Earnings Labs

Crescent Biopharma, Inc. (CBIO)

Q4 2019 Earnings Call· Fri, Feb 28, 2020

$24.12

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Transcript

Operator

Operator

Good morning and thank you all for joining the GlycoMimetics call. [Operator Instructions] I would now like to turn the call over to Shari Annes of Investor Relations Group at GlycoMimetics. Please go ahead. Shari Annes;Annes Associates: Good morning. Today, we will highlight the key developments of 2019, and of course, the fourth quarter of the year as well. The press release that we issued this morning on our year-end and fourth quarter financials is available on the company's website at www.glycomimetics.com under the Investors tab. This call is being recorded. A dial-in phone replay will be available for 24 hours after the close of the call. The webcast replay will also be available in the Investor Relations section of the company's website for 30 days. Joining me on the call today from GlycoMimetics are Rachel King, Chief Executive Officer; and Brian Hahn, Senior VP and Chief Financial Officer. We'll start today's call with comments from Rachel. And after that, Brian will provide an overview of the company's financial position. We will then open the call for Q&A. Our Senior VP of Development and our Chief Medical Officer; Dr. Helen Thackray, will join us for the Q&A. I'd like to remind you that today's call will include forward-looking statements based on current expectations. Forward-looking statements contained on this call include, but are not limited to, statements about the company's product candidates, uproleselan, GMI-1359 and rivipansel as well as our other pipeline programs. Such statements represent management's judgment and intention as of today and involve assumptions, risks and uncertainties. Glycomimetics undertakes no obligation to update or revise any forward-looking statement. For information concerning the risk factors that could affect the company, please refer to GlycoMimetics' filings with the SEC, which are available from the SEC or on the GlycoMimetics website. I'd now like to turn the call over to Rachel.

Rachel King

Analyst

Thank you, Shari, and thank you all for joining our call. This morning, I'd like to share my perspective on the achievements of 2019 and some recent events. We ended the year with robust enthusiasm for our uproleselan program in acute myeloid leukemia or AML. Our clinical team worked hard to wrap the year to advance our Phase III registration trial in relapsed or refractory AML. In addition, the team collaborated with the National Cancer Institute to advance their multicenter registration trial, evaluating uproleselan in the newly diagnosed patient population fit for intensive chemotherapy. I'll provide more details on the status of both of these trials later in the call. Turning to rivipansel. With Pfizer's recent decision to return the rights back to us in early April, we can now review the entire clinical data set, including the Phase II, Phase III and open-label extension study to determine if there's a potential path forward for this asset in vaso-occlusive crisis or VOC. We and many KOLs from the sickle cell community continue to believe that the role of the selectins in VOC has been clinically validated. As such, with the asset back in our hands, we intend to evaluate and share the efficacy, safety, PK and biomarker data from the Phase III RESET trial. Our primary focus in 2019 was on uproleselan. We had another very productive meeting at the American Society of Hematology or ASH in December. Our research and clinical groups reported on multiple developments relating to E-selectin that accentuate our precision medicine focus and reinforce our understanding of this mechanism, namely, first, that E-selectin acts as a major driver of environment-mediated drug resistance in AML through the upregulation of cancer survival pathways such as NF-kappaB; second, that expression of the E-selectin ligand on leukemic blast and leukemic…

Brian Hahn

Analyst

Thank you, Rachel. As of December 31, 2019, GlycoMimetics had cash and cash equivalents of $158.2 million compared to $209.9 million as of December 31, 2018. Company's research and development expenses decreased to $11.5 million for the quarter ended December 31, 2019, as compared to $12 million for the fourth quarter of 2018. This decrease was due to a reduction in manufacturing expenses partially offset with an increase in clinical expenses in the fourth quarter of 2019 as compared to the same quarter in 2018. In the fourth quarter of 2018, the manufacturing expenses were higher due to large purchases of raw materials for the NDA manufacturing batches that were initiated in 2019. The clinical expenses increased in the fourth quarter of 2019 due to site start-up activities related to the company-sponsored Phase III clinical trial. Research and development expenses increased to $6.9 million to $47 million for the year ended December 31, 2019, from $40.1 million for the year ended December 31, 2018. Clinical development expenses increased by $6.4 million, primarily as a result of increased clinical costs related to our ongoing global Phase III clinical trial and the Phase II/III clinical trial being conducted by the NCI, which opened for enrollment in early 2019. Personnel-related and stock-based compensation expenses increased due to an increase in clinical headcount and stock option and restricted stock unit awards granted in 2019. These increases were offset in part by $2.6 million decrease in manufacturing and formulation due to lower raw material costs in 2019 as compared to 2018. Turning now to G&A expenses. The company's general and administrative expenses increased to $3.9 million for the quarter ended December 31, 2019, as compared to $2.9 million for the fourth quarter of 2018. General and administrative expenses for the year ended December 31, 2019, increased to $14.4 million as compared to $11.4 million for the prior year. These increases were primarily due to an increase in legal and patent expenses as well as labor-related costs and stock-based compensation expense. Patent expenses were higher due to an increase in the number of patent applications filed in 2019 as compared to 2018. Personnel-related and stock-based compensation expenses increased due to additional headcount in 2019, annual salary adjustments and stock option grants. In summary, GlycoMimetics is well positioned to carry out its planned initiatives and to advance applications for its unique technology platform. I'll now turn the call back over to Rachel.

Rachel King

Analyst

Thank you, Brian. I'd like to close by saying our clinical pipeline is strong and our specialized GlycoMimetic chemistry platform is providing opportunities to improve the standard of care in AML as well as other cancers and fibrotic diseases. We have a stellar team in place to deliver results and we're financed to take the company through key milestones. Operator, please open the call for questions.

Operator

Operator

[Operator Instructions] Our first question comes from Stephen Willey from Stifel.

Bonnie Quach-Wong

Analyst

This is Bonnie Quach on for Stephen Willey. I was wondering if you could provide any more detail around your plans to pursue osteosarcoma? And I know it's early, but can you give us an idea of how you are thinking about the osteosarcoma market and the market opportunity for GMI-1359?

Rachel King

Analyst

Sure. Thank you for your question. It is early to say much about osteosarcoma in terms of the market opportunity. But what I can say is that we've identified it as an opportunity, which has a high unmet need, clinical need and one in which our GMI-1359 has performed very well in preclinical studies. It's also an area where, based on data in the literature, we recognize that both of the targets that GMI-1359 addresses are important potential targets in the progression of that disease. And for those reasons, we think there's excellent biological and clinical rationale to potentially pursue osteosarcoma. But let me take a moment and say a bit more about 1359 generally and what we're doing in the current clinical trial to position us a bit further. We're currently doing a dose-escalation trial in breast cancer patients who have disease that has metastasized to the bone. And that's a study that we expect will enable us to identify an appropriate Phase II dose. And once having done that, then to position the drug to be able to then be expanded into Phase II trials. And so at that time, we would be looking at potentially moving into osteosarcoma or potentially target indications within breast cancer. So now we're getting the initial clinical data in terms of pharmacodynamic activity in patients. And that, in combination with the other preclinical data, would direct us towards the final selection of the indication for the next Phase II trial.

Bonnie Quach-Wong

Analyst

And I wanted to know a bit more about the biomarkers that you've chosen to measure in your breast cancer with bone metastases patients?

Rachel King

Analyst

Sure. I'm going to actually turn that question over to Helen Thackray, our Chief Medical Officer. She could comment a bit more about that particular study.

Helen Thackray

Analyst

So in that study, we are assessing dose escalation and pharmacokinetics to support dose decision-making. Pharmacodynamic assessments are particularly important in also assessing that. We're looking for items that are -- biomarkers that are supportive of the proof of mechanism for the molecule in patients who have bony metastases with breast cancer tumors. For example, circulating tumor cells to demonstrate mobilization of the tumor cells from the bony metastasis for administration of GMI-1359. We're also looking for markers that are relevant to the disruption of the tumor microenvironment in the bones or markers that assess bony disruption. And we're looking at markers that -- of CXCR4 activity on the bone marrow such as mobilization of stem cells measured by CD34 process.

Operator

Operator

[Operator Instructions] I show no further questions in the queue. At this time, I'd like to turn the call over to Rachel King, CEO, for closing remarks.

Rachel King

Analyst

Thank you, operator, and thank you, everyone, for your questions and for taking the time to listen to the call.

Operator

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.