Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 158

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 158
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 support ethnic sensitivity and dose justification. |

| ● | New                                                                                          
 Drug Application (NDA) submission upon completion of pivotal data and CMC review. The NDA    
 will include full data on safety, efficacy, manufacturing, and quality, and must comply with 
 both ICH and Chinese Pharmacopoeia standards.                                                |

Given the increasing regulatory alignment
between NMPA and global standards, including China's implementation of ICH E6 (R2) and E17 for multi-regional clinical trials (MRCTs),
we are designing our development program to enable seamless inclusion of Chinese sites in global pivotal trials.

Japan: we plan to engage with the Pharmaceuticals
and Medical Devices Agency (PMDA) to pursue regulatory approval under Japan’s standard NDA pathway. Given the innovation and potential
life-extending benefit of Liposomal-ARB in pancreatic cancer, we may seek qualification for the Sakigake designation, which supports
expedited development and review of promising therapies addressing high unmet needs in Japan.

Employees

We currently have
three (3) full-time employees, four (4) part time employee, and 10 experienced consultants, including two (2) on administrative level,
five (5) in the scientific and product development and three (3) in the medical (clinical trials) field. Our employees work at will and
are not represented by a collective bargaining unit. We believe our relationship with our employees is excellent in most cases. We require
all our employees and consultants to sign a confidentiality and non-disclosure agreement. Our success relies on our ability to hire additional
employees, particularly on the local sales side. We believe there are numerous quality people to choose from throughout our area of targeted
expansion.

Subsidiaries

The Company has two wholly-owned subsidiary,
Revium Rx, Ltd. and LipoVation Ltd., each organized under the laws of the State of Israel.

Corporate Office

Our principal executive office is at 10 HaMenofim
Street Herzliya, Israel. Our main telephone number is 1 800 519-1687.

Legal Proceedings

There are no pending
legal proceedings to which the Company is a party or in which any director, officer or affiliate of the Company, any owner of record or
beneficially of more than 5% of any class of voting securities of the Company, or security holder is a party adverse to the Company or
has a material interest adverse to the Company. The Company’s property is not the subject of