Better Therapeutics, Inc. (NASDAQ: BTTX), a prescription digital therapeutics (PDT) company developing nutritional cognitive behavioral therapy (nCBT) to address the root causes of cardiometabolic diseases, today reported financial results for the second quarter of 2022 and provided an update on progress toward achieving key corporate milestones.
"Better Therapeutics is poised to enter the next phase of its growth as a commercial company, with the recent completion of the BT-001 pivotal trial and, if authorized by the FDA, the potential launch of our first-in-class prescription digital therapeutic for the treatment of type 2 diabetes next year," stated Frank Karbe, President and CEO of Better Therapeutics. "The pivotal trial of BT-001 met its primary and secondary endpoints and demonstrated a reassuring safety profile in a diverse and difficult to treat patient population, resulting in significant A1c reductions when compared with the current standard of care. We are on track to submit a de novo classification request for BT-001 with the FDA in the third quarter of 2022 and we believe we are well positioned to advance our digital therapeutic platform in type 2 diabetes and potentially other cardiometabolic conditions."
Recent Business Highlights
Expected Upcoming Milestones
Second Quarter 2022 Financial Results
Research and development expenses for the three months ended June 30, 2022 were $4.2 million, compared to $5.0 million for the same period in 2021. The decrease primarily reflects lower clinical study costs due to the wind down of the pivotal trial for BT-001, partially offset by an increase in personnel and consulting costs related to preparing the de novo submission for BT-001 as well as expanding our clinical research and software development capabilities.
Sales and marketing expenses for the three months ended June 30, 2022 were $1.7 million, compared to $0.6 million for the same period in 2021. The increase was primarily due to higher personnel, marketing and consulting expenses associated with commercial readiness activities to support the potential launch of BT-001.
General and administrative expenses for the three months ended June 30, 2022 were $3.7 million, compared to $0.9 million for the same period in 2021. The increase was primarily related to higher personnel-related costs driven by an increase in headcount and additional costs of being a publicly traded company, including a $1.1 million increase in our business insurance.
Interest expense, net for the three months ended June 30, 2022 was $0.3 million, compared to $0 for the same period in 2021. The increase in interest expense, net was the result of the interest incurred on the company's secured term loan agreement with Hercules Capital, which commenced in the fourth quarter of 2021.
Net loss for the three months ended June 30, 2022 was $9.9 million, compared to $8.7 million for the same period in 2021. On a per common share basis, net loss was $0.42 and $0.84 for the three months ended June 30, 2022 and 2021, respectively. The decline in loss per share is primarily related to an increase in weighted average shares outstanding as a result of the SPAC transaction in the fourth quarter of 2021.
Capital resources: Cash and cash equivalents were $29.7 million on June 30, 2022, compared to $40.6 million on December 31, 2021.
Conference Call and Webcast
Better Therapeutics will host a conference call and webcast today, August 11, 2022, at 8:30 a.m. ET / 5:30 a.m. PT. To access the conference call, please register at: https://register.vevent.com/register/BI6da59cc90fdb42a39adb1f216262cac7. Upon registering, each participant will be provided with call details and access codes. All participants are encouraged to join 10 minutes prior to the start time. The live webcast may be accessed by visiting the event link at: https://edge.media-server.com/mmc/p/zcn84y83. A replay of the webcast may be accessed from the Presentations & Events page in the Investors section of the Better Therapeutics corporate website at: investors.bettertx.com.
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). While CBT has been used for T2D and other cardiometabolic conditions before, until now the approach has not been scalable due to the need to deliver the therapy via a therapist. If authorized by FDA, BT-001 would be the first validated, prescription solution for delivering this therapeutic approach to T2D patients at scale, from their digital devices.
About the Better Therapeutics nCBT Platform
Better Therapeutics digital therapeutic platform is designed to delivers a novel form of CBT - nutritional CBT (nCBT) - to help people with cardiometabolic diseases potentially improve key measures related to T2D, nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, hypertension, hyperlipidemia and other cardiometabolic conditions. By adapting the principles and mechanisms of cognitive behavioral therapy, the 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 Better Therapeutics
Better Therapeutics is a prescription digital therapeutics (PDT) company developing a novel form of cognitive behavioral therapy (CBT) to address the root causes of cardiometabolic diseases. The company has developed a proprietary platform for the development of FDA-regulated, software-based solutions for type 2 diabetes, 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, if authorized for marketing, 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 clinical trial of BT-001 in patients with type 2 diabetes, Better Therapeutics' plans regarding FDA submissions, plans and expectations regarding the commercialization of BT-001, if authorized, expectations related to the 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 expectations related to the interest of healthcare providers and payers in PDTs, including BT-001, 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, including BT-001, for commercial distribution and insurance companies to reimburse their use, market acceptance of PDTs, including BT-001, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving the company's product candidates and other risks and uncertainties included under the header "Risk Factors" in the Better Therapeutics' annual report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission ("SEC") on March 28, 2022, and those that are included in any of the company's future filings with the SEC.
BETTER THERAPEUTICS, INC. |
||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
||||||||||||||||
(Unaudited, in thousands, except share and per share data) |
||||||||||||||||
|
Three Months Ended
|
Six Months Ended
|
||||||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
|
|
|
|
|
||||||||||||
Operating Expenses: |
|
|
|
|
||||||||||||
Research and development |
$ |
4,241 |
|
$ |
5,038 |
|
$ |
7,914 |
|
$ |
6,416 |
|
||||
Sales and marketing |
|
1,683 |
|
|
564 |
|
|
3,727 |
|
|
607 |
|
||||
General and administrative |
|
3,675 |
|
|
872 |
|
|
7,303 |
|
|
2,439 |
|
||||
Total operating expenses |
|
9,599 |
|
|
6,474 |
|
|
18,944 |
|
|
9,462 |
|
||||
Loss from operations |
|
(9,599 |
) |
|
(6,474 |
) |
|
(18,944 |
) |
|
(9,462 |
) |
||||
Interest expense, net |
|
(329 |
) |
|
(1 |
) |
|
(646 |
) |
|
(2 |
) |
||||
Change in fair value of SAFEs |
|
? |
|
|
(2,821 |
) |
|
? |
|
|
(5,313 |
) |
||||
Gain on loan forgiveness |
|
? |
|
|
647 |
|
|
? |
|
|
647 |
|
||||
Loss before provision (benefit) from income taxes |
|
(9,928 |
) |
|
(8,649 |
) |
|
(19,590 |
) |
|
(14,130 |
) |
||||
Provision (benefit) from income taxes |
|
? |
|
|
1 |
|
|
? |
|
|
(150 |
) |
||||
Net loss |
$ |
(9,928 |
) |
$ |
(8,650 |
) |
$ |
(19,590 |
) |
$ |
(13,980 |
) |
||||
Cumulative preferred dividends allocated to Series A Preferred Shareholders |
|
? |
|
|
(394 |
) |
|
? |
|
|
(782 |
) |
||||
Net loss attributable to common shareholders, basic and diluted |
$ |
(9,928 |
) |
$ |
(9,044 |
) |
$ |
(19,590 |
) |
$ |
(14,762 |
) |
||||
Net loss per share attributable to common shareholders, basic and diluted |
$ |
(0.42 |
) |
$ |
(0.84 |
) |
$ |
(0.83 |
) |
$ |
(1.38 |
) |
||||
Weighted-average shares used in computing net loss per share |
|
23,592,995 |
|
|
10,730,818 |
|
|
23,498,978 |
|
|
10,707,996 |
|
BETTER THERAPEUTICS, INC. |
||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||
(in thousands) |
||||||||
(Unaudited) |
||||||||
|
|
|
||||||
|
|
June 30, |
|
December 31, |
||||
|
|
2022 |
|
2021 |
||||
ASSETS |
|
|
|
|
||||
Current assets: |
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
29,685 |
|
|
$ |
40,566 |
|
Prepaid expenses |
|
|
2,380 |
|
|
|
4,409 |
|
Other current assets |
|
|
72 |
|
|
|
276 |
|
Total current assets |
|
|
32,137 |
|
|
|
45,251 |
|
Capitalized software development costs, net |
|
|
4,364 |
|
|
|
5,077 |
|
Property and equipment, net |
|
|
115 |
|
|
|
82 |
|
Other long-term assets |
|
|
487 |
|
|
|
548 |
|
Total Assets |
|
$ |
37,103 |
|
|
$ |
50,958 |
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
||||
Current liabilities: |
|
|
|
|
||||
Accounts payable |
|
$ |
1,088 |
|
|
$ |
1,523 |
|
Accrued payroll |
|
|
2,074 |
|
|
|
1,352 |
|
Other accrued expenses |
|
|
1,196 |
|
|
|
1,858 |
|
Current portion of long-term debt |
|
|
1,783 |
|
|
|
? |
|
Total current liabilities |
|
|
6,141 |
|
|
|
4,733 |
|
Long-term debt, net of current portion and debt issuance costs |
|
|
12,908 |
|
|
|
9,505 |
|
Total liabilities |
|
|
19,049 |
|
|
|
14,238 |
|
|
|
|
|
|
||||
Stockholders' equity: |
|
|
|
|
|
|
||
Common stock |
|
|
2 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
109,385 |
|
|
|
108,461 |
|
Accumulated deficit |
|
|
(91,333 |
) |
|
|
(71,743 |
) |
Total Stockholders' Equity |
|
|
18,054 |
|
|
|
36,720 |
|
Total Liabilities and Stockholders' Equity |
|
$ |
37,103 |
|
|
$ |
50,958 |
|
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