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LakeShore Biopharma (Nasdaq: LSB) has initiated a Biologics License Application to Pakistan's Drug Regulatory Authority for its PIKA rabies vaccine. The application is supported by successful pivotal trial results showing the vaccine's ability to provide accelerated protection in a one-week regimen, compared to conventional three- or four-week regimens. The Phase 3 trial involved 4,500 participants from the Philippines and Pakistan, demonstrating superior immunogenicity and safety. Pakistan, among the top five countries for human rabies cases, reports over 1.5 million dog bites and 2,000-5,000 human deaths annually. The vaccine, which received FDA orphan drug designation, utilizes proprietary PIKA adjuvant technology to produce stronger immune responses.
LakeShore Biopharma (Nasdaq: LSB) has announced regaining compliance with Nasdaq's minimum bid price requirement. The company received a compliance notice on October 21, 2024, confirming that its ordinary shares maintained a closing bid price of $1.00 or higher for 11 consecutive business days from October 4-18, 2024. This resolves the non-compliance notice issued on October 24, 2023, when the company's shares traded below $1.00 for 30 consecutive business days. LakeShore Biopharma, formerly YS Biopharma, develops vaccines and therapeutic biologics for infectious diseases and cancer using its PIKA® immunomodulating technology platform.
LakeShore Biopharma (Nasdaq: LSB) has received NMPA approval for a Phase III clinical trial to evaluate simplified four-dose regimens of its YSJA rabies vaccine. The trial will compare two alternative schedules: the Zagreb Regimen (2-1-1) and Modified Essen Regimen (1-1-1-1) against the conventional five-dose Essen regimen (1-1-1-1-1). The study, set to begin in December 2024, aims to improve patient adherence, reduce hospital visits, and decrease costs while maintaining comparable immunogenicity. The YSJA vaccine has already sold over 100M doses since market approval.
LakeShore Biopharma (Nasdaq: LSB) has provided financial guidance for the first half of fiscal year 2025 and reaffirmed its full-year guidance, highlighting strong execution and positive business momentum. The company anticipates double-digit year-over-year revenue growth for FY2025 and expects to achieve breakeven during this period. Preliminary total revenue for the first six months is estimated between RMB350 million to RMB380 million, representing a 28% to 39% growth from the same period in FY2024.
LakeShore Biopharma is pursuing strategic initiatives including cost reductions, organizational restructuring, and management process enhancements to boost operational efficiency. The company is also focused on driving future growth through strategic alliances, product licensing, asset purchases, partnerships, and co-promotion deals. CEO Xu Wang expressed confidence in maintaining positive momentum and achieving financial and operational objectives, noting the company's second position in China's Rabies vaccine market and its commitment to enhancing sustainability, efficiency, and innovation.
LakeShore Biopharma Co., (Nasdaq: LSB) announced the results of its extraordinary general meeting (EGM) held on September 27, 2024. Shareholders approved a 10-for-1 share consolidation effective October 1, 2024, to regain compliance with Nasdaq's minimum bid price requirement. The consolidation will change the company's authorized share capital from 2,500,000,000 ordinary shares at US$0.00002 par value to 250,000,000 ordinary shares at US$0.0002 par value.
The company's ordinary shares will trade on a split-adjusted basis starting October 4, 2024. Shareholders' percentage ownership and voting power will remain largely unchanged, except for minor adjustments due to fractional shares being rounded up. The stock will continue trading on Nasdaq under the symbol LSB.
LakeShore Biopharma (Nasdaq: LSB) has announced an extraordinary general meeting (EGM) of shareholders on September 27, 2024, to be held virtually via Zoom. The primary purpose is to approve resolutions aimed at regaining compliance with Nasdaq's minimum bid price requirement before October 21, 2024. Key proposals include:
1. A 10-to-1 share consolidation effective October 1, 2024
2. Amending and restating the company's memorandum and articles of association
The record date for shareholder participation is set for September 11, 2024. The board of directors fully supports these resolutions and recommends shareholders vote in favor.
LakeShore Biopharma (Nasdaq: LSB) has announced significant leadership transitions effective September 1, 2024. Xu Wang, previously Chief Operation Officer, has been appointed as the new Chief Executive Officer, succeeding Dave Chenn and Dr. Hui Shao. Dr. Shao transitions to the role of Chief Business Officer, focusing on global strategic planning and transactions. Additionally, he has been appointed as Vice Chairman of the Board.
Rachel Yu, formerly Interim Chief Financial Officer, has been promoted to Chief Financial Officer. She also maintains her role as a partner at Oceanpine Capital's healthcare practice. Xu Wang joins the company's Board of Directors as a new member. These changes aim to strengthen LakeShore Biopharma's leadership team as it continues its mission in developing vaccines and therapeutic biologics for infectious diseases and cancer.
LakeShore Biopharma (Nasdaq: LSB) announced financial results for Fiscal Year 2024, ending March 31, 2024. Despite revenue challenges due to supply chain issues, the company reported:
- Revenue of RMB573.4 million (US$80.8 million), down 16.6% year-over-year
- Gross profit of RMB455.7 million (US$64.2 million)
- Gross margin increased to 79.5%, up 1.8 percentage points
- Net loss of RMB433.5 million (US$61.1 million)
LakeShore Biopharma maintains its position as a leading rabies vaccine producer in China, having sold over 27.3 million doses since October 2020. The company's pipeline continues to advance, with positive interim results from the PIKA rabies vaccine Phase III trial. For Fiscal Year 2025, LakeShore anticipates double-digit revenue growth and expects to achieve breakeven.
LakeShore Biopharma (Nasdaq: LSB) will hold an Extraordinary General Meeting (EGM) on July 25, 2024, following a shareholders' requisition. The requisition, dated June 14, 2024, was issued by shareholders holding at least 10% of the voting shares, including Yi Zhang and several investment firms. The EGM will address key issues such as the reasons for recent director resignations, the establishment of new subsidiaries, and the potential impact of ongoing arbitration proceedings. The meeting will be held virtually via Zoom, and shareholders of record on July 15, 2024, are entitled to vote. Detailed information is available on the company's website and will be included in the Form 6-K filed with the SEC.
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