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ZETAGEN THERAPEUTICS, INC.

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Company Details

Name: ZETAGEN THERAPEUTICS, INC.
Jurisdiction: New York
Legal type: FOREIGN BUSINESS CORPORATION
Status: Active
Date of registration: 18 May 2018 (7 years ago)
Entity Number: 5344137
ZIP code: 13210
County: Onondaga
Place of Formation: Delaware
Address: 841 EAST FAYETTE STREET, SYRACUSE, NY, United States, 13210

DOS Process Agent

Name Role Address
THE CORPORATION DOS Process Agent 841 EAST FAYETTE STREET, SYRACUSE, NY, United States, 13210

Chief Executive Officer

Name Role Address
JOE C. LOY Chief Executive Officer 841 E FAYETTE STREET, SYRACUSE, NY, United States, 13210

U.S. Small Business Administration Profile

The U.S. Small Business Administration (SBA) helps Americans start, grow, and build resilient businesses.

Note: SBA was created in 1953 as an independent agency of the federal government to aid, counsel, assist and protect the interests of small business concerns; preserve free competitive enterprise; and maintain and strengthen the overall economy of our nation. SBA reviews Congressional and testifies on behalf of small businesses. It assesses the impact of regulatory burden on small businesses.

Phone Number:
E-mail Address:
Contact Person:
JESSICA PLETKA
User ID:
P1905601

Unique Entity ID

A UEI is a government-provided number, like a tax ID number, that’s used to identify businesses eligible for federal grants, awards and contracts.

Note: In April 2022, the federal government replaced its old identifier of choice, the Data Universal Numbering System (DUNS) number, with a government-issued UEI. Now all the federal government’s Integrated Award Environment systems use UEI numbers instead of DUNS numbers. So any entity doing business with the federal government must register for a UEI.

CAGE Code:
79FU5
UEI Expiration Date:
2020-08-14

Business Information

Activation Date:
2019-08-27
Initial Registration Date:
2014-11-12

Commercial and government entity program

The The Commercial And Government Entity Code (CAGE) is assigned by the Department of Defense's Defense Logistics Agency (DLA) and represents your company's physical address for GSA's mailings, payments, and administrative records.

Note: A CAGE Code enables a company to contract with the U.S. government, allowing bid on government contracts and to receive government payments. Also for business this means that it's a Verified business entity and Has a validated physical address.

CAGE number:
79FU5
Status:
Active
Type:
Non-Manufacturer
CAGE Update Date:
2024-12-09
CAGE Expiration:
2029-12-09
SAM Expiration:
2025-12-04

Contact Information

POC:
JESSICA PLETKA

Filings

Filing Number Date Filed Type Effective Date
210729001886 2021-07-29 BIENNIAL STATEMENT 2021-07-29
180518000356 2018-05-18 APPLICATION OF AUTHORITY 2018-05-18

USAspending Awards / Financial Assistance

Date:
2021-08-15
Awarding Agency Name:
Department of Health and Human Services
Transaction Description:
ELUTION OF A SMALL MOLECULE FROM A BIO CERAMIC COLLAGEN BONE GRAFT DEVICE HEALS BONE WHILE INHIBITINGBREAST CANCER BONE METASTASES - PROJECT SUMMARY: BONE GROWTH IS CRITICAL TO A FAVORABLE PROGNOSIS IN THE 70% OF DE NOVO METASTATIC BREAST CANCER PATIENTS THAT HAVE SKELETAL METASTASES, OR APPROXIMATELY 115,000 NEW PATIENTS PER YEAR IN THE US. LYTIC LESIONS, OR VOID-DEFECTS IN THE BONE, RESULT FROM LOCAL BONE DESTRUCTION CAUSED BY TUMOR CELL-DIRECTED OSTEOCLASTIC BONE RE- ABSORPTION AND LEAD TO PATHOLOGIC FRACTURES AND INCREASED PATIENT MORBIDITY. SURGICAL INTERVENTION IS NECESSARY TO PREVENT INITIAL FRACTURE OR OTHER SKELETAL RELATED EVENTS AND INVOLVES STABILIZING THE DEFECT CREATED BY THE TUMOR. UNFORTUNATELY, A GROWING POPULATION OF PATIENTS ARE AT RISK FOR IMPLANT FAILURE DUE TO THE INABILITY OF HARDWARE OR BONE CEMENT TO PROMOTE BONE FORMATION. BECAUSE OF HIGH FAILURE RATES AND INCREASED PATIENT SURVIVAL, LYTIC LESIONS ACCOUNT FOR APPROXIMATELY $2-BILLION IN US HEALTHCARE EXPENDITURES PER YEAR. PATIENTS WITH BREAST CANCER BONE METASTASES (I.E. A SKELETAL RELATED EVENT) REQUIRE SURGICAL INTERVENTION TO STABILIZE THE TUMOR-DIRECTED DEFECT USING INTRA-MEDULLAR NAILS, TOTAL JOINT PROSTHESES, AND/OR BONE CEMENT. HOWEVER, HARDWARE AND BONE CEMENT DON’T PROMOTE BONE FORMATION. THE UNDERLYING UNFILLED BONE DEFECTS CAN RESULT IN IMPLANT LOOSENING AND LOSS OF MECHANICAL STABILITY. GROWTH FACTORS HAVE BECOME A POPULAR OPTION TO INCREASE BONE HEALING. HOWEVER, THESE THERAPIES, SUCH AS BMP-2 (INFUSE®) AND PTH (FORTEO®), HAVE SAFETY RISKS FOR CANCER PATIENTS AND SOME HAVE BEEN CONTRAINDICATED FOR USE OR GIVEN A BLACK-BOX WARNING BY THE FDA FOR PATIENTS WITH ACTIVE TUMOR OR PATIENTS WITH HISTORY OF TUMOR. IN PARTICULAR, BMP-2 HAS BEEN ASSOCIATED WITH INCREASED TUMOR RISK IN PATIENTS WHO ARE UNDERGOING X-RADIATION THERAPY OR POSSESS NASCENT UNDETECTED TUMOR. IN RESPONSE TO THIS UNMET NEED, ZETAGEN THERAPEUTICS, INC., A NEW YORK REGENERATIVE MEDICINE STARTUP IS COMMERCIALIZING THE NALOVENT™ BONE GRAFT, A NEW COMBINATION PRODUCT WITH A DEMONSTRATED ABILITY TO TREAT LYTIC LESIONS BY INDUCING OSTEOGENESIS WHILE INHIBITING LOCAL GROWTH OF CANCER CELLS. BASED ON THE DISCOVERY OF A NOVEL MOLECULAR PATHWAY FOR BONE GROWTH, NALOVENT INDUCES OSTEOGENESIS VIA THE LOCAL IMPLANTATION OF A CALCIUM PHOSPHATE BIOCERAMIC / BOVINE COLLAGEN-BASED BONE GRAFT THAT CONTAINS THE OPIOID ANTAGONIST, NALOXONE. IF VALIDATED, THE NALOVENT BONE GRAFT WOULD EMPOWER CLINICIANS WITH A MUCH-NEEDED SOLUTION TO HEAL LYTIC BONE DEFECTS AND FIGHT RESIDUAL TUMOR IN ORDER TO DELIVER SIGNIFICANTLY IMPROVED OUTCOMES TO THE LARGE AND GROWING POPULATION OF BREAST CANCER PATIENTS WITH SKELETAL METASTASES. THIS PROPOSAL CONSISTS OF THREE AIMS MEANT TO DRIVE THE NALOVENT BONE GRAFT TOWARDS FDA APPROVAL USING STANDARD SAFETY, BIOAVAILABILITY, AND EFFICACY ASSESSMENTS: 1) ASSESS THE SAFETY OF NALOVENT, 2) TEST THE BIOAVAILABILITY OF NALOVENT AND 3) VALIDATE THAT THE NALOVENT BONE GRAFT PROMOTES BONE GROWTH. IF SUCCESSFUL, THIS PROPOSAL WILL DEMONSTRATE COMMERCIAL VALIDATION FOR THE NALOVENT BONE GRAFT IMPLANT AND ESTABLISH THE FOUNDATION FOR THE PREPARATION FOR FIRST-IN-MAN TRIALS.
Obligated Amount:
2249777.00
Face Value Of Loan:
0.00
Total Face Value Of Loan:
0.00
Date:
2019-09-11
Awarding Agency Name:
Department of Health and Human Services
Transaction Description:
VALIDATION OF A NOVEL, SMALL MOLECULE-BASED OSTEOINDUCTIVE LUMBAR FUSION IMPLANT
Obligated Amount:
224804.00
Face Value Of Loan:
0.00
Total Face Value Of Loan:
0.00
Date:
2018-09-05
Awarding Agency Name:
Department of Health and Human Services
Transaction Description:
VALIDATION OF A NOVEL, ADJUVANT IMPLANT FOR POST-METASTATIC SKELETAL LESIONS
Obligated Amount:
299958.00
Face Value Of Loan:
0.00
Total Face Value Of Loan:
0.00

Trademarks Section

Serial Number:
97753130
Mark:
ZETAGEN
Status:
FIRST EXTENSION - GRANTED
Mark Type:
TRADEMARK
Application Filing Date:
2023-01-13
Mark Drawing Type:
Standard character mark
Mark Literal Elements:
ZETAGEN

Goods And Services

For:
Pharmaceutical products for the treatment of bone diseases
International Classes:
005 - Primary Class
Class Status:
Active
For:
Bone setting machines and instruments; Medical apparatus and instruments for treating osteoarthritis, osteoporosis, osteotraumatic injuries, degenerative bone diseases and joint diseases; Medical apparatus and instruments for treating osteotraumatic injuries, degenerative bone diseases and joint dis...
International Classes:
010 - Primary Class
Class Status:
Active
Serial Number:
97367624
Mark:
ZETADENT
Status:
FOURTH EXTENSION - GRANTED
Mark Type:
TRADEMARK
Application Filing Date:
2022-04-18
Mark Drawing Type:
Standard character mark
Mark Literal Elements:
ZETADENT

Goods And Services

For:
Pharmaceutical products for the treatment of bone diseases
International Classes:
005 - Primary Class
Class Status:
Active
Serial Number:
97301062
Mark:
ZETAMET SETTABLE
Status:
FOURTH EXTENSION - GRANTED
Mark Type:
TRADEMARK
Application Filing Date:
2022-03-08
Mark Drawing Type:
Standard character mark
Mark Literal Elements:
ZETAMET SETTABLE

Goods And Services

For:
pharmaceutical products for the treatment of bone diseases; pharmaceutical preparations for the treatment of metastatic tumors and lesions; Pharmaceuticals, namely, for destroying, inhibiting or preventing the spread of uncontrolled growth of abnormal tissues, namely, metastatic tumors and lesions
International Classes:
005 - Primary Class
Class Status:
Active
Serial Number:
97119621
Mark:
ZETAONC
Status:
FOURTH EXTENSION - GRANTED
Mark Type:
TRADEMARK
Application Filing Date:
2021-11-11
Mark Drawing Type:
Standard character mark
Mark Literal Elements:
ZETAONC

Goods And Services

For:
Pharmaceutical products for the treatment of bone diseases; pharmaceutical preparations for the treatment of metastatic tumors and lesions; Pharmaceuticals, namely, for destroying, inhibiting or preventing the spread of uncontrolled growth of abnormal tissues, namely, metastatic tumors and lesions
International Classes:
005 - Primary Class
Class Status:
Active
Serial Number:
97119601
Mark:
METAPLASTY
Status:
FOURTH EXTENSION - GRANTED
Mark Type:
TRADEMARK
Application Filing Date:
2021-11-11
Mark Drawing Type:
Standard character mark
Mark Literal Elements:
METAPLASTY

Goods And Services

For:
Medical kits comprised of cannulae, surgical pushers, surgical needles, and syringes used for the delivery of pharmaceutical products for the treatment of bone diseases and metastatic tumors
International Classes:
010 - Primary Class
Class Status:
Active

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Date of last update: 23 Mar 2025

Sources: New York Secretary of State