Aug 6, 2026, 4:40 PM ETHealthcare

Relmada Therapeutics — Second Quarter 2026 Earnings Summary

RLMDRELMADA THERAPEUTICS INC

Financial Performance

Research and development expenses for the three months ended June 30, 2026, totaled $8.4 million, an increase of $5.6 million compared to $2.8 million in the same period of 2025, driven by higher study and manufacturing costs.
General and administrative expenses for the three months ended June 30, 2026, were $6.6 million, a decrease of approximately $0.8 million from $7.4 million in the prior year period, primarily due to lower stock-based and employee compensation.
Net cash used in operating activities for the three months ended June 30, 2026, was $9.6 million, compared to $6.4 million in the same period of 2025.
Net loss for the three months ended June 30, 2026, was $12.9 million ($0.11 per share), compared to a net loss of $9.9 million ($0.30 per share) in the prior year period.
Net loss for the six months ended June 30, 2026, was $32.0 million ($0.32 per share), compared to $27.4 million ($0.86 per share) in the prior year period.
Cash, cash equivalents, and short-term investments totaled $217.7 million as of June 30, 2026, compared to approximately $93.0 million as of December 31, 2025.
Total assets were $219.1 million as of June 30, 2026, compared to $94.0 million as of December 31, 2025.
Total stockholders' equity was $206.6 million as of June 30, 2026, compared to $86.5 million as of December 31, 2025.
The company had 106,669,846 shares outstanding as of August 4, 2026.

The Company expects to fund operations through 2029, including the completion of the NDV-01 Phase 3 RESCUE program.
NDV-01 IND filing is expected by year-end 2026, with Phase 3 RESCUE program initiation expected upon IND clearance.
Sepranolone IND filing is expected by year-end 2026, with Phase 2 proof-of-concept study initiation in Prader-Willi Syndrome expected upon IND clearance.
Clinical trial sites for NDV-01 are engaged and prepared to begin enrollment following IND clearance.

NDV-01: Manufacturing and CMC activities are ongoing to support the planned IND submission. The therapy is a novel, sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer (NMIBC).
Sepranolone: Formulation development is complete, and the pre-filled syringe delivery system is being finalized. The therapy is a synthetic isoallopregnanolone targeting disorders linked to excess GABAergic activity.
Over 335 patients have been treated with sepranolone in clinical trials to date with an excellent safety profile.
NDV-01 is encompassed by multiple patent applications that could provide protection until 2047 if issued.

NMIBC represents 75-80% of all bladder cancer cases with high recurrence rates (50–80% over 5 years) and limited treatment options for high-risk BCG-unresponsive disease.
The market includes over 744,000 prevalent cases in the U.S.
Prader-Willi Syndrome (PWS) has a global prevalence estimated at 350,000-400,000 patients.
The Company was added to the Russell 2000® and Russell 3000® Indexes effective June 26, 2026.

Risks include potential failure of product candidates to progress, failure of clinical trials to deliver statistically significant evidence of efficacy or safety, and failure to secure FDA agreement on regulatory paths.
Manufacturing risks include potential failure to execute CMC activities, secure drug supply, or achieve regulatory acceptance of manufacturing submissions.
Risks related to intellectual property include the failure of pending patent applications to issue or issued patents being challenged.
Uncertainties exist regarding the Company's cash runway and ability to fund future operations.

CEO Sergio Traversa stated the Company has entered a critical execution phase and is well-positioned to create long-term value, citing FDA alignment, a robust clinical dataset, and sufficient capital.
CEO Traversa emphasized that the immediate priority is manufacturing execution for NDV-01 to support the IND filing.
CBO Bipin Dalmia described NDV-01 as one of the most compelling opportunities in NMIBC, highlighting its differentiated profile and potential to become a foundational therapy.
The Company received written FDA feedback confirming alignment on two registrational development pathways for NDV-01, including study design and primary endpoints.

Bipin Dalmia, PhD, MBA, was appointed Chief Business Officer, bringing nearly three decades of biopharmaceutical leadership experience.
The Company raised $159.9 million in proceeds from the issuance of common stock during the six months ended June 30, 2026, with $9.8 million paid in issuance fees.
Stock-based compensation for the six months ended June 30, 2026, was $1.9 million, while stock appreciation rights compensation was $4.0 million.
The Company hosted a conference call and webcast on August 6, 2026, at 4:30 PM ET to discuss results.