Soligenix Inc. (SNGX), a late-stage biopharmaceutical company developing products to treat rare diseases, has multiple potential value drivers, making the stock worth watching.
The Company has three phase III compounds – SGX301 for Cutaneous T-cell lymphoma, SGX942 for oral mucositis and SGX203 for Pediatric Crohn’s disease.
Also in the pipeline are:
— SGX201 for the prevention of radiation enteritis, an inflammatory bowel condition resulting from radiation damage to the abdominal and pelvic areas, which is expected to enter into phase II trial, pending partnership or funding.
— RiVax, an investigational vaccine for the prevention of death following exposure to a lethal dose of ricin toxin, has demonstrated safety in two phase I clinical studies.
— OrbeShield, an oral, topical anti-inflammatory steroid for the treatment of the gut, under phase I development.
The phase III trial of SGX301, a topical drug candidate, in the treatment of cutaneous T-cell lymphoma, dubbed FLASH, is underway, with final results expected this quarter (Q1).
Cutaneous T-cell lymphoma (CTCL, which belongs to a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells, affects over 25,000 individuals in the US, with approximately 3,000 new cases seen annually.
Soligenix is of the view that SGX301 has the potential to be a valuable therapy in the front-line treatment of early-stage CTCL, which is an orphan disease and area of unmet medical need. The Company sees a $250 million market opportunity for SGX301.
— The phase III study of SGX942 for oral mucositis is enrolling patients, with topline data expected in the second quarter of 2020.
Oral mucositis is a multi-factorial disease linked to a dysregulation of the innate immune system, affecting over 180,000 head & neck (H&N) cancer patients worldwide. The market opportunity for SGX942 is estimated to be in excess of $500 million.
— The next advanced drug candidate is SGX203 in the treatment of pediatric Crohn’s disease, which is expected to enter into phase III testing, pending partnership or funding.
— A phase IC study of RiVax in healthy, normal adults, initiated last December is underway, with preliminary safety results expected in the second quarter of 2020.
Recent Quarterly Scorecard:
Soligenix’s net loss for the third quarter ended September 30, 2019, widened to $2.7 million or $0.14 per share from $1.9 million or $0.11 per share in the year-ago quarter. Revenues for the recent third quarter were $1.3 million compared to $1.4 million for the quarter ended September 30, 2018. Revenues included payments on a contract in support of RiVax, in addition to the grants received to support the development of SGX301 and SGX942.
As of September 30, 2019, the Company had cash of roughly $6.6 million.
SNGX has traded in a range of $0.65 to $3.54 in the last 1 year. The stock closed Friday’s trading at $3.16, down 5.39%.
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