Tenax Therapeutics Appoints Gillian Andor Vice President, Clinical Operations

Rhea-AI Summary

Tenax Therapeutics (NASDAQ: TENX) has appointed Gillian Andor, MSc, as Vice President of Clinical Operations. Andor brings over 20 years of experience and will lead the company's Clinical Operations function, supporting the ongoing Phase 3 LEVEL study of oral levosimendan (TNX-103) for PH-HFpEF treatment.

Andor's track record includes successful roles at Noema Pharma as Interim Head of Clinical Development Operations and at Sage Therapeutics, where she led programs resulting in NDA approvals for Zulresso® and Zurzuvae®. At Ironwood Pharmaceuticals, she contributed to the NDA approval of Linzess®.

The company granted Andor an inducement equity award of 250,000 stock options at $6.44 per share, vesting over four years in equal annual installments.

Positive

• Appointment of experienced executive with proven track record in successful NDA submissions
• Strategic hire to accelerate Phase 3 program execution
• Executive's experience includes multiple FDA drug approvals

Negative

• Equity compensation package creates potential dilution for shareholders

CHAPEL HILL, N.C., Jan. 22, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced the appointment of Gillian Andor, MSc, as Vice President, Clinical Operations.

Ms. Andor will lead the Company’s expanding Clinical Operations function in support of the ongoing Phase 3 program evaluating oral levosimendan (TNX-103) for the treatment of pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF).

“We are pleased to welcome Gillian to the Tenax team at a critical time for our Company, as we continue to enroll patients in the Phase 3 LEVEL study and finalize plans to initiate our second pivotal study,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “We believe Gillian’s significant experience executing clinical development programs resulting in NDA submissions and approvals will help us accelerate our Phase 3 program, and ensure we are prepared for global regulatory filings.”

Ms. Andor has over 20 years of experience in Clinical Operations. She served most recently as Interim Head, Clinical Development Operations with Noema Pharma, focused on CNS disorders, where she led Clinical Operations and Data Management functions. Prior, she served as Head of Portfolio Operations for Sage Therapeutics, achieving multiple promotions during her nine-year tenure and building a high-functioning Clinical Operations department. Ms. Andor led and supervised the global clinical development programs across Sage’s portfolio in neurology and CNS disorders including successful NDA submissions and approvals for Zulresso^® and Zurzuvae^®, the first approved medications for postpartum depression. Prior to joining Sage, Ms. Andor held multiple positions within Clinical Operations for Ironwood Pharmaceuticals where she successfully planned, managed, and executed U.S. and European clinical studies in GI disorders, most notably contributing to the NDA and approval of Linzess^® for IBS-C.

Ms. Andor received a BSc Anatomy (Honors) from the University of Glasgow, where she finished with first class honors, and an MSc in Forensic Science from the University of Strathclyde.

Tenax Therapeutics also announced the issuance on January 21, 2025 of an inducement equity award to Ms. Andor in connection with her appointment to the position of Vice President, Clinical Operations of the Company effective the same day. The award consists of an option to purchase 250,000 shares of the Company’s common stock. The award will vest in four equal annual installments beginning on the first anniversary of the date of issuance, subject to Ms. Andor’s continued employment with the Company through each applicable vesting date. The exercise price for the option is $6.44. The award was approved in accordance with Nasdaq Listing Rule 5635(c)(4).

About Tenax Therapeutics

Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company owns global rights to develop and commercialize levosimendan, which it has prioritized in the near term. Tenax Therapeutics also may resume developing its unique oral formulation of imatinib. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.

Caution Regarding Forward-Looking Statements

Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; risks related to our business strategy, including the prioritization and development of product candidates; risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; the potential advantages of our product candidates; risks associated with our cash needs; our competitive position; intellectual property risks; volatility and uncertainty in the global economy and financial markets in light of the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law.

Contacts

Investor Contact:
John Fraunces
Managing Director
LifeSci Advisors, LLC
C: 917-355-2395
jfraunces@lifesciadvisors.com

or

Brian Mullen
LifeSci Advisors, LLC
C: 203-461-1175
bmullen@lifesciadvisors.com

FAQ

What role did Tenax Therapeutics (TENX) appoint Gillian Andor to in January 2024?

Tenax Therapeutics appointed Gillian Andor as Vice President of Clinical Operations to lead the company's Clinical Operations function.

What are the details of TENX's inducement equity award to Gillian Andor?

The inducement equity award consists of 250,000 stock options at an exercise price of $6.44, vesting over four years in equal annual installments.

What is the current phase of TENX's levosimendan (TNX-103) development?

TNX-103 is currently in Phase 3 clinical trials (LEVEL study) for the treatment of pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF).

What major drug approvals has Gillian Andor been involved with before joining TENX?

Andor contributed to the NDA approvals of Zulresso® and Zurzuvae® at Sage Therapeutics for postpartum depression, and Linzess® at Ironwood Pharmaceuticals for IBS-C.