Obtained FDA Authorization for AspyreRxTM to
treat adults with type 2 diabetes
Established price and launch metrics in
preparation for expected launch in Q4
Completed financing transactions totaling $12.5
million in net proceeds
Company to host conference call and webcast
today at 4:30pm ET
Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in
developing prescription digital therapeutics to treat
cardiometabolic diseases, today reported financial results for the
second quarter 2023 and provided an update on progress towards
achieving key corporate milestones.
“Obtaining FDA authorization for AspyreRx was a pivotal
milestone for our company and a catalyst for strengthening our
financial position and advancing business development discussions,”
said Frank Karbe, Chief Executive Officer at Better Therapeutics.
“With a commercial release of AspyreRx anticipated later this year,
gaining broad payer coverage and building awareness amongst
targeted healthcare providers is a key priority for us.”
Second Quarter and Recent Business Highlights
- Announced FDA Authorization of AspyreRx: In July 2023,
Better Therapeutics announced that the U.S. Food and Drug
Administration (FDA) authorized AspyreRxTM (formerly BT-001), a
prescription-only digital therapeutic (PDT) treatment indicated to
provide cognitive behavioral therapy to patients 18 years or older
with type 2 diabetes (T2D). AspyreRx was reviewed through the FDA’s
De Novo pathway and its authorization creates a new class of
diabetes digital behavioral therapeutic devices.
- Set Price for AspyreRx: In July 2023, Better
Therapeutics completed final pricing research and set the Wholesale
Acquisition Cost (WAC), or list price, for AspyreRx at $750.00 for
a 90-day script. The Company also plans to offer the product on a
cash-pay basis at a discounted price, for a limited period of time,
to provide patients who are not covered by insurance at launch with
an affordable out-of-pocket option.
- Completed Multiple Financing Transactions: In April
2023, Better Therapeutics announced a private placement financing
for gross proceeds of approximately $6.5 million before deducting
offering expenses payable by the Company. In July 2023, Better
Therapeutics announced the completion of an additional $6.7 million
in net proceeds from multiple equity transactions. There was strong
participation in both financings from certain officers and
directors of the Company.
Expected Upcoming Milestones
- Commercial Launch of AspyreRx: AspyreRx is expected to
launch commercially in the fourth quarter of 2023. With FDA
authorization in hand, the Company is continuing to pursue payer
coverage as well as finalizing SAM registration, the System for
Award Management, a government-wide registry for vendors doing
business with the Federal government. Registration is followed by
negotiation for access via the Federal Supply Schedule.
- Complete Enrollment in BT-001 Real-world Evidence
Program: As of July 31st, 2023, Better Therapeutics has
enrolled approximately 90% of the target participant population in
its real-world evidence program and expects to complete enrollment
by the end of the third quarter. Pending sufficient power, the
Company expects to share the first dataset from these long-term
effectiveness studies in the fourth quarter of this year.
- Request Breakthrough Device Designation: Following the
successful completion of the LivVita Liver Study, Better
Therapeutics intends to submit a request to the FDA for
Breakthrough Device Designation for its investigational PDT in
non-alcoholic fatty liver disease (NAFLD) and non-alcoholic
steatohepatitis (NASH) by the end 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.
- 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, by the end
of this year.
Second Quarter 2023 Financial Results
Research and development expenses for the quarter ended
June 30, 2023 were $2.2 million, compared to $4.2 million for the
same period in 2022. The decrease was primarily due to a $1.0
million decrease in clinical study costs as a result of the
completion of the BT-001 pivotal trial in the third quarter of 2022
as well as a $0.7 million decline in personnel related costs as a
result of savings from the restructuring in the first quarter of
2023.
Sales and marketing expenses for the quarter ended June
30, 2023, were $1.7 million, compared to $1.7 million for the same
period in 2022. Personnel related costs increased $0.3 million as
we continue to prepare for the commercial launch of AspyreRx. This
was offset by $0.3 million in severance related costs in the prior
year.
General and administrative expenses for the quarter ended
June 30, 2023, were $3.1 million, compared to $3.7 million for the
same period in 2022. The decrease was primarily related to a
decrease in business insurance costs.
Interest expense, net for the quarter ended June 30,
2023, was $0.6 million, compared to $0.3 million for the same
period in 2022. The increase was primarily the result of higher
interest rates and 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 June 30, 2023 was $7.6
million, compared to $9.9 million for the same period in 2022. On a
per common share basis, net loss was $0.24 and $0.42 for the
quarter ended June 30, 2023 and 2022, respectively. The decline in
loss per share is related to a decline in net loss in the second
quarter of 2023 compared to the prior year as a result of savings
from the restructuring in the first quarter of 2023, and an
increase in weighted average shares outstanding.
Capital resources: Cash and cash equivalents were $6.2
million on June 30, 2023, compared to $15.7 million on December 31,
2022. In July 2023, the Company raised $6.7 million in net proceeds
from additional financings. The Company believes the proceeds from
the financings and the previously announced amendment to the
secured term loan agreement with Hercules Capital will extend its
runway into the fourth quarter.
Conference Call and Webcast
Better Therapeutics will host a conference call and webcast
today, August, 9, 2023, at 4:30 p.m. ET / 1:30 p.m. PT. To access
the conference call, please register at:
https://register.vevent.com/register/BI614fa4bfabc545808e507d9f77a536a6.
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/2drr9dwx. 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 AspyreRx
AspyreRx (fka BT-001) was granted marketing authorization by the
U.S. Food and Drug Administration (FDA) in July 2023 as the first
prescription-only digital behavioral therapeutic device delivering
a novel form of cognitive behavioral therapy (CBT) via smartphone
to treat adults with type 2 diabetes (T2D). AspyreRx is backed by
robust data demonstrating clinically meaningful and sustained
reduction in HbA1c as well as improvements in other markers of
cardiometabolic health when used up to 180 days. Using proven
techniques that target the underlying psychological, behavioral,
and cognitive factors that sustain or worsen T2D, AspyreRx is a
self-paced, engaging experience that patients can access
anytime/anywhere. It is prescribed by a healthcare provider in
90-day increments, with proprietary CBT delivered digitally in a
weekly step-by-step process. Through interactive therapy lessons,
skill-building modules, weekly goal setting and tracking, patients
connect changes in behavior to improvements in blood sugar and
other biometrics. Each step in the experience builds on the prior
to enable and reinforce cognitive restructuring, building the
emotional resilience and acceptance needed to make enduring
changes.
Indications for Use
AspyreRx is a prescription-only digital therapeutic device
intended to provide cognitive behavioral therapy to patients 18
years or older with type 2 diabetes. The device targets behavior to
aid in the management of type 2 diabetes in patients who are under
the care of a healthcare provider. AspyreRx provides cognitive
behavioral therapy as a treatment that should be used adjunctively
with standard of care.
About Better Therapeutics
Better Therapeutics is a prescription digital therapeutics
company developing a novel form of cognitive behavioral therapy to
address underlying factors that sustain or worsen 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 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 Better Therapeutics’ plans and expectations regarding FDA
submissions, plans related to the potential commercial launch of
AspyreRx (formerly BT-001) for the treatment of T2D, expectations
related to the efficacy and potential benefits of BT-001 and CBT
and their potential treatment applications, the timing of results
from, and Better Therapeutics’ plans for, its Real-world Evidence
Program, Better Therapeutics’ plans regarding the research and
advancement of its product candidates for additional treatments,
expectations related to pricing, research and its plans regarding
offering AspyreRx at a discounted price, Better Therapeutics’ plans
and expectations regarding the results of discussions with
healthcare providers and the interest of healthcare providers and
payers in PDTs, Better Therapeutics’ plans and expectations
regarding its financing and business developments strategy, and
statements related to its cash runway and long-term 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, for commercial distribution and insurance companies
to reimburse their use, market acceptance of PDTs, including
AspyreRx, 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 March 31, 2023
filed with the Securities and Exchange Commission (SEC) on May 11,
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)
June 30,
December 31,
2023
2022
ASSETS
(unaudited)
(audited)
Current assets:
Cash and cash equivalents
$
6,196
$
15,740
Prepaid expenses
1,166
2,496
Other current assets
60
210
Total current assets
7,422
18,446
Capitalized software development costs,
net
3,584
3,888
Property and equipment, net
115
121
Other long-term assets
483
488
Total Assets
$
11,604
$
22,943
LIABILITIES AND STOCKHOLDERS’
DEFICIT
Current liabilities:
Accounts payable
$
2,985
$
3,035
Accrued payroll
2,747
2,301
Other accrued expenses
2,448
3,626
Current portion of long-term debt
5,693
4,532
Total current liabilities
13,873
13,494
Long-term debt, net of current portion and
debt issuance costs
8,519
10,348
Total liabilities
22,392
23,842
Commitments and contingencies (Note 8)
Stockholders' deficit:
Common stock, $0.0001 par value per share,
200,000,000 shares authorized as of June 30, 2023 and December 31,
2022 and 31,797,101 and 23,851,022 shares issued and outstanding as
of June 30, 2023 and December 31, 2022, respectively
3
2
Additional paid-in capital
117,658
110,602
Accumulated deficit
(128,449
)
(111,503
)
Total Stockholders' Deficit
(10,788
)
(899
)
Total Liabilities and Stockholders’
Deficit
$
11,604
$
22,943
BETTER THERAPEUTICS,
INC.
CONDENSED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share
and per share data)
(Unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
2023
2022
2023
2022
Operating expenses:
Research and development
$
2,240
$
4,241
$
5,629
$
7,914
Sales and marketing
1,704
1,683
3,808
3,727
General and administrative
3,081
3,675
6,513
7,303
Total operating expenses
7,025
9,599
15,950
18,944
Loss from operations
(7,025
)
(9,599
)
(15,950
)
(18,944
)
Interest expense, net
(563
)
(329
)
(994
)
(646
)
Loss before provision for income taxes
(7,588
)
(9,928
)
(16,944
)
(19,590
)
Provision for income taxes
1
—
2
—
Net loss
$
(7,589
)
$
(9,928
)
$
(16,946
)
$
(19,590
)
Net loss per share, basic and diluted
$
(0.24
)
$
(0.42
)
$
(0.62
)
$
(0.83
)
Weighted-average shares used in computing
net loss per share
31,215,194
23,592,995
27,541,308
23,498,978
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230809311279/en/
Investor Relations: Mark Heinen IR@bettertx.com
Media Enquiries: Emma Williams
emma.williams@bettertx.com
Better Therapeutics (NASDAQ:BTTX)
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