Filing summary
Entity note: The request identifies HYPERION DEFI, INC., but the supplied Form 10-Q is for Eyenovia, Inc. (Nasdaq: EYEN). This summary reflects the filing provided. Reporting period ended June 30, 2019; filed August 13, 2019. Unaudited results are for a clinical-stage ophthalmic biopharmaceutical company.
Business context and operating outlook
Eyenovia is developing microdose ophthalmic therapies using its patented Optejet delivery technology. It reported no product revenue and had not completed development of any product candidate.
- MicroStat: Phase III trials completed with positive results; the company planned to submit an NDA to the FDA in 2020.
- MicroPine: FDA accepted the IND for its Phase III CHAPERONE study in February 2019; first patient enrolled in June 2019.
- MicroProst: The company reported FDA feedback on Phase III trial requirements. MicroTears, an OTC candidate, was not expected to require Phase III trials.
Financial results and liquidity
| Metric | Three months ended June 30, 2019 | Six months ended June 30, 2019 | Comparable 2018 period |
|---|---|---|---|
| Revenue | None | None | None |
| Research and development expense | $3.57 million | $7.58 million | $2.41 million and $4.51 million |
| General and administrative expense | $1.81 million | $3.75 million | $0.91 million and $2.25 million |
| Total operating expenses | $5.38 million | $11.33 million | $3.32 million and $6.75 million |
| Net loss | $5.33 million | $11.27 million | $3.32 million and $6.75 million |
| Basic and diluted loss per share | $0.44 | $0.94 | $0.33 and $0.77 |
| Net cash used in operating activities | Not provided by quarter | $11.04 million | $5.43 million |
There are no revenue-based margins to report. At June 30, 2019, cash and cash equivalents were $9.24 million, working capital was $7.4 million, total assets were $10.04 million, total liabilities were $2.42 million, and stockholders’ equity was $7.62 million. The company reported no debt outstanding. Accumulated deficit was $47.78 million.
In July 2019, after quarter-end, Eyenovia completed a public offering of 5,046,763 shares, including exercised over-allotment shares, for approximately $13.0 million in net proceeds. Management said available cash, including those proceeds, was expected to fund operating and capital requirements for at least 12 months from the financial statements’ issuance. Further capital may be needed thereafter.
Changes, commentary, risks, and unusual items
- Year-over-year losses and expenses increased as research and development activity, clinical and contracted services, hiring, stock compensation, marketing analysis, and public-company costs expanded. Six-month R&D expense rose 68%; G&A rose 67%.
- Operating cash use approximately doubled from the prior-year six-month period, while cash declined from $19.73 million at December 31, 2018 to $9.24 million at June 30, 2019.
- R&D expense included $0.61 million of accelerated stock-option compensation following the February 2019 acceleration of an executive’s options. Six-month stock-based compensation totaled $1.46 million.
- The July offering increased the share count and provided additional liquidity. The filing reported 12,053,963 common shares outstanding at June 30 and 17,100,726 as of August 8, 2019.
- Management expects R&D and G&A expenses to continue increasing. Failure to obtain additional financing when needed could require the company to curtail development or reduce costs; commercialization depends on successful development and regulatory approval.
- Related-party arrangements included consulting and contract engineering services involving board members or an executive’s company. The filing reported no legal proceedings and no material off-balance-sheet arrangements.
- Disclosure controls were assessed as effective at a reasonable assurance level; management reported no material second-quarter change in internal control over financial reporting.
Important facts for investors to verify
- Confirm the issuer: the supplied filing is Eyenovia, Inc., not the company named in the request.
- Check subsequent regulatory and clinical progress for MicroStat, MicroPine, MicroProst, and MicroTears, including whether the planned 2020 MicroStat NDA submission occurred.
- Review cash burn and runway against the July 2019 offering proceeds, and assess any later financing needs or dilution.
- Verify offering share totals and current shares outstanding; the reported August 8 count followed the post-quarter offering.
- Assess whether rising development and public-company costs are sustainable in the absence of product revenue, and review the disclosed related-party expenditures.