Sinovac Biotech(SVA)

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Sernova Biotherapeutics Secures $4 Million Loan to Further Advance its Clinical Development Plans
GlobeNewswire· 2025-04-17 12:00
LONDON, Ontario and BOSTON, April 17, 2025 (GLOBE NEWSWIRE) -- Sernova Biotherapeutics, (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a leading regenerative medicine company focused on developing it’s Cell Pouch Bio-hybrid Organ as a functional cure for type 1 diabetes (T1D), today announced that the Company has closed on a secured term loan in the amount of CAD$4,000,000 (the “Loan”) from Navigate Private Yield Fund LP III, a fund managed by Fraser Mackenzie Private Credit Inc. The Loan matures on April 16, ...
Heng Ren Partners Calls on Sinovac to Disclose the Record and Payment Dates of the Special Dividend and Distribute an Additional Dividend of $41 per Share
Prnewswire· 2025-04-10 19:44
Core Viewpoint - Heng Ren Partners is urging Sinovac Biotech Ltd. to disclose the record and payment dates of a special cash dividend and to consider an additional dividend, highlighting the company's significant cash reserves and the need for transparency [1][2][3]. Group 1: Dividend Announcement and Shareholder Demands - Sinovac announced a special cash dividend of $55 per share on April 1, 2025, but has not disclosed the record and payment dates, which Heng Ren deems essential for shareholder trust [2][5]. - Heng Ren is requesting an additional special dividend of $41 per share, which would result in a total payout of $96 per share while leaving Sinovac with over $1.3 billion in net cash, sufficient for its operational needs [1][3][6]. Group 2: Financial Position and Cash Management - After the proposed dividend payments, Sinovac would still hold more than $6.3 billion in net cash and cash equivalents, raising questions about the rationale for retaining such a large cash reserve [3][5]. - The company's financial report as of June 30, 2024, indicates that even without revenue or operating cash flow, the cash on hand could finance nearly nine years of capital expenditures [5]. Group 3: Regulatory Context and Shareholder Rights - The U.S. Securities and Exchange Commission (SEC) has previously inquired about Sinovac's ability to distribute earnings to U.S. investors, and the company has not identified any restrictions on such distributions [4]. - Heng Ren emphasizes the importance of addressing the issue of excess cash and the need for clear communication regarding dividend payments to ensure shareholders benefit from their investments [4][6].
Sernova Biotherapeutics Provides Update on Phase 1/2 Clinical Trial of Cell Pouch™ Bio-Hybrid Organ for Treatment of Type 1 Diabetes
GlobeNewswire· 2025-04-01 12:00
We believe that Sernova's Cell Pouch™ Bio-hybrid Organ, that is pre-vascularized prior to islet transplantation, is the only implantable and retrievable cell containment system for islet engraftment and function currently in U.S. clinical trials. Data from the ongoing trial has demonstrated islet cell survival in T1D patients from one year to more than five years as well as the ability to support insulin independence following protocol specified treatment. In addition, there has been no evidence of detrimen ...
Heng Ren Partners Demands Sinovac Distribute $8.9 Billion in Cash to its Shareholders and Cause Reinstatement of Trading
Prnewswire· 2025-03-20 15:05
BOSTON, March 20, 2025 /PRNewswire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA) ("Sinovac") shareholder Heng Ren Partners, LLC funds ("Heng Ren") today sent an open letter to Sinovac's shareholders outlining the significant and decisive action that Sinovac's Board of Directors must take to create liquidity and release cash to shareholders. Specifically, Heng Ren demands that Sinovac's Board of Directors announce a distribution of $8.9 billion in cash to its shareholders and cause the resumption of trading of the ...
Sernova Biotherapeutics Appoints Pericles Calias, Ph.D. as Chief Development Officer and Head of R&D
GlobeNewswire· 2025-03-10 12:00
Core Insights - Sernova Biotherapeutics has appointed Dr. Pericles Calias as Chief Development Officer and Head of R&D, enhancing its operational depth and expertise in cell therapy [1][2] Company Overview - Sernova Biotherapeutics is a clinical-stage company focused on developing regenerative medicine therapeutics, specifically its Cell Pouch Bio-hybrid Organ aimed at providing a functional cure for type 1 diabetes (T1D) [4] - The company collaborates with Evotec to create bio-hybrid organs that integrate human donor cells or stem-cell derived islet-like clusters with the Cell Pouch [4] Leadership and Expertise - Dr. Calias brings over 20 years of global operational experience in drug product development, having held leadership roles at various life sciences companies [2] - His background includes securing regulatory approvals and leading R&D efforts in areas such as rare diseases and autoimmune disorders [2][3] - Dr. Calias holds a Ph.D. in Bio-Organic Chemistry and is an inventor on over 40 patents, contributing significantly to regulatory filings [3]
Sernova Biotherapeutics Secures $1 Million Convertible Debt Financing
GlobeNewswire· 2025-03-05 13:00
LONDON, Ontario and BOSTON, March 05, 2025 (GLOBE NEWSWIRE) -- Sernova Biotherapeutics, (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a leading regenerative medicine company focused on developing its Cell Pouch Bio-hybrid Organ as a functional cure for type 1 diabetes, today announced a CAD$1,000,000 unsecured convertible debenture financing with Dr. Steven Sangha, a current Sernova shareholder and board member. Proceeds from the financing will be used to fund working capital. The debenture is repayable on Ma ...
Sernova Biotherapeutics Receives FDA Clearance for IND Application for its Cell Pouch Bio-hybrid Organ with Autograft Thyroid Cells in Patients with Hypothyroidism
GlobeNewswire· 2025-03-03 14:00
Core Insights - Sernova Biotherapeutics has received FDA clearance for its Investigational New Drug (IND) application to evaluate the Cell Pouch bio-hybrid organ with auto-transplanted thyroid cells for patients undergoing thyroid surgery for nodular thyroid disease [1][3] - The Cell Pouch aims to restore natural thyroid function without the need for hormone replacement medications or immune suppression therapy, addressing the needs of hypothyroid patients, particularly those post-thyroid surgery [2][4] Company Overview - Sernova Biotherapeutics is a clinical-stage company focused on developing regenerative medicine therapeutics that combine the Cell Pouch with human donor cells or stem cell-derived therapies to create bio-hybrid organs for chronic diseases [4] - The company's innovative approach targets chronic conditions, initially focusing on type 1 diabetes and thyroid disorders, with the potential to significantly improve patient quality of life [4] Clinical Development - Preclinical studies have shown that re-implantation of thyroid tissue into the Cell Pouch can restore primary thyroid hormones (T4 and T3) to pre-thyroidectomy levels without hormone supplementation, demonstrating the technology's effectiveness [3] - The FDA clearance allows Sernova to diversify its clinical trial activities in chronic conditions, enhancing its financial resources and potential market opportunities [3]
Sernova Biotherapeutics Submits IND Application for its Cell Pouch Bio-Hybrid Organ with Autograft Thyroid Cells in Patients with Hypothyroidism
GlobeNewswire· 2025-02-03 13:00
Company Overview - Sernova Biotherapeutics is a clinical-stage company focused on developing regenerative medicine therapeutics, specifically its Cell Pouch bio-hybrid organ, to treat chronic diseases such as type 1 diabetes and thyroid disorders [4]. Core Developments - The company has submitted an Investigational New Drug (IND) application to the U.S. FDA to evaluate the Cell Pouch auto-transplanted with thyroid cells for patients undergoing total thyroidectomy due to nodular thyroid disease [1]. - The Cell Pouch aims to restore natural thyroid function in patients suffering from post-operative hypothyroidism, providing a long-term solution without the need for immune suppression therapy [2]. Clinical Insights - Preclinical trials indicated that re-implantation of thyroid tissue into the pre-vascularized Cell Pouch restored the two main thyroid hormones, thyroxine (T4) and triiodothyronine (T3), to levels seen before thyroidectomy, without hormone supplementation [3]. - Imaging and histology assessments confirmed the presence of healthy and functional thyroid tissues within the Cell Pouch five months post-re-implantation [3]. Future Plans - Pending FDA clearance, Sernova plans to initiate a first-in-human clinical trial to assess the safety, tolerability, and efficacy of the Cell Pouch bio-hybrid organ with autologous thyroid cells in patients undergoing thyroidectomy for benign nodular disease [3].
Sernova Announces Appointment of Ross Haghighat as Chair of the Board and a Change of Name to Sernova Biotherapeutics
GlobeNewswire· 2025-01-30 13:00
Core Viewpoint - Sernova Biotherapeutics has appointed Ross Haghighat as Chair of the Board, emphasizing the company's commitment to advancing its innovative therapies for Type 1 diabetes [1][2][3] Company Developments - The company will complete its corporate jurisdiction continuance into British Columbia, transitioning from the Canada Business Corporations Act to the Business Corporations Act (British Columbia) [4] - Sernova has changed its name from Sernova Corp. to Sernova Biotherapeutics Inc. to better reflect its business focus, with no changes expected in its ticker symbols [5] Leadership Insights - Ross Haghighat brings over three decades of experience in healthcare technology ventures, which will support Sernova's strategic direction and innovation objectives [2][3] - The Board of Directors has expressed unanimous support for Mr. Haghighat's appointment, highlighting confidence in his leadership [3] Product Focus - Sernova is developing a Cell Pouch bio-hybrid organ aimed at providing a functional cure for Type 1 diabetes, integrating human donor cells or stem cells to replicate or enhance organ function [6] - The innovative approach of creating a bio-hybrid organ aims to deliver revolutionary treatments for chronic diseases, initially focusing on Type 1 diabetes and thyroid disorders [6]
Sernova Announces Voting Results from its Annual and Special General Meeting of Shareholders
GlobeNewswire· 2025-01-13 13:00
Core Insights - Sernova Corp. held its annual and special general meeting on January 10, 2025, with 74,190,067 common shares voted, representing 22.8% of all outstanding shares as of November 12, 2024 [1] Group 1: Shareholder Meeting Outcomes - Six directors were elected with high approval rates, including Tanya Lewis (99.6%), Bernd Muehlenweg (99.7%), and David Paterson (99.4%) [2] - The Board expressed satisfaction with shareholder support, indicating a new era for the company with a strengthened management team and corporate branding [3] Group 2: Company Overview - Sernova Corp. is focused on developing regenerative medicine therapeutics, specifically a bio-hybrid organ for type 1 diabetes and thyroid disorders [3] - The bio-hybrid organ integrates living cells with non-living materials to restore normal organ function, representing a potentially revolutionary treatment for chronic diseases [3] Group 3: Corporate Governance and Structure - KPMG LLP was appointed as auditors until the next annual meeting [5] - The company will continue as a British Columbia corporation and has adopted new articles, altering its authorized share structure to include an unlimited number of Preferred Shares [5] - The maximum number of common shares reserved for stock option grants has been increased to 50,000,000, with a conditional grant of 5,500,000 options to officers [5]