PharmiWeb.com - Global Pharma News & Resources
10-Mar-2022

KalVista Pharmaceuticals Reports Third Fiscal Quarter Results

– KVD900 Phase 3 KONFIDENT Trial Initiated –

– KVD824 Phase 2 KOMPLETE Clinical Trial Enrollment on Track –

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--$KALV--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, 2022.


“We made many significant clinical advances this quarter,” said Andrew Crockett, Chief Executive Officer of KalVista. “We are excited that the KVD900 Phase 3 KONFIDENT trial for on-demand treatment of HAE attacks is now underway, and we are encouraged by the progress of our KVD824 Phase 2 KOMPLETE trial for HAE prophylaxis. Based on initial enrollment trends, we expect we will be able to provide data for both studies in 2023.”

Third Fiscal Quarter and Recent Business Highlights:

  • Initiated KONFIDENT, the Phase 3 clinical trial of KVD900, that is expected to be sufficient to support an NDA filing. Data from this trial is currently anticipated in the second half of 2023.
  • Continued to enroll KOMPLETE, the Phase 2 clinical trial of KVD824. As of early March, the trial is enrolling on track with the Company’s targets and it is currently anticipated that data from this trial will be available in mid-2023.
  • Presented data for KVD900 at American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Scientific Meeting. Data presentations included two poster presentations with additional data from the Phase 2 clinical trial. The first poster showed that KVD900 was rapidly absorbed, leading to near-complete suppression of plasma kallikrein and significantly shorter time to symptom relief. The second poster provided data demonstrating that the Patient Global Impression of Change (PGI-C) scale was an effective tool to monitor attack symptoms and predict attack resolution for patients experiencing HAE attacks. PGI-C is the primary outcome measure in the KONFIDENT clinical trial.
  • Continued progress in the Factor XIIa inhibitor program, with multiple compounds advancing in the preclinical stage and an expected first IND for an oral Factor XIIa inhibitor candidate in 2023.

Third Fiscal Quarter Financial Results:

  • Revenue: No revenue was recognized for the three months ended January 31, 2022 or January 31, 2021.
  • R&D Expenses: Research and development expenses were $19.7 million for the three months ended January 31, 2022, compared to $9.1 million for the same period in the prior fiscal year. The increase in R&D expenses during the quarter primarily reflects the initiation of the Phase 3 KONFIDENT clinical trial for KVD900, the ongoing Phase 2 KOMPLETE clinical trial for KVD824, and increased preclinical spending.
  • G&A Expenses: General and administrative expenses were $6.9 million for the three months ended January 31, 2022, compared to $3.6 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 professional fees, commercial planning expenses, and other administrative costs.
  • Net Loss: Net loss was $22.5 million, or $(0.92) per weighted average basic and diluted share, for the three months ended January 31, 2022, compared to net loss of $10.0 million, or $(0.56) 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 $194.8 million as of January 31, 2022, 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 oral, 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 and has initiated the Phase 3 KONFIDENT clinical trial. 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 about KalVista, please visit www.kalvista.com.
For more information on the KVD900 HAE on-demand Phase 3 KONFIDENT study, please visit www.konfidentstudy.com.
For more information on the KVD824 HAE prophylaxis Phase 2 KOMPLETE study, please visit www.kompletestudy.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 clinical studies or complete ongoing clinical studies, including our Phase 3 KONFIDENT and Phase 2 KOMPLETE clinical trials, and to obtain regulatory approvals for KVD900, KVD824 and other candidates in development, the ability of KVD900, KVD824 and other candidates in development to treat HAE or DME, 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, 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)
 

January 31,

 

April 30,

2022

 

2021

Assets
Current assets:
Cash and cash equivalents

$

45,577

 

$

50,592

 

Marketable securities

 

149,212

 

 

198,337

 

Research and development tax credit receivable

 

11,287

 

 

10,418

 

Prepaid expenses and other current assets

 

8,388

 

 

4,917

 

Total current assets

 

214,464

 

 

264,264

 

Property and equipment, net

 

2,215

 

 

1,791

 

Right of use assets

 

8,180

 

 

5,758

 

Other assets

 

193

 

 

200

 

Total assets

$

225,052

 

$

272,013

 

Liabilities and stockholders' equity
Current liabilities:
Accounts payable

$

2,185

 

$

1,981

 

Accrued expenses

 

6,450

 

 

6,930

 

Lease liability - current portion

 

1,014

 

 

863

 

Total current liabilities

 

9,649

 

 

9,774

 

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

 

7,467

 

 

5,046

 

Total long-term liabilities

 

7,467

 

 

5,046

 

Stockholders’ equity:
Common stock, $0.001 par value

 

24

 

 

24

 

Additional paid-in capital

 

436,313

 

 

426,437

 

Accumulated deficit

 

(226,062

)

 

(167,836

)

Accumulated other comprehensive loss

 

(2,339

)

 

(1,432

)

Total stockholders’ equity

 

207,936

 

 

257,193

 

Total liabilities and stockholders' equity

$

225,052

 

$

272,013

 

 
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,

2022

 

2021

 

2022

 

2021

 
Revenue

$

 

$

 

$

 

$

 

Operating expenses:
Research and development

 

19,738

 

 

9,097

 

 

50,954

 

 

29,409

 

General and administrative

 

6,945

 

 

3,560

 

 

18,848

 

 

10,472

 

Total operating expenses

 

26,683

 

 

12,657

 

 

69,802

 

 

39,881

 

Operating loss

 

(26,683

)

 

(12,657

)

 

(69,802

)

 

(39,881

)

 
Other income:
Interest income

 

258

 

 

137

 

 

822

 

 

589

 

Foreign currency exchange (loss) gain

 

(198

)

 

301

 

 

(529

)

 

715

 

Other income

 

4,156

 

 

2,171

 

 

11,283

 

 

7,289

 

Total other income

 

4,216

 

 

2,609

 

 

11,576

 

 

8,593

 

Net loss

$

(22,467

)

$

(10,048

)

$

(58,226

)

$

(31,288

)

 
Net loss per share, basic and diluted

$

(0.92

)

$

(0.56

)

$

(2.38

)

$

(1.75

)

 
Weighted average common shares outstanding, basic and diluted

 

24,479,660

 

 

17,961,802

 

 

24,449,788

 

 

17,905,926

 

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

Nine Months Ended

January 31,

2022

 

2021

 
Cash flows from operating activities
Net loss

$

(58,226

)

$

(31,288

)

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

 

408

 

 

397

 

Stock-based compensation expense

 

8,432

 

 

3,677

 

Realized loss (gain) from sale of marketable securities

 

296

 

 

(192

)

Non-cash operating lease expense

 

153

 

 

25

 

Amortization of premium on marketable securities

 

2,081

 

 

247

 

Foreign currency exchange loss (gain)

 

698

 

 

(441

)

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

 

(1,477

)

 

10,135

 

Prepaid expenses and other current assets

 

(3,659

)

 

35

 

Accounts payable

 

228

 

 

(1,182

)

Accrued expenses

 

(279

)

 

(539

)

Net cash used in operating activities

 

(51,345

)

 

(19,126

)

 
Cash flows from investing activities
Purchases of marketable securities

 

(84,415

)

 

(26,814

)

Sales and maturities of marketable securities

 

130,686

 

 

45,692

 

Acquisition of property and equipment

 

(845

)

 

(49

)

Net cash provided by investing activities

 

45,426

 

 

18,829

 

 
Cash flows from financing activities
Issuance of common stock , net of offering expenses

 

-

 

 

1,648

 

Issuance of common stock from equity incentive plans

 

1,443

 

 

161

 

Net cash provided by financing activities

 

1,443

 

 

1,809

 

Effect of exchange rate changes on cash and cash equivalents

 

(539

)

 

426

 

Net (decrease) increase in cash and cash equivalents

 

(5,015

)

 

1,938

 

Cash and cash equivalents at beginning of period

 

50,592

 

 

15,789

 

Cash and cash equivalents at end of period

$

45,577

 

$

17,727

 

 


Contacts

KalVista Pharmaceuticals, Inc.
Ben Palleiko
CBO & CFO
857-999-0890
investors@kalvista.com

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Last Updated: 10-Mar-2022