“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
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).
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.
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.
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
Financial Results for the Fourth Quarter Ended
Cash Position: Cash, cash equivalents and marketable securities for the first quarter ended
Research and Development Expenses: Research and development expenses for the first quarter ended
General and Administrative Expenses: General and administrative expenses for the first quarter ended
Other Income: Other income for the first quarter ended
Net Loss: Net loss for the first quarter ended
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
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Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended | ||||||||
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 |
Condensed Consolidated Balance Sheets
(In thousands)
(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
Source:
2022 GlobeNewswire, Inc., source