Analyst Conference Summary


conference date: May 18, 2017
for quarter ending: March 31, 2017 (first quarter 2017, Q1)

Forward-looking statements

Note this summary includes information from the Q1 press release of May 8 as well as the May 18 conference about data presentations to be made at ASCO.

Overview: GlycoMimetics is a clinical developments stage biotechnology company. Aside from the suspense of waiting for trial results, the key question is gaining financing until profitability is reached.

Basic data (GAAP):

Revenue was zero (as usual).

Net loss was $8.0 million.

EPS (diluted) was negative $0.34.



Release & Conference Highlights:

On May 17, 2017 GlycoMimetics announced the FDA has granted Breakthrough Therapy designation for GMI-1271 for Adult Relapsed/Refractory AML (Acute Myeloid Leukemia). It had already been granted both Orphan Drug and Fast Track Status.

On May 18 GlycoMimetics announced the data from the Phase 1/2 trial of GMI-1271 for AML, with the full presentations to be made at ASCO and EHA. Mortality rates were lower than expected at 30 and 60 days. Biomarker correspondences for E-selectin were positive. This provides " what we believe is the first direct clinical evidence of the potential benefit of targeting of E-selectin in this difficult-to-treat population of AML patients."

47 patients were enrolled in the R/R study. ORR (overall response rate) was 50%. 30 day mortality was 0, and 60 day mortality was 7%. Median overall survival in Phase 1 was 7.6 months. Results are from a late January data cutoff.

In addition, data was released for 17 newly-diagnosed, treatment-naive, elderly patients. The CR/CRi (complete remission) rate was 71%. It was 75% for patients with new disease and 66% for patients with secondary disease. Historical remission rate is 50% to 55% for the chemotherapy alone.

GMI-1271 is given in addition to chemotherapy (MEC, which is mitoxantrone, etoposide, cyatarabine), and so far seems to add no safety issues to those presented by chemotherapy.

"Patients with high levels of E-selectin on their tumor cells had better responses to therapy." This may be true to other types of cancer.

90 patients will be evaluated in the Phase 2 trial in total, according to plan.

Generally, for standard chemotherapy, patients with high levels of E-selectin do worse, but by adding 1271 this group did better than average.

At a later date data from a 1271 multiple myeloma trial in Europe will be unveiled.

GlycoMimetics is working to find a rapid path to registration for GMI-1271.

Pfizer reports that the Phase 3 rivipansel trial for VOC (vascular occlusive crisis) of sickle cell disease remains on track for completion in the second half of 2018. There is a special protocol agreement with the FDA.

Cash balance ended at $34.6 million, down $5.4 million sequentially from $40.0 million. After the quarter ended $3.8 million was raised using the at-the-market stock issuance facility.

Shares outstanding on March 31 were 23,855,934.

Total cost of operations was $8.0 million, consisting of $5.9 million for R&D and $2.1 million for general and administrative expense.

In the quarter the GMI-1271 Phase 2 newly diagnosed Acute Myeloid Leukemia (AML) trial finished enrollment of its first cohort, with the second cohort's enrollment completion expected mid-year. It is a trial in combination with chemotherapy.

Preclinical results of GMI-1271 and GMI-1359 for multiple myeloma were presented at AACR and were promising, for mice anyway.


Biomarker data, any threshold for a good response? We have not announced anything, just what was in the abstract. Additional data will be disclosed at ASCO and EHA. [This was the response to other questions as well]

We have not talked to the FDA about the breakthrough designation, but believe we are in a good position for future discussions about the path to registration.

The breakthrough designation is not limited to patients with high levels of biomarker.

Phase 1, was 1271 allowed for consolidation, or just induction? Phase 1 and 2 were different. In Phase 1 we gave 1271 with induction, but it was not available for consolidation. In the Phase 2 study we added the ability of responders to receive 1271 with consolidation in R/R group, and in the newly diagnosed older populations. The data reported was for one cycle. We will have data on patients receiving more than one cycle at a later date.

Given the mitigation effect seen on chemotherapy toxicities, do you think it is even necessary to screen for E-selectin levels in relapsed/refractory setting? We do see the remission relationship. Reduction in chemo-induced mucositis was preclinical, we have not yet reported for the clinical setting. "I think you are correct in that one might not necessarily need to select for patients who see that benefit in the induction phase."

For an advanced trial would you have to specify MEC as the control arm? From preclinical data we have seen benefit for other types of chemo. We would want to discuss the design of the trial with the FDA.

Partner for Phase 3? Premature ... but we would want to preserve significant value within our company.

We are interested in evaluating is the durability of remission and whether that is sufficient for preparing for transplants. We reported some patients have gone on to transplants at ASH, and will report more at EHA.

Two sepsis deaths in R/R population? It was in newly diagnosed population that we reported 2 sepsis deaths. That population has a very high rate of death from sepsis, so that number of deaths "is not at all unusual." There was no indication that 1271 increased the risk. More at ASCO and EHA.

Europe strategy? We are exploring the business options. We expect to engage with the European regulatory agency.

Multiple myeloma enrollment, timeline? Enrolling in Ireland, adding sites in additional nations. No guidance yet on timeline.

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Disclaimer: My analyst call summaries may include both condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. These are my personal notes which I share with other investors and which I use as the basis of my blog and Seeking Alpha articles.

Copyright 2017 William P. Meyers