SOURCE: Adgero Biopharmaceuticals Holdings, Inc.

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February 22, 2018 08:00 ET

Adgero Biopharmaceuticals Granted FDA Orphan Drug Designation of REM-001 Therapy for the Treatment of Basal Cell Carcinoma Nevus Syndrome

Company expects to commence Phase 2 study of REM-001 Therapy in BCCNS in 2018

PRINCETON, NJ--(Marketwired - February 22, 2018) - Adgero Biopharmaceuticals Holdings, Inc. ("Adgero" or the "Company"), a privately-held biopharmaceutical company leveraging its late stage photodynamic therapy ("PDT") platform for the treatment of serious cutaneous oncology indications, announced today that the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation to REM-001, for the treatment of Basal Cell Carcinoma Nevus Syndrome ("BCCNS"), a rare genetic condition.

"We are pleased to have received Orphan Drug Designation for REM-001 for the treatment of BCCNS, representing an important milestone for the program. BCCNS is a rare but serious condition with few available therapies and many patients lack treatment options. We are committed to continue the development of the REM-001 Therapy in this indication," commented John Liatos, Chief Financial Officer and interim Chief Executive Officer of Adgero.

The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to treat, diagnose or prevent diseases and disorders that affect fewer than 200,000 people in the U.S. This designation provides for a seven-year marketing exclusivity period against competition upon regulatory product approval, as well as certain incentives, including federal grants, tax credits and a waiver of FDA filing fees for drug approval applications.

About Basal Cell Carcinoma Nevus Syndrome ("BCCNS")

BCCNS is often characterized by the formation of multiple and recurring cutaneous basal cell carcinoma lesions. In a previous Phase 1/2 clinical trial (CA001B), 14 patients with BCCNS were enrolled and treated with REM-001 Therapy. A total of 157 lesions were treated in these patients and showed a 91% overall response rate. This was composed of a 68% complete response rate (no remaining visible evidence of a lesion) and a 23% partial response rate (lesion was reduced in size by more than 50%). In addition, 7% of lesions had stable disease (any increase in lesion size was less than 25%).

About REM-001 Therapy

The Company's lead product in development, REM-001 Therapy consists of three parts -- a laser light source, a light delivery device and the drug REM-001 (collectively, REM-001 Therapy). REM-001 is a second-generation photosensitizer drug that has undergone late stage clinical development, and which Adgero believes possesses multiple advantages over earlier generation PDT compounds. The lead indication for REM-001 Therapy is unresectable cutaneous metastatic breast cancer ("CMBC"), a disease that may affect individuals with advanced breast cancer and for which effective treatment options are limited.

About Adgero

Adgero Biopharmaceuticals Holdings, Inc. is a privately-held biopharmaceutical company focused on building a pipeline by advancing its proprietary late stage photodynamic therapy ("PDT") platform with broad utility for the treatment of serious cutaneous oncology indications. Its lead product candidate, REM-001 Therapy, has been previously studied in four Phase 2 and/or Phase 3 clinical trials in patients with cutaneous metastatic breast cancer ("CMBC"), who had previously received chemotherapy and failed radiation therapy. Completion of a Phase 3 trial in individuals with CMBC could lead to approval of REM-001 Therapy.

For more information, please visit www.AdgeroBiopharm.com.

Forward-Looking Statements

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