On May 3, 2021 Genmab A/S (Nasdaq: GMAB) reported that In accordance with Article 19 of Regulation No. 596/2014 on Market Abuse and Implementing Regulation 2016/523, this document discloses the data of the transactions made in Genmab A/S (Nasdaq: GMAB) made by managerial employees and their closely associated persons (Press release, Genmab, MAY 3, 2021, View Source [SID1234579001]).

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The company’s managerial employees and their closely associated persons have given Genmab A/S power of attorney on their behalf to publish trading in Genmab shares by the company’s managerial employees and their closely associated persons.

On May 3, 2021 Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, reported that it will be releasing its financial results for the first quarter 2021 on Tuesday, May 11, 2021 (Press release, Biofrontera, MAY 3, 2021, View Source [SID1234579000]).

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Conference calls for shareholders and interested investors will be held on Wednesday, May 12, 2021, at the following times

On May 3, 2021 Roivant Sciences, a biopharmaceutical and healthcare technology company, and Montes Archimedes Acquisition Corp. (Nasdaq: MAAC), a special purpose acquisition company sponsored by Patient Square Capital, reported that they have entered into a definitive business combination agreement (Press release, Roivant Sciences, MAY 3, 2021, View Source [SID1234578996]). Upon closing of the transaction, outstanding shares and warrants of MAAC will be exchanged for newly issued shares and warrants of Roivant Sciences, which is expected to be listed on Nasdaq under the new ticker symbol "ROIV."

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The transaction is expected to deliver up to $611 million of gross proceeds to fund discovery and development programs. This includes up to $411 million currently held in MAAC’s trust account, as well as a concurrent $200 million common stock private investment in public equity ("PIPE") priced at $10.00 per share. New institutional and strategic investors and existing Roivant shareholders have committed to participate in the PIPE, including Fidelity Management & Research Company LLC, Eventide Asset Management, Suvretta Capital, Palantir Technologies, RTW Investments, LP, Viking Global Investors, Sumitomo Dainippon Pharma, and SB Management, a subsidiary of SoftBank Group Corp. Proceeds are expected to extend the company’s operating runway through mid-2024.

Patient Square Capital and key Roivant equity holders and management have agreed to long-term lockups, with at least 50% of their holdings locked up for three years. In addition, Patient Square Capital has agreed to convert an additional 30% of its shares of MAAC to earn-out shares subject to performance vesting thresholds: 20% of its shares will vest at $15.00 per share and 10% will vest at $20.00 per share for 20 of 30 trading days within five years of closing.

Jim Momtazee, Managing Partner of Patient Square Capital, will join Roivant’s board of directors. Prior to founding Patient Square Capital, Mr. Momtazee was a 21-year veteran of KKR where he helped form its health care investment team 20 years ago and ran that team for over a decade.

"Roivant is at the cutting edge of using technology to discover and develop transformative medicines for a wide range of serious diseases, and in a very short time they have established a remarkable track record of building subsidiaries that have run successful registrational clinical trials for approved medicines," said Mr. Momtazee. "I first met the company in 2015 and have watched its growth over the last 6 years with admiration. Based on our extensive due diligence spanning the last 5 months, I look forward to a long-lasting partnership with one of the most exciting and innovative companies in the life sciences industry."

Roivant will continue to operate under its current management team led by Chief Executive Officer Matthew Gline. Roivant founder Vivek Ramaswamy will continue to serve as Executive Chairman.

"I look forward to the next chapter of Roivant’s growth by beginning our life as a public company with an exceptionally strong and diverse base of long-term investors," said Mr. Gline. "We look forward to continuing to deliver important medicines to patients through our development engine and our rapidly growing drug discovery capabilities spanning multiple therapeutic areas and modalities."

The boards of directors of both Roivant and MAAC have unanimously approved the proposed transaction. Completion of the transaction, which is expected in the third quarter of 2021, is subject to approval of MAAC shareholders and the satisfaction or waiver of certain other customary closing conditions. A link to investor presentation materials is included below.

Roivant Sciences Overview
Since its founding in 2014, Roivant has put over 40 medicines into development across a wide range of disease areas. Companies built by Roivant have conducted eight consecutive positive Phase 3 studies with two FDA approvals to date. Roivant is also a leader in computational drug discovery through its combination of computational physics and machine learning-based platforms for the in silico design of small molecules. Roivant has over 800 employees across its family of companies today.

Transaction Overview
In this all-primary transaction, current holders of Roivant shares and equity awards will maintain their existing equity interests in Roivant. Current shareholders and warrant holders of MAAC will convert their shares and warrants of MAAC into common shares and warrants of Roivant on a one-for-one basis. Assuming a share price of $10.00 per share and no redemptions of MAAC shares, Roivant is expected to have an initial market capitalization of $7.3 billion inclusive of its pro forma net cash balance of approximately $2.3 billion.

Assuming no redemptions of MAAC shares, current shareholders of Roivant will own approximately 92% of Roivant immediately post-closing (including shares issued in connection with Roivant’s recent acquisition of Silicon Therapeutics and existing Roivant shareholder participation in the PIPE).

The closing of this transaction is expected in the third quarter of 2021 and is subject to the approval of MAAC’s shareholders and the satisfaction or waiver of certain other customary closing conditions.

Additional information about the proposed transaction, including a copy of the Business Combination Agreement and an investor presentation, will be provided in a Current Report on Form 8-K to be filed today by MAAC with the Securities and Exchange Commission ("SEC") and available at www.sec.gov.

Advisors
J.P. Morgan Securities LLC is serving as a financial advisor and capital markets advisor to Roivant and as a lead placement agent for the PIPE. SVB Leerink LLC is serving as a capital markets advisor to Roivant and as a lead placement agent for the PIPE. Goldman Sachs & Co. LLC is serving as a financial advisor to Roivant. Cowen and Company, LLC is serving as a financial advisor and capital markets advisor to Roivant. Citigroup Global Markets Inc. is serving as a placement agent for the PIPE. Truist Securities, Inc. is serving as a capital markets advisor to Roivant and as a placement agent for the PIPE. Davis Polk & Wardwell LLP is acting as legal counsel to Roivant. Kirkland & Ellis LLP is acting as legal counsel to MAAC.

On May 3, 2021 CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab (Vyrologix or PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, reported that it is preparing a request for a pre-Breakthrough Therapy designation (BTD) meeting ahead of preparing a Phase 3 clinical trial protocol for 22 solid tumor cancer indications (Press release, CytoDyn, MAY 3, 2021, View Source [SID1234578995]). The Company is extremely encouraged about the prospects of a Phase 3 trial and BTD based on preliminary indications of patients in the Company’s current Phase 2 basket trial, compassionate use study and a patient treated under an eIND, which may support a smaller trial.

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Scott Kelly, M.D., CytoDyn’s Chief Medical Officer, stated, "We are very encouraged by leronlimab’s potential to control metastasis by blocking CCR5 overexpression in cells that undergo malignant transformation. We also believe in the potential of leronlimab in the tumor microenvironment, including decreased angiogenesis, macrophage polarization, and blocking T regulatory cells that turn off the immune system’s ability to fight cancer."

Dr. Kelly recently presented "The Role of Leronlimab to Treat TNBC" at the Triple Negative Breast Cancer Drug Development Digital Summit 2021 and added, "We appreciate the warm reception of our oncology colleagues at the TNBC digital summit, and the recognition of the potential of leronlimab’s role in the future of immunotherapy."

Nader Pourhassan, Ph.D., President and Chief Executive Officer, commented, "Our multi-pathway approach to exploring all potential indications for leronlimab is proving to be very encouraging. We look forward to accelerating our efforts in the oncology field with leronlimab. We are equally excited to update our stockholders on Wednesday, especially concerning the potential use of leronlimab in treating COVID-19 in severe, critical, and long-hauler populations."

About Leronlimab (PRO 140)
Leronlimab has been studied in 11 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

Leronlimab is a viral-entry inhibitor in HIV/AIDS. It masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Nine clinical trials have demonstrated leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent with fewer side effects and less frequent dosing requirements than currently used daily drug therapies.

CytoDyn has successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn has been working diligently to resubmit its Biologics License Application ("BLA") for this HIV combination therapy since receiving a Refusal to File letter in July 2020 and subsequently meeting with the FDA telephonically to address their written guidance concerning the submission. CytoDyn expects to resubmit its BLA via a rolling submission starting in the third quarter of calendar 2021.

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.