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Outlook Therapeutics, Inc. Logo Outlook Therapeutics Appoints C. Russell Trenary III as President and Chief Executive Officer

Key Takeaway: Outlook Therapeutics, Inc. Logo Outlook Therapeutics Appoints C. Russell Trenary III as President and Chief Executive Officer Experienced executive with a track-record of successful eye care product launches Appointment reflects Outlook Therapeutics' dedication to transition

Full Press Release Details

Outlook Therapeutics, Inc. Logo
Outlook Therapeutics Appoints C. Russell Trenary III as
President and Chief Executive Officer
Experienced executive with a track-record of successful eye care product launches
Appointment reflects Outlook Therapeutics' dedication to transition to commercial-stage company
ISELIN, N.J., July 07, 2021 (GLOBE NEWSWIRE) -- Outlook
Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved
ophthalmic formulation of bevacizumab for use in retinal indications, today announced the appointment of C. Russell
Trenary III as President, Chief Executive Officer and a member of the Board of Directors. Lawrence A. Kenyon, who has served as
Outlook Therapeutics' President, CEO and CFO since June 2018, will continue serving as CFO and as a member of the Board of
"We are pleased to welcome Russ
to the executive leadership team. We believe his leadership and expertise is an invaluable asset as we look to optimize our position
in the retina industry and prepare to submit a Biologics License Application (BLA) for ONS-5010 and, if approved, launch our commercialization
efforts. With the addition of Russ, we have the right leadership team to develop a fully integrated ophthalmic company," stated
Randy Thurman, Executive Chairman of the Outlook Therapeutics Board of Directors.
Mr. Trenary brings over 35 years of
experience in the life sciences industry, specifically in medical ophthalmic implant sales, marketing, and business development. Over
the course of his career, he has closely led four major product launches in eye care medical devices. Additionally, Mr. Trenary has played
a key role in seven acquisitions including, most recently, the sale of InnFocus, Inc. to Santen.
to be joiningOutlook Therapeutics at such a critical point in the company's history. If approved, ONS-5010 represents a rare opportunity
to transform the standard of care and significantly impact the retina market for years to come," commented Mr. Trenary, President
and Chief Executive Officer of Outlook Therapeutics. "I would like to congratulate Larry and the rest of the executive leadership
team for their efforts in bringingOutlook Therapeutics to this transition point. I look forward to building on this momentum and driving
Outlook Therapeutics to the next transformational phase of growth."
Mr. Trenary joins Outlook Therapeutics
having most recently served as an Executive Advisor at InnFocus Inc., after serving as President & CEO for seven years, including
the company's acquisition in August 2016 by Santen Pharmaceutical Co., Ltd. InnFocus is an early-stage company, pending FDA approval
of the PRESERFLO MicroShunt glaucoma device, and other microsurgical solutions for glaucoma based on SIBS technology. Prior to that,
he served as President and CEO of G&H Orthodontics, a global medical device company, and served in a number of senior leadership
positions at Advanced Medical Optics (AMO), Inc., including as President of the cataract business unit. Prior to that, Mr. Trenary held
C-suite positions at Sunrise Technologies International, Inc., served as Senior Vice President, Worldwide Sales & Marketing / Officer
at VidaMed, Inc. and held several senior leadership roles at Allergan, Inc., including as Senior Vice President and General Manager of
the Medical Optics business unit.
Mr. Thurman on behalf of the Board
of Outlook Therapeutics added, "We are very fortunate to be able to bring Russ on to theOutlook Therapeutics team at this important
point in the ONS-5010 program. Russ' history of providing experienced CEO leadership, multiple successful eye health related product
launches and value creation for shareholders will be important as we turn our focus to building Outlook Therapeutics and launching the
next phase for ONS-5010. We are excited about the continued evolution of Outlook Therapeutics and believe we are poised for continued
progress in the near and long-term. Furthermore, the Board would like to thank Larry Kenyon who has served as Outlook's President,
CEO and CFO for the last 3 years. During that time, Larry successfully restructured the company, completed several rounds of fundraising
and led Outlook Therapeutics to this successful moment of transition. We are very pleased that Larry will continue as Chief Financial
Officer and a member of our Board."
Outlook Therapeutics remains on track
to report topline data from its pivotal NORSE TWO safety and efficacy study evaluating ONS-5010 (bevacizumab-vikg) for treatment of wet
age-related macular degeneration (wet AMD) in the third calendar quarter of 2021. Following the data readout for NORSE TWO, Outlook Therapeutics
plans to submit a new BLA filing under the PHSA 351(a) regulatory pathway in the first quarter of calendar 2022. If the BLA is approved,
it will result in 12 years of marketing exclusivity for ONS-5010 as the first and only ophthalmic formulation of bevacizumab approved
by the FDA to treat wet AMD.
Outlook Therapeutics is also developing
registration documents on a parallel path for approvals in Europe and expects to submit them shortly after completing the filing to the
FDA. While Outlook Therapeutics continues to target potential strategic commercialization partners, particularly for European markets,
it is preparing to launch ONS-5010 in the United States by itself, pending FDA approval.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical
company working to develop and launch ONS-5010 / LYTENAVA (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation
of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 ophthalmic bevacizumab is approved, Outlook
Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating
retinal diseases in the United States, United Kingdom, Europe, Japan and other markets. Outlook Therapeutics expects to file ONS-5010
ophthalmic bevacizumab with the U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway. For more information, please visit www.outlooktherapeutics.com.
Forward-Looking Statements
This press release contains
forward-looking statements. All statements other than statements of historical facts are "forward-looking statements," including
those relating to future events. In some cases, you can identify forward-looking statements by terminology such as "may,"
"might," "will," "should," "expect," "plan," "anticipate," "project,"
"believe," "estimate," "predict," "potential," "intend" or "continue,"
the negative of terms like the other comparable terminology, and other words or terms of similar meaning. These include, among others,
statements about the timing of completion of, and pivotal safety and efficacy data from, NORSE 2, ONS-5010's potential as the first
FDA-approved ophthalmic formulation of bevacizumab-vikg, including benefits therefrom to patients, payors and physicians, including expectations
of market exclusivity, the timing of BLA submission and commercial launch of ONS-5010, and plans for regulatory approvals in other markets.
Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based
on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating
to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk
factors include those risks associated with developing pharmaceutical product candidates, risks of conducting clinical trials and risks
in obtaining necessary regulatory approvals, as well as those risks detailed in Outlook Therapeutics' filings with the Securities
and Exchange Commission, including the Annual Report on Form 10-K for the fiscal year ended September 30, 2020, as amended, and subsequent
Quarterly Reports on Form 10-Q, which include the uncertainty of future impacts related to the ongoing COVID-19 pandemic. These risks
may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All
forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics
does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information,
future events or otherwise, except as may be required under applicable securities law.
LaVoie Health Science
Chief Executive Officer
Source: Outlook Therapeutics, Inc.
Last updated: Jul 7, 2021