On May 10, 2022 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported an upcoming presentation of initial results from the GARNER (Genomic Analysis of high-Risk Non-muscle invasive bladder cancer) real-world study at the 2022 American Urological Association (AUA) Annual Meeting, which is being held in New Orleans, Louisiana, May 13-16, 2022 (Press release, GeneCentric Therapeutics, MAY 10, 2022, View Source [SID1234614066]). In this moderated poster presentation, the frequency of fibroblast growth factor receptor (FGFR) alterations in high-risk non-muscle invasive bladder cancer (HR-NMIBC) and the association with bacillus Calmette-Guérin (BCG) outcome will be discussed.

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The GARNER Study is the largest HR-NMIBC real-world patient cohort ever assembled with both clinical and genomic detail and the first study of the broader GARNER Bladder Cancer Program. The study is a collaboration between the Department of Urology at Erasmus MC Cancer Institute (EMC), Janssen Research & Development, LLC (Janssen) and GeneCentric Therapeutics. The collaboration, led at EMC by Tahlita Zuiverloon, MD, PhD, Principal Investigator at the Erasmus MC Urothelial Cancer Research Group (EUCRG), involves retrospective longitudinal, genomic analysis of samples from a cohort of almost 600 NMIBC patients who underwent surgery and adjuvant BCG treatment.

"The initial results from the GARNER Study provide a comprehensive picture of FGFR alteration frequency and other findings and provides a deeper understanding of drivers of disease progression, as well as potential factors related to treatment response and failure or drug resistance," said Dr Zuiverloon. "We look forward to presenting the initial findings from the study with our collaborators at GeneCentric and Janssen as we continue to explore the complexities of FGFR in HR-NMIBC."

While topline clinicogenomic results from this study will be presented at AUA2022, further results will be presented as part of a subsequent publication.

Details regarding the presentation are provided below and will be available following the meeting at View Source

Title: Frequency of Fibroblast Growth Factor Receptor Alterations and Association with Bacillus Calmette-Guérin Outcomes in a Real-World Genomic Analysis of High-Risk Non-Muscle-Invasive Bladder Cancer (GARNER) Study

First Author: Tahlita C.M. Zuiverloon, MD, Department of Urology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands

On May 10, 2022 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage precision oncology company designing and developing novel targeted therapies for cancer treatment, reported financial results for the quarter ended March 31, 2022 and provided operational updates (Press release, Turning Point Therapeutics, MAY 10, 2022, View Source [SID1234614081]).

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"We are pleased with our continued progress led by our topline data for repotrectinib and now our third BTD being granted for our lead asset," said Athena Countouriotis, M.D., President and CEO. "We recently expanded our clinical pipeline with our first in-license of TPX-4589, our potential first-in-class ADC targeting Claudin18.2, which was recently granted Orphan Drug designation by the FDA for both gastric and pancreatic cancers. We continue to advance our pipeline including elzovantinib and look forward to a data-rich second half of the year, including updates from our repotrectinib and elzovantinib programs as well as a first look at our discovery program for KRAS G12D."

First quarter and recent operational highlights include:

REPOTRECTINIB, ROS1/TRK INHIBITOR

Announced that the U.S. Food and Drug Administration (FDA) granted an eighth regulatory designation, and third BTD, to lead drug candidate repotrectinib. BTD was granted for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with one ROS1 tyrosine kinase inhibitor and who have not received prior platinum-based chemotherapy (expansion cohort EXP-4 of the TRIDENT-1 study).
Reported positive topline blinded independent central review (BICR) data from all of the ROS1-positive advanced NSCLC cohorts from TRIDENT-1, utilizing a February 11, 2022 data cutoff date. Data in both TKI-naïve and TKI-pretreated cohorts are consistent with a potentially best-in-class drug candidate for patients with ROS1-positive advanced NSCLC.

In the ROS1-positive TKI-naïve advanced NSCLC population (EXP-1: n=71), the cORR was 79% (n=56/71; 95% CI: 68, 88), with 4 patients (6%) achieving a complete response (CR) and 52 patients (73%) achieving a partial response (PR). The cORR does not include one patient in an unconfirmed partial response (uPR) with tumor regression of -38% on the last scan, who remained on treatment awaiting the next scan as of the data cutoff date.

DOR ranged from 1.4+ to 35.1+ months with probability of patients in a response at 6, 9, 12 and 18 months reflected in Table 1 utilizing a Kaplan-Meier analysis, with a median duration of follow-up of 10.2 months.

Patients at Risk: Patients who have reached the specified timepoint without censoring or an event (progression or death).

PFS ranged from 0+ to 40.4+ months with probability of patients remaining progression free at 6, 9, 12 and 18 months reflected in Table 2 utilizing a Kaplan-Meier analysis, with a median duration of follow-up of 10.8 months.

οIn the ROS1-positive advanced NSCLC population pretreated with one prior TKI and prior platinum-based chemotherapy (EXP-2: n=26), the cORR was 42% (95% CI: 23, 63). Duration of response ranged from 3.6 to 18.3+ months.
οIn the ROS1-positive advanced NSCLC population pretreated with two prior TKIs without prior chemotherapy (EXP-3: n=18), the cORR was 28% (95% CI: 10, 54). Duration of response ranged from 1.9+ to 20.3+ months.
οIn the ROS1-positive advanced NSCLC population pretreated with one prior TKI without prior chemotherapy (EXP-4: n=56), the cORR was 36% (95% CI: 23, 50). The cORR does not include two patients with an uPR who both had tumor regressions of -47% on their last scans, both of whom remained on treatment awaiting their next scans as of the data cutoff date. Duration of response ranged from 1.9+ to 17.8 months.
Repotrectinib was generally well tolerated in a total of 380 patients with a safety and tolerability profile that was consistent with previously reported findings.
The TRIDENT-1 study continues to enroll patients globally and enrollment across all six cohorts of the study remains open and continues to progress steadily.
ELZOVANTINIB (TPX-0022), MET/SRC/CSF1R INHIBITOR

Phase 1 dose escalation completed utilizing intermediate dose level of 60 mg QD to 60 mg BID.
Patient enrollment continues in the SHIELD-1 study at 40 mg QD to 40 mg BID in Phase 1 dose expansion.
TPX-0046, RET INHIBITOR

Ongoing characterization of the pharmacokinetics, safety, and efficacy profile in the dose finding portion of the study before determining the recommended Phase 2 dose (RP2D).
TPX-0131, ALK INHIBITOR

Ongoing patient dosing in the Phase 1/2 FORGE-1 study of TPX-0131 in locally advanced or metastatic TKI-pretreated ALK-positive NSCLC.

TPX-4589, CLAUDIN18.2 ADC

Announced exclusive license agreement with LaNova Medicines to develop and commercialize TPX-4589 (LM-302), a novel, potentially first-in-class, antibody drug conjugate (ADC) targeting Claudin18.2 in the U.S. and rest of the world excluding Greater China and South Korea. Claudin18.2 is a protein expressed in many gastrointestinal cancers, including gastric, gastroesophageal, and pancreatic cancer. TPX-4589 (known in China as LM-302) is currently in Phase 1 clinical trials in both the U.S. and China.
Received two Orphan Drug designations (ODDs) from the FDA in the first quarter of 2022. ODDs were granted to LaNova Medicines for the treatment of pancreatic cancer and for the treatment of gastric cancer, including cancer of the gastroesophageal junction.
DISCOVERY

Continued advancement of internal discovery programs targeting aberrant GTPase signaling known to drive genomically defined cancers with significant unmet medical need. The most advanced programs target KRAS G12D and the p21 activated kinase, or "PAK" family. The company is targeting nomination of two development candidates in the second half of 2022 with a goal to achieve at least one new IND per year beginning in 2023.
Upcoming Milestones

REPOTRECTINIB

Discuss topline BICR data from all the ROS1-positive NSCLC cohorts from TRIDENT-1 with the FDA at a pre-NDA meeting in the second quarter of 2022.
Present detailed study results, including intracranial activity, from the ROS1-positive advanced NSCLC cohorts of the TRIDENT-1 study at a medical conference in the second half of 2022.
Provide a clinical data update from the NTRK+ advanced solid tumor cohorts from TRIDENT-1 in the second half of 2022.
ELZOVANTINIB

Initiate the Phase 1b/2 SHIELD-2 study of elzovantinib in combination with aumolertinib in mid-2022.
Initiate the Phase 2 portion of the SHIELD-1 study in the second half of 2022, pending FDA feedback on data from the intermediate dose level.
Provide a clinical data update from the Phase 1 SHIELD-1 study in the second half of 2022.
TPX-0131

Provide early interim data from initial patients treated in the dose-finding portion of the FORGE-1 study in the fourth quarter of 2022 or early 2023.
TPX-4589

Present preclinical data at a medical conference by early 2023.
Provide additional guidance on clinical development plan by early 2023.
DISCOVERY

Nominate 2 development candidates in the second half of 2022.
Provide details on the other 2 GTPase signaling discovery programs in the second half of 2022.
First Quarter 2022 Financial Results

Revenue: Revenue recognized during the three months ended March 31, 2022 was $0.4 million from the sale of clinical supply to Zai Lab for supporting the TRIDENT-1 Phase 2 clinical trials in the Zai Territory, compared to $25.2 million for the first quarter of 2021, consisting of $25.0 million related to an upfront payment received under the Zai Lab Elzovantinib Agreement and $0.2 million from the sale of clinical supply to Zai for TRIDENT-1.

R&D Expenses: Research and development expenses were $55.1 million for the first quarter compared to $41.3 million for the first quarter of 2021. Primary drivers of the year-over-year increase were investments made to develop repotrectinib, elzovantinib, discovery efforts and personnel expenses.

G&A Expenses: General and administrative expenses were $20.3 million for the first quarter compared to $20.0 million for the first quarter of 2021.

Net Loss: Net loss was $74.4 million for the first quarter compared to net loss of $35.5 million for the first quarter of 2021, which included revenue for $25 million as upfront payment related to Zai Lab collaboration agreement.

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2022 totaled $918.2 million, reflecting a net decrease of approximately $63 million from December 31, 2021. Turning Point projects its cash position is sufficient to fund current operations through the first half of 2024.

On May 10, 2022 Pfizer Inc. (NYSE: PFE) and Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) reported that the companies have entered into a definitive agreement under which Pfizer will acquire Biohaven, the maker of NURTEC ODT, an innovative dual-acting migraine therapy approved for both acute treatment and episodic prevention of migraine in adults (Press release, Pfizer, MAY 10, 2022, View Source [SID1234614097]).

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Under the terms of the agreement, Pfizer will acquire all outstanding shares of Biohaven not already owned by Pfizer for $148.50 per share in cash. Biohaven common shareholders, including Pfizer, will also receive 0.5 of a share of New Biohaven, a new publicly traded company that will retain Biohaven’s non-CGRP development stage pipeline compounds, per Biohaven common share. The boards of directors of both

Biohaven and Pfizer have unanimously approved the transaction. Pfizer will pay transaction consideration totaling approximately $11.6 billion in cash. Pfizer will also make payments at closing to settle Biohaven’s third party debt and for the redemption of all outstanding shares of Biohaven’s redeemable preferred stock. The $148.50 cash consideration represents a premium of approximately 33% to Biohaven’s volume weighted average selling price of $111.70 over the three months prior to the announcement of the transaction.

The proposed transaction includes the acquisition of Biohaven’s calcitonin gene-related peptide (CGRP) programs including:

Rimegepant:

Approved in the United States (U.S.) under the trade name, NURTEC ODT, for both the acute treatment of migraine and preventive treatment of episodic migraine

Approved in the European Union under the trade name, VYDURA, for both acute treatment of migraine and prophylaxis of episodic migraine

Zavegepant:

On track for a 2Q2022 acceptance (based on March 2022 submission) in the U.S. as an intranasal spray for the acute treatment of migraine and in development as an oral soft gel for chronic migraine prevention

A portfolio of five pre-clinical CGRP assets

"Today’s announcement builds on our legacy of delivering breakthroughs for patients living with complex pain disorders and diseases that disproportionately impact women," said Nick Lagunowich, Global President, Pfizer Internal Medicine. "NURTEC ODT, which is already the #1 prescribed migraine medicine in its class in the United States, coupled with Biohaven’s CGRP pipeline, offers hope for patients suffering from migraine worldwide. We believe Pfizer is uniquely positioned to help the portfolio reach its full potential given our leading scale and capabilities, including comprehensive field force engagement with Primary Care Physicians, specialists and health systems delivering the right information at the right time."

This agreement follows on the November 9, 2021 collaboration for the commercialization of rimegepant and zavegepant outside the United States, in connection with which Pfizer invested $350 million to acquire 2.6% of Biohaven’s common stock at $173 per share.

"We are excited to announce Pfizer’s proposed acquisition of Biohaven, recognizing the market leadership of NURTEC ODT, our breakthrough all in one migraine therapy, and the untapped potential of our CGRP franchise," said Vlad Coric, MD, Chairman and Chief Executive Officer of Biohaven. "Pfizer’s capabilities will accelerate our mission to deliver our migraine medicines to even more patients, while the new R&D company is well positioned to bring value to patients and shareholders by focusing on our innovative pipeline for neurological and other disorders. We believe this transaction represents significant future value creation for patients and our collective shareholders."

Following the closing, New Biohaven will continue to operate under the Biohaven name. New Biohaven will be led by Vlad Coric, MD, as Chairman and CEO, and include other members of the current management team of Biohaven. Biohaven common shareholders will receive, for each Biohaven share, 0.5 of a share of New Biohaven distributed via a pro rata distribution of SEC-registered, publicly listed shares. At distribution, New Biohaven will be capitalized with $275 million of cash. New Biohaven will also have the right to receive tiered royalties from Pfizer on any annual net sales of rimegepant and zavegepant in the United States in excess of $5.25 billion.

Pfizer expects to finance the transaction with existing cash on hand.

Pfizer’s acquisition of Biohaven is subject to the completion of the New Biohaven spin-off transaction and other customary closing conditions, including receipt of regulatory approvals and approval by Biohaven’s shareholders. The companies expect the transaction to close by early 2023.

Due to the proposed transaction, Biohaven will not hold a conference call to discuss its first quarter 2022 financial results and will issue a press release and file a quarterly report on Form 10-Q with the U.S. Securities and Exchange Commission announcing those results on May 10, 2022.

J.P. Morgan acted as Pfizer’s financial advisor for the transaction with Ropes & Gray LLP acting as its legal advisor. Centerview Partners acted as Biohaven’s financial advisor for the transaction with Sullivan & Cromwell LLP acting as its legal advisor.

Investor Call Details

Pfizer and Biohaven will host an analyst and investor call today at 10am EDT to discuss the proposed transaction.

Webcast Details | Pfizer Analyst and Investor Call | May 10

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About Migraine

Around one billion people suffer from migraine across the globe, of which 75 percent are women. The World Health Organization classifies migraine as one of the 10 most disabling medical illnesses. There is a large unmet need for new acute and preventive treatments, as a significant portion of migraine patients are unsatisfied with current standard of care migraine treatments due to a lack of efficacy or safety or tolerability burden.

About Rimegepant

Rimegepant targets a root cause of migraine by reversibly blocking CGRP receptors, thereby inhibiting the biologic cascade that results in a migraine attack. Rimegepant was approved by the U.S. Food and Drug Administration (FDA) under the trade name NURTEC ODT for the acute treatment of migraine in February 2020 and for the preventive treatment of episodic migraine in May 2021. In April 2022, the European Commission (EC) granted marketing authorization for VYDURA (rimegepant) for both the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month. NURTEC ODT is the #1 prescribed migraine treatment in its class with a cumulative launch to date of U.S. net revenue of approximately $650 million and with more than two million prescriptions. A single dose of 75 mg NURTEC ODT provides fast pain relief, significant pain reduction and return to normal function, and has a lasting effect of up to 48 hours in some patients. NURTEC ODT is taken orally as needed, up to 18 doses/month to stop migraine attacks or taken every other day to help prevent migraine attacks and reduce the number of monthly migraine days. NURTEC ODT does not have addiction potential and is not associated with medication overuse headache or rebound headache.

About Zavegepant

Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from Biohaven’s NOJECTION Migraine Platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. The efficacy and safety profile of intranasal zavegepant for the acute treatment of migraine, as compared to placebo, was shown in a randomized controlled Phase 2/3 dose-ranging trial with a total of over 1000 patients who received zavegepant. In this study, zavegepant showed statistical superiority to placebo on the coprimary endpoints of 2-hour freedom from pain and freedom from a patients’ most bothersome symptom (either nausea, photophobia or phonophobia). This was the second zavegepant pivotal clinical trial to meet these coprimary endpoints. Biohaven plans to file a new drug application with the U.S. Food and Drug Administration for zavegepant in the second quarter of 2022.

NURTEC ODT U.S. IMPORTANT SAFETY INFORMATION

NURTEC ODT (orally disintegrating tablet) is a prescription medicine that is used to treat migraine in adults. It is for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine. It is not known if NURTEC ODT is safe and effective in children.

Do not take NURTEC ODT if you are allergic to NURTEC ODT (rimegepant) or any of its ingredients.

Before you take NURTEC ODT, tell your healthcare provider (HCP) about all your medical conditions, including if you:

have liver problems,

have kidney problems,

are pregnant or plan to become pregnant,

are breastfeeding or plan to breastfeed.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NURTEC ODT may cause serious side effects including allergic reactions, including trouble breathing and rash. This can happen days after you take NURTEC ODT. Call your HCP or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing. This occurred in less than 1% of patients treated with NURTEC ODT.

The most common side effects of NURTEC ODT were nausea (2.7%) and stomach pain/indigestion (2.4%). These are not the only possible side effects of NURTEC ODT. Tell your HCP if you have any side effects.

You are encouraged to report side effects of prescription drugs to the FDA. Visit View Source or call 1-800-FDA-1088 or report side effects to Biohaven at 1-833-4Nurtec.

On May 10, 2022 Domain Therapeutics, a biopharmaceutical company specializing in the research and development of innovative drugs targeting G Protein-Coupled Receptors (GPCRs) in immuno-oncology, reported the closing of a US $42m (€39m) series A financing round co-led by Panacea Venture, CTI Life Sciences and 3B Future Health Fund, and joined by adMare BioInnovations, Schroders Capital, Omnes, Turenne Capital, Theodorus, Viva BioInnovator and existing investor Seventure Partners (Press release, Domain Therapeutics, MAY 10, 2022, View Source [SID1234614129]).

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This investment is a significant step forward for the French-Canadian company as it seeks to bring novel therapeutic solutions to cancer patients, aimed at bypassing immunosuppression mediated by GPCRs. Domain Therapeutics will use the proceeds of this financing to i) conduct the clinical development of its EP4R antagonist, DT-9081, ii) advance two additional GPCR programs, including an anti-CCR8 antibody, to the Investigational New Drug application stage, and iii) progress its discovery-stage pipeline of a number of first-in-class assets targeting GPCRs, identified through its proprietary platforms.

"We are pleased to welcome our new shareholders and I thank them all for their commitment at this decisive stage of our company’s growth," comments Pascal Neuville, CEO of Domain Therapeutics. "After having delivered a first GPCR drug candidate for immuno-oncology together with Merck KGaA, Domain is now committed to advance its own treatments reviving the immune system to defeat cancer."

With the expansion of immune checkpoint inhibitor treatments and the understanding of how tumors highjack and escape the immune system, even under immunostimulating treatments, GPCRs have recently emerged as strategic targets responsible of immunosuppression and treatment-resistance mechanisms. Domain Therapeutics is leveraging its insights into GPCR science and technology to develop a robust immuno-oncology pipeline designed to harness the power of immunity and to broaden the impact of immunotherapies. In addition, Domain Therapeutics scientists are hunting for biomarkers, tissue microarray data, genetic mutations and protein expression to select patients who will benefit most from its immunotherapy treatments.

"Panacea Venture foresees in Domain Therapeutics an outstanding potential in terms of value creation in the near future by leveraging the promise of GPCRs to deliver innovative immunotherapies," adds James Huang, Founding Managing Partner of Panacea. "We look forward to contributing to the success and the development of the company."

"We are very proud to co-lead this strategic financial round to support Domain Therapeutics capabilities to innovate and transform the company into a clinical-stage biotech." mentions Laurence Rulleau, Managing Partner at CTI Life Sciences. "The presence of Canadian investors in this Series A reinforces the footprint of Domain in Montreal and will increase the visibility of the company in North America for future financing and clinical development."

"Domain Therapeutics has a unique positioning in GPCR-mediated immunoresistance. The combination of two decades of expertise in GPCR drug discovery and the development of the oncology franchise over the last years holds great promise to deliver innovative immunotherapies to patients and to address high unmet medical needs," remarks Roberto de Ponti, Managing Director and General Partner of 3B Future Health Fund. "We are delighted to support Domain Therapeutics high-performing management team in transforming a comprehensive portfolio of programs into cancer treatments."

The Board of Directors of Domain Therapeutics is now composed of : James Huang (Director, Panacea Venture), Laurence Rulleau (Director, CTI Life Sciences), Roberto de Ponti (Director, 3B Future Health Fund), Emmanuel Fiessinger (Director, Seventure Partners), Youssef Bennani (Chairman of the Board of Directors), Sylvie Ryckebusch (Independent Director), Pascal Neuville (Director and CEO), Katherine Cohen (Observer, Panacea venture), Frédéric Lemaître Auger (Observer, adMare BioInnovations), Erwin Boos (Observer, Schroders Capital) et Guillaume Blavier (Observer, Omnes).

Advisors involved in this operation

Lawyers

Advisors of the company:

Bird & Bird (Paris, France) : Emmanuelle Porte (Partner) and Claire Tanguy (Associate).
Advisors of investors:

BCF (Montreal, Canada): Gino Martel, Julien Lefebvre (Partners), Luka Pavlovic (Associate);
Jones Day (Paris, France): Geoffroy Pineau-Valencienne (Partner) and Jeanne Plé (Associate) ;
Chammas & Marcheteau (Paris, France): Jerôme Chapron (Partner), Pauline Vigneron (Associate) ;
Taylor Wessing (Paris, France): Nicolas De Witt (Partner) ;
McDermott Will & Emery (Paris, France): Emmanuelle Trombe (Partner), Laetitia de Dinechin (Associate).
Intellectual Property

Advisors of the company:

Vossius & Partner (Munich, Allemagne) : Oswin Ridderbusch (European Patent Attorney);
Lavery Avocats (Montreal, Canada): Alain Dumont (Partner).
Advisors of investors:

Goodwin Procter LLP (Boston, United States): Theresa C. Kavanaugh (Partner).
Financial advisors

Advisors of the company:

Agile Capital Markets (Paris, France) : Eric Cohen (Managing Director), Michael Khayat (Associate) ;
CenPonts Healthcare (Paris, France) : Xianding Ma (Partner), Jinlong Yue (Executive Director).

On May 10, 2022 Celsius Holdings, Inc., (Nasdaq: CELH), maker of the leading global fitness drink, CELSIUS reported preliminary financial results for the first quarter ended March 31, 2022 (Press release, Celsius Therapeutics, MAY 10, 2022, View Source [SID1234614146]). Management will host a conference call today at 4:30 p.m. Eastern Time to discuss the results with the investment community.

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A PDF containing our first quarter 2022 results and full financial tables is available at:
View Source

To participate in the conference call, please call one of the following telephone numbers at least 10 minutes before the start of the call:

Webcast: View Source

An audio replay of the call will be available on the Company’s website at:
View Source