KalVista Pharmaceuticals Provides Operational Update and Fiscal Year Financial Results
Jul 11, 2024
– Submitted NDA for sebetralstat as first-ever, oral on-demand treatment for HAE attacks, a pivotal moment for the HAE community –– Potential FDA approval and launch of sebetralstat in first half 2025 CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--Jul. 11, 2024-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today provided
an operational update and released financial results for the fiscal year ended April 30, 2024.
“This last fiscal quarter was the most important in the history of KalVista,” said Ben Palleiko, CEO of KalVista. “Not only did we submit the NDA for
sebetralstat to the FDA, but the KONFIDENT phase 3 trial results were published in The New England Journal of Medicine, supporting our view on theimportance of this potential therapy. We look forward to building on these milestones as we submit additional marketing authorization applications toother national health authorities throughout 2024 and anticipate approval and launch in the US in the first half of 2025.”
Fiscal 2024 and Recent Business Highlights:
Sebetralstat

In June 2024, KalVista submitted a New Drug Application (NDA) for U.S. Food and Drug Administration (FDA) review ofsebetralstat, a novel investigational oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE)
attacks in adults and pediatric patients aged 12 years and older.
Also in June, the Company initiated ahead of schedule a pediatric clinical trial (KONFIDENT-KID) using an orally
disintegrating tablet (ODT) formulation of sebetralstat designed for this population. KONFIDENT-KID will enrollapproximately 24 children, with an age range of 2 to 11 years, across seven countries in North America, Europe and Asia.
If approved, sebetralstat would be the first oral, on demand treatment for this population and only the second approved
on-demand therapy of any type.
Data from phase 3 KONFIDENT trial of sebetralstat was published in the New England Journal of Medicine (NEJM) andpresented concurrently at the European Academy of Allergy and Clinical Immunology Congress 2024 (EAACI).
Presented the U.S. subgroup analysis from the phase 3 KONFIDENT trial at the Eastern Allergy Conference (EAC) 2024,
as well as the Japanese subgroup from KONFIDENT at the 123rd Annual Meeting of the Japanese Dermatological
Association (JDA) 2024.
KalVista is on track for Market Authorization Application submissions to both European Medicines Agency and UK
Medicines and Healthcare Products Regulatory Agency in Q3 2024 as well as a JNDA submission to the JapanesePharmaceuticals and Medical Devices Agency in Q4 2024.
Oral Factor XIIa Inhibitor Program

The Company believes its preclinical Factor XIIa inhibitor program may have the potential to yield the first orally delivered
Factor XIIa inhibitor for a variety of therapeutic indications. KalVista is undergoing a strategic review of this program toevaluate the potential for further development.
OrganizationalIn March 2024, KalVista announced the promotion of Benjamin L. Palleiko to Chief Executive Officer and his appointment
as a member of the Board.
In February, KalVista entered into an underwriting agreement with Jefferies LLC, Leerink Partners LLC, Stifel, Nicolaus &Company, Incorporated, and Cantor Fitzgerald & Co., as the representatives of several underwriters to sell an aggregate of
7,016,312 shares of the Company’s common stock at price of $15.25 per share and pre-funded warrants to purchase up to3,483,688 shares of common stock at a price of $15.249 per pre-funded warrant. The net proceeds from the Offering, after
deducting estimated expenses, were approximately $150.1 million.
In April, William C. Fairey was appointed to the KalVista Board of Directors.
Fourth Quarter and Full Year Financial Results:

Revenue: No revenue was recognized for the three months and fiscal years ended April 30, 2024, or April 30, 2023,
respectively.
R&D Expenses: Research and development expenses were $25.3 million for the three months ended April 30, 2024,
compared to $24.0 million for the same period in the prior fiscal year. Research and development expenses were $86.2
million for the fiscal year ended April 30, 2024, compared to $80.3 million for the prior fiscal year. The increase in spending
in the fiscal year ended April 30, 2024 primarily reflects the phase 3 KONFIDENT trial which concluded in February 2024,
the ongoing KONFIDENT-S trial, and a headcount driven increase in personnel costs.

G&A Expenses: General and administrative expenses were $23.2 million for the three months ended April 30, 2024,compared to $7.8 million for the same period in the prior fiscal year. General and administrative expenses were $54.3
million for the fiscal year ended April 30, 2024, compared to $30.6 million for the prior fiscal year. The increase in G&A
expenses was primarily due to increases in employee-related expenses and commercial planning expenses.
Net Loss: Net loss was $44.7 million, or $(1.02) per weighted average basic and diluted share, for the three months endedApril 30, 2024, compared to net loss of $26.3 million, or $(0.77) per weighted average basic and diluted share for the same
period in the prior fiscal year. Net loss was $126.6 million, or $(3.44) per weighted average basic and diluted share for thefiscal year ended April 30, 2024, compared to net loss of $92.9 million, or $(3.33) per weighted average basic and diluted
share in the prior fiscal year. The increase in net loss and net loss per share primarily resulted from the increase inoperating expenses, both research and development and general and administrative.
Cash position: Cash, cash equivalents and marketable securities were $210.4 million on April 30, 2024, compared to$149.4 million on April 30, 2023. The increase in the net cash and marketable securities position was primarily due to thenet proceeds received from the February 2024 underwritten offering of common stock and pre-funded warrants.
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases withsignificant unmet need. KalVista announced positive phase 3 data for the KONFIDENT trial for its oral, on-demand therapy sebetralstat in February
2024 and submitted an NDA with the FDA in June 2024. KalVista expects to file for approval in the UK, the European Union, and Japan later in 2024.
For more information about KalVista, please visit www.kalvista.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 tonumerous 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 andtiming of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S andKONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts tocommercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress andpotential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results aredetailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2023, ourquarterly 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 aresult of new information, future developments or otherwise.
KalVista Pharmaceuticals Inc.
Condensed Consolidated Balance Sheets(in thousands, except share and per share amounts)(Unaudited)
April 30,2024
AssetsCurrent assets:
Cash and cash equivalents
Marketable securities
Research and development tax credit receivable$

Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Right of use assets

Lease liability - current portion
Total current liabilities
Long-term liabilities:
Lease liability - net of current portion
Total long-term liabilities
Stockholders’ equity:
Common stock, $0.001 par value
Additional paid-in capital
Accumulated deficit$225,690
2,227
6,920
567

Other assets
Total assets
Liabilities and stockholders' equity
Current liabilities:
Accounts payable
Accrued expenses

31,789178,612
8,439
6,850

April 30,2023

56,238
93,137
16,568
6,383
172,326
2,948
7,822
106

$

235,404$

183,202$

9,107
12,398
1,302

$

4,817
9,128
1,087

22,807

15,032

6,015

7,145

6,015

7,145

42
679,754(469,726)

34
507,133(343,082)

Accumulated other comprehensive loss
Total stockholders’ equity$

Total liabilities and stockholders' equity(3,488)(3,060)206,582

161,025

235,404$

183,202KalVista Pharmaceuticals Inc.
Condensed Consolidated Statement of Operations(in thousands, except share and per share amounts)(Unaudited)Three Months Ended
April 30,2024
2023
Revenue
Operating expenses:
Research and development

$

—

$2024
—

25,24823,207

General and administrative

Years Ended
April 30,$

23,951
7,777

2023
—

$

—

86,16754,27880,27630,595

Total operating expenses

48,45531,728140,445

110,871

Operating loss

(48,455)(31,728)(140,445)(110,871)

1,513
(140)
2,432

808
327
4,288

3,896
138
9,767

2,232
90
15,642Other income:Interest income
Foreign currency exchange rate (loss) gain
Other income

3,805

Total other income
Net loss
Net loss per share, basic and diluted
Weighted average common shares outstanding, basic and diluted

5,423

13,801

17,964$(44,650)$(26,305)$(126,644)$(92,907)$(1.02)$(0.77)$(3.44)$(3.33)

43,590,657

34,342,664

36,786,575

27,890,846

KalVista Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows(in thousands, unaudited)Years EndedApril 30,2024
Cash flows from operating activities
Net lossAdjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
Stock-based compensation expense
Realized (gain) loss from sale of marketable securities
Non-cash operating lease expense
Amortization of premium on marketable securities
Foreign currency exchange loss (gain)
Changes in operating assets and liabilities:
Research and development tax credit receivable
Prepaid expenses and other current assets
Accounts payable$2023(126,644)$(92,907)

816
21,915(1,325)
(12)
92760

718
9,922
139
84
988
(1,618)

8,176
(538)
4,320
3,209

(2,316)
6,690
1,107
1,932

(89,231)(75,261)

Capitalized website development costs(189,231)
104,955(42)(401)(98,246)
140,857(1,196)-Net cash provided by investing activities(84,719)

41,415

Accrued expenses
Net cash used in operating activities
Cash flows from investing activities
Purchases of marketable securities
Sales and maturities of marketable securities
Acquisition of property and equipment

Cash flows from financing activities
Issuance of common stock, net of offering expenses
Issuance of pre-funded warrants, net of offering expenses
Issuance of common stock from equity incentive plans

106,560
43,508646

56,582
1,085449

Net cash provided by financing activities

150,714

58,116(1,213)

1,236(24,449)
56,23825,50630,732

Effect of exchange rate changes on cash and cash equivalents
Net (decrease) increase in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period$View source version on businesswire.com: https://www.businesswire.com/news/home/20240711453276/en/
KalVista Pharmaceuticals, Inc.
Jarrod AldomVice President, Corporate Communications(201) 705-0254
jarrod.aldom@kalvista.com
Ryan Baker
Head, Investor Relations(617) 771-5001
ryan.baker@kalvista.com
Source: KalVista Pharmaceuticals, Inc.

31,789$56,238