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KalVista Pharmaceuticals Reports Fiscal Second Quarter Results

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--

– KVD900 Enlarged Phase 2 Trial on Track for Potential On-Demand Treatment of Attacks in Patients with Hereditary Angioedema –

– Intravitreal Diabetic Macular Edema Candidate KVD001 Phase 2 Trial Enrollment on Track with Completion Expected in H2 2019 –

– Operations Funded into 2021 –

KalVista Pharmaceuticals, Inc. (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 second quarter ended October 31, 2018.

“We are still on track with our robust Phase 2 study for KVD900 as a potential acute therapy for patients with hereditary angioedema, or HAE,” said Andrew Crockett, Chief Executive Officer of KalVista. “Our intention is to have an aggressive development plan for KVD900, and use this Phase 2 data set as a basis for discussions with regulators about a faster approval pathway. KVD001, our intravitreal candidate for potential treatment of diabetic macular edema, or DME, currently enrolling a Phase 2 clinical trial, will complete in the second half of 2019.”

Second Quarter and Recent Business Highlights:

  • Announced a more aggressive development plan for KVD900 as an on-demand treatment for attacks of hereditary angioedema (HAE). Data from the enlarged Phase 2 study is expected in late 2019. The Company intends to investigate the efficacy of KVD900 as a potential on-demand treatment for HAE attacks in approximately 50 type 1 and 2 HAE patients.
  • Raised $78.2 million in gross proceeds from a previously announced public offering of 4.6 million shares of common stock at a price of $17.00 per share. The Company received $73.3 million in net proceeds from the offering after deducting underwriting fees and expenses, which is anticipated to fund operations into 2021.

Upcoming Events:

  • Presenting during a poster session at The American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, February 22-25, 2019 in San Francisco, CA:

    Presentation Date: Saturday, February 23, 2019
    Presentation Time: 9:45am-10:45am PT
    Abstract Title: KVD900 as a Single Dose, Rapid, Oral Plasma Kallikrein Inhibitor for the On-Demand Treatment of Hereditary Angioedema Attacks: Pharmacokinetic and Pharmacodynamic results from a Phase 1 Single Ascending Dose Study.
    Session: 2209; Poster 116
    Session Title: Urticaria and Angioedema

Fiscal Second Quarter Financial Results:

  • Revenue: Revenue was $5.6 million for the three months ended October 31, 2018, compared to $1.1 million for the same period in 2017. Revenue in the three months ended October 31, 2018 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 $7.9 million for the three months ended October 31, 2018, compared to $4.4 million for the same period in 2017. The increase in R&D expense primarily reflects the ongoing clinical trials for KVD001 and KVD900.
  • G&A Expenses: General and administrative expenses were $2.6 million for the three months ended October 31, 2018, compared to $2.7 million for the same period in 2017.
  • Net Loss: Net loss was $3.3 million, or $(0.22) per basic and diluted share for the three months ended October 31, 2018, compared to a net loss of $5.0 million, or $(0.50) per basic and diluted share, for the same period in 2017.
  • Cash: Cash and cash equivalents were $121.1 million as of October 31, 2018. The cash balance at October 31, 2018 includes $73.3 million of net proceeds from the Public Offering, which closed on September 10, 2018.

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 into Phase 1 clinical trials for HAE. The Company has selected KVD900 as its program to be advanced as an on-demand therapy for HAE attacks, and anticipates commencing a Phase 2 proof-of-concept study in HAE patients in late 2018. In DME, KalVista’s most advanced program, an intravitreally administered plasma kallikrein inhibitor known as KVD001, began a Phase 2 clinical trial in 2017 that is anticipated to complete in the second half of 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 and 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 30, 2018 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)
     
October 31,
2018
April 30,
2018
Assets
Current assets:
Cash and cash equivalents $ 121,116 $ 51,055
Research and development tax credit receivable 7,032 6,834
Prepaid expenses and other current assets   1,922     1,491  
Total current assets 130,070 59,380
Other assets 173 173
Property and equipment, net   2,316     1,836  
Total assets $ 132,559   $ 61,389  
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 3,018 $ 1,433
Accrued expenses 2,994 3,087
Deferred revenue - current portion 14,769 18,475
Capital lease liability - current portion   157     221  
Total current liabilities   20,938     23,216  
Long-term liabilities:
Deferred revenue - net of current portion 4,670 10,862
Capital lease liability - net of current portion   -     58  
Total long-term liabilities   4,670     10,920  
Stockholders’ equity:
Common stock, $0.001 par value 17 11
Additional paid-in capital 189,164 100,011
Accumulated deficit (79,994 ) (71,660 )
Accumulated other comprehensive loss   (2,236 )   (1,109 )
Total stockholders’ equity   106,951     27,253  
Total liabilities and stockholders' equity $ 132,559   $ 61,389  
 
 
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share amounts)
(Unaudited)
         
 
Three Months Ended
October 31,
Six Months Ended
October 31,
2018 2017 2018 2017
 
 
Revenue $ 5,592 $ 1,127 $ 9,311 $ 1,223
Operating expenses:
Research and development 7,876 4,361 16,232 7,837
General and administrative   2,609     2,703     4,979     4,776  
Total operating expenses   10,485     7,064     21,211     12,613  
Operating loss   (4,893 )   (5,937 )   (11,900 )   (11,390 )
 
Other income:
Interest income 204 1 293 3
Foreign currency exchange rate gain (loss) (231 ) 83 (165 ) 51
Other income   1,616     867     3,438     1,422  
Total other income   1,589     951     3,566     1,476  
Net loss $ (3,304 ) $ (4,986 ) $ (8,334 ) $ (9,914 )
 
Net loss per share to common stockholders, basic and diluted $ (0.22 ) $ (0.50 ) $ (0.64 ) $ (1.01 )
 
Weighted average common shares outstanding, basic and diluted 15,108,272 10,003,963 12,954,083 9,858,502
 
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands, unaudited)
     
Six Months Ended
October 31
2018 2017
 
Cash Flows from Operating Activities
Net loss $ (8,334 ) $ (9,914 )
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation and amortization 153 79
Stock-based compensation expense 1,323 494
Foreign currency remeasurement loss 226 31
Changes in operating assets and liabilities:
Research and development tax credit receivable (692 ) (1,397 )
Prepaid expenses and other current assets (517 ) (636 )
Grants and other receivables (590 )
Accounts payable 2,088 (139 )
Accrued expenses 66 365
Deferred revenue   (9,311 )    
Net cash used in operating activities   (14,998 )   (11,707 )
 
Cash Flows from Investing Activities
Acquisition of property and equipment   (786 )   (161 )
Net cash used in investing activities   (786 )   (161 )
 
Cash Flows from Financing Activities
Capital lease principal payments (104 ) (49 )
Issuance of common stock from stock option exercises 25
Issuance of common stock, net of offering expenses   87,811     9,100  
Net cash provided by financing activities   87,732     9,051  
Effect of exchange rate changes on cash and cash equivalents   (1,887 )   (5 )
Net decrease in cash and cash equivalents 70,061 (2,822 )
Cash and cash equivalents, beginning of period   51,055     30,950  
Cash and cash equivalents, end of period $ 121,116   $ 28,128  
 

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