Noveome to conduct Phase 2b trial of ST266 in Persistent Corneal Epithelial Defects

 

PITTSBURGH—June 12, 2020—Noveome Biotherapeutics, Inc., a clinical stage biopharmaceutical company developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced positive data from its Phase 2, multi-center, open-label clinical trial of ST266 in patients with persistent corneal epithelial defects (PEDs). These data were published today as an online presentation for the Association for Research in Vision and Ophthalmology (ARVO) 2020 Online Presentations and its associated platform, ARVOLearn.

 

“There remains a clear unmet need for patients suffering from PEDs as there is no gold standard for treating this condition. These non-healing wounds can lead to serious consequences such as infections and blindness, which makes identifying an effective treatment all the more critical,” said Lead Investigator Bennie H. Jeng, M.D., Chair of the Department of Ophthalmology and Visual Sciences at the University of Maryland School of Medicine. “While additional research is necessary to ensure the efficacy and safety of ST266 in treating PEDs, it is encouraging to see initial data that validate the potential for ST266 in this challenging condition.”

 

Corneal defects are classified as persistent when the defect has not healed within 14 days. There are many different causes of PEDs, and treatment varies depending on the etiology. As commonly used treatments such as autologous serum and amnionic membranes are not always successful, patients are at risk for permanent vision loss. Noveome’s Phase 2 multi-center, open-label clinical trial was designed to evaluate the safety and efficacy of topical delivery of ST266 in patients with PEDs. Each study eye received a total of four drops per day of ST266 over the course of 28 days.

 

At data cutoff for this analysis, 11 patients had been enrolled in the study. Of the 11 enrolled patients, 10 completed treatment. All 10 eyes demonstrated response to treatment by day 28 with significantly decreased size (p=0.001). Three eyes had complete healing during the 28-day treatment window. One of the three eyes with complete healing on day 21 had a re-opening on day 28; however, the PED was almost completely healed by day 35 of the study. The remaining 7 eyes all had smaller areas of defect compared with baseline. No drug-related serious adverse events (SAEs) were reported. One patient withdrew for reasons deemed unrelated to the trial or study drug.

 

These early results suggest that ST266 may be effective in healing PEDs that have been refractory to standard therapies. They are consistent with pre-clinical studies, in which ST266 treatment was associated with reduced inflammation, decreased neutrophil infiltration, and increased re-epithelization in a rabbit model for corneal incision and abrasion.

 

“Treating PEDs is just one of the many exciting uses we have identified for ST266, and it is promising to see this positive result. We will continue to advance this program alongside our diverse pipeline aimed at providing patients across multiple disease areas with safe and effective therapies,” said William Golden, Founder, Chairman and CEO of Noveome. “We look forward to further exploring ST266 for this indication in a Phase 2b masked, placebo-controlled trial in PEDs we are currently planning.”

 

About ST266

ST266 is a cell-free biologic made by culturing a novel population of human amnion-derived cells. Through a proprietary culturing method, these cells produce an array of growth factors and cytokines, known as the secretome, which promote cellular survival and reduce inflammation.

 

About Noveome Biotherapeutics, Inc.

Based in Pittsburgh, PA, 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 has launched a program to test its novel platform biologic, ST266, as a treatment for the severe inflammatory response seen in COVID-19 infection. In addition to the Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing persistent corneal epithelial defects (PEDs) reported here, ST266 is also being evaluated in a Phase 1 open label clinical trial to establish the safety of ST266 in intranasal transcribriform delivery from nose to brain and eye. Noveome is also currently planning follow-up clinical studies to characterize the efficacy and safety of ST266 further for the treatment of PEDs. For more information, visit www.noveome.com.

 

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Investor Contact:

Julie Seidel

Stern Investor Relations, Inc.

212-362-1200

julie.seidel@sternir.com

 

Media Contact:

Erik Clausen

CG Life

781-608-7091

noveome@cglife.com

Singota Solutions, a pharmaceutical contract development and manufacturing organization, will manufacture Noveome’s lead candidate for Phase I / II clinical trials

 

Bloomington, IN (May 12, 2020)- Singota Solutions has been selected to collaborate with Noveome Biotherapeutics, Inc. to manufacture the ST266 investigational drug product, a biologic being evaluated in clinical studies for its potential treatment of the severe inflammatory reaction known as Cytokine Release Syndrome (CRS), also known as the Cytokine Storm, observed in COVID-19 patients.

 

Singota specializes in small batch aseptic filling of high-value injectable products into vial, syringe, and cartridge formats using the robotic Vanrx SA25 Aseptic Filling Workcell. Singota will manufacture Noveome’s ST266 to be used for IV infusion in Phase I and II clinical trials. In preclinical and clinical studies, ST266 has demonstrated significant anti-inflammatory activity, which could potentially be lifesaving for patients experiencing the often-fatal CRS, a severe and systemic complication of COVID-19 that causes multi-organ damage, especially to the lungs.

 

“We commit to working quickly, yet carefully to get our clients’ products out to patients,” said Laura Englander, Sr. Business Development and Marketing Manager. “Noveome has been a great partner for Singota. They have moved swiftly on the front-end, entrusting us to excel at our promise of adhering to their tight timeline to get this critical product ready for their patients.”

 

Singota will manufacture 30 mL vial fills of ST266 in June. This timeline helps Noveome in its accelerated efforts to treat patients in the clinic, which they are prepared to initiate immediately should the FDA approve its requested authorization to proceed with dosing.

 

In response to the collaboration, Alisa Kilgas, CEO at Singota stated, “We’re all in this together. Singota is proud to work with Noveome in the fight against the Coronavirus, especially to help the patients around the world, but also those close to home.”

 

“Noveome is aggressively pursuing our investigational drug ST266 as an important therapeutic in the treatment of patients experiencing one of the most serious and life-threatening conditions brought about by COVID19 infection. Singota’s application of isolators paired with single-use technologies uniquely positions them to establish GMP manufacturing in weeks as opposed to what would typically take several months. In addition to this enabling technology, the response and flexibility of the team at Singota has been exceptional in the rapid establishment of this collaboration,” said Kevin McCracken, Chief Operating Officer, Noveome Biotherapeutics, Inc.

 

For more information about our services, please contact: Laura Englander, Sr. Business Development and Marketing Manager – laura.englander@singota.com or 812.961.1752.

About Singota Solutions

Singota Solutions is a contract development and manufacturing organization focused on moving products through the development pipeline faster—with agility, accountability, and transparency. Founded in 2006, the company is a woman-owned business operating in Bloomington, Indiana. Singota’s gloveless, robotic aseptic filling service is ideally suited for the production of clinical and niche commercial injectable products in vial, syringe, and cartridges formats. Singota also provides customized solutions for formulation development, supply chain & materials management, analytical testing, and labeling & kitting services. For more information, please visit www.singota.com.

About Noveome® Biotherapeutics

Based in Pittsburgh, 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 has launched a program to test its novel platform biologic, ST266, as a treatment for the severe inflammatory response seen in COVID-19 infection.  ST266 is currently being evaluated in multiple indications including a Phase 1 open label clinical trial to establish the safety of ST266 in intranasal transcribriform delivery from nose to brain and eye and a Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing persistent corneal epithelial defects (PEDs). For more information, visit www.noveome.com.

Funding Enables Existing Clinical Trials to Proceed as Company Joins Global Response with COVID-19 Program

 

PITTSBURGH – May 7, 2020 – Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, has received a $4 Million grant from the Commonwealth of Pennsylvania to continue clinical trials of its lead product candidate, ST266, in a wide range of diseases, including multiple ophthalmic indications. The funding will enable Noveome to shift its existing resources to support the company’s recently launched COVID-19 program evaluating ST266 as a treatment for the “cytokine storm”—the severe inflammatory response often observed in COVID-19 infections.

 

“While researchers around the world race to deliver a vaccine that will address this COVID-19 pandemic head on, we need a range of new therapeutics and diagnostics to stem the tide. This very timely funding will enable us to advance our ongoing programs while concurrently accelerating our evaluation of ST266 against COVID-19 in clinical trials,” said William Golden, Founder, Chairman and CEO of Noveome. “We’re incredibly grateful to the leaders and people of Pennsylvania who have provided tremendous support throughout our company’s journey—particularly Representative Frank Dermody and Senator Jay Costa, who both helped us to secure this timely grant.”

 

“It remains our top priority to do everything that we can to protect the public health of Pennsylvanians,” said Senator Costa. “Part of our strategy is to support innovative companies in the Commonwealth like Noveome that are working to find solutions in this unprecedented health crisis.”

 

“We are proud to support Pittsburgh-based Noveome as they pursue new potential treatments for a range of challenging conditions, including COVID-19,” added Representative Dermody.  “Now, more than ever, all of us in state government must do our part to enable science to bring new treatments into the fight against this virus.”

 

ST266 is a cell-free biologic made by culturing a novel population of cells derived from full term placentas donated after a birth. When cultured in a bioreactor, these cells produce an array of bioactive molecules, known as a secretome, which promote cellular survival and resuscitate damaged cells. The ST266 secretome contains a vast array of active biomolecules in very minute and safe physiologic concentrations that are anti-inflammatory, preserve cellular survival and resuscitate damaged cells. Given these observed characteristics, ST266 has the ability to potentially prevent the cytokine storm associated with COVID-19 as well as promote lung healing and prevent multiple organ injuries.

 

“Recent internal models in an acute systemic inflammation model demonstrated that ST266 was able to significantly reduce multiple inflammatory cytokines,” said Noveome Chief Science Officer Larry Brown, Sc.D. “ST266 has also been shown to have significant anti-inflammatory activity in both preclinical and clinical studies in other indications. Relevant preclinical studies showed that systemic administration of ST266 protected lung against elastase-induced lung injury, ischemia-induced lung injury and cytokine-related pulmonary inflammation. Based on these data, we believe ST266 has the capacity to potentially address multiple treatment requirements of COVID-19 infection.”

 

About Noveome Biotherapeutics, Inc.

Based in Pittsburgh, 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 has launched a program to test its novel platform biologic, ST266, as a treatment for the severe inflammatory response seen in COVID-19 infection.  ST266 is currently being evaluated in multiple indications including a Phase 1 open label clinical trial to establish the safety of ST266 in intranasal transcribriform delivery from nose to brain and eye and a Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing persistent corneal epithelial defects (PEDs). For more information, visit www.noveome.com.

 

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Investor Contact:

Julie Seidel

Stern Investor Relations, Inc.

212-362-1200

julie.seidel@sternir.com

 

Media Contact:

Erik Clausen

CG Life

781-608-7091

noveome@cglife.com

• ST266 may significantly mitigate the frequently fatal cytokine storm observed in COVID-19 patients
• Plans to initiate human clinical trial by 4Q2020

PITTSBURGH, PA – March 30, 2020 – Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced the launch of a new program to evaluate ST266, its lead product candidate, as a potential treatment of the severe inflammatory cytokine storm response frequently observed in the lungs of patients with COVID-19.  This new program is based on a body of evidence demonstrating that ST266 significantly reduces the body’s inflammatory response in a wide range of diseases and conditions and has been shown to be safe and effective in humans. Importantly, preventing or reducing the severe cytokine storm could substantially address the shortage of ventilators. Noveome is in discussions with the FDA to expeditiously complete an IND and is currently identifying clinical sites for a Phase 1/2 safety trial, expected to initiate in the fourth quarter of 2020.

“As we continue to learn from the emerging data on COVID-19, it is clear that mitigating the cytokine storm associated with severe cases is crucial to treating this condition and improving patient outcomes. Based on our positive preclinical and clinical data, we believe that ST266 has the potential to reduce the severe inflammatory response in patients with COVID-19 and we have initiated our efforts to evaluate ST266 in these patients,” said William Golden, Noveome’s Founder, Chairman and CEO. “We look forward to addressing this crucial need with the FDA and expect to begin the trial as soon as the FDA determines that we are safe to proceed.”

“This ongoing pandemic has mobilized an unprecedented and rapid response by the biopharmaceutical industry to identify possible new therapeutic interventions and Noveome’s science has a compelling rationale to add to these efforts,” said Robert Langer, Sc.D., Massachusetts Institute of Technology Institute Professor and member of Noveome’s Board of Directors. “The body’s response to severe infection in vulnerable COVID-19 patients is a dangerous and increasingly fatal inflammatory overreaction due to a cytokine storm.  ST266 has the potential to control this reaction to prevent deaths associated with COVID-19.”

About ST266

ST266 is a cell-free platform biologic containing hundreds of anti-inflammatory proteins. This collection of proteins, called a “secretome,” is made by a novel population of cells derived from the amnion, which is collected from donated, full term, Cesarean-sectioned placentas, normally discarded after birth. The ST266 secretome preserves cellular survival and/or resuscitates damaged cells. Importantly, ST266 has an established robust safety profile having treated 242 patients with no drug-related Serious Adverse Events reported.

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. Its novel platform biologic, ST266, is currently being evaluated in multiple ophthalmic indications including a Phase 1 open label clinical trial to establish the safety of ST266 when delivered intranasally to Glaucoma Suspects and a Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing Persistent Corneal Epithelial Defects (PEDs). Noveome has launched a program to test ST266 as a treatment for the severe inflammatory response seen in COVID-19 infection. To date, Noveome has received over $160 million of funding, including $129 million from the public sector (primarily the Department of Defense) and $34 million in private equity. 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

Noveome Biotherapeutics, Inc. To Present At The 8^thAnnual Neurodegenerative Drug Development Summit.

PITTSBURGH, PA–February 24, 2020 – 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 that Larry Brown, Sc.D., Executive Vice President and Chief Scientific Officer at Noveome, will present an oral presentation entitled, “Exploring Intranasal Administration to Bypass the Blood-Brain Barrier” at the 8^thAnnual Neurodegenerative Drug Development Summit on Thursday February 27, 2020 at 11:15 AM EDT in Boston, MA.

About ST266
ST266 is a cell-free platform biologic containing hundreds of proteins and other factors in physiologic levels that are involved in cellular healing, protection of the brain and nerves, and modulation of inflammation.  ST266 is the first potential therapeutic focused on treating the underlying nerve degeneration that occurs in glaucoma and optic nerve diseases and injuries through an innovative, non-invasive, targeted intranasal device to deliver ST266 directly to the retina and optic nerve by-passing the blood-brain barrier. Based on successful preclinical studies, Noveome is currently conducting a Phase 1 open-label clinical trial to establish the safety of ST266 in subjects with elevated ocular hypertension by intranasal deliverywith topline data expected in 2020.

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. Its novel platform biologic, ST266, is currently being evaluated in multiple ophthalmic indications including aPhase 1 open label clinical trial to establish the safety of ST266 when deliveredintranasally to Glaucoma Suspects and a Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing persistent Corneal Epithelial Defects (PEDs). To date, Noveome has received over $160 million in research and infrastructure funding. 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 9th Annual Glaucoma 360 Meeting

PITTSBURGH, PA – February 5, 2020 – 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, today announced that Larry Brown, Sc.D., Chief Scientific Officer, will present on its retinal and optic nerve disease clinical program at the Glaucoma Research Foundation’s 9^thAnnual Glaucoma 360 Meeting on Friday, February 7, 2020 at 3:29 PM P.T. (6:29 PM E.T.) in San Francisco, CA.

About the Retinal and Optic Nerve Disease Clinical Programs
To date, all glaucoma treatments are aimed at lowering intraocular hypertension. Noveome’s multi-target platform biologic and lead product, ST266, is the first potential therapeutic focused on treating the underlying nerve degeneration that occurs in glaucoma through an innovative, non-invasive, targeted intranasal device to deliver ST266 directly to the retina and optic nerve by-passing the blood-brain barrier. Based on successful preclinical studies, Noveome is currently conducting a Phase 1 open-label clinical trial to establish the safety of ST266 by intranasal deliverywith topline data expected in 2020.

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. Its novel platform biologic, ST266, is currently being evaluated in multiple ophthalmic indications. In addition to the Phase 1 open label clinical trial to establish the safety of ST266 when deliveredintranasally, Noveome is conducting a Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing Persistent Corneal Epithelial Defects (PEDs) when delivered topically to the eye withtopline data expected in 2020. To date, Noveome has received over $160 million in research and infrastructure funding. 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

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