Contract analysis

1. Purpose of This Letter Penterra Pharmaceuticals Corp. ("Penterra") is writing to correct and clarify certain promotional claims and data presentations contained in a physician-targeted email blast distributed on June 7, 2023 (Material ID: ZVR-2023-EML-019) concerning Zelvara® (trepivant sodium) tablets, 75 mg and 150 mg. This corrective communication is being issued in connection with an inquiry from the U.S. Food

2. Correction of Misleading Efficacy Data Presentation 2.1 The Truncated Y-Axis Bar Chart The June 7, 2023 email (Material ID: ZVR-2023-EML-019) included a bar chart depicting 2-hour pain-freedom rates from the Phase III SUMMIT-3 pivotal clinical trial (NDA #214-837; N = 1,842 randomized patients). This bar chart was the central visual element of the email and was intended to illustrate the primary efficacy endpoint

3. Retraction of Unsubstantiated Comparative Claim The June 7, 2023 email (Material ID: ZVR-2023-EML-019) and an associated digital banner advertisement (Material ID: ZVR-2023-BNR-044), which ran on the healthcare-provider-targeted medical-education platform MedLinkPro from April 15 through August 31, 2023, included the following promotional claim: "Fastest Onset in Its Class" This comparative superiority claim regar

4. Correction Regarding Cited Real-World Evidence A sales representative detail aid (Material ID: ZVR-2023-DA-007), which was approved by Penterra's Promotional Review Committee on March 22, 2023, and subsequently distributed to Penterra's field sales force for use in healthcare provider detailing visits, cited the following study as "real-world evidence" supporting the efficacy of Zelvara®: Harmon JT, Vasquez-Ortega

5. Important Risk Information — Zelvara® (trepivant sodium) The June 7, 2023 email (Material ID: ZVR-2023-EML-019) and the digital banner advertisement (Material ID: ZVR-2023-BNR-044) omitted or minimized important risk information from the approved prescribing information for Zelvara® (trepivant sodium) tablets, 75 mg and 150 mg. To ensure that healthcare providers have access to balanced information, the following

6. Penterra's Corrective Actions In response to the OPDP inquiry (reference number OPDP-2023-1847) and the findings of its own internal review, Penterra has taken the following voluntary corrective actions:

1. Immediate withdrawal of all three cited promotional materials. The following materials were permanently withdrawn from distribution and retired as of November 3, 2023: • ZVR-2023-EML-019 (physician-targeted email blast, dated June 7, 2023) • ZVR-2023-BNR-044 (digital banner advertisement, displayed on MedLinkPro from April 15 through August 31, 2023) • ZVR-2023-DA-007 (sales representative detail aid, approved Mar

2. Distribution of this corrective Dear Healthcare Provider letter. This letter is being sent to all approximately 42,000 neurologists and primary-care physicians who were recipients of the original June 7, 2023 email (ZVR-2023-EML-019). The letter is being sent via both U.S. mail and electronic mail to ensure maximum reach.

3. Implementation of revised Promotional Review Committee ("PRC") standard operating procedures. Effective January 2, 2024, Penterra's PRC standard operating procedures will require unanimous Medical Affairs sign-off for all promotional materials that contain efficacy claims, graphical data presentations, cross-trial comparisons, or citations to non-peer-reviewed data. Additionally, all bar charts and other graphical

4. Mandatory compliance retraining for all field sales representatives. All approximately 680 field sales representatives across Penterra's U.S. commercial organization will complete a mandatory retraining program covering FDA promotional regulations, fair balance requirements, appropriate presentation of clinical data, and the proper use and limitations of approved promotional materials. This retraining must be comp

7. Reporting Adverse Events Healthcare providers are encouraged to report any suspected adverse events or side effects associated with the use of Zelvara® (trepivant sodium). Adverse events may be reported through either of the following channels: • Penterra Drug Safety Department: 1-888-737-8477 (1-888-PENTERRA), available Monday through Friday, 8:00 AM to 8:00 PM Eastern Time, or by email at drugsafety@penterraphar

8. Contact Information For medical or scientific inquiries regarding Zelvara® (trepivant sodium), including requests for the full prescribing information, clinical trial data, or medical information letters, healthcare providers may contact: Penterra Pharmaceuticals Corp. — Medical Information Department Telephone: 1-877-463-7388 (1-877-INFO-PTV) Email: medinfo@penterrapharma.com Hours: Monday through Friday, 8:00 AM