Better Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Updates
Obtained FDA Authorization for AspyreRxTM to treat adults with type 2 diabetes
Established price and launch metrics in preparation for expected launch in Q4
Completed financing transactions totaling
Company to host conference call and webcast today at
“Obtaining FDA authorization for AspyreRx was a pivotal milestone for our company and a catalyst for strengthening our financial position and advancing business development discussions,” said
Second Quarter and Recent Business Highlights
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Announced FDA Authorization of AspyreRx: In
July 2023 ,Better Therapeutics announced that theU.S. Food and Drug Administration (FDA) authorized AspyreRxTM (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. -
Set Price for AspyreRx: In
July 2023 ,Better Therapeutics completed final pricing research and set the Wholesale Acquisition Cost (WAC), or list price, for AspyreRx at$750.00 for a 90-day script. The Company also plans to offer the product on a cash-pay basis at a discounted price, for a limited period of time, to provide patients who are not covered by insurance at launch with an affordable out-of-pocket option. -
Completed Multiple Financing Transactions: In
April 2023 ,Better Therapeutics announced a private placement financing for gross proceeds of approximately$6.5 million before deducting offering expenses payable by the Company. InJuly 2023 ,Better Therapeutics announced the completion of an additional$6.7 million in net proceeds from multiple equity transactions. There was strong participation in both financings from certain officers and directors of the Company.
Expected Upcoming Milestones
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Commercial Launch of AspyreRx: AspyreRx is expected to launch commercially in the fourth quarter of 2023. With FDA authorization in hand, the Company is continuing to pursue payer coverage as well as finalizing SAM registration, the System for Award Management, a government-wide registry for vendors doing business with the Federal government. Registration is followed by negotiation for access via the Federal Supply Schedule.
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Complete Enrollment in BT-001 Real-world Evidence Program: As of
July 31st, 2023 ,Better Therapeutics has enrolled approximately 90% of the target participant population in its real-world evidence program and expects to complete enrollment by the end of the third quarter. Pending sufficient power, the Company expects to share the first dataset from these long-term effectiveness studies in the fourth quarter of this year. -
Request Breakthrough Device Designation: Following the successful completion of the LivVita Liver Study,
Better Therapeutics intends to submit a request to the FDA for Breakthrough Device Designation for its investigational PDT in non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) by the end 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. -
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, by the end of this year.
Second 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 (fka 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, plans related to the potential commercial launch 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, the timing of results from, and Better Therapeutics’ plans for, its Real-world Evidence Program, Better Therapeutics’ plans regarding the research and advancement of its product candidates for additional treatments, expectations related to pricing, research and its plans regarding offering AspyreRx at a discounted price, Better Therapeutics’ plans and expectations regarding the results of discussions with healthcare providers and the interest of healthcare providers and payers in PDTs, Better Therapeutics’ plans and expectations regarding its financing and business developments strategy, and statements related to its cash runway and long-term plans and expectations, among others. These forward-looking statements are based on the current expectations of the management of
CONDENSED BALANCE SHEETS (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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Cash and cash equivalents |
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$ |
6,196 |
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$ |
15,740 |
|
Prepaid expenses |
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1,166 |
|
|
|
2,496 |
|
Other current assets |
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|
60 |
|
|
|
210 |
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Total current assets |
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7,422 |
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18,446 |
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Capitalized software development costs, net |
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3,584 |
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|
3,888 |
|
Property and equipment, net |
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|
115 |
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|
|
121 |
|
Other long-term assets |
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|
483 |
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|
|
488 |
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Total Assets |
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$ |
11,604 |
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$ |
22,943 |
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LIABILITIES AND STOCKHOLDERS’ DEFICIT |
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Current liabilities: |
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Accounts payable |
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$ |
2,985 |
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$ |
3,035 |
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Accrued payroll |
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2,747 |
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|
2,301 |
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Other accrued expenses |
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2,448 |
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3,626 |
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Current portion of long-term debt |
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5,693 |
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4,532 |
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Total current liabilities |
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13,873 |
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13,494 |
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Long-term debt, net of current portion and debt issuance costs |
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8,519 |
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10,348 |
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Total liabilities |
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22,392 |
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23,842 |
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Commitments and contingencies (Note 8) |
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Stockholders' deficit: |
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Common stock, |
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3 |
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2 |
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Additional paid-in capital |
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117,658 |
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110,602 |
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Accumulated deficit |
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(128,449 |
) |
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(111,503 |
) |
Total Stockholders' Deficit |
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(10,788 |
) |
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|
(899 |
) |
Total Liabilities and Stockholders’ Deficit |
|
$ |
11,604 |
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$ |
22,943 |
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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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Six Months Ended |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
2,240 |
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$ |
4,241 |
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$ |
5,629 |
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$ |
7,914 |
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Sales and marketing |
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1,704 |
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1,683 |
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3,808 |
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3,727 |
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General and administrative |
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3,081 |
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3,675 |
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6,513 |
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|
7,303 |
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Total operating expenses |
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7,025 |
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|
9,599 |
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|
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15,950 |
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|
|
18,944 |
|
Loss from operations |
|
|
(7,025 |
) |
|
|
(9,599 |
) |
|
|
(15,950 |
) |
|
|
(18,944 |
) |
Interest expense, net |
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|
(563 |
) |
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|
(329 |
) |
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(994 |
) |
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|
(646 |
) |
Loss before provision for income taxes |
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(7,588 |
) |
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(9,928 |
) |
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(16,944 |
) |
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(19,590 |
) |
Provision for income taxes |
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|
1 |
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— |
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2 |
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— |
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Net loss |
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$ |
(7,589 |
) |
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$ |
(9,928 |
) |
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$ |
(16,946 |
) |
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$ |
(19,590 |
) |
Net loss per share, basic and diluted |
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$ |
(0.24 |
) |
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$ |
(0.42 |
) |
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$ |
(0.62 |
) |
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$ |
(0.83 |
) |
Weighted-average shares used in computing net loss per share |
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31,215,194 |
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23,592,995 |
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27,541,308 |
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23,498,978 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20230809311279/en/
Investor Relations:
IR@bettertx.com
Media Enquiries:
emma.williams@bettertx.com
Source: