10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.

For the quarterly period ended January 31, 2023

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.

For the transition period from to .

Commission File No. 001-36830

 

KALVISTA PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

20-0915291

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. Employer Identification No.)

55 Cambridge Parkway

Suite 901E

Cambridge, Massachusetts

 

02142

(Address of principal executive offices)

 

(Zip Code)

 

857-999-0075

(Registrant’s telephone number, including area code)

n/a

 

 

Former name, former address and former fiscal year, if changed since last report

 

Securities registered pursuant to Section 12(b) of the Exchange Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value per share

KALV

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes NO

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes NO

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

 

Large accelerated filer

Accelerated filer

 

 

Non-accelerated filer

Smaller reporting company

 

 

 

 

Emerging growth company

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES NO

As of March 1, 2023, the registrant had 34,169,438 shares of common stock, $0.001 par value per share, issued and outstanding.

 

 


 

Table of Contents

 

 

 

Page

PART I. FINANCIAL INFORMATION

 

 

 

Item 1.

Financial Statements (unaudited)

3

 

 

 

 

Condensed Consolidated Balance Sheets

3

 

 

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

4

 

 

 

 

Condensed Consolidated Statements of Changes in Stockholders’ Equity

5

 

 

 

 

Condensed Consolidated Statements of Cash Flows

7

 

 

 

 

Notes to the Condensed Consolidated Financial Statements

8

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

13

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

20

 

 

 

Item 4.

Controls and Procedures

20

 

 

PART II. OTHER INFORMATION

 

 

 

 

Item 1.

Legal Proceedings

21

 

 

 

Item 1A.

Risk Factors

21

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

21

 

 

 

Item 3.

Defaults Upon Senior Securities

21

 

 

 

Item 4.

Mine Safety Disclosures

21

 

 

 

Item 5.

Other Information

21

 

 

 

Item 6.

Exhibits

22

 

 

 

Signatures

23

 

 

 

 


 

PART I. FINANCIAL INFORMATION

Item 1. FINANCIAL STATEMENTS

KalVista Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

(Unaudited)

 

 

 

January 31,

 

 

April 30,

 

 

 

2023

 

 

2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

85,049

 

 

$

30,732

 

Marketable securities

 

 

86,636

 

 

 

135,470

 

Research and development tax credit receivable

 

 

11,892

 

 

 

14,098

 

Prepaid expenses and other current assets

 

 

8,556

 

 

 

13,347

 

Total current assets

 

 

192,133

 

 

 

193,647

 

Property and equipment, net

 

 

3,037

 

 

 

2,178

 

Right of use assets

 

 

8,101

 

 

 

7,862

 

Other assets

 

 

197

 

 

 

193

 

Total assets

 

$

203,468

 

 

$

203,880

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,698

 

 

$

3,638

 

Accrued expenses

 

 

8,851

 

 

 

6,961

 

Lease liability - current portion

 

 

1,057

 

 

 

977

 

Total current liabilities

 

 

11,606

 

 

 

11,576

 

Long-term liabilities:

 

 

 

 

 

 

Lease liability - net of current portion

 

 

7,421

 

 

 

7,211

 

Total long-term liabilities

 

 

7,421

 

 

 

7,211

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

Common stock, $0.001 par value, 100,000,000 authorized

 

 

 

 

 

 

Shares issued and outstanding: 34,127,762 at January 31, 2023 and 24,550,748 at April 30, 2022

 

 

34

 

 

 

25

 

Additional paid-in capital

 

 

504,725

 

 

 

439,104

 

Accumulated deficit

 

 

(316,777

)

 

 

(250,175

)

Accumulated other comprehensive loss

 

 

(3,541

)

 

 

(3,861

)

Total stockholders’ equity

 

 

184,441

 

 

 

185,093

 

Total liabilities and stockholders’ equity

 

$

203,468

 

 

$

203,880

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

3


 

KalVista Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(Unaudited)

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

January 31,

 

 

January 31,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenue

 

$

 

 

$

 

 

$

 

 

$

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

20,063

 

 

 

19,738

 

 

 

56,325

 

 

 

50,954

 

General and administrative

 

 

6,882

 

 

 

6,945

 

 

 

22,818

 

 

 

18,848

 

Total operating expenses

 

 

26,945

 

 

 

26,683

 

 

 

79,143

 

 

 

69,802

 

Operating loss

 

 

(26,945

)

 

 

(26,683

)

 

 

(79,143

)

 

 

(69,802

)

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

732

 

 

 

258

 

 

 

1,424

 

 

 

822

 

Foreign currency exchange (loss) gain

 

 

597

 

 

 

(198

)

 

 

(237

)

 

 

(529

)

Other income

 

 

4,313

 

 

 

4,156

 

 

 

11,354

 

 

 

11,283

 

Total other income

 

 

5,642

 

 

 

4,216

 

 

 

12,541

 

 

 

11,576

 

Net loss

 

$

(21,303

)

 

$

(22,467

)

 

$

(66,602

)

 

$

(58,226

)

Other comprehensive (loss) income:

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation (loss) gain

 

 

1,128

 

 

 

(445

)

 

 

(573

)

 

 

(430

)

Unrealized holding (loss) gain on marketable securities

 

 

658

 

 

 

(350

)

 

 

808

 

 

 

(773

)

Reclassification adjustment for realized loss (gain) on marketable securities included in net loss

 

 

(1

)

 

 

176

 

 

 

84

 

 

 

296

 

Other comprehensive (loss) income

 

 

1,785

 

 

 

(619

)

 

 

319

 

 

 

(907

)

Comprehensive (loss) income

 

$

(19,518

)

 

$

(23,086

)

 

$

(66,283

)

 

$

(59,133

)

Net loss per share to common stockholders, basic and diluted

 

$

(0.75

)

 

$

(0.92

)

 

$

(2.58

)

 

$

(2.38

)

Weighted average common shares outstanding, basic and diluted

 

 

28,278,453

 

 

 

24,479,660

 

 

 

25,810,369

 

 

 

24,449,788

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

4


 

KalVista Pharmaceuticals, Inc.

Condensed Consolidated Statement of Changes in Stockholders’ Equity

(in thousands, except share amounts)

(Unaudited)

 

 

Nine Months Ended January 31, 2023

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

Other

 

 

Total

 

 

Common Stock

 

 

Paid-in

 

 

Accumulated

 

 

Comprehensive

 

 

Stockholders'

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Equity

 

Balance at May 1, 2022

 

24,550,748

 

 

$

25

 

 

$

439,104

 

 

$

(250,175

)

 

$

(3,861

)

 

$

185,093

 

Issuance of common stock from equity incentive plans

 

20,124

 

 

 

 

 

 

168

 

 

 

 

 

 

 

 

 

168

 

Stock-based compensation expense

 

 

 

 

 

 

 

2,642

 

 

 

 

 

 

 

 

 

2,642

 

Net loss

 

 

 

 

 

 

 

 

 

 

(23,042

)

 

 

 

 

 

(23,042

)

Foreign currency translation (loss) gain

 

 

 

 

 

 

 

 

 

 

 

 

 

(403

)

 

 

(403

)

Unrealized holding (loss) gain from marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

98

 

 

 

98

 

Reclassification adjustment for realized loss (gain) on marketable securities included in net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

16

 

 

 

16

 

Balance at July 31, 2022

 

24,570,872

 

 

$

25

 

 

$

441,914

 

 

$

(273,217

)

 

$

(4,150

)

 

$

164,572

 

Issuance of common stock from equity incentive plans

 

31,151

 

 

 

 

 

 

168

 

 

 

 

 

 

 

 

 

168

 

Stock-based compensation expense

 

 

 

 

 

 

 

2,506

 

 

 

 

 

 

 

 

 

2,506

 

Net loss

 

 

 

 

 

 

 

 

 

 

(22,257

)

 

 

 

 

 

(22,257

)

Foreign currency translation (loss) gain

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,297

)

 

 

(1,297

)

Unrealized holding (loss) gain from marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

52

 

 

 

52

 

Reclassification adjustment for realized loss (gain) on marketable securities included in net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

69

 

 

 

69

 

Balance at October 31, 2022

 

24,602,023

 

 

$

25

 

 

$

444,588

 

 

$

(295,474

)

 

$

(5,326

)

 

$

143,813

 

Issuance of common stock from equity incentive plans

 

41,540

 

 

 

 

 

 

146

 

 

 

 

 

 

 

 

 

146

 

Issuance of common stock, net of issuance costs of $0.3 million

 

9,484,199

 

 

 

9

 

 

 

56,573

 

 

 

 

 

 

 

 

 

56,582

 

Issuance of pre-funded warrants for the purchase of common stock, net of issuance costs

 

 

 

 

 

 

 

1,085

 

 

 

 

 

 

 

 

 

1,085

 

Stock-based compensation expense

 

 

 

 

 

 

 

2,333

 

 

 

 

 

 

 

 

 

2,333

 

Net loss

 

 

 

 

 

 

 

 

 

 

(21,303

)

 

 

 

 

 

(21,303

)

Foreign currency translation (loss) gain

 

 

 

 

 

 

 

 

 

 

 

 

 

1,128

 

 

 

1,128

 

Unrealized holding (loss) gain from marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

658

 

 

 

658

 

Reclassification adjustment for realized loss (gain) on marketable securities included in net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(1

)

 

 

(1

)

Balance at January 31, 2023

 

34,127,762

 

 

$

34

 

 

$

504,725

 

 

$

(316,777

)

 

$

(3,541

)

 

$

184,441

 

 

5


 

 

Nine Months Ended January 31, 2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

Other

 

 

Total

 

 

Common Stock

 

 

Paid-in

 

 

Accumulated

 

 

Comprehensive

 

 

Stockholders'

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Equity

 

Balance at May 1, 2021

 

24,422,531

 

 

$

24

 

 

$

426,437

 

 

$

(167,836

)

 

$

(1,432

)

 

$

257,193

 

Issuance of common stock from equity incentive plans

 

14,984

 

 

 

 

 

 

608

 

 

 

 

 

 

 

 

 

608

 

Stock-based compensation expense

 

 

 

 

 

 

 

2,795

 

 

 

 

 

 

 

 

 

2,795

 

Net loss

 

 

 

 

 

 

 

 

 

 

(16,109

)

 

 

 

 

 

(16,109

)

Foreign currency translation (loss) gain

 

 

 

 

 

 

 

 

 

 

 

 

 

49

 

 

 

49

 

Unrealized holding (loss) gain from marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

(129

)

 

 

(129

)

Reclassification adjustment for realized loss (gain) on marketable securities included in net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

23

 

 

 

23

 

Balance at July 31, 2021

 

24,437,515

 

 

$

24

 

 

$

429,840

 

 

$

(183,945

)

 

$

(1,489

)

 

$

244,430

 

Issuance of common stock from equity incentive plans

 

5,917

 

 

 

 

 

 

63

 

 

 

 

 

 

 

 

 

63

 

Stock-based compensation expense

 

 

 

 

 

 

 

2,860

 

 

 

 

 

 

 

 

 

2,860

 

Net loss

 

 

 

 

 

 

 

 

 

 

(19,650

)

 

 

 

 

 

(19,650

)

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

(33

)

 

 

(33

)

Unrealized holding losses from marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

(295

)

 

 

(295

)

Reclassification adjustment for realized loss on marketable securities included in net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

97

 

 

 

97

 

Balance at October 31, 2021

 

24,443,432

 

 

$

24

 

 

$

432,763

 

 

$

(203,595

)

 

$

(1,720

)

 

$

227,472

 

Issuance of common stock from equity incentive plans

 

93,662

 

 

 

 

 

 

773

 

 

 

 

 

 

 

 

 

773

 

Stock-based compensation expense

 

 

 

 

 

 

 

2,777

 

 

 

 

 

 

 

 

 

2,777

 

Net loss

 

 

 

 

 

 

 

 

 

 

(22,467

)

 

 

 

 

 

(22,467

)

Foreign currency translation adjustment