Business context and reporting period
This is GlycoMimetics, Inc.’s unaudited Form 10-Q for the quarter and nine months ended September 30, 2017, filed November 8, 2017. The request metadata names Crescent Biopharma, Inc.; that does not match the registrant identified in the filing. GlycoMimetics is a clinical-stage biotechnology company with no approved products or drug-sales revenue.
Its programs include rivipansel, licensed to Pfizer; GMI-1271, being studied with chemotherapy for AML and multiple myeloma; and GMI-1359, in early clinical development. The company’s operations and revenue prospects depend on clinical development, regulatory outcomes, and financing.
Financial results and liquidity
| Metric | Q3 2017 | Q3 2016 | Nine months 2017 | Nine months 2016 |
|---|---|---|---|---|
| Revenue | $0 | $18,500 | $0 | $18,500 |
| Research and development | $5.78 million | $5.92 million | $17.38 million | $17.22 million |
| General and administrative | $2.40 million | $1.98 million | $7.02 million | $6.35 million |
| Net loss | $7.95 million | $7.85 million | $24.02 million | $23.48 million |
| Loss per share, basic and diluted | $0.24 | $0.34 | $0.86 | $1.14 |
Cash and cash equivalents were $112.87 million at September 30, 2017, versus $40.04 million at December 31, 2016. Total assets were $115.82 million; total liabilities were $7.26 million, including $6.53 million current liabilities. No borrowings are reported on the balance sheet. Stockholders’ equity was $108.56 million. The balance sheet reports an accumulated deficit of $143.02 million.
For the first nine months, operating cash use was $21.40 million, investing cash use was $0.26 million, and financing provided $94.49 million. Financing included $86.8 million net proceeds from a May 2017 public offering and $7.4 million from the prior ATM program. The filing says the new ATM program subsequently raised $19.2 million net from 1.6 million shares; shares outstanding were 34,337,799 on November 7, compared with 32,737,799 at September 30. No meaningful operating margin is presented because the company had no product revenue and incurred operating losses.
Material changes versus prior comparable periods
- Q3 net loss increased by about $95,000 year over year; nine-month net loss increased by about $542,000.
- Nine-month R&D expense rose $159,000, with higher GMI-1271 and personnel costs partly offset by lower GMI-1359 spending. Q3 R&D fell $141,000, primarily as AML trial enrollment completed, offset partly by GMI-1271 manufacturing costs.
- Nine-month G&A expense increased $664,000, mainly from personnel and stock-based compensation.
- Cash rose substantially, principally due to equity financing. Weighted-average shares increased year over year, and the subsequent ATM sales added further shares.
- Other income increased to $373,000 for nine months from $74,000, primarily reflecting interest income on higher cash balances.
Outlook, commentary, and risks
Management expected September 30 cash and equivalents to fund operating expenses and capital needs at least through the second half of 2019. This estimate depends on assumptions that may prove incorrect; management expects continued losses and negative operating cash flow and may need further capital. It expects R&D spending to increase as programs advance. Additional equity financing could dilute shareholders; financing may not be available on acceptable terms.
Management planned further GMI-1271 AML updates in late 2017 and 2018, was discussing a potential pivotal trial with the FDA, and anticipated initiating that trial in mid-2018 subject to FDA feedback. The filing reports preliminary AML results, including a 41% CR/CRi rate among 54 evaluable relapsed/refractory patients and 7% 60-day mortality in that group, and a 68% CR/CRi rate among 25 newly diagnosed elderly patients. Management’s comparisons with historical controls are not assurance of future results. The company was continuing a multiple myeloma study of GMI-1271 and planned to select an initial cancer indication and dose for GMI-1359 in 2018.
Potential Pfizer milestones and royalties are contingent and uncertain; no Pfizer revenue or milestone payment was recognized in the periods reported. The company states that success depends on clinical-trial enrollment and outcomes, regulatory approval, manufacturing, intellectual-property protection, reimbursement, and future financing. It reported no material legal proceedings, no material changes to previously disclosed risk factors, and effective disclosure controls as of quarter-end. No off-balance-sheet arrangements were reported.
Important facts for investors to verify
- Confirm the registrant identity: the supplied metadata says Crescent Biopharma, while this filing is for GlycoMimetics, Inc.
- Reconcile the filing’s accumulated-deficit figures: the balance sheet reports $143.02 million at September 30, while the MD&A states $135.1 million for that date.
- Confirm cash runway assumptions and the timing and net proceeds of the post-quarter ATM issuance; assess resulting share dilution.
- Track FDA feedback and timing for a potential GMI-1271 pivotal AML trial, and evaluate clinical results as data mature.
- Assess uncertainty around Pfizer’s future milestones, royalties, and development of rivipansel; none were received in the periods reported.