Better Therapeutics Inc (BTTX)

[Frankestin]

https://www.liebertpub.com/doi/epdf/10.1089/dia.2024.2525.abstracts
RANDOMIZED, CONTROLLED TRIAL OF A NOVELDIGITAL THERAPEUTIC IN PATIENTS WITH TYPE 2DIABETES: BT-001 PIVOTAL TRIAL 180 DAYOUTCOMES
Background and Aims:BT-001 is a digital therapeutic in-tended to provide cognitive behavioral therapy to adults withtype 2 diabetes (T2D) through a mobile application (app). Safety,effectiveness and healthcare utilization were evaluated after 90and 180 days.
Methods:Adults with HbA1c‡7% were randomized (1:1) toaccess BT-001 or a control app. Both groups received standard ofcare. Treating clinicians were unblinded to HbA1c and allowedto adjust antihyperglycemic medication per guidelines.
Results:668 participants with a mean age of 58 years, HbA1cof 8.1%, 56% female, 29% Black and 16% Latino were enrolled.After 180 days, change from baseline in HbA1c was 0.4% in BT-001 participants, with a mean treatment difference betweengroups of 0.3% (LS Mean 0.28%, p=0.010), despite a significantincrease in medication use in the control group (p=0.025).Significant improvements in systolic blood pressure, weight,mood, and quality of life were also observed (p<0.05 for all).Adverse events were less frequent with BT-001 (p<0.001) withno adverse device effects reported.
Conclusions:Compared to standard of care treatment, BT-001 significantly reduced HbA1c at 180 days despite greaterintensification of medication use in the control group. Benefitsextended to other cardiometabolic factors including weight andblood pressure and were associated with fewer adverse events.These findings support the use of BT-001 as a safe and scalableadjunct to medical therapy in improving glycemic control andcardiometabolic markers in patients with T2D while also low-ering healthcare utilization.

[work-n-hard]

Bid/Ask finally touching. Which way will it go?

[Frankestin]

Interesting showcase
Stand 17
https://apps.kenes.com/floorplan/#/congress/ATTD24
Among the giants... to become giants
BTTX might attract a lot of attention

[Frankestin]

Interesting showcase
Stand 17
https://apps.kenes.com/floorplan/#/congress/ATTD24
Among the giants... to become giants
BTTX might attract a lot of attention

[work-n-hard]

BTTX: A little stretching this morning for the next move up.

[Frankestin]

Good Boy! Very! Very! Very!💪

[Frankestin]

Good Boy! Very!💪

[Frankestin]

Good Boy! Very!💪

[Frankestin]

gotta love Frank Karbe.
is this a clear message for shorts?
The Company is seeking withdrawal of the Form S-1 Registration Statement because the Company does not expect to proceed with an offering thereunder.
Let's see if the sale still comes

[Frankestin]

It's time to admit reimbursement!
it's good for the patient who needs help not just medicines!
It's better for insurance companies... less so for pharmaceutical companies!
IT IS A MATTER OF DIGNITY
https://www.fiercebiotech.com/medtech/2024-forecast-digital-therapeutics-makers-will-have-get-creative-conquer-reimbursement
https://www.adces.org/store/online-education/detail/introducing-aspyrerx
https://www.nationalalliancehealth.org/wp-content/uploads/NationalAlliance_PDT-Playbook_L-FINAL.pdf

[Frankestin]

I'm waiting for the reimbursement!!!!!!!!!!!!!!!
how quick they are to cut off the legs... mmmmm... i add
great risk but nothing ventured, nothing gained

[chuck9]

Good morning everyone

This looks like a great opportunity

$BTTX

[TheFinalCD]

https://ih.advfn.com/stock-market/NASDAQ/better-therapeutics-BTTX/stock-news/93006190/form-424b3-prospectus-rule-424b3

[Eagle1]

BTTX setting up superbly for a pop here IMO. Looking perky with a cup and handle formation. .24 we shall see.

[Eagle1]

Technically this will see green this week IMO. We shall see above .21s

[Eagle1]

Better Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Updates
Company obtained FDA authorization for AspyreRxTM to treat adults with type 2 diabetes and announced commercial launch

https://www.businesswire.com/news/home/20231109425949/en/

[Eagle1]

Parabolic SAR flipped positive on the daily today. Great sign. .21 after hours here. This is a Nasdaq stock.

[Eagle1]

Next week here should be nice. .21 ah

[Monksdream]

I suppose the thought you are expressing is the price rallied from a multi year low
“Been down so long it look like up to me”

[Eagle1]

Chart looks great here!

[getmoreshares]

10/30-- RS VOTE To approve an amendment to our amended and restated certificate of incorporation (the “Charter”), in the form attached to the proxy statement as Annex A, to, at the discretion of our Board of Directors (the “Board”), effect a reverse stock split with respect to our issued and outstanding common stock, par value $0.0001 per share (“Common Stock”), including any Common Stock held by Better Therapeutics, Inc. (the “Company”) as treasury shares, at any time prior to October 30, 2024, at a ratio of 1-for-10 to 1-for-25 (the “Range”), with the ratio within such Range to be determined at the discretion of the Board without further approval or authorization of our stockholders (the “Reverse Stock Split”).

[Monksdream]

BTTX new 52 week low

[varok]

Good to see that the issue has settled down from the AM. Now is the time for a great entry for folks that are on the sideline.
strong buying opportunity in this range -.27
Have a good day
varok

[TheFinalCD]

.57

[TheFinalCD]

.4777 THAT WAS EASY

[TheFinalCD]

.444 FILLED ON DIP

[TheFinalCD]

.57

[subslover]

Great news! Thanks.

[TheFinalCD]

.40 TO .50 BACK TO .40 REAL FAST

[TheFinalCD]

https://www.businesswire.com/news/home/20231016559397/en/

[INFINITI]

Better Therapeutics Announces New Data Highlighting Concurrent Use of AspyreRx and GLP-1 Receptor Agonists to Treat Type 2 Diabetes

Source: Business Wire
Pivotal trial established use of AspyreRx alongside standard of care demonstrating clinically meaningful and statistically significant reduction in HbA1c leading to FDA authorization

In a subgroup analysis, the use of AspyreRx and GLP-1 receptor agonists showed substantially greater A1c reductions than the previously reported results of the entire trial population

Recent draft guidance from the FDA indicates the intent to consider the combined effectiveness of pharmaceuticals and digital therapeutic solutions when making drug labeling decisions

Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in developing prescription digital therapeutics (PDTs) to treat cardiometabolic diseases, today announced top-line findings from a recent subgroup analysis of AspyreRx (formerly BT-001) in its pivotal trial for type 2 diabetes (T2D). The analysis reveals that adjunctive use of AspyreRx with standard of care, including GLP-1 receptor agonists (GLP-1), leads to a substantially greater clinical improvement compared to control participants who did not incorporate AspyreRx into their regimen. The subgroup analysis, involving approximately 160 participants on GLP-1s randomized to the active and control arm of the study, exhibited an average reduction in HbA1c of 0.7% at 90 days, between the two groups. This exceeds the results of the entire BT-001 pivotal trial population, where AspyreRx outperformed the standard of care control arm by 0.4%. Both reductions were statistically significant when compared to the corresponding control group.

In addition to improvements in HbA1c at day 90, participants that were on both GLP-1 medications and AspyreRx also showed greater HbA1c reduction, greater weight loss, and utilized fewer medications at day 180 when compared to participants on GLP-1 medications without AspyreRx. The data for this subgroup analysis are being submitted for peer-reviewed publication.

“The findings from this subgroup analysis support that patients receiving GLP-1 derive additional additive benefit from intensive behavioral modification provided by AspyreRx. Despite the important benefits of GLP-1 agents, patients receiving them may continue to struggle to achieve glycemic control for multiple reasons including therapeutic inertia and side-effects associated with these drugs. This new data underscores the importance of recognizing that behavior modification is a critical foundational component of diabetes treatment, including for patients taking GLP-1s. A comprehensive management approach that combines effective pharmacotherapy along with effective digital therapeutics to support patients in making and sustaining behavioral change appears to be an optimal approach to achieving treatment goals,” said Marc Bonaca, MD, Executive Director of CPC Clinical Research, providing independent scientific analysis for the trial.

As previously reported, the BT-001 pivotal trial, the largest randomized controlled study ever conducted of a digital therapeutic to evaluate glycemic response in participants with T2D, met both its primary and secondary endpoints demonstrating statistically and clinically meaningful reductions in HbA1c over the control group receiving standard of care. The results achieved were sustainable and improved between day 90 and day 180 of the trial, demonstrating that AspyreRx has the potential to deliver meaningful, durable improvements in blood sugar control for a complex range of patients with T2D already on blood sugar lowering medications.

In addition, exploratory data revealed a host of cardiometabolic improvements alongside reduced medication and healthcare utilization in comparison to the control group, supporting the potential for AspyreRx to improve the overall health of patients with T2D and potentially reduce increasingly costly interventions associated with the progression of the disease. A cost effectiveness analysis, which was part of a broader Health Economics and Outcomes Research (HEOR) conducted by Better Therapeutics, indicates that the utilization of AspyreRx may not only be more effective than standard of care alone but may also be less costly for payers.

The new subgroup analysis data may be particularly relevant in the context of recent draft guidance from the FDA, titled 'Regulatory Considerations for Prescription Drug Use-Related Software,' released in September, which provides clarity about the agency’s views and intent to consider the combined effectiveness of pharmaceuticals and digital therapeutic solutions when making drug labeling decisions.

"The FDA’s draft guidance opens up the possibility of expanding drug labeling to include the increased benefits patients may experience while also using PDTs. Strengthened drug labeling then has the potential to raise awareness about the concurrent benefits of drugs and PDTs, which enables providers to improve clinical outcomes. This differentiation may be particularly relevant within the highly competitive GLP-1 market. In this multi-billion-dollar category, PDTs like AspyreRx offer the chance to demonstrate added value by showing increased effectiveness of GLP-1 agents with a digital therapeutic," remarked Frank Karbe, CEO of Better Therapeutics.

RCT Trial Design

The BT-001 pivotal trial was an open-label, randomized, controlled trial designed to evaluate the efficacy and safety of a digitally delivered CBT approach among a diverse, nationally representative group of patients with difficult to treat T2D. The trial was designed with a high bar to pass and to avoid artificial designs that could produce large outcomes that do not apply to all patients. This included using a “Standard of Care” comparison, as well as not constraining patients to a specific medication profile and not incentivizing patients to use the BT-001 therapy.

The clinical trial included a diverse, nationally representative patient population including participants from minority groups often underrepresented in diabetes studies. 40.2% of participants were non-white; 15.7% were Hispanic or Latin American. Participants had long-standing type 2 diabetes, high cardiovascular risk, multiple comorbidities with use of multiple medications.

About AspyreRx

AspyreRx (fka BT-001) was granted marketing authorization by the U.S. Food and Drug Administration (FDA) in July 2023 as the first prescription-only digital behavioral therapeutic device delivering a novel form of cognitive behavioral therapy (CBT) via smartphone to treat adults with type 2 diabetes (T2D). AspyreRx is backed by robust data demonstrating clinically meaningful and sustained reduction in HbA1c as well as improvements in other markers of cardiometabolic health when used up to 180 days. Using proven techniques that target the underlying psychological, behavioral, and cognitive factors that sustain or worsen T2D, AspyreRx is a self-paced, engaging experience that patients can access anytime/anywhere. It is prescribed by a healthcare provider in 90-day increments, with proprietary CBT delivered digitally in a weekly step-by-step process. Through interactive therapy lessons, skill-building modules, weekly goal setting and tracking, patients connect changes in behavior to improvements in blood sugar and other biometrics. Each step in the experience builds on the prior to enable and reinforce cognitive restructuring, building the emotional resilience and acceptance needed to make enduring changes.

Indications for Use

AspyreRx is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. AspyreRx provides cognitive behavioral therapy as a treatment that should be used adjunctively with standard of care.

About Better Therapeutics

Better Therapeutics is a prescription digital therapeutics company developing a novel form of cognitive behavioral therapy to address underlying factors that sustain or worsen cardiometabolic diseases. The Company has developed a proprietary platform for the development of FDA-regulated, software-based solutions for T2D, heart disease and other conditions. The CBT delivered by Better Therapeutics’ PDT is designed to enable changes in neural pathways of the brain so lasting changes in behavior become possible. Addressing the underlying causes of these diseases has the potential to dramatically improve patient health while lowering healthcare costs. Better Therapeutics’ clinically validated mobile applications are intended to be prescribed by physicians and reimbursed like traditional medicines.

For more information visit: bettertx.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are typically identified by words such as “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “potential,” “predict,” “should,” “would” and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements in this press release include, but are not limited to, statements regarding Better Therapeutics’ expectations related to the efficacy and potential benefits of PDTs, including AspyreRx and CBT and their potential treatment applications and their ability to improve clinical outcomes, beliefs regarding the importance of behavior modification and comprehensive management approaches in diabetes treatment, statements related to recent draft guidance from the FDA and the potential of labeling to drive improved awareness of PDTs, among others. These forward-looking statements are based on the current expectations of the management of Better Therapeutics and are inherently subject to uncertainties and changes in circumstances and their potential effects and speak only as of the date of such statement. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements including: risks related to Better Therapeutics’ business, such as the willingness of the FDA to authorize PDTs, for commercial distribution and insurance companies to reimburse their use, market acceptance of PDTs, including AspyreRx, the risk that the results of previously conducted studies will not be interpreted favorably by the FDA or repeated or observed in ongoing or future studies involving Better Therapeutics’ product candidates and other risks and uncertainties included under the header “Risk Factors” in Better Therapeutics’ quarterly report on Form 10-Q for the quarter ended June 30, 2023 filed with the Securities and Exchange Commission (SEC) on August 9, 2023, and those that are included in any of Better Therapeutics’ subsequent filings with the SEC.

[INFINITI]

Nice news!!!!

[Monksdream]

BTTX new 52 week low

[Monksdream]

BTTX new 52 week low

[Monksdream]

BTTX new 52 week low

[subslover]

That must be why insiders bought it. 6 separate forms 4's filed today. Keep an eye on this one

[AJ Freely]

$BTTX - 👆Up 22.5% Pre-Market/ Current Price $0.76
Insiders Buys from the management
Over 2 million shares

[Monksdream]

BTTX new 52 week low

[AKATITUS]

Lots of volume.

[TIMGZ]

ANY UPDATE FROM THE CONFERENCE CALL***THANK YOU

[AJ Freely]

$CRKN - Up 25% Pre-Market/ Current Price $0.12
Secures an $85 million order from a client to work on a project based in Idaho

[AJ Freely]

$DFLI -Up 28% Pre-Market/ Current Price $1.95.
Partners with World’s Largest Teardrop Manufacturer to Provide Full Lithium Power Systems

[AJ Freely]

$BTTX - Up 33% Pre-Market/ Current Price $1.23
Receives FDA Authorization for AspyreRx™ to Treat Adults with Type 2 Diabetes

[Frankestin]

https://edge.media-server.com/mmc/p/adggoags

[tw0122]

Better Therapeutics Receives FDA Authorization for AspyreRx™ to Treat Adults with Type 2 Diabetes

Source: Business Wire
First prescription digital behavioral therapeutic device delivering novel form of cognitive behavioral therapy via smartphone

In a randomized controlled trial AspyreRx demonstrated clinically meaningful and statistically significant durable reductions in A1c

Company to host conference call and webcast on July 11 at 8:30 a.m. ET

Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in developing software to treat cardiometabolic diseases, today announced that the Food and Drug Administration (FDA) authorized AspyreRx™ (formerly BT-001), a prescription-only digital therapeutic (PDT) treatment indicated to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes (T2D). AspyreRx was reviewed through the FDA’s De Novo pathway and its authorization creates a new class of diabetes digital behavioral therapeutic devices. AspyreRx is expected to launch commercially in Q4 2023?.

"AspyreRx is a game-changer as we now have an evidence-based intervention to help clinicians and people living with type 2 diabetes address the underlying factors that contribute to disease progression and achieve treatment outcomes beyond glucose management alone,” said David Kerr MBChB, DM, FRCP, FRCPE, Director of Digital Health at the Diabetes Technology Society. "The cornerstone of modern diabetes care is helping to improve self-efficacy and AspyreRx now provides a prescription tool for physicians that seamlessly integrates with existing disease management programs to help patients make and sustain meaningful changes to improve their overall health.”

“This regulatory milestone signals a promising future where technology, psychology, and medicine converge to address for the first time the behavioral causes of disease for the 37 million patients living with T2D in the U.S.,” said Frank Karbe, Chief Executive Officer at Better Therapeutics. “This De Novo authorization also provides a foundation for potential future growth opportunities. Given cardiometabolic diseases share common underlying factors that contribute to their development and progression, we intend to expand our PDT platform to multiple related conditions in the future.”

AspyreRx was granted marketing authorization based on efficacy and safety data from a randomized controlled trial involving 668 participants, demonstrating clinically meaningful results, which were published in Diabetes Care.

Summary of Clinical Trial Results

The trial met its primary (p<0.0001) and secondary (p=0.01) endpoints showing statistically significant decreases in HbA1c levels when compared to a control group receiving standard of care and a control app. The results were sustained and improved between day 90 and day 180 of the trial, demonstrating that BT-001 has the potential to deliver meaningful, durable reductions in blood sugar for a complex range of patients with T2D.
1 in 2 people achieved a mean A1c reduction of 1.3% after 180 days of use.
On average, subjects who used BT-001 also experienced a host of cardiometabolic improvements including improved fasting blood glucose, reduced systolic blood pressure, reduced weight, improved mood, improved quality of life scores, lower medication utilization and fewer diabetes related risks compared to subjects who did not use BT-001.
A clear dose-response between greater engagement in CBT and greater reductions in HbA1c was found, supporting CBT as a mechanism of action to generate positive clinical outcomes.
Patient engagement and adherence was excellent with 94% of the participants using the intervention at day 90 and 81% still engaged at day 180.
The majority of patients with T2D progress in their disease, despite advances in pharmacotherapy. Treatment guidelines emphasize lifestyle behavior change as the cornerstone in the prevention and treatment of disease; however, given the constraints of delivering in-person therapy there has been limited advancement in helping patients make and sustain behavior change in a way that is standardized, convenient and scalable. AspyreRx is designed to address these barriers, leveraging technology to deliver an evidence-based therapeutic intervention to patients. The involvement of healthcare providers adds an important layer of expertise and oversight, ensuring seamless coordination between AspyreRx and other aspects of treatment.

“Our team has dedicated eight years to developing this treatment and we are grateful for the thousands of patients who have used our platform and for the many clinicians who have guided us to this point,” said Mark Berman, MD, Chief Medical Officer at Better Therapeutics. “We are immensely proud of this milestone and believe AspyreRx holds the promise to enhance access to care for the diversity of the patient population, empowering individuals to live healthier lives.”

Better Therapeutics Conference Call and Webcast

Better Therapeutics will hold a conference call on July 11 at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time to discuss the FDA authorization of AspyreRx. Investors and the general public may access a live webcast of the call by visiting https://edge.media-server.com/mmc/p/adggoags

About Type 2 Diabetes

Type 2 diabetes (T2D) is a widespread chronic disease in the U.S. According to the Centers for Disease Control and Prevention (CDC), around 35 million people in the U.S. have T2D. About half of the T2D patients have uncontrolled blood sugars despite being on multiple medications. The prevalence of T2D has been steadily increasing over the years, primarily due to factors such as sedentary lifestyles, poor dietary habits, and an aging population. T2D disproportionately affects certain populations, particularly racial and ethnic minority groups, and those from lower socioeconomic backgrounds. Factors like limited access to healthcare, health disparities, cultural differences, and social determinants of health contribute to these disparities. Addressing health inequities, slowing down disease progression and preventing costly complications, without overuse of high-cost therapies, is a major unmet need in T2D.

About AspyreRx

AspyreRx (formerly BT-001) is Better Therapeutics’ clinically validated prescription digital therapy for the treatment of T2D. Using proven techniques that target the underlying psychological, behavioral and cognitive factors that sustain or worsen T2D, AspyreRx is a self-paced, engaging experience that patients can access anytime/anywhere. It is prescribed by a healthcare provider in 90-day increments, with proprietary CBT delivered digitally in a weekly step-by-step process. Through interactive therapy lessons, skill-building modules, weekly goal setting and tracking, patients connect changes in behavior to improvements in blood sugar and other biometrics. Each step in the experience builds on the prior to enable and reinforce cognitive restructuring, building the emotional resilience and acceptance needed to make enduring changes. AspyreRx is backed by robust data demonstrating clinically meaningful and sustained reduction in HbA1c when used up to 180 days.

Indications for Use

BT-001 is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. BT-001 provides cognitive behavioral therapy as a treatment that should be used adjunctively with standard of care.

[Frankestin]

yesterday there was someone who sent it from 1.30 to 0.82!
Just for fun!

[Frankestin]

Since there are so many millions of patients, perhaps Musk should integrate Twitter with this service! Twitter users will be automatically signed into the diabetes tracker app!

[Frankestin]

Looks like they're going to put in a feature to make patients dance!
The best dance will win the lifetime membership!

[Frankestin]

TP 7
with a lot of patience
Is it more probable that a deserved offer or a BO will arrive since the MC is less than 40 million?

[Frankestin]

Expected Upcoming Milestones

Apply for Breakthrough Device Designation: Following the successful completion of the LivVita Liver Study, Better Therapeutics commenced work on an application to the FDA for Breakthrough Device Designation for its investigational PDT in NAFLD and NASH and is expected to submit the application in the first half of 2023. Currently, there is no FDA approved treatment for NAFLD and NASH, which affect approximately one in four Americans. Behavioral change is foundational to addressing the root causes of the diseases and having a prescription treatment option could be of significant benefit to millions of patients.
Potential FDA Authorization and Commercial Launch of BT-001: Better Therapeutics is diligently advancing its preparations for the potential commercial launch of BT-001 in mid-2023. Upcoming milestones in market access include the submission of health economic outcomes research (HEOR) for publication and commencing pre-authorization information exchange meetings with Payers beginning in April.
First Dataset from BT-001 Real-World Evidence Program: This randomized, controlled, multi-site program is designed to generate real-world evidence to provide payers and providers with long-term data related to usage and outcomes in a real-world setting. Interim study results are expected to be reported in the fourth quarter of 2023.
https://investors.bettertx.com/static-files/f6865b33-0d14-48e8-afc7-a0dffed37566