KalVista Pharmaceuticals, Inc.

    KALV ·NASDAQ ·Pharmaceutical Preparations ·Inc. in DE
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    Item 1. Business.

    Overview

    Our Company

    We are a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. On July 3, 2025, the U.S. Food and Drug Administration (the “FDA”) approved our new drug application (“NDA”) for the use of EKTERLY® (sebetralstat), a novel, orally delivered, small molecule plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (“HAE”) in adult and pediatric patients aged 12 years and older. EKTERLY (sebetralstat) is the first and only oral, on-demand therapy for HAE.

    The efficacy and safety of EKTERLY was established by the results from the phase 3 KONFIDENT clinical trial, published in the New England Journal of Medicine in May 2024. Based on data from KONFIDENT, together with confirmatory evidence from pharmacokinetic/pharmacodynamic studies, the 600 mg dose of EKTERLY (sebetralstat) was considered by the FDA to be the optimal dose and included in the approved labeling. The KONFIDENT clinical trial met all primary and key secondary endpoints and demonstrated a favorable safety profile. HAE attacks treated with 600 mg of sebetralstat achieved the primary endpoint of beginning of symptom relief significantly faster than placebo (p=0.0013 ) with a median time to beginning of symptom relief of 1.79 hours (CI 1.33, 2.27) as compared to 6.72 hours with placebo (CI 2.33, >12). Consistent with previous studies, sebetralstat was well-tolerated, with a safety profile similar to placebo. There were no patient withdrawals due to any adverse event and no treatment-related serious adverse events (SAEs) were observed. Treatment-related adverse event rates were 2.2% for 600 mg sebetralstat as compared to 4.8% for placebo. Primary and key secondary endpoints were analyzed in a fixed, hierarchical sequence and adjusted for multiplicity. Key secondary endpoints showed:

    Attacks treated with 600mg of sebetralstat achieved a significantly faster time to a reduction in attack severity from baseline, compared to placebo (p=0.0032); and
    Attacks treated with 600mg sebetralstat demonstrated a significantly faster time to complete attack resolution as compared to placebo (p<0.0001).

    Prior to the approval of EKTERLY (sebetralstat), all on-demand treatment options approved in the U.S. for HAE required intravenous or subcutaneous administration, which carries a significant treatment burden. Even with the use of long-term prophylaxis as a preventative therapy, most people living with HAE continue to have unpredictable attacks and require ready access to on-demand medication. We believe EKTERLY (sebetralstat) has the potential to fundamentally shift the manner in which HAE is managed, based upon extensive and continuing research conducted with patients, physicians and payers.

    Key Updates

    In August 2024, the European Medicines Agency (“EMA”) validated the submission of our Marketing Authorization Application (“MAA”) for sebetralstat. This application is currently being reviewed by the EMA’s Committee for Medicinal Products for Human Use under the centralized licensing procedure for all 27 Member States of the European Union, as well as the European Economic Area ("EEA") countries Norway, Iceland and Liechtenstein. In September 2024, we announced MAA submissions to the regulatory authorities in the United Kingdom, Switzerland, Australia, and Singapore via the Access Consortium framework for which we have obtained a four-way sharing agreement by the Medicines and Healthcare product Regulatory Agency ("MHRA"), Swissmedic, the Therapeutic Goods Administration and Health Sciences Authority. The Access Consortium is designed to maximize regulatory collaboration across countries and support a timely review process. In January 2025, we announced that Japan’s Ministry of Health, Labour and Welfare (“MHLW”) had granted sebetralstat orphan drug designation, and we also submitted an NDA for sebetralstat to that agency. To enable the broadest possible global availability of sebetralstat, if approved, we intend to engage commercial partners in certain international markets.

     

    Sebetralstat has received fast track and orphan drug designations from the FDA, orphan drug Designation from Japan’s MHLW, as well as orphan drug designation and an approved Pediatric Investigational Plan from the EMA. In November 2023, sebetralstat was granted orphan drug status in Switzerland. In February 2024, the U.K. MHRA awarded the Innovation Passport for sebetralstat.

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    In November 2024, we, as guarantor, and KalVista Pharmaceuticals Limited, our wholly owned subsidiary (the “Subsidiary”), entered into a Purchase and Sale Agreement the (“PSA”) with DRI Healthcare Acquisitions LP (the “Purchaser”), an affiliate of DRI Healthcare Trust, pursuant to which the Subsidiary sold to the Purchaser the right to receive payments from the Subsidiary at a tiered percentage of future worldwide net sales of sebetralstat. Under the terms of the PSA, the Subsidiary received an upfront payment of $100.0 million in exchange for tiered payments on worldwide net sales of sebetralstat, as follows: 5.00% on annual net sales up to and including $500.0 million; 1.10% on annual net sales above $500.0 million and up to and including $750.0 million; and 0.25% on annual net sales above $750.0 million. The Subsidiary is entitled to a potential one-time sales-based milestone payment of $50.0 million if annual global net sales of sebetralstat meet or exceed $550.0 million in any calendar year before January 1, 2031. If sebetralstat is approved prior to October 1, 2025, the Subsidiary will have the option to receive a one-time payment of $22.0 million. If the Subsidiary chooses to receive this optional payment, the royalty rate on net sales up to and including $500 million will increase from 5.00% to 6.00%, and the sales-based milestone amount will increase from $50.0 million to $57.0 million.

    In April 2025, KalVista Pharmaceuticals Limited licensed commercialization rights in Japan to Kaken Pharmaceutical, Co., Ltd. for sebetralstat. We received an upfront payment of $11.0 million on June 20, 2025, with an additional payment of up to $11.0 million upon achievement of a regulatory milestone anticipated in early 2026. Beyond these payments, we are eligible for commercial milestone payments of up to $2.0 million, plus royalties based on the Japan National Health Insurance (NHI) price, with the royalty rate as a percentage of sales approximately in the mid-twenties.

    Our Strategy

    We are committed to developing better solutions for the unmet needs of patients. The key elements of our strategy include:

    Position EKTERLY (sebetralstat) to become a foundational therapy for HAE. We launched EKTERLY (sebetralstat) for the treatment of acute attacks of HAE after receiving FDA approval in July 2025. With clinical experience encompassing over 2,000 attacks spanning all locations and severity, EKTERLY (sebetralstat) is indicated for use at the earliest recognition of an HAE attack for patients 12 years and older. As the first oral on-demand treatment for HAE attacks, we believe EKTERLY (sebetralstat) with its effectiveness as a tablet compared to injectable treatment options, its ability to treat all attacks and to enable early treatment, provides a new and unique opportunity for patients and healthcare providers to revise their approach to HAE disease management. Through our present and future patient and healthcare provider outreach, we anticipate that awareness of EKTERLY’s (sebetralstat) utility will create sustained and long-lasting demand.
    Provide access to sebetralstat globally through focused direct efforts and by entering commercialization agreements in certain locations. Outside the US, we intend to commercialize sebetralstat with internal sales and marketing capabilities in major markets within Europe and leverage the capabilities of partners to provide market access in other geographies, if approved. For example, in anticipation of receiving a decision on our marketing application in Germany and the UK in the second half of 2025, we are preparing internal sales and marketing teams. Similarly, we have recently announced commercialization partnerships for sebetralstat in Japan, where we anticipate a decision on our NDA in early 2026, and in Canada, through the efforts of our commercial partner.
    Develop a sustainable pipeline by employing our internal scientific expertise while also planning for growth by evaluating strategic opportunities to in-license or acquire best-in-class assets that complement our core strategy. Our scientific team has demonstrated the ability to design and formulate multiple drug candidate programs from a broad variety of chemical classes. Our initial focus is specifically on the development of oral plasma kallikrein inhibitors for HAE and Factor XIIa inhibitors for other indications. However, we believe our scientific capabilities also can be applied to develop other therapies for diseases with high unmet need. In addition, we seek to augment our internally developed pipeline projects by selectively and strategically acquiring pipeline assets that will add value to our portfolio. Our management team has decades of deep and expansive strategic expertise building new markets across rare disease, including HAE. We believe that this team, leveraging their experience, strong execution capabilities, and financial discipline, will enable the Company to continue to innovate and grow.

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    Plasma Kallikrein in HAE

    Plasma kallikrein is a serine protease enzyme that is a key mediator of inflammation and edema. The body modulates the downstream inflammatory effects of plasma kallikrein through a circulating inhibitor protein called C1-esterase inhibitor (“C1-INH”). Most patients with HAE have a genetic mutation that leads to C1-INH deficiency, which results in an inability to control activated plasma kallikrein in affected tissues. This excessive activation leads to inflammation, edema, and pain. The majority of the approved therapies in HAE today inhibit plasma kallikrein in some manner.

    Hereditary Angioedema

    Disease Overview

    HAE is a rare and potentially life-threatening genetic condition that occurs in about 1 in 35,000 to 1 in 50,000 people, according to published information from an HAE patient advocacy group. Excessive plasma kallikrein activation that is not sufficiently controlled by C1-INH leads to HAE attacks, which can vary with regard to the affected tissue or organ and severity. HAE attacks include episodes of intense swelling usually in the skin, gastrointestinal tract or airways. They often lead to temporary disfiguration of various body parts including the hands, feet, face, body trunk, and genitals. In addition, patients often have bouts of excruciating abdominal pain, nausea and vomiting that is caused by swelling in the intestinal wall. Airway swelling is particularly dangerous and can lead to death by asphyxiation. Untreated attacks can be functionally disabling and commonly take days to fully resolve.

    Attacks can occur spontaneously although they often are associated with triggers such as anxiety, stress, minor trauma, surgery, or illnesses. Trauma to the oral cavity caused by dental procedures makes HAE patients particularly vulnerable to airway attacks. The frequency of HAE attacks is highly variable, with some patients having attacks several times per week and others very infrequently. Population studies have shown that the mean number of attacks per month for people with HAE is approximately two. Although life-threatening airway swelling is rare, published research suggests at least half of HAE patients have experienced at least one such attack and airway attacks remain a major potential cause of mortality in HAE patients. The severity of attacks is unpredictable and not related to their underlying frequency, and even most patients on long-term prophylaxis continue to experience breakthrough attacks on some basis.

    HAE is an autosomal dominant disease, meaning that a defect in only one copy of the gene leads to symptoms and that it occurs at similar rates in both males and females. The most common cause of HAE is a defect or mutation in the gene responsible for the production of C1-INH. C1-INH is a natural plasma-borne protein that is an inhibitor of multiple serine proteases in both the complement and kallikrein-kinin systems. C1-INH is the predominant physiological inhibitor of plasma kallikrein, and thereby suppresses the generation of bradykinin, a potent hormone produced by plasma kallikrein, that activates its receptors on blood vessels to increase vascular leakage. Uncontrolled plasma kallikrein activity leads to the edema that is the hallmark of HAE.

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    While HAE most often results from the inheritance of a defective gene from a parent, it is estimated that up to 25% of cases also arise from spontaneous mutations. Patients with C1-INH-related disease are classified as Type 1 or Type 2; Type 1 is the most common form and results in low levels of circulating C1-INH and Type 2 results in production of a low function protein. An additional form of HAE, currently referred to as normal C1-INH HAE, can occur in patients with normal levels of C1-INH for a variety of reasons including mutations in genes for Factor XII, plasminogen or angiopoetin, although in most cases a specific genetic abnormality isn’t found. Selective plasma kallikrein inhibitors and a bradykinin receptor antagonist are approved therapies for HAE. As such, plasma kallikrein is a clinically validated target for HAE and previous studies have demonstrated that plasma kallikrein inhibition can both treat and prevent HAE attacks.

    HAE Treatment Landscape

    There are a number of marketed and development stage therapeutics for HAE, both for prophylaxis to prevent attacks of HAE as well as for the on-demand treatment of acute attacks of HAE. As a result of the lifelong nature of HAE and the challenges related to taking many of the injected therapies, patient surveys consistently indicate an overwhelming desire of patients for an oral on-demand therapy. Prior to the approval of EKTERLY (sebetralstat), all on-demand treatment options approved in the U.S. for HAE require intravenous or subcutaneous administration, which carries a significant treatment burden. Even with the use of long-term prophylaxis as a preventative therapy, most people living with HAE continue to have unpredictable attacks and require ready access to on-demand medication. We believe that a safe and effective oral on-demand agent has the potential to transform treatment for this disease.

    EKTERLY (sebetralstat)

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    Financial statements

    data from SEC XBRL filings. Values are as-reported; restatements supersede originals. Values reported in .

    From 10-Q filed 2026-05-14 (period ending 2026-03-31).

    You should read the following discussion in conjunction with our unaudited interim condensed financial statements and related notes included elsewhere in this report. This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential” or “continue” or the negative of these terms or other comparable terminology. These forward-looking statements, include, but are not limited to, statements regarding the proposed merger contemplated by the Merger Agreement, including the timing, completion and anticipated benefits of the Merger and the satisfaction of the conditions to closing; the success, cost and timing of our product development activities and clinical trials as well as other activities we may undertake; macroeconomic conditions, including rising inflation and changing interest rates, labor shortages, supply chain issues, and global conflicts such as the war in Ukraine and conflicts in the Middle East; our business strategy; our ability to receive, maintain and recognize the benefits of certain designations received by product candidates and the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates. Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or our future financial performance, are based on assumptions, and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under “Risk Factors” in our Transition Report on Form 10-KT or described elsewhere in this Quarterly Report on Form 10-Q. These forward-looking statements speak only as of the date hereof. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. Unless the context indicates otherwise, in this Quarterly Report on Form 10-Q, the terms “KalVista,” “Company,” “we,” “us” and “our” refer to KalVista Pharmaceuticals, Inc. and, where appropriate, its consolidated subsidiaries.

    Management Overview

    We are a global pharmaceutical company dedicated to delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. On July 3, 2025, we received approval from the U.S. Food and Drug Administration (the “FDA”) for our lead product candidate, EKTERLY® (sebetralstat), for the treatment of acute attacks of hereditary angioedema (“HAE”) in adults and adolescents aged 12 years and older. EKTERLY is the first and only oral on-demand therapy for HAE. Following FDA approval, EKTERLY received marketing authorization from the European Medicines Agency (“EMA”), the U.K.’s Medicines and Healthcare products Regulatory Agency (“MHRA”), the Swiss Agency for Therapeutic Products (“Swissmedic”), Japan’s Ministry of Health, Labour and Welfare (“MHLW”) as well as regulatory agencies in Australia and Singapore (collectively the “Current Global Approvals”). We currently market EKTERLY directly in the U.S. and Germany and through a commercial partner in Japan, and also have established commercialization partnerships for Canada, Brazil, Argentina, Colombia, and Mexico. We are incorporated in the State of Delaware and headquartered in Framingham, Massachusetts.

    Agreement and Plan of Merger

    On April 29, 2026, the Company entered into the Merger Agreement with Chiesi, Merger Sub, and KalVista Pharmaceuticals Limited. Pursuant to the Merger Agreement, and upon the terms and subject to the conditions thereof, among other things, Chiesi has agreed to cause Merger Sub to commence the Offer to acquire all of the outstanding shares of common stock of the Company, par value $0.001 per share, other than the Excluded Shares, for the Offer Price.

     

    Pursuant to the Merger Agreement, Merger Sub commenced the Offer on May 13, 2026. The Offer will expire one minute after 11:59 p.m., Eastern Time, on June 10, 2026, unless extended in accordance with the terms of the Merger Agreement.

     

    The consummation of the Offer is subject to the satisfaction or waiver of various conditions set forth in the Merger Agreement, including (i) there being validly tendered, and not validly withdrawn, in the Offer a number of shares that, considered together with all other shares (if any) beneficially owned by Chiesi and its affiliates, represent one more share than 50% of the total number of shares outstanding at the time of the expiration of the Offer; provided, however, that for purposes of determining whether such condition has been satisfied, the parties shall exclude shares tendered in the Offer pursuant to guaranteed delivery procedures that have not yet been “received” by the “depository” (as such terms are defined in Section 251(h)(6) of the DGCL); (ii) any waiting period (or any extension thereof) applicable to the Offer under the HSR Act, having expired or terminated and the obtainment of clearance, approval (including deemed clearance and approval, including as a result of waiting periods having lapsed, expired, or been terminated) or confirmation of non-notifiability (or equivalent confirmation that no filing or approval is required) by the Bundeskartellamt under applicable antitrust laws

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    in Germany and the Presidenza del Consiglio dei Ministri under applicable foreign investment laws in Italy; (iii) the accuracy of the representations and warranties of the Company contained in the Merger Agreement, subject to customary materiality standards, thresholds and exceptions; (iv) the Company’s compliance with, or performance of, in all material respects its covenants and agreements contained in the Merger Agreement; (v) there having not occurred any Material Adverse Effect; and (vi) other customary conditions set forth in Annex I to the Merger Agreement.

     

    As soon as practicable following the consummation of the Offer, the Merger will occur, with the Company continuing as the surviving corporation and a wholly owned subsidiary of Chiesi, on the terms and subject to the conditions set forth in the Merger Agreement. In the Merger, each issued and outstanding share as of the Effective Time (other than the Excluded Shares as Dissenting Shares (as defined in the Merger Agreement)) shall be converted into the right to receive the Offer Price.

     

    The parties expect the Merger to close in the third quarter of 2026. Following completion of the Merger, the Company’s common stock will no longer be publicly listed.

     

    The Merger Agreement contains certain termination rights for the Company and Chiesi. If the Merger Agreement is terminated under certain specified circumstances, the Company will be required to pay Chiesi a fee of $66.4 million.

    Results of Operations

    Comparison of the three months ended March 31, 2026 and 2025

    The following table summarizes the key components of our results of operations for the periods indicated (in thousands):
     

     

    Three Months Ended
    March 31,

    Change

     

    2026

     

    2025

    $

     

    %

    Product revenue, net

    $

    39,165

     

    $

    $

    39,165

     

     

    100%

    Partnership and other revenue

     

    1,698

     

     

     

    1,698

     

     

    100%

    Total revenues

     

    40,863

     

     

     

    40,863

     

     

    100%

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

    Cost of revenue

     

    3,090

     

     

     

    3,090

     

     

    100%

    Research and development

     

    12,420

     

     

    14,173

     

    (1,753)

     

     

    -12%

    Selling, general and administrative

     

    48,795

     

     

    35,535

     

    13,260

     

     

    37%

    Total operating expenses

     

    64,305

     

     

    49,708

     

    14,597

     

     

    29%

    Operating loss

     

    (23,442)

     

     

    (49,708)

     

    26,266

     

     

    -53%

    Other (expense) income

     

    (45)

     

     

    2,119

     

    (2,164)

     

     

    -102%

    Loss before income tax expense

    $

    (23,487)

     

    $

    (47,589)

    $

    24,102

     

     

    -51%

     

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    Product revenue, net. Product revenue, net was $39.2 million for the three months ended March 31, 2026 compared with $0 in the same period of the prior year as a result of our commercial launch of EKTERLY in the U.S. in July 2025, following the FDA approval of EKTERLY on July 3, 2025, and in Germany in the fourth quarter of 2025.

    Partnership and other revenue. Partnership and other revenue was $1.7 million for the three months ended March 31, 2026 compared with $0 in the same period of the prior year as a result of a product shipment to Kaken, following the Japanese launch by our partner Kaken in the first quarter of 2026, and pro-rated recognition of deferred revenue from the upfront and regulatory milestone payments.

    Cost of revenue. Cost of revenue was $3.1 million for the three months ended March 31, 2026 compared with $0 in the same period of the prior year and primarily consisted of direct and indirect costs related to the manufacturing and distribution of EKTERLY, including third-party manufacturing costs, packaging services, freight, and certain costs related to manufacturing services following regulatory approval.

    Research and development expenses. Research and development expenses decreased by $1.8 million for the three months ended March 31, 2026 compared with the same period in the prior year.

    The table below summarizes research and development expenses by major programs or categories for the periods indicated (in thousands):
     

     

    Three Months Ended
    March 31,

    Change

     

    2026

     

    2025

    $

     

    %

    Sebetralstat

    $

    2,757

     

    $

    4,673

    $

    (1,916)

     

     

    -41%

    Personnel

     

    6,751

     

     

    6,474

     

    277

     

     

    4%

    Other R&D

     

    2,912

     

     

    3,026

     

    (114)

     

     

    -4%

    Total research and development

    $

    12,420

     

    $

    14,173

    $

    (1,753)

     

     

    -12%

    Selling, general and administrative expenses. Selling, general and administrative expenses increased by $13.3 million for the three months ended March 31, 2026 compared with the same period in the prior year primarily due to increases in personnel costs of $10.1 million, other administrative expenses of $2.5 million, and marketing and advertising costs of $1.8 million offset by a decrease in medical related expenses of $1.1 million. We anticipate these expenses will continue at or above current levels to support the commercialization of EKTERLY.

    Other (expense) income. Other (expense) income decreased by $2.2 million for the three months ended March 31, 2026 compared with the same period in the prior year primarily due to unfavorable changes in foreign currency exchange rates of $2.7 million and an increase in interest expense of $2.6 million, respectively offset by the change in fair value of the derivative liability of $2.4 million and increase in interest income of $0.8 million.

    Liquidity and Capital Resources

    On April 29, 2026, we entered into the Merger Agreement with Chiesi, Merger Sub, and KalVista Pharmaceuticals Limited. In the Merger Agreement, we have agreed to various covenants, including, among others, agreements to conduct our business in the ordinary course consistent with past practice in all material respects during the period between the execution of the Merger Agreement and the Effective Time. Outside of certain limited exceptions, we may not take, authorize, or agree or commit to take, certain actions without Chiesi’s consent, including, but not limited to: (i) acquiring businesses and disposing significant assets; (ii) incurring capital expenditures above specified thresholds; (iii) issuing equity; (iv) incurring indebtedness above specified thresholds; and (v) repurchasing or paying dividends on shares. We do not believe these restrictions will prevent us from being able to fund our operations, working capital needs or capital expenditure requirements.

    For the three months ended March 31, 2026, we incurred losses and cash outflows from operating activities. As of March 31, 2026, we had an accumulated deficit of $786.2 million and cash, cash equivalents and marketable securities totaling $285.0 million. We have funded operations primarily through a combination of equity financings, collaborations, strategic partnerships, royalty financing, license arrangements, convertible debt and product sales. Our working capital, primarily cash and cash equivalents and marketable securities, is anticipated to be sufficient to fund our operations for at least the next twelve months from the date these unaudited interim condensed consolidated financial statements are issued.

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    Sources of Liquidity

    In July 2024, we filed a registration statement on Form S-3 (the “Registration Statement”) with the U.S. Securities and Exchange Commission (the “SEC”), pursuant to which we may offer and sell securities having an aggregate public offering price of up to $300 million.

    In April 2025, we entered into a License, Supply and Distribution Agreement (the “Kaken Agreement”) with Kaken Pharmaceutical Co., Ltd. (“Kaken”) pursuant to which we have licensed exclusive commercialization rights in Japan to Kaken for the Licensed Product (as defined in the Kaken Agreement) in exchange for a non-refundable upfront payment of $11.0 million, potential regulatory and sales milestone payments totaling approximately $13.0 million and effective royalty payments in the mid-twenties percentage that shall be payable for each unit of revenue of Licensed Product that we supply, which reflect a percentage of the Japanese National Health Insurance price of the Licensed Product. In June 2025, we received the upfront payment of $11.0 million.

    In July 2025, we received a one-time cash payment of $22.0 million as a result of obtaining FDA approval of sebetralstat before October 1, 2025, pursuant to the PSA with DRI.

    In July 2025, we entered into a sales agreement with TD Securities (USA) LLC (“TD Cowen”) pursuant to which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $100.0 million (the “ATM Shares”), under the prospectus supplement, dated July 10, 2025, to the Registration Statement, through TD Cowen as sales agent. As of March 31, 2026, we have not offered or sold any ATM Shares pursuant to the Registration Statement.

    In September 2025, we entered into an indenture agreement with U.S. Bank Trust Company, National Association, as trustee, to issue $143.8 million aggregate principal amount of convertible senior notes (the “Notes”). The Notes are senior, unsecured obligations of the Company and bear interest at a rate of 3.25% per year, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2026. The net proceeds were $139.1 million after deducting the discount and offering expenses of $4.7 million. The effective interest rate on the Notes is 3.85%.

    In March 2026, we received a one-time regulatory milestone payment of $11.0 million as a result of obtaining pricing approval in Japan, pursuant to the Kaken Agreement.

    Cash Flows

    The table below summarizes the net cash flow activity for the periods indicated (in thousands):
     

     

    Three Months Ended
    March 31,

    Change

     

    2026

     

    2025

    $

     

    %

    Cash used in operating activities

    $

    (14,455)

     

    $

    (47,567)

    $

    33,112

     

     

    -70%

    Cash used in investing activities

     

    (901)

     

     

    (3,718)

     

    2,817

     

     

    -76%

    Cash provided by financing activities

     

    1,465

     

     

    2,223

     

    (758)

     

     

    -34%

    Effect of exchange rate changes

     

    (1,683)

     

     

    2,240

     

    (3,923)

     

     

    -175%

    Net decrease in cash, cash equivalents and restricted cash

    $

    (15,574)

     

    $

    (46,822)

    $

    31,248

     

     

    -67%

    Cash used in operating activities

    Cash used in operating activities was $14.5 million for the three months ended March 31, 2026 and primarily consisted of a net loss of $23.5 million offset by non-cash adjustments totaling $13.2 million and changes in net working capital totaling $4.2 million. Cash used in operating activities was $47.6 million for the three months ended March 31, 2025 and primarily consisted of a net loss of $51.8 million offset by non-cash adjustments totaling $2.9 million and changes in net working capital totaling $1.4 million.

    Cash used in investing activities

    Cash used in investing activities was $0.9 million and $3.7 million for the three months ended March 31, 2026 and 2025, respectively, which was primarily attributable to the purchases and maturities of marketable securities as part of managing our cash and investments.

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    Held by

    holders ( registered funds via N-PORT, institutional investors via 13F). Showing top by dollar value.

    Holder Type ETF MF Position ($) % of holder Δ % of holder Holder AUM

    Recent insider activity

    Last 90 days. Open-market trades (purchases & sales) by directors, officers, and 10%+ owners. 17 transactions across 5 insiders. Net: -81,364 shares, -$2,074,007.

    Date Insider Role Action Shares Price Value
    2026-05-27 Yea Christopher CHIEF DEVELOPMENT OFFICER Sell -33,800 $26.78 -$905,225
    2026-05-26 Audhya Paul K. CHIEF MEDICAL OFFICER Sell -2,239 $26.78 -$59,955
    2026-05-26 Sweeny Nicole Chief Commercial Officer Sell -1,489 $26.78 -$39,872
    2026-05-26 Yea Christopher CHIEF DEVELOPMENT OFFICER Sell -1,966 $26.78 -$52,645
    2026-05-22 Palleiko Benjamin L CHIEF EXECUTIVE OFFICER Sell -10,926 $26.78 -$292,646
    2026-05-22 Piekos Brian Chief Financial Officer Sell -1,489 $26.78 -$39,882
    2026-05-22 Audhya Paul K. CHIEF MEDICAL OFFICER Sell -2,685 $26.78 -$71,916
    2026-05-22 Yea Christopher CHIEF DEVELOPMENT OFFICER Sell -2,358 $26.78 -$63,158
    2026-05-22 Sweeny Nicole Chief Commercial Officer Sell -1,861 $26.78 -$49,846
    2026-05-18 Audhya Paul K. CHIEF MEDICAL OFFICER Sell -1,032 $26.76 -$27,616
    2026-05-18 Yea Christopher CHIEF DEVELOPMENT OFFICER Sell -1,108 $26.76 -$29,650
    2026-05-18 Palleiko Benjamin L CHIEF EXECUTIVE OFFICER Sell -1,129 $26.76 -$30,212
    2026-05-12 Palleiko Benjamin L CHIEF EXECUTIVE OFFICER Sell -3,322 $26.71 -$88,731
    2026-04-17 Palleiko Benjamin L CHIEF EXECUTIVE OFFICER Sell -9,550 $20.22 -$193,066
    2026-04-17 Piekos Brian Chief Financial Officer Sell -1,862 $20.22 -$37,643
    2026-04-17 Sweeny Nicole Chief Commercial Officer Sell -1,862 $20.22 -$37,643
    2026-04-17 Audhya Paul K. CHIEF MEDICAL OFFICER Sell -2,686 $20.22 -$54,301

    Source: SEC Form 4 filings.

    Next expected filings

    • ~2026-07-12 10-K expected by 2026-07-14 (in 3 days)
    • ~2026-09-10 10-Q expected by 2026-09-12 (in 63 days)
    • ~2026-11-09 10-Q expected by 2026-11-11 (in 123 days)
    • ~2027-05-13 10-Q expected by 2027-05-15 (in 308 days)

    Predicted from historical filing cadence; not an SEC commitment.

    Recent SEC filings

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    • 2026-05-14 10-Q Quarterly Report
    • 2026-04-30 10-KT/A 10-KT/A
    • 2026-04-29 8-K Material Agreement Entered; Regulation FD Disclosure; Financial Statements and Exhibits
    • 2026-03-25 10-KT 10-KT
    • 2026-03-25 8-K Earnings Release; Financial Statements and Exhibits
    • 2026-01-08 8-K Earnings Release; Regulation FD Disclosure; Financial Statements and Exhibits
    • 2025-11-10 10-Q Quarterly Report
    • 2025-11-10 8-K Earnings Release; Financial Statements and Exhibits
    • 2025-10-06 8-K Officer/Director Change; Regulation FD Disclosure; Financial Statements and Exhibits
    • 2025-10-02 8-K Officer/Director Change; Shareholder Vote Results; Regulation FD Disclosure; Financial Statements and Exhibits
    • 2025-09-29 8-K Material Agreement Entered; Material Financial Obligation; Unregistered Equity Sale; Other Events; Financial Statements and Exhibits
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    • 2025-08-21 8-K Other Events