On May 3, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that Louis Matis, Senior Vice President and Chief Development Officer of Pieris Pharmaceuticals, Inc., will present at the 43rd Annual Deutsche Bank Healthcare Conference on Tuesday, May 8, 2018 at 8:00AM EDT at the Intercontinental Boston Hotel in Boston, Massachusetts. A webcast of the company’s presentation will be available at this link (Press release, Pieris Pharmaceuticals, MAY 3, 2018, View Source [SID1234526085]).

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Vical has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On May 3, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that it will present pre-clinical data for the drug candidate ATOR-1017 at the Protein Engineering Summit (PEGS) 14th Annual Meeting in Boston, US (Press release, Alligator Bioscience, MAY 3, 2018, View Source [SID1234538678]). ATOR-1017 is a monoclonal antibody that activates the costimulatory receptor 4-1BB expressed on T cells in the tumor area and is being developed for the treatment of metastasizing cancer.

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The data support a best-in-class profile for ATOR-1017, with a strong potential for high efficacy and tumor-directed immune activation.

ATOR-1017 is dependent on cross-linking with Fc-gamma receptors. This means that it has to bind both 4-1BB and Fc receptors for full activity. Both 4-1BB and Fc-gamma receptors are highly expressed in certain tumors and these receptors could be used as predictive efficacy biomarkers. Patients that overexpress these receptors should demonstrate a higher efficacy response to ATOR-1017, resulting in an increased immune activation in the tumors compared to the rest of the body. This supports that ATOR-1017 has the potential for a superior benefit/risk profile.

"I am very encouraged by these pre-clinical data. ATOR-1017 has the ideal profile to become a best-in-class 4-1BB antibody, with strong efficacy and minimal side-effects. This is perfectly in line with Alligator’s strategy to build a pipeline of tumor-directed immunotherapies" said Christina Furebring, SVP Research at Alligator Bioscience.

Today at 4:20 p.m. local EDT (10:20 pm CEST) Dr Peter Ellmark, VP Discovery at Alligator, will give an oral presentation with the title: "Tumor-directed targeting of Effector T cells and Regulatory T cells". Dr Ellmark is chairing the session on "Agonist Immunotherapy Targets" at PEGS.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 3:00 p.m. CEST on 3 May 2018.

About ATOR-1017
ATOR-1017 is an immunostimulatory antibody (IgG4) that binds to the costimulatory receptor 4-1BB (also known as CD137) expressed on tumor-specific T cells and NK cells. 4-1BB has the capacity to support the immune cells involved in tumor control, making 4-1BB a particularly attractive target for cancer immunotherapy.

ATOR-1017 is differentiated from other 4-1BB antibodies, partly because of its unique binding profile, but also because its immunostimulatory function is dependent on cross-linking to Fc-gamma receptors on immune cells. The aim is to achieve effective tumor-targeted immune stimulation with minimum side effects.

On May 3, 2018 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results for the first quarter ended March 31, 2018 and highlighted recent company achievements (Press release, GlycoMimetics, MAY 3, 2018, View Source [SID1234526009]). Quarter-end cash as a result of a follow-on financing in March was $242.6 million.

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"Our first-quarter 2018 accomplishments reflected both progress and transformation for GlycoMimetics. During this period, we laid a foundation – operationally and financially – from which we believe we will drive significant value creation. This foundation was built on the achievement of several key milestones, most notably, the announced design for our Phase 3 trial in relapsed/refractory acute myeloid leukemia (AML) patients, which forms the core of our comprehensive late-stage clinical development strategy for GMI-1271," said Rachel King, GlycoMimetics Chief Executive Officer.

"Our overall plan also includes a trial in Europe to test GMI-1271 in combination with a hypomethylating agent in newly diagnosed patients unfit for intensive chemotherapy. In addition, we continue to explore options for a trial in newly diagnosed patients fit for chemotherapy. Together these trials will position us, if successful, to offer a new standard treatment across the continuum of care in AML. Importantly, we now have the financial resources in place to achieve the key clinical milestones that we believe will drive value creation for the company," she added.

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 (U.S. and Canada) or (216) 562-0466 (international) and entering passcode 1096657. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.

Key Operational Highlights for the First Quarter of 2018:

Based on guidance from the US Food and Drug Administration (FDA), the company announced its design for a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate GMI-1271 in individuals with relapsed/refractory AML. The single pivotal trial is planned to enroll approximately 380 adult patients at 30 to 40 centers in the United States, Canada, Europe and Australia, with enrollment expected to begin in the third quarter of 2018.
The company entered into an agreement with the Haemato Oncology Foundation for Adults in the Netherlands, or HOVON, to initiate clinical trial startup activities to evaluate GMI-1271 in adults with newly diagnosed AML but who cannot tolerate intensive chemotherapy, as well as in patients with myelodysplastic syndrome, or MDS, with a high risk of leukemia.
The company’s strategic partner Pfizer continues to enroll individuals with sickle cell disease in its Phase 3 clinical study of rivipansel for the treatment of vaso-occlusive crisis. GlycoMimetics continues to expect rivipansel to advance to an anticipated topline Phase 3 readout in the fourth quarter of 2018.
First Quarter 2018 Financial Results:

Cash position: As of March 31, 2018, GlycoMimetics had cash and cash equivalents of $242.6 million as compared to $123.9 million as of December 31, 2017. GlycoMimetics successfully completed a follow-on public offering of 8,050,000 shares netting proceeds of approximately $128.4 million.
R&D Expenses: The Company’s research and development expenses increased to $9.0 million for the quarter ended March 31, 2018 as compared to $5.9 million for the first quarter of 2017. The increase was due to on-going costs related to manufacturing and process development for GMI-1271.
G&A Expenses: The Company’s general and administrative expenses increased to $2.9 million for the quarter ended March 31, 2018 as compared to $2.1 million for the quarter ended March 31, 2017. The increase was due to higher patent, legal and non-cash stock-based compensation expenses.
Shares Outstanding: Shares outstanding as of March 31, 2018 were 42,490,110.
About GMI-1271

GMI-1271 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, GMI-1271 was evaluated in both newly diagnosed elderly and relapsed/refractory patients with acute myeloid leukemia (AML). In both populations, patients treated with GMI-1271 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. The FDA has granted GMI-1271 Breakthrough Therapy designation for the treatment of adult AML patients with relapsed/refractory disease.

About Rivipansel

Rivipansel, the most advanced drug candidate in the GlycoMimetics pipeline, is a glycomimetic drug candidate that acts as a pan-selectin antagonist, meaning it binds to all three members of the selectin family – E-, P- and L-selectin. The first potential indication for rivipansel is vaso-occlusive crisis (VOC) of sickle cell disease (SCD), one of the most severe complications of SCD which can result in acute ischemic organ injury at one or more sites. By reducing cell adhesion, activation and inflammation that are believed to contribute to reduced blood flow through the microvasculature during VOC, GlycoMimetics believes that rivipansel could be the first drug to interrupt the underlying cause of VOC, thereby potentially enabling patients to leave the hospital more quickly. Pfizer is conducting a Phase 3 clinical trial for rivipansel in SCD.

On May 3, 2018 Editas Medicine, Inc. (NASDAQ:EDIT), a leading genome editing company, reported financial results for the first quarter ended March 31, 2018, and provided an update on recent achievements and upcoming events (Press release, Editas Medicine, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346904 [SID1234526067]).

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"We made steady progress in advancing our pipeline of CRISPR medicines toward the clinic and in building the company overall," said Katrine Bosley, President and Chief Executive Officer of Editas Medicine. "Our LCA10 program remains on track to file an IND by mid-2018, our leading experimental cell medicine in oncology is advancing towards an IND filing in our Celgene collaboration, and we have strong data in many of our earlier programs. In addition, we have significantly strengthened our Board of Directors with Jim Mullen joining as Chairman of the Board. All in all, 2018 is shaping up to be a transformative year for Editas and for the patients we aim to help."

Recent Achievements and Outlook

EDIT-101 for Leber Congenital Amaurosis type 10 (LCA10) on track for mid-2018 Investigational New Drug (IND) application filing. Editas has prepared what it believes is a strong package of preclinical data to support the IND filing. In data presented at the Association for Research in Vision and Ophthalmology 2018 Annual Meeting (ARVO Meeting), the Company demonstrated in transgenic mice that EDIT-101 caused predicted therapeutic levels of editing at adeno-associated virus doses that were safe and well tolerated in ocular gene therapy trials from other sponsors. At the American Society of Gene & Cell Therapy 21st Annual Meeting (ASGCT Meeting), the Company will demonstrate that EDIT-101 was well tolerated in a study of non-human primates.

Expanding oncology collaboration with Juno Therapeutics, Inc., a Celgene Company (Celgene). Editas is announcing today an expansion of its collaboration with Celgene to develop and commercialize chimeric antigen receptor and engineered T cell receptor medicines including Celgene’s lead program for human papillomavirus-associated solid tumors. As a result of the expansion and progress of the collaboration, Editas will receive an additional $10 million in cash and will be eligible to receive a fourth independent milestone and royalty stream.

Advancing research programs for recurrent ocular herpes simplex virus type 1 (HSV-1) and Usher syndrome type 2A (USH2A). The Company presented preclinical in vivo proof-of-concept data for its recurrent ocular HSV-1 program at the ARVO Meeting. Using the Company’s CRISPR gene editing approach in rabbits, HSV-1 viral load was reduced by 75% and corneal lesions by 91% relative to control. In addition, Editas and collaborators at Massachusetts Eye and Ear will present in vitro data at the ASGCT (Free ASGCT Whitepaper) Meeting validating the Company’s approach to deletion of exon 13 to treat USH2A.

Designing a potentially superior medicine for sickle cell disease and beta-thalassemia. Editas scientists have identified multiple sites at the beta-globin locus that regulate fetal hemoglobin induction, designed potent lead molecules, and demonstrated that these molecules drive upregulation of fetal hemoglobin in human mobilized peripheral blood stem cells. Data from this program will be presented at the upcoming ASGCT (Free ASGCT Whitepaper) Meeting.

Strong balance sheet to advance the Company through multiple value inflection points. The Company held cash, cash equivalents, and marketable securities of $359 million as of March 31, 2018, providing at least 24 months of funding for operating expenses and capital expenditures without any assumption of cash received from milestones or additional financings.
Strengthened organization with appointment of James C. Mullen and Jessica Hopfield, Ph.D., to Board of Directors. Mr. Mullen has been named Chairman of the Board of Directors and brings more than 30 years of experience in the biotechnology industry. He previously served as the Chief Executive Officer and President of Biogen, Inc., and as the Chief Executive officer of Patheon N.V. Dr. Hopfield is a former Partner of McKinsey & Company with more than 20 years of experience in healthcare.
Upcoming Events

Editas will participate in the following upcoming investor conferences:

Bank of America Merrill Lynch 2018 Health Care Conference, May 15-17, Las Vegas.
Editas will also participate in the following upcoming scientific and medical conferences:

TIDES 2018: Oligonucleotide and Peptide Therapeutics, May 7-10, Boston; and
American Society of Gene & Cell Therapy 21st Annual Meeting, May 16-19, Chicago.
First Quarter 2018 Financial Results

Cash, cash equivalents, and marketable securities at March 31, 2018, were $358.8 million, compared to $329.1 million at December 31, 2017.

For the first quarter ended March 31, 2018, net loss attributable to common stockholders was $30.9 million, or $0.67 per share, compared to $31.1 million, or $0.85 per share, for the same period in 2017.

Collaboration and other research and development revenues were $3.9 million for the quarter ended March 31, 2018, compared to $0.7 million for the same period in 2017. The $3.2 million increase was attributable to a $2.9 million increase in revenue recognized pursuant to our strategic alliance with Allergan Pharmaceuticals International Limited and a $0.3 million increase in reimbursable research and development expenses primarily resulting from the adoption of Accounting Standards Codification, Topic 606, Revenue From Contracts With Customers.
Research and development expenses were $21.3 million for the quarter ended March 31, 2018, compared to $19.0 million for the same period in 2017. The $2.3 million increase was primarily attributable to a $7.1 million increase in process and platform development costs and the acquisition of certain non-capitalized intangible assets, a $1.4 million increase in employee related expenses, a $0.3 million increase in stock-based compensation expenses, a $0.4 million increase in facility-related expenses and a $0.3 million increase in other expenses. This increase was partially offset by a $7.3 million decrease in sublicensing and success payment expenses.
General and administrative expenses were $14.2 million for the quarter ended March 31, 2018, compared to $12.3 million for the same period in 2017. The $1.9 million increase was primarily attributable to a $1.5 million increase in intellectual property legal expense and patent-related fees, a $0.4 million increase in stock-based compensation expenses, a $0.4 million increase in other expenses, and a $0.2 million increase in employee related expenses. This increase was partially offset by a $0.7 million decrease in professional service expenses.
Conference Call

The Editas management team will host a conference call and webcast today, May 3, 2018, at 5:00pm ET. To access the call, please dial 844-348-3801 (domestic) or 213-358-0955 (international) and provide the passcode 6079429. A live webcast of the call will be available on the Investors & Media section of the Editas Medicine website at www.editasmedicine.com and a replay will be available approximately two hours after its completion.