SOUTH SAN FRANCISCO, Calif., March 24, 2022 (GLOBE NEWSWIRE) — Surrozen, Inc., (“Surrozen” or the “Firm”) (Nasdaq: SRZN), an organization pioneering focused therapeutics that selectively activate the Wnt pathway for tissue restore and regeneration, at this time reported monetary outcomes for the fourth quarter and full yr ended December 31, 2021 and offered a company replace.
“Surrozen’s important achievements in 2021 have ready us to transition to a clinical-stage biotechnology firm as we drive towards a number of key milestones in 2022,” mentioned Craig Parker, President and Chief Government Officer of Surrozen. “We’re on observe to advance our lead therapeutic candidates, SZN-1326 and SZN-043, into the clinic within the third quarter for the potential remedy of reasonable to extreme ulcerative colitis and extreme alcoholic hepatitis, respectively. We’ve got additionally accelerated and broadened our novel Wnt focused antibody therapeutics discovery pipeline using our SWAP and SWEETS applied sciences for a number of different critical ailments, together with nominating a lead candidate in vascular-associated retinopathies.”
Fourth Quarter 2021 & Latest Highlights
Lead Product Candidates
SZN-1326 for Reasonable to Extreme Ulcerative Colitis and SZN-043 for Extreme Alcoholic Hepatis
- SZN-1326 is the primary growth candidate designed utilizing Surrozen’s SWAP™ expertise and targets the Wnt-signaling pathway within the intestinal epithelium. In preclinical animal fashions of acute and power colitis, SZN-1326 has been proven to activate Wnt signaling within the diseased gut, stimulate intestinal epithelial regeneration, cut back irritation and cut back illness exercise with no remedy associated adversarial results noticed in pharmacokinetic (PK) and toxicology analysis in non-human primates (NHPs). Surrozen is initially growing SZN-1326 for reasonable to extreme ulcerative colitis in inflammatory bowel illness.
- SZN-043 is the primary growth candidate designed utilizing Surrozen’s SWEETS™ expertise. In a number of preclinical animal fashions of liver harm and fibrosis, SZN-043 has been proven to selectively activate Wnt signaling within the liver, stimulate transient hepatocyte proliferation, enhance liver perform and cut back fibrosis with no treatment-related adversarial results noticed in PK and toxicology analysis in NHPs. Surrozen is growing SZN-043 for extreme liver ailments, initially centered on extreme alcoholic hepatitis.
- Following latest completion of IND-enabling GLP tox research, Surrozen expects to provoke Section 1 medical trials of each SZN-1326 and SZN-043 in wholesome volunteers within the third quarter of 2022.
- The Section 1 medical research had been posted to the Australian New Zealand Medical Trial Registry in March 2022. Click on HERE for SZN-1326 posting and click on HERE for SZN-043 posting.
- In 2021, the corporate introduced a broad spectrum of key pre-clinical research that assist the lead candidates and our SWAP™ and SWEETS™ applied sciences. The info included outcomes from a number of illness fashions and species and had been introduced by means of 26 posters and oral shows at 5 main medical conferences in 2021.
Analysis Pipeline
SZN-413 for Vascular-associated Retinopathies, Together with Moist AMD and Diabetic Retinopathy
- Surrozen just lately nominated SZN-413, a Fzd4 bi-specific antibody, as a growth candidate for the remedy of retinal vascular related ailments together with moist AMD and diabetic retinopathies.
- Fzd4 mediated Wnt signaling is thought to play a essential position in retinal vascular integrity and performance. Knowledge with Fzd4 particular Surrozen Wnt modulating software molecules has proven that selectively activating Wnt signaling can rescue a illness phenotype in a norrin knockout mannequin. Latest information generated with SZN-413 in preclinical fashions of retinopathy demonstrated:
- Stimulated Wnt signaling within the retinal vascular endothelial cells
- Elevated tight junction protein expression in retinal vascular endothelial cells
Lacrimal Gland
- Tear-producing glands depend on Wnt signaling for upkeep of perform. Restoration of gland perform by means of activation of Wnt signaling is a possible therapeutic strategy to deal with dry eye together with dry eye related to Sjogren’s Illness. Preclinical information demonstrated that Surrozen Wnt modulating molecules:
- Stimulated Wnt signaling within the lacrimal gland
- Elevated tear manufacturing inside 2 days in a mouse IL-1a lacrimal gland harm mannequin
Lung
- Latest discoveries of Wnt responsive progenitor cells within the lung recommend a possible position for Wnt in ailments equivalent to Idiopathic Pulmonary Fibrosis and COPD. Preclinical information demonstrated that Surrozen Wnt modulating molecules:
- Stimulated Wnt signaling within the lung
- Expands Alveolar AT2 cell organoids
- Diminished harm and improved fibrosis in an acute bleomycin mouse mannequin
About Wnt Signaling
Wnt signaling performs key roles within the management of growth, homeostasis, and regeneration of many important organs and tissues, together with liver, gut, lung, kidney, retina, central nervous system, cochlea, bone and others. Modulation of Wnt signaling pathways has potential for remedy of degenerative ailments and tissue accidents. Surrozen’s platform and proprietary applied sciences have the potential to beat the restrictions in pursuing the Wnt pathway as a therapeutic technique.
About Surrozen
Surrozen is a biotechnology firm discovering and growing drug candidates to selectively modulate the Wnt pathway. Surrozen is growing tissue-specific antibodies designed to have interaction the physique’s present organic restore mechanisms with potential utility throughout a number of illness areas, together with inflammatory bowel illness, hepatitis, eye ailments, listening to loss, lung and airway ailments, and sure neurological problems. For extra data, please go to surrozen.com.
Monetary Outcomes for the Fourth Quarter Ended December 31, 2021
MoneyPlace: Money, money equivalents and marketable securities had been $123.5 million as of December 31, 2021, in comparison with $135.4 million as of September 30, 2021.
Analysis and Improvement Bills: Analysis and growth bills for the three and twelve months ended December 31, 2021 had been $10.9 million and $40.2 million, respectively, as in comparison with $8.7 million and $25.7 million, respectively, for a similar intervals of 2020. The will increase had been primarily due the elevated exterior prices as we proceed to put money into analysis and growth actions associated to SZN-1326 and SZN-043 and the rise in employee-related prices, together with stock-based compensation bills, because of the next headcount in assist of progressing our analysis and growth applications in direction of the clinic. Analysis and growth bills embrace non-cash stock-based compensation bills of $0.2 million and $0.7 million for the three and twelve months ended December 31, 2021, respectively, as in comparison with $0.1 million and $0.4 million, respectively, for a similar intervals in 2020.
CommonandAdministrativeBills: Common and administrative bills for the three and twelve months ended December 31, 2021 had been $4.1 million and $14.2 million, respectively, as in comparison with $2.2 million and $7.1 million, respectively, for a similar intervals of 2020. The will increase had been primarily associated to skilled charges, consulting charges, insurance coverage prices and employee-related bills, together with stock-based compensation bills, supporting the expansion in our operations and prices related to being a public firm. Common and administrative bills embrace non-cash stock-based compensation bills of $0.5 million and $1.6 million for the three and twelve months ended December 31, 2021, respectively, as in comparison with $0.1 million and $0.2 million, respectively, for a similar intervals in 2020.
Different Expense, internet: Different expense, internet for the three and twelve months ended December 31, 2021 was $1,000 and $0.3 million, as in comparison with zero for a similar intervals of 2020. The rise was primarily associated to the transaction prices incurred in reference to the enterprise mixture consummated in August 2021 that had been allotted to the warrant liabilities assumed and the acquire or loss on the change in honest worth of warrant liabilities.
WebLoss: Web loss for the three and twelve months ended December 31, 2021 was $15.0 million and $54.6 million, respectively, as in comparison with $10.8 million and $32.7 million, respectively, for a similar intervals in 2020.
Ahead Trying Statements
This press launch accommodates sure forward-looking statements throughout the that means of the federal securities legal guidelines. Ahead-looking statements usually are accompanied by phrases equivalent to “will,” “proceed,” “plan,” “potential,” “anticipate,” “advance,” or the adverse of those phrases and related expressions that predict or point out future occasions or developments or that aren’t statements of historic issues. These forward-looking statements embrace, however usually are not restricted to, statements concerning Surrozen’s discovery, analysis and growth actions, particularly its growth plans for its product candidates SZN-1326 and SXN-043, together with anticipated medical growth timelines, and the potential for such product candidates for use to deal with human illness. These statements are based mostly on varied assumptions, whether or not or not recognized on this press launch, and on the present expectations of the administration of Surrozen and usually are not predictions of precise efficiency. These forward-looking statements are offered for illustrative functions solely and usually are not meant to function, and should not be relied on as, a assure, an assurance, a prediction, or a definitive assertion of truth or likelihood. Precise occasions and circumstances are tough or inconceivable to foretell and can differ from assumptions. Many precise occasions and circumstances are past the management of Surrozen. These forward-looking statements are topic to a variety of dangers and uncertainties, together with the initiation, price, timing, progress and outcomes of analysis and growth actions, preclinical or and medical trials with respect to SZN-1326, SZN-043, and potential future drug candidates; Surrozen’s means to determine, develop and commercialize drug candidates; Surrozen’s means to advance SZN-1326, SZN-043, or different future product candidates into, and efficiently full, preclinical research and medical research; the results of the continuing coronavirus (COVID-19) pandemic or different infectious ailments and pure disasters on Surrozen’s enterprise; volatility in world financial, regulatory and market situations, which can be adversely affected by the battle between Russia and Ukraine; and people elements mentioned in our Annual Report on Kind 10-Okay for the yr ended December 31, 2021 underneath the heading “Danger Components” and different paperwork Surrozen has filed, or will file, with the Securities and Alternate Fee. If any of those dangers materialize or our assumptions show incorrect, precise outcomes may differ materially from the outcomes implied by these forward-looking statements. There could also be further dangers that Surrozen presently doesn’t know, or that Surrozen at present believes are immaterial, that might additionally trigger precise outcomes to vary from these contained within the forward-looking statements. As well as, forward-looking statements replicate Surrozen’s expectations, plans, or forecasts of future occasions and views as of the date of this press launch. Surrozen anticipates that subsequent occasions and developments will trigger its assessments to alter. Nevertheless, whereas Surrozen could elect to replace these forward-looking statements sooner or later sooner or later, Surrozen particularly disclaims any obligation to take action, besides as required by regulation. These forward-looking statements shouldn’t be relied upon as representing Surrozen’s assessments of any date subsequent to the date of this press launch. Accordingly, undue reliance shouldn’t be positioned upon the forward-looking statements.
Media Contact:
Ian Stone, Managing Director
CanaleComm
Tel.: (619) 518-3518
Electronic mail: ian.stone@canalecomm.com
Investor Contact:
Electronic mail: Investorinfo@surrozen.com
Surrozen, Inc.
Consolidated Statements of Operations
(In 1000’s, besides share and per share quantities)
Yr Ended December 31, | ||||||||
2021 | 2020 | |||||||
Working bills: | ||||||||
Analysis and growth | $ | 40,177 | $ | 25,684 | ||||
Common and administrative | 14,214 | 7,123 | ||||||
Whole working bills | 54,391 | 32,807 | ||||||
Loss from operations | (54,391 | ) | (32,807 | ) | ||||
Curiosity revenue | 72 | 91 | ||||||
Different expense, internet | (329 | ) | — | |||||
Web loss | $ | (54,648 | ) | $ | (32,716 | ) | ||
Web loss per share attributable to widespread stockholders, fundamental and diluted |
$ | (2.21 | ) | $ | (2.05 | ) | ||
Weighted-average shares utilized in computing internet loss per share attributable to widespread stockholders, fundamental and diluted |
24,689,339 | 15,972,348 |
Surrozen, Inc.
Consolidated Stability Sheet Knowledge
(In 1000’s)
December 31, | |||||||||
2021 | 2020 | ||||||||
Belongings | |||||||||
Present belongings: | |||||||||
Money and money equivalents | $ | 33,091 | $ | 34,982 | |||||
Quick-term marketable securities | 68,760 | 14,200 | |||||||
Pay as you go bills and different present belongings | 3,338 | 1,042 | |||||||
Whole present belongings | 105,189 | 50,224 | |||||||
Property and gear, internet | 4,794 | 5,836 | |||||||
Working lease right-of-use belongings | 4,582 | 5,556 | |||||||
Lengthy-term marketable securities | 21,655 | — | |||||||
Restricted money | 405 | 405 | |||||||
Different belongings | 549 | 39 | |||||||
Whole belongings | $ | 137,174 | $ | 62,060 | |||||
Liabilities and stockholders’ fairness | |||||||||
Present liabilities: | |||||||||
Accounts payable | $ | 2,718 | $ | 1,776 | |||||
Accrued and different liabilities | 8,662 | 3,394 | |||||||
Lease liabilities, present portion | 2,193 | 2,108 | |||||||
Whole present liabilities | 13,573 | 7,278 | |||||||
Lease liabilities, noncurrent portion | 5,600 | 7,489 | |||||||
Warrant liabilities | 8,301 | — | |||||||
Whole liabilities | 27,474 | 14,767 | |||||||
Stockholders’ fairness: | |||||||||
Most well-liked inventory | — | — | |||||||
Widespread inventory | 4 | 2 | |||||||
Further paid-in-capital | 252,464 | 135,292 | |||||||
Accrued different complete loss | (119 | ) | — | ||||||
Accrued deficit | (142,649 | ) | (88,001 | ) | |||||
Whole stockholders’ fairness | 109,700 | 47,293 | |||||||
Whole liabilities and stockholders’ fairness | $ | 137,174 | $ | 62,060 |