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.

On May 3, 2018 Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) reported that the U.S. Food and Drug Administration (FDA) has approved Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding (Press release, Portola Pharmaceuticals, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2347018 [SID1234526086]).

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Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations and was approved under the FDA’s Accelerated Approval pathway based on the change from baseline in anti-Factor Xa activity in healthy volunteers. Continued approval for this indication may be contingent upon post-marketing study results to demonstrate an improvement in hemostasis in patients.

"Today’s approval represents a significant step forward in patient care and one that the medical community has been eagerly anticipating," said Stuart J. Connolly, M.D., ANNEXA-4 Executive Committee chairman and professor in the Department of Medicine of the Faculty of Health Sciences at McMaster University in Hamilton, Ontario. "Andexxa’s rapid reversal of the anticoagulating effects of rivaroxaban and apixaban will help clinicians treat life-threatening bleeds, where every minute counts."

The use of Factor Xa inhibitors is rapidly growing because of their efficacy and safety profile compared to enoxaparin and warfarin in preventing and treating thromboembolic conditions such as stroke, pulmonary embolism and venous thromboembolism (VTE). This growth has come with a related increase in the incidence of hospital admissions and deaths related to bleeding, the major complication of anticoagulation. In the U.S. alone in 2016, there were approximately 117,000 hospital admissions attributable to Factor Xa inhibitor-related bleeding and nearly 2,000 bleeding-related deaths per month.

"We are grateful to the patients who participated in our trials, our clinical trial collaborators, our employees and the FDA for their help in bringing this new drug to market for the benefit of patients with Factor Xa inhibitor-related bleeding," said Bill Lis, chief executive officer of Portola. "We are proud that Andexxa is a first-in-class medicine discovered in our labs. In addition to Bevyxxa, the first and only anticoagulant approved for extended VTE prevention in acute hospitalized medical patients, Andexxa is our second FDA-approved product with the potential to save lives and have a major impact on global public health. We remain committed to our scientific leadership in the fields of thrombosis and hematologic cancers."

The approval of Andexxa is supported by data from two Phase 3 ANNEXA studies (ANNEXA-R and ANNEXA-A) published in The New England Journal of Medicine, which evaluated the safety and efficacy of Andexxa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in healthy volunteers (Figure 1 and Figure 2, respectively). As described in the label, results demonstrated that Andexxa rapidly and significantly reversed anti-Factor Xa activity (the anticoagulant mechanism of these medicines). The median decrease in anti-Factor Xa activity from baseline was 97 percent for rivaroxaban and 92 percent for apixaban.

Interim data from the ongoing ANNEXA-4 single-arm, open-label study in patients with major bleeding also were assessed by the FDA as part of its review and approval. Data from 185 evaluable patients showed that Andexxa rapidly and significantly reversed anti-Factor Xa activity when administered as a bolus and sustained this reversal when followed by a 120-minute infusion. The median decrease from baseline was 90 percent for rivaroxaban and 93 percent for apixaban.

For additional Important Safety Information and Andexxa’s full Prescribing Information, please visit View Source

The post-marketing requirement is a clinical trial that randomizes patients to receive either Andexxa or usual care (the type of care the enrolling institution would provide in the absence of Andexxa). This study is scheduled to be initiated in 2019 and be reported in 2023.

"The expansion of available reversal agents for people prescribed newer oral anticoagulant therapies is crucial," said Randy Fenninger, chief executive officer of the National Blood Clot Alliance, a patient-led, voluntary health advocacy organization. "The availability now of a reversal agent specific to rivaroxaban and apixaban expands choice and enables patients and providers to consider these treatment options with greater confidence."

Consistent with the Company’s prior plan, Portola expects to launch Andexxa under an Early Supply Program with Generation 1 product in early June. Broader commercial launch is anticipated in early 2019 upon FDA approval of its Generation 2 manufacturing process.

The Marketing Authorization Application (MAA) for andexanet alfa is also under review by the European Medicines Agency. The Committee for Medicinal Products for Human Use (CHMP) communicated a positive trend vote on the MAA in February 2018. A formal opinion from the CHMP is expected by the end of 2018, and the European Commission is expected to issue a decision in early 2019.

Conference Call Details
The live conference call, scheduled for Friday, May 4, 2018 at 8:30 a.m. ET, can be accessed by phone by calling (844) 452-6828 from the U.S. and Canada, or 1 (765) 507-2588 internationally, and using the passcode 1357748. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.

About Andexxa
Andexxa is a recombinant protein specifically designed to bind to Factor Xa inhibitors and rapidly reverse their anticoagulant effect. Andexxa is a modified form of the human Factor Xa molecule, an enzyme that helps blood clot. Andexxa works by acting as a decoy for oral and injectable Factor Xa inhibitors, which target and bind to Factor Xa, which allows them to exert their anticoagulant effect. When Andexxa is given to a patient with Factor Xa inhibitor-related bleeding, it binds to the Factor Xa inhibitor and prevents it from inhibiting the activity of Factor Xa and reverses the anticoagulant effects of the inhibitor.

IMPORTANT INFORMATION FOR ANDEXXA [coagulation factor Xa (recombinant), inactivated-zhzo]

BOXED WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST AND SUDDEN DEATHS

See full prescribing information for complete boxed warning

Treatment with Andexxa has been associated with serious and life‑threatening adverse events, including:

Arterial and venous thromboembolic events
Ischemic events, including myocardial infarction and ischemic stroke
Cardiac arrest
Sudden deaths
Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.

Indication
Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo] is indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

This indication is approved under accelerated approval based on the change from baseline in anti-Factor Xa (FXa) activity in healthy volunteers. An improvement in hemostasis has not been established. Continued approval for this indication may be contingent upon the results of studies to demonstrate an improvement in hemostasis in patients.

Andexxa has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban and rivaroxaban.

SELECT IMPORTANT SAFETY INFORMATION

Thromboembolic Risk

Arterial and venous thromboembolic events, ischemic events, sudden deaths, or events where a thrombotic event could not be ruled out were observed within 30 days post- Andexxa administration in 33 of the 185 patients (17.8%) evaluable for safety in the ongoing ANNEXA-4 study. The median time to these events was six days. Of the 86 patients who were re-anticoagulated prior to a thrombotic event, 11 (12.7%) patients experienced a thromboembolic event, ischemic event, cardiac event or death.

Monitor patients treated with Andexxa for signs and symptoms of arterial and venous thromboembolic events, ischemic events, and cardiac arrest. To reduce thromboembolic risk, resume anticoagulant therapy as soon as medically appropriate following treatment with Andexxa.

No thromboembolic events were observed in 223 healthy volunteers who received Factor Xa inhibitors and were treated with Andexxa.

The safety of Andexxa has not been evaluated in patients who experienced thromboembolic events or disseminated intravascular coagulation within two weeks prior to the life-threatening bleeding event requiring treatment with Andexxa. Safety of Andexxa also has not been evaluated in patients who received prothrombin complex concentrates, recombinant Factor VIIa, or whole blood products within seven days prior to the bleeding event.

Re-elevation or Incomplete Reversal of Anti-FXa Activity
The time course of anti-FXa activity following Andexxa administration was consistent among the healthy volunteer studies and the ANNEXA-4 study in bleeding patients. Compared to baseline, there was a rapid and substantial decrease in anti-FXa activity corresponding to the Andexxa bolus. This decrease was sustained through the end of the Andexxa continuous infusion. Following the infusion, there was an increase in anti-FXa activity, which peaked four hours after infusion in ANNEXA-4 subjects. After this peak, the anti-FXa activity decreased at a rate similar to the clearance of the FXa inhibitors.

Thirty-eight patients who were anticoagulated with apixaban had baseline levels of anti-FXa activity > 150 ng/mL. Nineteen of these 38 (50%) patients experienced a > 93% decrease from baseline anti-FXa activity after administration of Andexxa. Eleven patients who were anticoagulated with rivaroxaban had baseline anti-FXa activity levels > 300 ng/mL. Five of the 11 patients experienced a > 90% decrease from baseline anti-FXa activity after administration of Andexxa.

Adverse Reactions
The most common adverse reactions (≥ 5%) in patients receiving Andexxa were urinary tract infections and pneumonia.

The most common adverse reactions (≥ 3%) in healthy volunteers treated with Andexxa were infusion-related reactions.

Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. Low titers of anti-Andexxa antibodies were observed in 26/145 healthy subjects (17%); 6% (9/145) were first observed at Day 30 with 20 subjects (14%) still having titers at the last time point (days 44 to 48). To date, the pattern of antibody response in patients in the ANNEXA-4 study has been similar to that observed in healthy volunteers with 6% of the patients having antibodies against Andexxa (6/98 patients). None of these anti-Andexxa antibodies were neutralizing. No antibodies cross-reacting with FX or FXa were detected in healthy subjects (0/145) or in bleeding patients to date (0/98).

On May 3, 2018 Coherus BioSciences, Inc. (NASDAQ:CHRS), reported the re-submission of its biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate, to the U.S. FDA under the 351(k) pathway (Press release, Coherus Biosciences, MAY 3, 2018, View Source [SID1234531702]).

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The BLA is supported by similarity data from analytical, pharmacokinetic, pharmacodynamics, and immunogenicity studies comparing CHS-1701 and Neulasta and integrates new immunogenicity data obtained from using a more revised immunogenicity assay.

"The CHS-1701 BLA re-submission marks a significant milestone in our ongoing transition to a commercial company as we tightly focus on execution of our strategic plan," said Denny Lanfear, President and CEO of Coherus BioSciences. "Pegfilgrastim is the largest selling oncology product in the U.S., and CHS-1701 is the cornerstone of our oncology franchise. We believe we have a strong competitive position with this product, exemplified by our comprehensive clinical immunogenicity data as well as our excellent analytical biosimilarity data."

On May 3, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that it will report first quarter 2018 financial results on Thursday, May 10, 2018 (Press release, Karyopharm, MAY 3, 2018, View Source [SID1234526011]). Karyopharm’s management team will host a conference call and audio webcast at 8:30 a.m. ET on Thursday, May 10, 2018 to discuss the financial results and recent business developments.

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To access the conference call, please dial (855) 437-4406 (local) or (484) 756-4292 (international) at least 10 minutes prior to the start time and refer to conference ID 6798355. A live audio webcast of the call will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source An archived webcast will be available on the Company’s website approximately two hours after the event.