KalVista Pharmaceuticals Reports First Fiscal Quarter Results and Provides Operational Update
- Sebetralstat Phase 3 KONFIDENT Clinical Trial Achieves Target Enrollment; Data Readout on Track for Q4 -
- Preparations Continue for NDA filing H1 2024 and Rapid Commercialization Upon Approval -
“We know from our extensive interactions with people living with hereditary angioedema (HAE) at the recent conferences how much they are anticipating having sebetralstat available to them, and the data from the KONFIDENT trial in Q4 is the next step,” said
First Fiscal Quarter and Recent Business Highlights:
- Published “Evaluation of patient-reported outcome measures for on-demand treatment of hereditary angioedema attacks and design of KONFIDENT, a phase 3 trial of sebetralstat” in Clinical and Translational Allergy. This publication outlines the rigorous, multi-factorial approach used to design a phase 3 trial with an optimized, patient- and physician-preferred measure to assess measure efficacy, and discusses reasons for the superiority of the selected primary endpoint over other potential measures
- Presented real-world patient data on the HAE Attack Journey at the HAEi Regional Conference EMEA meeting showing there remain important unmet needs for both people using only on-demand therapies as well as those on long-term prophylaxis
-
Achieved enrollment target of 114 patients in the phase 3 KONFIDENT trial. Data readout remains on track for the fourth quarter of 2023 and, if the trial is successful,
KalVista anticipates submitting an NDA to the FDA in the first half of 2024 - Presented real-world patient data at the 2023 US HAEA National Summit showing people living with HAE continue to delay treatment for attacks due to challenges from injections or infusions, even though they know early treatment means an earlier return to normal activities
-
Announced that
Nicole Sweeny joined the Senior Leadership Team atKalVista as Chief Commercial Officer -
Reported new data in five posters at the 2023 Meeting of the
European Academy of Allergy and Clinical Immunology . The presentations showed that sebetralstat pharmacokinetic and pharmacodynamic data support globalization of the KONFIDENT phase 3 clinical trial and use in short-term prophylaxis and that patients receiving modern long-term prophylaxis continued to have challenges associated with treatment decisions -
Presented at the 2023
Jefferies Global Healthcare Conference , Stifel Tailoring Genes: Genetic Medicines Day and Stifel BiotechSummer Summit -
Revealed patient survey data at the 13th
C1-inhibitor Deficiency & Angioedema Workshop demonstrating the burden associated with injectable on-demand treatments for HAE and that those living with HAE had a strong preference for oral medication for on-demand treatment of attacks over self-administered injectable treatments when efficacy and safety profiles were similar -
Continued to advance plans for the eventual worldwide launch of sebetralstat by hiring a General Manager,
Japan . Based on interactions to date with Japanese physicians and regulatory authorities,KalVista believes sebetralstat has the potential to significantly improve HAE therapeutic options inJapan .
First 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 |
$ |
49,409 |
|
$ |
56,238 |
|
|
Marketable securities |
|
73,848 |
|
|
93,137 |
|
|
Research and development tax credit receivable |
|
19,057 |
|
|
16,568 |
|
|
Prepaid expenses and other current assets |
|
7,528 |
|
|
6,383 |
|
|
Total current assets |
|
149,842 |
|
|
172,326 |
|
|
Property and equipment, net |
|
2,813 |
|
|
2,948 |
|
|
Right of use assets |
|
7,571 |
|
|
7,822 |
|
|
Other assets |
|
106 |
|
|
106 |
|
|
Total assets |
$ |
160,332 |
|
$ |
183,202 |
|
|
Liabilities and stockholders' equity | |||||||
Current liabilities: | |||||||
Accounts payable |
$ |
5,060 |
|
$ |
4,817 |
|
|
Accrued expenses |
|
7,950 |
|
|
9,128 |
|
|
Lease liability - current portion |
|
1,122 |
|
|
1,087 |
|
|
Total current liabilities |
|
14,132 |
|
|
15,032 |
|
|
Long-term liabilities: | |||||||
Lease liability - net of current portion |
|
6,865 |
|
|
7,145 |
|
|
Total long-term liabilities |
|
6,865 |
|
|
7,145 |
|
|
Stockholders’ equity: | |||||||
Common stock, |
|
34 |
|
|
34 |
|
|
Additional paid-in capital |
|
510,591 |
|
|
507,133 |
|
|
Accumulated deficit |
|
(368,399 |
) |
|
(343,082 |
) |
|
Accumulated other comprehensive loss |
|
(2,891 |
) |
|
(3,060 |
) |
|
Total stockholders’ equity |
|
139,335 |
|
|
161,025 |
|
|
Total liabilities and stockholders' equity |
$ |
160,332 |
|
$ |
183,202 |
|
|
Condensed Consolidated Statement of Operations | |||||||
(in thousands, except share and per share amounts) | |||||||
(Unaudited) | |||||||
Three Months Ended | |||||||
2023 |
2022 |
||||||
Revenue |
$ |
— |
|
$ |
— |
|
|
Operating expenses: | |||||||
Research and development |
|
19,307 |
|
|
18,186 |
|
|
General and administrative |
|
9,786 |
|
|
8,130 |
|
|
Total operating expenses |
|
29,093 |
|
|
26,316 |
|
|
Operating loss |
|
(29,093 |
) |
|
(26,316 |
) |
|
Other income: | |||||||
Interest income |
|
923 |
|
|
242 |
|
|
Foreign currency exchange gain (loss) |
|
456 |
|
|
(517 |
) |
|
Other income |
|
2,397 |
|
|
3,549 |
|
|
Total other income |
|
3,776 |
|
|
3,274 |
|
|
Net loss |
$ |
(25,317 |
) |
$ |
(23,042 |
) |
|
Net loss per share, basic and diluted |
$ |
(0.74 |
) |
$ |
(0.94 |
) |
|
Weighted average common shares outstanding, basic and diluted |
|
34,414,226 |
|
|
24,557,615 |
|
|
Condensed Consolidated Statements of Cash Flows | |||||||
(in thousands, unaudited) | |||||||
Three Months Ended | |||||||
2023 |
2022 |
||||||
Cash flows from operating activities | |||||||
Net loss |
$ |
(25,317 |
) |
$ |
(23,042 |
) |
|
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization |
|
193 |
|
|
158 |
|
|
Stock-based compensation expense |
|
3,254 |
|
|
2,642 |
|
|
Realized (gain) loss from sale of marketable securities |
|
(314 |
) |
|
16 |
|
|
Non-cash operating lease expense |
|
6 |
|
|
23 |
|
|
Amortization of premium on marketable securities |
|
62 |
|
|
391 |
|
|
Foreign currency exchange (gain) loss |
|
(395 |
) |
|
426 |
|
|
Changes in operating assets and liabilities: | |||||||
Research and development tax credit receivable |
|
(2,084 |
) |
|
(3,570 |
) |
|
Prepaid expenses and other current assets |
|
(1,003 |
) |
|
1,935 |
|
|
Accounts payable |
|
108 |
|
|
(678 |
) |
|
Accrued expenses |
|
(1,240 |
) |
|
(1,043 |
) |
|
Net cash used in operating activities |
|
(26,730 |
) |
|
(22,742 |
) |
|
Cash flows from investing activities | |||||||
Purchases of marketable securities |
|
(25,767 |
) |
|
(10,102 |
) |
|
Sales and maturities of marketable securities |
|
45,386 |
|
|
41,066 |
|
|
Acquisition of property and equipment |
|
(6 |
) |
|
(920 |
) |
|
Net cash provided by investing activities |
|
19,613 |
|
|
30,044 |
|
|
Cash flows from financing activities | |||||||
Issuance of common stock from equity incentive plans |
|
204 |
|
|
168 |
|
|
Net cash provided by financing activities |
|
204 |
|
|
168 |
|
|
Effect of exchange rate changes on cash and cash equivalents |
|
84 |
|
|
(339 |
) |
|
Net increase (decrease) in cash and cash equivalents |
|
(6,829 |
) |
|
7,131 |
|
|
Cash and cash equivalents at beginning of period |
|
56,238 |
|
|
30,732 |
|
|
Cash and cash equivalents at end of period |
$ |
49,409 |
|
$ |
37,863 |
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20230907226892/en/
Vice President, Corporate Communications
(201) 705-0254
jarrod.aldom@kalvista.com
Head, Investor Relations
(617) 771-5001
ryan.baker@kalvista.com
Source: