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KalVista Pharmaceuticals Reports Fiscal Third Quarter Results

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

CAMBRIDGE, Mass. & SALISBURY, England–(BUSINESS WIRE)–$KALV–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

 

 

 

Contacts

KalVista Pharmaceuticals, Inc.
Leah Monteiro

Senior Director, Corporate Communications & Investor Relations

857-999-0808

[email protected]

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