Part I [Business](index=5&type=section&id=Item%201.%20Business) Enochian BioSciences is a pre-clinical biotechnology company developing genetically modified cellular and immune-therapies for HIV and cancer, funded by security sales and subject to intense regulation - The company is a **pre-clinical biotechnology firm** developing genetically modified cellular and immune-therapies for **HIV and cancer**[17](index=17&type=chunk) - Operations are currently **funded by sales of securities**, not revenue, and profitability is not expected until products are approved and successfully marketed[35](index=35&type=chunk)[106](index=106&type=chunk) - As of June 30, 2019, the company had **8 full-time employees**[85](index=85&type=chunk) [Product Candidates](index=6&type=section&id=Item%201.%20Business%23Product%20Candidates) The company's pipeline focuses on gene therapies for HIV/AIDS and cancer, including cell therapies and dendritic cell-based vaccines Key Development Programs (as of September 2019) | Product Candidate | Indication | Development Stage | Description | | :--- | :--- | :--- | :--- | | **ENOB-HV-01** | HIV | Pre-clinical | Autologous cell therapy using patient's own CD34+ cells to silence the CCR5 gene, making cells resistant to HIV | | **ENOB-HV-11 / HV-12** | HIV | Pre-clinical | Preventative and therapeutic vaccine programs | | **ENOB-DB-01 / DC-01** | Colon Cancer | Discovery/Research | Dendritic cell cancer vaccine to prevent relapse after resection and chemotherapy | | **ENOB-DC-11** | Multiple Solid Tumors | Pre-clinical | Off-the-shelf, universal dendritic cell delivery system for tailored cancer treatments | | **ENOB-DC-21** | Cancer | Discovery/Research | Non-specific vaccine for intratumoral injection | [Intellectual Property](index=7&type=section&id=Item%201.%20Business%23Intellectual%20Property) Intellectual property strategy combines owned patents, in-licensed technology, and trade secrets, including a key exclusive license for HIV-related IP - The company holds a patent for a **melanoma cell lysate-pulsed dendritic cell vaccine**, granted in multiple jurisdictions including the US and Europe, with expiration beginning in **November 2022**[39](index=39&type=chunk) - A patent for a method of generating dendritic cells at reduced temperatures is owned by the company, with an expiry date of **December 2026**[40](index=40&type=chunk) - On February 16, 2018, the company entered into an **exclusive, perpetual, royalty-free worldwide license agreement** with Weird Science, LLC for its intellectual property related to the prevention and treatment of **HIV** in humans[42](index=42&type=chunk) [Competition](index=8&type=section&id=Item%201.%20Business%23Competition) The company faces intense competition from large pharmaceutical and biotech firms, new entrants, and academic institutions in gene and cell therapy - The company faces potential competition from **larger, better-funded pharmaceutical and biotechnology companies**, new market entrants, and new technologies[43](index=43&type=chunk) - Key competitors in gene therapy include **Sangamo**, **uniQure N.V.**, **bluebird bio, Inc.**, and **Pfizer**; cell therapy competitors include **Novartis AG**, **Kite Pharma**, and **Juno Therapeutics**[46](index=46&type=chunk)[47](index=47&type=chunk) - For its lead HIV candidate ENOB-HV-01, the company identifies **Sangamo** and **American Gene Technology** as direct competitors[49](index=49&type=chunk) [Government Regulation](index=9&type=section&id=Item%201.%20Business%23Government%20Regulation) Products are subject to extensive FDA regulation, requiring rigorous preclinical and multi-phase clinical trials for safety and efficacy, alongside compliance with healthcare laws - Products require **extensive preclinical and clinical trials** to demonstrate safety and efficacy before seeking **FDA approval** via a Biologics License Application (BLA) or New Drug Application (NDA)[57](index=57&type=chunk)[64](index=64&type=chunk) - The company may be eligible for **Orphan Drug Designation** for products treating rare diseases, which could provide **seven years of market exclusivity** if approved[68](index=68&type=chunk) - The company is subject to healthcare laws including the **federal Anti-Kickback Statute, False Claims Act, and HIPAA**, with violations carrying significant penalties[70](index=70&type=chunk)[71](index=71&type=chunk)[72](index=72&type=chunk) [Risk Factors](index=13&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, the registrant is not required to provide detailed risk factor information [Unresolved Staff Comments](index=13&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved SEC staff comments [Properties](index=14&type=section&id=Item%202.%20Properties) The company leases two office spaces in Los Angeles, CA, including its 3,554 sq ft corporate headquarters under a ten-year lease Leased Properties | Location | Size (sq. ft.) | Lease Term | | :--- | :--- | :--- | | 5901 W. Olympic Blvd, Los Angeles, CA | 2,325 | 5 years, 2 months (from Nov 2017) | | 2080 Century Park East, Los Angeles, CA | 3,554 | 10 years (expanded Feb 2019) | [Legal Proceedings](index=14&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to materially impact its business or financial condition [Mine Safety Disclosures](index=14&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=15&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Common stock trades on Nasdaq under 'ENOB', with 46.3 million shares outstanding as of September 2019, and no cash dividends paid or planned - Common Stock trades on the **Nasdaq Capital Market** under the symbol "**ENOB**"[99](index=99&type=chunk) - As of September 27, 2019, there were **46,273,924 shares** of common stock outstanding[5](index=5&type=chunk)[100](index=100&type=chunk) - The company has **not paid and does not plan to pay any cash dividends**[101](index=101&type=chunk) [Selected Financial Data](index=15&type=section&id=Item%206.%20Selected%20Financial%20Data) As a smaller reporting company, the registrant is not required to provide selected financial data [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported an $18.0 million net loss in FY2019, driven by increased operating expenses and a non-cash contingent consideration charge, with liquidity maintained through security sales [Results of Operations (FY 2019 vs. FY 2018)](index=17&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations%23Results%20of%20Operations) Net loss increased by 185.4% to $18.0 million in FY2019 due to higher G&A, R&D, and a non-cash contingent consideration charge Consolidated Statement of Operations Summary | Metric | FY 2019 | FY 2018 (As Revised) | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $0 | $0 | N/A | | Total Operating Expense | $10,990,032 | $5,329,329 | +106.2% | | General and administrative expenses | $8,271,540 | $3,899,718 | +112.1% | | Research and development expenses | $2,498,107 | $616,961 | +304.9% | | Loss from Operations | $(10,990,032) | $(5,329,329) | +106.2% | | Change in fair value of contingent consideration | $(7,073,579) | $(1,375,000) | +414.4% | | **Net Loss** | **$(18,016,480)** | **$(6,311,835)** | **+185.4%** | | **Basic and Diluted Loss Per Share** | **$(0.48)** | **$(0.29)** | **+65.5%** | - The increase in G&A expenses was primarily due to higher **non-cash compensation, salaries, and security expenses**[116](index=116&type=chunk) - The increase in R&D expenses was mainly attributable to **$1.5 million** in R&D consulting fees and costs for **pre-clinical studies** for ENOB-HV01 and ENOB-HV11/12[117](index=117&type=chunk) [Liquidity and Capital Resources](index=19&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations%23Liquidity%20and%20Capital%20Resources) Liquidity is maintained through equity and warrant sales, with cash at $12.3 million and working capital at $11.4 million as of June 30, 2019 Cash and Working Capital Comparison | Metric | June 30, 2019 | June 30, 2018 | Change (%) | | :--- | :--- | :--- | :--- | | Cash | $12,282,224 | $15,600,865 | -21.3% | | Working Capital | $11,384,571 | $14,888,293 | -23.5% | - In FY2019, the company received total proceeds of **$6,020,000** from the exercise of warrants[125](index=125&type=chunk)[133](index=133&type=chunk) - In FY2018, the company raised **$13.4 million** from a private placement and **$3.3 million** from warrant exercises[124](index=124&type=chunk)[125](index=125&type=chunk) [Cash Flows](index=20&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations%23Cash%20Flows) Net cash used in operating activities increased to $8.5 million in FY2019, while financing activities provided $6.0 million from warrant exercises Summary of Cash Flows | Cash Flow Activity | FY 2019 | FY 2018 (As Revised) | | :--- | :--- | :--- | | Net Cash Used by Operating Activities | $(8,507,341) | $(4,338,269) | | Net Cash Used by Investing Activities | $(716,669) | $(575,732) | | Net Cash Provided by Financing Activities | $6,020,000 | $16,712,715 | [Quantitative and Qualitative Disclosures About Market Risk](index=22&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the registrant is not required to provide market risk disclosures [Financial Statements and Supplementary Data](index=23&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Audited consolidated financial statements show decreased cash, reduced liabilities due to contingent consideration, and an increased net loss, with 2018 financials revised for asset classification Consolidated Balance Sheet Highlights (at June 30) | Metric | 2019 | 2018 (As Revised) | | :--- | :--- | :--- | | Cash | $12,282,224 | $15,600,865 | | Total Assets | $179,877,353 | $182,502,456 | | Contingent Consideration Liability | $5,667,000 | $22,891,000 | | Total Liabilities | $6,777,416 | $23,764,722 | | Total Stockholders' Equity | $173,099,937 | $158,737,734 | - The financial statements for the year ended June 30, 2018 were **revised** to correct an error in classifying IPR&D assets as **indefinite-lived** rather than finite-lived, which **reduced the reported 2018 net loss from $9.2 million to $6.3 million**[208](index=208&type=chunk)[209](index=209&type=chunk)[211](index=211&type=chunk) - Subsequent to year-end, on July 3, 2019, the company issued **500,000 shares** of common stock from the exercise of options for **$1.0 million** in proceeds and issued another **500,000 shares** related to the **Acquisition Agreement**[282](index=282&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=52&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) This item is not applicable [Controls and Procedures](index=52&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were ineffective as of June 30, 2019, due to inadequate resources and insufficient segregation of duties - The Certifying Officers concluded that disclosure controls and procedures were **not effective** as of June 30, 2019[287](index=287&type=chunk) - Management concluded that internal controls over financial reporting were **not effective** as of June 30, 2019[288](index=288&type=chunk) - The control deficiencies are attributed to **inadequate resources** for complex accounting and an **inadequate number of persons to segregate accounting tasks**[288](index=288&type=chunk) [Other Information](index=53&type=section&id=Item%209B.%20Other%20Information) This item is not applicable Part III [Directors, Executive Officers, Corporate Governance, Executive Compensation, Security Ownership, and Principal Accountant Fees](index=54&type=section&id=Items%2010%2C%2011%2C%2012%2C%2013%2C%20and%2014) Information for Items 10-14, covering governance, compensation, and ownership, is incorporated by reference from the 2019 Proxy Statement - Information for Part III (Items 10-14) is **incorporated by reference** from the company's 2019 Proxy Statement[294](index=294&type=chunk)[295](index=295&type=chunk)[296](index=296&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=55&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists exhibits filed with the Form 10-K, including key corporate documents, agreements, and officer certifications

Financial Performance - As of March 31, 2019, the company had $10,272,198 in cash, a decrease of 34.16% from $15,600,865 as of June 30, 2018[126] - Working capital decreased by 39.6% to $8,987,394 as of March 31, 2019, compared to $14,888,293 as of June 30, 2018[126] - For the nine months ended March 31, 2019, net cash used in operating activities was $6,821,134, compared to $(2,726,744) for the same period in 2018[127] - The company’s cash flow from financing activities was $1,700,000 for the nine months ended March 31, 2019, down from $16,712,715 in the same period in 2018[127] - Revenues from operations for the nine months ended March 31, 2019, and March 31, 2018, were $0[130] - Net loss for the three months ended March 31, 2019, was $4,705,846, or $0.13 per share, compared to a net loss of $2,960,165, or $0.12 per share, for the same period in 2018[143] - Cash used in operating activities for the nine months ended March 31, 2019, was $6,281,134, compared to $2,726,744 for the same period in 2018[145] - Other income (expense) for the nine months ended March 31, 2019, was ($10,307,336), a significant increase of ($11,791,117) compared to $871,781 for the same period in 2018[142] - The increase in net loss for the nine months ended March 31, 2019, was primarily due to increased general and administrative expenses and depreciation related to the Acquisition of Enochian Biopharma[144] Expenses - Total operating expenses for the three months ended March 31, 2019, were $4,661,641, an increase of approximately 43.94% compared to $3,238,558 for the same period in 2018[133] - General and administrative expenses for the nine months ended March 31, 2019, were $6,750,939, an increase of approximately 58.1% compared to $3,049,393 for the same period in 2018[136] - Research and development expenses for the three months ended March 31, 2019, were $730,255, representing an increase of approximately 429.5% compared to $137,916 for the same period in 2018[137] - Depreciation and amortization expenses for the nine months ended March 31, 2019, were $5,834,817, representing an increase of 658.61% compared to $769,150 for the same period in 2018[140] Assets and Capital - Total assets at March 31, 2019, were $169,305,692, a decrease from $179,662,426 as of June 30, 2018[149] Future Plans and Funding - The company plans to develop ENOB-HV-11 and ENOB-HV-12 for preventative and therapeutic vaccines, respectively[107] - The company expects to need additional funds for equipment purchases, research and development, and potential strategic acquisitions[125] - The company has historically funded operations through shareholder funding and the issuance of convertible notes[124] - The company aims to open an Investigational New Drug Application for ENOB-HV-01 as part of its research and development efforts[125] Research and Development Focus - The company is focused on using genetically modified cellular and immune-therapy technologies to potentially cure HIV and provide cancer remission[102] - The company’s innovative therapeutic vaccination platform targets deadly solid tumors, including pancreatic cancer and glioblastoma[108]

U.S. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FORM 10-Q For the quarterly period ended December 31, 2018 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 number 000-54478 Enochian Biosciences, Inc. (Exact name of registrant as specified in its charter) | Delaware | 45-2259340 | | --- | --- | ...