On May 13, 2024 Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, reported financial results and business highlights for the first quarter ended March 31, 2024 (Press release, Centessa Pharmaceuticals, MAY 13, 2024, View Source [SID1234643137]).

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"2024 is off to a strong start for Centessa. Following clearance of our IND, we recently initiated the Phase 1 first-in-human, clinical trial of ORX750, a highly potent and selective orexin receptor 2 (OX2R) agonist for the treatment of narcolepsy, and remain on track with our goal to share proof-of-concept data in acutely sleep-deprived healthy volunteers in the second half of this year," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "We believe this study has the potential to deliver robust translational results that could lay the foundation for an orexin agonist clinical development program targeting narcolepsy Type 1 and Type 2 with the potential to expand into other sleep-wake disorders including idiopathic hypersomnia, as well as broader neurological indications. Additionally, the PRESent registrational studies for SerpinPC for the treatment of hemophilia B are progressing, and we plan to conduct an interim analysis of the PRESent-2 study later this year."

Dr. Saha continued, "We are thrilled to now be progressing all three of our most advanced pipeline programs in clinical studies focused on areas with significant unmet need, including hemophilia B, sleep-wake disorders, and solid tumors. With our recently strengthened balance sheet, we believe we are well positioned to execute on our clinical plans through multiple clinical readouts."

Recent Highlights
•In April and May, the Company completed an underwritten public offering of 12,390,254 American Depositary Shares ("ADSs") in the aggregate, at a price to the public of $9.25 per ADS, resulting in net proceeds of approximately $107.2 million, which included the underwriters’ over-allotment option to purchase additional shares.
•In April, the Company announced that the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug application (IND) to initiate a Phase 1 first-in-human (FIH), clinical trial of ORX750 for the treatment of narcolepsy.
•In February, the Company presented data from the third year (Part 5) of the ongoing Phase 2a study of SerpinPC, an investigational subcutaneously administered novel inhibitor of activated protein C (APC) for the treatment of hemophilia, during an oral presentation at the European Association for Haemophilia and Allied Disorders (EAHAD). Part 5 data from the Phase 2a study showed a continued favorable safety and tolerability profile for SerpinPC, as well as sustained long-term efficacy results, as measured by a 96% reduction in the median all-bleed annualized bleeding rate (ABR) from the prospective baseline measured during the pre-exposure observation period. To date, there have been no thromboembolic events and no treatment-related sustained elevations of D-dimer observed throughout the Phase 2a study.

Anticipated Upcoming Program Milestones
•Hemophilia Program – The registrational PRESent-2 (moderately severe to severe hemophilia B without inhibitors, and severe hemophilia A with or without inhibitors) and PRESent-3 (hemophilia B with inhibitors) studies of SerpinPC are ongoing. For PRESent-2, the Company plans to review Part 1 data in 2024 (interim analysis) with the goal of confirming a dose and advancing to Part 2 of the study. The primary endpoint of the PRESent-2 study is the rate of treated bleeds (expressed as ABR) during the first 24 weeks of treatment with SerpinPC (Part 2) compared to the observation period. The Company plans to share Part 1 data at a medical conference in late 2024 or early 2025.
•Orexin Agonist Program – The Phase 1 FIH clinical study of ORX750, which is being progressed for the treatment of narcolepsy, has been initiated. The Company expects to share clinical proof-of-concept data in acutely sleep-deprived healthy volunteers in 2H of 2024.
•LockBody Technology Platform – The Phase 1/2a FIH clinical study of LB101 (PD-L1xCD47 LockBody) for the treatment of solid tumors is ongoing.

Where applicable, the Company plans to provide updates on preclinical assets including follow-up orexin agonists and LB206, a PD-L1xCD3 LockBody, when they advance toward clinical studies.

First Quarter 2024 Financial Results
•Cash, Cash Equivalents and Short-term Investments: $230.2 million as of March 31, 2024. The Company expects its cash, cash equivalents and short-term investments as of March 31, 2024, in combination with approximately $107.2 million in aggregate net proceeds from our offering of ADSs completed in April and May 2024, will fund operations into mid-2026, without drawing on the remaining available tranches under the Oberland credit facility.
•Research & Development Expenses: $22.7 million for the first quarter ended March 31, 2024, compared to $32.8 million for the first quarter ended March 31, 2023.
•General & Administrative Expenses: $13.4 million for the first quarter ended March 31, 2024, compared to $16.1 million for the first quarter ended March 31, 2023.
•Net Loss Attributable to Ordinary Shareholders: $38.0 million for the first quarter ended March 31, 2024, compared to $50.7 million for the first quarter ended March 31, 2023.

On May 13, 2024 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported that it held a conference for 75 oncologists and coordinators who are conducting the pivotal Phase 3 advanced liver cancer study, to accelerate patient enrolment (Press release, Can-Fite BioPharma, MAY 13, 2024, View Source [SID1234643136]).

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The participants have been presented with the drug chemical and biological profile and the study protocol as well as study procedures. Dr. Lencioni, a key opinion leader in radiology of liver tumors, Department of Radiology, Pisa University School of Medicine Italy, educated the oncologists on the way to measure tumor lesion size prior and post namodenoson treatment. The difference in tumor growth or regression defines progression free survival (PFS) and the objective response rate (ORR) to the drug, serving as part of the study objectives. US experts presented to the participants the electronic data entry of the patients’ data during the trial.

"The conference was very successful and we are very pleased with the enthusiasm of the participants with respect to the drug characteristics. They are looking forward to complete patient enrolment and conclude the data of this very promising anti-cancer drug," said Dr. Pnina Fishman, Can-Fite CSO and Executive Chairperson.

Can-Fite has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on a pivotal Phase 3 clinical study which is now enrolling patients is Israel, Europe and the US. The study is designed to perform an interim analysis by an Independent Data Monitoring Committee (IDMC) upon enrollment of 50% patients. Namodenoson will be evaluated as a 2nd or 3rd line treatment for CPB7 patients in whom other approved therapies have not been effective.

Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania.

According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $6.1 billion by 2027 for the G8 countries.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On May 13, 2024 Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, reported financial results for the first quarter of 2024 and highlighted recent progress (Press release, Boundless Bio, MAY 13, 2024, View Source [SID1234643135]).

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"It has been an exciting quarter at Boundless Bio. The Phase 1/2 POTENTIATE trial of BBI-355, our potentially best-in-class, oral, selective CHK1 inhibitor, advanced into initial combination therapy modules evaluating BBI-355 together with an EGFR inhibitor or an FGFR inhibitor in patients with tumors harboring EGFR or FGFR oncogene amplifications, respectively. We also dosed the first patient with our second ecDNA-directed therapy (ecDTx), BBI-825, a first-in-class, oral, selective RNR inhibitor, which marks the company’s rapid growth and transition into a multi-asset, clinical-stage oncology company" said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. "With the completion of our recent IPO, we have the capital to take the next steps toward delivering on the promise of our ecDTx, a potential new vertical in cancer therapeutics."

Recent Highlights

BBI-355, a novel CHK1 inhibitor and the first ecDTx in development

•
Patient enrollment is ongoing in Part 1 of the Phase 1/2 POTENTIATE (Precision Oncology Trial Evaluating Novel Therapeutic Interrupting Amplifications Tied to ecDNA) trial, which evaluates BBI-355 as a single agent in patients with locally advanced or metastatic solid tumors with oncogene amplifications.

•
Initiated dose escalation in Part 2 of the Phase 1/2 POTENTIATE trial, which evaluates BBI-355 in combination with the EGFR inhibitor erlotinib and BBI-355 in combination with the FGFR inhibitor futibatinib in patients with tumors harboring EGFR or FGFR oncogene amplifications,

respectively, to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of each combination regimen.

•
Presented preliminary preclinical and clinical pharmacodynamic data on BBI-355 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024. Findings further support the development of BBI-355 as a differentiated single agent and combination treatment approach for oncogene amplified cancers.

BBI-825, a novel, selective RNR inhibitor targeting ecDNA assembly and repair

•
Dosed the first patient in the STARMAP (Study Targeting Acquired Resistance: MAPK Amplifications) trial, a first-in-human, Phase 1/2 study of BBI-825 as a single agent and in combination with select targeted cancer therapies, for patients with locally advanced or metastatic cancer with resistance gene amplifications.

First Quarter 2024 Financial Highlights

•
Cash Position: Cash, cash equivalents, and short-term investments totaled $104.9 million as of March 31, 2024. In addition, Boundless Bio completed its IPO in early April 2024 in which it sold 6,250,000 shares of its common stock for gross proceeds of $100.0 million. Boundless Bio expects its current cash position to fund operations into the second half of 2026 and through key clinical data milestones.

•
R&D Expenses: Research and development (R&D) expenses were $13.1 million for the first quarter of 2024, compared to $9.5 million for the same period in 2023. The increase in R&D expenses was primarily due to a $1.8 million increase in the direct program costs for BBI-355, BBI-825, and other development programs, a $0.5 million increase in personnel-related costs resulting from an increase in headcount and salary increases, $0.3 million of additional stock-based compensation, and a $1.0 million increase in third-party services and other miscellaneous R&D costs.

•
G&A Expenses: General and administrative (G&A) expenses were $3.8 million for the first quarter of 2024, compared to $2.6 million for the same period in 2023. The increase in G&A expenses was primarily due to a $0.3 million increase in personnel-related costs due to an increase in headcount and salary increases, $0.5 million of additional stock-based compensation, an increase in professional service fees of $0.2 million, and a $0.2 million increase in other G&A costs.

•
Net Loss: Net loss totaled $15.4 million and $11.7 million for the first quarters of 2024 and 2023, respectively, with non-cash stock-based compensation expense of $1.3 million and $0.6 million for the first quarters of 2024 and 2023, respectively.

About BBI-355

Boundless Bio’s lead ecDNA-directed therapy (ecDTx), BBI-355, is a novel, oral, selective small molecule inhibitor of checkpoint kinase 1 (CHK1) being studied in the ongoing, first-in-human, Phase 1/2 POTENTIATE clinical trial (NCT05827614) in patients with oncogene amplified cancers. CHK1 is a master regulator of cells’ response to replication stress (RS). RS is elevated in ecDNA-enabled oncogene amplified cancer cells and, because of this, represents a key vulnerability of those cells. BBI-355 was designed to exploit the elevated RS in ecDNA-enabled oncogene amplified cancer cells by disrupting proper CHK1 function in regulating RS and thereby facilitating catastrophic RS to preferentially kill cancer cells relative to healthy cells.

About BBI-825

Boundless Bio’s second ecDTx, BBI-825, is a novel, oral, selective small molecule inhibitor of ribonucleotide reductase (RNR) being studied in the ongoing, first-in-human, Phase 1/2 STARMAP clinical trial (NCT06299761) in cancer patients with resistance gene amplifications. In preclinical studies, BBI-825 demonstrated low double digit nanomolar RNR inhibition and tumor growth inhibition, including regressions, in both the prevention and treatment of amplification-mediated resistance in mitogen-activated protein kinase (MAPK) pathway-activated tumors. RNR is the rate-limiting enzyme responsible for cellular de novo synthesis of deoxynucleotide triphosphates (dNTPs), the building blocks of DNA, and is essential to the assembly and repair of ecDNA. BBI-825 was shown to dysregulate ecDNA-reliant cancer cell dNTP pools, deplete ecDNA, and was synthetic lethal in multiple oncogene amplified preclinical cancer models.

On May 13, 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that it will share new research from across its innovative portfolio of approved and investigational cancer therapies during the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 31 – June 4 (Press release, Astellas, MAY 13, 2024, View Source [SID1234643133]). A total of 16 abstracts will be presented, including new data from pivotal trials supporting ongoing regulatory reviews. The volume of data being presented by Astellas reinforces its commitment to changing the course of cancer treatment through targeted therapies for hard-to-treat cancers like prostate, urothelial, and gastric/gastroesophageal junction (GEJ) cancers.

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Tadaaki Taniguchi, MD, PhD, Chief Medical Officer, Astellas
"The data at ASCO (Free ASCO Whitepaper) demonstrate the strength and breadth of our growing oncology portfolio and provide new insights into our transformative therapies for patients living with some of the most devastating cancers. Recent regulatory achievements mean our oncology medicines are reaching more patients than ever worldwide, and we are continuing to pursue novel targets and invest in research to improve overall survival and raise quality of life."

Highlights at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting include:

Further data from the Phase 3 EV-302 trial evaluating enfortumab vedotin in combination with pembrolizumab versus chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC), including data in cisplatin-eligible and cisplatin-ineligible populations. These results support the combination as a landmark advancement in the care of patients with la/mUC, regardless of cisplatin eligibility, and serve as the basis of ongoing regulatory reviews by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), Japan’s Ministry of Health, Labour and Welfare (MHLW), and the China National Medical Products Administration (NMPA).
Final overall survival (OS) results from the Phase 3 SPOTLIGHT study, evaluating the efficacy and safety of zolbetuximab – a first-in-class claudin (CLDN) 18.2-targeted monoclonal antibody approved by Japan’s MLHW and currently in review by multiple regulatory authorities for approval worldwide. In this abstract, zolbetuximab is evaluated in combination with mFOLFOX6 (a combination chemotherapy regimen that includes oxaliplatin, leucovorin, and fluorouracil) for the first-line treatment of patients with CLDN18.2 positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. These results underpin the strength of the zolbetuximab clinical data supporting the pursuit of regulatory approvals worldwide.
Two new post-hoc analyses of the Phase 3 EMBARK trial, which evaluated enzalutamide plus leuprolide, placebo plus leuprolide, and enzalutamide (single agent) in patients with nonmetastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC) with high-risk biochemical recurrence (BCR), including an oral presentation on the impact of treatment suspension on health-related quality of life and a poster presentation on sexual activity patient-reported outcomes.
Astellas Presentations at 2024 ASCO (Free ASCO Whitepaper) Annual Meeting

Enfortumab Vedotin

Presentation Title

Lead Author

Presentation Details

Impact of exposure on outcomes with enfortumab vedotin in patients with locally

advanced or metastatic urothelial cancer

D. Petrylak

Type: Oral

Presentation

Abstract

Number: 4503

Date: June 3, 2024

8:00-11:00 AM

CDT

Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab

vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in

previously untreated locally advanced or metastatic urothelial cancer (la/mUC)

S. Gupta

Type: Oral

Presentation

Abstract

Number: 4502

Date: June 3, 2024

8:00-11:00 AM

CDT

Enfortumab vedotin (EV) in triple-negative breast cancer (TNBC) and HR+/HER2-

breast cancer (BC) cohorts of EV-202

A. Giordano

Type: Oral

Presentation

Abstract

Number: 1005

Date: June 1, 2024

3:00-6:00 PM

CDT

Enfortumab vedotin (EV) with pembrolizumab (P) versus chemotherapy (chemo) in

previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): Analysis of

cisplatin (cis)-eligible population from EV-302/KEYNOTE-A39

J. Bedke

Type: Poster

Presentation

Abstract

Number: 4562

Date: June 2, 2024
9:00 AM-12:00

PM CDT

Enfortumab vedotin (EV) with pembrolizumab (P) versus chemotherapy (chemo) in

previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): Analysis of

the cisplatin (cis)-ineligible population from EV-302/KEYNOTE-A39

M. Van Der Heijden

Type: Poster

Presentation

Abstract

Number: 4563

Date: June 2, 2024

9:00 AM-12:00

PM CDT

Enfortumab vedotin (EV) in non-squamous and squamous non–small cell lung cancer

(NSCLC) cohorts of EV-202

K. Muro

Type: Poster

Presentation

Abstract

Number: 8585

Date: June 3,2024

1:30-4:30 PM

CDT

Enfortumab vedotin (EV) in previously treated gastric/esophageal cancers cohorts of

EV-202

K. Muro

Type: Poster

Presentation

Abstract

Number: 4046

Date: June 1, 2024

1:30-4:30 PM

CDT

Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in

cisplatin-ineligible patients with muscle invasive bladder cancer (MIBC): 2-year event-

free survival and safety data for Cohort H

P. O’Donnell

Type: Poster

Presentation

Abstract

Number: 4564

Date: June 2, 2024

9:00 AM-12:00

PM CDT

Enfortumab vedotin and pembrolizumab as first-line treatment in recurrent or

metastatic head and neck squamous cell carcinoma: a cohort of the EV-202 trial

P. Swiecicki

Type: Poster

Presentation

Abstract

Number: TPS6116

Date: June 2, 2024

9:00 AM-12:00

PM CDT

Systematic Literature Review and Network Meta-Analysis of First-Line Therapies for

Locally Advanced/Metastatic Urothelial Carcinoma

L. Bloudek

Type: Online

publication

Abstract

Number: e16547

Real-world first-line treatment patterns and outcomes in patients with locally advanced

or metastatic urothelial carcinoma in the United States

R. Chen

Type: Online

Publication

Abstract

Number: e23287

Enzalutamide

Presentation Title

Lead Author

Presentation Details

EMBARK post-hoc analysis of impact of treatment suspension (TxS) on health-

related quality of life (HRQoL)

S. Freedland

Type: Oral Presentation

Abstract Number: 5005

Date: June 1, 2024

3:00-6:00PM CDT

EMBARK post hoc analysis of sexual activity (SA) patient-reported outcomes

(PROs) in patients (pts) who were sexually active or interested in sex at baseline (BL)

S. Freedland

Type: Poster Presentation

Abstract Number: 5084

Date: June 2, 2024

9:00 AM-12:00 PM CDT

Physicians use of first-line treatment intensification in metastatic castration-

sensitive prostate cancer (mCSPC): A discrete choice experiment

S. Loeb

Type: Poster Presentation

Abstract Number: 5087

Date: June 2, 2024

9:00 AM-12:00 PM CDT

Characteristics and treatment (Tx) patterns (TxP) of high-risk biochemically

recurrent (HR-BCR) non-metastatic castration-sensitive prostate cancer in the

real-world by race, age, and prostate-specific antigen (PSA) doubling time

(PSADT)

A. Morgans

Type: Online-Only Abstract

Abstract Number: e17071

Zolbetuximab

Presentation Title

Lead Author

Presentation Details

Final overall survival results from phase 3 SPOTLIGHT study evaluating

zolbetuximab + mFOLFOX6 as first-line (1L) treatment for patients (pts) with

claudin 18 isoform 2 (CLDN18.2)+, HER2−, locally advanced (LA) unresectable or

metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma

K. Shitara

Type: Poster Presentation

Abstract Number: 4036

Date: June 1, 2024

1:30-4:30 PM CDT

About PADCEV and the Astellas, Pfizer and Merck Collaboration
Astellas and Pfizer have a clinical collaboration agreement with Merck to evaluate the combination of Astellas’ and Pfizer’s PADCEV (enfortumab vedotin-ejfv) and Merck’s KEYTRUDA (pembrolizumab) in patients with previously untreated metastatic urothelial cancer. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada).

About XTANDI and the Pfizer/Astellas Collaboration
In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a commercial agreement to jointly develop and commercialize XTANDI (enzalutamide) in the United States, while Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing the product outside the United States. Pfizer receives alliance revenues as a share of U.S. profits and receives royalties on sales outside the U.S.

On May 13, 2024 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea" or the "Company"), a clinical stage biopharmaceutical company focused on precision oncology through synthetic lethality, reported that management will attend the 2024 RBC Capital Markets Global Healthcare Conference that will take place May 14-15, 2024 in New York, NY. Details are as follows (Press release, Aprea, MAY 13, 2024, View Source [SID1234643132]):

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2024 RBC Capital Markets Global Healthcare Conference
Date: May 14-15, 2024
Location: New York, NY

Management will be available for one-on-one meetings. To request a meeting, please contact your conference representative.