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GILGAMESH PHARMACEUTICALS, INC.

Company Details

Name: GILGAMESH PHARMACEUTICALS, INC.
Jurisdiction: New York
Legal type: FOREIGN BUSINESS CORPORATION
Status: Active
Date of registration: 20 Aug 2019 (6 years ago)
Entity Number: 5607296
ZIP code: 10168
County: New York
Place of Formation: Delaware
Address: 122 EAST 42ND STREET, 18TH FLOOR, NEW YORK, NY, United States, 10168
Principal Address: 113 University Place, Suite 1019, New York, NY, United States, 10003

Chief Executive Officer

Name Role Address
JONATHAN SPORN Chief Executive Officer 230 RIVERSIDE DRIVE, 19D, NEW YORK, NY, United States, 10025

DOS Process Agent

Name Role Address
COGENCY GLOBAL INC. DOS Process Agent 122 EAST 42ND STREET, 18TH FLOOR, NEW YORK, NY, United States, 10168

Form 5500 Series

Employer Identification Number (EIN):
842552195
Plan Year:
2021
Number Of Participants:
4
Sponsors Telephone Number:
Plan Year:
2021
Number Of Participants:
2
Sponsors Telephone Number:
Plan Year:
2020
Number Of Participants:
0
Sponsors Telephone Number:

History

Start date End date Type Value
2023-08-01 2023-08-01 Address 230 RIVERSIDE DRIVE, 19D, NEW YORK, NY, 10025, USA (Type of address: Chief Executive Officer)
2019-11-27 2023-08-01 Address 122 EAST 42ND STREET, 18TH FLOOR, NEW YORK, NY, 10168, USA (Type of address: Service of Process)
2019-08-20 2019-11-27 Address 10 EAST 40TH STREET, 10TH FLOOR, NEW YORK, NY, 10016, USA (Type of address: Service of Process)

Filings

Filing Number Date Filed Type Effective Date
230801011072 2023-08-01 BIENNIAL STATEMENT 2023-08-01
210804002628 2021-08-04 BIENNIAL STATEMENT 2021-08-04
SR-112704 2019-11-27 CERTIFICATE OF CHANGE (BY AGENT) 2019-11-27
190820000464 2019-08-20 APPLICATION OF AUTHORITY 2019-08-20

USAspending Awards / Financial Assistance

Date:
2024-09-26
Awarding Agency Name:
Department of Health and Human Services
Transaction Description:
DEVELOPMENT OF A SAFER AND MORE EFFECTIVE IBOGAINE ANALOG FOR THE TREATMENT OF OPIOID USE DISORDER - SUMMARY OPIOID USE DISORDER (OUD) CONTRIBUTES TO DISABILITY, LOSS OF WORK, AND OVER 100,000 OVERDOSE DEATHS PER YEAR IN THE U.S., EMPHASIZING THE CRITICAL NEED FOR NOVEL MEDICATIONS FOR OUD TREATMENT. IBOGAINE, A PSYCHOACTIVE ALKALOID FROM THE TABERNANTHE IBOGA SHRUB, HAS SHOWN PROMISE IN INTERRUPTING OPIOID DEPENDENCE, REDUCING WITHDRAWAL SYMPTOMS, AND INCREASING ABSTINENCE RATES, EVEN AFTER A SINGLE TREATMENT. HOWEVER, IBOGAINE'S CARDIOTOXICITY AND NEUROTOXICITY POSE SIGNIFICANT BARRIERS TO ITS DEVELOPMENT AS A DRUG. TO LEVERAGE IBOGAINE’S POTENTIAL AS AN OUD THERAPEUTIC AND ADDRESS THE RISKS TO PATIENT SAFETY, WE HAVE DEVELOPED A NEW CLASS OF SYNTHETIC IBOGA ALKALOIDS, NAMED “OXA-IBOGA”. THESE COMPOUNDS SHOW NO PRO-ARRHYTHMIC POTENTIAL, NO NEUROTOXIC EFFECTS, AND ENHANCED EFFICACY IN OUD-RELEVANT PRECLINICAL BEHAVIORAL ASSAYS COMPARED TO IBOGAINE. WE PROPOSE TO ADVANCE ONE OF THESE COMPOUNDS, GM-3009, INTO CLINICAL STUDIES BY ADVANCING GMP-MANUFACTURING AND FORMULATION OF GM-3009, COMPLETING IND-ENABLING TOXICITY STUDIES, AND DETERMINING THE EXPECTED THERAPEUTIC EXPOSURES OF GM-3009 AND TARGET ENGAGEMENT VIA TRANSLATIONAL BIOMARKERS. THESE STUDIES WILL COMPLETE THE UG3 PORTION OF THIS GRANT. IF SUCCESSFUL, THE PROPOSAL WILL ADVANCE TO THE UH3 PORTION, WHICH WILL CONDUCT FIRST-IN-HUMAN TRIALS, INCLUDING SAFETY AND TOLERABILITY STUDIES IN HEALTHY VOLUNTEERS (A SINGLE ASCENDING DOSE STUDY, SAD) AND A SAFETY STUDY WITH EXPLORATORY MEASURES OF EFFICACY IN OUD PATIENTS UNDERGOING OPIOID WITHDRAWAL. THE ENDPOINT OF THE ENTIRE PROJECT IS GENERATION OF CLINICAL SAFETY AND PRELIMINARY EFFICACY DATA TO SUPPORT SUBSEQUENT PHASE 2 EFFICACY STUDIES IN OUD. THE DEVELOPMENT OF GM-3009 BUILDS ON DECADES OF RESEARCH ON IBOGAINE AND HAS THE POTENTIAL TO DELIVER AN INNOVATIVE OUD THERAPY WITH RAPID AND LONG-TERM MITIGATION OF ACUTE AND PROTRACTED WITHDRAWAL SYMPTOMS AND CRAVINGS, WHICH LEAD TO NON-MEDICAL OPIOID USE.
Obligated Amount:
5439548.00
Face Value Of Loan:
0.00
Total Face Value Of Loan:
0.00

Trademarks Section

Serial Number:
88563244
Mark:
GILGAMESH PHARMACEUTICALS
Status:
ABANDONED - NO STATEMENT OF USE FILED
Mark Type:
TRADEMARK
Application Filing Date:
2019-08-02
Mark Drawing Type:
Standard character mark
Mark Literal Elements:
GILGAMESH PHARMACEUTICALS

Goods And Services

For:
Pharmaceuticals, namely, pharmaceutical and drugs preparations and substances in the field of neuroscience for use in the treatment and therapy of psychiatric disorders, depression disorders, substance use, substance abuse, anxiety disorders, cognitive disorders, obsessive-compulsive disorder (OCD),...
International Classes:
005 - Primary Class
Class Status:
Active
Serial Number:
97526318
Mark:
GILGAMESH PHARMACEUTICALS
Status:
SECOND EXTENSION - GRANTED
Mark Type:
TRADEMARK
Application Filing Date:
2022-07-29
Mark Drawing Type:
Standard character mark
Mark Literal Elements:
GILGAMESH PHARMACEUTICALS

Goods And Services

For:
Pharmaceuticals, namely, pharmaceutical and drug preparations and substances for use in treating cancer and for use in the field of neuroscience for use in the treatment and therapy of psychiatric disorders, depression disorders, substance use, substance abuse, anxiety disorders, cognitive disorders...
International Classes:
005 - Primary Class
Class Status:
Active

Date of last update: 23 Mar 2025

Sources: New York Secretary of State