8-K

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 05, 2024

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. ☐

Item 2.02 Results of Operations and Financial Condition.

On December 5, 2024, KalVista Pharmaceuticals, Inc. (the “Company”) reported its financial results for the fiscal quarter ended October 31, 2024. 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 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 5, 2024
104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

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 5, 2024	By:	/s/ Brian Piekos
			Brian Piekos Chief Financial Officer (Principal Financial and Accounting Officer)

EX-99.1

Exhibit 99.1

KalVista Pharmaceuticals Reports Second Fiscal Quarter Results and Provides Operational Update

–Continuing to build commercial infrastructure; on track for potential sebetralstat launch in Q2 2025–

–Multinational regulatory submissions for sebetralstat position Company to transform hereditary angioedema (HAE)treatment worldwide–

– Pro forma cash and cash equivalents of $292.2 million provide runway into second half 2027–

Cambridge, Mass., and Salisbury, England, December 5, 2024 – KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today released financial results for the second fiscal quarter ended October 31, 2024. The Company also provided an operational update, highlighted by the U.S. Food and Drug Administration (FDA) acceptance of a New Drug Application (NDA) for sebetralstat, a novel, investigational treatment for hereditary angioedema (HAE).

“KalVista is successfully executing on the key milestones we announced at the beginning of our fiscal year as we move towards multiple potential commercial launches of sebetralstat in 2025,” said Ben Palleiko, Chief Executive Officer of KalVista. “With six marketing authorization applications filed to date and the first potential approval expected next June, we remain focused on achieving our goal of making sebetralstat available to people living with HAE globally. In support of that goal, during the quarter, we presented additional data from our clinical program at multiple conferences, demonstrating that patients used sebetralstat to treat attacks early and that early treatment with on-demand therapy resulted in meaningful clinical benefit. Finally, the additional capital we recently raised, including the non-dilutive synthetic royalty financing, will support our continued planning for the potential launch of sebetralstat in multiple markets.”

Second Fiscal Quarter and Recent Business Highlights:

Sebetralstat

•In September 2024, KalVista announced that the FDA accepted its NDA for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor that has the potential to be the first and only oral on-demand treatment for HAE attacks in people aged 12 years and older. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of June 17, 2025.

•Also in September, KalVista announced Marketing Authorization Application (MAA) submissions to regulatory authorities in the United Kingdom, Switzerland, Australia and Singapore via the Access Consortium framework, designed to maximize regulatory collaboration across countries and support a timely review process. This follows the August European Medicines Agency (EMA) validation of the MAA for sebetralstat.

•KalVista presented new sebetralstat data at the 2024 American College of Allergy Asthma and Immunology. Presentations included Phase 3 trial data that showed early treatment is correlated with shorter attack duration, as well as a rigorous comparison of Phase 3 results for

Exhibit 99.1

oral sebetralstat and pivotal trial results of IV recombinant C1-inhibitor for on-demand treatment of HAE attacks that showed no differences in time to the beginning of symptom relief.

•In addition, KalVista presented new data at the 2024 HAEi Global Angioedema Forum that highlighted the effectiveness of sebetralstat in reducing anxiety during HAE attacks and underscored the importance of having an oral, on-demand treatment option that could help people manage attacks earlier and more frequently. Patient perspectives shared at the forum also reinforced the high prevalence of anxiety associated with the use of injectable therapies, further supporting the call for more accessible oral alternatives.

Organizational

•In November, KalVista raised a total of $160 million in aggregate gross proceeds through concurrent synthetic royalty financing and equity offerings. The synthetic royalty financing agreement with DRI Healthcare provides up to $179 million in non-dilutive funding, including $100 million upfront. In addition, the Company closed a public offering raising $55 million as well as $5 million in a private placement to DRI Healthcare.

•The Company appointed Brian Piekos as Chief Financial Officer.

Second Fiscal Quarter Financial Results

•The Company did not record any revenue for the three months ended October 31, 2024 or three months ended October 31, 2023.

•Research and development expenses were $16.6 million for the three months ended October 31, 2024, compared to $19.1 million for the same period in the prior fiscal year. The decrease was primarily attributable to reduced preclinical activities and recognizing expense associated with sebetralstat pre-commercial awareness within General & Administrative.

•General and administrative expenses were $29.2 million for the three months ended October 31, 2024, compared to $10.7 million for the same period in the prior fiscal year. The increase was primarily due to pre-commercial planning activities related to sebetralstat.

•As of October 31, 2024, the Company had cash, cash equivalents and marketable securities of approximately $135.8 million ($292.2 million, on a pro forma basis, including the approximately $156.4 million net proceeds raised in November 2024 through the synthetic royalty financing and equity offerings). The Company anticipates that this pro forma balance provides sufficient runway into the second half of 2027.

About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a global pharmaceutical company whose mission is to develop and deliver life-changing oral medicines for people affected by rare diseases with significant unmet needs. Sebetralstat, our novel, investigational candidate for the oral, on-demand treatment of hereditary angioedema, is under regulatory review by the FDA with a PDUFA goal date of June 17, 2025. We have also completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency

Exhibit 99.1

and multiple other countries. For more information, please visit www.kalvista.com or follow us on social media at @KalVista and LinkedIn.

About Sebetralstat

Discovered and developed entirely by KalVista, sebetralstat is a novel, investigational oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). Our initial goal is to deliver sebetralstat as the first oral, on-demand treatment for HAE in people aged 12 years and older. In addition, we are studying the potential of sebetralstat for the on-demand treatment of HAE in children aged 2 to 11 years. We believe that, if approved, sebetralstat has the potential to become the foundational therapy for HAE disease management globally.

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 KONFIDENT-S and KONFIDENT-KID trials, 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, 2024, 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.

Media:

Jenn Snyder
Vice President, Corporate Affairs
(857) 356-0479

jennifer.snyder@kalvista.com

Investors:

Ryan Baker

Head, Investor Relations

(617) 771-5001

ryan.baker@kalvista.com

Exhibit 99.1

KalVista Pharmaceuticals Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(Unaudited)
	October 31,		April 30,
	2024		2024
Cash, Cash Equivalents & Marketable Securities	$	135,776	$	210,401
Other Current Assets		16,491		15,289
Total Current Assets		152,267		225,690
Other Assets		8,564		9,714
Total Assets	$	160,831	$	235,404
Current Liabilities		22,164		22,807
Long-term Liabilities		4,675		6,015
Total Liabilities		26,839		28,822
Total Stockholders’ Equity		133,992		206,582
Total Liabilities and Stockholders' Equity	$	160,831	$	235,404

Exhibit 99.1

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,
	2024			2023			2024			2023
Operating expenses:
Research and development		16,610			19,089			43,225			38,396
General and administrative		29,201			10,657			46,801			20,443
Total operating expenses		45,811			29,746			90,026			58,839
Operating loss		(45,811	)		(29,746	)		(90,026	)		(58,839	)
Other income:
Interest income		1,357			776			3,050			1,699
Foreign currency exchange rate (loss) gain		67			(1,299	)		581			(843	)
Other income		2,119			2,619			3,685			5,016
Total other income		3,543			2,096			7,316			5,872
Net loss	$	(42,268	)	$	(27,650	)	$	(82,710	)	$	(52,967	)
Net loss per share, basic and diluted	$	(0.91	)	$	(0.80	)	$	(1.78	)	$	(1.54	)
Weighted average common shares outstanding, basic and diluted		46,695,220			34,565,955			46,464,099			34,490,090

XML

Document And Entity Information	Dec. 05, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Dec. 05, 2024
Entity Registrant Name	KALVISTA PHARMACEUTICALS, INC.
Entity Central Index Key	0001348911
Entity Emerging Growth Company	false
Entity File Number	001-36830
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	20-0915291
Entity Address, Address Line One	55 Cambridge Parkway
Entity Address, Address Line Two	Suite 901E
Entity Address, City or Town	Cambridge
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02142
City Area Code	857
Local Phone Number	999-0075
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.001 par value per share
Trading Symbol	KALV
Security Exchange Name	NASDAQ