Advanced preparations for potential commercial
launch of BT-001 in U.S. in mid-2023
Reported positive topline results from
exploratory trial for fatty liver disease
Announced restructuring and other cost saving
actions to extend financial runway
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 a clinically validated,
software-based, novel form of cognitive behavioral therapy (CBT) to
address the root causes of cardiometabolic diseases, today reported
financial results for the fourth quarter and full year of 2022 and
provided an update on progress toward achieving key corporate
milestones.
“Better Therapeutics made significant progress in 2022
highlighted by the successful completion of our pivotal clinical
trial of BT-001 in type 2 diabetes, the submission of our de novo
classification request to the FDA seeking marketing authorization
for BT-001 and the positive topline results from our exploratory
trial for fatty liver disease,” stated Frank Karbe, President and
CEO of Better Therapeutics. “Despite our recent restructuring, the
long-term outlook for the potential of our digital therapeutics’
platform and our guidance for potential FDA authorization remains
unchanged, and we continue to prepare for commercial launch.”
Fourth Quarter and Recent Business Highlights
- U.S. Food and Drug Administration (FDA) Accepted De Novo
Request for BT-001: In October 2022, Better Therapeutics’ de
novo classification request seeking marketing authorization of
BT-001 for the treatment of adults with type 2 diabetes (T2D) was
accepted for substantive review by the FDA. In February 2023,
Better Therapeutics received a Request for Additional Information
from the FDA, as expected, and is working to address the FDA’s
questions. If authorized by the FDA, BT-001 would be the first
prescription solution intended to deliver highly scalable CBT to
adults with T2D from a digital device.
- Publication of BT-001 Pivotal Clinical Trial Results: In
October 2022, results from Better Therapeutics’ pivotal clinical
trial of BT-001 in adult patients with T2D were published in the
American Diabetes Association-produced, peer-reviewed journal
Diabetes Care. Data was also presented at the American Heart
Association and in March 2023 it was presented at the American
College of Cardiology.
- Reported Positive Topline Results from Exploratory Trial for
Fatty Liver Disease: In December 2022, Better Therapeutics
completed and reported positive results from a pilot study (the
LivVita Liver Study) evaluating the feasibility of using a PDT to
reduce fatty liver and improve liver disease biomarkers in
Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic
Steatohepatitis (NASH). The LivVita Liver Study met its primary
endpoint, showing a statistically significant positive signal with
an average relative reduction in Magnetic Resonance Imaging –
Proton Density Fat Fraction (MRI-PDFF) of 16% (p=0.01) in the
intent-to-treat population (N=19).
- Company Announces Restructuring To Preserve Cash Runway:
In March 2023, Better Therapeutics announced it would implement a
reduction in force impacting 35% of the workforce. The company is
also implementing other cost savings measures to further extend its
financial runway.
Expected Upcoming Milestones
- Apply for Breakthrough Device Designation: Following the
successful completion of the LivVita Liver Study, Better
Therapeutics commenced work on an application to the FDA for
Breakthrough Device Designation for its investigational PDT in
NAFLD and NASH and is expected to submit the application in the
first half 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 having a prescription treatment option
could be of significant benefit to millions of patients.
- Potential FDA Authorization and Commercial Launch of
BT-001: Better Therapeutics is diligently advancing its
preparations for the potential commercial launch of BT-001 in
mid-2023. Upcoming milestones in market access include the
submission of health economic outcomes research (HEOR) for
publication and commencing pre-authorization information exchange
meetings with Payers beginning in April.
- First Dataset from BT-001 Real-World Evidence Program:
This randomized, controlled, multi-site program is designed to
generate real-world evidence to provide payers and providers with
long-term data related to usage and outcomes in a real-world
setting. Interim study results are expected to be reported in the
fourth quarter of 2023.
Fourth Quarter and Full Year 2022 Financial Results
Research and development expenses for the quarter ended
December 31, 2022 were $3.0 million, compared to $6.4 million for
the same period in 2021. The decrease primarily reflects a $1.8
million decrease in clinical study costs as a result of the
completion of the BT-001 clinical trial in the third quarter of
2022 and a $1.6 million decrease in incentive compensation expense
compared to the prior year. Research and development expenses for
the year ended December 31, 2022 were $16.4 million, compared to
$19.4 million for the same period in 2021. The decrease was
primarily due to a $6.4 million decrease in clinical trial costs as
the Company completed the BT-001 clinical trial, offset by a $2.5
million increase in personnel related costs related to expanding
the Company’s software development capabilities and $0.8 million
increase in capitalized software amortization.
Sales and marketing expenses for the quarter ended
December 31, 2022 were $1.7 million, compared to $1.2 million for
the same period in 2021. The increase in sales and marketing
expenses was primarily related to an increase of $0.3 million in
personnel related costs and a $0.2 million increase in consulting
expenses associated with commercial readiness activities to support
the potential launch of BT-001, if authorized by the FDA. Sales and
marketing expenses for the year ended December 31, 2022 were $7.0
million, compared to $2.3 million for the same period in 2021. The
increase in sales and marketing expenses was primarily related to
an increase of $1.2 million in personnel related costs and a $3.4
million increase in consulting expenses associated with commercial
readiness activities to support the potential launch of BT-001, if
authorized by the FDA.
General and administrative expenses for the quarter ended
December 31, 2022 were $3.6 million, compared to $4.6 million for
the same period in 2021. The decrease was primarily related to
lower incentive compensation expenses compared to the prior year.
General and administrative expenses for the year ended December 31,
2022 were $14.8 million, compared to $8.8 million for the same
period in 2021. The overall increase in general and administrative
expenses was primarily related to the increased costs of being a
public company, including $3.4 million in business insurance, $1.6
million in personnel related costs and $1.6 million in outside
services, including consulting, audit, and legal fees.
Interest expense, net for the quarter ended December 31,
2022 was $0.4 million, compared to $0.2 million for the same period
in 2021. Interest expense, net for the year ended December 31, 2022
was $1.5 million, compared to $0.2 million for the same period in
2021. The increase 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 quarter ended December 31, 2022 was $8.8
million, compared to $13.9 million for the same period in 2021. On
a per common share basis, net loss was $0.37 and $0.71 for the
quarter ended December 31, 2022 and 2021, respectively. Net loss
for the year ended December 31, 2022 was $39.8 million, compared to
$40.3 million for the same period in 2021. On a per common share
basis, net loss was $1.69 and $3.11 for the year ended December 31,
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 Company’s business combination in
the fourth quarter of 2021.
Capital resources: Cash and cash equivalents were $15.7
million on December 31, 2022, compared to $40.6 million on December
31, 2021. As a result of the restructuring and other cost savings
initiatives, we expect operating cash burn for 2023 to be lower
than previously forecasted by approximately $10 million. The
company is actively seeking additional sources of capital to extend
its runway.
Conference Call and Webcast
Better Therapeutics will host a conference call and webcast
today, March 30, 2023, at 8:30 a.m. ET / 5:30 a.m. PT. To access
the conference call, please register at:
https://register.vevent.com/register/BI24e91f91597f4f97a40e32c908ac7be5.
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/cmdsh8s3. 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.
Available Information
Better Therapeutics periodically provides other information for
investors on its corporate website, http://www.bettertx.com, and
its investor relations website, https://investors.bettertx.com.
This includes press releases and other information about financial
performance, information on corporate governance, and details
related to its annual meeting of stockholders. Better Therapeutics
intends to use its website as a means of disclosing material
non-public information and for complying with its disclosure
obligations under Regulation FD. Accordingly, investors should
monitor Better Therapeutics’ website, in addition to following its
press releases, SEC filings, and public conference calls and
webcasts.
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 has been used for T2D and other
cardiometabolic conditions before, but until now the approach has
not been scalable due to the need to deliver the therapy in-person
via a therapist. If authorized by the FDA, BT-001 would be the
first prescription solution for delivering this therapeutic
approach to T2D patients at scale from their digital devices.
About the Better Therapeutics CBT Platform
Better Therapeutics’ investigational digital therapeutic
platform is designed to deliver a novel form of CBT to help people
with cardiometabolic diseases potentially improve key measures
related to T2D, NAFLD, NASH, hypertension, hyperlipidemia and other
cardiometabolic conditions. By adapting the principles and
mechanisms of CBT, Better Therapeutics’ 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
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 T2D, 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 and related
comments in our earnings conference call 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 and in our earning
conference call include, but are not limited to, statements
regarding Better Therapeutics’ plans and expectations regarding FDA
submissions, including its application for Breakthrough Device
designation for its investigational prescription digital therapy in
NAFLD and NASH, plans and expectations related to potential
marketing authorizations and the timing of and plans related to the
potential commercial launch of BT-001 for the treatment of T2D, if
authorized by the FDA, Better Therapeutics’ plans and expectations
regarding its real world evidence program for BT-001, including the
timing of results, expectations related to the efficacy and
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 pricing research and results and the
interest of healthcare providers and payers in PDTs, Better
Therapeutics’ plans regarding publications, statements related to
its financial outlook and expectations and statements regarding its
financing needs, plans and expectations, 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 interpreted
favorably by the FDA or repeated or observed in ongoing or future
studies involving Better Therapeutics’ product candidates and other
risks and uncertainties included under the header “Risk Factors” in
Better Therapeutics’ quarterly report on Form 10-Q for the quarter
ended September 30, 2022 filed with the Securities and Exchange
Commission (SEC) on November 14, 2022, and those that are included
in any of Better Therapeutics’ subsequent filings with the SEC.
BETTER THERAPEUTICS,
INC.
STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
(in thousands, except share
and per share data)
(unaudited)
Three Months Ended
December 31,
Year Ended
December 31,
2022
2021
2022
2021
Operating Expenses:
Research and development
$
3,049
$
6,354
$
16,440
$
19,436
Sales and marketing
1,695
1,177
6,979
2,336
General and administrative
3,578
4,573
14,843
8,788
Total operating expenses
8,322
12,104
38,262
30,560
Loss from operations
(8,322
)
(12,104
)
(38,262
)
(30,560
)
Interest expense, net
(439
)
(182
)
(1,491
)
(185
)
Change in fair value of SAFEs
—
(1,611
)
—
(10,390
)
Gain on loan forgiveness
—
—
—
647
Loss before provision (benefit) from
income taxes
(8,761
)
(13,897
)
(39,753
)
(40,488
)
Provision (benefit) from income taxes
4
(3
)
7
(153
)
Net loss
$
(8,765
)
$
(13,894
)
$
(39,760
)
$
(40,335
)
Net loss per share attributable to common
shareholders, basic and diluted
$
(0.37
)
$
(0.71
)
$
(1.69
)
$
(3.11
)
Weighted-average shares used in computing
net loss per share
23,745,700
19,68,940
23,557,846
12,982,472
BETTER THERAPEUTICS,
INC.
BALANCE SHEETS
(in thousands)
Unaudited
December 31,
Audited
December 31,
2022
2021
ASSETS
Current assets:
Cash and cash equivalents
$
15,740
$
40,566
Prepaid expenses
2,496
4,409
Other current assets
210
276
Total current assets
18,446
45,251
Capitalized software development costs,
net
3,888
5,077
Property and equipment, net
121
82
Other long-term assets
488
548
Total Assets
$
22,943
$
50,958
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
3,035
$
1,523
Accrued payroll
2,301
1,352
Other accrued expenses
3,626
1,858
Current portion of long-term debt
4,532
-
Total current liabilities
13,494
4,733
Long-term debt, net of current portion and
debt issuance costs
10,348
9,505
Total liabilities
23,842
14,238
Stockholders’ equity:
Common stock
2
2
Additional paid-in capital
110,602
108,461
Accumulated deficit
(111,503
)
(71,743
)
Total Stockholders’ Equity
(899
)
36,720
Total Liabilities and Stockholders’
Equity
$
22,943
$
50,958
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230330005285/en/
Investor Relations: Mark Heinen IR@bettertx.com
Media Enquiries: Emma Williams
emma.williams@bettertx.com
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