8-K
false000134891100013489112024-03-112024-03-11

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 11, 2024

 

 

KALVISTA PHARMACEUTICALS, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-36830

20-0915291

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

55 Cambridge Parkway

Suite 901E

 

Cambridge, Massachusetts

 

02142

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 857 999-0075

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, $0.001 par value per share

 

KALV

 

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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.

 


Item 2.02 Results of Operations and Financial Condition.

On March 11, 2024, KalVista Pharmaceuticals, Inc. (the “Company”) reported its financial results for the fiscal quarter ended January 31, 2024. A copy of the press release issued by the Company is furnished as Exhibit 99.1 to this report.

The information furnished with Item 2.02 of this report, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Exchange Act or under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit

Number

Description

99.1

Press release dated March 11, 2024

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 


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:

March 11, 2024

By:

/s/ Benjamin L. Palleiko

 

 

 

Benjamin L. Palleiko
Chief Executive Officer
(Principal Executive, Financial and Accounting Officer)

 


EX-99.1

Exhibit 99.1

KalVista Pharmaceuticals Reports Third Fiscal Quarter Results and Provides Operational Update

 

- Sebetralstat Phase 3 KONFIDENT clinical trial met all endpoints and demonstrated a favorable safety profile as first oral on-demand therapy for hereditary angioedema -

- CEO transition supports ongoing evolution into commercial company -

Cambridge, MA and Salisbury, England, March 11, 2024 –KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the third fiscal quarter ended January 31, 2024.

 

“This has been an exciting and busy period for KalVista, as we achieved key milestones with the release of our phase 3 KONFIDENT data and the completion of a substantial financing,” said Ben Palleiko, Chief Executive Officer of KalVista. “We remain on track to file the NDA with the U.S. Food and Drug Administration in the first half of this year, and we look forward to presenting further phase 3 data for sebetralstat at upcoming patient and medical meetings. We also continue to grow the commercial organization to enable us to deliver on the promise of providing the first oral, on-demand treatment option to the HAE community.”

 

Third Fiscal Quarter and Recent Business Highlights:

 

In February, the Company announced positive topline data from the Phase 3 KONFIDENT clinical trial evaluating the safety and efficacy of sebetralstat as the potential first oral, on-demand therapy for hereditary angioedema (HAE). KONFIDENT was the largest and most representative trial ever conducted in HAE, enrolling a total of 136 patients from 66 clinical sites across 20 countries. Eligible participants included adolescents, patients using long-term prophylaxis, and the trial evaluated all attack severities and locations. The clinical trial met all primary and key secondary endpoints across both the 300 and 600 mg doses and demonstrated a safety profile similar to placebo.
Also in February, KalVista closed an underwritten offering to sell an aggregate of 7,016,312 shares of common stock at price of $15.25 per share and pre-funded warrants to purchase up to 3,483,688 shares of common stock at a price of $15.249 per pre-funded warrant. The net proceeds from the offering were approximately $150.1 million and are expected to provide funding into 2026.
The Company announced that Benjamin L. Palleiko, the Company’s prior President, CBO and CFO, was appointed as Chief Executive Officer and a director of the Company. This appointment is the result of a planned transition as KalVista prepares to become a commercial entity following the success of the KONFIDENT Phase 3 trial for its program sebetralstat.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) awarded the Innovation Passport for sebetralstat, providing entry to the UK Innovative Licensing and

Exhibit 99.1

Access Pathway (ILAP), which aims to accelerate time to market and facilitate patient access to innovative medicines.
Presented additional Phase 3 KONFIDENT data as well as data on unmet need in HAE from a patient perspective at the 2024 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) in Washington, D.C.
Announced publication of the first report of a potent and specific Factor XIIa inhibitor with high oral availability in a peer-reviewed journal. The Frontiers in Pharmacology article describes the pharmacology of a representative compound from KalVista’s portfolio of structurally diverse, oral Factor XII inhibitors.

 

Third Fiscal Quarter Financial Results:

 

Revenue: No revenue was recognized for the three months ended January 31, 2024, or January 31, 2023.

R&D Expenses: Research and development expenses were $22.5 million for the three months ended January 31, 2024, compared to $20.1 million for the same period in the prior fiscal year. The increase in R&D expenses during the quarter primarily reflects the ongoing Phase 3 KONFIDENT and KONFIDENT-S trials.

G&A Expenses: General and administrative expenses were $10.6 million for the three months ended January 31, 2024, compared to $6.9 million for the same period in the prior fiscal year. The increase in G&A expenses was primarily due to increases in employee-related expenses and commercial planning expenses.

Net Loss: Net loss was $29.0 million, or $(0.84) per weighted average basic and diluted share, for the three months ended January 31, 2024, compared to net loss of $21.3 million, or $(0.75) per weighted average basic and diluted share for the same period in the prior fiscal year. The increase in net loss primarily resulted from the increase in operating expenses, primarily research and development.

Cash Position: Cash, cash equivalents and marketable securities were $75.6 million as of January 31, 2024, compared to $149.4 million as of April 30, 2023. The decrease in the net cash and marketable securities position was due to cash consumption from operating expenses.

About KalVista Pharmaceuticals, Inc.

 

KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need. KalVista disclosed positive phase 3 data for the KONFIDENT trial for its oral, on-demand therapy sebetralstat in February 2024. The Company anticipates submitting a new drug application to the U.S. Food and Drug Administration (FDA) for sebetralstat in the first half of 2024 and expects to file for approval in Europe and Japan later in 2024. In addition, KalVista’s oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment for people living with HAE and other diseases.

 

For more information about KalVista, please visit www.kalvista.com.


Exhibit 99.1

Forward-Looking Statements

 

This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates, our ability to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2023, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contact:

KalVista Pharmaceuticals, Inc.

Jarrod Aldom

Vice President, Corporate Communications

(201) 705-0254

jarrod.aldom@kalvista.com

 

Ryan Baker

Head, Investor Relations

(617) 771-5001

ryan.baker@kalvista.com

 

 

 


Exhibit 99.1

KalVista Pharmaceuticals Inc.

 

Condensed Consolidated Balance Sheets

 

(in thousands, except share and per share amounts)

 

(Unaudited)

 

 

 

 

 

 

 

 

January 31,

 

 

April 30,

 

 

2024

 

 

2023

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

$

23,056

 

 

$

56,238

 

Marketable securities

 

52,530

 

 

 

93,137

 

Research and development tax credit receivable

 

23,011

 

 

 

16,568

 

Prepaid expenses and other current assets

 

5,506

 

 

 

6,383

 

Total current assets

 

104,103

 

 

 

172,326

 

Property and equipment, net

 

2,423

 

 

 

2,948

 

Right of use assets

 

7,045

 

 

 

7,822

 

Other assets

 

397

 

 

 

106

 

Total assets

$

113,968

 

 

$

183,202

 

Liabilities and stockholders' equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

$

3,101

 

 

$

4,817

 

Accrued expenses

 

14,840

 

 

 

9,128

 

Lease liability - current portion

 

1,187

 

 

 

1,087

 

Total current liabilities

 

19,128

 

 

 

15,032

 

Long-term liabilities:

 

 

 

 

 

Lease liability - net of current portion

 

6,257

 

 

 

7,145

 

Total long-term liabilities

 

6,257

 

 

 

7,145

 

Stockholders’ equity:

 

 

 

 

 

Common stock, $0.001 par value

 

34

 

 

 

34

 

Additional paid-in capital

 

516,920

 

 

 

507,133

 

Accumulated deficit

 

(425,077

)

 

 

(343,082

)

Accumulated other comprehensive loss

 

(3,294

)

 

 

(3,060

)

Total stockholders’ equity

 

88,583

 

 

 

161,025

 

Total liabilities and stockholders' equity

$

113,968

 

 

$

183,202

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Exhibit 99.1

KalVista Pharmaceuticals Inc.

 

Condensed Consolidated Statement of Operations

 

(in thousands, except share and per share amounts)

 

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

January 31,

 

 

January 31,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

$

 

 

$

 

 

$

 

 

$

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

22,523

 

 

 

20,063

 

 

 

60,919

 

 

 

56,325

 

General and administrative

 

10,628

 

 

 

6,882

 

 

 

31,071

 

 

 

22,818

 

Total operating expenses

 

33,151

 

 

 

26,945

 

 

 

91,990

 

 

 

79,143

 

Operating loss

 

(33,151

)

 

 

(26,945

)

 

 

(91,990

)

 

 

(79,143

)

 

 

 

 

 

 

 

 

 

 

 

 

Other income:

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

684

 

 

 

732

 

 

 

2,383

 

 

 

1,424

 

Foreign currency exchange rate gain (loss)

 

1,120

 

 

 

597

 

 

 

277

 

 

 

(237

)

Other income

 

2,319

 

 

 

4,313

 

 

 

7,335

 

 

 

11,354

 

Total other income

 

4,123

 

 

 

5,642

 

 

 

9,995

 

 

 

12,541

 

Net loss

$

(29,028

)

 

$

(21,303

)

 

$

(81,995

)

 

$

(66,602

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

$

(0.84

)

 

$

(0.75

)

 

$

(2.37

)

 

$

(2.58

)

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding, basic and diluted

 

34,723,379

 

 

 

28,278,453

 

 

 

34,567,853

 

 

 

25,810,369

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Exhibit 99.1

KalVista Pharmaceuticals Inc.

 

Condensed Consolidated Statements of Cash Flows

 

(in thousands, unaudited)

 

 

 

 

 

 

 

 

Nine Months Ended

 

 

January 31,

 

 

2024

 

 

2023

 

 

 

 

 

 

 

Cash flows from operating activities

 

 

 

 

 

Net loss

$

(81,995

)

 

$

(66,602

)

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

 

 

 

 

 

Depreciation and amortization

 

597

 

 

 

530

 

Stock-based compensation expense

 

9,172

 

 

 

7,481

 

Realized (gain) loss from sale of marketable securities

 

(1,130

)

 

 

84

 

Non-cash operating lease expense

 

(11

)

 

 

52

 

Amortization of premium on marketable securities

 

88

 

 

 

890

 

Foreign currency exchange loss (gain)

 

596

 

 

 

(1,339

)

Changes in operating assets and liabilities:

 

 

 

 

 

Research and development tax credit receivable

 

(6,215

)

 

 

2,049

 

Prepaid expenses and other current assets

 

906

 

 

 

4,440

 

Accounts payable

 

(1,778

)

 

 

(1,911

)

Accrued expenses

 

5,644

 

 

 

1,701

 

Net cash used in operating activities

 

(74,126

)

 

 

(52,625

)

 

 

 

 

 

 

Cash flows from investing activities

 

 

 

 

 

Purchases of marketable securities

 

(47,687

)

 

 

(63,757

)

Sales and maturities of marketable securities

 

89,475

 

 

 

112,509

 

Acquisition of property and equipment

 

(27

)

 

 

(1,127

)

Website development costs

 

(294

)

 

 

 

Net cash provided by investing activities

 

41,467

 

 

 

47,625

 

 

 

 

 

 

 

Cash flows from financing activities

 

 

 

 

 

Issuance of common stock from equity incentive plans

 

616

 

 

 

482

 

Issuance of common stock, net of offering expenses of $0.3 million

 

 

 

 

56,582

 

Issuance of pre-funded warrants, net of offering expenses

 

 

 

 

1,085

 

Net cash provided by financing activities

 

616

 

 

 

58,149

 

Effect of exchange rate changes on cash and cash equivalents

 

(1,139

)

 

 

1,168

 

Net (decrease) increase in cash and cash equivalents

 

(33,182

)

 

 

54,317

 

Cash and cash equivalents at beginning of period

 

56,238

 

 

 

30,732

 

Cash and cash equivalents at end of period

$

23,056

 

 

$

85,049