KalVista Pharmaceuticals Reports Third Fiscal Quarter Results and Provides Operational Update
- None.
- No revenue was recognized for the quarter, indicating a lack of income generation.
- Increased R&D and G&A expenses led to a net loss of $29.0 million, reflecting higher operating costs.
- Cash position decreased to $75.6 million, signaling potential financial challenges.
Insights
The recent announcement by KalVista Pharmaceuticals regarding the successful Phase 3 KONFIDENT trial for sebetralstat marks a significant milestone for the company and its stakeholders. The positive clinical trial outcomes, demonstrating efficacy and a safety profile comparable to placebo, are pivotal for the drug's commercial potential. The trial's success has prompted the company to prepare for a New Drug Application (NDA) submission to the FDA, which, if approved, could lead to sebetralstat becoming the first oral, on-demand therapy for hereditary angioedema (HAE). This positions KalVista to capture a share of the HAE treatment market, which was valued at approximately $2.1 billion in 2021 and is expected to grow with the introduction of innovative treatments like sebetralstat.
The financial implications of this development are underscored by the company's recent capital raise of approximately $150.1 million, extending its funding runway into 2026. This capital infusion is crucial as it supports the company's transition into a commercial entity, a phase that typically entails significant investment in marketing, sales infrastructure and manufacturing readiness. Investors should note the increased R&D and G&A expenses, reflective of the company's investment in the KONFIDENT trial and commercial planning. While the net loss has widened compared to the previous fiscal year, this is not uncommon for clinical-stage biopharmaceutical companies ahead of potential product launches. The cash position, while decreased from the previous year, appears sufficient to support the company's near-term activities, which is a critical factor in evaluating the company's financial health.
The clinical significance of KalVista's sebetralstat cannot be overstated. HAE is a rare genetic condition characterized by recurrent episodes of severe swelling and the current standard of care often requires intravenous or subcutaneous injections. An oral, on-demand treatment option represents a paradigm shift in patient convenience and quality of life. The KONFIDENT trial's design, which included a broad patient population across various attack severities and locations, signals robustness in the data and suggests a wide applicability of the treatment. The 'Innovation Passport' awarded by the UK MHRA for sebetralstat further signifies recognition of its potential as a significant advancement in HAE therapy.
The therapeutic landscape for HAE is competitive, with several treatments already available and others in development. The success of sebetralstat will hinge not only on its clinical efficacy but also on its ability to differentiate itself in the market. Factors such as ease of use, cost, insurance coverage and patient support programs will be critical in determining its adoption. Long-term safety and efficacy data will also be instrumental in maintaining its market position against potential future competitors.
From a market perspective, the successful Phase 3 results for sebetralstat and the subsequent steps towards commercialization are likely to have a favorable impact on KalVista's market valuation. The company's strategic focus on oral protease inhibitors for HAE taps into a niche yet growing segment of the pharmaceutical market. The recent capital raise suggests strong investor confidence in the company's prospects and provides financial stability during the critical phase of regulatory review and potential market entry.
Market dynamics for HAE treatments are influenced by factors such as unmet medical needs, patient advocacy and the orphan drug status that often accompanies rare disease treatments, potentially offering benefits like market exclusivity and tax credits. KalVista's publication in 'Frontiers in Pharmacology' underscores its commitment to scientific innovation, which can further solidify its reputation in the biopharmaceutical community and potentially attract partnerships or acquisition interest.
Investors and stakeholders should monitor the company's progress in securing regulatory approvals, the execution of its commercial strategy and how it navigates market access challenges. The ability to successfully launch sebetralstat and gain market share will be critical in determining the long-term success of KalVista's investment in this program.
- 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 -
“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
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 $15.24 9$150.1 million - 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 theUK 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
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
Cash Position: Cash, cash equivalents and marketable securities were
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
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
| 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, |
|
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 |
|
— |
|
|
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
Source: KalVista Pharmaceuticals, Inc.
FAQ
What are the key highlights of the Phase 3 KONFIDENT clinical trial for sebetralstat by KalVista Pharmaceuticals (KALV)?
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