Creating a new generation of small molecule protease inhibitors

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KalVista Pharmaceuticals Reports Fiscal Third Quarter Results

– Enrollment Ongoing for a Phase 2 Clinical Trial of KVD001 in Diabetic Macular Edema (“DME”) and a Phase 1 Clinical Trial for the Second Candidate in the Oral Hereditary Angioedema (“HAE) Portfolio –

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 16, 2018-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today reported operational and financial results for the fiscal third quarter ended January 31, 2018.

“We are pleased to have the second candidate from our oral hereditary angioedema portfolio in a Phase 1 trial as we continue to pursue a best-in-class therapy,” said Andrew Crockett, Chief Executive Officer of KalVista. “Our diabetic macular edema compound KVD001 is enrolling in a Phase 2 clinical trial for which we expect to see data in the second half of 2019. The cash position of KalVista continues to be sufficient to reach data readouts in both of these ongoing trials.”

Recent Business Highlights:

  • Announced initiation of two clinical trials: A Phase 2 proof-of-concept clinical trial evaluating the safety, tolerability, and efficacy of KVD001 as a treatment for DME, as well as a Phase 1 trial for KVD900, the second clinical candidate in the HAE portfolio. KalVista also intends to bring at least one additional HAE drug candidate to the clinic before the end of 2018.
  • KalVista’s Chief Scientific Officer, Edward Feener, Ph.D., presented at The International Symposium on Ocular Pharmacology and Therapeutics (ISOPT) on March 2, 2018, in Tel-Aviv, Israel.

Upcoming Events:

  • Presenting “A Novel Oral Plasma Kallikrein (PKal) Inhibitor KV123833 Blocks VEGF-Mediated Retinal Vascular Hyperpermeability in a Murine Model of Retinal Edema,” at The Association for Research in Vision and Ophthalmology (ARVO) on May 1, 2018, in Honolulu, Hawaii.

Fiscal Third Quarter Financial Results:

  • Revenue: Revenue was $2.3 million for the three months ended January 31, 2018, compared to $0.2 million for the same period in 2017. The increase in revenue is primarily due to revenue recognized from the Merck option agreement.
  • R&D Expenses: Research and development expenses were $4.5 million for the three months ended January 31, 2018, compared to $3.3 million for the same period in 2017. The increase in R&D expense is due to an overall increase in research activities, primarily driven by the KVD001 Phase 2 trial as well as spending on our other development programs.
  • G&A Expenses: General and administrative expenses were $2.1 million for the three months ended January 31, 2018, compared to $5.0 million for the same period in 2017. The decrease was primarily due to a $2.1 million decrease in professional fees and $0.7 million of severance and payroll expenses related to the share purchase transaction with Carbylan Therapeutics, Inc. in the prior year.
  • Net Loss: Net loss was $5.2 million, or $(0.49) per basic and diluted share for the three months ended January 31, 2018, compared to a net loss of $7.6 million, or $(1.03) per basic and diluted share, for the same period in 2017.
  • Cash: Cash and cash equivalents were $58.7 million as of January 31, 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. KalVista’s most advanced program, an intravitreally administered plasma kallikrein inhibitor known as KVD001, has successfully completed its first-in-human study in patients with DME and began a Phase 2 clinical trial in 2017.

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 27, 2017, our most recent Quarterly Report on Form 10-Q, 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,
2018 2017
Assets
Current assets:
Cash and cash equivalents $ 58,678 $ 30,950
Research and development tax credit receivable 4,989 2,250
Grants and other receivables 40 297
Prepaid expenses and other current assets   2,003     701  
Total current assets 65,710 34,198
 
 
Other assets 173 50
Property and equipment, net   774     97  
Total assets $ 66,657   $ 34,345  
 
Liabilities and Stockholders' Equity
 
Accounts payable $ 1,575 $ 1,153
Accrued expenses 2,290 1,865
Deferred revenue - current portion 19,996 -
Capital lease liability - current portion   222     -  
Total current liabilities   24,083     3,018  
Long-term liabilities:
Deferred revenue - net of current portion 13,889 -
Capital lease liability, net of current portion   117     -  

Total long-term liabilities

  14,006     -  
Stockholders’ equity
Common stock, $0.001 par value 11 10
Additional paid-in capital 99,696 89,815
Accumulated deficit (71,003 ) (55,855 )
Accumulated other comprehensive loss   (136 )   (2,643 )
Total stockholders’ equity   28,568     31,327  
Total liabilities and stockholders' equity $ 66,657   $ 34,345  
 
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
               
 
Three Months Ended Nine Months Ended
January 31, January 31,
2018 2017 2018 2017
 
 
Revenue $ 2,331 $ 248 $ 3,554 $ 1,390
Operating expenses:
Research and development 4,548 3,339 12,385 9,670
General and administrative   2,129     5,026     6,905     8,973  
Total operating expenses   6,677     8,365     19,290     18,643  
Operating loss   (4,346 )   (8,117 )   (15,736 )   (17,253 )
 
Other income (expense):
Interest income 14 7 17 31
Foreign currency exchange gain (loss) (1,887 ) (195 ) (1,836 ) 1,511
Other income   985     661     2,407     1,310  
Total other income   (888 )   473     588     2,852  
Net loss $ (5,234 ) $ (7,644 ) $ (15,148 ) $ (14,401 )
 
Net loss per share to common stockholders, basic and diluted $ (0.49 ) $ (1.03 ) $ (1.49 ) $ (5.50 )
 
Weighted average common shares outstanding, basic and diluted 10,788,556 7,657,874 10,168,520 3,013,073
 
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands, unaudited)
       
 
Nine Months Ended
January 31
2018 2017
 
Cash Flows from Operating Activities
Net loss $ (15,148 ) $ (14,401 )
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Depreciation and amortization 129 29
Stock-based compensation 779 228
Foreign currency remeasurement (gain) loss (500 ) (1,464 )
Changes in operating assets and liabilities:
Research and development tax credit receivable (2,383 ) (1,303 )
Prepaid expenses and other current assets (1,206 ) (689 )
Grants and other receivables 281 36
Other assets (123 ) -
Accounts payable 548 (1,957 )
Accrued expenses 332 (1,560 )
Deferred revenue   33,804     -  
Net cash provided by (used in) operating activities   16,513     (21,081 )
 
Cash Flows from Investing Activities
Cash acquired in transaction - 34,139
Acquisition of property and equipment   (343 )   (67 )
Net cash provided by (used in) investing activities   (343 )   34,072  
 
Cash Flows from Financing Activities
Capital lease principal payments (101 ) -
Issuance of common stock   9,100     2  
Net cash from financing activities   8,999     2  
Effect of exchange rate changes on cash   2,559     (1,259 )
Net increase in cash and cash equivalents 27,728 11,734
Cash and cash equivalents, beginning of period   30,950     21,764  
Cash and cash equivalents, end of period $ 58,678   $ 33,498  

Source: KalVista Pharmaceuticals, Inc.

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