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[10-Q] KalVista Pharmaceuticals, Inc. Quarterly Earnings Report

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
10-Q
Rhea-AI Filing Summary

KalVista Pharmaceuticals (KALV) reported its first commercial quarter following EKTERLY (sebetralstat) approvals, recording product revenue, net of $13.7 million for the three months ended September 30, 2025. Operating expenses rose with the launch, led by S,G&A of $46.5 million and R&D of $12.0 million, driving an operating loss of $46.1 million and a net loss of $49.5 million (basic and diluted loss per share of $0.92).

Liquidity strengthened: cash and cash equivalents were $243.5 million and marketable securities were $65.7 million. The company issued $143.8 million aggregate principal of convertible notes (balance sheet carrying amount $139.0 million) and reported a royalty obligation with a $125.0 million net carrying amount tied to its DRI agreement. Deferred revenue was $11.5 million from the Kaken upfront. EKTERLY received U.S., UK, EU, Switzerland and Australia approvals in 2025, with commercial sales initiated in the U.S. and Germany.

Positive
  • None.
Negative
  • None.

Insights

First EKTERLY sales arrive; losses widen on launch spending.

KalVista entered commercialization with $13.7M in net product revenue for the quarter ended September 30, 2025. Launch investments lifted expenses: S,G&A reached $46.5M, while R&D was $12.0M, yielding an operating loss of $46.1M and net loss of $49.5M.

Liquidity comprised $243.5M in cash and $65.7M in marketable securities. Financing actions included $143.8M of 3.250% convertible notes due 2031 (initial conversion price $16.81) and a royalty liability with a net carrying amount of $125.0M tied to the DRI arrangement.

Regulatory momentum was notable: 2025 approvals in the U.S., UK, EU, Switzerland, and Australia, with sales initiated in the U.S. and Germany. Actual commercial trajectory will be reflected in subsequent periods as distribution and payer dynamics progress.

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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 September 30, 2025

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.)

200 Crossing Boulevard

Framingham, Massachusetts

 

01702

(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 Global Market

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 November 3, 2025, the registrant had 50,546,293 shares of common stock, $0.001 par value per share, 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 Unaudited Condensed Consolidated Financial Statements

8

 

 

 

Item 2.

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

17

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

23

 

 

 

Item 4.

Controls and Procedures

23

 

 

PART II. OTHER INFORMATION

 

 

 

 

Item 1.

Legal Proceedings

24

 

 

 

Item 1A.

Risk Factors

24

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

24

 

 

 

Item 3.

Defaults Upon Senior Securities

24

 

 

 

Item 4.

Mine Safety Disclosures

24

 

 

 

Item 5.

Other Information

24

 

 

 

Item 6.

Exhibits

25

 

 

 

Signatures

27

 

 

 

 


 

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

KalVista Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

(Unaudited)

 

 

September 30,
2025

 

December 31,
2024

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

243,497

 

$

182,326

Marketable securities

 

 

65,661

 

 

86,019

Accounts receivable, net

 

 

5,779

 

 

Inventory

 

 

458

 

 

Research and development tax credit receivable

 

 

1,343

 

 

11,417

Prepaid expenses and other current assets

 

 

8,488

 

 

6,217

Total current assets

 

 

325,226

 

 

285,979

Property and equipment, net

 

 

3,190

 

 

1,884

Right of use assets

 

 

9,096

 

 

5,574

Other assets

 

 

2,419

 

 

1,379

Total assets

 

$

339,931

 

$

294,816

Liabilities and stockholders' equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

8,074

 

$

5,726

Accrued expenses

 

 

20,767

 

 

18,936

Deferred revenue

 

 

11,512

 

 

Lease liability - current portion

 

 

1,429

 

 

1,452

Royalty obligation - current portion

 

 

3,287

 

 

Total current liabilities

 

 

45,069

 

 

26,114

Lease liability - net of current portion

 

 

9,128

 

 

4,437

Royalty obligation - net of current portion

 

 

129,707

 

 

99,906

Convertible notes

 

 

139,028

 

 

Total liabilities

 

 

322,932

 

 

130,457

Stockholders' equity:

 

 

 

 

 

 

Common stock, $0.001 par value; 100,000,000 shares authorized
        at September 30, 2025 and December 31, 2024;
50,542,711 and 49,433,611 shares
        issued and outstanding at September 30, 2025 and December 31, 2024, respectively

 

 

50

 

 

49

Additional paid-in capital

 

 

762,776

 

 

746,912

Accumulated deficit

 

 

(739,098)

 

 

(580,184)

Accumulated other comprehensive loss

 

 

(6,729)

 

 

(2,418)

Total stockholders' equity

 

 

16,999

 

 

164,359

Total liabilities and stockholders' equity

 

$

339,931

 

$

294,816

 

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

 

 

September 30,

 

September 30,

 

 

2025

 

2024

 

2025

 

2024

Product revenue, net

 

$

13,692

 

$

 

$

13,692

 

$

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

1,232

 

 

 

 

1,232

 

 

Research and development

 

 

11,993

 

 

18,680

 

 

41,207

 

 

70,170

Selling, general and administrative

 

 

46,517

 

 

24,800

 

 

125,997

 

 

63,511

Total operating expenses

 

 

59,742

 

 

43,480

 

 

168,436

 

 

133,681

Operating loss

 

 

(46,050)

 

 

(43,480)

 

 

(154,744)

 

 

(133,681)

Other (expense) income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

1,875

 

 

1,580

 

 

5,314

 

 

4,369

Interest expense

 

 

(4,757)

 

 

 

 

(10,695)

 

 

Foreign currency exchange (loss) gain

 

 

(884)

 

 

1,072

 

 

2,607

 

 

1,058

Other income, net

 

 

2,491

 

 

1,744

 

 

4,153

 

 

5,725

Total other (expense) income

 

 

(1,275)

 

 

4,396

 

 

1,379

 

 

11,152

Loss before income tax expense

 

 

(47,325)

 

 

(39,084)

 

 

(153,365)

 

 

(122,529)

Income tax expense

 

 

2,157

 

 

 

 

5,549

 

 

Net loss

 

$

(49,482)

 

$

(39,084)

 

$

(158,914)

 

$

(122,529)

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive (loss) income:

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation gain (loss)

 

 

911

 

 

29

 

 

(3,296)

 

 

(15)

Unrealized holding gain on marketable securities

 

 

187

 

 

1,155

 

 

736

 

 

1,929

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

 

 

(771)

 

 

(557)

 

 

(1,751)

 

 

(983)

Total other comprehensive (loss) income

 

 

327

 

 

627

 

 

(4,311)

 

 

931

Comprehensive loss

 

$

(49,155)

 

$

(38,457)

 

$

(163,225)

 

$

(121,598)

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding-basic and diluted

 

 

53,883,681

 

 

46,590,154

 

 

53,430,874

 

 

44,165,934

Net loss per share

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.92)

 

$

(0.84)

 

$

(2.97)

 

$

(2.77)

 

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)

 

 

 

Common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

Amount

 

Additional
Paid-in
Capital

 

Accumulated
Deficit

 

Accumulated
Other
Comprehensive
Loss

 

Total
Stockholders' Equity

Balance at December 31, 2024

 

 

49,433,611

 

$

49

 

$

746,912

 

$

(580,184)

 

$

(2,418)

 

$

164,359

Issuance of common stock from equity incentive plans

 

 

178,323

 

 

1

 

 

1,794

 

 

 

 

 

 

1,795

Issuance of common stock from employee stock purchase plan

 

 

59,599

 

 

 

 

429

 

 

 

 

 

 

429

Release of restricted stock units

 

 

84,915

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

3,240

 

 

 

 

 

 

3,240

Net loss

 

 

 

 

 

 

 

 

(51,836)

 

 

 

 

(51,836)

Foreign currency translation loss

 

 

 

 

 

 

 

 

 

 

(1,236)

 

 

(1,236)

Unrealized holding gain on marketable securities

 

 

 

 

 

 

 

 

 

 

263

 

 

263

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

 

 

 

 

 

 

 

 

 

 

(256)

 

 

(256)

Balance at March 31, 2025

 

 

49,756,448

 

 

50

 

 

752,375

 

 

(632,020)

 

 

(3,647)

 

 

116,758

Issuance of common stock from equity incentive plans

 

 

11,716

 

 

 

 

124

 

 

 

 

 

 

124

Release of restricted stock units

 

 

185,575

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

3,568

 

 

 

 

 

 

3,568

Net loss

 

 

 

 

 

 

 

 

(57,596)

 

 

 

 

(57,596)

Foreign currency translation loss

 

 

 

 

 

 

 

 

 

 

(2,971)

 

 

(2,971)

Unrealized holding gain on marketable securities

 

 

 

 

 

 

 

 

 

 

286

 

 

286

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

 

 

 

 

 

 

 

 

 

 

(724)

 

 

(724)

Balance at June 30, 2025

 

 

49,953,739

 

 

50

 

 

756,067

 

 

(689,616)

 

 

(7,056)

 

 

59,445

Issuance of common stock from equity incentive plans

 

 

61,269

 

 

 

 

593

 

 

 

 

 

 

593

Issuance of common stock from employee stock purchase plan

 

 

92,127

 

 

 

 

692

 

 

 

 

 

 

692

Release of restricted stock units

 

 

435,576

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

5,424

 

 

 

 

 

 

5,424

Net loss

 

 

 

 

 

 

 

 

(49,482)

 

 

 

 

(49,482)

Foreign currency translation gain

 

 

 

 

 

 

 

 

 

 

911

 

 

911

Unrealized holding gain on marketable securities

 

 

 

 

 

 

 

 

 

 

187

 

 

187

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

 

 

 

 

 

 

 

 

 

 

(771)

 

 

(771)

Balance at September 30, 2025

 

 

50,542,711

 

$

50

 

$

762,776

 

$

(739,098)

 

$

(6,729)

 

$

16,999

 

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

 

 

 

 

 

 

 

 

5


 

KalVista Pharmaceuticals, Inc.

Condensed Consolidated Statement of Changes in Stockholders’ Equity

(in thousands, except share amounts)

(Unaudited)

 

 

 

Common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

Amount

 

Additional
Paid-in
Capital

 

Accumulated
Deficit

 

Accumulated
Other
Comprehensive
Loss

 

Total
Stockholders' Equity

Balance at December 31, 2023

 

 

34,558,709

 

$

35

 

$

515,757

 

$

(414,616)

 

$

(3,305)

 

$

97,871

Issuance of common stock from equity incentive plans

 

 

3,632

 

 

 

 

30

 

 

 

 

 

 

30

Issuance of common stock from employee stock purchase plan

 

 

36,914

 

 

 

 

284

 

 

 

 

 

 

284

Release of restricted stock units

 

 

723,955

 

 

1

 

 

(1)

 

 

 

 

 

 

Issuance of common stock, net of issuance costs of $0.5 million

 

 

7,016,312

 

 

7

 

 

96,938

 

 

 

 

 

 

96,945

Issuance of pre-funded warrants for the purchase of common stock

 

 

 

 

 

 

53,123

 

 

 

 

 

 

53,123

Stock-based compensation

 

 

 

 

 

 

12,412

 

 

 

 

 

 

12,412

Net loss

 

 

 

 

 

 

 

 

(43,105)

 

 

 

 

(43,105)

Foreign currency translation loss

 

 

 

 

 

 

 

 

 

 

(17)

 

 

(17)

Unrealized holding gain on marketable securities

 

 

 

 

 

 

 

 

 

 

192

 

 

192

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

 

 

 

 

 

 

 

 

 

 

(133)

 

 

(133)

Balance at March 31, 2024

 

 

42,339,522

 

 

43

 

 

678,543

 

 

(457,721)

 

 

(3,263)

 

 

217,602

Issuance of common stock from equity incentive plans

 

 

38,959

 

 

 

 

282

 

 

 

 

 

 

282

Release of restricted stock units

 

 

174,713

 

 

 

 

 

 

 

 

 

 

Exercise of pre-funded warrants for the purchase of common stock

 

 

182,453

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

3,121

 

 

 

 

 

 

3,121

Net loss

 

 

 

 

 

 

 

 

(40,340)

 

 

 

 

(40,340)

Foreign currency translation loss

 

 

 

 

 

 

 

 

 

 

(27)

 

 

(27)

Unrealized holding gain on marketable securities

 

 

 

 

 

 

 

 

 

 

582

 

 

582

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

 

 

 

 

 

 

 

 

 

 

(293)

 

 

(293)

Balance at June 30, 2024

 

 

42,735,647

 

 

43

 

 

681,946

 

 

(498,061)

 

 

(3,001)

 

 

180,927

Issuance of common stock from equity incentive plans

 

 

323,180

 

 

 

 

2,440

 

 

 

 

 

 

2,440

Issuance of common stock from employee stock purchase plan

 

 

44,574

 

 

 

 

447

 

 

 

 

 

 

447

Release of restricted stock units

 

 

152,841

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

3,173

 

 

 

 

 

 

3,173

Net loss

 

 

 

 

 

 

 

 

(39,084)

 

 

 

 

(39,084)

Foreign currency translation gain

 

 

 

 

 

 

 

 

 

 

29

 

 

29

Unrealized holding gain on marketable securities

 

 

 

 

 

 

 

 

 

 

1,155

 

 

1,155

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

 

 

 

 

 

 

 

 

 

 

(557)

 

 

(557)

Balance at September 30, 2024

 

 

43,256,242

 

$

43

 

$

688,006

 

$

(537,145)

 

$

(2,374)

 

$

148,530

 

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

 

6


 

KalVista Pharmaceuticals, Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)

 

 

Nine Months Ended
September 30,

 

 

2025

 

2024

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(158,914)

 

$

(122,529)

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

 

 

 

 

 

 

Depreciation and amortization

 

 

867

 

 

664

Stock-based compensation expense

 

 

12,232

 

 

18,706

Realized gain from sale of marketable securities

 

 

(1,752)

 

 

(983)

Non cash operating lease expense

 

 

(33)

 

 

(4)

Amortization of premium on marketable securities

 

 

22

 

 

14

Foreign currency exchange loss (gain)

 

 

(6,879)

 

 

(110)

Non-cash interest expense and amortization of issuance costs

 

 

10,569

 

 

Fair value adjustment to derivative liability

 

 

1,306

 

 

Impairment of right of use assets

 

 

1,190

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Research and development tax credit receivable

 

 

10,616

 

 

12,458

Accounts receivable, net

 

 

(5,779)

 

 

Inventory

 

 

(457)

 

 

Prepaid expenses and other assets

 

 

(3,163)

 

 

(514)

Accounts payable

 

 

6,093

 

 

1,011

Accrued expenses and other liabilities

 

 

(4,154)

 

 

(365)

Deferred revenue

 

 

11,251

 

 

Net cash used in operating activities

 

 

(126,985)

 

 

(91,652)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of marketable securities

 

 

(105,772)

 

 

(148,437)

Sales and maturities of marketable securities

 

 

127,889

 

 

93,079

Acquisition of property and equipment

 

 

(1,863)

 

 

(53)

Disposal of property and equipment

 

 

12

 

 

Capitalized website development costs

 

 

(394)

 

 

(293)

Net cash provided by (used in) investing activities

 

 

19,872

 

 

(55,704)

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from sale of convertible notes

 

 

139,438

 

 

Proceeds from the royalty agreement

 

 

21,259

 

 

Issuance of common stock, net of issuance costs of $0.5 million

 

 

 

 

96,945

Issuance of pre-funded warrants

 

 

 

 

53,123

Issuance of common stock from equity incentive plans

 

 

2,539

 

 

2,808

Issuance of common stock from employee stock purchase plan

 

 

1,154

 

 

730

Net cash provided by financing activities

 

 

164,390

 

 

153,606

Effect of exchange rate changes

 

 

4,042

 

 

571

Net increase in cash, cash equivalents and restricted cash

 

 

61,319

 

 

6,821

Cash, cash equivalents and restricted cash at beginning of the period

 

 

182,978

 

 

33,778

Cash, cash equivalents and restricted cash at end of the period

 

$

244,297

 

$

40,599

Less: Restricted cash in other assets

 

 

800

 

 

Cash and cash equivalents

 

$

243,497

 

$

40,599

 

 

 

 

 

 

 

Supplemental disclosure of non-cash activities

 

 

 

 

 

 

Lease liabilities arising from obtaining right of use assets

 

$

4,978

 

$

433

Property and equipment included in accounts payable and accrued expenses

 

$

188

 

$

Accrued debt issuance costs

 

$

412

 

$

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

7


 

Notes to the Unaudited Condensed Consolidated Financial Statements

 

1.
The Company

Company Background

KalVista Pharmaceuticals, Inc. (“KalVista” or the “Company”) is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet need. The Company has used its capabilities to develop sebetralstat, a novel, orally delivered, small molecule plasma kallikrein inhibitor targeting the disease hereditary angioedema (“HAE”).

On July 3, 2025, the U.S. Food and Drug Administration (the “FDA”) approved EKTERLY® (sebetralstat) for the treatment of acute attacks of HAE in adult and pediatric patients aged 12 years and older. Subsequently, in July 2025, the UK's Medicines and Healthcare products Regulatory Agency (“MHRA”) approved EKTERLY; in September 2025, both the European Commission and the Swiss Agency for Therapeutic Products, Swissmedic, approved EKTERLY for the symptomatic treatment of acute attacks of HAE in adults and adolescents aged 12 years and older; and most recently in October 2025, Australia approved EKTERLY for the symptomatic treatment of acute attacks of HAE in adults and adolescents aged 12 years and older. As of October 2025, the Company has initiated commercial sales in the U.S. and Germany.

These regulatory approvals were based on data from the phase 3 KONFIDENT clinical trial, published in the New England Journal of Medicine. Prior to the approval of EKTERLY, all on-demand treatment options approved in the U.S. required intravenous or subcutaneous administration, which carries a significant treatment burden. Even with the use of long-term prophylaxis, most people living with HAE continue to have unpredictable attacks and require ready access to on-demand medication.

The Company’s headquarters is located in Framingham, Massachusetts, with additional offices and research activities located in Cambridge, Massachusetts; Porton Down, United Kingdom; Salt Lake City, Utah; Zug, Switzerland; Tokyo, Japan; Berlin, Germany and Dublin, Ireland.

Liquidity

The Company has incurred operating losses since its inception. As of September 30, 2025, the Company had an accumulated deficit of $739.1 million and $309.2 million of cash, cash equivalents and marketable securities. The three months ended September 30, 2025 is the first period in which the Company generated revenue from product sales, following the FDA approval of EKTERLY. The Company has funded its operations primarily through the issuance of capital stock, pre-funded warrants, convertible debt and royalty financing.

In July 2025, the Company entered into a sales agreement with TD Securities (USA) LLC (“TD Cowen”) pursuant to which the Company is able to offer and sell, from time to time at its sole discretion, shares of its common stock with an aggregate offering price of up to $100.0 million (the “ATM Shares”) under the prospectus supplement, dated July 10, 2025, to the registration statement on Form S-3 (the “Registration Statement”) filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 19, 2024. During the three months ended September 30, 2025, the Company did not offer or sell any ATM Shares pursuant to the Registration Statement.

In September 2025, the Company entered into an indenture agreement with U.S. Bank Trust Company, National Association, as trustee to issue $143.8 million aggregate principal amount of convertible senior notes (“Notes”).

The Company anticipates that it will continue to incur losses for the foreseeable future in connection with the global commercialization of EKTERLY, continued development activity to expand the treatable patient population of EKTERLY to include pediatric patients ages 2-11, and efforts to develop other potential additional product candidates. The Company may continue to incur substantial operating losses even as it continues to generate revenue from EKTERLY. The Company may seek to finance future cash needs through equity offerings, debt financings, corporate partnerships and product sales. The Company is subject to risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, and it may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect its business. The Company currently anticipates that, based upon its operating plans and existing capital resources, it has sufficient funding to operate for at least the next twelve months from the date these unaudited interim condensed consolidated financial statements are issued.

Change in fiscal year

On March 13, 2025, the Company's Board of Directors approved a change to the Companys fiscal year end from April 30 to December 31, effective December 31, 2025, resulting in an eight-month transition period from May 1, 2025 to December 31, 2025. Beginning with this Quarterly Report on Form 10-Q for the quarter ending September 30, 2025, the Company will file quarterly reports based on the new fiscal year, pursuant to Rule 15d-10(e)(2) of the Exchange Act.

8


 

2.
Summary of Significant Accounting Policies

Principles of Consolidation: The accompanying unaudited interim condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.

The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. Such financial statements reflect all adjustments that are, in management’s opinion, necessary to present fairly, in all material respects, the Company’s consolidated financial position, results of operations, and cash flows. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the annual financial statements. There were no adjustments other than normal recurring adjustments. These unaudited interim condensed consolidated financial results are not indicative of any future annual or interim period. The accompanying unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements as of and for the fiscal year ended April 30, 2025 in the Company’s Annual Report on Form 10-K filed with the SEC on July 10, 2025.

Segment Reporting: The chief operating decision maker, the CEO, manages the Company’s operations as a single operating segment for the purposes of assessing performance and making operating decisions.

Use of Estimates: The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Accounting estimates and management judgments reflected in the consolidated financial statements include: the accrual of research and development expenses, stock-based compensation, operating lease liabilities, product revenue reserve, interest expense on the Company’s royalty obligation, and assumptions used to value the embedded derivative in its royalty obligation. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may materially differ from these estimates and assumptions.

Recent Accounting Pronouncements: The Company does not expect any recently issued accounting standards to have a material impact to its financial statements or disclosures.

Significant Accounting Policies: The Company has included its accounting policies for accounts receivable, inventories, revenue recognition related to product sales, net, and cost of revenue as a result of the launch of EKTERLY in the U.S. For details about the Company's accounting policies, please read Note 2, Summary of Significant Accounting Policies in the Annual Report on Form 10-K for the fiscal year ended April 30, 2025, filed with the SEC on July 10, 2025.

Accounts receivable, net: The Company’s trade accounts receivable arise from product sales and represent amounts due from specialty distributors and specialty pharmacy providers. The Company monitors the financial performance and creditworthiness of its customers so that it can properly assess and respond to changes in its customers’ credit profile. The Company reserves against these receivables for estimated losses that may arise from a customer’s inability to pay. Amounts determined to be uncollectible are charged or written-off against the reserve.

Inventory: The Company values inventory at the lower of cost or estimated net realizable value with cost determined on a first-in, first-out basis. Raw materials and work-in-process include all inventory costs prior to packaging and labeling, including raw material, active product ingredient, and the drug product. Finished goods include packaged and labeled products. At each reporting date, the Company evaluates the carrying value of inventory and provides valuation reserves for any estimated excess, obsolete, short-dated or unmarketable inventory. In the event that certain batches or units of product do not meet quality specifications, the Company will record a write-down of any potential unmarketable inventory to its estimated net realizable value and record the expense as cost of revenue in the consolidated statements of operations and comprehensive loss. Prior to obtaining initial regulatory approval for an investigational product candidate, costs relating to production of pre-launch inventory are expensed as research and development expense in the period incurred. After initial regulatory approval has been received, inventory costs are capitalized.

Revenue recognition: The Company recognizes revenue from product sales when the customer obtains control of the Company’s product. The transaction price is the amount that reflects the consideration which the Company expects to receive. The Company estimates reserves for variable consideration related to applicable discounts, rebates, chargebacks and other allowances included in its agreements with customers, payors and other third parties. The Company includes the amount of variable consideration in the transaction price to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not

9


 

occur in a future period. If actual results vary significantly from the Company’s estimates, the Company adjusts its estimates in the period that the Company becomes aware of such variances.

Cost of revenue: The Company's cost of revenue is comprised of costs related to its commercial revenue, including manufacturing costs and indirect costs associated with the manufacturing and distribution of its products. The Company also may include certain period costs related to manufacturing services and inventory adjustments in cost of revenue. Cost of revenue for EKTERLY does not currently include the full cost of manufacturing until the Company manufactures and sells additional inventory after exhausting its pre-launch supply. Such pre-launch supply has previously been recorded as research and development expense.

The Company’s other significant accounting policies have not changed substantially from those included in the Company’s Annual Report on Form 10-K for the fiscal year ended April 30, 2025.

3.
Fair Value Measurements

The following tables present information about financial assets and liability that have been measured at fair value and indicate the fair value hierarchy of the valuation inputs utilized to determine such fair value as of September 30, 2025 and December 31, 2024 (in thousands):

 

 

As of September 30, 2025

 

 

Total

 

Level 1

 

Level 2

 

Level 3

Assets

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents

 

$

74,035

 

$

74,035

 

$

 

$

Corporate debt securities

 

 

49,289

 

 

 

 

49,289

 

 

U.S. government agency securities

 

 

16,372

 

 

 

 

16,372

 

 

Total assets

 

$

139,696

 

$

74,035

 

$

65,661

 

$

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

Derivative liability

 

$

8,020

 

$

 

$

 

$

8,020

Total liabilities

 

$

8,020

 

$

 

$

 

$

8,020

 

 

 

As of December 31, 2024

 

 

Total

 

Level 1

 

Level 2

 

Level 3

Assets

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents

 

$

29,488

 

$

29,488

 

$

 

$

Corporate debt securities

 

 

76,199

 

 

 

 

76,199

 

 

U.S. government agency securities

 

 

9,820

 

 

 

 

9,820

 

 

Total assets

 

$

115,507

 

$

29,488

 

$

86,019

 

$

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

Derivative liability

 

$

4,430

 

$

 

$

 

$

4,430

Total liabilities

 

$

4,430

 

$

 

$

 

$

4,430

The objectives of the Company’s investment policy are to ensure the safety and preservation of invested funds, as well as to maintain liquidity sufficient to meet cash flow requirements. The Company invests its excess cash in securities issued by financial institutions, commercial companies, and government agencies that management believes to be of high credit quality in order to limit the amount of its credit exposure. The Company has not realized any material losses from its investments.

The Company classifies all of its debt securities as available-for-sale. Unrealized gains and losses on investments are recognized in accumulated other comprehensive loss in the consolidated balance sheets, unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company believes the individual unrealized losses represent temporary declines primarily resulting from interest rate changes. Realized gains and losses are included in other income, net in the consolidated statements of operations and comprehensive loss and are determined using the specific identification method with transactions recorded on a trade date basis.

The estimated fair value of the derivative liability as of September 30, 2025 relates to the Purchase and Sale Agreement that the Company, as guarantor, and KalVista Pharmaceuticals Limited, a wholly owned subsidiary of the Company (the “Subsidiary”), entered into with DRI Healthcare Acquisitions LP, an affiliate of DRI Healthcare Trust (“DRI”) in November 2024 (the “PSA”) and was determined using Level 3 inputs. Refer to Note 7, Purchase and Sale Agreement, for a description of the PSA. The fair value

10


 

measurement of the derivative liability is sensitive to changes in the unobservable inputs used to value the financial instrument. Changes in the inputs could result in changes to the fair value of each financial instrument.

The embedded derivative liability associated with the royalty obligation contained in the PSA, as discussed further in Note 7, Purchase and Sale Agreement, is measured at fair value using an option pricing Monte Carlo simulation model and is included as a component of the royalty obligation in the consolidated balance sheets. The embedded derivative liability is subject to remeasurement at the end of each reporting period, with changes in fair value recognized as a component of other income, net in the consolidated statements of operations and comprehensive loss. The assumptions used in the option pricing Monte Carlo simulation model incorporates certain Level 3 inputs including: (1) the risk-adjusted discount rate and (2) the probability of a change in control occurring during the term of the instrument.

The Company recorded $4.4 million for the initial fair value of the derivative liability upon the closing of the PSA and subsequently recorded an incremental $2.0 million when the $22.0 million drawdown was recorded by Company. The initial fair value allocated to the derivative liability was recorded against the royalty obligation as a debt discount, which is being amortized in interest expense in the consolidated statements of operations and comprehensive loss over the expected term using the effective interest method. The embedded derivative is subsequently remeasured at fair value each reporting period, with the change in fair value being recorded as a component of other income, net in the consolidated statements of operations and comprehensive loss. For the three and nine months ended September 30, 2025, the Company recognized $0.5 million and $1.3 million, respectively as a component of other income, net as the change in fair value for the embedded derivative liability, recorded as a component of the royalty obligation in the consolidated balance sheets as of September 30, 2025. Refer to Note 7, Purchase and Sale Agreement, for details regarding the valuation methodology related to the embedded derivative and its related inputs.

Marketable Securities

The following tables summarize the fair values of the Company’s marketable securities by type as of September 30, 2025 and December 31, 2024 (in thousands):

 

 

As of September 30, 2025

 

 

Amortized Cost

 

Gross
Unrealized Gains

 

Gross
Unrealized Losses

 

Fair Market Value

Corporate debt securities

 

$

49,101

 

$

189

 

$

(1)

 

$

49,289

U.S. government agency securities

 

 

16,320

 

 

52

 

 

 

 

16,372

Total

 

$

65,421

 

$

241

 

$

(1)

 

$

65,661

 

 

 

As of December 31, 2024

 

 

Amortized Cost

 

Gross
Unrealized Gains

 

Gross
Unrealized Losses

 

Fair Market Value

Corporate debt securities

 

$

75,085

 

$

1,116

 

$

(2)

 

$

76,199

U.S. government agency securities

 

 

9,734

 

 

86

 

 

 

 

9,820

Total

 

$

84,819

 

$

1,202

 

$

(2)

 

$

86,019

The following table summarizes the scheduled maturity for the Company’s marketable securities at September 30, 2025 (in thousands):

 

 

As of September 30, 2025

Maturing in one year or less

 

$

20,302

Maturing after one year through two years

 

 

39,012

Maturing after two years through four years

 

 

6,347

Total

 

$

65,661

 

11


 

4.
Accrued Expenses

Accrued expenses consisted of the following as of September 30, 2025 and December 31, 2024 (in thousands):

 

 

As of

 

As of

 

 

September 30, 2025

 

December 31, 2024

Accrued compensation

 

$

10,997

 

$

8,336

Accrued professional fees

 

 

4,234

 

 

3,924

Accrued research expense

 

 

3,020

 

 

5,983

Other accrued expenses

 

 

2,516

 

 

693

Total accrued expenses

 

$

20,767

 

$

18,936

 

5.
Leases

The Company maintains leases for office space and research laboratory space, and as of September 30, 2025, all leases were classified as operating leases. These leases have remaining lease terms ranging from 1 to 10 years, some of which include options to extend or terminate the leases.

Pursuant to the headquarter lease in Framingham, which commenced in September 2025, the Company provided a security deposit in the form of a letter of credit in the amount of $0.7 million which is classified in other assets in the consolidated balance sheets. The Company continues to utilize the Cambridge office for the manufacture, sale or distribution of prescription drugs.

Total rent expense was approximately $2.4 million and $1.7 million for the nine months ended September 30, 2025 and 2024, respectively, and is reflected in selling, general and administrative expenses and research and development expenses as determined by the underlying activities.

In September 2025, the Company entered into a sublease agreement for the entirety of its office space in Cambridge for the remaining lease term for total rental payments of approximately $1.2 million. As a result of the sublease, the Company recorded an impairment charge of $1.2 million to the right of use asset related to the sublease, reducing the carrying value of the lease asset to its estimated fair value. The impairment charge is included in selling, general and administrative expenses in the consolidated statements of operations and comprehensive loss. For the three and nine months ended September 30, 2025, the Company recognized $31.2 thousand of sublease income, which is included in other income, net in the consolidated statements of operations and comprehensive loss.

The following table summarizes the maturity of undiscounted payments due under lease liabilities and the present value of those liabilities as of September 30, 2025 (in thousands):

Years ending December 31,

 

 

 

2025

 

$

403

2026

 

 

2,317

2027

 

 

2,735

2028

 

 

2,204

2029

 

 

1,226

Thereafter

 

 

7,529

Total minimum lease payments

 

 

16,414

Less: imputed interest and tenant incentive reimbursable by lessor

 

 

5,857

Total operating lease liabilities

 

$

10,557

Included in the condensed consolidated balance sheet:

 

 

 

Lease liability - current portion

 

$

1,429

Lease liability - net of current portion

 

 

9,128

Total operating lease liabilities

 

$

10,557

Total lease payments in the table above excludes approximately $1.5 million of legally binding minimum lease payments for the lease in Zug, Switzerland that was signed in July 2025 but had not commenced as of September 30, 2025.

6.
Indebtedness

In September 2025, the Company issued $143.8 million aggregate principal amount of Notes due on October 1, 2031. The Notes are senior, unsecured obligations of the Company and bear interest at a rate of 3.250% per year, payable semi-annually in arrears on April

12


 

1 and October 1 of each year, beginning on April 1, 2026. The net proceeds were $139.0 million after deducting the discount and offering expenses of $4.7 million. The debt discount is amortized under the effective interest method and recorded as additional interest expense over the life of the Notes. The effective interest rate on the Notes is 3.86%.

The Notes are not redeemable by the Company prior to October 5, 2028. On or after October 5, 2028 and prior to July 1, 2031, the Company may redeem for cash all or part of the Notes at a redemption price equal to the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, based on certain criteria, as noted in the indenture agreement.

Upon conversion, the Company may pay cash, deliver shares of its common stock or a combination of cash and common stock, as determined by the Company at its discretion. The Notes may be convertible into shares of the Company's common stock under certain circumstances prior to maturity at a conversion rate of 59.4919 shares per $1,000 principal amount of the Notes, which represents an initial conversion price of $16.81 per share, subject to adjustment.

7.
Purchase and Sale Agreement

Royalty Liability

In November 2024, the Company entered into the PSA pursuant to which it is potentially eligible to receive payments from DRI up to $179 million. Under the terms of the synthetic royalty financing agreement, the Subsidiary received an upfront payment of $100.0 million in exchange for tiered royalty payments on worldwide net sales of sebetralstat, as follows: 5.00% on annual net sales up to and including $500.0 million (the “First Tier Royalty Rate”); 1.10% on annual net sales above $500.0 million and up to and including $750.0 million; and 0.25% on annual net sales above $750.0 million. In May 2025, the Company and DRI entered into a non-material amendment to the PSA (the “First Amendment to the PSA”) pursuant to which the parties agreed to amend the PSA to change the definition of “fiscal quarter” to mean each period of three (3) consecutive months ending on March 31, June 30, September 30, and December 31. The foregoing description of the First Amendment to the PSA does not purport to be complete and is qualified in its entirety by the full text of the First Amendment to the PSA, a copy of which is filed as Exhibit 10.1 to this Quarterly Report on Form 10-Q.

Beginning in calendar year 2031, the First Tier Royalty Rate for any calendar year will be determined based on annual net sales of sebetralstat for the prior calendar year: 5.00% if the prior year’s annual net sales are at or above $500.0 million or 5.65% if the prior year’s annual net sales are below $500.0 million. Additionally, if sebetralstat achieves annual net sales of at least $550.0 million in any calendar year ending before January 1, 2031, the Subsidiary will earn a sales-based milestone payment of $50.0 million.

As sebetralstat was approved prior to October 1, 2025, the Subsidiary elected to receive the one-time cash payment of $22.0 million in July 2025. As a result, the First Tier Royalty Rate on net sales up to and including $500.0 million increased from 5.00% to 6.00% and the sales-based milestone increased from $50.0 million to $57.0 million. Additionally, beginning in calendar year 2031, the First Tier Royalty Rate will increase from 5.00% to 6.00% if the prior year's annual net sales are at or above $500.0 million and from 5.65% to 6.75% if the prior year's annual net sales are below $500.0 million.

On receipt of the $100.0 million payment from DRI, the Company recorded a royalty obligation of $93.6 million, net of the initial fair value of the bifurcated embedded derivative liability upon execution of the PSA, and debt issuance costs incurred. With the additional $22.0 million payment from DRI obtained in July 2025, the Company recorded a royalty obligation of $122.9 million, net of the fair value of the bifurcated embedded derivative liability. See the Sources of Liquidity in Item 2 of this Quarterly Report on Form 10-Q for further discussion of the DRI agreement. In September 2025, the Company and DRI entered into a second non-material amendment to the PSA (the “Second Amendment to the PSA”) pursuant to which the parties agreed to amend the PSA solely to replace the original DRI counterparty, DRI Healthcare Acquisitions, LP, with a new entity, DRI UK LP. The foregoing description of the Second Amendment to the PSA does not purport to be complete and is qualified in its entirety by the full text of the Second Amendment to the PSA, a copy of which is filed as Exhibit 10.2 to this Quarterly Report on Form 10-Q.

The PSA is considered a sale of future revenues and is accounted for as long-term debt recorded at amortized cost using the effective interest rate method. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the anticipated life of the arrangement. During the three and nine months ended September 30, 2025, the Company recorded $4.7 million and $10.7 million of interest expense, respectively, related to this arrangement in the consolidated statements of operations and comprehensive loss. The interest rate on this liability may vary during the term of the agreement depending on a number of factors, including the level of forecasted net sales. The Company evaluates the interest rate quarterly based on its current net sales forecasts utilizing the prospective method. A significant increase or decrease in actual or forecasted net sales may materially impact the revenue

13


 

interest liability, interest expense, other income, and the time period for repayment. The royalty obligation, net of the bifurcated embedded derivative liability had a net carrying amount of $125.0 million as of September 30, 2025.

The PSA is denominated in US Dollars and was executed with the Company’s wholly owned U.K. Subsidiary, whose functional currency is the British Pound.

Embedded Derivative Liability

Under the PSA, the Subsidiary has the option (the “Buy-Back Option”) to repurchase future Revenue Participation Rights at any time until December 31, 2026 either (i) in the event of a change of control of the Subsidiary or (ii) in the event that confirmation that payment of the Revenue Participation Rights will not receive certain tax treatment has not been obtained. Additionally, the Purchaser has an option (the “Put Option”) to require the Subsidiary to repurchase future Revenue Participation Rights in the event of a change of control of the Subsidiary exercisable until December 31, 2026. If the Put Option or the Buy-Back Option is exercised terminating the PSA, the required repurchase price is an amount equal to (a) 1.5 multiplied by (b) the Investment Amount, net of the sum of any payments received by the Purchaser prior to such Put Option or Buy-Back Option repurchase date, as applicable.

The Buy-Back and Put Options are considered embedded derivatives requiring bifurcation as a single compound derivative instrument. The Company estimated the fair value of the derivative liability using a “with-and-without” method. The with-and-without methodology involves valuing the whole instrument on an as-is basis and then valuing the instrument without the individual embedded derivative. The difference between the entire instrument with the embedded derivative compared to the instrument without the embedded derivative is the fair value of the derivative liability.

The Company recorded $4.4 million for the initial fair value of the derivative liability upon the closing of the PSA and subsequently recorded an incremental $2.0 million when the $22.0 million drawdown was recorded by Company. The initial fair value allocated to the derivative liability was recorded against the royalty obligation as a debt discount, which is being amortized in interest expense in the consolidated statements of operations and comprehensive loss over the expected term using the effective interest method. The embedded derivative is subsequently remeasured at fair value each reporting period, with the change in fair value being recorded as a component of other income, net in the consolidated statements of operations and comprehensive loss. For the three and nine months ended September 30, 2025, the Company recognized $0.5 million and $1.3 million, respectively, as a component of other income, net as the change in fair value for the embedded derivative liability. Bifurcated embedded derivatives are classified with the related host contract in the Company’s consolidated balance sheets. Of the $133.0 million royalty obligation as of September 30, 2025, the embedded derivative had a fair value of $8.0 million.

The estimated probability and timing of underlying events triggering the exercisability of the Buy-Back and Put Options contained in the PSA, forecasted cash flows and the discount rate are significant unobservable inputs used to determine the estimated fair value of the entire instrument with the embedded derivative. Management concluded the Buy-Back Option probability was in the lower quartile of possible outcomes. At inception, the estimated market yield used for the valuation of the derivative liability was 9.15%. As of September 30, 2025, the estimated market yield used for valuation of the derivative liability was 10.40%.

8.
License, Supply and Distribution Agreement

Kaken Pharmaceutical Co., Ltd. (Kaken)

In April 2025, the Company entered into a License, Supply and Distribution Agreement (the “Kaken Agreement”) with Kaken Pharmaceutical Co., Ltd. (“Kaken”) pursuant to which the Company licensed exclusive commercialization rights in Japan to Kaken for the Licensed Product (as defined under the Kaken Agreement) in exchange for a non-refundable upfront payment of $11.0 million, potential regulatory and sales milestone payments totaling approximately $13.0 million, and effective royalty payments in the mid-twenties percentage that shall be payable for each unit of revenue of Licensed Product that the Company supplies, which reflect a percentage of the Japanese National Health Insurance price of the Licensed Product. The Kaken Agreement has a 10-year initial term.

Per the terms of the Kaken Agreement, the Company is responsible for obtaining and maintaining all regulatory approvals, performing regulatory submissions for the Licensed Product in Japan and supplying the Licensed Product to Kaken. Kaken received an exclusive license to commercialize the Licensed Product in Japan, including the right to ship, store, and distribute the Licensed Product for such commercialization during the term of the Kaken Agreement. The Company retains manufacturing rights for the Licensed Product and is responsible for the Company’s own costs associated with the performance of activities under the Kaken Agreement.

Under the terms of the Kaken Agreement, Kaken paid the Company a non-refundable upfront payment of $11.0 million on June 20, 2025. The obligations have not been met as of September 30, 2025, and as such, the $11.0 million non-refundable upfront payment has been recorded as deferred revenue.

14


 

The potential regulatory and sales milestone payments that the Company is eligible to receive will be recorded if and when they become probable.

Any future potential revenue from units sold to Kaken will be recorded in accordance with Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers.

9.
Product Revenues and Accounts Receivable, net

The Company’s product revenue, net of sales discounts, allowances and reserves for both the three and nine months ended September 30, 2025 and 2024 was $13.7 million and $0.0 million, respectively.

The Company had product sales to certain customers that each accounted for more than 10% of total gross product sales for the three and nine months ended September 30, 2025 and 2024. Sales for each of these customers as a percentage of the Company’s total gross product revenue are as follows:

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

2025

 

2024

 

2025

 

2024

Customer A

 

 

35%

 

 

0%

 

 

35%

 

 

0%

Customer B

 

 

33%

 

 

0%

 

 

33%

 

 

0%

Customer C

 

 

27%

 

 

0%

 

 

27%

 

 

0%

As of September 30, 2025, the Company’s accounts receivable, net were $5.8 million, which was related to product sales, net of $0.6 million of discounts and allowances. As of December 31, 2024, the Company’s accounts receivable, net related to product sales was $0.0 million. The Company does not have a reserve related to credit losses against its accounts receivable and expects to collect accounts receivable in the ordinary course of business.

 

10.
Net Loss per Share

Basic net loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the sum of the weighted average number of common shares and the number of potential dilutive common share equivalents outstanding during the period. Potential dilutive common share equivalents consist of outstanding options, unvested restricted stock units, unvested performance stock units, and shares committed to be purchased under the employee stock purchase plan.

Potential dilutive common share equivalents consist of:

 

 

September 30,

 

 

2025

 

2024

Common stock issuable under equity incentive plans

 

 

6,743,124

 

 

5,804,326

Common stock issuable upon conversion of notes

 

 

8,551,960

 

 

Total

 

 

15,295,084

 

 

5,804,326

In computing diluted earnings per share, common share equivalents are not considered in periods in which a net loss is reported, as the inclusion of the common share equivalents would be anti-dilutive. As a result, there is no difference between the Company’s basic and diluted loss per share for the periods presented.

 

11.
Segment Information

Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision-maker (“CODM”) in deciding how to allocate resources and assess performance. The Company operates in one business segment. The Company’s CODM is its Chief Executive Officer, who reviews financial information presented on a consolidated basis. The CODM’s financial review is focused on the consolidated financial results of the Company which is used as the basis for financial performance assessment and allocation of resources.

The following table presents selected financial information with respect to the Company’s single operating segment for the three and nine months ended September 30, 2025 and 2024 (in thousands):

15


 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

2025

 

2024

 

2025

 

2024

Product revenue, net

 

$

13,692

 

$

 

$

13,692

 

$

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

1,232

 

 

 

 

1,232

 

 

Clinical development

 

 

4,891

 

 

9,739

 

 

22,445

 

 

35,859

Research

 

 

9,941

 

 

10,131

 

 

29,799

 

 

33,378

Regulatory & QA

 

 

2,070

 

 

2,696

 

 

6,647

 

 

4,819

Commercial

 

 

28,086

 

 

13,070

 

 

72,891

 

 

29,295

Other SG&A

 

 

13,522

 

 

7,844

 

 

35,422

 

 

30,330

Total operating expenses

 

 

59,742

 

 

43,480

 

 

168,436

 

 

133,681

Operating loss

 

 

(46,050)

 

 

(43,480)

 

 

(154,744)

 

 

(133,681)

Other (expense) income

 

 

(1,275)

 

 

4,396

 

 

1,379

 

 

11,152

Loss before income tax expense

 

 

(47,325)

 

 

(39,084)

 

 

(153,365)

 

 

(122,529)

Income tax expense

 

 

2,157

 

 

 

 

5,549

 

 

Net loss

 

$

(49,482)

 

$

(39,084)

 

$

(158,914)

 

$

(122,529)

 

12.
Income Taxes

 

The provision for income taxes for the three and nine months ended September 30, 2025 was $2.2 million and $5.5 million, respectively, compared to $0.0 million for the three and nine months ended September 30, 2024. The Company accounts for income taxes in accordance with ASC Topic 740, Income Taxes. These standards establish financial accounting and reporting standards for the effects of income taxes that result from an enterprise’s activities during the current and preceding years. The Company takes an asset and liability approach for financial accounting and reporting of income taxes. The Company pays income taxes in the UK based on the profits realized, which can be significantly impacted by terms of intercompany transactions between the Company and its UK affiliate. Deferred tax assets and liabilities are created in this process. The Company has netted these deferred tax assets and deferred tax liabilities by jurisdiction. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be ultimately realized.

16


 

Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion in conjunction with our unaudited interim condensed financial statements and related notes included elsewhere in this report. This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential” or “continue” or the negative of these terms or other comparable terminology. These forward-looking statements, include, but are not limited to, statements regarding the success, cost and timing of our product development activities and clinical trials as well as other activities we may undertake, macroeconomic conditions, including rising inflation and changing interest rates, labor shortages, supply chain issues, and global conflicts such as the war in Ukraine and conflicts in the Middle East, our business strategy, our ability to receive, maintain and recognize the benefits of certain designations received by product candidates and the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates. Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or our future financial performance, are based on assumptions, and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under “Risk Factors” in our Annual Report on Form 10-K or described elsewhere in this Quarterly Report on Form 10-Q. These forward-looking statements speak only as of the date hereof. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. Unless the context indicates otherwise, in this Quarterly Report on Form 10-Q, the terms “KalVista,” “Company,” “we,” “us” and “our” refer to KalVista Pharmaceuticals, Inc. and, where appropriate, its consolidated subsidiaries.

Management Overview

We are a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our product, EKTERLY® (sebetralstat), is a novel, orally delivered, small molecule plasma kallikrein inhibitor for the treatment of acute attacks of hereditary angioedema (“HAE”) in adult and pediatric patients aged 12 years and older. EKTERLY (sebetralstat) is the first and only oral, on-demand therapy for HAE. On July 3, 2025, the U.S. Food and Drug Administration (the “FDA”) approved EKTERLY® (sebetralstat) for the treatment of acute attacks of HAE in adult and pediatric patients aged 12 years and older. Subsequently, in July 2025, the UK's Medicines and Healthcare products Regulatory Agency (“MHRA”) approved EKTERLY; in September 2025, both the European Commission and the Swiss Agency for Therapeutic Products, Swissmedic, approved EKTERLY for the symptomatic treatment of acute attacks of HAE in adults and adolescents aged 12 years and older; and most recently in October 2025, Australia approved EKTERLY for the symptomatic treatment of acute attacks of HAE in adults and adolescents aged 12 years and older. As of October 2025, the Company has initiated commercial sales in the U.S. and Germany.

The efficacy and safety of EKTERLY (sebetralstat) was established by the results from the phase 3 KONFIDENT clinical trial, published in the New England Journal of Medicine in May 2024. The clinical trial met all primary and key secondary endpoints and demonstrated a favorable safety profile. HAE attacks treated with 600 mg of sebetralstat achieved the primary endpoint of beginning of symptom relief significantly faster than placebo (p=0.0013 ) with a median time to beginning of symptom relief of 1.79 hours (CI 1.33, 2.27) as compared to 6.72 hours with placebo (CI 2.33, >12). Consistent with previous studies, sebetralstat was well-tolerated, with a safety profile similar to placebo. There were no patient withdrawals due to any adverse event and no treatment-related serious adverse events (SAEs) were observed. Treatment-related adverse event rates were 2.2% for 600 mg sebetralstat as compared to 4.8% for placebo. Primary and key secondary endpoints were analyzed in a fixed, hierarchical sequence and adjusted for multiplicity. Key secondary endpoints showed:

Attacks treated with 600mg of sebetralstat achieved a significantly faster time to a reduction in attack severity from baseline, compared to placebo (p=0.0032); and
Attacks treated with 600mg sebetralstat demonstrated a significantly faster time to complete attack resolution as compared to placebo (p<0.0001).

Prior to the approval of EKTERLY, all on-demand treatment options approved in the U.S. for HAE required intravenous or subcutaneous administration, which carries a significant treatment burden. Even with the use of long-term prophylaxis as a preventative therapy, most people living with HAE continue to have unpredictable attacks and require ready access to on-demand medication. We believe that EKTERLY has the potential to fundamentally shift the manner in which HAE is managed, based upon extensive and continuing research conducted with patients, physicians and payers. Sebetralstat is currently under review with regulatory authorities in Japan and Singapore.

17


 

Key Updates

On July 3, 2025, the U.S. Food and Drug Administration (the “FDA”) approved our New Drug Application for EKTERLY, a novel, orally delivered, small molecule plasma kallikrein inhibitor, for the treatment of acute attacks of HAE in adult and pediatric patients aged 12 years and older. EKTERLY is the first and only oral, on-demand therapy for HAE.

In July 2025, the Medicines and Healthcare products Regulatory Agency (“MHRA”) of the UK granted marketing authorization for EKTERLY (sebetralstat). EKTERLY (sebetralstat) also met the requirements of the MHRA Orphan Designation criteria and will be added to the Orphan Register held by the MHRA, allowing it to benefit from up to 10 years of market exclusivity.

Also in July, the Committee for Medicinal Products for Human Use of the European Medicines Agency (“EMA”) adopted a positive opinion recommending market authorization for sebetralstat. We received the European Commission's (“EC”) final decision in September 2025.

Additionally, the Committee for Orphan Medicinal Products of the EMA confirmed maintenance of orphan designation for sebetralstat. The decision to maintain orphan designation was based on a finding of comparable efficacy of sebetralstat to injectable on-demand treatments while offering a major contribution to patient care by reducing the morbidity of HAE attacks. Maintenance of orphan designation provides several important regulatory and financial benefits, including 10 years of market exclusivity in the EU following approval. Sebetralstat is now one of only two HAE medicines to have maintained orphan designation in the EU, highlighting its distinctive position within the HAE treatment landscape.

In June 2025, KalVista Pharmaceuticals Limited granted Pendopharm, a division of Pharmascience Inc., the exclusive rights to manage the regulatory approval process and commercialization of sebetralstat in Canada. Financial terms of the agreement were not disclosed.

Upon FDA approval of EKTERLY, we notified DRI Healthcare Acquisitions LP, an affiliate of DRI Healthcare Trust (“DRI”) that we elected to receive the optional payment of $22.0 million as part of the November 2024 royalty transaction. As a result of receiving this one-time payment from DRI, the royalty rate on the first sales tranche steps up from 5.00% to 6.00% on net sales up to and including $500.0 million and the sales-based milestone amount increases from $50.0 million to $57.0 million if annual worldwide net sales of EKTERLY meet or exceed $550.0 million in any calendar year before January 1, 2031.

In September 2025, the EC and the Swiss Agency for Therapeutic Products, Swissmedic, approved EKTERLY for the symptomatic treatment of acute attacks of HAE in adults and adolescents aged 12 years and older. We initiated our first European launch in Germany in October 2025, with availability in Switzerland anticipated in the second half of 2026, pending finalization of reimbursement plans.

Results of Operations

Refer to Note 2, Summary of Significant Accounting Policies, for a description of our significant accounting policies related to product revenue recognition and cost of revenue,

Comparison of the three and nine months ended September 30, 2025 and 2024

The following table sets forth the key components of our results of operations for the three and nine months ended September 30, 2025 and 2024 (in thousands):

 

 

Three Months Ended
September 30,

 

Change

 

 

2025

 

2024

 

$

 

%

Product revenue, net

 

$

13,692

 

$

 

$

13,692

 

 

100%

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

1,232

 

 

 

 

1,232

 

 

100%

Research and development

 

 

11,993

 

 

18,680

 

 

(6,687)

 

 

-36%

Selling, general and administrative

 

 

46,517

 

 

24,800

 

 

21,717

 

 

88%

Total operating expenses

 

 

59,742

 

 

43,480

 

 

16,262

 

 

37%

Operating loss

 

 

(46,050)

 

 

(43,480)

 

 

(2,570)

 

 

6%

Other (expense) income

 

 

(1,275)

 

 

4,396

 

 

(5,671)

 

 

-129%

Loss before income tax expense

 

$

(47,325)

 

$

(39,084)

 

$

(8,241)

 

 

21%

 

18


 

 

 

 

Nine Months Ended
September 30,

 

Change

 

 

2025

 

2024

 

$

 

%

Product revenue, net

 

$

13,692

 

$

 

$

13,692

 

 

100%

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

1,232

 

 

 

 

1,232

 

 

100%

Research and development

 

 

41,207

 

 

70,170

 

 

(28,963)

 

 

-41%

Selling, general and administrative

 

 

125,997

 

 

63,511

 

 

62,486

 

 

98%

Total operating expenses

 

 

168,436

 

 

133,681

 

 

34,755

 

 

26%

Operating loss

 

 

(154,744)

 

 

(133,681)

 

 

(21,063)

 

 

16%

Other income

 

 

1,379

 

 

11,152

 

 

(9,773)

 

 

-88%

Loss before income tax expense

 

$

(153,365)

 

$

(122,529)

 

$

(30,836)

 

 

25%

Product revenue, net. Product revenue, net increased by $13.7 million for the three and nine months ended September 30, 2025 compared with the three and nine months ended September 30, 2024 as a result of our commercial launch of EKTERLY in the United States in July 2025, following the FDA approval of EKTERLY on July 3, 2025.

Cost of revenue. Cost of revenue increased by $1.2 million for the three and nine months ended September 30, 2025 compared with the three and nine months ended September 30, 2024 and primarily consisted of manufacturing costs and costs associated with the distribution of EKTERLY following the FDA approval.

Research and Development Expenses. Research and development expenses decreased by $6.7 million for the three months ended September 30, 2025 compared with the three months ended September 30, 2024 due to decreases in spending on sebetralstat of $4.6 million and other R&D activities of $2.7 million offset by an increase in personnel costs. For the nine months ended September 30, 2025 compared with the nine months ended September 30, 2024, spending decreased by $29.0 million due to decreases in spending on sebetralstat of $15.2 million, personnel costs of $6.2 million, and other R&D activities of $7.5 million. The impact of exchange rates on research and development expenses was immaterial for the three and nine months ended September 30, 2025 compared to the same periods in the prior fiscal year, which is reflected in the figures above.

Research and development expenses by major programs or categories were as follows for the three and nine months ended September 30, 2025 and 2024 (in thousands):

 

 

Three Months Ended
September 30,

 

Change

 

 

2025

 

2024

 

$

 

%

Sebetralstat

 

$

3,074

 

$

7,625

 

$

(4,551)

 

 

-60%

Personnel

 

 

8,029

 

 

7,484

 

 

545

 

 

7%

Other R&D

 

 

890

 

 

3,571

 

 

(2,681)

 

 

-75%

Total research and development

 

$

11,993

 

$

18,680

 

$

(6,687)

 

 

-36%

 

 

 

Nine Months Ended
September 30,

 

Change

 

 

2025

 

2024

 

$

 

%

Sebetralstat

 

$

13,218

 

$

28,452

 

$

(15,234)

 

 

-54%

Personnel

 

 

21,867

 

 

28,064

 

 

(6,197)

 

 

-22%

Other R&D

 

 

6,122

 

 

13,654

 

 

(7,532)

 

 

-55%

Total research and development

 

$

41,207

 

$

70,170

 

$

(28,963)

 

 

-41%

 

19


 

Other R&D costs decreased primarily due to recognizing expense associated with sebetralstat pre-commercial awareness within Selling, general and administrative expenses. We anticipate these expenses will remain approximately at current levels as the KONFIDENT-S and KONFIDENT-KID trials are ongoing and we continue preclinical research including the oral Factor XIIa inhibitor program.

Selling, General and Administrative Expenses. Selling, general and administrative expenses increased by $21.7 million for the three months ended September 30, 2025 compared with the three months ended September 30, 2024 primarily due to increases in personnel costs of $13.2 million, professional fees of $1.7 million, commercial expenses of $0.7 million, and other administrative expenses of $6.1 million. Selling, general and administrative expenses increased by $62.5 million for the nine months ended September 30, 2025 compared with the nine months ended September 30, 2024 primarily due to increases in personnel costs of $33.9 million, commercial expenses of $8.0 million, medical awareness expenses of $6.1 million, professional fees of $4.9 million, and other administrative expenses of $9.6 million. We anticipate these expenses will continue at or above current levels to support the commercialization of EKTERLY.

Other (Expense) Income. Other (expense) income decreased by $5.7 million for the three months ended September 30, 2025 compared with the three months ended September 30, 2024 primarily due to an increase in interest expense and unfavorable changes in foreign currency exchange rates of $4.8 million and $2.0 million, respectively offset by the change in fair value of the derivative liability of $0.6 million. Other income decreased by $9.8 million for the nine months ended September 30, 2025 compared with the nine months ended September 30, 2024 primarily due to an increase in interest expense, change in fair value of the derivative liability, and decrease in the R&D tax credit of $10.7 million, $1.2 million, and $1.1 million, respectively, offset by the change in foreign currency exchange rate gains, interest income, and realized gains on marketable securities of $1.5 million, $0.9 million, and $0.8 million, respectively.

Liquidity and Capital Resources

The three months ended September 30, 2025 is the first period in which we have generated revenue from product sales, following the FDA approval of EKTERLY on July 3, 2025. We have funded operations primarily through the issuance of capital stock, pre-funded warrants, convertible debt and royalty financing. Our working capital, primarily cash and marketable securities, is anticipated to fund our operations for at least the next twelve months from the date these unaudited interim condensed consolidated financial statements are issued.

Sources of Liquidity

In February 2024, we entered into an underwriting agreement with Jefferies LLC, Leerink Partners LLC, Stifel, Nicolaus & Company, Incorporated, and Cantor Fitzgerald & Co., as the representatives of several underwriters to sell an aggregate of 7,016,312 shares of our common stock at a price of $15.25 per share and pre-funded warrants to purchase up to 3,483,688 shares of our common stock at a price of $15.249 per pre-funded warrant. The net proceeds from the offering, after deducting expenses, were approximately $150.1 million. As of September 30, 2025, no pre-funded warrants from the offering have been exercised.

In July 2024, we filed a registration statement on Form S-3 (the “Registration Statement”) with the U.S. Securities and Exchange Commission (the “SEC”), pursuant to which we may offer and sell securities having an aggregate public offering price of up to $300 million.

In November 2024, we entered into an underwriting agreement with Jefferies LLC, BofA Securities, Inc., TD Securities (USA) LLC and Stifel Nicolaus & Company, Incorporated, as the representatives of several underwriters to sell an aggregate of 5,500,000 shares of our common stock at an offering price of $10.00 per share (the “November 2024 Offering”) pursuant to the Registration Statement. The net proceeds from the November 2024 Offering, after deducting expenses, were approximately $51.3 million.

Also in November 2024, we entered into a securities purchase agreement with DRI to sell an aggregate of 500,000 shares of our common stock at a price of $10.00 per share in a private placement. The net proceeds from the private placement, after deducting placement agent fees and other expenses, were approximately $4.7 million.

Also, in November 2024, we entered into a royalty purchase agreement with DRI to monetize a portion of our future sebetralstat worldwide net sales. Under the terms of the agreement, we received an upfront payment of $100.0 million in exchange for tiered royalty payments on worldwide net sales of sebetralstat, which is recorded as the Royalty Liability in our consolidated balance sheets. In July 2025, we received a one-time cash payment of $22.0 million as a result of obtaining FDA approval of sebetralstat before October 1, 2025.

20


 

In April 2025, we entered into a License, Supply and Distribution Agreement (the “Kaken Agreement”) with Kaken Pharmaceutical Co., Ltd. (“Kaken”) pursuant to which we have licensed exclusive commercialization rights in Japan to Kaken for the Licensed Product (as defined under the Kaken Agreement) in exchange for a non-refundable upfront payment of $11.0 million, potential regulatory and sales milestone payments totaling approximately $13.0 million and effective royalty payments in the mid-twenties percentage that shall be payable for each unit of revenue of Licensed Product (as defined in the Kaken Agreement) that we supply, which reflect a percentage of the Japanese National Health Insurance price of the Licensed Product. On June 20, 2025, we received the upfront payment of $11.0 million.

In July 2025, we entered into a sales agreement with TD Securities (USA) LLC (“TD Cowen”) pursuant to which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $100.0 million (the “ATM Shares”), under the prospectus supplement, dated July 10, 2025, to the Registration Statement, through TD Cowen as sales agent. During the three months ended September 30, 2025, we did not offer or sell any ATM Shares pursuant to the Registration Statement.

In September 2025, we entered into an indenture agreement with U.S. Bank Trust Company, National Association, as trustee to issue $143.8 million aggregate principal amount of convertible senior notes.

Cash Flows

The following table shows a summary of the net cash flow activity for the nine months ended September 30, 2025 (in thousands):

 

 

Nine Months Ended
September 30,

 

Change

 

 

2025

 

2024

 

$

 

%

Cash used in operating activities

 

$

(126,985)

 

$

(91,652)

 

$

(35,333)

 

 

39%

Cash provided by (used in) investing activities

 

 

19,872

 

 

(55,704)

 

 

75,576

 

 

-136%

Cash provided by financing activities

 

 

164,390

 

 

153,606

 

 

10,784

 

 

7%

Effect of exchange rate changes

 

 

4,042

 

 

571

 

 

3,471

 

 

608%

Increase in cash, cash equivalents and restricted cash

 

$

61,319

 

$

6,821

 

$

54,498

 

 

799%

Cash used in operating activities

Cash used in operating activities was $127.0 million for the nine months ended September 30, 2025 and primarily consisted of a net loss of $158.9 million adjusted for stock-based compensation of $12.2 million, interest expense and issuance cost amortization associated with the sale of future royalties of $10.6 million, a decrease in the research and development tax credit receivable of $10.6 million, an increase in deferred revenue of $11.3 million, foreign currency gains of $6.9 million, and other changes in net working capital. Cash used in operating activities was $91.7 million for the nine months ended September 30, 2024 and primarily consisted of a net loss of $122.5 million adjusted for stock-based compensation of $18.7 million, a decrease in the research and development tax credit receivable of $12.5 million, and other changes in net working capital.

Cash provided by (used in) investing activities

Cash provided by investing activities for the nine months ended September 30, 2025 was $19.9 million and primarily consisted of the sales and maturities of marketable securities of $127.9 million offset by purchases of marketable securities of $105.8 million, as compared to $55.7 million used in investing activities during the same period in the prior year primarily due to purchases of marketable securities of $148.4 million offset by sales and maturities of marketable securities of $93.1 million.

Cash provided by financing activities

Cash provided by financing activities during the nine months ended September 30, 2025 was $164.4 million and primarily consisted of the proceeds from the sale of convertible notes of $139.4 million and the increase of the royalty liability of $21.3 million related to our drawdown of the optional milestone payment from DRI after FDA approval of EKTERLY. Cash provided by financing activities during the same period in the prior year was $153.6 million from the issuance of common stock.

Contractual Obligations and Commitments

We enter into contracts in the normal course of business with contract research organizations and clinical trial sites for the conduct of clinical trials, preclinical and clinical studies, professional consultants and other vendors for clinical supply manufacturing or

21


 

other services. These contracts generally provide for termination on notice, and therefore are cancelable contracts and not included in the table of contractual obligations and commitments in our Annual Report on Form 10-K for the fiscal year ended April 30, 2025, filed with the SEC on July 10, 2025. We are party to several operating leases for office and laboratory space as of September 30, 2025.

Critical Accounting Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of our financial statements and the reported revenue and expenses during the reported periods. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience, known trends and events, contractual milestones and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. See Note 2 to the unaudited interim condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report on Form 10-Q for a description of our significant accounting policies and assumptions used in applying those policies. The accounting policies and estimates that we deem to be critical are discussed in more detail in our Annual Report on Form 10-K for the fiscal year ended April 30, 2025, filed with the SEC on July 10, 2025. Other than as described below, there have been no material changes to our critical accounting estimates in the nine months ended September 30, 2025.

Revenue Recognition

To determine revenue recognition for arrangements within the scope of ASC Topic 606, Revenue from Contracts with Customers, we perform the following five steps: (1) identify the contracts with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when or as we satisfy a performance obligation.

Net revenue from sales of EKTERLY is recorded at net selling price (transaction price), which includes reserves for variable consideration such as estimated government rebates, patient assistance programs, prompt payment discounts, distribution fees, and product returns. These estimated reserves, representing our best estimates of the amount of consideration to which we expect to be entitled based on the terms of the applicable contracts and statutory requirements. The related reserves are recorded as reductions of accounts receivable when no payments are required of us or a current liability when payment is expected. Actual amounts of consideration may differ from our estimates. If actual results vary from estimates, these estimates are adjusted, which would affect net product revenue and earnings in the period such variances become known.

Rebates. We estimate rebates we will provide to governmental programs, including Medicaid and Medicare, and deduct these estimated amounts from total gross product revenues at the time the revenues are recognized, resulting in a reduction of product revenue and the establishment of a current liability. Rebate reserves are calculated based on the terms of applicable government statutory requirements and estimated product utilization by eligible patients.

Patient assistance. We provide financial assistance programs such as co-pay assistance to eligible commercially insured patients to help reduce out-of-pocket costs. The calculation is based on claims processed during a given period. Reserves for these programs are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue and establishment of a current liability.

Prompt payment discounts. We estimate credits to be granted to specialty pharmacies that remit payment within established incentive periods. These amounts are recorded as reductions of product revenue and accounts receivable at the time the related revenue is recognized.

Distribution fees. Distribution fees relate to payments made to customers in the distribution channel that provide inventory management, data reporting and product distribution services. These fees are generally recorded as a reduction of product revenue and a current liability at the time related revenues are recognized. If the services provided by the customer are distinct from the sale of product, the payments are instead classified as selling, general and administrative expenses.

Product returns. Reserves for estimated product returns are established in the period that the related revenue is recognized and recorded as reductions of both product revenue and accounts receivable.

22


 

Recently Issued Accounting Pronouncements

See Note 2 to the unaudited interim condensed financial statements in Part I, Item 1 of this Quarterly Report on Form 10-Q for a description of recent accounting pronouncements, including the expected dates of adoption and expected effects on results of operations and financial condition, if known.

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information under this item.

Item 4. CONTROLS AND PROCEDURES.

Evaluation of Disclosure Controls and Procedures

As required by Rule 13a-15(b) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), our management, under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of September 30, 2025. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute assurance of achieving the desired objectives. Also, the design of a control system must reflect the fact that there are resource constraints and the benefits of controls must be considered relative to their costs. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of September 30, 2025.

Changes in Internal Controls over Financial Reporting

As a result of our commercial launch of EKTERLY in the United States during the quarter ended September 30, 2025, we implemented processes and internal controls related to product revenue, net. We consider the accounting for our product revenue, net to be material to our results of operations in future periods. There have been no other changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

23


 

PART II

OTHER INFORMATION

From time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. We are currently not aware of any such legal proceedings or claims that we believe will have a material adverse effect on our business, financial condition or operating results.

Item 1A. RISK FACTORS

There have been no material changes to the risk factors described in the section captioned “Part I, Item 1A, Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended April 30, 2025.

In addition to the other information set forth in this report, you should carefully consider the factors discussed in the section captioned “Part I, Item 1A, Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended April 30, 2025 filed with the SEC on July 10, 2025, which may materially affect our business, financial condition, or future results. The risks described in our Annual Report on Form 10-K and in our Quarterly Reports on Form 10-Q are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may have a material adverse effect on our business, financial condition, or operating results.

Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Sales of Unregistered Securities

Not applicable.

Use of Proceeds

None.

Issuer Purchases of Equity Securities

Not applicable.

Item 3. DEFAULTS UPON SENIOR SECURITIES

Not applicable.

Item 4. MINE SAFETY DISCLOSURES

Not applicable.

Item 5. OTHER INFORMATION

(c) Insider Trading Arrangements and Policies

In the third quarter of calendar year 2025, no trading plans were adopted, modified or terminated by a director or officer of the Company.

24


 

Item 6. EXHIBITS

 

 

 

 

 

Incorporated by Reference

 

 

Exhibit Number

 

Exhibit Description

 

Form

 

File No.

 

Exhibit

 

Filing Date

 

Filed

Herewith

 

 

 

 

 

 

 

 

 

 

 

 

 

4.1

 

Indenture, dated as of September 29, 2025, between KalVista Pharmaceuticals, Inc. and U.S. Bank Trust Company, National Association, as trustee

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

4.2

 

Form of 3.250% Convertible Senior Notes due 2031 (included as Exhibit A to Exhibit 4.1)

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

10.1

 

Amendment to Purchase and Sale Agreement, dated May 22, 2025, by and among KalVista Pharmaceuticals Limited, DRI Healthcare Acquisitions LP, and solely for the purposes of the Guarantor Provisions therein, KalVista Pharmaceuticals, Inc.

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

10.2

 

Second Amendment to Purchase and Sale Agreement, dated September 2, 2025, by and among KalVista Pharmaceuticals Limited, DRI Healthcare Acquisitions LP, DRI UK LP, and solely for the purposes of the Guarantor Provisions therein, KalVista Pharmaceuticals, Inc.

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

31.1

 

Certification of Principal Executive Officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

31.2

 

Certification of Principal Financial Officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

32.1#

 

Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 

 

101.INS

 

Inline XBRL Instance Document - the instance document does not appear in the interactive data file because its XBRL tags are embedded within the inline XBRL document

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

104

 

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

 

 

 

 

 

 

 

 

 

 

† Registrant has omitted portions of the exhibit as permitted under Item 601(b)(10) of Regulation S-K.

^ Registrant has omitted schedules and exhibits pursuant to Item 601(a)(5) of Regulation S-K. The Registrant agrees to furnish supplementally a copy of the omitted schedules and exhibits to the SEC upon request.

25


 

# This certification is deemed not filed for purpose of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act.

 

 

26


 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

KALVISTA PHARMACEUTICALS, INC.

 

 

 

 

 

Date: November 10, 2025

By:

/s/ Benjamin L. Palleiko

 

Benjamin L. Palleiko

Chief Executive Officer

(Principal Executive Officer)

 

Date: November 10, 2025

By:

/s/ Brian Piekos

 

 

Brian Piekos

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

27


FAQ

What did KALV report for Q3 2025 product revenue?

$13.7 million in product revenue, net, reflecting EKTERLY’s initial commercial sales.

What was KalVista’s Q3 2025 net loss and loss per share (KALV)?

Net loss was $49.5 million, with basic and diluted net loss per share of $0.92.

How much cash and marketable securities did KALV have at 9/30/2025?

Cash and cash equivalents were $243.5 million; marketable securities were $65.7 million.

What are the terms of KALV’s 2025 convertible notes?

Issued $143.8 million principal, 3.250% due 2031, initial conversion price $16.81 per share (59.4919 shares per $1,000).

What is the status of KALV’s royalty financing with DRI?

Net royalty obligation carrying amount was $125.0 million; the first-tier royalty rate increased to 6.00% after a $22.0 million draw.

Which EKTERLY approvals and launches occurred in 2025?

Approvals in the U.S., UK, EU, Switzerland, and Australia; commercial sales began in the U.S. and Germany.

How many KALV shares were outstanding as of November 3, 2025?

50,546,293 shares of common stock were outstanding.
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