0000950170-22-009148.txt : 20220511 0000950170-22-009148.hdr.sgml : 20220511 20220511081631 ACCESSION NUMBER: 0000950170-22-009148 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20220511 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220511 DATE AS OF CHANGE: 20220511 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Surrozen, Inc./DE CENTRAL INDEX KEY: 0001824893 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 981556622 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39635 FILM NUMBER: 22912158 BUSINESS ADDRESS: STREET 1: 171 OYSTER POINT BLVD STREET 2: SUITE 400 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 650-475-2820 MAIL ADDRESS: STREET 1: 171 OYSTER POINT BLVD STREET 2: SUITE 400 CITY: SOUTH SAN FRANCISCO STATE: CA ZIP: 94080 FORMER COMPANY: FORMER CONFORMED NAME: Consonance-HFW Acquisition Corp. DATE OF NAME CHANGE: 20200915 8-K 1 srzn-20220511.htm 8-K 8-K
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 11, 2022

 

 

Surrozen, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-39635

98-1556622

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

171 Oyster Point Blvd

Suite 400

 

South San Francisco, California

 

94080

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: +1 (650) 489-9000

 

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, $0.0001 par value per share

 

SRZN

 

The Nasdaq Capital Market

Redeemable warrants, each whole warrant exercisable for one share of Common Stock

 

SRZNW

 

The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 


Item 2.02 Results of Operations and Financial Condition.

On May 11, 2022, Surrozen, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2022. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information set forth under this “Item 2.02. Results of Operations and Financial Condition” (including the exhibit referenced herein) shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference in any filing made by the Company pursuant to the Securities Act of 1933, as amended.

Item 9.01 Financial Statements and Exhibits.

(d)

Exhibits

 

 

 

 

Exhibit
No.

 

Description

 

 

 

99.1

 

Press Release of Surrozen, Inc. dated May 11, 2022.

104

 

Cover Page Interactive Data File - the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document

 

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

SURROZEN, INC.

 

 

 

 

Date:

May 11, 2022

By:

/s/ Charles Williams

 

 

 

Name: Charles Williams
Title: Chief Financial Officer

 


EX-99.1 2 srzn-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

 

 

Surrozen Reports First Quarter 2022 Financial Results

 

On Track to Initiate Phase 1 Clinical Trials in Healthy Volunteers for SZN-1326 and SZN-043 in the Third Quarter of 2022

 

SOUTH SAN FRANCISCO, Calif., May 11, 2022 (GLOBE NEWSWIRE) -- 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 reported financial results for the first quarter of 2022 and provided a corporate update.

 

“Surrozen remains on track to transition into a clinical-stage organization as our lead product candidates move into clinical investigation in the coming months,” said Craig Parker, President and Chief Executive Officer of Surrozen. “In addition, we recently presented data on SZN-413 for the potential treatment of retinal vascular diseases at The Association for Research in Vision and Ophthalmology and data from our lead product candidates have been accepted for presentation at an upcoming medical conference.”

 

First Quarter 2022 & Recent Highlights

 

Lead Product Candidates

SZN-1326 for Moderate to Severe Ulcerative Colitis and SZN-043 for Severe Alcoholic Hepatis

 

SZN-1326 is the first development candidate designed using Surrozen’s SWAP™ technology and targets the Wnt-signaling pathway in the intestinal epithelium. In preclinical animal models of acute and chronic colitis, SZN-1326 has been shown to activate Wnt signaling in the diseased intestine, stimulate intestinal epithelial regeneration, reduce inflammation and reduce disease activity with no treatment-related adverse effects observed in 13-week GLP toxicology evaluations in rats and non-human primates (NHPs). Surrozen is initially developing SZN-1326 for moderate to severe ulcerative colitis.

 

SZN-043 is the first development candidate designed using Surrozen’s SWEETS™ technology. In multiple preclinical animal models of liver injury and fibrosis, SZN-043 has been shown to selectively activate Wnt signaling in the liver, stimulate transient hepatocyte proliferation, improve liver function and reduce fibrosis with no treatment-related adverse effects observed in 4-week GLP toxicology evaluations in mice and NHPs. Surrozen is developing SZN-043 for severe liver diseases, initially focusing on severe alcoholic hepatitis.

 

Surrozen expects to initiate separate Phase 1 clinical trials of SZN-1326 and SZN-043 in healthy volunteers in the third quarter of 2022. The Phase 1 clinical studies were posted to the Australian New Zealand Clinical Trial Registry in March 2022. Click HERE for the SZN-1326 posting and click HERE for the SZN-043 posting.


 

Research Pipeline

 

SZN-413 for Vascular-associated Retinopathies, Including Diabetic Retinopathy and Diabetic Macular Edema

SZN-413, a Fzd4 bi-specific antibody, has the potential to treat retinal vascular associated diseases including diabetic retinopathy and diabetic macular edema. Surrozen recently presented a poster supporting the potential of SZN-413 for the treatment of retinal vascular diseases at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting.

 

Fzd4-mediated Wnt signaling is known to play a critical role in retinal vascular integrity and function. Data with Fzd4-specific Surrozen Wnt modulating tool molecules have shown that selectively activating Wnt signaling can rescue a disease phenotype in a norrin knockout model. Recent data generated with SZN-413 in preclinical models of retinopathy demonstrated that SZN-413 stimulated Wnt signaling and was able to induce normal retinal vessel regrowth while suppressing pathological vessel growth.

 

Lacrimal Gland

Tear-producing glands rely on Wnt signaling for maintenance of function. Restoration of gland function through activation of Wnt signaling is a potential therapeutic approach to treat dry eye. Preclinical data demonstrated that Surrozen Wnt modulating molecules stimulated Wnt signaling in the lacrimal gland andincreased tear production within 2 days in a mouse IL-1a lacrimal gland injury model

 

Lung

Recent discoveries of Wnt responsive progenitor cells in the lung suggest a potential role for Wnt in diseases such as Idiopathic Pulmonary Fibrosis and COPD. Preclinical data demonstrated that Surrozen Wnt modulating molecules stimulated Wnt signaling in the lungexpanded Alveolar AT2 cell organoids and reduced injury and improved fibrosis in an acute bleomycin mouse model

 

About Wnt Signaling

Wnt 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 Surrozen

Surrozen is a 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 potential application across multiple disease areas, including inflammatory bowel disease, hepatitis, eye diseases, hearing


loss, lung and airway diseases, and certain neurological disorders. For more information, please visit surrozen.com.

 

Financial Results for the Fourth Quarter Ended December 31, 2021

 

Cash Position: Cash, cash equivalents and marketable securities for the first quarter ended March 31, 2022 were $104.3 million, compared to $123.5 million as of December 31, 2021.

 

Research and Development Expenses: Research and development expenses for the first quarter ended March 31, 2022 were $9.4 million, as compared to $8.6 million for the same period in 2021. The increase was primarily due to the increase in employee-related costs, including stock-based compensation expenses, as a result of higher headcount in support of progressing our research and development programs towards the clinic. Research and development expenses include non-cash stock-based compensation expenses of $0.3 million for the first quarter ended March 31, 2022, as compared to $0.2 million for the same period in 2021.

 

General and Administrative Expenses: General and administrative expenses for the first quarter ended March 31, 2022 were $5.1 million, as compared to $4.4 million for the same period in 2021. The increase was primarily related to employee-related expenses, including stock-based compensation expenses, and insurance costs, supporting the growth in our operations and costs associated with being a public company. General and administrative expenses include non-cash stock-based compensation expenses of $0.6 million for the first quarter ended March 31, 2022, as compared to $0.3 million for the same period in 2021.

 

Other Income: Other income for the first quarter ended March 31, 2022 was $6.5 million, as compared to zero for the same period in 2021. The increase was primarily related to the gain on the change in fair value of warrant liabilities.

 

Net Loss: Net loss for the first quarter ended March 31, 2022 was $7.9 million, as compared to $13.0 million for the same period in 2021.

 

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,” “continue,” “plan,” “potential,” “expect,” “advance,” “suggest,” “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 potential for such product candidates to be used to treat human disease. 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; Surrozen’s ability to identify, develop and commercialize drug candidates; Surrozen’s ability to advance SZN-1326, SZN-043, SZN-413, or other future product candidates into, and successfully complete, preclinical studies and clinical studies; the effects of the ongoing coronavirus (COVID-19) pandemic or other infectious diseases and natural disasters on Surrozen’s business; volatility in global economic, regulatory and market conditions, which may be adversely affected by the conflict between Russia and Ukraine; and those factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2021, primarily under the heading “Risk Factors,” our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, 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 subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

 

Media Contact:

Ian Stone, Managing Director

CanaleComm

Tel.: (619) 518-3518

Email: ian.stone@canalecomm.com

 

Investor Contact:

Email: Investorinfo@surrozen.com


SURROZEN, INC.

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

2022

 

2021

Operating expenses:

 

 

 

 

Research and development

 

 $ 9,371

 

 $ 8,601

General and administrative

 

                 5,122

 

                   4,430

Total operating expenses

 

               14,493

 

                 13,031

Loss from operations

 

            (14,493)

 

 (13,031)

Interest income

 

                       49

 

9

Other income

 

                 6,497

 

Net loss

 

 $ (7,947)

 

 $ (13,022)

 

 

 

 

 

Net loss per share attributable to common
   stockholders, basic and diluted

 

 

$ (0.23)

 

$ (0.72)

 

 

 

 

 

Weighted-average shares used in computing net
   loss per share attributable to common
   stockholders, basic and diluted

 

  34,863

 

                18,154

 

 


SURROZEN, INC.

Condensed Consolidated Balance Sheets

(In thousands)

 

 

 

March 31,
2022

 

December 31, 2021(1)

 

 

(Unaudited)

 

 

Assets

 

 

 

 

Current assets:

 

 

 

 

Cash and cash equivalents

 

 $ 14,305

 

 $ 33,091

Short-term marketable securities

 

             78,209

 

             68,760

Prepaid expenses and other current assets

 

              3,165

 

                3,338

Total current assets

 

             95,679

 

           105,189

 

 

 

 

 

Property and equipment, net

 

               4,672

 

               4,794

Operating lease right-of-use assets

 

               4,215

 

                4,582

Long-term marketable securities

 

             11,780

 

             21,655

Restricted cash

 

                  405

 

                   405

Other assets

 

                   904

 

                   549

Total assets

 

 $ 117,655

 

 $ 137,174

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

Current liabilities:

 

 

 

 

Accounts payable

 

$ 1,045

 

 $ 2,718

Accrued and other liabilities

 

              4,927

 

                8,662

Lease liabilities, current portion

 

              2,143

 

                2,193

Total current liabilities

 

               8,115

 

             13,573

 

 

 

 

 

Lease liabilities, noncurrent portion

 

               5,074

 

                5,600

Warrant liabilities

 

               1,804

 

8,301

Total liabilities

 

             14,993

 

             27,474

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

Preferred stock

 

 

Common stock

 

                     4

 

                       4

Additional paid-in capital

 

          253,683

 

           252,464

Accumulated other comprehensive loss

 

                (429)

 

(119)

Accumulated deficit

 

        (150,596)

 

        (142,649)

Total stockholders’ equity

 

         102,662

 

          109,700

Total liabilities and stockholders’ equity

 

 $ 117,655

 

 $ 137,174

(1) Derived from the audited financial statements, included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021.


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Trading Symbol SRZNW
Security Exchange Name NONE
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