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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]
Sernova Reschedules its Annual General and Special Meeting of Shareholders to January 10, 2025
Globenewswire· 2024-12-20 13:00
Company Overview - Sernova Corp. is a clinical-stage company focused on developing regenerative medicine therapeutics, specifically its Cell Pouch bio-hybrid organ aimed at treating type 1 diabetes and thyroid disorders [2]. Meeting Announcement - Sernova Corp. will hold its annual general and special meeting of shareholders on January 10, 2025, at 1:00 PM ET, postponed from January 7, 2025, due to a postal strike in Canada [1]. - The record date for the meeting remains November 12, 2024, and proxies must be submitted by January 8, 2025, at 1:00 PM ET [6]. Technology and Innovation - The Cell Pouch is designed to integrate with living tissue, replicating or enhancing the function of natural organs, which could provide revolutionary treatment options for chronic diseases [2].
Sinovac Biotech(SVA) - 2023 Q4 - Annual Report
2024-04-29 20:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ...
Sinovac Amends Shareholder Rights Plan
Businesswire· 2024-02-21 07:56
BEIJING--(BUSINESS WIRE)--Sinovac Biotech Ltd. (“Sinovac” or the “Company”) (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced that its board of directors has amended its shareholder rights plan. The amendment extends the expiration date of the plan from February 22, 2024 to February 22, 2025. About SINOVAC Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of biomedical products tha ...
Sinovac Board of Directors Unanimously Rejects an Unsolicited Partial Tender Offer
Businesswire· 2024-01-18 12:00
BEIJING--(BUSINESS WIRE)--Sinovac Biotech Ltd. (NASDAQ: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, announced today that its Board of Directors (the “Board of Directors”) unanimously determined that the partial tender offer (the “Tender Offer”) by Alternative Liquidity Index LP (“Alternative Liquidity”) to acquire up to 10,000,000 common shares of Sinovac (the “Shares”) for $0.03 per share in cash (the “Offer Price”) is NOT advisable and is NOT in the best i ...
Sinovac Biotech(SVA) - 2023 Q3 - Quarterly Report
2023-08-14 16:00
Exhibit 99.1 SINOVAC Reports Unaudited First Half of 2023 Financial Results BEIJING, China, August 15, 2023 /Business Wire/ -- Sinovac Biotech Ltd. (NASDAQ: SVA) ("SINOVAC" or the "Company"), a leading provider of biopharmaceutical products in China, announced today its unaudited financial results for the six months ended June 30, 2023. First Half of 2023 Financial Summary · Sales for the six months ended June 30, 2023 were $140.4 million, compared to $1.2 billion in the prior year period. · The Company pos ...
Sinovac Biotech(SVA) - 2022 Q4 - Annual Report
2023-04-30 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ...