On May 4, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) reported that it will report its financial results for the quarter March 31, 2022 on Monday, May 9, 2022, after the close of the U.S. financial markets (Press release, Y-mAbs Therapeutics, MAY 4, 2022, View Source [SID1234613541]). The announcement will be followed by a conference call and webcast with the investment community on Tuesday, May 10, 2022, at 9 a.m. ET. Participating on the call from Y-mAbs will be Thomas Gad, founder, Chairman and Interim CEO; Bo Kruse, Chief Financial Officer; and Sue Smith, Chief Commercial Officer.

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On May 4, 2022 Rhizen Pharmaceuticals AG (Rhizen), a Switzerland-based privately held, clinical-stage biopharmaceutical company reported that it is presenting promising interim data from an ongoing Ph2 trial of Tenalisib in locally advanced or metastatic breast cancer patients, at the ESMO (Free ESMO Whitepaper) Breast Cancer Meeting, in Berlin, Germany from May 3-5, 2022 (Press release, Rhizen Pharmaceuticals, MAY 4, 2022, View Source [SID1234613560]).

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This multi-center, randomized phase II study is being conducted in eastern Europe and is designed to assess Tenalisib’s anti-tumor activity (clinical benefit rate at the end of 6 months, disease control rate and overall response rates) and safety across two dose levels. The study also includes translational assessments intended to delineate the effect of Tenalisib’s multivalent mechanism on relevant cytokines/chemokine levels and gene expression changes within the tumor microenvironment.

The study included 40 enrolled patients (39 HR+/Her2- and 1 TNBC) presenting with stage IV A or IV B advanced or metastatic disease with majority of the patients having significant distal metastases to the bone, lymph nodes, lung and liver. The study population included patients with both primary resistance (~40%) and secondary resistance (~60%) to endocrine therapy and with ~50% of the patients undergoing prior chemotherapy treatment in a metastatic setting.

As of April 18th 2022, the initial results from the study showed that Tenalisib was well tolerated across dose levels with majority of reported adverse events being mild-to-moderate in severity. Discontinuations and dose reductions due to related AEs were minimal (5-7.5%). The median duration of treatment thus far was ~4 months (0.93 to 6.23+ months) with ~60% of patients continuing on the study. The median time to response was 1.8 months and preliminary efficacy results indicate an encouraging 67.5% DCR which is maintained across patients with primary endocrine resistance as well. Correlation of responses observed with gene expression profiles by RNA sequencing from tumor biopsy samples post treatment with Tenalisib and analysis of cytokine/chemokine levels post Tenalisib treatment are underway.

"We are encouraged by the early activity seen with Tenalisib in the advanced/metastatic disease setting where patients have limited treatment options once they have failed CDK inhibitors and endocrine therapies. As these results continue to translate into durable responses, we will be engaging with key opinion leaders and regulatory agencies to discuss the monotherapy and combination development plans and registration-enabling study designs." said Swaroop Vakkalanka, Founder & CEO of Rhizen Pharma. Swaroop also added that "Given the relevance of Tenalisib’s multi-valent mechanism across solid tumors, we expect these results will pave the way Tenalisib’s development to be expanded into other solid tumors. We are designing Tenalisib’s clinical programme carefully to arrive at an optimized dose and also deploy randomized study designs to fully elucidate its efficacy and safety."

Rhizen indicated that Tenalisib, in addition to its selective dual PI3K δ/γ inhibitory activity, also has Salt-Inducible Kinase 3 (SIK3) activity via its principal metabolite, that could potentially contribute to its chemo-sensitization effect, especially in breast cancer. Rhizen hopes to establish the single agent activity of Tenalisib in this current study after which it plans to expand the assessment across additional solid tumor indications and combinations both with chemotherapeutic agents and with immune-checkpoint inhibitors.

About Tenalisib (RP6530):

Tenalisib (RP6530) is a highly selective, next-generation, orally active, dual PI3K δ/γ inhibitor with additional SIK3 activity, that is currently in phase II clinical development for solid tumors & haematological malignancies. Tenalisib has been granted US FDA Fast Track & Orphan-Drug Designations for treatment of r/r PTCL and CTCL and had recently published data from its phase II study evaluating Tenalisib both as monotherapy and in combination with Romidepsin in r/r PTCL & CTCL which showed robust responses of ~75% ORR in r/r PTCL and ~54% in r/r CTCL. The combination was well tolerated with no additional toxicities noted over & above those of the individual agents, confirming Tenalisib’s superior safety profile in its class. Overall, Tenalisib has been studied in ~200 patients across studies till now and has shown potentially better safety outcomes vis-à-vis other agents in the PI3K class.

On May 4, 2022 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2022. Net loss for the first quarter was $89.4 million, or $1.05 per share, compared to net loss for the first quarter of 2021 of $47.1 million, or $0.66 per share (Press release, Cytokinetics, MAY 4, 2022, View Source [SID1234613588]). Cash, cash equivalents and investments totaled $686.1 million at March 31, 2022.

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"We achieved meaningful progress during the first quarter of 2022 with especially notable milestones relating to our cardiovascular pipeline, including the acceptance and filing of our NDA for omecamtiv mecarbil with FDA and the opening to enrollment in both SEQUOIA-HCM and Cohort 4 of REDWOOD-HCM. Additionally we shared positive data from Cohort 3 of REDWOOD-HCM demonstrating a substantial treatment effect with aficamten in patients taking disopyramide, and additional data from GALACTIC-HF reinforcing its safety, ease of initiation in the hospital setting and potential to reduce costs associated with fewer hospitalizations," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "Having secured long-term capital from Royalty Pharma also in the first quarter, our stronger balance sheet enables us to both accelerate our development of aficamten as well as to advance commercial readiness activities supportive of the potential approval of omecamtiv mecarbil this year."

Q1 and Recent Highlights

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

The U.S. Food and Drug Administration (FDA) accepted and filed our New Drug Application (NDA) for omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction (HFrEF). The NDA was assigned standard review with a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2022.

Continued building our commercial infrastructure and launch readiness capabilities for omecamtiv mecarbil in the U.S. including initiation of hiring first line field-based sales force leaders, selection of a patient services partner, and activities related to field force operations and market access.

Doubled the size of our therapeutic Medical Scientist team, hired a Field Director, and began recruitment for our Managed Healthcare Medical Scientist team.

Completed risk assessment of an end-to-end supply chain and advanced appropriate mitigating actions; initiated several major digital systems supportive of supply chain logistics.

Presented additional data from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) at the American College of Cardiology 71st Annual Scientific Session (ACC.22) including:

An analysis showing that a subgroup of patients in GALACTIC-HF treated with omecamtiv mecarbil led to a reduction in resource intensity, with an estimated cost offset of $3,085, or 19% reduction per patient. The majority of these cost reductions were due to heart failure hospitalizations avoided by patients who were treated with omecamtiv mecarbil.

An analysis showing that the effect of treatment with omecamtiv mecarbil was associated with similar risk reduction in the primary composite endpoint in both hospitalized patients and in outpatients, indicating that initiation of omecamtiv mecarbil was safe and well tolerated in both hospitalized patients and outpatients.
Announced results of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), a Phase 3 clinical trial of omecamtiv mecarbil in patients with HFrEF that evaluated the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET). After 20 weeks of treatment, there was no change in peak oxygen uptake (pVO2) in patients treated with omecamtiv mecarbil versus placebo. Adverse events, including major cardiac events, were similar between the treatment arms, and the safety profile of omecamtiv mecarbil was consistent with prior clinical trials, including GALACTIC-HF.

Published a manuscript entitled "Influence of Atrial Fibrillation on Efficacy and Safety of Omecamtiv Mecarbil in Heart Failure: The GALACTIC-HF Trial" in the European Heart Journal.

Published a manuscript entitled "Developments in Exercise Capacity Assessment in Heart Failure Clinical Trials and the Rationale for the Design of METEORIC-HF" in Circulation: Heart Failure.
aficamten (cardiac myosin inhibitor)

Announced positive data from Cohort 3 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), which enrolled patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) and a resting left ventricular outflow tract gradient (LVOT-G) ≥50, or resting LVOT-G ≥30 mmHg and post-Valsalva LVOT-G ≥50 mmHg, whose background therapy included disopyramide and in the majority a beta-adrenergic blocker. Results showed that substantial reductions in the average resting LVOT-G as well as the post-Valsalva LVOT-G (defined as resting gradient <30 mmHg and post-Valsalva gradient <50 mmHg) were achieved. The safety and tolerability of aficamten were consistent with prior experience in REDWOOD-HCM with no treatment interruptions and no serious adverse events attributed to treatment reported by the investigators.

Opened enrollment in Cohort 4 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), which will enroll, in an open label fashion, 30-40 patients with symptomatic non-obstructive hypertrophic cardiomyopathy receiving background medical therapy. The primary objective is to determine the safety and tolerability of aficamten in patients with non-obstructive hypertrophic cardiomyopathy.

Opened enrollment in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), a Phase 3 randomized, placebo-controlled, double-blind, multi-center clinical trial designed to evaluate the effect of aficamten on exercise capacity, heart failure symptoms, and New York Heart Association (NYHA) Functional Class in patients with symptomatic obstructive HCM on background medical therapy for 24 weeks.
Skeletal Muscle Program

reldesemtiv (fast skeletal muscle troponin activator (FSTA))

Continued conduct and enrollment of COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), the Phase 3 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS).
Pre-Clinical Development and Ongoing Research

Continued to advance new muscle directed compounds and conduct IND-enabling studies with the expectation of our potentially moving 1-2 drug candidates into clinical development in the next year.

Continued research activities directed to our other muscle biology research programs.
Corporate

Secured long-term capital from entities affiliated with Royalty Pharma to support the potential commercialization of omecamtiv mecarbil and the further development of aficamten. Royalty Pharma will provide Cytokinetics long-term capital and debt financing of up to $300 million, subject to certain conditions, to support the potential commercialization of omecamtiv mecarbil and the further development of aficamten, and other general corporate purposes. Royalty Pharma also purchased a royalty on aficamten of 4.5% on sales up to $1 billion and 3.5% on sales above $1 billion, subject to certain potential step-downs, in exchange for payments of up to $150 million.

Announced changes to the Board of Directors including the retirement of L. Patrick Gage, Ph.D., former Chairman of the Board, the appointment of John T. Henderson, M.B., Ch.B. as the company’s new Chairman, and the appointment of Robert A. Harrington, M.D., Arthur L. Bloomfield Professor and Chair, Department of Medicine, Stanford University, to the Board.

Joined with the European Organisation for Rare Diseases (EURORDIS) and the National Organization for Rare Disorders (NORD) to recognize Rare Disease Day, an international campaign elevating the public understanding of rare diseases.

Announced a three-year collaboration with the American Heart Association (AHA) Bay Area to accelerate education and awareness of heart disease, in which Cytokinetics will provide funding and support for several initiatives led by AHA Bay Area.

Awarded Cytokinetics Communications Fellowship Grants to patient advocacy organizations serving the heart failure, HCM and ALS communities to support increased capacity in communications, awareness building and community engagement for nonprofit organizations serving the patient community.
2022 Corporate Milestones

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

Launch omecamtiv mecarbil in the U.S. pending FDA approval in Q4 2022.
aficamten (cardiac myosin inhibitor)

Continue enrolling patients with obstructive HCM in SEQUOIA-HCM through 2022.

Continue enrolling patients with non-obstructive HCM in Cohort 4 of REDWOOD-HCM.

Begin second Phase 3 clinical trial of aficamten in obstructive HCM in 2H 2022.

Expect to share data from the open label extension study of aficamten, REDWOOD-HCM OLE, at Heart Failure 2022 on May 23, 2022.
CK-3828136 (CK-136) (cardiac troponin activator)

Reactivate development program for CK-136 in 2H 2022.
Skeletal Muscle Program

reldesemtiv (fast skeletal muscle troponin activator (FSTA))

Expect the Data Monitoring committee to conduct the first interim analysis from COURAGE-ALS in 2H 2022, assessing for futility, 12 weeks after approximately one-third or more of the planned sample size is randomized.
Financials

Revenues for the first quarter 2022 were $1.1 million compared to $6.5 million for the corresponding period in 2021. The decrease in revenues was primarily due to the termination of the Amgen agreement effective May 20, 2021.

Research and development expenses for the first quarter 2022 increased to $45.9 million compared to $31.6 million for the same period in 2021, due primarily to increases in spending for clinical development activities for our cardiac muscle inhibitor programs, facility expenses, COURAGE-ALS, and early research programs.

General and administrative expenses for the first quarter 2022 increased to $33.1 million from $15.6 million for the same period in 2021 due primarily to higher outside services spending in anticipation of the potential commercial launch of omecamtiv mecarbil, an increase in personnel related costs including stock-based compensation and facilities expenses for our new headquarters.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s first quarter results on a conference call today at 4:30 PM Eastern Time. The call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 5771758.

An archived replay of the webcast will be available via Cytokinetics’ website until May 18, 2022. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 5771758 from May 4, 2022 at 8:00 PM Eastern Time until May 18, 2022.

On May 4, 2022 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, reported that it will participate in BofA Securities 2022 Healthcare Conference (Press release, Novavax, MAY 4, 2022, View Source [SID1234613691]). Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion.

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A replay of the recorded fireside session will be available through the events page of the Company’s website at ir.novavax.com for 90 days.

On May 4, 2022 Juniper Biologics Pte Ltd, a science-led healthcare company focused on researching, developing and commercializing novel therapies, and Helsinn Group, a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track-record of commercial execution, reported the signing of an exclusive license agreement to develop and commercialise infigratinib (INN) in Australia, New Zealand, Southeast Asia and certain markets in the Middle East and Africa (see full list below) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement (Press release, Juniper Biologics, MAY 4, 2022, View Source [SID1234615015]).

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In 2021 infigratinib obtained accelerated approval from the U.S. Food and Drug Administration (FDA) under the brand name "TRUSELTIQ" for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is based on overall response rate and duration of response. Additionally, infigratinib received conditional approval by Health Canada and provisional approval by the Therapeutics Goods Association in Australia for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement. Continued approval in the U.S., Canada and Australia for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Infigratinib is not FDA-, Health Canada-or Therapeutics Goods Association-approved for any other indication in the United States, Canada and Australia, and is not approved for use by any other health authority.

Raman Singh, CEO of Juniper Biologics, commented: "The acquisition of infigratinib is an important addition to our oncology portfolio and a much-needed treatment for patients whose cancer has spread or cannot be removed by surgery. Our mission is to increase access to proven treatments and we trust that infigratinib will help advance the treatment of patients in markets, where there remains an unmet patient need."

Giorgio Calderari, Helsinn CEO commented: "This agreement with Juniper is another example of our Fully Integrated Targeted Therapy (FITT) Strategy in action as we continue to widen our network of partners for infigratinib. Helsinn’s renewed strategic focus is on developing highly innovative oncology assets to address unmet needs, and this license agreement with our trusted partner, Juniper Biologics, will ensure that this important treatment is accessible to patients in Australia, Southeast Asia and certain markets in Middle East and Africa." *The full list of countries covered by the license agreement includes: Algeria, Angola, Australia, Bahrain, Brunei, Cambodia, Egypt, India, Indonesia, Ivory Coast, Jordan, Kenya, Kuwait, Laos, Lebanon, Libya, Malaysia, Mauritius, Morocco, Myanmar, Nepal, New Zealand, Nigeria, Oman, Pakistan, Philippines, Qatar, Saudi Arabia, Seychelles, Singapore, South Africa, South Korea, Taiwan, Tanzania, Thailand, Tunisia, Sri Lanka, United Arab Emirates, Vietnam, Zimbabwe. About Infigratinib Infigratinib is an orally administered, selective, ATP‐competitive, kinase inhibitor of FGFR 1, 2, and 3. The therapy is currently under investigation as a potential first-line treatment for individuals with unresectable locally advanced or metastatic cholangiocarcinoma (bile duct cancer) with FGFR2 fusion/rearrangement and in the adjuvant setting for individuals with invasive urothelial carcinoma (bladder cancer) with susceptible FGFR3 genetic alterations.

About Cholangiocarcinoma (CCA) CCA represents an aggressive group of malignancies that form in the bile ducts. Although rare in most countries (with a worldwide estimated incidence of <6 per 100,000 people), the incidence of this malignancy is increasing worldwide. Because the disease is usually asymptomatic at early-stages, diagnosis may be delayed until advanced stages, when CCA typically presents as locally advanced or metastatic disease. Despite continuing advances in treatments, the prognosis for this disease remains poor, with a 5-year survival rate of <20%. FGFR2 genetic alterations are present in approximately 15% to 20% of CCA patients and represent potential targets for treatments.1,2 U.S. Indication and Important Safety Information for TRUSELTIQ (infigratinib) TRUSELTIQ (infigratinib) is indicated for the treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. Accelerated approval was granted based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). The recommended dosage of TRUSELTIQ is 125 mg (one 100 mg capsule and one 25 mg capsule) orally once daily for 21 consecutive days followed by 7 days off therapy, in 28-day cycles. Warnings and precautions · Ocular toxicity: Retinal pigment epithelial detachment (RPED), which may cause blurred vision, occurred in 11% of 351 patients treated with TRUSELTIQ, including patients with asymptomatic RPED, with a median onset of 26 days. Perform comprehensive ophthalmological exam including optical coherence tomography prior to initiating, at 1 month, at 3 months, and then every 3 months during treatment with TRUSELTIQ. Urgently evaluate patients for onset of visual symptoms and follow up every 3 weeks until resolved or TRUSELTIQ is discontinued. Withhold TRUSELTIQ as recommended. Dry eye occurred in 29% of 351 patients; treat with ocular demulcents as needed ·

Hyperphosphatemia and soft tissue mineralization: Hyperphosphatemia, which can lead to soft tissue mineralization, cutaneous calcinosis, non-uremic calciphylaxis, vascular calcification, and myocardial calcification, occurred in 82% of 351 patients treated with TRUSELTIQ, with a median time to onset of 8 days (range 1-349); 83% of 351 patients treated with TRUSELTIQ received phosphate binders. Monitor for hyperphosphatemia throughout treatment. Initiate phosphate-lowering therapy for serum phosphate >5.5 mg/dL; withhold TRUSELTIQ and initiate phosphate-lowering therapy for serum phosphate >7.5 mg/dL; withhold, reduce the dose, or permanently discontinue TRUSELTIQ based on duration and severity of hyperphosphatemia · Embryo-fetal toxicity: TRUSELTIQ can cause fetal harm. Advise pregnant women of the potential risk to the fetus; advise females of reproductive potential and men who are partnered with women of reproductive potential to use effective contraception during treatment with TRUSELTIQ and for 1 month after the final dose. Adverse reactions · Most common adverse reactions (incidence ≥20%, all grades): nail toxicity, stomatitis, dry eye, fatigue, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, constipation, abdominal pain, dry mouth, eyelash changes, diarrhea, dry skin, decreased appetite, blurred vision, and vomiting. · Most common laboratory abnormalities (incidence ≥20%, all grades): increased creatinine, increased phosphate, decreased phosphate, increased alkaline phosphatase, decreased hemoglobin, increased alanine aminotransferase, increased lipase, increased calcium, decreased lymphocytes, decreased sodium, increased triglycerides, increased aspartate aminotransferase (AST), increased urate, decreased platelets, decreased leukocytes, decreased albumin, increased bilirubin, and decreased potassium.

Drug interactions · CYP3A inhibitors: Avoid use with strong and moderate CYP3A inhibitors · CYP3A inducers: Avoid use with strong and moderate CYP3A inducers · Gastric acid–reducing agents: Avoid coadministration with proton pump inhibitors, histamine-2 receptor antagonists (H2RA), and locally acting antacids. If coadministration of H2RA or locally acting antacids cannot be avoided, separate TRUSELTIQ administration · H2RA: Take TRUSELTIQ 2 hours before or 10 hours after · Locally-acting antacid: Take TRUSELTIQ 2 hours before or 2 hours after Dosage and administration · Prior to initiating TRUSELTIQ: Confirm FGFR2 fusion or rearrangement; perform comprehensive ophthalmic exam including OCT; confirm negative pregnancy test in females of reproductive potential. · Starting dose: Take TRUSELTIQ orally once daily on Days 1-21 of 28-day cycles; continue treatment until disease progression or unacceptable toxicity. Take TRUSELTIQ on an empty stomach with a glass of water at least 1 hour before or 2 hours after food at approximately the same time each day. · No renal or hepatic impairment · 125 mg (one 100 mg capsule and one 25 mg capsule) · Mild and moderate renal impairment (creatinine clearance 30-89 mL/min) · 100 mg (one 100 mg capsule) · Mild hepatic impairment (total bilirubin >upper limit of normal [ULN] to 1.5 x ULN or AST > ULN) · 100 mg (one 100 mg capsule) · Moderate hepatic impairment (total bilirubin >1.5 to 3 x ULN with any AST) · 75 mg (three 25 mg capsules) · Dose modification: Consult the TRUSELTIQ full Prescribing Information for dose modifications and monitoring recommendations for RPED, hyperphosphatemia, and other Grades 3-4 adverse reactions.