Reported positive primary endpoint results from pivotal trial of
BT-001 after 90 days of treatment for type 2 diabetes
Represents a first-in-class randomized,
controlled clinical trial of a prescription digital therapeutic
(PDT) for treating a cardiometabolic disorder
Data supports filing of a de novo
classification request with the FDA, which is expected in the third
quarter of 2022, subject to supportive secondary endpoint data and
study completion in the second quarter of 2022
Initiated first-ever clinical study evaluating nutritional
Cognitive Behavior Therapy (nCBT) as potential treatment for
Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic
Steatohepatitis (NASH)
Expanded real-world evidence study of BT-001 through
collaboration with Mass General Brigham and Durham Veterans
Administration to further establish durability of effect and impact
on healthcare costs
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
first quarter of 2022 and provided an update on progress toward
achieving key corporate milestones.
“Better Therapeutics has made significant progress in advancing
the clinical development of its first-in-class digital therapeutic
platform for the treatment of cardiometabolic diseases,” stated
Kevin Appelbaum, Co-Founder and CEO of Better Therapeutics. “Our
pivotal trial of BT-001, evaluating the use of nCBT for the
treatment of patients with uncontrolled type 2 diabetes achieved
its primary endpoint, supporting the filing of a de novo
classification request with the FDA for potentially the first ever
PDT in this widespread indication. nCBT has the potential to treat
a broad range of other cardiometabolic conditions and our team has
achieved key pipeline milestones with the initiation of a
feasibility study evaluating nCBT as a potential treatment for
Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic
Steatohepatitis (NASH). Together, these initiatives reflect an
emerging standard of care for the treatment of cardiometabolic
diseases, built on a foundation of behavioral therapy delivered as
prescription digital therapeutics.”
First Quarter 2022 Financial Results
Research and development expenses for the quarter ended
March 31, 2022 were $3.7 million, compared to $1.4 million for the
comparable period in 2021. The increase was primarily related to
the costs of advancing research in conjunction with the company's
prescription digital therapeutic, BT-001.
Sales and marketing expenses for the quarter ended March
31, 2022 were $2.0 million, compared to $43 thousand for the
comparable period in 2021. The increase primarily reflects
personnel, marketing and consulting expenses associated with
pre-launch preparations of BT-001.
General and administrative expenses for the quarter ended
March 31, 2022 were $3.6 million, compared to $1.6 million for the
comparable period in 2021. The increase was primarily related to
personnel costs to support company growth and additional costs of
being a publicly traded company.
Capital resources: Cash and cash equivalents were $31.7
million on March 31, 2022, compared to $40.6 million on December
31, 2021. Borrowing capacity on the company's secured loan
agreement with Hercules Capital, Inc. was $5 million on March 31,
2022.
Recent Business Highlights
Clinical Programs
- BT-001 Pivotal Clinical Trial Results: Reported positive
primary endpoint data at day 90 evaluating the use of nCBT for the
treatment of patients with uncontrolled type 2 diabetes. The study
met its primary efficacy endpoint and demonstrated an excellent
safety profile. Patients who received BT-001 demonstrated
clinically meaningful and statistically significant improvement in
A1c compared to control (mean improvement 0.4%; p-value <
0.0001). 45% of patients receiving BT-001 demonstrated a reduction
in A1c of at least 0.4% (mean improvement 1.1%) vs. 27% of the
patients in the control group.
- BT-001 Real-World Evidence Study: The Durham Veterans
Administration (VA) Medical Center joined Mass General Brigham,
Colorado Prevention Center, and Catalyst Health System in an
ongoing randomized, controlled, multi-site study to generate
evidence supporting payer coverage and reimbursement. These centers
are expected to enroll approximately 1,000 patients for a treatment
period of at least 12 months. Change in A1c and healthcare resource
utilization will be evaluated and compared to usual care. Study
results will be reported on a rolling basis as cohorts of 250
patients complete an incremental 90 days of treatment.
- LivVita Liver Study: Initiated first-ever clinical study
evaluating the feasibility of nCBT to reduce liver fat and improve
liver disease biomarkers as a potential treatment for NAFLD and
NASH. The study is being conducted in collaboration with Arizona
Liver Health, a leading liver clinical research center. This single
arm interventional cohort study is expected to enroll approximately
20 patients for a treatment period of 90 days. The primary endpoint
is the mean change in percent liver fat, as measured by Magnetic
Resonance Imaging Proton Density Fat Fraction (MRI-PDFF). The study
is expected to be completed in the third quarter of 2022.
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.
Treatment Guidelines and Reimbursement
- Evolution of Treatment Guidelines: The American Diabetes
Association (ADA) added a recommendation for using mobile apps and
digital solutions to facilitate behavior change in treating type 2
diabetes to its 2022 Standard of Care Guidelines (SOC). Upon
FDA-authorization, BT-001 has the potential to become the first
prescription digital therapeutic available to physicians for use in
the treatment of patients with diabetes.
- Coverage: The Centers for Medicare & Medicaid
Services (CMS) established a new Healthcare Common Procedure Coding
System (HCPCS) code to become effective in the second quarter of
2022, creating a new pathway for the reimbursement of PDTs. In
addition, the Access to Prescription Digital Therapeutics Act of
2022, was introduced and, if enacted, will expand Medicare coverage
to include PDTs as a benefit class.
Expected Upcoming Milestones
- Completion of BT-001 Pivotal Trial and De Novo
Submission: Secondary endpoint data following 180 days of
treatment are expected at the end of the second quarter of 2022. In
addition to the secondary endpoint which compares the mean change
in A1c between the treated group to the control group, exploratory
endpoints will include a comparison of the change in medications of
the two groups. With continued positive data, the company expects
to file a de novo classification request with the FDA in the third
quarter of 2022, seeking marketing authorization of BT-001 for the
treatment of patients with type 2 diabetes.
- Real World Evidence Study: Data are expected on the
first 250 patients to complete 90 days of treatment in the fourth
quarter of 2022.
- BT-002 and BT-003 Pivotal Trials: The company
will gather pilot data from the BT-001 study that will inform the
initiation of pivotal trials of BT-002 and BT-003 for the treatment
of hypertension and hyperlipidemia, respectively. Pending favorable
data and sufficient capital, these studies will commence as soon as
the first half of 2023.
- Key Opinion Leader (KOL) Webinar: The company will host
a key opinion leader webinar concurrent with the ADA annual meeting
being held June 3-7, 2022. The webinar will explain the use of nCBT
as a mechanism of action, the intersection of clinical intent,
behavioral science and designing software for behavior change. It
will then connect the dots and demonstrate how nCBT can fill the
gap in current standard of care guidelines. Participating KOL’s
will be announced at a later date.
Conference Call and Webcast
Better Therapeutics will host a conference call and webcast
today, May 13, 2022, at 8:30 a.m. ET to provide a business update.
The conference call may be accessed by dialing (833) 945-2463
(domestic) or (678) 825-8211 (international) and referring to
conference ID: 9776049. The live webcast may be accessed by
visiting the event link at:
https://edge.media-server.com/mmc/p/xqrnp5by. Following the
webcast, 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 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, the timing of and expectations regarding receipt
of marketing authorization and the commercial launch of BT-001,
expectations related to the potential benefits of BT-001 and nCBT
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
heading “Risk Factors” in 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,
available at the SEC’s website at www.sec.gov, and those that are
included in any of Better Therapeutics’ future filings with the
SEC. Should one or more of these risks or uncertainties
materialize, or should any of Better Therapeutics’ assumptions
prove incorrect, actual results may vary in material respects from
those projected in these forward-looking statements.
BETTER THERAPEUTICS,
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
March 31, 2022
December 31, 2021
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
31,673
$
40,566
Prepaid expenses
3,242
4,409
Other current assets
264
276
Total current assets
35,179
45,251
Capitalized software development costs,
net
4,526
5,077
Property and equipment, net
98
82
Other long-term assets
488
548
Total Assets
$
40,291
$
50,958
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
735
$
1,523
Accrued payroll
862
1,352
Other accrued expenses
1,666
1,858
Current portion of long-term debt
304
-
Total current liabilities
3,567
4,733
Long-term debt, net of current portion and
debt issuance costs
9,299
9,505
Total liabilities
12,866
14,238
Stockholders’ equity:
Common stock
2
2
Additional paid-in capital
108,828
108,461
Accumulated deficit
(81,405
)
(71,743
)
Total Stockholders’ Equity
27,425
36,720
Total Liabilities and Stockholders’
Equity
$
40,291
$
50,958
BETTER THERAPEUTICS,
INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share
and per share data)
(Unaudited)
Three Months Ended
March 31,
2022
2021
Operating Expenses:
Research and development
$
3,673
$
1,378
Sales and marketing
2,044
43
General and administrative
3,628
1,566
Total operating expenses
9,345
2,987
Loss from operations
(9,345
)
(2,987
)
Interest expense, net
(317
)
(2
)
Change in fair value of SAFEs
—
(2,492
)
Loss before benefit from income taxes
(9,662
)
(5,481
)
Benefit from income taxes
—
(151
)
Net loss
$
(9,662
)
$
(5,330
)
Cumulative preferred dividends allocated
to Series A Preferred Shareholders
—
(388
)
Net loss attributable to common
shareholders, basic and diluted
$
(9,662
)
$
(5,718
)
Net loss per share attributable to common
shareholders, basic and diluted
$
(0.41
)
$
(0.54
)
Weighted-average shares used in computing
net loss per share
23,413,213
10,684,920
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220513005104/en/
Investor Relations: Mark Heinen IR@bettertx.com
Media: Peter Duckler at Real Chemistry
pduckler@realchemistry.com
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