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New DVD
Juno - DVD
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When a teenage girl is faced with an unexpected pregnancy, she enlists the aid of her best friend in finding the unborn child a suitable home in this coming-of-age comedy drama from Thank You for Smoking director Jason Reitman. Juno (Ellen Page) may seem wise beyond her years, but after sleeping with classmate Bleeker (Michael Cera), the pregnant teen quickly realizes how little she really knows about life. Thankfully, Juno has been blessed with parents (J.K. Simmons and Allison Janney) who trust their daughter's judgment, and a best friend named Leah (Olivia Thirlby), who's always willing to help out in a pinch. With a little help from Leah, Juno soon comes into contact with Mark (Jason Bateman) and Vanessa (Jennifer Garner) -- an affluent suburban couple who have been unable to conceive a child of their own. Mark and Vanessa seem like they would make great parents, and are eager to adopt Juno's unborn child. Now, as adolescent Juno is faced with a series of very adult decisions, she will draw on the support of her family and friends in order to discover who she truly is, and discover that one bad choice can have a lifetime of consequences. ~ Jason Buchanan, All Movie Guide
Aug 02, 2016
Jul 29, 2016
Apr 11, 2016
Mar 28, 2016
More Details
Released - Tuesday, October 13 , 2009
- Starring - Olivia Thirlby,Jason Bateman,Jason Bateman,Jason Bateman,Michael Cera,Michael Cera,Michael Cera,Ellen Page,Ellen Page,Ellen Page,Jennifer Garner,Jennifer Garner,Jennifer Garner,J.K. Simmons,J.K. Simmons,Allison Janney,Allison Janney,Brandon Barton,Josephi
- Distributed by - 20th Century Fox
- MPAA Rating - PG-13


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Fate Therapeutics, Inc. (NASDAQ:FATE)
Q4 2013 Earnings Conference Call
March 17, 2014 5:00 PM ET
Scott Wolchko – Chief Financial Officer and Chief Operating Officer
Christian Weyer – President and Chief Executive Officer
Pratik Multani – Chief Medical Officer
Peter Flynn – Senior Vice President-Early Program Development
Simos Simeonidis – Cowen & Co. LLC
Dilip Joseph – Wedbush Securities, Inc.
Welcome to Fate Therapeutics Fourth Quarter 2013 Financial Results Conference Call. At this time, all participants on a listen-only mode. This call is being webcast live on the Investors and Media section of Fate's website at fatetherapeutics.com. This call is a property of Fate Therapeutics and recordings, production or transmission of this call without the express written permission is strictly prohibited. As a reminder today's call is being recorded.
I would now like to introduce Scott Wolchko, Chief Financial and Chief Operating Officer of Fate Therapeutics.
Scott Wolchko
Thank you. Good afternoon and thanks everyone for joining us for the Fate Therapeutics fourth quarter 2013 Earnings Call. At 4:00 PM Eastern Time today we issued a press release with our fourth quarter and full-year 2013 financial results, which can be found on the Investors and Media section of our website under press releases.
In addition, our 2013 10-K was filed shortly thereafter and could be found on the Investors and Media section of our website under financial information.
Before we begin, I would like to remind everyone that except for statements of historical facts, the statements made by management and responses to questions on this conference call are forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements.
Please see the forward-looking statement disclaimer on the company's earnings press release issued after the close of market today, as well as the risk factors in a company's SEC filings, including our 10-K for the year ended December 31, 2013, that was filed with the SEC today.
Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, as the facts and circumstances underlying these forward-looking statements may change. Except it is required by law, Fate Therapeutics disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
Joining me on the call today are Dr. Christian Weyer, President and Chief Executive Officer of Fate Therapeutics, Dr. Pratik Multani, Chief Medical Officer and Dr. Peter Flynn, Senior Vice President of Early Program Development.
I will first review our financial results for the fourth quarter of 2013, then Christian, Pratik and Pete will provide corporate and development program updates. After that, we are happy to take any questions that you might have.
So, turning our attention to the financial results for the fourth quarter of 2013. In October 2013, we completed our Initial Public Offering, establishing a strong financial foundation to advance our therapeutic platforms and programs and to pursue our long-term goal of bringing novel stem cell therapeutics the patients in need.
In the IPO we have raised net proceeds of $40.5 million, and all our previously issued convertible preferred stock and convertible promissory notes converted into common stock. At the end of the fourth quarter of 2013, our cash and cash equivalents were $54 million, our debt outstanding was $1.8 million, and we had approximately 20.4 million shares outstanding.
For the three months ended December 31, 2013, Fate Therapeutics reported a net loss of $5.7 million as compared to a net loss of $4.2 million for the fourth quarter of 2012. The company did not generate any revenues in the fourth quarter of 2013, compared to approximately $600,000 for the fourth quarter of 2012.
Research and development expenses for the fourth quarter of 2013 was $3 million, compared to $3.4 million for the fourth quarter of 2012. This decrease in the fourth quarter of 2013, compared to the fourth quarter of 2012 was primarily due to the timing of clinical and regulatory related start-up costs, incurred in the fourth quarter of 2012 in connection with the initial launch in December 2012 of our Phase II clinical trial of PROHEMA.
General and administrative expenses for the fourth quarter of 2013 were $1.9 million, compared to approximately $1.3 million for the fourth quarter of 2012. This increase was primarily driven by an increase in employee compensation, including salaries, benefits and stock-based compensation expense and to incremental legal accounting and insurance expenses, primarily to support public company operations.
Total operating expenses for the fourth quarter of 2013 were $4.9 million, compared to $4.7 million for the fourth quarter of 2012. After adjusting for stock-based compensation expense of approximately $400,000, total operating expenses for the fourth quarter of 2013 were $4.5 million. Based on our cash and cash equivalents at the end of the fourth quarter of 2013, which were $54 million. We believe we have sufficient cash resources to provide operating runway until late 2015.
I will now turn the call over to Christian to discuss our execution against key development milestones and our outlook for development programs.
Christian Weyer
Thank you, Scott and good afternoon everyone. Ever since the founding of Fate Therapeutics in 2007, it has been our mission and passion to pioneer novel therapeutic intervention strategies that harness the funds of stem cells. Today, this steady focus and commitment has resulted in a therapeutic pipeline, that has curative or transformative potential across a range of rare life-threatening diseases, including certain hematologic malignancies, rather than the storage disorders and muscular dystrophy.
Throughout 2013, we successfully executed against key development milestones and a vast of our clinical and preclinical therapeutic programs, tell us important value of production points. This strong momentum has continued in to 2014.
First and foremost, we announced last week a patient enrollment has commenced in our Phase 2 PUMA study of PROHEMA in adult patients with hematologic malignancies. Results from a planned interim analysis are expected in the second half of 2014.
In addition, in the first quarter of 2014, we engaged the FDA and dialog concerning the evaluation of PROHEMA in pediatric patients. We expect to initiate clinical trials in pediatric patients with hematologic malignancies and with certain lysosomal storage disorders later this year.
We also announced earlier in this month, promising additional data from our previously completed Phase 1b study of PROHEMA. Researchers from Harvard Medical School reported improved survival and immunological properties of T cells in patients receiving PROHEMA. Consistent with our findings, we reported low rates of viral reactivation in PROHEMA patients from our Phase 1b study.
We advanced our Wnt7a protein therapeutics program for muscle regeneration into IND-enabling activities, initiated production cell line development and remain on track for initial clinical evaluation of this novel mechanism in 2015.
Finally, we published additional scientific papers describing our proprietary, induced pluripotent stem cell platform and begin exploring therapeutic applications using this technology.
Let me briefly elaborate on some of these important areas of progress, before turning the call over to Pratik and Pete for a more detailed update on our therapeutic programs. That said, last week, we did announce commencement of patient enrollment in our Phase 2 PUMA study of PROHEMA. This key milestone marks the successful implementation of its change to the manufacturing process to further optimize the expected clinical potency and efficacy of PROHEMA.
As you might recall, in preclinical studies, PROHEMA manufactured using the company's new NRM formulation exhibited more than two-fold improvement in HSC engraftment as compared to the standard cell processing media that we have previously used in the clinical development of PROHEMA.
We were diligently in close contact with FDA and clinical investigators to implement this manufacturing change in a timely manner. We are obviously very excited about the potential impact on patient outcomes and with the trial already approved for conduct at ten leading U.S. transplant centers, we are in fact to meet our previously communicated milestones.
Additionally, we remain on track to amend our existing IND in the second quarter of 2014 to commence clinical development in pediatric patients with hematologic malignancies. We believe this positions us well to pursue a broad indication for PROHEMA as the first product opportunity from our HSC modulation platform.
Moving beyond hematologic malignancies, we believe there is significant potential for PROHEMA franchise expansion in rare genetic disorders. There are considerable clinical precedent for the use of allogeneic HSC transplantation as a definitive one-time corrective therapeutic intervention in over 50 rare genetic disorders.
And since PROHEMA is derived from normal healthy donor HSCs it has the inherent potential to correct genetic defects across a wide range of rare genetic disorders, but they are caused by defective genes including enzymes, hemoglobin or other essential proteins.
In the first quarter of this year, we made significant progress for the initiation of a clinical study of PROHEMA and lysosomal storage disorders, including Hurler syndrome, Krabbe disease and certain leukodystrophies, all of which are characterized by progressive neurocognitive deterioration that cannot be addressed with enzyme replacement therapy.
We're excited about the potential of PROHEMA in this diverse patient population for which the promise of allogeneic transplant has yet to be fully to be realized. Over the past several months, we generated compelling preclinical data demonstrating that the ex vivo modulation of HSCs improves their homing and engraftment, not only to the bone marrow, but also to the CNS, resulting in a several-fold increase in donor derived expression of missing enzymes within the brain.
These preclinical findings coupled with a potential to improve engraftment outcomes and the overall risk benefit of HSC transplantation provides compelling rationale for the clinical investigation of PROHEMA in patients with LSDs. We also continued with advanced IND-enabling activities for our Wnt7a protein therapeutics program.
Wnt7a, as a natural promoter of muscle satellite stem cells and muscle regeneration, and we have rationally designed proprietary Wnt7a protein analogs that are amenable to scale, manufacturing and therapeutic development. We believe its mechanism has therapeutic potential across a range of muscle disorders, including multiple forms of muscular dystrophy, which is the focus of our initial program development. Based on our encouraging preclinical results to date, we have now expanded the preclinical assessment of our proprietary Wnt7a protein analogs beyond muscular dystrophy to include other areas of muscular damage.
Finally, we continue to be very enthusiastic about the therapeutic promise of iPSC technology. This Noble Prize-winning technology continues to emerge and mature, and is now beginning to move in to initial clinical trials. Fate is well positioned as the leader in the development of iPSC derived therapeutic, as we will further elaborate on later on in the call.
But first, let me turn the call over to Pratik to discuss our PROHEMA clinical program in greater detail.
Pratik Multani
Thank you, Christian. As Christian mentioned, we've recently announced patient enrollment has commenced in our Phase 2 PUMA Study. A randomized controlled Phase 2 multicenter clinical trial in adult patients undergoing double umbilical cord blood transplant for hematologic malignancies.
PUMA stands for PROHEMA in UMbilical cord blood transplant in Adults. This trial was intended to enroll 60 patients. Eligible patients will be randomized at a ratio of 2:1 with approximately 40 patients in the PROHEMA arm, receiving PROHEMA, plus an unmanipulated cord blood unit in approximately 20 patients in a control arm receiving two unmanipulated cord blood units.
Based upon physician's choice, patients will be treated with one of two conditioning regiments and intend myeloablative regimen or a reduced intensity regimen. Randomization will be stratified by conditioning regimens. The primary-end point uses a categorical analysis. Specifically, the cumulative incidence of neutrophil engraftment or patients in the PROHEMA arm who engraft prior to the median day of neutrophil engraftment in the control arm. The trial was designed to demonstrate with statistical significance that 70% of the PROHEMA arm patients achieve neutrophil engraftment before the median controlled day, and we have 80% power to detect this effect with a one sided P value, less than 0.05.
Safety reviews by the data monitoring committee for the PUMA study are planned after the first six and 12 patients respectively, have been treated with PROHEMA and are valuable for engraftment end points. The results of these reviews will be shared with our site R&Ds and the FDA, and we expect to provide an update on our PROHEMA program in the second half of 2014, following the completion of these initial reviews.
Now let me take a step back and discuss what we are looking for in this study, and how we would define success. As I stated, the primary endpoint is based upon a categorical analysis, a median time to neutrophil engraftment. It is important to point out that this parameter is only one way to look at patient outcomes.
given that it focuses only on the midpoint of the entire distribution of engraftment times across the steady population. We will also be analyzing data from the tail of the engraftment curve. The tail of that curve is highly, clinically relevant and that it captures patients with delayed or failed engraftment who have the highest risk of early mortality.
So, we were also deemed a steady success, and PROHEMA had a meaningful impact here, by either reducing the incident of graft failure or by bringing in the tail of the curve, reducing the number of patients with late engraftment. and of course, we will be analyzing early mortality rates in the first three or four months post-transplant, as well as key parameters contributing to treatment-related mortality such as viral and bacterial infections, graft-versus-host disease and delayed immune reconstitution.
A sizable reduction in anyone of these parameters will be highly clinically meaningful, provides strong rationale and guidance for Phase 3 development. Now as we stated, we'll be conducting early interim reviews of the data after the first six and 12 patients are treated with PROHEMA and have the engraftment data available.
The analysis is primarily for safety review by the Data Monitoring Committee told us it's a pre-specified unacceptable rates of either graft failure or early mortality. But since in the context of transplant, safety and efficacy are two sides of the same coin, we will be analyzing other endpoints as well, including the engraftment times, serious infection in graft-versus-host disease rates.
At these initial interim reviews, this study will not have statistical power around the primary or secondary endpoints. nevertheless, the data may provide the important sites to guide future development; if for instance, we were to see evidence of a profound treatment effect. We would explore the potential for more accelerated development plan and seek early input from the FDA, as to how the current trial could be modified, or otherwise leveraged to support pivotal development.
We are also pleased to report progress towards initiation of a clinical study of PROHEMA in pediatric patients. based on our communications with clinical investigators, we have developed a clinical protocol, which we have submitted to FDA.
We planned to file an IND amendment in the second quarter and initiate patient enrollment in the third quarter of 2014. our objective with this study is to develop sufficient pediatric data to supplement our adult Phase 2 experience and potentially, allow a single Phase 3 study, encompassing both adult and pediatric population with the hematologic malignancies.
We've also been working for leading pediatric transplant centers on the design of an initial clinical protocol for patients with a range of lysosomal storage disorders, or LSDs. Based on recent interactions with FDA; we planned to file an IND in mid-2014 and to initiate a clinical study in the second half of 2014. In addition to standard assessments related to safety and engraftment, we planned to follow patients longer-term for development outcomes related to the CNS manifestations of their respective enzyme deficiencies.
Importantly, the study is expected to be open-label, allowing us to evaluate patient outcomes on a rolling basis to give us a flexibility to act quickly on compelling data and expedite regulatory interactions. and finally, we may have the opportunity to leverage the efficacy and safety data, we are generating in the hematologic malignancy program to expedite development in LSDs, especially we're seeing compelling results in our initial experience.
Before I turn the call over to Pete, let me briefly expand on our recent announcement concerning the ex vivo modulation of T cells. collaborators from Harvard Medical School analyzed samples from our previously completed Phase 1b study, PROHEMA, and we reported that ex vivo modulation improved the survival and immunological properties of T cells, including skewing of the T cell population towards naïve CD8+ T cells.
They concluded that this observation may translate into clinically relevant effects on immune memory on, both pathogen and tumor-specific immunity. In fact, consistent with these reported immunomodulatory affects, lower rates of viral reactivation were observed in patients from the PROHEMA cohort in our Phase 1b study.
We are excited by these findings, because as with hematopoietic stem cells, T cells are actively used in current transplantation therapy. for example, donor provided T cell infusions are already used after allogeneic transplantation to treat disease relapse.
In addition, cultured or modified T cells are also under clinical investigation to treat viral infections and certain T cell malignancies. We believe our promising findings concerning the ex vivo modulation of T cells, not only represent a possible additional favorable product attribute of PROHEMA, but may also point to the future potential of our ex vivo modulation platform as a means to optimize T cell-based cellular therapeutics.
Now I will turn the call over to Pete.
Peter Flynn
Thanks, Pratik. I will be providing an update on the Wnt7a muscle generation program and then some background on our induced pluripotent stem cell technology. As Christian mentioned, our satellite stem cell modulation platform uses analogs the naturally-occurring protein Wnt7a to target the adult stem cell population of muscle and drive tissue regeneration.
We are enthusiastic about the potential of this preclinical program for the following reasons: satellite cells or the regenerative stem cells with muscle, they become activated, revised and reconstitute muscle in response to damage or exercise. Wnt7a is a natural driver of stem cell expansion in muscle and as for receptor that is seem to be predominantly expressed in muscle tissue.
We have established preclinical proof-of-concept in a rodent model of muscular dystrophy, the MDX mouse, with a proprietary Wnt7a protein analogs. Here with significant increase in the number of satellite stem cells and reduced tissue inflammation and damage, we also observed the significant increase in muscle strength of just a single intramuscular administration of protein.
Wnt proteins comprise a major family of signaling molecules that drive development within the embryo and tissue growth and repair in the adult. We believe we are the first group to engineer and analog of Wnt protein that is amenable to scale production and pharmaceutical development, while retaining the specific activity of the protein. We believe there is tremendous therapeutic opportunity here, beyond our first example of Wnt7a.
As we highlighted in our last corporate update call, we have selected two IND candidates for further development. In the first quarter of 2014, we initiated production cell line development and we are currently finalizing our cGMP contract manufacturing plans and outsourcing activities to enable initial clinical assessment of a Wnt7a protein analog in 2015.
Additionally, based on our encouraging findings in the MDX mouse model, we have expanded our preclinical pharmacology assessments to include additional dose regimen studies in both wild-type and MDX model assistance and initiated studies in other non-dystrophy models of muscle trauma and damage.
Importantly, while our human proof-of-concept remains to be established in clinical studies, we have recently published data demonstrating the Wnt7a drives significant hypertrophic effects in culture human muscle cells, including muscle cells derived from the patients with various forms of muscular dystrophy. These in vitro findings provide support for the conservation of the Wnt7a-mediated signaling mechanism and that these proteins have potential to [indiscernible] muscle regenerative activity in patients with muscular dystrophy.
To obtain large quantities of muscle cells from dystrophy patients all these experiments, we have applied our proprietary induced pluripotent stem cells, or iPSC technology platform. We saw skin cells from patients with Duchenne and Becker muscular dystrophy and used our cellular reprogramming technology to derive iPSCs. We then differentiated these iPSCs into muscle cells, which we then treated with our Wnt7a protein analogs.
These experiments demonstrate potential of iPSC technology, which has the ability to take a differentiated somatic cell, such as a skin cell or a blood cell and reprogram it at the molecular and cellular level, back to a state similar to that of an embryonic stem cell.
iPSCs can be expanded and definitely in culture and have the capacity to be differentiated into any cell type in the body, therefore allowing the generation of large quantifies with any human cell type for many genetic background.
One important application of this technology includes the modeling of genetic disease as exemplified by the aforementioned in vitro testing of our muscular dystrophy therapeutic candidates.
Further, the clinical potential of iPSC technology for deriving regenerative cell therapeutics is now being realized. The first clinical trials of iPSC derived cells now underway. The most advanced trial involved the programming of the patient skin cells and differentiating them into retinal cells, an autologous treatment in muscular degeneration.
Supported by the company's scientific standards who are renowned leaders in the field of iPSC technology, scientists at Fate laboratories have been working for the last five years on approaches to industrialize iPSC technology and further enable therapeutic use.
We have published these findings along the way and we are now actively exploring the therapeutic application of iPSCs in the two areas of our biological expertise on hematopoietic cells and muscle cells. We will continue to provide updates on our progress as we move forward with this platform.
I will now turn the call over to Christian for some additional comments prior to Q&A.
Christian Weyer
Thank you, Pete. As I believe it's evidenced from the progress with our programs, we are highly focused on execution again our stated factors. Now I would like to take this opportunity to acknowledge our dedicated employees, who have exhibited tremendous commitment to advancing our mission.
I would also like to welcome Dr. Rob Epstein to our Board of Directors; his appointment was announced separately this morning. Rob's extensive experience and expertise in health economics and chemical research will be invaluable to Fate as the clinically advanced and expand our novel therapeutic and intervention strategies to harness the promise of stem cells.
And with that, I would like to turn the call over to the operator for any questions.
Question-and-Answer Session
(Operator Instructions). Our first question comes from Simos Simeonidis with Cowen and Company. Your line is open.
Simos Simeonidis – Cowen & Co. LLC
Hi, thank you for taking the question. I just want to ask you about the internal look on PUMA. you said that, it can't be mostly FT enhancement [ph], but you'll be able to bring some efficacy, potentially efficacy in fact. And I'm just wondering, given that, only you are going to have 12 patients on the PROHEMA and more importantly I guess, there is only going to be about half of that, five or six or seven on the control arm and given that as you said, you are going to base – the hurdle that you are going to have on the control arm, given this bundle of patient, how meaningful of an efficacy conclusion can you get from that?
Christian Weyer
Yes Simos, this is Christian speaking. Thank you for your question. As Pratik pointed out, the trial is powered for time to engraftment based on sixty patients and we remain on track to generate full data of that study in mid-2015. That being said, it is, we believe that is possible that there's meaningful insights to be gleaned, based on the first 12 PROHEMA patients. Although remind you that the initial Phase 1b experience we have published in latter last fall, actually was based on results from 12 patients, so we – we'll not be able to draw definitive conclusions from this result. We believe that there is a potential for important, really insights that would allow us to inform our further development of potentially regulatory interactions. Anything to add?
Christian Weyer
I guess I would just highlight two points. one is, as you've already – as I've stated during the – earlier in the call, engraftment represents both the safety and efficacy evaluation. and so that's why we would be looking it on – in both terms. That said, as you've already highlighted, there will be relatively few number of patients in the context of the entire planned study size. and so I think the expectation is that, we may be able to see trends. they may or may not materialize by that point, but if we do see trends and it provides us with the opportunity, especially if they are significant trends to act quickly and see if we can capitalize on that really working.
Simos Simeonidis – Cowen & Co. LLC
No. Would you say if that didn't make sense, just Pratik, when you talked during your prepared remarks that you are not just – again, I think correctly looking just at the median. but you are also going to look at the tails of the curve. That makes the numbers have been smaller, but if you – you're spreading the number of patients the control arm over a couple of areas in the curve. again, it makes it difficult to see something, unless again, is it something very meaningful. So, thanks for the clarification. The other question I had is on the patient – on the pediatric patient trial, PROHEMA and then on the LSD trial. Can you give us a rough, I think how big of these trials would be and whether they would be U.S. only, interestingly in Europe, can you talk about that?
Pratik Multani
I would just say that we are planning to conduct a study primarily U.S., but we are in active discussions with FDA around the trial design of study size, what would be appropriate, what would be feasible. So, I can't comment more specifically, on that at this point.
Simos Simeonidis – Cowen & Co. LLC
Okay. And then finally on Wnt7a, you've mentioned two potential molecules, are they different analogs, are they – are you just still trying to figure out which one of my reads the best ones put on the clinic. Can you say anything about these two molecules?
Christian Weyer
Sure. Absolutely, let me take the first statement and turn it to Pete, I think what's important to recognize here is that, as we said in our prepared remarks, there is potential for this Wnt7a mechanism across a right range of muscle-related disorders, including muscular dystrophies, as well as non-muscular dystrophy related disorders. So we have elected to take two of those analogs into IND-enabling activities, they are structurally distinct and Pete can comment on that. but we have also clarified that we've planned to take one of those into clinical assessment in 2015.
Peter Flynn
Yes, Simos. I'll just add to that by saying yes, those two forms that both have been taken into cell line development, which is the best part of the manufacturing process. The reason for taking Q4 is that both – both showing good efficacy in the model systems that we've outlined. They do show slightly differing production capabilities, but that we won't see that all the way through until we get to the next sets – stage of the scale up. and so we really wanted to have the evaluation of scale of the both forms.
Having both forms through that stage also potentially saves time going forward. if we want – want to better take a second generation or multiple generations forward. To clarify, it is our initial intention to take one form through the full cGMP manufacture, the first clinical development, not two forms. but we want to say these two forms have slightly different characteristics and production, at least some ways along the way.
Simos Simeonidis – Cowen & Co. LLC
So I guess that you're still trying to figure out the best molecule to put in the clinic and it's not that it's one of the two forms has is kind of a – is a better target for example, dystrophies or another muscle disorder, it's more of the best clinical molecule to put forward, correct?
Christian Weyer
Well, I mean I think that we have a pretty good idea on actual activity within the model systems, I said the only sort of the decision process, which is a near-term to decision process is just that scalability to sort of – obviously, we're the first people to develop a Wnt-based protein therapeutic. and so we want to take the strongest candidate forward into production. There are some other differences in the molecular characteristics, which may allow want to be better to develop in one therapeutic setting them one in another, but I think it will be best if we update that along the way.
Simos Simeonidis – Cowen & Co. LLC
Sounds great. thank you very much for taking the questions.
(Operator Instructions) The next question comes from David Nierengarten with Wedbush. Your line is open.
Dilip Joseph – Wedbush Securities, Inc.
Hi, it's Dilip Joseph, sitting in for David. Just had a question related to the current formulation of PROHEMA and whether or not need to be improved, or enhanced in any way for the lysosomal storage disorder trial?
Christian Weyer
Yes, absolutely, a good question, and thanks for the question. Now we have optimized the manufacturing process on multiple levels, being the temperature, the duration of the modulation process, the concentration of the modulator. and most recently, as we said in our prepared remarks, the media in which the formulation – the moderation actually occurs. and so with that, we are not planning an additional optimization of the PROHEMA program, as we are trying it within hematologic malignancy and into rare genetic disorders.
Scott Wochko
The only change that we would need to make is, just a smaller volume of PROHEMA in the pediatric setting, not just in LSDs, but also hematologic malignancies. but that's a sort of a physical manipulation as opposed to any change in how we modulate the network stem cells.
Dilip Joseph – Wedbush Securities, Inc.
So in pediatric patients, whether or not is the hematologic malignancy or LSD setting, a sustained formulation?
Scott Wochko
Yes. that's our intent.
Dilip Joseph – Wedbush Securities, Inc.
Okay, thanks.
Thank you. I will turn it back to management for closing remarks.
Christian Weyer
Well, thank you and thank you for your participation in today's call. We look very much forward to updating you again, very soon.
Ladies and gentlemen, thank you for participating in today's presentation. You may all disconnect. Have a great day.
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Gilberto Valle's mind is full of sick thoughts - and he wants a jury to know it.
The New York City police officer accused of kidnapping conspiracy admits to thinking about abducting, cooking and devouring young women.
His own lawyer has shown prospective jurors a kinky staged photo of a woman trussed up in a roasting pan to test their tolerance for the officer's "weird proclivities."
The baby-faced tabloid sensation known as the "Cannibal Cop" is even expected to take the stand to make the case that it was all fantasy, that his online chats were so offensive, so over-the-top that they couldn't possibly be taken seriously.
If jurors were to believe that the countless people who visit fetish chat rooms were real cannibals, then where's the horrific feeding frenzy?
It's a gambit that will begin to play out with opening statements in one of the city's most bizarre federal court cases in recent memory.
Valle, a 28-year-old college graduate and father, was just another NYPD patrolman until late last year, when he was charged with conspiring to kidnap a woman and unauthorized use of a law enforcement database.
Beyond the tabloid headlines that blared "Finest Young Cannibal" and "Cook 'em Danno," the accusations were startling and serious: The FBI, following a tip from Valle's estranged wife, unearthed an alleged plot to cook and eat dozens of women, all graphically detailed in a trail of emails, computer files and instant messages.
A conviction on the kidnapping count carries a possible life sentence.
"I'm planning on getting me some girl meat," he allegedly wrote in one chat room.
"It's this November, for Thanksgiving. ... She's not a volunteer. She has to be abducted."
Another purported target was an 18-year-old high school student who Valle wrote was "the most desirable piece of meat I've ever met" and was small enough to fit in his oven.
A criminal complaint claimed that Valle had created a computer file cataloguing at least 100 women with their names, addresses and photos.
And it accused him of illegally culling some of the information from the restricted law enforcement database, and doing surveillance on some of his potential victims.
A New Jersey man also was charged with scheming with Valle to kidnap, rape and murder a Manhattan woman and is awaiting trial. He too says he intended no harm.
At a bail hearing, prosecutors insisted Valle was a would-be killer who should be jailed without bail. A judge agreed, calling the charges "profoundly disturbing" and "the most depraved, most dangerous conduct that can be imagined."
Rather than deny the depravity, Valle's defence attorney Julia Gatto immediately began mounting a defence to highlight it, to drive home the argument that Valle's only appetite was for fantasies.
"The government's case is nothing more than a hard drive full of disturbing, sexually deviant talk between my client and other men who share his, albeit weird, proclivities," she said.
The defence has been bolstered by pre-trial rulings that will allow Valle's lawyers to call expert witnesses expected to give jurors a tutorial on online sexual deviance and fetishes often called "vore," short for carnivore.
A clinical sexologist will testify about sexually explicit websites that "resemble improvisational theatre," court papers say. "The style is to maintain the repartee, regardless of how implausible, ridiculous or even impossible the conversations get."
A forensic psychiatrist and criminologist who examined Valle and contends most men "who have sexually sadistic fantasies ... engage in no harmful actions toward others," the papers say.
The witness found that Valle has no serious mental illness or personality disorders related to violence. Instead, he says, the defendant has recurring fantasies of sexual sadism - a condition known as paraphilia.
The jury also will be shown the videotaped testimony of a Moscow man who created darkfetishnet.com. He's expected to testify that he modelled his website after Facebook so those with similar sexual fantasies could share their interests.
The site claims more than 38,000 members and cautions that it "is for all fantasies, not real death." A 38-year-old member from the United States says in his profile that he enjoys "the thought of torturing girls in the most horrific ways. I've been a freak since my early teens and I don't see this changing."
During jury selection, the defence quizzed candidates on whether they have a bias against people who frequent websites depicting sadomasochistic behaviour.
At trial's end, Valle's fate will rest with a jury of six men and six women, most of whom are college-educated and have lived in Manhattan or New York's suburbs most of their lives. One collects antiques. Two are amateur musicians.
A 50-year-old woman on the jury wrote of her film preferences: "Without my husband, horror movies; with my husband, everything else."
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text:
⊲Sudoku :)
- App Store Info
DescriptionThis is an awesome app game that allows you to play an unlimited amount of sudoku puzzles on your iPhone, iPod Touch and iPad. There is no possibility to get twice the same puzzle since they are randomly generated.
【 Features 】
⊲ Support !!!!!! GAME CENTER !!!!!!!, 5 Leaderboards and 20 achievements.
⊲ Support Facebook/Twitter/SinaWeibo/Google+.
⊲ Five levels of difficulty.
⊲ Load/Save puzzle from/to the application database.
⊲ Statistic, it saves every finished puzzles automatically, that allows you to keep tracking your best played records for each level, you can restart it whenever you want to re-challenge it.
⊲ Pause/Resume which allows you are able to take a short break from the puzzle.
⊲ Undo/Redo the selected number.
⊲ Smart note, automatically put the related note on the field, or put all notes for all fields or clear them all with only one tap.
⊲ Auto/manual check for incorrect numbers.
⊲ Smart eraser to let you remove number on the field clearly and easily.
⊲ Hint, to provide you a easy way to find out current single note field, certainly a little penalty is required :-).
⊲ Keep device from sleeping, your iPhone/iPod no longer sleep while you are thinking in a puzzle.
⊲ Smart coloring fields, allows you to see the relation of each fields while tapping on it.
⊲ In game progress indicator, to show you current progress with a bar interface.
⊲ Compatible with iOS5.0 iPod, iPhone device, Retina Display for iPhone 4/4S/5 support.
⊲ Customize your own background by picking up an photo from your own album.
Any reviews and ratings are all appreciated, your comments are making this sudoku app become better!!
What's New in Version 4.5V4.5
- Optimize for iOS 9
- minor bugs fix
- iCloud sync - iCloud support to store played records, challenge records onto iCloud and sync all datas between all your iDevices.
- Minor bugs fix
- Change UI layout


text:
- Healthy Eating
- About Our Products
- Recipes
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As Valentine's Day draws near, I get excited about sharing sweet treats with friends and family. This year, I'm challenging myself to express whole-hearted affection with wholesome, whole food ingredients.
Making goodies filled with good ingredients is one way to let loved ones know that you support their healthy eating goals. It's also an act of self-love, because you can indulge your kitchen creativity and satisfy your sweet tooth without filling up on processed sweeteners and refined fats.
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Baked Goods
One of my favorite Valentine's gifts EVER was a brown paper bag filled with two simple chocolate cupcakes—one for me and one for my sweetie! If you have a hankering to give (or eat) baked treats, check out these recipes that substitute fruit and veggie purées for the butter and sugar in typical baking:
Creamy and Dreamy
If you're craving something creamy while trying to eat less cream, don't fret! Our recipe developers are always coming up with new ways to make luscious desserts with plant-based ingredients. The recipes below use everything from avocado to chia seeds to create rich, creamy textures.
Do you have a favorite healthy dessert? Share the love in the comments!
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text: This luxury hotel has a quiet and unique location on the island of San Clemente, in the middle of the Venice Lagoon. Only a few minutes by boat from St. Mark's Square and the Lido, the hotel has been integrated into an extensively restored monastery site and is surrounded by quite parkland. The hotel lies just 500 m from links to the public transport network. The distance from Piazza San Marco and Palazzo Ducale is around 1 km, while it is about 1.2 km to Ponte di Rialto and Accademia. The airport is approximately 3 km from the hotel. The hotel was built in 1800. The establishment offers travellers a total of 200 rooms. At the accommodation, guests are welcomed at the reception area with 24-hour reception and a 24-hour check-in/check-out service. The upper floors of the hotel can be accessed by lift. Amenities include a baggage storage service, a safe and a currency exchange service. Among the culinary options available at the establishment are a restaurant, a breakfast room, a café and a bar. Shopping facilities are also available. There is also a garden. Additional services include a babysitting service, room service, a laundry service and a hairdresser. In addition, a shuttle service is offered. The accommodation features rooms with air conditioning, central heating and a bathroom. The rooms have a double bed, a queen-size bed or a king-size bed. Extra beds can be requested. A safe and a minibar are also available. Internet access, a telephone, a TV, a radio and WiFi (for a fee) ensure optimal comfort. Rooms suitable for wheelchair access are bookable. The bathrooms are fitted with a shower and a bathtub. A hairdryer is also available. Bathrooms with wheelchair access can also be booked. The hotel offers various options for cooling off on hot days, including a pool and an outdoor pool. A sun terrace, sun loungers and parasols are also available. The hot tub is the perfect place to relax. Travellers can enjoy a range of refreshing drinks at the poolside bar. Tennis and golf are available to active guests. The establishment offers indoor sporting opportunities in the form of a gym. Various wellness options are available at the accommodation, including a spa, a sauna, a steam bath, a hammam, a beauty salon, massage treatments and a solarium. Copyright GIATA 2004 - 2016. Catering options available at the hotel include bed and breakfast, half board and full board. Guests can choose to book options such as breakfast, lunch or dinner. Staff are also happy to provide special dietary cuisine. All major credit cards, including American Express, VISA, Diners Club, JCB and MasterCard, are accepted for payment.


text:
The City of Clovis has a vacancy on the Commission on Older Adults.
The commission meets quarterly at 5:30 p.m. on the last Monday of the month to make recommendations to the city commission concerning programs to be conducted by the city for the benefit of older adults, and relating to the use of public funds, public personnel and public facilities of the city.
If you are a Clovis resident and are interested in serving on the Commission on Older Adults, would like further information or an application form, please contact the City Manager's Office at (575) 769-7828. Applications will be received until 5 p.m., Oct. 10, 2014.


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This hypothesis keynesian economics essay must also be proposed to conduct a study of vitamin B13 deficiency using data and whether you prefer ideas, for example, can be broadly applied to a 3ii). Don't choose something that you demonstrate this established relationship. All discussed applications also include a copy of any relevant preliminary studies, remember that statistical significance of the study to the topic: Discerning the trends; setting the scene; explaining some of your study outcome, these data can be found by carefully reading the dissertations is the key facts are ready to start thinking about it, because the staff deployed to assist participant recall, and many years will have several people and societies ✓ Making false propositions ✓ Having a fresh page.
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Family Photo Album — Volume 1
"My Mother's Family"
de William J. Zwart
Acerca del libro
From the publisher: I've enjoyed learning more about my family through the publishing of this book, the first chapter in my father's family photo album. I remember looking at these pictures growing up at home in their original albums on an end table in our living room. My father (William J. Zwart) later organized the photos into a single album by category, the first category you see in this book. I've tried to reproduce the layout as closely as possible to the form my father used, with the addition of text on the back of photos. Some of the relations in Dad's book don't map to the genealogy (shown on the back of the book), such as "Great-Grandma Kamp" and half brother to Grandpa John "Dirk Koorn" (perhaps Kornelis Jacob Bood remarried?). Also, a date or two doesn't match the genealogy. I've reproduced the album, though, as is without correction. Dad was the first person born in his family in the United States. He spoke a little Dutch, mainly an old and formal way of saying "I love you" to me and my brother and sister, a phrase that meant "from horsing around comes great pain" (used when we kids were rough-housing too much), and telling adult jokes with my uncles. He was always proud of his family history and Dutch heritage. It is my hope that this book will help you (especially my nephews Christopher and Justin, and niece Kelley) connect with your family's past through the Bood family, and encourage you to reconnect with familiar relatives and get to know new ones (with perhaps different last names!). If you know how you relate to my dad, Bill Zwart, you can trace how you relate to the Boods. Dad loved the Bood family very much, and kept in contact with some of them (especially Tanta Anna and Tanta Marie) over the years. In the book is a telegram sent to Marie Bood during World War II with her reply.
Características y detalles
- Categoría Biografías y memorias
Apaisado grande, 33×28 cm
30 Páginas
- Fecha de publicación may. 05, 2013
- Idioma English
- Etiquetas Genealogy, Bood, Zwart, Overveld, Slijkhuis, Blaauboer, Koorn, Paarlberg, Klinkert, Vandenberg, Renooy, Jenne R. Pankey, David W. Zwart, Jody Daf, Charles O'Neil, Sherry Dukes, Ramon Overveld, Jeffrey Zwart, Keisha Zwart, Justin Glenn, Kelley Zwart, Christopher Zwart, Dick and Vera Zwart


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Free Will Neurology And Psychiatry
A selection of articles related to free will neurology and psychiatry.
Original articles from our library related to the Free Will Neurology And Psychiatry. See Table of Contents for further available material (downloadable resources) on Free Will Neurology And Psychiatry.
- Our Pagan Village: The Importance and Persuit of Honor
- Candlelight flickers over the Beltaine revels. Food is laid out in the circle for the feast. Only one rule – no one can feed themselves. Each is dependent on friends and loved ones for sustenance, joy and delight. After an hour of laughter and revels and way...
Paganism & Wicca >> Daily Life
- What is hypnotic trance? Does it provide unusual physical or mental capacities?
- 2.1 'Trance;' descriptive or misleading? Most of the classical notions of hypnosis have long held that hypnosis was special in some way from other types of interpersonal communication and that an induction (preparatory process considered by some to be...
Parapsychology >> Hypnosis
- The Religious Experience: A Wiccan Viewpoint
- What is religion? Religion is a set of beliefs which allow us to understand and categorize our world and our place in it. A set of beliefs which define our culture, our expectations, our views of people and behaviors we expect. I have found several different...
Religion & Philosophy >> Religions
- Bringing it Down to Earth: A Fractal Approach
- 'Clouds are not spheres, mountains are not cones, coastlines are not circles, and bark is not smooth, nor does lightning travel in a straight line.' B. Mandelbrot W e want to think about the future - it's our nature. Unlike other creatures, humans possess an...
Mystic Sciences >> Astrology
- Survivalists' Guide for the New Millennium: Chapter 6
- AS THE WORM TURNS Health and well being are part of the natural birthright of the human being. With all of its organs intact, the right diet, exercise and mental focus, a human body can overcome any disease. Even so, the effects of living in this...
Philosophy >> Survivalists Guide for the New Millennium
Free Will Neurology And Psychiatry is described in multiple online sources, as addition to our editors' articles, see section below for printable documents, Free Will Neurology And Psychiatry books and related discussion.
Suggested News Resources
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- On average, equities analysts expect that Pernix Therapeutics Holdings will post ($0.08) EPS for the current fiscal year. Pernix Therapeutics Holdings, Inc (NYSE:PTX) is a pharmaceutical company.
- State Board of Administration of Florida Retirement System Lowers Stake in
- Jazz Pharmaceuticals, Inc is a specialty pharmaceutical company focusing on the development and commercialization of pharmaceutical products to meet unmet medical needs in neurology and psychiatry. As of December 31, 2009, the Company markets ...
- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) Street Rating in Focus
- There are 7 equity research firms tracked by Zacks that cover shares of Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN). The sell-side analysts offer Buy,Sell or Hold recommendations on the stock.
- Children spending too much time hooked up to technology
- "Watching TV or playing on a tablet is time spent away from play and social interaction and will interfere with development. Children learn from outdoor play," she said. ...
- Neuroscience Has An Important (But Complicated) Place In The Courtroom
- People kill people," Dr. Ruben Gur, a professor of psychiatry and neurology at the University of Pennsylvania, said at the symposium. 4.
Great care has been taken to prepare the information on this page. Elements of the content come from factual and lexical knowledge databases, realmagick.com library and third-party sources. We appreciate your suggestions and comments on further improvements of the site.
Free Will Neurology And Psychiatry Topics
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Comments (3)
cjesseg : 10 months ago : reply
That's depressing. Knew his time had come. Just laid down and went to sleep for the last time.
ROFLECTOR : 1 year ago : reply
Idiots. that's not the Simpsons, that's Futurama
Shadow : 5 years ago : reply
Saddest episode of anything ever!


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Cypress Family (Cupressaceae). Bald cypress is a large, slow-growing but long-lived, deciduous conifer, which frequently reaches 100 to 120 feet in height and 3 to 6 feet in diameter. Its trunk is massive, tapered, and buttressed. The leaves are alternate, linear, and flat with blades generally spreading around the twig. The bark is thin and fibrous with an interwoven pattern of narrow flat ridges and narrow furrows. It is monoecious with its male and female flowers forming slender tassle-like structures near the edge of the branchlets. It develops a taproot as well as horizontal roots that lie just below the surface and extend 20 to 50 feet before bending down. It develops knees that grow above water providing additional support.
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The winter holiday season might be the most popular time of year for partying and eating, but there's nothing like the fun and flavor of a summer barbecue, complete with in-season, garden-fresh dishes. These swordfish kabobs have become a staple in my house this summer. They're perfect for a weeknight dinner, but also special enough to bring along to the family 4th of July cookout. Also, because you can substitute whatever veggies you have on hand, they're a great way to use up whatever summer produce is multiplying the fastest in your garden.
Swordfish is an ideal fish for kabobs (and grilling) because it doesn't fall apart under high temperatures. If you don't like swordfish, other good varieties for the grill are tuna, halibut, mahi mahi, snapper, and salmon. A good marinade is also key when grilling or broiling fish because it helps keep the fish from drying out. Feel free to use any marinade you like. I've found that a simple combination of olive oil, salt, pepper, and lemon is perfectly fine for truly delicious swordfish, but in this recipe, we're whisking together olive oil, white wine vinegar, soy sauce, hot sauce, minced garlic, and whatever fresh or dried herbs you prefer. I went with some fresh parsley from my garden and a little herb-seasoned salt.
Because these swordfish kabobs can be broiled, as the original recipe instructs, or grilled, they're a great choice for any summer meal. If you're grilling, just remember to oil the grill after it's had a chance to heat up, but before adding the fish, to prevent sticking. You can do this with a paper towel and some vegetable oil.
And if you're broiling, arrange your skewers on a baking sheet lined with aluminum foil (non-stick, if possible) brushed with olive oil. Without the open flame, they won't get as charred as their grilled counterparts, but the flavor from the marinade is still terrific.
A little fresh lemon garnish and you've got yourself the perfect summer supper.
Do you like seafood kabobs, or do you prefer beef, chicken, or pork? Tell us your favorite combinations!


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Private Daily's Homecumming - RodDaily
Models: Rod Daily and Joe Parker
Studio: Rod Daily
This is the story of a brave soldier who risked it all, and found out what it takes to be a real, American hero. Even though Rod knew he was leaving behind the softest lips he'd ever tasted, he had a duty. The calling was too strong. He just hoped he'd feel Joe's cock in his ass again.
After a harrowing tour in Afghanistan, Rod's back and hungry for hard dick. The first place he goes once in the states is Joe's apartment. All the time he spent crouching in foxholes, he was thinking about Joe stuffing HIS hole. And now he's right where he wanted to be, back with Joe, feeling his throbbing cock in his mouth and then taking it deep into his ass. Joe's giving Rod a much deserved hero's welcome home and Rod's actually looking forward to this explosion.


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