Nature of Business

6 Months Ended

Jun. 30, 2019

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Nature of Business

Note 1. Nature of Business

Basis of Presentation

Soligenix, Inc. (the "Company") is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The Company maintains two active business segments: Specialized BioTherapeutics (formerly "BioTherapeutics") and Public Health Solutions (formerly "Vaccines/BioDefense").

The Company's Specialized BioTherapeutics business segment is developing a novel photodynamic therapy (SGX301) utilizing topical synthetic hypericin activated with safe visible fluorescent light for the treatment of cutaneous T-cell lymphoma ("CTCL"), its first-in-class innate defense regulator ("IDR") technology, dusquetide (SGX942) for the treatment of 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) and acute radiation enteritis (SGX201).

The Company's Public Health Solutions business segment includes active development programs for RiVax^®, its ricin toxin vaccine candidate and SGX943, a therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of the vaccine program is currently supported by the heat stabilization technology, known as ThermoVax^®, under existing and on-going government contract funding. With the government contract from the National Institute of Allergy and Infectious Diseases ("NIAID"), the Company will attempt to advance the development of RiVax^® to protect against exposure to ricin toxin.

The Company generates revenues under government grants primarily from the National Institutes of Health ("NIH") and government contracts from NIAID. The Company is currently developing RiVax^® under a NIAID contract of up to $24.7 million over six years, and SGX301 and SGX942 under two separate NIH grants of approximately $1.5 million each over two years. The Company will continue to apply for additional government funding.

The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, development of new technological innovations, dependence on key personnel, protections of proprietary technology, compliance with the United States Food and Drug Administration (the "FDA") regulations, and other regulatory authorities, litigation, and product liability. Results for the six months ended June 30, 2019 are not necessarily indicative of results that may be expected for the full year.

Liquidity

In accordance with Accounting Standards Codification 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date the consolidated financial statements are issued. As of June 30, 2019, the Company had an accumulated deficit of $169,933,168. During the six months ended June 30, 2019, the Company incurred a net loss of $3,763,148 and used $2,808,372 of cash in operating activities. The Company expects to continue to generate losses in the foreseeable future. The Company's liquidity needs will be largely determined by the budgeted operational expenditures incurred in regards to the progression of its product candidates. The Company's plans to meet its liquidity needs primarily include its ability to control the timing and spending on its research and development programs and raising additional funds through potential partnership and/or financings. Management is evaluating all options to raise sufficient funds to fund the Company's working capital requirements. These options include proceeds from government contract and grant programs, proceeds available from the At Market Issuance Sales Agreement ("FBR Sales Agreement") with B. Riley FBR Inc. ("FBR") and raising additional funds through potential partnerships and /or debt and equity financings. There can be no assurances, however, that management will be able to obtain sufficient additional funds when needed, or that such funds, if available, will be on terms satisfactory to the Company. The ability of the Company to continue as a going concern is dependent upon its ability to raise additional capital. The financial statements do not include any adjustments relating to the recoverability and classification of recorded assets and liabilities that might be necessary should the Company be unable to continue as a going concern.

As of June 30, 2019, the Company had cash and cash equivalents of $6,986,289 as compared to $8,983,717 as of December 31, 2018, representing a decrease of $1,997,428 or 22%. As of June 30, 2019, the Company had working capital of $3,311,412 as compared to working capital of $6,131,178 as of December 31, 2018, representing a decrease of $2,819,766 or 46%. The decrease in cash and working capital was primarily related to expenditures incurred in the expansion of the pivotal Phase 3 trial of SGX942 in addition to the ongoing expenditures incurred in the pivotal Phase 3 clinical trial of SGX301.

Management's business strategy can be outlined as follows:

● Following positive interim analysis, complete enrollment and report final results in the Company's pivotal Phase 3 clinical trial of SGX301 for the treatment of CTCL;

● Continue enrollment of the pivotal Phase 3 clinical trial of SGX942 for the treatment of oral mucositis in head and neck cancer;

● Continue development of RiVax^® in combination with the Company's ThermoVax^® technology to develop a new heat stable vaccine in biodefense with NIAID 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; and

● Acquire or in-license new clinical-stage compounds for development.

The Company's plans with respect to its liquidity management include, but are not limited to, the following:

● The Company has up to $12.4 million in active government contract and grant funding still available as of June 30, 2019, to support its associated research programs through 2019 and beyond, provided the federal agencies exercise all options and do not elect to terminate the contracts or grants for convenience. The Company plans to submit additional contract and grant applications for further support of its programs with various funding agencies;

● The Company has continued to use equity instruments to provide a portion of the compensation due to vendors and collaboration partners and expects to continue to do so for the foreseeable future;

● The Company will continue to pursue Net Operating Loss ("NOL") sales in the state of New Jersey pursuant to its Technology Business Tax Certificate Transfer Program if available;

● The Company plans to pursue potential partnerships for pipeline programs. However, there can be no assurances that it can consummate such transactions;

● The Company has up to $6.6 million remaining from the FBR Sales Agreement as of August 8, 2019 under the prospectus supplement updated October 3, 2018; and

● The Company may seek additional capital in the private and/or public equity markets, to continue its operations, respond to competitive pressures, develop new products and services, and to support new strategic partnerships. The Company is evaluating additional equity/debt financing opportunities on an ongoing basis and may execute them when appropriate. However, there can be no assurances that the Company can consummate such a transaction, or consummate a transaction at favorable pricing.