On track for an FDA decision mid-year
Announced restructuring to extend cash
runway
Completed private placement financing
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 first quarter 2023 and provided an update
on progress toward achieving key corporate milestones.
“We successfully navigated several challenges in the first
quarter of this year, laying the foundations for long-term success.
The reduction in force, coupled with the completion of a private
placement financing, extended our cash runway sufficiently to reach
multiple significant milestones,” stated Frank Karbe, President and
CEO of Better Therapeutics. “We look forward to a decision from the
FDA on our de novo submission within the next 90 days and remain
focused on preparing for the potential commercial launch of BT-001
in type 2 diabetes.”
First Quarter and Recent Business Highlights
- Responded to FDA’s Request for Information: In February
2023, Better Therapeutics received a Request for Additional
Information from the U.S. Food and Drug Administration (FDA)
related to its de novo submission for BT-001, which is an expected
part of the review process. The Company responded to the Request
for Additional Information on April 17, 2023 and the FDA confirmed
its review is progressing. If authorized by the FDA, BT-001 would
be the first and only PDT delivering highly scalable CBT to adults
with type 2 diabetes (T2D) from a digital device.
- Executives with Extensive Diabetes Experience Join Team:
In March 2023, Better Therapeutics hired Chip Amrein as Head of
Marketing, bringing with him two decades of experience in diabetes,
most recently with Novo Nordisk. Elizabeth Pash, PhD, RDN, an
accomplished leader with decades of cardiometabolic disease
experience with Abbott and Medtronic, also joined Better
Therapeutics as Head of Medical Affairs, bringing deep clinical
insight and product launch experience to the commercial
organization.
- Announced Restructuring to Extend Runway Through Multiple
Milestones: In March 2023, Better Therapeutics implemented a
reduction in force impacting approximately 35% of the workforce.
The Company also implemented other cost savings measures to further
extend its cash runway.
- Completed $6.5 million Private Placement: In April 2023,
Better Therapeutics announced a private placement of 7,878,786
shares of the Company’s common stock at a price of $0.825 per
share, which was the closing price of the Company’s common stock on
the Nasdaq Capital Market on April 5, 2023, for gross proceeds of
approximately $6.5 million before deducting offering expenses
payable by the Company. There was strong participation in the
transaction from certain officers and directors of the
Company.
Expected Upcoming Milestones
- Potential FDA Authorization and Commercial Launch of
BT-001: Better Therapeutics continues to expect the FDA’s
decision on the Company’s de novo submission for marketing
authorization of BT-001 by the middle of the year and is
anticipating a commercial launch within a few months following such
decision if the FDA approves the submission. Additional upcoming
milestones include the submission of health economic data for peer
review and publication.
- 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
non-alcoholic fatty liver disease (NAFLD) and non-alcoholic
steatohepatitis (NASH), and now expects to submit the application
in the third quarter 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 the Company believes that a
prescription treatment option could be of significant benefit to
millions of patients.
- Complete Enrollment in BT-001 Real-world Evidence
Program: Better Therapeutics reported almost 75% of the target
participant population has been enrolled in its real-world evidence
program and expects to complete enrollment by the end of the third
quarter. Following this milestone, the Company expects to share the
first dataset from these long-term effectiveness studies in the
fourth quarter of this year.
- Further Strengthen Financial Position: Better
Therapeutics expects to deliver on multiple elements of its
financing strategy to further enhance its financial position,
including a potential business development partnership and / or
royalty monetization transaction.
First Quarter 2023 Financial Results
Research and development expenses for the quarter ended
March 31, 2023 were $3.4 million, compared to $3.7 million for the
same period in 2022. The decrease was primarily due to an increase
in capitalized software development costs, offset by a decrease in
clinical study costs.
Sales and marketing expenses for the quarter ended March
31, 2023 were $2.1 million, compared to $2.0 million for the same
period in 2022. The increase was primarily related to higher
personnel related costs associated with commercial readiness
activities, partially offset by slightly lower real world evidence
study related expenses.
General and administrative expenses for the quarter ended
March 31, 2023 were $3.4 million, compared to $3.6 million for the
same period in 2022. The decrease was primarily related to a
decrease in business insurance costs, offset somewhat by an
increase in personnel and related costs.
Interest expense, net for the quarter ended March 31,
2023 was $0.4 million, compared to $0.3 million for the same period
in 2022. The increase was primarily the result of an additional
$5.0 million borrowed under the Company’s secured term loan
agreement with Hercules Capital in the second quarter of 2022.
Net loss for the quarter ended March 31, 2023 was $9.4
million, compared to $9.7 million for the same period in 2022. On a
per common share basis, net loss was $0.39 and $0.41 for the
quarter ended March 31, 2023 and 2022, respectively. The decline in
loss per share is primarily related to an increase in weighted
average shares outstanding and a decline in net loss.
Capital resources: Cash and cash equivalents were $6.1
million on March 31, 2023, compared to $15.7 million on December
31, 2022. In April 2023, the Company completed a private placement
of 7,878,786 shares of common stock for gross proceeds of
approximately $6.5 million, before deducting offering expenses
payable by the Company. In addition, the Company amended its
secured term loan agreement with Hercules Capital in April 2023,
which provides for a delay in principal payments for up to six
months. The Company believes the proceeds from the private
placement combined with the amendment to the secured term loan
agreement with Hercules Capital and the previously announced cost
savings initiative will allow it to meet several key milestones
included in its financing strategy.
Conference Call and Webcast
Better Therapeutics will host a conference call and webcast
today, May 11, 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/BI5d9690c447df48b2b930b971560acd4f.
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/khcj9g2y. A replay of the
webcast may be accessed from the Presentations & Events page in
the Investors section of the Better Therapeutics corporate website
at: https://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 cash runway 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’
annual report on Form 10-K for the year ended December 31, 2022
filed with the Securities and Exchange Commission (SEC) on March
30, 2023, and those that are included in any of Better
Therapeutics’ subsequent filings with the SEC.
BETTER THERAPEUTICS,
INC.
CONDENSED BALANCE
SHEETS
(in thousands, except share
data)
March 31,
December 31,
2023
2022
ASSETS
(unaudited)
(audited)
Current assets:
Cash and cash equivalents
$
6,068
$
15,740
Prepaid expenses
1,968
2,496
Other current assets
406
210
Total current assets
8,442
18,446
Capitalized software development costs,
net
3,752
3,888
Property and equipment, net
131
121
Other long-term assets
483
488
Total Assets
$
12,808
$
22,943
LIABILITIES AND STOCKHOLDERS’
DEFICIT
Current liabilities:
Accounts payable
$
2,513
$
3,035
Accrued payroll
3,078
2,301
Other accrued expenses
2,510
3,626
Current portion of long-term debt
5,539
4,532
Total current liabilities
13,640
13,494
Long-term debt, net of current portion and
debt issuance costs
9,001
10,348
Total liabilities
22,641
23,842
Commitments and contingencies
Stockholders' deficit:
Common stock
2
2
Additional paid-in capital
111,025
110,602
Accumulated deficit
(120,860
)
(111,503
)
Total Stockholders' Deficit
(9,833
)
(899
)
Total Liabilities and Stockholders’
Deficit
$
12,808
$
22,943
BETTER THERAPEUTICS,
INC.
CONDENSED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share
and per share data)
(Unaudited)
Three Months Ended
March 31,
2023
2022
Operating expenses:
Research and development
$
3,389
$
3,673
Sales and marketing
2,104
2,044
General and administrative
3,432
3,628
Total operating expenses
8,925
9,345
Loss from operations
(8,925
)
(9,345
)
Interest expense, net
(431
)
(317
)
Loss before provision for income taxes
(9,356
)
(9,662
)
Provision for income taxes
1
—
Net loss
$
(9,357
)
$
(9,662
)
Net loss per share, basic and diluted
$
(0.39
)
$
(0.41
)
Weighted-average shares used in computing
net loss per share
23,826,594
23,413,213
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230511005385/en/
Investor Relations: Mark Heinen IR@bettertx.com
Media Enquiries: Emma Williams
emma.williams@bettertx.com
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