8-K
0001348911false00013489112023-09-072023-09-07

 

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): September 07, 2023

 

 

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 September 7, 2023, KalVista Pharmaceuticals, Inc. (the “Company”) reported its financial results for the fiscal quarter ended July 31, 2023. 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 September 7, 2023

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:

September 7, 2023

By:

/s/ Benjamin L. Palleiko

 

 

 

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

 


EX-99.1

 

 

Exhibit 99.1

 

KalVista Pharmaceuticals Reports First Fiscal Quarter Results and Provides Operational Update

– Sebetralstat Phase 3 KONFIDENT Clinical Trial Achieves Target Enrollment; Data Readout on Track for Q4 –

– Preparations Continue for NDA filing H1 2024 and Rapid Commercialization Upon Approval –

 

Cambridge, MA and Salisbury, England, September 7, 2023 –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 first fiscal quarter ended July 31, 2023.

 

“We know from our extensive interactions with people living with hereditary angioedema (HAE) at the recent conferences how much they are anticipating having sebetralstat available to them, and the data from the KONFIDENT trial in Q4 is the next step,” said Andrew Crockett, Chief Executive Officer of KalVista. “We continue to build our Commercial operation with the addition of Nicole Sweeny as Chief Commercial Officer and other key members of the team to support an NDA submission in the first half of 2024 and a rapid launch upon FDA approval.”

 

First Fiscal Quarter and Recent Business Highlights:

Published “Evaluation of patient-reported outcome measures for on-demand treatment of hereditary angioedema attacks and design of KONFIDENT, a phase 3 trial of sebetralstat” in Clinical and Translational Allergy. This publication outlines the rigorous, multi-factorial approach used to design a phase 3 trial with an optimized, patient- and physician-preferred measure to assess measure efficacy, and discusses reasons for the superiority of the selected primary endpoint over other potential measures
Presented real-world patient data on the HAE Attack Journey at the HAEi Regional Conference EMEA meeting showing there remain important unmet needs for both people using only on-demand therapies as well as those on long-term prophylaxis
Achieved enrollment target of 114 patients in the phase 3 KONFIDENT trial. Data readout remains on track for the fourth quarter of 2023 and, if the trial is successful, KalVista anticipates submitting an NDA to the FDA in the first half of 2024
Presented real-world patient data at the 2023 US HAEA National Summit showing people living with HAE continue to delay treatment for attacks due to challenges from injections or infusions, even though they know early treatment means an earlier return to normal activities
Announced that Nicole Sweeny joined the Senior Leadership Team at KalVista as Chief Commercial Officer

 


 

 

 

Reported new data in five posters at the 2023 Meeting of the European Academy of Allergy and Clinical Immunology. The presentations showed that sebetralstat pharmacokinetic and pharmacodynamic data support globalization of the KONFIDENT phase 3 clinical trial and use in short-term prophylaxis and that patients receiving modern long-term prophylaxis continued to have challenges associated with treatment decisions
Presented at the 2023 Jefferies Global Healthcare Conference, Stifel Tailoring Genes: Genetic Medicines Day and Stifel Biotech Summer Summit
Revealed patient survey data at the 13th C1-inhibitor Deficiency & Angioedema Workshop demonstrating the burden associated with injectable on-demand treatments for HAE and that those living with HAE had a strong preference for oral medication for on-demand treatment of attacks over self-administered injectable treatments when efficacy and safety profiles were similar
Continued to advance plans for the eventual worldwide launch of sebetralstat by hiring a General Manager, Japan. Based on interactions to date with Japanese physicians and regulatory authorities, KalVista believes sebetralstat has the potential to significantly improve HAE therapeutic options in Japan.

 

First Fiscal Quarter Financial Results:

 

Revenue: No revenue was recognized for the three months ended July 31, 2023 or July 31, 2022.

R&D Expenses: Research and development expenses were $19.3 million for the three months ended July 31, 2023, compared to $18.2 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 trial for sebetralstat and increased personnel costs.

G&A Expenses: General and administrative expenses were $9.8 million for the three months ended July 31, 2023, compared to $8.1 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 professional fees.

Net Loss: Net loss was $25.3 million, or $(0.74) per weighted average basic and diluted share, for the three months ended July 31, 2023, compared to net loss of $23.0 million, or $(0.94) 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 $123.3 million as of July 31, 2023, 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 is developing sebetralstat as an oral on-demand therapy for HAE attacks and has achieved target enrollment for the phase 3 KONFIDENT clinical trial. 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.

For more information on the sebetralstat HAE on-demand Phase 3 KONFIDENT study, please visit www.konfidentstudy.com.

Forward-Looking Statements

This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our Phase 3 KONFIDENT trial, and 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

 

 


 

 

 

KalVista Pharmaceuticals Inc.

 

Condensed Consolidated Balance Sheets

 

(in thousands, except share and per share amounts)

 

(Unaudited)

 

 

 

 

 

 

 

 

July 31,

 

 

April 30,

 

 

2023

 

 

2023

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

$

49,409

 

 

$

56,238

 

Marketable securities

 

73,848

 

 

 

93,137

 

Research and development tax credit receivable

 

19,057

 

 

 

16,568

 

Prepaid expenses and other current assets

 

7,528

 

 

 

6,383

 

Total current assets

 

149,842

 

 

 

172,326

 

Property and equipment, net

 

2,813

 

 

 

2,948

 

Right of use assets

 

7,571

 

 

 

7,822

 

Other assets

 

106

 

 

 

106

 

Total assets

$

160,332

 

 

$

183,202

 

Liabilities and stockholders' equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

$

5,060

 

 

$

4,817

 

Accrued expenses

 

7,950

 

 

 

9,128

 

Lease liability - current portion

 

1,122

 

 

 

1,087

 

Total current liabilities

 

14,132

 

 

 

15,032

 

Long-term liabilities:

 

 

 

 

 

Lease liability - net of current portion

 

6,865

 

 

 

7,145

 

Total long-term liabilities

 

6,865

 

 

 

7,145

 

Stockholders’ equity:

 

 

 

 

 

Common stock, $0.001 par value

 

34

 

 

 

34

 

Additional paid-in capital

 

510,591

 

 

 

507,133

 

Accumulated deficit

 

(368,399

)

 

 

(343,082

)

Accumulated other comprehensive loss

 

(2,891

)

 

 

(3,060

)

Total stockholders’ equity

 

139,335

 

 

 

161,025

 

Total liabilities and stockholders' equity

$

160,332

 

 

$

183,202

 

 

 


 

 

 

KalVista Pharmaceuticals Inc.

Condensed Consolidated Statement of Operations

(in thousands, except share and per share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

July 31,

 

 

 

2023

 

 

2022

 

 

 

 

 

 

 

 

 

Revenue

$

 

 

$

 

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

19,307

 

 

 

18,186

 

 

General and administrative

 

9,786

 

 

 

8,130

 

 

Total operating expenses

 

29,093

 

 

 

26,316

 

 

Operating loss

 

(29,093

)

 

 

(26,316

)

 

 

 

 

 

 

 

 

Other income:

 

 

 

 

 

 

Interest income

 

923

 

 

 

242

 

 

Foreign currency exchange gain (loss)

 

456

 

 

 

(517

)

 

Other income

 

2,397

 

 

 

3,549

 

 

Total other income

 

3,776

 

 

 

3,274

 

 

Net loss

$

(25,317

)

 

$

(23,042

)

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

$

(0.74

)

 

$

(0.94

)

 

 

 

 

 

 

 

 

Weighted average common shares outstanding, basic and diluted

 

34,414,226

 

 

 

24,557,615

 

 


 

 

 


 

 

 

KalVista Pharmaceuticals Inc.

 

Condensed Consolidated Statements of Cash Flows

 

(in thousands, unaudited)

 

 

 

 

 

 

 

 

Three Months Ended

 

 

July 31,

 

 

2023

 

 

2022

 

 

 

 

 

 

 

Cash flows from operating activities

 

 

 

 

 

Net loss

$

(25,317

)

 

$

(23,042

)

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

 

 

 

 

 

Depreciation and amortization

 

193

 

 

 

158

 

Stock-based compensation expense

 

3,254

 

 

 

2,642

 

Realized (gain) loss from sale of marketable securities

 

(314

)

 

 

16

 

Non-cash operating lease expense

 

6

 

 

 

23

 

Amortization of premium on marketable securities

 

62

 

 

 

391

 

Foreign currency exchange (gain) loss

 

(395

)

 

 

426

 

Changes in operating assets and liabilities:

 

 

 

 

 

Research and development tax credit receivable

 

(2,084

)

 

 

(3,570

)

Prepaid expenses and other current assets

 

(1,003

)

 

 

1,935

 

Accounts payable

 

108

 

 

 

(678

)

Accrued expenses

 

(1,240

)

 

 

(1,043

)

Net cash used in operating activities

 

(26,730

)

 

 

(22,742

)

 

 

 

 

 

 

Cash flows from investing activities

 

 

 

 

 

Purchases of marketable securities

 

(25,767

)

 

 

(10,102

)

Sales and maturities of marketable securities

 

45,386

 

 

 

41,066

 

Acquisition of property and equipment

 

(6

)

 

 

(920

)

Net cash provided by investing activities

 

19,613

 

 

 

30,044

 

 

 

 

 

 

 

Cash flows from financing activities

 

 

 

 

 

Issuance of common stock from equity incentive plans

 

204

 

 

 

168

 

Net cash provided by financing activities

 

204

 

 

 

168

 

Effect of exchange rate changes on cash and cash equivalents

 

84

 

 

 

(339

)

Net increase (decrease) in cash and cash equivalents

 

(6,829

)

 

 

7,131

 

Cash and cash equivalents at beginning of period

 

56,238

 

 

 

30,732

 

Cash and cash equivalents at end of period

$

49,409

 

 

$

37,863