Filing summary
Issuer discrepancy: The request identifies Crescent BioPharma, Inc., but the supplied Form 10-Q is for GlycoMimetics, Inc. (Nasdaq: GLYC), filed November 7, 2019, for the quarter ended September 30, 2019. The summary below reflects the supplied filing, not Crescent BioPharma.
Business context and reporting period
GlycoMimetics is a clinical-stage biotechnology company developing glycomimetic drug candidates for diseases including cancer and inflammatory conditions. It had no approved products and generated no revenue in the three or nine months ended September 30, 2019. Its lead candidate, uproleselan, was in a Phase 3 trial for relapsed or refractory acute myeloid leukemia (AML); a separate Phase 2/3 trial in older adults with AML was being conducted with the National Cancer Institute. The company also planned a Phase 1b trial of GMI-1359 in breast cancer patients with bone metastases.
Financial results and liquidity
| Metric | Q3 2019 | Q3 2018 | Nine months 2019 | Nine months 2018 |
|---|---|---|---|---|
| Revenue | $0 | $0 | $0 | $0 |
| Research and development expense | $10.7 million | $9.7 million | $35.6 million | $28.1 million |
| General and administrative expense | $3.4 million | $2.8 million | $10.5 million | $8.5 million |
| Net loss | $13.3 million | $11.6 million | $43.2 million | $34.4 million |
| Net loss per share, basic and diluted | $0.31 | $0.27 | $1.00 | $0.85 |
| Net cash used in operating activities | Not provided for quarter | Not provided for quarter | $39.2 million | $33.4 million |
At September 30, 2019, cash and cash equivalents were $170.9 million, down from $209.9 million at December 31, 2018. Total assets were $180.5 million, total liabilities $13.4 million, and stockholders’ equity $167.1 million. The balance sheet reports no borrowings; liabilities primarily include accrued expenses and operating lease obligations. No product gross margin is applicable because there was no revenue. Interest income was $0.9 million for Q3 and $2.9 million year to date.
Changes, outlook, and risks
- Year-to-date operating expenses rose $9.5 million, or about 26%, and net loss increased $8.8 million versus 2018. Management attributed the increase mainly to uproleselan clinical development and manufacturing, plus higher personnel and stock-based compensation costs.
- Operating cash outflow increased by $5.8 million year over year. Financing provided only $0.3 million in the first nine months of 2019, compared with $129.3 million in 2018, largely reflecting the prior-year $128.4 million public offering.
- Pfizer announced on August 2, 2019 that rivipansel failed to meet the primary and key secondary endpoints in its pivotal Phase 3 sickle cell disease trial. The agreement remained in effect, but GlycoMimetics did not expect further milestone or royalty income from it.
- Management expected existing cash to fund operations through preliminary results from the uproleselan Phase 3 trial, then anticipated by the end of 2020. This estimate depends on assumptions that may prove incorrect; the company warned that additional capital may be required and may not be available on acceptable terms.
- Key risks include clinical-trial success and timing, regulatory approval, manufacturing, commercialization, and future financing. The company reported no material change to its previously disclosed risk factors, no material legal proceedings, and effective disclosure controls.
Important facts for investors to verify
- Confirm the intended issuer: the supplied filing is GlycoMimetics, Inc., not Crescent BioPharma, Inc.
- Check subsequent updates to the uproleselan trials, including enrollment, timing, results, and cash needs.
- Assess the impact of the rivipansel Phase 3 failure and whether Pfizer continues the agreement.
- Review cash burn, remaining financing capacity, and potential dilution; $80.0 million remained available under the company’s at-the-market sales agreement at September 30, 2019.