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Provention Bio (Nasdaq: PRVB) announced a term loan facility worth up to $125 million with Hercules Capital (NYSE: HTGC) to bolster its financial standing ahead of the potential commercial launch of teplizumab. The loan is structured in five tranches, with an initial draw of $25 million at closing and the possibility of further disbursements contingent on FDA approval and achievement of specific milestones. This financing aims to enhance the development of therapies for type 1 diabetes and improve the lives of affected individuals.
Provention Bio (Nasdaq: PRVB) reported Q2 2022 financial results, including a net loss of $29.7 million. The company completed a $60 million private placement to bolster cash reserves, now totaling $96.1 million. The FDA has extended the user fee goal date for teplizumab's Biologics License Application to November 17, 2022, due to additional information requests. The company remains optimistic about teplizumab's potential approval for delaying clinical type 1 diabetes. Future guidance expects cash expenses between $27 million to $31 million for Q3 2022.
Provention Bio, Inc. (Nasdaq: PRVB) granted stock options for 118,000 shares to nine non-executive employees as part of an inducement to join the company. The options, with a 10-year term, have an exercise price of $3.67, equal to the closing price on August 1, 2022. Vesting occurs 25% after one year, with the remaining 75% vesting monthly over four years. This grant was made without stockholder approval under Nasdaq Listing Rule 5635(c)(4) and was sanctioned by the board's compensation committee.
Provention Bio, Inc. (Nasdaq: PRVB) announced it will report its second quarter 2022 financial results on August 4, 2022, before the U.S. market opens. A conference call will follow at 8:00 am E.T. to discuss the results and company updates. The company focuses on immune-mediated diseases, with its lead investigational drug, teplizumab, having a filed Biologics License Application (BLA) to delay Stage 3 clinical type 1 diabetes. Provention Bio is also developing additional therapies for autoimmune diseases.
Provention Bio, Inc. (Nasdaq: PRVB) announced a private placement agreement with institutional investors for approximately $60 million in common stock and warrants. The deal involves the issuance of 13,318,535 Warrants at an exercise price of $6.00 per share. Proceeds from this placement will fund preparations for the potential launch of teplizumab, advance clinical candidates, and cover general corporate purposes. Closing is expected around July 13, 2022, pending customary conditions.
Provention Bio, Inc. (Nasdaq: PRVB) announced the grant of stock options to a new non-executive employee, totaling 7,000 shares, without stockholder approval, as per Nasdaq Listing Rule 5635(c)(4). The options have a 10-year term with an exercise price of $3.43, based on the closing price on July 1, 2022. They will vest 25% after one year and the remaining 75% monthly over four years, contingent on employment status. The company is dedicated to developing therapies for immune-mediated diseases, including a Biologics License Application for teplizumab to delay type 1 diabetes progression.
Provention Bio, Inc. (Nasdaq: PRVB) announced a three-month extension of the FDA's review period for its Biologics License Application (BLA) for teplizumab, now due by November 17, 2022. The FDA indicated that a timely response to an information request constitutes a Major Amendment, leading to the delay. If no major deficiencies arise, proposed labeling will be communicated by October 17, 2022. CEO Ashleigh Palmer reaffirmed the commitment to collaborate with the FDA to potentially bring the first disease-modifying therapy for type 1 diabetes to market.
On June 3, 2022, Provention Bio, Inc. (Nasdaq: PRVB) announced the granting of stock options for 166,000 shares to eight new employees, as an inducement for their employment, in accordance with Nasdaq Listing Rule 5635(c)(4). The options have a 10-year term with an exercise price of $4.00, equal to the company's stock closing price on June 1, 2022. Vesting occurs 25% after one year and the remaining 75% monthly over three years. Provention is focused on developing therapies for immune-mediated diseases and has filed a Biologics License Application for its lead candidate.
Provention Bio, Inc. (Nasdaq: PRVB) announced its participation in the Jefferies Global Healthcare Conference on June 8, 2022, at 9:00 am EST in New York City. The corporate presentation will be available via live webcast through the company's website, where it will be archived for 30 days post-event. Provention Bio focuses on developing therapies for immune-mediated diseases, with ongoing research in conditions like type 1 diabetes and lupus.
Provention Bio, Inc. (Nasdaq: PRVB) has announced the resignation of Dr. Jeffrey Bluestone from its board of directors, effective June 3, 2022, to focus on his role at Sonoma Biotherapeutics. Dr. Bluestone will maintain his connection with Provention as a Scientific Advisor. The company expresses gratitude for his contributions, particularly in the advancement of teplizumab, which is pending FDA review for treating at-risk individuals for type 1 diabetes. Provention Bio aims to intercept immune-mediated diseases with its investigational therapies.
