- The company said that these interim results support advancement into the Phase 3 RESCUE registrational trial program to evaluate NDV-01.
- Relmada also announced that it has entered into a securities purchase agreement for a private investment in public equity financing, with gross proceeds of $160 million expected.
- The company stated that it intends to use the proceeds for working capital and general corporate purposes, including advancing the research and development of its product candidates.
Relmada Therapeutics Inc. (RLMD) shares soared more than 66% in Monday’s pre-market trade before paring some of the gains after the company announced an update in the Phase 2 trial of its bladder cancer treatment.
Relmada stated that NDV-01 demonstrated a durable 76% complete response (CR) rate at 12 months, with 95% CR rate at any time in high-risk non-muscle invasive bladder cancer (NMIBC).
Relmada Therapeutics shares were up nearly 38% in Monday’s opening trade. Retail sentiment on Stocktwits around the company trended in the ‘bullish’ territory at the time of writing.
What Do These Findings Signify?
Relmada stated that its Phase 2 trial findings of NVD-01 demonstrated a 12-month CR rate of 80% in the BCG-unresponsive population. The company stated that this is one of the most difficult-to-treat segments of NMIBC.
“We continue to observe strong responses in patients with BCG-unresponsive disease, with no progression to muscle-invasive disease and no patients requiring radical cystectomy,” said Relmada’s Chief Medical Officer-Oncology, Raj S. Pruthi.
The company said that these interim results support advancement into the Phase 3 RESCUE registrational trial program to evaluate NDV-01.
What Is NDV-01?
NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce) being developed to treat non-muscle invasive bladder cancer. It is designed to retain the drugs in the bladder and release them gradually over a 10-day period.
NDV-01 comes ready to use and can be administered in about five minutes without anesthesia or specialized equipment. It is protected by patents through 2038.
The company highlighted three upcoming milestones of NDV-01. It expects clearance for its Investigational New Drug (IND) application and the initiation of its Phase 3 RESCUE Program by mid-2026. The initial 3-month results from its Phase 3 2L BCG-unresponsive study are expected by the end of the year.
Relmada Announces $160 Million Financing
Relmada also announced that it has entered into a securities purchase agreement for a private investment in public equity (PIPE) financing, expecting gross proceeds of $160 million.
The company stated that it intends to use the proceeds for working capital and general corporate purposes, including advancing the research and development of its product candidates.
RLMD stock is up 24% year-to-date and 1,987% over the past 12 months.
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