KalVista Pharmaceuticals Reports Fiscal First Quarter Results of 2019

Sept. 9, 2019 11:30 UTC
  • Phase 2 Clinical Trial of KVD900 for On-Demand Oral Treatment of Hereditary Angioedema (HAE) Attacks Expected to Complete in Late 2019
  • KVD001 Phase 2 Clinical Trial for Patients with Diabetic Macular Edema (DME) Data Expected in Q4 2019

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- 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 first quarter ended July 31, 2019.

“With enrollment complete in our Phase 2 trial for KVD001, we expect data in the fourth quarter of 2019,” said Andrew Crockett, Chief Executive Officer of KalVista. “Our second ongoing Phase 2 trial, with KVD900 for on-demand treatment of hereditary angioedema attacks is currently enrolling, and we continue to expect to complete that trial late this year. On the research side, our team continues to work on our earlier stage programs including KVD824, for which we expect to announce further development plans in the first half of 2020.”

First Quarter 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.

Fiscal First Quarter Financial Results:

  • Revenue: Revenue was $3.4 million for the three months ended July 31, 2019, compared to $3.7 million for the same period in 2018. Revenue in the three months ended July 31, 2019 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 $9.7 million for the three months ended July 31, 2019, compared to $8.4 million for the same period in 2018. The increase in R&D expense primarily reflects the ongoing clinical trial for KVD900 and an increase in preclinical activities. These increases in expense were somewhat offset by a decrease in expense related to KVD001 as it heads toward completion of a Phase 2 clinical trial later this year.
  • G&A Expenses: General and administrative expenses were $3.2 million for the three months ended July 31, 2019, compared to $2.4 million for the same period in 2018. The increase was primarily due to an increase in compensation related expenses and professional fees in the three months ended July 31, 2019 compared to those incurred in the same period in 2018.
  • Net Loss: Net loss was $7.3 million, or $(0.42) per basic and diluted share for the three months ended July 31, 2019, compared to a net loss of $5.0 million, or $(0.47) per basic and diluted share, for the same period in 2018.
  • Cash: Cash, cash equivalents and marketable securities were $100.4 million as of July 31, 2019.

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. The Company has selected KVD900 as its program to be advanced as an on-demand therapy for acute HAE attacks and commenced 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 report data in the fourth quarter 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, 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 15, 2019 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)
           
    July 31,   April 30,
   

2019

 

2019

Assets          
Current assets:          
Cash and cash equivalents  

$

30,107

   

$

32,006

 
Marketable securities    

70,259

     

68,805

 
Research and development tax credit receivable    

12,625

     

11,315

 
Prepaid expenses and other current assets    

2,728

     

3,420

 
Total current assets    

115,719

     

115,546

 
Right of use assets    

1,737

     
Property and equipment, net    

2,255

     

2,413

 
Other assets    

173

     

173

 
Total assets  

$

119,884

   

$

118,132

 
Liabilities and Stockholders' Equity          
Current liabilities:          
Accounts payable  

$

3,103

   

$

2,860

 
Accrued expenses    

4,261

     

5,647

 
Deferred revenue - current portion    

6,023

     

9,545

 
Lease liability - current portion    

580

     

 
Total current liabilities    

13,967

     

18,052

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

2,873

     

3,342

 
Lease liability - net of current portion    

1,177

     
Total long-term liabilities    

4,050

     

3,342

 
Stockholders’ equity:          
Common stock, $0.001 par value    

18

     

17

 
Additional paid-in capital    

203,650

     

191,123

 
Accumulated deficit    

(99,814

)

   

(92,476

)

Accumulated other comprehensive loss    

(1,987

)

   

(1,926

)

Total stockholders’ equity    

101,867

     

96,738

 
Total liabilities and stockholders' equity  

$

119,884

   

$

118,132

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

2019

 

2018

 
           
Revenue  

$

3,369

   

$

3,718

   
Operating expenses:          
Research and development    

9,686

     

8,356

   
General and administrative    

3,247

     

2,371

   
Total operating expenses    

12,933

     

10,727

   
Operating loss    

(9,564

)

   

(7,009

)

 
           
Other income:          
Interest income    

590

     

89

   
Foreign currency exchange rate gain (loss)    

(453

)

   

67

   
Other income    

2,089

     

1,823

   
Total other income    

2,226

     

1,979

   
Net loss  

$

(7,338

)

 

$

(5,030

)

 
           
Net loss per share, basic and diluted  

$

(0.42

)

 

$

(0.47

)

 
           
Weighted average common shares outstanding, basic and diluted    

17,488,997

     

10,799,895

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

2019

   

2018

         
Cash Flows from Operating Activities        
Net loss  

$

(7,338

)

 

$

(5,030

)

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

121

     

50

 
Stock-based compensation expense    

1,074

     

347

 
Realized (gain) loss from available for sale securities    

(29

)

 
Amortization of right of use assets    

138

   
Amortization of discount/premium on available for sale securities    

35

   
Foreign currency remeasurement loss    

454

     

6

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

(2,060

)

   

919

 
Prepaid expenses and other current assets    

561

     

(69

)

Other assets    
Accounts payable    

392

     

1,126

 
Accrued expenses    

(1,117

)

   

157

 
Lease obligations    

(137

)

 
Deferred revenue    

(3,369

)

   

(3,718

)

Net cash used in operating activities    

(11,275

)

   

(6,212

)

         
Cash Flows from Investing Activities        
Acquisition of property and equipment    

(98

)

   

(565

)

Purchases of available for sale securities    

(19,646

)

 
Sales and maturities of available for sale securities    

18,214

   
Net cash used in investing activities    

(1,530

)

   

(565

)

         
Cash Flows from Financing Activities        
Capital lease principal payments    

(54

)

   

(52

)

Proceeds from issuance of common stock from equity incentive plans    

32

   
Proceeds from issuance of common stock, net of $123 of offering expenses    

11,422

     

5,000

 
Net cash provided by financing activities    

11,400

     

4,948

 
Effect of exchange rate changes on cash and cash equivalents    

(494

)

   

(1,156

)

Net decrease in cash and cash equivalents    

(1,899

)

   

(2,985

)

Cash and cash equivalents, beginning of period    

32,006

     

51,055

 
Cash and cash equivalents, end of period  

$

30,107

   

$

48,070

 

Contacts

KalVista Pharmaceuticals, Inc.
Leah Monteiro
Senior Director, Corporate Communications & Investor Relations
857-999-0808
leah.monteiro@kalvista.com

Source: KalVista Pharmaceuticals, Inc.

Back to news