Category Archives: Progress

Progress Software (PRGS) is expected to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended February 2021. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.

The earnings report, which is expected to be released on March 25, 2021, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower.

While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise.

Zacks Consensus Estimate

This business software maker is expected to post quarterly earnings of $0.75 per share in its upcoming report, which represents a year-over-year change of -1.3%.

Revenues are expected to be $121.8 million, up 7.1% from the year-ago quarter.

Estimate Revisions Trend

The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period.

Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change.

Price, Consensus and EPS Surprise

Earnings Whisper

Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction).

The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier.

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Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only.

A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP.

Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell).

How Have the Numbers Shaped Up for Progress Software?

For Progress Software, the Most Accurate Estimate is the same as the Zacks Consensus Estimate, suggesting that there are no recent analyst views which differ from what have been considered to derive the consensus estimate. This has resulted in an Earnings ESP of 0%.

On the other hand, the stock currently carries a Zacks Rank of #3.

So, this combination makes it difficult to conclusively predict that Progress Software will beat the consensus EPS estimate.

Does Earnings Surprise History Hold Any Clue?

While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number.

For the last reported quarter, it was expected that Progress Software would post earnings of $0.77 per share when it actually produced earnings of $0.91, delivering a surprise of +18.18%.

Over the last four quarters, the company has beaten consensus EPS estimates three times.

Bottom Line

An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss.

That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported.

Progress Software doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release.

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Progress Software Corporation (PRGS) : Free Stock Analysis Report

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Earnings Preview: Progress Software (PRGS) Q1 Earnings Expected to Decline - Yahoo Finance

About halfway through the 2021 legislative session, Idaho Republicans and Democrats are weighing in on legislative priorities and what's still to come.

BOISE, Idaho The Idaho Legislature is about halfway through the 2021 session. Lawmakers are expected to work through the month of March and still have a large variety of issues to take on.

Democratic leaders say they are concerned about the priorities and efficiency of the Idaho Legislature.

We in the minority caucus are very concerned that the most important issues are being left wholly unaddressed while the Legislature spends its time and energy on power grabs, almost all of them completely unconstitutional, said House Minority Leader Ilana Rubel.

Rubel says instead of focusing on solving problems for Idahoans, the focus by GOP lawmakers is to take more power for themselves.

Weve seen non-stop efforts from the majority party to take power from every other entity and put it into the hands of the Legislature. From the governor, then from local governments, and then from the attorney general, and most alarmingly from the people of Idaho, Rubel said.

This really causes us serious concern," she said. "This bill would impose such strict signature collecting requirements that it would effectively drive a stake through the heart of the citizen ballot initiative process in Idaho, Rubel said.

Minority Caucus Chair Sen. Janie Ward-Engelking believes the focus should be on issues like improving Idaho education.

We are looking at record surpluses," Ward-Engelking said. "We have a chance to really invest in our children his year, we have a chance to invest in Idahos future. We know that education is the greatest economic development tool we have."

Idaho Republican leaders were guests on an AARP virtual town hall Wednesday. Senate President Pro Tempore Chuck Winder said lawmakers are working on a variety of important issues.

There is a lot more going on down at the Legislature than maybe what the media focuses on," Winder said. "It isnt all about regaining our legislative authority but that is part of it. Budgeting, we are setting budgets now. We are on schedule to do that. There is a lot of things going on with how are we going to have tax relief, how are we going to return money to the people. There are lots of issues there.

Republican House Speaker Scott Bedke said there is a major focus on tax legislation. There has been criticism of early proposals but Bedke says they are simply working through ideas.

Its a starting point with an idea," he said. "Our goal as we craft tax policy is to create policy for our citizens where it becomes tax relief and not a shift or increases taxes."

Winder addressed critics who say there is an attempt to just take power from the executive branch with a collection of Republican proposals aimed at tailoring emergency power. He says its not a blind power grab but a focused effort to address months and months of executive actions on the pandemic.

I think the Legislature just wants to have a say on some of those decisions and not just take away from the governors ability to make instantaneous decisions for emergencies, because there will be times he has to. But after a longer period of time, the Legislature should have some say on some of these questions that are out there, Winder said.

Democrats are optimistic that their priorities can be addressed heading into the second half of the session, but there is also concern with proposals they believe go far.

A lot is in flux right now, it has the potential to be a great session or one of the worst sessions ever, Rubel said.

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Idaho Dems, GOP disagree over progress made so far in the 2021 legislative session - KTVB.com

Ayear ago at this time, many of us probably didnt know much about COVID-19. Some had heard that a weird illness had started in China, but our knowledge of what was going on was extremely limited.

And when you think about the last year its impossible to remember every little thing that took place. It all started with fear, at least for most of us. We were concerned about our own health and about the health of the people close to us. We had to adjust our work, our lifestyles everything.

Schools were closed and scrambling to figure out a plan for the 2021 school year. Stores were closed for in-person shopping. Restaurants couldnt serve you inside. Movie theaters shut down.

It was hard to fathom any of these things ever happening until COVID-19 turned our world upside down.

But boy have we come a long way.

With that in mind, we point you toward an upcoming special section weve produced. Each year The LaGrange Daily News produces its Progress section, and that section will publish this Saturday with a focus on recovery.

We tried to look at COVID-19 from many different angles. For one, how are vaccines being distributed locally? We also looked at how the lack of broadband service in parts of the county might be impacting people, whether its via work or school.

We talked to the Troup County School System about the future of its virtual academy, which has given students the option to stay home and learn if they were worried about COVID-19.

We also published a story on a couple who managed to get married during COVID-19, and a business that opened during the pandemic.

These are people and entities who worked hard, made a plan and overcame the obstacles that COVID-19 threw their way. Weve all tried to do that in our personal lives.

Weve all adjusted so much to masks, social distancing and other preventative measures. COVID-19 is currently under control, based on the number of cases were currently seeing across the country, in Georgia and in Troup County. Obviously, that can change quickly, especially with the different variants going around.

But we wanted to take a hard look at issues COVID-19 brought to light, as well as feature some locals who had perservered through a difficult time.

We know many have done it, but we imagine it takes a lot of willpower to get married during this pandemic due to all the uncertainty and the ongoing changes. And it takes a lot of faith and belief to open a business, especially given all of the economic uncertainty last year.

Our Progress section will publish on Saturday, and we hope youll look for it. Its a good look at many different angles of how COVID-19 impacted our daily lives.

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Progress section to look at how COVID-19 has impacted Troup County - LaGrange Daily News - LaGrange Daily News

FIFA President Gianni Infantino has spoken of the need for football to strengthen its cooperation across the African continent, and has shown his support for the promotion of womens football locally, following discussions with Moroccan Minister for Foreign Affairs and International Cooperation, Nasser Bourita, and the President of the Moroccan Football Association (FMRF), Fouzi Lekjaa.

The FIFA President was speaking in the Moroccan capital, Rabat, following discussions that also looked at the countrys role in continental African football and the victory of the Atlas Lions, as winners of the CAF African Nations Championship (CHAN), earlier this month.

Its a pleasure to be here in this magnificent country where football is so strong, the FIFA President said after the first series of meetings with FMRF officials. I have already visited Morocco several times in the past and I noticed not only the passion for football but also the serious work of the federation, we are here to try find out how we can benefit even more from this work. The MoulayAbdellah Sports Complex in Rabat and the infrastructure in the whole country, this can benefit the country, the whole of Africa and beyond. This is why we are here, to see what else we can do through football infrastructures in Morocco to benefit mens and womens football, as well as youth football, and we will leave here with lots of ideas for programmes about the future.

Subsequent discussions followed with members of the Moroccan government, where the FIFA President congratulated Minister Bourita on the success of the mens national football team in their success in the CHAN tournament in Cameroon. The FIFA President also highlighted both the country and the FMRFs initiatives to get more girls and women involved in football, and commended the recent launch of a four-year womens football development plan, as a significant initiative to raise the value of women's football by actively engaging girls at grassroots level in football.

My talks with Minister Bourita were both interesting and productive, and I mentioned that Morocco is recognised as a leader in integrating more girls and women in football, the FIFA President said. There are many positive moves, from appointment of female referee Bouchra Karboubi in the domestic league last October, to the introduction of the new womens football development strategy by the FMRF last summer.

"There are great opportunities here, and I look forward to seeing Morocco stake their claim for a place at the FIFA Womens World Cup. I informed the Minister that FIFA will help the federation in further developing and nurturing the womens game throughout Morocco, so even more girls and women can become involved in football.

The rest is here:

Womens football progress highlighted in Morocco meetings - FIFA.com

Fast-Moving Snow Blankets Denver Metro AreaA strong snow storm quickly moved in on Wednesday evening.

'It's About Time They Are Prioritized': Union Organizing JBS Mass Vaccination EventThousands of workers at the JBS meatpacking plant in Greeley will soon have access to the COVID-19 vaccine.

'It's Our Livelihood': Businesses Near Convention Center Eager For EventsThe announcement that events are returning to the Colorado Convention Center is leading many to believe a rebirth of downtown Denver is near.

Cars, Fire Trucks Stuck On Highways As Winter Snow Barrels Across Denver Metro AreaDrivers were met with dangerous, snowy conditions just after sunset on Wednesday.

Denver Weather: Quick Burst Of Snow Hitting ColoradoAfter a few warm days in the 60s, we are now much cooler with snow already falling along the Front Range.

Appointments Available For Weekend COVID Vaccination Event For 70+ At National JewishNational Jewish Health is hosting an appointment-only vaccine event this Saturday, Feb. 27 from 9 a.m. to 4 p.m. The event is only for those 70 and older.

Black Colorado Leaders Stress Need For Continued Movement & Social JusticeWhile a summer of unrest magnified the need to march and rally for social justice, it is only the lasted evolution in a long history for the Black community.

Rules Regarding Pride Flag Center Of First Amendment Lawsuit In ColoradoA hearing is set for March 8 in Denver Federal District Court in which a man is challenging his metropolitan district's rules regarding when he can fly his gay pride flag.

State Senate Passes Bill Eliminating Statute Of Limitations For Civil Sexual AssaultsFive years after Colorado eliminated the statute of limitations for criminal cases involving sexual assaults involving children, state lawmakers are considering doing the same for all civil sex assault cases.

In-Person Events To Resume At Colorado Convention CenterThe Outdoor Retailer Summer Show is set to return to the Colorado Convention Center in August.

UCHealth Connects With Spanish-Speaking Patients To Promote COVID Vaccine EquityA fifth of Colorado's population is Latino, yet only 5% of the vaccines are going to them.

Trash Truck Backs Into Denver House, Causing Partial CollapseA house in southwest Denver partially collapsed after a garbage truck backed into it.

Quick Shot Of Snow Arrives In ColoradoWatch Lauren Whitney's forecast

Johnson & Johnson Vaccine Awaits Emergency Approval For Use In The United StatesThe J&J vaccine only requires one dose compared to two doses needed for the Moderna and Pfizer vaccine.

Girls & Science Goes Virtual With Events Throughout The Month Of MarchThe new format features virtual clubhouses, clubhouse chats, and stories with scientists focused on connecting future scientists with women in STEAM careers.

UCHealth Researchers Studying If Convalescent Plasma Can Keep High-Risk COVID Patients Out Of The HospitalResearchers at UCHealth University of Colorado Hospital are looking at the effectiveness of convalescent plasma in keeping high-risk COVID-19 patients out of the hospital.

Colorado COVID Survivor Meets Plasma Donors Who Helped Save His LifeA Colorado man got to meet the two people who donated convalescent plasma which he credits in saving his life when he suffered from COVID-19. Paul Nielsen got sick in May 2020.

Foundation Still Helping East Troublesome Fire Victims Months LaterVictims of the East Troublesome Fire in Grand County are still receiving support from the community.

Colorado Lawmakers Discuss Creation Of Health Service Reserve Corps Modeled After National GuardColorado lawmakers discussed a bill that would create a so-called health service reserve corps.

Check Out The Progress With DIA's Great Hall ProjectThe Great Hall Project continues at Denver International Airport. DIA shared the images which show the work in progress.

Denver Restaurant Week Moved To Spring With Outdoor Dining In MindFoodies in Denver will be able to enjoy a slightly different Denver Restaurant Week this year. VISIT DENVER says the popular event will be pushed to April 23-May 2 with a patio-friendly approach.

Emergency Declared For SkyWest Flight Landing At Aspen-Pitkin County Airport After Possible Smoke Reported In CabinAn emergency was called for SkyWest flight 3150 as it approached the Aspen-Pitkin County Airport on Wednesday morning.

$6,800 Tip: 'COVID Bandit' Gives $200 To Each Employee At Guard And Grace In DenverA man who identified himself only as "COVID Bandit" hit employees at a Denver restaurant with something unexpected -- an extremely generous tip!

Trash Truck Backs Into Denver House, Causing Partial CollapseA house in southwest Denver partially collapsed after a garbage truck backed into it. It happened in the 3300 block of South Julian Street on Wednesday.

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Check Out The Progress With DIA's Great Hall Project - CBS Denver

February 24th 2021Marina Emborg, MD PhD, Jeremy Bailoo, PhD and Doris Doudet, PhD

Parkinsons disease (PD) is the second most common neurodegenerative disease after Alzheimers disease. The population prevalence of PD increases from about 1% at age 60 to 4% by age 80. From 1999 to 2017, the age-adjusted death rate for Parkinson disease among adults aged 65 years has increased from 41.7 to 65.3 per 100,000 population. PD is more prevalent in men than women.

Typical signs and symptoms of PD include motor disturbances like bradykinesia (slowness of movement), rigidity, postural instability and, in a majority of patients, the characteristic pill rolling tremor. The characteristic underlying pathology of PD motor symptoms is the death of dopamine-generating cells in the substantia nigra, a part of the brain involved in movement, reward and addiction. Non-motor symptoms like constipation, mood and sleep problems often occur before the motor symptoms, and cognitive decline and lower quality of life are common at later stages. Like other common diseases, PD is thought to arise from complex interactions between genetic and environmental factors, which remain mostly unknown.

The history of animal models and Parkinsons

Animal models have and continue to be important for basic and applied research of human diseases. They are not only important for understanding basic processes underlying disease, but also for the development of disease-specific as well as generalized principles for therapeutic strategies. Further, they are essential for pre-clinical safety and efficacy testing of drugs developed using such research, prior to human clinical trials.

Parkinsons disease (PD) is not known to spontaneously appear in animals other than humansin humans the most prevalent presentation PD is idiopathic (spontaneous) in nature. The features characteristic of PD, however, can be induced through the administration of neurotoxic agents. Using these techniques, the motor symptoms and underlying pathological changes of PD have been researched in drosophila, goldfish, mice, rats, cats, minipigs, sheep, and Central and South American World and Asian and African monkeys.

Parkinsons disease is not just an older persons disease: The hidden side of the disease. Verbeeldingskr8 a.k.a. Sparks [CC BY-SA 4.0 (https://creativecommons.org/licenses/by-sa/4.0)It has become clear, due to decades of research, that PD is complex. Some researchers who study PD using animal models are concerned that true progress in understanding the causes and potential cures for PD will never be realized because animal models do not faithfully recapitulate all the features of human PD statethat is, they do not spontaneously occur, showing a developmental progression in debilitating effects across time or do not present the full spectrum of neuronal loss or protein accumulation. Those opposed to animal research have seized upon this criticism and mis-contextualized itmost likely because of their limited understanding of what constitutes an animal model. This criticism is applied to many other diseases and disorders as well and is indeed valid, but does not recognize the value of animal models as blueprints for the understanding of complex and specific mechanisms of initiation and progression. It also does not recognize that even in humans, no two patients are exactly alike and have the exact same presentation of the diseasemany diseases present as a continuum and not as a black and white block with every feature, symptom and pathology expressed in every individual.

Most animal models of complex diseases characterize particular aspects of a disease rather than its entirety. The simple reason for this is because most diseases present as a mix of symptoms. Correspondingly, different symptoms may require particular drugs or interventions for treatment. Thus, animal models, much like any model, represent very specific aspects (e.g., symptoms) of the disease it is modeling. If this were not the case, then by definition alone, it could not be termed a model. There are specific standards for a relevant model to meet to be termed as such, including homology of at least some symptoms (face validity), behavioral persistence, similarity to some of the human pathology (construct validity), and improvement in response to effective human therapies (predictive validity)to name a few. A good model will meet at least some of these criteria. Replicability of the model is also critical so the results can be validated across laboratories. The choice of which symptom to modelthe specificity of the model if you willis prompted by what is known via hypothesis driven research using the scientific method, prioritizing what patients need most.

When considering animal models of PD induced symptoms, there is a long history of animal research which has directly resulted in the therapeutic strategies used to treat humansa fact which directly refutes claims that induced animal models of PD are of limited value.

Take for example, levodopa (L-DOPA), the most common drug used to control symptoms of PD and Parkinsonismany condition that causes a combination of the movement abnormalities seen in PD. The use of L-DOPA in alleviating PD related symptoms was discovered by an animal researcher named Arvid Carlsson. He found that rats slowly given reserpine (a drug that depletes dopamine in the brain) lost their ability to move their muscles, and that this state could be rescued by administering L-DOPA. L-DOPA works because it can get inside the brain (cross the blood brain barrier), where neurons use it to make extra dopamine, the missing chemical messenger in PD.

Carlssons research launched a prolific body of animal research in the sixties and seventies, where, using rodents and primates, it was discovered that reserpine resulted in the initial release of many neurotransmittersnot just dopamine, followed by the inability to store and depletion of existing stores of neurotransmitters. This knowledge prompted the development of other animal models of induced PD. Among those, the use of toxins like 6OHDA, MPTP or rotenone produced models with various courses and symptoms severity but common motor symptoms of bradykinesia and rigidity. The development of these models also provided clues on mechanisms of neuronal cell loss in PD and the relationship between the exposure to pesticides and increased risk of developing PD. Further animal research demonstrated that prolonged use of L-DOPA in these characterized models results in debilitating involuntary movement (dyskinesia)a major drug-induced adverse event of PDthus limiting its use for very long term treatment.

In most cases of PD, however, early L-DOPA treatment of PD guarantees a quality of life standard for many years that could not previously have been realizeda significant fact for those with the disease as well as their caregivers.

That research, in turn, led to the recognition that other drugs derivatives such as amphetamine, MK-801, amantadine and memantine, drugs that increase DA directly or indirectly, were effective in ameliorating PD related symptomsall made possible thanks to #AnimalResearch. Carlsson subsequently won the Nobel Prize in 2000 in Medicine/Physiology for this research.

Another primary PD treatment with high efficacy is Deep Brain Stimulation (DBS), an invasive surgical procedure which is usually recommended when the L-DOPA-induced dyskinesias become themselves disabling and justify the surgical risk. Notably, DBS was extended to treat many other diseases including Dystonia, Epilepsy, Essential tremor, and obsessive-compulsive disorder (OCD), and is being tested as a treatment for Addiction, Chronic pain, Cluster headache, Dementia, Major Depression, Huntingtons disease, Multiple sclerosis, Stroke recovery, Tourette syndrome and Traumatic brain injury. DBS was logically designed and strictly based on extensive research in the 70s and 80s on the anatomy and normal and pathologic functions of the basal ganglia nuclei. Many open questions about mechanism, efficacy and efficiency, identification of novel brain targets and optimization of current ones have been researched using rats, mice and primates.

The early research using animal models for DBS, however, owes much to basic primate research. Starting in the 1970s, Mahlon DeLong used recordings of individual neurons in various regions of the brain that are part of the basal ganglia, to meticulously characterize the functions of neurons as animals performed movements (e.g., here, here, here and here). Over the next several years, primate research yielded a working understanding of the circuitry underlying motor control in the brain. By this time, researchers understood that it was the loss of dopamine-producing neurons in the basal ganglia neural network that contributed to PD onset and had access to a reliable primate model to study the pathology associated with the symptoms.

In the early 1980s, after reports described how a few young people, in their 20s, developed severe PD-like symptoms after injecting themselves with a synthetic heroin, scientists determined that the cause was an impurity later known as 1-methyl-4-phenyl-1,2,5,6-tetrahydropyridine (MPTP). MPTP selectively kills some of the same neurons lost in PD. After it was found that the toxin was ineffective in inducing PD-like motor symptoms in rats but from clinical experience, was highly effective in humans, researchers developed a MPTP-induced non-human primate (monkey) model of PD. The monkey model recapitulated most of the motor symptoms, bradykinesia, rigidity, postural imbalance, freezing but less so of tremor (not a basal ganglia symptom).

DeLong and others used this model to understand how the lack of dopamine leads to motor symptoms of PD and map the circuitry and abnormal firing of its various components. Guided by the circuitry map he previously developed in primates, DeLong lesioned the subthalamic nucleus (STN) in MPTP-treated monkeys and achieved dramatic results: a rapid reduction in PD-like motor symptoms. Studies by other researchers produced similar results, using either surgical lesions or electrodes to induce high frequency stimulation in the STN, internal globus pallidus (GPi) or thalamus. Together, the findings altered prevailing assumptions about how circuit abnormalities might drive motor symptoms, and importantly, provided scientific rationale for targeted therapy.

Meanwhile, with the new understanding of the limitations of L-DOPA treatment for PD, the rapid advancement of medical device technologies, and the new found knowledge of subcortical circuitry, Alim Louis Benabid, a French-Algerian neurosurgeon, proposed in the late 1980s, the development of a device to chronically stimulate the deep nuclei involved in motor control, to reversibly mimic the effects of lesions. Small scale clinical trials in humans with an implantable DBS device developed by Medtronic, a specialized biotech company, which stimulated the ventral intermediate nucleus of the thalamus (VIM) caused PD patients tremors to cease. In 1997, the FDA granted approval for Medtronics DBS device for VIM-DBS to treat essential tremor and tremor associated with PD.

While DBS in the thalamus reduced tremor, it did not reverse other symptoms reported by patients as even more debilitating, including rigidity and slowed (bradykinesia) or reduced (hypokinesia) voluntary movement, nor did it treat non-motor symptoms that also impact quality of life. Researchers applied DBS to the STN or the GPi in patients with PD. Both improved rigidity and bradykinesia, yielding their best results in patients yet, and successfully bridging basic and clinical neuroscience research. Based on results from a large clinical trial, the FDA approved DBS in the STN/GPI to treat motor symptoms in advanced PD in 2002.

The future of PD research requires primates

Through clinical research, a number of genetic mutations have been found in families of PD patients. Depending on the type of mutation and the population, they can be present in 5% or up to 40% of PD patients. This new knowledge combined with new tools is helping create animal models to study the mechanism that causes neuronal cell death in PD.

The identification of genetic mutations associated with human PD are giving investigators clues about which proteins play a role in neurodegeneration, i.e., how and why neurons die in PD. One of the villains seems to be the neuronal protein -synuclein, which in PD accumulates and binds to other proteins to form Lewy bodies. A new generation of animal models are being created to study how this protein needed for brain function, over time becomes a neuron assassin and to test new therapies. To make this kind of model, investigators may inject directly into the brain, either the faulty protein or a modified virus to produce the protein in excess. Novel technologies to modify genes are being used to introduce the mutations. In addition to anatomical and functional differences between mice, rats, monkeys and humans, genetic differences are also considered for models of genetic PD.

Thus, a primate model is essential for further empirical investigation and progress in our understanding and treatment of PD.

An exciting opportunity of having genetic models of PD is that investigators can study when the disease starts and test for therapies that can prevent neuronal loss, effectively stopping PD in its tracks. That research requires animal research occurring over many years, in the same animals. The availability of non-invasive neuroimaging methods like Magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET) for large (monkeys) and small animals (rodents) also allows researchers to probe the functional and neurochemical changes during disease progression across time. While some studies can be done in PD patients, long term follow up from initiation, to symptoms progression vs changes in brain chemistry and response to therapies can be assessed in a non-human primate model non-invasively. As the same animals can be studied overtime, fewer animals are used compared to what was needed 3-4 decades ago.

To date, however, there is a need to further develop and refine the models in primates before programmatic research can begin in earnest. Plus, novel therapies for motor and nonmotor symptoms, including methods to replace neurons lost to PD are being created.

This means that we need more, not less primate research. Those opposed to animal research will always do so. For those of us who are considerate of improving the human conditionwhile weighing the risks and the benefits of doing versus not doing such researchthe answer is clearly in favor of animal research for PD in the hopes of finding a cure for this debilitating disease.

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Progress in Parkinsons disease depends on Primate and other #AnimalResearch - Speaking of Research

Achieved Oxbryta (voxelotor) net revenues of $41.3 million in the fourth quarter and$123.8 million for full year 2020

Further established leadership in sickle cell disease (SCD) with data presentations on pipeline programs inclacumab and GBT021601 (GBT601)

Conference call today at 4:30 p.m. ET

SOUTH SAN FRANCISCO, Calif., Feb. 24, 2021 (GLOBE NEWSWIRE) -- Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) today reported recent business progress and financial results for the fourth quarter and year ended December 31, 2020.

In 2020, GBT adapted to the challenging conditions of the global COVID-19 pandemic to safely and successfully execute the launch of Oxbryta. It is a testament to our teams dedication and the need for innovative therapies for sickle cell disease that we ended the year with thousands of patients on Oxbryta, an established base of prescribers, broad payer coverage, and a growing body of real-world evidence demonstrating statistically significant decreases in VOCs and transfusions and improved overall health-status. In addition, we announced robust progress for our pipeline with plans to advance inclacumab and GBT601 in 2021. We believe both these programs have the potential to become best-in-class SCD therapies, further expanding our leadership in SCD, said Ted W. Love, M.D., president and CEO of GBT.

We continue to be confident in the long-term potential of Oxbryta and are well positioned to build on our strong fundamentals to enhance our commercialization efforts in the U.S. and accelerate adoption. Furthermore, we continue to make important progress on our goal to provide access to Oxbryta to more SCD patients. We will also continue to support the SCD community and efforts to improve access to care, which has become even more important because of the impact of the COVID-19 pandemic that has dramatically magnified long-standing health inequities, added Dr. Love.

Recent Business Progress

Commercial

Clinical

Corporate

Financial Results for the Fourth Quarter and Year-End 2020Total net product sales for the fourth quarter of 2020 was $41.3 million, resulting from sales of Oxbryta, compared with $2.1 million for the same period in 2019. Net product sales resulted from sales of Oxbryta, which was launched in the United States in December 2019. Total net product sales for the full year 2020 was $123.8 million, compared with $2.1 million for the same period in 2019.

Cost of sales for the three months ended December 31, 2020, was $1.0 million compared with $48,000 for the same period in 2019. Total cost of sales for the full year 2020 was $2.0 million, compared with $48,000 for the same period in 2019. Manufacturing costs incurred prior to FDA approval of Oxbryta in November 2019 were previously recorded as research and development expense in the companys consolidated statement of operations. GBT expects that the cost of Oxbryta sales as a percentage of revenue will increase in future periods as product manufactured prior to FDA approval, and therefore fully expensed, is utilized.

Research and development (R&D) expenses for the three months endedDecember 31, 2020, were$41.1 millioncompared with$65.0 millionfor the same period in 2019. R&D expense in the fourth quarter 2019 included a $20 million upfront expense incurred in December 2019 related to the companys Syros collaboration agreement. Excluding this expense, the decrease in R&D expense compared to the prior year was primarily due to lower expense as a result of capitalization of Oxbryta manufacturing costs to inventory, which was partially offset by higher pre-clinical development activities under the Syros collaboration and other clinical programs. Following FDA approval of Oxbryta in November 2019, GBT capitalizes manufacturing of Oxbryta to inventory. R&D expenses for the year endedDecember 31, 2020, were$155.1 millioncompared with$174.6 millionfor the same period in 2019. The year-over-year decrease was primarily due to a $33.9 million decrease in Oxbryta related manufacturing costs and medical affairs costs that were previously expensed to R&D and a $1.7 million decrease in other preclinical programs. The decrease was partially offset by a $16.3 million increase in external costs associated with inclacumab and driven by the manufacturing activities. Total R&D non-cash stock compensation expense incurred for the three months ended December 31, 2020, was $3.7 million compared with $5.3 million for the same period in 2019. Total R&D non-cash stock compensation expense incurred for the year ended December 31, 2020, was $18.1 million compared with $19.1 million for the same period in 2019.

Selling, general and administrative (SG&A) expenses for the three months endedDecember 31, 2020, were$58.6 millioncompared with$44.6 millionfor the same period in 2019. SG&A expenses for the year endedDecember 31, 2020, were$210.9 millioncompared with$117.1 millionfor the same period in 2019. The increase in SG&A expenses for both comparative periods was primarily attributable to increased employee-related costs, including non-cash stock compensation expense, and increased professional and consulting services associated with the build-out of the companys commercial operations and launch of Oxbryta. Total SG&A non-cash stock compensation expense incurred in the three months endedDecember 31, 2020, was$14.3 million compared with$7.5 millionfor the same period in 2019. Total SG&A non-cash stock compensation expense incurred in the year endedDecember 31, 2020, was$53.4 million compared with$26.5 millionfor the same period in 2019.

A non-cash gain on the companys lease modification for the year ended December 31, 2020, was $1.0 million compared with $8.3 million for the same period in 2019. This is a non-recurring item related to the move to the companys new headquarters in 2020 and related termination of its previous lease in 2019.

Net loss for the three months endedDecember 31, 2020, was$61.8 millioncompared with$96.0 millionfor the same period in 2019. Basic and diluted net loss per share for the three months endedDecember 31, 2020, was$1.00compared with$1.59for the same period in 2019. Net loss for the year ended December 31, 2020, was $247.6 million compared with $266.8 million for the same period in 2019. Basic and diluted net loss per share for the year ended December 31, 2020, was $4.04 compared with $4.57 for the same period in 2019. The company expects its operating costs to increase during 2021 due to costs associated with expanding commercialization activities related to Oxbryta and the advancement of its clinical pipeline.

Cash, cash equivalents, and marketable securities totaled$560.9 millionatDecember 31, 2020, compared with$695.0 millionatDecember 31, 2019.

Conference Call DetailsGBT will host a conference call today,Wednesday, February 24, 2021, at4:30 p.m. ET to provide a general business update and discuss the financial results for the fourth quarter and full year 2020. To participate in the conference call, please dial 877-407-3982 (domestic) or 201-493-6780 (international). A live audio webcast of the conference call can be accessed on GBTs website at http://www.gbt.com under the Investors section. An archived audio webcast will be available for one month following the event.

About Sickle Cell DiseaseSickle cell disease (SCD) affects an estimated 100,000 people inthe United States,1an estimated 52,000 people inEurope,2and millions of people throughout the world, particularly among those whose ancestors are from sub-Saharan Africa.1It also affects people of Hispanic, South Asian, Southern European, and Middle Eastern ancestry.1SCD is a lifelong inherited rare blood disorder that impacts hemoglobin, a protein carried by red blood cells that delivers oxygen to tissues and organs throughout the body.3Due to a genetic mutation, individuals with SCD form abnormal hemoglobin known as sickle hemoglobin. Through a process called hemoglobin polymerization, red blood cells become sickled deoxygenated, crescent-shaped, and rigid.3-5The sickling process causes hemolytic anemia (low hemoglobin due to red blood cell destruction) and blockages in capillaries and small blood vessels, which impede the flow of blood and oxygen throughout the body. The diminished oxygen delivery to tissues and organs can lead to life-threatening complications, including stroke and irreversible organ damage.4-7

About Oxbryta(voxelotor) tabletsOxbryta (voxelotor) is an oral, once-daily therapy for patients with sickle cell disease (SCD). Oxbryta works by increasing hemoglobins affinity for oxygen. Since oxygenated sickle hemoglobin does not polymerize, GBT believes Oxbryta blocks polymerization and the resultant sickling and destruction of red blood cells, which are primary pathologies faced by every single person living with SCD. With the potential to improve hemolytic anemia and oxygen delivery, GBT believes that Oxbryta has the potential to modify the course of SCD. OnNovember 25, 2019, Oxbryta receivedU.S. Food and Drug Administration(FDA) accelerated approval for the treatment of SCD in adults and children 12 years of age and older.8As a condition of accelerated approval, GBT will continue to study Oxbryta in the HOPE-KIDS 2 Study, a post-approval confirmatory study using transcranial Doppler (TCD) flow velocity to assess the ability of the therapy to decrease stroke risk in children 2 to 15 years of age.

In recognition of the critical need for new SCD treatments, the FDA granted Oxbryta Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease designations for the treatment of patients with SCD. Additionally, Oxbryta has been granted Priority Medicines (PRIME) designation from theEuropean Medicines Agency(EMA), and theEuropean Commission(EC) has designated Oxbryta as an orphan medicinal product for the treatment of patients with SCD.

The EMA has accepted for review GBTs MAA seeking full marketing authorization of Oxbryta in the European Union to treat hemolytic anemia in SCD patients ages 12 years and older. GBT also plans to seek regulatory approval to expand the potential use of Oxbryta inthe United Statesfor the treatment of SCD in children as young as 4 years old.

Important Safety InformationOxbryta should not be taken if the patient has had an allergic reaction to voxelotor or any of the ingredients in Oxbryta. See the end of the patient leaflet for a list of the ingredients in Oxbryta. Oxbryta can cause serious side effects, including serious allergic reactions. Patients should tell their healthcare provider or get emergency medical help right away if they get rash, hives, shortness of breath, or swelling of the face.

Patients receiving exchange transfusions should talk to their healthcare provider about possible difficulties with the interpretation of certain blood tests when taking Oxbryta.

The most common side effects of Oxbryta include headache, diarrhea, stomach (abdominal) pain, nausea, tiredness, rash, and fever. These are not all the possible side effects of Oxbryta.

Before taking Oxbryta, patients should tell their healthcare provider about all medical conditions, including if they have liver problems; if they are pregnant or plan to become pregnant as it is not known if Oxbryta can harm an unborn baby; or if they are breastfeeding or plan to breastfeed as it is not known if Oxbryta can pass into breastmilk or if it can harm a baby. Patients should not breastfeed during treatment with Oxbryta and for at least 2 weeks after the last dose.

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how Oxbryta works. Oxbryta may also affect how other medicines work.

Patients are advised to call their doctor for medical advice about side effects. Side effects can be reported to FDA at 1-800-FDA-1088. Side effects can also be reported toGlobal Blood Therapeuticsat 1-833-428-4968 (1-833-GBT-4YOU).

Full Prescribing Information for Oxbryta is available atOxbryta.com.

About Global Blood TherapeuticsGlobal Blood Therapeutics(GBT) is a biopharmaceutical company dedicated to the discovery, development, and delivery of life-changing treatments that provide hope to underserved patient communities. Founded in 2011, GBT is delivering on its goal to transform the treatment and care of sickle cell disease (SCD), a lifelong, devastating inherited blood disorder. The company has introduced Oxbryta(voxelotor), the first FDA-approved treatment that directly inhibits sickle hemoglobin polymerization, the root cause of red blood cell sickling in SCD. GBT is also advancing its pipeline program in SCD with inclacumab, a P-selectin inhibitor in development to address pain crises associated with the disease, and GBT021601 (GBT601), the companys next generation hemoglobin S polymerization inhibitor. In addition, GBTs drug discovery teams are working on new targets to develop the next wave of treatments for SCD. To learn more, please visitwww.gbt.comand follow the company on Twitter@GBT_news.

Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995, including statements containing the words will, anticipates, plans, believes, forecast, estimates, expects, and intends, or similar expressions. These forward-looking statements are based on GBTs current expectations and actual results could differ materially. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. GBT intends these forward-looking statements, including statements regarding GBTs priorities, commitment, dedication, focus, goals, and vision; the safety, efficacy, and mechanism of action of Oxbryta, and other product characteristics; the commercialization, delivery, availability, use, adoption, and commercial and medical potential of Oxbryta; building on fundamentals and enhancing commercialization efforts; use of telemedicine and provider and patient interaction; payer coverage for Oxbryta; ongoing and planned studies and related protocols, activities, and expectations; GBTs financial position, outlook, guidance, and expectations; the COVID-19 pandemic and related expectations; the expanded access protocol and early access program for Oxbryta, including the potential availability, use and impact; providing access to Oxbryta to more patients; regulatory submissions, review and approval to potentially expand the approved use of Oxbryta for more patients in the U.S. and to treat patients in Europe; supporting the SCD community and impacting the treatment, care and course of SCD; expanding GBTs leadership in SCD; the potential and advancement of GBTs pipeline, including inclacumab and other product candidates; working on new targets, and discovering, developing, and delivering treatments, to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, and GBT makes this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect GBTs current views about its plans, intentions, expectations, strategies, and prospects, which are based on the information currently available to the company and on assumptions the company has made. GBT can give no assurance that the plans, intentions, expectations, or strategies will be attained or achieved, and, furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond GBTs control including, without limitation, risks and uncertainties relating to the COVID-19 pandemic, including the extent and duration of the impact on GBTs business, including commercialization activities, regulatory efforts, research and development, corporate development activities, and operating results, which will depend on future developments that are highly uncertain and cannot be accurately predicted, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing, and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease; the risks that GBT is continuing to establish its commercialization capabilities and may not be able to successfully commercialize Oxbryta; risks associated with GBTs dependence on third parties for development, manufacture, distribution and commercialization activities related to Oxbryta; government and third-party payer actions, including those relating to reimbursement and pricing; risks and uncertainties relating to competitive products and other changes that may limit demand for Oxbryta; the risks regulatory authorities may require additional studies or data to support continued commercialization of Oxbryta; the risks that drug-related adverse events may be observed during commercialization or clinical development; data and results may not meet regulatory requirements or otherwise be sufficient for further development, regulatory review, or approval; compliance with obligations under the Pharmakon loan; and the timing and progress of GBTs and Syros research and development activities under their collaboration; along with those risks set forth in GBTs Annual Report on Form 10-K for the fiscal year ended December 31, 2019, and in GBTs most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors in GBTs subsequent filings with the U.S. Securities and Exchange Commission. Except as required by law, GBT assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.

References

GLOBAL BLOOD THERAPEUTICS, INC.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share amounts)

GLOBAL BLOOD THERAPEUTICS, INC.

Condensed Consolidated Balance Sheets

(In thousands)

Contact:Steven Immergut(media)650.410.3258simmergut@gbt.com

Courtney Roberts(investors)650.351.7881croberts@gbt.com

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GBT Reports Recent Business Progress and Fourth Quarter and Full Year 2020 Financial Results - GlobeNewswire

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In this episode of The Daily Orange podcast, former US Attorney General Loretta Lynch discusses her year-long, 97-page review of The Department of Public Safety in a conversation with News Editor Michael Sessa.

Also in this episode, host Marnie Muoz and Assistant Digital Editor Chris Hippensteel look back on the #NotAgainSU occupation of Crouse-Hinds Hall one year later, Editorial Editor Cori Dill discusses D.O. Opinions Black Voices project and Assistant Culture Editor Chris Scarglato talks about how Syracuses Black Artist Collective has created a space for artists of color to share resources.

Our host is Marnie Muoz, Adam Garrity is our Executive Producer, Moriah Humiston is our Podcast Editor, Chris Hippensteel is our Assistant Digital Editor and Adam Wolff is our music producer.

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Published on February 23, 2021 at 2:29 am

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Pain and progress: Black History Month in Syracuse - The Daily Orange

Vaccination efforts in Stanislaus County are growing and COVID-19 cases are decreasing, giving some room to hope that the area will be able to move into a less restrictive tier by mid-March.

This is the first good news weve had in a while, said Stanislaus County Supervisor Vito Chiesa after being briefed on the current COVID-19 status at Tuesdays meeting.

As of Monday, Stanislaus County expanded the vaccination efforts to Phase 1B, which is for people 50 years and older who work in education and childcare, emergency services and food and agriculture sectors.

For this week the County was allocated about 9,000 vaccines, up from the 5,800 from the previous week.

The County also is seeing COVID-19 cases drop recently. Since Feb. 8, Stanislaus County has seen cases dropping at a small but steady rate, according to the Stanislaus County Health Services Agency data.

There is some encouraging data in the community, said County CEO Jody Hayes.

As of Tuesday, Stanislaus County has recorded 49,970 positive COVID-19 cases. Of those, 1,165 are presumed active. There have been 937 COVID-19 deaths in the county. Currently, 116 people are hospitalized with the virus, including 27 in intensive care units.

If the county continues to see cases drop, while also maintaining a certain level of testing, its possible by the start of March that the area would reach the requirements for moving out of the purple tier to the red tier, said Stanislaus County Public Health Officer Dr. Julie Vaishampayan. That would allow for several businesses to re-open or expand operations by mid-March.

On Monday Gov. Gavin Newsom announced the state is partnering with OptumServe and local counties to open up to 11 vaccination sites within the next week to serve some of the hardest-hit or most at-risk communities in the Central Valley.

The efforts announced today will help us meet vulnerable and vital Central Valley communities where they are, helping our entire state combat this pandemic effectively, efficiently and equitably.

The state is also increasing vaccine allocations to the Central Valley by 58 percent above last week, based on recent changes in the states allocation methodology that better reflect this regions workforce. The states vaccine allocation formula began factoring in the employment sectors in Phase 1b, Tier 1 (education, emergency services and food and agriculture). The new formula weights age 65+ at 70 percent and employment sectors at 30 percent, which increases allocations to the Central Valley due to its heavy concentration of food and agricultural workers.

While the County is working on vaccinating as many residents as possible, it is still critical that all residents continue to follow the recommendations to wear a mask, avoid gatherings, wash hands often, stay 6 feet from others whenever in public places and get tested if exposed or experiencing symptoms. These steps, along with vaccines, are essential in ending the pandemic by stopping the spread of COVID 19 and protecting the community, according to health officials.

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County seeing progress in COVID-19 fight - The Turlock Journal

While the pandemic-induced downturn has eased stratospheric rents in San Francisco and other parts of the Bay Area, it has only exacerbated the underlying cause of unaffordable housing: a chronic shortage of homes and apartments. State statistics show 2020 marked yet another horrible year for housing construction in California, suggesting any immediate relief from the crisis will be fleeting at best.

The continuing slump comes at a time of dramatically diminished attempts to address the shortage in the Legislature, which has struggled since 2017 to pass bills to boost the housing supply. Perhaps the best hope for turning around the states historical hostility to housing can be found in the most unlikely of places: the cities that have been hotbeds of housing obstruction.

Since Gov. Gavin Newsom took office aiming to boost housing production to 500,000 units a year, construction has headed in the opposite direction. Just over 100,000 new housing units were authorized in 2020, according to a state Department of Finance report released last week, a drop of nearly 9% from 2019, which saw a decline of nearly 4% from the year before.

Worse, last years decrease was driven by a precipitous 18.5% fall in new multifamily housing, the kind that is most likely to make a dent in the shortage and provide affordable housing near transit and jobs. Single-family housing, meanwhile, grew slightly even as prices put it further out of reach for most. While the number of Californians working shrank by 1.5 million during the year, the median single-family home price grew by more than 11% to nearly $660,000.

While the trend is remarkably contrary to Newsoms goals, its not surprising given a series of implosions of housing legislation in Sacramento. Last years legislating began with the Senate killing a sweeping housing production bill by Sen. Scott Wiener, SB50, which would have ended single-family zoning statewide and allowed multifamily development near transit and job centers in the most populous counties. The session ended with a moderated housing package mired in squabbling between the Senate and Assembly.

Last week, reflecting the shift toward more incremental measures, Wiener introduced a bill to limit local governments power to cap square footage in multifamily zones, a means of limiting apartment construction. Wiener, D-San Francisco, also has reintroduced a bill that would allow cities to streamline zoning for small multifamily developments, while state Senate President Pro Tem Toni Atkins, D-San Diego, has revived a proposal to allow up to two duplexes on most lots zoned for single-family homes.

As the Legislature scales back its efforts to overcome local barriers to housing, a few cities are showing signs of acknowledging the need at long last. The Berkeley City Council, for example, was expected to consider a resolution by Vice Mayor Lori Droste on Tuesday night declaring its intent to eliminate single-family zoning by the end of next year. Its evidence of a surprising and heartening pro-housing shift for a city that, according to the resolution, invented single-family zoning a century ago to keep certain neighborhoods white, wealthy and free of what a former city attorney called the less desirable ... floating renter class.

Sacramento, beset by Bay Area refugees, is considering a similar proposal. In San Francisco, meanwhile, Supervisor Rafael Mandelmans more modest proposal to roll back single-family zoning earned immediate blowback from his colleagues. Berkeley may open its borders to the less desirable, but dont count on San Francisco to join the enlightenment.

This commentary is from The Chronicles editorial board. We invite you to express your views in a letter to the editor. Please submit your letter via our online form: SFChronicle.com/letters.

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Editorial: Californias housing crisis darkens amid glimmers of progress in the Bay Area - San Francisco Chronicle