On May 3, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it will host Organon management at a meeting with the investment community (Press release, Merck & Co, MAY 3, 2021, View Source [SID1234579010]). Management will detail plans for how Organon is expected to drive sustainable growth and shareholder value as a standalone company.

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"The spinoff of Organon will help Merck become a leaner, more focused and agile company with stronger growth, and will enable significant operating efficiencies. Organon, as a standalone company, will be better positioned to realize its potential and to have a meaningful impact, particularly in women’s health", said Rob Davis, president, Merck. "We believe this transaction will create value for the patients both companies serve and for Merck shareholders."

At launch, Organon’s portfolio will consist of more than 60 medicines and products across its three core franchises: Women’s Health, Biosimilars and Established Brands.

"On June 3rd, Organon will launch as a new company, with solid growth opportunities and the ability to make an impact in women’s health," said Kevin Ali, Organon’s chief executive officer. "Our day one portfolio consists of many well-known products that were once core to Merck’s business but have since strategically received limited resources and investment. These are important medicines that we believe will be responsive to commercial investment, and with renewed management focus, we expect the portfolio to generate low to mid-single organic revenue growth off of a 2021 base. Additionally, as the only company of our size to be focused on women’s health, we have a significant opportunity to do more to support women and their health, and the time is right to bring forward more options for patients and healthcare providers."

During the event, members of Organon’s leadership team will outline the company’s strategic priorities to generate value for patients and shareholders. These include:

Developing a new commercial strategy and roadmap for sustainable growth. Organon has a strong and balanced foundation with a diverse portfolio of impactful brands built on a broad geographic footprint. With management focus and renewed investment, the company intends to capitalize on the growth potential of the existing Women’s Health and Biosimilars portfolios, while optimizing the well-known brands and associated cash flows of the Established Brands business. Organon will launch with a large commercial footprint with a direct sales presence in 58 markets, while supplying products to over 140 markets. The company has also begun to execute on its vision of becoming a leader in women’s health, with the recently announced proposed acquisition of Alydia Health.
Driving leadership in women’s health. Organon has a scaled portfolio of contraceptive and fertility brands, anchored by market exclusivity for NEXPLANON (etonogestrel implant), that delivered approximately $1.6 billion in global sales in 2020 and has long-term growth potential. Organon will also broaden its definition of women’s health beyond contraception and fertility to address conditions that are unique to women as well as health issues that disproportionately affect women, placing Organon in an addressable market of more than $60 billion by 2026.
Executing on the commercialization of Biosimilars. Organon will be in a strong position with the products in its current portfolio through its long-standing collaboration with Samsung Bioepis. Growth drivers in Organon’s Biosimilars portfolio are expected to include the continued success of RENFLEXIS (infliximab-abda) in the U.S., the launch of AYBINTIO (bevacizumab) in the EU and HADLIMA (adalimumab-bwwd) in Canada, as well as the anticipated launch of HADLIMA in the U.S. in 2023.
Leveraging the Established Brands portfolio for steady cash flow. The Established Brands business consists of 49 products across a range of therapeutic areas, including respiratory, cardiovascular, dermatology and non-opioid pain, and delivered $4.5 billion of revenue in 2020. This portfolio includes brands beyond their patent loss in most markets, with only modest remaining LOE exposure beyond 2021. The company will look to capitalize on these well-known and recognizable brands in international markets by selectively increasing commercial spend in areas that have the potential to offer solid returns.
Developing a new R&D approach with women at the center. Organon will look across academic centers, as well as early and established companies, to find promising drugs, diagnostics and devices to develop through its global capabilities in clinical development and patient safety, regulatory and medical affairs. Its R&D philosophy is to build a business around patient needs, advancing healthcare options for women that enable them to live their best lives every day.
2021 Investor Day Presenters
Investor Day will feature presentations from the following Merck and Organon executives in order of their appearance:

Rob Davis, President, Merck
Kevin Ali, Chief Executive Officer, Organon
Susanne Fiedler, Chief Commercial Officer, Organon
Simon Holland, Women’s Health, Commercial Lead, Organon
Elisabeth Weis, Fertility, Commercial Lead, Organon
Joe Azzinaro, Biosimilars, Commercial Lead, Organon
Ger Brennan, Established Brands, Commercial Lead, Organon
Sandy Milligan, Head of Research & Development, Organon
Matthew Walsh, Chief Financial Officer, Organon
The full biographies of the speakers can be found at www.merck.com/events/organon-co-investor-day.

Webcast Details
Merck invites shareholders, the investment community, the media and the general public to tune into the webcast of the Investor Day event today from 10:00 am to 12:15 pm EDT. To register for the webcast and view related materials, including presentations and speaker biographies, please visit the website at www.merck.com/events/organon-co-investor-day or listen-in to the audio-only teleconference with the opportunity to ask questions by dialing 1-844-340-4759 or internationally at 1-412-717-9615. A replay and transcript will be available shortly after the completion of the live webcast.

On May 3, 2021 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that management will participate in two upcoming virtual conferences (Press release, BioMarin, MAY 3, 2021, View Source [SID1234579027]). An audio webcast of the presentations will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

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On May 3, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results for the quarter ended March 31, 2021 and highlighted recent company events. Cash and cash equivalents at March 31, 2021 were $132.5 million (Press release, GlycoMimetics, MAY 3, 2021, View Source [SID1234578982]).

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"Our recent achievements, both in our collaboration with Apollomics and in data presentations at AACR (Free AACR Whitepaper), underscore the productivity of our pipeline. Working closely with investigators, regulators and collaborators, we are seeing great enthusiasm for our lead program, uproleselan, globally. The Chinese health agency’s granting of a Breakthrough Therapy Designation as well as Apollomics’ announcement of dosing of the first patient in Greater China support our outlook for this drug candidate. Complementing that achievement is our work with uproleselan in the U.S., namely, continued progress on our own Phase 3 AML trial and that of the National Cancer Institute, or NCI. Finally, with a focus on the early results from our GMI-1359 proof-of-concept trial and our preclinical work in the galectin-3 space, the AACR (Free AACR Whitepaper) meeting added visibility for our pipeline opportunities that have the potential to address key unmet needs in hematology and beyond," commented Rachel King, Chief Executive Officer.

Operational Highlights

Uproleselan

Enrollment of GlycoMimetics’ pivotal Phase 3 trial in relapsed/refractory AML continued in the U.S., Australia and Europe at a steady pace throughout the first quarter of 2021. The Company continues to be confident that enrollment will be completed by year-end 2021.
The pace of enrollment in the NCI-sponsored Phase 2/3 registration trial, designed to evaluate uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy, continues to support our expectation that the Phase 2 portion will complete in 2021, and allow for a subsequent interim Event-Free Survival analysis of 262 patients.
Apollomics, our exclusive collaborator for development and commercialization of uproleselan in Greater China, received Breakthrough Therapy Designation from the Center for Drug Evaluation of the China National Medical Products Administration in early January. In March, Apollomics reported the dosing of its first patient in a Phase 1 clinical trial that will bridge to a Phase 3 study in China.
GMI-1359

In April 2021 at the AACR (Free AACR Whitepaper) meeting, Duke University clinicians reported biologic activity, cell mobilization and immune activation in the first two patients treated in a proof-of-concept Phase 1b study to evaluate GMI-1359 in patients with advanced breast cancer with bone metastases. The ongoing study’s data support the dual functionality of the compound.
GMI-1687

The Company announced it would focus on advancing GMI-1687, designed for subcutaneous dosing, towards an Investigational New Drug Application and further development in sickle cell disease. Published preclinical data support the compound’s profile as a fast-acting, subcutaneously-dosed, E-selectin inhibitor that could potentially be self-administered at the onset of a vaso-occlusive crisis to obviate the need for opioids, acute care visits and inpatient hospitalization.
Executive Management Team

The Company announced the promotion of Eric Feldman, M.D., to Senior Vice President and Chief Medical Officer. Dr. Feldman, who joined the Company two years ago as Vice President, Global Clinical Development, is internationally recognized for his work in the development of new therapies for the treatment of leukemias and related bone marrow disorders.
First Quarter 2021 Financial Results

Cash position: As of March 31, 2021, GlycoMimetics had cash and cash equivalents of $132.5 million as compared to $137.0 million as of December 31, 2020.
R&D Expenses: The Company’s research and development expenses decreased to $11.2 million for the quarter ended March 31, 2021 as compared to $12.7 million for the same period in 2020 primarily due to lower clinical assay development and manufacturing expenses related to uproleselan.
G&A Expenses: The Company’s general and administrative expenses decreased to $4.2 million for the quarter ended March 31, 2021 as compared to $4.4 million for the same period in 2020, primarily due to lower stock-based compensation expense.
Shares Outstanding: Shares of common stock outstanding as of March 31, 2021 were 51,539,010.
The Company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 for domestic participants or (216) 562-0466 for international participants, with participant code 9891637. Participants are encouraged to connect 15 minutes in advance of the call to ensure that all callers are able to connect. A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, participant code 9891637.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. FDA and from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.

About GMI-1687

Discovered and developed by GlycoMimetics, GMI-1687 is a highly-targeted, highly-potent E-selectin antagonist. It has been shown in preclinical studies to be bioavailable via subcutaneous administration. During 2020, data from oral presentations at major scientific conferences pointed to the potential for a self-administered drug to treat VOC of sickle cell disease. Previously, GlycoMimetics demonstrated in preclinical models that GMI-1687 could be a potentially self-administered drug to be used in treatment of AML. The investigational drug also represents a potential life cycle extension opportunity for uproleselan.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4, which are adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow, such as AML and multiple myeloma, or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor affecting about 900 adolescents a year in the United States. GMI-1359 completed a Phase 1 clinical trial in healthy volunteers, and a Phase 1b clinical study designed to enable investigators to study dose ranging and to generate initial biomarker data around the drug’s activity in breast cancer patients is in progress. In the first two patients evaluated, the study showed evidence of on-target effects, immune-activation and cell mobilization. GMI-1359 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the treatment of osteosarcoma.

On May 3, 2021 AVEO Oncology (Nasdaq: AVEO), a commercial and clinical development stage biopharmaceutical company, reported that it will report first quarter 2021 financial results on Monday, May 10, 2021 (Press release, AVEO, MAY 3, 2021, View Source [SID1234579011]). AVEO’s management team will host a conference call and audio webcast at 4:30 p.m. ET on Monday, May 10, 2021, to discuss the financial results and provide a business update.

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The call can be accessed by dialing (844) 882-7841 (U.S. and Canada) or (574) 990-9828 (international). The passcode for the conference call is 3996993. To access the live webcast, or the subsequent archived recording, please visit the Investors section of the AVEO website at www.aveooncology.com.

On May 3, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the Company will release its first quarter 2021 financial results on Thursday, May 13, 2021 before the U.S. financial markets open (Press release, Compugen, MAY 3, 2021, View Source [SID1234579028]). Management will host a conference call and webcast to review the results and provide a corporate update at 8:30 AM ET.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S.,
or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.