Relmada Therapeutics, Inc.

What they do

Relmada is a Nevada corporation and Nasdaq-listed clinical-stage company developing new chemical entities and novel versions of existing drugs; none of its product candidates is approved for sale anywhere and it has no sales or marketing infrastructure. Its lead candidate, NDV-01, is an in-licensed controlled-release intravesical formulation of gemcitabine and docetaxel currently in a Phase 2 trial in Israel in aggressive NMIBC. Its second candidate, sepranolone, acquired from Asarina Pharma, is a neurosteroid epimer of allopregnanolone being developed for PWS, Tourette Syndrome, essential tremor and other conditions tied to excessive GABAergic activity.

Revenue drivers

• No product revenue — The company states it has not generated revenues, has no commercial products, and does not anticipate revenues for the foreseeable future; XBRL revenue figures of $7,941 (2012) and $5,129 (2013) are legacy amounts far smaller than any operating scale.
• NDV-01 (gemcitabine/docetaxel intravesical) — Lead program in-licensed from Trigone Pharma on March 24-25, 2025; would generate revenue only if approved, with planned development in high-risk 2nd-line BCG-unresponsive NMIBC and intermediate-risk adjuvant NMIBC.
• Sepranolone (neurosteroid) — Acquired from Asarina Pharma on February 6, 2025; a Phase 2b-ready asset in PWS, TS, essential tremor and other GABAergic conditions, with no revenue unless approved.
• Terminated programs — REL-1017 (esmethadone) was terminated effective July 7, 2025 and REL-P11 (modified-release psilocybin) effective May 12, 2025, so neither is a future revenue source.

Recent performance

The 10-K reports a net loss of approximately $57,385,200 for the year ended December 31, 2025, with an accumulated deficit of approximately $698,267,200 at that date. R&D expense fell to approximately $26,879,100 in 2025 from $46,175,500 in 2024, a $19,296,400 decrease, mainly from a $19,011,500 drop in other research expenses tied to fewer Phase 3 consultants, partly offset by $1,964,500 higher manufacturing and drug storage costs. G&A expense fell to approximately $32,221,100 from $37,715,500, a $5,494,400 decrease, including a $10,705,800 drop in stock-based compensation. For the second quarter of 2026, the August 6, 2026 release reports R&D expense of $8.4 million versus $2.8 million a year earlier, an increase of $5.6 million attributable to higher NDV-01 and sepranolone study costs and increased manufacturing. The company reported a cash balance of $217.7 million as of June 30, 2026, expected to fund operations through 2029.

Strategy

After a late-2024/early-2025 strategic review, management terminated work on esmethadone (REL-1017) and psilocybin (REL-P11) and redirected the company toward in-licensed and acquired assets: NDV-01 from Trigone Pharma and sepranolone from Asarina Pharma. The stated priority is manufacturing and CMC execution to support IND filings for both programs by year-end 2026. NDV-01 is to be developed in two indications, high-risk 2nd-line BCG-unresponsive NMIBC and intermediate-risk adjuvant NMIBC, with the Phase 3 RESCUE registrational program to start upon IND clearance. Sepranolone's formulation work is complete and the company is finalizing the pre-filled syringe delivery system before its IND, with a Phase 2 proof-of-concept study in PWS planned after clearance. The company also added Bipin Dalmia as Chief Business Officer and was added to the Russell 2000 and Russell 3000 Indexes effective June 26, 2026.

Risks

• No revenue and no approved products — Relmada states it has no commercial products or sales and marketing infrastructure and does not anticipate revenues for the foreseeable future, so results depend entirely on financing and clinical outcomes.
• Clinical and regulatory failure — The company's own risk factors state that trials must be successfully completed with supporting data to obtain approval, and the prior REL-1017 setback shows its programs can fail after late-stage investment.
• Dependence on in-licensed/acquired assets — Both current candidates came from third parties — NDV-01 from Trigone Pharma and sepranolone from Asarina Pharma — exposing the company to licensing, development and third-party execution risks.
• Manufacturing and CMC execution — The August 2026 release says the immediate priority is manufacturing execution for NDV-01 and that sepranolone's pre-filled syringe delivery system remains to be finalized ahead of its IND.

Outlook

Management expects to file U.S. INDs for both NDV-01 and sepranolone by year-end 2026, with the NDV-01 Phase 3 RESCUE registrational program and a sepranolone Phase 2 proof-of-concept study in Prader-Willi Syndrome to begin upon IND clearance. The 10-K had previously listed NDV-01 FDA IND clearance, Phase 3 initiations in both NMIBC indications and sepranolone Phase 2 initiation as mid-2026 milestones, plus initial 3-month data from the high-risk BCG-unresponsive Phase 3 trial at year-end 2026, so timelines in the latest quarterly update are later than the annual report. The company states its $217.7 million cash balance as of June 30, 2026 is expected to fund operations through 2029, including completion of the NDV-01 Phase 3 RESCUE program.