shareholders, will similarly unlock the significant value of the previously embedded BioTime assets related to the treatment of aging and age-related diseases, such as diabetes, obesity, heart disease, stroke and cancer."
AgeX Therapeutics focuses on technologies relating to cellular immortality and the regenerative biology of aging. Aging and age-related diseases have recently garnered significant investor interest, as evidenced by the formation of companies such as Calico, Human Longevity Inc., Unity Biotechnology, and Samumed, as well as others. These companies have attracted major financial supporters, many of whose investments were made at multibillion-dollar market valuations. AgeX's initial investors similarly include institutions and accomplished business leaders, whose support creates a foundation for the company's potential future success.
AgeX closed its initial $10 million equity financing in August of 2017 with a post-money valuation of approximately $68 million. BioTime currently owns approximately 85% of the outstanding shares of AgeX, with a post-money valuation of approximately $58 million, or 50 cents per BioTime share.
The equity financing is expected to fund AgeX's general operations and product development well into 2019, while saving BioTime more than $5 million annually on these programs and associated operational expenses.
Building on the recent success of the formation, funding and launch of AgeX, BioTime's management and Board are now exploring all options for making AgeX a publicly-traded company, including a potential tax-free distribution of all AgeX shares to BioTime shareholders. Once BioTime's management completes its discussions with investment banks and other financial firms, and its analysis of remaining tax, legal, commercial and regulatory issues, BioTime will announce further details of the resulting plan.
$BTX's management has a great ability to find non-dilutive financing.
Title: BioTime Awarded Grant from the NIH
• $1.56 Million Award
• Accelerates Retinal Restoration Program
ALAMEDA, Calif.--(BUSINESS WIRE)--Sep. 18, 2017-- BioTime, Inc. (NYSE American:BTX), a clinical-stage biotechnology company focused on developing and commercializing products addressing degenerative diseases, today announced that it has been awarded a grant of up to $1.56 million from the Small Business Innovation Research program of the National Institutes of Health (NIH).
The grant provides funding to further develop BioTime's innovative, next-generation vision restoration program for more advanced retinal diseases and injuries, which severely impact the quality of life for millions of people with no treatment option. This initiative aims at improving vision in people affected by blindness, whether caused by retinal injuries, age-related macular degeneration, retinitis pigmentosa or other causes.
"This grant is a significant validation of our vision restoration program from the NIH, which funds research and development that they believe has a strong potential for technology commercialization," said Francois Binette, Ph.D., Head of Global Development at BioTime. "At BioTime, we are leveraging our expertise to develop a rich pipeline of cell therapy products for ophthalmology. We remain focused on working with various institutions to support these activities through important non-dilutive funding like this grant."
BioTime scientists have grown a piece of 3-dimensional (3-D) retinal tissue using the Company's proprietary pluripotent cell technology platform. The 3-D retinal tissue contains all the cell types that comprise the human retina, including retinal pigment epithelium cells, photoreceptors and ganglion cells. Data presented at ARVO demonstrates that BioTime's 3-D retinal tissue closely resembles a developing human retina. The technology may ultimately be used to repair and restore sections of degenerated retinal tissue to improve vision caused by retinal degeneration and traumatic injury. The Company's 3-D retinal tissue technology may address the unmet need of implementing a retinal restoration strategy to address severe retinal degenerative diseases, with a mutation-free retinal tissue produced in a strictly controlled laboratory setting.
This vision restoration program will be a collaborative effort led by BioTime's Principal Investigator Igor O. Nasonkin Ph.D., with Dr. Simon Petersen-Jones, Michigan State University (MSU) and Dr. Magdalene Seiler, University of California, Irvine (UCI).
Dr. Petersen-Jones is the Myers-Dunlap Endowed Chair in Canine Health in the Department of Small Animal Clinical Sciences at MSU and is a board-certified veterinary surgeon. Dr. Petersen-Jones specializes in ophthalmology and has characterized numerous large-eye animal models that will play an essential role in demonstrating the feasibility and utility of BioTime's vision restoration therapies. Dr. Seiler is an Assistant Professor in the Department of Physical Medicine & Rehabilitation at the Sue and Bill Gross Stem Cell Research Center at UCI's School of Medicine and has developed a well-characterized small animal model for assessing structure/function of subretinal tissue transplantation.
About BioTime, Inc.
BioTime is a clinical-stage biotechnology company focused on developing and commercializing products addressing degenerative diseases. The Company's current clinical programs are targeting three primary sectors, aesthetics, ophthalmology and cell/drug delivery. Its clinical programs are based on two platform technologies: pluripotent cells and cell/drug delivery. 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. The foundation of the Company's cell delivery platform is its HyStem® cell and drug delivery matrix technology. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. and OncoCyte Corporation, and one private company, AgeX Therapeutics.
$BTX sub, Oncocyte, nearing the commercial launch of DetermaVU™ 4th Q 2017.
OncoCyte Reports Positive Analytical Validation Study Results of DetermaVu™ Lung Cancer Diagnostic Test
DetermaVu™ Launch On-Track for Fourth Quarter 2017
ALAMEDA, Calif., Sept. 18, 2017 (GLOBE NEWSWIRE) -- OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive blood-based liquid biopsy tests to assist in the early detection of cancer, announced today positive final results from the Analytical Validation Study of its liquid biopsy lung cancer diagnostic test, DetermaVU™. The data were presented by Philip McQuary Ph.D., Director of Product Development, OncoCyte Corporation, at the International Association for the Study of Lung Cancer (IASLC), in Chicago.
The accuracy results of the Analytical Validation Study reported today demonstrate sensitivity of 94.4%, specificity of 67.5% and Area Under the Curve (AUC) of 0.93, which means that 93 percent of the samples tested during the Analytical Validation were correctly diagnosed. These data are consistent with the data reported in May at the American Thoracic Society 2017 International Conference.
Sensitivity and specificity are statistical measures of test performance, with sensitivity measuring the percentage of malignant nodules that are identified correctly by the test and specificity measuring the percentage of benign nodules correctly identified. The AUC of a test is a measure of overall global accuracy that combines sensitivity and specificity, with 1.0 being perfect accuracy and 0.50 being a random result. The score of 0.93 reported at the recent IASLC meeting means that 93 percent of the samples were correctly identified.
The next step in the process leading to commercial launch of DetermaVu is a CLIA Validation study, which is now underway and expected to be completed in the third quarter of this year. If the CLIA Validation study is successful, the final step will be a Clinical Validation study, which is expected to be completed in the fourth quarter of this year. If the Clinical Validation study is successful, OncoCyte plans to launch DetermaVu. OncoCyte believes that at launch DetermaVu will be the only commercially available liquid biopsy lung cancer product in what the Company estimates is an up to $4.7 billion annual market opportunity in the U.S.
“The new data seen in the Analytical Validation Study provide further evidence of the reliability of the DetermaVu assay system in identifying cancerous nodules,” stated Lyndal Hesterberg, Ph.D., Senior Vice President, Research and Development. “These data give support our belief that physicians will be able to use DetermaVu with confidence in their clinical practice to help patients make more informed treatment decisions.”
William Annett, President and Chief Executive Officer, commented, “We are excited that the results reported at the IASLC conference confirm the positive data reported in May at the American Thoracic Society meeting. If our upcoming Clinical Validation study is successful, we intend to commercialize DetermaVu in the fourth quarter of 2017.”
Analytical Validation
The studies required for Analytical Validation have been established in the CLSI (Clinical Lab Standards Institute) Guidelines. These guidelines cover the testing for such matters as limits of quantitation, precision, reproducibility, and interfering substances. OncoCyte has completed all of these studies successfully.
The new Analytical Validation data support expectations that the test’s performance will continue to be robust. The completion of the study establishes the performance characteristics of OncoCyte’s lung cancer diagnostic test and, if the Clinical Validation studies are successful, will allow for industrial-scale operations under real world conditions.
OncoCyte believes that DetermaVu could result in a substantial reduction in the number of unnecessary, expensive lung biopsies performed annually in the U.S., thereby representing a fundamental advancement in the more accurate diagnosis of suspicious lung nodules by allowing physicians to determine which patients need biopsies versus those who may only need follow-up imaging. The Company estimates that approximately 1.4 million patients annually in the U.S. could benefit from the test. Depending on market penetration and reimbursable pricing, this could translate into a market opportunity of up to $4.7 billion annually.
Clinical Validation Stage Underway
The final stage of development following the now completed Analytical Validation Study is Clinical Validation. This stage consists of two distinct sets of studies that will be carried out in OncoCyte’s new CLIA approved clinical laboratory. The first step is CLIA Lab Validation. In this study, OncoCyte will assay approximately 120 samples previously tested in the 299-patient study presented at the ATS meeting, with the goal of demonstrating that OncoCyte’s new clinical laboratory provides the same results on clinical samples as those obtained in OncoCyte’s R&D lab. This study is underway.
Upon successful completion of the CLIA Lab Validation study, the second step will be two CLIA Lab Clinical Validation studies. In these studies, OncoCyte will perform assays on blinded prospectively collected samples to assess the performance of the full diagnostic system against clinically confirmed diagnoses. OncoCyte will perform Clinical Validation on two sets of samples. The first study will consist of approximately 300 samples. If the results of the study are consistent with results to date, OncoCyte will launch DetermaVu.
The second study will be conducted post-launch on approximately 200 additional samples to provide additional data to increase the likelihood that physicians will adopt the test and that insurance companies and Medicare will provide reimbursement coverage for the test.
About OncoCyte Corporation
OncoCyte is focused on the development and commercialization of novel, non-invasive blood and urine (“liquid biopsy”) diagnostic tests for the early detection of cancer to improve health outcomes through earlier diagnoses, to reduce the cost of care through the avoidance of more costly diagnostic procedures, including invasive biopsy and cystoscopic procedures, and to improve the quality of life for cancer patients. While current biopsy tests use invasive surgical procedures to provide tissue samples in order 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’s pipeline products are intended to be confirmatory diagnostics for detecting lung, breast and bladder cancer. OncoCyte’s diagnostic tests are being developed using proprietary sets of genetic and protein markers that differentially express in specific types of cancer.
WDDD?
Let me get it straight: You are saying that an OTC Biz worth <8Mill Patent Troll, Zero Rev., Burning through >2M yearly losses, who pays its execs >200M per Annum, has a case to take down Bungie, ATVI, 7 Bill Rev, limitless legal and tech resources in a legal action from 2012?
You're saying that this is so important that ATVI treats this "Risk" with a general "immaterial" comment on the Financial Reports, against the advice of the top legal counsel money can buy?
You're saying that this is going to crater the stock but the CEO and insiders are not getting rid of the stock, even though they are closely aware of this terrible risk?
You're saying they know it from 2012 and yet did not find a workaround with all the infinite resources, man hours, and brain power they pack?
You're saying they can't buy the whole damn money losing troll for ten times its market cap and still not feel pinched if this is a real issue, and still don't do so?
Well. I would suggest you contact IR or just buy some puts if you're spooked. I would not suggest you panic as yet. it's 'wee bit too early, mate.
$BTX Sub Oncocyte recruits Sales Exec as commercialization efforts begin.
Seasoned Diagnostics Sales Executive Joins OncoCyte to Drive Commercialization and Future Sales Initiatives of DetermaVu™, the Company’s Novel Liquid Biopsy Lung Cancer Diagnostic
ALAMEDA, Calif., Sept. 05, 2017 (GLOBE NEWSWIRE) -- OncoCyte Corporation (NYSE AMERICAN:OCX), a developer of novel, non-invasive tests for the early detection of cancer, today announced that Michael G. Vicari has been appointed to the newly created position of Vice President of Sales.
Mr. Vicari will report directly to William Annett, President and Chief Executive Officer. He will be responsible for the development and successful implementation of the Company’s domestic and international sales strategies, with an initial focus on the expected fourth quarter U.S. launch of DetermaVu™, the Company’s liquid biopsy lung cancer diagnostic.
“Our commitment to building out and executing our sales strategy reflects our plan to make DetermaVu™ the first test of its kind to reach the medical market, and we expect the U.S. commercial launch in the fourth quarter of this year,” said Mr. Annett. “Michael’s experience building and leading sales organizations at major diagnostic companies, and proven success in driving significant revenues, will be invaluable as we launch DetermaVu™ and drive adoption by physicians.”
Mr. Vicari brings 35 years of successful sales and marketing leadership within the healthcare industry, including the launch of several important diagnostic products. Before joining OncoCyte, he was with Eurofins Scientific as Vice President of Sales & Marketing for the Clinical Diagnostics business where he established two separate sales and marketing organizations for EGL (rare genetic testing) & NTD (prenatal testing) while leading all commercial functions.
Prior to Eurofins, he was Vice President of Sales for Sequenom, Inc., leading sales and strategy for nearly five years. While at Sequenom, Mr. Vicari led the successful launch of their revolutionary women’s health test, NIPT MaterniT21, and launching of the Universal Carrier Screen, NIPT VisibiliT, and drove overall Sequenom sales from $0 to over $150 million per year. Prior to Sequenom, Mr. Vicari was the Vice President of Sales and Marketing for Oncology/HIV at Monogram Biosciences before it was acquired by LabCorp. In this role, he led sales, marketing and clinical training and also managed the launch of HerMark for breast cancer. Mr. Vicari has served in senior commercial leadership roles at Genentech, Corixa Oncology, and MedImmune.
“OncoCyte is approaching an exciting inflection point as it prepares for the anticipated launch of DetermaVu™, and I’m thrilled that I will be spearheading the launch and commercial rollout of this important product,” commented Mr. Vicari. “DetermaVu™ has the potential to change the paradigm in lung cancer diagnostics, thereby saving lives and lowering treatment costs for millions of patients by helping to identify lung cancer at an earlier, more treatable stage, and reducing the need for potentially dangerous and expensive invasive biopsies. I look forward to working tirelessly with the entire team to make DetermaVu™ a commercial success.”
Insiders buy @ 2.8
I also hold a small long position.
Mind you, watch the FD Outstanding figure. The larger it is (due to dilution) the LESS impact the good news WILL HAVE on your holding.
The LARGER stock (not derivatives) position EXECUTIVES own, the LESS they are inclined to allow dilution.
Earlier caution is still warranted
Israel Innovation Authority invests another $2M in $BTX to develop #Opragen.
$BTX management has very good track of finding non Dillutive financing, Just what you want to see in a pre revenue Biotech.
BioTime, Inc. has added a news release to its Investor Relations website.
Title: BioTime Announces $2 Million Grant for Further Development of OpRegen® for Dry-AMD
Date(s): 14-Aug-2017 7:00 AM
For a complete listing of our news releases, please click here
ALAMEDA, Calif.--(BUSINESS WIRE)--Aug. 14, 2017-- BioTime, Inc. (NYSE MKT:BTX), a clinical-stage biotechnology company focused on developing and commercializing products addressing degenerative diseases, has been awarded a new grant for 2017 of up to 7.2 million Israeli New Shekels (approximately $2 million) from the Israel Innovation Authority (the "IIA"). The grant provides funding for the continued development of OpRegen®, and to date the IIA has provided annual grants totaling approximately $12 million.
OpRegen® is currently in a Phase I/IIa dose-optimization clinical study, which in July 2017 received authorization from the Data Safety Monitoring Board (DSMB) to move forward with enrollment of cohort 3. In cohort 3, BioTime plans to treat patients at sites in Israel and the U.S. Data reported to date have shown continued engraftment through the one year follow-up with encouraging potential structural improvement. In addition, no serious adverse events have been reported, indicating a continued favorable safety profile. BioTime expects to share more data at the American Academy of Ophthalmology (AAO) later this year.
"This new grant demonstrates the continued high level of support and confidence that the Israel Innovation Authority has in our development of cell therapy-based treatments," said Adi Mohanty, co-Chief Executive Officer of BioTime.
As noted above, the grant was awarded by the IIA for the development of OpRegen® to Cell Cure Neurosciences, a majority-owned subsidiary of BioTime.
Mike West @ 2ndQ conference call:
“Of all the technology I have even been involved with, from Telomeres to Pluripotent Stem Cells, the constellation of AgeX Assets are the finest, most powerful platform I have EVER been associated with”.
Subscribers Up 64% YOY, Rev up 56%. All as planned.
BOULDER, Colo., Aug. 07, 2017 (GLOBE NEWSWIRE) -- Gaia, Inc. (NASDAQ:GAIA), a conscious media company, reported financial results for the second quarter ended June 30, 2017.
Second Quarter 2017 vs. Same Year-Ago Quarter
64% subscriber growth generated 68% increase in streaming revenues to $6.1 million
Total revenues up 56% to $6.6 million
Gross margin up 390 basis points to 86.1%
“The momentum in our business has continued to strengthen as we again exceeded our accelerated subscriber growth target, while customer acquisition costs continue to track below plan,” said Jirka Rysavy, Gaia’s CEO. “We also continued to grow our content library, ending the quarter at 8,000 titles.”
Gaia’s special report “Unearthing Nazca,“ part of a new series exploring a rare archeological discovery in Peru, has garnered over 60 million views on Gaia’s website, YouTube and other social channels. While initial discoveries are provided free of charge, this level of views demonstrates the size of the market interested in Gaia’s content.
Gaia’s paying subscriber count increased 64% to 277,800 on June 30, 2017 from 169,500 on June 30, 2016. This follows 58% year-over-year subscriber growth in the first quarter of 2017 and 45% growth in the second quarter of 2016. The company expects to further increase its year over year subscriber growth rate to 70% during the third quarter of 2017.
Second Quarter 2017 Financial Results
Total revenues in the second quarter increased 56% to $6.6 million from $4.2 million in the same year-ago quarter. This was due to 68% growth in streaming revenues, which was driven by the 64% increase in paying subscribers versus June 30, 2016.
Gross profit in the second quarter increased 64% to $5.6 million compared to $3.5 million in the year-ago quarter. Gross margin increased 390 basis points to 86.1% from 82.2% in the second quarter of 2016 due to increased revenues and the related leverage on streaming costs and Gaia’s media library.
Total operating expenses in the second quarter were $12.0 million compared to $6.4 million in the year-ago quarter. The increase was due to the planned increase in marketing expenses associated with the announced acceleration of subscriber growth throughout 2017.
Net loss in the second quarter was $6.3 million or $0.42 per share, compared to a net loss of $2.4 million or $0.10 per share in the year-ago quarter. The 2017 per share amount reflects Gaia’s repurchase of approximately 40% of its outstanding shares in July 2016.
As of June 30, 2017, the company had $36.9 million in cash, an unencumbered corporate campus and no debt.
2Q2017: "The second quarter of 2017 was very productive for BioTime, with numerous significant clinical, financial and operational accomplishments. BioTime and its subsidiaries and affiliates now have six products in clinical trials. The data from those trials continue to be positive and encouraging," said Adi Mohanty, Co-Chief Executive Officer.
"On the strength of the positive results from our pivotal study of Renevia, we are preparing to file for a CE mark for commercial approval in Europe. Our goal is to commercialize Renevia in its first indication in 2018. For OpRegen, our therapeutic product candidate for the treatment of dry AMD, we were pleased to receive DSMB approval to advance the ongoing Phase I/IIa trial to the third cohort, which will include clinical sites in the U.S."
"We continue to make progress on simplifying our corporate structure to allow us to execute our objectives more efficiently, as well as to make it easier for investors and other external stakeholders to better understand BioTime," continued Mr. Mohanty.
"We achieved an important milestone toward accomplishing these goals with the launch of AgeX Therapeutics, a subsidiary formed to consolidate our early-stage research and development programs related to the biology of aging and age-related disease. AgeX recently commenced operations following a $10 million equity financing."
Highlights & Clinical Progress:
Renevia® (adipose cells + cell delivery matrix)
• Renevia® successfully met its primary endpoint in a pivotal trial in patients with HIV-associated lipoatrophy(facial fat loss) conducted in Europe. Treated patients retained approximately 100% of transplanted volume at 6 months compared to no incremental hemifacial volume in the untreated patients (p<0.001). All Renevia transplants were shown to be safe and well tolerated and there were no serious adverse events during the trial.
• BioTime is on track to file for CE Mark for commercial approval for Renevia in Europe by the end of 2017.
• Additional trials in the U.S. are planned that target a broader $7 billion aesthetics market opportunity, which is consistent with the previously stated goal of indication and geographic expansion for Renevia.
OpRegen® (retinal pigment epithelial cells)
• In April, new positive clinical data on OpRegen were presented at the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO). The data, from the first and second cohorts of the ongoing Phase I/IIa clinical trial in the advanced form of dry-AMD, showed that OpRegen cells engraft and that there was evidence of a biological response.
• The Data Safety Monitoring Board (DSMB) monitoring the Phase I/IIa OpRegen trial has authorized BioTime to move forward with enrollment for cohort 3 which will include two US sites with leading ophthalmologists.
• An abstract related to the Phase I/IIa OpRegen trial has been accepted for presentation at the American Academy of Ophthalmology (AAO) annual meeting being held in New Orleans, November 11-14, 2017.
• BioTime expanded its ophthalmology program with the signing of a revised and expanded licensing agreement with Hadassah Medical Organization of Jerusalem, Israel. The revised and expand license agreement increases BioTime's field-of-use for RPE cells to all eye disorders, and also adds photoreceptor cells for all eye disorders.
AST-OPC1 (oligodendrocyte progenitor cells)
• In June, BioTime's affiliate, Asterias Bio-Therapeutics (NYSE MKT: AST) announced new 9-month follow-up data from the company's ongoing SCiStar Phase I/IIa clinical trial. The results showed that previously reported meaningful improvements in arm, hand and finger function in the 10 million cell cohort treated with AST-OPC1 cells have been maintained and in some patients have been further enhanced 9 months following dosing.
• The FDA has accepted Asterias' amendment to the clinical research protocol for the SCiStar trial to include patients with a C-4 spinal cord injury, the second most common form of cervical spinal cord injury.
Liquid Biopsy (lung cancer confirmatory blood test)
• In May, BioTime's affiliate, OncoCyte (NYSE MKT: OCX) presented positive results from its 300-patient multi-site R&D validation study for its lung cancer diagnostic test at the American Thoracic Society 2017 International Conference (ATS) in Washington, D.C. Results from this study of the optimized final predictive algorithm confirmed the data from a previous study completed in 2016 and further validate the test's commercial potential.
• OncoCyte is on track to launch its lung cancer confirmatory liquid biopsy diagnostic test in 2017. The test could eventually replace a high percentage of invasive, risky, and expensive lung biopsies with simple blood tests, improving outcomes for patients while also capturing significant cost savings for the U.S. healthcare system. The test targets a market opportunity believed to exceed $4 billion annually.
Simplification and Unlocking Value
New Subsidiary AgeX Therapeutics, Inc.
• In April, BioTime announced the formation of AgeX Therapeutics, Inc. a new subsidiary that will focus on applying technology relating to cell immortality and regenerative biology, to aging and age-related diseases. AgeX has three initial areas of product development: pluripotent stem cell-derived brown adipocytes (AGEX-BAT1); vascular progenitors (AGEX-VASC1); and induced Tissue Regeneration (iTR). Initial planned indications for these products are Type II diabetes, cardiac ischemia, and cancer, respectively.
• In August, AgeX closed an equity financing to raise $10 million. The transaction values AgeX at approximately $68 million. BioTime retains approximately 87% ownership of AgeX.
Value of Holdings in Public Affiliates
At June 30, 2017, BioTime held common stock in publicly-traded affiliates valued at $153.5 million. This amount was the market value of BioTime's 21.7 million shares in Asterias Bio-Therapeutics (NYSE MKT: AST) and 14.7 million shares in OncoCyte (NYSE MKT: OCX).
Second Quarter Financial Results
Cash Position and Marketable Securities: Cash, cash equivalents, restricted cash in escrow, and available for sale securities totaled $20.9 million as of June 30, 2017, compared to $24.7 million as of March 31, 2017.
Revenues: BioTime's revenue is generated primarily from research grants, licensing fees and royalties, and subscription and advertising from the marketing of online database products. Total revenue was $381,000 for the second quarter of 2017, compared to $1.3 million in the second quarter of 2016.
Operating Expenses: Operating expenses for the second quarter of 2017 were $10.7 million. On an adjusted basis, operating expenses were $8.8 million, of which $7.5 million was mainly attributable to our clinical programs, $0.8 million in expenses is expected to be funded by AgeX investors going forward and $0.5 million was incurred by our subsidiary LifeMap Solutions, expenses, which are not expected to recur.
Our operating expenses for the six months ended June 30, 2017 were $22.3 million. Adjusted operating expenses were $18.2 million for this period, including $14.4 million spent on our clinical and early stage programs. The remaining $3.8 million in expenses were contributed by OncoCyte during the period in 2017 in which it was consolidated or were in areas to be funded by AgeX going forward; these expenses are not expected to recur.
Cash expenditures in the first half of 2017 were higher than normal due to annual bonuses, AgeX formation costs and some project-based, non-recurring legal expenses. Cash expenditures were further impacted in the second quarter of 2017 due to timing of the payments of certain expenses, including executive bonuses and an extra payroll period.
The reconciliation between GAAP and non-GAAP operating expenses by entity, is provided in the financial tables included with this press release.
R&D Expenses: Research and development expenses were $6.3 million for the second quarter of 2017, compared to $8.9 million for the comparable period in 2016, a decrease of $2.6 million. This decrease was primarily attributable to the deconsolidation of Asterias in May 2016 and OncoCyte in February 2017.
G&A Expenses: General and administrative expenses were $4.4 million for the second quarter of 2017 compared to $6.6 million for the comparable period in 2016. The $2.2 million decrease was primarily due to the deconsolidation of Asterias and OncoCyte.
Net Income or loss attributable to BioTime: Net loss attributable to BioTime was $11.7 million, or ($0.11) per basic and diluted common share for the three months ended June 30, 2017, compared to net income of $24.5 million, or $0.26 per basic and diluted common share for the three months ended June 30, 2016. For the six months ended June 30, 2017, net income attributable to BioTime was $37.6 million, or $0.34 per diluted common share, compared to $7.4 million, or $0.08 per share for the six months ended June 30, 2016. Results in each period were primarily driven by noncash deconsolidation gains and noncash gains and losses in the changes in share prices of our public affiliate investments in Asterias and OncoCyte common stock.
Conference Call and Webcast Details
BioTime is hosting a conference call and webcast today, Wednesday, August 2, at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss the results and recent corporate developments. 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 13665025. 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/.
BioTime $BTX Subsidiary AgeX gets 10$ funding. 87% Ownership. Possible distribution to BTX holders.
Leverages Intellectual Property Assets from the BioTime Group of Companies Relating to Cellular Immortality and Regenerative Biology
Funding to Advance the Development of Products Targeting Large Markets Associated with Age-Related Disease
ALAMEDA, Calif. --(BUSINESS WIRE)--Aug. 2, 2017-- AgeX Therapeutics, Inc. (AgeX), a subsidiary of BioTime, Inc. (NYSE MKT: BTX), today reported that it has successfully raised $10 million in equity financing to fund its operations. Following the financing, BioTime continues to own about 87% of AgeX's outstanding shares.
The financing is expected to fund preclinical development at AgeX as well as building the company's operational infrastructure. The financing may also lead to a registration and distribution of a to-be-determined percentage of the AgeX shares to BioTime shareholders, after which AgeX would trade as a public company.
Aging is the demographic trend of our time. It is estimated that approximately 80% of the $3 trillion of health care expenditures in the United States is attributable to chronic disease.
Approximately 90% of the elderly have one chronic degenerative disease and 77% have two or more. There is, therefore, strong interest in the biopharmaceutical industry for novel and cost-effective regenerative therapies targeting these large and growing markets.
AgeX was formed in early 2017 to develop BioTime technology relating to cell immortality and regenerative biology by developing products for the treatment of aging and age-related diseases.
Initial product development plans include: pluripotent stem cell-derived brown adipocytes (AGEX-BAT1); vascular progenitors (AGEX-VASC1); and induced Tissue Regeneration (iTR).
Initial planned indications for these products are type II diabetes, cardiac ischemia, and cancer, respectively.
A recent keynote presentation on The Future of Aging as well as a discussion with Dr. Aubrey de Grey on AgeX business plans is available online for viewing.
BioTime has licensed or assigned to AgeX certain assets related to the development of these and related products.
BioTime has retained all assets related to its core areas of focus in ophthalmology, orthopedics, medical aesthetics, and drug delivery, including its Renevia and OpRegen products.
In addition to its ownership of AgeX shares, BioTime will retain its ownership in Asterias Biotherapeutics (NYSE MKT: AST) and OncoCyte Corporation (NYSE MKT: OCX).
BioTime has assigned to AgeX its ownership of the private subsidiaries LifeMap Sciences, Ascendance Biotechnology, and ReCyte Therapeutics.
BioTime's Co-Chief Executive Officer, Michael D. West, Ph.D. will serve as AgeX's Chief Executive Officer.
Participants in the financing included: IBS Capital LLC managed by David A. Taft; KIZOO Technology Capital GmbH , which provides early stage financing in SaaS, Internet & Mobile Services with a growing focus on Rejuvenation Biotechnology as part of Michael Greve's Forever Healthy Initiative, to directly support companies turning research on molecular and cellular repair of the root causes of aging into therapies for human application; and Jim Mellon, a visionary entrepreneur known for his skills in identifying emerging global trends. He has authored a number of books, including: Wake Up! Survive and Prosper in the Coming Economic Turmoil, published by John Wiley in 2005; Cracking the Code, published by John Wiley in 2012; and is soon to publish Juvenescence, on the aging of the baby boom population and the anticipated boom in the biotechnology of aging.
Other participants in the financing included BioTime and founders of successful firms in the health care, technology, and financial fields, including John Mauldin, founder of Mauldin Economics, and BioTime's Chairman, Alfred Kingsley.
"The technology of AgeX is the culmination of over 25 years of research and development," said Michael D. West, Ph.D., CEO of AgeX and co-CEO of BioTime . "We believe AgeX is well-positioned to lead in the emerging field of aging biotechnology, delivering on regenerative therapies targeting some of the largest market opportunities in the aging demographic."
"AgeX's formation and funding is an important step in the execution of our strategy, by allowing us to focus our resources on our core clinical programs, Renevia and OpRegen, which have recently reported positive data," stated Adi Mohanty, co-CEO of BioTime . "As a part of our strategy of unlocking value for our shareholders, we may distribute some or all of our holdings in AgeX to BioTime shareholders in the coming quarters. The timing of such distribution has not been determined. We are carefully examining all strategies including the ones we implemented to achieve increased shareholder value when we created Asterias and OncoCyte."
About AgeX Therapeutics
AgeX Therapeutics, Inc. , a subsidiary of BioTime, Inc. (NYSE MKT:BTX), is a biotechnology company applying technology relating to cell immortality and regenerative biology, to aging and age-related diseases. The company has three initial areas of product development: pluripotent stem cell-derived brown adipocytes (AGEX-BAT1); vascular progenitors (AGEX-VASC1); and induced Tissue Regeneration (iTR). Initial planned indications for these products are Type II diabetes, cardiac ischemia, and cancer respectively. More information on AgeX can be found on the company's web site.
About BioTime
BioTime is a clinical-stage biotechnology company focused on developing and commercializing products addressing degenerative diseases. Its clinical programs are based on two platform technologies: pluripotent cells and cell/drug delivery. 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. The foundation of the Company's cell delivery platform is its HyStem® cell and drug delivery matrix technology. The Company's current clinical programs are targeting three primary sectors, aesthetics, ophthalmology and cell/drug delivery. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. ("Asterias") and OncoCyte Corporation ("OncoCyte").
https://www.yahoo.com/amphtml/finance/news/reliq-health-technologies-announces-live-120000258.html
That's good news for the Reliq Health Technologies.
However, what serious Investors will be paying very close attention to is this:
Will Dr. Lisa Crossley establish (at the market) a sizable position of the stock (trading now at 0.125$CAD, M.Cap 10 Mill)?
will IUGO Health (the underlying business) founders @LeoGodreault and Giancarlo De Lio @gdelio be buying ANY STOCK AT ALL?
Pay close attention to this indicator.
When all founders (Leo, Giancarlo, Lisa) come to the conclusion their IUGO Health (held by Reliq Health Technologies) is going to make investors rich, they will be the first ones to buy at the market at least a year's salary worth of Stock.
If they Don't - trust they have serious doubt of know not to risk their hard earned dollar, and you should follow what they do, not what they say.
careful study of financials and reports and deep DD on the people involves raises serious issues, per our opinions:
- Serious issues with the Board.
- Serious issues with the credibility of the financial backers.
- Serious issues with the Capital structure and massive dilution.
- Serious issues with compensation of the CEO.
- Serious issues with the stock holdings of the KEY terminals and leaders.
This business is still third rate nano business, being gutted for insiders.
Dr. Lisa Crossley has yet to succeed in bringing the credibility the business needs, even when the issues at stake were communicated to her.
Some paid stock promotion is going on on the internet, pay attention to cheerleaders who fail to point out the obvious failures of the business or fail to ask the CEO serious questions and just pump "good news" on twitter.
IUGO + Lisa's contacts may be a great idea.
Wrapped in the current corporate envelope and managed as it is right now - it should be off long term investor's list.
We will be monitoring the situation closely.
The best path forward for investors is a serious R/S (at least 10:1), bringing the S. count to single millions FD, wiping out old shady owners in the company and bringing in serious investors, board and large fully paid holding by execs, IUGO staff, and Board. Shrinking the Board to under 7 participants who actually bring serious value (no puppet board, no individuals reprimanded by Canadian securities commissions).
in other words, real business.
Until that time, the likelihood (IOHO) is any dollar value created will be funneled out by behind the curtain controllers of the company.
'HEARTHSTONE' INSPIRES CHINA'S EVOLVING DIGITAL GAMING MARKET IN SHANGHAI.
https://goo.gl/ZSwjuU
$BTX OpRegen® Briefing links.
http://lifesci.rampard.com/20170725/BioTime%20Final.pdf
Great one hour video of the presentation: http://lifesci.rampard.com/20170725/index.jsp
Lot of important Data - Worth Investor's time.
OncoCyte Receives $5.74 Million in Proceeds from Exercise of Warrants
ALAMEDA, Calif., July 25, 2017 (GLOBE NEWSWIRE) -- OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive tests for the early detection of cancer, today announced the receipt of $5.74 million through the cash exercise of 1,766,923 common stock purchase warrants. Each warrant was exercised to purchase one share of common stock for $3.25 per share. The warrants were issued as part of a $10.5 million financing completed in August 2016 and would have otherwise been exercisable until August 2021.
The exercise transactions were negotiated with certain warrant holders as a means of raising additional near-term working capital. In consideration for the exercise of the warrants, two warrant holders received new warrants to purchase the same number of shares purchased on exercise of the prior warrant, with an exercise price of $5.50 per share; another warrant holder received a new warrant to purchase the 50% of the number of shares purchased on exercise of the prior warrant, with an exercise price of $3.25 per share. The three warrants have a five-year term from the date of issuance.
A fourth warrant holder received (i) a new warrant to purchase 50% of the number of shares purchased on exercise of the prior warrant with an exercise price of $5.50 per share and (ii) a second new warrant to purchase 50% of the number of shares purchased on exercise of the prior warrant with an exercise price of $3.25 per share. These two warrants each have a two-year term from the date of issuance.
Following the exercise of the warrants, there were 31,313,200 shares of common stock outstanding and warrants to purchase an aggregate of 2,779,221 shares of common stock outstanding, including the warrants issued during August 2016 and February 2017 and the new warrants, with exercise prices ranging from $3.25 to $5.50. The proceeds from the warrant exercises strengthen OncoCyte’s balance sheet and will be used for general working capital purposes.
“The exercise of warrants by some of our largest shareholders provides additional working capital to advance the development of our novel liquid biopsy diagnostics for lung and breast cancer and prepare for the launch of our lung cancer diagnostic in the second half of 2017,” stated William Annett, President and CEO. “We appreciate the continued confidence in OncoCyte demonstrated by these warrant exercises and look forward to the achievement of additional significant milestones in 2017.”
BioTime’s subsidiary Oncocyte makes another successful step toward commercialization of Lung Cancer Diagnostic Test!
- Abstract to Present Complete Study Findings Submitted to a Scientific Conference -
- Final Stage of Development Commences-
ALAMEDA, Calif., July 24, 2017 (GLOBE NEWSWIRE) -- OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive blood-based liquid biopsy tests to assist in the early detection of cancer, announced today that it has successfully completed the Analytical Validation study of its liquid biopsy lung cancer diagnostic test. The results are consistent with the data reported in May at the American Thoracic Society 2017 International Conference (ATS), which demonstrated sensitivity of 95%, specificity of 73%, and Area Under the Curve (AUC) of 0.92. (An AUC of .92 means that 92% of samples were correctly identified.)
The final development step before the commercial launch of the lung cancer diagnostic test will be Clinical Validation, which has commenced with a planned completion in the fourth quarter of this year.
If Clinical Validation is successful and OncoCyte’s clinical laboratory receives CLIA certification, then the lung cancer test will be the only commercially available product in what the Company estimates is an up to $4.7 billion annual market opportunity in the U.S.
Analytical Validation
The studies required for Analytical Validation have been established in the CLSI (Clinical Lab Standards Institute) Guidelines. These guidelines cover the testing for such matters as limits of quantitation, precision, reproducibility, and interfering substances. OncoCyte has completed all of these studies successfully.
The new Analytical Validation data supports expectations that the test’s performance will continue to be robust.
The completion of the study establishes the performance characteristics of OncoCyte’s lung cancer diagnostic test and, if the Clinical Validation studies are successful, will allow for industrial scale operations under real world conditions.
The Company has submitted an abstract to present the data at a scientific conference this year.
“The data seen in this study ensure reliable and actionable liquid biopsy test results that physicians can use in clinical practice to help patients make more informed treatment decisions,” stated Lyndal Hesterberg, Ph.D., Senior Vice President, Research and Development. “The successful completion of the Analytical Validation study is an important milestone as we progress toward commercialization of the test in the second half of 2017 following CLIA certification of the Company’s laboratory and completion of the Clinical Validation stage.”
“We estimate that our lung cancer confirmatory diagnostic could result in a substantial reduction in the number of unnecessary, expensive lung biopsies performed annually in the U.S., thereby representing a fundamental advancement in the more accurate diagnosis of suspicious lung nodules by allowing physicians to determine which patients need biopsies versus those who may only need follow-up imaging,” said William Annett, President and Chief Executive Officer.
“We estimate that approximately 1.4 million patients annually in the U.S. could benefit from the test. Depending on market penetration and reimbursable pricing, we believe this could translate into a market opportunity of up to $4.7 billion annually.”
Clinical Validation Stage Underway
The final stage of development following the now completed Analytical Validation Study is Clinical Validation. This stage consists of two distinct sets of studies that will be carried out in OncoCyte’s new clinical laboratory. The first step is CLIA Lab Validation. In this study, OncoCyte will assay approximately 120 samples previously tested in the 299-patient study presented at the ATS meeting, with the goal of demonstrating that OncoCyte’s new clinical laboratory provides the same results on clinical samples as those obtained in OncoCyte’s R&D lab. This study has now begun.
On completion of the CLIA Lab Validation study the second step will be two CLIA Lab Clinical Validation studies. In these studies, OncoCyte will perform assays on blinded prospectively collected samples to assess the performance of the full diagnostic system against clinically confirmed diagnoses. OncoCyte will perform Clinical Validation on two sets of samples. The first study will consist of approximately 300 samples, and if the results of the study are consistent with results to date OncoCyte will launch its liquid biopsy lung cancer diagnostic test. All of the samples required for this first study have now been collected.
The second study will be conducted post-launch and on approximately 200 additional samples to provide additional data to increase the likelihood that physicians will adopt the test and that insurance companies and Medicare will provide reimbursement coverage for the test.
CLIA Certification
OncoCyte’s clinical laboratory must receive Clinical Laboratory Improvement Amendment (CLIA) certification from the state of California. The Company’s complete application for CLIA certification was submitted in March 2017 to the California Department of Public Health and is now under active review. The Company expects to receive CLIA certification during the second half of 2017.
Diagnostic Test Accuracy
Sensitivity and specificity are statistical measures of test performance, with sensitivity measuring the percentage of malignant nodules that are identified correctly by the test and specificity measuring the percentage of benign nodules correctly identified. The AUC of a test is a measure of overall global accuracy that combines sensitivity and specificity, with 1.0 being perfect accuracy and 0.50 being a random result. The score of 0.92 reported at the recent ATS meeting means that 92% of samples were correctly identified.
About OncoCyte Corporation
OncoCyte is focused on the development and commercialization of novel, non-invasive blood and urine (“liquid biopsy”) diagnostic tests for the early detection of cancer to improve health outcomes through earlier diagnoses, to reduce the cost of care through the avoidance of more costly diagnostic procedures, including invasive biopsy and cystoscopic procedures, and to improve the quality of life for cancer patients. While current biopsy tests use invasive surgical procedures to provide tissue samples in order 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’s pipeline products are intended to be confirmatory diagnostics for detecting lung, breast and bladder cancer. OncoCyte’s diagnostic tests are being developed using proprietary sets of genetic and protein markers that differentially express in specific types of cancer.
#OpRegen by Biotime $BTX:
The Company announced data from the Phase I/IIa clinical trial of OpRegen at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in May. The presentation reported new clinical trial data with two patients that were treated in cohort 2, where they received a dose of 200,000 cells. Imaging analysis suggests the transplanted OpRegen cells remained in place (engrafted) in an area of the scar that was completely depleted of retinal pigment epithelium (RPE) because of the advanced stages of the disease. Cell engraftment appears evident in four of the five patients treated thus far. There was also possible evidence of a biological response with some areas appearing to show structural improvement (a thickening of the area of the neural retina above the scar) without any signs of retinal edema, a fluid build-up that can further compromise vision.
PR:
Data From BioTime's Phase I/IIa OpRegen® Trial to be Presented at the 2017 American Academy of Ophthalmology (AAO) Annual Meeting
Date(s): 19-Jul-2017 7:00 AM
For a complete listing of our news releases, please click here
ALAMEDA, Calif.--(BUSINESS WIRE)--Jul. 19, 2017-- BioTime, Inc. (NYSE MKT: BTX), a clinical-stage biotechnology company developing and commercializing products addressing degenerative diseases, today announced that an abstract related to the Company's retinal tissue implant has been accepted for a paper presentation at the American Academy of Ophthalmology (AAO) annual meeting being held in New Orleans, Louisiana, November 11-14.
The abstract accepted for paper presentation is titled, "Phase 1 and 2a Study of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells Transplanted Subretinally in Advanced Dry-Form AMD Patients." The data will be presented by Dr. Oscar Cuzzani MD PhD, BioTime's Vice President of Clinical Development. With more than 30 years of experience as a physician and in clinical development, Dr. Cuzzani has a wealth of experience practicing retinal surgery, and has held senior level positions working at some of the best research organizations including the National Eye institute and the Bascom Palmer Eye Institute.
"The clinical work that our team, along with the principal investigators and other leading ophthalmologists, is conducting is of great importance for the millions of patients suffering from this debilitating disease and leading cause of blindness among the elderly population," commented Adi Mohanty, co-Chief Executive Officer. "This is a significant opportunity to broaden awareness among clinicians about the significant progress of the OpRegen program."
The Company announced data from the Phase I/IIa clinical trial of OpRegen at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in May. The presentation reported new clinical trial data with two patients that were treated in cohort 2, where they received a dose of 200,000 cells. Imaging analysis suggests the transplanted OpRegen cells remained in place (engrafted) in an area of the scar that was completely depleted of retinal pigment epithelium (RPE) because of the advanced stages of the disease. Cell engraftment appears evident in four of the five patients treated thus far. There was also possible evidence of a biological response with some areas appearing to show structural improvement (a thickening of the area of the neural retina above the scar) without any signs of retinal edema, a fluid build-up that can further compromise vision.
OpRegen is now in a Phase I/IIa dose finding study to evaluate its safety and efficacy in patients who have an advanced stage of the disease, and has received fast track designation by the FDA.
About OpRegen®
OpRegen®, which is being studied for the treatment of the dry form of age-related macular degeneration (AMD), consists of a suspension of Retinal Pigment Epithelial (RPE) cells that are delivered subretinally during a simple intraocular injection. RPE cells are essential components of the back lining of the retina, and function to help nourish the retina including photoreceptors. A proprietary process that drives the differentiation of human pluripotent stem cells is used to generate high purity OpRegen® RPE cells. OpRegen® RPE cells are also "xeno-free," meaning that no animal products are used at any point in the derivation and production process. The avoidance of the use of animal products eliminates some potential safety concerns. Preclinical studies in rats have shown that following a single subretinal injection of OpRegen®, the cells can rapidly organize into its natural monolayer structure in the subretinal space and survive throughout the lifetime of the animal. OpRegen® is designed to be an "off-the-shelf" allogeneic (non-patient specific) product. Unlike treatments that require multiple, frequent injections into the eye, it is expected that OpRegen® would be administered in a single procedure. OpRegen® was granted Fast Track designation from FDA, which allows more frequent interactions with the agency, and eligibility for accelerated approval and priority review. OpRegen® is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of BioTime, Inc.
About Dry Age-Related Macular Degeneration (Dry-AMD)
Macular degeneration affects approximately 11 million people in the U.S. and is the leading cause of blindness in people over the age of 60. Approximately 90 percent of these patients suffer from the dry form, for which there are no FDA-approved therapies. In dry-AMD, there is a loss or dysfunction of the layer of retinal pigment epithelial (RPE) cells generally in the region of the eye called the macula, which is the part of the retina responsible for sharp, central vision that is important for facial recognition, reading and driving. These RPE cells support the light detecting photoreceptor cells that are so critical to vision. When we look at something, the photoreceptors (rods and cones) detect the light and send the information to the brain allowing us to perceive our surroundings. The age-dependent loss of the RPE cells therefore leads to degeneration of nearby photoreceptors and this can lead to severe vision loss or even legal blindness. Generally, the damage caused by the "dry" form is not as severe or rapid as that of the "wet" form. However, in the advanced stage of dry macular degeneration widespread loss of RPE and photoreceptors in the macular area, called geographic atrophy, leads to severe vision loss. While therapeutics are available to treat the wet form of AMD, there are currently no FDA-approved therapies for dry-AMD.
It's the pattern it trades.
If you want to trade some of your position to relieve boredom, under 3$ been good place to buy trading position and over 3.5$ been good place to sell.
It's insignificant. Use it to add to full position if don't have one yet.
$BTX – OpRegen to be introduced to institutional investors, sell-side analysts, investment bankers, and business development professionals on 12 noon EDT on Tuesday, July 25, Live Webcast.
ALAMEDA, Calif.--(BUSINESS WIRE)--Jul. 18, 2017-- BioTime, Inc. (NYSE MKT: BTX), a clinical-stage biotechnology company developing and commercializing products addressing degenerative diseases, announced today that it will host a Key Opinion Leader event on the topic of dry age-related macular degeneration (AMD) in New York City on Tuesday, July 25. The meeting will feature a presentation by key opinion leader David S. Boyer, MD, Retina-Vitreous Associates, who will discuss the clinical perspective and cell therapy treatment options for patients with dry age-related macular degeneration.
Dr. Boyer is a world-renowned clinician, surgeon and educator. He completed his medical degree at the Chicago Medical School. In 1976, he finished his residency at the U.S.C. County Medical Center. A yearlong retinal surgery fellowship at the Wills Eye Hospital, located in Philadelphia, completed his training. He is currently a leading investigator for various national clinical trials on retinal diseases and serves as an advisor for multiple research, educational and charitable institutions.
BioTime's management team will also provide an overview of the Company's ongoing clinical development work with OpRegen®, being studied for patients with dry AMD, including recently presented new clinical trial data from this year's Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO). OpRegen is now in a Phase I/IIa dose finding study to evaluate its safety and efficacy in patients who have an advanced stage of the disease, and has received fast track designation by the FDA.
The lunch event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance to Mac@LifeSciAdvisors.com if you plan to attend in person, as space is limited.
A live webcast of the event, with slides, will be available at lifesci.rampard.com/20170725/reg.jsp and within the Investors section of the Company's website at www.biotimeinc.com.
So, Reliq Health Technologies Inc $RHT.V had am amazing full ZERO revenues the last report (for 1Q2017), after CEO Lisa forcasted millions in the Bank for shareholders.
to fund its 1.5 million net loss with hardlly ANY CASH LEFT, the company issued more and more stock and warrants creating a very unfavourable FD share Count.
some posters here did not understand why leading figures, led by Lisa, made sure NOT to buy shares at the market, and the results explain well why.
Dr. Lisa Crossley gets an F in Financial control and D in Execution for first quarter 2017.
Massive damage to the Share count and massive damage to credibility.
The Board is a MESS of dilitants (IMHO), count the number of Directors! Google has less Directors.
Still heavy influence of stock promoters trying to offload.
Lisa KEEPS on making a point of not building a position in the business. It seems she knows her hard earned cash is better off elsewhere.
You just might take here lead. do as she does, not as she says.
Next up: second quarter 2017 results.
will we see breaking even business or more losses?
$BTX DD links for AST-OPC1
Reminder:
a. $BTX owns $AST.
b. AST- OPC1 is the same treatment that gave a man with spinal cord injury the ability to use hands and arms, after just 10 million cells treatment. Last PR is double the amount.
List of Helpful links about the Biotime and Atrerias OPC-1 for DD purposes and new Shareholders:
- A video explaining about the company & therapies developed (2016)
So true.
Time arbitrage is one of the best advantages for investors.
I waited 5 years for ATVI to break through 10-12$ range.
Now, my returns are beating most investors you can think of.
I only care about next 5 years. In some cases 10.
Jefferies just woke up to figure out what that statement means, find the release that explains the short term impact no one seem to understand. In addition study the market for Esport-the company provided a good summery in resent filing.
Do the math,
ATVI is the top dog here. Next competitor is light years behind,
Good luck
More data, video, coming from ageX, Biotime, $BTX:
As you will recall AgeX is the new Subsidiary chosen to promote new therapies relating to Aging as a medical condition. Among the target are the preclinical development of Brown Fat Progenitor cells which are the reason why when we are young we can eat so much and not gain weight – they increase metabolism and burn energy (even without the exercise), as we grow old, we lose brown fat tissue and therefore are more inclined to gain fat just from looking at too many carbohydrates…
More about AgeX: lecture by Dr. West from July 2017. https://vimeo.com/224802223
My notes from the Video:
- “we are now in a position of succeeding, … , in demonstrating to investors, in rigorous ways that many of these technologies (to resolve aging as a medical condition) are at these point (possible to generate profitability).”
- Tidal wave of baby boomers causing demand + power of medical tech to address complex problems such as aging generate the ‘perfect storm’, opportunity to build significant value to shareholders by attacking the core biology of aging ITSELF, not just ‘a new pill for stroke’.
- This is a very early stage – there will be challenges and failures, but 10, 15 years from now, these technologies will change the world. Make no mistake, Agex is a long term play (which all investors should know and appreciate).
- Biotime’s pluripotent stem cell platform (PureStem) is a key element of the therapies that will be developed.
- The best payoff targets (in the context of Aging) out of 200 choices are:
o Brown Adipocytes (brown fat cells): Agex-BAT1 – can correct imbalance of metabolism in aging (weight gain) and metabolism of glucose – metabolic disorders. Insulin resistance. Type 2 diabetics.
o Coronary disease, heart disease. Blood plumbing problem is no. 1 killer. At embrio stage an embrio has vascular progenitors that simply flow to the heart and build the plumbing. BTX has identified them and patented them. AGEX – VASC1 Vascular aging is a big problem. Many ways heart fails and these can resolve them.
o Top secret program for some time, BTX's 'SkunkWorks' project: ITR (induced tissue regeneration): instead of scar tissue, straight regeneration of tissue (rebuilding tissue afresh). Patents filed on key aspects. Pan Organ concept. Solve fibrosis (major problems).
- To treat Aging will take a different business approach than other BioTech development course: Aging will require several approaches and will dictate a lot of cooperation - therefore perhaps different kind of competition with better chances of success (less direct competition and more cooperation form of development).
The mission of AgeX is to apply technology related to pluripotent stem cells and telomere biology to aging and age-related disease. AgeX is expected to have three initial areas of focus: 1) the development of pluripotent stem cell-derived brown adipocytes for the treatment of Type II diabetes and potentially obesity; 2) the development of vascular progenitors to improve circulation to ischemic tissues in patients suffering from heart disease; and 3) Induced Tissue Regeneration (iTR)TM - an emerging technology invented and patented by BioTime scientists that is designed to profoundly reprogram aged tissues in the body in a way that can restore a regenerative phenotype normally expressed only in the first few weeks of human development.
Link: https://goo.gl/LgbP83
These technologies were presented by Dr. Michael West in the following lecture “The Future of Human Aging” - video:
What is very exciting about AgeX is that all these new therapies can be now funded in a manner that better to BioTime and investors: a. Investors can fund these therapies directly (rather through BTX), b. BTX holding itself will be diluted somewhat in these undertakings, but Investors in BTX will not be diluted regarding the Assets held directly, c. PreClinical progress can continue while the short term assets can be further developed.
Managerial attention can remain focused on the very long term and the very short terms, and executives can push to attain the medium term business objectives.
PR Snip:
World-Renowned Aging Researcher and Biomedical Gerontologist to Lead AgeX's Research
ALAMEDA, Calif. & MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Jul. 13, 2017-- AgeX Therapeutics ("AgeX"), a subsidiary of BioTime, Inc. (NYSE MKT:BTX) with a focus on developing new therapies in the field of biomedical gerontology, today announced the appointment of distinguished researcher and advocate Aubrey de Grey, Ph.D. as Vice-President of New Technology Discovery.
"One of the world's foremost researchers in the science of aging, and a tireless advocate for such research, Aubrey will be a strong addition to AgeX as the Company is positioned to emerge as a leader in the field of biomedical gerontology," commented Michael D. West, Ph.D., co-CEO of BioTime. "He has already moved the field forward to a considerable degree and will help accelerate our research and development programs."
A biomedical gerontologist, Dr. de Grey is Co-Founder and Chief Science Officer of SENS Research Foundation, a 501(c)(3) public charity dedicated to researching, developing and promoting comprehensive regenerative medicine solutions for the diseases of aging. He will continue in his current capacity at SENS Research and his role at AgeX will be part-time. He is also editor-in-chief of the bimonthly academic journal Rejuvenation Research, from Mary Ann Liebert publishers. He has authored the books Ending Aging: The Rejuvenation Breakthroughs That Could Reverse Human Aging in Our Lifetime (co-author, 2008, St. Martin's Griffin) and The Mitochondrial Free Radical Theory of Aging (1999, R.J Landes) as well as numerous articles in peer-reviewed scientific journals. He is a Fellow of the Gerontological Society of America and the American Aging Association, and sits on the editorial and scientific advisory boards of many journals and organizations. He has been interviewed by a variety of top-tier media outlets, including CBS' "60 Minutes," the New York Times, FORTUNE, the Washington Post, TIME, and "The Colbert Report," among many others. He received his B.A. and Ph.D. from the University of Cambridge, in Cambridge, England.
"The opportunity to help Mike West shape AgeX is a huge next step in my vision of how to hasten the defeat of aging," said Dr. de Grey. "In creating a rejuvenation biotechnology industry, it is critically important to engage new companies and investors in this work. I am delighted to be involved in the work of a private company like AgeX to make this happen."
"Attracting Dr. de Grey to AgeX represents a significant milestone in the company's development and further enhances AgeX's emerging leadership," stated Adi Mohanty, co-CEO of BioTime. "Additionally, Dr. de Grey's appointment allows BioTime to better focus on its three core segments of ophthalmology, aesthetics and cell and drug delivery."
$BTX news: Asterias, Sub, provides an update about AST-OPC1:
As you'll recall, the medical researchers were wondering if the wonderful results gotten on AIS-A patients (extraordinary spinal trauma) may be even better with AIS-B patients will lesser degree of trauma. We will see come Jan 2018.
FREMONT, Calif., July 12, 2017 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (AST), a biotechnology company pioneering the field of regenerative medicine, today announced completion of enrollment and dosing of the AIS-B 10 million cell cohort in the company's ongoing SCiStar Phase 1/2a clinical study of AST-OPC1 in complete cervical spinal cord injury (SCI). In this cohort, five patients with AIS-B grade SCIs were administered 10 million AST-OPC1 cells. The company expects to report top-line six-month results from this cohort in January 2018.
"Completing enrollment and dosing of the first cohort of AIS-B patients marks another important milestone for our AST-OPC1 program," said Dr. Edward Wirth, Chief Medical Officer of Asterias. "AIS-B patients have some levels of sensation following their injury but like AIS-A patients have severe spinal cord injuries and no meaningful motor function below the injury site. We have already reported meaningful improvements in arm, hand and finger function for AIS-A patients dosed with 10 million AST-OPC1 cells and we are looking forward to reporting initial efficacy and safety data for this cohort early in 2018."
The SCiStar study has now completed enrollment and dosing in three of the five planned cohorts. The first completed cohort included three AIS-A patients who were administered a low dose of 2 million AST-OPC1 cells for the purpose of evaluating the safety of administering AST-OPC1 in the cervical spinal cord. The second completed cohort (Cohort 2) included six AIS-A patients who were administered 10 million AST-OPC1 cells, which is the first cohort dosed within the predicted efficacy dose range of 10 million to 20 million cells. In June 2017, Asterias reported 9 month data from Cohort 2 that showed improvements in arm, hand and finger function observed at 3-months and 6-months following administration of AST-OPC1 were confirmed and in some patients further increased at 9-months. Asterias will report 12-month efficacy and safety data from Cohort 2 later this year after the 12-month results are collected for the entire cohort.
The company is currently enrolling AIS-A patients dosed with the highest dose of 20 million cells, and the study's final cohort of AIS-B patients receiving 20 million AST-OPC1 cells is planned to begin enrollment later this quarter. The company intends to complete enrollment of the entire SCiStar study later this year, with multiple safety and efficacy readouts anticipated during 2017 and 2018.
On July 10, 2017, Asterias announced that the U.S. Food and Drug Administration accepted the company's amendment to the clinical research protocol for the SCiStar study. The amendment expands the eligibility criteria to include patients with a C-4 spinal cord injury and extends the dosing window from 14 to 30 days to 21 to 42 days post-injury.
The investment Thesis with BioTime is that this innovative leader in the field of Stem Cell Regenerative Medicine will continue developing and bringing to market innovative therapy after therapy for unmet conditions and diseases, centered around age and cell failure to correct or regenerate.
In the near future we are talking about the wrapping up of preparations to market and marketing of Renevia and Oncocyte cancer Blood tests. Then we have RPE cell therapy studies progressing nicely. Then – the main problem with BTX management is to choose what to develop. It’s a whole blue and empty ocean for them to enter.
Even the short term is 6 months at minimum, and even after launch, months will pass before the full commercial significance is visible.
But there is a high probability that within 5 years, we will own a profitable business spinning off / generating a massive host of regenerative medicine therapy.
With biotech things take time and then, one day – Boom, the valuation reflects the assets the business possesses.
Probably not a good idea to try trade this one, other than buying below 3$ and selling above 4.5$
Read prior posts to get a handle on the business.
Good luck.
Esport revenues alone will double it
Patience. You'll see double today's prices within due time and it will be at higher CAGR than the S&P500 buy FAR.
Input Capital Corp. Receives Grain Dealer Licence From Canadian Grain Commission
http://www.newswire.ca/news-releases/input-capital-corp-receives-grain-dealer-licence-from-canadian-grain-commission-631388153.html
Input is still a very low risk business for investors.
The main variable to determin what rate of return occurs from here on out is the speed the business increases its MT of Canola using all sorts of streams.
A Good expantion in the coming quarter, even off season for main streams, generated by the marketing streams will be a good sign.
curious to see how this develops.
Market Trends & What's happening out there, In the Aesthetics market.
Renevia.
Young people are turning to cosmetic procedures such as botox and dermal fillers as a result of social media pressure, according to a report.
A study by the Nuffield Council on Bioethics says government must protect people from an unregulated industry.
The report also condemns makeover apps and online plastic surgery games aimed at children as young as nine.
The authors fear such apps are contributing to growing anxieties around body image.
Much of the cosmetic procedures industry is unregulated so reliable data on its size is hard to come by.
In 2015 one market research company estimated the UK market could be worth as much as £3.6bn.
http://www.bbc.co.uk/news/amp/40358138
Switching from alternatives to Revenia is worth a discussion.
1. I don’t think the health of the drive to look good although aging needs explaining, nor the fact the market will only grow as people living in developing countries accumulate more wealth. People will seek better aesthetics treatment and will generate demand to get the newest, best therapy. That’s one very powerful driver for adoption.
2. Perhaps more important is the nature and dynamics of the Aesthetics providers (I’m talking about using Renevia solo). These are, on the most part, private small businesses such as Spas, quasi medical (Plastic Surgery Clinique’s). These players operate almost without moat as businesses and depend on their survival on retaining the costumers. You really need to go and see how these outfits operates: from Botox parties (doctors comes and injects 10-15 middle aged women at a private residence) or small spa, with women entering a room for 5-7 minutes, being injected and getting out. These outfits are usually competing against one another on price and / or technology. Customer loyalty is very low and these types of procedures are high gross margin (and more importantly don’t require high capex on machines such as laser hair removal, etc). The result is a natural business push by proprietors to get in people on the lower margin commodity business (such as hair removal or brow treatment or what have you) and then, upsell this type of high margin service, which only needs a nurse or doctor that can handle many people in one hour and generate large amount of profit. The bottom line is there is always a “nuclear arms race” to provide the best treatment, the newest option. Those that don’t – go bankrupt. So between the economic incentive and the end client demand, believe me, I feel confident in saying the demand for the treatment is going to take care of the uptake. Only little marketing is needed to inform the market about the new product. This is not Hospitals or Medical Doctors or some other very slow process (such as insurance companies requiring proof). The Fads that are in the market are ridiculous and still sell. This is good science good product better results. This is the first (I believe) market to blast forward.
3. Other more “Clinical” uses will pick up second as sheer private useage will increase penetration into society and act as a sort of Goodwill generator.
4. A hint confirming my assessment is how the Company is thinking about the possibility to use Renevia as a breast implant in the recent podcast . This is the private business setting Im talking about and I think they are dead on a big hungry market.
5. Much later will come all sort of more medical usage of the product and these will be longer term therapies slower to uptake as the medical and insurance institution are briefed and acquainted with the product and more research is done. The usage here will most likely be linked to the original purpose of the product: a delivery platform for the Stem Cell treatment the company is developing.
Hope this helps, TJ.
That's actually a very good sign. Means the Regen. Medicine subject crosses from being perceived "science fiction" to contemporary modern science. Good sign.
$BTX Investor presentation covering Renevia and AMD Therapy. Relatively low key IMHO considering the timelines to market with Renevia but providing hints to long term applications.
goo.gl/N0hLcu