Graybug Vision Makes Key Hires to Further Build Momentum Behind its Pipeline

Rhea-AI Summary

Graybug Vision, Inc. (NASDAQ: GRAY) announced the hiring of six new employees to bolster its Research & Development, Regulatory Affairs, and Program Management teams. CEO Fred Guerard emphasized the importance of expanding their ophthalmology team to enhance their clinical pipeline in 2022. Key hires include Fang Li, VP of Regulatory Affairs, and Ali Kakavand, VP of Program Management, both bringing over 20 years of relevant experience. Additionally, the company granted inducement options for 234,200 shares at an exercise price of $1.55, aligned with its strategic growth initiatives.

Positive

• Expansion of the leadership team with experienced hires in critical areas, enhancing R&D and regulatory capabilities.
• Potential improvement in clinical pipeline execution with new expertise in regulatory affairs and program management.

Negative

• Concerns about continuity and the integration of new management personnel into existing teams.
• Potential risks associated with execution delays in the clinical pipeline due to transitions.

BALTIMORE, Jan. 20, 2022 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today announced the hiring of six new employees who will enhance Graybug’s Research & Development (R&D), Regulatory Affairs and Program Management capabilities, as the Company further builds momentum behind its pipeline in 2022.

“We are at a critical stage in our efforts to further progress and diversify our pipeline with new, high-value programs. I strongly believe that strengthening our world-class ophthalmology team is key to our future success. I am therefore pleased to welcome several new team members, who add critical leadership in Regulatory Affairs and Program Management, as well as further deepen our teams’ capabilities in R&D,” said Fred Guerard, Pharm D, CEO of Graybug.

Among Graybug’s key hires are Fang Li, Vice President, Regulatory Affairs, and Ali Kakavand, Vice President, Head of Program Management:

• Fang Li, PhD, RAC, brings over 30 years of drug development and more than 20 years of regulatory affairs experience. She worked across small molecules, biologics, gene therapy, over-the-counter products, in-vitro diagnostic products, and medical devices, with a focus on ophthalmology. She has a proven track record in negotiating and gaining regulatory approvals in the US and other regions. Most recently, Fang was VP, Regulatory Affairs at Hurley Consulting Associated, Ltd where she led the regulatory affairs department providing strategic and operational services to clients in the pharmaceutical and biotech industry. Fang holds a doctoral degree in medicinal chemistry from China Pharmaceutical University, Nanjing, a master’s degree in organic chemistry from Wuhan University, and a bachelor's degree in organic chemistry from Xiamen University, P. R. China.
  
  
• Ali Kakavand, PhD, has over 20 years of experience in program and project management for the development of medical devices and pharmaceuticals across multiple therapeutic areas. He has extensive knowledge in the management of global clinical studies, device development, clinical manufacturing, as well as regulatory submissions. Most recently, Ali served as Director of Strategy, Program and Portfolio Management at Alexion (acquired by AstraZeneca) managing a first-of-its-kind marketed drug in hematology, as well as a drug/device combination product in phase 1 clinical development. Ali received his PhD in Biomedical Engineering from Arizona State University, where he completed his dissertation conducting research at The Neurosciences Institute in the field of Biomechanics and Neuromuscular Control.
  

The compensation committee of Graybug’s board of directors granted the six newly-hired employees inducement options to purchase an aggregate of 234,200 shares of Graybug common stock on January 14, 2022, as inducements material to each employee entering employment with Graybug. The options were granted in accordance with Nasdaq Listing Rule 5635(c)(4).

The options have an exercise price of $1.55 per share, which was equal to the closing price of Graybug common stock on the grant date. One-fourth of the options vest on the one-year anniversary of the vesting commencement date and the remainder vest in equal monthly installments over the next three years, in each case subject to the new employee’s continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of a stock option agreement covering the grant.

About Graybug

Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve. The company’s proprietary ocular delivery technologies are designed to maintain effective drug levels in ocular tissue for six months and potentially longer, improving disease management, reducing healthcare burdens and ultimately delivering better clinical outcomes. Graybug’s lead product candidate, GB-102, a formulation of the pan-vascular endothelial growth factor (VEGF) inhibitor, sunitinib malate targeting a six-month or longer dosing regimen, inhibits multiple neovascular pathways for the intravitreal treatment of retinal diseases, including wet age-related macular degeneration. Graybug’s other product candidates developed using its proprietary technologies also include GB-401, an injectable sustained release formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer. Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug has offices in Redwood City, California, and in Baltimore, Maryland. For more information, please visit www.graybug.vision.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 including, but not limited to, statements regarding the company’s clinical pipeline, its ability to advance GB-102, GB-401, or any future product candidate through preclinical or clinical development, its ability to achieve its anticipated milestones within the timing outlined above or at all, its ability to conduct planned operations within the evolving constraints arising from the COVID-19 pandemic, and the timing, cost, and results of its clinical trials. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties described under the heading “Risk Factors” in the company’s annual report on Form 10-K filed for the year ended December 31, 2020, in its subsequent quarterly reports on Form 10-Q, and in the other reports the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

Investor Contact IR@graybug.vision (650) 487-2409

Media Contact media@graybug.vision (404) 384-0067

FAQ

What recent management changes occurred at Graybug Vision?

Graybug Vision announced the hiring of six new employees to strengthen its Research & Development, Regulatory Affairs, and Program Management teams.

Who are the notable new hires at Graybug Vision?

Notable new hires include Fang Li, VP of Regulatory Affairs, and Ali Kakavand, VP of Program Management, both with extensive industry experience.

What is the significance of the new hires for Graybug Vision's stock (GRAY)?

The new hires are expected to enhance Graybug's R&D and regulatory capabilities, potentially benefiting the company's clinical pipeline and stock performance.

What stock options were granted to new employees at Graybug Vision?

Six new employees were granted inducement options to purchase a total of 234,200 shares at an exercise price of $1.55 per share.