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KalVista Pharmaceuticals(KALV) - 2022 Q4 - Annual Report
2022-07-07 20:19
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended April 30, 2022 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 001-36830 KalVista Pharmaceuticals, Inc. (Exact name of Registrant as specified in its Charter) Delaware 20-0915291 (State or other jurisdic ...
KalVista Pharmaceuticals (KALV) Investor Presentation - Slideshow
2022-06-15 15:59
K KalVista Pharmaceuticals Corporate Overview June 2022 Forward-Looking Statements This presentation and the accompanying oral presentation contain "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future, "likely," "may," "should," "will" and similar re ...
KalVista Pharmaceuticals (KALV) Investor Presentation - Slideshow
2022-03-14 17:50
K KalVista Pharmaceuticals Corporate Overview March 2022 Forward-Looking Statements This presentation and the accompanying oral presentation contain "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future, "likely," "may," "should," "will" and similar r ...
KalVista Pharmaceuticals(KALV) - 2022 Q3 - Quarterly Report
2022-03-10 21:10
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Presents KalVista's unaudited condensed consolidated financial statements, highlighting increased net loss and cash used in operations due to R&D [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Metric | Jan 31, 2022 (in thousands) | Apr 30, 2021 (in thousands) | Change | |:---|:---|:---|:---| | Total Assets | $225,052 | $272,013 | $(46,961) | | Cash and cash equivalents | $45,577 | $50,592 | $(5,015) | | Marketable securities | $149,212 | $198,337 | $(49,125) | | Total Liabilities | $17,116 | $14,820 | $2,296 | | Total Stockholders' Equity | $207,936 | $257,193 | $(49,257) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) | Metric (in thousands) | 3 Months Ended Jan 31, 2022 | 3 Months Ended Jan 31, 2021 | Change (YoY) | 9 Months Ended Jan 31, 2022 | 9 Months Ended Jan 31, 2021 | Change (YoY) | |:---|:---|:---|:---|:---|:---|:---|\n| Revenue | $— | $— | $— | $— | $— | $— | | Research and development | $19,738 | $9,097 | $10,641 | $50,954 | $29,409 | $21,545 | | General and administrative | $6,945 | $3,560 | $3,385 | $18,848 | $10,472 | $8,376 | | Total operating expenses | $26,683 | $12,657 | $14,026 | $69,802 | $39,881 | $29,921 | | Operating loss | $(26,683) | $(12,657) | $(14,026) | $(69,802) | $(39,881) | $(29,921) | | Total other income | $4,216 | $2,609 | $1,607 | $11,576 | $8,593 | $2,983 | | Net loss | $(22,467) | $(10,048) | $(12,419) | $(58,226) | $(31,288) | $(26,938) | | Net loss per share (basic & diluted) | $(0.92) | $(0.56) | $(0.36) | $(2.38) | $(1.75) | $(0.63) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) | Metric (in thousands) | Balance at May 1, 2021 | Balance at Jan 31, 2022 | Change | |:---|:---|:---|:---|\n| Common Stock Amount | $24 | $24 | $0 | | Additional Paid-in Capital | $426,437 | $436,313 | $9,876 | | Accumulated Deficit | $(167,836) | $(226,062) | $(58,226) | | Accumulated Other Comprehensive Loss | $(1,432) | $(2,339) | $(907) | | Total Stockholders' Equity | $257,193 | $207,936 | $(49,257) | - Issuance of common stock from equity incentive plans contributed to additional paid-in capital[17](index=17&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Metric (in thousands) | 9 Months Ended Jan 31, 2022 | 9 Months Ended Jan 31, 2021 | Change | |:---|:---|:---|:---|\n| Net cash used in operating activities | $(51,345) | $(19,126) | $(32,219) | | Net cash provided by investing activities | $45,426 | $18,829 | $26,597 | | Net cash provided by financing activities | $1,443 | $1,809 | $(366) | | Net (decrease) increase in cash and cash equivalents | $(5,015) | $1,938 | $(6,953) | | Cash and cash equivalents at end of period | $45,577 | $17,727 | $27,850 | [Notes to the Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) [1. The Company](index=8&type=section&id=1.%20The%20Company) - KalVista is a clinical-stage pharmaceutical company developing small molecule protease inhibitors for Hereditary Angioedema (HAE) and Diabetic Macular Edema (DME)[23](index=23&type=chunk) - KVD900 is in Phase 3 KONFIDENT clinical trial as a potential oral, on-demand therapy for HAE attacks[24](index=24&type=chunk) - KVD824 is in Phase 2 KOMPLETE clinical trial as a potential oral prophylactic treatment for HAE[24](index=24&type=chunk) - The company has not generated product sales revenue and had an accumulated deficit of **$226.1 million** as of January 31, 2022[28](index=28&type=chunk) - The COVID-19 pandemic has caused and may cause future delays in clinical trials, potentially impacting financial performance and requiring earlier capital raises[26](index=26&type=chunk) - The company anticipates sufficient funding to operate for at least the next twelve months based on current operating plans and existing capital resources[29](index=29&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) - The company manages its operations as a single operating segment[33](index=33&type=chunk) - Basic and diluted net loss per share are identical because potential dilutive common share equivalents are anti-dilutive during periods of net loss[37](index=37&type=chunk) | Asset Type | Level 1 (Jan 31, 2022, in thousands) | Level 2 (Jan 31, 2022, in thousands) | Total (Jan 31, 2022, in thousands) | Level 1 (Apr 30, 2021, in thousands) | Level 2 (Apr 30, 2021, in thousands) | Total (Apr 30, 2021, in thousands) | |:---|:---|:---|:---|:---|:---|:---|\n| Cash equivalents | $12,094 | $— | $12,094 | $2,985 | $— | $2,985 | | Corporate debt securities | $— | $115,041 | $115,041 | $— | $157,873 | $157,873 | | U.S. government agency securities | $— | $34,171 | $34,171 | $— | $40,464 | $40,464 | | **Total** | **$12,094** | **$149,212** | **$161,306** | **$2,985** | **$198,337** | **$201,322** | [3. Marketable Securities](index=10&type=section&id=3.%20Marketable%20Securities) - All debt securities are classified as available-for-sale, with unrealized gains and losses recognized in accumulated comprehensive loss[41](index=41&type=chunk) | Type | Amortized Cost (Jan 31, 2022, in thousands) | Fair Value (Jan 31, 2022, in thousands) | Amortized Cost (Apr 30, 2021, in thousands) | Fair Value (Apr 30, 2021, in thousands) | |:---|:---|:---|:---|:---|\n| Corporate debt securities | $115,644 | $115,041 | $158,063 | $157,873 | | Obligations of the U.S. Government and its agencies | $34,245 | $34,171 | $40,473 | $40,464 | | **Total** | **$149,889** | **$149,212** | **$198,536** | **$198,337** | | Maturity | Amount (in thousands) | |:---|:---|\n| One year or less | $109,859 | | After one year through two years | $23,931 | | After two years through five years | $15,422 | | **Total** | **$149,212** | [4. Accrued Expenses](index=11&type=section&id=4.%20Accrued%20Expenses) | Category | Jan 31, 2022 (in thousands) | Apr 30, 2021 (in thousands) | |:---|:---|:---|\n| Compensation expense | $3,252 | $3,507 | | Research expense | $2,415 | $2,476 | | Professional fees | $596 | $557 | | Other expenses | $187 | $390 | | **Total** | **$6,450** | **$6,930** | [5. Commitments and Contingencies](index=11&type=section&id=5.%20Commitments%20and%20Contingencies) - Contractual obligations for preclinical studies and clinical trials total **$35.7 million** as of January 31, 2022, with cancellation provisions[46](index=46&type=chunk) - No contingent liabilities required accrual as of January 31, 2022[49](index=49&type=chunk) [6. Leases](index=12&type=section&id=6.%20Leases) - Total rent expense for the nine months ended January 31, 2022, was approximately **$1,289,000**, compared to **$606,000** for the same period in 2021[52](index=52&type=chunk) | Years ending April 30, | Operating Leases (in thousands) | |:---|:---|\n| 2022 | $435 | | 2023 | $1,631 | | 2024 | $1,511 | | 2025 | $1,547 | | 2026 | $1,585 | | Thereafter | $4,721 | | **Total minimum lease payments** | **$11,430** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=13&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses KalVista's financial condition, operational results, and clinical program progress, highlighting increased expenses and liquidity [Management Overview](index=13&type=section&id=Management%20Overview) - KalVista is developing oral plasma kallikrein inhibitors for HAE, with KVD900 for on-demand treatment and KVD824 for prophylactic treatment[56](index=56&type=chunk) - KVD900 is the most advanced potential oral therapy for acute HAE attacks, having met its primary endpoint in Phase 2 and now in Phase 3 KONFIDENT trial, with data anticipated in the second half of 2023[58](index=58&type=chunk)[59](index=59&type=chunk)[61](index=61&type=chunk)[64](index=64&type=chunk) - KVD824 is in the Phase 2 KOMPLETE clinical trial for prophylactic HAE treatment, with data anticipated in mid-2023[65](index=65&type=chunk)[66](index=66&type=chunk) - A novel oral Factor XIIa inhibitor program is in the research stage, with an IND filing anticipated in 2023, targeting HAE and other indications[67](index=67&type=chunk)[69](index=69&type=chunk) - **93%** of HAE patients surveyed expressed willingness to switch to oral therapy for both on-demand and prophylactic use, emphasizing the need for comparable efficacy and safety[57](index=57&type=chunk) - The COVID-19 pandemic continues to impact operations and clinical trials, potentially causing delays and affecting financial performance[71](index=71&type=chunk) [Financial Overview](index=15&type=section&id=Financial%20Overview) - No product sales revenue has been generated to date, and none is expected until regulatory approval and commercialization of product candidates[72](index=72&type=chunk) - Research and development expenses are expected to continue to increase as product candidates advance through clinical development, particularly for later-stage trials[75](index=75&type=chunk) - General and administrative expenses are anticipated to increase due to expanding operating activities, patent portfolio maintenance, and public company compliance costs[78](index=78&type=chunk) - Other income includes interest income and research and development tax credits from the UK government[79](index=79&type=chunk) [Results of Operations](index=17&type=section&id=Results%20of%20Operations) Key Components of Results of Operations (in thousands) - Three Months Ended January 31 | Metric | 2022 | 2021 | Increase (decrease) | |:---|:---|:---|:---|\n| Research and development expenses | $19,738 | $9,097 | $10,641 | | General and administrative expenses | $6,945 | $3,560 | $3,385 | | Interest, exchange rate gain and other income | $4,216 | $2,609 | $1,607 | Research and Development Expenses by Program (in thousands) - Three Months Ended January 31 | Program/Category | 2022 | 2021 | |:---|:---|:---|\n| KVD900 | $7,265 | $2,736 | | KVD824 | $3,798 | $1,925 | | Personnel | $5,250 | $2,764 | | Preclinical activities | $3,375 | $1,594 | Key Components of Results of Operations (in thousands) - Nine Months Ended January 31 | Metric | 2022 | 2021 | Increase (decrease) | |:---|:---|:---|:---|\n| Research and development expenses | $50,954 | $29,409 | $21,545 | | General and administrative expenses | $18,848 | $10,472 | $8,376 | | Interest, exchange rate gain and other income | $11,576 | $8,593 | $2,983 | Research and Development Expenses by Program (in thousands) - Nine Months Ended January 31 | Program/Category | 2022 | 2021 | |:---|:---|:---|\n| KVD900 | $16,556 | $9,944 | | KVD824 | $10,277 | $6,594 | | Personnel | $14,454 | $8,013 | | Preclinical activities | $9,544 | $4,636 | [Liquidity and Capital Resources](index=19&type=section&id=Liquidity%20and%20Capital%20Resources) - Working capital, primarily cash and marketable securities, is anticipated to fund operations for at least the next twelve months[98](index=98&type=chunk) Summary of Net Cash Flow Activity (in thousands) - Nine Months Ended January 31 | Metric | 2022 | 2021 | Change | |:---|:---|:---|:---|\n| Net cash used in operating activities | $(51,345) | $(19,126) | $(32,219) | | Net cash provided by investing activities | $45,426 | $18,829 | $26,597 | | Net cash provided by financing activities | $1,443 | $1,809 | $(366) | | Net (decrease) increase in cash and cash equivalents | $(5,015) | $1,938 | $(6,953) | - Future funding may involve equity or debt financings, collaborations, strategic partnerships, or licensing arrangements, which could dilute existing stockholders or require relinquishing valuable rights[105](index=105&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=20&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) - Financial statements require management estimates and assumptions, which are evaluated on an ongoing basis, and actual results may differ[108](index=108&type=chunk)[109](index=109&type=chunk) [Recently Issued Accounting Pronouncements](index=21&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) - No recently issued accounting pronouncements are applicable[110](index=110&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=21&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, KalVista Pharmaceuticals, Inc. is exempt from providing quantitative and qualitative market risk disclosures - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[111](index=111&type=chunk) [Item 4. Controls and Procedures](index=21&type=section&id=Item%204.%20Controls%20and%20Procedures) Details the evaluation of disclosure controls and procedures, confirming effectiveness and reporting no material changes in internal controls [Evaluation of Disclosure Controls and Procedures](index=21&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Disclosure controls and procedures were evaluated and deemed effective as of January 31, 2022[112](index=112&type=chunk) [Changes in Internal Controls over Financial Reporting](index=21&type=section&id=Changes%20in%20Internal%20Controls%20over%20Financial%20Reporting) - No material changes in internal control over financial reporting occurred during the quarter ended January 31, 2022[113](index=113&type=chunk) - The company is monitoring and assessing the COVID-19 pandemic's impact on internal controls[113](index=113&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=22&type=section&id=Item%201.%20Legal%20Proceedings) KalVista Pharmaceuticals, Inc. is not currently involved in any material legal proceedings or claims that would adversely affect its operations - No material legal proceedings or claims are currently known to the company[116](index=116&type=chunk) [Item 1A. Risk Factors](index=22&type=section&id=Item%201A.%20Risk%20Factors) Updated risk factors highlight potential adverse consequences from unstable global market conditions, including the COVID-19 pandemic and Ukraine conflict - Updated risk factors reflect adverse consequences from unstable global market and economic conditions, including the COVID-19 pandemic and the conflict in Ukraine[117](index=117&type=chunk) - Global disruptions could reduce access to capital, delay or abandon development plans, and affect clinical trial sites in Eastern European countries[117](index=117&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=22&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable to KalVista Pharmaceuticals, Inc. for the current reporting period - Not applicable[119](index=119&type=chunk) [Item 3. Defaults Upon Senior Securities](index=22&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to KalVista Pharmaceuticals, Inc. for the current reporting period - Not applicable[120](index=120&type=chunk) [Item 4. Mine Safety Disclosures](index=22&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to KalVista Pharmaceuticals, Inc. for the current reporting period - Not applicable[121](index=121&type=chunk) [Item 5. Other Information](index=23&type=section&id=Item%205.%20Other%20Information) This item is not applicable to KalVista Pharmaceuticals, Inc. for the current reporting period - Not applicable[122](index=122&type=chunk) [Item 6. Exhibits](index=23&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including executive certifications and Inline XBRL documents - Includes certifications from the Principal Executive Officer and Principal Financial Officer (Exhibits 31.1, 31.2, 32.1)[123](index=123&type=chunk) - Contains Inline XBRL documents for financial data (Exhibits 101.INS, 101.SCH, 101.CAL, 101.DEF, 101.LAB, 101.PRE, 104)[123](index=123&type=chunk) [Signatures](index=24&type=section&id=Signatures) The report is officially signed by KalVista Pharmaceuticals, Inc.'s Chief Executive Officer and Chief Financial Officer on March 10, 2022 - Report signed by T. Andrew Crockett (CEO) and Benjamin L. Palleiko (CFO) on March 10, 2022[128](index=128&type=chunk)
KalVista Pharmaceuticals(KALV) - 2022 Q2 - Quarterly Report
2021-12-09 21:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended October 31, 2021 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to . Commission File No. 001-36830 KALVISTA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpo ...
Kalvista Pharmaceuticals (KALV) Investor Presentation - Slideshow
2021-11-23 13:12
K KalVista Pharmaceuticals Corporate Presentation November 2021 Forward-Looking Statements This presentation and the accompanying oral presentation contain "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future, "likely," "may," "should," "will" and si ...
KalVista Pharmaceuticals(KALV) - 2022 Q1 - Quarterly Report
2021-09-09 20:16
PART I. FINANCIAL INFORMATION [Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) For the quarter ended July 31, 2021, the company reported no revenue, a net loss of $16.1 million, and a decrease in total assets to $259.1 million, driven by increased expenses and reduced cash holdings [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of July 31, 2021, total assets decreased to $259.1 million from $272.0 million, primarily due to reduced cash and marketable securities, with total stockholders' equity also decreasing to $244.4 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | July 31, 2021 | April 30, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $48,343 | $50,592 | | Marketable securities | $182,288 | $198,337 | | **Total Assets** | **$259,133** | **$272,013** | | Total current liabilities | $8,229 | $9,774 | | **Total Liabilities** | **$14,703** | **$14,820** | | **Total Stockholders' Equity** | **$244,430** | **$257,193** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended July 31, 2021, the company reported no revenue and a net loss of $16.1 million, an increase from $10.8 million in the prior year, driven by higher R&D and G&A expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended July 31, 2021 | Three Months Ended July 31, 2020 | | :--- | :--- | :--- | | Revenue | $— | $— | | Research and development | $13,669 | $11,165 | | General and administrative | $5,847 | $3,278 | | **Operating loss** | **($19,516)** | **($14,443)** | | **Net loss** | **($16,109)** | **($10,814)** | | Net loss per share, basic and diluted | ($0.66) | ($0.61) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Total stockholders' equity decreased to $244.4 million by July 31, 2021, primarily due to the **$16.1 million net loss**, partially offset by stock-based compensation and common stock issuances - The primary driver for the decrease in stockholders' equity during the three months ended July 31, 2021 was the **net loss of $16.1 million**[17](index=17&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the three months ended July 31, 2021, net cash used in operating activities was $17.7 million, leading to a net decrease of $2.2 million in cash and equivalents, ending the period with $48.3 million Summary of Cash Flows (in thousands) | Activity | Three Months Ended July 31, 2021 | Three Months Ended July 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($17,735) | ($3,588) | | Net cash provided by investing activities | $14,881 | $5,513 | | Net cash provided by financing activities | $608 | $46 | | **Net (decrease) increase in cash** | **($2,249)** | **$2,225** | | **Cash and cash equivalents at end of period** | **$48,343** | **$18,014** | [Notes to the Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's focus on developing small molecule protease inhibitors for HAE and DME, confirming sufficient funding for the next twelve months and outlining contractual commitments - The company is a clinical-stage pharmaceutical firm focused on small molecule protease inhibitors for hereditary angioedema (HAE) and diabetic macular edema (DME)[22](index=22&type=chunk) - The company anticipates it has **sufficient funding to operate for at least the next twelve months**, with **$230.6 million** in cash, cash equivalents, and marketable securities as of July 31, 2021[27](index=27&type=chunk) - The company has contractual obligations of **$29.1 million** at July 31, 2021, related to ongoing preclinical studies and clinical trials[45](index=45&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=12&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the clinical development of oral plasma kallikrein inhibitors for HAE and DME, highlighting KVD900's Phase 2 success and KVD824's ongoing trial despite a U.S. clinical hold, while confirming sufficient capital for the next twelve months [Management Overview](index=12&type=section&id=Management%20Overview) The company focuses on developing oral plasma kallikrein inhibitors for HAE, with KVD900 showing positive Phase 2 results and KVD824's Phase 2 trial progressing outside the U.S. despite an FDA clinical hold - KVD900, an on-demand HAE therapy, **met all primary and secondary endpoints** in its Phase 2 trial, and the company is preparing for a **Phase 3 trial** pending FDA feedback[57](index=57&type=chunk)[60](index=60&type=chunk) - KVD824, a prophylactic HAE therapy, is under an **FDA clinical hold in the U.S.**; however, the **Phase 2 KOMPLETE trial has commenced enrollment** in Canada, Australia, New Zealand, and the UK[62](index=62&type=chunk)[63](index=63&type=chunk) - A **new oral Factor XIIa inhibitor program** is in lead optimization, with plans to **initiate IND-enabling studies in 2021**[68](index=68&type=chunk)[69](index=69&type=chunk) [Results of Operations](index=16&type=section&id=Results%20of%20Operations) For the three months ended July 31, 2021, R&D expenses increased by $2.5 million to $13.7 million, and G&A expenses rose by $2.6 million to $5.8 million, primarily due to preclinical activities and higher compensation Research and Development Expenses by Program (in thousands) | Program | Three Months Ended July 31, 2021 | Three Months Ended July 31, 2020 | | :--- | :--- | :--- | | KVD001 | $32 | $86 | | KVD900 | $4,097 | $4,451 | | KVD824 | $2,380 | $2,288 | | Preclinical activities | $7,160 | $4,340 | | **Total** | **$13,669** | **$11,165** | - **R&D expenses increased by $2.5 million**, mainly due to a **$2.8 million rise in spending on preclinical activities**[84](index=84&type=chunk) - **General and administrative expenses increased by $2.6 million**, primarily from a **$1.4 million increase in compensation expense** due to higher headcount and stock-based compensation[89](index=89&type=chunk) [Liquidity and Capital Resources](index=17&type=section&id=Liquidity%20and%20Capital%20Resources) The company funds operations primarily through equity issuances, confirming sufficient working capital for the next twelve months, despite using $17.7 million in operating cash for the quarter and no sales under its $100.0 million equity offering agreement - The company anticipates its working capital, primarily cash and marketable securities, will **fund operations for at least the next twelve months**[91](index=91&type=chunk) - **Net cash used in operating activities was $17.7 million** for the three months ended July 31, 2021, compared to $3.6 million in the prior-year period[93](index=93&type=chunk) - In May 2021, the company entered into a sales agreement to offer and sell **up to $100.0 million of its common stock**; however, **No shares were sold** during the three months ended July 31, 2021[96](index=96&type=chunk)[97](index=97&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=19&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, KalVista is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, KalVista is **not required to provide quantitative and qualitative disclosures about market risk**[104](index=104&type=chunk) [Controls and Procedures](index=19&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of July 31, 2021, with no material changes in internal control over financial reporting during the quarter - Based on an evaluation as of July 31, 2021, the Chief Executive Officer and Chief Financial Officer concluded that the company's **disclosure controls and procedures were effective**[105](index=105&type=chunk) - **No changes in internal control over financial reporting occurred** during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[106](index=106&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=20&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently aware of any legal proceedings expected to have a material adverse effect on its business, financial condition, or operating results - The company is **not currently aware of any legal proceedings that would have a material adverse effect** on its business[109](index=109&type=chunk) [Risk Factors](index=20&type=section&id=Item%201A.%20Risk%20Factors) No material changes have been made to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended April 30, 2021 - **No material changes have been made to the risk factors** described in the Annual Report on Form 10-K for the fiscal year ended April 30, 2021[110](index=110&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=20&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section is not applicable to the current report - This item is not applicable[112](index=112&type=chunk) [Exhibits](index=21&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer and Inline XBRL documents - The report includes **certifications from the CEO and CFO** pursuant to Sarbanes-Oxley Act Sections 302 and 906, along with **XBRL data files**[117](index=117&type=chunk)
KalVista Pharmaceuticals(KALV) - 2021 Q4 - Annual Report
2021-07-13 20:09
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended April 30, 2021 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 001-36830 KalVista Pharmaceuticals, Inc. (Exact name of Registrant as specified in its Charter) Delaware 20-0915291 (State or other jurisdic ...
KalVista Pharmaceuticals(KALV) - 2021 Q3 - Quarterly Report
2021-03-11 21:08
UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended January 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. For the transition period from to . Commission File No. 001-36830 KALVISTA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) WASHINGTON, DC 20549 (State or other jurisdiction of inc ...
KalVista Pharmaceuticals(KALV) - 2021 Q2 - Quarterly Report
2020-12-10 21:05
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Presents the company's unaudited condensed consolidated financial statements for the periods ended October 31, 2020 and 2019 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | October 31, 2020 | April 30, 2020 | | :--- | :--- | :--- | | Total Current Assets | $72,076 | $88,696 | | Total Assets | $75,448 | $92,529 | | Total Current Liabilities | $9,536 | $7,720 | | Total Long-Term Liabilities | $932 | $1,057 | | Total Stockholders' Equity | $64,980 | $83,752 | | Total Liabilities and Stockholders' Equity | $75,448 | $92,529 | - Total assets decreased from **$92.5 million** at April 30, 2020, to **$75.4 million** at October 31, 2020[9](index=9&type=chunk) - Stockholders' equity decreased from **$83.8 million** to **$65.0 million** over the same period[9](index=9&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended Oct 31, 2020 | Three Months Ended Oct 31, 2019 | Six Months Ended Oct 31, 2020 | Six Months Ended Oct 31, 2019 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $— | $3,920 | $— | $7,289 | | Research and Development Expenses | $9,148 | $9,789 | $20,313 | $19,476 | | General and Administrative Expenses | $3,633 | $3,420 | $6,912 | $6,665 | | Operating Loss | $(12,781) | $(9,289) | $(27,225) | $(18,852) | | Total Other Income | $2,355 | $3,386 | $5,984 | $5,611 | | Net Loss | $(10,426) | $(5,903) | $(21,241) | $(13,241) | | Net Loss per Share, Basic and Diluted | $(0.58) | $(0.33) | $(1.19) | $(0.75) | - Revenue for both the three and six months ended October 31, 2020, was **$0**, a significant decrease from **$3.9 million** and **$7.3 million** in the prior year periods, respectively, due to the expiration of the Merck Option Agreement[11](index=11&type=chunk) - Net loss increased to **$10.4 million** for the three months ended October 31, 2020, from **$5.9 million** in the prior year, and to **$21.2 million** for the six months ended October 31, 2020, from **$13.2 million** in the prior year[11](index=11&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Changes in Stockholders' Equity (Six Months Ended October 31, 2020, in thousands) | Item | Amount | | :--- | :--- | | Balance at May 1, 2020 | $83,752 | | Issuance of common stock from exercise of stock options | $106 | | Stock-based compensation expense | $2,436 | | Net loss | $(21,240) | | Foreign currency translation adjustment | $211 | | Unrealized holding losses from marketable securities | $(169) | | Reclassification adjustment for realized (gain) on marketable securities included in net loss | $(116) | | Balance at October 31, 2020 | $64,980 | - Total stockholders' equity decreased from **$83.8 million** at May 1, 2020, to **$65.0 million** at October 31, 2020, primarily due to a net loss of **$21.2 million**[14](index=14&type=chunk) - Stock-based compensation expense contributed **$2.4 million** to additional paid-in capital during the six months ended October 31, 2020[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows (Six Months Ended October 31, in thousands) | Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(11,540) | $(19,089) | | Net cash provided by (used in) investing activities | $11,884 | $(3,044) | | Net cash provided by financing activities | $106 | $11,538 | | Effect of exchange rate changes on cash and cash equivalents | $(65) | $308 | | Net increase (decrease) in cash and cash equivalents | $385 | $(10,287) | | Cash and cash equivalents at end of period | $16,174 | $21,719 | - Net cash used in operating activities decreased to **$11.5 million** for the six months ended October 31, 2020, from **$19.1 million** in the prior year[17](index=17&type=chunk) - Net cash provided by investing activities significantly improved to **$11.9 million** in 2020, compared to **$3.0 million** used in 2019, primarily due to higher sales and maturities of marketable securities[17](index=17&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) [1. The Company](index=8&type=section&id=1.%20The%20Company) - KalVista Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on small molecule protease inhibitors for hereditary angioedema (HAE) and diabetic macular edema (DME)[19](index=19&type=chunk) - The COVID-19 pandemic has caused and may continue to cause delays in clinical trials, potentially impacting business, results of operations, and financial performance, and may require earlier additional capital[21](index=21&type=chunk) - The company anticipates sufficient funding for at least the next twelve months based on current operating plans and existing capital resources, but expects to incur continued losses and increase expenses as product candidates advance[23](index=23&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) - The financial statements are prepared in accordance with U.S. GAAP for interim financial information, reflecting all necessary adjustments for fair presentation[27](index=27&type=chunk) - The CEO manages operations as a single operating segment[28](index=28&type=chunk) Potential Dilutive Common Share Equivalents (October 31, in thousands) | Item | 2020 | 2019 | | :--- | :--- | :--- | | Stock options and awards | 3,019,711 | 2,274,648 | - Due to net losses, common share equivalents are anti-dilutive, resulting in no difference between basic and diluted loss per share[30](index=30&type=chunk) Fair Value Measurement of Cash Equivalents and Marketable Securities (October 31, 2020, in thousands) | Category | Level 1 | Level 2 | Level 3 | Balance | | :--- | :--- | :--- | :--- | :--- | | Cash equivalents | $1,257 | $— | $— | $1,257 | | Corporate debt securities | $— | $30,837 | $— | $30,837 | | U.S. government agency securities | $— | $8,863 | $— | $8,863 | | **Total** | **$1,257** | **$39,700** | **$—** | **$40,957** | [3. Marketable Securities](index=10&type=section&id=3.%20Marketable%20Securities) - The company invests excess cash in high credit quality securities to ensure safety, preservation, and liquidity, classifying all debt securities as available-for-sale[34](index=34&type=chunk)[35](index=35&type=chunk) Marketable Securities Held (October 31, 2020, in thousands) | Security Type | Amortized Cost | Unrealized Gains | Unrealized Losses | Estimated Fair Value | | :--- | :--- | :--- | :--- | :--- | | Corporate debt securities | $30,726 | $148 | $(37) | $30,837 | | Obligations of the U.S. Government and its agencies | $8,791 | $72 | $— | $8,863 | | **Total** | **$39,517** | **$220** | **$(37)** | **$39,700** | Scheduled Maturity for Marketable Securities (October 31, 2020, in thousands) | Maturity Period | Amount | | :--- | :--- | | Maturing in one year or less | $25,192 | | Maturing after one year through two years | $5,817 | | Maturing after two years | $8,691 | | **Total** | **$39,700** | [4. Accrued Expenses](index=11&type=section&id=4.%20Accrued%20Expenses) Accrued Expenses (in thousands) | Expense Type | October 31, 2020 | April 30, 2020 | | :--- | :--- | :--- | | Compensation expense | $2,952 | $2,333 | | Research expense | $3,501 | $2,821 | | Professional fees | $410 | $173 | | Other expenses | $78 | $128 | | **Total** | **$6,941** | **$5,455** | - Total accrued expenses increased to **$6.9 million** at October 31, 2020, from **$5.5 million** at April 30, 2020, driven primarily by increases in compensation and research expenses[38](index=38&type=chunk) [5. Commitments and Contingencies](index=11&type=section&id=5.%20Commitments%20and%20Contingencies) - The company has remaining contractual commitments of **$1.8 million** at October 31, 2020, related to preclinical studies and clinical trials[39](index=39&type=chunk) - No contingent liabilities required accrual at October 31, 2020[40](index=40&type=chunk) - Upon successful regulatory approval and first commercial sale of certain DME products, the company may be required to pay royalty fees of up to **$1.0 million**, with additional follow-on payments depending on commercial success[41](index=41&type=chunk) [6. Leases](index=11&type=section&id=6.%20Leases) - The company has lease agreements for its Cambridge, Massachusetts headquarters (5-year term from Sept 2017) and Porton Down, UK office/research lab space (through April 2023, with option to extend)[42](index=42&type=chunk) - Total rent expense for operating leases was **$396,000** for the six months ended October 31, 2020, an increase from **$378,000** in the prior year[43](index=43&type=chunk) Maturity of Undiscounted Lease Payments (October 31, 2020, in thousands) | Fiscal Years | Operating Leases | | :--- | :--- | | 2021 | $297 | | 2022 | $390 | | 2023 | $245 | | 2024 | $149 | | 2025 | $149 | | Thereafter | $459 | | **Total Lease Payments** | **$1,689** | | Less: imputed interest | $(335) | | **Total Lease Liabilities** | **$1,354** | | Current lease liabilities | $422 | | Long-term lease liabilities | $932 | [7. Subsequent Events](index=12&type=section&id=7.%20Subsequent%20Events) - On November 20, 2020, the company amended its Cambridge lease to include an additional 5,600 square feet for an eight-year term, with an average annual rent of **$0.6 million**, and extended the existing space's term to be coterminous[46](index=46&type=chunk) - Subsequent to October 31, 2020, the company issued 27,508 shares of common stock for approximately **$0.5 million** in cash proceeds under a Sales Agreement with Cantor Fitzgerald & Co[47](index=47&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=13&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's analysis of financial condition, operational results, and progress of key drug candidates [Management Overview](index=13&type=section&id=Management%20Overview) - KalVista is a clinical-stage pharmaceutical company developing small molecule protease inhibitors for hereditary angioedema (HAE) and diabetic macular edema (DME)[49](index=49&type=chunk) - For HAE, the company aims to offer a complete set of oral options, including KVD900 for on-demand treatment (currently in Phase 2, completed patient dosing) and KVD824 for prophylactic treatment (IND application for Phase 2 expected Q1 2021)[51](index=51&type=chunk)[52](index=52&type=chunk) - A novel oral Factor XIIa inhibitor program is in lead optimization, with IND-enabling studies anticipated in 2021, aiming to be the first orally delivered Factor XIIa inhibitor in clinical development[56](index=56&type=chunk)[57](index=57&type=chunk) - The COVID-19 pandemic continues to pose risks of delays in preclinical studies and clinical trials, potentially impacting operational and financial performance[60](index=60&type=chunk) [Financial Overview](index=15&type=section&id=Financial%20Overview) - No revenue was generated in the current fiscal year due to the expiration of the Merck Option Agreement in February 2020[62](index=62&type=chunk) - Research and development expenses are expected to remain substantial and increase as product candidates advance through clinical development, manufacturing, and toxicology studies[65](index=65&type=chunk) - General and administrative expenses are anticipated to increase due to expanding operating activities, patent portfolio maintenance, and public company compliance costs[68](index=68&type=chunk) - Other income includes interest income, UK R&D tax credits, and realized/unrealized foreign currency exchange gains/losses[69](index=69&type=chunk) [Results of Operations](index=16&type=section&id=Results%20of%20Operations) Key Components of Results of Operations (Three Months Ended October 31, in thousands) | Metric | 2020 | 2019 | Increase (decrease) | | :--- | :--- | :--- | :--- | | Revenue | $— | $3,920 | $(3,920) | | Research and development expenses | $9,148 | $9,789 | $(641) | | General and administrative expenses | $3,633 | $3,420 | $213 | | Interest, exchange rate gain and other income | $2,355 | $3,386 | $(1,031) | Research and Development Expenses by Program (Three Months Ended October 31, in thousands) | Program | 2020 | 2019 | | :--- | :--- | :--- | | KVD001 | $58 | $1,385 | | KVD900 | $2,757 | $2,914 | | KVD824 | $2,381 | $818 | | Preclinical activities | $3,952 | $4,672 | | **Total** | **$9,148** | **$9,789** | - R&D expenses decreased by **$0.6 million** for the three months ended October 31, 2020, primarily due to decreases in KVD001 (**$1.3M**) and preclinical activities (**$0.7M**), partially offset by an increase in KVD824 spending (**$1.6M**)[72](index=72&type=chunk) Key Components of Results of Operations (Six Months Ended October 31, in thousands) | Metric | 2020 | 2019 | Increase (decrease) | | :--- | :--- | :--- | :--- | | Revenue | $— | $7,289 | $(7,289) | | Research and development expenses | $20,313 | $19,476 | $837 | | General and administrative expenses | $6,912 | $6,665 | $247 | | Interest, exchange rate gain and other income | $5,984 | $5,611 | $373 | Research and Development Expenses by Program (Six Months Ended October 31, in thousands) | Program | 2020 | 2019 | | :--- | :--- | :--- | | KVD001 | $144 | $3,268 | | KVD900 | $7,209 | $4,448 | | KVD824 | $4,669 | $2,324 | | Preclinical activities | $8,291 | $9,436 | | **Total** | **$20,313** | **$19,476** | - R&D expenses increased by **$0.8 million** for the six months ended October 31, 2020, driven by increased spending on KVD900 (**$2.8M**) and KVD824 (**$2.3M**), partially offset by decreases in KVD001 (**$3.1M**) and preclinical activities (**$1.1M**)[80](index=80&type=chunk) [Liquidity and Capital Resources](index=18&type=section&id=Liquidity%20and%20Capital%20Resources) - Operations are primarily funded through capital stock issuance and the former Merck Option Agreement; future funding is expected from capital stock issuance, including sales under the Sales Agreement with Cantor Fitzgerald & Co[88](index=88&type=chunk) - The company anticipates sufficient funding for at least the next twelve months based on current operating plans and existing capital resources, subject to potential COVID-19 impacts[88](index=88&type=chunk)[93](index=93&type=chunk) Summary of Net Cash Flow Activity (Six Months Ended October 31, in thousands) | Activity | 2020 | 2019 | | :--- | :--- | :--- | | Cash flows used in operating activities | $(11,540) | $(19,089) | | Cash flows provided by (used in) investing activities | $11,884 | $(3,044) | | Cash flows provided by financing activities | $106 | $11,538 | | Net increase (decrease) in cash and cash equivalents | $385 | $(10,287) | - Net cash used in operating activities decreased to **$11.5 million** in 2020 from **$19.1 million** in 2019, primarily due to favorable changes in working capital, including R&D tax credit receivable and prepaid expenses[90](index=90&type=chunk) - Net cash provided by investing activities was **$11.9 million** in 2020, a significant improvement from **$3.0 million** used in 2019, driven by higher sales and maturities of marketable securities[91](index=91&type=chunk) - Net cash provided by financing activities decreased substantially to **$0.1 million** in 2020 from **$11.5 million** in 2019, as the prior year included significant common stock sales[92](index=92&type=chunk) [Contractual Obligations and Commitments](index=20&type=section&id=Contractual%20Obligations%20and%20Commitments) - There were no material changes to contractual obligations and commitments during the three months ended October 31, 2020, compared to those disclosed in the Annual Report on Form 10-K for the fiscal year ended April 30, 2020[96](index=96&type=chunk) [Off-Balance Sheet Arrangements](index=20&type=section&id=Off-Balance%20Sheet%20Arrangements) - As of October 31, 2020, the company was not a party to any off-balance sheet arrangements as defined by SEC rules and regulations[97](index=97&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=20&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) - The preparation of financial statements requires management to make estimates and assumptions that affect reported amounts, which are evaluated on an ongoing basis using historical experience, known trends, and other reasonable factors[98](index=98&type=chunk) - Actual results may differ from these estimates under different assumptions or conditions[98](index=98&type=chunk) [Recently Issued Accounting Pronouncements](index=20&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) - No recently issued accounting pronouncements are applicable to the company[99](index=99&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=20&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, KalVista is exempt from providing disclosures about market risk - The company is a smaller reporting company and is not required to provide disclosures about market risk[100](index=100&type=chunk) [Item 4. Controls and Procedures](index=21&type=section&id=Item%204.%20Controls%20and%20Procedures) Confirms the effectiveness of disclosure controls and procedures as of October 31, 2020, with no material changes identified [Evaluation of Disclosure Controls and Procedures](index=21&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Management, under the supervision of the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of October 31, 2020[102](index=102&type=chunk) [Changes in Internal Controls over Financial Reporting](index=21&type=section&id=Changes%20in%20Internal%20Controls%20over%20Financial%20Reporting) - No material changes in internal control over financial reporting were identified during the quarter ended October 31, 2020[103](index=103&type=chunk) - The company is continuously monitoring and assessing the impact of the COVID-19 pandemic on its internal controls[103](index=103&type=chunk) [PART II. OTHER INFORMATION](index=22&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=22&type=section&id=Item%201.%20Legal%20Proceedings) The company is not aware of any legal proceedings expected to materially impact its business or financial condition - The company is not aware of any legal proceedings or claims that are expected to have a material adverse effect on its business, financial condition, or operating results[106](index=106&type=chunk) [Item 1A. Risk Factors](index=22&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 - No material changes to the risk factors described in the Annual Report on Form 10-K for the fiscal year ended April 30, 2020[107](index=107&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=22&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable to the company for the reporting period - This item is not applicable[109](index=109&type=chunk) [Item 3. Defaults Upon Senior Securities](index=22&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company for the reporting period - This item is not applicable[110](index=110&type=chunk) [Item 4. Mine Safety Disclosures](index=22&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company for the reporting period - This item is not applicable[111](index=111&type=chunk) [Item 5. Other Information](index=22&type=section&id=Item%205.%20Other%20Information) This item is not applicable to the company for the reporting period - This item is not applicable[112](index=112&type=chunk) [Item 6. Exhibits](index=23&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including a lease amendment and officer certifications - Exhibits include the First Amendment of Lease dated November 20, 2020, and certifications from the Principal Executive Officer and Principal Financial Officer[114](index=114&type=chunk) - XBRL Instance Document and Taxonomy Extension Documents are also filed as exhibits[114](index=114&type=chunk) [SIGNATURES](index=24&type=section&id=SIGNATURES) The report is duly signed on behalf of the company by its CEO and CFO on December 10, 2020 - The report was signed by T. Andrew Crockett, Chief Executive Officer, and Benjamin L. Palleiko, Chief Business Officer and Chief Financial Officer, on December 10, 2020[119](index=119&type=chunk)