About Soligenix

Soligenix, Inc., a late-stage biopharmaceutical company, focuses on developing and commercializing products to treat rare diseases where there is an unmet medical need. Segments The company operates through two segments, Specialized BioTherapeutics and Public Health Solutions. Specialized BioTherapeutics segment This segment is developing and moving toward potential commercialization of HyBryte (a proposed proprietary name of SGX301 or synthetic hypericin), a novel photodynamic therapy (PDT), utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With a successful Phase 3 study completed, regulatory approval is being sought and commercialization activities for this product candidate are being advanced initially in the U.S. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, the company's first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation, including pediatric Crohn's disease (SGX203). Synthetic Hypericin Synthetic Hypericin is a potent photosensitizer that is topically applied to skin lesions, taken up by cutaneous T-cells and then activated by safe visible light. Hypericin is also found in several species of Hypericum plants, although this active moiety is chemically synthesized by a proprietary manufacturing process and not extracted from plants. Importantly, hypericin is optimally activated with visible light thereby avoiding the negative consequences of ultraviolet (UV) light. Other light therapies using ultraviolet A (UVA) or ultraviolet B (UVB) light can result in serious adverse effects including secondary skin cancers. Combined with photoactivation, in clinical trials synthetic hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In both settings, it appears that the mode of action is an induction of cell death in a concentration, as well as a light dose-dependent fashion. These effects appear to result, in part, from the generation of singlet oxygen during photoactivation of hypericin. Synthetic hypericin is one of the most efficient known generators of singlet oxygen, the key component for phototherapy. The generation of singlet oxygen induces necrosis and apoptosis in adjacent cells. The use of topical synthetic hypericin coupled with directed visible light results in generation of singlet oxygen only at the treated site. In a small published Phase 1/2 proof of concept pilot clinical study using synthetic hypericin twice weekly for six weeks, statistically significant efficacy was demonstrated in patients with CTCL and psoriasis. Subsequently, a pivotal Phase 3 study in CTCL has further confirmed the biological efficacy of synthetic hypericin (termed HyBryte in the context of CTCL). HyBryte - for Treating Cutaneous T-Cell Lymphoma HyBryte is a novel, first-in-class, PDT, that utilizes safe visible light for activation. The active ingredient in HyBryte is synthetic hypericin, a photosensitizer which is topically applied to skin lesions and then activated by visible fluorescent light 16 to 24 hours later. Based on the positive and previously published Phase 1/2 results, the company initiated its pivotal Phase 3 clinical study of HyBryte for the treatment of CTCL during December 2015 and completed the trial in 2020. This trial, referred to as the FLASH (Fluorescent Light Activated Synthetic Hypericin) study, aimed to evaluate the response to HyBryte as a skin directed therapy to treat early stage CTCL. HyBryte has received Orphan Drug designation, as well as Fast Track designation from the FDA. In January 2021, the company signed an exclusive Supply, Distribution and Services Agreement with The Daavlin Distributing Co. (Daavlin), securing long-term supply and distribution of a commercially ready light device, which is an integral component of the regulatory and commercial strategy for HyBryte for the treatment of CTCL. Pursuant to the agreement, Daavlin will exclusively manufacture the proprietary light device for use with HyBryte for the treatment of CTCL. Upon approval of HyBryte by the FDA, the company will promote HyBryte and the companion light device, and facilitate the direct purchase of the device from Daavlin. Daavlin will exclusively distribute and sell the HyBryte light device to the company, physicians, and patients. In April 2021, the FDA conditionally accepted HyBryte as the proposed brand name for SGX301 or synthetic hypericin, in the treatment of early stage CTCL. The name HyBryte was developed in compliance with the FDA's Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names. The FDA's conditional approval validates HyBryte as a proprietary name that is consistent with the FDA's goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use. Final approval of the HyBryte proprietary name is conditioned on FDA approval of the product candidate, SGX301. In May 2021, HyBryte was awarded an Innovation Passport for the treatment of early stage CTCL in adults under the United Kingdom's (U.K.'s) Innovative Licensing and Access Pathway (ILAP). The decision to award the Innovation Passport to the HyBryte program was made by the Innovative Licensing and Access Pathway Steering Group, which includes representatives from Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC). ILAP was launched at the start of 2021 to accelerate the development and access to promising medicines, thereby facilitating patient access to new medicines. The pathway, part of the U.K.'s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with the MHRA, NICE, and SMC. The innovation passport designation is the first step in the ILAP process and triggers the MHRA and its partner agencies to create a target development profile to chart out a roadmap for regulatory and development milestones with the goal of early patient access in the U.K. Other benefits of ILAP include a 150-day accelerated assessment, rolling review and a continuous benefit risk assessment. In June 2021, the company received a Paediatric Investigation Plan (PIP) waiver from the EMA for HyBryte. As part of the regulatory process for the registration of new medicines with the EMA, pharmaceutical companies are required to provide a PIP outlining their strategies for investigation of the new medicinal products in the pediatric population. In some instances, a waiver negating the need for a PIP for certain conditions may be granted by the EMA when development of a medicine for use in children is not feasible or appropriate, as is the case for HyBryte in CTCL which is extremely rare in children. In September 2021, the company was granted orphan drug designation for the active ingredient hypericin for the treatment of T-cell lymphoma, extending the target population beyond CTCL as previously granted by the FDA. In July 2022, the results of the company's successful Phase 3 FLASH study evaluating HyBryte for the treatment of CTCL were published in the Journal of the American Medical Association (JAMA) Dermatology. In July 2022, the company received agreement from the FDA on an initial pediatric study plan (iPSP) for HyBryt for the treatment of CTCL. The agreed iPSP stipulates that the company intends to request a full waiver of pediatric studies upon submission of the NDA. In September 2022, the FDA awarded an Orphan Products Development grant to support the evaluation of HyBryte for expanded treatment in patients with early-stage CTCL. The grant was awarded to a prestigious academic institution that was a leading enroller in the recently published positive Phase 3 FLASH study in the treatment of early stage CTCL. In December 2022, the company submitted the HyBryte NDA for the treatment of CTCL with the FDA. In February 2023 the company received a RTF letter from the FDA for the HyBryte NDA. Upon preliminary review, the FDA determined that the NDA was not sufficiently complete to permit substantive review. The company is preparing for a Type A meeting with the FDA to clarify and respond to the issues identified in the RTF letter and to seek additional guidance concerning information that the agency would require for a resubmitted NDA to be deemed acceptable. SGX302 - for Treating Mild-to-Moderate Psoriasis SGX302 (synthetic hypericin) is a potent photosensitizer that is topically applied to skin lesions and taken up by cutaneous T-cells. With subsequent activation by safe, visible light, T-cell apoptosis is induced, addressing the root cause of psoriasis lesions. Other PDTs have shown efficacy in psoriasis with a similar apoptotic mechanism, albeit using UV light associated with more severe potential long-term toxicities. The use of visible light in the red-yellow spectrum has the advantage of deeper penetration into the skin (much more than UV light) potentially treating deeper skin disease and thicker plaques and lesions, similar to what was observed in the positive Phase 3 FLASH study in CTCL. Further, this treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with both the frequently used DNA-damaging drugs and other phototherapies that are dependent on UVA or UVB exposure. The use of SGX302 coupled with safe, visible light also avoids the risk of serious infections and cancer associated with the systemic immunosuppressive treatments used in psoriasis. In September 2021, following the validation of synthetic hypericin's biologic activity in the positive pivotal Phase 3 FLASH study in CTCL, as well as positive proof-of-concept demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients, the company decided to expand this novel therapy into a Phase 2a clinical trial in mild-to-moderate psoriasis. In June 2022, the company received FDA Investigation New Drug (IND) clearance for its Phase 2a clinical trial (protocol number HPN-PSR-01) titled, Phase 2 Study Evaluating SGX302 in the Treatment of Mild-to-Moderate Psoriasis. In December 2022, the company initiated patient enrollment for the Phase 2a study (protocol number HPN-PSR-01) evaluating SGX302 in the treatment of mild-to-moderate psoriasis. The Phase 2a clinical trial (protocol number HPN-PSR-01) will target enrollment of up to 42 patients ages 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of the body. Dusquetide Dusquetide (research name: SGX94) is an IDR that regulates the innate immune system to simultaneously reduce inflammation, eliminate infection and enhance tissue healing. Dusquetide is based on a new class of short, synthetic peptides known as IDRs. It has a novel mechanism of action in that it modulates the body's reaction to both injury and infection and is both simultaneously anti-inflammatory and anti-infective. Preclinical data indicate that IDRs may be active in models of a wide range of therapeutic indications including life-threatening bacterial infections, as well as the severe side-effects of chemo- and radiation-therapy. Additionally, due to selective binding to p62, dusquetide may have potential anti-tumor action. Dusquetide has demonstrated efficacy in numerous animal disease models, including mucositis, oncology, colitis, skin infection, and other bacterial infections and has been evaluated in a double-blind, placebo-controlled Phase 1 clinical trial in 84 healthy volunteers with both single ascending dose and multiple ascending dose components. Dusquetide was shown to have a good safety profile and be well-tolerated in all dose groups when administered by IV over 7 days and was consistent with safety results seen in pre-clinical studies. Market opportunities for dusquetide include, but are not limited to, oral and gastrointestinal mucositis, oncology (e.g., breast cancer), acute Gram-positive bacterial infections (e.g., methicillin resistant Staphylococcus aureus (MRSA)), acute Gram-negative infections (e.g., acinetobacter, melioidosis), and acute radiation syndrome. SGX942 - for Treating Oral Mucositis in Head and Neck Cancer SGX942 is the company's product candidate containing its IDR technology, dusquetide, targeting the treatment of oral mucositis in head and neck cancer patients. Oral mucositis in this patient population is an area of unmet medical need where there are currently no approved drug therapies. Accordingly, the company received Fast Track designation for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients from the FDA. In addition, dusquetide has been granted PIM designation in the U.K. by the MHRA for the treatment of SOM in head and neck cancer patients receiving chemoradiation therapy. Following analysis of the full dataset, including the 12-month long-term follow-up safety data in late 2021, the company held a meeting with the MHRA to review the study results and to obtain further clarity on the future of the oral mucositis development program. The meeting was informative with the outcome being that based on the SGX942 biologic activity observed and the consistency in response between the Phase 2 and Phase 3 trials, the Phase 3 DOM-INNATE study could serve as the first of two Phase 3 studies required to support potential marketing authorization, assuming the second Phase 3 clinical trial achieves the required level of statistical significance in its primary endpoint. In January 2022, dusquetide proved effective at reducing tumor size in nonclinical xenograft models. Recent studies, recapitulating results from previously published studies, have confirmed the efficacy of dusquetide as a stand-alone and combination anti-tumor therapy, with radiation, chemotherapy, and targeted therapy, in the context of the MCF-7 breast cancer cell line. Of note, these results are consistent with a potential direct anti-tumor effect identified with SGX942 and is another important consideration in the oral mucositis treatment space. In June 2022, an article was published describing the binding of the compnay's Innate Defense Regulator (IDR), dusquetide, to the p62 protein. Dusquetide binds to p62 or SQSTM-1, a scaffold protein implicated in a number of intracellular signaling networks implicated in tumor cell survival, including autophagy. This recent publication elaborates on the direct interaction of dusquetide with p62, as well as some of the direct downstream consequences of that interaction, consistent with its observed anti-infective, anti-tumor and anti-inflammatory activities. This information advances the understanding of dusquetide's novel mechanism of action and supports the development of analogs related to dusquetide. Oral BDP BDP (beclomethasone 17,21-dipropionate) has been marketed in the U.S. and worldwide as the active pharmaceutical ingredient in a nasal spray and in a metered-dose inhaler for the treatment of patients with allergic rhinitis and asthma. BDP is specifically formulated for oral administration as a single product consisting of two tablets. One tablet is intended to release BDP in the upper sections of the GI tract and the other tablet is intended to release BDP in the lower sections of the GI tract. Based on its pharmacological characteristics, BDP may have utility in treating other conditions of the GI tract having an inflammatory component, such as pediatric Crohn's disease. SGX203 - for Treating Pediatric Crohn's Disease SGX203 (BDP) represents a first-of-its-kind oral, locally acting therapy tailored to treat GI inflammation. Based on its pharmacological characteristics, BDP may have utility in treating multiple conditions of the GI tract having an inflammatory component. SGX203 for the treatment of pediatric Crohn's disease is specifically formulated as a two tablet delivery system for oral use that allows for administration of immediate and delayed release BDP throughout the small bowel and the colon. The FDA has given SGX203 Orphan Drug designation, as well as Fast Track designation for the treatment of pediatric Crohn's disease. The company will pursue a pivotal Phase 3 clinical trial of SGX203 for the treatment of pediatric Crohn's disease contingent upon additional funding, such as through partnership funding support. Public Health Solutions segment This segment includes active development programs for RiVax, the company's ricin toxin vaccine candidate and SGX943, its therapeutic candidate for antibiotic resistant and emerging infectious disease and its vaccine programs targeting filoviruses (such as Marburg and Ebola), and CiVax, its vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of the company's vaccine programs incorporates the use of its proprietary heat stabilization platform technology, known as ThermoVax. To date (December 31, 2022), this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA) and the Defense Threat Reduction Agency (DTRA). ThermoVax - Thermostability Platform Technology ThermoVax is a novel method for thermostabilizing vaccines with a variety of adjuvants, resulting in a single vial which can be reconstituted with water for injection immediately prior to use. One of the adjuvants utilized in ThermoVax is aluminum salts (known colloquially as Alum). The value of ThermoVax lies in its potential ability to eliminate the need for cold chain production, transportation, and storage for Alum-adjuvanted vaccines. This would relieve the high costs of producing and maintaining vaccines under refrigerated conditions. ThermoVax has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines for ricin exposure in emergency settings. ThermoVax development, specifically in the context of an Alum adjuvant, was supported pursuant to the company's NIAID grant enabling development of thermo-stable ricin (RiVax) and anthrax vaccines. Proof-of-concept preclinical studies with ThermoVax indicate that it is able to produce stable vaccine formulations using adjuvants, protein immunogens, and other components that ordinarily would not withstand long temperature variations exceeding customary refrigerated storage conditions. These studies were conducted with the company's Alum-adjuvanted ricin toxin vaccine, RiVax and its Alum-adjuvanted anthrax vaccine. Moreover, the company also has demonstrated the compatibility of its thermostabilization technology with other secondary adjuvants, such as TLR-4 agonists. In March 2020, the company entered into a research collaboration with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, JABSOM, UH Manoa to further expand the filovirus collaboration to investigation of potential coronavirus vaccines, including for SARS-CoV-2 (causing COVID-19). This research collaboration will utilize the technology platform developed in the search for filovirus vaccines and will use well-defined surface glycoprotein(s) from one or more coronaviruses, which are expected to be protective for COVID-19. During April 2020, the company obtained an exclusive worldwide license for CoVaccine HT, a novel vaccine adjuvant, from SERB Pharmaceuticals (formerly BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation) (SERB), for the fields of coronavirus infection (including SARS-CoV-2, the cause of COVID-19), and pandemic flu. CoVaccine HT is a novel adjuvant, which has been shown to enhance both cell-mediated and antibody-mediated immunity. CoVaccine HT will potentially be an important component of the company's vaccine technology platform being assessed for use against coronaviruses, including SARS-CoV-2, the cause of COVID-19. The license agreement was executed between the company and SERB, which owns the CoVaccine HT intellectual property. In December 2020, NIAID awarded the company a Direct to Phase II Small Business Innovation Research (SBIR) grant to support manufacture, formulation (including thermostabilization) and characterization of COVID-19 and Ebola Virus Disease (EVD) vaccine candidates in conjunction with the CoVaccine HT adjuvant. This award also is supporting immune characterization of this novel, emulsified adjuvant that has unique potency and compatibility with lyophilization strategies to enable thermostabilization of subunit vaccines. RiVax - Ricin Toxin Vaccine RiVax is the company's proprietary vaccine candidate being developed to protect against exposure to ricin toxin and if approved, would be the first ricin vaccine. The immunogen in RiVax induces a protective immune response in animal models of ricin exposure and functionally active antibodies in humans. The immunogen consists of a genetically inactivated ricin A chain subunit that is enzymatically inactive and lacks residual toxicity of the holotoxin. The development of RiVax has been sponsored through a series of overlapping challenge grants, UC1, and cooperative grants, U01, from the NIH, granted to the company and to University of Texas Southwestern Medical Center (UTSW) where the vaccine originated. The second clinical trial was supported by a grant from the FDA's Office of Orphan Products to UTSW. RiVax has been granted Orphan Drug designation, as well as Fast Track designation by the FDA for the prevention of ricin intoxication. In addition, RiVax has also been granted Orphan Drug designation in the European Union (EU) from the EMA Committee for Orphan Medical Products. In July 2022, the company signed a worldwide exclusive agreement to license and supply its ricin antigen, used in its RiVax vaccine, to SERB, for the development of a novel therapeutic treatment against ricin toxin poisoning. This specialized manufacturing process generates binding fragments from antibodies that are specific to a given antigen, helping to ensure potency and purity. This platform is used to manufacture two of SERB's marketed products, CroFab and DigiFab. GX943 - for Treating Emerging and/or Antibiotic-Resistant Infectious Diseases SGX943 is an IDR, containing the same active ingredient as SGX942. Dusquetide is a fully synthetic, 5-amino acid peptide with high aqueous solubility and stability. Extensive in vivo preclinical studies have demonstrated enhanced clearance of bacterial infection with SGX943 administration. SGX943 has shown efficacy against both Gram-negative and Gram-positive bacterial infections in preclinical models, independent of whether the bacteria is antibiotic-resistant or antibiotic-sensitive. As part of the regulatory process for the registration of new medicines with the EMA and the MHRA, pharmaceutical companies are required to provide a PIP outlining the company's strategy for investigation of the new medicinal products in the paediatric population. Business Strategy The company's business strategies include the following: Following positive primary endpoint results for the Phase 3 FLASH (Florescent Light Activated Synthetic Hypericin) clinical trial of HyBryte in CTCL, as well as further statistically significant improvement in response rates with longer treatment (18 weeks compared to 12 and 6 weeks of treatment), meet with the United States (U.S.) Food and Drug Administration (FDA) to discuss the contents of a refusal to file (RTF) letter recently issued by the FDA in response to the HyBryte new drug application (NDA) for the treatment of CTCL. The company is preparing for a meeting, categorized as Type A, with the FDA to clarify and respond to the issues identified in the RTF letter and to seek additional guidance concerning information that the FDA would require for a resubmitted NDA to be deemed acceptable to file, in order to advance HyBryte towards marketing approval and U.S. commercialization while continuing to explore ex-U.S. partnership. Expanding the development of synthetic hypericin under the research name SGX302 into psoriasis with the conduct of a Phase 2a clinical trial, following the positive Phase 3 FLASH study and positive proof-of-concept demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients. Following feedback from the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) that a second Phase 3 clinical trial of SGX942 Phase 3 DOM-INNATE (Dusquetide treatment in Oral Mucositis - by modulating INNATE Immunity) would be required to support a marketing authorization; design a second study and attempt to identify a potential partner(s) to continue this development program. Continue development of the company's therapeutic SGX943 and its heat stabilization platform technology, ThermoVax, in combination with its programs for RiVax (ricin toxin vaccine), CiVax (COVID-19 vaccine), and filovirus vaccines (targeting Ebola, Sudan, and Marburg viruses), with U.S. government funding support. Continue to apply for and secure additional government funding for each of the company's Specialized BioTherapeutics and Public Health Solutions programs through grants, contracts, and/or procurements. Pursue business development opportunities for the company's pipeline programs, as well as explore merger/acquisition strategies. Acquire or in-license new clinical-stage compounds for development, as well as evaluate new indications with existing pipeline compounds for development. Patents and Other Proprietary Rights In 2014, the company acquired a novel PDT that utilizes safe visible light for activation, which it refers to as HyBryte. The active ingredient in HyBryte is synthetic hypericin, a photosensitizer which is topically applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. As part of the acquisition, the company acquired a license agreement relating to the use of photo-activated hypericin, composition of matter patent for HyBryte (U.S. patent 8,629,302) and additional issued and pending applications, both in the U.S. and abroad. U.S. patent 8,629,302 is expected to expire in September 2030. In August 2018, the company was granted a U.S. patent (No. 10,053,513) titled Systems and Methods for Producing Synthetic Hypericin. This newly issued patent, expected to expire in 2036, broadens the production around synthetic hypericin. The company's proprietary formulation of synthetic hypericin also has been granted a European patent for the treatment of psoriasis, EP 2571507, and complements the method of treatment claims covered by the previously issued U.S. patent 6001882, Photoactivated hypericin and the use thereof. Further, on January 7, 2020, the company also was granted a U.S. patent (No. 10,526,268) titled Systems and Methods for Producing Synthetic Hypericin, which further expanded protection for the composition of purified synthetic hypericin. This patent is also expected to expire in 2036. Patent protection is also pursued worldwide with similar patents and expiry dates. In addition to issued and pending patents, the company has Orphan Drug designations for HyBryte in the U.S. and the EU for CTCL, SGX203 in the U.S. for pediatric Crohn's disease, as well as for RiVax in the U.S. and EU. The company's Orphan Drug designations provide for seven years of post-approval marketing exclusivity in the U.S. and ten years exclusivity in Europe. The company has pending patent applications for this indication that, if granted, may extend its anticipated marketing exclusivity beyond the U.S. seven year or EU ten year post-approval exclusivity provided by Orphan Drug legislation. In 2013, the company expanded its patent portfolio to include innate defense regulation through the acquisition of the novel drug technology, known as SGX94. By binding to the pivotal regulatory protein p62, also known as sequestosome-1, SGX94 regulates the innate immune system to reduce inflammation, eliminate infection and enhance healing. As part of the acquisition, the company acquired all rights, including composition of matter patents for SGX94, as well as other analogs and crystal structures of SGX94 with its protein target p62, including U.S. patent 8,124,721 (expiring 2028), 9,416,157 (expiring 2028) and 8,791,061 (expiring 2029), both in the U.S. and abroad. The company also has rights to the background technology patents (U.S. patent numbers 7,507,787 [expiring 2024], 7,687,454 [expiring 2026] and 11,311,598 [expiring 2034]). The U.S. Patent Office has also granted patents titled Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis. The issued patents (U.S. patent numbers 9,850.279 and 10,253,068, both expiring in 2034) claim therapeutic use of dusquetide and related IDR analogs, and adds to composition of matter claims for dusquetide and related analogs that have been granted in the U.S. and worldwide. The company also has European patent EP 2242477 claiming the use of orally ingested BDP for the treatment of interstitial lung disease which will expire in January 2029. The subject of U.S. patent application number 12/633,631 filed December 8, 2009 and continued into patent application 15/495,798 filed April 24, 2017 and corresponding European patent application number 09836727.9, which was granted as patent 2373160 in October 2017 and pursued in multiple European countries, is the use of topically active BDP in radiation and chemotherapeutics injury. Additionally, the company has numerous patent filings issued or pending in foreign jurisdictions covering this subject matter, including Australia, Canada, China, Hong Kong, Israel, Japan, South Korea, and New Zealand. ThermoVax is the subject of U.S. patents 8,444,991 (expiring February 2030) and 8,808,710 (expiring March 2028) both issued on May 21, 2013 titled Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition and licensed to the company by VitriVax, Inc. ThermoVax is also U.S. patent application number 15/694.023 filed September 17, 2017 titled Thermostable Vaccine Compositions and Methods of Preparing Same and jointly invented by the University of Colorado (UC) and the company. The patent application and the corresponding foreign filings are pending or granted and they address the use of adjuvants in conjunction with vaccines that are formulated to resist thermal inactivation. The license agreement covers thermostable alum-adjuvanted vaccines for ricin toxin and Ebola virus. An additional patent, covering vaccine combinations, such as ricin toxin and anthrax, was filed in 2015 and granted on May 21, 2019, in the U.S. (No. 10,293,041, titled Multivalent Stable Vaccine Composition and Methods of Making Same) and is expected to expire in 2035. Patent protection is also pursued worldwide with similar patents and expiry dates. Additional vaccine thermostabilization patents specific for anti-viral vaccines, including filovirus and coronavirus have been filed but are not yet granted. If granted, expiry dates would range from 2040 to 2041. Patent protection is also pursued worldwide with similar patents and expiry dates. HyBryte License Agreement In September 2014, the company acquired a worldwide exclusive license agreement with New York University and Yeda Research and Development Company Ltd. for the rights to a novel PDT that utilizes safe visible light for activation, which the company refers to as HyBryte. The exclusive license includes rights to several issued U.S. patents, including U.S. patent number 7,122,518, among other domestic and foreign patent applications. U.S. Patent number 7,122,518 is expected to expire in November 2023. The company acquired the license agreement for HyBryte and related intangible assets, including U.S. patent 8,629,302, properties and rights pursuant to an asset purchase agreement with Hy Biopharma Inc. (Hy Biopharma). SGX94 License Agreements On December 18, 2012, the company acquired a first in class drug technology, known as SGX94 (dusquetide), representing a novel approach to modulation of the innate immune system. SGX94 is an IDR that regulates the innate immune system to reduce inflammation, eliminate infection and enhance tissue healing by binding to the pivotal regulatory protein p62, also known as sequestosome-1. As part of the acquisition, the company acquired all rights, including composition of matter patents, preclinical and Phase 1 clinical study datasets for SGX94. The company also assumed a license agreement with UBC to advance the research and development of the SGX94 technology. The license agreement with University of British Columbia (UBC) provides the company with exclusive worldwide rights to manufacture, distribute, market sell and/or license or sublicense products derived or developed from this technology. Oral BDP License Agreement On November 24, 1998, the company, known at the time as Enteron Pharmaceuticals, Inc. (Enteron) and George B. McDonald (Dr. McDonald) entered into an exclusive license agreement for the rights to intellectual property, including know-how, relating to BDP. The company has an exclusive license to commercially exploit the covered products worldwide, subject to Dr. McDonald's right to make and use the technology for research purposes and the U.S. Government's right to use the technology for government purposes. ThermoVax License Agreement On December 21, 2010, the company executed a worldwide exclusive license agreement with the UC for ThermoVax, which is the subject of U.S. patent number 8,444,991 issued on May 21, 2013 titled Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition. This patent and its corresponding foreign filings are licensed to the company by the UC and they address the use of adjuvants in conjunction with vaccines that are formulated to resist thermal inactivation. U.S. Patent 8,444,991 is expected to expire in December 2031. The license agreement also covers thermostable vaccines for biodefense, as well as other potential vaccine indications. In addition, the company, in conjunction with UC, filed domestic and foreign patent applications claiming priority back to a provisional application filed on May 17, 2011 titled: Thermostable Vaccine Compositions and Methods of Preparing Same. iVax License Agreement In June 2003, the company executed a worldwide exclusive option to license patent applications with UTSW for the nasal, pulmonary, and oral uses of a non-toxic ricin vaccine. In June 2004, the company entered into a license agreement with UTSW for the injectable rights to the ricin vaccine and, in October 2004, the company negotiated the remaining oral rights to the ricin vaccine. Through this license, the company have rights to the issued patent number 7,175,848 titled Ricin A chain mutants lacking enzymatic activity as vaccines to protect against aerosolized ricin. This patent includes methods of use and composition claims for RiVax. CoVaccine HT License Agreement In April 2020, the company executed an agreement for the exclusive worldwide license of CoVaccine HT, a novel vaccine adjuvant, from BTG, a division of Boston Scientific Corporation, for the fields of SARS-CoV-2, the cause of COVID-19 and pandemic flu. The agreement was executed with Protherics Medicines Development, one of the companies that make up the BTG specialty pharmaceuticals business, which owns the CoVaccine HT intellectual property. Research and Development The company spent approximately $7.9 million on research and development in the year ended December 31, 2022. Competition The company faces intense competition in the biodefense area from various public and private companies and universities, as well as governmental agencies, such as the U.S. Army. History The company was incorporated in Delaware in 1987. It was formerly known as DOR BioPharma, Inc. and changed its name to Soligenix, Inc. in 2009.