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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): March 09, 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. ☐

 

 

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Item 2.02 Results of Operations and Financial Condition.

On March 9, 2023, KalVista Pharmaceuticals, Inc. (the “Company”) reported its financial results for the fiscal quarter ended January 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 March 9, 2023
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

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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:	March 9, 2023	By:	/s/ Benjamin L. Palleiko
			Benjamin L. Palleiko President, Chief Business Officer and Chief Financial Officer (Principal Financial and Accounting Officer)

 

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Exhibit 99.1

 

KalVista Pharmaceuticals Reports Third Fiscal Quarter Results

- Enrollment in sebetralstat KONFIDENT phase 3 trial passes 50% milestone; data remains H2 2023 -

- Sebetralstat phase 2 data published in The Lancet -

- Company funded into 2025 -

 

Cambridge, MA and Salisbury, England, March 9, 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 third fiscal quarter ended January 31, 2023.

 

“We have made significant advances at KalVista over this quarter, including completing a financing that funds us into 2025, well beyond our phase 3 data results, which remain on track for the second half of this year,” said Andrew Crockett, Chief Executive Officer of KalVista. “We continue to publish sebetralstat data across a wide variety of outlets, including influential medical journals such as The Lancet, and make presentations at prestigious medical and patient meetings. We remain committed to addressing the unmet needs of the hereditary angioedema (HAE) community by providing sebetralstat as a significant advancement in treatment for this disease.”

 

Third Fiscal Quarter and Recent Business Highlights:

 

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Third Fiscal Quarter Financial Results:

 

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

 

R&D Expenses: Research and development expenses were $20.1 million for the three months ended January 31, 2023, compared to $19.7 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, offset by a decrease in expense from KVD824.

 

G&A Expenses: General and administrative expenses were $6.9 million for the three months ended January 31, 2023, compared to $6.9 million for the same period in the prior fiscal year. G&A expenses remained consistent primarily due to increases in commercial planning and other administrative expenses offset by decreases in employee related expenses and professional fees.

 

Net Loss: Net loss was $21.3 million, or $(0.75) per weighted average basic and diluted share, for the three months ended January 31, 2023, compared to net loss of $22.5 million, or $(0.92) per weighted average basic and diluted share for the same period in the prior fiscal year. The decrease in net loss and net loss per share primarily resulted from increases in interest income and currency exchange rate gains from transactions denominated in foreign currencies in our U.K. subsidiary.

 

Cash Position: Cash, cash equivalents and marketable securities were $171.7 million as of January 31, 2023, compared to $166.2 million as of April 30, 2022. The increase in the net cash and marketable securities position was primarily due to the net proceeds received from the December 2022 registered direct offering of common stock and pre-funded warrants.

 

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 is enrolling 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.

 

 

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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, 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.

 

Contact:

KalVista Pharmaceuticals, Inc.

Jarrod Aldom

Vice President, Corporate Communications

(201) 705-0254

jarrod.aldom@kalvista.com

 

 

 

 

 

 

 

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KalVista Pharmaceuticals Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(Unaudited)
	January 31,				April 30,
	2023				2022
Assets
Current assets:
Cash and cash equivalents	$	85,049			$	30,732
Marketable securities		86,636				135,470
Research and development tax credit receivable		11,892				14,098
Prepaid expenses and other current assets		8,556				13,347
Total current assets		192,133				193,647
Property and equipment, net		3,037				2,178
Right of use assets		8,101				7,862
Other assets		197				193
Total assets	$	203,468			$	203,880
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	1,698			$	3,638
Accrued expenses		8,851				6,961
Lease liability - current portion		1,057				977
Total current liabilities		11,606				11,576
Long-term liabilities:
Lease liability - net of current portion		7,421				7,211
Total long-term liabilities		7,421				7,211
Stockholders’ equity:
Common stock, $0.001 par value		34				25
Additional paid-in capital		504,725				439,104
Accumulated deficit		(316,777	)			(250,175	)
Accumulated other comprehensive loss		(3,541	)			(3,861	)
Total stockholders’ equity		184,441				185,093
Total liabilities and stockholders' equity	$	203,468			$	203,880

 

 

 

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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,
	2023		2022		2023		2022
Revenue	$—		$—		$—		$—
Operating expenses:
Research and development	20,063		19,738		56,325		50,954
General and administrative	6,882		6,945		22,818		18,848
Total operating expenses	26,945		26,683		79,143		69,802
Operating loss	(26,945)		(26,683)		(79,143)		(69,802)
Other income:
Interest income	732		258		1,424		822
Foreign currency exchange rate (loss) gain	597		(198)		(237)		(529)
Other income	4,313		4,156		11,354		11,283
Total other income	5,642		4,216		12,541		11,576
Net loss	$(21,303)		$(22,467)		$(66,602)		$(58,226)
Net loss per share, basic and diluted	$(0.75)		$(0.92)		$(2.58)		$(2.38)
Weighted average common shares outstanding, basic and diluted	28,278,453		24,479,660		25,810,369		24,449,788

 

 

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KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands, unaudited)
	Nine Months Ended
	January 31,
	2023				2022
Cash flows from operating activities
Net loss	$	(66,602	)		$	(58,226	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		530				408
Stock-based compensation expense		7,481				8,432
Realized loss (gain) from sale of marketable securities		84				296
Non-cash operating lease expense		52				153
Amortization of premium on marketable securities		890				2,081
Foreign currency exchange loss (gain)		(1,339	)			698
Changes in operating assets and liabilities:
Research and development tax credit receivable		2,049				(1,477	)
Prepaid expenses and other current assets		4,440				(3,659	)
Accounts payable		(1,911	)			228
Accrued expenses		1,701				(279	)
Net cash used in operating activities		(52,625	)			(51,345	)
Cash flows from investing activities
Purchases of marketable securities		(63,757	)			(84,415	)
Sales and maturities of marketable securities		112,509				130,686
Acquisition of property and equipment		(1,127	)			(845	)
Net cash provided by investing activities		47,625				45,426
Cash flows from financing activities
Issuance of common stock from equity incentive plans		482				1,443
Issuance of common stock, net of offerin expenses of $0.3 million		56,582				-
Issuance of pre-funded warrants, net of offering expenses		1,085				-
Net cash provided by financing activities		58,149				1,443
Effect of exchange rate changes on cash and cash equivalents		1,168				(539	)
Net (decrease) increase in cash and cash equivalents		54,317				(5,015	)
Cash and cash equivalents at beginning of period		30,732				50,592
Cash and cash equivalents at end of period	$	85,049			$	45,577

 

 

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