Analyst Conference Summary


conference date: May 3, 2018 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2018 (first quarter 2018, Q1)

Forward-looking statements

Overview: Moved up expected Rivipansel Phase 3 data readout to Q4 2018.

Basic data (GAAP):

Revenue was $0, up sequentially from $0, and down from $0 year-earlier.

Net income was negative $11.5 million, down sequentially from negative $9.3 million, and down from negative $7.9 million year-earlier.

EPS (diluted) was negative $0.33, down sequentially from negative $0.27, and down from negative $0.34 year-earlier.



Release & Conference Highlights:

Rachel King, Chief Executive Officer, said "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."

$128.4 million was raised in the quarter through a common stock offering. The offering was oversubscribed. Believes has sufficient cash to last until top-line data is released in the Phase 3 r/r AML trial.

GMI-1271 has Breakthrough Therapy designation from the FDA. Positive data was presented at ASH in December 2017l. Will start the Phase 3 trial in Q3 2018, will enroll 380 patients. Data should be available in Q4 2020. Overall survival (OS) will be the primary endpoint for the trial, and will not be censored for transplants, allowing more patients to receive transplants. Mucositis will be a secondary endpoint, as will CR. Trial will be international to facilitate approvals in key EU countries.

Plans to expand 1271 into the unfit-for-chemo, newly diagnosed AML and high-risk MDS setting, in combination with HMA (hypomethylating agents). A trial was announced to be sponsored by the Hovon group. Could begin in second half of 2018.

Hopes to announce plans for 1271 for fit for chemo, newly diagnosed AML in the near future.

A European proof-of-concept trail of 1271 in multiple myeloma continued in Europe, with topline data expected in Q1 2019. Also looking for a combination trial in the setting.

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. Topline data could read out in Q4 2018. There is a special protocol agreement with the FDA. It is being conducted by licensed partner Pfizer. Possible peak sales are greater than $1 billion, per Pfizer. Could get a milestone payment in 2019. Royalties would be in double digits, and could receive up to $250 million in milestone payments.

A third therapy, GMI-1359, Phase 1 trial continued, and may be an improvement on GMI-1271 in treating bone marrow cancers.

Preclinical studies to move other candidates to the clinic continue.

Cash balance ended at $242.6 million, up sequentially from $123.9 million. The increase was from a public share offering generating $128.4 million.

Total cost of operations was $11.9 million, consisting of $9.0 million for R&D and $2.9 million for general and administrative expense.


Rivipansel changes in primary endpoint for Phase 3 v. Phase 2 trials? Phase 3 endpoint is time to readiness for discharge, which has a checklist of elements. It is very similar to, but not identical to, the Phase 2 readiness for discharge endpoint. The Phase 2 difference in time to discharge was greater than 24 hours. Believe we need at least a day for Phase 3. It is under a Special Protocol Agreement, so it just needs to hit that. The secondary endpoints would be supportive. There is no other drug approved in this indication.

1271 fit for chemo population plans? We emphasize the potential use of 1271 across a continuum of care. The R/R trial is the cornerstone. In newly diagnosed for fit for chemo we are in discussions to define a program, we should be able to say more soon.

We do have prior frontline fit for chemo data. We need to reach an agreement with the consortia on trial design.

1359? Can mobilize tumor reactive T-cells, so could be used in the immuno-oncology space. It would have a differentiated method of action. We have filed IP on uses of the compound, but continue to do preclinical work. Will give guidance on the first patient population later in they year. Healthy volunteer data not likely to be submitted to a science meeting.

Competitiveness in multiple myeloma? The new study is a proof-of-concept study. This is the first setting for 1271 outside of AML. It is a complex and crowded space, so we would look at a sub-population where we would have an advantage.

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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 2018 William P. Meyers