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, 2022

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 8, 2022, the registrant had 24,543,256 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)

1

 

 

 

 

Condensed Consolidated Balance Sheets

1

 

 

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

2

 

 

 

 

Condensed Consolidated Statements of Changes in Stockholders’ Equity

3

 

 

 

 

Condensed Consolidated Statements of Cash Flows

5

 

 

 

 

Notes to the Condensed Consolidated Financial Statements

6

 

 

 

Item 2.

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

11

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

19

 

 

 

Item 4.

Controls and Procedures

19

 

 

PART II. OTHER INFORMATION

 

 

 

 

Item 1.

Legal Proceedings

20

 

 

 

Item 1A.

Risk Factors

20

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

20

 

 

 

Item 3.

Defaults Upon Senior Securities

20

 

 

 

Item 4.

Mine Safety Disclosures

20

 

 

 

Item 5.

Other Information

21

 

 

 

Item 6.

Exhibits

21

 

 

 

Signatures

22

 

 

 

 


 

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,

 

 

 

2022

 

 

2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

45,577

 

 

$

50,592

 

Marketable securities

 

 

149,212

 

 

 

198,337

 

Research and development tax credit receivable

 

 

11,287

 

 

 

10,418

 

Prepaid expenses and other current assets

 

 

8,388

 

 

 

4,917

 

Total current assets

 

 

214,464

 

 

 

264,264

 

Property and equipment, net

 

 

2,215

 

 

 

1,791

 

Right of use assets

 

 

8,180

 

 

 

5,758

 

Other assets

 

 

193

 

 

 

200

 

Total assets

 

$

225,052

 

 

$

272,013

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

2,185

 

 

$

1,981

 

Accrued expenses

 

 

6,450

 

 

 

6,930

 

Lease liability - current portion

 

 

1,014

 

 

 

863

 

Total current liabilities

 

 

9,649

 

 

 

9,774

 

Long-term liabilities:

 

 

 

 

 

 

Lease liability - net of current portion

 

 

7,467

 

 

 

5,046

 

Total long-term liabilities

 

 

7,467

 

 

 

5,046

 

Commitments and contingencies (Note 5)

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

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

 

 

 

 

 

 

Shares issued and outstanding: 24,537,094 at January 31, 2022 and 24,422,531 at April 30, 2021

 

 

24

 

 

 

24

 

Additional paid-in capital

 

 

436,313

 

 

 

426,437

 

Accumulated deficit

 

 

(226,062

)

 

 

(167,836

)

Accumulated other comprehensive loss

 

 

(2,339

)

 

 

(1,432

)

Total stockholders’ equity

 

 

207,936

 

 

 

257,193

 

Total liabilities and stockholders’ equity

 

$

225,052

 

 

$

272,013

 

 

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

 

1


 

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,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue

 

$

 

 

$

 

 

$

 

 

$

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

19,738

 

 

 

9,097

 

 

 

50,954

 

 

 

29,409

 

General and administrative

 

 

6,945

 

 

 

3,560

 

 

 

18,848

 

 

 

10,472

 

Total operating expenses

 

 

26,683

 

 

 

12,657

 

 

 

69,802

 

 

 

39,881

 

Operating loss

 

 

(26,683

)

 

 

(12,657

)

 

 

(69,802

)

 

 

(39,881

)

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

258

 

 

 

137

 

 

 

822

 

 

 

589

 

Foreign currency exchange (loss) gain

 

 

(198

)

 

 

301

 

 

 

(529

)

 

 

715

 

Other income

 

 

4,156

 

 

 

2,171

 

 

 

11,283

 

 

 

7,289

 

Total other income

 

 

4,216

 

 

 

2,609

 

 

 

11,576

 

 

 

8,593

 

Net loss

 

$

(22,467

)

 

$

(10,048

)

 

$

(58,226

)

 

$

(31,288

)

Other comprehensive (loss) income:

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

(445

)

 

 

813

 

 

 

(430

)

 

 

1,024

 

Unrealized holding loss on marketable securities

 

 

(350

)

 

 

(48

)

 

 

(773

)

 

 

(217

)

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

 

 

176

 

 

 

(76

)

 

 

296

 

 

 

(192

)

Other comprehensive (loss) income

 

 

(619

)

 

 

689

 

 

 

(907

)

 

 

615

 

Comprehensive loss

 

$

(23,086

)

 

$

(9,359

)

 

$

(59,133

)

 

$

(30,673

)

Net loss per share to common stockholders, basic and diluted

 

$

(0.92

)

 

$

(0.56

)

 

$

(2.38

)

 

$

(1.75

)

Weighted average common shares outstanding, basic and diluted

 

 

24,479,660

 

 

 

17,961,802

 

 

 

24,449,788

 

 

 

17,905,926

 

 

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

2


 

KalVista Pharmaceuticals, Inc.

Condensed Consolidated Statement of Changes in Stockholders’ Equity

(in thousands, except share amounts)

(Unaudited)

 

 

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 adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

49

 

 

 

49

 

Unrealized holding losses from marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

(129

)

 

 

(129

)

Reclassification adjustment for realized loss 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

 

 

 

 

 

 

 

 

 

 

 

 

 

(445

)

 

 

(445

)

Unrealized holding losses from marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

(350

)

 

 

(350

)

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

 

 

 

 

 

 

 

 

 

 

 

 

 

176

 

 

 

176

 

Balance at January 31, 2022

 

24,537,094

 

 

$

24

 

 

$

436,313

 

 

$

(226,062

)

 

$

(2,339

)

 

$

207,936

 

 

 

Nine Months Ended January 31, 2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

Other

 

 

Total

 

 

Common Stock

 

 

Paid-in

 

 

Accumulated

 

 

Comprehensive

 

 

Stockholders'

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Loss

 

 

Equity

 

Balance at May 1, 2020

 

17,845,599

 

 

$

18

 

 

$

207,208

 

 

$

(121,592

)

 

$

(1,882

)

 

$

83,752

 

Issuance of common stock from equity incentive plans

 

34,815

 

 

 

 

 

 

46

 

 

 

 

 

 

 

 

 

46

 

Stock-based compensation expense

 

 

 

 

 

 

 

1,188

 

 

 

 

 

 

 

 

 

1,188

 

Net loss

 

 

 

 

 

 

 

 

 

 

(10,814

)

 

 

 

 

 

(10,814

)

 

3


 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

338

 

 

 

338

 

Unrealized holding losses from marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

(5

)

 

 

(5

)

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

 

 

 

 

 

 

 

 

 

 

 

 

 

(70

)

 

 

(70

)

Balance at July 31, 2020

 

17,880,414

 

 

$

18

 

 

$

208,442

 

 

$

(132,406

)

 

$

(1,619

)

 

$

74,435

 

Issuance of common stock from exercise of stock options

 

35,101

 

 

 

 

 

 

60

 

 

 

 

 

 

 

 

 

60

 

Stock-based compensation expense

 

 

 

 

 

 

 

1,248

 

 

 

 

 

 

 

 

 

1,248

 

Net loss

 

 

 

 

 

 

 

 

 

 

(10,426

)

 

 

 

 

 

(10,426

)

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

(127

)

 

 

(127

)

Unrealized holding losses from marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

(164

)

 

 

(164

)

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

 

 

 

 

 

 

 

 

 

 

 

 

 

(46

)

 

 

(46

)

Balance at October 31, 2020

 

17,915,515

 

 

$

18

 

 

$

209,750

 

 

$

(142,832

)

 

$

(1,956

)

 

$

64,980

 

Issuance of common stock, net of issuance costs of $132

 

97,332

 

 

 

 

 

 

1,648

 

 

 

 

 

 

 

 

 

1,648

 

Issuance of common stock from equity incentive plans

 

8,377

 

 

 

 

 

 

55

 

 

 

 

 

 

 

 

 

55

 

Stock-based compensation expense

 

 

 

 

 

 

 

1,241

 

 

 

 

 

 

 

 

 

1,241

 

Net loss

 

 

 

 

 

 

 

 

 

 

(10,048

)

 

 

 

 

 

(10,048

)

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

813

 

 

 

813

 

Unrealized holding losses from marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

(48

)

 

 

(48

)

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

 

 

 

 

 

 

 

 

 

 

 

 

 

(76

)

 

 

(76

)

Balance at January 31, 2021

 

18,021,224

 

 

$

18

 

 

$

212,694

 

 

$

(152,880

)

 

$

(1,267

)

 

$

58,565

 

 

4


 

KalVista Pharmaceuticals, Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands, unaudited)

 

 

Nine Months Ended

 

 

January 31,

 

 

2022

 

 

2021

 

Cash flows from operating activities

 

 

 

 

 

Net loss

$

(58,226

)

 

$

(31,288

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Depreciation and amortization

 

408

 

 

 

397

 

Stock-based compensation expense

 

8,432

 

 

 

3,677

 

Realized loss (gain) from sale of marketable securities

 

296

 

 

 

(192

)

Non-cash operating lease expense

 

153

 

 

 

25

 

Amortization of premium on marketable securities

 

2,081

 

 

 

247

 

Foreign currency exchange loss (gain)

 

698

 

 

 

(441

)

Changes in operating assets and liabilities:

 

 

 

 

 

Research and development tax credit receivable

 

(1,477

)

 

 

10,135

 

Prepaid expenses and other assets

 

(3,659

)

 

 

35

 

Accounts payable

 

228

 

 

 

(1,182

)

Accrued expenses

 

(279

)

 

 

(539

)

Net cash used in operating activities

 

(51,345

)

 

 

(19,126

)

Cash flows from investing activities

 

 

 

 

 

Purchases of marketable securities

 

(84,415

)

 

 

(26,814

)

Sales and maturities of marketable securities

 

130,686

 

 

 

45,692

 

Acquisition of property and equipment

 

(845

)

 

 

(49

)

Net cash provided by investing activities

 

45,426

 

 

 

18,829

 

Cash flows from financing activities