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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): December 08, 2022

 

 

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 December 8, 2022, KalVista Pharmaceuticals, Inc. (the “Company”) reported its financial results for the fiscal quarter ended October 31, 2022. 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 December 8, 2022
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:	December 8, 2022	By:	/s/ Benjamin L. Palleiko
			Benjamin L. Palleiko Chief Business Officer and Chief Financial Officer

 

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Exhibit 99.1

 

KalVista Pharmaceuticals Reports Second Fiscal Quarter Results

- Phase 1 Clinical Trial for Orally Disintegrating Tablet Formulation of Sebetralstat Completed -

-Sebetralstat Data Published in the Journal of Medicinal Chemistry and Xenobiotica –

- Sebetralstat Phase 3 Data Remain on Track for H2 2023 –
 

Cambridge, MA and Salisbury, England, December 8, 2022 – 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 second fiscal quarter ended October 31, 2022.

“We made a very difficult decision this quarter in terminating our phase 2 KOMPLETE trial for KVD824, but the safety of patients is of utmost importance to our Company,” said Andrew Crockett, Chief Executive Officer of KalVista. “We remain committed to providing best-in-class oral treatments for the hereditary angioedema (HAE) community. We are particularly excited about our recent data for the orally disintegrating tablet (ODT) formulation of sebetralstat, which will enable people to take a dose without requiring chewing or swallowing. We are also pleased with the progress of our Phase 3 KONFIDENT clinical trial for sebetralstat, which remains on our enrollment target for data in the second half of 2023."

Second Fiscal Quarter and Recent Business Highlights:
 

 

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Second Fiscal Quarter Financial Results:

Revenue: No revenue was recognized for the three months ended October 31, 2022 or October 31, 2021.

R&D Expenses: Research and development expenses were $18.1 million for the three months ended October 31, 2022, compared to $17.5 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 $7.8 million for the three months ended October 31, 2022, compared to $6.1 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, professional fees, and to a lesser extent, increases in investor and public relations expenses.

Net Loss: Net loss was $22.3 million, or $(0.90) per weighted average basic and diluted share, for the three months ended October 31, 2022, compared to net loss of $19.7 million, or $(0.80) 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 $122.3 million as of October 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.

 

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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 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. 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.

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 trial, and to obtain regulatory approvals for sebetralstat and other candidates in development, the ability of sebetralstat 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.

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)
	October 31,				April 30,
	2022				2022
Assets
Current assets:
Cash and cash equivalents	$	38,585			$	30,732
Marketable securities		83,688				135,470
Research and development tax credit receivable		20,029				14,098
Prepaid expenses and other current assets		8,914				13,347
Total current assets		151,216				193,647
Property and equipment, net		3,060				2,178
Right of use assets		8,365				7,862
Other assets		197				193
Total assets	$	162,838			$	203,880
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	3,384			$	3,638
Accrued expenses		6,910				6,961
Lease liability - current portion		1,026				977
Total current liabilities		11,320				11,576
Long-term liabilities:
Lease liability - net of current portion		7,705				7,211
Total long-term liabilities		7,705				7,211
Stockholders’ equity:
Common stock, $0.001 par value		25				25
Additional paid-in capital		444,588				439,104
Accumulated deficit		(295,474	)			(250,175	)
Accumulated other comprehensive loss		(5,326	)			(3,861	)
Total stockholders’ equity		143,813				185,093
Total liabilities and stockholders' equity	$	162,838			$	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				Six Months Ended
	October 31,				October 31,
	2022		2021		2022		2021
Revenue	$—		$—		$—		$—
Operating expenses:
Research and development	18,077		17,546		36,262		31,215
General and administrative	7,806		6,057		15,936		11,903
Total operating expenses	25,883		23,603		52,198		43,118
Operating loss	(25,883)		(23,603)		(52,198)		(43,118)
Other income:
Interest income	449		290		691		564
Foreign currency exchange rate (loss) gain	(317)		(280)		(834)		(331)
Other income	3,494		3,943		7,042		7,127
Total other income	3,626		3,953		6,899		7,360
Net loss	$(22,257)		$(19,650)		$(45,299)		$(35,758)
Net loss per share, basic and diluted	$(0.90)		$(0.80)		$(1.84)		$(1.46)
Weighted average common shares outstanding, basic and diluted	24,595,039		24,439,623		24,576,327		24,434,852

 

 

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KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands, unaudited)
	Six Months Ended
	October 31,
	2022				2021
Cash flows from operating activities
Net loss	$	(45,299	)		$	(35,758	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		331				259
Stock-based compensation expense		5,148				5,655
Realized loss (gain) from sale of marketable securities		85				120
Non-cash operating lease expense		42				46
Amortization of premium on marketable securities		678				1,424
Foreign currency exchange loss (gain)		(739	)			266
Changes in operating assets and liabilities:
Research and development tax credit receivable		(7,137	)			(7,252	)
Prepaid expenses and other current assets		3,650				(2,419	)
Accounts payable		(81	)			1,163
Accrued expenses		(14	)			(784	)
Net cash used in operating activities		(43,336	)			(37,280	)
Cash flows from investing activities
Purchases of marketable securities		(10,102	)			(51,695	)
Sales and maturities of marketable securities		61,356				84,862
Acquisition of property and equipment		(1,112	)			(643	)
Net cash provided by investing activities		50,142				32,524
Cash flows from financing activities
Issuance of common stock from equity incentive plans		336				671
Net cash provided by financing activities		336				671
Effect of exchange rate changes on cash and cash equivalents		711				(16	)
Net (decrease) increase in cash and cash equivalents		7,853				(4,101	)
Cash and cash equivalents at beginning of period		30,732				50,592
Cash and cash equivalents at end of period	$	38,585			$	46,491

 

 

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