Completed pivotal trial of BT-001 for type 2
diabetes and reported positive secondary endpoint results after 180
days of treatment
On track to submit de novo classification
request for BT-001 with FDA in third quarter of 2022
Completed enrollment in LivVita Liver Study for
nonalcoholic fatty liver disease
Appointed Frank Karbe as President and Chief
Executive Officer and member of Board of Directors
Company to host conference call and webcast
today at 8:30 a.m. ET
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
- Completed BT-001 Pivotal Clinical Trial: Reported
positive secondary endpoint results in July, following the
announcement of positive primary endpoint results in March. The
secondary endpoint evaluated the effectiveness and safety of the
company’s investigational nCBT for the treatment of adult patients
with uncontrolled type 2 diabetes (T2D) after 180 days of
treatment. Among the encouraging results shown were:
- Sustained and improved A1c levels in patients using BT-001,
with average absolute A1c reduction improving from 0.3% at day 90
to 0.4% at day 180, supporting that the treatment effects of BT-001
were durable.
- The difference in A1c levels after 180 days of treatment
between BT-001 treated patients and Standard of Care (SOC) control
group patients receiving standard of care remained statistically
significant (p=0.01) even as more SOC patients increased blood
sugar lowering medications.
- Half of patients using BT-001 experienced clinically meaningful
A1c reductions with a mean reduction of 1.3% in this subgroup at
180 days (SD 0.8%).
- Results indicated that patients who did not use BT-001 were
more likely to be placed on additional medications to improve A1c
control. After the day 180 A1c draw, 1.7 times more SOC control
patients increased their medications compared to BT-001
patients.
- BT-001 demonstrated reassuring safety, with significantly fewer
adverse (p<0.001) and serious adverse events (p=0.01) as
compared to the SOC control group.
- A clear dose-response between greater engagement in nCBT and
greater reductions in A1c was found, supporting nCBT as a mechanism
of action.
- Completed Enrollment in the LivVita Liver Study for
Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic
Steatohepatitis (NASH): The company completed enrollment in a
first ever clinical study evaluating the feasibility of nCBT to
reduce liver fat and improve liver disease biomarkers as a
potential treatment for fatty liver disease. This single arm
interventional cohort study has now completed enrollment of 22
adult patients from two specialized liver treatment clinics based
in Arizona. NAFLD/NASH affects over 64 million adults in the U.S.,
resulting in over $100 billion in direct healthcare costs annually.
There are currently no FDA approved therapeutics for treating
NASH/NAFLD.
- CEO Appointment: Frank Karbe joined the company as
President and Chief Executive Officer and as a member of the Board
of Directors on July 5, 2022, succeeding Kevin Appelbaum. Frank is
a widely experienced senior executive with extensive leadership and
capital raising expertise, serving most recently as President and
Chief Financial Officer of Myovant Sciences. Previously, he served
for over a decade as Executive Vice President and Chief Financial
Officer at Exelixis, Inc. Earlier in his career, he worked as an
investment banker for Goldman Sachs & Co. focusing on the life
sciences industry.
- Granted Patent on Prescription Digital Therapeutics
Platform: In June 2022, the U.S. Patent and Trademark Office
(USPTO) granted patent protection for several key features (methods
and apparatus for generating and monitoring a therapy regimen) core
to the company’s digital therapeutics platform, designed to help
treat cardiometabolic diseases through the delivery of digital
behavioral therapy as a PDT. Better Therapeutics’ patent coverage
for its platform will extend until at least September of 2039.
- Publication of BT-001 Pivotal Clinical Trial Design: A
manuscript detailing the study design and methodology for the
company’s pivotal clinical trial of BT-001 in adult patients with
T2D was published in the medical journal, Clinical Cardiology in
July.
Expected Upcoming Milestones
- BT-001 De Novo Submission: Based on positive primary and
secondary endpoint data from the BT-001 pivotal clinical trial,
Better Therapeutics expects to submit a de novo classification
request with the FDA in the third quarter of 2022, seeking
marketing authorization of BT-001 for the treatment of adult
patients with T2D.
- Health Economic Model for BT-001 and Payer Coverage
Discussions: The company expects to complete its health
economic models for BT-001 and plans to begin engaging payers in
potential coverage discussions in the third quarter of 2022.
- LivVita Liver Study: Better Therapeutics is on track to
complete the LivVita study and announce top-line results in the
fourth quarter of 2022. The study is being conducted in
collaboration with Arizona Liver Health and is evaluating the
feasibility of investigational nCBT to reduce liver fat and improve
liver disease biomarkers as a potential treatment for NAFLD and
NASH.
- BT-001 Real-World Evidence Program: This randomized,
controlled, multi-site program is designed to generate real-world
evidence to provide additional support in the company’s payer
coverage and reimbursement discussions. The program is expected to
enroll approximately 1,000 patients for a treatment period of at
least 12 months. Interim data is expected in 2023.
- Address Financing Needs: Better Therapeutics has
initiated a broad assessment of potential financing options. The
company expects to address its financing needs within the next six
months to ensure it has the financial resources to continue to
prepare for a potential commercial launch of BT-001, if authorized
by the FDA, and to potentially expand its digital platform into
other cardiometabolic diseases.
- Commercial Launch of BT-001: The company is diligently
advancing its preparations for the potential commercial launch of
BT-001 upon FDA authorization.
- Pipeline Expansion: Better Therapeutics will gather
pilot data from the BT-001 pivotal study and LivVita Liver Study to
inform the potential initiation of an additional pivotal trial.
Pending sufficient capital, the company is targeting 2023 for
commencement of this study.
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 June
30,
Six Months Ended June
30,
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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220811005186/en/
Investor Relations: Mark Heinen IR@bettertx.com
Media: Ryan McKenna at Real Chemistry
rmckenna@realchemistry.com
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