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
third quarter 2023 financial results and business updates.
“We look forward to announcing data from the Phase 1a clinical
studies for both SZN-043 and SZN-1326 in Q1 2024,” said Craig
Parker, President and Chief Executive Officer of Surrozen. “With
the significant progress that we made this quarter on the Phase 1a
studies, we are looking forward to potentially initiating our Phase
1b studies and providing proof-of-concept data for our lead
clinical candidates in 2024. We remain focused on transforming the
treatment of severe diseases where Wnt modulation could play an
essential role.”
Research and Development Pipeline
Highlights
Phase 1a data from SZN-043 and SZN-1326 primes Company
to deliver key 2024 milestones focused on proof-of-concept
data
SZN-043
- Phase 1a study in healthy volunteers and chronic liver disease
patients is ongoing and we expect to announce data in Q1 2024
- We expect to initiate a Phase 1b clinical study in patients
with alcoholic hepatitis in 2024 and anticipate proof-of-concept
data may be available in the second half of 2024
SZN-1326
- Phase 1a study in healthy volunteers is ongoing and we expect
to announce data in Q1 2024
- We expect to initiate a Phase 1b clinical study in patients
with ulcerative colitis in 2024 and anticipate proof-of-concept
data may be available in the second half of 2024
Corporate Updates
Intellectual Property Surrozen has filed or licensed over 20
patent families related to key discoveries involving the WNT
pathway and its modulation. In September 2023, Surrozen was
granted two of those patents from USPTO - Patents No.:
11/746,150 and 11/773,171 – related to Surrozen’s SZN-1326 clinical
candidate and broader SWAP™ technology.
Corporate PartnershipsSurrozen executed a partnership with
Boehringer Ingelheim (BI) 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 Third Quarter Ended September
30, 2023
Cash Position: Cash, cash equivalents and
marketable securities were $43.4 million as of September 30, 2023,
compared to $53.4 million as of June 30, 2023.
Research and Development Expenses: Research and
development expenses for the third quarter ended September 30, 2023
were $6.1 million, as compared to $8.6 million for the same period
in 2022. The decrease was primarily as a result of the
restructuring plans implemented in 2023 to prioritize and focus our
resources on clinical stage programs. Research and development
expenses include non-cash stock-based compensation expenses of $0.2
million for the third quarter ended September 30, 2023, as compared
to $0.4 million for the same period in 2022.
General and Administrative Expenses: General
and administrative expenses for the third quarter ended September
30, 2023 were $3.6 million, as compared to $5.0 million for the
same period in 2022. The decrease was primarily due to the
restructuring plans implemented in 2023 and the employee retention
tax credits received in 2023. General and administrative expenses
include non-cash stock-based compensation expenses of $0.7 million
for the third quarter ended September 30, 2023 and 2022.
Restructuring: Restructuring charges for the
third quarter ended September 30, 2023 were $1.5 million, as
compared to zero for the same period in 2022. The increase was
attributable to a workforce reduction implemented in the third
quarter of 2023.
Interest Income: Interest income for the third
quarter ended September 30, 2023 was $0.7 million, as compared to
$0.2 million for the same period in 2022. The increase was
primarily related to an increase in interest rates on money market
funds and marketable securities.
Other Income, Net: Other income, net for the
third quarter ended September 30, 2023 was $83,000, as compared to
$50,000 for the same period in 2022. The increase was primarily due
to the non-cash change in the fair value of warrant
liabilities.
Net Loss: Net loss for the third quarter ended
September 30, 2023 was $10.4 million, as compared to $13.4 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
trials in patients with chronic liver disease and healthy
volunteers, and the Company expects to announce data in Q1
2024. Surrozen expects to initiate a Phase 1b clinical
trial in patients with alcoholic hepatitis in 2024 and anticipates
proof-of-concept data may 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, and the Company expects to
announce data in Q1 2024. Surrozen also expects to initiate a Phase
1b clinical trial in patients with ulcerative colitis in 2024 and
anticipates proof-of-concept data may 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 September 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 |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
6,112 |
|
|
$ |
8,624 |
|
|
$ |
21,135 |
|
|
$ |
27,576 |
|
General and administrative |
|
|
3,572 |
|
|
|
4,981 |
|
|
|
12,209 |
|
|
|
14,594 |
|
Restructuring |
|
|
1,505 |
|
|
|
— |
|
|
|
2,712 |
|
|
|
— |
|
Total operating expenses |
|
|
11,189 |
|
|
|
13,605 |
|
|
|
36,056 |
|
|
|
42,170 |
|
Loss from operations |
|
|
(11,189 |
) |
|
|
(13,605 |
) |
|
|
(36,056 |
) |
|
|
(42,170 |
) |
Interest income |
|
|
661 |
|
|
|
198 |
|
|
|
1,831 |
|
|
|
307 |
|
Other income, net |
|
|
83 |
|
|
|
50 |
|
|
|
96 |
|
|
|
6,634 |
|
Net loss |
|
$ |
(10,445 |
) |
|
$ |
(13,357 |
) |
|
$ |
(34,129 |
) |
|
$ |
(35,229 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.34 |
) |
|
$ |
(0.38 |
) |
|
$ |
(1.13 |
) |
|
$ |
(1.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used
in computing net loss per share attributable to common
stockholders, basic and diluted |
|
|
30,497 |
|
|
|
34,968 |
|
|
|
30,182 |
|
|
|
34,926 |
|
SURROZEN, INC.Condensed
Consolidated Balance Sheets(In
thousands)
|
|
September 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022(1) |
|
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
33,975 |
|
|
$ |
24,690 |
|
Accounts receivable |
|
|
1,978 |
|
|
|
1,978 |
|
Short-term marketable securities |
|
|
9,457 |
|
|
|
51,148 |
|
Prepaid expenses and other current assets |
|
|
2,947 |
|
|
|
3,489 |
|
Total current assets |
|
|
48,357 |
|
|
|
81,305 |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
2,483 |
|
|
|
3,630 |
|
Operating lease right-of-use
assets |
|
|
2,331 |
|
|
|
3,268 |
|
Restricted cash |
|
|
426 |
|
|
|
405 |
|
Other assets |
|
|
376 |
|
|
|
827 |
|
Total assets |
|
$ |
53,973 |
|
|
$ |
89,435 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
287 |
|
|
$ |
658 |
|
Accrued and other liabilities |
|
|
3,953 |
|
|
|
6,848 |
|
Lease liabilities, current portion |
|
|
2,432 |
|
|
|
2,226 |
|
Total current liabilities |
|
|
6,672 |
|
|
|
9,732 |
|
|
|
|
|
|
|
|
Lease liabilities, noncurrent
portion |
|
|
1,527 |
|
|
|
3,376 |
|
Warrant liabilities |
|
|
243 |
|
|
|
326 |
|
Total liabilities |
|
|
8,442 |
|
|
|
13,434 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
3 |
|
|
|
3 |
|
Additional paid-in-capital |
|
|
258,309 |
|
|
|
254,892 |
|
Accumulated other comprehensive income (loss) |
|
|
1 |
|
|
|
(241 |
) |
Accumulated deficit |
|
|
(212,782 |
) |
|
|
(178,653 |
) |
Total stockholders’ equity |
|
|
45,531 |
|
|
|
76,001 |
|
Total liabilities and
stockholders’ equity |
|
$ |
53,973 |
|
|
$ |
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)
과거 데이터 주식 차트
부터 8월(8) 2024 으로 9월(9) 2024
Surrozen (NASDAQ:SRZN)
과거 데이터 주식 차트
부터 9월(9) 2023 으로 9월(9) 2024