Surrozen Provides Third Quarter 2024 Financial Results and Business Update
Surrozen reported Q3 2024 financial results with significant progress in its clinical programs. The company received a $10 million milestone payment from Boehringer Ingelheim for SZN-413 development. Key highlights include substantial enrollment in the Phase 1b trial of SZN-043 for severe alcohol-associated hepatitis, with proof-of-concept data expected in H1 2025. The first cohort showed no drug-related serious adverse events and potential clinical benefits. The company reported Q3 revenue of $10 million and a net loss of $1.4 million, with cash position at $31 million as of September 30, 2024.
Surrozen ha riportato i risultati finanziari del terzo trimestre 2024 con progressi significativi nei suoi programmi clinici. L'azienda ha ricevuto un pagamento di milestone di 10 milioni di dollari da Boehringer Ingelheim per lo sviluppo di SZN-413. Tra i punti salienti ci sono l'iscrizione sostanziale nella fase 1b dello studio SZN-043 per l'epatite severa associata all'alcol, con dati di proof-of-concept attesi nel primo semestre del 2025. Il primo gruppo non ha mostrato eventi avversi gravi correlati al farmaco e potenziali benefici clinici. L'azienda ha registrato entrate del terzo trimestre di 10 milioni di dollari e una perdita netta di 1,4 milioni di dollari, con una posizione di cassa di 31 milioni di dollari al 30 settembre 2024.
Surrozen informó los resultados financieros del tercer trimestre de 2024, destacando un progreso significativo en sus programas clínicos. La compañía recibió un pago por hitos de 10 millones de dólares de Boehringer Ingelheim para el desarrollo de SZN-413. Los puntos clave incluyen una inscripción sustancial en el ensayo de fase 1b de SZN-043 para la hepatitis severa asociada al alcohol, con datos de prueba de concepto esperados para el primer semestre de 2025. El primer grupo no mostró eventos adversos graves relacionados con el fármaco y posibles beneficios clínicos. La compañía reportó ingresos del tercer trimestre de 10 millones de dólares y una pérdida neta de 1,4 millones de dólares, con una posición de efectivo de 31 millones de dólares a fecha del 30 de septiembre de 2024.
Surrozen은 2024년 3분기 재무 결과를 발표하며 임상 프로그램에서 큰 발전을 이루었습니다. 이 회사는 SZN-413 개발을 위한 Boehringer Ingelheim로부터 1천만 달러의 이정표 지급금을 받았습니다. 주요 하이라이트로는 심각한 알코올 관련 간염을 위한 SZN-043의 1b상 시험에서 상당한 모집이 있었으며, 개념 증명 데이터가 2025년 상반기에 예상됩니다. 첫 번째 코호트에서는 약물 관련 심각한 이상 반응이 없었고 잠재적인 임상 혜택이 있었습니다. 회사는 3분기 매출 1천만 달러 및 140만 달러의 순손실을 보고했으며, 2024년 9월 30일 기준으로 현금 보유액은 3천1백만 달러입니다.
Surrozen a publié les résultats financiers du troisième trimestre 2024, avec des progrès significatifs dans ses programmes cliniques. La société a reçu un paiement d'étape de 10 millions de dollars de Boehringer Ingelheim pour le développement de SZN-413. Les points essentiels comprennent une inscription importante dans l'essai de phase 1b de SZN-043 pour l'hépatite sévère associée à l'alcool, avec des données de preuve de concept attendues au premier semestre 2025. Le premier groupe n'a montré aucun événement indésirable grave lié au médicament et des bénéfices cliniques potentiels. La société a déclaré des revenus du troisième trimestre de 10 millions de dollars et une perte nette de 1,4 million de dollars, avec une position de trésorerie de 31 millions de dollars au 30 septembre 2024.
Surrozen hat die finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht und dabei erhebliche Fortschritte in seinen Klinikprogrammen gezeigt. Das Unternehmen erhielt eine Meilensteinzahlung von 10 Millionen Dollar von Boehringer Ingelheim für die Entwicklung von SZN-413. Zu den wichtigsten Punkten gehören eine beträchtliche Einschreibung in die Phase-1b-Studie von SZN-043 zur schweren alkoholassoziierten Hepatitis, wobei Daten zum Proof-of-Concept im ersten Halbjahr 2025 erwartet werden. Die erste Kohorte zeigte keine ernsthaften unerwünschten Ereignisse, die mit dem Arzneimittel in Verbindung stehen, sowie potenzielle klinische Vorteile. Das Unternehmen meldete Umsätze im dritten Quartal von 10 Millionen Dollar und einen Nettoverlust von 1,4 Millionen Dollar, mit einer Liquiditätsposition von 31 Millionen Dollar am 30. September 2024.
- Received $10 million milestone payment from Boehringer Ingelheim partnership
- Successful completion of first cohort in Phase 1b trial with no serious adverse events
- Net loss decreased significantly to $1.4M from $10.4M in Q3 2023
- Research and development expenses reduced to $5.2M from $6.1M YoY
- Cash position decreased to $31.0M from $37.8M in Q2 2024
- Interest income declined to $0.4M from $0.7M YoY
- Reported $3.1M other expense compared to $0.1M income in Q3 2023
Insights
Surrozen's Q3 results show significant financial developments. The
The new TCGFB collaboration could bring up to
The Phase 1b trial of SZN-043 shows promising early safety and efficacy signals in severe alcohol-associated hepatitis. The absence of drug-related serious adverse events and zero mortality at 30 days in cohort 1 is noteworthy, given the typical
The expansion into ophthalmology with novel candidates SZN-8141, SZN-8143 and SZN-113 demonstrates pipeline diversification. These candidates' multi-modal approach, combining Wnt pathway activation with other mechanisms like VEGF and IL-6 antagonism, could potentially offer advantages over existing treatments in major eye diseases.
Substantial enrollment progress in Phase 1b trial of SZN-043 in severe alcohol-associated hepatitis patients with proof-of-concept data expected in the first half of 2025
Nominated novel portfolio of preclinical ophthalmology product candidates to R&D pipeline
Received
SOUTH SAN FRANCISCO, Calif., Nov. 06, 2024 (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 provided third quarter 2024 financial results and business updates.
“In the third quarter, we made substantial progress on enrolling patients in the SZN-043 Phase 1b trial, received notification that Boehringer planned to further develop SZN-413 to advance the compound and prepare it for clinical testing and nominated a portfolio of novel preclinical ophthalmology candidates,” said Craig Parker, President and Chief Executive Officer of Surrozen. “More recently, we also announced a research collaboration with TCGFB to utilize Surrozen’s antibody developments capabilities and expertise to discover antibodies targeting TGF-β. We remain focused on transforming the treatment of severe diseases of the liver and eye through leveraging our research capabilities and expertise in antibody engineering technologies.”
Research and Development Pipeline Highlights
SZN-043
Surrozen is developing SZN-043 for severe liver disease with an initial focus on severe alcohol-associated hepatitis. The Phase 1b study is enrolling patients and the Company expects proof-of-concept data in the first half of 2025. The study is being conducted at nine sites in five countries.
Surrozen successfully completed dosing and 30-day follow-up for cohort 1 in its Phase 1b trial of SZN-043 in severe alcohol-associated hepatitis (sAH). No drug related serious adverse events (SAEs) were observed in the first cohort of six patients receiving 0.5mg/kg of SZN-043. There were no patient deaths at day 30 of the study, and the company observed a potential clinical benefit based on reductions in bilirubin and MELD score. A majority of patients experienced improvements in AST and ALT levels. Surrozen expects to present data from the Phase 1b study at an upcoming liver disease conference.
“Published data in the severe alcohol-associated hepatitis population indicates an expected mortality rate of approximately 15 to
Nominated Novel Portfolio of Ophthalmology Preclinical Product Candidates to R&D Pipeline
Surrozen developed multiple novel ophthalmology product candidates targeting Fzd4
leveraging the Company’s antibody research capabilities and expertise in antibody engineering technologies. Wnt signaling has been implicated in multiple diseases and tissues in the eye. These product candidates do not fall within the scope of the partnership with BI and are wholly owned by Surrozen.
Product Candidates SZN-8141 and SZN-8143
Data generated in preclinical models of retinopathy demonstrated that SZN-8141 and SZN-8143 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth.
- SZN-8141 combines Frizzled 4 (Fzd4) agonism and Vascular Endothelial Growth Factor (VEGF) antagonism which has the potential to provide benefits over treatment with single agents for Diabetic Macular Edema (DME) and neovascular Age Related Macular Degeneration (wet AMD)
- SZN-8143: combines Fzd4 agonism, VEGF antagonism, and interleukin-6 (IL-6) antagonism which may have benefits over single agents for treatment of DME/wet AMD/uveitic macular edema (UME)
Product Candidate SZN-113
SZN-113 targets Fzd127 and is in development for Fuchs’ Endothelial Corneal Dystrophy (FECD) and Geographic Atrophy (GA).
- FECD preclinical models: SZN-113 enhanced proliferation of primary human corneal endothelial cells in vitro, demonstrated evidence of wound healing in acute corneal endothelial injury models, and rapidly reduced central corneal thickness along with demonstrating improved corneal clarity in a cryoinjury model in mouse and rabbit.
- GA preclinical models: Fzd127 molecules stimulated retinal pigment epithelium cell proliferation and differentiation in culture and provided neuroprotection in acute injury and progressive degeneration models of photoreceptor degeneration.
Corporate Updates
Corporate Partnerships
Surrozen 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. In September 2024, Surrozen announced that Boehringer Ingelheim will further develop SZN-413 to advance the compound and prepare it for clinical testing. The milestone achievement triggered a
Research Collaboration with TCGFB
In November, Surrozen announced a strategic research collaboration with privately-held TCGFB, Inc. (“TCGFB”) to discover antibody therapeutics targeting Transforming Growth Factor Beta (TGF-β) for the potential treatment of patients with idiopathic pulmonary fibrosis (IPF). TCGFB will own all TGF-β product related intellectual property. Under the terms of the agreement, Surrozen will provide antibody discovery services for a period of up to two years. In exchange for Surrozen’s research services, TCGFB will pay Surrozen up to
Financial Results for the Second Quarter Ended September 30, 2024
Cash Position: Cash and cash equivalents were
Collaboration and License Revenue: Collaboration and license revenue for the third quarter ended September 30, 2024 was
Research and Development Expenses: Research and development expenses for the third quarter ended September 30, 2024 were
General and Administrative Expenses: General and administrative expenses were
Restructuring: Restructuring charges for the third quarter ended September 30, 2024 were zero, as compared to
Interest Income: Interest income for the third quarter ended September 30, 2024 was
Other (Expense) Income, Net: Other (expense) income, net for the third quarter ended September 30, 2024 was a net other expense of
Net Loss: Net loss for the third quarter ended September 30, 2024 was
About SZN-043 for Severe Alcohol-Associated Hepatitis
SZN-043 is the first development candidate using Surrozen’s SWEETS™ technology. Surrozen is developing SZN-043 for severe liver diseases, initially focusing on alcohol-associated hepatitis. The Company has completed the Phase 1a clinical trial in patients with chronic liver disease and healthy volunteers. SZN-043 demonstrated acceptable safety and tolerability in all subjects, with evidence of target engagement, Wnt signal activation and effects on liver function. Enrollment is ongoing in the Phase 1b clinical trial in patients with severe alcohol-associated hepatitis. Cohort 1 in the Phase 1b trial completed enrollment in 6 patients with no drug related SAEs. There were no patient deaths at day 30 of the study and the company observed a potential clinical benefit based on reductions in bilirubin and MELD score. A majority of patients experienced improvements in AST and ALT levels. Proof-of-concept data is anticipated in the first half of 2025.
About SZN-413 for Retinal Diseases
SZN-413 is a bi-specific antibody targeting Fzd4-mediated Wnt signaling designed using Surrozen’s SWAP™ technology. SZN-413 is 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
In September 2024, Surrozen announced that Boehringer Ingelheim will further develop SZN-413 to advance the compound and prepare it for clinical testing. The milestone achievement triggered a
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 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 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 (including anticipated clinical development plans and timelines, the availability of data, the potential for such product candidates to be used to treat human disease, as well as the potential benefits of such product candidates), the Company’s partnership with Boehringer Ingelheim, including the potential for future success-based development, regulatory, and commercial milestone payments, in addition to mid-single digit to low-double digit royalties on sales, and the potential of TGF-β to be a novel, first-in-class therapeutic to treat the pathology of Idiopathic Pulmonary Fibrosis. 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 and clinical trials with respect to its product 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 its 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, 2023 and Surrozen’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 to be filed with the Securities and Exchange Commission (“SEC”) under the heading “Risk Factors,” and other documents Surrozen has filed, or will file, with the SEC. 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, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Collaboration and license revenue | $ | 10,000 | $ | — | $ | 10,000 | $ | — | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 5,200 | 6,112 | 15,782 | 21,135 | ||||||||||||
| General and administrative | 3,568 | 3,572 | 11,165 | 12,209 | ||||||||||||
| Restructuring | — | 1,505 | — | 2,712 | ||||||||||||
| Total operating expenses | 8,768 | 11,189 | 26,947 | 36,056 | ||||||||||||
| Income (loss) from operations | 1,232 | (11,189 | ) | (16,947 | ) | (36,056 | ) | |||||||||
| Interest income | 431 | 661 | 1,306 | 1,831 | ||||||||||||
| Other (expense) income, net | (3,097 | ) | 83 | 513 | 96 | |||||||||||
| Loss on issuance of common stock, pre-funded warrants and warrants | — | — | (20,397 | ) | — | |||||||||||
| Net loss | $ | (1,434 | ) | $ | (10,445 | ) | $ | (35,525 | ) | $ | (34,129 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.44 | ) | $ | (5.14 | ) | $ | (12.57 | ) | $ | (16.96 | ) | ||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 3,228 | 2,033 | 2,826 | 2,012 | ||||||||||||
| SURROZEN, INC. Condensed Consolidated Balance Sheets (In thousands) | ||||||||
| September 30, | December 31, | |||||||
| 2024 | 2023(1) | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 31,012 | $ | 36,043 | ||||
| Accounts receivable | 12,196 | 2,152 | ||||||
| Prepaid expenses and other current assets | 2,078 | 2,937 | ||||||
| Total current assets | 45,286 | 41,132 | ||||||
| Property and equipment, net | 856 | 1,969 | ||||||
| Operating lease right-of-use assets | 817 | 1,889 | ||||||
| Restricted cash | 688 | 688 | ||||||
| Other assets | 351 | 402 | ||||||
| Total assets | $ | 47,998 | $ | 46,080 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 276 | $ | 525 | ||||
| Accrued and other liabilities | 4,317 | 4,126 | ||||||
| Lease liabilities, current portion | 1,527 | 2,497 | ||||||
| Total current liabilities | 6,120 | 7,148 | ||||||
| Lease liabilities, noncurrent portion | — | 882 | ||||||
| Warrant liabilities | 36,211 | 115 | ||||||
| Total liabilities | 42,331 | 8,145 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock | — | — | ||||||
| Common stock | — | — | ||||||
| Additional paid-in-capital | 262,887 | 259,630 | ||||||
| Accumulated deficit | (257,220 | ) | (221,695 | ) | ||||
| Total stockholders’ equity | 5,667 | 37,935 | ||||||
| Total liabilities and stockholders’ equity | $ | 47,998 | $ | 46,080 | ||||
(1) Derived from the audited financial statements, included in the Company's Annual Report on Form 10-K for the year ended December 31, 2023.
FAQ
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