KalVista Pharmaceuticals Reports Second Fiscal Quarter Results

– Preparing for Initiation of KVD900 Phase 3 Clinical Trial–

– KVD824 Phase 2 KOMPLETE Clinical Trial Enrolling –

– Funded Beyond Data on Both HAE Trials –

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--$KALV--KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, today provided an operational update and released financial results for the second fiscal quarter ended October 31, 2021.

“This quarter we made great strides in advancing the two distinct compounds in our oral hereditary angioedema franchise into later stage trials. We are very pleased with the Phase 3 trial design for KVD900, our candidate for on-demand HAE therapy, where we believe the primary endpoint is both meaningful to patients and was successful in our Phase 2 trial. The KVD824 KOMPLETE Phase 2 protocol for prophylactic treatment of HAE has regulatory approvals in 12 of the 13 countries where the trial will be conducted,” said Andrew Crockett, Chief Executive Officer of KalVista. “Importantly, we are funded into at least early 2024, beyond both the KVD900 Phase 3 and KVD824 Phase 2 clinical trial data sets.”

Second Fiscal Quarter and Recent Business Highlights:

• Initiated KOMPLETE, the Phase 2 clinical trial of KVD824 that is currently enrolling patients.
• Presented Phase 2 data for KVD900 at American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting. Data presentations included an oral presentation and poster presentation on Phase 2 clinical trial data. The data showed that KVD900 was rapidly absorbed which was associated with a significantly shorter median time to initial symptom relief with KVD900 than with placebo. Patient reported outcomes captured in the phase 2 trial suggested that attack symptom improvement with use of KVD900 was clinically meaningful from the patients’ perspective.
• Completed an End-of-Phase 2 meeting with the FDA which confirmed that KalVista’s Phase 3 trial design, similar to the successful Phase 2 trial, is expected to be appropriate to support an NDA submission. The primary endpoint of this Phase 3 trial is time to beginning of symptom relief using the PGI-C scale that was one of the endpoints in the Phase 2 study. The trial is expected to be conducted at more than 50 sites worldwide and recruit approximately 100 patients, consistent with late stage trials of approved on-demand treatments for HAE. The trial is intended to evaluate all HAE attacks, including laryngeal attacks and breakthrough attacks for patients using prophylaxis. Similar to the Phase 2 trial for KVD900, patients will administer treatment as soon as they recognize the onset of an attack. Patients are expected to begin dosing in the trial during the first quarter of calendar year 2022.

Second Fiscal Quarter Financial Results:

• Revenue: No revenue was recognized for the three months ended October 31, 2021 or October 31, 2020.
• R&D Expenses: Research and development expenses were $17.5 million for the three months ended October 31, 2021, compared to $9.1 million for the same period in the prior fiscal year. The increase in R&D expenses during the quarter primarily reflects increased preclinical spending, the ongoing Phase 2 KOMPLETE clinical trial for KVD824, and the ongoing preparation for the Phase 3 clinical trial for KVD900.
• G&A Expenses: General and administrative expenses were $6.1 million for the three months ended October 31, 2021, compared to $3.6 million for the same period in the prior fiscal year. The increase in G&A expenses was primarily due to an increase in compensation related expenses and to a lesser extent, increases in facility expenses, commercial planning expenses, and other administrative costs.
• Net Loss: Net loss was $19.7 million, or $(0.80) per weighted average basic and diluted share, for the three months ended October 31, 2021, compared to net loss of $10.4 million, or $(0.58) per weighted average basic and diluted share for the same period in the prior fiscal year. The increase in net loss and net loss per share primarily resulted from the increase in operating expenses, primarily research and development.
• Cash Position: Cash, cash equivalents and marketable securities were $209.8 million as of October 31, 2021, compared to $248.9 million as of April 30, 2021. The decrease in the net cash position was due to increased operating expenses.

About the KOMPLETE Clinical Trial

KOMPLETE is the worldwide Phase 2 clinical trial of KVD824 as a potential oral prophylactic therapy for HAE. The trial is a randomized, double-blind, parallel group design evaluating twice-daily dosing of 300 mg, 600 mg, and 900 mg KVD824 against placebo for 12 weeks. KOMPLETE is intended to enroll 48 HAE patients randomized into four equal arms after they report experiencing a minimum of three attacks in an eight-week run-in period. The primary endpoint of the trial is the rate of investigator confirmed HAE attacks during the treatment period. Secondary endpoints include the proportion of participants without investigator confirmed HAE attacks and the rate of investigator confirmed HAE attacks that require conventional treatment. KOMPLETE will be conducted at more than 30 sites in 13 countries.

About KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors for diseases with significant unmet need. KalVista has developed a proprietary portfolio of novel, small molecule plasma kallikrein inhibitors initially targeting hereditary angioedema (HAE) and diabetic macular edema (DME). KalVista is developing KVD900 as an oral on-demand therapy for acute HAE attacks, which completed a Phase 2 efficacy trial in February 2021. KVD824 is in development for prophylactic treatment of HAE with the Phase 2 KOMPLETE clinical trial underway. In addition, KalVista’s oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment of HAE for patients. In DME, an intravitreally administered plasma kallikrein inhibitor, called KVD001, has completed a Phase 2 clinical trial.

For more information, 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, including the potential impact of COVID-19, that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence or complete clinical studies, including our Phase 2 KOMPLETE clinical trial, and to obtain regulatory approvals for KVD900, KVD824 and other candidates in development, our ability to resolve a clinical hold with regards to KVD824, the ability of KVD900, KVD824 and other candidates in development to treat HAE or DME, the future progress and potential success of our oral Factor XIIa program, and the sufficiency of our cash, cash equivalents and investments to fund our operations. 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, 2021, 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.
Leah Monteiro
Senior Director, Corporate Communications & Investor Relations
857-999-0808
leah.monteiro@kalvista.com