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It's just the right time to jump in :)
Loving this! Going go hang busters!
I understand your position on him being a con, but I really do think this is happening this time. I have not been in this stock as long as some folks, but I see this exploding soon. Being that people cannot purchase this at present saves them if you are correct.
I spoke with Mark and trust the direction here.
atai Life Sciences Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical Pipeline Highlights
https://uk.finance.yahoo.com/news/atai-life-sciences-reports-fourth-105900699.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAKKb-7TpGGzGCgudpqBnttD1wImKuB_QCGh2zpNIddZNTQRmAlw280wjjCZNs7IVjHfzBY3gwBIAbJ_3iQ8NV7gY2Y4-UwfyFs45BLuUkHDGDHTBi07lnuziLyt4DoptbOBDoUk-P4F0OwBAHDzoR-xQkIzbxo10_0lRaTshs3YA
atai Life Sciences
Fri, 24 March 2023 at 6:59 am GMT-4·15-min read
In this article:
ATAI
+1.71%
atai Life Sciences
atai Life Sciences
atai’s development candidates, such as RL-007 and GRX-917, all represent significant opportunities to address unmet medical needs of patients living with mental health conditions
Continued operational progress on robust clinical pipeline, with multiple phase 1 and phase 2 proof-of-concept datasets expected in the next two years
$273 million in cash, cash equivalents and short-term investments at end of 2022 and access to a term loan facility of up to an additional $160 million provide anticipated runway into the first half of 2026
NEW YORK and BERLIN, March 24, 2023 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, reported fourth quarter and full year 2022 financial results and provided clinical pipeline highlights.
“With multiple clinical-stage programs aimed at addressing significant unmet patient needs in mental health and the capital to fund us into the first half of 2026, we believe we are in a strong position to advance our clinical candidates towards proof of concept in patients,” said Florian Brand, CEO and Co-Founder of atai. “Recently we announced dosing the first patient in our Phase 2 study of RL-007 in CIAS and the modification of the GRX-917 clinical development plan to advance directly into a proof-of-concept study in patients with anxiety.”
Clinical Pipeline Highlights
RL-007 (Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS))
The first patient was recently dosed in the phase 2b study of RL-007 in patients with CIAS and topline results from this study are expected in the 2nd half of 2024.
The phase 2b US-based study is a randomized, placebo-controlled, double-blind, 3-arm study evaluating 20mg and 40mg of RL-007 vs placebo in approximately 230 patients with CIAS. The primary endpoint of the study is the change from baseline in the MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score, a well-established regulatory endpoint, at week 6.
RL-007 is an orally available compound that modulates cholinergic, glutamatergic and GABA-B receptors, thereby putatively altering the excitatory/inhibitory balance in the brain to produce pro-cognitive effects. It has previously been evaluated in 10 clinical studies with over 500 unique participants dosed to-date and in which it was well tolerated at all doses tested.
Notably, in four clinical studies that assessed cognition, including one in patients with CIAS, the compound consistently demonstrated pro-cognitive effects. In atai’s previous Phase 2a proof-of-mechanism study in CIAS of RL-007, the compound showed a large effect size on Symbol Coding, a sub-component of the MCCB that correlates with the overall composite.
GRX-917 (Deuterated Etifoxine for Anxiety Disorders)
The clinical development plan was modified to proceed with a phase 2 study in patients, which is intended to generate the robust clinical data needed to best inform a future registrational program. More details of the phase 2 clinical development plan will be provided upon initiation of the study.
In January 2022, positive results were announced from the phase 1 single and multiple ascending dose study of GRX-917. In this study, GRX-917 was well-tolerated. Additionally, GRX-917 had an improved pharmacokinetic profile relative to etifoxine and provided pharmacodynamic evidence of GABA receptor target engagement through qEEG.
GRX-917 is a deuterated version of etifoxine, a drug used for anxiety and first approved in France in 1979. Etifoxine has a rapid onset and efficacy comparable to benzodiazepines, which are currently considered standard of care. In contrast to benzodiazepines, etifoxine appears to be non-addictive, less sedating, and better tolerated. It is believed that etifoxine achieves its anxiolytic activity by increasing the endogenous production of brain neurosteroids like allopregnanolone.
COMP360 (Psilocybin Therapy for Treatment-Resistant Depression (TRD))
COMPASS Pathways (“COMPASS”) recently announced an acceleration of the Pivotal Trial 1 (COMP 005) part of the phase 3 program in TRD, with top line data from Pivotal Trial 1 now expected in the summer 2024.
The on-going phase 3 program is composed of two pivotal trials, each of which will have a long-term follow-up component. The primary endpoint in both pivotal trials is the change from baseline in MADRS total score at week 6.
COMP360 is a proprietary formulation of synthetic psilocybin that is administered in conjunction with psychological support. Previously, COMPASS completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support.
VLS-01 (N,N-dimethyltryptamine (DMT) for TRD)
In the fourth quarter of 2022, the first subject was dosed in a Phase 1 study of VLS-01. Initial results from the study are expected in the 1st half of 2023.
The phase 1 study is a two-part single-ascending dose study designed to evaluate the safety, tolerability and relative bioavailability of oral transmucosal film (OTF) versus intravenous (IV) formulations of VLS-01.
The study includes atai’s IDEA-1 companion digital therapeutic for psychological support to be used in combination with VLS-01. The app-based support comprises “(mind)set-and-setting” prior to dosing and limited post-dose integration appropriate for healthy volunteers.
VLS-01 is an OTF formulation of DMT. DMT is a partial agonist of the 5-HT 1A/2A/2C receptors, characterized by an intrinsically short duration of psychedelic effect, with a serum half-life estimated at less than 10 minutes. DMT results in rapid-acting antidepressant effects when administered via IV infusion in patients with major depressive disorder (MDD). VLS-01 is formulated for oral delivery, potentially eliminating the need for IV infusion.
DMX-1002 (Ibogaine for Opioid Use Disorder)
In the third quarter of 2022, the first subject was dosed in a phase 1/2 study of Ibogaine. Initial results from the Phase 1 portion of the study are expected in the 1st half of 2023.
EMP-01 (MDMA Derivative for PTSD)
In the third quarter of 2022, a phase 1 study of EMP-01 was initiated. Initial results from this study are expected in the 2nd half of 2023.
Consolidated Financial Results
Cash, Cash Equivalents, and Short-term investments: Cash and cash equivalents and short-term investments were $273.1 million as of December 31, 2022, as compared to $362.3 million as of December 31, 2021. The decrease of $89.2 million was primarily driven by net cash used in operating activities of $104.5 million and $3.6 million additional investment in platform companies, partially offset by $15.0 million draw on the Hercules debt, $4.6 million of proceeds from the conversion of notes and $2.9 million of proceeds from stock sales and stock option exercises. The Company expects its cash position, combined with access to up to $160M in additional capital from its term loan facility with Hercules Capital, Inc., will be sufficient to fund operations into 1H 2026.
Research and development (R&D) expenses: R&D expenses were $21.9 million and $74.3 million for the three and twelve months ended December 31, 2022, respectively, as compared to $13.0 million and $48.0 million for the same prior year periods. The year-over-year full-year increase of $26.3 million was primarily attributable to an increase of $22.2 million of contract research organization expenses related to advancements of R&D programs and $3.5 million increase in R&D personnel costs.
General and administrative (G&A) expenses: G&A expenses for the three and twelve months ended December 31, 2022 were $15.7 million and $70.4 million, respectively, as compared to $25.9 million and $92.7 million in the same prior year periods. The year-over-year decrease of $22.3 million was primarily attributable to a decrease of $18.0 million in non-cash stock compensation expense, $9.8 million decrease in value added tax expense, $4.0 million decrease in professional consulting services. These decreases were partially offset by an increase of $7.3 million in personnel expenses and $1.9 million increase in insurance expense.
Net loss: Net loss attributable to shareholders for the three and twelve months ended December 31, 2022 was $45.0 million and $152.4 million, respectively, as compared to $88.9 million and $167.8 million for the comparable prior year periods.
About atai Life Sciences
atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape, atai is dedicated to acquiring, incubating, and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.
By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies to achieve clinically meaningful and sustained behavioral change in mental health patients.
atai's vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. For more information, please visit www.atai.life.
NYC Ketamine Center Co-Founder On Prices, Insurance, Competition & Expansion
Mentioned: CMPS DMTTF MNMD
This is the third article of a three-part series, you can find the first and second stories here.
Ketamine-assisted therapy has been in the headlines lately as several clinics have closed down and others reaffirmed they are continuing to be providers of these services.
One example is NYC-based Nushama, whose co-founder Jay Godfrey replied to a couple of industry inquiries in a recent interview with Benzinga.
Accessibility
How did ketamine become so broadly prescribed and administered? Godfrey suggests that 'the overhang and the halo effect' of ketamine therapy's efficacy under medical supervision is partly responsible for its inclusion in the COVID extension of the Ryan Haigh Act waiver, though oversight and regulation are necessary, as well as thoughtfulness in terms of who administers these medications, how, and to whom and where.
Most patients come to Nushama directly, though a small portion are referred by psychiatrists, psychologists, primary care physicians or addictions specialists.
The clinic's ketamine therapy main protocol is $4,500 though discounts and alternative payment plans are available for veterans and first responders. An 8-member group therapy discount, which cuts the price in half, and scholarships are also available.
'About 15% of patients get what we call the â??hero's journey' discount (veterans and first responders, including nurses, doctors and school teachers). Since we have offered it, the demographics of our members base have changed drastically,' Godfrey told Benzinga.
Godfrey confirmed that classic insurance companies are not yet including psychedelic therapy, though the clinic is in discussions with third-party administrators like Enthea.
Competition And Business Growth
Godfrey noted that the NYC population is so vast and the need for these kinds of therapies is so great that not even filling every Nushama room every single hour of every day would cover the current demand.
While the brand is planning to expand its clinic services most likely to Philadelphia, Washington DC, Boston, Toronto and Florida, they're facing two general constraints.
'One, fundraising markets are not what they were, let's call it, in 2020 and 2021, so we are being cautious; but also and more importantly, psychedelics companies should see these medicines as sacred tools. So before spreading the Earth with Nushama locations, we want to make sure we are doing this right in every location, and part of that is finding the right doctor in every city and the right set of nurses and medical assistance, as well as location,' Godfrey says.
Also, the co-founder positions Nushama as 'molecule agnostic,' meaning once other psychedelics are approved for use in the mental health treatment space, they will administer 'so long as we feel we can do it safely and according to the standards that we feel are necessary.'
Godfrey believes all these other molecules will never be self-administered at home, and that the drug development community, including COMPASS (NASDAQ: CMPS), MindMed (NASDAQ: MNMD), atai (NASDAQ: ATAI) and Small Pharma OTCMKTS: DMTTF), recognizes that they are going to require, even before legalization, sites that are responsible to conduct clinical research.
Requirements would include clinics with experience in psychedelic administration that can act as delivery channels for these medicines.
That's why, Godfrey confirms that conversations have begun between Nushama and these psychedelics-developing companies, adding that it is still too early to determine what psilocybin or MDMA legalization would look like in clinical practice.
This will go from nothing to close to silver on just gates opening... immediate launch!
It's coming...
Most people here bought in way above where this will go with any volume.
Nice hammer on this chart right now. I feel a huge swing coming in. Volume will push this hard.
As long as we stay above the 50SMA and the MACD Histogram is a blip above yesterday we are preparing for a run. Still looking good right now.
$IDVV - Possible Antelope Acres, CA Connection?!
So this started off as a tip from BB (Thank you sir of sirs)... but I looked further into this. I own a parcel of land in this area and I have had many offers to buy it and I never sold because of what I have been watching happen in the area.
If you look around there is an absolute ton of solar panel farms in this area of CA. I am all for the AI side of their business and right now that is their big win, BUT do not think for a second they are not eyeing this area of CA. Could $IDVV be working with the department of Energy to bid projects for the farm build out??? I see this as a high probability given their business vertical of Green Energy.
They are 3 hours from this location which makes sense logistically. And understating the construction industry - all they need to do is "hang paper"... PM subcontractors and generate revenues.
Need to get a hold off William :) :) $ $
Go look at the amount of open land but more importantly the massive build out in this area:
https://www.google.com/maps/search/antelope+acres+solar/@34.7830669,-118.4092433,30782m/data=!3m1!1e3
ANTELOPE VALLEY SOLAR RANCH
This launch north could happen at any time, but this will run fast and hard when it does. Some extra news on the closing of the acquisition is close.
Good Morning Everyone. Let's see what the chart draws today :)
Sure thing. Currently number 2. Follow this link:
https://investorshub.advfn.com/boards/breakoutboards.aspx
New Dracula movie drops April 14, good timing to ride the coat tails with Vampirella news and MIKP getting current.
:)
I put a test order in at TD and it worked. Wonder why Etrade wont take. It's pink current correct?
Reminder to look back at this one
Agreeing - nice float too
Another interesting find BB
Whoa buddy what is going on here?!
Oh my!!! Tripled Bandwidth for Private VPN. I smell money being made.
Sekur Private Data Ltd. Completes Increased Network Connection for SekurVPN - Triples Bandwidth Successfully for its Swiss Hosted VPN Solution
https://finance.yahoo.com/news/sekur-private-data-ltd-completes-142000087.html
Newsfile Corp.
Wed, March 22, 2023 at 10:20 AM EDT·8 min read
In this article:
SWISF
+12.16%
Toronto, Ontario and New York, New York--(Newsfile Corp. - March 22, 2023) - Sekur Private Data Ltd. (CSE: SKUR) (OTCQX: SWISF) (FSE: GDT0) ("Sekur" or the "Company"), a leading Swiss hosted secure and private communications platform, is pleased to announce that it has successfully connected increased bandwidth in order to provide high speed service for its non-big tech, Swiss hosted private VPN solution, SekurVPN. All servers are at location in Switzerland and are ready to be connected in the Company's multi locations data centers by April 5, 2023.
The Company has launched the website www.sekurvpn.com in order to take pre-registrations for SekurVPN and has started to receive some pre-registrations. SekurVPN is planned to be priced at US$ 7/month/user and US$ 70/year/user for the service. However, a special launch price of US$ 28/year for the first 2 years will be offered to the first 5,000 people registering to the service. This represents a 60% to the yearly price, which already offers 2 months free usage.
The official launch of SekurVPN is set to be April 7, 2023 and plans to launch a campaign to all its existing Sekur users and existing shareholders with the 60% promotional code after the launch of SekurVPN April 7, 2023.
SekurVPN is meant for privacy enthousiasts and users wanting to mask their IP address from hackers. An example would be users going to their e-banking or shopping online, using their emails, and wanting to have full privacy and protection from hackers hyjacking their location and signal. The service has been tested and results show that it is also perfectly fine for watching YouTube videos according to the Company's focus group testers. The Company will guarantee proper speed and high encryption for normal privacy usage and regular email, messaging, and web surfing.
Alain Ghiai, CEO of Sekur Private Data said: "We are very excited to finally install the servers in Switzerland and start the SekurVPN service. We have had great feedback from our testers, and we look forward to offering another layer of privacy and security for all our users. The launch of SekurVPN is set for April 7, 2023.
Volume hasn't even started. Still a good entry. Grabbing more.
Really sorry for everyone here. I warned all of you over the last 12-18 months... Wish I could have convinced you to get out. So very sorry.
Get in boys and girls before the the rush of eyes... kinda odd we raised to the top that quick. :)
We are number 1 on Breakout Board?!
Chasing here would be fine... still low form the potential. As long as the SS stays the same.
Sooner than than later ;)
Watched it and was it was good quality for what they are aiming for. We are in store for a lot of updates over the next few weeks.
Share Structure
Market Cap Market Cap
2,599,021
03/21/2023
Authorized Shares
1,000,000,000
03/20/2023
Outstanding Shares
928,221,854
03/20/2023
Restricted
696,696,000
03/20/2023
Unrestricted
231,525,854
03/20/2023
Held at DTC
222,168,184
03/20/2023
I believe we are fine. I really do. It's not like this can get any worse... this is quite low and figure this a gamble play.
But optimistic heavily in this play. Got in at the right time.
Did I see somewhere we are getting a QA from the CEO soon along with other material updates?
This is really cool. Needed as well. Never looked at AI from this angle. Big industry.
Is that 222M the non-restricted float? That's incredibly low. This gets hard volume it will rip. This is the next loading zone.
Added more here... this is likely the lowest anyone will get before launch.
Hard tree shaking today. Yikes.
See a penny within a week, hoping this sees silver by end of April.