KalVista Pharmaceuticals Reports Fiscal First Quarter Results

September 14, 2018 at 7:00 AM EDT

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

– KVD900 Phase 2 On Track to Begin in 2018 for Potential On-Demand Treatment of Acute Attacks in Patients with Hereditary Angioedema –

– Intravitreal Diabetic Macular Edema Candidate KVD001 Enrollment On Track with Data Expected in H2 2019 –

– Over $87 million Net Proceeds from Two Recent Equity Offerings –

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 first quarter ended July 31, 2018.

“Our two recent financings provide significant additional capital for late stage development of KVD900, our oral plasma kallikrein inhibitor for potential treatment of on-demand acute attacks in patients with hereditary angioedema, or HAE,” said Andrew Crockett, Chief Executive Officer of KalVista. “KVD001, our intravitreal candidate for potential treatment of diabetic macular edema, or DME, currently enrolling a Phase 2 clinical trial, continues with data expected as planned in the second half of 2019. Additionally, we remain committed to our work in discovering and developing oral plasma kallikrein inhibitors for prophylactic treatment of HAE as well as DME. Finally, we recently moved to our new facility in Porton Down, England, which is intended to support our scientific team as they continue to work on discovery and development of additional drug programs.”

First Quarter and Recent Business Highlights:

  • 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 expects to receive approximately $73.3 million in net proceeds from the offering after deducting underwriting fees and expenses, which is anticipated to fund operations into 2021.
  • Occupied a new, 8,873 square foot laboratory and office facility in Porton Science Park, Salisbury, England. The opening of this facility is an important step in our planned growth, and reflects the ongoing commitment to our internal research capabilities as a key strategic strength of the Company. The KalVista research team has decades of experience in discovering and developing protease inhibitors, and this new facility will significantly expand our capacity and capabilities.
  • Selected KVD900 to advance to a Phase 2 proof-of-concept clinical trial for potential on-demand treatment of acute attacks in patients with HAE.
  • In July 2018, announced the sale of approximately $14.6 million in common stock to Venrock Healthcare Capital Partners and BVF Partners L.P. in a registered direct transaction. This transaction was closed in August.

Fiscal First Quarter Financial Results:

  • Revenue: Revenue was $3.7 million for the three months ended July 31, 2018, compared to $0.1 million for the same period in 2017. Revenue in the three months ended July 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 $8.4 million for the three months ended July 31, 2018, compared to $3.5 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 $2.4 million for the three months ended July 31, 2018, compared to $2.1 million for the same period in 2017. The increase was primarily due to an increase in payroll related expenses and expenses related to our new facility in the U.K. in the three months ended July 31, 2018 compared to those incurred in the same period in 2017.
  • Net Loss: Net loss was $5.0 million, or $(0.47) per basic and diluted share for the three months ended July 31, 2018, compared to a net loss of $4.9 million, or $(0.51) per basic and diluted share, for the same period in 2017.
  • Cash: Cash and cash equivalents were $48.1 million as of July 31, 2018. The cash balance at July 31, 2018 includes $5.0 million of proceeds from the $14.6 million registered direct financing, which closed on August 2, 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 acute 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 report data 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)
                     
            July 31,       April 30,
            2018       2018
Assets                    
Current assets:                    
Cash and cash equivalents           $ 48,070         $ 51,055  
Research and development tax credit receivable             5,604           6,834  
Prepaid expenses and other current assets             1,511           1,491  
Total current assets             55,185           59,380  
Other assets             173           173  
Property and equipment, net             2,260           1,836  
Total assets           $ 57,618         $ 61,389  
Liabilities and Stockholders' Equity                    
Current liabilities:                    
Accounts payable           $ 2,345         $ 1,433  
Accrued expenses             3,137           3,087  
Deferred revenue - current portion             17,207           18,475  
Capital lease liability - current portion             214           221  
Total current liabilities             22,903           23,216  
Long-term liabilities:                    
Deferred revenue - net of current portion             8,465           10,862  
Capital lease liability - net of current portion             -           58  
Total long-term liabilities             8,465           10,920  
Stockholders’ equity:                    
Common stock, $0.001 par value             11           11  
Additional paid-in capital             105,358           100,011  
Accumulated deficit             (76,690 )         (71,660 )
Accumulated other comprehensive loss             (2,429 )         (1,109 )
Total stockholders’ equity             26,250           27,253  
Total liabilities and stockholders' equity           $ 57,618         $ 61,389  
                     
 
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share amounts)
(Unaudited)
                     
            Three Months Ended
            July 31,
            2018       2017
                     
                     
Revenue           $ 3,718         $ 96  
Operating expenses:                    
Research and development             8,356           3,476  
General and administrative             2,371           2,073  
Total operating expenses             10,727           5,549  
Operating loss             (7,009 )         (5,453 )
                     
Other income:                    
Interest income             89           2  
Foreign currency exchange rate gain (loss)             67           (32 )
Other income             1,823           555  
Total other income             1,979           525  
Net loss           $ (5,030 )       $ (4,928 )
                     
Net loss per share to common stockholders, basic and diluted           $ (0.47 )       $ (0.51 )
                     
Weighted average common shares outstanding, basic and diluted             10,799,895           9,713,042  
                     
 
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands, unaudited)
                     
            Three Months Ended
            July 31
            2018       2017
                     
Cash Flows from Operating Activities                    
Net loss           $ (5,030 )       $ (4,928 )
Adjustments to reconcile net loss to net cash used in operating activities                    
Depreciation and amortization             50           32  
Stock-based compensation expense             347           221  
Foreign currency remeasurement loss             6           32  
Changes in operating assets and liabilities:                    
Research and development tax credit receivable             919           (530 )
Prepaid expenses and other current assets             (69 )         (85 )
Grants and other receivables                       224  
Accounts payable             1,126           771  
Accrued expenses             157           (185 )
Deferred revenue             (3,718 )          
Net cash used in operating activities             (6,212 )         (4,448 )
                     
Cash Flows from Investing Activities                    
Acquisition of property and equipment             (565 )         (110 )
Net cash used in investing activities             (565 )         (110 )
                     
Cash Flows from Financing Activities                    
Capital lease principal payments             (52 )          
Proceeds from issuance of common stock             5,000            
Net cash provided by financing activities             4,948            
Effect of exchange rate changes on cash and cash equivalents             (1,156 )         64  
Net decrease in cash and cash equivalents             (2,985 )         (4,494 )
Cash and cash equivalents, beginning of period             51,055           30,950  
Cash and cash equivalents, end of period           $ 48,070         $ 26,456  

 

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