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Anixa Biosciences(ANIX) - 2019 Q2 - Quarterly Report
2019-06-11 21:51
PART I. FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements.) This section presents the unaudited condensed consolidated financial statements for the quarterly period ended April 30, 2019, including balance sheets, statements of operations, shareholders' equity, cash flows, and notes, showing increased assets and a widening net loss [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of April 30, 2019, total assets increased to **$7.77 million** from **$6.45 million** at October 31, 2018, driven by higher cash, investments, and receivables, while total liabilities rose to **$1.60 million** and total equity increased to **$6.17 million** Condensed Consolidated Balance Sheet Highlights (Unaudited) | Metric | April 30, 2019 | October 31, 2018 | | :--- | :--- | :--- | | **Total Current Assets** | $7,493,532 | $5,538,372 | | **Total Assets** | $7,765,426 | $6,448,542 | | **Total Current Liabilities** | $1,595,761 | $1,265,111 | | **Total Shareholders' Equity** | $6,543,052 | $5,434,808 | | **Total Liabilities and Equity** | $7,765,426 | $6,448,542 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net loss attributable to common shareholders of **$7.42 million** for the six months ended April 30, 2019, significantly higher than the **$3.22 million** loss in the prior-year period, primarily due to increased operating costs and a patent impairment charge Six Months Ended April 30, (Unaudited) | Metric | 2019 | 2018 | | :--- | :--- | :--- | | Revenue | $250,000 | $750,000 | | Total Operating Costs and Expenses | $7,826,962 | $4,025,540 | | Loss from Operations | ($7,576,962) | ($3,275,540) | | Net Loss Attributable to Common Shareholders | ($7,419,533) | ($3,216,606) | | Net Loss Per Share (Basic and Diluted) | ($0.38) | ($0.19) | Three Months Ended April 30, (Unaudited) | Metric | 2019 | 2018 | | :--- | :--- | :--- | | Revenue | $250,000 | $750,000 | | Total Operating Costs and Expenses | $2,843,234 | $2,150,954 | | Loss from Operations | ($2,593,234) | ($1,400,954) | | Net Loss Attributable to Common Shareholders | ($2,537,692) | ($1,378,534) | | Net Loss Per Share (Basic and Diluted) | ($0.13) | ($0.08) | [Condensed Consolidated Statement of Shareholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statement%20of%20Shareholders'%20Equity) For the six months ended April 30, 2019, total shareholders' equity increased to **$6.54 million** from **$5.43 million**, driven by **$4.36 million** in net proceeds from an at-the-market stock offering and over **$4.0 million** in non-cash stock-based compensation, partially offset by a net loss of **$7.42 million** - Key changes in shareholders' equity for the six months ended April 30, 2019 include a net loss of **$7.42 million**, stock compensation of over **$4.0 million**, and proceeds from an at-the-market offering of **$4.36 million**[8](index=8&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended April 30, 2019, net cash used in operating activities was **$2.76 million**, investing activities used **$0.93 million**, and financing activities provided **$4.46 million**, resulting in a net increase in cash and cash equivalents of **$0.77 million**, ending the period at **$3.82 million** Cash Flow Summary for the Six Months Ended April 30, (Unaudited) | Cash Flow Activity | 2019 | 2018 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($2,764,290) | ($2,082,481) | | Net Cash (Used in) Provided by Investing Activities | ($925,457) | $2,238,187 | | Net Cash Provided by Financing Activities | $4,456,163 | $677,370 | | **Net Increase in Cash and Cash Equivalents** | **$766,416** | **$833,076** | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The notes detail the company's primary operations in cancer therapeutics (CER-T technology) and diagnostics (Cchek™ platform), covering funding, accounting policies, stock-based compensation, segment information, and a pending shareholder derivative lawsuit - The company's primary focus is on developing its CER-T technology for ovarian cancer and its AI-driven Cchek™ liquid biopsy platform for early cancer detection[12](index=12&type=chunk) - Management believes existing cash and expected cash flows are sufficient to fund activities for the next twelve months, supported by an at-the-market equity offering that raised approximately **$4.36 million** in the period[14](index=14&type=chunk) Net Loss by Segment (Six Months Ended April 30) | Segment | 2019 | 2018 | | :--- | :--- | :--- | | Cancer Diagnostics | ($3,052,355) | ($1,362,451) | | Cancer Therapeutics | ($3,517,219) | ($1,551,067) | | Patent licensing | ($971,969) | ($344,470) | | **Total** | **($7,541,543)** | **($3,257,988)** | [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses financial results, highlighting decreased revenue from legacy patent licensing and a significant increase in operating expenses due to intensified R&D and higher non-cash stock-based compensation, while confirming sufficient liquidity for the next 12 months [Results of Operations](index=27&type=section&id=RESULTS%20OF%20OPERATIONS) For the six months ended April 30, 2019, revenue decreased to **$0.25 million** from **$0.75 million** in the prior year, while research and development expenses surged by **$2.08 million** to **$3.52 million**, and general and administrative expenses rose by **$1.45 million** to **$3.35 million**, both primarily due to increased stock compensation, alongside a **$0.42 million** patent asset impairment charge - Revenue for the six months ended April 30, 2019, was **$0.25 million** from a single license agreement, down from **$0.75 million** in the same period of 2018[63](index=63&type=chunk) - Research and development expenses increased by approximately **$2.08 million** for the six-month period, mainly due to a **$1.25 million** increase in stock award compensation and a **$0.82 million** increase in stock option compensation[67](index=67&type=chunk) - General and administrative expenses increased by approximately **$1.45 million** for the six-month period, principally due to a **$0.75 million** increase in stock option compensation and a **$0.70 million** increase in stock award compensation[68](index=68&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) The company's liquidity position is considered sufficient for the next twelve months, with cash, cash equivalents, and short-term investments totaling approximately **$6.57 million** as of April 30, 2019, bolstered by **$4.36 million** raised through an at-the-market equity offering - The company believes its existing cash, cash equivalents, and short-term investments are sufficient to fund activities for the next twelve months[79](index=79&type=chunk) - During the six months ended April 30, 2019, the company raised approximately **$4.36 million** through its at-the-market equity offering of 1,061,032 shares of common stock[79](index=79&type=chunk) - Cash, cash equivalents, and short-term investments increased by approximately **$1.52 million** to **$6.57 million** at April 30, 2019, from **$5.06 million** at the end of fiscal year 2018[79](index=79&type=chunk) [Critical Accounting Policies](index=32&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES) The company identifies Revenue Recognition and Stock-Based Compensation as its most critical accounting policies, requiring significant judgment in recognizing one-time license fees upon agreement execution and valuing stock-based compensation using fair value models with subjective assumptions - Revenue from one-time, paid-up license fees is recognized upon the execution of the agreement, as the company has no further performance obligations[82](index=82&type=chunk) - Stock-based compensation cost is measured at the grant date using fair value models like Black-Scholes or Monte Carlo Simulation, which require significant assumptions regarding expected term, volatility, and risk-free rates[84](index=84&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) The company's exposure to market risk is limited, primarily related to interest rate changes affecting returns on its short-term, fixed-rate investments upon reinvestment - The company's market risk is primarily related to interest rate changes affecting returns on its short-term, fixed-rate investments at the time of reinvestment[88](index=88&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures.) Based on management's evaluation, including the CEO and CFO, the company's disclosure controls and procedures were effective as of April 30, 2019, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures are effective as of April 30, 2019[89](index=89&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings.) The company is named as a nominal defendant in a putative shareholder derivative complaint filed in November 2018, alleging breach of fiduciary duty by certain current and former officers and directors, with defense costs funded by the company, and potential losses currently inestimable - A shareholder derivative complaint was filed against certain officers and directors, with the company named as a nominal defendant, and the company is indemnifying the individuals and cannot estimate potential losses at this time[90](index=90&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors.) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended October 31, 2018 - No material changes in risk factors were reported since the last Annual Report on Form 10-K[91](index=91&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) None - The company reported no unregistered sales of equity securities during the period[91](index=91&type=chunk) [Exhibits](index=35&type=section&id=Item%206.%20Exhibits.) This section lists the exhibits filed with the Form 10-Q, including certifications by the Chief Executive Officer and Chief Financial Officer as required by the Sarbanes-Oxley Act of 2002 - The report includes required CEO and CFO certifications pursuant to Section 302 and Section 1350 of the Sarbanes-Oxley Act[91](index=91&type=chunk)
Anixa Biosciences(ANIX) - 2019 Q1 - Quarterly Report
2019-03-13 20:29
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 January 31, 2019 Commission file number 0-11254 ANIXA BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) Delaware 11-2622630 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 3150 Almaden Expressway, Suite 250 San Jose, CA 95118 (Address o ...
Anixa Biosciences, Inc. (ANIX) CEO Amit Kumar on Outlook for 2019 Transcript
2019-01-25 03:11
Summary of Anixa Biosciences, Inc. Conference Call Company Overview - **Company**: Anixa Biosciences, Inc. (NASDAQ: ANIX) - **Industry**: Biotechnology, specifically focusing on cancer detection and treatment technologies Key Points and Arguments Major Goals for 2019 - **Launch of Cchek Cancer Detection Tests**: Aiming to launch the first of their Cchek cancer detection tests in Q3 2019, which is a liquid biopsy technology designed to detect cancer early through noninvasive blood samples [6][7] - **Human Clinical Testing of CAR-T Therapy**: Plans to begin human clinical testing of CAR-T therapy for ovarian cancer patients, which is expected to be a significant milestone for the company [6][7] Cchek Technology - **Technology Description**: Cchek utilizes artificial intelligence and machine learning to analyze white blood cells for patterns indicative of tumors, potentially identifying up to 20 different tumor types [11] - **Focus on Prostate and Breast Cancer**: Initial commercial focus on prostate cancer, followed by breast cancer, with data showing better detection rates than current methods like PSA tests and mammography [12] - **FDA Interaction**: Productive meeting with the FDA regarding the Cchek prostate test, with expectations to launch the confirmatory test for prostate cancer [13][14] Market Opportunity - **Prostate Biopsy Statistics**: Approximately 1.5 million prostate biopsies are performed annually in the U.S., with 1.3 million yielding negative results. Cchek aims to reduce unnecessary biopsies, potentially saving the healthcare system over $1 billion annually [15][16] - **Launch Strategy**: Cchek will be launched as a laboratory developed test under CLIA guidelines while continuing discussions with the FDA [17][18] CAR-T Therapy Development - **Technology Overview**: CAR-T therapy is a form of immunotherapy that uses genetically engineered T-cells to target cancers, particularly liquid tumors. Anixa aims to adapt this technology for solid tumors, starting with ovarian cancer [20][21] - **Animal Studies**: Previous animal studies have shown efficacy against ovarian cancer, with plans to file an IND application by the end of Q2 2019 and begin human trials in July 2019 [23][24] - **Potential Impact**: If successful, this therapy could significantly improve outcomes for ovarian cancer patients and potentially other solid tumors, representing a major scientific achievement [25] Financial Efficiency - **Cost Management**: Anixa has managed to advance its technologies with a capital expenditure of approximately $7 million over the past year and a half, significantly lower than typical costs in the biotech industry [10] Future Outlook - **Investor Engagement**: The company aims to increase visibility to institutional biotech investors and create shareholder value through the successful launch of Cchek and the initiation of CAR-T clinical trials [26] Additional Important Information - **Regulatory Pathways**: Discussions with the FDA regarding the regulatory pathway for Cchek are ongoing, with potential options including 510(k) or PMA [38][71] - **Market Size**: The estimated market size for the Cchek test in the U.S. is around 1.5 million patients annually, with a flexible pricing strategy to ensure accessibility [62] This summary encapsulates the key points discussed during the Anixa Biosciences conference call, highlighting the company's strategic goals, technological advancements, market opportunities, and regulatory considerations.
Anixa Biosciences(ANIX) - 2018 Q4 - Annual Report
2019-01-11 21:31
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