NASDAQ:SNGX
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Business Update
Plans in Place for Confirmatory Phase 3 Trial of HyBryte in CTCL
Soligenix, Inc. (NASDAQ:SNGX) is on track to initiate a confirmatory Phase 3 trial of HyBryte for the treatment of cutaneous T cell lymphoma (CTCL) before the end of 2024. The FLASH2 trial will be very similar in design to the Phase 3 FLASH trial, as shown in the following figure, which provides a comparison between the two studies. This similarity in design increases our confidence in a positive outcome for the FLASH2 trial. With the trial expected to begin enrollment prior to the end of 2024, we anticipate topline results in the second half of 2026. After reaching agreement with the European Medicines Agency (EMA) on the key design elements of the FLASH2 trial, the company is continuing discussions with the U.S. Food and Drug Administration (FDA) on an appropriate study design as the agency has expressed a preference for a longer duration comparative study over a placebo-controlled trial.
Multiple Recent Positive Readouts for HyBryte
Over the past couple of months, Soligenix has announced positive results from clinical studies examining HyBryte in the treatment of CTCL:
• In July 2024, the company announced positive interim results from an open-label, investigator-initiated study, which is being supported by a $2.6 million FDA Orphan Products Development Grant. This study is designed to enroll up to 50 patients at select U.S. clinical sites, with patients having the potential to be treated for up to 12 months with twice a week dosing. There is also an option for the patients to transition to a “real-world” setting with home use. The primary endpoint is evaluating the number of “treatment successes”, which is defined as ≥50% reduction in the cumulative mCAILS (modified Composite Assessment of Index Lesion Severity).
Results thus far show that of the four evaluable patients enrolled and treated with HyBryte for at least 12 weeks of therapy, three of them already achieved “treatment success”. The fourth evaluable patient had a substantial improvement documented at the Week 18 visit but has not achieved the success threshold. Importantly, HyBryte continues to be safe and well tolerated by patients and no treatment-related adverse events have been reported.
• In June 2024, Soligenix announced positive results from a comparability study evaluating HyBryte versus Valchlor® (mechlorethamine gel) in the treatment of CTCL. The results showed that 60% of patients treated with HyBryte achieved “treatment success” compared to 20% of Valchor-treated patients. In addition, HyBryte had a more favorable safety profile than Valchlor and all patients tolerated HyBryte well and had no adverse events.
Phase 2 Trial in Behcet’s Disease to Initiate in 2H24
Soligenix is planning to initiate a Phase 2 clinical trial of SGX945 in Behcet’s Disease (BD) in the second half of 2024. In January 2024, the FDA granted Fast Track designation to SGX945 for the treatment of oral lesions of BD.
BD is a chronic recurrent multisystemic disease that causes oral aphthous ulcers, genital ulcers, skin lesions, and other pathologies (Mendes et al., 2009). Interestingly, the epidemiology of BD is distributed along the ancient Silk Road from Mediterranean countries (Turkey has 370 cases per 100,000 population), to Middle Eastern and East Asian countries. In contrast, there are very few cases found in Northern Europe (0.64 cases per 100,000 population), North America (0.12-0.33 cases per 100,000 population), Australia, and Africa (Deuter et al., 2007). Thus, BD is an orphan disease in the U.S., however there may be as many as 500,000 people worldwide with the disease.
There are no standardized regimens for treating BD. Systemic corticosteroids, interferon-alpha (INF-α) therapy, and anti-tumor necrosis factor alpha (TNF-α) therapy are all used as first-line agents and have shown good efficacy. Apremilast (Otezla®), a phosphodiesterase 4 inhibitor, was effective in a Phase 3 clinical trial in BD patients with oral ulcers (Hatemi et al., 2019). It was subsequently approved by the FDA for the treatment of oral ulcers in BD patients.
Dusquetide was previously tested as a treatment for oral mucositis in which it showed biological activity against aphthous ulcers induced by chemotherapy and radiation, thus serving as a proof-of-concept for the treatment of oral ulcers in BD.
Financial Update
On August 9, 2024, Soligenix announced financial results for the second quarter of 2024. The company reported revenues of less than $0.1 million for the second quarter of 2024, compared to $0.2 million for the second quarter of 2023. The revenues are derived from government contracts and grants to support the development of SGX943 for treatment of emerging and/or antibiotic resistant infectious diseases, development of CiVax™, and evaluation of HyBryte for expanded treatment in patients with early-stage CTCL. R&D expenses for the second quarter of 2024 were $0.5 million, compared to $0.8 million for the second quarter of 2023. The decrease was primarily due to adjustment of estimated accruals for completed clinical trials offset by preliminary costs associated with the anticipated initiation of the Phase 2 trial in Behcet’s disease and the second Phase 3 CTCL trial. G&A expenses for the second quarter of 2024 were $1.2 million, compared to $0.9 million for the second quarter of 2023. The increase was primarily due to an increase in legal and professional fees.
Soligenix exited the second quarter of 2024 with approximately $9.1 million in cash and cash equivalents. Subsequent to the end of the quarter, the company raised net proceeds of $4.1 million through the exercise of warrants. As of August 2, 2024, Soligenix had approximately 2.3 million shares outstanding, and when factoring in stock options, warrants, and the potential convertible debt the fully diluted share count is approximately 2.8 million.
Conclusion
We look forward to the initiation of the confirmatory Phase 3 trial in CTCL for HyBryte and the Phase 2 trial in Behcet’s disease for SGX942 in the second half of 2024. Looking ahead to next year, we anticipate data from the ongoing Phase 2 trial of SGX302 in mild-to-moderate psoriasis and the Phase 2 trial in Behcet’s disease to be available in the first half of 2025. With no changes to our model our valuation remains at $35 per share.
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