Feniralstat

After weathering an earlier-stage clinical setback last year, KalVista Pharmaceuticals reported Tuesday that its more advanced hereditary angioedema (HAE) candidate sebetralstat succeeded in a Phase III trial as an on-demand treatment.CEO Andrew Crockett said the company plans to submit the oral plasma kallikrein inhibitor for FDA approval in the first half of 2024, with applications in Europe and Japan to follow later this year. "We believe [the KONFIDENT results] position sebetralstat to become the first oral, on-demand therapy for the treatment of HAE," he added.Last October, KalVista was forced to terminate the Phase II KOMPLETE trial of another oral plasma kallikrein inhibitor, called KVD824, after seven patients given the drug had experienced high liver enzyme increases.While both KVD824 and sebetralstat belong to the same drug class, KalVista has described sebetralstat as a "distinct compound" with no treatment-related liver enzyme elevations seen in any clinical studies, including the Phase III KONFIDENT trial top-lined on Tuesday.Quicker recovery from attacksThat study included adolescents, patients using long-term prophylaxis, and all attack severities. A total of 110 had treated at least 1 HAE attack. KalVista said the results, which will be shared in more detail at the American Academy of Allergy Asthma and Immunology (AAAAI) meeting later this month, showed that HAE attacks got better significantly faster when treated with either 300mg or 600mg of sebetralstat compared to placebo.The median time to beginning of symptom relief was 1.61 hours with sebetralstat 300mg and 1.79 hours with the 600mg dose, whereas it was 6.72 hours with placebo. While not powered to statistically test treatment effect within subgroups, KalVista said the benefit was "consistent" across various demographic cohorts, including adolescents.Sebetralstat also succeeded on secondary endpoints such as time to reduction in attack severity, which was 9.3 hours and 7.8 hours with the low and higher doses, respectively, versus over 12 hours with placebo. The proposition of patients achieving complete HAE attack resolution within 24 hours was also significantly greater with sebetralstat, where the rates were 44% and nearly 52% for the low and high doses, respectively, compared with just over 28% for placebo.But shares downNevertheless, despite the positive readout sending company shares up roughly 39% in pre-trade on Tuesday, the stock was down 13% when the markets opened. That may be due to results showing that about 40% of patients given sebetralstat need a second dose, while close to 14% in the 300mg and 9% in the 600mg groups required conventional treatment within 12 hours.That could put the drug at a disadvantage with a potential rival from Pharvaris, which is due to enter late-stage testing. Last month, the company said it would be moving its deucrictibant programme into Phase III as a prophylactic treatment for HAE attacks after the FDA lifted a clinical hold on the oral bradykinin B2-receptor antagonist.Clean safety profileMeanwhile, KalVista said is drug did not appear to raise any flags that had scuttled its KVD824 project. The company said sebetralstat had "a safety profile similar to placebo" in the KONFIDENT study, with no patient withdrawals due to any adverse event and no treatment-related serious adverse events. Treatment-related adverse event rates were 2.3% for sebetralstat 300mg, 2.2% for the 600mg dose, and 4.8% for placebo.

CAMBRIDGE, Mass. & SALISBURY, United Kingdom--( 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, 2023. “We have made significant advances at KalVista over this quarter, including completing a financing that funds us into 2025, well beyond our phase 3 data results, which remain on track for the second half of this year,” said Andrew Crockett, Chief Executive Officer of KalVista. “We continue to publish sebetralstat data across a wide variety of outlets, including influential medical journals such as The Lancet , and make presentations at prestigious medical and patient meetings. We remain committed to addressing the unmet needs of the hereditary angioedema (HAE) community by providing sebetralstat as a significant advancement in treatment for this disease.” Third Fiscal Quarter and Recent Business Highlights: Reported new data in five posters at the 2023 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The data showed the impact of HAE attacks on anxiety and quality of life in people living with HAE, that sebetralstat significantly decreased cumulative attack and symptom severity while increasing cumulative symptom relief of HAE attacks relative to placebo over a 24-hour period following administration, and that phase 1 data for an orally disintegrating tablet formulation supported further clinical development of that formulation. Provided multiple progress updates on sebetralstat development, including the announcement that KalVista has enrolled more than 50% of the targeted number of patients in the pivotal phase 3 KONFIDENT clinical trial. In addition, the Company received FDA regulatory guidance that efficacy trials are not required to support a supplemental NDA (sNDA) filing for the orally disintegrating tablet (ODT) formulation of sebetralstat. KalVista also received guidance from the Japanese regulatory authority (PMDA) on the clinical development pathway to a regulatory submission in that country. Published a manuscript in The Lancet focused on the phase 2 clinical trial results for sebetralstat. Presented data at Western Society of Allergy, Asthma & Immunology (WSAAI) 60th Annual Scientific Session examining the use of sebetralstat as a possible treatment for short-term prophylaxis (STP) as part of the KONFIDENT-S open-label extension clinical trial. Other data assessed the pharmacokinetic and pharmacodynamic parameters of sebetralstat in Japanese adults supporting the expansion of the KONFIDENT phase 3 trial to Japan and delineated a post hoc analysis of phase 2 trial data demonstrating that sebetralstat provided similar symptom relief, reduction in attack severity, and use of rescue regardless of abdominal or peripheral attack location. Promoted Chief Financial/Business Officer Benjamin L. Palleiko to President of KalVista and tasked him with the development of the Company’s commercial and business organization. Announced $58 million of new funding via a registered direct offering. KalVista intends to use the proceeds of this $58 million offering to fund clinical trials, commercial sales development, research, working capital, capital expenditures and other general corporate purposes. With the financing, the Company now expects to be able to fund operations into 2025. Third Fiscal Quarter Financial Results: Revenue: No revenue was recognized for the three months ended January 31, 2023 or January 31, 2022. R&D Expenses: Research and development expenses were $20.1 million for the three months ended January 31, 2023, compared to $19.7 million for the same period in the prior fiscal year. The increase in R&D expenses during the quarter primarily reflects the ongoing Phase 3 KONFIDENT trial for sebetralstat, increased preclinical spending, and increased personnel costs, offset by a decrease in expense from KVD824. G&A Expenses: General and administrative expenses were $6.9 million for the three months ended January 31, 2023, compared to $6.9 million for the same period in the prior fiscal year. G&A expenses remained consistent primarily due to increases in commercial planning and other administrative expenses offset by decreases in employee related expenses and professional fees. Net Loss: Net loss was $21.3 million, or $(0.75) per weighted average basic and diluted share, for the three months ended January 31, 2023, compared to net loss of $22.5 million, or $(0.92) per weighted average basic and diluted share for the same period in the prior fiscal year. The decrease in net loss and net loss per share primarily resulted from increases in interest income and currency exchange rate gains from transactions denominated in foreign currencies in our U.K. subsidiary. Cash Position: Cash, cash equivalents and marketable securities were $171.7 million as of January 31, 2023, compared to $166.2 million as of April 30, 2022. The increase in the net cash and marketable securities position was primarily due to the net proceeds received from the December 2022 registered direct offering of common stock and pre-funded warrants. 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 is developing sebetralstat as an oral on-demand therapy for HAE attacks and is enrolling the Phase 3 KONFIDENT clinical trial. 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 . 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 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 Phase 3 KONFIDENT trial, 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, 2022, 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, 2023 2022 Assets Current assets: Cash and cash equivalents $ 85,049 $ 30,732 Marketable securities 86,636 135,470 Research and development tax credit receivable 11,892 14,098 Prepaid expenses and other current assets 8,556 13,347 Total current assets 192,133 193,647 Property and equipment, net 3,037 2,178 Right of use assets 8,101 7,862 Other assets 197 193 Total assets $ 203,468 $ 203,880 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 1,698 $ 3,638 Accrued expenses 8,851 6,961 Lease liability - current portion 1,057 977 Total current liabilities 11,606 11,576 Long-term liabilities: Lease liability - net of current portion 7,421 7,211 Total long-term liabilities 7,421 7,211 Stockholders’ equity: Common stock, $0.001 par value 34 25 Additional paid-in capital 504,725 439,104 Accumulated deficit (316,777) (250,175) Accumulated other comprehensive loss (3,541) (3,861) Total stockholders’ equity 184,441 185,093 Total liabilities and stockholders' equity $ 203,468 $ 203,880 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, 2023 2022 2023 2022 Revenue $ — $ — $ — $ — Operating expenses: Research and development 20,063 19,738 56,325 50,954 General and administrative 6,882 6,945 22,818 18,848 Total operating expenses 26,945 26,683 79,143 69,802 Operating loss (26,945) (26,683) (79,143) (69,802) Other income: Interest income 732 258 1,424 822 Foreign currency exchange rate (loss) gain 597 (198) (237) (529) Other income 4,313 4,156 11,354 11,283 Total other income 5,642 4,216 12,541 11,576 Net loss $ (21,303) $ (22,467) $ (66,602) $ (58,226) Net loss per share, basic and diluted $ (0.75) $ (0.92) $ (2.58) $ (2.38) Weighted average common shares outstanding, basic and diluted 28,278,453 24,479,660 25,810,369 24,449,788 KalVista Pharmaceuticals Inc. Condensed Consolidated Statements of Cash Flows (in thousands, unaudited) Nine Months Ended January 31, 2023 2022 Cash flows from operating activities Net loss $ (66,602) $ (58,226) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 530 408 Stock-based compensation expense 7,481 8,432 Realized loss (gain) from sale of marketable securities 84 296 Non-cash operating lease expense 52 153 Amortization of premium on marketable securities 890 2,081 Foreign currency exchange loss (gain) (1,339) 698 Changes in operating assets and liabilities: Research and development tax credit receivable 2,049 (1,477) Prepaid expenses and other current assets 4,440 (3,659) Accounts payable (1,911) 228 Accrued expenses 1,701 (279) Net cash used in operating activities (52,625) (51,345) Cash flows from investing activities Purchases of marketable securities (63,757) (84,415) Sales and maturities of marketable securities 112,509 130,686 Acquisition of property and equipment (1,127) (845) Net cash provided by investing activities 47,625 45,426 Cash flows from financing activities Issuance of common stock from equity incentive plans 482 1,443 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 58,149 1,443 Effect of exchange rate changes on cash and cash equivalents 1,168 (539) Net (decrease) increase in cash and cash equivalents 54,317 (5,015) Cash and cash equivalents at beginning of period 30,732 50,592 Cash and cash equivalents at end of period $ 85,049 $ 45,577