Better Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Updates
On track for an FDA decision mid-year
Announced restructuring to extend cash runway
Completed private placement financing
Company to host conference call and webcast today at
“We successfully navigated several challenges in the first quarter of this year, laying the foundations for long-term success. The reduction in force, coupled with the completion of a private placement financing, extended our cash runway sufficiently to reach multiple significant milestones,” stated
First Quarter and Recent Business Highlights
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Responded to FDA’s Request for Information: In
February 2023 ,Better Therapeutics received a Request for Additional Information from theU.S. Food and Drug Administration (FDA) related to its de novo submission for BT-001, which is an expected part of the review process. The Company responded to the Request for Additional Information onApril 17, 2023 and the FDA confirmed its review is progressing. If authorized by the FDA, BT-001 would be the first and only PDT delivering highly scalable CBT to adults with type 2 diabetes (T2D) from a digital device. -
Executives with Extensive Diabetes Experience Join Team: In
March 2023 ,Better Therapeutics hiredChip Amrein as Head of Marketing, bringing with him two decades of experience in diabetes, most recently with Novo Nordisk.Elizabeth Pash , PhD, RDN, an accomplished leader with decades of cardiometabolic disease experience with Abbott and Medtronic, also joinedBetter Therapeutics as Head of Medical Affairs, bringing deep clinical insight and product launch experience to the commercial organization. -
Announced Restructuring to Extend Runway Through Multiple Milestones: In
March 2023 ,Better Therapeutics implemented a reduction in force impacting approximately 35% of the workforce. The Company also implemented other cost savings measures to further extend its cash runway. -
Completed
$6.5 million Private Placement: InApril 2023 ,Better Therapeutics announced a private placement of 7,878,786 shares of the Company’s common stock at a price of$0.825 per share, which was the closing price of the Company’s common stock on the Nasdaq Capital Market onApril 5, 2023 , for gross proceeds of approximately$6.5 million before deducting offering expenses payable by the Company. There was strong participation in the transaction from certain officers and directors of the Company.
Expected Upcoming Milestones
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Potential FDA Authorization and Commercial Launch of BT-001:
Better Therapeutics continues to expect the FDA’s decision on the Company’s de novo submission for marketing authorization of BT-001 by the middle of the year and is anticipating a commercial launch within a few months following such decision if the FDA approves the submission. Additional upcoming milestones include the submission of health economic data for peer review and publication. -
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 non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), and now expects to submit the application in the third quarter 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 the Company believes that a prescription treatment option could be of significant benefit to millions of patients. -
Complete Enrollment in BT-001 Real-world Evidence Program:
Better Therapeutics reported almost 75% of the target participant population has been enrolled in its real-world evidence program and expects to complete enrollment by the end of the third quarter. Following this milestone, the Company expects to share the first dataset from these long-term effectiveness studies in the fourth quarter of this year. -
Further Strengthen Financial Position:
Better Therapeutics expects to deliver on multiple elements of its financing strategy to further enhance its financial position, including a potential business development partnership and / or royalty monetization transaction.
First 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 BT-001
BT-001 is Better Therapeutics’ investigational prescription digital therapy for the treatment of T2D. The investigational therapy is delivered via software that provides a tailored experience to patients designed to help them address the underlying causes of T2D by making meaningful, sustainable behavioral changes. The BT-001 investigational therapy is rooted in the well-studied, gold standard of behavioral modification therapies, cognitive behavioral therapy. CBT has been used for T2D and other cardiometabolic conditions before, but until now the approach has not been scalable due to the need to deliver the therapy in-person via a therapist. If authorized by the FDA, BT-001 would be the first prescription solution for delivering this therapeutic approach to T2D patients at scale from their digital devices.
About the Better Therapeutics CBT Platform
Better Therapeutics’ investigational digital therapeutic platform is designed to deliver a novel form of CBT to help people with cardiometabolic diseases potentially improve key measures related to T2D, NAFLD, NASH, hypertension, hyperlipidemia and other cardiometabolic conditions. By adapting the principles and mechanisms of CBT, Better Therapeutics’ digital therapeutic platform is designed to address and modify the cognitive patterns that affect eating habits and other behavioral factors associated with cardiometabolic diseases.
About
For more information visit: bettertx.com
Forward-Looking Statements
Certain statements made in this press release and related comments in our earnings conference call 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 and in our earning conference call include, but are not limited to, statements regarding Better Therapeutics’ plans and expectations regarding FDA submissions, including its application for Breakthrough Device designation for its investigational prescription digital therapy in NAFLD and NASH, plans and expectations related to potential marketing authorizations and the timing of and plans related to the potential commercial launch of BT-001 for the treatment of T2D, if authorized by the FDA, Better Therapeutics’ plans and expectations regarding its real world evidence program for BT-001, including the timing of results, 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, expectations related to pricing research and results and the interest of healthcare providers and payers in PDTs, Better Therapeutics’ plans regarding publications, statements related to its financial outlook and cash runway and expectations and statements regarding its financing needs, plans and expectations, among others. These forward-looking statements are based on the current expectations of the management of
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CONDENSED BALANCE SHEETS |
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(in thousands, except share data) |
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2023 |
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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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|
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Cash and cash equivalents |
|
$ |
6,068 |
|
|
$ |
15,740 |
|
Prepaid expenses |
|
|
1,968 |
|
|
|
2,496 |
|
Other current assets |
|
|
406 |
|
|
|
210 |
|
Total current assets |
|
|
8,442 |
|
|
|
18,446 |
|
|
|
|
|
|
|
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||
Capitalized software development costs, net |
|
|
3,752 |
|
|
|
3,888 |
|
Property and equipment, net |
|
|
131 |
|
|
|
121 |
|
Other long-term assets |
|
|
483 |
|
|
|
488 |
|
Total Assets |
|
$ |
12,808 |
|
|
$ |
22,943 |
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|
|
|
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LIABILITIES AND STOCKHOLDERS’ DEFICIT |
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Current liabilities: |
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Accounts payable |
|
$ |
2,513 |
|
|
$ |
3,035 |
|
Accrued payroll |
|
|
3,078 |
|
|
|
2,301 |
|
Other accrued expenses |
|
|
2,510 |
|
|
|
3,626 |
|
Current portion of long-term debt |
|
|
5,539 |
|
|
|
4,532 |
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Total current liabilities |
|
|
13,640 |
|
|
|
13,494 |
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|
|
|
|
|
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Long-term debt, net of current portion and debt issuance costs |
|
|
9,001 |
|
|
|
10,348 |
|
Total liabilities |
|
|
22,641 |
|
|
|
23,842 |
|
|
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|
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Commitments and contingencies |
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Stockholders' deficit: |
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Common stock |
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|
2 |
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|
|
2 |
|
Additional paid-in capital |
|
|
111,025 |
|
|
|
110,602 |
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Accumulated deficit |
|
|
(120,860 |
) |
|
|
(111,503 |
) |
Total Stockholders' Deficit |
|
|
(9,833 |
) |
|
|
(899 |
) |
Total Liabilities and Stockholders’ Deficit |
|
$ |
12,808 |
|
|
$ |
22,943 |
|
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CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
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(in thousands, except share and per share data) |
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(Unaudited) |
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Three Months Ended |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
|
$ |
3,389 |
|
|
$ |
3,673 |
|
Sales and marketing |
|
|
2,104 |
|
|
|
2,044 |
|
General and administrative |
|
|
3,432 |
|
|
|
3,628 |
|
Total operating expenses |
|
|
8,925 |
|
|
|
9,345 |
|
Loss from operations |
|
|
(8,925 |
) |
|
|
(9,345 |
) |
Interest expense, net |
|
|
(431 |
) |
|
|
(317 |
) |
Loss before provision for income taxes |
|
|
(9,356 |
) |
|
|
(9,662 |
) |
Provision for income taxes |
|
|
1 |
|
|
|
— |
|
Net loss |
|
$ |
(9,357 |
) |
|
$ |
(9,662 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.39 |
) |
|
$ |
(0.41 |
) |
Weighted-average shares used in computing net loss per share |
|
|
23,826,594 |
|
|
|
23,413,213 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20230511005385/en/
Investor Relations:
IR@bettertx.com
Media Enquiries:
emma.williams@bettertx.com
Source: