Category Archives: Neuroscience

Neuroscience

Meet 10 Companies Working On Reading Your Thoughts (And Even Those Of Your Pets) – Forbes

Brain-machine interfaces (BMI) and brain-computer interfaces (BCI) are devices that enable direct ... [+] communication between a brain and an external device.

Philosopher John Locke said, I have always thought the actions of men the best interpreters of their thoughts. Locke lived during the Age of Enlightenment. He probably wasnt thinking about human machine actions during his philosophical ponderings. But what does it mean when machine actions are the result of human thoughts? No longer part of science fiction, many would argue that brain-machine and brain-computer interfaces are the next way we will communicate with machines and even with one another.

Brain-machine interfaces (BMI) and brain-computer interfaces (BCI) are devices that enable direct communication between a brain and an external device. BCIs let someone type onto a screen without a keyboard. Brain-machine interfaces make it possible for amputees to move robotic limbs. BCIs can be as intricate as placing devices directly on the brain or via devices that communicate directly to machines without invasive surgery.

This type of technology opens a whole world of business applications. From dangerous jobs that already utilize robots to manufacturing, and even the consumer space. Brain-machine interfaces create a new way for humans to interact with technology, whether it be their smartphones, smart speakers, voice assistants, cars, and even each other. Startups and established companies alike realize the promise of brain-machine interfaces. They are racing to link humans to tech and machines, allowing humans to control digital technology using only their minds, which in turn opens up a whole new world of opportunities for businesses and brands to reach the customer of the future.

Here are 10 companies that are working on connecting our brains or actions to our machines and creating the future of input.

Testing out Neurable at FutureX Live in Atlanta in April 2019.

Neurables mission is very exciting. Ramses Alcaide, founder of Neurable, got the idea for helping people with technology when he was a kid after his uncle lost his legs in a trucking accident. Alcaide said, the idea of developing technology for people who are differently abled has been my big, never-ending quest. Neurable launched onto the brain-computer interface scene in 2017 at SIGGRAPH with a proof of concept BCI game called The Awakening. Users put on a VR headset to escape from a room with only their minds. In December 2019, Neurable raised a $6 million Series A round to develop an everyday consumer based brain-computer interface in the form of headphones.

Alcaide sees neurotechnology built into a pair of headphones as the first step towards a BCI for consumers. Think about stopping, starting, or skipping songs with your mind without ever touching your phone. Interacting with smart devices with just our thoughts through a headphone-like device is impressive enough on its own. For Neurable, its the data behind the interactions that show the real value of BCIs.

Cognitive analytics are, measures of different mental states, especially those aligned with performance. BCI enabled headphones could help a person, enter their desired emotion and then have a customized playlist generated to provoke that response. Not to mention open a whole new world of metrics for marketers, training, health professionals, and a variety of other industries. Alcaide believes computing is going to become more spatial. He said, As it continues to go down that path, we need forms of interaction that enable us to more seamlessly interact with our technology.

MindX believes the next frontier in computing is a direct link from the brain to the digital world. Theyre creating this link by combining neurotechnology, augmented reality and artificial intelligence to create a "look-and-think interface for next-generation spatial computing applications. Part of spatial computing, is being able to interact with computers beyond a two-dimensional screen.

MindX uses smart glasses to create a link between human brains and technology. Julia Brown, MindXs CEO, said smart glasses will let wearers access information with a single thought. Glasses connect to the mind from eye movements. Brain waves signal back what the wearer is thinking and where they are looking. BCI enabled smart glasses opens a world of opportunities for visual search. Think about your lost car keys and the smart glasses can locate them. Wonder what someone is wearing and get the brand and link to places to buy from the glasses - all with a thought.

While some brain-computer interface companies focus on understanding the brain and cognitive metrics, others focus on real-time device control. NextMind, headquartered in Paris, France, uses a non-invasive BMI that translates brain signals instantly from the user's visual cortex into digital commands for any device in real-time. NextMind debuted their device at CES 2020. Visitors to the booth demoed changing channels on a TV with just their thoughts.

Testing the NextMind device at CES 2020 and using thoughts to turn on lights and dim them.

Users wear NextMind on the back of their heads. It creates a symbiotic connection with the digital world by combining neural networks and neural signals. The Next Mind SDK is open to developers. Theyre at a price point that the industry believes consumers are ready for the next phase in computer interaction.

Unboxing Neurosity's Notion developer's kit in January 2020.

Neurositys goal is to help developers get focused faster and stay focused longer. Notion (Neurositys thought-powered computer) has eight sensors as part of an EEG headset. In their demo, a woman scrolls through a recipe on her tablet while cooking. In another, a man changes the lighting in the room with his mind. The Notion brain sensor can be pre-ordered. The device touts its secure design saying, it never stores your brainwaves. Something to look out for in a BCI.

Neurosity launched dev kits in 2019. The Neurosity developer community is one of the signs that brain-computer interfaces have arrived. Developers can write apps for Notions brain sensor, which is developed to do two things: to detect human intent and to quantify the self. Think of it like wearing a fitness tracker for the brain. In April 2020, Neurosity temporarily cut the price of Notion pre-orders to $799 for developers. Neurosity pledges their support to developers interested in helping quantify the human mind even further by making their team available to brainstorm, code, and deploy neuro apps.

Kernel is a neurotechnology company based in Los Angeles, California. Their aim is to create a brain interface that develops real-world applications of high-resolution brain activity. Kernals founder and CEO, Bryan Johnson, believes in a world where people are empowered by technology, not limited by it. He sees neuroscience, specifically Kernals neuroscience as a service (NaaS) as a way to get there. Kernel was featured in I Am Human, a 2020 award-winning documentary about the the scientists and entrepreneurs on a quest to unlock the secrets of the brain.

Kernel created two different experiments with their technology. One is Speller which allows participants to type with only their gaze and a visual keyboard. The other is Sound ID that can decode song IDs based on the brain signals from the listener. These experiments show that with just a helmet, brain scientists can run the same type of experiments as those in labs with room size equipment. With the use of a helmet, brain scientists can study thousands of more people than they can currently. Johnson believes this can help people who have suffered strokes and are unable to speak or those dealing with mental disorders.

There are so many applications when it comes to brain-machine interfaces and neuroscience. Nectomes technology is developed to preserve human memory by studying how the brain physically creates memories. Nectome isnt just creating a BMI for the present. Theyre hoping to change how people preserve the languages, cultures, and wisdom of the past, and how health care engages with individuals memories and personal narratives.

President of Y Combinator, Sam Altman, is one of 25 people who have put down a $10,000 refundable deposit to join a waiting list at Nectome. The only catch is, Nectome needs a living brain to capture the memories. The procedure kills the patient. Nectome planned to test it with terminally ill volunteers in California, which permits doctor-assisted suicide for those patients. Sam said of the procedure, I assume my brain will be uploaded to the cloud. The startup has faced some setbacks but seems to still be in operation.

Eventually, Nectome believes their biological preservation techniques will be like an episode from Amazons Upload TV series. At the end of their life, patients can choose to upload themselves into a digital afterlife.

CRTL-Labs uses non-invasive neural interfaces to expand human bandwidth. CRTL-Labs recreates the 0s and 1s of neurons by listening to muscle twitches. They send the signals into machine learning to decode a persons intention. This network is fed back to the wearer to create a symbiotic relationship. Thomas Reardon, CEO of CRTL-Labs said, AI and Machine Learning can be dominated by us. CRTL-Labs does all of this with a wristband.

Facebooks leadership have talked about a new type of interface that includes work around direct brain interfaces that are going to, eventually, one day, let you communicate using only your mind. In September 2019, they bought CRTL-Labs and have said the following about the acquisition, The goal is to eventually make it so that you can think something and control something in virtual or augmented reality.

Neuralink is a company owned by none other than Elon Musk. The man who made electric cars cool (Tesla) and sends astronauts to space is his own spacecraft (SpaceX) also wants to connect humans to machines. Neuralink takes a slightly different approach to brain-machine interfaces by placing threads into the brain. Elon Musk wants his brain implants to stop humans being outpaced by artificial intelligence.

Neuralink threads are connected to a 4mm chip called the N1. The chips are placed close to important parts of the brain and are able to detect messages as they are relayed between neurons, recording each impulse and stimulating their own. The chip connects to a wireless device worn over the ear which is Bluetooth enabled. Currently, the chip is placed via traditional brain surgery but Musk envisions the chip will be inserted virtually painlessly in the future. Applications for the Neuralink are endless - from treating neurological disorders to replacing language, and eventually turning humans into cyborgs.

Paradromics developed brain-computer interface technology to help those disconnected from the world by mental illness, paralysis, or other types of brain disorders. Paradromics believes they can meet medical challenges with technical solutions. That is, a high-data rate brain-computer interface. Similar to the Neuralink, Paradromics places electrode arrays on the brain. They do this with a computer chip that plugs into a part of the brain called the cortex. With Paradromics technology, mental disorders and injuries no longer have to be debilitating. They can connect those affected back to the world.

Brain-computer interfaces arent just for people. Zoolingua, owned by Con Slobodchikoff, wants people to understand dogs. Their device will allow both dog and human to communicate in both directions. The translating dog collar from the movie UP is coming to real life. Zoolingua bases their technology on research. Observing (through video) dog vocalizations and behavior in specific contexts; classifying the complex forms of communication that occur; and working with computer programs to effectively and accurately decode and translate into US-English.

According to an Amazon report, advances in AI and machine learning will enable companies to make devices that can accurately translate a cats meows and a dogs barks into English. William Higham, co-author of the report, believes devices that can talk dog could be less than 10 years away.

All these companies are working on the future of input.

Separate from Zoolingua, another example of someone working on decoding Fidos thoughts is Dr. Gregory Berns from Emory University. He is a neuroscientist whos also interested in what dogs think. Dr. Berns developed a go/no-go test to scan dog brains in M.R.I machines. The results show dogs use corresponding parts of their brain to solve similar tasks as people do. This isnt something seen in non-primates before.

Neuroscience technology is a quickly developing field. Its one with endless applications for understanding the brain, unlocking human potential, and preserving todays minds for the future. Some of the companies listed above are working towards specific use cases. Some use direct-brain sensors while others use non-invasive devices.

What each brain-machine interface company has in common is that they see the world as a connected place. Its going to become even more so. The future of computing is beyond two-dimensional interactions. Its more than voice, facial recognition, artificial intelligence, and augmented reality.

Its all these things coming together under the power of the human brain.

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Meet 10 Companies Working On Reading Your Thoughts (And Even Those Of Your Pets) - Forbes

Neuroscience

Edited Transcript of BTAI.OQ earnings conference call or presentation 12-May-20 12:30pm GMT – Yahoo Finance

Jun 22, 2020 (Thomson StreetEvents) -- Edited Transcript of BioXcel Therapeutics Inc earnings conference call or presentation Tuesday, May 12, 2020 at 12:30:00pm GMT

* Richard I. Steinhart

BioXcel Therapeutics, Inc. - CFO

BioXcel Therapeutics, Inc. - VP of Clinical Development

* Vimal D. Mehta

BioXcel Therapeutics, Inc. - Founder, CEO, President, Secretary & Director

* Vincent J. O'Neill

BioXcel Therapeutics, Inc. - Senior VP & Chief Medical Officer

Good morning, and welcome to BioXcel Therapeutics First Quarter Earnings Conference Call and Audio Webcast. Before we start, I would like to inform you that this conference is being recorded. (Operator Instructions).

Just to remind everyone, certain matters discussed in today's conference call or answers that may be given to questions asked are forward-looking statements that are subject to risks and uncertainties relating to future events and/or the future financial performance of the company. Actual results could differ materially from those anticipated in these forward-looking statements. The risk factors that may affect results are detailed in the company's most recent public filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarterly period ended March 31, 2020, which can be found on its website, http://www.bioxceltherapeutics.com or on http://www.sec.gov.

I would now like to turn the conference over to Vimal Mehta, Chief Executive Officer of BioXcel Therapeutics. Please go ahead.

Vimal D. Mehta, BioXcel Therapeutics, Inc. - Founder, CEO, President, Secretary & Director [2]

Thank you, operator. Good morning, everyone, and thank you for joining our conference call to discuss BioXcel Therapeutics' financial results and business highlights for the first quarter 2020. We appreciate everyone's time and attention. Joining me for the call today are Richard Steinhart, Chief Financial Officer; Frank Yocca, Chief Scientific Officer; and Vince O'Neill, Chief Medical Officer.

Before we begin, I want to take some time to address these unprecedented times. The COVID-19 pandemic, a crisis that has created uncertainty around the world has truly affected each and every one of us. I personally want to thank all health care workers who are tirelessly fighting on the front line caring for patients and preventing the

Following the guidance from the U.S. Centers for Disease Control and Prevention and the State of Connecticut, we have made vital adjustments across our company aimed at protecting our employees' health and safety, while maintaining key activities needed to advance the development of our clinical programs.

The BioXcel team remains motivated and on track to reach our 2020 milestones. In order to monitor the potential impact of this pandemic on our ongoing trials, we have been in close contact with our clinical sites. To date, we have not experienced any significant delays in our ongoing clinical trials, and have made great strides with our clinical programs.

We will continue to closely monitor the COVID-19 situation and provide any updates as needed.

Shifting our discussion back to our corporate highlights, I would like to first discuss our lead neuroscience clinical program, BXCL501. As a reminder, BXCL501 is our proprietary thin film formulation of dexmedetomidine or Dex for the acute treatment -- for the treatment of acute agitation. We have designed this candidate to be easily administered and have a rapid onset of actions in order to produce a calming effect without excessive sedation.

We have made key advances this quarter in our pivotal trials, SERENITY I and II, which are Phase III studies of BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder.

Back in March, we announced that more than 1/3 of the patients in both trials had been enrolled and treated. Enrollment continues to be progressing as planned, and we have not observed a change in enrollment rate due to the COVID-19 pandemic. We are on track to report top line data from the SERENITY program in mid-2020, and will communicate updates as we get closer to our clinical data readout.

It is important to note that all is schizophrenia and bipolar patients enrolled have successfully self-administered the BXCL501 treatment guided by a health care provider. With our pivotal program readouts only a few months away, we are hopeful that we will be able to submit our first NDA for BXCL501 during the first half of 2021, bringing a noninvasive fast-acting treatment with-in millions of patients who suffer from acute agitation associated with neuropsychiatric disorders.

Our clinical progress continued with the initiation of TRANQUILITY. This study, a Phase IB/II trial for the treatment of acute agitation in geriatric dementia highlight the potential versatility of neuro -- of our neuroscience program in treating disorders beyond neuropsychiatric conditions. Since the TRANQUILITY trial has an adaptive design, we are currently reviewing safety and tolerability data in order to choose the next test in dose. This trial's enrollment is on track, and top line data is expected in mid-2020.

With off-label drugs having a black box warning for the elderly and no FDA-approved therapies to treat agitation in geriatric dementia, there is a desperate need for a safe and effective treatment for patients that struggle with this psychological behavior. We designed BXCL501 to be a fast-acting easy to administer therapy to try to fill this unmet need and provide a treatment, if approved for caregivers, that have travel managing dementia-related agitation.

In parallel, we continue to investigate the use of wearable digital device technologies, such as the Apple Watch, to hopefully enhance the prevention and treatment of dementia-related agitation. Considering this patient population is among the highest risk category for severe illness and death associated with COVID-19, we have taken a cautionary measure to preserve the safety and health of our elderly patients. For the TRANQUILITY trial, all BXCL501 doses have already been manufactured and have been provided to the long-term care facility running the TRANQUILITY study, reducing the risk of exposing the patients.

Additionally, we are continuing our investigation of BXCL501's calming capabilities through the initiation of a Phase II study being performed by researchers at Yale University. The aim of this study is to assess biomarkers associated with agitation, such as skin conductors response, heart rate variability and blood pressure in patients with schizophrenia and their response to treatment with BXCL501. Managing agitation is a challenge for both physicians and caregivers than being able to use these biomarkers as an initial signal prior to the onset of visible symptoms could be very beneficial. These bodily signals could provide sufficient time for caregivers to deliver BXCL501 to patients before an agitation episode becomes dangerous. Even though this study is being performed only on schizophrenia patients, we believe this trial will help open the door to investigate the potential use of BXCL501 in additional indications that exhibit similar physiological signals of hyperarousal, expanding the potential market of this candidate into chronic agitation.

To wrap up this quarter's neuroscience highlights, we received FDA clearance of our IND application for BXCL501 for the treatment of opioid withdrawal symptoms, a potential fourth indication for this candidate. As the #1 cause of death in the U.S. for individuals under the age of 50 years old, accidental drug overdose is rampant in this country, with a majority of fatalities opioid-related.

Furthermore, opioid withdrawal can be very debilitating and uncomfortable, and many addicts continue to take these drugs or relapse to avoid feeling these disturbing symptoms.

There is a desperate need for new efficacious treatment options to help aid this underserved population from continuous abuse. Due to BXCL501's intrinsic potency, favorable delivery method and mechanism of action, we feel this candidate has the potential to offer advantages to treating withdrawal symptoms, helping to combat and abuses urge to relapse.

We are encouraged by the promising results we've witnessed with intravenous drugs in elevating withdrawal symptoms, and we are planning to initiate the RELEASE trial, a Phase Ib 2 trial for the treatment of patients experiencing symptoms of opioid withdrawal shortly.

This past quarter, we have focused our efforts on expanding our neuroscience programs, clinical development strategy, exploring numerous indication in hopes of reaching an extensive patient population. We believe BXCL501 offers a differentiated therapy to treating the millions of patients that suffer from hyperarousal and lack effective alternative. We are focused on increasing the commercial value of this candidate and plan on exploring BXCL501 as a potential treatment for acute agitation in hyperactive delirium as well as for chronic agitation.

Turning the conversation over to our immuno-oncology clinical candidate, BXCL701, our orally available systemic innate immunity activator designed with a dual mechanism of action. Recently, we announced that we are initiating the Phase II efficacy portion of the Phase Ib/II trial of BXCL701 in combination with KEYTRUDA for treatment emergent Neuroendocrine Prostate Cancer or tNEPC. Results from the Phase Ib safety lead-in showed that a split dose, totaling 0.6 milligram per day, is the recommended dose when used in combination with KEYTRUDA. This split dose has shown on target side effects consistent with cytokine activation and has an improved safety profile. In the Phase II efficacy trial, approximately 30 eligible men with tNEPC will receive 0.3 milligram of BXCL701 twice daily on days 1 to 14 of each 21-day cycle plus 200 milligram of KEYTRUDA administered intravenously on Day 1 and then every 21 days. We expect to report initial interim data from the Phase II trial in the fourth quarter of 2020. Currently, there are no approved treatments for tNEPC, a rare and highly aggressive form of prostate cancer.

We believe BXCL701 has the potential to be an effective treatment for the subpopulation as it creates an aggressive adaptive immune response, making tumors more reactive to immunotherapies, including KEYTRUDA.

Furthermore, the company is also advancing the clinical evaluation of BXCL701 via the ongoing open-label Phase II basket trial conducted at the MD Anderson Cancer Center. This study is evaluating the combination of BXCL701 and KEYTRUDA in patients with advanced solid cancer that are either naive to or refractory to checkpoint happy and is following the dosing schedule using the Phase Ib/II study for tNEPC. The combination trial of BXCL701, bempeg from Nektar and avelumab from Pfizer and Merck KGaA in pancreatic cancer will start following the completion of Nektar and Pfizer's Phase Ib safety study of bempeg and avelumab and the outcome of that trial.

In February, we raised net proceeds of approximately $60 million in a public offering, which helped to significantly strengthen our balance sheet. This cash, together with our current results, provide BioXcel enough cash runway to fund preclinical regulatory and operational milestones into 2021.

With that, I would like to turn the call over to our CFO, Richard Steinhart. Richard?

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Richard I. Steinhart, BioXcel Therapeutics, Inc. - CFO [3]

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Thanks, Vimal. Once again, thank you all for joining us this morning, and welcome to our shareholders. BTI reported a net loss of $14.9 million for the first quarter of 2020 compared to a net loss of $7.2 million for the same period in 2019. The first quarter of 2020 results include about $800,000 in noncash stock-based compensation. The increase in net loss was primarily due to cost associated with our pivotal Phase III trials. Research and development expenses were $12.4 million for this first quarter of 2020 as compared to $5.7 million for the same period in 2019. The increase was primarily due to an increase in clinical trial costs, salaries, bonus and related costs, professional research and project-related costs and chemical manufacturing and controls related to our BXCL501 and BXCL701 product candidates. General and administrative expenses were $2.6 million for the first quarter of 2020 compared to $1.7 million for the same period in 2019. The increase was primarily due to professional fees for legal and patent matters. Total operating expenses for the first quarter of 2020 were approximately $15 million as compared to total operating expenses of approximately $7.4 million for the same period in 2019. We had cash and cash equivalents of $80.1 million as of March 31, 2020.

That concludes the financial review of the first quarter. Now I'd like to turn the call back to Vimal for any further comments. Vimal?

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Vimal D. Mehta, BioXcel Therapeutics, Inc. - Founder, CEO, President, Secretary & Director [4]

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Thanks, Richard. We would now like to open the call to questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions)

Our first question today comes from Geoff Meacham of Bank of America.

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Scott Daniel Puckhaber, Barclays Bank PLC, Research Division - Former Research Analyst [2]

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This is Scott on for Jeff. I wanted to ask about the Phase I/II study for 501 in dementia. It seems the doses are lower at 30, 60, 90 micrograms due to the elderly patient population. However, in the Phase Ib trial in schizophrenia, the 60 milligram -- microgram dose was not statistically significant. So I was wondering if we should anticipate a tighter window for success given the need to balance dosing and efficacy in these patients. And then as a follow-up for 701, you recently noted the 0.6 milligram dose is recommended. And that's flooding the dose can be associated with an improved safety profile. There are certainly concerns around the safety for 701 given the drug's prior history. So can you give us any insight as to whether splitting the dose might impact efficacy for any reason? And the potential concerns you're seeing around dosing it as a once daily?

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Vimal D. Mehta, BioXcel Therapeutics, Inc. - Founder, CEO, President, Secretary & Director [3]

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Thanks, Scott. This is Vimal. I'm going to pass this question to Rob Risinger, who is our VP of Clinical Neuroscience, to answer the fiber on question, and then Vince will pick up the question related to BXCL701. Rob?

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Robert Risinger, BioXcel Therapeutics, Inc. - VP of Clinical Development [4]

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Sure. Thank you, Geoff. Good question. The dose range in schizophrenia, we're not banking, if you will, on a thing identical in dementia. As you point out, they are older. They tend to be more frail. And so we are testing a slightly different dose range, simply to determine the doses that may be safe, but also effective.

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Vimal D. Mehta, BioXcel Therapeutics, Inc. - Founder, CEO, President, Secretary & Director [5]

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Vince?

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Vincent J. O'Neill, BioXcel Therapeutics, Inc. - Senior VP & Chief Medical Officer [6]

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Yes. Thanks, Scott, for the question. So on 701, it was really around splitting dose versus not, I believe. So what we saw on the once daily dosing, so non-split dose at 0.6 milligrams or 600 micrograms was an event of syncope. And this was presented at the ASCO GU poster just a couple of months ago. That required us to expand the cohort, or otherwise, essentially identify a better tolerated dose and schedule. What we found is that by splitting the dose, we no longer saw those types of events. We certainly still saw some on target toxicity. And in oncology, as you know, that's not necessarily a bad thing at all. It speaks that the drug is doing what it's expected to do, but the events of syncope were simply no longer present. So that's -- we believe we fixed the tolerability by splitting the dose. Hopefully, that answers your question.

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Operator [7]

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The next question is from Robyn Karnauskas of SunTrust Robinson Humphrey.

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Robyn Kay Shelton Karnauskas, SunTrust Robinson Humphrey, Inc., Research Division - Research Analyst [8]

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So first of all, can you give us some data points on what steps are needed to be completed in order to start the opioid withdrawal trial? And what are the rate limiting steps? And then do you think we'll -- we still can see a -- do you think we still can see data this year? And then on 701, so when you think about what you've learned on the safety profile, what is the safety sort of hints you around the efficacy of the drug? Did you learn anything about if the drug is working in the way it should be working? Just give us some thoughts on what you've learned so far from the early data.

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Vimal D. Mehta, BioXcel Therapeutics, Inc. - Founder, CEO, President, Secretary & Director [9]

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Thanks, Robyn. This is Vimal. Regarding the opioid withdrawal trial, we had all the pieces ready to go to initiate the trials. And we were running 3 trials, SERENITY 1 into our pivotal Phase III and TRANQUILITY trial and this COVID situation a role. We made a conscious choice, as a company to, like, not start the opioid withdrawal trial, right, in the middle of COVID-19 in the interest of our employees, our partners, employees as well as for the patient safety. As you might have noticed that COVID-19 is creating even a bigger opioid crisis, which is in the press all over the place. The number of patients are plenty, and they keep coming to these sites, and that's what we have been advised by our CRO and the clinical side. We could initiate this study any time. I don't think there is any rate-limiting step. And we will provide the guidance shortly as we indicated that we are about to initiate that trial. So we are in a good position to initiate that opioid withdrawal trial. Regarding the 701 question, I will ask Vince to weigh in what we have been able to observe, besides the safety, any signal from the efficacy aspect. Vince?

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Vincent J. O'Neill, BioXcel Therapeutics, Inc. - Senior VP & Chief Medical Officer [10]

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Sure. Thanks, Vimal and good morning, Robyn. So again, I'm going to turn it back to the data that we presented at ASCO GU. In terms of the learnings, I think an important one is that this drug seems to be a strong activator of the innate immune system, and I think that's important because thus far, many of the other potential approaches to activating in the community have been weak. So we do see things like fever and chills, myalgias and puffy ankles, all of which are actually transient. They tend to settle down after the first or second cycle. What we did see, as I mentioned from the previous question, was hypotension and one episode of syncope. By splitting the dose, hypotension events seem to have mitigated substantially. And yet, we see -- we still see the remainder of those on target toxicity. So our belief is that we have a strong innate activator that is, at the same time, safe. And of course, you'll know we have a large safety database behind the drug already at this point. So that's 1 important learning. We havent released any new data from the ASCO GU or since the ASCO GU presentation, but I would simply point out that on efficacy, I mean, this is the Ib portion. This is fundamentally a safety study. The majority of patients were stable and if they would disease and remained on study at the time of that presentation.

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Robyn Kay Shelton Karnauskas, SunTrust Robinson Humphrey, Inc., Research Division - Research Analyst [11]

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Can you just also give an update on the other trials in going with 701? And if they're proceeding with any issues due to COVID and just the latest update there, and when we can see the next data set from 701?

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Vincent J. O'Neill, BioXcel Therapeutics, Inc. - Senior VP & Chief Medical Officer [12]

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Sure. So I'll take them off. I mean, I'll take the triple combination study first. So I think as we've mentioned, the doublet of bempeg on NKTR-214 plus avelumab has to be combined before we add in 701. So that study is in the hands of Pfizer. Pfizer did announce maybe 6 weeks ago that they were pausing all trials. They announced approximately a week ago that they're reopening all trials. So that study was underway, the patients were enrolled, and it's now reopened again to accrual. So our anticipation is that, as we previously guided, we will add in the 701 portion to that doublet once we have safety data later on this year. So that's the triple combination. And then the MD Anderson study, and that's an important part of the development plan. As you're aware, that's in hot tumors, both in patients who are KEYTRUDA naive and also patients who feel KEYTRUDA progressed through it. That study is open. It opened just at the turn of the year, and that's progressing. Again, consistent with guidance, we are anticipating to be able to present data at the end of the year from that trial study.

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Operator [13]

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The next question is from Do Kim of BMO Capital Markets.

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Go here to see the original:
Edited Transcript of BTAI.OQ earnings conference call or presentation 12-May-20 12:30pm GMT - Yahoo Finance

Neuroscience

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Neuroscience

Neuroscience Antibodies and Assays Market Share, Growth, Statistics, by Application, Production, Revenue & Forecast to 2025 – Jewish Life News

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This Neuroscience Antibodies and Assays Industry market research study is a collection of insights that translate into a gist of this industry. It is explained in terms of a plethora of factors, some of which include the present scenario of this marketplace in tandem with the industry scenario over the forecast timeframe.

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The report is also inclusive of some of the major development trends that characterize the Neuroscience Antibodies and Assays Industry market. A comprehensive document in itself, the Neuroscience Antibodies and Assays Industry market research study also contains numerous other pointers such as the current industry policies in conjunction with the topographical industry layout characteristics. Also, the Neuroscience Antibodies and Assays Industry market study is comprised of parameters such as the impact of the current market scenario on investors.

The pros and cons of the enterprise products, a detailed scientific analysis pertaining to the raw material as well as industry downstream buyers, in conjunction with a gist of the enterprise competition trends are some of the other aspects included in this report.

How has the competitive landscape of this industry been categorized?

Regional landscape: How will the details provided in the report help prominent stakeholders?

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Neuroscience Antibodies and Assays Market Share, Growth, Statistics, by Application, Production, Revenue & Forecast to 2025 - Jewish Life News

Neuroscience

COVID-19 Survey Shows One-Third of Researchers Could Leave Neuroscience – Technology Networks

A UK-wide survey has exposed the damaging effects of the COVID-19 pandemic on neuroscience research. A third of respondents to the survey, organized by the British Neuroscience Association (BNA), said that they were considering leaving the field. Nearly nine in ten respondents felt that the pandemic had had a negative impact on their research. The survey, recorded between May and June, highlights the wide-ranging impacts of the pandemic across academia, the full effects of which are still to be felt.The survey findings were published yesterday (18th June) by the BNA. The findings reveal huge anxiety among researchers around the future of their work in a post-pandemic world.

The survey found that researchers had felt immediate impacts of COVID-19 on their work:

Over 400 neuroscience researchers from around the UK contributed to the survey, with the majority of respondents in early career researcher positions. The survey showed an uncertain outlook for researchers whose external funding timelines have been thrown into jeopardy. Over a quarter of researchers had requested further funding to maintain their research. Worryingly, just under half of these respondents reported that their requests had gone unanswered.The survey included quotes from respondents that bring into sharp focus the human cost of a field put into stasis. My fellowship is due to finish next year. We have received a three-month salary extension and a six-month extension to the end date. However, this year was the key year to be collecting the data after several years of training the animals and developing the new techniques to use in my lab. I am worried that there won't be enough time to re-train the animals and complete all the experiments in time. We have had to maintain the implants on the animals, which has been difficult as we continue to go into work and clean them but can't train them or collect any data from them, said a senior academic behavioural scientist who contributed to the survey.

Speaking to Technology NetworksAnne Cooke, CEO of the BNA, said the most concerning reports from the survey were about the number of researcher looking to a future outside of science. The most worrying and surprising finding was about the number of people who are considering or really think they will have to leave frontline neuroscience research as a direct result of coronavirus. I think we anticipated responses that the impact had been negative, but I think the finding that people really thought they wouldn't be able to carry on was, for me, the most shocking result.

The early stages of research have a notoriously high attrition rate, but Cooke said that some of the respondents insights suggest that COVID-19 is exerting an additional pressure to leave the sector. One of our next steps will be digging into these key findings more, said Cooke. When you look at the career pyramid in science, you get a lot of early-career researchers who leave science naturally. But when we looked at the comments behind the survey, we realized that this is a direct result of coronavirus, this isnt just the natural career progression attrition that you get at that stage.

Cooke continued, People commenting on the fact that they've had to look after children at home has had a really detrimental effect. They are no longer going to be able to compete their research project. They therefore don't think they'll get the next fellowship or the next set of funding.

Whilst around half of respondents hoped that their work will resume pre-lockdown levels by the end of 2020, four out of five believed that this progress will be hindered by insufficient funding. Additional concerns for respondents included:

The BNA have written a letter to the science minister, Amanda Solloway MP, asking for clarity on how existing projects will be brought back on track.Joseph Clift, the BNAs head of policy, said any response should support researchers as they return to the workplace and also secure supplies of lab equipment that have been disrupted by the pandemic. What researchers need now is little bit more detail on how those funds can help support efforts to salvage research, said Clift.

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COVID-19 Survey Shows One-Third of Researchers Could Leave Neuroscience - Technology Networks

Neuroscience

What Innovations, Technologies Are Emerging in the Pipeline of Parkinson Disease Treatment? – AJMC.com Managed Markets Network

Central nervous system gene therapies and advanced technologies to provide these treatments were noted as emerging opportunities in treatment for neurological conditions such as Parkinson disease, according to review findings. Researchers also highlighted the lack of experience and technology in medical centers nationwide to provide these services.

Currently, vector-based intracerebral gene therapies are being used to treat specific neurodegenerative conditions. While these therapies have been included in clinical trials for PD and other similar conditions, there has yet to be a breakthrough treatment.

However, researchers note that new molecular agents, device innovations, and improved neurosurgical techniques have unlocked the potential of therapies delivered directly via infusion into the CNS. With this opportunity emerging, they sought to review how these CNS gene therapy treatments performed in neurological diseases, as well as if skill sets and health delivery strategies within the clinical neuroscience practices are aligned with future demand for these therapies.

Focusing on patients with idiopathic PD, researchers referenced image-guided convection enhanced delivery (CED) as optimizing the parenchymal distribution of gene therapies applied within the CNS. Citing this as the potential therapeutic breakthrough, researchers then highlighted how image-guided CED and gene therapy are not part of training programs for most neurosurgeons and neurologists. This could prove to lessen the impact among patients as treatment will be limited by factors such as geographic location and specialization.

If CNS gene therapies prove to be efficacious for PD and/or other conditions, the demand for such treatments will overwhelm the available number of experienced clinical neuroscience teams and treatment centres, warned the study authors.

To address this potential demand, researchers said that a worldwide education effort to provide this training to clinical neuroscience practitioners would be warranted. Moreover, they say to begin this transition, at least a limited number of Centers of Excellence will need to establish relevant educational training requirements and best practice for these therapies.

The crucial availability of advanced technologies, such as robotics and artificial intelligence, were then cited by researchers as they will expand the treatment team's capabilities while assisting in the safe and timely care of those afflicted.

Reference

Fiandaca MS, Lonser RR, Elder JB, et al. Advancing gene therapies, methods, and technologies for Parkinson disease and other neurological disorders. Neurol Neurochir Pol. Published online June 18, 2020. doi:10.5603/PJNNS.a2020.0046

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What Innovations, Technologies Are Emerging in the Pipeline of Parkinson Disease Treatment? - AJMC.com Managed Markets Network

Neuroscience

AMSA and Sunovion Team Up For Second Year of Neuroscience Peer Teaching Program While Transitioning to Remote Learning Experience – Business Wire

MARLBOROUGH, Mass.--(BUSINESS WIRE)--The Advanced Math & Science Academy Charter School (AMSA) and Sunovion Pharmaceuticals Inc. (Sunovion) today announced completion of the second year of a program to help students understand Science, Technology, Engineering and Math (STEM) life science career paths within a pharmaceutical company and foster a deeper knowledge of neuroscience. Six AMSA upper school level students, five seniors and one junior, were selected as a team to participate in this collaborative project with Sunovion for their schools Capstone Project. Due to the Commonwealth of Massachusetts response to COVID-19 and schools moving to remote learning for the remainder of the 2020 school year, Sunovion and AMSA worked together to adjust and transition the program to a virtual experience.

The high school student team developed a lesson plan about the central and peripheral nervous systems that they successfully taught seventh grade students at AMSA via a video classroom, with the goal to enhance and complement their existing biology class curriculum. This material was developed in consultation with a cross-functional team from Sunovion with a range of expertise.

Our goal at AMSA is to create an atmosphere of celebration of knowledge where children of diverse backgrounds and abilities excel, especially in math, science and technology, and we empower them to succeed in the workplace in our modern high-tech world. The partnership between AMSA and Sunovion was what AMSA founders envisioned in our charter with the State, when they located the school in Marlborough for close proximity to a growing innovation ecosystem. AMSA is proud of this program, which has leveraged access to Sunovions in-depth expertise to enhance our science education. We thank the Sunovion team for their positive impact and inspiring our students, said Ellen Linzey, Executive Director, AMSA.

This important program with AMSA reinforces our commitment to advancing the next generation of innovators and leaders and we appreciate the continued collaboration with administrators and faculty. We were impressed by the students and their ability to absorb and convey complex neurobiology information to their peers in an accessible way. They adapted to a remote peer teaching environment this year with great effectiveness and success, said Ken Koblan, PhD, Chief Scientific Officer, who serves as Sunovions executive sponsor of the program with AMSA.

The student teachers were honored during a virtual ceremony on May 13, 2020 as they look forward to the next chapters in their academic careers and consider pursuing further learning in healthcare, the life sciences, or neurobiology. Seniors were provided with certificates and scholarships upon completion of their Capstone Project. The program was initiated in 2019 through the collaboration of Mark Vital, Community Outreach Manager, AMSA and Wendy Scoppa, Senior Manager, Community Relations, Sunovion. A video of the ceremony and project can be viewed here.

About Advanced Math & Science Academy (AMSA)

Ranked as the #4 public high school in Massachusetts by U.S. News & World Report, The Advanced Math & Science Academy Charter School (AMSA) was chartered by the Massachusetts Department of Education in February 2004 and opened in September 2005. AMSAs teaching model is centered on rigorous college-oriented education for all students. AMSAs teaching philosophy involves starting challenging abstract learning, typically expected for high school students, early in the middle school grades. AMSA creates an atmosphere of celebration of knowledge where children of all backgrounds and abilities excel in all subjects, especially in math, science and technology, empowering them to succeed in the workplace in our modern, high-tech world. AMSA's core values are collective and individual values: Model Integrity, Pursue Your Excellence and Foster Community. Learn more about AMSA at http://www.amsacs.org and join AMSA on social media at http://www.amsacs.org/social.

About Sunovion Pharmaceuticals Inc. (Sunovion)

Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovions vision is to lead the way to a healthier world. The companys spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions. Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the companys web sites: http://www.sunovion.com, http://www.sunovion.eu and http://www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.

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AMSA and Sunovion Team Up For Second Year of Neuroscience Peer Teaching Program While Transitioning to Remote Learning Experience - Business Wire

Neuroscience

Engrail Therapeutics Raises $32 Million in Series A Financing – Business Wire

SAN DIEGO--(BUSINESS WIRE)--Engrail Therapeutics (Engrail) (the Company) today announced the close of a $32 million Series A financing round. Nan Fung Life Sciences (NFLS), the global investment platform of the Nan Fung Group, led the round. The Company plans to use the proceeds from the financing to support the clinical development of its first pipeline asset, ENX-101, a sub-type selective GABA A modulator.

Neuroscience is making massive strides. As the brains complexities and molecular mechanisms have become clearer, we are better able to identify disease targets, which has also a supported a resurgence in funding neuroscience drug development, said Vikram Sudarsan, Ph.D., CEO and president, Engrail Therapeutics. These factors have contributed to recent clinical and commercial success across the industry. However, significant unmet needs persist, placing immense disease burden on patients. Our goal is to build a leading neuroscience company fueled by a robust pipeline. We are focused on the acquisition, development and commercialization of patient-centric neuroscience therapeutics. ENX-101 represents the first milestone in this effort.

Dr. Sudarsan continued, We are pleased to close this financing round with a world-class investor who believes in the bold vision of our new company. With these resources and a long-term commitment from NFLS to invest $1.5 billion in the life sciences sector, we will leverage our unique, flexible transaction model to build a world-class neuroscience company.

Engrail adopts a 'science-first' approach that begins with a thorough biological understanding of disease and rational therapeutic targeting, enabling the Company to identify compounds with greater opportunity to address patient unmet needs. This, combined with a comprehensive view of clinical development strategy, regulatory considerations, intellectual property and optimal commercial positioning, allows Engrail to acquire high-quality assets with a lower-risk path to market. The Company expects to acquire assets with validated mechanisms, ultimately catalyzing a diverse portfolio of therapies to treat diseases of the nervous system. Engrails flexible transaction model includes licensing, co-development and company acquisitions.

Engrails dynamic model for advancing drugs aimed at treating life-limiting diseases of the nervous system is exactly the innovation this complex field requires, said Peter Bisgaard, managing director of NFLS and chairman of Engrails board of directors. We look forward to supporting Engrails team of passionate entrepreneurs as it acquires assets and moves these compelling therapies through the clinic.

About Engrail Therapeutics

Founded in 2019, Engrail is forging a new direction to reduce the enormous burden of diseases that impact the nervous system. We unite biological insights with clinically meaningful solutions to build and catalyze a diversified portfolio of transformative medicines. Harnessing our rigorous scientific approach to identify the most promising therapies, we leverage our flexible transaction model to advance assets with validated mechanisms and efficiently move them through development to commercialization. Engrail is supported by a long-term capital commitment from Nan Fung Life Sciences. For more information, visit http://www.engrail.com.

About Nan Fung Life Sciences

Nan Fung Life Sciences is a global life sciences investment platform with a long-term capital commitment from the Nan Fung Group. Our team possesses diverse experience with long track records in company formation, venture capital, growth/buyout investments, and drug discovery and development. Through direct investments via Pivotal bioVenture Partners US and Pivotal bioVenture Partners China as well as fund investments, we cover the full spectrum of the life sciences industry including therapeutics, medical devices and diagnostics and across all development stages. To learn more, visit http://www.nanfunglifesciences.com.

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Engrail Therapeutics Raises $32 Million in Series A Financing - Business Wire

Neuroscience

Theres no such thing as an objective view of something – Medical News Today

Researchers from Johns Hopkins University used a series of sophisticated experiments to test a philosophical idea. They found that it is nearly impossible to separate an objects true identity from the viewers perception of it.

A persons ability to see the world objectively, separate from their perspective, is the subject of intense debate in philosophy and neuroscience.

What happens when a person looks at an object that appears different from its true nature because of their perspective on it? For example, a circular coin rotated toward them will appear as an oval.

The classical view is that the brain transforms the image that hits the retina and removes our perspective from the representation. This means that the brain represents the object in its true form in this case, a circle.

Researchers from the Perception and Mind Lab at Johns Hopkins in Baltimore, MD, have turned this view on its head.

They carried out a series of experiments to find out how people detect objects under different conditions. They suggest that the brains representation of an object includes how someone perceives it not just how it truly is. They conclude that a person cannot see an object in a way that is entirely separate from their point of view.

Their findings challenge previous assumptions in the philosophy, psychology, and neuroscience of perception and appear in the journal PNAS.

A persons perception of the world around them is a complex process that goes far beyond wavelengths of light hitting the back of the eye. It involves multipart transformations by the brain and is biased by what we a person has seen previously and what they know to be true about the world.

The way a person perceives things depends on their perspective, their point of view. What happens when perspective distorts an objects form is the subject of a long-standing philosophical debate. As the paper puts it, do we ever escape the perspective from which we view the world?

This question about the influence of ones own perspective on perception is one [that] philosophers have been discussing for centuries, says senior author Chaz Firestone, assistant professor of Psychological and Brain Sciences and Director of the Perception & Mind Lab.

Firestone and his team are investigating whether the brain represents an object based on how a person sees it (their perspective) and influences this perception, even when the person knows that the true form of the object is different.

To test this idea experimentally, the researchers conducted nine separate experiments, the first seven involving computer-generated objects and the final two using real-world objects viewed under natural conditions.

Most of the experiments featured coins that were either circular shown head-on (immediately recognizable as a circle), oval shown head-on (immediately recognizable as an oval), or a circular coin rotated in such a way that it appeared similar to the oval coin.

In the first experiment, researchers showed the participants a series of images and asked them to determine which showed the oval coin. An oval coin presented head-on was present in all images, and a circular coin appeared either head-on or turned 45 degrees.

Further experiments involved coins of different sizes, rotations, the number of coins, and the movement of the coins. Other experiments included variations on this theme using different shapes.

In the final experiments, the participants sat in front of a real-life display containing wooden coins, and the researchers asked them to indicate the location of the oval coin.

The results showed that when the researchers presented the participants with tilted, circular coins at the same time as the oval coins, their response times slowed significantly. This was the case whether the coins were still or moving and whether the volunteers saw them on a computer screen or in real life.

The fact that the subjects were distracted by the tilted circles suggests that their brains did represent the tilted coin as oval in shape, rather than as the circular object it is in reality. All of the experiments generated results consistent with this idea.

The results indicate that people cannot separate an objects true identity from how they see it.

Our subjective approach to the world stays with us, says lead author Jorge Morales, postdoctoral fellow and resident philosopher in the Perception & Mind Lab. Even when we try to perceive the world the way it really is, we cant completely discard our perspective.

This study also shows that researchers can test ideas from philosophy empirically, and is the first of several experiments the lab is working on to understand human perception better.

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Theres no such thing as an objective view of something - Medical News Today

Neuroscience

Madrid-based Kymatio raises 725K to expand its cybersecurity tools for employees – EU-Startups

Spanish startup Kymatio, the SaaS platform that manages cyber risk for employees, has increased its first round of investment by 40% to accommodate two new partners, Banco Sabadell, BStartup and the JME Ventures fund. These new investors joined the round led by The Crowd Angel, which also had support from Wayra, Telefnicas open innovation hub, and prominent business angels such as Enrico Raggini.

Kymatio, founded in 2017, addresses cybersecurity from one of the most significant parts of risk: that associated with people. According to Kymatio, around 60% of security incidents involve internal personnel. The startup states that organizations face massive losses in domestic incidents with an average cost of 8 million in large corporations and 40K in the case of SMEs.

As stated Fernando Mateus, CEO of Kymatio: 70% of organizations have suffered an internal incident. Kymatio determines the cyber risks being faced, and assesses the level of awareness of each employee in the main areas of cybersecurity, to automatically deploy measures focused on customized strengthening of the individuals in those areas of risk, and enhancing the role of the first and last line of defense that employees have.

With this round, Kymatio aims to fuel its sales and boost the product, adding functionality that identifies, analyses, and overall covers everything an organization needs to address the security risks linked to information and employees.

According to Yolanda Prez, Director of BStartup: Cybersecurity is a field of growing importance to businesses and with the expansion of remote work it will be even more relevant. Kymatio allows a holistic prevention strategy, tackling the problem from the human factor by the means of state-of-the-art techniques and innovative technology. At Banco Sabadell we hope to be able to contribute to the growth of this company that has a first-class team and product.

As indicated by Lourdes lvarez de Toledo , Principal at JME Venture Capital: Kymatio is a pioneer in addressing vulnerability and internal cyber risk threats by coupling technology with neuroscientific tools. This position, together with the team that leads it, as well as the distribution agreements that it is carrying out, are the factors that make us trust in the future success of this company.

To date, Kymatio has had the support and validation of important cybersecurity institutions, such as INCIBE, and leading neuroscience research centers, such as the Autonomous University of Madrid. The startup was acclaimed winner of the first call for Cybersecurity by ElevenPaths , and the Ministry of Science and Innovation, granted the NEOTEC grant from the CDTI for technology companies of 160K.

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Madrid-based Kymatio raises 725K to expand its cybersecurity tools for employees - EU-Startups