On February 15, 2019 Eli Lilly and Company (NYSE:LLY) reported the successful completion of its acquisition of Loxo Oncology, Inc. (NASDAQ:LOXO) (Press release, Eli Lilly, FEB 15, 2019, View Source [SID1234533343]). The acquisition broadens the scope of Lilly’s oncology portfolio into precision medicines through the addition of a pipeline of highly selective potential medicines for patients with genomically defined cancers.

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Lilly’s tender offer for all outstanding shares of common stock of Loxo Oncology, at a price of $235.00 per share in cash, expired as scheduled at one minute past 11:59 p.m., Eastern time, on Thursday, February 14, 2019. As of the expiration of the tender offer, 26,043,820 shares of Loxo Oncology common stock were validly tendered and not properly withdrawn, representing approximately 84.6 percent of the shares of Loxo Oncology common stock outstanding, and have been accepted for payment under the terms of the tender offer. Following completion of the tender offer, Lilly completed the acquisition of Loxo Oncology through the previously-planned second-step merger.

"We are pleased to announce the completion of our acquisition of Loxo Oncology, which will expand the breadth of our portfolio into precision medicines and target cancers that are caused by specific gene abnormalities," said Anne White, president of Lilly Oncology. "We look forward to working with the Loxo Oncology team and continuing to rapidly advance this pioneering scientific innovation and improve the lives of people with cancer."

"The Loxo Oncology team has always been relentless and unified around the common goal of bringing highly selective medicines to patients with genomically defined cancers," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "With the acquisition now complete, we look forward to realizing the full value of our pipeline with the ongoing support of our teams in Connecticut, Colorado and California."

The acquisition of Loxo Oncology provides Lilly with a promising pipeline of investigational medicines, including:

LOXO-292, a first-in-class oral RET inhibitor that has been granted Breakthrough Therapy designation by the FDA for three indications, with an initial potential launch in 2020. LOXO-292 targets cancers with alterations to the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types, including certain lung and thyroid cancers as well as a subset of other cancers.
LOXO-305, an oral BTK inhibitor currently in Phase 1/2. LOXO-305 targets cancers with alterations to the Bruton’s tyrosine kinase (BTK), and is designed to address acquired resistance to currently available BTK inhibitors. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas.
In November 2017, Loxo Oncology and Bayer Consumer Care AG entered into a global collaboration for the development and commercialization of the TRK inhibitors Vitrakvi (larotrectinib) and LOXO-195. The Bayer/Loxo agreement provides that Bayer may elect to convert the co-exclusive license to an exclusive license in the U.S. and Puerto Rico in the event of a change of control of Loxo Oncology. Bayer exercised its election under the Bayer/Loxo agreement to convert its co-exclusive license to an exclusive license in the U.S. and Puerto Rico, pending clearance under the Hart-Scott-Rodino Antitrust Improvements Act. When the new exclusive licensing arrangement takes effect, Lilly will receive royalties from Bayer on future sales of Vitrakvi and LOXO-195 both in the U.S. and in international markets.

Lilly has reaffirmed its current 2019 financial guidance. The expected financial impact of Lilly’s acquisition of Loxo Oncology has been previously communicated and is reflected in Lilly’s current 2019 financial guidance, as announced on February 6, 2019.

The Offer and the Merger
The tender offer for all of the outstanding shares of common stock of Loxo Oncology at a price of $235.00 per share, net to the seller in cash, without interest and less any required tax withholding (the "Offer"), expired as scheduled at one minute past 11:59 p.m., Eastern time, on Thursday, February 14, 2019. Computershare Trust Company, N.A., the depositary and paying agent for the Offer, has advised Lilly that 26,043,820 shares of Loxo Oncology common stock were validly tendered and not properly withdrawn in the Offer, representing approximately 84.6 percent of the shares of Loxo Oncology common stock outstanding. All of the conditions to the Offer have been satisfied and on February 15, 2019, Lilly and its wholly-owned subsidiary, Bowfin Acquisition Corporation, accepted for payment, and will promptly pay for, all shares validly tendered and not properly withdrawn in the Offer.

Following completion of the Offer, Lilly completed the acquisition of Loxo Oncology through the merger of Bowfin Acquisition Corporation with and into Loxo Oncology, without a vote of Loxo Oncology’s stockholders pursuant to Section 251(h) of the General Corporation Law of the State of Delaware, with Loxo Oncology surviving the merger as a wholly-owned subsidiary of Lilly. In connection with the merger, each share of common stock of Loxo Oncology not validly tendered into the Offer (other than (1) shares owned by Loxo Oncology immediately prior to the effective time of the merger, (2) shares owned by Lilly or Bowfin Acquisition Corporation at the commencement of the Offer and owned by Lilly or Purchaser immediately prior to the effective time of the merger or (3) shares held by any stockholder that was entitled to and has properly demanded statutory appraisal of its shares) has been converted into the right to receive the same $235.00 per share in cash, without interest and less applicable tax withholding, as will be paid for all shares that were validly tendered and not properly withdrawn in the Offer. Loxo Oncology’s common stock will be delisted from the NASDAQ Stock Market.

On February 14, 2019 Aromics, a biotech company located at the Barcelona Science Park (PCB), reported that it has been awarded with 1,085.659€ from the European Union – through the SME instrument of the Horizon 2020 (H2020-EIC-SMEInst-2018-2020-Phase 2)– for the development of the BERMES project, whose objective is the completion of the regulatory preclinics of NAX035, an innovative therapy for the treatment of malignant mesothelioma, an aggressive and highly refractory tumor directly related to asbestos exposure (Press release, Aromics, FEB 14, 2019, View Source [SID1234554043]).

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BERMES, an acronym for "A novel derivative BERberine for Malignant MESothelioma", started on first November 2018 has a duration of two and a half years and a total budget of 1.55 M €. The contribution from the European Union joins the capital of 400,000 euros already raised by the company in 2017 – with the participation of the current owners, corporative partners and also small investors that were incorporated through the crowdfunding biomedicine platform Capital Cells – and the participative loan of 120.000 € allocated by the Catalan Institute of Finance through the corporate entrepreneurship programme IFEM, which is supported by the Agency for Enterprise Competitiveness (ACC1Ó) under the program of grants in the form of a guarantee for the financing of companies participating in corporate entrepreneurship projects by means of co-investment loans (FINPEC).

Malignant mesothelioma is a tumour that emerges in the mesothelium, a thin layer of tissue that surrounds many organs such as the lung, peritoneal cavity, heart or testicles. It is an aggressive malignancy that is highly resistant to current therapies. "Patients with malignant pleural mesothelioma, the most common type, continue to have a poor prognosis, with a survival of less than 10% at five years after diagnosis. Available therapies include surgery combined with chemotherapy and radiotherapy. Most patients, however, are diagnosed in advanced stages of the disease, when chemotherapy is usually the treatment of choice. A chemotherapy with a low rate of response, despite the significant effort made over the last ten years to find a more effective treatment," explains Dr. Carmen Plasencia, the co-founder and CEO of Aromics.

El This is the focus of the BERMES project, which seeks to develop a new cure for this devastating cancer, thus meeting an important medical need.

A public health problem not yet solved

The World Health Organization (WHO) has recognized that all forms of mesothelioma are strongly associated with asbestos exposure. Although recognized as a first-level carcinogen, asbestos is still being used daily in alarming quantities in more than 150 countries according to the International Ban Asbestos Secretariat (IBAS). In fact, the WHO estimates that more than 125 million people are daily at risk of exposure, of which approximately 10% will eventually develop mesothelioma.

"Asbestos still represent a great labour, environmental and public health problem that has not been solved. Even in those countries like EU countries where it is forbidden, this material still remain in many buildings and installations. Factors such as the high costs for the safe removal of elements that contain these mineral, increase the risk of appearance of these tumours," assures Carme Plasencia.

The incidence of this cancer is increasing all over the world, being the countries of the European Union (EU) those that register the highest number of cases despite the use of asbestos was definitively prohibited on 1st January 2005 (Directive 1999/77/EC).

El Notwithstanding, the malignancy has a long latency period (a 44.6 year average from the exposure to the diagnosis) being the incidence peak expected from 2020 onwards. In fact, the European Economic and Social Committee (EESC) estimates that more than 300,000 Europeans will die of mesothelioma by 2030, at that time it is expected that the maximum number of diseases caused by exposure to asbestos will be observed.

A first-in-class drug

The NAX035 compound is one of the most advanced in the Aromics therapy portfolio. It is the first candidate molecule of a new family of antitumour agents (first-in-class) to advance up to the clinical stage.

"It is a pioneering drug, very attractive to the pharmaceutical industry. The Aromics molecule binds to a specific messenger RNA and reduces the levels of a protein that is abnormally expressed in the tumour, and that is causing resistance to current chemotherapy treatments in mesothelioma patients. In this way we aim to address the root cause, stopping the synthesis of this abnormal protein and therefore controlling the disease", says Dr. Plasencia.

The drug has already demonstrated its effectiveness in reducing the tumour size when administered both, orally or intraperitoneally in experimental animal models, showing a good toxicological and safety profile. At the same time, the biotech is working to achieve the orphan designation for NAX035, which would represent an important milestone for the company.

"This project is a clear example of the company’s activity in the area of translational medicine that leads to a better understanding of the progression of the disease and the identification of specific molecular markers relevant to the treatment response, that allow us to develop more efficient therapeutic solutions for the treatment of complex pathologies such as cancer," Dr. Plasencia says.

After completing BERMES project, Aromics’ objective is continuing with the development of the compound up to early clinical stage to prove the efficacy in patients. After the clinical proof of concept, the biotechnology foresees a licencing or co-development agreement on the product with the pharmaceutical industry that will be finally the one leading the development up to the market. Aromics is already in contact with some pharmaceutical companies that have shown interest in the drug.

On February 14, 2019 Glenmark Pharmaceuticals Ltd, a research-led integrated global pharmaceutical company, reported that its Board of Directors has given an in-principle approval to spin off the innovation business into a new company in the US. Setting up of the new company will provide an enhanced focus to the innovation business and help accelerate the pipeline towards commercialization (Press release, Glenmark, FEB 14, 2019, View Source [SID1234553887]).

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The new innovation company will be a wholly-owned subsidiary of Glenmark and will be based in the US. It will have an independent board and a new Chief Executive Officer. The other members of the management and the team remain unchanged.

According to the plan, all innovative molecules in the pipeline, including preclinical assets and technology; the R&D centres in Switzerland, R&D centre at Paramus in the US and R&D centre at Navi Mumbai, India related to the innovation business, and the biologics manufacturing facility in Switzerland along with all employees associated with innovative R&D will be part of the new company. The new company will have over 400 employees as part of this business. The specialty and generics business will continue to be housed in the parent company and will not be part of this new company.

The transfer of the assets and employees to the new innovation company is expected to be completed in the next 6 to 9 months.

"Glenmark has built strong capabilities in the area of innovation in terms of world class infrastructure, talent pool, and technology. We currently have a pipeline of 8 NMEs most of which are first-in-class globally. The cutting edge work that the innovation team has delivered over the years has resulted in numerous achievements most notably among them being the fact that we have out-licensed our novel molecules to big pharmaceutical organizations consistently. With the pipeline at an advanced stage, we believe it’s the right time for the innovation business to be an independent entity and charter its own journey towards becoming a leading biotech organization globally. This change will provide enhanced focus to the business, a better operating ecosystem and additional opportunities to unlock value for the parent company in future," said Glenn Saldanha, chairman and managing director of Glenmark Pharmaceuticals.

Glenmark has been a pioneer in the area of drug discovery and development globally. For nearly two decades, the company has been expanding its capabilities for world-class research in small molecules and biologics. To date, Glenmark has generated around USD 250 million through 8 out-licensing deals for novel molecules to global pharmaceutical companies including Merck, Eli Lilly, Sanofi and Forest Laboratories.

Glenmark’s current innovation pipeline consists of 8 assets, including new chemical entities (NCEs) and new biological entities (NBEs), in various stages of development in the areas of immunology, oncology and pain management. The pipeline includes 3 immuno-oncology bispecific antibodies developed through Glenmark’s proprietary BEAT platform. The new company will further leverage the BEAT platform to enhance the pipeline. Of the 5 clinical and 3 pre-clinical assets in development, 2 clinical assets are currently in Phase 2b, and 1 asset is likely to enter Phase 2b in FY20.

The new innovation company will operate in an environment of cutting edge technology, biotech research and attract best in class talent to complement existing capabilities, which will help provide further impetus to the innovation business.

About Glenmark’s innovative pipeline
Glenmark has the following innovative assets in its pipeline currently:

Oncology: Glenmark has 4 assets in the area of oncology. The 2 assets in Phase 1 clinical development are: GBR 1302, a HER2xCD3 bispecific antibody (bsAb), being evaluated for HER2 positive cancers and GBR 1342, a CD38xCD3 bsAb, being studied for multiple myeloma and other malignancies of hematopoietic origin as well as a variety of solid tumours. The 2 assets in pre-clinical studies are GBR 1372, an EGFRxCD3 bsAb, being evaluated for treatment of colorectal cancer and a small molecule oncology program based on tumor antigen presenting biology.

Immunology: The company has 2 assets in this area: GBR 830, an anti-OX40R monoclonal antibody, is currently in Phase 2b clinical development for indication in moderate-to-severe atopic dermatitis and GRC 39815, a new chemical entity, currently being evaluated in pre-clinical studies as an inhaled compound for the possible treatment of Chronic Obstructive Pulmonary Disorder (COPD). GRC 39815 is an inhibitor of the Retinoid-related Orphan Receptor gamma t (RORγt).

Pain: Glenmark has 2 assets for pain management in clinical studies: GRC 27864, a non-opioid, potent, selective and orally bioavailable inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1), is currently being evaluated in Phase 2b clinical development for osteoarthritic pain and GRC 17536, a TRPA1 antagonist, has completed a Phase 2a proof of concept study in patients with painful diabetic neuropathy.

On February 14, 2019 Orion’s and Bayer’s reported that darolutamide plus androgen deprivation therapy (ADT) significantly extends metastasis-free survival with a favorable safety profile compared to placebo plus ADT in non-metastatic castration-resistant prostate cancer (Press release, Orion Biotechnology, FEB 14, 2019, View Source [SID1234533350]).

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Statistically significant improvement in metastasis-free survival (MFS), with a median MFS of 40.4 months with darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT (18.4 months).

Positive trend in overall survival with a 29% reduction in risk of death at interim analysis (P=0.045).

Incidence of treatment-emergent adverse events was similar for darolutamide plus ADT and placebo plus ADT.

Health-related quality of life was maintained.
First results from the Phase III ARAMIS trial with the androgen receptor antagonist darolutamide were presented in an oral presentation at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium and simultaneously published in The New England Journal of Medicine.
Abstract: 140 – ARAMIS

Results from the pivotal Phase III ARAMIS trial in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) showed a statistically significant improvement in metastasis-free survival (MFS) with darolutamide plus standard of care (ADT) compared to placebo plus ADT (HR=0.41, 95% CI 0.34-0.50; P<0.001). This translates to a 59 percent reduction in the risk of metastasis or death. The median MFS was 40.4 months in the darolutamide arm compared with 18.4 months for the placebo arm – an overall improvement in median MFS of 22 months.

A positive trend in overall survival (OS) was also observed (HR=0.71, 95% CI 0.50-0.99; P=0.045), and all other secondary endpoints demonstrated a benefit in favor of darolutamide. Importantly, the incidence of treatment-emergent adverse events (AEs) with greater than or equal to 5 percent frequency or of grade 3-5 was comparable between darolutamide and placebo arms; only fatigue occurred in more than 10 percent of patients (darolutamide plus ADT resulted in 12.1 percent versus 8.7 percent in patients with placebo plus ADT). Quality of life outcomes were similar between the treatment groups.

These data were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) in San Francisco and published simultaneously in The New England Journal of Medicine.

"In addition to a benefit in MFS, a favorable safety profile is critical for these largely asymptomatic nmCRPC patients because treatment decisions can impact their overall well-being, prognosis, compliance with the treatment as well as other medications that are typical for this patient population. These data are exciting for the prostate cancer community; they not only show darolutamide’s significant efficacy in preventing the spread of prostate cancer, but also its favorable tolerability profile that, once approved, may allow patients to continue their day-to-day life without adding any burden," said Karim Fizazi, M.D., Ph.D., Professor of Medicine at the Institut Gustave Roussy, University of Paris Sud, France.

"Prostate cancer patients are still in need of treatments that are not only effective but also safe without adverse events that would compromise their quality of life. Orion is working hard to bring innovative treatments to cancer patients. With the positive results of ARAMIS trial we together with Bayer are one step closer of bringing darolutamide to patients and their treating physicians", said Christer Nordstedt, PhD, MD, Senior Vice President, Research and Development, Orion Corporation.

Bayer plans to discuss the data from the ARAMIS trial with health authorities regarding the submission of new drug applications. Bayer has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for darolutamide in men with nmCRPC. Darolutamide is being developed jointly by Bayer and Orion Corporation.

Detailed study results

The MFS benefit observed with darolutamide was consistent across all subgroups of patients. In an interim analysis of OS, darolutamide showed a positive trend, with a 29 percent reduction in the risk of death (HR=0.71, 95% CI 0.50-0.99; P=0.045, median not reached).

In addition, darolutamide plus ADT demonstrated a significant benefit over placebo plus ADT for time to pain progression (40.3 months compared to 25.4 months; HR=0.65, 95% CI 0.53-0.79; P<0.001) and time to cytotoxic chemotherapy (median not reached compared to 38.2; HR=0.43, 95% CI 0.31-0.60; P<0.001). Another secondary endpoint, time to first symptomatic skeletal event (SSE), also demonstrated a benefit in favor of darolutamide (median not reached). Darolutamide extended progression-free survival (PFS) (36.8 months compared to 14.8 months; HR=0.38, 95% CI 0.32-0.45; P<0.001), with a 62 percent risk reduction of local progression, distant metastases or death.

Incidence of treatment-emergent AEs was similar between darolutamide and placebo; most AEs were grade 1 and 2 (55 percent with darolutamide plus ADT and 54 percent with placebo plus ADT). Compared to placebo plus ADT, darolutamide plus ADT did not increase rates of critical AEs including, but not limited to, seizures, falls, fractures, rash, cognitive disorder, mental impairment or hypertension. Patients with a history of seizure were not excluded from the study.

The results of Patient Reported Outcomes (PRO)-based endpoints (based on the Functional Assessment of Cancer Therapy-Prostate; FACT-P, European Organisation for Research and Treatment of Cancer quality of life; EORTC-QLQ-PR25, and EQ-5D-3L questionnaires) demonstrated maintenance of health-related quality of life (HRQoL) with a positive trend favoring darolutamide over placebo.

About the ARAMIS trial design

The ARAMIS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral darolutamide in patients with nmCRPC who are currently being treated with ADT as standard of care and are at high risk for developing metastatic disease. 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide twice a day or placebo along with ADT.

The primary endpoint of this trial is MFS defined as time between randomization and evidence of metastasis or death. The secondary endpoints of this trial are OS, time to pain progression, time to initiation of first cytotoxic chemotherapy, time to first SSE, and characterization of the safety and tolerability of darolutamide.

About castration-resistant prostate cancer (CRPC)

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide. Prostate cancer is the fifth leading cause of death from cancer in men. Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system. It mainly affects men over the age of 50, and the risk increases with age. Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e. substances that stop the formation of testosterone or prevent its effect at the target location. However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.

CRPC is an advanced form of the disease where the cancer keeps progressing even when the amount of testosterone is reduced to very low levels in the body. The field of treatment options for castration-resistant patients is evolving rapidly, but until recently, there have been no effective treatment options for CRPC patients who have rising Prostate-Specific Antigen (PSA) levels while on ADT and no detectable metastases. In men with progressive nmCRPC, a short PSA doubling time has been consistently associated with reduced time to first metastasis and death.

About darolutamide

Darolutamide is a non-steroidal androgen receptor antagonist with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. In addition to the Phase III trial ARAMIS in men with nmCRPC, darolutamide is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS). Information about these trials can be found at www.clinicaltrials.gov.

On February 14, 2019 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, repored full-year 2018 financial results on Wednesday, February 27, 2019, after the close of U.S. markets (Press release, CytomX Therapeutics, FEB 14, 2019, View Sourcenews-releases/news-release-details/cytomx-therapeutics-announce-full-year-2018-financial-results" target="_blank" title="View Sourcenews-releases/news-release-details/cytomx-therapeutics-announce-full-year-2018-financial-results" rel="nofollow">View Source [SID1234533349]). Following the announcement, the company will host a conference call beginning at 5:00 p.m. ET to discuss its results.

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Participants may access the live audio webcast of the teleconference from the "Investors & News" section of CytomX’s website at View Source . Please access the website 15 minutes prior to the start of the call to download and install any necessary audio software.

Audio Conference Call:
U.S. Dial-in Number: (877) 809-6037
International Dial-in Number: (615) 247-0221
Conference ID: 3748238
An archived webcast replay will be available on the Company’s website from February 27, 2019, until March 6, 2019.

CytomX Therapeutics’ 2019 Research and Development Day

CytomX plans to host a Research and Development Day on February 26, 2019 from 8:00 a.m. – 11:30 a.m. ET in New York City.

The event will be webcast live under the "Investors & News" section of CytomX’s website at View Sourceevents-and-presentations. Please connect to the webcast several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. An archived webcast replay will be available on the Company’s website for 90 days following the event.

Institutional investors and equity analysts seeking information on or registration for the live event in New York City please contact Chris Keenan at [email protected].