CYTK

SOUTH SAN FRANCISCO, Calif., Oct. 21, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that it is scheduled to report third quarter results on November 4, 2026 at 4:00 PM Eastern Time. Following the announcement, Cytokinetics' senior management will host a conference call at 4:30 PM Eastern Time to discuss financial results and provide business updates. The conference call will be simultaneously webcast and can be accessed from the Investors & Media section of Cytokinetics' website at www.cytokinetics.com or directly at the following link: Cytokinetics Q3 2026 Earnings Conference Call. An archived replay of the webcast will be available via Cytokinetics' website for six months. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics' MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, European Union, United Kingdom and Canada for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive topline results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Disclaimer Omecamtiv mecarbil and ulacamten are investigational medicines. They have not been approved nor determined to be safe or efficacious for any disease state or any indication by FDA or any other regulatory agency. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics' and its partners' research and development activities of Cytokinetics' product candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics' business outlines in Cytokinetics' filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics' actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. MYQORZO® is a registered trademark of Cytokinetics in the U.S., the European Union, the United Kingdom and Canada. Contact: Cytokinetics Diane Weiser Senior Vice President, Corporate Affairs (415) 290-7757

BridgeBio Pharma (BBIO), Madrigal Pharmaceuticals (MDGL) and Cytokinetics (CYTK) traded meaningfully lower in recent weeks as investors question the merits of holding positions in the US biotech stocks amid a lack of major near-term catalysts, BofA Securities said in a note previewing the companies' Q3 results. Ligand Pharmaceuticals (LGND) is the exception, having outperformed the broader biotech sector this year. BofA noted that BridgeBio shares have fallen 22% since its Q2 results. Beyond the near-term outlook for Attruby, a treatment for transthyretin amyloid cardiomyopathy, investors remain reluctant to step in amid few near-term catalysts and the likelihood of elevated operating losses through 2027. However, the investment firm believes these overhangs are masking solid fundamentals. It cut its price target to $102 from $104 and reiterated its buy rating, citing significant upside not yet reflected in the shares. For Madrigal, BofA expects a steady quarter but said investor debate is likely to shift toward the growing competitive landscape for treatments for metabolic dysfunction-associated steatohepatitis, or MASH. The firm expects commentary on patient additions, prescribing depth, access and market growth to remain largely unchanged from the Q2 earnings call, which may not be enough to support the shares. BofA lowered its price target to $533 from $543 and reiterated its neutral rating. For Cytokinetics, BofA expects the launch of Myqorzo, a treatment for obstructive hypertrophic cardiomyopathy, to dominate the Q3 results discussion as the drug enters its second full quarter on the market. However, the firm sees little likelihood that the update will materially improve investor sentiment. The investment firm noted that Cytokinetics' recent messaging has become more cautious, with management pointing to a linear near-term trajectory. The firm reiterated its neutral rating, citing uncertainties around the growth outlook, and cut its price target to $81 from $85. BofA sees upside in Ligand that investors may be overlooking and expects a strong quarter despite cooling sentiment. In addition to continued momentum from Filspari, a treatment for kidney disease, and Ohtuvayre, the firm believes investors are underestimating the contribution from Ligand's acquisition of Xoma and stronger second-half Captisol sales. BofA raised its price target on Ligand to $406 from $388 and reiterated its buy rating.

- TRAX plans to release top-line data from the first ANB033 celiac-disease study cohort on Monday. - CYTK will present additional Aficamten analyses at HFSA, while EPRX presents previously disclosed EP-104GI data at ACG. - ARWR and VSTM have clinical updates scheduled for Wednesday on Alzheimer's research and the cancer drug VS-7375. Biotech investors face a packed week, with First Tracks set to report early data on a celiac-disease drug, Verastem preparing an update on a cancer treatment, and the FDA approaching decisions on two eye therapies. The Health Care Select Sector SPDR Fund (XLV) gained 2.8% last week, outperforming SPDR S&P 500 ETF Trust (SPY), up 1.2%, and Invesco QQQ Trust (QQQ), up 0.2%. The iShares Biotechnology ETF (IBB) rose 0.6%, trailing SPY but beating QQQ, while the SPDR S&P Biotech ETF (XBI) fell 0.4%. See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox Date | Ticker/Event | Development Oct.12 | TRAX | First Tracks plans to report Cohort 1 top-line data for ANB033 in celiac disease; investor call at 8:30 a.m. ET Oct.12 | CYTK / HFSA | Two late-breaking analyses of Aficamten in nonobstructive hypertrophic cardiomyopathy at the HFSA meeting Oct.12 | EPRX / ACG | Poster on EP-104GI and dysphagia improvements through 52 weeks in the RESOLVE study Oct.13 | JNJ | Third-quarter results; investor call at 8:30 a.m. ET Oct.14 | ARWR | Webinar with interim clinical data from the ARO-MAPT study in Alzheimer's disease and other tauopathies Oct.14 | VSTM | Investor event with initial efficacy and updated safety data for VS-7375 Oct.14-Oct.17 | PHAR / ESID | Late-breaking presentation of Phase 2 Leniolisib data in primary immunodeficiencies with immune dysregulation Oct.15 | RHHBY | FDA target action date for Roche's Enspryng in thyroid eye disease Oct.17 | VTRS / IRD | FDA target action date for phentolamine ophthalmic solution 0.75% in presbyopia Oct.17-Oct.20 | UEG Week | Gastroenterology conference in Barcelona, with presentations from EPRX, ABVX, Agomab and PALI First Tracks Biotherapeutics plans to report top-line data on Monday from Cohort 1 of its Phase 1b study of ANB033, a drug that blocks the immune target CD122. The gluten-challenge study is testing whether the drug can protect the intestinal lining from damage in people with celiac disease. Cytokinetics (CYTK) will present two late-breaking analyses of Aficamten on Monday at the Heart Failure Society of America's meeting in Phoenix. The ACACIA-HCM analyses examine the drug's overall effectiveness and impact on exercise performance in nonobstructive hypertrophic cardiomyopathy, where a thickened heart muscle does not block blood flow. The company plans to submit a supplemental new drug application in the fourth quarter. Eupraxia Pharmaceuticals (EPRX) will present a poster on Monday at the American College of Gastroenterology meeting on EP-104GI in eosinophilic esophagitis, an inflammatory condition of the esophagus. It will examine improvements in difficulty swallowing that lasted up to 52 weeks in the Phase 1b/2 Resolve study. Eupraxia reported the 52-week results from its highest-dose group late last month. Johnson & Johnson (JNJ) will report its third-quarter results on Tuesday. According to Koyfin, analysts expect revenue of $25.38 billion, up 0.3%. They forecast earnings before interest, taxes, depreciation and amortization (EBITDA) at $8.24 billion, down 8%, and earnings before interest and taxes (EBIT) at $7.42 billion, down 10%. GAAP earnings per share (EPS) are projected at $2.07, down 9%. On Wednesday, Arrowhead Pharmaceuticals (ARWR) will share interim results from an early-stage study of ARO-MAPT, its treatment for Alzheimer's disease and other disorders linked to abnormal tau protein. A webinar on the same day will also include an update on the company's central nervous system pipeline. Verastem Oncology (VSTM) will host an investor event on Wednesday to present initial efficacy results and updated safety data for VS-7375. The oral drug targets KRAS G12D, a cancer-driving mutation, and is being studied in pancreatic, lung and colorectal cancers as part of the Target-D program. Roche (RHHBY) is awaiting an FDA decision by Thursday on its application to use Enspryng (Satralizumab) to treat thyroid eye disease. The application received Priority Review. If approved, Roche says Enspryng could become the first at-home, under-the-skin treatment for the condition. The Phase 3 SatraGO results were presented last year. Viatris (VTRS) and Opus Genetics (IRD) face an Oct.17 FDA target date for phentolamine eye drops, also known as MR-141, as a treatment for presbyopia — the age-related difficulty focusing on nearby objects. The FDA accepted the application seeking approval for this new use. Pharming (PHAR) will present previously announced Phase 2 results for Leniolisib at the European Society for Immunodeficiencies meeting, running Oct.14-Oct.17 in the Netherlands. The study involved patients with rare, genetically defined immune disorders. Pharming released the top-line findings last month. Meanwhile, the United European Gastroenterology Week runs from Oct.17-Oct.20 in Barcelona. Abivax (ABVX) will present seven Obefazimod abstracts, including results from a Phase 3 maintenance study and patient subgroup analyses, longer-term Phase 2 findings and a preclinical study. Agomab will present long-term data from an extension of its STENOVA Phase 2a study, in which patients continued Ontunisertib treatment for up to 60 weeks. The study focuses on fibrostenosing Crohn's disease, which can cause narrowing of the bowel. Palisade Bio (PALI) will make four presentations on PALI-2108, including Phase 1b findings on early clinical improvements and evidence that the drug affects PDE4, a protein involved in inflammation. Three additional posters will cover gut-targeted delivery, safety and potential biomarkers that could help predict treatment response. Separately, Filana Therapeutics (FLNA) said it will attend the Maxim Growth Summit, running Oct.12-Oct.14, for one-on-one meetings. For updates and corrections, email newsroom[at]stocktwits[dot]com. Read Next: SLS Stock Jumps Overnight: Retail Sees Big Pharma Buyout Clues In 'M&A Negotiation Lounge' Booth At ASH Deepti Sri has no position in any of the stocks mentioned in this article. StockTwits' news team content is for informational purposes only and is not intended as investment advice. For more, see our editorial policy. This article was originally published on StockTwits. Related: - SPCX, TSM, APLD, AMZN, TSLA: Why Retail Traders Couldn't Take Their Eyes Off These Stocks Last Week - IREN's Mystery Customer Is Anthropic? Fresh Buzz Pushes Stock Higher - SLS Stock Jumps Overnight: Retail Sees Big Pharma Buyout Clues In 'M&A Negotiation Lounge' Booth At ASH

Additional Results from ACACIA-HCM Demonstrate Improvements in Cardiac Structure and Diastolic Function in Patients with Non-Obstructive HCM New Analysis of MAPLE-HCM Finds Aficamten Outperformed Metoprolol Across Pre-Trial Treatment Groups in Patients with Obstructive HCM SOUTH SAN FRANCISCO, Calif., Aug. 29, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional results from ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM) and MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM) were presented in a Late Breaking Clinical Session at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany and simultaneously published in Circulation and the Journal of the American College of Cardiology: Heart Failure, respectively. “The findings from these additional analyses of ACACIA-HCM and MAPLE-HCM elaborate on the primary results from each trial and expand the body of evidence supporting the potential use of aficamten across the spectrum of HCM,” said Stephen Heitner, M.D., Cytokinetics’ Chief Medical Officer. “In particular, the additional results from ACACIA-HCM suggest that the benefits of aficamten in non-obstructive HCM extend beyond exercise capacity and symptom burden to also include improvements in wall thickness and diastolic function, pointing to the potential mechanisms by which aficamten is effective in these patients. Given the lack of approved therapies for non-obstructive HCM, these findings highlight the potential impact aficamten could have on this population independent from relief of left ventricular outflow tract obstruction.” ACACIA-HCM: Effect of Aficamten on Cardiac Structure and Function in Patients with Symptomatic Non-Obstructive HCM Results from a pre-specified exploratory analysis of ACACIA-HCM, the Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), were presented in a Late Breaking Clinical Trial Session and simultaneously published in Circulation.1 As previously reported, the primary results from ACACIA-HCM showed that treatment with aficamten was associated with significant improvements from baseline to Week 36 compared to placebo in both Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and maximal exercise performance (pVO2). This analysis showed that treatment with aficamten also demonstrated improvements in measures of cardiac structure and diastolic function at the time of the primary analysis (36 weeks) and at end of treatment (EOT) (up to 72 weeks; median time to end of treatment = 49 weeks). At Week 36 and at EOT, aficamten significantly improved measures of diastolic function including peak E velocity (p=0.001 and p=0.034, respectively) and septal e’ velocity (paficamten improves diastolic function independent of reducing left ventricular outflow tract (LVOT) obstruction, providing support for the importance of diastolic function as the potential underlying mechanism for the improvements in functional capacity and symptom relief in this population. Aficamten was associated with a modest but statistically significant (p<0.001) reduction in systolic function as measured by left ventricular ejection fraction (LVEF) which remained within normal range at EOT. Left ventricular wall thickness decreased by 0.2 cm at EOT (p<0.001) while left ventricular end-systolic and end-diastolic left ventricular volumes increased (p<0.001). MAPLE-HCM: Aficamten vs. Metoprolol in Obstructive HCM According to Pre-Trial Treatment Results of a post-hoc analysis from MAPLE-HCM, the Phase 3 clinical trial of aficamten compared to metoprolol in patients (n=175) with symptomatic obstructive HCM (oHCM), were presented in a Late Breaking Clinical Trial Session and simultaneously published in the Journal of the American College of Cardiology: Heart Failure.2 As previously reported, the primary results of MAPLE-HCM demonstrated superiority of aficamten to metoprolol on pVO2 (change from baseline to Week 24, least squares mean (LSM) treatment difference (SE), +2.3 (0.39) mL/kg/min, paficamten or metoprolol on the primary endpoint and key secondary endpoints according to pre-trial medical therapy. At screening, 123 patients were taking a beta blocker while 52 patients were not taking a beta blocker. Of the 52 patients not taking a beta blocker at screening, 22 patients had received no standard of care therapy for at least 12 months before screening. Prior to randomization, all patients underwent a two-week washout period of standard of care therapy. Independent of pre-trial medical therapy, aficamten demonstrated a consistent treatment effect across multiple efficacy endpoints compared with metoprolol. Aficamten improved pVO2 compared with metoprolol for patients not previously taking beta blockers (LSM difference +3.1 mL/kg/min, p<0.001), as well as for patients previously taking beta blockers (LSM difference +1.9 mL/kg/min, p<0.001) with no difference between groups in the improvement (interaction p = 0.133). Similarly, compared to metoprolol, aficamten significantly improved key secondary endpoints independent of pre-trial treatment, including KCCQ-CSS and New York Heart Association (NYHA) Functional Class, Valsalva left ventricular outflow tract gradient (LVOT-G) and NT-proBNP. There were no differences in the safety profile of aficamten, including the rates of serious adverse events, between pre-trial treatment groups. About ACACIA-HCM ACACIA-HCM was a Phase 3, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of aficamten compared to placebo in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). The dual primary endpoint was the change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score and change in maximal exercise performance (peak VO2) from baseline to Week 36. Secondary endpoints included the proportion of participants with ≥1 class improvement in NYHA functional class, and changes in the composite z-score of two cardiopulmonary exercise testing (CPET) parameters of sub-maximal exercise performance (VE/VCO2 and pVO2), NT-proBNP, and left atrial volume index (LAVI) from baseline to Week 36. After 36 weeks of treatment, participants continued treatment with aficamten or placebo for up to 72 weeks to evaluate additional secondary and exploration analyses including the time to first cardiovascular event. The trial (outside Japan) concluded when at least 200 patients completed 52 weeks of treatment. ACACIA-HCM randomized and treated 517 participants (outside Japan) on a 1:1 basis with aficamten or placebo. Randomization was stratified by persistent atrial fibrillation and presence of intracavitary obstruction. At screening, participants enrolled in ACACIA-HCM were required to have resting left ventricular outflow tract gradient (LVOT-G) 2 ≤90% predicted, NT-proBNP ≥300 pg/mL or ≥900 pg/mL if atrial fibrillation or atrial flutter were present at screening, NYHA functional class II or III and KCCQ Clinical Summary Score ≤85. Each patient received up to four escalating doses of aficamten or placebo based on echocardiographic guidance. Participants who received aficamten began with 5 mg dosed once daily. At weeks 2, 4 and 6 participants received an echocardiogram to determine if they would be up-titrated to escalating doses of 10, 15 or 20 mg. Dose escalation occurred only if a participant had an LVEF ≥60%. Participants who did not meet escalation criteria continued the same dose or were down-titrated if their LVEF was <50%. About MAPLE-HCM MAPLE-HCM was a Phase 3, multi-center, randomized, double-blind active-comparator clinical trial of aficamten compared to metoprolol in patients with symptomatic obstructive HCM (oHCM). The primary endpoint was the change in peak oxygen uptake (pVO2) from baseline to Week 24 measured by cardiopulmonary exercise testing (CPET). Secondary endpoints include the change from baseline to Week 24 in Kansas City Cardiomyopathy Questionnaire (KCCQ) score, the proportion of patients with ≥1 class improvement in New York Heart Association (NYHA) functional class, and changes in left ventricular mass index (LVMI), left atrial volume index (LAVI), post-Valsalva left ventricular outflow tract gradient (LVOT-G) and NT-proBNP. MAPLE-HCM enrolled 175 patients, randomized on a 1:1 basis to receive aficamten or metoprolol as monotherapy in a double-blind, double dummy fashion. Randomization was stratified by CPET exercise modality (treadmill or bicycle) and recently diagnosed versus chronic obstructive HCM. At screening, patients enrolled in MAPLE-HCM had a resting LVOT-G ≥30 mmHg and/or post-Valsalva LVOT-G ≥50 mmHg in addition to left ventricular ejection fraction (LVEF) ≥ 60%, respiratory exchange ratio (RER) ≥ 1.05 and pVO2 aficamten or metoprolol based on echocardiographic guidance as well as a matching placebo for the alternate therapy. About MYQORZO® (aficamten) MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, European Union and United Kingdom for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and consequently, left ventricular outflow tract (LVOT) obstruction. MYQORZO was engineered to achieve a predictable exposure response, rapid onset of action and reversibility.3 Aficamten is also under clinical investigation in CEDAR-HCM in a pediatric population with oHCM. Safety and efficacy of aficamten have not been established in a pediatric patient population. In addition, aficamten is being studied in FOREST-HCM, an open-label extension clinical study. INDICATION MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS MYQORZO is contraindicated with concomitant use of rifampin. WARNINGS AND PRECAUTIONS Heart Failure MYQORZO reduces cardiac contractility, which can reduce LVEF and cause heart failure. Patients who experience a serious intercurrent illness (eg, serious infection) or arrhythmia (eg, new or uncontrolled atrial fibrillation) may be at greater risk of developing systolic dysfunction and heart failure. Assess patients’ clinical status and LVEF prior to and during treatment and adjust the MYQORZO dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide may be signs and symptoms of heart failure. Initiation of MYQORZO in patients with LVEF <55% is not recommended. MYQORZO REMS Program MYQORZO is available only through a restricted program called the MYQORZO REMS Program, because of the risk of heart failure due to systolic dysfunction. Notable requirements of the MYQORZO REMS Program include: Prescribers must be certified by enrolling in the MYQORZO REMS Program Patients must enroll in the MYQORZO REMS Program and comply with ongoing monitoring requirements Pharmacies must be certified by enrolling in the MYQORZO REMS Program and must only dispense to patients who are authorized to receive MYQORZO Wholesalers and distributors must only distribute to certified pharmacies Further information is available at www.MYQORZOREMS.com, or at 1-844-285-7367. Cytochrome P450 Interactions Leading to Heart Failure or Loss of Effectiveness MYQORZO is metabolized primarily by CYP2C9, and to a lesser extent by CYP3A, CYP2D6, and CYP2C19 enzymes. Initiation of medications that inhibit multiple P450 pathways of MYQORZO elimination (eg, fluconazole, voriconazole, or fluvoxamine) or strong CYP2C9 inhibitors, and discontinuation of moderate-to-strong CYP3A inducers may lead to increased blood concentrations of aficamten and increase the risk of heart failure due to systolic dysfunction. Conversely, initiation of medications that induce P450 pathways of MYQORZO (eg, rifampin, moderate-to-strong CYP3A inducers) may lead to decreased blood concentrations of aficamten and potential loss of effectiveness. Assess LVEF 2 to 8 weeks after initiation of such inhibitors or after discontinuation of such inducers and adjust the dose of MYQORZO accordingly. Advise patients of the potential for drug interactions. Advise patients to inform their healthcare provider of all concomitant medications prior to and during MYQORZO treatment. ADVERSE REACTIONS Hypertension (8% vs 2%) was the only adverse reaction occurring in >5% of patients and more commonly on MYQORZO than on placebo in the pivotal trial. INDICATIONS AND USAGE MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. Please see full Prescribing Information approved in the U.S., including Boxed WARNING. Please see full Summary of Product Characteristics approved in the European Union. About Hypertrophic Cardiomyopathy Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle becomes abnormally thick. HCM can be obstructive, when thickened muscle blocks blood flow, or non-obstructive, when blood flow is not blocked but heart function is still affected. In obstructive HCM, the thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller, stiffer and less able to relax and fill with blood. Ultimately, HCM limits the heart’s pumping function, leading to reduced exercise capacity and a variety of symptoms. HCM is the most common monogenic inherited cardiovascular disorder, affecting approximately 1 out of 350 individuals worldwide.4 Approximately half of patients with HCM have obstructive HCM (oHCM) and half have non-obstructive HCM (nHCM).5 People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease.6 People with HCM are at risk for potentially fatal ventricular arrhythmias and it is one of the leading causes of sudden cardiac death in younger people or athletes.7 A subset of patients with HCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure necessitating cardiac transplantation. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the approved in the U.S., China, European Union and United Kingdom for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to our ability to obtain regulatory approval for aficamten in nonobstructive hypertrophic cardiomyopathy in any jurisdiction by any particular date, if ever, the number of patients comprising the eligible treatment population for aficamten, or market acceptance of aficamten for the treatment of nonobstructive hypertrophic cardiomyopathy. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission. CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. MYQORZO® is a registered trademark of Cytokinetics in the U.S., the European Union and the United Kingdom. References Maron MS, et al. Global Efficacy of Aficamten in Nonobstructive Hypertrophic Cardiomyopathy: Results From ACACIA-HCM. Circ. 2026 Dominguez, F. Efficacy of Aficamten vs Metoprolol According to Pretrial Beta-Blocker Treatment in Obstructive Hypertrophic Cardiomyopathy. JACC: HF. 2026. Maron, MS, et al. Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. doi:10.1056/NEJMoa2401424 Tsenov et al. Healthcare access, symptom burden, and psychological impact in hypertrophic cardiomyopathy: a multinational patient-driven survey. Int J Cardiol Cardiovasc Risk Prev2025 Aug 4;27:200485. doi: 10.1016/j.ijcrp.2025.200485 Butzner M, et al. Epidemiology of Hypertrophic Cardiomyopathy in the United States From 2016 to 2023. JACC Adv. 2026. 2026;5(2):102552. doi:10.1016/j.jacadv.2025.102552 Gersh, B.J., Maron, B.J., Bonow, R.O., Dearani, J.A., Fifer, M.A., Link, M.S., et al. 2011 ACCF/AHA guidelines for the diagnosis and treatment of hypertrophic cardiomyopathy. A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Journal of the American College of Cardiology and Circulation, 58, e212-260. Hong Y, Su WW, Li X. Risk factors of sudden cardiac death in hypertrophic Contact:CytokineticsDiane WeiserSenior Vice President, Corporate Affairs(415) 290-7757

ACACIA-HCM is the First Phase 3 Clinical Trial to Successfully Demonstrate Statistically Significant Improvements Across Both Patient-Reported and Physician-Assessed Endpoints in Non-Obstructive HCM Supplemental New Drug Application to be Submitted to FDA in Fourth Quarter Company to Host Investor Event and Webcast Today at 2:00 PM Central European Summer Time (8:00 AM Eastern Time) SOUTH SAN FRANCISCO, Calif., Aug. 28, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the primary results from ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) were presented in a Hot Line Session at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany, and simultaneously published in The New England Journal of Medicine.1 ACACIA-HCM met both dual primary endpoints, demonstrating statistically significant improvements from baseline to Week 36 compared to placebo in both Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and maximal exercise performance (pVO2). Results for the dual primary endpoint analysis consistently favored aficamten across prespecified subgroups studied. Based on the positive results from ACACIA-HCM, Cytokinetics plans to submit a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for aficamten for the treatment of adult patients with symptomatic nHCM in the fourth quarter of 2026. “ACACIA-HCM is the first-ever positive clinical trial in non-obstructive HCM,” said Stephen Heitner, M.D., Cytokinetics’ Chief Medical Officer. “As shown in presentation and publication, the results from ACACIA-HCM are both statistically robust, consistent across prespecified subgroups and other secondary endpoints, and clinically impactful for these patients with non-obstructive HCM. As such, these data may potentially translate into a new treatment option for patients with HCM with no available medical treatments that directly address their underlying disease. If approved, we look forward to seeing aficamten become the first cardiac myosin inhibitor to treat the full spectrum of symptomatic HCM.” “We are grateful to the patient community and the clinical trial team who contributed to the successful completion of ACACIA-HCM, a fitting tribute to the patients and families who have struggled with this disease for many years and across generations. We are also pleased that most of the eligible patients from ACACIA-HCM are continuing treatment with aficamten in FOREST-HCM,” said Ahmad Masri, M.D., M.S., Director, Hypertrophic Cardiomyopathy Center and Cardiac Amyloidosis Program, Oregon Health & Science University and Principal Investigator of ACACIA-HCM. “We look forward to applying this study’s groundbreaking scientific knowledge into clinical practice upon potential approval, addressing this area of HCM where patients do not have adequate treatment options.” ACACIA-HCM: Efficacy The baseline characteristics of patients enrolled in ACACIA-HCM were well-matched between treatment groups and consistent with a symptomatic nHCM phenotype with substantial disease burden despite normal left ventricular ejection fraction (LVEF). There were two pre-specified primary endpoints, KCCQ-CSS and pVO₂, evaluated in parallel. For each endpoint, a p-value of 0.025 or less was considered statistically significant. Compared to placebo, treatment with aficamten demonstrated statistically significant improvements in both dual primary endpoints at 36 weeks (Table 1). Table 1: Dual Primary Endpoint Results Improvements in KCCQ-CSS relative to placebo were noted beyond titration and throughout the treatment period in participants treated with aficamten, such that patients remaining on treatment at 72 weeks demonstrated a least square mean (LSM) change from baseline in KCCQ-CSS of 7.0 points. Of note, following a washout of aficamten for four weeks, the KCCQ-CSS declined from the end of treatment for participants on aficamten to match that in the placebo group (Figure 1). Figure 1: Assessment of KCCQ-CSS The figure is based on the observed data, except that the inset box of Week 36 LSM difference and p-value are from the primary analysis imputed data. At Week 36, pVO2 increased for participants on aficamten while it remained unchanged for participants on placebo (Figure 2). Figure 2: Assessment of pVO2 The treatment effect of aficamten on both dual primary endpoints was consistent across all prespecified subgroups, including baseline LVEF, atrial fibrillation status, genotype, age, sex, whether patients were receiving background beta-blocker therapy and whether patients had intracavitary obstruction at baseline (Figure 3). Figure 3: Pre-Specified Subgroups for KCCQ-CSS and pVO2 Statistically significant improvements compared to placebo were observed in key ranked secondary endpoints, including New York Heart Association (NYHA) Functional Class, the composite z-score of two cardiopulmonary exercise testing (CPET) parameters (VE/VCO2 and pVO2), and NT-proBNP, a biomarker of cardiac wall stress. Statistical significance was not met on the endpoints of change from baseline in left atrial volume index or the time to first cardiovascular event for aficamten compared to placebo (Table 2). Table 2: Secondary Endpoints ACACIA-HCM: Safety Aficamten was generally well-tolerated in the study. Non-fatal adverse events that led to early study drug discontinuation occurred in 18 (7.0%) and 5 (1.9%) patients on aficamten and placebo, respectively. Serious adverse events occurred in 52 (20.2%) patients on aficamten compared to 38 (14.7%) patients on placebo. In the time to the first cardiovascular event endpoint, an event (cardiovascular death, heart transplantation or left ventricular assist device, aborted sudden cardiac death, non-fatal stroke, heart failure hospitalization, or cardiac arrhythmia [atrial fibrillation or ventricular tachyarrhythmia] requiring treatment or hospitalization) occurred in 22 (8.5%) patients in the aficamten arm and 20 (7.7%) in the placebo arm. LVEF aficamten and in two (0.8%) patients taking placebo. At baseline, patients who experienced LVEF aficamten, 21 completed treatment while receiving the same or lower doses. As previously reported, two participants on aficamten experienced a serious adverse event of heart failure associated with LVEF aficamten had serious adverse events of heart failure not associated with LVEF aficamten occurred during dose titration or prior to Week 12 and were generally responsive to a short course of diuretic therapy. ACACIA-HCM: Global Efficacy Analysis An additional analysis from ACACIA-HCM was also presented during the Hot Line presentation which evaluated the global efficacy of aficamten in patients with symptomatic nHCM. The analysis assessed clinical improvements across five key domains: exercise capacity, cardiac structure, cardiac biomarkers, diastolic function and symptom burden. At 36 weeks, treatment with aficamten demonstrated statistically significant improvements across all five efficacy metrics compared to placebo (paficamten demonstrating a clinical response in three or more outcome measures compared to only 13% of patients on placebo. These results help place the primary results into clinical context and underscore the opportunity to impact several aspects of disease burden by addressing the underlying pathobiology in patients living with symptomatic nHCM. The results from this sub-analysis were also published in Circulation.2 Investor Webcast Information Cytokinetics will host an in-person investor event in Munich, Germany on August 28, 2026, at 2:00 PM Central European Summer Time (8:00 AM Eastern Time). The event will also be simultaneously webcast live online. Interested parties must register to attend in-person or online at https://acacia-hcm-investor-event-esc-2026.open-exchange.net/welcome. Registered attendees may access the webcast by visiting the Investor & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay will be archived on the Cytokinetics website for six months. About ACACIA-HCM ACACIA-HCM was a Phase 3, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of aficamten compared to placebo in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). The dual primary endpoint was the change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score and change in maximal exercise performance (pVO2) from baseline to Week 36. Secondary endpoints included the proportion of participants with ≥1 class improvement in NYHA functional class, and changes in the composite z-score of two cardiopulmonary exercise testing (CPET) parameters of sub-maximal exercise performance (VE/VCO2 and pVO2), NT-proBNP, and left atrial volume index (LAVI) from baseline to Week 36. After 36 weeks of treatment, participants continued treatment with aficamten or placebo for up to 72 weeks to evaluate additional secondary and exploration analyses including the time to first cardiovascular event. The trial (outside Japan) concluded when at least 200 patients completed 52 weeks of treatment. ACACIA-HCM randomized and treated 517 participants (outside Japan) on a 1:1 basis with aficamten or placebo. Randomization was stratified by persistent atrial fibrillation and presence of intracavitary obstruction. At screening, participants enrolled in ACACIA-HCM were required to have resting left ventricular outflow tract gradient (LVOT-G) 2 ≤90% predicted, NT-proBNP ≥300 pg/mL or ≥900 pg/mL if atrial fibrillation or atrial flutter were present at screening, NYHA functional class II or III and KCCQ Clinical Summary Score ≤85. Each patient received up to four escalating doses of aficamten or placebo based on echocardiographic guidance. Participants who received aficamten began with 5 mg dosed once daily. At weeks 2, 4 and 6 participants received an echocardiogram to determine if they would be up-titrated to escalating doses of 10, 15 or 20 mg. Dose escalation occurred only if a participant had an LVEF ≥60%. Participants who did not meet escalation criteria continued the same dose or were down-titrated if their LVEF was <50%. About MYQORZO® (aficamten) MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, European Union and United Kingdom for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and consequently, left ventricular outflow tract (LVOT) obstruction. MYQORZO was engineered to achieve a predictable exposure response, rapid onset of action and reversibility.3 Aficamten is also under clinical investigation in CEDAR-HCM in a pediatric population with oHCM. Safety and efficacy of aficamten have not been established in a pediatric patient population. In addition, aficamten is being studied in FOREST-HCM, an open-label extension clinical study. INDICATION MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS MYQORZO is contraindicated with concomitant use of rifampin. WARNINGS AND PRECAUTIONS Heart Failure MYQORZO reduces cardiac contractility, which can reduce LVEF and cause heart failure. Patients who experience a serious intercurrent illness (eg, serious infection) or arrhythmia (eg, new or uncontrolled atrial fibrillation) may be at greater risk of developing systolic dysfunction and heart failure. Assess patients’ clinical status and LVEF prior to and during treatment and adjust the MYQORZO dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide may be signs and symptoms of heart failure. Initiation of MYQORZO in patients with LVEF <55% is not recommended. MYQORZO REMS Program MYQORZO is available only through a restricted program called the MYQORZO REMS Program, because of the risk of heart failure due to systolic dysfunction. Notable requirements of the MYQORZO REMS Program include: Prescribers must be certified by enrolling in the MYQORZO REMS Program Patients must enroll in the MYQORZO REMS Program and comply with ongoing monitoring requirements Pharmacies must be certified by enrolling in the MYQORZO REMS Program and must only dispense to patients who are authorized to receive MYQORZO Wholesalers and distributors must only distribute to certified pharmacies Further information is available at www.MYQORZOREMS.com, or at 1-844-285-7367. Cytochrome P450 Interactions Leading to Heart Failure or Loss of Effectiveness MYQORZO is metabolized primarily by CYP2C9, and to a lesser extent by CYP3A, CYP2D6, and CYP2C19 enzymes. Initiation of medications that inhibit multiple P450 pathways of MYQORZO elimination (eg, fluconazole, voriconazole, or fluvoxamine) or strong CYP2C9 inhibitors, and discontinuation of moderate-to-strong CYP3A inducers may lead to increased blood concentrations of aficamten and increase the risk of heart failure due to systolic dysfunction. Conversely, initiation of medications that induce P450 pathways of MYQORZO (eg, rifampin, moderate-to-strong CYP3A inducers) may lead to decreased blood concentrations of aficamten and potential loss of effectiveness. Assess LVEF 2 to 8 weeks after initiation of such inhibitors or after discontinuation of such inducers and adjust the dose of MYQORZO accordingly. Advise patients of the potential for drug interactions. Advise patients to inform their healthcare provider of all concomitant medications prior to and during MYQORZO treatment. ADVERSE REACTIONS Hypertension (8% vs 2%) was the only adverse reaction occurring in >5% of patients and more commonly on MYQORZO than on placebo in the pivotal trial. INDICATIONS AND USAGE MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. Please see full Prescribing Information approved in the U.S., including Boxed WARNING. Please see full Summary of Product Characteristics approved in the European Union. About Hypertrophic Cardiomyopathy Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle becomes abnormally thick. HCM can be obstructive, when thickened muscle blocks blood flow, or non-obstructive, when blood flow is not blocked but heart function is still affected. In obstructive HCM, the thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller, stiffer and less able to relax and fill with blood. Ultimately, HCM limits the heart’s pumping function, leading to reduced exercise capacity and a variety of symptoms. HCM is the most common monogenic inherited cardiovascular disorder, affecting approximately 1 out of 350 individuals worldwide.4 Approximately half of patients with HCM have obstructive HCM (oHCM) and half have non-obstructive HCM (nHCM).5 People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease.6 People with HCM are at risk for potentially fatal ventricular arrhythmias and it is one of the leading causes of sudden cardiac death in younger people or athletes.7 A subset of patients with HCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure necessitating cardiac transplantation. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the approved in the U.S., China, European Union and United Kingdom for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to our ability to obtain regulatory approval for aficamten in nonobstructive hypertrophic cardiomyopathy in any jurisdiction by any particular date, if ever, the number of patients comprising the eligible treatment population for aficamten, or market acceptance of aficamten for the treatment of nonobstructive hypertrophic cardiomyopathy. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission. CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. MYQORZO® is a registered trademark of Cytokinetics in the U.S., the European Union and the United Kingdom. References Masri A, et al. Aficamten for symptomatic nonobstructive hypertrophic cardiomyopathy. N Engl J Med. 2026 Maron MS, et al. Global Efficacy of Aficamten in Nonobstructive Hypertrophic Cardiomyopathy: Results From ACACIA-HCM. Circ. 2026 Maron, MS, et al. Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. doi:10.1056/NEJMoa2401424. Tsenov et al. Healthcare access, symptom burden, and psychological impact in hypertrophic cardiomyopathy: a multinational patient-driven survey. Int J Cardiol Cardiovasc Risk Prev2025 Aug 4;27:200485. doi:10.1016/j.ijcrp.2025.200485. Butzner M, et al. Epidemiology of Hypertrophic Cardiomyopathy in the United States From 2016 to 2023. JACC Adv. 2026. 2026;5(2):102552. doi:10.1016/j.jacadv.2025.102552. Gersh, B.J., Maron, B.J., Bonow, R.O., Dearani, J.A., Fifer, M.A., Link, M.S., et al. 2011 ACCF/AHA guidelines for the diagnosis and treatment of hypertrophic cardiomyopathy. A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Journal of the American College of Cardiology and Circulation, 58, e212-260. Hong Y, Su WW, Li X. Risk factors of sudden cardiac death in hypertrophic. Contact:CytokineticsDiane WeiserSenior Vice President, Corporate Affairs(415) 290-7757 Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/edb218c1-c4c3-4406-b131-923f67e43616 https://www.globenewswire.com/NewsRoom/AttachmentNg/4f024223-05f7-4f5f-8a0c-8e9fb68b71e9 https://www.globenewswire.com/NewsRoom/AttachmentNg/689723c6-7261-49a1-bc36-3758840580b3

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET Senior Vice President of Corporate Affairs - Diane Weiser President and Chief Executive Officer - Robert I. Blum Executive Vice President and Chief Commercial Officer - Andrew Callos Executive Vice President of Research & Development - Fady Malik Senior Vice President and Chief Medical Officer - Stephen Heitner Executive Vice President and Chief Financial Officer - Sung Lee Senior Vice President of Clinical Development - Stuart Kupfer Operator: Thank you for standing by, and welcome to the Cytokinetics Q2 2026 Earnings Conference Call. This call is being recorded. [Operator Instructions] I would now like to turn the call over to Diane Weiser, Cytokinetics Senior Vice President of Corporate Affairs. Diane, please go ahead. Diane Weiser: Good afternoon, and thanks for joining us on the call today. The slides accompanying today's webcast can be found on the Investors & Media section of our website at cytokinetics.com, along with today's press release. Robert Blum, President and Chief Executive Officer, will begin with an overview of the quarter and recent developments. Andrew Callos, EVP and Chief Commercial Officer, will discuss the commercial launch of MYQORZO in the U.S. and Europe. Fady Malik, EVP of R&D, will provide updates related to aficamten. Steve Heitner, SVP and Chief Medical Officer, will provide updates related to our ongoing clinical development programs. Sung Lee, EVP and Chief Financial Officer, will provide a financial overview for the quarter. And finally, Robert will make closing remarks and review key milestones for the year ahead. As you can see on this slide, today's discussion will include forward-looking statements, which are subject to risks and uncertainties. Please refer to our SEC filings for a discussion of these factors. And now I will turn the call over to Robert. Robert I. Blum: Thank you, Diane, and thanks to all for joining us on the call today. The second quarter was another solid period of execution for Cytokinetics, marked by strong commercial momentum for MYQORZO in the United States, our first European launch in Germany, progress towards additional market access globally, potential regulatory milestones internationally and continued advancement of our later-stage specialty cardiology pipeline. Just 5 months into the commercial launch of MYQORZO, we are demonstrating increased velocity that's exceeding expectations. As Andrew will discuss, growth in prescribing and dispensing for MYQORZO reflects increasing awareness and physician engagement, expanding patient access and adoption across multiple segments of the targeted prescriber base, all of which reinforce confidence in MYQORZO and its clinical, therapeutic and commercial opportunities. During the quarter, we also executed well on our global commercialization strategy with the launch of MYQORZO in Germany, the first in a series of European launches expected over the next 6 to 12 months. This is a key milestone for Cytokinetics and for patients in Europe, and it serves as the foundation upon which we will build broader access across Europe and beyond over the coming years. To that end, more recently, the MHRA granted MYQORZO Marketing Authorization across the United Kingdom for the treatment of symptomatic oHCM in adult patients. And at the same time, NICE issued guidance recommending MYQORZO for use in England and Wales. We're pleased that the concurrent regulatory approval and reimbursement recommendation will help MYQORZO reach patients sooner. We expect drug supply and full launch in the U.K. later this year. During the second quarter, we highlighted the opportunity for aficamten to potentially treat the full spectrum of HCM as we shared the top line results from ACACIA-HCM in patients with nonobstructive HCM showed that the Phase III trial met both of its dual primary end points, demonstrating statistically significant improvements from baseline to week 36 in both KCCQ Clinical Summary Score and Peak VO2 compared to placebo. These results represent an important scientific achievement for an nHCM patient population with no currently approved therapies and they define a meaningful step toward expanding the potential reach of aficamten beyond oHCM, subject, of course, to regulatory review and subsequent potential approval. Following our announcement of the top line results from ACACIA-HCM, we met with the FDA to discuss our next steps. We reviewed the clinical trial results together, and we posed questions to which the FDA responded. Those discussions and the FDA feedback now inform our plan to submit a supplemental NDA for aficamten in nHCM in the fourth quarter of this year. We also plan to meet with EU regulators to hold similar discussions in support of future potential regulatory submissions in Europe. In the meantime, we look forward to presenting the full results from ACACIA-HCM in a hotline session at the European Society of Cardiology Congress to occur later this month. Alongside progress towards making MYQORZO available to more patients with oHCM in the United States and internationally, we're prioritizing potential regulatory approvals for aficamten in patients with nHCM and that could lead to MYQORZO being the only approved therapy for patients across the wider spectrum of HCM. Moreover, in the second quarter, as you'll hear, we continue to advance our later-stage specialty cardiology pipeline with further progress evidenced in important clinical trials for novel drug candidates that have emerged from our pioneering leadership in innovative muscle biology and pharmacology. And we fortified our balance sheet with a successful financing that supports our plans and objectives. Taken all together, the progress we made in the second quarter underscores that Cytokinetics is executing well on a global commercial stage and integrated biopharmaceutical company. We're building commercial growth and velocity, expanding global scale and access, proceeding towards expanded product labeling and advancing pipeline. All with focus and discipline to capital access and allocation. I look forward to sharing more about that now from our colleagues. And with that, I'll turn the call over to Andrew. Andrew Callos: Thank you, Robert. In the second quarter, the launch of MYQORZO continued to exhibit strong growth. While still early, we are encouraged by the steady progress we're seeing across physician awareness, prescribing activity, patient demand and market access. We believe these early indicators are beginning to demonstrate that the differentiated profile of MYQORZO is resonating well with both health care providers, payers and most importantly, also with patients. Since our commercial launch at the end of January, MYQORZO has accelerated quarter-over-quarter growth in new-to-brand prescriptions within the CMI category, by 24% in Q1 and 15% in Q2 compared to the single-digit growth rate observed when only a single CMI was available. The introduction of MYQORZO is helping drive increased breadth and depth of new patient starts as well as greater engagement and awareness among a broad range of physicians and prescribers within the category. In fact, in our most recent market research survey, which was conducted during the second quarter, unaided awareness among HCPs increased to 68% compared to 52% in the first quarter. We're also seeing encouraging engagement among patients. Our patient marketing campaign has driven early and increased awareness, resulting in over 30% awareness among oHCM patients in the United States. In addition, we have generated more than 390 million impressions and 2.1 million social media clicks through our focused and directed digital media campaigns across a broad range of channels and platforms. We're also pleased to see continuing perception of clinical differentiation favoring MYQORZO among HCPs. In our most recent physician survey conducted in May, HCPs are continuing to favor the clinical profile of MYQORZO. Treating physicians that we surveyed also view MYQORZO favorably across several attributes, including the convenience of dosing flexibility, safety and tolerability and the flexibility associated with differentiated REMS requirements. In this stage of our commercial launch, our emphasis remains on deepening prescribing among high-volume CMI prescribers. Historically, these physicians have generated approximately 80% of CMI prescriptions. While our call universe spans more than 10,000 health care providers we are prioritizing engagement with high-volume prescribers. And at the end of the second quarter, our sales team had reached more than 90% of these HCPs. We plan to maintain that same priority emphasis to high-volume prescribers until we achieve greater than 50% new-to-brand prescription share, which we believe could occur by the end of this year, if not sooner. At the same time, we're encouraged by the degree to which adoption is already broadening beyond the historically high-volume CMI writers. In fact, by the end of the second quarter, more than 50% of MYQORZO prescribers were either low-volume CMI prescribers or first-time CMI writers. Our field force reached more than half of these physicians during the second quarter. We see prescribing from this cohort as an important signal that MYQORZO is gaining traction across a wider segment in the oHCM treating community something we anticipated based on the differentiated profile of MYQORZO and it is validating to see that in actual prescribing. Importantly, our field-based teams are also bringing the data from MAPLE-HCM to the attention of the oHCM treating community. These important data from our second Phase III trial of aficamten both support findings from SEQUOIA-HCM and further demonstrate that MYQORZO is superior to beta-blocker metoprolol, an important point of differentiation that resonates with physicians to further reinforce the safety, efficacy and utility of MYQORZO in patients with oHCM. As we committed at launch, we continue to evaluate performance using 3 key metrics: breadth of prescribing measured by the number of HCPs who have written prescriptions, depth of prescribing measured by the number of patients to which each HCP prescribed MYQORZO, and patient volume, which reflects a total number of unique patients prescribed MYQORZO. Across all 3 metrics, we are encouraged by the progress and rate of growth achieved during the quarter. By the end of the quarter, more than 700 unique health care providers in the U.S. have prescribed MYQORZO including approximately 300 physicians from the high-volume CMI writer segment. On average, HCPs prescribed MYQORZO to approximately 3 of their patients, the figure is even higher among the subset of high-volume CMI writers who have now already prescribed MYQORZO to approximately 5 of their patients on average. Although limitations with syndicated data make it difficult to precisely calculate new-to-brand Q2 exit share in the CMI category, our internal analysis suggests that the exit share for MYQORZO has increased to greater than 40% in the second quarter. We also continue to see encouraging leading indicators of future demand, including more than 25 health care -- 2,500 health care providers who have now completed REMS certification since launch. Turning to patient demand. In the first quarter, we reported approximately 680 MYQORZO prescriptions, of which 400 were dispensed to patients by end of Q1. By the end of the second quarter, MYQORZO was dispensed to 1,500 patients, approximately nearly tripling the number of new patients dispensed MYQORZO in the quarter. The majority of prescriptions continue to be dispensed within approximately 3 weeks, once all patient documentation and benefits investigation is complete. Going forward, we plan to report on patient dispense versus prescriptions to better align with product revenue. In Q2, over 80% of the dispensed prescriptions were paid for with the remainder associated with either free trial, bridge or other patient assistance programs. These too are encouraging indicators of commercial launch growth and velocity. From an access perspective, we maintain our aspiration of broad coverage across key payer channels. We ended the quarter with nearly 90% parity coverage for Medicare lives. We also continue to broaden our commercial wide coverage achieving over 50% commercial coverage by quarter end and remain on track to achieve parity access by the end of 2026. Outside the United States, we successfully launched MYQORZO in Germany in June to support expanding access throughout Europe, we have also submitted 10 HTA dossiers across Europe reimbursement approval received effective August 1 in the Netherlands. And in England and Wales, NICE published guidance recommending MYQORZO for use as we continue to make progress broadening the pathway to further patient access, in key markets with additional markets anticipated to launch later this year during the first half of 2027. We are very encouraged by the performance we have seen in our launch markets. The launch velocity we are seeing reflects the differentiated profile of MYQORZO, but also the dedication and execution of our colleagues across the U.S. and Europe who are delivering excellence with both integrity and focus. And with that, I'll turn the call over to Fady. Fady Malik: Thanks, Andrew. The second quarter was an important period for our HCM portfolio, most notably with our announcement of positive top line results from ACACIA-HCM, our pivotal Phase III clinical trial in patients with symptomatic nHCM. As we shared by top line press release in May, ACACIA-HCM met both dual primary end points, demonstrating statistically significant improvements from baseline to week 36 in both KCCQ Clinical Summary Score and Peak VO2 compared to placebo. In addition, statistically significant improvements compared to placebo were observed across key secondary endpoints, and no new safety signals were identified. We believe these findings are particularly meaningful because they demonstrate the potential of aficamten in nHCM, which represents as much as 1/2 or more of the overall HCM population and for which there are no currently approved therapies. For many years, treatment options for patients with nHCM have been limited despite the significant burden associated with the disease. We believe the results from ACACIA-HCM represent an important step towards potentially changing that treatment paradigm. Later this month, we look forward to presenting the primary results from ACACIA-HCM during a hotline session at the European Society of Cardiology Congress. Alongside the presentation of the primary results, which will provide a more comprehensive and detailed look at the results for both primary endpoints, secondary endpoints and of course, safety. We'll also be presenting additional analysis regarding the effect of aficamten on cardiac structure and function in a separate late-breaker session to help further inform treatment effect of aficamten in this population. At ESC, we also plan to hold an event both in person and online for investors and analysts to hear their perspectives and insights on the results from prominent HCM KOLs. As Robert mentioned, after we shared the top line results publicly, we then met with FDA to discuss the results of ACACIA-HCM, and next steps for aficamten, which informed our plan to submit a supplemental NDA, expected during the fourth quarter of this year. While we prepare for that filing, we also expect to engage with European regulatory authorities in a similar fashion regarding a potential submission to the European Medicines Agency. There is still much work ahead, but the positive top line results and our regulatory interactions to date reinforce our continued confidence in opportunities for aficamten in nHCM. In oHCM we continue to support review activities and engage constructively with FDA regarding the sNDA based on MAPLE-HCM that's currently under review with a PDUFA date of November 14, 2026. We continue to believe that the results from MAPLE-HCM have the potential to meaningfully inform treatment guidelines and clinical practice by providing evidence supporting the use of aficamten as an earlier treatment option in appropriate patients. In the meantime, given that the efficacy and safety profile of aficamten observed in MAPLE-HCM are consistent with our labeling, our field medical team have been sharing these results with potential prescribers. In addition, our field medical team continued to support the launch of MYQORZO. They completed more than 800 scientific exchanges with U.S.-based HCPs across a variety of topics, including questions related to the USPI and our public announcement of the results from ACACIA-HCM. Our medical science liaisons also supported our cardiovascular account specialists or CAS with introductory HCP meetings. During the quarter, our medical colleagues were pleased to support the initiation of our first ever investigator-initiated research study utilizing aficamten. Studies investigating the feasibility, safety and efficacy of physician seamlessly transitioning patients from mavacamten to aficamten in patients with oHCM. Taken together, the progress made this quarter reinforces our conviction in the potential role of aficamten to address the full spectrum of HCM. With MYQORZO now available for patients and -- I mean, for adults with symptomatic oHCM and the positive results from ACACIA-HCM supporting a potential expansion into nHCM, we continue to see a substantial opportunity to bring this medicine to a broader population of patients in the United States and also around the world. Next, I'm pleased to hand it over to Steve Heitner, but before I do, I'd like to formally announce that Steve has been promoted to Chief Medical Officer. Steve, who joined Cytokinetics in March 2020, will continue to lead clinical research with responsibility for conception, conduct and execution of our clinical trial as well as contributing to the expansion of our pipeline and evolution of our clinical research infrastructure as we move into a new age of artificial intelligence aided R&D. Served by his experience in treating patients with HCM and deep expertise in this disease, Steve has been an exemplary leader in helping to bring aficamten to patients. His insights and guidance contributed immeasurably to the approvals of MYQORZO in the U.S., EU and China. He's also played major roles in the innovative study designs and quality of conduct of ACACIA-HCM for aficamten, AMBER-HFpEF for ulacamten and COMET-HF for omecamtiv mecarbil. This transition represents a passing of a baton from Stuart Kupfer, who had served as Chief Medical Officer at Cytokinetics since 2020 and who contributed enormously to many of our successes in recent years through his seasoned leadership and expert oversight of clinical research, clinical pharmacology and drug safety. We're pleased that Stuart will remain at Cytokinetics as Senior Vice President of Clinical Development; contributing to our clinical programs and external innovation with a special focus on pharmacovigilance. And with that, I'll hand it over to Steve. Stephen Heitner: Thank you, Fady. The first, starting with our ongoing programs for aficamten, we continue to advance studies supporting broader availability worldwide. During the third quarter, we expect to complete the conduct of the Japan cohort of ACACIA-HCM and for our partner, Bayer, to complete the conduct of CAMELLIA-HCM evaluating the treatment of obstructive HCM patients in Japan. We also advanced CEDAR-HCM, a study evaluating aficamten in pediatric patients with obstructive HCM. In fact, during the quarter, we completed enrollment in the adolescent cohort ahead of prior expectations. In addition to the progress for aficamten, we continue to advance the remainder of our cardiovascular pipeline during the second quarter. Starting with omecamtiv mecarbil, the continued conduct of COMET-HF, our confirmatory Phase III clinical trial in patients with heart failure and severely reduced ejection fraction. We've now enrolled just over 1/3 of patients across North America, Europe and China. With the additional sites from China this past quarter, more than 90% of planned sites are now activated. We are encouraged that the baseline characteristics of patients with heart failure and their severity are tracking very closely with those in the subgroup of heart failure patients from GALACTIC heart failure with severely reduced ejection fraction in whom the treatment effect appeared most concentrated and whom informed the design of this trial. We expect to continue enrollment through 2026. For ulacamten, we continue to enroll Cohort 1 of AMBER-HFpEF, our Phase II study in patients with heart failure with preserved ejection fraction towards our expected completion of enrollment in the second half of this year. We remain focused on continuing trial conduct and generating data to help define the potential role of cardiac myosin inhibition in heart failure with preserved ejection fraction. Overall, we are pleased with the continued progress across our later-stage specialty cardiology development portfolio and look forward to important milestones over the coming quarters. With that, I'll hand over to Sung. Sung Lee: Thanks, Steve. Beginning with revenue. Total revenues for the second quarter were $28.6 million compared to $66.8 million for the same period in 2025. Net product revenues of MYQORZO reached $25.3 million, serving as the foundational driver of our top line moving forward. Of this amount, U.S. net product revenues were $23 million powered by robust demand and more than 80% of patients on paid prescriptions. Europe contributed $2.3 million in net product revenues, reflecting initial inventory purchased by distributors in Germany. Other components that contributed to total revenues in the second quarter include $3.3 million in collaboration revenue compared to $2.4 million for the same period in 2025. No licensing or milestone revenues were recorded in the second quarter of 2026 compared to $64.4 million in the second quarter of 2025, which benefited from the achievement of milestones from our collaboration agreement for aficamten in Japan with Bayer. Turning to operating expenses. R&D expenses for the second quarter were $97.8 million compared to $110.1 million for the same period in 2025. The decrease was primarily due to higher clinical trial activity, supply chain costs and medical affairs activities in 2025, partially offset by higher personnel-related costs in 2026. SG&A expenses for the second quarter were $104.4 million compared to $65.7 million for the same period in 2025. The increase was primarily due to commercial launch costs for MYQORZO, the U.S. sales force and higher nonsales personnel-related costs, including stock-based compensation. Cost of goods sold for the second quarter of 2026 was $2.7 million driven almost entirely by a nonroutine charge related to drug supply optimization. Collaboration cost of revenues for the second quarter of 2026 was $2.9 million compared to $2.4 million for the same period in 2025, reflecting primarily partner cost reimbursement. Net loss for the second quarter of 2026 was $198.8 million or $1.50 per share compared to a net loss of $134.4 million or $1.12 per share for the same period in 2025. Turning to the balance sheet. We ended the second quarter with approximately $1.7 billion in cash and investments compared to $1.1 billion at the end of the first quarter of 2026. The increase in cash and investments in the second quarter was primarily driven by our May public offering generating approximately $760 million in net proceeds. Turning to financial guidance. We are updating full year 2026 GAAP combined R&D and SG&A expense to a range of $860 million to $890 million from the previous range of $830 million to $870 million. Stock-based compensation included in the GAAP combined R&D and SG&A expense is being adjusted to a range of $130 million to $140 million, up from the previous range of $120 million to $130 million. Excluding stock-based compensation from the updated GAAP combined R&D and SG&A expense, results in a range of $720 million to $760 million. This increase in guidance is primarily driven by commercial readiness investments prompted by the positive results from ACACIA-HCM to support the potential 2027 launch of MYQORZO in nHCM. With that, I'll hand it back to Robert. Robert I. Blum: Thank you, Sung. As we reflect on the first half of 2026, I believe the progress that we've made demonstrates the strength of our execution and our strategic positioning as a maturing global growth enterprise. In less than 6 months of our commercial launch, we've seen encouraging demand for MYQORZO, growing physician adoption and expanding patient access, the breadth of prescribing increasing depth of use amongst physicians and growth in patient volume all provide evidence that our launch is gaining momentum. We also executed a successful launch in our first European market. And while we're early in our commercial journey, the trajectory we're seeing reinforces our belief that MYQORZO has the potential to become the CMI of choice in oHCM. Our near-term priorities for aficamten are clear. In oHCM firstly, executing successful global launches for MYQORZO and pursuing additional approvals across Europe. In nHCM, presenting the primary results from ACACIA-HCM at ESC and preparing and submitting an sNDA to FDA later this year as well as planning for the commercialization in nHCM. Beyond Europe, regulatory reviews for aficamten also remain active in multiple geographies, including Canada, Hong Kong and Taiwan. In parallel, we continue to evaluate opportunities to broaden global access through potential partners in additional regions outside of North America, Europe and Asia where we believe MYQORZO may address meaningful unmet need. Building our specialty cardiology franchise also relies on the promise of both omecamtiv mecarbil and ulacamten, which we're pleased are progressing well in respective later-stage trials. As we look ahead, I believe our strategic positioning has never been stronger. We're entering this next phase of growth with a strong balance sheet that provides financial flexibility to support the global commercialization of MYQORZO and continuing investing across our pipeline to pursue opportunities that can enhance longer-term shareholder value. Together with our growing commercial presence, expanding clinical evidence base, and advancing pipeline, we believe we're well positioned to create meaningful value for patients and shareholders in the years ahead. Now I'll recap our 2026 milestones. For aficamten, we expect to submit a supplemental NDA in nHCM in Q4 later this year. And we potentially will receive FDA approval of the sNDA for MAPLE-HCM and also in Q4 later this year. We expect to prepare to launch aficamten in the U.K. later in Q4, continued conduct of the adolescent cohort of CEDAR-HCM throughout the year and potentially receive approval from Health Canada in the second half of 2026. For omecamtiv mecarbil, we expect to continue patient enrollment and the conduct of COMET-HF through this year. For ulacamten, we expect to complete patient enrollment in Cohort 1 of AMBER-HFpEF in the second half of this year. And for CK-089, we expect to continue the second Phase I study -- and finally, for preclinical development and ongoing research, we expect to continue those activities directed to additional muscle biology-focused programs. And operator, with that, we can now open up the call to questions, please. Operator: [Operator Instructions] Your first question comes from the line of Salim Syed with Mizuho. Salim Syed: Congrats on the great number. Robert, Andrew, maybe just one from us on the dispensed versus prescribed. We're certainly getting a lot of e-mails just on the clarification here. Could you -- just so we have the apples-to-apples on the Rx. So I think you said it was 400 dispensed versus the 680 in the 1Q and then 1,500 dispensed this quarter. What's the Rx this quarter, if you could provide that? And is the ratio of 59% consistent between the 2 quarters if you don't want to get too granular? Robert I. Blum: Yes. I'll turn that over to Andrew to address. But obviously, it's the dispensing that drives the revenue. So we thought it important to align to that number. But Andrew, could you address the specific prescriptions and dispensing in Q2? Andrew Callos: Yes. Thanks for the question, Salim. Happy to clarify. So you're right, 680 to 400 in Q1 to around 2,000 to 1,500 in Q2, launched to date overall. That difference of pending patients. We described patients in the process. Once a prescription is sent in, I mean, that's really the underlying demand and there has not been a change. Actually, there's a growth in underlying demand as you saw from the market share for new-to-brand that we reported. But there is a process, a REMS enrollment has to occur, a prescription has to occur, signatures, both on physician and patient side, benefit investigation, oftentimes prior auths. So there's a process that takes several weeks. We're getting about 100-plus prescriptions per week. So the majority of the difference is that pending patient in process of getting a prescription filled and dispensed. There is a small mid-single-digit prescriptions that do get canceled, but the vast majority are in process and will wind up as a dispense. Hopefully, that answers your question. Salim Syed: Okay. So about 2,000, Andrew Callos: Yes, you got it. Operator: Our next question comes from the line of Roanna Ruiz with Leerink Partners. Roanna Clarissa Ruiz: So I was curious regarding the different metrics that you're tracking for MYQORZO's U.S. launch, just a big picture. Are there any that seem to be accelerating more than others into the quarter? And could you comment on the -- what you can see in terms of number of switches versus new patient starts? Is that proportion holding from last quarter? Or are you seeing some changes there? Robert I. Blum: Sure. So maybe I'll turn that also to Andrew, please? Andrew Callos: Sure. Thanks for the question. So we are seeing a couple of changes. One, the higher percentage of paid for prescriptions, which is encouraging. Around the same in terms of how long it's taking that prescription paid. We're seeing acceleration in that low volume to first-time member CMI prescribers from a switching point of view and both of those certainly speak to breadth of prescribing. Switching, we reported very kind of low single digit. We are actually seeing probably in the 5% to 7% of our overall dispenses are from switching. The switching has increased slightly, but not dramatically and not a major driver. Operator: Our next question comes from the line of Carter Gould with Cantor Fitzgerald. Carter Gould: Doing a bunch of math on the fly here, but it would seem to suggest that the overall class sort of adds per month or per week are only sort of up modestly and what you're seeing so far is primarily share capture versus growing the pie. Is that sort of a fair characterization? And separately, I guess, a clarification question. Was there any impact from stocking in that $23 million figure? Robert I. Blum: So Andrew, again, I'll turn to you, please. Andrew Callos: Sure. So we are actually seeing an increase in growth. I showed you the new-to-brand prescription growth overall. I think last year, we were seeing at least in syndicated data about 2,000 new prescriptions per quarter. I think in the first quarter, the number was probably around 2,500. In the second quarter, it's starting to approach 3,000. So you're seeing a growth in terms of new patients entering the market. And there really hasn't been a change in kind of compliance and persistency overall. So you're seeing an increase in patients dispensed. And I'll send the question over to Sung around stocking relative to revenue. Sung Lee: Yes. So thanks, Carter. So as demand increases, our distributors would carry higher inventory, but that inventory is commensurate with the demand. So this quarter was demand led. Operator: Our next question comes from the line of Ash Verma with UBS. Ashwani Verma: So yes, I have kind of like a similar question just a prescription with the dispense. So I know when you provided the first quarter update, you mentioned about the April prescription. And if I take that 420 number and apply this 60%, I get to 250 dispensed during April, versus like when you did it for the full quarter is like 1,500. So 1 month had 250. And then for the full quarter, you have 1500, as you're thinking about like month-over-month, are you seeing more of a growth acceleration at this point? And anything that you can share about how July is shaped out to be? Robert I. Blum: So we will resist the temptation to talk about July, but Andrew, could you speak to the second quarter? Andrew Callos: Sure. So you can see from the ratios, we are -- we do see an increase in dispense. I would expect dispenses to level out once managed care and access level out, oftentimes, that time frame of a pending patient. The REMS certainly adds to it because of certifications needed, but pending patient often stays impending longer because of the benefits investigation and a prior auth process. So we would look to shrink that time frame down over time, but I would not anticipate that in the near term. Operator: Our next question comes from the line of Tessa Romero with JPMorgan. Tessa Romero: So taking a step back, as you think about ESC here coming up in a few weeks, what do you believe will be better understood by physicians and investors on the other side of the conference? And then secondly, just to double click here, you talked about reaching 50% new-to-brand share by end of the year, if not sooner, for MYQORZO. With that in mind, where do you sit now? Robert I. Blum: So let's take the first part of your question regarding ESC, what might be elaborated from -- with regard to what has already been disclosed in our top line press release. Firstly, we've been very clear that we believe that when we actually present the fuller data that investors will better understand what we've meant by words like consistent and robust. As we now can speak to magnitudes of change across all endpoints, including secondary endpoints and how we believe that tells a very consistent robust story of efficacy measured by those various endpoints. Maybe I'll ask Fady and Steve, if they want to speak more to that before we address your second question, which relates to a proportion of new scripts. Stephen Heitner: So we have both the top line data, which kind of goes through the endpoints delineated in the SAP. But those are going to be put into both clinical and mechanistic context. So the clinical context will be deliberated by Dr. Masri in his presentation on Friday. And then on the Saturday, you'll see that there is the echo analysis that's being done by Dr. Hegde where we'll be talking about what the mechanism by which these clinical benefits are being enjoyed by patients. And I think that, that's going to be very elucidating to scientists and patients hopefully moving forward. Robert I. Blum: So I do think that as these data will be fully presented, we'll be able to speak much more completely about the effects, how they were observed across time, as well as ultimately across endpoints that measure both function and quality of life. With regard to your second question, let's turn to Andrew. I think he may have already addressed it in part by speaking to over 40% proportion of new scripts coming out of second quarter, but maybe Andrew, if there's anything more you want to elaborate? Andrew Callos: Yes. I mean that's the number we're reporting at the end of Q2 as an exit share, meaning our share in the month of June was over 40% new to brand share. So we're not going to report July. We'll report the third quarter during that call. Robert I. Blum: Tessa to the point, if not sooner, the trends are demonstrating that we are seeing a higher proportion of new scripts to MYQORZO than might have been expected. And when we talk about exceeding expectations, we are coming out of the gate very strongly with respect to new scripts, knowing that some of that could be a transient effect. I think we're going to be still conservative with respect to timing on when we might expect majority share. But certainly, it's moving very swiftly in that direction. Operator: Our next question comes from the line of Akash Tewari with Jefferies. Unknown Analyst: This is [Manoj] on for Akash. Just one from our end. Are you hearing any feedback from the prescribers who switched from Camzyos, especially like the efficacy with the lower doses? And approximately what percentage of your new patients that are outside the treatment of the center of excellence. Robert I. Blum: So if I understood your question correctly, are we hearing anything with respect to mavacamten as it relates to lower uses and prescription... Unknown Analyst: Yes, the patient switch from mavacamten, like your efficacy with the lower doses of aficamten? Robert I. Blum: Yes. So it's not for us really to comment on Camzyos and lower doses. But Andrew, is there anything you want to say about aficamten and MYQORZO and how doses are being titrated and then perhaps tackle the second question, which relates to prescribing outside of velocity accounts. Andrew Callos: Sure. So in terms of dosing, so we do have a flexible dosing window. A physician can increase a dose with each echo and we're seeing that dosing window play out in real world where some patients are being dosed as quickly as 2 weeks and other patients are being increased dose as long as 2 months. And that's really between the logistics of a center of patients and the physicians scheduling. So that window is taking place across every dose change. Relative to breadth and depth of prescribing we have a really good mix in terms of breadth. The majority of our prescriptions and prescribers are in that high CMI category, that's about 40% overall. And then that low volume category is about 30% and the CMI naive, meaning they had not written a CMI until we've entered the market is 30% of our prescribers. So we're doing really well across a broader range of prescribers. When we talk to those CMI-naive prescribers anecdotally, we're really hearing what you saw in that slide around differentiation. It really comes down to the REMS, the dosing window, the dosing flexibility, the lack of DDI monitoring as part of the overall REMS program. And there are the reasons we hear from those -- generally from that CMI naive in terms of why initiation of the CMI at this point. Hopefully, that answers your question. Robert I. Blum: If you think about what may be auguring well with regard to a exceeding of expectations associated with prescribing down the road, it's going to be the number of prescriptions, repeat prescriptions coming from each of these segments and an expansion of the category. And I think Andrew commented on both of those in his scripted comments. We're especially encouraged to see the high-volume writers writing the number of prescriptions that they are, but also that 50% of the prescriptions are coming from folks who were otherwise new or low-volume prescribers, that suggests to me that we're seeing category expansion, as you should expect of us. Operator: Our next question comes from the line of Paul Choi with Goldman Sachs. Kyuwon Choi: Apologies for any background noise. As you think about your commercialization efforts over the coming year, you'll be launching in symptomatic oHCM frontline oHCM and then nHCM, which is a lot of data is put in front of doctors. And as you think about your messaging, maybe clarify for us how you'll sort of think about all these opportunities and presenting them to doctors as your sales force is in the field over the next year. Robert I. Blum: Yes. So maybe I'll ask both Fady and Steve to start because they're obviously on the forward edge of these studies and as they get reported, presented and published, the medical colleagues are already speaking to some of these things. And then Andrew and his commercial team pick up from there. So Fady, do you want to start and then Andrew afterwards? Fady Malik: Yes. I mean it really starts with dissemination of the data through the published literature. And Steve and his team have been strictly productive in terms of not just the primary publications, but secondary publications that expand on the initial findings. With that, our medical affairs team is regularly interacting with the most elite prescribers and physicians taking care of these HCM patients, bringing them the information, helping walk them through it in a concise but complete manner. And finally, through executing a number of educational programs either through CME or industry-sponsored symposia. So pretty complete program from the primary publications through to delivering the information through a variety of channels. And ultimately, our commercial colleagues we'll build on what gets into a label and be able to then also disseminate the information broadly to their customer base. So excellent question. Andrew, do you want to answer? Andrew Callos: Sure, I can -- maybe just add to it from a commercial point of view. It's a great challenge in terms of having so much data in this period of time. When we think about Maple, Maple will -- we've done a lot of research on this as well. from a physician point of view, it broadens their horizon in terms of who they think an appropriate patient is for a CMI. So we'll certainly highlight that for a physician. That's especially true for those low writers and the naive CMI writers meaning they haven't written before where they certainly feel like they have the appropriate patient when you consider them relative to a beta blocker. Guidelines to certainly fuel that more if that were to change in 2027, nHCM then really just broadens the spectrum of the number of patients, a physician and a cardiology office can have with a single agent in my MYQORZO if it's approved for nHCM to treat a broader range of patients. So we have our messaging cascaded. We have our [messages] cascaded, et cetera, and I think we'll be ready to take well advantage of that further differentiation should those approvals come in from a regulatory point of view? Robert I. Blum: Paul, to your question, we aim to keep it simple. And what I especially am pleased to see is how we have great coordination across functions at Cytokinetics. You asked about publications and communications in the field. What I'll also point you to is the abundance of secondary manuscripts and other publications that build off of the primary manuscript. There's a plethora of information that's informing physicians about how best to think about aficamten, MYQORZO. And I do think that's translated to awareness, significant education and pull-through in patient demand as is enabling of our commercial colleagues to do so well. So hats off to the medical colleagues who make it happen on the publication side and then the commercial folks can keep it simple when they are out there detailing physicians. Operator: Our next question comes from the line of James Condulis with Stifel. James Condulis: And congrats on all the progress. Maybe on the nonobstructive side, I'm sure just curious, as you started sort of the sNDA discussions, do you expect any sort of differences on the label or the REMS with the potential approval of nonobstructive? I appreciate any color you can share? Robert I. Blum: Yes. So it's premature to speak to that. Obviously, we haven't even submitted the sNDA nor had conversations with FDA following their review of a submitted NDA -- but I do expect that for what could be this being a separate trial, there will be some distinctions that will have to reflect nHCM versus oHCM, but maybe we shouldn't front run any of that until we have actually interacted with FDA following the submission. Operator: Our next question comes from the line of Jason Butler with Citizens. Jason Butler: Congrats on the quarter. Robert, can you just walk us through your expectations for the cohort 1 of ulacamten. How are you thinking about what you can learn from that cohort specifically about the safety profile as well as PK/PD? Robert I. Blum: Sure. So I'll turn that over to Fady, please. Fady Malik: Yes. So I mean I think as we've said before, AMBER-HFpEF is a, let's say, a dose-finding trial and to understand how the unique mechanism of ulacamten might play out in AMBER-HFpEF population. So we'll have initial PK. We'll be looking broadly across cardiographic parameters. Of course, we'll have safety. And we'll also understand the feasibility of enrolling a population focused to where we think the impact might be felt with a mechanism like ulacamten. So I think over the course of the study that will help inform the continued development of ulacamten in this indication. Operator: Our next question comes from the line of Cory Kasimov with Evercore. Unknown Analyst: This is Josh on for Cory. What percent of the oHCM market is penetrated by CMI today? And what do you anticipate a peak penetration could be for the class? Robert I. Blum: So maybe I'll turn it to you, Andrew, for that, please? Andrew Callos: So our guess is around 110,000 to 120,000. It's more than a guess based on the analytics we've done from an Epi point of view around that number is the eligible patient population, that's if diagnosis doesn't increase. There's probably in the 20,000 to 25,000 range of treated patients, so you get a penetration in around 20% range. Peak penetration, I think it will depend over time on access, demonstrated safety of REMS programs change, et cetera, but I would anticipate peak penetration in the 60% to 70% range. Robert I. Blum: Yes. So what Andrew is citing would suggest that we've got a long way to go. Still to see CMIs penetrate a majority of the patients who are diagnosed and eligible and there could be still others that could be diagnosed now that there's new medicines available to those patients. So this is the beginning of what hopefully will be penetration of MYQORZO into more and more of those patients. But assume we're closer to 20% of the total eligible today, and that number -- hopefully denominator grows. Operator: Our next question comes from the line of Leonid Timashev with RBC. Leonid Timashev: I wanted to ask on COMET, just given the pace of enrollment, how are you thinking about the timing of the interim, your expectations for that interim? And then ultimately, what would be clinically meaningful in COMET? Robert I. Blum: Fady, please? Fady Malik: Yes. I mean the pace of enrollment in COMET has been pretty pleasing to us over the last few months, and we're, I would say, not providing specific guidance on when we think it will complete enrollment, but it will be into the beginning of 2027 for sure. The interim analysis has a pretty high bar to stop the trial on the basis of efficacy. So I wouldn't necessarily -- I mean my expectations for stopping at the interim analysis are pretty low because it's a very minute bit of alpha that's spent there. Clinically, we think anything -- trial was designed and we're always trying to do this, design a trial with a number of patients you think, to demonstrate a minimally clinically beneficial effect and not overpower it to show de minimis effects, if you will. So this trial was powered with that in mind, and I think it should be statistically significant around 0.86, 0.87, 0.88 terms in that range in terms of the hazard ratio for the primary endpoint. But of course, I think when you looked at this treatment effect in GALACTIC, we saw more sizable treatment effects on that, and we hope to see that in COMET emerge as well. I hope that addresses your question, Leo. Operator: Our next question comes from the line of Amine Chaherli with B. Riley Securities. Amine Chaherli: Congratulations on the quarter. This is Amine on for Mayank. I just had a question for Andrew, on the greater than 40% exit on NBRx share. Can you talk about what gets you to 50 plus by the end of the year? Is that mostly the 300 high-volume docs going deeper? Or do you need kind of the rest of that Velocity group coming on? And then relatedly, when you put the full ACACIA data up at ESC what do you think that does to oHCM prescribing near term? Robert I. Blum: Andrew, do you want to take that? Andrew Callos: So in terms of what gets us there, it's not going to be any one segment that gets us there. It really is continuing utilization across all segments. The definition of a velocity account for us was 80% of the market. That is actually shifting in terms of who are the Velocity prescribers as compared to who they were when we launched. So our expectation is that on a physician-by-physician basis, especially the academic centers and centers of excellence where we certainly want to continue to grow share as we have been doing for the majority of them, but also getting on board the CMI-naive segment as well as a kind of a segment who hasn't really written much from a CMI. Many of them were referring. And with nHCM, getting to your second question, obviously, it's not approved. We're not going to be promoting it or discussing it until it is approved. But the fact that it will be published in the public domain. Our expectation, there probably will be some kind of overhang effect, if you will, in terms of increasing prescribing. When you have a third clinical trial, the obstructive HCM 2 trials with SEQUOIA and MAPLE and a third one with ACACIA, the continuous safety evidence -- efficacy is very reassuring to a physician as well. So I think all this collectively will have an effect on oHCM. So we anticipate continuing to grow share over time. And as we've said all along, our aspiration is to have greater than 50% of the share by the end of the year. We're certainly on our way to do that. Operator: Our next question comes from the line of Maxwell Skor with Morgan Stanley. Maxwell Skor: So if we draw on the Camzyos experience, how should we think about persistence as the treated base builds? And could it look different from MYQORZO given that differentiated dosing and titration regimen? And also, if I could ask, any thoughts on seasonality or how we should frame quarterly cadence heading into 2027? Robert I. Blum: Andrew, do you want to take that? Andrew Callos: Sure. So from a persistence point of view, I mean, our expectation is that we will be the same, if not slightly better from Camzyos point of view, just given the profile of the drugs and some of the programs were put in place, but I think it's reasonable to assume they'd be similar, if not slightly improved for MYQORZO. In terms of your second question was around -- can you repeat that part again? I'm not sure if I heard it. Maxwell Skor: Yes. Just in regards to any thoughts on seasonality or how we should think or frame the quarterly cadence heading into '27? Andrew Callos: So I mean, I think it's -- we always see a lag right before -- right during a holiday week. There is flattening during the summertime. Physicians are on holiday or vacation as are patients. We see an uptick again in the fourth quarter. So the seasonality you'll see it's usually around holidays, which is a minor point, but it's more flattening during that summer time, especially in the months of July and August. Operator: Our next question comes from the line of Yasmeen Rahimi with Piper Sandler Company. Dominic Lorenzi: This is Dominic on for Yas. Congrats on a good quarter. Just had a quick question on European launch. How are you envisioning that panning out especially as you continue to progress with U.S. launch and launches in other European countries, do you think that, that will be a driver for subsequent launches. Robert I. Blum: Yes. So maybe I'll start there and ask Andrew and also Sung maybe to comment. We're very committed to ensuring that MYQORZO is available to patients throughout Europe. Now with our focus on certain countries and in partnering discussions as relate to others, we believe we can make that happen. But at the same time, we're realistic about what moves the needle for the revenue line, and that's going to be more primarily, obviously, the U.S. business. With that said, we're off to a great start in Germany. And we are very pleased with how we got some initial traction there in terms of stocking towards really just the last few weeks of the quarter. And now we've got to ensure that we're going to be enabling a demand and pull through. Andrew, do you want to speak to expectations in Europe and relative to U.S.? And Sung, anything you want to add after that? Andrew Callos: Yes, sure. So from a German point of view, it's early. We just launched in June. Data lags, but the data we've seen beyond the stocking is at, if not above our expectations from a German point of view. Other major markets, we're starting to get reimbursements in. We've talked about the England and Wales. We've talked about the Netherlands. We have major markets launching probably one at the end of this year, several first half of next year. Europe takes more time to build up over -- from a revenue point of view, pricing is in the 10% to 20% range. So my expectation would be that Europe will be a contribution, but not a driver of growth. And over time, it will probably be in the 15% range of our overall revenue, but maybe Sung wants to add to that. Sung Lee: Yes. I think Andrew characterized the pace in Europe well. The launches are staggered as we go through the HTA process in each country and the next likely country that we will launch in Q4 is the U.K., and we'll have subsequent launches into 2027 all the way to the end of the -- end of 2027. Robert I. Blum: We don't underestimate the challenges of going to market in the United States and also in multiple countries in Europe at the same time. But I do believe we're executing very well across all these geographies and setting the table for the kinds of things that matter to shareholders, including the top line growth. Operator: Our next question comes from the line of Srikripa Devarakonda with Truist. Srikripa Devarakonda: Congratulations on the quarter. Given the launch curve that you're seeing now and PDUFA date for MAPLE in November, how are you expecting a potential approval to change this curve? Do you expect it to have an immediate effect? Or do you think it could take time for doctors to be more educated about MAPLE. And then just a quick follow-up on the doctors that are REMS-certified, it looks like about 1,400 of them are REMS-certified. Can you remind me what percentage of them have prescribed the drug and if you're seeing any bottlenecks going from certification to prescription? Robert I. Blum: Andrew, do you want to tackle those, please? Andrew Callos: Sure. So from a REMS -- I'll go backwards from a REMS certification point of view, the ratio is about a 30% ratio in terms of those who are prescribed versus those who are certified from a REMS point of view. We continue to get REMS enrollment week after week. It certainly shows an intention to -- attention to prescribe overall. Sometimes the certification occurs and prescribing occurs within the institution by another physician. So it's a good indicator of future prescribing. And again, we're confident that, that growth is going to continue from broad-based prescribing. In terms of MAPLE, when MAPLE gets -- assuming MAPLE gets added to the label, that certainly provides greater ability from a promotion point of view. Probably the 2 things that I discussed earlier that really MAPLE does is one is it paints a picture, especially for low to nonprescribers of appropriate patients for a CMI and it broadens or widens their mind in terms of who that appropriate patient is for. The other thing it does is it certainly increases preference share and market growth. So there's kind of a multiplier factor there. If guidelines do get updated relative to MAPLE that certainly would -- as many physicians want to follow guidelines and understand guidelines. So that would be a further accelerator but obviously, that would take more time. So to answer your question specifically, I would expect that we would get some level of impact whether it will be noticeable right at launch or if it's going to take a bit of time, I would expect that it's probably going to take a bit of time more likely than this big bolus of prescribing change. Operator: Our next question comes from the line of Eric Joseph with Citi. Eric Joseph: Just wanted to actually follow up on this point about HCP or sorry, REMS certified HCPs, given the growth that you saw this past quarter. Can you just talk about sort of how that metric contrasts with the number of REMS-certified writers for potential writers for Camzyos? And what does that metric look like fully baked? Andrew Callos: Are you asking what -- how our REMS certification number compares to the Camzyos certification number? Is that your question? Eric Joseph: Yes, that and sort of what you anticipate the total number of potential REMS-certified providers would be in the U.S. Andrew Callos: Got it. So I can't comment on the Camzyos REMS certification number. I don't know that number. I don't need to know if that number is reported. I know BMS reported early in their launch, and it stopped reporting it at some point in time. In terms of our expectation, so we sized our field force for around 11,000 prescribers. Those 11,000 prescribers are around 80% of the treaters of HCM. Meaning that the majority of them are obviously using beta blockers, calcium channel blockers. So we were going to where we thought the market would go with CMI penetration over time. So with oHCM, if nHCM could get approved, our expectation is that prescribing base from around 3,000 in total today, will increase to probably in the 7,000 to 10,000 range. So over time, I would expect we'd have greater than 5,000 REMS certifications, but we're happy, very happy with the pace. The pace is outpacing the number of prescribers, which is exactly where we want to be. Robert I. Blum: Talk about exceeding expectations. We're seeing those numbers track in terms of REMS-certified HCPs and how that's converting so promptly to new prescriptions prescribers, especially outside of velocity accounts. Operator: Our next question comes from the line of Yanan Zhu with Wells Fargo. Yanan Zhu: Great. And congrats on the quarter. Maybe a question on your FDA interaction for the filing of the nHCM indication. I was just curious, has there been any particular questions or focuses from the agency? And then a quick question on the pattern of the dose -- the final doses patients land on in a commercial setting? And how does -- whether that is similar or different compared with your clinical trial experience? Robert I. Blum: So I'll ask Fady to comment. But I caution you that it's not our practice to be speaking on a play-by-play basis with regard to ongoing FDA interactions. And then maybe Andrew and Steve can talk about the doses that we're seeing patients relative commercial to clinical? Fady Malik: Sure. I think we presented as we presented the data, the natural questions that anybody would have around reviewing product for potential approval in that indication include the clinical meaningfulness of the endpoints and the results. The safety that was observed. How we might deploy those things and understand the interplay of those with the patient population. I think those are some of the themes of our discussion without getting too granular. And I think we're well placed to be able to address any questions in those areas. Robert I. Blum: What I can say is we were pleased that there were no surprises. And then, Andrew, do you want to talk about the dose levels that people are achieving already commercially and then Steve can comment about that in the context of clinical research. Andrew Callos: Yes, sure. So I mean we are seeing a broad range of dosing all the way up to the 20-milligram. I think it's too early to tell exactly where the mix is going to wind up given the number of new patients. We continue to have. The dosing window that the physicians and patients are taking advantage of that 2- to 8-week window. So I think that, that certainly is something we're monitoring and trying to understand exactly where is dosing going to compare to clinical trials. Typically, what I've seen is dosing usually winds up slightly lower in terms of a percentage in clinical trials, but we'll certainly report on that number in the future. Steve, anything you want to add? Stephen Heitner: Well, I mean, nothing more than to say the obvious that the clinical trial did show the preponderance of patients ended up on the 15-milligram and 20-milligram doses, both in MAPLE, SEQUOIA and the data that we published out of the FOREST experience. Robert I. Blum: That gives an opportunity to underscore one of the things that we think is important regarding MYQORZO is that one can uptitrate and that's enabling of convenience and flexibility for physicians and patients to feel like they can be moving to that dose, which is most likely to be the best balance between efficacy and safety without having to compromise. Operator: Our next question comes from the line of Serge Belanger with Needham. Serge Belanger: Maybe the first one for Andrew. In your slides, you mentioned about [indiscernible]. Is there any indication at this point on whether these high-volume prescribers will continue using both products? Or eventually, they'll adopt just one. And then secondly for Robert, was there any discussions in your FDA meeting about a potential priority review for the upcoming nHCM sNDA? Robert I. Blum: Andrew, I'm not sure if you heard all of that question. Did you get it? Andrew Callos: I think I got the essence of it at the very beginning of it was very broken up. Serge, thanks for the question. I don't anticipate the majority of the prescribers will go 100% one way or the other. There certainly are those that are advocates for one product or the other that prescribed that way. The vast majority will use both products over time. Our expectation is that use of MYQORZO is greater than that of Camzyos for most prescribers, hence, our aspiration in terms of greater than 50% share, but I'm not anticipating that we would have 100% share for the majority of prescribers or anywhere near that. Robert? Robert I. Blum: Your question about the FDA and reasonableness of a priority review. I don't think we'll comment again on any of our specific interactions with FDA, but as we've stated publicly already, independent of any interactions with FDA, it's not unreasonable. It's reasonable to assume that the priority review might be possible. It's not a base case assumption, but it certainly would be great if that happens. And we'll see if we can make that happen. Operator: Our next question comes from the line of Jason Zemansky with Bank of America. Jason Zemansky: Congrats on the quarter and appreciate you squeezing us in. Maybe as a follow-up, potentially the last question. You indicated, I think, that about 5% to 7% of MYQORZO dispenses are for those switching therapies. What are the primary factors driving those switches? And then among those transitioning from mavacamten what sort of feedback are you getting regarding the maintenance of symptoms and gradient control? Robert I. Blum: Yes. So obviously, there's nothing so systematic about that understanding that we can speak to it with any kind of robust fidelity. But there are anecdotes that we hear. Maybe, Steve, if you want to comment on what might motivate a physician who would switch from Camzyos to MYQORZO? Stephen Heitner: Sure. Before I get to that, I'll just point out that in MAPLE-HCM prior exposure to mavacamten was allowed, and those participants had an expected therapeutic response to aficamten in that setting. Then to Robert's point, there are some pharmacologic benefits that we believe suits certain patients more and those are related, firstly, to the speed of onset and offset. So patients who may have specific indications where they may need to start and stop the drug with a rapid onset and offset. Those are patients who would naturally be selected for aficamten. Individuals who are considering starting a family, as you might be aware, with the Camzyos label, it's a black box warning with MYQORZO. On the other hand, it certainly hasn't been studied, but it isn't a black box warning based on our preclinical data. The drug-drug interaction is something that you're well aware of. Patients who have had good experiences on certain kinds of antidepressants or therapies for things like gastroesophageal reflux disease may not necessarily want to switch medications in order to start a new medication for their hypertrophic cardiomyopathy. That would be another indication to preferentially use MYQORZO clinically. Robert I. Blum: Maybe just indicating a bit on what Steve said. It is not -- fundamentally not our strategy to drive switches. We are observing that there are certain physicians who are asking questions about how to switch and some investigators have chosen to do a study that will inform that practice were that to be of interest. But as Andrew has spoken to prescribing and new prescriptions and share of new scripts, it's a modest percentage of the total that's driven by switches, and that's potentially something for which there was more of a bolus of that activity early on the launch. And as we get deeper into the launch, we expect that, that may not continue to be a motivating factor for some of those physicians. So all in all, what we're focused on is those patients who are naive to CMI and where they may benefit from the addition of MYQORZO to their regimen. And that's where we're seeing the velocity. That's where we're seeing the growth and that's where we see ultimately the potential and upside for MYQORZO. So thank you. Operator: We have reached the end of our Q&A session. I will now turn the call back to Robert Blum, CEO, for closing remarks. Robert I. Blum: Thank you, operator. I want to thank the participants on the call today. I want to thank you for your continued support and interest in how we're doing here at Cytokinetics. I do believe that our Q2 report here is a very positive one, reflecting on the things that we've indicated matter. That which speaks to how we go commercial and enabling a strong commercial launch momentum and velocity here initially in the United States and hopefully also as we're building the foundation in Europe. And having that occur at the same time, we're enabling a better information to inform patient and market access and also preparing for what we hope will be an expanded label to include nHCM based on the ACACIA data. I'll remind you that we're going to have several presentations, including hotline presentation at ESC later this month. And coming out of that, we'll also have an investor event that we look forward to communicating to you from Munich and at the same time, advancing our pipeline, that's a key tenet and hallmark of how we see our business growing over time for the benefit of patients, science and shareholders. With that, operator, we're going to bring this call to a conclusion, and we thank you very much for all of your time and attention today. Operator: Thank you. This concludes today's call. Thank you for attending. You may now disconnect. Before you buy stock in Cytokinetics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Cytokinetics wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $400,209!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,375,393!* That performance is why people listen. With a track record of beating the S&P 500 by 4x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 13, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has positions in and recommends Cytokinetics. The Motley Fool has a disclosure policy. Cytokinetics (CYTK) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. MYQORZO launch velocity in the U.S. is exceeding expectations, driven by increased physician engagement and expanding patient access just five months post-launch. The company achieved its first European launch in Germany, establishing a foundation for a series of planned market entries across Europe over the next 6 to 12 months. Positive Phase III ACACIA-HCM results demonstrate aficamten's potential to treat non-obstructive HCM (nHCM), a population with no currently approved therapies. Management attributes commercial success to the differentiated clinical profile of MYQORZO, specifically its dosing flexibility and lack of drug-drug interaction monitoring. Strategic focus remains on deepening penetration among high-volume prescribers while simultaneously capturing a growing segment of first-time CMI writers. The company fortified its balance sheet with a $760 million public offering to support global commercialization and pipeline advancement. Management plans to submit a supplemental NDA for aficamten in nHCM in Q4 2026 following constructive feedback from the FDA. The company expects to achieve parity commercial insurance access for MYQORZO by the end of 2026, building on current 90% Medicare parity. Aspiration to reach greater than 50% new-to-brand prescription share by the end of 2026., driven by superior clinical data from the MAPLE-HCM trial. Full launch in the United Kingdom is anticipated later this year following recent Marketing Authorization and NICE reimbursement recommendations. Updated 2026 financial guidance reflects increased investment in commercial readiness for a potential 2027 launch in the nHCM indication. Operating expenses increased primarily due to commercial launch costs, including the U.S. sales force and higher personnel-related stock-based compensation. Cost of goods sold included a $2.7 million non-routine charge related to drug supply optimization efforts. Management noted that while switching from competitors exists (5-7% of dispenses), the primary growth driver is patients naive to cardiac myosin inhibitors. The transition of the Chief Medical Officer role from Stuart Kupfer to Steve Heitner was formalized to lead the next phase of clinical research. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management clarified that while cumulative prescriptions since launch reached approximately 2,000 by the end of Q2, the cumulative dispensed patients (1,500) better align with product revenue. The gap is attributed to the 3-week administrative process involving REMS enrollment, benefit investigation, and prior authorizations. MYQORZO achieved an exit share of greater than 40% for new-to-brand prescriptions in June. Management believes the drug's profile, including rapid onset/offset and lack of black box warnings for certain risks, favors long-term adoption over competitors. While not yet promoted for nHCM, management expects the publication of robust safety and efficacy data across the full HCM spectrum to reassure oHCM prescribers. The data reinforces the utility of the cardiac myosin inhibitor class, potentially expanding the total treated patient population. Enrollment for the Phase III heart failure trial, COMET-HF, is expected to continue through 2026 and into the beginning of 2027., with over 90% of sites now activated. Management set a high bar for the interim analysis, suggesting a low probability of stopping early for efficacy due to conservative alpha spending.

Cytokinetics, Incorporated CYTK reported a second-quarter 2026 loss of $1.50 per share, narrower than the Zacks Consensus Estimate of a loss of $1.63 per share. In the year-ago quarter, the company reported a loss of $1.12 per share. Loss widened year over year due to higher SG&A expenses tied to costs associated with the commercial launch of Myqorzo and lower revenues. Revenues amounted to $28.6 million, which went down from $66.8 million in the year-ago quarter but surpassed the Zacks Consensus Estimate of $20 million. Cytokinetics’ shares have surged 28.1% year to date compared with the industry’s 3.6% growth. Image Source: Zacks Investment Research In December 2025, the FDA approved Myqorzo (aficamten) for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Net product revenues from Myqorzo were $25.3 million in the second quarter. U.S. net product revenues totaled $23.0 million, while Europe contributed $2.30 million, reflecting initial distributor inventory purchases in Germany. Commercial adoption continued to broaden. More than 700 unique U.S. healthcare providers prescribed Myqorzo by June 30. More than 80% of dispensed prescriptions were paid, and management’s internal analysis indicated Myqorzo exited the quarter with greater than 40% new-to-brand prescription share in the cardiac myosin inhibitor category. Cytokinetics launched Myqorzo in Germany in June, marking its first European commercial rollout. The drug also received marketing authorization across the United Kingdom, while NICE recommended it for use in England and Wales. Beyond product sales, quarterly revenues included collaboration revenues of $3.29 million, up from $2.42 million in the year-ago quarter. No license and milestone revenues were recorded in the period. That absence caused the sharp year-over-year decline in total revenues. The second quarter of 2025 included $64.35 million in license and milestone revenues tied to the Bayer BAYRY collaboration for aficamten in Japan. Research and development expenses declined 11.2% year over year to $97.81 million. The decrease reflected higher clinical trial activity, supply-chain costs and medical affairs spending in the prior-year period, partly offset by higher personnel-related costs in 2026. Selling, general and administrative expenses rose 58.8% to $104.40 million. The increase reflected Myqorzo launch costs, the U.S. sales force and higher nonsales personnel-related expenses, including stock-based compensation. Cash, cash equivalents and investments totaled approximately $1.7 billion as of June 30, 2026, compared with $1.1 billion at the end of the first quarter. The increase primarily reflected a May public offering that generated approximately $760.1 million in net proceeds. The additional liquidity provides Cytokinetics with the financial flexibility to support the commercialization of Myqorzo and continue investing across its specialty cardiology pipeline. Cytokinetics now expects combined 2026 GAAP R&D and SG&A expenses of $860-$890 million, up from its prior projection of $830-$870 million. The company also raised its stock-based compensation expense guidance to $130-$140 million from $120-$130 million. Excluding stock-based compensation, combined R&D and SG&A expenses are projected to be in the $720-$760 million band. Management tied the increase primarily to commercial-readiness investments following positive ACACIA-HCM results and preparations for a potential 2027 Myqorzo launch in non-obstructive hypertrophic cardiomyopathy (nHCM). On the clinical front, ACACIA-HCM met both primary endpoints in symptomatic nHCM, showing statistically significant improvements in KCCQ Clinical Summary Score and peak VO2 versus placebo. Cytokinetics plans to submit a supplemental new drug application (sNDA) for aficamten in this indication in the fourth quarter of 2026. The FDA accepted CYTK’s sNDA for MAPLE-HCM, a phase III study of aficamten as monotherapy compared with metoprolol as monotherapy in patients with oHCM. The regulatory body assigned a target action date of Nov. 14, 2026. The company has also submitted new drug applications for aficamten in Hong Kong and Taiwan under its collaboration with Sanofi. Aficamten has been granted Priority Review designation by the Taiwan Food and Drug Administration. Meanwhile, regulatory filings for Myqorzo are also under review in Canada and Switzerland. The clinical development of aficamten, including the ongoing Japan cohort of the ACACIA-HCM study, is advancing. The company expects to complete the study in the third quarter of 2026. CAMELLIA-HCM, a phase III study of aficamten in Japanese patients with oHCM, is also ongoing. The study is being conducted by Bayer in collaboration with Cytokinetics to support potential marketing authorization in Japan. Other studies include CEDAR-HCM, a clinical trial of aficamten in a pediatric population with symptomatic oHCM. The study recently completed patient enrollment in the adolescent cohort of the study. Other pipeline candidates include omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. A confirmatory phase III multi-center, double-blind, randomized, placebo-controlled trial, COMET-HF, to assess the efficacy and safety of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction is ongoing. Enrollment is expected to continue through 2026. The company continued enrolling patients in cohort 1 of the phase II AMBER-HFpEF trial evaluating ulacamten in patients with symptomatic heart failure with preserved ejection fraction and a left ventricular ejection fraction of at least 60%. Patient enrollment is expected to be completed in the Cohort 1 in the second half of 2026. The company recently initiated the second phase I randomized, double-blind, placebo-controlled, single ascending dose study of CK-4015089 (CK-089) in healthy volunteers. CYTK performance in the second quarter was encouraging. Myqorzo’s uptake is a strong early signal. The oHCM market represents a meaningful commercial opportunity, given the sizable population of symptomatic patients who have historically had limited pharmacologic options beyond beta-blockers, calcium channel blockers, or invasive procedures. The approval positions Cytokinetics as a key player in this growing specialty cardiology segment. Cytokinetics, Incorporated price-consensus-eps-surprise-chart | Cytokinetics, Incorporated Quote A potential approval in nHCM will expand the addressable market. However, Myqorzo faces competition from Camzyos (mavacamten), a first-in-class cardiac myosin inhibitor marketed by Bristol Myers Squibb BMY. BMY obtained FDA approval for the drug in 2022 for the treatment of adults with symptomatic New York Heart Association class II-III obstructive HCM to improve functional capacity and symptoms. Camzyos has put up a stellar performance since its approval. Cytokinetics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Cytokinetics, Incorporated (CYTK) : Free Stock Analysis Report Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Cytokinetics Inc (NASDAQ:CYTK) reported strong commercial momentum for Mycorzo in the US, with Q2 dispensed patients nearly tripling to 1,500 and new-to-brand prescription share exceeding 40% by quarter end. The company successfully launched Mycorzo in Germany, its first European market, and received marketing authorization and reimbursement guidance in the UK, expanding its global footprint. Positive top-line results from the Acacia-HCM Phase 3 trial in non-obstructive HCM met both dual primary endpoints, supporting a potential label expansion and a planned sNDA submission in Q4 2026. Physician awareness and engagement are rising, with unaided awareness among high-volume prescribers increasing to 68% and over 2,500 healthcare providers completing REMS certification since launch. The company fortified its balance sheet with a public offering generating approximately $760 million in net proceeds, ending Q2 with about $1.7 billion in cash and investments. Pipeline progress continues with enrollment advancing in the confirmatory Phase 3 COMET-HF trial for omecamtiv mecarbil and the Phase 1 AMBER-HF study for aficamten, alongside a planned presentation of full Acacia-HCM data at ESC. Cytokinetics Inc (NASDAQ:CYTK) reported a net loss of $198.8 million for Q2 2026, wider than the $134.4 million loss in the same period of 2025, driven by increased SG&A expenses. The company raised its full-year 2026 GAAP combined R&D and SG&A expense guidance to $860-$890 million, up from the prior range, reflecting higher commercial readiness investments. Product revenue of $25.3 million remains modest relative to operating expenses, with US net product revenues of $23 million and European contributions of only $2.3 million. The launch is still early, with only about 700 unique US prescribers and an average of 3 patients per prescriber, indicating limited depth of prescribing among the broader physician base. A significant gap exists between prescriptions written (approximately 2,000 in Q2) and dispensed (1,500), with a lengthy process involving REMS enrollment, benefit investigation, and prior authorization potentially delaying revenue recognition. The company faces uncertainty regarding regulatory approval for the NHCM indication, with no guarantee of priority review or successful sNDA submission, and potential label distinctions between OHCM and NHCM remain unclear. Warning! GuruFocus has detected 8 Warning Signs with CYTK. Is CYTK fairly valued? Test your thesis with our free DCF calculator. Q: Can you clarify the dispensed versus prescribed numbers for Q2, and is the ratio of dispensed to prescribed consistent between the two quarters? A: Andrew Callos, EVP and Chief Commercial Officer: We reported 680 prescriptions and 400 dispensed in Q1, and around 2,000 prescriptions and 1,500 dispensed in Q2. The difference represents patients in the process of getting prescriptions filled, which involves REMS enrollment, benefit investigation, and prior authorization, a process that takes several weeks. We are getting over 100 prescriptions per week, and the majority of the difference is pending patients. There is a small mid-single-digit percentage of prescriptions that get canceled. Q: What will be better understood by physicians and investors after the ESC presentation, and where does the new-to-brand share sit now versus the goal of 50% by year-end? A: Robert Blum, CEO: At ESC, we will present the full Acacia-HCM data, which will provide a more comprehensive look at the magnitude of changes across all endpoints, including secondary endpoints, and how they tell a consistent, robust story. Andrew Callos, EVP and Chief Commercial Officer: We reported over 40% new-to-brand exit share for Q2 (June). We are seeing a higher proportion of scripts for mycorzo than expected, and while we remain conservative on timing, we are moving swiftly toward the majority share. Q: Is the overall class growth primarily share capture versus growing the pie, and was there any impact from stocking in the $23 million US revenue figure? A: Andrew Callos, EVP and Chief Commercial Officer: We are seeing an increase in overall new-to-brand prescription growth. Last year, the class saw about 2,000 new prescriptions per quarter; in Q1 it was around 2,500, and in Q2 it approached 3,000. So we are seeing growth in new patients entering the market. Sung Lee, EVP and CFO: As demand increases, distributors carry inventory commensurate with demand, so this quarter was demand-led, not stocking-driven. Q: What feedback are you hearing from prescribers who switched from Camzyos, especially regarding efficacy at lower doses, and what percentage of new patients are outside centers of excellence? A: Andrew Callos, EVP and Chief Commercial Officer: We have a flexible dosing window, and we are seeing it play out in the real world, with some patients dosed as quickly as 2 weeks and others up to 2 months. The majority of our prescribers are in the high CMI category (about 40%), with about 30% low-volume and 30% CMI-naive prescribers. For CMI-naive prescribers, the differentiation points that resonate are the REMS program, dosing flexibility, and lack of DDI monitoring. Q: How are you thinking about the launch sequencing for OHCM, frontline OHCM (Maple), and NHCM, and how will you message these to doctors? A: Patty Malek, EVP of R&D: It starts with data dissemination through publications and medical affairs interactions with elite prescribers, followed by educational programs. Andrew Callos, EVP and Chief Commercial Officer: Maple will broaden physicians' horizons on who is an appropriate patient for a CMI, especially for low and naive writers. NHCM, if approved, broadens the spectrum of patients a physician can treat with a single agent. We have our messaging and visual aids cascaded to take advantage of further differentiation as approvals come in. Q: What is the current penetration of CMIs in the OHCM population, and what do you anticipate peak penetration could be? A: Andrew Callos, EVP and Chief Commercial Officer: The eligible patient population is around 110,000 to 120,000, with about 200,000 to 250,000 treated patients, putting penetration around 20%. I would anticipate peak penetration in the 60-70% range, depending on access, demonstrated safety, and REMS program changes. Robert Blum, CEO: We have a long way to go, and the denominator could grow as new medicines become available. Q: Given the pace of enrollment in COMET-HF, how are you thinking about the timeline and what would be clinically meaningful on the primary endpoint? A: Steve Heitner, SVP and Chief Medical Officer: The pace of enrollment has been pleasing, and we expect to complete enrollment at the beginning of 2027. The interim analysis has a very high bar to stop early, so my expectations for stopping are low. The trial was powered to demonstrate a minimally clinically beneficial effect, with a hazard ratio around 0.86-0.88 for the primary endpoint. We saw more sizable treatment effects in the GALACTIC-HF subgroup, and we hope to see that in COMET as well. Q: What gets you to over 50% new-to-brand share by year-end, and what do you think the full Acacia data at ESC will do to OHCM prescribing near-term? A: Andrew Callos, EVP and Chief Commercial Officer: It won't be any one segment; it will be continued utilization across all segments. The definition of velocity accounts is shifting, and we are focusing on academic centers and centers of excellence while also bringing on CMI-naive prescribers. Regarding Acacia, while we can't promote it until approved, the publication of a third positive trial will likely have a halo effect on OHCM prescribing, reinforcing safety and efficacy evidence. Q: How should we think about persistence as the treated base builds, and could it look different for mycorzo given its differentiated dosing and titration regimen? A: Andrew Callos, EVP and Chief Commercial Officer: Our expectation is that persistence will be the same, if not slightly better, than Camzyos given the profile of the drug and the programs we have in place. Regarding seasonality, we typically see flattening during the summer months (July and August) and an uptick in the fourth quarter, with minor dips around holidays. Q: How is the European launch panning out, and what are the expectations for subsequent launches? A: Robert Blum, CEO: We are committed to making mycorzo available throughout Europe, but we are realistic that the US business is the primary revenue driver. We are off to a great start in Germany. Andrew Callos, EVP and Chief Commercial Officer: It's early, but the data from Germany is at or above expectations For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Cytokinetics, Incorporated? Here are five stocks we like better. MYQORZO’s U.S. launch is gaining traction: The drug reached 1,500 dispensed patients and more than 700 prescribers in the second quarter, with over 80% of prescriptions paid and new-to-brand share above 40% in June. Cytokinetics plans to expand aficamten into nHCM: After positive Phase III ACACIA-HCM results, the company expects to file a supplemental application with the FDA in the fourth quarter; it also made progress toward broader European commercialization. Financial results reflected launch investment: Q2 revenue fell to $28.6 million due to lower licensing income, while the net loss widened to $198.8 million. The company ended the quarter with approximately $1.7 billion in cash and raised its 2026 operating-expense guidance. Analysts Think There's Still Time to Get in on Edgewise, Up 332% Cytokinetics (NASDAQ:CYTK) reported second-quarter results marked by early commercial momentum for MYQORZO, international market-access progress and plans to seek an expanded indication for aficamten in non-obstructive hypertrophic cardiomyopathy, or nHCM. Chief Executive Officer Robert Blum said the company was seeing launch performance for MYQORZO that was “exceeding expectations” five months after the product’s U.S. introduction at the end of January. MYQORZO is approved for adults with symptomatic obstructive hypertrophic cardiomyopathy, or oHCM. → 3 Drone Stocks That Should Soar After the Summer Slump Want Diversified Upside in Biotechnology? Check out LABU During the second quarter, MYQORZO was dispensed to 1,500 patients, compared with 400 patients at the end of the first quarter, according to Executive Vice President and Chief Commercial Officer Andrew Callos. The company said approximately 2,000 prescriptions were written in the second quarter, with the difference largely reflecting patients progressing through REMS enrollment, benefits investigations, prior authorization and other dispensing requirements. More than 80% of dispensed prescriptions in the quarter were paid prescriptions, while the remainder were associated with free trials, bridge programs or other patient-assistance initiatives. Callos said most prescriptions were dispensed within about three weeks after documentation and benefits reviews were completed. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Cytokinetics said its internal analysis indicated that MYQORZO’s new-to-brand prescription exit share in the cardiac myosin inhibitor, or CMI, category exceeded 40% in June. The company is targeting more than 50% new-to-brand prescription share by the end of 2026, though management said it expects adoption to continue across multiple physician segments rather than relying on one group alone. More than 700 U.S. healthcare providers had prescribed MYQORZO by quarter-end. About 300 prescribers were high-volume CMI writers. More than half of MYQORZO prescribers were low-volume CMI prescribers or first-time CMI writers. More than 2,500 healthcare providers had completed REMS certification since launch. Cytokinetics had reached more than 90% of its targeted high-volume prescribers by the end of the quarter. Callos said roughly 5% to 7% of total MYQORZO dispenses came from patients switching therapies, but management emphasized that switching is not the company’s principal commercial strategy. The company instead is focused on patients who are new to the CMI category and broader adoption among treating physicians. → Jersey Mike's Serves Fresh Gains After IPO Stumble On the access front, Cytokinetics ended the quarter with nearly 90% parity coverage for Medicare lives and more than 50% commercial coverage. The company said it remains on track to achieve commercial parity access by the end of 2026. Cytokinetics launched MYQORZO in Germany in June, its first European launch. European net product revenue totaled $2.3 million in the quarter and reflected initial distributor inventory purchases in Germany. The company also submitted 10 health technology assessment dossiers across Europe and said reimbursement approval became effective in the Netherlands on Aug. 1. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency granted marketing authorization for MYQORZO in symptomatic oHCM, while the National Institute for Health and Care Excellence recommended the treatment for use in England and Wales. Management expects full U.K. launch and drug supply later this year, followed by additional European launches through 2027. Callos said Europe is expected to become a contributor to revenue but not the primary driver of growth, estimating it could represent about 15% of overall revenue over time. The company highlighted positive top-line findings from ACACIA-HCM, its Phase III trial of aficamten in symptomatic nHCM. Cytokinetics said the study met both dual primary endpoints, showing statistically significant improvements from baseline to week 36 in Kansas City Cardiomyopathy Questionnaire clinical summary score and peak oxygen consumption, compared with placebo. Fady Malik, executive vice president of research and development, said key secondary endpoints also showed statistically significant improvements and that no new safety signals were identified. Cytokinetics plans to present full ACACIA-HCM results, including analyses of cardiac structure and function, at the European Society of Cardiology Congress later this month. Following discussions with the FDA, Cytokinetics plans to submit a supplemental new drug application for aficamten in nHCM during the fourth quarter. The company also plans discussions with European regulators regarding potential submissions. Management noted there are currently no approved therapies for nHCM. Separately, an sNDA based on the MAPLE-HCM trial in oHCM remains under FDA review, with a PDUFA target date of Nov. 14, 2026. The company said MAPLE-HCM could support use of aficamten as an earlier treatment option in appropriate patients if approved. Total second-quarter revenue was $28.6 million, down from $66.8 million a year earlier. The prior-year period included $64.4 million in licensing and milestone revenue from Cytokinetics’ aficamten collaboration with Bayer in Japan. MYQORZO generated $25.3 million in net product revenue in the latest quarter, including $23 million in the U.S. Research and development expense declined to $97.8 million from $110.1 million a year earlier, while selling, general and administrative expense rose to $104.4 million from $65.7 million, primarily due to MYQORZO launch costs, the U.S. sales force and personnel expenses. Cytokinetics reported a net loss of $198.8 million, or $1.50 per share, compared with a loss of $134.4 million, or $1.12 per share, in the prior-year quarter. The company ended the quarter with approximately $1.7 billion in cash and investments, up from $1.1 billion at the end of the first quarter, following a May public offering that generated about $760 million in net proceeds. Cytokinetics raised its 2026 guidance for combined GAAP R&D and SG&A expense to $860 million to $890 million, from $830 million to $870 million. The increase reflects commercial-readiness investments for a potential 2027 MYQORZO launch in nHCM. Elsewhere in its pipeline, the company said it had enrolled more than one-third of patients in COMET-HF, a confirmatory Phase III trial of omecamtiv mecarbil in heart failure with severely reduced ejection fraction. Enrollment is expected to continue through 2026. Cytokinetics also expects to complete enrollment in the first cohort of the Phase II AMBER-HFpEF trial of ulacamten in the second half of 2026. Cytokinetics, Inc is a late‐stage biopharmaceutical company focused on the discovery and development of novel small‐molecule therapeutics that modulate muscle function. Founded in 1998 and headquartered in South San Francisco, California, the company applies its proprietary insights in muscle biology to address diseases characterized by impaired muscle performance. Its research spans both cardiac and skeletal muscle targets, aiming to deliver innovative medicines for conditions with significant unmet medical need. The company's most advanced program, omecamtiv mecarbil, is being evaluated for the treatment of heart failure by enhancing cardiac muscle contractility. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Cytokinetics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

MYQORZO® (aficamten) Net Product Revenue of $25 Million Full Results from ACACIA-HCM to be Presented in Hot Line Session at ESC; Expect to Submit Supplemental NDA for Aficamten in Non-Obstructive HCM in Q4 2026 MYQORZO Launched in Germany, Approved in United Kingdom and Regulatory Review Ongoing in Canada, Switzerland, Hong Kong and Taiwan ~$1.7 Billion in Cash, Cash Equivalents and Investments as of June 30, 2026 SOUTH SAN FRANCISCO, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the second quarter of 2026. “Our second quarter results demonstrate commercial launch momentum for MYQORZO alongside continued excellence for our development pipeline, both hallmarks of continued strong execution for our maturing business. In the U.S., we continued to build launch velocity evidenced by expanding physician adoption and increasing patient access. Internationally, we launched MYQORZO in Germany and laid the foundation for broadening access to aficamten by submitting reimbursement dossiers alongside regulatory filings advancing in multiple countries in Europe,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We look forward to sharing results from ACACIA-HCM later this month and submitting a supplemental NDA to the U.S. Food and Drug Administration in the fourth quarter. Having also secured additional capital during the recent quarter, we have the financial resources to invest in both the global commercialization of MYQORZO and the continued progression of our pipeline, positioning us well to maximize the potential of our specialty cardiology franchise.” Q2 and Recent Highlights Cardiac Muscle Programs MYQORZO® (aficamten) (cardiac myosin inhibitor) Continued U.S. commercial launch of MYQORZO for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), with increasing physician and patient awareness of MYQORZO driven by both strong engagement and successful marketing campaigns. Continued to drive launch momentum for MYQORZO. As of June 30, 2026: Successfully brought MYQORZO to market in Germany in June. MYQORZO was granted marketing authorization across the United Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of symptomatic (New York Heart Association, NYHA class II-III) oHCM in adult patients. At the same time, the National Institute for Health and Care Excellence (NICE) issued guidance recommending aficamten for use in England and Wales. MYQORZO received reimbursement approval, effective August 1, from The Dutch Ministry of Health in the Netherlands. Submitted 10 Health Technology Assessment (HTA) dossiers to support market access across Europe and expect to launch in more than five additional markets by the first half of 2027. Submitted New Drug Applications (NDA) for aficamten in Hong Kong and Taiwan under our collaboration with Sanofi. Aficamten was granted priority review designation by the Taiwan Food & Drug Administration. Regulatory filings for MYQORZO are also under review in Canada and Switzerland. Announced positive topline results from ACACIA-HCM, the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). The primary results from ACACIA-HCM will be presented in a Hot Line Session at the European Society of Cardiology (ESC) Congress in August 2026. We expect to file a Supplemental NDA for nHCM in Q4 2026. Advanced the ongoing clinical trials program for aficamten: Presented new analyses at the ESC Heart Failure 2026 Congress from SEQUOIA-HCM, MAPLE-HCM and FOREST-HCM supporting previously published data related to the safety and efficacy of aficamten in oHCM. omecamtiv mecarbil (cardiac myosin activator) Continued conduct of COMET-HF, a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction. We expect to continue patient enrollment through 2026. ulacamten (cardiac myosin inhibitor) Continued conduct of Cohort 1 of AMBER-HFpEF, a Phase 2 clinical trial of ulacamten in patients with symptomatic heart failure with preserved ejection fraction (HFpEF) with left ventricular ejection fraction (LVEF) ≥ 60%. We expect to complete patient enrollment in Cohort 1 in the second half of 2026. CK-4015089 (CK-089, fast skeletal muscle troponin activator) Recently initiated the second Phase 1 randomized, double-blind, placebo-controlled single ascending dose clinical study of CK-4015089 (CK-089) in healthy human participants. Pre-Clinical Development and Ongoing Research Continued pre-clinical development and research activities directed to additional muscle biology focused programs. Q2 2026 Financial Results Cash, Cash Equivalents and Investments As of June 30, 2026, the company had approximately $1.7 billion in cash, cash equivalents and investments compared to $1.1 billion at March 31, 2026. In the second quarter, the company completed a public offering of 11,338,028 shares of its common stock, including the underwriters’ exercise in full of their option to purchase additional shares, at a price of $71.00 per share. Net proceeds to the Company from the offering were approximately $760.1 million, after deducting underwriting discounts and commissions and offering expenses payable to the Company. Revenues Total revenues for the second quarter of 2026 were $28.6 million, compared to $66.8 million for the same period in 2025. Total revenues in the second quarter of 2026 include: Research and Development (R&D) Expenses R&D expenses for the second quarter of 2026 were $97.8 million, which included $15.9 million of non-cash stock-based compensation expense, compared to $110.1 million for the same period in 2025, which included $13.5 million of non-cash stock-based compensation expense. The decrease was primarily due to higher clinical trial activity, supply chain costs, and medical affairs activities in 2025 partially offset by higher personnel-related costs in 2026. Selling, General and Administrative (SG&A) Expenses SG&A expenses for the second quarter of 2026 were $104.4 million, which included $19.8 million of non-cash stock-based compensation expense, compared to $65.7 million for the same period in 2025, which included $14.0 million of non-cash stock-based compensation expense. The increase was primarily due to costs associated with the commercial launch of MYQORZO and higher personnel-related costs, including stock-based compensation. Cost of Goods Sold Cost of goods sold related to MYQORZO for the second quarter of 2026 was $2.7 million. Collaboration Cost of Revenues Collaboration cost of revenues for the second quarter of 2026 was $2.9 million, compared to $2.4 million for the same period in 2025. Collaboration cost of revenues includes cost reimbursements as well as costs incurred in connection with manufacturing drug supplies for collaboration partners. Net Income (Loss) Net loss for the second quarter of 2026 was $198.8 million, or $(1.50) per share, basic and diluted, compared to a net loss of $134.4 million, or $(1.12) per share, basic and diluted, for the same period in 2025. 2026 Financial Guidance The company is updating its full year 2026 financial guidance: GAAP combined R&D and SG&A expense guidance increase is primarily driven by commercial readiness investments, prompted by the positive results from ACACIA-HCM, to support the potential 2027 launch of MYQORZO in nHCM. The financial guidance does not include the effect of GAAP adjustments as may be caused by events that occur subsequent to publication of this guidance including, but not limited to, Business Development activities. Conference Call and Webcast Information Members of Cytokinetics’ senior management team will review the company’s second quarter 2026 results on a conference call today at 4:30 PM Eastern Time. The conference call will be simultaneously webcast and can be accessed from the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com or directly at the following link: Cytokinetics Q2 2026 Earnings Conference Call. An archived replay of the webcast will be available via Cytokinetics’ website for six months. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, Europe and the UK for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive topline results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Disclaimer Omecamtiv mecarbil, ulacamten and CK-089 are investigational medicines. They have not been approved nor determined to be safe or efficacious for any disease state or any indication by FDA or any other regulatory agency. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to the full results from ACACIA-HCM to be presented in a Hot Line Session at the European Society of Cardiology (ESC) Congress; our plans to submit a Supplemental NDA for aficamten in non-obstructive HCM in the fourth quarter of 2026, and the timing and outcome of any related regulatory review; our plans to launch MYQORZO in additional markets outside the U.S., including our expectation to launch in more than five additional markets by the first half of 2027, and the timing and outcome of pending regulatory and reimbursement reviews in Canada, Switzerland, Hong Kong, Taiwan and other jurisdictions, our or our partners’ research and development and commercial readiness activities, including the initiation, conduct, design, enrollment, progress, continuation, completion, timing and results of any of our clinical trials, including ACACIA-HCM (including its Japan cohort), CAMELLIA-HCM, COMET-HF, AMBER-HFpEF and CEDAR-HCM; the clinical meaningfulness, persuasiveness, or interpretation of the results of MAPLE-HCM, ACACIA-HCM or any of our other clinical trials, including for purposes of regulatory approval, labeling, or market acceptance, the results of long-term, secondary or exploratory analyses, our ability to announce the results of any of our clinical trials by any particular date, the timing of interactions with FDA or any other regulatory authorities in connection to any of our drug candidates and the outcomes of such interactions; statements related to our receipt of regulatory approvals for aficamten in any ex-US jurisdiction for any indication and by any particular date, statements relating to the potential patient population who could benefit from aficamten, omecamtiv mecarbil, ulacamten, CK-089 or any of our other drug candidates; statements related to the potential launch of MYQORZO in non-obstructive HCM in 2027; our full year 2026 financial guidance, including our combined GAAP research and development and selling, general and administrative expense guidance and related non-cash stock-based compensation expense estimates, and the assumptions underlying such guidance; statements relating to our ability to receive additional capital or other funding, including, but not limited to, our ability to meet any of the conditions relating to or to otherwise secure additional loan disbursements under any of our agreements with entities affiliated with Royalty Pharma or additional milestone payments from Sanofi or Bayer in connection with our collaborations for aficamten in China or Japan respectively; statements relating to our operating expenses or cash utilization for the remainder of 2026 or any other period, and statements relating to our cash balance at any particular date or the amount of cash runway such cash balances represent at any particular time. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to Cytokinetics’ need for additional funding and such additional funding may not be available on acceptable terms, if at all; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; patient enrollment for or conduct of clinical trials may be difficult or delayed; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Cytokinetics may incur unanticipated research and development and other costs; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. MYQORZO® is a registered trademark of Cytokinetics in the U.S. and European Union. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757