Relmada Beats On Per-Share Loss, But Dilution Drives The Number As 18-Month NDV-01 Data Reveal Its First Progressions

Relmada Therapeutics reported a third-quarter loss of $0.12 per share, beating the consensus estimate of a $0.14 loss by 14.3%. Earnings improved 60.0% year over year. The headline flatters the quarter, though. The improvement comes almost entirely from a larger share count, not a smaller loss. The more important development for a pre-revenue company is that Relmada held its year-end 2026 IND timeline for NDV-01. It also posted its first 18-month durability data. Those data, however, included the program's first progressions to muscle-invasive disease. That is the central tension: execution improved, but the clinical narrative picked up its first real blemish.

The quality of the beat deserves scrutiny. Net loss widened to $13.9 million from $10.1 million a year earlier. The per-share figure improved only because weighted average shares rose to 112.4 million from 33.2 million after this year's equity raises.

Operating loss grew to $13.1 million from $10.3 million, for two reasons:

• R&D more than doubled to $9.2 million on NDV-01 and sepranolone study preparation, manufacturing and drug storage.
• G&A fell to $3.9 million, mainly on lower stock-based compensation and stock appreciation rights expense, which partly offset the R&D increase.

Investment income of $2.3 million was more than erased by $3.0 million of realized and unrealized losses on short-term investments, leaving other expense of $0.8 million. Sequentially, R&D has climbed steadily from $8.1 million in Q1 to $8.4 million in Q2 to $9.2 million now. That is consistent with a company preparing for Phase 3.

The call marked a clear shift from the defensive tone of the second quarter, when the Phase 3 timeline slipped. In Q2, management said the manufacturing process was locked and it was waiting for GMP slots. This quarter, it reported GMP batches from two parallel processes, at Piramal in the U.S. and Sinai in Israel. It cited roughly nine weeks of stability data it characterized as within FDA requirements and said the IND is being written. Year-end IND targets for both NDV-01 and sepranolone were reaffirmed with no further slippage. Management also described a manufacturing plan to provide uninterrupted clinical supply through completion of the Phase 3 program, now renamed SPECTRUM with its design unchanged.

The clinical update was larger but less pristine:

• **Dataset size:** the Phase 2 dataset grew to 51 evaluable patients from 38.
• **12-month complete response:** edged up to 77% from 76%.
• **Anytime complete response:** slipped to 94% from 95%.
• **18-month durability:** 86% (12 of 14) of evaluable 12-month responders remained in complete response, and 88% (7 of 8) in the BCG-unresponsive subgroup.
• **Safety:** still clean, with no Grade 3 or higher treatment-related adverse events and no treatment-related discontinuations.

But two BCG-naïve T1 patients progressed to T2a muscle-invasive disease at the month-15 assessment. Every prior call had emphasized zero progressions. The sample is small, and the progressions fall outside the BCG-unresponsive population at the core of the lead registrational pathway. Still, they remove a talking point and give bears legitimate ammunition. Other open questions remain:

• The split between carcinoma in situ and papillary disease is still undisclosed and was deferred to a future medical meeting.
• The Phase 3 protocol allows re-induction only at the start of treatment, a narrower allowance than Phase 2. That raises a fair question about how well Phase 2 response rates will translate.
• There is no updated timing for first three-month SPECTRUM data, originally expected by year-end 2026.

The balance sheet removes financing as a near-term overhang. Cash and investments ended at $202.1 million, down from $217.7 million in Q2 and $234 million in Q1, a burn of roughly $15 to $16 million per quarter. Management continues to expect that cash to fund operations through 2029, including completion of both registrational SPECTRUM cohorts. The near-term catalyst is binary and procedural: IND submissions by year-end, with Phase 3 and the Phase 2b sepranolone trial in Prader-Willi syndrome starting only upon clearance.

Investor sentiment became meaningfully less negative heading into the report, improving to -0.03 from -0.24 at the prior report, though it remains slightly below neutral. Price action has been rough. Shares closed at $4.43 before the release, down 18.7% from the $5.45 open after the August report. They sit about 17% below the 200-day moving average of $5.36. The stock set a 52-week low of $3.07 on October 16 and has since rebounded about 44% off that level, though it remains about 20% below the quarter's $5.55 high. Most Earnings Whispers trend readings, including price and momentum, remain negative, while AVWAP is positive, consistent with a stock trying to stabilize after a sharp drawdown.

The bottom line is that Relmada's EPS beat is a dilution artifact rather than an operating improvement. The quarter's real substance lies in execution. Manufacturing has moved into GMP production, the year-end IND target survived without another slip, and the cash runway extends through 2029. The first muscle-invasive progressions, the undisclosed CIS/papillary data and the narrower Phase 3 re-induction rules keep the clinical story from being clean. With the stock still well below its 200-day average, the next test is whether the IND is filed and cleared on schedule.

Read our earnings preview for Relmada Therapeutics, Inc.: https://www.earningswhispers.com/article/RLMD/22942

This earnings review was originally published on Earnings Whispers.

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