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Biopharmaceutical company Ocugen, Inc. (NASDAQ:OCGN) has announced the appointment of PricewaterhouseCoopers LLP (PwC) as its new independent registered public accounting firm for the fiscal year ending December 31, 2024. This change comes after the company's previous auditor, Ernst & Young LLP (EY), opted not to participate in a request-for-proposal process and declined to stand for re-election for the coming fiscal year.
The decision by EY was not due to any disagreements with Ocugen regarding accounting principles or practices, financial statement disclosures, or auditing scope or procedures. The transition to PwC is scheduled to occur following the filing of Ocugen's Form 10-Q for the quarter ending June 30, 2024, as confirmed in a recent filing with the U.S. Securities and Exchange Commission (SEC).
During the past two fiscal years and the subsequent interim period through July 2, 2024, Ocugen did not consult with PwC on any matters related to the application of accounting principles, the audit of its financial statements, or any disagreements or reportable events as defined by SEC regulations.
In compliance with SEC regulations, Ocugen has provided EY with the details of this announcement, and EY has submitted a letter to the SEC, dated July 8, 2024, agreeing with the statements made by Ocugen regarding their relationship and the absence of disagreements.
The appointment of PwC reflects Ocugen's continued commitment to maintaining robust financial reporting and compliance practices. The company, headquartered in Malvern, Pennsylvania, specializes in developing transformative therapies for rare and underserved eye diseases. This transition in the company's auditing firm is part of normal corporate governance practices and is not expected to have any adverse impact on the company's operations or financial reporting.
In other recent news, Ocugen, Inc. has made significant strides in its gene therapy programs. The biopharmaceutical company has received approval to begin high-dose cohort dosing in the Phase 1/2 GARDian clinical trial of OCU410ST, a gene therapy candidate for Stargardt disease. This comes after the successful administration of medium doses, which were deemed safe and tolerable. The trial aims to address the medical needs of approximately 100,000 individuals affected by Stargardt disease in the U.S. and Europe.
Furthermore, Ocugen is set to join the Russell 3000® Index, a recognition of its market capitalization and validation of its growth strategy. This development comes as the company advances three modifier gene therapies aimed at treating various blindness diseases, including the Phase 3 liMeliGhT clinical trial of OCU400 for broad retinitis pigmentosa.
On the financial front, Ocugen reported a net loss of $11.9 million for the first quarter of 2024, with research and development expenses amounting to $6.8 million. The company's cash position stood at $26.4 million as of the end of March 2024. These are recent developments that underline the company's commitment to advancing its innovative gene therapy programs while managing the financial aspects of research-intensive operations.
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