Soligenix, Inc. Quarterly Report for the Period Ended March 31, 2024

Press release · 05/11 02:20
Soligenix, Inc. Quarterly Report for the Period Ended March 31, 2024

Soligenix, Inc. Quarterly Report for the Period Ended March 31, 2024

Soligenix, Inc. reported a net loss of $1.2 million for the quarter ended March 31, 2024, compared to a net loss of $0.9 million for the same period in 2023. The company’s total assets increased to $15.8 million, while total liabilities remained stable at $0.3 million. The number of outstanding shares of common stock was 15.8 million.

Company Overview

Soligenix is a late-stage biopharmaceutical company developing products to treat rare diseases where there is an unmet need. The company has two business segments:

  • Specialized BioTherapeutics - Developing HyBryteTM for the treatment of cutaneous T-cell lymphoma (CTCL), SGX302 for the treatment of mild-to-moderate psoriasis, SGX942 for the treatment of oral mucositis in head and neck cancer patients, and SGX945 for the treatment of aphthous ulcers in Behçet’s Disease.

  • Public Health Solutions - Developing heat stabilization platform technology ThermoVax®, ricin toxin vaccine RiVax®, therapeutic SGX943 for emerging infectious diseases, and vaccine programs for filoviruses like Ebola and Marburg virus as well as a COVID-19 vaccine CiVaxTM. Many programs in this segment have been supported by government funding.

Financial Highlights

  • Net loss for Q1 2024 was $1.9 million compared to $1 million in Q1 2023. The increased loss was primarily due to no income tax benefit recognized in Q1 2024.

  • Revenues decreased 54% to $117,000 in Q1 2024 from $257,000 in Q1 2023 due to conclusion of some government grants.

  • R&D expenses increased 16% to $1.1 million in Q1 2024 from $946,000 in Q1 2023 due to costs for upcoming trials.

  • G&A expenses decreased 17% to $1 million in Q1 2024 from $1.2 million in Q1 2023 due to lower legal/professional fees.

  • Cash and equivalents were $7.1 million as of March 31, 2024, down from $8.4 million as of December 31, 2023. The company believes it has sufficient resources to fund operations through Q1 2025.

Business Highlights

  • Amended agreement with Pontifax for $20 million debt financing. Reduced principal balance to $3 million after repaying $5 million.

  • Pontifax converted $99,000 of the debt principal into 146,000 shares of common stock in January 2024.

  • Completed a public offering in April 2024 raising approximately $4.75 million in gross proceeds.

  • Received agreement from the EMA on the protocol for a second confirmatory Phase 3 placebo-controlled study of HyBryteTM in CTCL patients. Study targeted to begin enrollment by end of 2024.

  • Continued discussions with FDA regarding requirements for HyBryteTM marketing approval. FDA expressed preference for longer study over placebo-controlled trial.

  • Advanced Phase 2a trial of SGX302 in mild-to-moderate psoriasis and expanded trial after positive preliminary data.

  • Received IND clearance from FDA and Fast Track designation for SGX945 for the treatment of aphthous ulcers in Behçet’s Disease. Phase 2a study initiation targeted for 2H 2024.

Nasdaq Listing Requirements

The company continues to face challenges meeting Nasdaq’s minimum bid price rule after receiving another delisting notice in December 2023. Management pursuing options to maintain compliance but there is substantial doubt about the company’s ability to continue meeting listing requirements.