KalVista Pharmaceuticals Reports Second Fiscal Quarter Results and Provides Operational Update
- Sebetralstat Phase 3 KONFIDENT Clinical Trial Achieves Targeted Number of Attacks to Complete Trial -
- Data Readout on Track for Early 2024; NDA Filing Expected H1 2024 -
“We are in the process of completing the KONFIDENT trial and we look forward to advancing sebetralstat for a NDA submission in the first half of 2024,” said
Second Fiscal Quarter and Recent Business Highlights:
-
Achieved the targeted number of on-treatment attacks required to complete the phase 3 KONFIDENT trial. Topline data readout is expected in early 2024, remaining on track for a New Drug Application (NDA) submission to the
U.S. Food and Drug Administration (FDA) in the first half of 2024. The Company also expects to file for approval in theEuropean Union andJapan later in 2024 -
Received Orphan Drug Status (ODS) approval from
Switzerland for sebetralstat, allowing for shorter review time, priority authorization, and 15 years market protection and exclusivity -
Presented real-world patient data at the 2023 Annual Scientific Meeting of the
American College of Allergy, Asthma & Immunology discussing compliance challenges of currently available parenteral on-demand HAE treatments and evidence of the global prevalence of normal C1-inhibitor HAE (HAE-nC1-INH) -
Conducted fireside chats at the
Cantor Global Healthcare Conference , Stifel 2023 Healthcare Conference, andJefferies London Healthcare Conference -
Reported data at the
Asia Pacific Association of Allergy , Asthma and Clinical Immunology 2023International Conference characterizing HAE attacks in patients receiving long-term prophylaxis (LTP)
Second Fiscal Quarter Financial Results:
Revenue: No revenue was recognized for the three months ended
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
Cash Position: Cash, cash equivalents and marketable securities were
About
For more information about
For more information on the sebetralstat HAE on-demand Phase 3 KONFIDENT study, please visit www.konfidentstudy.com.
Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the
Condensed Consolidated Balance Sheets | |||||||
(in thousands, except share and per share amounts) | |||||||
(Unaudited) | |||||||
|
2023 |
|
|
2023 |
|
||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents |
$ |
57,666 |
|
$ |
56,238 |
|
|
Marketable securities |
|
45,506 |
|
|
93,137 |
|
|
Research and development tax credit receivable |
|
19,976 |
|
|
16,568 |
|
|
Prepaid expenses and other current assets |
|
5,458 |
|
|
6,383 |
|
|
Total current assets |
|
128,606 |
|
|
172,326 |
|
|
Property and equipment, net |
|
2,502 |
|
|
2,948 |
|
|
Right of use assets |
|
7,298 |
|
|
7,822 |
|
|
Other assets |
|
337 |
|
|
106 |
|
|
Total assets |
$ |
138,743 |
|
$ |
183,202 |
|
|
Liabilities and stockholders' equity | |||||||
Current liabilities: | |||||||
Accounts payable |
$ |
4,896 |
|
$ |
4,817 |
|
|
Accrued expenses |
|
11,707 |
|
|
9,128 |
|
|
Lease liability - current portion |
|
1,148 |
|
|
1,087 |
|
|
Total current liabilities |
|
17,751 |
|
|
15,032 |
|
|
Long-term liabilities: | |||||||
Lease liability - net of current portion |
|
6,546 |
|
|
7,145 |
|
|
Total long-term liabilities |
|
6,546 |
|
|
7,145 |
|
|
Stockholders’ equity: | |||||||
Common stock, |
|
34 |
|
|
34 |
|
|
Additional paid-in capital |
|
513,926 |
|
|
507,133 |
|
|
Accumulated deficit |
|
(396,049 |
) |
|
(343,082 |
) |
|
Accumulated other comprehensive loss |
|
(3,465 |
) |
|
(3,060 |
) |
|
Total stockholders’ equity |
|
114,446 |
|
|
161,025 |
|
|
Total liabilities and stockholders' equity |
$ |
138,743 |
|
$ |
183,202 |
|
Condensed Consolidated Statement of Operations | |||||||||||||||
(in thousands, except share and per share amounts) | |||||||||||||||
(Unaudited) | |||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
Revenue |
$ |
— |
|
$ |
— |
|
$ |
— |
|
$ |
— |
|
|||
Operating expenses: | |||||||||||||||
Research and development |
|
19,089 |
|
|
18,077 |
|
|
38,396 |
|
|
36,262 |
|
|||
General and administrative |
|
10,657 |
|
|
7,806 |
|
|
20,443 |
|
|
15,936 |
|
|||
Total operating expenses |
|
29,746 |
|
|
25,883 |
|
|
58,839 |
|
|
52,198 |
|
|||
Operating loss |
|
(29,746 |
) |
|
(25,883 |
) |
|
(58,839 |
) |
|
(52,198 |
) |
|||
Other income: | |||||||||||||||
Interest income |
|
776 |
|
|
449 |
|
|
1,699 |
|
|
691 |
|
|||
Foreign currency exchange rate (loss) gain |
|
(1,299 |
) |
|
(317 |
) |
|
(843 |
) |
|
(834 |
) |
|||
Other income |
|
2,619 |
|
|
3,494 |
|
|
5,016 |
|
|
7,042 |
|
|||
Total other income |
|
2,096 |
|
|
3,626 |
|
|
5,872 |
|
|
6,899 |
|
|||
Net loss |
$ |
(27,650 |
) |
$ |
(22,257 |
) |
$ |
(52,967 |
) |
$ |
(45,299 |
) |
|||
Net loss per share, basic and diluted |
$ |
(0.80 |
) |
$ |
(0.90 |
) |
$ |
(1.54 |
) |
$ |
(1.84 |
) |
|||
Weighted average common shares outstanding, basic and diluted |
|
34,565,955 |
|
|
24,595,039 |
|
|
34,490,090 |
|
|
24,576,327 |
|
Condensed Consolidated Statements of Cash Flows | |||||||
(in thousands, unaudited) | |||||||
Six Months Ended | |||||||
|
2023 |
|
|
2022 |
|
||
Cash flows from operating activities | |||||||
Net loss |
$ |
(52,967 |
) |
$ |
(45,299 |
) |
|
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization |
|
390 |
|
|
331 |
|
|
Stock-based compensation expense |
|
6,461 |
|
|
5,148 |
|
|
Realized loss (gain) from sale of marketable securities |
|
(909 |
) |
|
85 |
|
|
Non-cash operating lease expense |
|
(13 |
) |
|
42 |
|
|
Amortization of premium on marketable securities |
|
83 |
|
|
678 |
|
|
Foreign currency exchange loss (gain) |
|
811 |
|
|
(739 |
) |
|
Changes in operating assets and liabilities: | |||||||
Research and development tax credit receivable |
|
(4,109 |
) |
|
(7,137 |
) |
|
Prepaid expenses and other current assets |
|
761 |
|
|
3,650 |
|
|
Accounts payable |
|
163 |
|
|
(81 |
) |
|
Accrued expenses |
|
2,774 |
|
|
(14 |
) |
|
Net cash used in operating activities |
|
(46,555 |
) |
|
(43,336 |
) |
|
Cash flows from investing activities | |||||||
Purchases of marketable securities |
|
(29,537 |
) |
|
(10,102 |
) |
|
Sales and maturities of marketable securities |
|
77,917 |
|
|
61,356 |
|
|
Acquisition of property and equipment |
|
(8 |
) |
|
(1,112 |
) |
|
Website development costs |
|
(203 |
) |
|
— |
|
|
Net cash provided by investing activities |
|
48,169 |
|
|
50,142 |
|
|
Cash flows from financing activities | |||||||
Issuance of common stock from equity incentive plans |
|
332 |
|
|
336 |
|
|
Net cash provided by financing activities |
|
332 |
|
|
336 |
|
|
Effect of exchange rate changes on cash and cash equivalents |
|
(518 |
) |
|
711 |
|
|
Net (decrease) increase in cash and cash equivalents |
|
1,428 |
|
|
7,853 |
|
|
Cash and cash equivalents at beginning of period |
|
56,238 |
|
|
30,732 |
|
|
Cash and cash equivalents at end of period |
$ |
57,666 |
|
$ |
38,585 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20231207291767/en/
Vice President, Corporate Communications
(201) 705-0254
jarrod.aldom@kalvista.com
Head, Investor Relations
(617) 771-5001
ryan.baker@kalvista.com
Source: