KalVista Pharmaceuticals Reports First Fiscal Quarter Results

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– FDA End-of-Phase 2 Meeting for KVD900 Oral HAE Phase 3 Program Scheduled for This Month –

– KVD824 Phase 2 KOMPLETE Clinical Trial Enrolling –

CAMBRIDGE, Mass. & SALISBURY, EnglandKalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today provided an operational update and released financial results for the first fiscal quarter ended July 31, 2021.

“We have made excellent progress in the rollout of our Phase 2 KOMPLETE clinical trial for KVD824,” said Andrew Crockett, Chief Executive Officer of KalVista. “Site initiations are underway, and patients are being enrolled in the trial to evaluate KVD824 as a potential oral prophylactic treatment for HAE. We will be having an end-of-Phase 2 meeting with the FDA later this month regarding KVD900, our oral on-demand candidate for treatment of HAE attacks and are ready to initiate the Phase 3 study quickly afterwards. We look forward to advancing both of these compounds as we continue with our strategy of bringing a full spectrum of oral treatment options to HAE patients.”

First Fiscal Quarter and Recent Business Highlights:

  • Presented Phase 2 data for KVD900 in late-breaking session at European Academy of Allergy and Clinical Immunology (EAACI) Congress. The data showed that a single on-demand treatment with orally administered KVD900 significantly slows progression and accelerates resolution of attacks in patients with hereditary angioedema (HAE). KalVista also presented four other posters at EAACI related to the HAE clinical landscape and unmet needs, as well as preclinical data from other oral molecules.
  • Scheduled an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to review the proposed development plans for KVD900, KalVista’s oral on-demand candidate for treatment of HAE attacks, expected to take place in September 2021. KVD900 also received Orphan Drug Designation from the FDA.
  • Presented data at the International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress showcasing small molecule Factor XIIa inhibitor research.
  • Provided a progress update on the KVD824 Phase 2 KOMPLETE Clinical Trial. KVD824 is in development for oral prophylactic treatment of HAE. Regulatory submissions have been approved in Canada, Australia, and the UK with patient enrollment now underway. KalVista also submitted a response to the clinical hold related to the U.S. Investigational New Drug (IND) filing for KVD824 and is prepared to initiate the study in the U.S. upon clearance from the FDA.
  • Presented KVD001 data at American Chemical Society (ACS) Meeting.

First Fiscal Quarter Financial Results:

  • Revenue: No revenue was recognized for the three months ended July 31, 2021 or July 31, 2020.
  • R&D Expenses: Research and development expenses were $13.7 million for the three months ended July 31, 2021, compared to $11.2 million for the same period in the prior fiscal year. The increase in R&D expenses during the quarter primarily reflects increased preclinical spending and the ongoing clinical trial for KVD824, offset by a decrease in spending on KVD900 and KVD001 due to their concluded Phase 2 clinical trials in February 2021 and December 2019, respectively.
  • G&A Expenses: General and administrative expenses were $5.9 million for the three months ended July 31, 2021, compared to $3.3 million for the same period in the prior fiscal year. The increase in G&A expenses was primarily due to an increase in compensation related expenses and to a lesser extent, increases in commercial planning expenses, professional fees, and other administrative costs.
  • Net Loss: Net loss was $16.1 million, or $(0.66) per weighted average basic and diluted share, for the three months ended July 31, 2021, compared to net loss of $10.8 million, or $(0.61) per weighted average basic and diluted share for the same period in the prior fiscal year. The increase in net loss and net loss per share primarily resulted from the increase in operating expenses, primarily research and development.
  • Cash Position: Cash, cash equivalents and marketable securities were $230.6 million as of July 31, 2021, compared to $248.9 million as of April 30, 2021. The decrease in the net cash position was due to increased operating expenses.

About KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). KalVista is developing KVD900 as an oral on-demand therapy for acute HAE attacks, which completed a Phase 2 efficacy trial in February 2021, demonstrating statistical and clinical significance across all endpoints. KVD824 is in development for prophylactic treatment of HAE with the Phase 2 KOMPLETE clinical trial underway. In addition, KalVista’s oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment of HAE for patients. In DME, an intravitreally administered plasma kallikrein inhibitor, called KVD001, has completed a Phase 2 clinical trial.

For more information, 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, including the potential impact of COVID-19, 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 or complete clinical studies, including our Phase 2 KOMPLETE clinical trial, and to obtain regulatory approvals for KVD900, KVD824 and other candidates in development, our ability to resolve a clinical hold with regards to KVD824, the ability of KVD900, KVD824 and other candidates in development to treat HAE or DME, the future progress and potential success of our oral Factor XIIa program, and the sufficiency of our cash, cash equivalents and investments to fund our operations. 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, 2021, 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)
 

July 31,

 

April 30,

2021

 

2021

Assets
Current assets:
Cash and cash equivalents

$

48,343

 

$

50,592

 

Marketable securities

 

182,288

 

 

198,337

 

Research and development tax credit receivable

 

13,613

 

 

10,418

 

Prepaid expenses and other current assets

 

5,538

 

 

4,917

 

Total current assets

 

249,782

 

 

264,264

 

Property and equipment, net

 

1,944

 

 

1,791

 

Right of use assets

 

7,207

 

 

5,758

 

Other assets

 

200

 

 

200

 

Total assets

$

259,133

 

$

272,013

 

Liabilities and stockholders' equity
Current liabilities:
Accounts payable

$

1,448

 

$

1,981

 

Accrued expenses

 

5,876

 

 

6,930

 

Lease liability - current portion

 

905

 

 

863

 

Total current liabilities

 

8,229

 

 

9,774

 

Long-term liabilities:
Lease liability - net of current portion

 

6,474

 

 

5,046

 

Total long-term liabilities

 

6,474

 

 

5,046

 

Stockholders’ equity:
Common stock, $0.001 par value

 

24

 

 

24

 

Additional paid-in capital

 

429,840

 

 

426,437

 

Accumulated deficit

 

(183,945

)

 

(167,836

)

Accumulated other comprehensive loss

 

(1,489

)

 

(1,432

)

Total stockholders’ equity

 

244,430

 

 

257,193

 

Total liabilities and stockholders' equity

$

259,133

 

$

272,013

 

 
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share amounts)
(Unaudited)
 
 

Three Months Ended

July 31,

2021

 

2020

 
Revenue

$

 

$

 

Operating expenses:
Research and development

 

13,669

 

 

11,165

 

General and administrative

 

5,847

 

 

3,278

 

Total operating expenses

 

19,516

 

 

14,443

 

Operating loss

 

(19,516

)

 

(14,443

)

 
Other income:
Interest income

 

274

 

 

259

 

Foreign currency exchange rate (loss) gain

 

(51

)

 

438

 

Other income

 

3,184

 

 

2,932

 

Total other income

 

3,407

 

 

3,629

 

Net loss

$

(16,109

)

$

(10,814

)

 
Net loss per share, basic and diluted

$

(0.66

)

$

(0.61

)

 
Weighted average common shares outstanding, basic and diluted

 

24,429,919

 

 

17,848,583

 

 
KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands, unaudited)
 

Three Months Ended

July 31,

2021

 

2020

 
Cash flows from operating activities
Net loss

$

(16,109

)

$

(10,814

)

Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization

 

132

 

 

128

 

Stock-based compensation expense

 

2,795

 

 

1,188

 

Realized loss (gain) from sale of marketable securities

 

23

 

 

(70

)

Non-cash operating lease expense

 

22

 

 

8

 

Amortization of premium on marketable securities

 

753

 

 

68

 

Foreign currency exchange loss (gain)

 

14

 

 

(432

)

Changes in operating assets and liabilities:
Research and development tax credit receivable

 

(3,211

)

 

4,462

 

Prepaid expenses and other current assets

 

(625

)

 

1,301

 

Accounts payable

 

(528

)

 

35

 

Accrued expenses

 

(1,001

)

 

538

 

Net cash used in operating activities

 

(17,735

)

 

(3,588

)

 
Cash flows from investing activities
Purchases of marketable securities

 

(19,036

)

 

(9,807

)

Sales and maturities of marketable securities

 

34,204

 

 

15,342

 

Acquisition of property and equipment

 

(287

)

 

(22

)

Net cash provided by investing activities

 

14,881

 

 

5,513

 

 
Cash flows from financing activities
Issuance of common stock from equity incentive plans

 

608

 

 

46

 

Net cash provided by financing activities

 

608

 

 

46

 

Effect of exchange rate changes on cash and cash equivalents

 

(3

)

 

254

 

Net (decrease) increase in cash and cash equivalents

 

(2,249

)

 

2,225

 

Cash and cash equivalents at beginning of period

 

50,592

 

 

15,789

 

Cash and cash equivalents at end of period

$

48,343

 

$

18,014

 

 

 

KalVista Pharmaceuticals, Inc.
Leah Monteiro
Senior Director, Corporate Communications & Investor Relations
857-999-0808
leah.monteiro@kalvista.com

Source: KalVista Pharmaceuticals, Inc.