On November 8, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN, an intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems to turn ‘cold’ tumors ‘hot’, reported its financial results and operational highlights for the quarter ended September 30, 2017 (Press release, Oncolytics Biotech, NOV 8, 2017, View Source [SID1234521802]).

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"Towards the end of the third quarter we made a very important announcement regarding feedback from the FDA following our End-of-Phase 2 meeting. The favorable meeting resulted in the support of our proposed target patient population of hormone receptor positive, HER2 receptor negative metastatic breast cancer patients for our registration study," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "With this support and guidance outlining a single, four hundred patient study, we have prepared to file for breakthrough designation which we expect to do very soon, prepared for communications with the European regulators, conducted preliminary preparations to file for a special protocol assessment, or SPA, and advanced our business development activities. We expect to be able to announce the results of these filings and communications with the European regulators over the next several months as we continue to prepare the company to relist its shares on NASDAQ in 2018."

Selected Highlights from Q2 and through the end of July 2017

Clinical Updates

· Announced a favorable End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for REOLYSIN in combination with paclitaxel, for the treatment of hormone receptor positive, HER2 receptor negative (HR+/HER2-) metastatic breast cancer (mBC) patients. The agency’s guidance proposed a single, 400 patient registration study to support a future Biologics License Application submission in the U.S.
· Presented mBC data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress, that demonstrated a doubling of overall survival benefit for patients with HR double-positive, HER2-negative breast cancer – a major genetic subgroup – when treated with REOLYSIN/paclitaxel combination treatment versus paclitaxel alone.
· Announced the first patient treated in our phase 1b MUK Eleven collaborative study with Myeloma UK and Celgene, studying REOLYSIN in combination with Celgene immunomodulatory drugs (IMiDs), Revlimid or Imnovid as a rescue treatment in relapsing myeloma patients.
· Presented the largest ever safety database for an oncolytic virus at the ESMO (Free ESMO Whitepaper) 2017 Congress, that demonstrated REOLYSIN is safe and well tolerated when administered in combination with chemotherapy.
Corporate Updates

· Appointed Deborah Brown to the Board of Directors, to expand the Board’s experience with product launches, market expansion, regulatory affairs, research and development and business development.
Anticipated Milestones

• First quarter 2018: Results from regulatory filings
• First half of 2018: Update on our exploration of strategic and regional alliances
NASDAQ
Preliminary MUK eleven data
• Mid-2018: Initiate phase 3 registration study in mBC
Q3 2017 Financial Results

· At September 30, 2017, the Company reported $14.0 million in cash and cash equivalents. Cash runway expected to the end of 2018.
· As at November 7, 2017, the Company had an unlimited number of authorized common shares with 140,700,722 common shares issued and outstanding, 7,448,327 options outstanding (with exercise prices ranging between $0.26 and $6.72 and expiry dates ranging from 2017 to 2027), 16,445,000 warrants outstanding (with a $0.95 strike price expiring in June 2022) and 2,428,039 RSU’s and PSU’s outstanding.

On November 8, 2017 OncoSec Medical Incorporated ("OncoSec" or "Company") (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported positive updated long-term follow-up data from its Phase 2 OMS I-102 combination study of ImmunoPulse IL-12 and pembrolizumab in patients unlikely to respond to anti-PD-1 therapy (Press release, OncoSec Medical, NOV 8, 2017, View Source [SID1234521755]). The updated data will be presented in an oral poster presentation (P524) by Dr. Alain Alagzi at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, MD on November 10th, 2017 at 12:45 p.m. EST.

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The updated clinical and correlative immune-focused biomarker data demonstrated a 57% progression free survival (PFS) rate at 15 months with 100% (11/11) duration of response and median PFS not yet reached. Building upon previously reported data of a best overall response rate (BORR) of 50% (41% complete response [CR] rate), the updated data further demonstrate that the combination of these therapies can prime a coordinated innate and adaptive immune response, and strongly suggests a synergistic relationship with anti-PD-1. The latest findings further demonstrate that this combination approach can reshape the tumor microenvironment, yielding a robust intratumoral and systemic anti-tumor response converting "cold" tumors to "hot," potentially improving clinical outcomes in patients predicted to not respond to anti-PD-1 therapy.

"Overall, the Phase 2 trial results, including progression free survival beyond two years in multiple patients, duration of response, best overall response rate, and tolerability of the combination, provide a strong and consistent theme across multiple endpoints, underscoring the promise of ImmunoPulse IL-12 plus pembrolizumab as a viable treatment option for patients diagnosed with metastatic melanoma," said Dr. Alain Algazi, Lead Trial Investigator, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.

Dan O’Connor, CEO of OncoSec noted: "The robust PFS benefit and tolerability observed with ImmunoPulse IL-12 plus pembrolizumab is the first demonstrating efficacy in a predicted PD-1 non-responder population and shows that the combination represents a potentially important addition to the treatment landscape for metastatic melanoma patients who have progressed or are progressing on anti-PD-1 therapy."

The full abstract is available and can be viewed on the STIC website at www.sitcancer.org. The poster is available in the Publications section of OncoSec’s website.

Analyst Event in National Harbor, MD

OncoSec will host an analyst and investor event with clinical investigators on Friday, November 10, 2017 at 7:00 a.m. EST in National Harbor, MD during the 2017 Society of Immunotherapy for Cancer Annual Meeting. The event will include a presentation and discussion of updated clinical data for the company’s ImmunoPulse IL-12 program, highlighting the global, registration-directed PISCES/KEYNOTE-695 trial. The event will be held in-person and via live webcast.

Investors and analysts are invited to listen to a live audio webcast of the presentation. To access the audio broadcast, please dial (877) 731-1960 and enter the conference ID number 4938639. To join via webcast, please use the following link: View Source An archived version of the presentation will be available for 90 days on the "Investors" section of OncoSec’s website: View Source

For those interested in attending this event in person, please contact [email protected]. Please RSVP in advance as seating is limited.

Peer-Reviewed Publication

The findings published in Immunotherapy provide an overview of OncoSec’s preclinical and Phase 1 clinical data demonstrating that ImmunoPulse IL-12 plus electroporation is safe and well-tolerated by patients. Many patients do not respond to anti-PD-1 therapies alone, representing a significant unmet medical need. ImmunoPulse IL-12 has shown to increase intratumoral lymphocyte infiltration, pro-inflammatory cytokines and TH1 immune responses, potentially boosting the activity of PD-1 antibodies without significant systemic toxicity.

For the full-article please visit, View Source

About the SITC (Free SITC Whitepaper) Annual Meeting

The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is a non-profit medical professional society of influential scientists, academicians, researchers, clinicians, government representatives, and industry leaders from around the world dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Currently, SITC (Free SITC Whitepaper) has nearly 1,600 members representing 17 medical specialties and are engaged in research and treatment of at least a dozen types of cancer. The 32nd SITC (Free SITC Whitepaper) Annual Meeting & Associated Programs will take place November 8-12, 2017 at the Gaylord National Hotel & Convention Center in National Harbor, MD. For more information, please go to View Source

About PISCES/KEYNOTE-695

PISCES/KEYNOTE-695 is a global, multicenter phase 2b, open-label trial of intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or "tavo") delivered by electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of intratumoral tavo plus electroporation in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).

On November 8, 2017 Alkermes plc (NASDAQ: ALKS) reported the presentation of positive preclinical data on the company’s immuno-oncology drug candidate, ALKS 4230. Data presented by Dr. Brian Gastman of the Cleveland Clinic at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, Md. showed that treatment with ALKS 4230 significantly delayed tumor growth and led to accumulation of tumor-killing T cells in the tumor microenvironment in individualized and humanized melanoma xenograft models of tumor immunology (Press release, Alkermes, NOV 8, 2017, View Source;p=RssLanding&cat=news&id=2315292 [SID1234521736]). ALKS 4230 is an engineered fusion protein designed to preferentially bind and signal through the intermediate affinity interleukin-2 (IL-2) receptor complex, thereby selectively activating and increasing the number of immunostimulatory tumor-killing immune cells while avoiding the expansion of immunosuppressive cells that interfere with anti-tumor response.

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"These data add to the growing body of evidence supporting the unique profile of ALKS 4230, a novel immuno-oncology candidate designed to harness the IL-2 mechanism in a selective way to enhance anti-tumor activity with the potential for improved safety and tolerability," said Elliot Ehrich, M.D., Executive Vice President, Research and Development of Alkermes. "We continue to progress in the ongoing dose-escalation stage of the phase 1 study for ALKS 4230 in patients with solid tumors, and look forward to determining the optimal dose range of ALKS 4230 and initiating dose expansion in 2018."

In the preclinical data presented at SITC (Free SITC Whitepaper), treatment with ALKS 4230 significantly delayed tumor growth and led to increased numbers of CD8 T cells and non-regulatory CD4 T cells in the tumor microenvironment in individualized melanoma xenograft tumor models. Xenografts were established in immunocompromised mice using tumor cells derived from metastatic melanoma patients, and the mice subsequently received an adoptive transfer of autologous, unexpanded peripheral blood mononuclear cells (PBMC) from the same patient. These data support the rationale for ALKS 4230 as a novel immunotherapeutic for the treatment of melanoma and potentially other solid cancers as well as the strategy of screening individual, patient-specific xenograft models to assess potential treatment efficacy.

A poster on the preclinical data, titled, "A Novel, Individualized Xenograft Model of Cancer Immunotherapy and Tumor Growth Inhibition by ALKS 4230," will be presented by Dr. Brian Gastman of the Cleveland Clinic at SITC (Free SITC Whitepaper) in National Harbor, Md. on Friday, Nov. 10, 2017 (Poster #P351). For more information, please visit the conference website at View Source

About ALKS 4230
ALKS 4230 is an engineered fusion protein designed to preferentially bind and signal through the intermediate affinity interleukin-2 (IL-2) receptor complex, thereby selectively activating and increasing the number of immunostimulatory tumor-killing immune cells while avoiding the expansion of immunosuppressive cells that interfere with anti-tumor response. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects while overcoming limitations of existing IL-2 therapy, which activates both immunosuppressive and tumor-killing immune cells.

On November 8, 2017 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq: EGRX) reported its financial results for the three- and nine-months ended September 30, 2017 (Press release, Eagle Pharmaceuticals, NOV 8, 2017, View Source [SID1234521738]). Highlights of and subsequent to the third quarter of 2017 include:

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Financial Highlights:

Total revenue for the third quarter of 2017 grew 67% to $63.0 million compared to $37.8 million in the third quarter of 2016;
Royalty revenue increased to $43.6 million compared to $26.2 million in Q3 2016;
Product sales decreased to $6.9 million compared to $7.8 million in Q3 2016;
Q3 2017 income before income tax provision was $24.5 million;
Q3 2017 net income was $15.4 million, or $1.03 per basic and $0.98 per diluted share, compared to a net income of $12.0 million, or $0.77 per basic and $0.73 per diluted share in Q3 2016;
Q3 2017 Adjusted Non-GAAP net income was $19.2 million, or $1.27 per basic and $1.22 per diluted share, compared to Adjusted Non-GAAP net income of $14.7 million, or $0.95 per basic and $0.89 per diluted share in the prior year quarter. For a full reconciliation of Adjusted Non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release; and,
Cash and cash equivalents were $97.5 million and accounts receivable were $71.6 million as of September 30, 2017.
Business and Recent Highlights:

BENDEKA total market share of 97%, as of September 30, 2017;
Sales of RYANODEX grew 29% to $3.3 million during the third quarter of 2017 compared to $2.5 million in Q3 2016;
Received tentative U.S. Food and Drug Administration (FDA) approval for PEMFEXY (pemetrexed injection) ready-to-dilute formulation;
Granted a new patent related to RYANODEX formulation (dantrolene sodium) by the United States Patent and Trademark Office, expiring June 2022;
Licensed Japanese rights for bendamustine hydrochloride ready-to-dilute and rapid infusion injection products to SymBio Pharmaceuticals Limited and received a $12.5 million upfront payment;
Announced positive results of an initial study in over 50 rodents to evaluate the neuroprotective effects of RYANODEX in an established rodent model of Nerve Agent-induced seizures and seizure-related brain damage;
Filed for a second source drug product manufacturing site for BENDEKA;
2017 R&D and SG&A guidance updated:
We expect our full year 2017 R&D expense will be consistent with the upper end of the $31-$35 million range. This reflects ongoing expenses for the enrollment of the fulvestrant and RYANODEX for Ecstasy and methamphetamine intoxication clinical trials. Excluding stock based compensation, the R&D expense would be in the range of $27 – $31 million.
We expect our full year SG&A expense to be in the range of $67 – $70 million, slightly higher than previous guidance. Excluding stock based compensation and other non-cash items, SG&A expense would be in the range of $53 – $56 million.
"This was another strong quarter for Eagle with record revenue driven by BENDEKA, a growing cash position and significant movement in our pipeline," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"During the quarter, we advanced multiple pipeline candidates. We plan to begin dosing patients in our fulvestrant study in a few weeks and expect to file an NDA in the fourth quarter of 2018. With one dose, our formulation will deliver a 5mL solution, using a smaller needle and in less time than the current commercially available product. In addition, we received tentative approval from the FDA for PEMFEXY, our ready-to-dilute pemetrexed IV formulation. As the first company to receive tentative approval for this product using the 505(b)2 pathway, we hope to find a way to market as soon as possible, once our litigation with Eli Lilly is resolved," added Tarriff.

"We remain confident in our RYANODEX portfolio. We are continuing our dialogue with the FDA regarding EHS, while advancing our clinical work for the Ecstasy and methamphetamine, and nerve agent programs. We have also made progress on an intramuscular delivery formulation for RYANODEX, which we believe will provide patients and healthcare professionals with a valuable delivery option," Tarriff added.

"Eagle continues to generate strong cash flow, which allows us to invest in our pipeline, evaluate additional strategic opportunities and return capital to shareholders when it maximizes value. We have completed the first $75 million share repurchase program and will continue purchasing up to an additional $100 million shares under our current share repurchase plan, reflecting our belief in the potential of our products and pipeline," concluded Tarriff.

Third Quarter 2017 Financial Results

Total revenue for the three months ended September 30, 2017 was $63.0 million, as compared to $37.8 million for the three months ended September 30, 2016. A summary of total revenue is outlined below:

Three Months Ended September 30,
2017 2016

Revenue ($ in 000’s):
Product sales $ 6,905 $ 7,837
Royalty revenue 43,616 26,246
License and other income 12,500 3,750
Total revenue 63,021 37,833

Product sales decreased to $6.9 million driven by lower net product sales of BENDEKA and Argatroban, partially offset by an increase in net product sales of RYANODEX. Royalty revenue increased to $43.6 million, as a result of the increased market share on Teva sales of BENDEKA, as well as an increase in the royalty rate from 20% to 25%.

Research and development expenses increased to $9.0 million in the three months ended September 30, 2017, compared to $3.2 million in the prior year quarter. The increase is due to continued spending on the Company’s pipeline, and in particular, our fulvestrant, RYANODEX for Ecstasy and methamphetamine intoxication, and pemetrexed projects.

SG&A expenses increased to $16.7 million in the third quarter of 2017 compared to $11.7 million in the three months ended September 30, 2016. Personnel-related expenses grew as a result of the expansion of our sales force in the second quarter of 2017. External legal expenses also increased, due to ongoing litigation.

An income tax provision of $9.0 million was recorded during the third quarter of 2017.

Net income for the third quarter of 2017 was $15.4 million, or $1.03 per basic share and $0.98 per diluted share, compared to net income of $12.0 million, or $0.77 per basic and $0.73 per diluted share in the three months ended September 30, 2016, due to the factors discussed above.

Adjusted Non-GAAP net income for the third quarter of 2017 was $19.2 million, or $1.27 per basic and $1.22 per diluted share, compared to Adjusted Non-GAAP net income of $14.7 million or $0.95 per basic and $0.89 per diluted share in the prior year quarter. For a full reconciliation of Adjusted Non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

Liquidity

As of September 30, 2017, the Company had $48 million in net cash and cash equivalents and $72 million in net accounts receivable, $46 million of which was due from Teva. For the nine months ended September 30, 2017, net cash provided by operating activities, excluding the increase in net accounts receivable, was $62 million. The Company had $50 million in outstanding debt.

As part of our stock repurchase plan, we purchased $13.5 million worth of our shares during the quarter, completing our original $75 million share repurchase plan initiated in August 2016. We expanded the program by $100 million during the second quarter of 2017.

Conference Call

As previously announced, Eagle management will host its third quarter 2017 conference call as follows:

Date Wednesday, November 8, 2017
Time 8:30 A.M. EST
Toll free (U.S.) 866-518-6930
International 203-518-9797
Webcast (live and replay)
www.eagleus.com, under the "Investor Relations" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-839-8705 (US) or 402-220-6075 (International) and entering conference call ID EGRXQ317. The webcast will be archived for 30 days at the aforementioned URL.

On November 8, 2017 GlycoMimetics, Inc. (NASDAQ: GLYC) reported progress on its clinical development programs and its financial results for the third quarter and nine months ended September 30, 2017 (Press release, GlycoMimetics, NOV 8, 2017, View Source [SID1234521739]).

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The Company will host a conference call and webcast to provide a corporate update and report its third-quarter 2017 financial results today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants with participant code 8794188. 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, participant code 8794188.

"In the third quarter of 2017, we initiated productive discussions with the FDA to review data emerging from the ongoing Phase 1/2 clinical trial of our specific E-selectin inhibitor product candidate, GMI-1271, for the treatment of acute myeloid leukemia (AML) and to plan a mid-2018 start of the Phase 3 trial. The discussions reflect the FDA’s granting of Breakthrough Therapy designation to GMI-1271 for the treatment of relapsed/refractory AML patients. Our focus is on finalizing the design of the registrational trial in relapsed/refractory disease. While in the near term we are preparing to provide an update on the GMI-1271 program via two oral presentations at the ASH (Free ASH Whitepaper) meeting, we also continue to make progress across our clinical pipeline and in the preclinical arena," stated Rachel King, Chief Executive Officer.

Key Operational Highlights for the Third Quarter of 2017:

GlycoMimetics engaged with the FDA under the terms of the Breakthrough Therapy designation the Company received in May. Discussions are focused on the design of a Phase 3 clinical trial protocol, including appropriate endpoints to capture GMI-1271’s potential benefits and a plan for other aspects of the program required for registration.
Data related to GMI-1271 will be highlighted in two oral presentations at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Expo. The ASH (Free ASH Whitepaper) meeting will take place in Atlanta, GA, December 9-12, 2017. The oral presentations at the ASH (Free ASH Whitepaper) meeting will include results from the ongoing Phase 1/2 clinical trial of GMI-1271, as well as a preclinical study in which the mechanism by which E-selectin mediates resistance to chemotherapy was observed. In the Phase 1/2 clinical trial, improved clinical outcomes were seen in both relapsed/refractory and newly diagnosed AML patients following treatment with GMI-1271. The preclinical data point to E-selectin dependent upregulation of tumor survival pathways, which are inhibited by GMI-1271.
The rivipansel Phase 3 trial, being conducted by the Company’s collaborator Pfizer, is evaluating patients hospitalized for vaso-occlusive crisis of sickle cell disease. Pfizer reports that the study remains on track for completion in the second half of 2018.
Third Quarter 2017 Financial Results:

Cash position: As of September 30, 2017, GlycoMimetics had cash and cash equivalents of $112.9 million as compared to $40.0 million as of December 31, 2016. The Company raised $86.8 million in net proceeds from a public offering of common stock completed in May 2017. Subsequent to September 30, the Company raised an additional $19.2 million in net proceeds under an at-the-market equity facility, resulting in a pro forma cash balance of $132.1 million as of September 30.
R&D Expenses: The Company’s research and development expenses decreased slightly to $5.8 million for the quarter ended September 30, 2017 as compared to $5.9 million for the third quarter of 2016. The decrease was primarily caused by lower clinical trial expenses related to the Phase 1/2 clinical trial of GMI-1271 for the treatment of AML due to patient enrollment completion in May 2017 and a decrease in costs for non-clinical toxicology studies and clinical studies for GMI-1359. These decreases were offset in part by additional costs related to the manufacturing of Phase 3 clinical supplies of GMI-1271.
G&A Expenses: The Company’s general and administrative expenses increased to $2.4 million for the quarter ended September 30, 2017 as compared to $2.0 million for the third quarter of 2016. These increases were primarily attributable to annual salary adjustments and stock-based compensation expense from 2017 equity awards to employees and directors.
Shares Outstanding: Shares of common stock outstanding as of September 30, 2017 were 32,737,799.
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 that has now completed enrollment, GMI-1271 is being evaluated in both newly diagnosed elderly and relapsed/refractory patients with acute myeloid leukemia (AML). In both populations in this trial, patients treated with GMI-1271 together with standard chemotherapy have achieved higher than expected remission rates based on historical controls, as well as lower than expected induction-related mortality rates. Importantly, treatment in these patient populations has been well tolerated with minimal adverse effects.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. Since E-selectin and CXCR4 are both adhesion molecules that keep cancer cells in the bone marrow, the Company believes that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of both liquid and solid tumors that affect the bone marrow, as compared to targeting CXCR4 alone. GMI-1359 is currently being evaluated in a Phase 1 clinical trial.

About Rivipansel

Rivipansel, a pan-selectin antagonist, is being developed for the treatment of vaso-occlusive crisis (VOC) in sickle cell disease and is being evaluated in a Phase 3 clinical trial being conducted by GlycoMimetics’ strategic collaborator, Pfizer. Sickle cell disease is a genetic disease that, according to the U.S. Centers for Disease Control and Prevention, affects millions of people throughout the world, including an estimated 90,000 to 100,000 people in the United States. VOC is one of the most severe complications of sickle cell disease.