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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)
KalVista Pharmaceuticals(KALV) - 2021 Q1 - Quarterly Report
2020-09-14 20:15
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 July 31, 2020 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 incorp ...
KalVista Pharmaceuticals (KALV) Presents At BTIG Virtual Biotechnology Conference - Slideshow
2020-08-12 16:12
| --- | --- | --- | --- | |-------|-------------------------------|-------|-------| | | | | | | | | | | | | BTIG Biotechnology Conference | | | | | August 10, 2020 | | | | | | | | | | | | | 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," "pl ...
KalVista Pharmaceuticals(KALV) - 2020 Q4 - Annual Report
2020-07-01 20:16
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, 2020 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) Presents At SVB Leerink Global Healthcare Conference - Slideshow
2020-03-11 10:32
K Vall liato | --- | --- | --- | --- | |-------|-------|-------|-------| | | | | | | | | | | 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," " ...
KalVista Pharmaceuticals(KALV) - 2020 Q3 - Quarterly Report
2020-03-10 20:18
For the quarterly period ended January 31, 2020 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. 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 inc ...
KalVista Pharmaceuticals(KALV) - 2020 Q2 - Quarterly Report
2019-12-03 21:16
[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%2E%20FINANCIAL%20INFORMATION) This section presents the company's financial statements, management's discussion and analysis, market risk disclosures, and internal controls [Financial Statements](index=4&type=section&id=Item%201%2E%20Financial%20Statements) KalVista reported a net loss of $13.2 million for the six months ended October 31, 2019, with total assets of $112.1 million and decreased revenue [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $112.1 million as of October 31, 2019, primarily due to reduced cash, while liabilities decreased and equity slightly increased Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Oct 31, 2019 (Unaudited) | Apr 30, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $21,719 | $32,006 | | Marketable securities | $71,742 | $68,805 | | **Total Assets** | **$112,064** | **$118,132** | | Total current liabilities | $10,470 | $18,052 | | Total long-term liabilities | $3,807 | $3,342 | | **Total Liabilities** | **$14,277** | **$21,394** | | **Total Stockholders' Equity** | **$97,787** | **$96,738** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Revenue decreased and operating expenses increased for the three and six months ended October 31, 2019, leading to a widened net loss Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended Oct 31, 2019 | Three Months Ended Oct 31, 2018 | Six Months Ended Oct 31, 2019 | Six Months Ended Oct 31, 2018 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $3,920 | $5,592 | $7,289 | $9,311 | | Research and development | $9,789 | $7,876 | $19,476 | $16,232 | | General and administrative | $3,420 | $2,609 | $6,665 | $4,979 | | **Operating loss** | **($9,289)** | **($4,893)** | **($18,852)** | **($11,900)** | | **Net loss** | **($5,903)** | **($3,304)** | **($13,241)** | **($8,334)** | | Net loss per share | ($0.33) | ($0.22) | ($0.75) | ($0.64) | [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Stockholders' equity increased to $97.8 million, driven by common stock issuance offsetting the net loss for the six months ended October 31, 2019 - Stockholders' equity increased to **$97.8 million** at October 31, 2019, up from **$96.7 million** at May 1, 2019[14](index=14&type=chunk) - Key changes in equity for the six months ended October 31, 2019 include a net loss of **$13.2 million** and net proceeds of **$11.4 million** from the issuance of common stock[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $19.1 million, partially offset by financing activities, resulting in a $10.3 million decrease in cash and equivalents Summary of Cash Flows (in thousands) | Activity | Six Months Ended Oct 31, 2019 | Six Months Ended Oct 31, 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | ($19,089) | ($14,998) | | Net cash used in investing activities | ($3,044) | ($786) | | Net cash from financing activities | $11,538 | $87,732 | | **Net (decrease) increase in cash** | **($10,287)** | **$70,061** | | **Cash and cash equivalents at end of period** | **$21,719** | **$121,116** | [Notes to the Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's drug development focus, funding sources, adoption of ASC 842, and revenue recognition from the Merck Option Agreement - The company 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) - Key drug candidates include KVD900 (on-demand HAE therapy, Phase 2), KVD001 (DME, Phase 2 data expected Q4 2019), and KVD824 (oral HAE prophylaxis or DME therapy)[20](index=20&type=chunk)[21](index=21&type=chunk) - The company adopted new lease standard ASC 842 on May 1, 2019, resulting in the recognition of a **$1.9 million** right-of-use asset and a **$1.9 million** lease liability[36](index=36&type=chunk)[37](index=37&type=chunk) - Under the Merck Option Agreement, the company recognized **$7.3 million** in revenue for the six months ended October 31, 2019, with **$5.4 million** remaining in deferred revenue as of that date[61](index=61&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202%2E%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses decreased revenue and increased R&D expenses, affirming sufficient liquidity for at least the next twelve months [Results of Operations](index=17&type=section&id=Results%20of%20Operations) For the six months ended October 31, 2019, revenue decreased by $2.0 million, while R&D expenses increased by $3.2 million and G&A expenses rose by $1.7 million Comparison of Results for Six Months Ended October 31 (in thousands) | Metric | 2019 | 2018 | Change | | :--- | :--- | :--- | :--- | | Revenue | $7,289 | $9,311 | $(2,022) | | Research and development expenses | $19,476 | $16,232 | $3,244 | | General and administrative expenses | $6,665 | $4,979 | $1,686 | R&D Expenses by Program for Six Months Ended October 31 (in thousands) | Program | 2019 | 2018 | | :--- | :--- | :--- | | KVD001 | $3,268 | $5,831 | | KVD900 | $4,448 | $1,698 | | KVD824 | $2,324 | $2,643 | | Preclinical activities | $9,436 | $6,060 | | **Total** | **$19,476** | **$16,232** | - The decrease in revenue is attributed to the near completion of the Phase 2 clinical trial for KVD001, which is part of the Merck Option Agreement[84](index=84&type=chunk) - The increase in R&D expenses was primarily due to advancing the KVD900 Phase 2 trial and other non-clinical expenses for later-stage development[87](index=87&type=chunk) [Liquidity and Capital Resources](index=19&type=section&id=Liquidity%20and%20Capital%20Resources) The company funds operations through stock issuance and the Merck agreement, with current capital sufficient for twelve months, and may seek future funding through various means - The company anticipates its current working capital will fund operations for at least the next twelve months from the report's issue date[92](index=92&type=chunk) - Net cash used in operating activities increased to **$19.1 million** for the six months ended Oct 31, 2019, from **$15.0 million** in the prior-year period[93](index=93&type=chunk)[94](index=94&type=chunk) - Net cash from financing activities was **$11.5 million** for the six months ended Oct 31, 2019, primarily from the sale of common stock, compared to **$87.7 million** in the prior year period which included proceeds from a private placement and public offering[96](index=96&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=21&type=section&id=Item%203%2E%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces interest rate and foreign exchange risks, with significant GBP cash holdings, but does not currently engage in hedging - The company's primary market risks are interest rate and foreign exchange rate fluctuations[104](index=104&type=chunk)[105](index=105&type=chunk) - As of October 31, 2019, **68%** of cash and cash equivalents were held in British Pound Sterling (GBP), exposing the company to foreign exchange risk as it incurs significant expenses in GBP[105](index=105&type=chunk) [Controls and Procedures](index=21&type=section&id=Item%204%2E%20Controls%20and%20Procedures) Management concluded that disclosure controls were effective as of October 31, 2019, with no material changes to internal control over financial reporting - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of October 31, 2019[106](index=106&type=chunk) - No changes occurred during the quarter ended October 31, 2019, that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[107](index=107&type=chunk) [PART II. OTHER INFORMATION](index=22&type=section&id=PART%20II%2E%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, and a list of exhibits filed with the report [Legal Proceedings](index=22&type=section&id=Item%201%2E%20Legal%20Proceedings) The company reports no material legal proceedings or claims expected to adversely affect its business or financial condition - The company reports no material legal proceedings[110](index=110&type=chunk) [Risk Factors](index=22&type=section&id=Item%201A%2E%20Risk%20Factors) No material changes to the risk factors previously disclosed in the Annual Report on Form 10-K have been reported - No material changes to risk factors from the Annual Report on Form 10-K for the fiscal year ended April 30, 2019, have been reported[111](index=111&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=22&type=section&id=Item%202%2E%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section is not applicable for the current reporting period - Not applicable[112](index=112&type=chunk) [Exhibits](index=23&type=section&id=Item%206%2E%20Exhibits) The report includes various exhibits, such as CEO and CFO certifications and XBRL data files - Exhibits filed include CEO and CFO certifications under Rule 13a-14(a) and 13a-14(b), and various XBRL documents[117](index=117&type=chunk)[119](index=119&type=chunk)
KalVista Pharmaceuticals (KALV) Investor Presentation - Slideshow
2019-10-04 17:59
KalVista Pharmaceuticals Corporate Presentation October 2019 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 simil ...
KalVista Pharmaceuticals(KALV) - 2020 Q1 - Quarterly Report
2019-09-09 20:18
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q Commission File No. 001-36830 KALVISTA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 20-0915291 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 55 Cambridge Parkway Suite 901E Cambridge, Massachusetts (Address of principal executive offices) (Zip Code) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANG ...