Noveome Biotherapeutics, Inc. Receives Rare Pediatric Disease Designation and Orphan Drug Designation for the Treatment of Necrotizing Enterocolitis in Neonates

PITTSBURGH, PA – May 24, 2022 – Noveome Biotherapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) to the company’s lead product ST266 for the treatment of Necrotizing Enterocolitis (NEC).

“NEC is a devastating disease that affects the most vulnerable among us,” said Christopher Velis, Chief Executive Officer of Noveome. “We remain motivated by the prospect of providing the first major improvement in lifesaving therapy for infants affected by NEC in over 40 years. These babies, their families, and the doctors and nurses who have devoted their own lives to fighting this disease deserve our collective best efforts to advance our therapy into clinical practice.”

The FDA grants RPDD for serious and life-threatening diseases affecting children aged 18 years or younger and ODD for rare diseases that impact fewer than 200,000 people in the United States. ST266 is being evaluated in multiple preclinical animal models and the company is in the planning stages for clinical trials to investigate treatment with ST266 for NEC.

About Necrotizing Enterocolitis (NEC)
Necrotizing Enterocolitis (NEC) is a devastating disease caused by inflammation of the intestines observed primarily in premature and very low birth weight babies (VLBWB). The inflammation can result in an overwhelming infection which quickly becomes a medical emergency and often requires surgery as a life-saving measure. NEC affects between 4,000 – 6,000 VLBWB each year in the United States and carries a 30% mortality rate. Babies that do survive are often left with life-long intestinal complications and are also at increased risk for neurodevelopmental delay with cognitive, visual, and motor impairment. Treating and managing NEC costs over $5 billion annually in Neonatal Intensive Care Unit (NICU) expenditures.

There is currently no FDA-approved treatment for NEC.

About ST266
ST266 is a cell-free sterile biologic solution containing hundreds of proteins and other factors at physiologic levels. Extensive preclinical studies have shown that ST266’s multiple components result in a variety of anti-inflammatory and neuroprotective responses. A drug master file has been submitted to the FDA, supporting all ST266 investigational new drug (IND) applications.

About Noveome Biotherapeutics, Inc.
Based in Pittsburgh, PA, Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologic therapeutics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome has a robust pipeline developing novel treatments for various systemic and ophthalmic indications and has recently completed a Phase 1 study evaluating the safety of intravenously administered ST266 in the treatment of systemic inflammation associated with COVID-19. For more information, visit www.noveome.com.

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Media Contact: press@noveome.com

Exploratory Phase II Multicenter, Open-Label, Clincal Trial of ST266, a Novel Secretome for Treatment of Persistent Corneal Epithelial Defects

Jeng, Bennie H., Hamrah, Pedram. Kirshner, Ziv Z., Mendez, Benjamin C., Wessel, Howard C., Brown, Larry R., Steed, David L. (January 2022).

Exploratory Phase II Multicenter, Open-Label, Clinical Trial of ST266, a Novel Secretome for Treatment of Persistent Corneal Epithelial Defects. Translational Vision Science & Technology January 2022 Volume 11 No 1 Article 8.

Full publication here.

Noveome Biotherapeutics, Inc. Commences Phase 1 Clinical Study of ST266 Application for Infectious Disease (including COVID-19)

PITTSBURGH, PA – June 23, 2021 – Noveome Biotherapeutics, Inc. (Noveome) announced that it has commenced its Phase 1 clinical trial by dosing its first patient. This Phase 1 trial is evaluating the safety and tolerability of intravenous (IV) administration of their ST266 product to treat deadly inflammatory responses in COVID-19 patients. ST266, a novel platform biologic that possesses anti-inflammatory and neuroprotective properties, already has Phase 1 and Phase 2 clinical study data through other forms of administration.

ST266 is an investigational treatment for severe systemic inflammation, known as a cytokine storm, and ultimately sepsis, which is frequently associated with infectious diseases such as COVID-19. Sepsis accounts for nearly $24 billion in annual costs in the U.S. alone, making it the most costly condition for the healthcare system to treat. Previous preclinical and clinical studies have demonstrated that ST266 has the potential to significantly reduce this inflammatory response.

“When successful, this study will advance tools to treat one of the world’s most prevalent and deadly conditions, sepsis. The impact of ST266 on the inflammatory response in COVID-19 patients will give us an understanding of the drug’s ability to treat this response across a wide variety of bacterial, fungal and viral infections,” said Christopher Velis, CEO of Noveome.

To date, Noveome has received approximately $115 million in grant funding from the U.S. Department of Defense and approximately $10 million from other public and private sources to support their studies. This study brings them one step closer to translating ST266 out of the lab and to patients in need.

The clinical outcome status of ST266-treated patients and the potential effects on clinical laboratory parameters and inflammatory markers will be monitored from baseline through the post-treatment follow-up period. These effects with be observed through clinical and serologic assessments that are measured for the duration of the trial.

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About Noveome
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. In addition, the Phase 1 trial described above, the company recently announced the results from their Phase 2 open-level clinical trial evaluating ST266 as a treatment for Persistent Corneal Epithelial Defects (PEDs). ST266 was found to be both safe and beneficial in treating PEDs. A Phase 2b PED trial is scheduled to begin in the third quarter of 2021. The company also recently announced positive preliminary safety results for its Phase 1 transcribriform delivery of intranasal ST266 for traumatic brain injury and diseases of the retina and optic nerve. For more information, please visit www.noveome.com.

Media Contact: press@noveome.com

Noveome Biotherapeutics, Inc. Announces Preliminary Results of its Phase 1 Open Label Clinical Trial Evaluating Intranasal Delivery of Lead Candidate ST266 In Glaucoma Suspect Patients

Preliminary results show intranasally delivered ST266 is safe

PITTSBURGH, PA – June 7, 2021 – 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 preliminary results of a Phase 1 open label clinical trial to establish the safety of ST266 when delivered intranasally in Glaucoma Suspect patients. The trial was conducted at the University of Pennsylvania by Ahmara Ross, M.D., Ph.D. and Kenneth Shindler, M.D., Ph.D. of the University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA.

ST266 is a novel “secretome”, a cell-free platform biologic containing hundreds of proteins and other growth factors involved in cellular healing and was administered as a targeted nasal spray using the SipNose, Ltd. Cribriform Targeted Device, for which Noveome recently announced a commercial license agreement (http://ow.ly/TqOj50EZYyy.) The device is able to deliver ST266 to the cribriform plate at the back of the upper nasal cavity where is able to reach the optic nerve, eye and brain, bypassing the blood-brain barrier. Previously published preclinical efficacy and distribution studies laid the groundwork for the Phase 1 clinical trial reported here.

The Phase 1 open label clinical trial was designed to assess the safety of intranasally delivered ST266 in Glaucoma Suspect patients diagnosed as having pre-glaucoma conditions that have not yet caused damage to the optic nerve. Dosing occurred in three cohorts. In the first cohort, subjects were intranasally administered ST266 at a dose of two hundred microliters (200 µL) daily for 14 days, in alternating single nostrils. In the second cohort, subjects were intranasally administered 200 µL to each nostril daily (400 µL total per day) for 14 days. In the third cohort, subjects were intranasally administered 200 µL to each nostril daily (400 µL total per day) for 28 days. No drug-related serious adverse events were reported. Preliminary safety assessments, reported here, were performed at baseline and at the end of drug treatment and included visual acuity, slit lamp exam, tonometry, retina exam and ERG, OCT for optic nerve fiber thickness layer, corneal pachymetry, gonioscopy, neuro-cognitive exam, MRI, lumbar puncture, chemistry panel, hematology, and nasopharyngeal exam. All results were normal. Three-, six- and twelve-month safety follow-up visits are planned for all subjects. More information about the study is available at www.clinicaltrials.gov under the identifier NCT03901781.

“The preliminary safety results of this Phase 1 clinical trial of intranasally delivered ST266 is an important milestone for Noveome. Now that we have established safety of ST266 by this route of administration, we are actively planning efficacy trials in a variety of neurological and ophthalmological indications” said Christopher Velis, CEO of Noveome. “We intend to pursue intranasal ST266 in our broad pipeline of indications such as concussion, glaucoma, optic neuritis, and retinal diseases.”

About ST266
ST266 is a cell-free biologic containing hundreds of proteins and other factors involved in cellular healing, neuroprotection, 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. 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.
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. In addition to the Phase 1 trial reported above, Noveome has completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial defects (PEDs). The company has initiated a Phase 1 study evaluating the safety of intravenously administered ST266 in COVID-19 patients and is currently planning a Phase 2 clinical study to further characterize the efficacy and safety of ST266 for the treatment of PEDs. For more information, visit www.noveome.com.

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Media Contact:
Erik Clausen
CG Life for Noveome Biotherapeutics, Inc.
781-608-7091
noveome@cglife.com

 

Noveome Biotherapeutics, Inc. and SipNose, Ltd. Announce Commercial License Agreement For SipNose Cribriform Targeted Device

Agreement furthers study of intranasal delivery of ST266 for ophthalmology and brain-related conditions

PITTSBURGH – June 1, 2021, Noveome Biotherapeutics, Inc., Pittsburgh, PA and SipNose, Ltd., Yokneam, Israel, announced today that they have entered into a Commercial License Agreement (“Agreement”) for Noveome’s use of SipNose’s proprietary intranasal Cribriform Targeted Device (CT6) to deliver Noveome’s first-of-its-kind biologic, ST266 to the central nervous system (CNS). The two companies have been collaborating since 2015. This Agreement represents an important and significant step forward for both companies as they work together to develop promising therapies for patients in need.

The field of use includes intranasal delivery of ST266 in ophthalmological conditions and brain-related conditions. In addition to the license terms, the companies have agreed to terms for a supply agreement which is expected to be finalized before Phase 3 trials are initiated.

“Noveome and SipNose have established a great working relationship which has enabled a successful collaboration” said William J. Golden, Founder and Chairman of the Board at Noveome. “Noveome recently closed enrollment and completed the treatment phase of its Phase 1 safety study using the SipNose device to administer ST266 to Glaucoma Suspect patients. Safety analyses are underway and are expected to be announced soon. Once we have established the safety of ST266 by this novel route of administration, we plan to execute on the vast potential of our cell-free platform biologic in a variety of neurological and ophthalmological indications.”

“This Agreement represents a breakthrough in the area of non-invasive direct nose to brain delivery resulting from our intensive collaboration over the past 5 years” said Dr. Iris Shichor, Co-Founder and CEO at SipNose. “We are proud to collaborate with Noveome and to promote the use of their biologic ST266 with our proprietary delivery technology for the benefit of patients suffering from ophthalmological and neurological conditions.”

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About ST266
ST266 is a cell-free biologic containing hundreds of proteins and other factors involved in cellular healing, neuroprotection, 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 CNS conditions, gastrointestinal conditions, and cytokine storm associated with COVID-19 infection. 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.
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 completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial defects (PEDs). In addition to the Phase 1 study mentioned above, the company has initiated a Phase 1 study evaluating the safety of intravenously administered ST266 in COVID-19 patients and is currently planning a follow-up clinical study to further characterize the efficacy and safety of ST266 for the treatment of PEDs. For more information, visit www.noveome.com.

About SipNose Cribriform Targeted Device
SipNose’s innovative Cribriform Targeted Device (CT6) represents a new generation of nasal delivery devices that utilize a unique combination of parameters to allow aerosolize drugs to be delivered to the cribriform area in the upper area of the nasal cavity. The outcome is highly reproducible dosing, high absorption of drug, the potential for higher efficacy, and an improved user experience.

About SipNose Ltd.
Based in Israel, SipNose is a clinical stage nasal delivery company that has developed an innovative Cribriform Targeted Device for non-invasive delivery of pharmaceuticals. SipNose is a leader in the challenging area of direct nose to brain administration. This technology bypasses the Blood-Brain Barrier that typically blocks delivery of about 98% of existing drugs and potentially all biologic drugs. The device platform allows for the delivery of a wide range of liquid formulations (ranging from low to high viscosity), as well as powders. For more information, visit www.sipnose.com.

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Media Contact:
Erik Clausen
CG Life for Noveome Biotherapeutics, Inc.
781-608-7091
noveome@cglife.com

Noveome Biotherapeutics, Inc. Announces Christopher J. P. Velis as Chief Executive Officer

  • Appointment is Effective May 24, 2021
  • Mr. Velis will continue his role on Noveome’s Board of Directors
  • William J. Golden steps down as CEO, remains as Founder and Chairman of the Board of Directors

PITTSBURGH, PA – May 24, 2021 – Noveome Biotherapeutics, Inc., a clinical stage biopharmaceutical company focused on developing next-generation biologics for the restoration of cellular integrity of damaged tissues, has announced that Christopher J. P. Velis has joined the Company as Chief Executive Officer. Mr. Velis was appointed to the Company’s Board of Directors in March 2021.
“We are thrilled to have Chris take on this additional role as our new CEO. His vast experience in innovative medical technologies will help guide Noveome as it continues to develop and commercialize its novel platform biologic, ST266,” said William Golden, Founder, Chairman and prior CEO of Noveome.

Mr. Velis added, “I’m proud to join Noveome as CEO. It’s a very innovative company with next generation therapeutic applications such as traumatic brain injury and COVID-19. I intend to apply my leadership experience to guide the Company, advance commercialization, and get therapies to patients in need as quickly and safely as possible.”

Mr. Velis, who has pioneered some of the most innovative medical technologies brought to market, brings extensive entrepreneurial and venture capital experience to Noveome. He is the Founder and Executive Chairman of Miraki Innovation, where he forecasts global health and medical challenges, uncovers innovative technologies and assembles teams of industry experts to build companies that solve these global problems. He brings a differentiated approach to venture investing through entrepreneurial science. Auris Health is one of several ventures founded, grown or brought to exit by Mr. Velis’ leadership. Chris has set the gold standard for motion preservation, regeneration of cartilage and soft tissue through the use of novel peptides, tissue regeneration using DNA pairs, and stem cell and PRP technologies for use in regenerative medicine. Throughout his 27-year career, Mr. Velis has also represented more than 150 medical device companies in a variety of business transactions. He is now focused on revolutionizing the way we battle infectious disease, greater advancements in surgical robotics, and bringing technologies that optimize human performance to the world.

Mr. Velis graduated from the University of Massachusetts Amherst with a Bachelor of Arts in Economics and earned a Master of Business from the Questrom School of Business at Boston University. He has given talks at the Hamlyn Symposium on Medical Robotics, China’s Global Innovation and Entrepreneurship Fair, the U.A.E.’s Innovation Week, Massachusetts General Hospital’s Biotech Funding Panel, LSI’s Emerging MedTech Summit, and Harvard University’s Medical and Kennedy Schools. He has been featured on NBC10, the Wall Street Journal, Boston Business Journal and PE Hub. Companies he has founded have won numerous awards including MedTech Insight Award for Best Technological Innovation, CNBC Disrupter 50, Acquisition International Finance Award for Best Medical Technology VC Firm and Corporate LiveWire M&A Award for Health & Medical Technology Consultancy of the Year.

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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 completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial
defects (PEDs). 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. The
company is actively planning a follow-up clinical study to further characterize the efficacy and safety of ST266 for the treatment of PEDs and has initiated a Phase 1 study evaluating the
safety of intravenously administered ST266 in COVID-19 patients. For more information, visit www.noveome.com.

Media Contact:
Erik Clausen
CG Life for Noveome Biotherapeutics, Inc.
781-608-7091
noveome@cglife.com

Noveome Biotherapeutics, Inc. Makes New Appointment to Board of Directors

PITTSBURGH, PA – March 8, 2021 – Noveome Biotherapeutics, Inc., a clinical stage biopharmaceutical company focused on developing next-generation biologics for the restoration of cellular integrity of damaged tissues, has appointed Christopher J. P. Velis to the company’s Board of Directors.

Mr. Velis is an entrepreneur and venture capitalist who has pioneered some of the most innovative medical technologies brought to market in the last decades. As Founder and Executive Chairman of Miraki Innovation, he forecasts imminent global health and medical challenges, uncovers technologies at leading research institutions and assembles teams of industry experts to solve these global problems. Mr. Velis not only offers investment guidance and critical research and industry connections, but also helps guide each portfolio company along the fund’s proven, repeatable process that reduces new venture risk and enhances returns.

Auris Health, recognized by CNBC as one of the 50 most disruptive companies in the world, is one of a number of ventures founded, grown or brought to exit by Mr. Velis. Companies Mr. Velis has worked on have set the industry gold standard for motion preservation, regeneration of cartilage and soft tissue through the use of novel peptides, tissue regeneration using DNA pairs, and stem cell and PRP technologies for use in regenerative medicine. Throughout his 27-year career, Mr. Velis has also represented more than 150 medical device companies in a variety of business transactions including licensing agreements, joint ventures and M&A.

Mr. Velis has spoken at the Hamlyn Symposium on Medical Robotics, China’s Global Innovation and Entrepreneurship Fair, the U.A.E.’s Innovation Week, Massachusetts General Hospital’s Biotech Funding Panel and Harvard University’s Medical and Kennedy Schools. In 2016, Mr. Velis was honored by the U.A.E.’s Ministry of Health for his commitment to bringing medtech innovation to Middle East and North Africa. He graduated from the University of Massachusetts Amherst with a Bachelor of Arts in Economics and earned a Master of Business from the Questrom School of Business at Boston University.

“We are delighted to welcome Chris to our Board of Directors. His vast entrepreneurial and venture capitalist experience in innovative medical technologies will provide significant value to Noveome,” said William Golden, Founder, Chairman and CEO of Noveome.

Mr. Velis added, “I’m excited to join the Noveome board and look forward to helping the company move toward commercialization of its novel biologic ST266.”

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 completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial defects (PEDs). 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. The company is currently planning a follow-up clinical study to further characterize the efficacy and safety of ST266 for the treatment of PEDs and is about to begin a Phase 1 study evaluating the safety of intravenously administered ST266 in COVID-19 patients. For more information, visit www.noveome.com.

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Media Contact:
Erik Clausen
CG Life for Noveome Biotherapeutics, Inc.
781-608-7091
noveome@cglife.com

 

Noveome Biotherapeutics, Inc. Launches Program to Evaluate ST266 for the Treatment of the Severe Inflammatory Response Associated with COVID-19

  • 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 8th Annual Neurodegenerative Drug Development Summit

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

PITTSBURGH, PAFebruary 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 8thAnnual 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

Noveome Biotherapeutics, Inc. to Present at 9th Annual Glaucoma 360 Meeting

PITTSBURGH, PAFebruary 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 9thAnnual 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