KalVista Pharmaceuticals Reports Third Fiscal Quarter Results and Provides Operational Update
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) announces positive results from the Phase 3 KONFIDENT clinical trial for sebetralstat, a potential first oral on-demand therapy for hereditary angioedema. The trial met all endpoints, demonstrating a favorable safety profile. The company closed a successful underwritten offering, appointing Benjamin L. Palleiko as the new CEO. Financially, the company reported no revenue for the quarter, with increased R&D and G&A expenses leading to a net loss of $29.0 million. Cash position decreased to $75.6 million as of January 31, 2024.
Negative
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.
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.
03/11/2024 - 06:30 AM
- 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 -
CAMBRIDGE, Mass. & SALISBURY, England --(BUSINESS WIRE)--
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 $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 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 $20.1 million
G&A Expenses: General and administrative expenses were $10.6 million $6.9 million
Net Loss: Net loss was $29.0 million $(0.84) $21.3 million $(0.75)
Cash Position: Cash, cash equivalents and marketable securities were $75.6 million $149.4 million
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, $0.00 1
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@kalvista.com
Ryan Baker
ryan.baker@kalvista.com
Source: KalVista Pharmaceuticals, Inc.
What are the key highlights of the Phase 3 KONFIDENT clinical trial for sebetralstat by KalVista Pharmaceuticals (KALV)?
The trial met all endpoints, demonstrating a favorable safety profile as a potential first oral on-demand therapy for hereditary angioedema.
Who was appointed as the new Chief Executive Officer of KalVista Pharmaceuticals (KALV)?
Benjamin L. Palleiko was appointed as the new CEO of KalVista Pharmaceuticals.
What was the net loss reported by KalVista Pharmaceuticals (KALV) for the three months ended January 31, 2024?
KalVista Pharmaceuticals reported a net loss of $29.0 million for the three months ended January 31, 2024.
What was the cash position of KalVista Pharmaceuticals (KALV) as of January 31, 2024?
KalVista Pharmaceuticals had a cash, cash equivalents, and marketable securities position of $75.6 million as of January 31, 2024.
