Certara, Inc. Stock Price, News & Analysis

Certara, Inc. (Nasdaq: CERT) has announced its participation in two upcoming investor conferences. The first is the Jeffries London Healthcare Conference on November 15 at 4:25 PM GMT, followed by the Stephens Annual Investment Conference on November 17 at 9:00 AM CT. Live webcasts will be available on Certara's investor relations website and can be replayed for 90 days. Certara specializes in biosimulation software and services that enhance drug discovery and development for over 2,000 clients worldwide.

Certara has announced the renewal of its software licenses with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the ninth consecutive year.

Certara's Simcyp™ Simulator, Phoenix™, and Pinnacle 21™ Enterprise software will continue to support PMDA in drug development and regulatory submissions.

The PMDA has utilized Certara’s software since 2014, significantly enhancing its data validation processes, including new compliance rules introduced in 2021.

Certara collaborates with over 140 biopharmaceutical companies in Japan, including the top 20 by R&D spending.

Certara, a leader in biosimulation, will release its Q3 2022 financial results on November 7, 2022, after market close. A conference call with management will follow at 5:00 p.m. ET to discuss the results. Interested investors must register online, ideally a day in advance. The event will be accessible via a live and archived webcast on the Certara website. The company aids over 2,000 clients globally in drug discovery and development through its innovative software and services.

Certara, Inc. (Nasdaq: CERT), a leader in biosimulation, will participate in two upcoming investor conferences. The first is the Morgan Stanley 20th Annual Global Healthcare Conference on September 13 at 11:45 a.m. ET. The second is the Baird Global Healthcare Conference on September 14 at 12:15 p.m. ET. Live webcasts will be available on Certara’s investor relations website and can be replayed for 90 days. Certara uses advanced biosimulation software to enhance drug discovery and development for over 2,000 clients in 62 countries.

Certara, Inc. (Nasdaq: CERT) announced an underwritten secondary offering of 7,000,000 shares of common stock by certain stockholders, including EQT Avatar Parent L.P. The offering allows for a 30-day option for the underwriter to purchase an additional 1,050,000 shares. No shares are being sold by Certara, and the proceeds will go entirely to the Selling Stockholders. The last reported stock price was $20.19, with the closing expected around August 16, 2022. Morgan Stanley is the underwriter for this offering.

Certara reported a strong second quarter of fiscal year 2022, achieving $82.8 million in revenue, an 18% increase compared to the prior year. Revenue excluding Pinnacle 21 was $75.8 million, up 8%. Net loss decreased to $0.6 million from $2.9 million, marking a significant improvement. Adjusted EBITDA rose to $28.0 million, reflecting 9% growth. While full-year guidance has been adjusted to $325-$335 million due to currency fluctuations and slow regulatory market recovery, Certara remains optimistic about its biosimulation and Pinnacle 21 services.

Certara, Inc. recently announced the release of Pinnacle 21 Enterprise version 5.2.0, enhancing biosimulation software for validating clinical trial data. This update includes new analytics features to ensure compliance with FDA regulations, improved team collaboration tools, and enhanced security measures. The new Pinnacle 21 Data Exchange module streamlines data ingestion from external sources, promising significant time savings in clinical studies, as evidenced by a recent pilot with a major pharmaceutical client.

Certara has announced a two-year collaboration with Memorial Sloan Kettering Cancer Center (MSK) to develop a new biosimulation platform aimed at enhancing CAR T-cell therapies for multiple myeloma. The initiative will utilize de-identified clinical data from MSK to optimize dosing strategies and evaluate combination therapies. Dr. Sham Mailankody emphasized the need for improved treatments for relapsed patients. This partnership aims to accelerate innovative solutions to improve cancer therapy outcomes.

Certara, a leader in biosimulation, has appointed Rosemary Crane to its Board of Directors, effective July 21, 2022. This addition increases the board to eleven members. CEO William F. Feehery expressed enthusiasm about Crane's experience in executive leadership and commercialization, which is expected to significantly benefit the company’s growth in the biopharmaceutical sector. Crane brings over 35 years of industry experience, having held leadership positions at several major pharmaceutical companies, including a successful IPO at Epocrates.