Hepion Pharmaceuticals(HEPA) - 2018 Q4 - Annual Report

Cautionary Note Regarding Forward-Looking Statements Forward-Looking Statements This section highlights that the Annual Report contains forward-looking statements subject to substantial risks and uncertainties, which are not guarantees of performance and actual results may differ materially - The report contains forward-looking statements that are not guarantees of performance and involve substantial risks and uncertainties[9] - Key risk factors include market conditions, capital position, competition, uncertainty of product development, regulatory approvals, intellectual property, financing, cost control, key employee retention, strategic collaborations, government regulation changes, litigation, market acceptance, and third-party reimbursement policies[10] PART I ITEM 1. BUSINESS ContraVir Pharmaceuticals focuses on developing pleiotropic drug therapies for chronic liver diseases, prioritizing CRV431 in Phase 1 over TXL - ContraVir Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing pleiotropic drug therapy for chronic liver disease, including NASH, viral hepatitis, and HCC[13] - CRV431, a cyclophilin inhibitor, is the lead molecule, targeting multiple biochemical pathways involved in liver disease progression, with preclinical studies showing reductions in liver inflammation, fibrosis, and cancerous tumors, and antiviral activity against HBV, HCV, and HDV[13][19][20] - TXL, a nucleotide pro-drug of tenofovir, is more clinically advanced (Phase 2 completed) for inhibiting HBV viral replication, but the company plans to out-license, partner, or divest it to focus resources on CRV431[21][35] - The company completed a Phase 1 study for CRV431, demonstrating safety, tolerability, and pharmacokinetics, and received FDA approval for its IND in June 2018[20][26] - TXL has completed Phase 1 and Phase 2 clinical trials, demonstrating efficacy and a favorable safety profile with lower systemic tenofovir levels compared to TDF, reducing the risk of bone and kidney-related toxicities[27][29][30] - The FDA granted Orphan Drug Designation to TXL for chronic hepatitis B infection in pediatric patients (up to 11 years of age) on February 22, 2018[33] Transition Period The company's fiscal year end changed from June 30 to December 31, effective December 31, 2017 - The Company's Board of Directors approved a change in its fiscal year end from June 30 to December 31, effective December 31, 2017[12] Overview ContraVir is a biopharmaceutical company developing pleiotropic drug therapies for chronic liver diseases like NASH, viral hepatitis, and HCC - ContraVir is a biopharmaceutical company focused on developing pleiotropic drug therapy for chronic liver disease, including NASH, viral hepatitis, and HCC[13] - NASH is a rapidly increasing liver disease, predicted to be the leading reason for liver transplants in the USA by 2020, with no approved drugs specifically for its treatment[14] - HCC is the major type of liver cancer, with high mortality rates, often preceded by significant liver damage, inflammation, and fibrosis[15][16] - Chronic HBV, HCV, and HDV infections are major triggers of progressive liver disease, with chronic HBV affecting an estimated 240 million people worldwide and being the leading cause of HCC[17][18] - CRV431 is a cyclophilin inhibitor in Phase 1, showing reductions in HBV DNA, HBsAg, HBeAg, inhibition of virus uptake, and stimulation of innate immunity, as well as reducing fibrosis and liver tumor burden in NASH models[19][20] - TXL is a nucleotide pro-drug of tenofovir, more clinically advanced (Phase 2 completed), that inhibits HBV replication and targets the liver, but the company plans to out-license or divest it to focus on CRV431[21] CRV431 CRV431, a novel cyclophilin inhibitor, targets multiple liver disease pathways, demonstrated nanomolar efficacy against HBV in vitro, and completed a positive Phase 1 clinical trial in October 2018 - CRV431 is a novel cyclophilin inhibitor targeting multiple isoforms involved in liver disease and viral hepatitis, including cell death, inflammation, fibrosis, cirrhosis, and cancer[22][23] - In vitro testing showed nanomolar efficacy and micromolar toxicity against HBV, with a wide selective index, and in vivo studies demonstrated reduced HBV DNA and HBsAg[25] - An Investigational New Drug Application (IND) for CRV431's HBV clinical development program was submitted to the FDA on May 10, 2018, and approved in June 2018. A Phase 1 clinical trial was completed in October 2018 with positive data[26] - The positive Phase 1 data triggered a $1 million milestone payment and the issuance of 100,737 shares of common stock to Ciclofilin shareholders as per the merger agreement[26] TXL TXL, a lipid acyclic nucleoside phosphonate, completed Phase 1 and 2 trials showing efficacy and a favorable safety profile, and received Orphan Drug Designation for pediatric HBV in February 2018 - TXL is a novel lipid acyclic nucleoside phosphonate designed to deliver high intracellular concentrations of tenofovir diphosphate, reducing systemic exposure and potential renal side effects[27] - Phase 1 and Phase 2 clinical trials in healthy volunteers and HBV patients demonstrated TXL as an efficacious agent with a favorable safety and tolerability profile[27][29] - Phase 2a data showed TXL doses of 50-100mg achieved comparable HBV viral load reductions to 300mg TDF after 28 days, with substantially lower systemic tenofovir levels, indicating reduced risk of bone and kidney toxicities[30] - A safety study in patients with severe renal impairment confirmed TXL's safety and tolerability, showing no need for dosing adjustments in patients with compromised renal function[31] - The FDA granted Orphan Drug Designation to TXL for chronic hepatitis B infection in a pediatric patient population (up to 11 years of age) on February 22, 2018[33] - The company decided to out-license/partner TXL to focus resources on advancing CRV431, aligning programs to address broader liver diseases (NASH, fibrosis, HCC) and HBV infection[35] License Agreement ContraVir licensed TXL from Chimerix for an upfront payment of $1.2 million in Series B Preferred Stock, with Chimerix eligible for up to $20 million in milestones and royalties - ContraVir licensed TXL from Chimerix for an upfront payment of 120,000 shares of Series B Convertible Preferred Stock, valued at $1.2 million[36] - Chimerix is eligible for up to approximately $20 million in clinical, regulatory, and initial commercial milestones, plus royalties and additional milestones based on commercial sales[36] - Chimerix converted all Series B Preferred Stock into approximately 134,000 shares of ContraVir's common stock on September 30, 2016[37] Intellectual Property The company protects its product candidates through patents, trade secrets, and licensing, including two U.S. patents for TXL from Chimerix and five from UC, and acquired CRV431 with future milestone payments - The company relies on patents, trade secrets, know-how, and licensing to protect its product candidates and maintain a competitive advantage[38] - Patents filed on or after June 8, 1995, have a term of 20 years from the filing date, which may shorten the period of protection for biopharmaceutical products due to long development times[40] - The company licenses two issued U.S. patents related to TXL from Chimerix, covering composition of matter (expiring 2031) and methods of use (expiring 2030)[44] - Through the UC Agreement, the company licenses five issued U.S. patents and one allowed patent application for TXL's composition of matter (expiring 2020-2021) and one U.S. patent for methods of use (expiring 2020)[45][46] - The company also licenses numerous foreign granted patents and pending applications for TXL, with expiration dates ranging from 2020 to 2033[44][47] - The company acquired Ciclofilin Pharmaceuticals, Inc. in June 2016, gaining its lead asset CPI-431-32 (renamed CRV431), with future milestone payments up to CAD $2.9 million and a 2.5% royalty on net sales[41] Sales and Marketing The company lacks internal commercialization capabilities and plans to partner or license product rights to larger pharmaceutical companies for late-stage development and commercialization - The company currently lacks commercialization or internal sales and marketing capabilities and plans to partner or license rights to larger pharmaceutical companies for late-stage development and commercialization[51] Manufacturing The company relies on contract manufacturers for all preclinical and clinical trial materials under cGMP, without owning its own manufacturing facilities - The company does not own manufacturing facilities and intends to rely on contract manufacturers for all preclinical and clinical trial materials under cGMP, with management oversight[52][53] Pharmaceutical Pricing and Reimbursement Future product revenue depends on reimbursement from third-party payers, who increasingly challenge prices, and healthcare cost-reduction legislation could limit reimbursement - Future revenue from product sales, if approved, will largely depend on reimbursement availability from third-party payers (government, managed-care, private insurers)[54] - Third-party payers are increasingly challenging prices and cost-effectiveness, and there is significant uncertainty regarding reimbursement status for new pharmaceutical products[54] - Legislation and regulations aimed at reducing healthcare costs could limit reimbursement for pharmaceuticals, potentially affecting future sales and profitability[55] Regulatory Matters Drug products are subject to extensive U.S. and foreign governmental regulations, involving rigorous preclinical and clinical trials, IND/NDA/BLA submissions, and ongoing post-approval compliance - Drug products are subject to extensive regulation by governmental authorities in the U.S. (FDA) and foreign countries, covering testing, manufacturing, labeling, distribution, and more[57] - Non-compliance can lead to suspension of development, manufacturing, or marketing, failure to obtain approval, withdrawal of approvals, fines, and criminal prosecution[58] - The U.S. regulatory approval process is long and rigorous, involving preclinical studies (GLP), IND submission, IRB approval, and successful completion of Phase 1, 2, and 3 clinical trials (GCP) before NDA/BLA submission and FDA approval[59][62][64][65][66][67][69][70] - Post-approval, products are subject to ongoing FDA regulation, including record-keeping, adverse event reporting, cGMP compliance for manufacturing, and review of product changes[83][84] - Foreign regulatory approval processes are similar to the U.S., requiring separate approvals (e.g., CTA in Europe) and compliance with local regulations and ethical principles like the Declaration of Helsinki[90][91][92][93] - The European Union offers centralized and national authorization procedures for medicinal products, with the centralized procedure providing a single marketing authorization valid across the EU[94][95] Employees As of December 31, 2018, the company had fourteen employees, maintaining satisfactory employee relations - As of December 31, 2018, the company had fourteen employees, and relations with employees were satisfactory[97] Corporate Information The company, incorporated in Delaware in May 2013, has principal executive offices in Edison, New Jersey, and a research laboratory in Edmonton, Canada - The company was incorporated in Delaware in May 2013, with principal executive offices in Edison, New Jersey, and a research laboratory in Edmonton, Canada[98] Available Information Annual, Quarterly, and Current Reports, along with other SEC filings, are freely available on the company's and SEC's websites - Annual, Quarterly, and Current Reports, along with other SEC filings, are available free of charge on the company's website (www.contravir.com) and the SEC's website (www.sec.gov)[98](index=98&type=chunk) ITEM 1A. RISK FACTORS ContraVir faces significant risks including going concern uncertainty, early-stage product development, regulatory hurdles, competition, IP challenges, and financial volatility - The company has incurred losses since inception, anticipates continued losses, and its independent registered public accounting firm's report expresses substantial doubt about its ability to continue as a going concern[100][101] - Substantial additional funding is required for preclinical and clinical development, regulatory approval, and commercialization, which may not be available on acceptable terms, potentially leading to delays or discontinuation of product candidates[103][104][105] - CRV431 is in early development, and its commercial viability depends on successful preclinical studies, clinical trials, and regulatory approvals, with no assurance of favorable results or market approval[106][109][110] - Product candidates may exhibit undesirable side effects, delaying or precluding development, regulatory approval, or limiting use if approved[112] - The company relies on third-party vendors for preclinical studies and clinical trials; their failure to perform or comply with regulations could cause delays, termination, or increased expenses[116] - The pharmaceutical industry is highly competitive, with larger companies possessing greater resources and experience, posing a significant challenge to ContraVir's ability to develop and commercialize products[176][177] - The company has limited experience in small molecule antiviral development and relies on outsourcing, requiring continuous attraction and retention of qualified personnel and consultants[125][126][127] - Regulatory approval processes are lengthy, expensive, and unpredictable, with no guarantee of approval for product candidates, and even if approved, products may face restrictions or withdrawal[133][134][135][140][141] - Failure to adequately protect or expand intellectual property rights could harm business prospects, as patents may be challenged, invalidated, or circumvented, and trade secrets are difficult to protect[197][198][199][200][211][212] - Market acceptance and sales of approved products depend on factors like safety, efficacy, convenience, pricing, reimbursement, and competition, with no assurance of meaningful market penetration[166][169][189][191] - Healthcare reform measures, such as the PPACA, could adversely impact pricing and reimbursement for pharmaceutical products, limiting potential revenue and profitability[228][229][230][233][235] Risks Related to Our Business The company faces substantial doubt about its going concern ability due to accumulated losses of $76.5 million and the need for additional capital, alongside risks in early-stage product development, regulatory compliance, and intense competition - The company has an accumulated deficit of $76.5 million as of December 31, 2018, and expects continued significant operating losses, raising substantial doubt about its ability to continue as a going concern[101] - Failure to raise additional capital could lead to significant delays in clinical and regulatory efforts, or require scaling back/discontinuing product development[102][104] - Product candidates are in early development, and success is uncertain, with no guarantee of favorable results in clinical trials or regulatory approval[106][109][110] - Undesirable side effects from product candidates could delay or prevent further development or regulatory approval[112] - Reliance on third-party vendors for preclinical studies and clinical trials poses risks of delays or failures if they do not perform or comply with regulations[116] - Limited capacity for recruiting and managing clinical trials could impair timing for initiation or completion[117][118] - The company faces extensive government regulations for product development and marketing, with potential for delays, failures, or withdrawal of approvals[121][122] - Limited experience in small molecule antiviral development necessitates supplementing capabilities through key employees, consultants, or third-party contractors[125][126] - Delays in clinical testing increase costs and delay revenue generation[132] - The regulatory approval process is lengthy, time-consuming, and unpredictable, with many reasons for potential failure to receive approval[133][134] - Failure to comply with healthcare regulations could lead to substantial enforcement actions, including civil and criminal penalties[142][143] - The industry is highly competitive and subject to rapid technological changes, with larger competitors having significantly more resources[176][177] - Dependence on in-licensing or acquiring development programs from third parties due to limited internal drug discovery capabilities[181] - Product liability claims, if uninsured or exceeding coverage, could result in substantial damage awards[182] - Use of hazardous materials in clinical activities carries risks of contamination or injury, potentially leading to significant financial loss[183] Risks Relating to the Commercialization of our Product Candidates Commercialization risks include market opportunity, reliance on third-party collaborations, uncertain reimbursement, low market acceptance, and intellectual property protection - Development of a product candidate may be delayed or terminated if the perceived market or commercial opportunity does not justify further investment[184] - Failure to enter into collaborations or licensing agreements to accelerate development means the company bears the full risk of developmental failure[185] - Lack of internal sales and marketing organization means reliance on third parties for commercialization, which may not be successful or yield favorable terms[186] - Product revenues depend heavily on adequate reimbursement and coverage from government and third-party payers, which are increasingly challenging prices and cost-effectiveness[187][188] - Even if approved, products may not gain meaningful market acceptance among physicians, patients, or third-party payers, limiting revenue generation[189][191] - Social or political pressure to lower drug costs could lead to downward pricing pressure, reducing revenue and profitability[192] - Reliance on collaborators for product development and commercialization means risks if collaborators do not perform, terminate agreements, or delay efforts[193][194][195] - Inability to adequately protect or expand intellectual property related to product candidates could harm business prospects, as patents may be challenged or circumvented[197][198][199][200] - Claims of intellectual property infringement by third parties could lead to significant expenses or prevent further development/commercialization[201][205][206][207] - Material breach or default under the Chimerix License Agreement could result in loss of critical license rights for TXL[209] - Confidentiality agreements may not adequately prevent disclosure of trade secrets or protect intellectual property[211][212] - Failure to successfully discover, acquire, develop, and market additional product candidates would impair growth[213][214][215] - Even with regulatory approval, products may face future development and regulatory difficulties, including significant restrictions or post-approval studies[216][217] - Failure to obtain foreign regulatory approval could prevent commercialization outside the U.S.[219] - Reliance on third parties to conduct clinical trials means risks if they fail to perform or meet deadlines, potentially delaying or terminating trials[220][221] - Need to increase organization size to support clinical trials and commercialization, imposing significant responsibilities on management[222][224] - Uncertainty of reimbursement availability for product candidates could impede sales[225][226][227] - Healthcare reform measures could hinder commercial success by impacting pricing and reimbursement[228][229][230][233][235] - Security breaches and other disruptions could compromise information, leading to liability and reputational damage[237] - Handling hazardous materials in clinical activities requires compliance with environmental laws, with risks of contamination or injury[238] Risks Related to Our Common Stock Common stock risks include ineffective controls, potential Nasdaq delisting, price volatility, future dilution, and reduced investor appeal as an 'emerging growth company' - Ineffective disclosure controls and procedures and material weaknesses in internal control over financial reporting as of December 31, 2018, could lead to material misstatements and negatively impact stock price[239][240] - Failure to comply with Nasdaq's minimum bid price and other listing requirements could result in delisting, reducing liquidity and ability to raise capital[241][242] - The market price of common stock may be volatile due to various factors, including industry developments, financial results, and economic conditions[243][245] - U.S. federal income tax reform (TCJA) has not materially impacted projections but could adversely affect stockholders[246] - Provisions in the certificate of incorporation, by-laws, and Delaware law may prevent or delay an acquisition of the company, potentially decreasing stock price[247][248] - Future sales and issuances of common stock or rights to purchase common stock could result in additional dilution for existing stockholders[249][251] - As an 'emerging growth company' under the JOBS Act, reduced disclosure requirements may make common stock less attractive to investors, leading to less active trading or more volatile stock price[252] - The company is at risk of securities class action litigation, especially due to dependence on clinical trial outcomes and regulatory approvals[254] - Lack of research coverage by industry or securities analysts, or adverse changes in recommendations, could cause stock price and trading volume to decline[255] - The company does not intend to pay cash dividends on its common stock in the foreseeable future, retaining earnings for business expansion[256] ITEM 1B. UNRESOLVED STAFF COMMENTS There are no unresolved staff comments from the SEC - No unresolved staff comments[257] ITEM 2. PROPERTIES The company's corporate headquarters are in Edison, New Jersey, occupying 6,400 square feet of leased space, with a research laboratory in Edmonton, Canada, of 2,200 square feet - Corporate headquarters are in Edison, New Jersey (6,400 sq ft leased space)[258] - Research laboratory and office space in Edmonton, Canada (2,200 sq ft leased space)[258] ITEM 3. LEGAL PROCEEDINGS The company is not currently involved in any legal proceedings but may face future actions that could materially affect its financial performance - Not currently involved in any legal proceedings[258] - May become party to various legal actions and complaints in the ordinary course of business[258] - Unfavorable resolution of contingencies could materially affect cash flows or results of operations[258] ITEM 4. MINE SAFETY DISCLOSURES This item is not applicable to the company's operations - Not applicable[259] PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES The company's common stock trades on Nasdaq under 'CTRV' since February 27, 2015, with approximately 207 record holders as of December 31, 2018, and no cash dividends are anticipated - Common stock traded on The Nasdaq Capital Market under symbol "CTRV" since February 27, 2015[262] - As of December 31, 2018, there were approximately 207 holders of record of common stock[262] - The company has never paid cash dividends and does not anticipate paying any in the foreseeable future, intending to retain all available funds for business development and expansion[263][256] Equity Compensation Plan Information as of December 31, 2018 | Plan Category | Number of Shares of Common Stock to be Issued upon Exercise of Outstanding Options (a) | Weighted Average Exercise Price of Outstanding Options ($) | Number of Options Remaining Available for Future Issuance Under Equity Compensation Plans (excluding securities reflected in column (a)) | | :--- | :--- | :--- | :--- | | Equity Compensation Plans Approved by Stockholders | 642,596 | $12.32 | 694,904 | ITEM 6. SELECTED FINANCIAL DATA This item is not applicable to the company - Not applicable[266] ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS MD&A reviews ContraVir's financial condition, detailing significant losses, going concern uncertainty, and the need for capital to advance CRV431 and TXL drug candidates - The company changed its fiscal year end from June 30 to December 31, effective December 31, 2017[268] - The company is a biopharmaceutical company focused on developing targeted pharmaceutical therapies for liver disease, including those arising from chronic alcohol use, viral hepatitis (HBV, HCV, HDV), and non-alcoholic steatohepatitis (NASH)[269] - CRV431, a cyclophilin inhibitor, is the lead compound, having completed a Phase 1 study demonstrating safety, tolerability, and pharmacokinetics, and showing preclinical efficacy in reducing liver inflammation, fibrosis, and tumors, as well as antiviral activity against HBV[272] - TXL, a nucleotide pro-drug of tenofovir, is clinically more advanced (Phase 2 completed) for inhibiting HBV replication, but the company plans to out-license/partner it to focus resources on CRV431[273][285] - From inception through December 31, 2018, the company had an accumulated deficit of approximately $76.5 million and has not generated any revenue from operations[286] - As of December 31, 2018, the company had $2.8 million in cash and a working capital of $0.1 million, down from $5.95 million cash and $3.5 million working capital as of December 31, 2017[293][355] - Management concluded there is substantial doubt about the company's ability to continue as a going concern without additional capital, as it expects to incur significant and continuing losses[294][405][406] - Net cash used in operating activities was $15.6 million for the year ended December 31, 2018, primarily for clinical R&D and G&A operations[293][355] - Net cash provided by financing activities for the year ended December 31, 2018, was $12.5 million, mainly from a rights offering ($9.9 million net proceeds) and debt financing ($2.0 million)[356][357] - The company will need to raise additional capital within the next year to continue development and commercialization of product candidates and fund operations[295][373][407] Business Overview ContraVir focuses on liver diseases, with CRV431 as its lead Phase 1 cyclophilin inhibitor and TXL (Phase 2 completed) planned for out-licensing - ContraVir focuses on liver diseases from chronic alcohol use, HBV, HCV, HDV, and NASH, which can progress to cirrhosis and hepatocellular carcinoma (HCC)[269][270] - Chronic HBV infection leads to liver failure, cirrhosis, or liver cancer in up to 25% of infected individuals, accounting for nearly 1 million deaths annually[271] - CRV431 is a cyclophilin inhibitor in Phase 1, showing reductions in HBV DNA, HBsAg, HBeAg, and liver inflammation, fibrosis, and tumor burden in NASH models[272] - TXL is a Phase 2 completed nucleotide pro-drug for HBV, which the company plans to out-license/partner to focus on CRV431[273][285] - CRV431's mechanism involves inhibiting host cyclophilins, making it less susceptible to viral mutations and drug resistance[276] - A Phase 1 clinical trial for CRV431 was completed in October 2018 with positive data, triggering a $1 million milestone payment and issuance of common stock[278] - TXL Phase 2a data showed comparable HBV viral load reductions to TDF with substantially lower systemic tenofovir levels, indicating reduced bone and kidney toxicities[281] - TXL received Orphan Drug Designation for chronic HBV in pediatric patients in February 2018 and FDA agreement to use the 505(b)(2) regulatory pathway[284] Financial Operations Overview As of December 31, 2018, the company had an accumulated deficit of $76.5 million with no revenue, and raised $9.9 million net proceeds from a July 2018 rights offering - From inception through December 31, 2018, the company had an accumulated deficit of approximately $76.5 million and no revenue from operations[286] - In July 2018, the company completed a rights offering, selling 10,826 units (Series C Preferred Stock and common stock warrants) for net proceeds of $9.9 million[289] - Product development is in early stages, with high risk and uncertain costs/timelines due to clinical testing, regulatory approvals, capital needs, and competition[290] Critical Accounting Policies GAAP financial statements show an accumulated deficit of $76.5 million as of December 31, 2018, raising substantial doubt about the company's going concern ability without additional capital - The financial statements are prepared under GAAP, requiring estimates and assumptions that affect reported amounts[291] - As of December 31, 2018, the company had $2.8 million in cash, $15.6 million net cash used in operating activities, a $9.4 million net loss, and an accumulated deficit of $76.5 million[293] - There is substantial doubt about the company's ability to continue as a going concern without additional capital, as it expects recurring losses[294] - Financial instruments (convertible notes, contingent consideration, derivative instruments) are stated at fair value, with Level 3 measurements due to unobservable market data[297][298][299][302] - Warrants issued in equity financings are classified as derivative liabilities and adjusted to fair value each reporting period using the Black-Scholes model with Level 3 inputs[300][301][302] - Income taxes are accounted for under the asset and liability method, recognizing deferred tax assets and liabilities for temporary differences and operating loss carry-forwards[303] - Research and development costs are expensed as incurred due to the absence of commercial biopharmaceutical products and no history of successful commercialization[308][309] - Goodwill and acquired in-process research & development (IPR&D) are indefinite-lived assets, tested annually for impairment; no impairment was found as of December 31, 2018[311][313][314][316] - Share-based payment expense for employees is measured at fair value at grant date and recognized over the vesting period; for non-employees, it's remeasured at each reporting period[318][319][320] Off-Balance Sheet Arrangements The company had no off-balance sheet arrangements as of December 31, 2018 - The company had no off-balance sheet arrangements as of December 31, 2018[324] Recent Accounting Pronouncements This section outlines recent accounting pronouncements, including ASU 2018-13 (Fair Value Measurement), ASU 2016-02 (Leases), and ASU 2018-07 (Stock Compensation), with the company evaluating their impacts - ASU 2018-13 (Fair Value Measurement) amends disclosure requirements for fair value measurements, effective for fiscal years beginning after December 15, 2019[325][448] - ASU 2018-11 and ASU 2018-10 (Leases) provide targeted improvements and codification improvements to ASU 2016-02, with the company evaluating their impact[326][327][449][451] - ASU 2018-07 (Stock Compensation) expands Topic 718 to include share-based payments for nonemployees, effective for fiscal years beginning after December 15, 2018[328][452] - ASU 2018-05 (Income Taxes) amends codification based on the Tax Cuts and Jobs Act (2017) and SAB 118, with the company incorporating changes into deferred tax liability determination[329][453] - ASU 2017-09 (Stock Compensation) provides guidance on modification accounting, adopted by the company with no material impact[330][454] - ASU 2017-04 (Goodwill and Other Intangibles) simplifies goodwill impairment testing by eliminating step 2, effective for fiscal years beginning after December 15, 2019[331][455] - ASU 2016-15 (Cash Flows) amends classification issues for cash flows, required adoption in Q1 2019, with retrospective application[332][456] - ASU 2016-09 (Stock Compensation) simplifies accounting for share-based payments, adopted by the company with no material impact[333][457] - ASU 2016-02 (Leases) establishes a right-of-use (ROU) model, effective for annual periods beginning after December 15, 2018, expected to have a material impact on the balance sheet[334][458][459] JOBS Act The company qualifies as an 'emerging growth company' under the JOBS Act, allowing reduced disclosure requirements, and has irrevocably opted out of the extended transition period for new accounting standards - The company qualifies as an 'emerging growth company' under the JOBS Act, allowing for reduced disclosure requirements[335] - The company irrevocably elected not to use the extended transition period for complying with new or revised accounting standards[335] - The 'emerging growth company' status will cease upon meeting certain criteria, such as total annual gross revenues of $1.07 billion or more, or exceeding $1 billion in nonconvertible debt[336] - As a 'smaller reporting company,' certain exemptions from the Sarbanes-Oxley Act and scaled executive compensation disclosures may continue to be available[339] Results of Operations No revenues for 2018 and 2017; net loss of $9.4 million in 2018, an improvement from $13.0 million in 2017, due to decreased R&D expenses - The company had no revenues for the years ended December 31, 2018 and 2017, and does not expect any for several years[341] Comparison of Financial Results (Years Ended December 31, 2018 vs. 2017) | Item | December 31, 2018 ($) | December 31, 2017 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Revenues | 0 | 0 | 0 | | Research and development | 7,593,715 | 13,368,165 | (5,774,450) | | General and administrative | 7,000,444 | 7,277,951 | (277,507) | | Loss from operations | (14,594,159) | (20,646,116) | 6,051,957 | | Change in fair value of debt | (108,942) | 0 | (108,942) | | Interest on debt | (339,158) | 0 | (339,158) | | Change in fair value of derivatives | 5,056,964 | 5,618,598 | (561,634) | | Loss before income taxes | (9,985,295) | (15,027,518) | 5,042,223 | | Income tax benefit | 536,000 | 1,947,760 | (1,411,760) | | Net loss | (9,449,295) | (13,079,758) | 3,630,463 | - Research and development expenses decreased by $5.8 million in 2018 compared to 2017, mainly due to lower Valnivudine and TXL clinical trial costs, partially offset by increased CRV431 clinical trial costs[342] - General and administrative expenses decreased by $0.3 million in 2018, primarily due to lower stock compensation expense, partially offset by increased payroll and severance costs[343] - Net loss for 2018 was $9.4 million, an improvement from $13.0 million in 2017, influenced by operating expenses and changes in fair value of derivative instruments[345] Comparison of Financial Results (Transition Period Ended December 31, 2017 vs. 2016) | Item | December 31, 2017 ($) | December 31, 2016 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Revenues | 0 | 0 | 0 | | Research and development | 7,163,530 | 7,447,352 | (283,822) | | General and administrative | 3,358,091 | 3,452,025 | (93,934) | | Loss from operations | (10,521,621) | (10,899,377) | (377,756) | | Change in fair value of warrant liability and contingent consideration | 1,062,769 | (331,010) | 1,393,779 | | Loss before income taxes | (9,458,852) | (11,230,387) | 1,771,535 | | Income tax benefit | 1,947,760 | 1,908,003 | 39,757 | | Net loss | (7,511,092) | (9,322,384) | 1,811,292 | - R&D expenses decreased by $0.3 million in the transition period ended December 31, 2017, primarily due to lower TXL and Valnivudine costs, offset by increased CRV431 preclinical costs[348] Comparison of Financial Results (Years Ended June 30, 2017 vs. 2016) | Item | June 30, 2017 ($) | June 30, 2016 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Revenues | 0 | 0 | 0 | | Research and development | 13,651,987 | 15,019,276 | (1,367,289) | | General and administrative | 7,371,885 | 5,786,209 | 1,585,676 | | Loss from operations | (21,023,872) | (20,805,485) | (218,387) | | Change in fair value of warrant liability and contingent consideration | 4,224,819 | 3,806,847 | 417,972 | | Loss before income taxes | (16,799,053) | (16,998,638) | 199,585 | | Income tax benefit | 1,908,003 | 0 | 1,908,003 | | Net loss | (14,891,050) | (16,998,638) | 2,107,588 | - R&D expenses decreased by $1.4 million in FY2017, mainly due to lower Valnivudine clinical trial expenses, partially offset by increased payroll, TXL development, and stock-based compensation[351] - G&A expenses increased by $1.6 million in FY2017, primarily due to increased payroll, general operating costs from the June 2016 acquisition, and stock-based compensation[352] Liquidity and Capital Resources Cash decreased to $2.8 million as of December 31, 2018, with $15.6 million used in operations, requiring additional capital within the next year due to going concern uncertainty Cash Flow Summary | Cash Flows From | Year ended December 31, 2018 ($) | For the transition period ended December 31, 2017 ($) | Year ended June 30, 2017 ($) | | :--- | :--- | :--- | :--- | | Operating activities | (15,646,027) | (8,209,286) | (19,172,110) | | Investing activities | 900 | 0 | (14,709) | | Financing activities | 12,523,539 | 1,180,555 | 24,765,627 | | Net (decrease) increase in cash | (3,121,588) | (7,028,731) | 5,578,808 | | Cash at end of period | 2,832,429 | 5,954,017 | 12,982,748 | - As of December 31, 2018, cash was $2.8 million, down from $6.0 million at December 31, 2017, and $13.0 million at June 30, 2017[355] - Net cash used in operating activities was $15.6 million in 2018, primarily for clinical R&D and G&A[355] - Net cash provided by financing activities in 2018 was $12.5 million, including $9.9 million net proceeds from a rights offering and $2.0 million from debt financing[356][357] - The company has an accumulated deficit of $76.5 million as of December 31, 2018, and expects continued operating losses, indicating substantial doubt about its going concern ability[371][372] - Additional capital is required within the next year to continue development and commercialization, with uncertainty regarding funding availability and potential for significant dilution or restrictive covenants[373] Contractual Obligations and Commitments as of December 31, 2018 | Contractual Obligations | Total ($) | Less Than 1 Year ($) | 1-3 Years ($) | 4-5 Years ($) | After 5 Years ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | Operating lease | 872,723 | 202,734 | 616,087 | 53,902 | 0 | | Convertible debt (remaining principal) | 1,556,000 | 1,556,000 | 0 | 0 | 0 | | Total contractual obligations | 2,428,723 | 1,758,734 | 616,087 | 53,902 | 0 | - Contingent consideration and accrued milestone/royalty payments from licensing agreements are not included in the table as management cannot reasonably estimate if or when they will occur[374] ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK This item is not applicable to the company - Not applicable[376] ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA This section refers to the consolidated financial statements and supplementary data, including the Report of Independent Registered Public Accounting Firm, presented on subsequent pages - Refers to the Index to Consolidated Financial Statements on page 55 of the report[377][379] PART III ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING FINANCIAL DISCLOSURE This item is not applicable to the company - Not applicable[542] ITEM 9A. CONTROLS AND PROCEDURES As of December 31, 2018, the company's disclosure controls and internal control over financial reporting were ineffective due to material weaknesses, which management is committed to remediating - As of December 31, 2018, disclosure controls and procedures were not effective due to material weaknesses in internal control over financial reporting[543] - Material weaknesses identified include an ineffective control environment due to insufficient personnel with appropriate accounting knowledge and ineffective controls over the preparation and review of financial statements[547][549] - Management is committed to remediating these weaknesses and continues to evaluate internal controls, including using external consultants for non-routine/technical accounting issues[543] - The Annual Report does not include an attestation report from the registered public accounting firm regarding internal control over financial reporting, due to exemptions for non-accelerated filers or emerging growth companies[548][550] - No material changes in internal control over financial reporting occurred during the quarter ended December 31, 2018[551] ITEM 9B. OTHER INFORMATION There is no other information to report under this item - None[552] Item 10. Directors, Executive Officers and Corporate Governance This section details ContraVir's executive officers and Board of Directors, their roles, and the structure and functions of the Audit, Compensation, and Corporate Governance/Nominating Committees Executive Officers, Directors and Key Employees as of March 07, 2019 | Name | Age | Present Position with ContraVir Pharmaceuticals, Inc. | | :--- | :--- | :--- | | Gary S. Jacob | 71 | Chairman of the Board of Directors | | Dr. Robert T. Foster | 60 | Chief Executive Officer | | John Cavan | 60 | Chief Financial Officer | | John P. Brancaccio | 70 | Director | | Timothy Block | 64 | Director | | Arnold Lippa | 72 | Director | | Thomas Adams | 76 | Director | - Dr. Robert T. Foster has served as Chief Executive Officer since October 3, 2018, and Chief Scientific Officer since June 10, 2016[556] - John Cavan has served as Chief Financial Officer since April 1, 2016[557] - The Board of Directors oversees management, establishes corporate policies, and reviews overall performance, meeting 15 times in 2018[565][566] - The Board has established Audit, Compensation, and Corporate Governance/Nominating Committees, all operating under written charters and composed of independent directors[567][569][571][574] - John Brancaccio is the audit committee financial expert[569] - All officers, directors, and greater than ten percent stockholders complied with Section 16(a) beneficial ownership reporting requirements for the year ended December 31, 2018[577][578] - The company has adopted a Code of Business Conduct and Ethics, available on its website, requiring compliance from all employees, executive officers, and directors[579][580] Item 11. Executive Compensation This section details executive compensation for 2018, 2017, and June 30, 2017, including salaries, bonuses, and equity awards, noting separation agreements with former CEO James Sapirstein and EVP Theresa Matkovits Summary Compensation Table | Name & Principal Position | Year | Salary ($) | Bonus(1) ($) | Stock In Lieu of Cash Bonus ($) | Options granted(2) ($) | Non-equity incentive plan compensation(1)(3) ($) | Other ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | James Sapirstein, R.Ph. Former Chief Executive Officer | December 2018 | 380,000 | 0 | 199,179 | 0 | 0 | 835,335(4) | 1,414,514 | | | December 2017 | 240,000 | 0 | 0 | 0 | 0 | 0 | 240,000 | | | June 2017 | 410,000 | 0 | 0 | 610,995 | 228,940 | 0 | 1,249,935 | | Theresa Matkovits, Ph.D. Former Executive Vice President | December 2018 | 249,129 | 28,490 | 34,331 | 0 | 0 | 116,563(5) | 428,513 | | | December 2017 | 153,414 | 0 | 0 | 11,769 | 0 | 0 | 165,183 | | | June 2017 | 275,000 | 0 | 0 | 0 | 64,870 | 0 | 339,870 | | Dr. Robert Foster Chief Executive Officer(6) | December 2018 | 312,345 | 0 | 62,244 | 0 | 0 | 0 | 374,589 | | John Sullivan-Bolyai, M.D. Former Chief Medical Officer(7) | December 2018 | 0 | 0 | 34,622 | 0 | 0 | 0 | 34,622 | | | December 2017 | 166,400 | 0 | 0 | 0 | 0 | 0 | 166,400 | | | June 2017 | 332,800 | 0 | 0 | 102,904 | 0 | 0 | 435,704 | - Dr. Robert Foster's Executive Agreement commenced October 1, 2018, with an annual base compensation of $400,000 and eligibility for a cash bonus up to 50% of base salary[585] - James Sapirstein, former CEO, received approximately $0.8 million in severance and COBRA payments as per his separation agreement in October 2018, and his vested stock options' exercise period was extended to two years[587] - Theresa Matkovits, former COO, received approximately $0.1 million in severance and COBRA payments as per her settlement agreement in October 2018, and her vested stock options' exercise period was extended to two years[590] Outstanding Equity Awards as of December 31, 2018 for Named Executive Officers | Name | Options () Exercisable | Options () Unexercisable | Exercise Price ($) | Expiration Date | | :--- | :--- | :--- | :--- | :--- | | James Sapirstein, Former Chief Executive Officer | 125,000 | — | 18.48 | 10/15/2020 | | | 60,416 | — | 12.00 | 10/15/2020 | | | 18,750 | — | 28.80 | 10/15/2020 | | | 41,666 | — | 7.92 | 10/15/2020 | | | 13,079 | — | 11.44 | 10/15/2020 | | | 13,079 | — | 11.44 | 10/15/2020 | | Theresa Matkovits, Former Executive Vice President | 6,250 | — | 30.64 | 10/12/2020 | | | 833 | — | 7.60 | 10/12/2020 | | | 2,083 | — | 7.92 | 10/12/2020 | | | 1,041 | — | 4.64 | 10/12/2020 | | Dr. Robert Foster, Chief Executive Officer | 6,250 | 6,250 | 7.36 | 6/10/2026 | Director Compensation for Year Ended December 31, 2018 | Name | Cash Fees ($) | Option Awards(1) ($) | Total ($) | | :--- | :--- | :--- | :--- | | Gary S. Jacob | 38,000 | 0 | 38,000 | | John P. Brancaccio | 59,000 | 0 | 59,000 | | Arnold Lippa | 41,625 | 0 | 41,625 | | Timothy Block | 55,500 | 0 | 55,500 | | Thomas Adams | 50,500 | 0 | 50,500 | - As of December 31, 2018, a liability of approximately $82,000 related to director fees was recorded, which was paid in January 2019[597] Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. Beneficial ownership of common stock as of March 07, 2019, for key personnel, includes shares acquirable within 60 days via options/warrants, based on 17,179,331 shares outstanding Beneficial Ownership of Common Stock as of March 07, 2019 | Beneficial Owner | Number of Shares Beneficially Owned | Shares of common stock issuable upon exercise of stock options | Shares of common stock issuable upon exercise of warrants | Percentage of Common Stock Beneficially Owned | | :--- | :--- | :--- | :--- | :--- | | John Cavan | 20,993 | 11,557 | 8,625 | * | | Dr. Robert Foster | 18,092 | 6,250 | — | * | | Gary S. Jacob | 4,116 | 126,875 | 8,625 | * | | John Brancaccio | 251 | 25,081 | 1,725 | * | | Timothy Block | — | 21,210 | — | * | | Arnold Lippa | — | 9,687 | 8,625 | * | | Thomas Adams | — | 3,750 | — | * | | All current executive officers and directors as a group (7 persons) | 43,452 | 204,410 | 27,600 | 1.6% | - Beneficial ownership is determined by SEC rules and includes voting or investment power, as well as shares acquirable within 60 days via options or warrants[598] - Percentage of ownership is based on 17,179,331 shares of common stock outstanding as of March 07, 2019[598] Item 13. Certain Relationships, Related Person Transactions and Director Independence. There are no certain relationships, related person transactions, or director independence matters to report under this item - None[603] Item 14. Principal Accountant Fees and Services. This section details audit fees of approximately $318,000 for 2018 and tax fees of $40,000, all pre-approved by the Audit Committee Principal Accountant Fees and Services | Fee Type | Year Ended December 31, 2018 ($) | Transition Period Ended December 31, 2017 ($) | Fiscal Year Ended June 30, 2017 ($) | | :--- | :--- | :--- | :--- | | Audit Fees | 318,000 | 105,000 | 298,800 | | Tax and Other Fees | 40,000 | 31,000 | 21,400 | - The Audit Committee is responsible for pre-approving all audit and permissible non-audit services provided by the principal accountants, and all services provided have been pre-approved[605] PART IV ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES This section lists the financial statements, schedules, and exhibits filed as part of the 10-K report, including corporate governance documents and various agreements - Refers to the Index to Consolidated Financial Statements on page 55 of the report[607] - Financial statement schedules are omitted due to absence of conditions or inclusion of information in consolidated financial statements/notes[608] - A comprehensive list of exhibits is provided, including corporate governance documents, agreements, and certifications[609][610][611][612] ITEM 16. FORM 10-K SUMMARY This item indicates that no Form 10-K Summary is provided - None[614] SIGNATURES Signatures This section contains the required signatures for the Annual Report on Form 10-K from the CEO, CFO, and Board of Directors, all dated March 13, 2019 - The Annual Report on Form 10-K is signed by the Chief Executive Officer (Robert Foster), Chief Financial Officer (John Cavan), and members of the Board of Directors (Gary S. Jacob, John Brancaccio, Arnold Lippa, Timothy Block, Thomas Adams)[617][619] - All signatures are dated March 13, 2019[617][619]