KalVista Pharmaceuticals Reports Fiscal Second Quarter Results

December 3, 2019 at 7:30 AM EST

KVD900 Phase 2 Trial Data for On-Demand Treatment of HAE Expected in 2020

KVD001 Phase 2 Clinical Trial for Patients with Diabetic Macular Edema (DME) Data Expected This Month

KVD900 Receives FDA Fast Track Designation

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--Dec. 3, 2019-- 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 second quarter ended October 31, 2019.

“We recently received Fast Track designation for KVD900, illustrating the high level of unmet need in the HAE community for efficacious and safe, orally-delivered therapies, said Andrew Crockett, Chief Executive Officer of KalVista. “Our Phase 2 clinical trial for KVD900 continues, and we expect to have data from that trial in 2020. The Phase 2 clinical trial of KVD001 in DME will provide data this month.”

Second Quarter and Recent Business Highlights:

  • Presented at The International Symposium on Ocular Pharmacology and Therapeutics (ISOPT). KalVista’s Chief Scientific Officer, Edward P. Feener, PhD, spoke on “Kallikrein-Kinin System in Diabetic Retinopathy – Novel Target.”
  • Announced that the Phase 2 trial of KVD900 as an on-demand therapy for HAE is anticipated to complete enrollment in 2019 with data expected in 2020. The trial is being conducted in approximately 20 sites in Europe and the U.S.
  • Received Fast Track designation for KVD900 from the U.S. FDA, supporting the Company’s belief in the high level of unmet need in HAE and providing a potentially expedited path to drug approval.

Fiscal Second Quarter Financial Results:

  • Revenue: Revenue was $3.9 million for the three months ended October 31, 2019, compared to $5.6 million for the same period in 2018. Revenue in the three months ended October 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 $9.8 million for the three months ended October 31, 2019, compared to $7.9 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 expense related to preclinical activities.
  • G&A Expenses: General and administrative expenses were $3.4 million for the three months ended October 31, 2019, compared to $2.6 million for the same period in 2018.
  • Net Loss: Net loss was $5.9 million, or $(0.33) per basic and diluted share for the three months ended October 31, 2019, compared to a net loss of $3.3 million, or $(0.22) per basic and diluted share, for the same period in 2018.
  • Cash: Cash, cash equivalents and marketable securities were $93.5 million as of October 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 Company’s 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 HAE attacks and is conducting a Phase 2 proof-of-concept study in HAE patients that is expected to provide data in 2020. In DME, KalVista’s most advanced program, an intravitreally administered plasma kallikrein inhibitor known as KVD001, is anticipated to report data from a Phase 2 clinical trial 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 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 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)
 
October 31, April 30,

 

2019

 

 

2019

 

Assets
Current assets:
Cash and cash equivalents

$

21,719

 

$

32,006

 

Marketable securities

 

71,742

 

 

68,805

 

Research and development tax credit receivable

 

11,814

 

 

11,315

 

Prepaid expenses and other current assets

 

2,617

 

 

3,420

 

Total current assets

 

107,892

 

 

115,546

 

Right of use assets

 

1,634

 

Property and equipment, net

 

2,365

 

 

2,413

 

Other assets

 

173

 

 

173

 

Total assets

$

112,064

 

$

118,132

 

Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable

$

2,238

 

$

2,860

 

Accrued expenses

 

5,029

 

 

5,647

 

Deferred revenue - current portion

 

2,601

 

 

9,545

 

Lease liability - current portion

 

602

 

Total current liabilities

 

10,470

 

 

18,052

 

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

 

2,754

 

 

3,342

 

Lease liability - net of current portion

 

1,053

 

Total long-term liabilities

 

3,807

 

 

3,342

 

Stockholders’ equity:
Common stock, $0.001 par value

 

18

 

 

17

 

Additional paid-in capital

 

204,950

 

 

191,123

 

Accumulated deficit

 

(105,717

)

 

(92,476

)

Accumulated other comprehensive loss

 

(1,464

)

 

(1,926

)

Total stockholders’ equity

 

97,787

 

 

96,738

 

Total liabilities and stockholders' equity

$

112,064

 

$

118,132

 

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

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 
Revenue

$

3,920

 

$

5,592

 

$

7,289

 

$

9,311

 

Operating expenses:
Research and development

 

9,789

 

 

7,876

 

 

19,476

 

 

16,232

 

General and administrative

 

3,420

 

 

2,609

 

 

6,665

 

 

4,979

 

Total operating expenses

 

13,209

 

 

10,485

 

 

26,141

 

 

21,211

 

Operating loss

 

(9,289

)

 

(4,893

)

 

(18,852

)

 

(11,900

)

 
Other income:
Interest income

 

505

 

 

204

 

 

1,095

 

 

293

 

Foreign currency exchange gain (loss)

 

560

 

 

(231

)

 

108

 

 

(165

)

Other income

 

2,321

 

 

1,616

 

 

4,408

 

 

3,438

 

Total other income

 

3,386

 

 

1,589

 

 

5,611

 

 

3,566

 

Net loss

$

(5,903

)

$

(3,304

)

$

(13,241

)

$

(8,334

)

 
Net loss per share, basic and diluted

$

(0.33

)

$

(0.22

)

$

(0.75

)

$

(0.64

)

 
Weighted average common shares outstanding, basic and diluted

 

17,823,302

 

 

15,108,272

 

 

17,656,150

 

 

12,954,083

 

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

 

2019

 

 

2018

 

 
Cash Flows from Operating Activities
Net loss

$

(13,241

)

$

(8,334

)

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

 

248

 

 

153

 

Stock-based compensation expense

 

2,236

 

 

1,323

 

Realized (gain) loss from available for sale securities

 

(129

)

Amortization of right of use assets

 

273

 

Amortization of discount/premium on available for sale securities

 

79

 

Foreign currency remeasurement (gain) loss

 

(81

)

 

226

 

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

 

(577

)

 

(692

)

Prepaid expenses and other current assets

 

785

 

 

(517

)

Accounts payable

 

(558

)

 

2,088

 

Accrued expenses

 

(564

)

 

66

 

Lease obligations

 

(271

)

Deferred revenue

 

(7,289

)

 

(9,311

)

Net cash used in operating activities

 

(19,089

)

 

(14,998

)

 
Cash Flows from Investing Activities
Acquisition of property and equipment

 

(212

)

 

(786

)

Purchases of available for sale securities

 

(42,561

)

Sales and maturities of available for sale securities

 

39,729

 

Net cash used in investing activities

 

(3,044

)

 

(786

)

 
Cash Flows from Financing Activities
Capital lease principal payments

 

(54

)

 

(104

)

Issuance of common stock from equity incentive plans

 

170

 

 

25

 

Issuance of common stock, net of $123 of offering expenses

 

11,422

 

 

87,811

 

Net cash provided by financing activities

 

11,538

 

 

87,732

 

Effect of exchange rate changes on cash and cash equivalents

 

308

 

 

(1,887

)

Net (decrease) increase in cash and cash equivalents

 

(10,287

)

 

70,061

 

Cash and cash equivalents, beginning of period

 

32,006

 

 

51,055

 

Cash and cash equivalents, end of period

$

21,719

 

$

121,116

 

 

Source: KalVista Pharmaceuticals, Inc.

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