- Sebetralstat Phase 3 KONFIDENT clinical trial
met all endpoints and demonstrated a favorable safety profile as
first oral on-demand therapy for hereditary angioedema -
- CEO transition supports ongoing evolution
into commercial company -
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, 2024.
“This has been an exciting and busy period for KalVista, as we
achieved key milestones with the release of our phase 3 KONFIDENT
data and the completion of a substantial financing,” said Ben
Palleiko, Chief Executive Officer of KalVista. “We remain on track
to file the NDA with the U.S. Food and Drug Administration in the
first half of this year, and we look forward to presenting further
phase 3 data for sebetralstat at upcoming patient and medical
meetings. We also continue to grow the commercial organization to
enable us to deliver on the promise of providing the first oral,
on-demand treatment option to the HAE community.”
Third Fiscal Quarter and Recent Business Highlights:
- In February, the Company announced positive topline data from
the Phase 3 KONFIDENT clinical trial evaluating the safety and
efficacy of sebetralstat as the potential first oral, on-demand
therapy for hereditary angioedema (HAE). KONFIDENT was the largest
and most representative trial ever conducted in HAE, enrolling a
total of 136 patients from 66 clinical sites across 20 countries.
Eligible participants included adolescents, patients using
long-term prophylaxis, and the trial evaluated all attack
severities and locations. The clinical trial met all primary and
key secondary endpoints across both the 300 and 600 mg doses and
demonstrated a safety profile similar to placebo.
- Also in February, KalVista closed an underwritten offering to
sell an aggregate of 7,016,312 shares of common stock at price of
$15.25 per share and pre-funded warrants to purchase up to
3,483,688 shares of common stock at a price of $15.249 per
pre-funded warrant. The net proceeds from the offering were
approximately $150.1 million and are expected to provide funding
into 2026.
- The Company announced that Benjamin L. Palleiko, the Company’s
prior President, CBO and CFO, was appointed as Chief Executive
Officer and a director of the Company. This appointment is the
result of a planned transition as KalVista prepares to become a
commercial entity following the success of the KONFIDENT Phase 3
trial for its program sebetralstat.
- The UK Medicines and Healthcare products Regulatory Agency
(MHRA) awarded the Innovation Passport for sebetralstat, providing
entry to the UK Innovative Licensing and Access Pathway (ILAP),
which aims to accelerate time to market and facilitate patient
access to innovative medicines.
- Presented additional Phase 3 KONFIDENT data as well as data on
unmet need in HAE from a patient perspective at the 2024 American
Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI)
in Washington, D.C.
- Announced publication of the first report of a potent and
specific Factor XIIa inhibitor with high oral availability in a
peer-reviewed journal. The Frontiers in Pharmacology article
describes the pharmacology of a representative compound from
KalVista’s portfolio of structurally diverse, oral Factor XII
inhibitors.
Third Fiscal Quarter Financial Results:
Revenue: No revenue was recognized for the three months ended
January 31, 2024, or January 31, 2023.
R&D Expenses: Research and development expenses were $22.5
million for the three months ended January 31, 2024, compared to
$20.1 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 and KONFIDENT-S trials.
G&A Expenses: General and administrative expenses were $10.6
million for the three months ended January 31, 2024, compared to
$6.9 million for the same period in 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 $29.0 million, or $(0.84) per weighted
average basic and diluted share, for the three months ended January
31, 2024, compared to net loss of $21.3 million, or $(0.75) per
weighted average basic and diluted share for the same period in the
prior fiscal year. The increase in net loss primarily resulted from
the increase in operating expenses, primarily research and
development.
Cash Position: Cash, cash equivalents and marketable securities
were $75.6 million as of January 31, 2024, compared to $149.4
million as of April 30, 2023. The decrease in the net cash and
marketable securities position was due to cash consumption from
operating expenses.
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 disclosed positive phase 3 data
for the KONFIDENT trial for its oral, on-demand therapy
sebetralstat in February 2024. The Company anticipates submitting a
new drug application to the U.S. Food and Drug Administration (FDA)
for sebetralstat in the first half of 2024 and expects to file for
approval in Europe and Japan later in 2024. 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.
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, our ability 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, 2023, 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.
KalVista Pharmaceuticals Inc. Condensed Consolidated
Balance Sheets (in thousands, except share and per share
amounts) (Unaudited)
January 31,
April 30,
2024
2023
Assets Current assets: Cash and cash equivalents
$
23,056
$
56,238
Marketable securities
52,530
93,137
Research and development tax credit receivable
23,011
16,568
Prepaid expenses and other current assets
5,506
6,383
Total current assets
104,103
172,326
Property and equipment, net
2,423
2,948
Right of use assets
7,045
7,822
Other assets
397
106
Total assets
$
113,968
$
183,202
Liabilities and stockholders' equity Current liabilities:
Accounts payable
$
3,101
$
4,817
Accrued expenses
14,840
9,128
Lease liability - current portion
1,187
1,087
Total current liabilities
19,128
15,032
Long-term liabilities: Lease liability - net of current portion
6,257
7,145
Total long-term liabilities
6,257
7,145
Stockholders’ equity: Common stock, $0.001 par value
34
34
Additional paid-in capital
516,920
507,133
Accumulated deficit
(425,077
)
(343,082
)
Accumulated other comprehensive loss
(3,294
)
(3,060
)
Total stockholders’ equity
88,583
161,025
Total liabilities and stockholders' equity
$
113,968
$
183,202
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,
2024
2023
2024
2023
Revenue
$
—
$
—
$
—
$
—
Operating expenses: Research and development
22,523
20,063
60,919
56,325
General and administrative
10,628
6,882
31,071
22,818
Total operating expenses
33,151
26,945
91,990
79,143
Operating loss
(33,151
)
(26,945
)
(91,990
)
(79,143
)
Other income: Interest income
684
732
2,383
1,424
Foreign currency exchange rate gain (loss)
1,120
597
277
(237
)
Other income
2,319
4,313
7,335
11,354
Total other income
4,123
5,642
9,995
12,541
Net loss
$
(29,028
)
$
(21,303
)
$
(81,995
)
$
(66,602
)
Net loss per share, basic and diluted
$
(0.84
)
$
(0.75
)
$
(2.37
)
$
(2.58
)
Weighted average common shares outstanding, basic and
diluted
34,723,379
28,278,453
34,567,853
25,810,369
KalVista Pharmaceuticals Inc. Condensed
Consolidated Statements of Cash Flows (in thousands,
unaudited)
Nine Months Ended
January 31,
2024
2023
Cash flows from operating activities Net loss
$
(81,995
)
$
(66,602
)
Adjustments to reconcile net loss to net cash used in operating
activities: Depreciation and amortization
597
530
Stock-based compensation expense
9,172
7,481
Realized (gain) loss from sale of marketable securities
(1,130
)
84
Non-cash operating lease expense
(11
)
52
Amortization of premium on marketable securities
88
890
Foreign currency exchange loss (gain)
596
(1,339
)
Changes in operating assets and liabilities: Research and
development tax credit receivable
(6,215
)
2,049
Prepaid expenses and other current assets
906
4,440
Accounts payable
(1,778
)
(1,911
)
Accrued expenses
5,644
1,701
Net cash used in operating activities
(74,126
)
(52,625
)
Cash flows from investing activities Purchases of
marketable securities
(47,687
)
(63,757
)
Sales and maturities of marketable securities
89,475
112,509
Acquisition of property and equipment
(27
)
(1,127
)
Website development costs
(294
)
—
Net cash provided by investing activities
41,467
47,625
Cash flows from financing activities Issuance of
common stock from equity incentive plans
616
482
Issuance of common stock, net of offering expenses of $0.3 million
—
56,582
Issuance of pre-funded warrants, net of offering expenses
—
1,085
Net cash provided by financing activities
616
58,149
Effect of exchange rate changes on cash and cash equivalents
(1,139
)
1,168
Net (decrease) increase in cash and cash equivalents
(33,182
)
54,317
Cash and cash equivalents at beginning of period
56,238
30,732
Cash and cash equivalents at end of period
$
23,056
$
85,049
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240311841357/en/
KalVista Pharmaceuticals, Inc. Jarrod Aldom Vice
President, Corporate Communications (201) 705-0254
jarrod.aldom@kalvista.com
Ryan Baker Head, Investor Relations (617) 771-5001
ryan.baker@kalvista.com
KalVista Pharmaceuticals (NASDAQ:KALV)
Historical Stock Chart
From Apr 2024 to May 2024
KalVista Pharmaceuticals (NASDAQ:KALV)
Historical Stock Chart
From May 2023 to May 2024