Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a
company pioneering targeted therapeutics that selectively activate
the Wnt pathway for tissue repair and regeneration, today provided
second quarter 2023 financial results and corporate and pipeline
updates.
“During the second quarter of 2023, we made important progress
in the Phase 1a clinical trials for our lead candidates, SZN-043
and SZN-1326,” said Craig Parker, President and Chief Executive
Officer of Surrozen. “Continued corporate prioritization activities
in 2023 are targeted to deliver proof-of-concept data on our two
clinical development candidates in the second half of 2024. We
remain focused on clinical validation of our innovative
technologies for Wnt pathway modulation to deliver high-value
therapies to people with severe diseases.”
Research and Development Pipeline Updates
SZN-043
- Enrollment in the Phase 1a clinical trial continues in patients
with chronic liver disease and healthy volunteers
- Expect safety data by the end of 2023
- Expect to initiate a Phase 1b clinical trial in patients with
alcoholic hepatitis in 2024 and anticipate proof of concept data
will potentially be available in the second half of 2024
SZN-1326
- Enrollment in the Phase 1a clinical trial continues in healthy
volunteers
- Expect safety data by the end of 2023
- Expect to initiate a Phase 1b clinical trial in 2024 in
patients with ulcerative colitis and anticipate proof of concept
data will potentially be available in the second half of 2024
Corporate Updates
Corporate Prioritization Activities
In July 2023, Surrozen implemented a plan to further prioritize
and focus resources on the development of the clinical programs for
SZN-043 and SZN-1326 which is expected to extend the cash runway
into 2025.
Corporate Partnerships
Surrozen executed a partnership with Boehringer Ingelheim in the
fourth quarter of 2022 to develop a Wnt agonist, SZN-413, for the
treatment of people with retinal diseases. We anticipate the
potential to nominate the lead Fzd-4 targeted Wnt agonist
development candidate in 2024, which would trigger a $10.0 million
milestone payment to the Company.
Financial Results for the Second Quarter Ended June 30,
2023
Cash Position: Cash, cash equivalents and
marketable securities for the second quarter ended June 30, 2023
were $53.4 million, compared to $61.7 million as of March 31,
2023.
Research and Development Expenses: Research and
development expenses for the second quarter ended June 30, 2023
were $6.9 million, as compared to $9.6 million for the same period
in 2022. The decrease was primarily as a result of the
restructuring plan implemented in the first quarter of 2023 to
prioritize and focus our resources on key clinical and discovery
programs. Research and development expenses include non-cash
stock-based compensation expenses of $0.3 million for the second
quarter ended June 30, 2023, as compared to $0.4 million for the
same period in 2022.
General and Administrative Expenses: General
and administrative expenses for the second quarter ended June 30,
2023 were $3.3 million, as compared to $4.5 million for the same
period in 2022. The decrease was primarily related to the employee
retention tax credits received in 2023. General and administrative
expenses include non-cash stock-based compensation expenses of $0.8
million for the second quarter ended June 30, 2023, as compared to
$0.6 million for the same period in 2022.
Interest Income: Interest income for the second
quarter ended June 30, 2023 was $0.6 million, as compared to $0.1
million for the same period in 2022. The increase was primarily
related to the increase in interest rates on money market funds and
marketable securities.
Other Income (Expense), Net: Other income
(expense), net for the second quarter ended June 30, 2023 was a net
other income of $0.3 million, as compared to $0.1 million for the
same period in 2022. The increase was primarily due to a decrease
in expense related to the commitment shares issued under an equity
purchase agreement entered into in 2022.
Net Loss: Net loss for the second quarter ended
June 30, 2023 was $9.4 million, as compared to $13.9 million for
the same period in 2022.
About SZN-043 for Severe Alcoholic
HepatitisSZN-043 is the first development candidate using
Surrozen’s SWEETS™ technology. Surrozen is developing SZN-043 for
severe liver diseases, initially focusing on severe alcoholic
hepatitis. The company is enrolling patients in a Phase 1a clinical
trial in patients with chronic liver disease and healthy
volunteers. The Phase 1a clinical trial is ongoing and the company
expects safety data by the end of 2023. Surrozen expects to
initiate a Phase 1b clinical trial in patients with alcoholic
hepatitis in 2024 and anticipates proof of concept data could
potentially be available in the second half of 2024.
About SZN-1326 for Ulcerative ColitisSZN-1326
is the first development candidate designed using Surrozen’s SWAP™
technology and targets the Wnt-signaling pathway in the intestinal
epithelium. Surrozen is initially developing SZN-1326 for moderate
to severe ulcerative colitis. Enrollment is ongoing in the Phase 1a
clinical trial in healthy volunteers. Surrozen expects safety data
from the Phase 1a clinical trial in healthy volunteers by the end
of 2023. Surrozen also expects to initiate a Phase 1b clinical
trial in patients with ulcerative colitis in 2024 and anticipates
proof-of-concept data will potentially be available in the second
half of 2024.
About SZN-413 for Retinal DiseasesSZN-413 is a
bi-specific antibody targeting Fzd4-mediated Wnt signaling designed
using Surrozen’s SWAP™ technology. It is currently being developed
for the treatment of retinal vascular-associated diseases. Data
generated by Surrozen with SZN-413 in preclinical models of
retinopathy demonstrated that SZN-413 could potently stimulate Wnt
signaling in the eye, induce normal retinal vessel regrowth,
suppress pathological vessel growth and reduce vascular leakage.
This novel approach could thus potentially allow for regeneration
of healthy eye tissue, not only halting retinopathy, but possibly
allowing for a full reversal of the patient’s disease.
In the fourth quarter of 2022, Surrozen entered into a strategic
partnership with Boehringer Ingelheim for the research and
development of SZN-413 for the treatment of retinal diseases. Under
the terms of the agreement, Boehringer Ingelheim received an
exclusive, worldwide license to develop SZN-413 and other
Fzd4-specific Wnt-modulating molecules for all purposes, including
as a treatment for retinal diseases, in exchange for an upfront
payment to Surrozen of $12.5 million. Surrozen will also be
eligible to receive up to $587.0 million in success-based
development, regulatory, and commercial milestone payments, in
addition to mid-single digit to low-double digit royalties on
sales. After an initial period of joint research, Boehringer
Ingelheim will assume all development and commercial
responsibilities.
About Wnt SignalingWnt signaling plays key
roles in the control of development, homeostasis, and regeneration
of many essential organs and tissues, including liver, intestine,
lung, kidney, retina, central nervous system, cochlea, bone, and
others. Modulation of Wnt signaling pathways has potential for
treatment of degenerative diseases and tissue injuries. Surrozen’s
platform and proprietary technologies have the potential to
overcome the limitations in pursuing the Wnt pathway as a
therapeutic strategy.
About SurrozenSurrozen is a clinical stage
biotechnology company discovering and developing drug candidates to
selectively modulate the Wnt pathway. Surrozen is developing
tissue-specific antibodies designed to engage the body’s existing
biological repair mechanisms with a current focus on inflammatory
bowel, severe liver and eye diseases. For more information, please
visit www.surrozen.com.
Forward-Looking Statements
This press release contains certain forward-looking statements
within the meaning of the federal securities laws. Forward-looking
statements generally are accompanied by words such as “will,”
“plan,” “intend,” “potential,” “expect,” “could,” or the negative
of these words and similar expressions that predict or indicate
future events or trends or that are not statements of historical
matters. These forward-looking statements include, but are not
limited to, statements regarding Surrozen’s discovery, research and
development activities, in particular its development plans for its
product candidates SZN-1326, SZN-043, and SZN-413 (including
anticipated clinical development timelines and the availability of
data, the potential for such product candidates to be used to treat
human disease), the potential and timeline to nominate the lead
development candidate pursuant to its partnership with Boehringer
Ingelheim and its expectations with respect to its cash runway.
These statements are based on various assumptions, whether or not
identified in this press release, and on the current expectations
of the management of Surrozen and are not predictions of actual
performance. These forward-looking statements are provided for
illustrative purposes only and are not intended to serve as, and
must not be relied on as, a guarantee, an assurance, a prediction,
or a definitive statement of fact or probability. Actual events and
circumstances are difficult or impossible to predict and will
differ from assumptions. Many actual events and circumstances are
beyond the control of Surrozen. These forward-looking statements
are subject to a number of risks and uncertainties, including the
initiation, cost, timing, progress and results of research and
development activities, preclinical or and clinical trials with
respect to SZN-1326, SZN-043, SZN-413 and potential future drug
candidates; the Company’s ability to fund its preclinical and
clinical trials and development efforts, whether with existing
funds or through additional fundraising; Surrozen’s ability to
identify, develop and commercialize drug candidates; Surrozen’s
ability to successfully complete preclinical and clinical studies
for SZN-1326, SZN-043, SZN-413, or other future product candidates;
the effects that arise from volatility in global economic,
political, regulatory and market conditions; and all other factors
discussed in Surrozen’s Annual Report on Form 10-K for the year
ended December 31, 2022 and Surrozen’s Quarterly Report on Form
10-Q for the quarter ended June 30, 2023 under the heading “Risk
Factors,” and other documents Surrozen has filed, or will file,
with the Securities and Exchange Commission. If any of these risks
materialize or our assumptions prove incorrect, actual results
could differ materially from the results implied by these
forward-looking statements. There may be additional risks that
Surrozen presently does not know, or that Surrozen currently
believes are immaterial, that could also cause actual results to
differ from those contained in the forward-looking statements. In
addition, forward-looking statements reflect Surrozen’s
expectations, plans, or forecasts of future events and views as of
the date of this press release. Surrozen anticipates that
subsequent events and developments will cause its assessments to
change. However, while Surrozen may elect to update these
forward-looking statements at some point in the future, Surrozen
specifically disclaims any obligation to do so, except as required
by law. These forward-looking statements should not be relied upon
as representing Surrozen’s assessments of any date after the date
of this press release. Accordingly, undue reliance should not be
placed upon the forward-looking statements.
Investor and Media
Contact:Investorinfo@surrozen.com
SURROZEN, INC.Condensed Consolidated Statements of
Operations(In thousands, except per share
amounts)(Unaudited) |
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
6,937 |
|
|
$ |
9,581 |
|
|
$ |
15,023 |
|
|
$ |
18,952 |
|
General and administrative |
|
|
3,338 |
|
|
|
4,491 |
|
|
|
8,637 |
|
|
|
9,613 |
|
Restructuring |
|
|
— |
|
|
|
— |
|
|
|
1,207 |
|
|
|
— |
|
Total operating expenses |
|
|
10,275 |
|
|
|
14,072 |
|
|
|
24,867 |
|
|
|
28,565 |
|
Loss from operations |
|
|
(10,275 |
) |
|
|
(14,072 |
) |
|
|
(24,867 |
) |
|
|
(28,565 |
) |
Interest income |
|
|
623 |
|
|
|
60 |
|
|
|
1,170 |
|
|
|
109 |
|
Other income (expense),
net |
|
|
265 |
|
|
|
87 |
|
|
|
13 |
|
|
|
6,584 |
|
Net loss |
|
$ |
(9,387 |
) |
|
$ |
(13,925 |
) |
|
$ |
(23,684 |
) |
|
$ |
(21,872 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.31 |
) |
|
$ |
(0.40 |
) |
|
$ |
(0.79 |
) |
|
$ |
(0.63 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used
in computing net loss per share attributable to common
stockholders, basic and diluted |
|
|
30,073 |
|
|
|
34,945 |
|
|
|
30,022 |
|
|
|
34,904 |
|
SURROZEN, INC.Condensed Consolidated Balance
Sheets(In thousands) |
|
|
June 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022(1) |
|
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
36,496 |
|
|
$ |
24,690 |
|
Accounts receivable |
|
|
1,978 |
|
|
|
1,978 |
|
Short-term marketable securities |
|
|
16,899 |
|
|
|
51,148 |
|
Prepaid expenses and other current assets |
|
|
2,206 |
|
|
|
3,489 |
|
Total current assets |
|
|
57,579 |
|
|
|
81,305 |
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
2,966 |
|
|
|
3,630 |
|
Operating lease right-of-use
assets |
|
|
2,655 |
|
|
|
3,268 |
|
Restricted cash |
|
|
405 |
|
|
|
405 |
|
Other assets |
|
|
394 |
|
|
|
827 |
|
Total assets |
|
$ |
63,999 |
|
|
$ |
89,435 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
186 |
|
|
$ |
658 |
|
Accrued and other liabilities |
|
|
3,901 |
|
|
|
6,848 |
|
Lease liabilities, current portion |
|
|
2,364 |
|
|
|
2,226 |
|
Total current liabilities |
|
|
6,451 |
|
|
|
9,732 |
|
|
|
|
|
|
|
|
Lease liabilities, noncurrent
portion |
|
|
2,164 |
|
|
|
3,376 |
|
Warrant liabilities |
|
|
326 |
|
|
|
326 |
|
Total liabilities |
|
|
8,941 |
|
|
|
13,434 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
3 |
|
|
|
3 |
|
Additional paid-in-capital |
|
|
257,387 |
|
|
|
254,892 |
|
Accumulated other comprehensive income (loss) |
|
|
5 |
|
|
|
(241 |
) |
Accumulated deficit |
|
|
(202,337 |
) |
|
|
(178,653 |
) |
Total stockholders’
equity |
|
|
55,058 |
|
|
|
76,001 |
|
Total liabilities and
stockholders’ equity |
|
$ |
63,999 |
|
|
$ |
89,435 |
|
(1) Derived from the audited financial statements, included in the
Company's Annual Report on Form 10-K for the year ended December
31, 2022. |
Surrozen (NASDAQ:SRZN)
過去 株価チャート
から 4 2024 まで 5 2024
Surrozen (NASDAQ:SRZN)
過去 株価チャート
から 5 2023 まで 5 2024