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): March 21, 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 March 24, 2022, Surrozen, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2021. 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 5.08. Shareholder Director Nominations.

On March 21, 2022, the Company's Board of Directors established the date of the Company’s 2022 Annual Meeting of Stockholders (the “2022 Annual Meeting”). The 2022 Annual Meeting will be held on June 7, 2022, and the record date for the 2022 Annual Meeting will be April 11, 2022. The time of the 2022 Annual Meeting will be set forth in the Company’s definitive proxy statement for the 2022 Annual Meeting to be filed with the Securities and Exchange Commission. The Company is holding the 2022 Annual Meeting as a virtual-only meeting, which will be conducted via live audio online webcast.

The Company’s bylaws permit stockholders to bring director nominations and other proposals for consideration at the 2022 Annual Meeting, provided they comply with the notice and other requirements set forth in the bylaws and SEC rules. Because the Company did not hold an annual meeting of stockholders during the previous year, all stockholder notices to bring director nominations and other matters before the 2022 Annual Meeting must be received by the Company no later than April 3, 2022, which is the tenth date following this public announcement of the 2022 Annual Meeting date. This is also the date the Company has determined to be a reasonable time before it expects to begin to print and distribute its proxy materials, and therefore, under SEC rules, any stockholder who wishes to include director nominations or other proposals in the Company's proxy materials for the 2022 Annual Meeting must submit proper notice no later than April 3, 2022. Stockholders may submit written notice for any director nomination or other proposal to:

Surrozen, Inc.,

Attn: Corporate Secretary

171 Oyster Point Blvd., Suite 400

South San Francisco, California 94080

Any written notice pursuant to the foregoing must also comply with all other applicable requirements found in the rules of the U.S. Securities and Exchange Commission, including Rule 14a-8, the Delaware General Corporation Law, and the Company’s bylaws.

 

 

 


Item 9.01 Financial Statements and Exhibits.

(d)

Exhibits

 

 

 

 

Exhibit
No.

 

Description

 

 

 

99.1

 

Press Release of Surrozen, Inc. dated March 24, 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:

March 24, 2022

By:

/s/ Charles Williams

 

 

 

Name: Charles Williams
Title: Chief Financial Officer

 


EX-99.1

 

 

https://cdn.kscope.io/ddcbcbfffd46135edb1e4aa2f74d9d19-img94851506_0.jpg 

 

Surrozen Reports Fourth Quarter and Full Year 2021 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., March 24, 2022 – 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 fourth quarter and full year ended December 31, 2021 and provided a corporate update.

 

“Surrozen’s significant achievements in 2021 have prepared us to transition to a clinical-stage biotechnology company as we drive toward multiple key milestones in 2022,” said Craig Parker, President and Chief Executive Officer of Surrozen. “We are on track to advance our lead therapeutic candidates, SZN-1326 and SZN-043, into the clinic in the third quarter for the potential treatment of moderate to severe ulcerative colitis and severe alcoholic hepatitis, respectively. We have also accelerated and broadened our novel Wnt targeted antibody therapeutics discovery pipeline utilizing our SWAP and SWEETS technologies for several other serious diseases, including nominating a lead candidate in vascular-associated retinopathies.”

 

Fourth Quarter 2021 & 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 SWAPTM 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 pharmacokinetic (PK) and toxicology evaluation in non-human primates (NHPs). Surrozen is initially developing SZN-1326 for moderate to severe ulcerative colitis in inflammatory bowel disease.
SZN-043 is the first development candidate designed using Surrozen’s SWEETSTM 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 PK and toxicology evaluation in NHPs. Surrozen is developing SZN-043 for severe liver diseases, initially focused on severe alcoholic hepatitis.
Following recent completion of IND-enabling GLP tox studies, Surrozen expects to initiate Phase 1 clinical trials of both SZN-1326 and SZN-043 in healthy volunteers in the third quarter of 2022.
o
The Phase 1 clinical studies were posted to the Australian New Zealand Clinical Trial Registry in March 2022. Click HERE for SZN-1326 posting and click HERE for SZN-043 posting.
In 2021, the company presented a broad spectrum of key pre-clinical studies that support the lead candidates and our SWAP TM and SWEETS TM technologies. The data included results from multiple

 


 

disease models and species and were presented through 26 posters and oral presentations at 5 major medical meetings in 2021.

 

Research Pipeline

SZN-413 for Vascular-associated Retinopathies, Including Wet AMD and Diabetic Retinopathy

Surrozen recently nominated SZN-413, a Fzd4 bi-specific antibody, as a development candidate for the treatment of retinal vascular associated diseases including wet AMD and diabetic retinopathies.
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 has 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:
o
Stimulated Wnt signaling in the retinal vascular endothelial cells
o
Increased tight junction protein expression in retinal vascular endothelial cells

 

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 including dry eye associated with Sjogren’s Disease. Preclinical data demonstrated that Surrozen Wnt modulating molecules:
o
Stimulated Wnt signaling in the lacrimal gland
o
Increased 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:
o
Stimulated Wnt signaling in the lung
o
Expands Alveolar AT2 cell organoids
o
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 were $123.5 million as of December 31, 2021, compared to $135.4 million as of September 30, 2021.

 

Research and Development Expenses: Research and development expenses for the three and twelve months ended December 31, 2021 were $10.9 million and $40.2 million, respectively, as compared to $8.7 million and $25.7 million, respectively, for the same periods of 2020. The increases were primarily due the increased external costs as we continue to invest in research and development activities related to SZN-1326 and SZN-043 and the increase in employee-related costs, including stock-based compensation expenses, as a result of a 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 $0.2 million and $0.7 million for the three and twelve months ended December 31, 2021, respectively, as compared to $0.1 million and $0.4 million, respectively, for the same periods in 2020.

 

Generaland Administrative Expenses:General and administrative expenses for the three and twelve months ended December 31, 2021 were $4.1 million and $14.2 million, respectively, as compared to $2.2 million and $7.1 million, respectively, for the same periods of 2020. The increases were primarily related to professional fees, consulting fees, insurance costs and employee-related expenses, including stock-based compensation expenses, 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 $0.5 million and $1.6 million for the three and twelve months ended December 31, 2021, respectively, as compared to $0.1 million and $0.2 million, respectively, for the same periods in 2020.

 

Other Expense, net: Other expense, net for the three and twelve months ended December 31, 2021 was $1,000 and $0.3 million, as compared to zero for the same periods of 2020. The increase was primarily related to the transaction costs incurred in connection with the business combination consummated in August 2021 that were allocated to the warrant liabilities assumed and the gain or loss on the change in fair value of warrant liabilities.

 

NetLoss: Net loss for the three and twelve months ended December 31, 2021 was $15.0 million and $54.6 million, respectively, as compared to $10.8 million and $32.7 million, respectively, for the same periods in 2020.

 

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,” 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 and SXN-043, 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, and potential future drug candidates; Surrozen’s ability to identify, develop and commercialize drug candidates; Surrozen’s ability to advance SZN-1326, SZN-043, 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 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 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.

Consolidated Statements of Operations

(in thousands, except share and per share amounts)

 

 

 

Year Ended December 31,

 

 

2021

 

2020

Operating expenses:

 

 

 

 

Research and development

 

 $ 40,177

 

 $ 25,684

General and administrative

 

                    14,214

 

                     7,123

Total operating expenses

 

                    54,391

 

                  32,807

Loss from operations

 

                  (54,391)

 

                  (32,807)

Interest income

 

                           72

 

                           91

Other expense, net

 

                       (329)

 

                           —

Net loss

 

 $ (54,648)

 

 $ (32,716)

 

 

 

 

 

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

 

 $ (2.21)

 

 $ (2.05)

 

 

 

 

 

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

 

            24,689,339

 

             15,972,348

 

 

 


 

Surrozen, Inc.

Consolidated Balance Sheet Data

(in thousands)

 

 

 

December 31,

 

 

2021

 

2020

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

 $ 33,091

 

 $ 34,982

 

Short-term marketable securities

 

                    68,760

 

                 14,200

 

Prepaid expenses and other current assets

 

                      3,338

 

                  1,042

 

Total current assets

 

                 105,189

 

                 50,224

 

 

 

 

 

 

 

Property and equipment, net

 

                      4,794

 

                    5,836

 

Operating lease right-of-use assets

 

                      4,582

 

                    5,556

 

Long-term marketable securities

 

                    21,655

 

 

Restricted cash

 

                          405

 

405

 

Other assets

 

                          549

 

39

 

Total assets

 

 $ 137,174

 

 $ 62,060

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

 $ 2,718

 

 $ 1,776

 

Accrued and other liabilities

 

                      8,662

 

                    3,394

 

Lease liabilities, current portion

 

                      2,193

 

                    2,108

 

Total current liabilities

 

                    13,573

 

                    7,278

 

 

 

 

 

 

 

Lease liabilities, noncurrent portion

 

                      5,600

 

                    7,489

 

Warrant liabilities

 

                      8,301

 

 

Total liabilities

 

                    27,474

 

                 14,767

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock

 

 

 

Common stock

 

                              4

 

                           2

 

Additional paid-in-capital

 

               252,464

 

               135,292

 

Accumulated other comprehensive loss

 

                       (119)

 

 

Accumulated deficit

 

               (142,649)

 

               (88,001)

 

Total stockholders’ equity

 

                  109,700

 

                 47,293

 

Total liabilities and stockholders’ equity

 

 $ 137,174

 

 $ 62,060