Graybug Vision, Inc. — Q2 2021 Form 10-Q
Entity note: The filing identifies the registrant as Graybug Vision, Inc., not CalciMedica, Inc. The company name in the request metadata does not match the filing.
Business context and reporting period
Unaudited quarterly report for the three and six months ended June 30, 2021. Graybug was a clinical-stage biopharmaceutical company developing sustained-release medicines for retinal and optic-nerve diseases; it reported no product revenue.
Financial results and liquidity
| Metric (USD millions, except per-share data) | Q2 2021 | Q2 2020 | Six months 2021 | Six months 2020 |
|---|---|---|---|---|
| Revenue | None reported | None reported | None reported | None reported |
| Research and development expense | 4.166 | 4.632 | 10.614 | 10.717 |
| General and administrative expense | 3.575 | 1.408 | 8.615 | 3.119 |
| Total operating expenses / operating loss | 7.741 | 6.040 | 19.229 | 13.836 |
| Net loss | 7.708 | 5.869 | 19.157 | 13.663 |
| Basic and diluted net loss per share | $0.36 | $6.79 | $0.91 | $13.40 |
| Cash used in operating activities | Not provided for quarter | Not provided for quarter | 17.045 | 16.933 |
At June 30, cash and cash equivalents were $7.864 million, short-term investments $65.722 million, and long-term investments $4.628 million. Management cited $73.6 million of cash, cash equivalents and short-term investments as available liquidity. Total liabilities were $4.154 million, including $4.141 million current; the filing reports no debt or credit facility. No operating margins are meaningful because the company had no revenue.
Material changes versus prior comparable periods
- Q2 net loss increased $1.839 million year over year; six-month net loss increased $5.494 million.
- G&A rose substantially, driven mainly by higher stock-based compensation, public-company directors’ and officers’ insurance, and increased headcount. Six-month G&A also included a $1.3 million write-off of equipment deposits.
- R&D was broadly flat for the first half: lower clinical-trial spending after the GB-102 Phase 2b treatment phase ended was largely offset by cancellation-related costs and higher compensation.
- Cash and cash equivalents declined from $33.418 million at year-end 2020 to $7.864 million; investments increased, reflecting investment purchases and maturities. Operating cash use was $17.045 million for the first half.
Outlook, commentary, risks and unusual items
- In March 2021, Graybug decided not to fund the substantial costs of starting two GB-102 Phase 3 trials in late 2021. Further clinical development of GB-102 for wet AMD depends on obtaining a partner; the company said it was pursuing partnership and financing alternatives.
- Management expected existing cash, cash equivalents and short-term investments to fund the operating plan for more than 12 months from filing issuance, based on not proceeding with GB-102 Phase 3 without partner funding. The estimate depends on assumptions; additional capital is still needed for broader development and operations, and may not be available on acceptable terms or at all.
- Further GB-102 development was limited to reformulation and preclinical work pending a partner. GB-102 for DME and GB-103 for diabetic retinopathy were on hold. A GB-401 Phase 1 glaucoma trial was planned no earlier than the second half of 2022.
- Management expected 2021 R&D expense to increase modestly compared with 2020. It expected continued losses and no near-term product revenue.
- Cancellation of equipment-vendor and manufacturing contracts eliminated $3.7 million of previously disclosed commitments. The company recognized $2.2 million of expense, including $1.3 million in equipment-deposit write-offs and $0.9 million in other commitments and cancellation fees; it reported no unpaid cancellation costs at June 30.
- Clinical and funding risks are significant. The filing discusses Phase 2b GB-102 results, including median durability of five months for the 1 mg dose, 48% of patients achieving six months without supportive therapy, and average BCVA approximately nine letters below the Eylea control across time points. The trial was not powered for statistical efficacy conclusions. The 2 mg dose was discontinued following anterior-chamber medication events, including serious ocular events in earlier studies.
- COVID-19 had not materially affected operations or liquidity to date, according to management, but could disrupt trials, suppliers, staffing, or financing. Other disclosed risks include clinical failure or adverse events, manufacturing and regulatory hurdles, competition, intellectual-property exposure, and the need for additional financing.
Important facts for investors to verify
- Confirm the intended issuer: this filing is for Graybug Vision, Inc., despite the CalciMedica, Inc. request metadata.
- Track whether Graybug secures a partner to fund further GB-102 trials, and the resulting scope, timing, and economics of any agreement.
- Assess cash runway against actual spending and the stated greater-than-12-month estimate, including the impact of financing needs and possible dilution.
- Review complete GB-102 clinical data and safety findings, and any updates to plans for GB-102, GB-103, and GB-401.
- Evaluate the $2.2 million contract-cancellation charge and whether any new commitments, contingencies, or financing arrangements arise after the reporting date.