KalVista Pharmaceuticals Reports Third Fiscal Quarter Results and Provides Operational Update - March 11, 2024

KalVista Pharmaceuticals, Inc. provided an operational update and released financial results for the third fiscal quarter ended January 31, 2024.

  • 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, Mass. & SALISBURY, England--(BUSINESS WIRE)-- 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 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.

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.

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

 
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

 
               
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

 
       

View source version on businesswire.com: https://www.businesswire.com/news/home/20240311841357/en/

Contacts

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

Source: KalVista Pharmaceuticals, Inc.

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