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–(BUSINESS WIRE)–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.”

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.

Contacts

Erik Clausen

CG Life for Noveome Biotherapeutics, Inc.

781-608-7091

[email protected]