Soligenix Inc. - Rising to the challenges of rare disease treatment
Transforming research into reality
Since its founding in 1987, Soligenix, Inc. has established itself as a front runner in the development and commercialization of products that address unmet medical needs in the areas of inflammation, oncology, and biodefense.
The company is also known for its advanced work on treatments for cutaneous t-cell lymphoma (CTCL), oral mucositis, and pediatric Chrohn’s disease.
A late-stage research and development biopharmaceutical company headquartered in Princeton, NJ., the company’s main focus is on developing products to treat rare diseases, the life-threatening side effects of cancer treatment, gastrointestinal diseases and cancer. Soligenix also develops vaccines and therapeutics for military and civilian applications.
Two Distinct Business Segments
Soligenix divides its areas of focus into two unique business segments that support its rare disease pipeline:
- Specialized BioTherapeutics – Soligenix is dedicated to the development of products for orphan diseases and areas of unmet medical needs. This business segment focuses on the development of oral beclomethasone dipropionate (orBec or oral BDP) and other biotherapeutic products, including LPMTM Leuprolide. The company is also focused on developing a novel photodynamic therapy (SGX301) that utilizes the topical synthetic hypericin activated with safe visible fluorescent light for the treatment of cutaneous T-cell lymphoma (CTCL). Through its Bio Therapeutics division, Soligenix is developing lead candidate orBec, an orally administered drug using the same active ingredient as GlaxoSmithKline’s allergy and asthma drug Beconase. orBec is a potential therapy for intestinal graft-versus-host disease, a life-threatening complication of bone marrow transplantation.
- Public Health Solutions – This business unit develops vaccines and therapeutics for military and civilian applications in the areas of ricin exposure, emerging and antibiotic infectious disease, and viral diseases, including Ebola, Marburg, and Covid-19. The Public Health Solutions segment comprises of active development programs for RiVax (which is in early-stage clinical trial), and SGX943, a therapeutic candidate for antibiotic resistant and emerging infectious disease. The Public Health Solutions business segment is funded by the U.S. Government to the amount of approximately $70 million to date
Interview With Christopher Schaber CEO - Soligenix Inc.
The Richmond Club has selected Soligenix Inc. as a 2020-2021 top stock pick that we feel is currently undervalued and set for ongoing growth.
2020 Highlights and Achievements
Covid-19 has done little to slow the company’s ongoing work, and 2020 has seen Soligenix reach a number of major goals and accomplishments, all while flying under the radar of investors and setting themselves apart from competitors like Celtaxsys, Alder Biopharmaceuticals, Teva Pharmaceuticals, and VBI Vaccines.
During the course of 2020 the company has developed multiple products with fast track and/or orphan designations, each of which holds potential for significant commercial returns. As of mid-2020, Soligenix has two active Phase 3 clini cal programs in its Bio Therapeutics segment, including crucial breakthroughs in:
- SGX301 for Cutaneous T-cell lymphoma: SGX301 (synthetic hypericin) is a novel photodynamic therapy for the treatment of CTCL, which is a rare class of non-Hodgkin’s lymphoma. In June of 2020, Soligenix also announced positive and statistically significant results in the pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) SGX301 study. The study is now complete with a new drug application (NDA) currently being prepared for submission to the U.S. Food and Drug Administration (FDA). The company believes positive results back up their belief that SGX301 could be a major game-changer for CTCL patients. The global market for a CTCL product is approximately $250 million. Click here for detailed information on this recent Soligenix success.
- SGX942 for Oral mucositis in head & neck cancer: SGX942 (dusquetide) is a novel ingestible drug that modulates the body’s own immune system to reduce inflammation, clear infections, and promote tissue healing. This crucial Phase 3 trial clinical trial to treat oral mucositis in patients with head and neck cancer completed patient enrollment in June 2020. A pivotal study is now in progress, with interim analysis and patient enrollment complete. Top-line results are expected in the fourth quarter of 2020. Upon successful clinical trials, Soligenix will start preparing market authorization for SGX942 where the global market potential for an oral mucositis product could exceed $500 million. Click here to read a press release on these latest SGW942 developments.
The company also continues to develop SGX203 for the prevention and treatment of gastrointestinal disorders characterized by severe inflammation, including pediatric Crohn’s disease. SGX203 is an oral steroid that coats the gastrointestinal tract to reduce inflammation. The company is currently poised to begin Phase 3 double blind trial designs. SGX203 has the potential to be the first FDA-approved therapy for Crohn’s disease in children.
Under its Public Health Solutions business segment, Soligenix continues its forward progress with work on heat stable filovirus vaccines that protect against viruses like Ebola and Marburg.
This program has been extended to the development of vaccines to potentially combat coronavirus, including SARS-CoV-2, which is the cause of COVID-19.
Soligenix also continues to support its heat stable ricin RiVax vaccine that has been fast tracked by the FDA with a NIH contract award of $21.2 million.
Other Investment Highlights
Aside from the accomplishments highlighted above, a number of other factors contribute to the company’s robust growth over the past few years. These include:
A Strong and Experienced, Management Team
The company boasts a strong management team, each of whom brings to the table considerable expertise in the pharmaceutical and biotechnology industries and in developing orphan/rare disease therapies. Since 2006, Soligenix has been led by chairman, president, and CEO Christopher J. Schaber. The company also partners with renowned scientific experts with their own track records of success.
Soligenix plans to bring their proposed products to market in the next two years, so the success of the company may depend on the experience, abilities, and continued services of its senior officers, sales staff, and key scientific personnel.
Soligenix actively pursues non-dilutive government funding helps cover operating expenses and to support their rare disease pipeline. In 2014 the National Institute of Health (NIH) awarded to company a ~$21.2M contract to support the development of RiVax® for pre-exposure to ricin toxin.
There is also the potential to receive biodefense priority review vouchers with USFDA approval. The company’s rare disease pipeline is funded by the U.S. government, which allows the company to use cash efficiently and effectively.
With over $9 million in cash as of the second quarter 10Q financial filing, Soligenix anticipates having sufficient capital to achieve multiple inflection points across its rare disease pipeline, including the top results in the SGX301 and SGX942 clinical trials referenced earlier.
The company hopes that ongoing and confidential business development strategies may lead to more capital inflows and the potential for additional non-dilutive funding.
Other investment highlights include a steady stream of material milestones and catalysts to build value, productive collaborations with biotech, academia, and government agencies, and an active evaluation of strategic alternatives, collaborations, and partnerships.
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