Noveome Biotherapeutics, Inc. Announces Appointment of Kevin E. McCracken as Senior Vice President of Operations

PITTSBURGH, PA – October 24, 2019 – Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced the appointment of Kevin E. McCracken, B.S., M.B.A., as Senior Vice President of Operations.

“Kevin brings over two decades of biopharmaceutical operational expertise and we are excited to welcome him to the Noveome team as we begin to shift to a later-stage clinical company and expand the breadth of our leadership team,” said William J. Golden, CFA, Founder, Chairman and CEO of Noveome. “We look forward to Kevin’s strategic insights as we continue to grow Noveome and further refine our scalable manufacturing capabilities.”

“I am thrilled to join Noveome at such an exciting time,” said Mr. McCracken. “In recent years, the company has made great progress exploring the potentially broad applications of ST266 and I look forward to contributing to an efficient clinical and manufacturing progression of ST266 and its diverse application across numerous indications.”

Mr. McCracken joins Noveome with over 24 years of experience in the biopharmaceutical industry, with roles in quality control, quality assurance, validation, manufacturing and supply chain operations. Most recently, Mr. McCracken was the Vice President of Chemistry, Manufacturing and Controls at Kadmon Pharmaceuticals, where he spent 11 years. His additional roles included various quality roles at MedImmune supporting the development, approval and commercial production of Synagis® and other biologics. Mr. McCracken also served as the Director of Quality for Acambis overseeing QA, QC and validation activities at a facility for the aseptic filling of live smallpox vaccine. Mr. McCracken holds a B.S. in Microbiology from the University of Pittsburgh as well as an M.B.A from Frostburg State University.

About Noveome Biotherapeutics, Inc.
Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome’s multi-target platform biologic and lead product, ST266, is currently being evaluated in multiple indications across ophthalmic, CNS, dermatologic, gastrointestinal and pulmonary therapeutic areas. In addition to the Phase 1 open label clinical trial to establish the safety of ST266 when delivered intranasally, Noveome is currently conducting a Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing PEDs when delivered topically to the eye. Preclinical results testing ST266 in chronic traumatic encephalopathy (CTE), emphysema, polytrauma, and necrotizing enterocolitis (NEC) are expected in late 2019 / early 2020. The Company received seed funding from Lancet Capital, a venture capital consortium of leading Pittsburgh healthcare institutions including UPMC Health System, Highmark Health, University of Pittsburgh and Carnegie Mellon University. To date, Noveome has received over $120 million in research and infrastructure funding from the U.S. Department of Defense, the Commonwealth of Pennsylvania and Allegheny County. Noveome is based in Pittsburgh, PA. For more information, please visit, www.noveome.com.

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Investor Contact:
Julie Seidel
Stern Investor Relations, Inc.
212-362-1200
julie.seidel@sternir.com

Noveome Biotherapeutics, Inc. To Present At The 2019 Flagship Ophthalmology Innovation Summit

PITTSBURGH, PA – October 3, 2019 – Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced David Steed, M.D., Executive VP of Medical Affairs, Chief Medical Officer of Noveome Biotherapeutics, will present details on its optic nerve disease clinical program at the 2019 Flagship Ophthalmology Innovation Summit (OIS) on Thursday, October 10, 2019 at 11:44 am P.T. in San Francisco, CA. Dr. Steed’s presentation will follow an introduction by long time Ophthalmology Commercial Executive, Patrick Welch, MBA, who was previously VP of Sales and Marketing for the U.S. Retina Business Unit at Allergan.

About The Optic Nerve Disease Clinical Program

ST266 has been shown to protect and resuscitate neural and retinal ganglion cells in preclinical models of optic neuritis and optic nerve crush. Noveome is employing an innovative, non-invasive, targeted intranasal device to deliver ST266 directly to the optic nerve. This route of administration by-passes the blood-brain barrier, historically a major hurdle to the successful delivery of medicines to the central nervous system. Noveome is currently conducting a Phase 1 open label clinical trial to establish the safety of ST266 when delivered by this intranasal route. Topline data are expected in 2019.

About Noveome Biotherapeutics, Inc.

Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next- generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome’s multi-target platform biologic and lead product, ST266, is currently being evaluated in multiple indications across ophthalmic, CNS, pulmonary, and gastrointestinal therapeutic areas. In addition to the Phase 1 open label clinical trial to establish the safety of ST266 when delivered intranasally, Noveome is currently conducting a Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing PEDs when delivered topically to the eye. Topline data for thistrial are expected in 2019. Preclinical resultstesting ST266 in chronic traumatic encephalopathy (CTE), emphysema, polytrauma, and necrotizing enterocolitis (NEC) are also expected later in 2019. The Company received seed funding from Lancet Capital, a venture capital consortium of leading Pittsburgh healthcare institutions including UPMC Enterprises, Highmark Blue Cross/Blue Shield, University of Pittsburgh and Carnegie Mellon University. To date, Noveome has received over $120 million in research and infrastructure funding from the U.S. Department of Defense, the Commonwealth of Pennsylvania and Allegheny County. Noveome is based in Pittsburgh, PA. For more information, please visit, www.noveome.com.

Investor Contact:
Julie Seidel
Stern Investor Relations, Inc.
212-362-1200
julie.seidel@sternir.com

– Topline results expected by end of the second quarter of 2020 –

PITTSBURGH, PA – September 26, 2019 – Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced initiation of a Phase 1 open label clinical trial to establish the safety of ST266 when delivered intranasally in patients diagnosed with intraocular hypertension who have not yet developed optic nerve damage.

ST266 is a novel “secretome,” cell-free platform biologic, containing hundreds of proteins and other biological factors involved in cellular healing. For delivery to the optic nerve and brain, ST266 is administered as a nasal spray using the SipNose, Ltd. device and is delivered to the cribriform plate, located at the back of the upper nasal cavity directly to the optic nerve and brain, bypassing the blood-brain barrier.

“The initiation of this Phase 1 clinical trial of intranasally delivered ST266 is an exciting milestone for Noveome as we continue to execute on the vast potential of our cell-free platform biologic in a variety of indications. Based on foundational preclinical results in animal models demonstrating the safety and efficacy of this approach to nerve damage and inflammation, published in Nature Scientific Reports, we believe that ST266 is poised to not only treat the symptoms of optic nerve damage and inflammation, but also the underlying disease,” said William J. Golden, Founder, Chairman and Chief Executive Officer of Noveome. “We hope to continue to execute across our broad pipeline of indications and develop potential treatments for additional ophthalmologic and central nervous system conditions such as optic neuritis, glaucoma and chronic traumatic encephalopathy.”

“ST266 is a first-of-its-kind platform biologic product that we believe holds great promise in relieving the suffering of patients across a diverse set of diseases and conditions who currently have limited treatment options,” said David L. Steed, M.D., Executive Vice President, Medical Affairs and Chief Medical Officer of Noveome. “Noveome has already treated more than 237 patients with ST266 in nine clinical trials in various indications and in all cases, ST266 demonstrated a strong safety profile with no drug related serious adverse events reported.”

The Phase 1 open label clinical trial is being conducted at the University of Pennsylvania and is designed to assess the safety of intranasally delivered ST266 in patients diagnosed with a pre-glaucoma condition called intraocular hypertension, characterized by a lack of damage to the optic nerve. Dosing will occur in three cohorts. In the first cohort, subjects will be administered ST266, delivered intranasally, at a dose of two hundred microliters (200 µL) daily for 14 days, in alternating single nostrils. In the second cohort, subjects will be administered 200 µL to each nostril daily (400 µL total per day) for 14 days. In the third cohort, subjects will be administered 200 µL to each nostril daily (400 µL total per day) for 28 days. More information about the study is available at www.clinicaltrials.gov under the identifier NCT03901781. Topline results are expected in the second quarter of 2020.

About ST266
ST266 is a cell-free biologic containing hundreds of proteins and other factors involved in cellular healing, protection of the brain and nerves, and modulation of inflammation. ST266 is produced by collecting proteins and other factors secreted by a novel population of cells generated by a proprietary method of culturing amnion-derived epithelial cells collected from full term placentas which are normally discarded after birth. This secretome contains physiologic levels of multiple growth factors and cytokines and stimulates a variety of anti-inflammatory and neuroprotective responses in preclinical studies. In addition to ophthalmologic conditions, ST266 is being evaluated in central nervous system (CNS) conditions, pulmonary, gastrointestinal and polytrauma conditions. The ST266 platform biologic enables the use of a scalable manufacturing process to produce quantities for all indications, A drug master file has been submitted with the FDA, supporting all ST266 investigational new drug (IND) applications.

About Noveome Biotherapeutics, Inc.
Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome’s – platform biologic and lead product, ST266, is currently being evaluated in multiple indications across ophthalmic, CNS, pulmonary and gastrointestinal therapeutic areas. Noveome has an ongoing Phase 2 trial in nonhealing persistent corneal defects for which topline results are expected in the first quarter of 2020. The Company expects to begin a Phase 2 trial in cataract surgery in the first quarter of 2020. In addition to the clinical pipeline, preclinical results testing ST266 in chronic traumatic encephalopathy (CTE), emphysema necrotizing enterocolitis (NEC) and polytrauma are also expected later in 2019. The Company received seed funding from Lancet Capital, a venture capital consortium of leading Pittsburgh healthcare institutions including UPMC Enterprises, Highmark Blue Cross/Blue Shield, University of Pittsburgh and Carnegie Mellon University. To date, Noveome has received over $120 million in research and infrastructure funding from the U.S. Department of Defense, the Commonwealth of Pennsylvania and Allegheny County. Noveome is based in Pittsburgh, PA. For more information, please visit, www.noveome.com.

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Investor Contact:
Julie Seidel
Stern Investor Relations, Inc.
212-362-1200
julie.seidel@sternir.com

PITTSBURGH, PA – September 5, 2019 – Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced the passing of long-time and valued member of the company’s Board of Directors, John H. McArthur.

“We are deeply saddened by the passing of John McArthur. He was a dedicated member of Noveome’s Board of Directors for over ten years and provided invaluable insight, support and knowledge. We greatly benefited from his extensive network and credentials in both healthcare and academia, including his 15 years as dean of Harvard Business School,” said William J. Golden, Founder, Chairman and Chief Executive Officer of Noveome. “We appreciate all of his contributions to Noveome and our thoughts are with John’s family.”

About Noveome Biotherapeutics, Inc.
Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome’s multi-target platform biologic and lead product, ST266, is currently being evaluated in multiple indications across ophthalmic, CNS, pulmonary, and gastrointestinal therapeutic areas. In addition to the Phase 1 open label clinical trial to establish the safety of ST266 when delivered intranasally, Noveome is currently conducting a Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing PEDs when delivered topically to the eye. Topline data for this trial are expected in 2019. Preclinical results testing ST266 in chronic traumatic encephalopathy (CTE), emphysema, polytrauma, and necrotizing enterocolitis (NEC) are also expected later in 2019. The Company received seed funding from Lancet Capital, a venture capital consortium of leading Pittsburgh healthcare institutions including UPMC Enterprises, Highmark Blue Cross/Blue Shield, University of Pittsburgh and Carnegie Mellon University. To date, Noveome has received over $140 million in research and infrastructure funding from the U.S. Department of Defense, the Commonwealth of Pennsylvania and Allegheny County. Noveome is based in Pittsburgh, PA. For more information, please visit, www.noveome.com.

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Investor Contact:
Julie Seidel
Stern Investor Relations, Inc.
212-362-1200
julie.seidel@sternir.com

Topline results expected by end of 2019
PITTSBURGH, PA – June 13, 2019 – Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced the dosing of the first patient in its Phase 2 open label, multi-center clinical trial evaluating topical ocular delivery of ST266 for the treatment of persistent corneal epithelial defects (PEDs), for which there are limited treatment options.

“The dosing of the first patient in our Phase 2 clinical trial marks an important milestone for Noveome as we continue to explore ST266’s safety, efficacy and broad therapeutic applicability. We believe that ST266 has the potential to provide an innovative treatment option as a novel cell-free platform biologic based on the results we have seen to date in both preclinical and clinical trials demonstrating a strong safety profile,” said William J. Golden, Founder, Chairman and Chief Executive Officer of Noveome. “In this trial, we will measure both the magnitude and speed of response, as well as the number of completely healed patients and the time to complete healing in the study eye of PED patients.”

The Phase 2 open label, multi-center clinical trial will evaluate the safety and efficacy of topical delivery of ST266 in patients with PEDs. The primary endpoint of the clinical trial is to complete healing as determined by fluorescein dye after 28 days of therapy. Each patient will receive a total of 4 doses per day of ST266 over the course of 28 days in the study eye. More information about the study is available at www.clinicaltrials.gov under the identifier NCT03687632. Topline results are expected later in 2019.

About Persistent Corneal Epithelial Defects (PEDs)
PEDs are non-healing wounds of the cornea caused by trauma, surgery and infection for which there are limited treatment options. Failure of the epithelial cells in the cornea to migrate and close the wound can lead to scarring and possibly perforation and blindness, especially in patients with severe dry eye and diabetes.

About ST266
ST266 is a cell-free “platform” biologic containing hundreds of proteins and other factors involved in cellular healing, protection of the brain and nerves, and modulation of inflammation. The components of ST266 are secreted by a novel population of cells generated by a proprietary method of culturing amnion-derived epithelial cells collected from full term placentas, which are normally discarded after birth. This “secretome” contains physiologic levels of multiple growth factors and cytokines and stimulates a variety of anti-inflammatory and neuroprotective responses in preclinical studies. In addition to central nervous system (CNS) conditions, ST266 is being evaluated in ophthalmologic, pulmonary and gastrointestinal conditions. The ST266 platform biologic enables the use of a scalable manufacturing process to produce quantities for all indications, A drug master file has been submitted with the FDA, supporting all ST266 investigational new drug (IND) applications.

About Noveome Biotherapeutics, Inc.
Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome’s multi-target platform biologic and lead product, ST266, is currently being evaluated in multiple indications across CNS, ophthalmic, pulmonary and gastrointestinal therapeutic areas. Noveome is planning to start a Phase 1 open label clinical trial to establish the safety of ST266 when delivered intranasally in 2Q 2019 as well as a Phase 2/3 clinical trial of ST266 in patients with cataracts in 4Q 2019. In addition to the clinical pipeline, preclinical results testing ST266 in chronic traumatic encephalopathy (CTE), emphysema and necrotizing enterocolitis (NEC) are also expected later in 2019. The Company received seed funding from Lancet Capital, a venture capital consortium of leading Pittsburgh healthcare institutions including UPMC Enterprises, Highmark Blue Cross/Blue Shield, University of Pittsburgh and Carnegie Mellon University. To date, Noveome has received over $120 million in research and infrastructure funding from the U.S. Department of Defense, the Commonwealth of Pennsylvania and Allegheny County. Noveome is based in Pittsburgh, PA. For more information, please visit, www.noveome.com.
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Investor Contact:
Julie Seidel
Stern Investor Relations, Inc.
212-362-1200
julie.seidel@sternir.com

PITTSBURGH, PA – May 9, 2019 – Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced the publication of preclinical results for ST266, its proprietary, cell-free platform biologic, published in the Journal of Neuro-Ophthalmology. These new results further support the neuroprotective properties of intranasally delivered ST266 in mice with experimental autoimmune encephalomyelitis (EAE)-induced experimental optic neuritis (ON).

The publication entitled, “Effects of Varying Intranasal Treatment Regimens in ST266-Mediated Retinal Ganglion Cell Neuroprotection,” details the preclinical study exploring the neuroprotective effects of daily and twice daily intranasally delivered ST266 to evaluate different treatment regimens an EAE-induced experimental ON mouse model.

“In previous studies, we showed that a single daily dose of ST266 administered through the nose diminished visual dysfunction, prevented retinal ganglion cell loss, and reduced both inflammation and demyelination six weeks after induction of EAE,” said Larry Brown, Sc.D., Noveome’s Chief Scientific Officer.

Kenneth S. Shindler, M.D., Ph.D., an associate professor of Ophthalmology in the Perelman School of Medicine at the University of Pennsylvania and Penn’s Scheie Eye Institute, and senior author on the paper continued, “In this study we demonstrated the ability of ST266 to confer longer-term neuroprotective effects, by showing that EAE mice that received either once or twice daily intranasal drops of ST266 starting from day 15 and repeated through day 56 showed significant preservation of vision, significant preservation of retinal ganglion cells, and significant reduction in optic nerve inflammation.”

“We are pleased to see these strong preclinical results that further validate this approach to non-cellular therapeutic treatment for optic nerve diseases. These results demonstrate the promise of our novel platform biologic, in which the multiple growth factors and anti-inflammatory cytokines present in ST266 are able to achieve neuroprotective benefits in varying intranasal treatment regimens,” said William J. Golden, Founder, Chairman and Chief Executive Officer of Noveome. “With this foundational science in hand, we look forward to further exploring ST266’s neuroprotective properties in our growing CNS pipeline with data from our Phase 1 clinical trial of intranasal ST266 in patients at risk of developing optic nerve disease expected later this year.”

About Noveome Biotherapeutics, Inc.
Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome’s multi-target platform biologic and lead product, ST266, is a complex, non-cellular product containing hundreds of biologically active proteins and other biologic factors. ST266 is currently being evaluated in multiple indications across CNS, ophthalmic, pulmonary and gastrointestinal therapeutic areas. Topline data from an ongoing Phase 1 trial using a novel intranasal delivery method to deliver ST266 to the optic nerve and brain and an ongoing Phase 2 trial in corneal defects are expected later in 2019. In addition, preclinical results testing ST266 in chronic traumatic encephalopathy, emphysema and necrotizing enterocolitis are also expected later in 2019. The Company received seed funding from Lancet Capital, a venture capital consortium of leading Pittsburgh healthcare institutions including UPMC Enterprises, Highmark Blue Cross/Blue Shield, University of Pittsburgh and Carnegie Mellon University. To date, Noveome has received over $120 million in research and infrastructure funding from the U.S. Department of Defense, the Commonwealth of Pennsylvania and Allegheny County. Noveome is based in Pittsburgh, PA. For more information, please visit, www.noveome.com.

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Investor Contact:
Julie Seidel
Stern Investor Relations, Inc.
212-362-1200
julie.seidel@sternir.com

PITTSBURGH, PA – April 9, 2019 – Noveome Biotherapeutics, Inc., a Pittsburgh-based biopharmaceutical company in clinical-stages focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced the closing of a $15 million Series D financing. The financing was led by a new institutional investor in addition to existing investors. Prior to this Series D financing, Noveome has raised a total of $144 million in capital from both private equity investors and non-dilutive capital from the U.S. Department of Defense and the Commonwealth of Pennsylvania and Allegheny County.

Proceeds from the financing will be used to support the advancement of the Company’s clinical stage programs investigating its proprietary, cell-free platform biologic, ST266, for the treatment of both ophthalmological and central nervous system (CNS) disorders.

“We are encouraged by the support from both our new and existing investors in this Series D financing, providing Noveome with the necessary funding to progress our clinical stage ophthalmological and CNS disorder programs into further clinical studies, in addition to advancing our broader pipeline of exciting indications,” said William J. Golden, Founder, Chairman and Chief Executive Officer of Noveome Biotherapeutics, Inc. “We look forward to executing on the promise of our growing pipeline, focusing on the potential broad therapeutic applicability of our novel, cell-free platform biologic, ST266, as we work to deliver novel treatment methods to patients suffering from a wide variety of complex diseases.”

About Noveome Biotherapeutics, Inc.
Noveome Biotherapeutics, Inc. is a Pittsburgh-based biopharmaceutical company in clinical-stages focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome’s multi-target platform biologic and lead product, ST266, is a complex, non-cellular product containing hundreds of biologically active proteins and other biologic factors. ST266 is currently being evaluated in multiple indications across CNS, ophthalmic, pulmonary and gastrointestinal therapeutic areas. Topline data from an ongoing Phase 1 trial using a novel intranasal delivery method to deliver ST266 to the optic nerve and brain and an ongoing Phase 2 trial in corneal defects are expected later in 2019. In addition, preclinical results testing ST266 in chronic traumatic encephalopathy, emphysema and necrotizing enterocolitis are also expected later in 2019. The Company received seed funding from Lancet Capital, a venture capital consortium of leading Pittsburgh healthcare institutions including UPMC Enterprises, Highmark Blue Cross/ Blue Shield, University of Pittsburgh and Carnegie Mellon University. To date, Noveome has received over $120 million in research and infrastructure funding from the U.S. Department of Defense, the Commonwealth of Pennsylvania and Allegheny County. Noveome is based in Pittsburgh, PA. For more information, please visit, www.noveome.com.

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Investor Contact:
Julie Seidel
Stern Investor Relations, Inc.
212-362-1200
julie.seidel@sternir.com
https://www.bizjournals.com/pittsburgh/news/2019/04/22/this-pittsburgh-biotechcompany-just-raised-15m.html

PITTSBURGH, PA – April 2, 2019 – Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, announced today that William J. Golden, Founder, Chairman and Chief Executive Officer of Noveome Biotherapeutics, Inc., will present a company overview at the 18th Annual Needham Healthcare Conference on Tuesday, April 9, 2019 at 10:20 a.m. EDT in New York, NY.

About Noveome Biotherapeutics, Inc.
Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome’s multi-target platform biologic and lead product, ST266, is a complex, non-cellular product containing hundreds of biologically active proteins and other biologic factors. ST266 is currently being evaluated in multiple indications across CNS, ophthalmic, pulmonary and gastrointestinal therapeutic areas. Topline data from an ongoing Phase 1 trial using a novel intranasal delivery method to deliver ST266 to the optic nerve and brain and an ongoing Phase 2 trial in corneal defects are expected later in 2019. In addition, preclinical results testing ST266 in chronic traumatic encephalopathy, emphysema and necrotizing enterocolitis are also expected later in 2019. The Company received seed funding from Lancet Capital, a venture capital consortium of leading Pittsburgh healthcare institutions including UPMC Enterprises, Highmark Blue Cross/ Blue Shield, University of Pittsburgh and Carnegie Mellon University. To date, Noveome has received over $120 million in research and infrastructure funding from the U.S. Department of Defense, the Commonwealth of Pennsylvania and Allegheny County. Noveome is based in Pittsburgh, PA. For more information, please visit, www.noveome.com.

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Investor Contact
Julie Seidel
Stern Investor Relations, Inc.
212-362-1200
julie.seidel@sternir.com

Preclinical Data Suggests Use Beyond Conditions of the Eye
PITTSBURGH – May 24, 2018 – A newly published scientific study has demonstrated that damage to the optic nerve can be significantly reduced, with the potential for improved visual function, when treated with ST266, the lead product of Noveome Biotherapeutics, Inc.

The preclinical study involved animals with a crushed optic nerve, a condition humans can experience through head injury or eye disease.

Currently there are no existing treatments to lessen or reverse damage and vision loss resulting from optic nerve trauma, and no existing methods are able to restore the function of the optic nerve.

The research was conducted in collaboration with Kenneth S. Shindler, M.D., Ph.D., a professor of Ophthalmology in the Perelman School of Medicine at the University of Pennsylvania.

The findings were published this week in Investigative Ophthalmology and Visual Science in an article titled, “RGC Neuroprotection Following Optic Nerve Trauma Mediated by Intranasal Delivery of Amnion Cell Secretome.” http://iovs.arvojournals.org/article.aspx?articleid=2681860

“These results offer hope for this untreatable cause of permanent vision loss,” said Dr. Shindler. “Further testing and development of this novel therapy may provide an opportunity to reduce future vision loss and neurologic disability in a host of diseases that currently have little or no treatment options.”

Wider Implications
ST266 is a rich, complex solution of biologically active molecules secreted from Noveome’s proprietary cells. Instead of a single drug and target, ST266 targets numerous pathways involved in the regenerative repair of inflamed or damaged tissues.
In the study, Dr. Shindler administered ST266 non-invasively through the nasal passages such that the ST266 reached the olfactory nerve in the back of the nose. This method allows ST266 to be delivered directly to the optic nerve and brain, a different route than traditional intranasal delivery that requires absorption of drugs through nasal tissue into the bloodstream.
Dr. Shindler found that ST266 significantly reduced damage to the optic nerve, as measured by a standard vision test called optokinetic response (OKR). Furthermore, showing a trend toward improved visual function and more active nerve cells, ST266 increased survival of the retinal ganglion cells (RGCs) that transmit visual signals from the eye to the brain.

Noveome’s Chief Scientific Officer, Larry R. Brown, Sc.D., sees even greater possibilities for delivery of ST266 based on these results. “These promising results reinforce the multifaceted potential of targeted ST266 in multiple neurodegenerative conditions of the brain including traumatic brain injury, chronic traumatic encephalopathy, or diseases such as Alzheimer’s Disease, Parkinson’s Disease, amyotrophic lateral sclerosis and stroke,” said Dr. Brown.

The model used in this study is particularly useful for testing therapies for glaucoma, where increased eye pressure can damage the optic nerve, and for vision problems that afflict a majority of military service personnel who have been diagnosed with traumatic brain injury. Both glaucoma and traumatic optic nerve injury can lead to severe or even permanent vision loss.
Later this year, Noveome plans to begin a Phase 1 clinical human safety trial for targeted delivery of ST266 deep into the nasal passages, in collaboration with the Israeli medical device maker SipNose and through funding provided by the Commonwealth of Pennsylvania.

Editor’s Note: Shindler has served as a scientific advisory board member and consultant to Noveome and has received funds from Noveome for his consulting services. In addition, Noveome has provided unrestricted funds to Penn to support research in Shindler’s laboratory.

About ST266
ST266 is a novel secretome developed and manufactured by Noveome in its GMP manufacturing facility in Pittsburgh, Pennsylvania. In multiple preclinical studies, ST266 has demonstrated unique attributes of modulating inflammation, restoring nerve function, speeding impaired wound healing, and restoring cellular homeostasis, indicating that it can be applied across a wide range of disease indications to improve patient outcomes. Noveome has already treated 233 subjects with ST266 in eight clinical trials in various indications. It was found to be well-tolerated and there were no drug-related adverse events reported, attesting to its strong safety profile. Previous studies using an optic neuritis model were reported in Scientific Reports volume 7, Article number: 41768 (2017).

About Noveome
Noveome is a clinical stage company focused on breakthrough therapies for the regenerative repair of inflamed or damaged tissues. The company, formerly called Stemnion, Inc., is located in the heart of Pittsburgh’s riverfront Technology Center. The company received seed money from UPMC Enterprises, University of Pittsburgh and Carnegie Mellon University when it was founded in 2000. To date, Noveome has received $114 million in research funding, primarily from the U.S. Department of Defense as well as other state and county government agencies. Noveome is passionate about growing its business in Allegheny County and helping the region to become a world leader in biotechnology research and development. www.noveome.com.

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CONTACT:
Noveome Biotherapeutics, Inc.
Gail Kempler, Ph.D., (412) 402-9914
Director, Investor Relations
gkempler@noveome.com

Media Inquiries:
Rich Creehan
(412) 341-1607
creehanmedia@gmail.com