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Soligenix(SNGX) - 2019 Q3 - Quarterly Report
2019-11-12 21:13
[PART I - FINANCIAL INFORMATION](index=4&type=section&id=Part%20I%20FINANCIAL%20INFORMATION) This section covers consolidated financial statements, management's analysis, market risk, and internal controls [ITEM 1 - Consolidated Financial Statements](index=4&type=section&id=Item%201%20-%20Consolidated%20Financial%20Statements) This section presents Soligenix, Inc.'s unaudited consolidated financial statements and detailed notes [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) This section details the company's financial position, including assets, liabilities, and equity Consolidated Balance Sheets Summary | Metric | Sep 30, 2019 (Unaudited) | Dec 31, 2018 | Change ($) | Change (%) | | :------------------------ | :----------------------- | :----------- | :--------- | :--------- | | Cash and cash equivalents | $6,551,793 | $8,983,717 | $(2,431,924) | -27.07% | | Total current assets | $8,010,209 | $10,342,710 | $(2,332,501) | -22.55% | | Total assets | $8,331,821 | $10,491,702 | $(2,159,881) | -20.59% | | Total current liabilities | $5,634,423 | $4,211,532 | $1,422,891 | 33.78% | | Total liabilities | $5,654,306 | $4,211,532 | $1,442,774 | 34.26% | | Total shareholders' equity| $2,677,515 | $6,280,170 | $(3,602,655) | -57.37% | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) This section presents the company's revenues, expenses, and net loss, highlighting operational performance Consolidated Statements of Operations Summary | Metric (3 Months Ended Sep 30) | 2019 | 2018 | Change ($) | Change (%) | | :----------------------------- | :----------- | :----------- | :--------- | :--------- | | Total revenues | $1,254,904 | $1,381,353 | $(126,449) | -9.15% | | Gross profit | $289,451 | $144,123 | $145,328 | 100.84% | | Research and development | $2,266,799 | $1,394,913 | $871,886 | 62.57% | | General and administrative | $789,251 | $667,799 | $121,452 | 18.19% | | Net loss | $(2,720,783) | $(1,861,608) | $(859,175) | 46.15% | | Basic & diluted net loss per share | $(0.14) | $(0.11) | $(0.03) | 27.27% | | Metric (9 Months Ended Sep 30) | 2019 | 2018 | Change ($) | Change (%) | | :----------------------------- | :----------- | :----------- | :--------- | :--------- | | Total revenues | $3,944,655 | $4,226,670 | $(282,015) | -6.67% | | Gross profit | $964,464 | $516,843 | $447,621 | 86.61% | | Research and development | $5,763,467 | $4,377,483 | $1,385,984 | 31.66% | | General and administrative | $2,432,550 | $2,041,340 | $391,210 | 19.16% | | Net loss | $(6,483,931) | $(5,795,156) | $(688,775) | 11.89% | | Basic & diluted net loss per share | $(0.34) | $(0.50) | $0.16 | -32.00% | [Consolidated Statements of Comprehensive Loss](index=6&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) This section details net loss and other comprehensive income/loss, including foreign currency adjustments Consolidated Statements of Comprehensive Loss Summary | Metric (3 Months Ended Sep 30) | 2019 | 2018 | Change ($) | Change (%) | | :----------------------------- | :----------- | :----------- | :--------- | :--------- | | Net loss | $(2,720,783) | $(1,861,608) | $(859,175) | 46.15% | | Foreign currency translation adjustments | $(7,985) | $(1,767) | $(6,218) | 352.07% | | Comprehensive loss | $(2,728,768) | $(1,863,375) | $(865,393) | 46.44% | | Metric (9 Months Ended Sep 30) | 2019 | 2018 | Change ($) | Change (%) | | :----------------------------- | :----------- | :----------- | :--------- | :--------- | | Net loss | $(6,483,931) | $(5,795,156) | $(688,775) | 11.89% | | Foreign currency translation adjustments | $(11,324) | $(1,767) | $(9,557) | 540.86% | | Comprehensive loss | $(6,495,255) | $(5,796,923) | $(698,332) | 12.05% | [Consolidated Statements of Changes in Shareholders' Equity](index=7&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Equity) This section outlines changes in shareholders' equity, including stock issuances and net loss Consolidated Statements of Changes in Shareholders' Equity Summary | Shareholder Equity Item (9 Months Ended Sep 30, 2019) | Amount |\n| :---------------------------------------------------- | :----------- |\n| Balance, December 31, 2018 | $6,280,170 |\n| Issuance of common stock (FBR At Market Sales) | $2,554,147 |\n| Issuance costs (FBR At Market Sales) | $(101,277) |\n| Issuance of restricted common stock to vendors | $205,738 |\n| Share-based compensation expense | $233,992 |\n| Foreign currency translation adjustment | $(11,324) |\n| Net loss | $(6,483,931) |\n| Balance, September 30, 2019 | $2,677,515 | [Consolidated Statements of Cash Flows](index=9&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes cash flows from operating, investing, and financing activities Consolidated Statements of Cash Flows Summary | Cash Flow Activity (9 Months Ended Sep 30) | 2019 | 2018 | Change ($) | Change (%) | | :----------------------------------------- | :------------- | :------------- | :--------- | :--------- | | Net cash used in operating activities | $(4,866,288) | $(4,568,927) | $(297,361) | 6.51% |\n| Net cash provided by (used in) investing activities | $5,500 | $(1,924) | $7,424 | -385.86% |\n| Net cash provided by financing activities | $2,446,939 | $8,483,216 | $(6,036,277) | -71.15% |\n| Net (decrease) increase in cash and cash equivalents | $(2,431,924) | $3,910,598 | $(6,342,522) | -162.19% |\n| Cash and cash equivalents at end of period | $6,551,793 | $11,720,085 | $(5,168,292) | -44.10% | [Notes to Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) This section provides essential context and detailed explanations for financial figures and accounting policies - The notes are an integral part of the consolidated financial statements, providing essential context and detail for understanding the reported financial figures[11](index=11&type=chunk)[13](index=13&type=chunk)[16](index=16&type=chunk)[19](index=19&type=chunk)[21](index=21&type=chunk)[23](index=23&type=chunk) [Note 1. Nature of Business](index=10&type=section&id=Note%201.%20Nature%20of%20Business) This note describes business segments, product development, and financial viability concerns - The company operates in two segments: Specialized BioTherapeutics (developing therapies for CTCL, oral mucositis, GI disorders) and Public Health Solutions (developing vaccines for ricin toxin and therapeutics for infectious diseases)[25](index=25&type=chunk)[26](index=26&type=chunk)[27](index=27&type=chunk) - Revenues are primarily generated from government grants and contracts, including a **$24.7 million** NIAID contract for RiVax and NIH grants for SGX301 and SGX942[28](index=28&type=chunk) - The company had an **accumulated deficit of $172.7 million** and **used $4.9 million cash in operating activities** for the **nine months** ended September 30, 2019, **raising substantial doubt** about its ability to continue as a going concern **without additional funding**[30](index=30&type=chunk) - Cash and cash equivalents **decreased by 27% to $6.55 million**, and working capital **decreased by 61% to $2.38 million** as of September 30, 2019, primarily due to expenditures on Phase 3 clinical trials for SGX942 and SGX301[31](index=31&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=12&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines key accounting principles and methods applied in financial statements - The company adopted ASC 2016-02 "Leases" (Topic 842) on January 1, 2019, recognizing right-of-use assets and corresponding lease liabilities for its office space and copier machine[57](index=57&type=chunk)[60](index=60&type=chunk) - Research and development costs are **expensed as incurred**, including clinical trial expenses, contracted research, and license agreement fees without alternative future use[47](index=47&type=chunk)[167](index=167&type=chunk) - Share-based compensation for nonemployees is measured at grant date fair value and recognized when services are performed, following the adoption of ASU 2018-07[49](index=49&type=chunk)[170](index=170&type=chunk) [Note 3. Intangible Assets](index=17&type=section&id=Note%203.%20Intangible%20Assets) This note details intangible assets, including licenses and patents, and their amortization Intangible Assets Summary | Intangible Asset | Cost | Accumulated Amortization | Net Book Value (Sep 30, 2019) | Net Book Value (Dec 31, 2018) | | :--------------- | :----------- | :----------------------- | :---------------------------- | :---------------------------- | | Licenses | $462,234 | $435,744 | $26,490 | $46,863 | | Patents | $1,893,185 | $1,893,185 | $- | $- | | Total | $2,355,419 | $2,328,929 | $26,490 | $46,863 | - Amortization expense for intangible assets was **$20,373** for the **nine months** ended September 30, 2019, and **$6,791** for the **three months** ended September 30, 2019[62](index=62&type=chunk) [Note 4. Accrued Expenses](index=17&type=section&id=Note%204.%20Accrued%20Expenses) This note provides a breakdown of accrued expenses, primarily clinical trial costs Accrued Expenses Summary | Accrued Expense | Sep 30, 2019 | Dec 31, 2018 | Change ($) | Change (%) | | :-------------- | :----------- | :----------- | :--------- | :--------- | | Clinical trial expenses | $3,075,943 | $1,633,713 | $1,442,230 | 88.28% | | Other | $85,836 | $156,976 | $(71,140) | -45.32% | | Total | $3,161,779 | $1,790,689 | $1,371,090 | 76.57% | [Note 5. Income Taxes](index=17&type=section&id=Note%205.%20Income%20Taxes) This note explains income tax position, including NOL carryforwards and tax benefits - The company recognized an **income tax benefit of $610,676** from the sale of its 2017 New Jersey NOL carryforwards during the **nine months** ended September 30, 2019[53](index=53&type=chunk)[66](index=66&type=chunk)[172](index=172&type=chunk) - As of December 31, 2018, the company had approximately **$104.1 million in federal NOLs**, **$14.0 million in state NOLs**, and **$0.7 million in foreign NOLs**, subject to limitations under IRC Section 382[65](index=65&type=chunk) [Note 6. Shareholders' Equity](index=18&type=section&id=Note%206.%20Shareholders'%20Equity) This note details changes in shareholders' equity, including stock issuances and compensation - During the **nine months** ended September 30, 2019, the company issued **2,529,050 shares of common stock** through the FBR At Market Sales Issuance Agreement, **generating $2,554,147 in proceeds** (net of issuance costs)[19](index=19&type=chunk) - The company also issued **245,700 restricted shares of common stock** to vendors, **valued at $205,738**, as partial consideration for services performed[19](index=19&type=chunk) - As of November 7, 2019, **$6.3 million remained available for sale** of common stock under the FBR Sales Agreement[32](index=32&type=chunk)[72](index=72&type=chunk)[186](index=186&type=chunk) [Note 7. Related Party Transaction](index=20&type=section&id=Note%207.%20Related%20Party%20Transaction) This note describes transactions with related parties, including stock issuances for services - The company issued **78,338 shares of common stock** to Altamont Pharmaceutical Holdings, LLC (a related party) for **website development costs ($46,500 capitalized)** and **investor relations/web hosting services ($4,290 expensed)**[74](index=74&type=chunk) [Note 8. Commitments and Contingencies](index=20&type=section&id=Note%208.%20Commitments%20and%20Contingencies) This note outlines contractual obligations, future commitments, and contingent liabilities Commitments and Contingencies Summary | Year | Research and Development | Property and Other Leases | Total | | :------------------------ | :----------------------- | :------------------------ | :----------- | | Oct 1 - Dec 31, 2019 | $50,000 | $37,527 | $87,527 | | 2020 | $100,000 | $127,374 | $227,374 | | 2021 | $100,000 | $6,408 | $106,408 | | 2022 | $100,000 | $- | $100,000 | | 2023 | $100,000 | $- | $100,000 | | Total | $450,000 | $171,309 | $621,309 | - The company has commitments of approximately **$450,000** for licensing agreements and **potential future milestone payments of up to $7.9 million** and **royalties up to 6% of net sales** under collaboration and license agreements, contingent on clinical or commercialization success[75](index=75&type=chunk)[185](index=185&type=chunk) [Note 9. Operating Segments](index=21&type=section&id=Note%209.%20Operating%20Segments) This note provides financial information by operating segments: Public Health and BioTherapeutics Operating Segments Summary | Metric (3 Months Ended Sep 30) | Public Health Solutions | Specialized BioTherapeutics | Corporate | Total | | :----------------------------- | :---------------------- | :-------------------------- | :----------- | :----------- | | Revenues | $991,087 | $263,817 | $- | $1,254,904 | | Income (Loss) from Operations | $72,491 | $(1,926,883) | $(912,207) | $(2,766,599) | | Amortization and Depreciation | $4,312 | $4,141 | $6,448 | $14,901 | | Share-Based Compensation | $8,072 | $18,609 | $54,846 | $81,527 | | Metric (9 Months Ended Sep 30) | Public Health Solutions | Specialized BioTherapeutics | Corporate | Total | | :----------------------------- | :---------------------- | :-------------------------- | :----------- | :----------- | | Revenues | $2,767,304 | $1,177,351 | $- | $3,944,655 | | Income (Loss) from Operations | $267,601 | $(4,725,774) | $(2,773,380) | $(7,231,553) | | Amortization and Depreciation | $13,030 | $12,986 | $11,876 | $37,892 | | Share-Based Compensation | $21,340 | $58,611 | $154,041 | $233,992 | [ITEM 2 – Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202%20%E2%80%93%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, operational results, business segments, and critical accounting policies [Our Business Overview](index=23&type=section&id=Our%20Business%20Overview) This section provides an overview of the biopharmaceutical business, its segments, and strategic objectives - The company is a late-stage biopharmaceutical company with two active business segments: Specialized BioTherapeutics and Public Health Solutions[85](index=85&type=chunk) - Key business strategies include completing Phase 3 trials for SGX301 and SGX942, continuing RiVax development with ThermoVax, securing additional government funding, pursuing business development, and acquiring new clinical-stage compounds[88](index=88&type=chunk) [Corporate Information](index=24&type=section&id=Corporate%20Information) This section provides basic corporate details, including incorporation, location, and historical context - Soligenix, Inc was incorporated in Delaware in 1987 and has undergone several name changes, with its principal executive offices located in Princeton, New Jersey[89](index=89&type=chunk) [Our Product Candidates in Development](index=24&type=section&id=Our%20Product%20Candidates%20in%20Development) This section details the company's pipeline across specialized biotherapeutics and public health solutions - The company has product candidates in development across two segments: Specialized BioTherapeutics (SGX301, SGX942, SGX203, SGX201) and Public Health Solutions (ThermoVax, RiVax, OrbeShield, SGX943)[91](index=91&type=chunk)[93](index=93&type=chunk) [Specialized BioTherapeutics Overview](index=25&type=section&id=Specialized%20BioTherapeutics%20Overview) This section overviews product candidates targeting rare diseases within specialized biotherapeutics - The Specialized BioTherapeutics segment includes SGX301 for Cutaneous T-Cell Lymphoma, SGX942 for Oral Mucositis in Head and Neck Cancer, and oral BDP formulations (SGX203 for Pediatric Crohn's disease, SGX201 for Acute Radiation Enteritis)[91](index=91&type=chunk) [SGX301 – for Treating Cutaneous T-Cell Lymphoma](index=25&type=section&id=SGX301%20%E2%80%93%20for%20Treating%20Cutaneous%20T-Cell%20Lymphoma) This section describes SGX301, a photodynamic therapy for CTCL, its development and designations - SGX301 is a novel photodynamic therapy for CTCL, utilizing topical synthetic hypericin activated by visible light, avoiding the negative effects of UV light[94](index=94&type=chunk)[96](index=96&type=chunk) - SGX301 has received Orphan Drug and Fast Track designations from the FDA, and Orphan Drug and PIM designations from the EMA/MHRA, providing market exclusivity and expedited review benefits[98](index=98&type=chunk) - The pivotal Phase 3 FLASH study for SGX301, initiated in December 2015, received a **positive interim analysis** in October 2018, recommending additional patient enrollment, with final results expected in Q1 2020[91](index=91&type=chunk)[101](index=101&type=chunk)[103](index=103&type=chunk) [Cutaneous T-Cell Lymphoma](index=27&type=section&id=Cutaneous%20T-Cell%20Lymphoma) This section provides background on CTCL, its prevalence, and limitations of current treatments - CTCL is a rare non-Hodgkin's lymphoma affecting over **20,000 individuals** in the U.S annually, with **no FDA-approved front-line treatment** for early stages[105](index=105&type=chunk)[107](index=107&type=chunk) - Current unapproved therapies like PUVA carry serious adverse effects, including secondary skin cancers, due to mutagenic chemicals and carcinogenic UVA light[106](index=106&type=chunk) [Dusquetide](index=27&type=section&id=Dusquetide) This section introduces Dusquetide (SGX94), an innate defense regulator, and its mechanism of action - Dusquetide (SGX94) is an innate defense regulator (IDR) that modulates the innate immune system to simultaneously reduce inflammation, eliminate infection, and enhance tissue healing[108](index=108&type=chunk)[109](index=109&type=chunk) - IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections and accelerating tissue damage resolution, with potential anti-tumor action[109](index=109&type=chunk) [SGX942 – for Treating Oral Mucositis in Head and Neck Cancer](index=28&type=section&id=SGX942%20%E2%80%93%20for%20Treating%20Oral%20Mucositis%20in%20Head%20and%20Neck%20Cancer) This section details SGX942 for oral mucositis, its clinical trial results, and development progress - SGX942, containing the IDR dusquetide, targets oral mucositis in head and neck cancer patients, an area with **no approved drug therapies**[111](index=111&type=chunk) - The Phase 2 study showed SGX942 **reduced the median duration of severe oral mucositis by 50%** (**from 18 to 9 days**) and **by 67%** (**from 30 to 10 days**) in patients receiving aggressive chemoradiation therapy[112](index=112&type=chunk) - The pivotal Phase 3 DOM–INNATE study received a **positive recommendation** from the DMC in August 2019 to continue enrollment, increasing the **sample size to 260 subjects**, with final results expected in Q2 2020[91](index=91&type=chunk)[124](index=124&type=chunk) [Oral Mucositis](index=30&type=section&id=Oral%20Mucositis) This section describes oral mucositis, its incidence in cancer patients, and clinical impact - Mucositis affects approximately **500,000 people** in the U.S per year, with oral mucositis being a subpopulation of about **90,000 patients** in the U.S and a comparable number in Europe[127](index=127&type=chunk)[129](index=129&type=chunk) - Oral mucositis is common in head and neck cancer patients treated with radiation therapy (over **80% incidence** of severe mucositis) and can lead to severe debilitation, infection, and limit cancer treatment doses[127](index=127&type=chunk)[129](index=129&type=chunk) [Oral BDP](index=30&type=section&id=Oral%20BDP) This section describes Oral BDP, a locally acting therapy for GI inflammation, and its patent status - Oral BDP is a first-of-its-kind oral, locally acting therapy specifically formulated to treat GI inflammation, with a two-tablet delivery system for immediate and delayed release throughout the GI tract[130](index=130&type=chunk)[131](index=131&type=chunk) - The European Patent Office issued two patents in July 2019 for the use of oral BDP in treating GI tract damage resulting from acute radiation injury[132](index=132&type=chunk) [SGX203 – for Treating Pediatric Crohn's Disease](index=31&type=section&id=SGX203%20%E2%80%93%20for%20Treating%20Pediatric%20Crohn's%20Disease) This section details SGX203 for pediatric Crohn's disease, its regulatory status, and future plans - SGX203 has received Orphan Drug and Fast Track designations from the FDA for the treatment of pediatric Crohn's disease[134](index=134&type=chunk) - A pivotal Phase 3 clinical trial for SGX203 is planned, contingent upon securing additional funding, potentially through partnerships[134](index=134&type=chunk) [SGX201 – for Preventing Acute Radiation Enteritis](index=31&type=section&id=SGX201%20%E2%80%93%20for%20Preventing%20Acute%20Radiation%20Enteritis) This section describes SGX201 for acute radiation enteritis, its clinical results, and regulatory status - SGX201, a delayed-release BDP formulation, showed safety and potential dose-response efficacy in a Phase 1/2 clinical trial for preventing acute radiation enteritis[138](index=138&type=chunk) - SGX201 has received Fast Track designation from the FDA for acute radiation enteritis[139](index=139&type=chunk) [Public Health Solutions Overview](index=32&type=section&id=Public%20Health%20Solutions%20Overview) This section overviews product candidates addressing public health threats within this segment - The Public Health Solutions segment includes ThermoVax (thermostability technology), RiVax (ricin toxin vaccine), and SGX943 (therapeutic for antibiotic-resistant and emerging infectious diseases)[93](index=93&type=chunk) [ThermoVax– Thermostability Technology](index=32&type=section&id=ThermoVax%E2%80%93%20Thermostability%20Technology) This section describes ThermoVax, a technology for thermostabilizing vaccines, and its development - ThermoVax is a novel technology that renders aluminum salt-adjuvanted vaccines stable at elevated temperatures, potentially eliminating the need for cold chain storage and distribution[144](index=144&type=chunk) - Preclinical studies demonstrated ThermoVax's ability to produce stable vaccine formulations, with RiVax remaining potent for **up to one year at 40°C** and anthrax vaccine for **16 weeks at 70°C**[145](index=145&type=chunk) - The company holds a worldwide exclusive sublicense agreement for ThermoVax for use in ricin and Ebola vaccines, with ongoing collaboration for a trivalent thermostabilized Ebola vaccine[149](index=149&type=chunk)[150](index=150&type=chunk) [RiVax – Ricin Toxin Vaccine](index=34&type=section&id=RiVax%20%E2%80%93%20Ricin%20Toxin%20Vaccine) This section details RiVax, a ricin toxin vaccine candidate, its clinical development, and funding - RiVax is a proprietary ricin toxin vaccine candidate that has demonstrated **100% protection** in an aerosol exposure non-human primate model and was **safe and immunogenic** in two Phase 1 human clinical trials[153](index=153&type=chunk) - The development of RiVax is supported by a NIAID contract of **up to $24.7 million**, with **$6.9 million still available** as of August 2017, funding preclinical, manufacturing, and clinical development[154](index=154&type=chunk)[155](index=155&type=chunk) - RiVax has been granted Orphan Drug designation by the FDA and EMA and has the potential to qualify for a biodefense Priority Review Voucher upon approval[156](index=156&type=chunk)[158](index=158&type=chunk) [SGX943 – for Treating Emerging and/or Antibiotic-Resistant Infectious Diseases](index=35&type=section&id=SGX943%20%E2%80%93%20for%20Treating%20Emerging%20and%2Fior%20Antibiotic-Resistant%20Infectious%20Diseases) This section describes SGX943 for infectious diseases, its preclinical efficacy, and government support - SGX943, an innate defense regulator (IDR), has demonstrated **efficacy against** both Gram-negative and Gram-positive bacterial infections, including antibiotic-resistant strains, in preclinical models[161](index=161&type=chunk) - The IDR mechanism acts on the host, not the pathogen, making it unlikely to generate bacterial resistance and applicable to systemic inflammation and multi-organ failure caused by biothreat agents[162](index=162&type=chunk)[163](index=163&type=chunk) - The company was **awarded a $600,000 Defense Threat Reduction Agency (DTRA) subcontract** in May 2019 to develop medical countermeasures against bacterial threat agents using SGX943[164](index=164&type=chunk) [Critical Accounting Policies](index=36&type=section&id=Critical%20Accounting%20Policies) This section outlines key accounting policies, including revenue recognition and R&D expense treatment - Revenue from government contracts and grants is recognized when subcontractor or internal reimbursable expenses are incurred[166](index=166&type=chunk) - Research and development costs are **expensed as incurred**, including clinical trial expenses and license fees without alternative future use[167](index=167&type=chunk) - Share-based compensation for nonemployees is measured at grant date fair value and recognized when services are performed, following ASU 2018-07[170](index=170&type=chunk)[171](index=171&type=chunk) [Material Changes in Results of Operations](index=38&type=section&id=Material%20Changes%20in%20Results%20of%20Operations) This section discusses significant changes in revenues, expenses, and net loss for reporting periods Material Changes in Results of Operations Summary | Metric (3 Months Ended Sep 30) | 2019 | 2018 | Change ($) | Change (%) | | :----------------------------- | :----------- | :----------- | :--------- | :--------- | | Net loss | $(2,720,783) | $(1,861,608) | $(859,175) | 46.15% | | Total revenues | $1,254,904 | $1,381,353 | $(126,449) | -9.15% | | Gross profit | $289,451 | $144,123 | $145,328 | 100.84% | | R&D expenses | $2,266,799 | $1,394,913 | $871,886 | 62.57% | | G&A expenses | $789,251 | $667,799 | $121,452 | 18.19% | | Metric (9 Months Ended Sep 30) | 2019 | 2018 | Change ($) | Change (%) | | :----------------------------- | :----------- | :----------- | :--------- | :--------- | | Net loss | $(6,483,931) | $(5,795,156) | $(688,775) | 11.89% | | Total revenues | $3,944,655 | $4,226,670 | $(282,015) | -6.67% | | Gross profit | $964,464 | $516,843 | $447,621 | 86.61% | | R&D expenses | $5,763,467 | $4,377,483 | $1,385,984 | 31.66% | | G&A expenses | $2,432,550 | $2,041,340 | $391,210 | 19.16% | - The increase in net loss for the **nine months** ended September 30, 2019, was partially offset by a **$610,676 income tax benefit** from NOL carryforward sales and **$373,557 milestone fee income** from the RiVax program[175](index=175&type=chunk)[176](index=176&type=chunk) [Financial Condition](index=38&type=section&id=Financial%20Condition) This section analyzes liquidity, capital resources, and plans to address future funding needs Financial Condition Summary | Metric | Sep 30, 2019 | Dec 31, 2018 | Change ($) | Change (%) | | :---------------- | :----------- | :----------- | :--------- | :--------- | | Cash & equivalents| $6,551,793 | $8,983,717 | $(2,431,924) | -27.07% | | Working capital | $2,375,787 | $6,131,178 | $(3,755,391) | -61.25% | - The decrease in cash and working capital was primarily due to expenditures for the pivotal Phase 3 clinical trials of SGX942 and SGX301[180](index=180&type=chunk) - The company plans to address liquidity needs through government contracts/grants (**up to $8.0 million available**), equity instruments for vendor compensation, NOL sales, potential partnerships, and additional equity/debt financings (**up to $6.3 million remaining** from FBR Sales Agreement)[181](index=181&type=chunk)[182](index=182&type=chunk)[32](index=32&type=chunk) [Expenditures](index=40&type=section&id=Expenditures) This section details research and development expenditures and anticipated reimbursements - **Projected R&D expenditures** for the next **12 months** are approximately **$10.0 million**, with **$6.9 million for Specialized BioTherapeutics** and **$3.1 million for Public Health Solutions**[183](index=183&type=chunk) - The company **anticipates approximately $3.2 million in contract and grant reimbursements** to offset R&D expenses in the next **12 months**[183](index=183&type=chunk) Expenditures Summary | R&D Program (9 Months Ended Sep 30) | 2019 Expenses | 2018 Expenses | Change ($) | Change (%) | | :---------------------------------- | :------------ | :------------ | :--------- | :--------- | | RiVax and ThermoVax Vaccines | $303,149 | $313,735 | $(10,586) | -3.37% | | Dusquetide (SGX94) | $3,853,182 | $2,332,590 | $1,520,592 | 65.19% | | SGX301 | $1,260,664 | $1,451,349 | $(190,685) | -13.14% | | Other | $346,472 | $279,809 | $66,663 | 23.82% | | Total R&D Expenses | $5,763,467 | $4,377,483 | $1,385,984 | 31.66% | | Reimbursements (9 Months Ended Sep 30) | 2019 | 2018 | Change ($) | Change (%) | | :------------------------------------- | :------------ | :------------ | :--------- | :--------- | | RiVax and ThermoVax Vaccines | $2,195,743 | $3,125,027 | $(929,284) | -29.74% | | SGX942 | $405,055 | $271,011 | $134,044 | 49.46% | | SGX301 | $379,392 | $313,789 | $65,603 | 20.91% | | Total Reimbursements | $2,980,191 | $3,709,827 | $(729,636) | -19.67% | [Contractual Obligations](index=40&type=section&id=Contractual%20Obligations) This section outlines future contractual commitments, including R&D and lease obligations Contractual Obligations Summary | Year | Research and Development | Property and Other Leases | Total | | :------------------------ | :----------------------- | :------------------------ | :----------- | | Oct 1 - Dec 31, 2019 | $50,000 | $37,527 | $87,527 | | 2020 | $100,000 | $127,374 | $227,374 | | 2021 | $100,000 | $6,408 | $106,408 | | 2022 | $100,000 | $- | $100,000 | | 2023 | $100,000 | $- | $100,000 | | Total | $450,000 | $171,309 | $621,309 | - The company has commitments of approximately **$450,000** for licensing agreements and **potential future milestone payments of up to $7.9 million** and **royalties up to 6% of net sales** upon clinical or commercialization success[185](index=185&type=chunk) [ITEM 3 – Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203%20%E2%80%93%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk exposure primarily stems from interest income sensitivity and foreign exchange fluctuations - The company's **primary market risk exposure** is interest income sensitivity from short-term marketable securities and foreign exchange rate fluctuations[190](index=190&type=chunk) - The company does not have any derivative financial instruments and believes it is not subject to any material market risk exposure due to the nature of its short-term investments[190](index=190&type=chunk) [ITEM 4 – Controls and Procedures](index=41&type=section&id=Item%204%20%E2%80%93%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of September 30, 2019, with no material changes - Management concluded that the company's disclosure controls and procedures were **effective at the reasonable assurance level** as of September 30, 2019[192](index=192&type=chunk) - **No material changes** in internal control over financial reporting occurred during the last fiscal quarter[193](index=193&type=chunk) [PART II – OTHER INFORMATION](index=43&type=section&id=Part%20II%20%E2%80%93%20OTHER%20INFORMATION) This section provides additional information, including risk factors, equity sales, and exhibits [ITEM 1A – Risk Factors](index=43&type=section&id=Item%201A%20%E2%80%93%20Risk%20Factors) The company's business faces significant risks, detailed in its Annual Report on Form 10-K - The company's business faces **significant risks**, which are disclosed in Item 1A of its Annual Report on Form 10-K for the fiscal year ended December 31, 2018[196](index=196&type=chunk) [ITEM 2 – Unregistered Sales of Equity Securities and Use of Proceeds](index=43&type=section&id=Item%202%20%E2%80%93%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company issued restricted common stock to vendors, exempt from registration under Section 4(2) of the Securities Act - During the **nine months** ended September 30, 2019, the company issued restricted shares of common stock to third-party vendors as partial compensation for services performed[197](index=197&type=chunk) - Specific issuances included **60,000 shares at $0.96** on Jan 2, 2019; **8,681 shares at $0.73** on Apr 29, 2019; **50,000 shares at $0.83** on May 15, 2019; **78,338 shares at $0.71** on Jun 28, 2019; **8,681 shares at $0.72** on Jul 1, 2019; **25,000 shares at $0.98** on Jul 15, 2019; **5,000 shares at $1.05** on Aug 15, 2019; and **10,000 shares at $0.88** on Sep 15, 2019[197](index=197&type=chunk)[198](index=198&type=chunk)[199](index=199&type=chunk)[200](index=200&type=chunk)[201](index=201&type=chunk)[202](index=202&type=chunk)[203](index=203&type=chunk)[204](index=204&type=chunk) - The company believes these issuances were **exempt from registration** pursuant to Section 4(2) of the Securities Act of 1933, as they did not involve a public offering[205](index=205&type=chunk) [ITEM 6 – Exhibits](index=45&type=section&id=Item%206%20%E2%80%93%20Exhibits) This section lists filed exhibits, including CEO/CFO certifications and XBRL taxonomy documents - The exhibits include certifications from the Chief Executive Officer and Chief Financial Officer pursuant to Exchange Act Rule 13(a)-14(a) and Section 906 of the Sarbanes-Oxley Act of 2002[212](index=212&type=chunk) - XBRL Instance Document and Taxonomy Extension Schema, Calculation, Definition, Label, and Presentation Linkbase Documents are also filed as exhibits[212](index=212&type=chunk) [SIGNATURES](index=44&type=section&id=SIGNATURES) This section formally attests to the accuracy and completeness of the financial report by authorized officers - The report is signed by Christopher J Schaber, PhD, President and Chief Executive Officer, and Jonathan Guarino, Chief Financial Officer, Senior Vice President, and Corporate Secretary, on November 12, 2019[210](index=210&type=chunk)
Soligenix(SNGX) - 2019 Q2 - Quarterly Report
2019-08-13 20:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File No. 000-16929 SOLIGENIX, INC. (Exact name of registrant as specified in its charter) DELAWARE 41-1505029 (State or other juri ...
Soligenix(SNGX) - 2019 Q1 - Quarterly Report
2019-05-14 20:29
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File No. 000-16929 SOLIGENIX, INC. (Exact name of registrant as specified in its charter) DELAWARE 41-1505029 (State or other jurisdiction of incorporation or organization) 29 EMMONS DRIVE, SUITE B-10 PRINCETON, NJ 08540 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 ...
Soligenix(SNGX) - 2018 Q4 - Annual Report
2019-03-26 20:36
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) þ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the Fiscal Year Ended December 31, 2018 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from ____________ to ____________ Commission File No. 000-16929 SOLIGENIX, INC. (Exact name of registrant as specified in its charter) | Delaware | 41-1505029 | | --- | --- | ...