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Provention Bio, Inc. (Nasdaq: PRVB) announced the granting of stock options for 84,000 shares to three non-executive employees. These options were approved without stockholder consent under Nasdaq Listing Rule 5635(c)(4), as part of inducements for new employees. Each option has a 10-year term with an exercise price of $9.30, the closing price on December 1, 2022. Vesting of these options will occur 25% after one year and 75% through monthly installments over the next three years, contingent on continued employment.
Provention Bio announced FDA approval for TZIELD (teplizumab-mzwv), the first therapy to delay the onset of Stage 3 Type 1 Diabetes (T1D) in patients aged 8 and older with Stage 2 T1D. In clinical trials, TZIELD delayed median onset of Stage 3 T1D by 25 months compared to placebo. Side effects noted were lymphopenia (73%), rash (36%), leukopenia (21%), and headache (11%). Provention has also partnered with Sanofi for commercialization and launched a patient support program named COMPASS to assist with coverage and access.
Provention Bio, Inc. (Nasdaq: PRVB) announced on November 4, 2022, the grant of stock options to five non-executive employees totaling 80,000 shares. These options, priced at $6.85 per share, were issued as inducements for new hires and did not require stockholder approval. The options have a 10-year term and will vest over four years, contingent on continued employment. The grant complies with Nasdaq Listing Rule 5635(c)(4) and follows approval from the company's compensation committee.
Provention Bio, Inc. (Nasdaq: PRVB) is preparing for the potential U.S. launch of teplizumab ahead of the FDA's November 17 action date. The company has received expected labeling and post-marketing commitments from the FDA. Recently, Provention entered a co-promotion agreement with Sanofi, securing a $20 million upfront payment and a $35 million investment contingent on FDA approval. Financially, Provention reported a net loss of $28.6 million for Q3 2022, with cash reserves of $186.5 million, expected to sustain operations for the next 12 months.
Provention Bio, Inc. (Nasdaq: PRVB) announced it will report its third quarter 2022 financial results on November 3, 2022, before U.S. market opening. A conference call is scheduled for 8:00 AM E.T. to discuss results and provide updates. The company focuses on developing therapies for immune-mediated diseases, with its lead drug candidate, teplizumab, having a Biologics License Application filed with the FDA for delaying progression of Stage 3 clinical type 1 diabetes. Investors are encouraged to monitor the company’s website for updates.
Provention Bio, Inc. (Nasdaq: PRVB) announced the grant of stock options to a non-executive employee, allowing the purchase of 10,000 shares of common stock. The options, with a 10-year term, feature an exercise price of $4.52, reflecting the company's closing stock price on October 3, 2022. The vesting schedule includes 25% after one year and the remaining 75% in monthly increments over four years. This issuance aligns with Nasdaq Listing Rule 5635(c)(4) and received approval from the company's compensation committee.
Provention Bio (Nasdaq: PRVB) announced a co-promotion agreement with Sanofi U.S. for their investigational drug, teplizumab, aimed at delaying clinical type 1 diabetes (T1D) in at-risk individuals. Sanofi will invest $20 million for exclusive negotiation rights and commit $35 million at a premium contingent on FDA approval. The partnership leverages Sanofi's commercial infrastructure to enhance product awareness and screening efforts. Teplizumab's FDA review is anticipated by November 17, 2022, with a conference call scheduled for 8:30 AM ET today to discuss updates.
Provention Bio, Inc. has appointed Sarah O'Brien as Chief People Officer, effective immediately. O'Brien brings over 20 years of experience in human resources within the biotech sector, aiming to enhance the company’s organizational structure and culture. She was previously Chief People Officer at Ardelyx and has held senior roles at various biotech firms. In connection with her appointment, O'Brien received a stock option to purchase 200,000 shares with an exercise price of $5.35. This option will vest based on performance milestones and continued employment.
Provention Bio, Inc. (Nasdaq: PRVB) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference. The virtual presentation is scheduled for September 12, 2022, at 7:00 AM EST. Investors can access the live webcast via the Company's website, where it will also be archived for 30 days. Provention Bio is focused on developing therapies for immune-mediated diseases, including its lead candidate, teplizumab, which has received FDA filing for delaying Stage 3 type 1 diabetes.
On September 2, 2022, Provention Bio, Inc. (Nasdaq: PRVB) announced the grant of stock options to two non-executive employees totaling 38,000 shares of common stock. This grant, made without stockholder approval, serves as an employment inducement and adheres to Nasdaq Listing Rule 5635(c)(4). The options have a 10-year term with an exercise price of $4.51, and will vest 25% after one year and the remaining 75% in monthly installments over the next three years, contingent upon continued employment. Provention Bio is focused on therapies for immune-mediated diseases.
