Company Highlights Positive Pivotal Clinical
Trial Data for BT-001, a Prescription Digital Therapeutic for Type
2 Diabetes
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 announced its financial results for
the fourth quarter and full year ending December 31, 2021. These
results follow the recent announcement of positive primary endpoint
data from the pivotal clinical trial for the company’s BT-001
prescription digital therapeutic.
“Better Therapeutics is at a transformational moment in our
company’s history as we close our first quarter as a public company
and begin to see the results of the investments we’ve made in using
digitally-delivered nCBT to treat cardiometabolic diseases,” stated
Kevin Appelbaum, Co-Founder and CEO of Better Therapeutics. “The
primary endpoint data we announced last week showed that our PDT
for treating uncontrolled type 2 diabetes has the potential to
significantly change how we treat this complex, costly, and all too
common condition. We look forward to completing our pivotal study
next quarter and submitting our de novo classification request to
the FDA immediately thereafter.”
Pivotal Clinical Trial Data for BT-001
The data released by Better Therapeutics demonstrated the safety
and efficacy of BT-001 in an open label, randomized, controlled,
parallel group trial enrolled 669 adults with type 2 diabetes and
mean baseline A1c of 8.1%. Participants were randomized to receive
standard of care with or without BT-001 and the primary efficacy
endpoint was the difference in mean change from baseline in A1c
after 90 days of treatment between the two groups. The six-month
trial is ongoing and is expected to be completed in Q2 2022. The
findings included data showing:
- A highly statistically significant primary efficacy endpoint
(n=602) improvement in A1c between the intervention and control
groups (-0.4%, p <0.001).
- Clinically meaningful changes (A1c reductions of 0.4% or more)
in 42.7% of the group receiving standard of care and BT-001 vs.
25.4% in the group receiving standard of care alone (difference of
17.3%, p <0.0010).
- A clear dose-response between greater engagement in nCBT and
greater reductions in A1c, supporting nCBT as a mechanism of
action.
- Measures of patient engagement, adherence, persistence, and
satisfaction were all positive.
Fourth Quarter and Full-Year 2021 Financial Results
- Research and development expenses for the fourth quarter of
2021 were $6.4 million, compared to $0.8 million for the same
period in 2020. Research and development expenses for the twelve
months ended December 31, 2021 were $19.4 million, compared to $3.7
million for the same period in 2020. The increase in research and
development expenses is primarily due to an increase in personnel
and clinical trial expenses related to advancing research in
conjunction with the Company’s prescription digital therapeutic,
BT-001.
- Sales and marketing expenses for the fourth quarter of 2021
were $1.2 million, compared to $0.1 million for the same period in
2020. Sales and marketing expenses for the twelve months ended
December 31, 2021 were $2.3 million, compared to $0.2 million for
the same period in 2020. The increase in sales and marketing
expenses is due to an increase in personnel, marketing and
consulting expenses associated with pre-launch preparations of
BT-001.
- General and administrative expenses for the fourth quarter of
2021 were $4.6 million, compared to $0.6 million for the same
period in 2020. General and administrative expenses for the twelve
months ended December 31, 2021 were $8.8 million, compared to $2.5
million for the same period in 2020. The increase in general and
administrative expenses is primarily due to higher personnel
related and other costs to support company growth and additional
costs of being a public company.
- Net loss attributable to common shareholders for the fourth
quarter of 2021 was $13.9 million or $0.71 per basic and diluted
share, compared to net loss attributable to common shareholders of
$2.1 million, or $0.20 per basic and diluted share for the same
period in 2020. Net loss attributable to common shareholders for
the twelve months ended December 31, 2021 was $40.3 million or
$3.11 per basic and diluted share, compared to net loss
attributable to common shareholders of $7.9 million, or $0.79 per
basic and diluted share for the same period in 2020.
- Cash and cash equivalents were $40.6 million on December 31,
2021.
About Better Therapeutics
Better Therapeutics is a prescription digital therapeutics (PDT)
company developing a novel form of cognitive behavioral therapy 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 cognitive behavioral therapy
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 the timing and results of the ongoing trial of BT-001 in
patients with type 2 diabetes, Better Therapeutics’ plans regarding
FDA submissions, 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, expectations related
to the interest of healthcare providers and payers in PDTs and
legislative developments affecting PDTs and the outcome of such
developments, 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, the risk that
the results of previously conducted studies will not be repeated or
observed in ongoing or future studies involving our product
candidates and other risks and uncertainties included under the
header “Risk Factors” in the definitive proxy statement/prospectus
filed by us on October 12, 2021.
BETTER THERAPEUTICS,
INC.
BALANCE SHEETS
(in thousands)
December 31,
2021
2020
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
40,566
$
123
Prepaid expenses
4,409
124
Other current assets
276
216
Total current assets
45,251
463
Capitalized software development costs,
net
5,077
5,555
Property and equipment, net
82
89
Other long-term assets
548
280
Total Assets
$
50,958
$
6,387
LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT)
Current liabilities:
Accounts payable
$
1,523
$
514
Accrued payroll
1,352
39
Other accrued expenses
1,858
60
Total current liabilities
4,733
613
Long-term debt, net of debt issuance
costs
9,505
640
Deferred tax liability
—
152
Simple Agreements for Future Equity
—
11,740
Total liabilities
14,238
13,145
Commitments and contingencies
Stockholders’ equity (deficit):
Common stock
2
1
Additional paid-in capital
108,461
24,649
Accumulated deficit
(71,743
)
(31,408
)
Total Stockholders’ Equity (Deficit)
36,720
(6,758
)
Total Liabilities and Stockholders’ Equity
(Deficit)
$
50,958
$
6,387
BETTER THERAPEUTICS,
INC.
STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
(in thousands, except share
and per share data)
Three Months Ended
December 31,
Year Ended December
31,
2021
2020
2021
2020
(Unaudited)
(Unaudited)
(Unaudited)
Revenue
$
—
$
—
$
—
$
8
Operating Expenses:
Research and development
6,354
811
19,436
3,660
Sales and marketing
1,177
77
2,336
216
General and administrative
4,573
630
8,788
2,455
Total operating expenses
12,104
1,518
30,560
6,331
Loss from operations
(12,104
)
(1,518
)
(30,560
)
(6,323
)
Interest expense, net
(182
)
(2
)
(185
)
(100
)
Gain on Loan Forgiveness
—
—
647
—
Change in fair value of SAFEs
(1,611
)
(149
)
(10,390
)
189
Loss before provision for (benefit from)
income taxes
(13,897
)
(1,669
)
(40,488
)
(6,234
)
Provision for (benefit from) income
taxes
(3
)
82
(153
)
153
Net loss
$
(13,894
)
$
(1,751
)
$
(40,335
)
$
(6,387
)
Cumulative preferred dividends allocated
to Series A Preferred Shareholders
—
(389
)
—
(1,507
)
Net loss attributable to common
shareholders, basic and diluted
$
(13,894
)
$
(2,140
)
$
(40,335
)
$
(7,894
)
Net loss per share attributable to common
shareholders, basic and diluted
$
(0.71
)
$
(0.20
)
$
(3.11
)
$
(0.79
)
Weighted-average shares used in computing
net loss per share
19,686,940
10,629,023
12,982,472
9,949,376
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version on businesswire.com: https://www.businesswire.com/news/home/20220328005123/en/
Better Therapeutics Press Contact: Ryan McKenna at Real
Chemistry rmckenna@realchemistry.com
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