KALV KalVista Pharmaceuticals Inc.

12.12
+0.36  (+3%)
Previous Close 11.76
Open 11.75
52 Week Low 5.605
52 Week High 19
Market Cap $216,308,355
Shares 17,847,224
Float 12,542,443
Enterprise Value $143,814,354
Volume 161,937
Av. Daily Volume 146,914
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Upcoming Catalysts

Drug Stage Catalyst Date
KVD900
Hereditary Angioedema (HAE)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
KVD824
Hereditary angioedema
Phase 1
Phase 1
Phase 2 trial to be initiated 2H 2020.
KVD001
Diabetic macular edema (DME)
Phase 2
Phase 2
Phase 2 data did not meet primary endpoint - December 9, 2019.

Latest News

  1. – KVD900 Phase 2 Clinical Trial for Oral Treatment of Hereditary Angioedema (HAE) Data Expected in 2H 2020 –

    – Oral HAE Prophylactic Candidate KVD824 Phase 2 Clinical Trial Planned to Commence in 2H 2020 –

    – Operations Funded into 2022 –

    KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors today provided an operational update and released financial results for the fiscal year ended April 30, 2020.

    "We have two oral candidates in clinical trials that have the potential to provide HAE patients with a complete set of options to treat their disease," said Andrew Crockett, Chief Executive Officer of KalVista…

    – KVD900 Phase 2 Clinical Trial for Oral Treatment of Hereditary Angioedema (HAE) Data Expected in 2H 2020 –

    – Oral HAE Prophylactic Candidate KVD824 Phase 2 Clinical Trial Planned to Commence in 2H 2020 –

    – Operations Funded into 2022 –

    KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors today provided an operational update and released financial results for the fiscal year ended April 30, 2020.

    "We have two oral candidates in clinical trials that have the potential to provide HAE patients with a complete set of options to treat their disease," said Andrew Crockett, Chief Executive Officer of KalVista. "We are pleased with our progress with the formulation work for KVD824 to deliver a twice-daily treatment for prevention of HAE attacks. Subjects have begun dosing with these new formulations to obtain additional pharmacokinetic and pharmacodynamic data, and we look forward to providing these data later this year in advance of starting a Phase 2 clinical trial. Patients also continue to be treated in our Phase 2 clinical trial for KVD900 as an on-demand therapy, and we expect data from that trial in the second half of this year."

    Fiscal 2020 and Recent Business Highlights:

    • Opened an Investigational New Drug (IND) Application for KVD900 with the U.S. Food and Drug Administration (FDA) to enable clinical development in the United States.
    • Presented at The International Symposium on Ocular Pharmacology and Therapeutics (ISOPT). KalVista's Chief Scientific Officer, Edward P. Feener, PhD, spoke on "Kallikrein-Kinin System in Diabetic Retinopathy – Novel Target."
    • Received Fast Track designation for KVD900 from the FDA, supporting KalVista's belief in the high level of unmet need in HAE for oral therapy and providing a potentially expedited path to drug approval.
    • Announced results of the Phase 2 trial of KVD001, an intravitreal candidate for treatment of diabetic macular edema (DME). KVD001 did not meet its primary endpoint in the overall study population, but it did demonstrate a protection against vision loss and a pre-specified subgroup analysis showed a clinical benefit on vision. The trial was designed to evaluate patients who were poor responders to previous treatment with anti-VEGF therapy. KVD001 was generally safe and well tolerated with no drug-related serious adverse events. Both KVD001 and future oral DME molecules were subject to an option agreement with Merck, which subsequently expired in February.
    • Selected KVD824 for development as a twice-daily oral prophylactic treatment for HAE. KVD824 is a highly potent and selective plasma kallikrein inhibitor which achieved high exposures and a favorable safety and tolerability profile in a first-in-human study. Additional formulation work on KVD824 is ongoing, and the Company expects to provide this and other data before initiating a Phase 2 clinical trial, which is anticipated to be in the second half of 2020.
    • Adjusted expectations for KVD900 data to the second half of 2020 due to the impact of COVID-19, and revised financial guidance that activities are funded into at least early 2022.

    Fourth Quarter and Full Year Financial Results:

    • Revenue: Revenue was $3.8 million for the three months ended April 30, 2020, compared to $2.9 million for the same period in the prior fiscal year. Revenue was $12.7 million for the fiscal year ended April 30, 2020, compared to $16.1 million for the prior fiscal year. All of the revenue recognized in the fiscal year ended April 30, 2020 was recognized from deferred revenue that existed at the beginning of the period. No future revenue exists under the Merck Option Agreement.
    • R&D Expenses: Research and development expenses were $9.5 million for the three months ended April 30, 2020, compared to $11.1 million for the same period in the prior fiscal year. The decrease in spending during the quarter was primarily due to the conclusion of the Phase 2 clinical trial for KVD001 in the previous quarter. Research and development expenses were $40.2 million for the fiscal year ended April 30, 2020, compared to $35.0 million for the prior fiscal year. The increase in spending in the fiscal year ended April 30, 2020 primarily reflects increased costs related to the ongoing clinical trial for KVD900 as well as increased expenses on preclinical activities.
    • G&A Expenses: General and administrative expenses were $3.3 million for the three months ended April 30, 2020, compared to $3.0 million for the same period in the prior fiscal year. General and administrative expenses were $13.0 million for the fiscal year ended April 30, 2020, compared to $10.9 million for the prior fiscal year. The increase in G&A expenses was primarily due to an increase in compensation related expenses and to a lesser extent, increases in commercial planning expenses, professional fees, and insurance costs.
    • Net Loss: Net loss was $6.6 million, or $(0.37) per weighted average basic and diluted share, for the three months ended April 30, 2020, compared to net loss of $8.5 million, or $(0.49) per weighted average basic and diluted share for the same period in the prior fiscal year. Net loss was $29.1 million, or $(1.64) per weighted average basic and diluted share for the fiscal year ended April 30, 2020, compared to net loss of $20.8 million, or $(1.38) per weighted average basic and diluted share in the prior fiscal year. The decrease in net loss and net loss per share in the three months ended April 30, 2020 as compared to the same period in the prior fiscal year primarily resulted from decreased research and development spending due to the completion of the Phase 2 clinical trial for KVD001 in the previous quarter. The increase in net loss and net loss per share in year ended April 30, 2020 was primarily related to the ramp up of research and development activities in the current year compared to the prior fiscal year.
    • Cash Position: Cash, cash equivalents and marketable securities were $67.7 million as of April 30, 2020, compared to $100.8 million as of April 30, 2019. The decrease in the net cash position was due to increased spending, primarily on research and development activities during the year ended April 30, 2020 compared to the prior fiscal year.

    About KalVista Pharmaceuticals, Inc.

    KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. The initial focus is on inhibitors of plasma kallikrein, which is an important component of the body's inflammatory response and which, in excess, can lead to increased vascular permeability, edema and inflammation. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). The Company has created a structurally diverse portfolio of oral plasma kallikrein inhibitors and is advancing multiple drug candidates for HAE as well as DME. KalVista has selected KVD900 as its program to be advanced as an on-demand therapy for acute HAE attacks and is conducting a Phase 2 proof-of-concept study in HAE patients with data expected in the second half of 2020. KVD824 is in development for prophylactic treatment of HAE and is expected to enter a Phase 2 clinical trial in the second half of 2020. In DME, an intravitreally administered plasma kallikrein inhibitor known as KVD001, completed a Phase 2 clinical trial in 2019.

    For more information, please visit www.kalvista.com.

    Forward-Looking Statements

    This press release contains "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 references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, available funding, our cash runway, potential future clinical trial timing and results, potential benefits of our product candidates, and the impact of COVID-19. Further information on potential risk factors that could affect our business and its financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2020 once filed, and our other reports that we may file from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

    KalVista Pharmaceuticals Inc.
    Condensed Consolidated Balance Sheets
    (in thousands, except share and per share amounts)
    (Unaudited)
     

    April 30,

    April 30,

    2020

    2019

    Assets
    Current assets:
    Cash and cash equivalents

    $ 15,789

    $ 32,006

    Marketable securities

    51,925

    68,805

    Research and development tax credit receivable

    16,527

    11,315

    Prepaid expenses and other current assets

    4,455

    3,420

    Total current assets

    88,696

    115,546

    Property and equipment, net

    2,043

    2,413

    Right of use assets

    1,612

    Other assets

    178

    173

    Total assets

    $ 92,529

    $ 118,132

    Liabilities and stockholders' equity
    Current liabilities:
    Accounts payable

    $ 1,677

    $ 2,860

    Accrued expenses

    5,455

    5,647

    Deferred revenue - current portion

    9,545

    Lease liability - current portion

    588

    Total current liabilities

    7,720

    18,052

    Long-term liabilities:
    Deferred revenue - net of current portion

    3,342

    Lease liability - net of current portion

    1,057

    Total long-term liabilities

    1,057

    3,342

    Stockholders' equity:
    Common stock, $0.001 par value

    18

    17

    Additional paid-in capital

    207,208

    191,123

    Accumulated deficit

    (121,592)

    (92,476)

    Accumulated other comprehensive loss

    (1,882)

    (1,926)

    Total stockholders' equity

    83,752

    96,738

    Total liabilities and stockholders' equity

    $ 92,529

    $ 118,132

    KalVista Pharmaceuticals Inc.
    Condensed Consolidated Statement of Operations
    (in thousands, except share and per share amounts)
    (Unaudited)
     
     
    Three Months Ended Years Ended
    April 30, April 30,

    2020

    2019

    2020

    2019

     
    Revenue

    $ 3,824

    $ 2,926

    $ 12,690

    $ 16,127

    Operating expenses:
    Research and development

    9,485

    11,139

    40,194

    35,021

    General and administrative

    3,296

    3,047

    13,029

    10,926

    Total operating expenses

    12,781

    14,186

    53,223

    45,947

    Operating loss

    (8,957)

    (11,260)

    (40,533)

    (29,820)

     
    Other income:
    Interest income

    363

    381

    1,830

    1,397

    Foreign currency exchange rate gain (loss)

    (613)

    (34)

    (367)

    49

    Other income

    2,498

    2,511

    9,830

    7,682

    Total other income

    2,248

    2,858

    11,293

    9,128

    Loss before income taxes

    (6,709)

    (8,402)

    (29,240)

    (20,692)

    Income tax (benefit) expense

    (124)

    124

    (124)

    124

    Net loss

    $ (6,585)

    $ (8,526)

    $ (29,116)

    $ (20,816)

     
    Net loss per share, basic and diluted

    $ (0.37)

    $ (0.49)

    $ (1.64)

    $ (1.38)

     
    Weighted average common shares outstanding, basic and diluted

    17,845,599

    17,253,938

    17,748,666

    15,080,863

    KalVista Pharmaceuticals Inc.
    Condensed Consolidated Statements of Cash Flows
    (in thousands, unaudited)
     
    Years Ended
    April 30,

    2020

    2019

     
    Cash flows from operating activities
    Net loss

    $ (29,116)

    $ (20,816)

    Adjustments to reconcile net loss to net cash used in operating activities:
    Depreciation and amortization

    512

    378

    Stock-based compensation expense

    4,448

    2,966

    Realized (gain) from marketable securities

    (300)

    (23)

    Non-cash operating lease expense

    13

    Amortization of premium on available for sale securities

    193

    Foreign currency exchange (gain) loss

    74

    (80)

    Changes in operating assets and liabilities:
    Research and development tax credit receivable

    (5,781)

    (4,883)

    Prepaid expenses and other current assets

    (1,112)

    (1,979)

    Other assets

    (5)

    Accounts payable

    (1,004)

    1,534

    Accrued expenses

    (48)

    2,665

    Deferred revenue

    (12,690)

    (16,127)

    Net cash used in operating activities

    (44,816)

    (36,365)

     
    Cash flows from investing activities
    Purchases of available for sale securities

    (49,797)

    (79,889)

    Sales and maturities of available for sale securities

    66,770

    11,548

    Acquisition of property and equipment

    (220)

    (1,081)

    Net cash provided by (used in) investing activities

    16,753

    (69,422)

     
    Cash flows from financing activities
    Issuance of common stock, net of offering expenses

    11,422

    87,910

    Issuance of common stock from equity incentive plans

    216

    242

    Finance lease principal payments

    (54)

    (209)

    Net cash provided by financing activities

    11,584

    87,943

    Effect of exchange rate changes on cash and cash equivalents

    262

    (1,205)

    Net decrease in cash and cash equivalents

    (16,217)

    (19,049)

    Cash and cash equivalents, beginning of year

    32,006

    51,055

    Cash and cash equivalents, end of year

    $ 15,789

    $ 32,006

     

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  2. KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today announced that it will present at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020, at 3:00 p.m. ET.

    A live webcast of the presentation will be available on the Company's website at www.kalvista.com. An audio archive will be available on the website for 30 days following the presentation.

    About KalVista Pharmaceuticals, Inc.

    KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. The…

    KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today announced that it will present at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020, at 3:00 p.m. ET.

    A live webcast of the presentation will be available on the Company's website at www.kalvista.com. An audio archive will be available on the website for 30 days following the presentation.

    About KalVista Pharmaceuticals, Inc.

    KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. The initial focus is on inhibitors of plasma kallikrein, which is an important component of the body's inflammatory response and which, in excess, can lead to increased vascular permeability, edema and inflammation. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). The Company has created a structurally diverse portfolio of oral plasma kallikrein inhibitors and is advancing multiple drug candidates for HAE as well as DME. KalVista has selected KVD900 as its program to be advanced as an on-demand therapy for acute HAE attacks and is conducting a Phase 2 proof-of-concept study in HAE patients with data expected in the second half of 2020. KVD824 is in development for prophylactic treatment of HAE and is expected to enter a Phase 2 clinical trial in the second half of 2020. In DME, an intravitreally administered plasma kallikrein inhibitor known as KVD001, completed a Phase 2 clinical trial in 2019.

    For more information, please visit www.kalvista.com.

    Forward-Looking Statements

    This press release contains "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 references to future periods. These statements are subject to numerous risks and uncertainties, including the impact of COVID-19, that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, available funding, our cash runway, potential future clinical trial timing and results. Further information on potential risk factors that could affect our business and its financial results are detailed in the annual report on Form 10-K filed on July 16, 2019, the quarterly report on Form 10-Q filed on March 10, 2020, and other reports as filed from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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  3. KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today announced that it will present at the Needham Virtual Healthcare Conference on Wednesday, April 15, 2020, at 11:20 a.m. ET.

    A live webcast of the presentation will be available on the Company's website at www.kalvista.com. An audio archive will be available on the website for 30 days following the presentation.

    About KalVista Pharmaceuticals, Inc.

    KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. The initial…

    KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today announced that it will present at the Needham Virtual Healthcare Conference on Wednesday, April 15, 2020, at 11:20 a.m. ET.

    A live webcast of the presentation will be available on the Company's website at www.kalvista.com. An audio archive will be available on the website for 30 days following the presentation.

    About KalVista Pharmaceuticals, Inc.

    KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. The initial focus is on inhibitors of plasma kallikrein, which is an important component of the body's inflammatory response and which, in excess, can lead to increased vascular permeability, edema and inflammation. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). The Company has created a structurally diverse portfolio of oral plasma kallikrein inhibitors and is advancing multiple drug candidates for HAE as well as DME. KalVista has selected KVD900 as its program to be advanced as an on-demand therapy for acute HAE attacks and is conducting a Phase 2 proof-of-concept study in HAE patients with data expected in the second half of 2020. KVD824 is in development for prophylactic treatment of HAE and is expected to enter a Phase 2 clinical trial in the second half of 2020. In DME, an intravitreally administered plasma kallikrein inhibitor known as KVD001, completed a Phase 2 clinical trial in 2019.

    For more information, please visit www.kalvista.com.

    Forward-Looking Statements

    This press release contains "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 references to future periods. These statements are subject to numerous risks and uncertainties, including the impact of COVID-19, that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, available funding, our cash runway, potential future clinical trial timing and results. Further information on potential risk factors that could affect our business and its financial results are detailed in the annual report on Form 10-K filed on July 16, 2019, the quarterly report on Form 10-Q filed on March 10, 2020, and other reports as filed from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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  4. – Response to Coronavirus Impact on Ongoing Clinical Trials –

    – Cash Runway Extended into 2022 –

    KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today announced potential impact of coronavirus disease 2019 (COVID-19) on its ongoing operations and provided revised financial guidance that activities are funded into at least early 2022.

    "Patient safety remains our top priority," said Andrew Crockett, Chief Executive Officer of KalVista. "The Phase 2 clinical trial for KVD900 as an on-demand oral therapy for HAE attacks remains active, but we anticipate a delay in timing of data due to the unprecedented…

    – Response to Coronavirus Impact on Ongoing Clinical Trials –

    – Cash Runway Extended into 2022 –

    KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today announced potential impact of coronavirus disease 2019 (COVID-19) on its ongoing operations and provided revised financial guidance that activities are funded into at least early 2022.

    "Patient safety remains our top priority," said Andrew Crockett, Chief Executive Officer of KalVista. "The Phase 2 clinical trial for KVD900 as an on-demand oral therapy for HAE attacks remains active, but we anticipate a delay in timing of data due to the unprecedented worldwide impact of COVID-19. A number of our participating physicians and clinical sites have shifted their focus to address the pandemic, and patients also are dealing with challenges that may limit their ability to participate. We offer all of these groups our full support and appreciation during this time, and we are working closely with all of them to follow changing regulatory, institutional and governmental policies to navigate through this situation. Assuming that participants are able to resume their activity during the second quarter of 2020, we anticipate we will provide results in the second half of 2020. To enhance our financial strength until we have further clarity, we have revised our projected spend and now expect our funding to last into at least early 2022."

    KVD900 is being developed as an on-demand oral therapy for the treatment of HAE attacks. The ongoing Phase 2 trial is being conducted in approximately 20 sites in Europe and the U.S. and is a placebo-controlled, crossover study designed to evaluate the safety and efficacy of KVD900. Patients in the study treat a total of two eligible attacks, taking the medication at home after a telephone consultation with the investigator to confirm eligibility of the attack. Patients do not need to treat sequential attacks, and the intermittent dosing regimen allows those whose participation is paused by the ongoing crisis to remain active in the study and resume dosing as it becomes appropriate. The data collected to date is not affected by any potential delays and will contribute to final study outcomes as originally planned. The clinical trial remains active and KalVista is working with investigators and patients to enable them to continue their participation under the evolving circumstances as appropriate in each geographic region, given the ongoing health response to the pandemic.

    KalVista previously announced that the Company's cash and cash equivalents at January 31, 2020 were $80.5 million and were sufficient to fund operations into 2021. Due to the ongoing pandemic, the Company has adjusted its plans and now anticipates that the current cash balance can fund operations into at least early 2022, without significantly impacting the timing of its development activities for either KVD900 or KVD824. The Company continues to monitor events closely and will further adjust its spending plan to extend the duration of its cash runway if warranted.

    About KalVista Pharmaceuticals, Inc.

    KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. The initial focus is on inhibitors of plasma kallikrein, which is an important component of the body's inflammatory response and which, in excess, can lead to increased vascular permeability, edema and inflammation. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). The Company has created a structurally diverse portfolio of oral plasma kallikrein inhibitors and is advancing multiple drug candidates for HAE as well as DME. KalVista has selected KVD900 as its program to be advanced as an on-demand therapy for acute HAE attacks and is conducting a Phase 2 proof-of-concept study in HAE patients with data expected in the second half of 2020. KVD824 is in development for prophylactic treatment of HAE and is expected to enter a Phase 2 clinical trial in the second half of 2020. In DME, an intravitreally administered plasma kallikrein inhibitor known as KVD001, completed a Phase 2 clinical trial in 2019.

    For more information, please visit www.kalvista.com.

    Forward-Looking Statements

    This press release contains "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 references to future periods. These statements are subject to numerous risks and uncertainties, including the impact of COVID-19, that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, available funding, our cash runway, potential future clinical trial timing and results. Further information on potential risk factors that could affect our business and its financial results are detailed in the annual report on Form 10-K filed on July 16, 2019, the quarterly report on Form 10-Q filed on March 10, 2020, and other reports as filed from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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  5. – Oral Hereditary Angioedema Franchise Phase 2 Clinical Trials on Track –

    KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today provided an operational update and released financial results for the fiscal third quarter ended January 31, 2020.

    "Our work to bring multiple best-in-class oral therapies to patients with hereditary angioedema is advancing well," said Andrew Crockett, Chief Executive Officer of KalVista. "First, we look forward to delivering data in the second quarter of this year from our Phase 2 clinical trial with KVD900, our on-demand therapy for HAE attacks. We believe KVD900 has the potential…

    – Oral Hereditary Angioedema Franchise Phase 2 Clinical Trials on Track –

    KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today provided an operational update and released financial results for the fiscal third quarter ended January 31, 2020.

    "Our work to bring multiple best-in-class oral therapies to patients with hereditary angioedema is advancing well," said Andrew Crockett, Chief Executive Officer of KalVista. "First, we look forward to delivering data in the second quarter of this year from our Phase 2 clinical trial with KVD900, our on-demand therapy for HAE attacks. We believe KVD900 has the potential to offer patients an attractive option for control of their disease through a fast-acting tablet that can be taken at the earliest stages of an incipient attack. Second, we continue to make progress in our optimization of KVD824 as a potential oral prophylactic treatment. We still plan to initiate a Phase 2 trial of KVD824 for prophylaxis of HAE attacks in the second half of the year."

    Third Quarter and Recent Business Highlights:

    • Announced results of the Phase 2 trial of KVD001, an intravitreal candidate for treatment of diabetic macular edema (DME). KVD001 did not meet its primary endpoint in the overall study population, but it did demonstrate a protection against vision loss and a pre-specified subgroup analysis showed a clinical benefit on vision. The trial was designed to evaluate patients who were poor responders to previous treatment with anti-VEGF therapy. KVD001 was generally safe and well tolerated with no drug-related serious adverse events. Both KVD001 and future oral DME molecules were subject to an option agreement with Merck, which subsequently expired in February.
    • Selected KVD824 for development as an oral prophylactic treatment for hereditary angioedema (HAE). KVD824 is a highly potent and selective plasma kallikrein inhibitor which achieved high exposures and a favorable safety and tolerability profile in a first-in-human study. KalVista intends to initiate a Phase 2 clinical trial in the second half of 2020.

    Fiscal Third Quarter Financial Results:

    • Revenue: Revenue was $1.6 million for the three months ended January 31, 2020, compared to $3.9 million for the same period in 2019. Revenue in the three months ended January 31, 2020 consisted of the recognition of a portion of the upfront payment from Merck related to the agreement signed in October 2017.
    • R&D Expenses: Research and development expenses were $11.2 million for the three months ended January 31, 2020, compared to $7.7 million for the same period in 2019. The increase in R&D expense primarily reflects the ongoing clinical trial for KVD900 and an increase in expense related to preclinical activities in relation to the development of KVD824.
    • G&A Expenses: General and administrative expenses were $3.1 million for the three months ended January 31, 2020, compared to $2.9 million for the same period in 2019.
    • Net Loss: Net loss was $9.3 million, or $(0.52) per basic and diluted share for the three months ended January 31, 2020, compared to a net loss of $4.0 million, or $(0.23) per basic and diluted share, for the same period in 2019.
    • Cash: Cash, cash equivalents and marketable securities were $80.6 million as of January 31, 2020.

    About KalVista Pharmaceuticals, Inc.

    KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. The initial focus is on inhibitors of plasma kallikrein, which is an important component of the body's inflammatory response and which, in excess, can lead to increased vascular permeability, edema and inflammation. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). The Company has created a structurally diverse portfolio of oral plasma kallikrein inhibitors and is advancing multiple drug candidates for HAE as well as DME. KalVista has selected KVD900 as its program to be advanced as an on-demand therapy for acute HAE attacks and is conducting a Phase 2 proof-of-concept study in HAE patients with data expected in the second quarter of 2020. KVD824 is in development for prophylactic treatment of HAE and is expected to enter a Phase 2 clinical trial in the second half of 2020. In DME, an intravitreally administered plasma kallikrein inhibitor known as KVD001, completed a Phase 2 clinical trial in 2019.

    For more information, please visit www.kalvista.com.

    Forward-Looking Statements

    This press release contains "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 references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, available funding, our cash runway, potential future clinical trial timing and results. Further information on potential risk factors that could affect our business and its financial results are detailed in the annual report on Form 10-K filed on July 16, 2019, the quarterly report on Form 10-Q filed on March 10, 2020, and other reports as filed from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

     
    KalVista Pharmaceuticals Inc.
    Condensed Consolidated Balance Sheets
    (in thousands, except share and per share amounts)
    (Unaudited)
     
    January 31, April 30,

    2020

    2019

    Assets
    Current assets:
    Cash and cash equivalents

    $

    18,615

     

    $

    32,006

     

    Marketable securities

     

    61,955

     

     

    68,805

     

    Research and development tax credit receivable

     

    14,803

     

     

    11,315

     

    Prepaid expenses and other current assets

     

    3,632

     

     

    3,420

     

    Total current assets

     

    99,005

     

     

    115,546

     

    Right of use assets

     

    1,497

     

    Property and equipment, net

     

    2,260

     

     

    2,413

     

    Other assets

     

    173

     

     

    173

     

    Total assets

    $

    102,935

     

    $

    118,132

     

    Liabilities and Stockholders' Equity
    Current liabilities:
    Accounts payable

    $

    2,951

     

    $

    2,860

     

    Accrued expenses

     

    4,876

     

     

    5,647

     

    Deferred revenue - current portion

     

    1,343

     

     

    9,545

     

    Lease liability - current portion

     

    592

     

    Total current liabilities

     

    9,762

     

     

    18,052

     

    Long-term liabilities:
    Deferred revenue - net of current portion

     

    2,500

     

     

    3,342

     

    Lease liability - net of current portion

     

    926

     

    Total long-term liabilities

     

    3,426

     

     

    3,342

     

    Stockholders' equity:
    Common stock, $0.001 par value

     

    18

     

     

    17

     

    Additional paid-in capital

     

    206,119

     

     

    191,123

     

    Accumulated deficit

     

    (115,008

    )

     

    (92,476

    )

    Accumulated other comprehensive loss

     

    (1,382

    )

     

    (1,926

    )

    Total stockholders' equity

     

    89,747

     

     

    96,738

     

    Total liabilities and stockholders' equity

    $

    102,935

     

    $

    118,132

     

     
    KalVista Pharmaceuticals Inc.
    Condensed Consolidated Statement of Operations
    (in thousands, except share and per share amounts)
    (Unaudited)
     
     
    Three Months Ended Nine Months Ended
    January 31, January 31,

    2020

    2019

    2020

    2019

     
    Revenue

    $

    1,577

     

    $

    3,890

     

    $

    8,866

     

    $

    13,201

     

    Operating expenses:
    Research and development

     

    11,233

     

     

    7,650

     

     

    30,709

     

     

    23,882

     

    General and administrative

     

    3,068

     

     

    2,900

     

     

    9,733

     

     

    7,879

     

    Total operating expenses

     

    14,301

     

     

    10,550

     

     

    40,442

     

     

    31,761

     

    Operating loss

     

    (12,724

    )

     

    (6,660

    )

     

    (31,576

    )

     

    (18,560

    )

     
    Other income:
    Interest income

     

    372

     

     

    723

     

     

    1,467

     

     

    1,016

     

    Foreign currency exchange gain

     

    138

     

     

    248

     

     

    245

     

     

    83

     

    Other income

     

    2,923

     

     

    1,733

     

     

    7,332

     

     

    5,171

     

    Total other income

     

    3,433

     

     

    2,704

     

     

    9,044

     

     

    6,270

     

    Net loss

    $

    (9,291

    )

    $

    (3,956

    )

    $

    (22,532

    )

    $

    (12,290

    )

     
    Net loss per share to common stockholders, basic and diluted

    $

    (0.52

    )

    $

    (0.23

    )

    $

    (1.27

    )

    $

    (0.85

    )

     
    Weighted average common shares outstanding, basic and diluted

     

    17,838,872

     

     

    17,231,449

     

     

    17,717,057

     

     

    14,379,872

     

     
    KalVista Pharmaceuticals Inc.
    Condensed Consolidated Statements of Cash Flows
    (in thousands, unaudited)
     
    Nine Months Ended
    January 31,

    2020

    2019

     
    Cash Flows from Operating Activities
    Net loss

    $

    (22,532

    )

    $

    (12,290

    )

    Adjustments to reconcile net loss to net cash used in operating activities:
    Depreciation and amortization

     

    382

     

     

    256

     

    Stock-based compensation expense

     

    3,358

     

     

    2,120

     

    Realized (gain) from available for sale securities

     

    (229

    )

    Amortization of right of use assets

     

    418

     

    Amortization of discount/premium on available for sale securities

     

    136

     

    Foreign currency exchange gain

     

    (224

    )

     

    (20

    )

    Changes in operating assets and liabilities:
    Research and development tax credit receivable

     

    (3,405

    )

     

    (2,409

    )

    Prepaid expenses and other current assets

     

    (187

    )

     

    (2,475

    )

    Accounts payable

     

    133

     

     

    1,748

     

    Accrued expenses

     

    (766

    )

     

    417

     

    Lease obligations

     

    (416

    )

    Deferred revenue

     

    (8,866

    )

     

    (13,201

    )

    Net cash used in operating activities

     

    (32,198

    )

     

    (25,854

    )

     
    Cash Flows from Investing Activities
    Acquisition of property and equipment

     

    (212

    )

     

    (806

    )

    Purchases of available for sale securities

     

    (45,114

    )

     

    (55,419

    )

    Sales and maturities of available for sale securities

     

    52,052

     

     

    850

     

    Net cash provided by (used in) investing activities

     

    6,726

     

     

    (55,375

    )

     
    Cash Flows from Financing Activities
    Capital lease principal payments

     

    (53

    )

     

    (155

    )

    Issuance of common stock from equity incentive plans

     

    214

     

     

    132

     

    Issuance of common stock, net of offering expenses

     

    11,422

     

     

    87,811

     

    Net cash provided by financing activities

     

    11,583

     

     

    87,788

     

    Effect of exchange rate changes on cash and cash equivalents

     

    498

     

     

    (1,269

    )

    Net (decrease) increase in cash and cash equivalents

     

    (13,391

    )

     

    5,290

     

    Cash and cash equivalents at beginning of period

     

    32,006

     

     

    51,055

     

    Cash and cash equivalents at end of period

    $

    18,615

     

    $

    56,345

     

     

     

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