U.S. FDA accepted the company’s submission of
its de novo request for BT-001 investigational prescription digital
therapy for type 2 diabetes in adults
BT-001 pivotal clinical trial 90-day results
published in peer-reviewed journal Diabetes Care
Appointed highly experienced healthcare
executive as Chief Commercial Officer
On track to report topline results from LivVita
study in fourth quarter of 2022
Company to host conference call and webcast
today at 4:30 p.m. ET
Better Therapeutics, Inc. (NASDAQ: BTTX), a prescription digital
therapeutics (PDT) company developing a novel form of cognitive
behavioral therapy (CBT) to address the root causes of
cardiometabolic diseases, today reported financial results for the
third quarter of 2022 and provided an update on progress toward
achieving key corporate milestones.
“Better Therapeutics continued its strong momentum in the third
quarter, with the completion of the BT-001 pivotal clinical trial
and acceptance of its de novo classification request to the U.S.
Food and Drug Administration seeking marketing authorization for
BT-001,” stated Frank Karbe, President and CEO of Better
Therapeutics. “We believe the publication of our trial results in a
leading peer-reviewed journal further highlights the quality of our
data and novelty of our approach as does the encouraging feedback
we have received from our payer interactions to date. Additionally,
we significantly advanced our financing discussions, and our team
is laser-focused on preparing for the potential launch of our
first-in-class prescription digital therapeutic for the treatment
of type 2 diabetes (T2D) in adults next year, if authorized by
FDA.”
Third Quarter and Recent Business Highlights
- Completed BT-001 Pivotal Clinical Trial: Better
Therapeutics reported positive secondary endpoint results from the
BT-001 pivotal trial in July, following the announcement of
positive primary endpoint results in March. The trial met both its
primary and secondary endpoints demonstrating statistically and
clinically meaningful reductions in A1c over the current standard
of care, even as control group patients increased use of blood
sugar lowering medications. The results achieved were sustainable
and improved between day 90 and day 180 of the trial, supporting
our belief that BT-001 has the potential to deliver meaningful,
durable improvements in blood sugar control for adults with T2D
already on standard of care blood sugar lowering medications.
- Submitted De Novo Request to U.S. Food and Drug
Administration (FDA) for BT-001: In October, our de novo
classification request, seeking marketing authorization of BT-001
for the treatment of adults with T2D, was accepted for substantive
review by the FDA. If authorized by the FDA, BT-001 would be the
first validated, prescription solution for delivering highly
scalable cognitive behavioral therapy to adults with T2D from a
digital device.
- Published BT-001 Pivotal Clinical Trial Results: The
encouraging 90-day results from the company’s pivotal clinical
trial of BT-001 in patients 18 years and older with T2D were
published in the American Diabetes Association-produced,
peer-reviewed journal Diabetes Care in October 2022.
- Presented BT-001 Pivotal Clinical Trial Results: The
pivotal trial results were presented by independent physician
experts to the medical community at the Society for Vascular
Medicine’s Annual Scientific Sessions as well as at a late breaking
featured science session at the American Heart Association’s annual
meeting in November 2022.
- Began Payer Coverage Discussions: Better Therapeutics
initiated its health economic models for BT-001 and began engaging
payers to share data from the BT-001 pivotal trial and inform its
approach to gaining coverage.
- Appointed Diane J. Gómez-Thinnes as Chief Commercial
Officer: Ms. Gómez-Thinnes brings more than two decades of
experience in the healthcare industry, leading the
commercialization and launch of prescription and consumer health
products for companies, including Johnson & Johnson and
Galderma.
Expected Upcoming Milestones
- LivVita Liver Study: Better Therapeutics is on track to
report topline results from the LivVita study in the fourth quarter
of 2022. The study is being conducted in collaboration with Arizona
Liver Health and is evaluating the feasibility of CBT to reduce
liver fat and improve liver disease biomarkers as a potential
treatment for nonalcoholic fatty liver disease (NAFLD) and
nonalcoholic steatohepatitis (NASH).
- Address Financing Needs: Better Therapeutics has
initiated a broad assessment of potential financing options. The
company expects to address its financing needs in the coming 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, which, if authorized by the FDA, is anticipated in
2023.
Third Quarter 2022 Financial Results
Research and development expenses for the quarter ended
September 30, 2022 were $5.5 million, compared to $6.7 million for
the same period in 2021. The decrease primarily reflects lower
clinical study costs as a result of the winddown of the clinical
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 an expansion of the company’s software
development capabilities.
Sales and marketing expenses for the quarter ended
September 30, 2022 were $1.6 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, if authorized by FDA.
General and administrative expenses for the quarter ended
September 30, 2022 were $4.0 million, compared to $1.8 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 business insurance.
Interest expense, net for the quarter ended September 30,
2022 was $0.4 million, compared to $0 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 September 30, 2022 was
$11.4 million, compared to $12.5 million for the same period in
2021. On a per common share basis, net loss was $0.48 and $1.20 for
the quarter ended September 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 deSPAC
transaction in the fourth quarter of 2021.
Capital resources: Cash and cash equivalents were $22.3
million on September 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, November 14, 2022, at 4:30 p.m. ET / 1:30 p.m. PT. To access
the conference call, please register at:
https://register.vevent.com/register/BI2c729f96a5894042b72aa89ac43ae0c8.
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/uritguso. 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, http://www.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). While in-person 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 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, nonalcoholic fatty liver disease, nonalcoholic
steatohepatitis, hypertension, hyperlipidemia and other
cardiometabolic conditions. By adapting the principles and
mechanisms of CBT, 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 treating
cardiometabolic 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 include, but are
not limited to, statements regarding the results of the completed
trial of BT-001 in patients with type 2 diabetes, Better
Therapeutics’ plans and expectations regarding FDA submissions and
the potential for marketing authorizations, 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 the interest of
healthcare providers and payers in PDTs 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 our 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.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share
and per share data)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2022
2021
2022
2021
Operating Expenses:
Research and development
$
5,477
$
6,667
$
13,391
$
13,082
Sales and marketing
1,557
552
5,284
1,159
General and administrative
3,962
1,776
11,265
4,215
Total operating expenses
10,996
8,995
29,940
18,456
Loss from operations
(10,996
)
(8,995
)
(29,940
)
(18,456
)
Interest expense, net
(406
)
—
(1,052
)
(3
)
Change in fair value of SAFEs
—
(3,466
)
—
(8,779
)
Gain on loan forgiveness
—
—
—
647
Loss before provision (benefit) from
income taxes
(11,402
)
(12,461
)
(30,992
)
(26,591
)
Provision (benefit) from income taxes
3
—
3
(150
)
Net loss
$
(11,405
)
$
(12,461
)
$
(30,995
)
$
(26,441
)
Cumulative preferred dividends allocated
to Series A Preferred Shareholders
—
(403
)
—
(1,185
)
Net loss attributable to common
shareholders, basic and diluted
$
(11,405
)
$
(12,864
)
$
(30,995
)
$
(27,626
)
Net loss per share attributable to common
shareholders, basic and diluted
$
(0.48
)
$
(1.20
)
$
(1.32
)
$
(2.58
)
Weighted-average shares used in computing
net loss per share
23,693,154
10,752,790
23,533,290
10,723,091
BETTER THERAPEUTICS,
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
(unaudited)
September 30,
(audited)
December 31,
2022
2021
ASSETS
Current assets:
Cash and cash equivalents
$
22,305
$
40,566
Prepaid expenses
1,123
4,409
Other current assets
62
276
Total current assets
23,490
45,251
Capitalized software development costs,
net
4,121
5,077
Property and equipment, net
122
82
Other long-term assets
488
548
Total Assets
$
28,221
$
50,958
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable
$
1,255
$
1,523
Accrued payroll
2,477
1,352
Other accrued expenses
2,451
1,858
Current portion of long-term debt
3,129
-
Total current liabilities
9,312
4,733
Long-term debt, net of current portion and
debt issuance costs
11,657
9,505
Total liabilities
20,969
14,238
Stockholders’ equity:
Common stock
2
2
Additional paid-in capital
109,988
108,461
Accumulated deficit
(102,738
)
(71,743
)
Total Stockholders’ Equity
7,252
36,720
Total Liabilities and Stockholders’
Equity
$
28,221
$
50,958
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221114005259/en/
Investor Relations: Mark Heinen IR@bettertx.com
Media: Ryan McKenna at Real Chemistry
rmckenna@realchemistry.com
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