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
Company to host a conference call and webcast today at
"We made tremendous progress in Q3, which included the FDA authorization of AspyreRx and the completion of the work required for a commercial launch in early October. AspyreRx offers healthcare providers a clinically proven, convenient, and cost-effective treatment option that aligns with current diabetes treatment guidelines and is suitable for a broad range of people with type 2 diabetes," said
Third Quarter and Recent Business Highlights
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Obtained FDA Authorization: In
July 2023 ,Better Therapeutics announced that theU.S. Food and Drug Administration (FDA) authorized AspyreRxTM (formerly BT-001) as the first prescription-only digital therapeutic (PDT) treatment indicated to provide cognitive behavioral therapy (CBT) 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. -
Completed Enrollment in AspyreRx Real-world Evidence Program: In
September 2023 ,Better Therapeutics announced the completion of enrollment of 1,000 participants in its real-world evidence program evaluating the long-term effectiveness of AspyreRx in T2D. -
New Patent Issued: In
September 2023 ,Better Therapeutics patent - "Managing lifestyle and health interventions with predictive analytics" - was issued in theEuropean Union (EU). This is the Company’s second patent issued of 4 patent families filed, covering the breadth of Better Therapeutics’ novel method for delivering CBT, innovative use of patient engagement data, and AI methods such as machine learning to predict outcomes and adjust treatment. -
Commercially Launched AspyreRx: In
October 2023 ,Better Therapeutics announced the commercial launch of AspyreRx, with healthcare providers in theU.S. now able to prescribe the treatment for adults with T2D. Prescriptions are being written and patients are actively on treatment. If the patient's insurance does not cover AspyreRx, the Company is offering eligible patients a self-pay option, for a limited time, as payer coverage is established. -
LivVita Study Results Published: In
October 2023 ,Better Therapeutics announced the pre-print publication of the results of its LivVita Liver Study in Gastro Hep Advances, a peer-reviewed journal produced by theAmerican Gastroenterological Association (AGA). Authors concluded the totality of positive efficacy, safety, and usability data indicates the potential of Better Therapeutics’ digitally delivered CBT to help address the significant unmet clinical needs observed in metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). -
New Data Shows Superior Clinical Outcomes with Concurrent Use of AspyreRx and GLP-1 Receptor Agonists to Treat Type 2 Diabetes: In
October 2023 ,Better Therapeutics announced that new data from a subgroup analysis revealed 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 used GLP-1s but did not incorporate AspyreRx into their regimen. -
Showcased AspyreRx at First Promotional Meeting: In
October 2023 ,Better Therapeutics announced its participation at theAmerican College of Lifestyle Medicine’s 2023 Annual Meeting. At this meeting, AspyreRx was presented for the first time, allowing over 2,000 medical professionals, healthcare executives, and researchers the opportunity to experience the product firsthand and attend the sponsored education session. -
Additional Capital Raise: In
October 2023 ,Better Therapeutics raised$2.9 million through its At-The-Market (ATM) facility, with an average price per share of$0.42 . This additional capital extends the Company's financial runway into the first quarter of 2024.
Expected Upcoming Milestones
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Obtain Commercial Payer Coverage for AspyreRx:
Better Therapeutics is currently engaged in advanced discussions with multiple commercial payers and expects to announce an agreement by the end of this year. The Company has submitted its Federal Supply Schedule (FSS) application and is awaiting to be assigned a contract negotiator. Once on the FSS, AspyreRx would be available to be prescribed to Veterans that receive care via theVA network. -
Request Breakthrough Device Designation: Following the successful completion of the LivVita Liver Study and publication of the results in the peer-reviewed journal Gastro Hep Advances,
Better Therapeutics intends to submit a request to the FDA for Breakthrough Device Designation for its investigational PDT in MASLD and MASH by the end of 2023. Currently, there is no FDA approved treatment for MASLD and MASH, which affect approximately one in four Americans. Behavioral change is foundational to addressing the root causes of the diseases and the Company believes that a prescription treatment option could be of significant benefit to millions of patients. -
Announce a
Business Development Partnership : To support the commercialization of AspyreRx,Better Therapeutics expects to announce a business development partnership by the end of this year. -
Further Strengthen Financial Position:
Better Therapeutics expects to further strengthen its financial position in the fourth quarter to extend its financial runway.
Third Quarter 2023 Financial Results
Research and development expenses for the quarter ended
Sales and marketing expenses for the quarter ended
General and administrative expenses for the quarter ended
Interest expense, net for the quarter ended
Net loss for the quarter ended
Capital resources: Cash and cash equivalents were
Conference Call and Webcast
Available Information
About AspyreRx
AspyreRx (formerly BT-001) was granted marketing authorization by the
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
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’ plans and expectations regarding FDA submissions, including a request to the FDA for Breakthrough Device Designation for its investigational PDT in MASLD and MASH, and the timing of such submissions, plans related to the commercialization of AspyreRx (formerly BT-001) for the treatment of T2D, expectations related to the efficacy and potential benefits of BT-001 and CBT and their potential treatment applications, Better Therapeutics’ plans regarding the research and advancement of its product candidates for additional treatments and other upcoming milestones, Better Therapeutics’ plans and expectations regarding the results of discussions with healthcare providers and payers and the interest of healthcare providers and payers in PDTs, the timing of and expectations related to Better Therapeutics’ engagement with
CONDENSED BALANCE SHEETS (in thousands, except share data) |
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|
|
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2023 |
|
|
2022 |
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ASSETS |
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(unaudited) |
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(audited) |
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||
Current assets: |
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|
|
|
|
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||
Cash and cash equivalents |
|
$ |
6,598 |
|
|
$ |
15,740 |
|
Prepaid expenses |
|
|
674 |
|
|
|
2,496 |
|
Other current assets |
|
|
73 |
|
|
|
210 |
|
Total current assets |
|
|
7,345 |
|
|
|
18,446 |
|
|
|
|
|
|
|
|
||
Capitalized software development costs, net |
|
|
2,792 |
|
|
|
3,888 |
|
Property and equipment, net |
|
|
102 |
|
|
|
121 |
|
Other long-term assets |
|
|
483 |
|
|
|
488 |
|
Total Assets |
|
$ |
10,722 |
|
|
$ |
22,943 |
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
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Current liabilities: |
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Accounts payable |
|
$ |
2,308 |
|
|
$ |
3,035 |
|
Accrued payroll |
|
|
1,886 |
|
|
|
2,301 |
|
Other accrued expenses |
|
|
2,158 |
|
|
|
3,626 |
|
Current portion of long-term debt |
|
|
6,586 |
|
|
|
4,532 |
|
Total current liabilities |
|
|
12,938 |
|
|
|
13,494 |
|
Long-term debt, net of current portion and debt issuance costs |
|
|
7,721 |
|
|
|
10,348 |
|
Total liabilities |
|
|
20,659 |
|
|
|
23,842 |
|
Commitments and contingencies |
|
|
|
|
|
|
||
Stockholders' deficit: |
|
|
|
|
|
|
||
Common stock |
|
|
4 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
124,370 |
|
|
|
110,602 |
|
Accumulated deficit |
|
|
(134,311 |
) |
|
|
(111,503 |
) |
Total Stockholders' Deficit |
|
|
(9,937 |
) |
|
|
(899 |
) |
Total Liabilities and Stockholders’ Deficit |
|
$ |
10,722 |
|
|
$ |
22,943 |
|
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) (Unaudited) |
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Three Months Ended |
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Nine Months Ended |
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||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
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Operating expenses: |
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|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
1,833 |
|
|
$ |
5,477 |
|
|
$ |
7,462 |
|
|
$ |
13,391 |
|
Sales and marketing |
|
|
1,392 |
|
|
|
1,557 |
|
|
|
5,200 |
|
|
|
5,284 |
|
General and administrative |
|
|
2,116 |
|
|
|
3,962 |
|
|
|
8,629 |
|
|
|
11,265 |
|
Total operating expenses |
|
|
5,341 |
|
|
|
10,996 |
|
|
|
21,291 |
|
|
|
29,940 |
|
Loss from operations |
|
|
(5,341 |
) |
|
|
(10,996 |
) |
|
|
(21,291 |
) |
|
|
(29,940 |
) |
Interest expense, net |
|
|
(518 |
) |
|
|
(406 |
) |
|
|
(1,512 |
) |
|
|
(1,052 |
) |
Loss before provision for income taxes |
|
|
(5,859 |
) |
|
|
(11,402 |
) |
|
|
(22,803 |
) |
|
|
(30,992 |
) |
Provision for income taxes |
|
|
3 |
|
|
|
3 |
|
|
|
5 |
|
|
|
3 |
|
Net loss |
|
$ |
(5,862 |
|
$ |
(11,405 |
) |
|
$ |
(22,808 |
) |
|
$ |
(30,995 |
) |
|
Net loss per share, basic and diluted |
|
$ |
(0.15 |
) |
|
$ |
(0.48 |
) |
|
$ |
(0.73 |
) |
|
$ |
(1.32 |
) |
Weighted-average shares used in computing net loss per share |
|
|
38,495,150 |
|
|
|
23,693,154 |
|
|
|
31,214,093 |
|
|
|
23,533,290 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20231109425949/en/
Investor Relations:
IR@bettertx.com
Media Enquiries:
emma.williams@bettertx.com
Source: