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News Article | May 10, 2017
Site: www.prnewswire.com

Revenue for the third quarter of fiscal 2017 was , a 7% increase compared to revenue for the third quarter of fiscal 2016 and a 24% increase from reported in the second quarter of fiscal 2017. The increase in revenue is primarily due to improving results from the investments in sales personnel and implementation of a more aggressive sales and marketing strategy made earlier in the fiscal year. Prostate brachytherapy represented 89% of total revenue for the third quarter of fiscal 2017 compared to 82% in the third quarter of fiscal 2016 and 86% in the second quarter of fiscal 2017. Gross Profit was compared to in the same period last year and a gross loss in the second quarter of fiscal 2017. Gross Profit Margin was 23% in the third quarter compared to 6% in the third quarter of fiscal 2016. Gross Profit was positively impacted by process and manufacturing cost reductions and the leveraging of the increased revenue from improved sales. The 23% Gross Profit Margin for the third quarter is a 337% gain from the third quarter fiscal 2016. Total operating expenses were $1.68 million in the third quarter of fiscal 2017, a 21% increase compared to $1.39 million recorded in the third quarter of fiscal 2016. Increases in research and development and sales and marketing expenses of 79% and 76% respectively, were partially offset by a 9% decrease in general and administrative (G&A) expenses. The G&A decrease is primarily due to lower legal fees as well as the absence of other one-time personnel related expenses recorded in the year ago period. Operating loss was $1.39 million, a slight increase from the operating loss of $1.33 million for the third quarter of fiscal 2016. The net loss was $1.36 million, or $(0.02) per basic and diluted share, compared to a net loss of $1.20 million, or $(0.02), per basic and diluted share, for the same period of fiscal 2016. Basic and diluted per share results are based on weighted average shares outstanding of approximately 55.0 million shares in both periods. IsoRay had cash, cash equivalents and certificates of deposit of $10.4 million as of March 31, 2017, and no debt. "IsoRay's sales improved in the third quarter with revenue increasing 7% from the same period last year and 24% from the previous quarter. The revenue increase was driven by the more aggressive sales and marketing strategy we introduced earlier in the fiscal year that positions IsoRay and Cesium-131 as a leader in brachytherapy for prostate cancer treatment. This turnaround also underscores the quality of our recently expanded sales force, which is comprised of highly experienced brachytherapy sales people, most of whom are new to IsoRay. Combined with our renewed commitment to the prostate brachytherapy community, our message is gaining traction as our client roster has expanded with both new and returning accounts," said Thomas LaVoy, Chairman and CEO. "Our results also benefited from the cost reductions and production and process improvements that we've put in place over the last year. These actions, in concert with the quarterly revenue increase, led to an expansion of the Gross Profit Margin to 23%, a significant increase over prior periods. We've strategically reallocated the funds we've freed up from operating more efficiently throughout our organization into revenue producing areas such as sales and marketing and research and development, and we believe that it is these substantial investments which have led to the improved results in the third quarter." "We continue to have an ongoing commitment in the development of the GammaTile, a novel system that is a combination of Cesium-131 seeds embedded into collagen tiles, developed and owned by GammaTile LLC, that delivers brain brachytherapy treatment at the time of surgery. GammaTile LLC collaborates with the Barrows Neurological Institute, one of the largest neurological disease treatment and research institutions and consistently ranked as one of the best neurosurgical training centers in U.S. Over 80 patients have been treated in clinical trials with GammaTile to date and results point to an extension of the median time to recurrence and a very low rate of side effects. We submitted an application for 510(k) clearance in March, 2017 related to embedding our Cesium-131 seeds into collagen tiles and look forward to the FDA's decision in the coming months. Other R&D investments include updates to loading and other placement devices for prostate applications," continued Mr. LaVoy. "We were pleased that the study entitled "Long-term Quality of Life in Prostate Cancer Patients Treated with Cesium-131" was accepted for publication in the highly respected International Journal of Radiation Oncology, Biology, Physics (the "Red Journal").  The study was conducted by a respected team of doctors from the departments of Radiation Oncology and Urology at the University of Pittsburgh Medical Center (UPMC) that we have worked closely with. The aim of the study was to evaluate the long-term quality of life (QOL) as reported by men treated at UPMC with Cesium-131 prostate brachytherapy. The report concluded that patients treated with Cesium-131 are able to recover from prostate cancer treatment quickly and then maintain their baseline quality of life over the long term. These results, combined with results from other recent studies that support triple therapy - external beam radiation, brachytherapy and hormone therapy – have begun to drive increasing growth in multiple prostate patient segments such as targeted and salvage treatments and higher risk patients." "Looking ahead, we're encouraged by the third quarter results. We believe that IsoRay's renewed commitment and messaging is resonating with the brachytherapy community. We're also continuing to invest in sales and marketing activities and the automation of our production processes which are expected to continue to lower our cost of production in the months ahead. As such, if revenue levels continue to increase, and costs stabilize or move lower, as we experienced this quarter, our financial results are expected to benefit from increasing operating leverage in the fourth quarter and next fiscal year. We remain on track for a combined third and fourth quarter revenue increase of approximately 20% over last year's second half revenue," concluded Mr. LaVoy. For the first nine months of fiscal 2017 ended March 31, 2017, revenue was $3.39 million, a 7% decrease compared to revenue of $3.65 million for the same period of fiscal 2016. Prostate brachytherapy represented 88% of total revenue for the first nine months of fiscal 2017 and 86% of total revenue in fiscal 2016. Operating expenses were $4.78 million, a 19% increase compared to $4.00 million for the nine months ended March 31, 2016. Operating loss was $4.44 million for the nine months ended March 31, 2017, compared to a $3.83 million operating loss for the comparable period of fiscal 2016. The net loss for the nine month period was $4.31 million, or $(0.08) per basic and diluted share, compared to a net loss of $3.54 million, or $(0.06), per basic and diluted share, for the nine month period of fiscal 2016. Basic and diluted per share results are based on weighted average shares outstanding of approximately 55.0 million shares in both periods. About IsoRay, Inc. IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of Cesium-131 by visiting www.isoray.com. Join us on Facebook/IsoRay. Follow us on Twitter @IsoRay. Safe Harbor Statement Statements in this news release about IsoRay's future expectations, including: the advantages of our products and their delivery systems, whether interest in and use of our products will increase or continue, whether the new marketing strategy will increase sales, whether the changes to the sales staff will result in increased sales, whether the additional resources being added to IsoRay's online presence will increase patient or clinician engagement and interest, whether use of Cesium-131 in non-prostate applications will increase revenue, whether we obtain and the timing of obtaining our application for 510(k) clearance, our ongoing relationship with GammaTile LLC, whether further automation of production processes will be completed or will result in lower costs, whether revenue will increase and costs decrease in the upcoming quarters, the perception by patients of quality of life outcomes, and all other statements in this release, other than historical facts, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of our products, our ability to successfully manufacture, market and sell our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, our ability to enforce our intellectual property rights, whether additional studies are released and support the conclusions of past studies, whether ongoing patient quality of life results with our products are favorable and in line with the conclusions of clinical studies and initial patient results, patient results achieved when our products are used for the treatment of cancers and malignant diseases whether or not used in conjunction with other treatments, successful completion of future research and development activities, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our products in its various forms, continued compliance with ISO standards as audited by BSI, the success of our sales and marketing efforts, changes in reimbursement rates, the procedures and regulatory requirements mandated by the FDA for 510(k) approval and agreements we ultimately negotiate with third parties related to distribution of GammaTile products, changes in laws and regulations applicable to our products, the scheduling of physicians who either delay or do not schedule patients in the six month period that an increase is anticipated, the use of competitors' products in lieu of our products over the six month period we expect an increase, less favorable reimbursement rates during the six month period we expect an increase, and other risks detailed from time to time in IsoRay's reports filed with the SEC. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/isoray-announces-third-quarter-fiscal-2017-financial-results-300454868.html


University of Pittsburgh and UPMC researchers are paving the way for genome-targeted treatments in pancreatic cancer, an especially deadly form of cancer with few existing therapeutic options, according to a pair of recent studies. The first study used genomic profiling to identify targeted therapies that resulted in benefits for patients with pancreatic cancer, including one whose tumor contained a mutation in the anaplastic lymphoma kinase (ALK) gene. In the second study, researchers used existing drugs already treating other types of ALK-mutated cancers to improve outcomes in pancreatic cancer patients with the same genetic alterations. "Together, these two findings begin to capture the promise of precision medicine in pancreatic cancer, which has so far not experienced the same success with targeted treatments as other cancer types," said the senior author of both studies, Nathan Bahary, M.D., Ph.D., associate professor of medicine at Pitt, and co-director of the UPMC Pancreatic Cancer Center of Excellence. "The assessment of these actionable alterations is now part of routine pancreatic cancer care at UPMC." As the third-leading cause of cancer deaths in the United States, and with a five-year survival rate of just 8 percent, pancreatic cancer is one of the most lethal forms of the disease. Currently available treatments are largely ineffective, so there is a desperate need for better therapeutic options, explained Bahary. In the first study, published in the January issue of Cancer Medicine, first author Mashaal Dhir, M.D., an oncologic surgical fellow at UPMC, and colleagues used DNA sequencing to look for gene changes in over 100 patient samples of advanced gastrointestinal cancers, including colorectal and pancreatic tumors. They identified several mutations in each cancer type and used that information to make treatment recommendations in 38 percent of cases. Approximately 14 percent of patients could receive the recommended therapy due to rapid decline in the other patients. However, half of those who received genomic-guided therapy experienced significant clinical benefit with improvement in overall survival, which would not have been possible on standard-of-care therapies. This suggests that mutational analyses done earlier during therapy may provide benefit to more patients, the authors said. One patient's pancreatic tumor had a mutation in the ALK gene. Genetic mutations involving ALK have been identified in several different types of cancer, including those of the breast, colon and lung, and drugs targeting this pathway have been successfully used for treatment of these tumors. The second study, published online this month in the Journal of the National Comprehensive Cancer Network (JNCCN), took a closer look at ALK mutations in pancreatic cancer. Co-lead authors Aatur Singhi, M.D., Ph.D., assistant professor of pathology at UPMC, and Siraj Ali, M.D., Ph.D., director of clinical development and medical affairs, Foundation Medicine Inc., Cambridge, Massachusetts, performed comprehensive genomic profiling of more than 3,000 pancreatic cancers. Alterations in the ALK gene were present in five patients (.2 percent). Four of these five were treated with drugs that inhibit ALK, and three experienced a positive response, as evidenced by either stable disease, tumor shrinkage or a reduction in levels of a pancreatic cancer biomarker. Patients with pancreatic cancer are typically diagnosed late in life, at an average age of 71. Patients with ALK mutations averaged just 38 years at diagnosis. The prospect of having an effective and clinically available treatment to offer a small subset of pancreatic cancer patients, a population with so few options, is extremely encouraging, said Bahary. The new work also highlights the importance of ALK mutation screening in young pancreatic cancer patients. The new studies also have much broader implications for pancreatic cancer. "Modern DNA sequencing techniques have brought with them the hope of targeting anti-cancer therapies to a particular cancer's vulnerabilities," Bahary said. "However, the potential of these precision medicine initiatives has not yet been achieved in pancreatic cancer. Beyond ALK mutations, our two studies describe some of the initial steps needed to utilize targeted therapies more generally in pancreatic cancer." The JNCCN study was supported in part by a grant from the Western Pennsylvania Chapter of the National Pancreas Foundation and Pitt. Additional collaborators on the Cancer Medicine study are Haroon Choudry, M.D., Matthew Holtzman, M.D., James Pingpank, M.D., Steven Ahrendt, M.D., Amer Zureikat, M.D., Melissa Hogg, M.D., David Bartlett, M.D., Herbert Zeh, M.D., and Aatur Singhi, M.D., Ph.D., all of UPMC. Khanh Nguyen, M.D., Marina Nikiforova, M.D., Herbert Zeh, M.D., Inderpal Sarkaria, M.D., and Anil Dasyam, M.D., all of UPMC; Jill Lacy, M.D., of Yale University; Andrew Hendifar, M.D., and Jamie Koo, M.D., both of Cedars-Sinai Medical Center; and Jon Chung, Ph.D., Joel Greenbowe, Ph.D., and Jeffrey Ross, M.D., all of Foundation Medicine, also contributed to the JNCNN study. A $14 billion world-renowned health care provider and insurer, Pittsburgh-based UPMC is inventing new models of patient-centered, cost-effective, accountable care. UPMC provides nearly $900 million a year in benefits to its communities, including more care to the region's most vulnerable citizens than any other health care institution. The largest nongovernmental employer in Pennsylvania, UPMC integrates 65,000 employees, more than 25 hospitals, 600 doctors' offices and outpatient sites, and a more than 3.2 million-member Insurance Services Division, the largest medical and behavioral health services insurer in western Pennsylvania. Affiliated with the University of Pittsburgh Schools of the Health Sciences, UPMC ranks No. 12 in the prestigious U.S. News & World Report annual Honor Roll of America's Best Hospitals. UPMC Enterprises functions as the innovation and commercialization arm of UPMC while UPMC International provides hands-on health care and management services with partners in 12 countries on four continents. For more information, go to UPMC.com. About the University of Pittsburgh Schools of the Health Sciences The University of Pittsburgh Schools of the Health Sciences include the schools of Medicine, Nursing, Dental Medicine, Pharmacy, Health and Rehabilitation Sciences and the Graduate School of Public Health. The schools serve as the academic partner to the UPMC (University of Pittsburgh Medical Center). Together, their combined mission is to train tomorrow's health care specialists and biomedical scientists, engage in groundbreaking research that will advance understanding of the causes and treatments of disease and participate in the delivery of outstanding patient care. Since 1998, Pitt and its affiliated university faculty have ranked among the top 10 educational institutions in grant support from the National Institutes of Health. For additional information about the Schools of the Health Sciences, please visit http://www. .


News Article | May 10, 2017
Site: www.scientificamerican.com

The origins of space and time are among the most mysterious and contentious topics in science. Our February 2017 article “Pop Goes the Universe” argues against the dominant idea that the early cosmos underwent an extremely rapid expansion called inflation. Its authors instead advocate for another scenario—that our universe began not with a bang but with a bounce from a previously contracting cosmos. In the letter below, a group of 33 physicists who study inflationary cosmology respond to that article. It is followed by a reply from the authors (an extended version of their reply can be found here). In “Pop Goes the Universe,” by Anna Ijjas, Paul J. Steinhardt and Abraham Loeb, the authors (hereafter “IS&L”) make the case for a bouncing cosmology, as was proposed by Steinhardt and others in 2001. They close by making the extraordinary claim that inflationary cosmology “cannot be evaluated using the scientific method” and go on to assert that some scientists who accept inflation have proposed “discarding one of [science’s] defining properties: empirical testability,” thereby “promoting the idea of some kind of nonempirical science.” We have no idea what scientists they are referring to. We disagree with a number of statements in their article, but in this letter, we will focus on our categorical disagreement with these statements about the testability of inflation. There is no disputing the fact that inflation has become the dominant paradigm in cosmology. Many scientists from around the world have been hard at work for years investigating models of cosmic inflation and comparing these predictions with empirical observations. According to the high-energy physics database INSPIRE, there are now more than 14,000 papers in the scientific literature, written by over 9,000 distinct scientists, that use the word “inflation” or “inflationary” in their titles or abstracts. By claiming that inflationary cosmology lies outside the scientific method, IS&L are dismissing the research of not only all the authors of this letter but also that of a substantial contingent of the scientific community. Moreover, as the work of several major, international collaborations has made clear, inflation is not only testable, but it has been subjected to a significant number of tests and so far has passed every one. Inflation is not a unique theory but rather a class of models based on similar principles. Of course, nobody believes that all these models are correct, so the relevant question is whether there exists at least one model of inflation that seems well motivated, in terms of the underlying particle physics assumptions, and that correctly describes the measurable properties of our universe. This is very similar to the early steps in the development of the Standard Model of particle physics, when a variety of quantum field theory models were explored in search of one that fit all the experiments. Although there is in principle a wide space of inflationary models to examine, there is a very simple class of inflationary models (technically, “single-field slow-roll” models) that all give very similar predictions for most observable quantities—predictions that were clearly enunciated decades ago. These “standard” inflationary models form a well-defined class that has been studied extensively. (IS&L have expressed strong opinions about what they consider to be the simplest models within this class, but simplicity is subjective, and we see no reason to restrict attention to such a narrow subclass.) Some of the standard inflationary models have now been ruled out by precise empirical data, and this is part of the desirable process of using observation to thin out the set of viable models. But many models in this class continue to be very successful empirically. The standard inflationary models predict that the universe should have a critical mass density (that is, it should be geometrically flat), and they also predict the statistical properties of the faint ripples that we detect in the cosmic microwave background (CMB). First, the ripples should be nearly “scale-invariant,” meaning that they have nearly the same intensity at all angular scales. Second, the ripples should be “adiabatic,” meaning that the perturbations are the same in all components: the ordinary matter, radiation and dark matter all fluctuate together. Third, they should be “Gaussian,” which is a statement about the statistical patterns of relatively bright and dark regions. Fourth and finally, the models also make predictions for the patterns of polarization in the CMB, which can be divided into two classes, called E-modes and B-modes. The predictions for the E-modes are very similar for all standard inflationary models, whereas the levels of B-modes, which are a measure of gravitational radiation in the early universe, vary significantly within the class of standard models. The remarkable fact is that, starting with the results of the Cosmic Background Explorer (COBE) satellite in 1992, numerous experiments have confirmed that these predictions (along with several others too technical to discuss here) accurately describe our universe. The average mass density of the universe has now been measured to an accuracy of about half of a percent, and it agrees perfectly with the prediction of inflation. (When inflation was first proposed, the average mass density was uncertain by at least a factor of three, so this is an impressive success.) The ripples of the CMB have been measured carefully by two more satellite experiments, the Wilkinson Microwave Anisotropy Probe (WMAP) and the Planck satellite, as well as many ground- and balloon-based experiments—all confirming that the primordial fluctuations are indeed nearly scale-invariant and very accurately adiabatic and Gaussian, precisely as predicted (ahead of time) by standard models of inflation. The B-modes of polarization have not yet been seen, which is consistent with many, though not all, of the standard models, and the E-modes are found to agree with the predictions. In 2016 the Planck satellite team (a collaboration of about 260 authors) summarized its conclusions by saying that “the Planck results offer powerful evidence in favour of simple inflationary models.” So if inflation is untestable, as IS&L would have us believe, why have there been so many tests of it and with such remarkable success? While the successes of inflationary models are unmistakable, IS&L nonetheless make the claim that inflation is untestable. (We are bewildered by IS&L’s assertion that the dramatic observational successes of inflation should be discounted while they accuse the advocates of inflation of abandoning empirical science!) They contend, for example, that inflation is untestable because its predictions can be changed by varying the shape of the inflationary energy density curve or the initial conditions. But the testability of a theory in no way requires that all its predictions be independent of the choice of parameters. If such parameter independence were required, then we would also have to question the status of the Standard Model, with its empirically determined particle content and 19 or more empirically determined parameters. An important point is that standard inflationary models could have failed any of the empirical tests described above, but they did not. IS&L write about how “a failing theory gets increasingly immunized against experiment by attempts to patch it,” insinuating that this has something to do with inflation. But despite IS&L’s rhetoric, it is standard practice in empirical science to modify a theory as new data come to light, as, for example, the Standard Model has been modified to account for newly discovered quarks and leptons. For inflationary cosmology, meanwhile, there has so far been no need to go beyond the class of standard inflationary models. IS&L also assert that inflation is untestable because it leads to eternal inflation and a multiverse. Yet although the possibility of a multiverse is an active area of study, this possibility in no way interferes with the empirical testability of inflation. If the multiverse picture is valid, then the Standard Model would be properly understood as a description of the physics in our visible universe, and similarly the models of inflation that are being refined by current observations would describe the ways inflation can happen in our particular part of the universe. Both theories would remain squarely within the domain of empirical science. Scientists would still be able to compare newly obtained data—from astrophysical observations and particle physics experiments—with precise, quantitative predictions of specific inflationary and particle physics models. Note that this issue is separate from the loftier goal of developing a theoretical framework that can predict, without the use of observational data, the specific models of particle physics and inflation that should be expected to describe our visible universe. Like any scientific theory, inflation need not address all conceivable questions. Inflationary models, like all scientific theories, rest on a set of assumptions, and to understand those assumptions we might need to appeal to some deeper theory. This, however, does not undermine the success of inflationary models. The situation is similar to the standard hot big bang cosmology: the fact that it left several questions unresolved, such as the near-critical mass density and the origin of structure (which are solved elegantly by inflation), does not undermine its many successful predictions, including its prediction of the relative abundances of light chemical elements. The fact that our knowledge of the universe is still incomplete is absolutely no reason to ignore the impressive empirical success of the standard inflationary models. During the more than 35 years of its existence, inflationary theory has gradually become the main cosmological paradigm describing the early stages of the evolution of the universe and the formation of its large-scale structure. No one claims that inflation has become certain; scientific theories don’t get proved the way mathematical theorems do, but as time passes, the successful ones become better and better established by improved experimental tests and theoretical advances. This has happened with inflation. Progress continues, supported by the enthusiastic efforts of many scientists who have chosen to participate in this vibrant branch of cosmology. Empirical science is alive and well! »Click here to jump to the authors’ reply Alan H. Guth             Victor F. Weisskopf Professor of Physics, Massachusetts Institute of Technology             http://web.mit.edu/physics/people/faculty/guth_alan.html David I. Kaiser             Germeshausen Professor of the History of Science and Professor of Physics, Massachusetts Institute of Technology             http://web.mit.edu/physics/people/faculty/kaiser_david.html Andrei D. Linde             Harald Trap Friis Professor of Physics, Stanford University             https://physics.stanford.edu/people/faculty/andrei-linde Yasunori Nomura             Professor of Physics and Director, Berkeley Center for Theoretical Physics, University of California, Berkeley             http://physics.berkeley.edu/people/faculty/yasunori-nomura Charles L. Bennett             Bloomberg Distinguished Professor and Alumni Centennial Professor of Physics and Astronomy, Johns Hopkins University             Principal Investigator, Wilkinson Microwave Anisotropy Probe (WMAP) mission             Deputy Principal Investigator and Science Working Group member, Cosmic Background Explorer (COBE) mission             http://physics-astronomy.jhu.edu/directory/charles-l-bennett/ J. Richard Bond             University Professor, University of Toronto and Director, Canadian Institute for Advanced Research Cosmology and Gravity Program, Canadian Institute for Theoretical Astrophysics             Member of the Planck collaboration             http://www.cita.utoronto.ca/~bond/ François Bouchet             Director of Research, Institut d’Astrophysique de Paris, CNRS and Sorbonne Université-UPMC             Deputy Principal Investigator, Planck satellite HFI (High Frequency Instrument) Consortium and Member, Planck Science Team             http://savoirs.ens.fr/conferencier.php?id=145 Sean Carroll             Research Professor of Physics, California Institute of Technology             http://www.astro.caltech.edu/people/faculty/Sean_Carroll.html George Efstathiou             Professor of Astrophysics, Kavli Institute for Cosmology, University of Cambridge             Member, Planck Science Team             http://www.ast.cam.ac.uk/~gpe/ Stephen Hawking             Lucasian Professor of Mathematics (Emeritus) and Dennis Stanton Avery and Sally Tsui Wong-Avery Director of Research, Department of Applied Mathematics and Theoretical Physics, University of Cambridge             http://www.damtp.cam.ac.uk/people/s.w.hawking/ Renata Kallosh             Professor of Physics, Stanford University             https://physics.stanford.edu/people/faculty/renata-kallosh Eiichiro Komatsu             Director of the Department of Physical Cosmology, Max-Planck-Institute für Astrophysik, Garching             Member, Wilkinson Microwave Anisotropy Probe (WMAP) collaboration             http://wwwmpa.mpa-garching.mpg.de/~komatsu/ Lawrence Krauss             Foundation Professor in the School of Earth and Space Exploration and Department of Physics, and Director, The Origins Project at Arizona State University             http://krauss.faculty.asu.edu David H. Lyth             Professor of Physics (Emeritus), Lancaster University             http://www.lancaster.ac.uk/physics/about-us/people/david-lyth Juan Maldacena             Carl P. Feinberg Professor of Physics, Institute for Advanced Study             https://www.sns.ias.edu/malda John C. Mather             Senior Astrophysicist and Goddard Fellow, NASA Goddard Space Flight Center and recipient of the Nobel Prize in Physics (2006)             Project Scientist, Cosmic Background Explorer (COBE) mission and             Senior Project Scientist, James Webb Space Telescope             https://science.gsfc.nasa.gov/sed/bio/john.c.mather Hiranya Peiris             Professor of Astrophysics, University College London and Director, Oskar Klein Centre for Cosmoparticle Physics, Stockholm             Member, Wilkinson Microwave Anisotropy Probe (WMAP) collaboration and Planck collaboration             http://zuserver2.star.ucl.ac.uk/~hiranya/ Malcolm Perry             Professor of Theoretical Physics, University of Cambridge             http://www.damtp.cam.ac.uk/people/m.j.perry/ Lisa Randall             Frank B. Baird, Jr., Professor of Science, Department of Physics, Harvard University             https://www.physics.harvard.edu/people/facpages/randall Martin Rees             Astronomer Royal of Great Britain, former President of the Royal Society of London, and Professor (Emeritus) of Cosmology and Astrophysics, University of Cambridge             http://www.ast.cam.ac.uk/~mjr/ Misao Sasaki             Professor, Yukawa Institute for Theoretical Physics, Kyoto University             http://www2.yukawa.kyoto-u.ac.jp/~misao.sasaki/ Leonardo Senatore             Associate Professor of Physics, Stanford University             https://physics.stanford.edu/people/faculty/leonardo-senatore Eva Silverstein             Professor of Physics, Stanford University             https://physics.stanford.edu/people/faculty/eva-silverstein George F. Smoot III             Professor of Physics (Emeritus), Founding Director, Berkeley Center for Cosmological Physics, and recipient of the Nobel Prize in Physics (2006)             Principal Investigator, Cosmic Background Explorer (COBE) mission             http://physics.berkeley.edu/people/faculty/george-smoot-iii Alexei Starobinsky             Principal Researcher, Landau Institute for Theoretical Physics, Moscow             http://www.itp.ac.ru/en/persons/starobinsky-aleksei-aleksandrovich/ Leonard Susskind             Felix Bloch Professor of Physics and Wells Family Director, Stanford Institute for Theoretical Physics, Stanford University             https://physics.stanford.edu/people/faculty/leonard-susskind Michael S. Turner             Bruce. V. Rauner Distinguished Service Professor, Department of Astronomy and Astrophysics and Department of Physics, University of Chicago             https://astro.uchicago.edu/people/michael-s-turner.php Alexander Vilenkin             L. and J. Bernstein Professor of Evolutionary Science and Director, Institute of Cosmology, Tufts University             http://cosmos2.phy.tufts.edu/vilenkin.html Steven Weinberg             Jack S. Josey-Welch Foundation Chair and Regental Professor and Director, Theory Research Group, Department of Physics, University of Texas at Austin, and recipient of the Nobel Prize in Physics (1979)             https://web2.ph.utexas.edu/~weintech/weinberg.html Rainer Weiss                         Professor of Physics (Emeritus), Massachusetts Institute of Technology             Chair, Science Working Group, Cosmic Background Explorer (COBE) mission             Co-Founder, Laser Interferometric Gravitational-wave Observatory (LIGO)             http://web.mit.edu/physics/people/faculty/weiss_rainer.html Frank Wilczek                      Herman Feshbach Professor of Physics, Massachusetts Institute of Technology, and recipient of the Nobel Prize in Physics (2004)             http://web.mit.edu/physics/people/faculty/wilczek_frank.html Edward Witten                      Charles Simonyi Professor of Physics, Institute for Advanced Study and recipient of the Fields Medal (1990)             https://www.sns.ias.edu/witten Matias Zaldarriaga               Professor of Astrophysics, Institute for Advanced Study             https://www.sns.ias.edu/matiasz THE AUTHORS REPLY: We have great respect for the scientists who signed the rebuttal to our article, but we are disappointed by their response, which misses our key point: the differences between the inflationary theory once thought to be possible and the theory as understood today. The claim that inflation has been confirmed refers to the outdated theory before we understood its fundamental problems. We firmly believe that in a healthy scientific community, respectful disagreement is possible and hence reject the suggestion that by pointing out problems, we are discarding the work of all of those who developed the theory of inflation and enabled precise measurements of the universe. Historically, the thinking about inflation was based on a series of misunderstandings. It was not understood that the outcome of inflation is highly sensitive to initial conditions. And it was not understood that inflation generically leads to eternal inflation and, consequently, a multiverse—an infinite diversity of outcomes. Papers claiming that inflation predicts this or that ignore these problems. Our point is that we should be talking about the contemporary version of inflation, warts and all, not some defunct relic. Logically, if the outcome of inflation is highly sensitive to initial conditions that are not yet understood, as the respondents concede, the outcome cannot be determined. And if inflation produces a multiverse in which, to quote a previous statement from one of the responding authors (Guth), “anything that can happen will happen”—it makes no sense whatsoever to talk about predictions. Unlike the Standard Model, even after fixing all the parameters, any inflationary model gives an infinite diversity of outcomes with none preferred over any other. This makes inflation immune from any observational test. For more details, see our 2014 paper “Inflationary Schism” (preprint available at https://arxiv.org/abs/1402.6980). We are three independent thinkers representing different generations of scientists. Our article was not intended to revisit old debates but to discuss the implications of recent observations and to point out unresolved issues that present opportunities for a new generation of young cosmologists to make a lasting impact. We hope readers will go back and review our article’s concluding paragraphs. We advocated against invoking authority and for open recognition of the shortcomings of current concepts, a reinvigorated effort to resolve these problems and an open-minded exploration of diverse ideas that avoid them altogether. We stand by these principles.


PARIS, May 11, 2017 (GLOBE NEWSWIRE) -- BIOPHYTIS (Alternext Paris:ALBPS), a biotechnology company specialized in the development of drug candidates to treat ageing diseases, has announced that it has received the approval from the US regulatory authorities for the recruitment of sarcopenia patients in the observational study SARA-OBS on Sarconeos. It has therefore been able to open the two clinical centers and start the recruitment of sarcopenia patients in the United States. These patients, if they give their consent, could participate in the clinical trial of phase 2b SARA-INT, on Sarconeos. Stanislas Veillet, Chief Executive Officer of BIOPHYTIS, said: “We are delighted to announce the recruitment of the first patient in the SARA-OBS clinical study in the United States. The US clinical centers of Boston and Gainesville are now open and recruiting patients. These centers are specialized in sarcopenia patients care, led by internationally renowned clinicians, and ideally complete our European clinical network. It marks an important step of our development strategy in the US, our primary market, which was announced one year ago. We are now focusing on the preparation of the interventional phase, SARA-INT, which will follow on this observational study.” BIOPHYTIS has obtained the authorization of the regulatory authorities to start the SARA-OBS clinical study in sarcopenia. The first two clinical centers have therefore been opened, in Boston at the Jean Mayer Human Nutrition Research Center on Aging, Tufts University with head investigator Professor Roger Fielding, and in Gainesville at the Institute of Aging, University of Florida, with investigator Professor Marco Pahor. The recruitment of the 300 patients in the 8 clinical centers opened in Europe (France, Belgium and Italy) and the United States has now begun. Sarcopenia patients will be monitored for 6 months before being possibly included in the interventional phase 2b SARA-INT study, after obtaining their consent. The opening of centers in the United States is a critical marker of the development strategy initiated a year ago. It consists in a doubling of the size of the clinical study by recruiting patients in the US (the most important market for BIOPHYTIS in terms of number of patients), opening of a subsidiary in Boston, recruitment of reputable clinicians, in particular Roger A Fielding who joined BIOPHYTIS’ Scientific Advisory Board, and is the head researcher of the SARA-OBS/SARA-INT study. To know more about the SARA clinical program and Sarcopenia, you may also watch the introductory video by following this link: http://www.biophytis.com/en/actualites/SARA-ICFSR-2017/ About SARA-OBS: SARA-OBS is a 6-months clinical observational study, conducted in over 300 sarcopenia patients recruited in 8 clinical centers in Europe and the United States. Patients’ mobility and muscular quality will be assessed, based on the following criteria: 6-minute walk test, mobility (SPPB test), muscle strength (grip test), body composition and plasmatic parameters. Data from SARA-OBS will provide a better characterization of the target population for the Sarconeos treatment. Patients in the SARA-OBS study will be included in the phase 2b study of SARA-INT at the end of 6 months, once consent is given. ABOUT SARCONEOS: Sarconeos is the first representative of a new class of drug candidates, based on the activation of the MAS receptor (major player of the renin-angiotensin system) stimulating anabolism in the muscle, inhibitor of myostatin and favoring muscle mass development in animal models of muscular dystrophies. Sarconeos is developed in the treatment of sarcopenia, an age-related degeneration of skeletal muscle and strength, leading to a loss of mobility in elderly people.  This new pathology, for which no medical treatment currently exists, was first described in 1993 and just entered the WHO International Classification of Diseases (M62.84), affects more than 50 million people worldwide. About BIOPHYTIS: BIOPHYTIS SA (www.biophytis.com), founded in 2006, develops drug candidates targeting diseases of aging. Using its technology and know-how, BIOPHYTIS has begun clinical development of innovative therapeutics to restore the muscular and visual functions in diseases with significant unmet medical need. Specifically, the company is advancing two lead products into mid-stage clinical testing this year: Sarconeos (BIO101) to treat sarcopenic obesity and Macuneos (BIO201) to treat dry age-related macular degeneration (AMD). The company was founded in partnership with researchers at the UPMC (Pierre and Marie Curie University) and also collaborates with scientists at the Institute of Myology, and the Vision Institute. BIOPHYTIS is listed on the Alternext market of Euronext Paris (ALBPS; ISIN: FR0012816825). BIOPHYTIS is eligible for the SMEs scheme Disclaimer This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of risks and uncertainties which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Listing Prospectus upon the admission of Company’s shares for trading on the regulated market Alternext of Euronext Paris filed with the AMF, which is available on the AMF website (www.amf-france.org) or on BIOPHYTIS’ website (www.biophytis.com). This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in BIOPHYTIS in any country. Items in this press release may contain forward-looking statements involving risks and uncertainties. The Company’s actual results could differ substantially from those anticipated in these statements owing to various risk factors which are described in the Company’s prospectus. This press release has been prepared in 5 both French and English. In the event of any differences between the two texts, the French language version shall supersede.


PARIS, May 11, 2017 (GLOBE NEWSWIRE) -- BIOPHYTIS (Alternext Paris:ALBPS), a biotechnology company specialized in the development of drug candidates to treat ageing diseases, has announced that it has received the approval from the US regulatory authorities for the recruitment of sarcopenia patients in the observational study SARA-OBS on Sarconeos. It has therefore been able to open the two clinical centers and start the recruitment of sarcopenia patients in the United States. These patients, if they give their consent, could participate in the clinical trial of phase 2b SARA-INT, on Sarconeos. Stanislas Veillet, Chief Executive Officer of BIOPHYTIS, said: “We are delighted to announce the recruitment of the first patient in the SARA-OBS clinical study in the United States. The US clinical centers of Boston and Gainesville are now open and recruiting patients. These centers are specialized in sarcopenia patients care, led by internationally renowned clinicians, and ideally complete our European clinical network. It marks an important step of our development strategy in the US, our primary market, which was announced one year ago. We are now focusing on the preparation of the interventional phase, SARA-INT, which will follow on this observational study.” BIOPHYTIS has obtained the authorization of the regulatory authorities to start the SARA-OBS clinical study in sarcopenia. The first two clinical centers have therefore been opened, in Boston at the Jean Mayer Human Nutrition Research Center on Aging, Tufts University with head investigator Professor Roger Fielding, and in Gainesville at the Institute of Aging, University of Florida, with investigator Professor Marco Pahor. The recruitment of the 300 patients in the 8 clinical centers opened in Europe (France, Belgium and Italy) and the United States has now begun. Sarcopenia patients will be monitored for 6 months before being possibly included in the interventional phase 2b SARA-INT study, after obtaining their consent. The opening of centers in the United States is a critical marker of the development strategy initiated a year ago. It consists in a doubling of the size of the clinical study by recruiting patients in the US (the most important market for BIOPHYTIS in terms of number of patients), opening of a subsidiary in Boston, recruitment of reputable clinicians, in particular Roger A Fielding who joined BIOPHYTIS’ Scientific Advisory Board, and is the head researcher of the SARA-OBS/SARA-INT study. To know more about the SARA clinical program and Sarcopenia, you may also watch the introductory video by following this link: http://www.biophytis.com/en/actualites/SARA-ICFSR-2017/ About SARA-OBS: SARA-OBS is a 6-months clinical observational study, conducted in over 300 sarcopenia patients recruited in 8 clinical centers in Europe and the United States. Patients’ mobility and muscular quality will be assessed, based on the following criteria: 6-minute walk test, mobility (SPPB test), muscle strength (grip test), body composition and plasmatic parameters. Data from SARA-OBS will provide a better characterization of the target population for the Sarconeos treatment. Patients in the SARA-OBS study will be included in the phase 2b study of SARA-INT at the end of 6 months, once consent is given. ABOUT SARCONEOS: Sarconeos is the first representative of a new class of drug candidates, based on the activation of the MAS receptor (major player of the renin-angiotensin system) stimulating anabolism in the muscle, inhibitor of myostatin and favoring muscle mass development in animal models of muscular dystrophies. Sarconeos is developed in the treatment of sarcopenia, an age-related degeneration of skeletal muscle and strength, leading to a loss of mobility in elderly people.  This new pathology, for which no medical treatment currently exists, was first described in 1993 and just entered the WHO International Classification of Diseases (M62.84), affects more than 50 million people worldwide. About BIOPHYTIS: BIOPHYTIS SA (www.biophytis.com), founded in 2006, develops drug candidates targeting diseases of aging. Using its technology and know-how, BIOPHYTIS has begun clinical development of innovative therapeutics to restore the muscular and visual functions in diseases with significant unmet medical need. Specifically, the company is advancing two lead products into mid-stage clinical testing this year: Sarconeos (BIO101) to treat sarcopenic obesity and Macuneos (BIO201) to treat dry age-related macular degeneration (AMD). The company was founded in partnership with researchers at the UPMC (Pierre and Marie Curie University) and also collaborates with scientists at the Institute of Myology, and the Vision Institute. BIOPHYTIS is listed on the Alternext market of Euronext Paris (ALBPS; ISIN: FR0012816825). BIOPHYTIS is eligible for the SMEs scheme Disclaimer This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of risks and uncertainties which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Listing Prospectus upon the admission of Company’s shares for trading on the regulated market Alternext of Euronext Paris filed with the AMF, which is available on the AMF website (www.amf-france.org) or on BIOPHYTIS’ website (www.biophytis.com). This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in BIOPHYTIS in any country. Items in this press release may contain forward-looking statements involving risks and uncertainties. The Company’s actual results could differ substantially from those anticipated in these statements owing to various risk factors which are described in the Company’s prospectus. This press release has been prepared in 5 both French and English. In the event of any differences between the two texts, the French language version shall supersede.


PARIS, May 11, 2017 (GLOBE NEWSWIRE) -- BIOPHYTIS (Alternext Paris:ALBPS), a biotechnology company specialized in the development of drug candidates to treat ageing diseases, has announced that it has received the approval from the US regulatory authorities for the recruitment of sarcopenia patients in the observational study SARA-OBS on Sarconeos. It has therefore been able to open the two clinical centers and start the recruitment of sarcopenia patients in the United States. These patients, if they give their consent, could participate in the clinical trial of phase 2b SARA-INT, on Sarconeos. Stanislas Veillet, Chief Executive Officer of BIOPHYTIS, said: “We are delighted to announce the recruitment of the first patient in the SARA-OBS clinical study in the United States. The US clinical centers of Boston and Gainesville are now open and recruiting patients. These centers are specialized in sarcopenia patients care, led by internationally renowned clinicians, and ideally complete our European clinical network. It marks an important step of our development strategy in the US, our primary market, which was announced one year ago. We are now focusing on the preparation of the interventional phase, SARA-INT, which will follow on this observational study.” BIOPHYTIS has obtained the authorization of the regulatory authorities to start the SARA-OBS clinical study in sarcopenia. The first two clinical centers have therefore been opened, in Boston at the Jean Mayer Human Nutrition Research Center on Aging, Tufts University with head investigator Professor Roger Fielding, and in Gainesville at the Institute of Aging, University of Florida, with investigator Professor Marco Pahor. The recruitment of the 300 patients in the 8 clinical centers opened in Europe (France, Belgium and Italy) and the United States has now begun. Sarcopenia patients will be monitored for 6 months before being possibly included in the interventional phase 2b SARA-INT study, after obtaining their consent. The opening of centers in the United States is a critical marker of the development strategy initiated a year ago. It consists in a doubling of the size of the clinical study by recruiting patients in the US (the most important market for BIOPHYTIS in terms of number of patients), opening of a subsidiary in Boston, recruitment of reputable clinicians, in particular Roger A Fielding who joined BIOPHYTIS’ Scientific Advisory Board, and is the head researcher of the SARA-OBS/SARA-INT study. To know more about the SARA clinical program and Sarcopenia, you may also watch the introductory video by following this link: http://www.biophytis.com/en/actualites/SARA-ICFSR-2017/ About SARA-OBS: SARA-OBS is a 6-months clinical observational study, conducted in over 300 sarcopenia patients recruited in 8 clinical centers in Europe and the United States. Patients’ mobility and muscular quality will be assessed, based on the following criteria: 6-minute walk test, mobility (SPPB test), muscle strength (grip test), body composition and plasmatic parameters. Data from SARA-OBS will provide a better characterization of the target population for the Sarconeos treatment. Patients in the SARA-OBS study will be included in the phase 2b study of SARA-INT at the end of 6 months, once consent is given. ABOUT SARCONEOS: Sarconeos is the first representative of a new class of drug candidates, based on the activation of the MAS receptor (major player of the renin-angiotensin system) stimulating anabolism in the muscle, inhibitor of myostatin and favoring muscle mass development in animal models of muscular dystrophies. Sarconeos is developed in the treatment of sarcopenia, an age-related degeneration of skeletal muscle and strength, leading to a loss of mobility in elderly people.  This new pathology, for which no medical treatment currently exists, was first described in 1993 and just entered the WHO International Classification of Diseases (M62.84), affects more than 50 million people worldwide. About BIOPHYTIS: BIOPHYTIS SA (www.biophytis.com), founded in 2006, develops drug candidates targeting diseases of aging. Using its technology and know-how, BIOPHYTIS has begun clinical development of innovative therapeutics to restore the muscular and visual functions in diseases with significant unmet medical need. Specifically, the company is advancing two lead products into mid-stage clinical testing this year: Sarconeos (BIO101) to treat sarcopenic obesity and Macuneos (BIO201) to treat dry age-related macular degeneration (AMD). The company was founded in partnership with researchers at the UPMC (Pierre and Marie Curie University) and also collaborates with scientists at the Institute of Myology, and the Vision Institute. BIOPHYTIS is listed on the Alternext market of Euronext Paris (ALBPS; ISIN: FR0012816825). BIOPHYTIS is eligible for the SMEs scheme Disclaimer This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of risks and uncertainties which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Listing Prospectus upon the admission of Company’s shares for trading on the regulated market Alternext of Euronext Paris filed with the AMF, which is available on the AMF website (www.amf-france.org) or on BIOPHYTIS’ website (www.biophytis.com). This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in BIOPHYTIS in any country. Items in this press release may contain forward-looking statements involving risks and uncertainties. The Company’s actual results could differ substantially from those anticipated in these statements owing to various risk factors which are described in the Company’s prospectus. This press release has been prepared in 5 both French and English. In the event of any differences between the two texts, the French language version shall supersede.

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