– 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 -
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 the importance of this potential
therapy. We look forward to building on these milestones as we
submit additional marketing authorization applications to other
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 of sebetralstat,
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 enroll approximately 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) and presented
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 Japanese Pharmaceuticals 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 to
evaluate the potential for further development.
Organizational
- In 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 to 3,483,688
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 ended April
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 the fiscal 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 in operating 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 the net 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 with significant 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 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, 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) April 30,
April 30,
2024
2023
Assets Current assets: Cash and cash equivalents
$
31,789
$
56,238
Marketable securities
178,612
93,137
Research and development tax credit receivable
8,439
16,568
Prepaid expenses and other current assets
6,850
6,383
Total current assets
225,690
172,326
Property and equipment, net
2,227
2,948
Right of use assets
6,920
7,822
Other assets
567
106
Total assets
$
235,404
$
183,202
Liabilities and stockholders' equity Current liabilities:
Accounts payable
$
9,107
$
4,817
Accrued expenses
12,398
9,128
Lease liability - current portion
1,302
1,087
Total current liabilities
22,807
15,032
Long-term liabilities: Lease liability - net of current portion
6,015
7,145
Total long-term liabilities
6,015
7,145
Stockholders’ equity: Common stock, $0.001 par value
42
34
Additional paid-in capital
679,754
507,133
Accumulated deficit
(469,726
)
(343,082
)
Accumulated other comprehensive loss
(3,488
)
(3,060
)
Total stockholders’ equity
206,582
161,025
Total liabilities and stockholders' equity
$
235,404
$
183,202
KalVista Pharmaceuticals Inc. Condensed
Consolidated Statement of Operations (in thousands, except
share and per share amounts) (Unaudited)
Three Months Ended Years Ended April 30,
April 30,
2024
2023
2024
2023
Revenue
$
—
$
—
$
—
$
—
Operating expenses: Research and development
25,248
23,951
86,167
80,276
General and administrative
23,207
7,777
54,278
30,595
Total operating expenses
48,455
31,728
140,445
110,871
Operating loss
(48,455
)
(31,728
)
(140,445
)
(110,871
)
Other income: Interest income
1,513
808
3,896
2,232
Foreign currency exchange rate (loss) gain
(140
)
327
138
90
Other income
2,432
4,288
9,767
15,642
Total other income
3,805
5,423
13,801
17,964
Net loss
$
(44,650
)
$
(26,305
)
$
(126,644
)
$
(92,907
)
Net loss per share, basic and diluted
$
(1.02
)
$
(0.77
)
$
(3.44
)
$
(3.33
)
Weighted average common shares outstanding, basic and
diluted
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 Ended April 30,
2024
2023
Cash flows from operating activities Net loss
$
(126,644
)
$
(92,907
)
Adjustments to reconcile net loss to net cash used in operating
activities: Depreciation and amortization
816
718
Stock-based compensation expense
21,915
9,922
Realized (gain) loss from sale of marketable securities
(1,325
)
139
Non-cash operating lease expense
(12
)
84
Amortization of premium on marketable securities
92
988
Foreign currency exchange loss (gain)
760
(1,618
)
Changes in operating assets and liabilities: Research and
development tax credit receivable
8,176
(2,316
)
Prepaid expenses and other current assets
(538
)
6,690
Accounts payable
4,320
1,107
Accrued expenses
3,209
1,932
Net cash used in operating activities
(89,231
)
(75,261
)
Cash flows from investing activities Purchases of
marketable securities
(189,231
)
(98,246
)
Sales and maturities of marketable securities
104,955
140,857
Acquisition of property and equipment
(42
)
(1,196
)
Capitalized website development costs
(401
)
-
Net cash provided by investing activities
(84,719
)
41,415
Cash flows from financing activities Issuance of
common stock, net of offering expenses
106,560
56,582
Issuance of pre-funded warrants, net of offering expenses
43,508
1,085
Issuance of common stock from equity incentive plans
646
449
Net cash provided by financing activities
150,714
58,116
Effect of exchange rate changes on cash and cash equivalents
(1,213
)
1,236
Net (decrease) increase in cash and cash equivalents
(24,449
)
25,506
Cash and cash equivalents at beginning of period
56,238
30,732
Cash and cash equivalents at end of period
$
31,789
$
56,238
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240711453276/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
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