Oragenics(OGEN) - 2019 Q4 - Annual Report

Part I Business Oragenics, Inc. is a clinical-stage biopharmaceutical company developing treatments for oral mucositis and novel antibiotics through collaboration agreements - The company's primary focus is on developing treatments for oral mucositis and creating novel antibiotics against infectious diseases[19] Product Candidate Pipeline Status | Product/Candidate | Description | Application | Status | | :--- | :--- | :--- | :--- | | AG013 | Treatment of Oral Mucositis | Treatment of oral mucositis in cancer patients | Enrollment completed. Awaiting top-line results | | OG716 | A homolog of MU1140: Member of lantibiotic class of antibiotics | Healthcare-associated infections (e.g., C. difficile) | Nonclinical testing | Oral Mucositis Program (AG013) AG013, an oral rinsing solution for oral mucositis, has FDA Fast Track and EU Orphan Drug status, with Phase 2 results expected in H1 2020 - AG013 is an oral rinsing solution designed to deliver human Trefoil Factor 1 (hTFF1) to protect and regenerate the mucosal lining of the oral cavity in cancer patients suffering from oral mucositis[20] - The Phase 2 clinical trial for AG013 completed enrollment in December 2019, with top-line results expected in the first half of 2020[25] - AG013 has been granted Fast Track designation by the U.S. FDA and Orphan Drug status in the European Union, potentially expediting its development and review process[22] - Initial blinded data from the Phase 2 trial showed an overall severe oral mucositis (SOM) incidence of 47%, which the company believes is lower than historical data for this patient population[29] Antibiotic Program (OG716 and Lantibiotics) The company is developing OG716, a lantibiotic for C. diff infection, showing promising preclinical efficacy, with IND filing contingent on funding - The lead antibiotic candidate, OG716, is a new, orally-active homolog from the MU1140 lantibiotic platform, targeting C. difficile infections[36] - In preclinical animal models, OG716 demonstrated promising efficacy, reducing C. diff infections as measured by increased animal survival, decreased relapse, and reduced production of toxins and spores[36] - The company held a pre-IND meeting with the FDA for OG716 in Q3 2017; the IND filing is subject to available capital and manufacturing progress[51][57] Collaboration Agreements Oragenics' programs are governed by Exclusive Channel Collaboration agreements with ILH Holdings and Precigen, outlining development, funding, and payment obligations Key Terms of Collaboration Agreements | Agreement | Partner | Product Program | Oragenics' Royalty/Sublicense Obligation | | :--- | :--- | :--- | :--- | | Lantibiotic ECC | ILH Holdings, Inc. | Lantibiotics (e.g., OG716) | 10% of net sales; 25% of sublicense revenue | | Oral Mucositis ECC | Precigen ActoBio Inc. | Oral Mucositis (AG013) | 12% of net sales; 25% of sublicense revenue | Potential Milestone Payments | Program | Milestone Event | Payment Amount | | :--- | :--- | :--- | | Lantibiotic | FDA Approval (New Product) | $25,000,000 | | Oral Mucositis | FDA Approval (New Product) | $27,500,000 | - In January 2020, Precigen assigned the Lantibiotic ECC to its affiliate ILH Holdings, Inc., which was subsequently divested to TS Biotechnology Holdings, LLC[33][50] Government Regulations Product development is subject to extensive FDA regulation, requiring preclinical and multi-phase clinical trials for safety and efficacy, with special designations expediting review - Pharmaceutical product development requires preclinical tests and three sequential phases of clinical trials to establish safety and efficacy before submitting an NDA or BLA to the FDA for marketing approval[92][96] - The FDA's Fast Track program, for which AG013 is designated, facilitates the development and expedites the review of drugs for serious conditions with unmet medical needs[98][113] - The Orphan Drug Act provides incentives, including a seven-year market exclusivity period in the U.S., for drugs treating rare diseases affecting fewer than 200,000 people[112] - The company's operations are also subject to healthcare laws regarding fraud and abuse (e.g., Anti-Kickback Statute), pricing and reimbursement policies, and data privacy regulations like HIPAA[162][168] Risk Factors The company faces significant financial losses, capital needs, operational risks in product development and regulatory approval, and stock-related risks including dilution and delisting Risks Related to Our Business The company faces significant net losses, requires additional capital beyond Q2 2021, and has substantial risks in clinical trials, regulatory approval, manufacturing, and collaboration dependencies - The company has a history of significant losses, reporting a net loss of approximately $15.6 million for the year ended December 31, 2019, and an accumulated deficit of $127.4 million[186] - Existing cash resources are anticipated to be sufficient to fund operations only through the second quarter of 2021, necessitating future capital raises which may not be available on favorable terms[187][190] - The company's success is highly dependent on obtaining regulatory approval for its product candidates, AG013 and OG716, which is a long, expensive, and uncertain process[196][230] - There is a risk of being unable to produce MU1140 homologs (like OG716) in large-scale commercial quantities, which would prevent revenue generation from the antibiotic program[193] Risks Related to Our Common Stock Investment in common stock carries high risk, including potential NYSE American delisting, stock price volatility, and significant dilution from preferred stock conversions and warrant exercises - The company has previously been non-compliant with NYSE American continued listing standards and faces a risk of delisting if it fails to meet these standards in the future[305][307] - Significant dilution could result from the conversion of outstanding Series A and Series B Preferred Stock and the exercise of warrants to purchase over 26.5 million shares of common stock[313] - The Series C Preferred Stock has a liquidation preference senior to all other classes of stock and accrues dividends payable in additional shares of Series C Preferred Stock, which could negatively affect common stock value[309][312] Properties The company leases a corporate office in Tampa and a research facility in Alachua, with recent lease extensions for both locations Leased Properties | Location | Type | Size (sq. ft.) | 2019 Lease Cost | | :--- | :--- | :--- | :--- | | Tampa, FL | Corporate Office | ~2,207 | ~$64,000 | | Alachua, FL | Research Facility | ~5,300 | ~$154,000 | Part II Market for Registrant's Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities The company's common stock trades on NYSE American (OGEN) with no cash dividends, while Series C Preferred Stock accrues dividends in kind at an increased rate - The company's common stock is listed on the NYSE American under the ticker symbol "OGEN"[341] - No cash dividends have been paid on common stock, and none are anticipated, as earnings are intended to be retained to finance growth[342] - The Series C Preferred Stock dividend rate increased from 12% to 20% per year after May 10, 2019, with dividends paid in additional shares of Series C Preferred Stock[343] Management's Discussion and Analysis of Financial Condition and Results of Operations The company reported no revenue, with net loss increasing to $15.6 million in 2019 due to higher R&D, and requires additional financing beyond Q2 2021 despite current cash reserves Results of Operations Net loss increased to $15.6 million in 2019 from $9.9 million in 2018, primarily due to a 103% rise in R&D expenses to $12.1 million Comparison of Results of Operations (Years Ended December 31) | Metric | 2019 | 2018 | Change (%) | | :--- | :--- | :--- | :--- | | Revenue, net | $0 | $0 | N/A | | Research and Development | $12,120,318 | $5,971,833 | 103.0% | | General and Administrative | $3,757,251 | $4,022,307 | (6.6%) | | Loss from Operations | ($15,877,569) | ($9,994,140) | 58.9% | | Net Loss | ($15,566,003) | ($9,914,141) | 57.0% | - The $6.1 million (103%) increase in R&D expenses in 2019 was primarily due to increased costs for clinical trial work under the Oral Mucositis ECC and other work under the Lantibiotic ECC[397] Liquidity and Capital Resources Funded by equity sales, the company held $18.3 million cash as of Dec 2019, sufficient until Q2 2021, requiring further capital after using $13.0 million in operations - The company believes its cash and cash equivalents of $18.3 million as of December 31, 2019, are sufficient to fund operations through the second quarter of 2021[400][434] Key Liquidity Metrics (as of December 31, 2019) | Metric | Amount | | :--- | :--- | | Cash and cash equivalents | $18,267,994 | | Working capital surplus | $16,987,690 | | Accumulated deficit | ($127,352,826) | - In March 2019, the company closed an underwritten public offering for gross proceeds of approximately $12.5 million, selling 16.7 million shares of common stock and accompanying warrants[425] Controls and Procedures Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2019, with no significant changes reported - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of December 31, 2019[445] - Management's assessment, based on the 2013 COSO framework, concluded that the company's internal control over financial reporting was effective as of December 31, 2019[453] Part III Directors, Executive Officers and Corporate Governance The company's five-member board, with a majority of independent directors, includes key executives and operates through standing committees under a code of ethics Key Management & Board Members | Name | Position | | :--- | :--- | | Dr. Frederick W. Telling, Ph.D. | Chairman and Director | | Alan Joslyn, Ph.D. | President, Chief Executive Officer and Director | | Michael Sullivan | Chief Financial Officer, Secretary and Treasurer | - The Board of Directors has determined that a majority of its members are independent under NYSE American listing standards[476] Executive Compensation 2019 executive compensation included salary, performance bonuses, and equity awards, with CEO Alan Joslyn receiving $488,394 total, and non-employee directors receiving cash and equity 2019 Summary Compensation Table | Name and Principal Position | Year | Salary | Bonus | Total Compensation | | :--- | :--- | :--- | :--- | :--- | | Dr. Alan Joslyn, President and CEO | 2019 | $367,500 | $87,282 | $488,394 | | Michael O. Sullivan, CFO | 2019 | $229,950 | $76,458 | $313,307 | | Dr. Martin Handfield, SVP Discovery Research | 2019 | $205,380 | $33,374 | $244,916 | - The 2019 bonus plan provided for target bonuses of up to 50% of base salary for the CEO, 35% for the CFO, and 25% for the SVP of Discovery Research, based on achieving corporate and individual objectives[503] - Non-employee directors received an annual base fee of $45,000, additional fees for committee service, and an annual equity award valued at $75,000 in 2019[546][550] Security Ownership of Certain Beneficial Owners and Management As of Feb 25, 2020, directors and officers collectively owned 11.4% of common stock, with Intracoastal Capital LLC holding 6.7% - As of February 25, 2020, all directors and executive officers as a group beneficially owned 5,723,454 shares, representing 11.4% of the outstanding common stock[560] - Intracoastal Capital LLC reported beneficial ownership of 3,333,334 shares, or 6.7% of the common stock, primarily through warrants[560][561] Certain Relationships and Related Transactions, and Director Independence Certain directors and the CEO participated in the company's 2018 and 2019 public offerings, purchasing shares and warrants, with transactions approved by the Audit Committee - Directors Frederick Telling and Alan Dunton participated in the July 2018 underwritten public offering[566] - Director Frederick Telling and CEO Alan Joslyn participated in the March 2019 underwritten public offering[572] Principal Accountant Fees and Services Mayer Hoffman McCann P.C. served as the principal accountant, billing $163,700 in 2019 and $164,250 in 2018, primarily for audit services Accountant Fees | Services Rendered | 2019 | 2018 | | :--- | :--- | :--- | | Audit Fees | $151,500 | $155,000 | | Tax Fees | $12,200 | $9,250 | | Total Fees | $163,700 | $164,250 | Part IV Exhibits and Financial Statement Schedules This section details financial statements, schedules, and exhibits filed with the Form 10-K, including corporate governance, material contracts, and SOX certifications - The report includes financial statements for the years ended December 31, 2019 and 2018, along with the report of the independent registered public accounting firm[581] - Filed exhibits include key agreements such as the Lantibiotic ECC and Oral Mucositis ECC with Precigen and its affiliates, as well as various financing and employment agreements[582][585]