Gravity Analytica

KalVista Pharmaceuticals Reports Second Fiscal Quarter Results and Provides Operational Update

KALV 12.05.2024

SERA-AI Powered Highlights

Drug:sebetralstat-unknown sebetralstat

Diseases:hereditary angioedema

Date of Upcoming Event:2024-11-08

Name of Upcoming Event:2024 American College of Allergy Asthma and Immunology

Date of Upcoming Event:2024-11-09

Name of Upcoming Event:2024 HAEi Global Angioedema Forum

Full Press Release SEC Filings Our KALV Tweets

About Gravity Analytica

Recent Filings

–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 millionprovide runway into second half 2027–

CAMBRIDGE, Mass.&SALISBURY, England--(BUSINESS WIRE)--Dec. 5, 2024--KalVista Pharmaceuticals, Inc.(NASDAQ: KALV), today released financial results for the second fiscal quarter endedOctober 31, 2024. The Company also provided an operational update, highlighted by theU.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,” saidBen Palleiko, Chief Executive Officer ofKalVista. “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

InSeptember 2024,KalVistaannounced 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 ofJune 17, 2025.
Also in September,KalVistaannounced Marketing Authorization Application (MAA) submissions to regulatory authorities in theUnited Kingdom,Switzerland,AustraliaandSingaporevia theAccess Consortiumframework, designed to maximize regulatory collaboration across countries and support a timely review process. This follows theAugust European Medicines Agency(EMA) validation of the MAA for sebetralstat.
KalVistapresented new sebetralstat data at the 2024American 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 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,KalVistapresented new data at the 2024HAEi Global Angioedema Forumthat 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,KalVistaraised a total of$160 millionin aggregate gross proceeds through concurrent synthetic royalty financing and equity offerings. The synthetic royalty financing agreement with DRI Healthcare provides up to$179 millionin non-dilutive funding, including$100 millionupfront. In addition, the Company closed a public offering raising$55 millionas well as$5 millionin a private placement to DRI Healthcare.
The Company appointedBrian Piekosas Chief Financial Officer.

Second Fiscal Quarter Financial Results

The Company did not record any revenue for the three months endedOctober 31, 2024or three months endedOctober 31, 2023.
Research and development expenses were$16.6 millionfor the three months endedOctober 31, 2024, compared to$19.1 millionfor 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 withinGeneral & Administrative.
General and administrative expenses were$29.2 millionfor the three months endedOctober 31, 2024, compared to$10.7 millionfor the same period in the prior fiscal year. The increase was primarily due to pre-commercial planning activities related to sebetralstat.
As ofOctober 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 millionnet proceeds raised inNovember 2024through the synthetic royalty financing and equity offerings). The Company anticipates that this pro forma balance provides sufficient runway into the second half of 2027.

AboutKalVista 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 ofJune 17, 2025. We have also completed Marketing Authorization Applications for sebetralstat to theEuropean Medicines Agencyand multiple other countries. For more information, please visitwww.kalvista.comor follow us on social media at@KalVistaandLinkedIn.

About Sebetralstat

Discovered and developed entirely byKalVista, 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 forHAE inpeople aged 12 years and older. In addition, we are studying the potential of sebetralstat for the on-demand treatment ofHAE inchildren 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 theU.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 theSecurities and Exchange Commission, including in our annual report on Form 10-K for the year endedApril 30, 2024, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with theSecurities 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)

	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

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

View source version onbusinesswire.com:https://www.businesswire.com/news/home/20241205552223/en/

Media:Jenn SnyderVice President, Corporate Affairs(857) 356-0479jennifer.snyder@kalvista.comInvestors:Ryan BakerHead, Investor Relations(617) 771-5001ryan.baker@kalvista.com

Source:KalVista Pharmaceuticals, Inc.

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