KalVista Pharmaceuticals Reports First Fiscal Quarter Results

Rhea-AI Summary

KalVista Pharmaceuticals (KALV) announced a significant milestone as its KVD824 Phase 2 clinical trial surpassed 50% enrollment, marking a key step in developing a potential oral prophylactic treatment for hereditary angioedema (HAE). The company has also initiated the KONFIDENT-S open label extension study for sebetralstat, aimed at providing detailed safety data and exploring its usage in adolescents. However, KalVista reported no revenue for the first fiscal quarter, with a net loss of $23 million, reflecting increased R&D and G&A expenses. Cash holdings decreased to $142.1 million.

Positive

• KVD824 Phase 2 trial reached 50% enrollment, indicating strong progress.
• KONFIDENT-S open label extension study initiated for sebetralstat, expanding its clinical data.
• Data from sebetralstat trial showed effectiveness in treating HAE attacks.

Negative

• No revenue recognized for the quarter.
• Net loss increased to $23 million, up from $16.1 million year-over-year.
• R&D expenses rose to $18.2 million, reflecting higher investment in clinical trials.

- KVD824 Phase 2 Clinical Trial Reaches 50% Enrollment Milestone –

- Open Label Extension Study Initiated for Sebetralstat –

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 first fiscal quarter ended July 31, 2022.

“We are pleased to announce we have surpassed the 50% enrollment mark for our KVD824 KOMPLETE Phase 2 clinical trial, a major milestone in its development as a potential oral prophylactic treatment for hereditary angioedema (HAE),” said Andrew Crockett, Chief Executive Officer of KalVista. “Enrollment for our Phase 3 KONFIDENT trial for the first potential oral on-demand HAE treatment is also progressing as anticipated. We look forward to continuing to advance both programs 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:

• Announced the initiation of the KONFIDENT-S open label extension study for sebetralstat in the on-demand treatment of HAE. The study will provide up to two years of additional safety and tolerability data, assess sebetralstat’s pharmacokinetic (PK) profile in adolescents aged 12-17, and evaluate the compound for use as a short-term prophylactic treatment prior to medical procedures.
• Reported new data from the Phase 2 clinical trial of sebetralstat at the Australasian Society of Clinical Immunology and Allergy (ASCIA) 2022 conference. The data showed that sebetralstat treatment provided relief of mild and moderate HAE attacks, showing meaningful treatment effect regardless of baseline attack severity, as shown by measurements of Patient Global Impression of Change (PGI-C), Patient Global Impression of Severity (PGI-S), and Visual Analog Scale (VAS).
• Enrollment is proceeding as expected for the Phase 3 KONFIDENT trial for sebetralstat, with data expected in the second half of 2023. The Phase 2 KOMPLETE clinical trial for KVD824 also remains on track with enrollment targets. Data from the KOMPLETE trial is expected in mid-2023.
• Presented at the 1^st Annual H.C. Wainwright Hereditary Angioedema Conference. KalVista CEO Andrew Crockett also participated on an expert panel discussing oral treatments in HAE.

First Fiscal Quarter Financial Results:

• Revenue: No revenue was recognized for the three months ended July 31, 2022 or July 31, 2021.
• R&D Expenses: Research and development expenses were $18.2 million for the three months ended July 31, 2022, compared to $13.7 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, increased preclinical spending, and increased personnel costs.
• G&A Expenses: General and administrative expenses were $8.1 million for the three months ended July 31, 2022, compared to $5.9 million for the same period in the prior fiscal year. The increase in G&A expenses was primarily due to an increase in commercial planning expenses, investor and public relations expenses, and to a lesser extent, increases in compensation expenses and other administrative costs.
• Net Loss: Net loss was $23.0 million, or $(0.94) per weighted average basic and diluted share, for the three months ended July 31, 2022, compared to net loss of $16.1 million, or $(0.66) 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 $142.1 million as of July 31, 2022, compared to $166.2 million as of April 30, 2022. 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 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 sebetralstat as an oral on-demand therapy for acute HAE attacks and is enrolling 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 sebetralstat 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 sebetralstat, KVD824 and other candidates in development, the ability of sebetralstat, 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, 2022, 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,
		2022				2022
Assets
Current assets:
Cash and cash equivalents		$	37,863			$	30,732
Marketable securities			104,212				135,470
Research and development tax credit receivable			17,248				14,098
Prepaid expenses and other current assets			11,084				13,347
Total current assets			170,407				193,647
Property and equipment, net			3,030				2,178
Right of use assets			8,664				7,862
Other assets			218				193
Total assets		$	182,319			$	203,880
Liabilities and stockholders' equity
Current liabilities:
Accounts payable		$	2,908			$	3,638
Accrued expenses			5,828				6,961
Lease liability - current portion			997				977
Total current liabilities			9,733				11,576
Long-term liabilities:
Lease liability - net of current portion			8,014				7,211
Total long-term liabilities			8,014				7,211
Stockholders’ equity:
Common stock, $0.001 par value			25				25
Additional paid-in capital			441,914				439,104
Accumulated deficit			(273,217	)			(250,175	)
Accumulated other comprehensive loss			(4,150	)			(3,861	)
Total stockholders’ equity			164,572				185,093
Total liabilities and stockholders' equity		$	182,319			$	203,880

KalVista Pharmaceuticals Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share amounts)
(Unaudited)
	Three Months Ended
	July 31,
	2022				2021
Revenue	$	—			$	—
Operating expenses:
Research and development		18,186				13,669
General and administrative		8,130				5,847
Total operating expenses		26,316				19,516
Operating loss		(26,316	)			(19,516	)
Other income:
Interest income		242				274
Foreign currency exchange (loss) gain		(517	)			(51	)
Other income		3,549				3,184
Total other income		3,274				3,407
Net loss	$	(23,042	)		$	(16,109	)
Net loss per share, basic and diluted	$	(0.94	)		$	(0.66	)
Weighted average common shares outstanding, basic and diluted		24,557,615				24,429,919

KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands, unaudited)
		Three Months Ended
		July 31,
		2022				2021
Cash flows from operating activities
Net loss		$	(23,042	)		$	(16,109	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization			158				132
Stock-based compensation expense			2,642				2,795
Realized loss (gain) from sale of marketable securities			16				23
Non-cash operating lease expense			23				22
Amortization of premium on marketable securities			391				753
Foreign currency exchange loss (gain)			426				14
Changes in operating assets and liabilities:
Research and development tax credit receivable			(3,570	)			(3,211	)
Prepaid expenses and other current assets			1,935				(625	)
Accounts payable			(678	)			(528	)
Accrued expenses			(1,043	)			(1,001	)
Net cash used in operating activities			(22,742	)			(17,735	)
Cash flows from investing activities
Purchases of marketable securities			(10,102	)			(19,036	)
Sales and maturities of marketable securities			41,066				34,204
Acquisition of property and equipment			(920	)			(287	)
Net cash provided by investing activities			30,044				14,881
Cash flows from financing activities
Issuance of common stock from equity incentive plans			168				608
Net cash provided by financing activities			168				608
Effect of exchange rate changes on cash and cash equivalents			(339	)			(3	)
Net increase (decrease) in cash and cash equivalents			7,131				(2,249	)
Cash and cash equivalents at beginning of period			30,732				50,592
Cash and cash equivalents at end of period		$	37,863			$	48,343

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20220908005213/en/

KalVista Pharmaceuticals, Inc.

Jarrod Aldom

Vice President, Corporate Communications

(201) 705-0254

jarrod.aldom@kalvista.com

Source: KalVista Pharmaceuticals, Inc.

FAQ

What is the current status of KalVista Pharmaceuticals' KVD824 clinical trial?

KalVista Pharmaceuticals announced that the KVD824 Phase 2 clinical trial has surpassed 50% enrollment.

When is data expected from the KVD824 Phase 2 trial?

Data from the KVD824 Phase 2 trial is expected in mid-2023.

What were the financial results for KalVista Pharmaceuticals for the first fiscal quarter?

KalVista reported no revenue and a net loss of $23 million for the quarter ended July 31, 2022.

How much cash does KalVista Pharmaceuticals have as of July 31, 2022?

KalVista's cash, cash equivalents, and marketable securities totaled $142.1 million as of July 31, 2022.