UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
(Address of principal executive offices including zip code)
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES
The number of shares of the Registrant’s common stock outstanding as of May 5, 2022 was
Table of Contents
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Item 1. |
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4 |
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5 |
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Condensed Consolidated Statements of Comprehensive Loss (unaudited) |
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Condensed Consolidated Statements of Stockholders’ Equity (unaudited) |
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Notes to the Condensed Consolidated Financial Statements (unaudited) |
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Item 2. |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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24 |
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Item 4. |
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24 |
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Item 1. |
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25 |
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Item 1A. |
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25 |
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Item 2. |
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70 |
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Item 3. |
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70 |
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Item 4. |
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70 |
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Item 5. |
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70 |
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Item 6. |
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71 |
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In this Quarterly Report on Form 10-Q, “we,” “our,” “us,” “Graybug” and the “Company” refer to Graybug Vision, Inc. This report contains references to trademarks belonging to other entities, which are the property of their respective holders. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
2
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements, other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking statements. In some cases you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” or the negative or plural of these words or similar expressions. These forward-looking statements include, but are not limited to, statements concerning the following:
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the potential of our technologies and our ability to execute on our corporate strategy; |
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our ability to fund our working capital needs; |
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our ability to develop and commercialize our product candidates; |
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our ability to use and expand our technologies to build a pipeline of product candidates; |
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our ability to secure a partnership for GB-102; |
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our ability to obtain and maintain regulatory approval of our product candidates; |
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the strength and breadth of our patent portfolio; |
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the potential for receipt of additional milestone payments; |
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our ability to obtain and adequately protect intellectual property rights for our product candidates; |
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our continued reliance on third parties for manufacturing our product candidates, conducting our clinical trials and certain research activities; |
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our ability to in-license, acquire or invest in complementary businesses, technologies, products or assets to further expand or complement our portfolio of product candidates; |
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expected timing of our clinical trials; |
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the timing and availability of results of our clinical trials and those of our collaborators; and |
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our ability to extend our operating capital. |
These statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in greater detail under the heading “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. You should not rely upon forward-looking statements as predictions of future events. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risks and uncertainties.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, after the date of this report, we are under no duty to update or revise any of the forward-looking statements, whether as a result of new information, future events or otherwise.
We obtained industry, market and competitive position data in this report from our own internal estimates and research as well as from industry and general publications and research surveys and studies conducted by third parties. These data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such information or estimates.
3
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
GRAYBUG VISION, INC.
Condensed Consolidated Balance Sheets
(in thousands)
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March 31, 2022 |
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December 31, 2021 |
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(unaudited) |
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(See Note 2) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Short-term investments |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use asset |
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— |
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Prepaid expenses and other non-current assets |
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Total assets |
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$ |
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$ |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued research and development |
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Operating lease liability, current |
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— |
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Other current liabilities |
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Total current liabilities |
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Deferred rent, long term portion |
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— |
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Operating lease liability, net of current portion |
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— |
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Total liabilities |
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Commitments and contingencies (Note 5) |
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Stockholders’ equity: |
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Preferred stock |
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Common stock |
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Additional paid-in capital |
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Accumulated deficit |
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Accumulated other comprehensive loss |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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See accompanying notes to unaudited condensed consolidated financial statements.
4
GRAYBUG VISION, INC.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended March 31, |
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2022 |
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2021 |
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Operating expenses: |
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Research and development |
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$ |
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$ |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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Interest income |
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Net loss |
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Net loss per common share—basic and diluted |
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$ |
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$ |
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Weighted-average number of shares outstanding used in computing net loss per common share—basic and diluted |
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See accompanying notes to unaudited condensed consolidated financial statements.
5
GRAYBUG VISION, INC.
Condensed Consolidated Statements of Comprehensive Loss
(in thousands)
(Unaudited)
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Three Months Ended March 31, |
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2022 |
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2021 |
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Net loss |
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$ |
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$ |
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Unrealized (loss) gain on available-for-sale securities, net of tax |
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Comprehensive loss |
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$ |
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$ |
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See accompanying notes to unaudited condensed consolidated financial statements.
6
GRAYBUG VISION, INC.
Condensed Consolidated Statements of Stockholders’ Equity
(in thousands, except share amounts)
(Unaudited)
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Common Stock |
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Additional Paid-In |
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Accumulated |
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Accumulated Other Comprehensive |
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Total Stockholders’ |
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Shares |
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Amount |
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Capital |
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Deficit |
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Loss |
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Equity |
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Balance—December 31, 2021 |
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$ |
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$ |
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$ |
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$ |
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$ |
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Stock-based compensation expense |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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Unrealized loss on available-for-sale securities, net of tax |
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— |
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— |
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— |
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— |
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Balance—March 31, 2022 |
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$ |
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$ |
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$ |
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$ |
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$ |
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Common Stock |
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Additional Paid-In |
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Accumulated |
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Accumulated Other Comprehensive |
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Total Stockholders’ |
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Shares |
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Amount |
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Capital |
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Deficit |
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Income (Loss) |
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Equity |
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Balance—December 31, 2020 |
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$ |
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$ |
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$ |
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$ |
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$ |
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Stock issued on exercise of stock options |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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Unrealized gain on available-for-sale securities, net of tax |
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— |
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— |
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— |
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— |
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Balance—March 31, 2021 |
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$ |
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$ |
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$ |
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$ |
— |
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$ |
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See accompanying notes to unaudited condensed consolidated financial statements.
7
GRAYBUG VISION, INC.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
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Three Months Ended March 31, |
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2022 |
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2021 |
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Operating activities: |
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Net loss |
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$ |
( |
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$ |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation expense |
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Depreciation |
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Noncash lease expense |
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— |
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Accretion of premium and discounts on short-term investments |
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Acquired in-process research and development |
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— |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other current and non-current assets |
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Accounts payable |
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Accrued research and development |
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Operating lease liability |
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( |
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— |
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Other current and non-current liabilities |
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( |
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Net cash used in operating activities |
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Investing activities: |
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Purchases of property and equipment |
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— |
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Purchases of investments |
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Maturity of investments |
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Acquisition of in-process research and development |
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— |
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Net cash provided by (used in) investing activities |
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Financing activities: |
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Proceeds from exercise of stock options |
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— |
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Net cash provided by financing activities |
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— |
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Net decrease in cash and cash equivalents |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period |
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$ |
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$ |
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Supplemental disclosure of noncash items: |
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Right-of-use asset obtained in exchange for operating lease liability |
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$ |
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$ |
— |
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Acquired in-process research and development in accrued liabilities |
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$ |
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$ |
— |
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Property and equipment purchases included in accounts payable |
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$ |
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$ |
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See accompanying notes to unaudited condensed consolidated financial statements.
8
GRAYBUG VISION, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Organization
Graybug Vision, Inc., the Company or Graybug, is a clinical-stage biopharmaceutical company developing medicines for the treatment of diseases of the retina and optic nerve. The Company presently devotes substantially all of its resources to conducting research and development and raising capital. The Company was founded in May 2011 and maintains facilities in Redwood City, California and Baltimore, Maryland.
The Company is subject to risks common to clinical stage companies in the biopharmaceutical industry, including dependence on the clinical success of its product candidates, ability to obtain regulatory approvals of its product candidates, compliance with regulatory requirements, the need for substantial additional financing and protection of its proprietary technology.
Going Concern Considerations
The Company incurred losses from operations and had negative cash flows from operating activities for the three months ended March 31, 2022, and 2021, and the Company’s accumulated deficit at March 31, 2022 was $
In March 2021, the Company decided not to proceed with the significant investment required to initiate two Phase 3 clinical trials for GB-102 in late 2021. As a result, management continues to believe that the Company’s current cash, cash equivalents and short-term investments are adequate to meet its cash needs for at least 12 months from the issuance date of this Quarterly Report on Form 10-Q. The Company will seek to raise additional funds in order to further advance its research and development programs, operate its business, secure research and development collaborations, and meet its obligations as they come due. The Company is pursuing financing alternatives, similar to what the Company has previously executed, which include debt and equity financing. Such sources of capital may not, however, be available to the Company in the necessary time frame, in the amounts that the Company requires, on terms that are acceptable to the Company, or at all. If the Company is unable to raise the necessary funds when needed or reduce spending on currently planned activities, it may not be able to continue the development of its products or the Company could be required to delay, scale back, or eliminate some or all of its research and development programs and other operations, which may materially harm its business, financial position and results of operations.
COVID-19 Pandemic
The impact of the worldwide spread of a novel strain of coronavirus (“COVID-19”) has been unprecedented and unpredictable, including the emergence of new variants of the coronavirus, such as the Delta and Omicron variants, and resurgences in number and rates of infections, but based on the Company’s current assessment, the Company does not expect any material impact on its long-term strategic plans, operations, or its liquidity due to the worldwide spread of COVID-19. However, the Company is continuing to assess the effect on its operations by monitoring the spread of COVID-19 and the actions implemented to combat the virus and new variants thereof throughout the world and its assessment of the impact of COVID-19 may change.
2. Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The accompanying unaudited condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q have been prepared in accordance with the rules and regulations of the U.S. Securities and Exchange Commission, or SEC, and, therefore, certain information and disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, have been omitted.
In the opinion of management, the information reflects all adjustments necessary to make the results of operations for the interim periods a fair statement of such operations. All such adjustments are of a normal recurring nature. Interim results are not necessarily indicative of results for the full year. The condensed balance sheet at December 31, 2021 has been derived from the audited financial statements at that date, but does not include all information and footnotes required by GAAP for complete financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements included in the Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 11, 2022.
9
The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary, RainBio, Inc. (RainBio), which was acquired in March 2022 (see Note 5). All intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting periods. Actual results could differ from those estimates. Significant items subject to estimates include estimates related to accrued research and development expenses, contingent milestone payments, other long-lived assets, stock-based compensation, incremental borrowing rates for leases and the valuation of deferred tax assets. The Company bases its estimates using historical experience, Company forecasts and future plans, current economic conditions, and information from third-party professionals that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities and recorded amounts of expenses that are not readily apparent from other sources, and adjusts those estimates and assumptions when facts and circumstances dictate.
The Company’s results can also be affected by economic, political, legislative, regulatory and legal actions. Economic conditions, such as recessionary trends, inflation, interest, changes in regulatory laws and monetary exchange rates, and government fiscal policies, can have a significant effect on operations. While the Company maintains reserves for anticipated liabilities, the Company could be adversely affected by civil, criminal, regulatory or administrative actions, claims, or related proceedings.
Leases
The Company adopted Accounting Standards Codification (ASC) Topic 842, Leases (ASC 842) on January 1, 2022, as discussed below in the section titled Recently Adopted Accounting Pronouncements. Under ASC 842, the Company determines if an arrangement is or contains a lease at contract inception.
Operating lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term, and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized based on the present value of lease payments over the lease term at the commencement date of the lease. Right-of-use assets also include any initial direct costs incurred and any lease payments made at or before the lease commencement date, less any lease incentive received. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its incremental borrowing rate. The incremental borrowing rate reflects the rate of interest that a lessee would have to pay to borrow, on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Lease expense for an operating lease is recognized on a straight-line basis over the lease term.
The Company elected the practical expedient to not separate lease and non-lease components for all classes of assets. Additionally, the Company has elected an accounting policy to not recognize short-term leases, which have a lease term of twelve months or less, on the condensed consolidated balance sheet. Variable lease payments are primarily related to property taxes, insurance and common area maintenance, and are recognized as lease cost when incurred.
Recently Adopted Accounting Pronouncements
In February 2016, the FASB issued Accounting Standards Update (ASU) 2016-02, Leases (Topic 842), as amended, with guidance regarding the accounting for and disclosure of leases. The update requires lessees to recognize on the balance sheet the liabilities related to all leases, including operating leases, with a term greater than 12 months. This update also requires lessees and lessors to disclose key information about their leasing transactions. As an emerging growth company, this standard is effective for the Company for fiscal years beginning after December 15, 2021, and interim periods within annual periods beginning after December 15, 2022. The Company adopted this standard on
In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, which removes certain exceptions and amends certain requirements in the existing income tax guidance to ease accounting
10
requirements. As an emerging growth company, this standard is effective for the Company for fiscal years beginning after December 15, 2021, and interim periods within annual periods beginning after December 15, 2022, and must be applied on a retrospective basis. The Company adopted ASU 2019-12 on
3. Fair Value Measurements
The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following three levels:
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Level 1: Observable inputs such as unadjusted quoted prices in active markets for identical assets or liabilities at the measurement date. |
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Level 2: Inputs (other than quoted prices included in Level 1) that are either directly or indirectly observable for the asset or liability. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. |
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Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
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March 31, 2022 |
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Level 1 |
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Level 2 |
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Level 3 |
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Total |
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Current assets: |
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Cash equivalents: |
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Money market funds |
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$ |
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$ |
— |
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$ |
— |
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$ |
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Commercial paper |
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— |
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— |
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Total cash equivalents |
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— |
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Short-term investments: |
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Corporate debt securities |
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— |
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— |
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Commercial paper |
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— |
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— |
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U.S. Treasury notes |
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— |
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— |
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Total short-term investments |
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— |
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— |
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Total assets measured at fair value |
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$ |
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$ |
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$ |
— |
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$ |
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December 31, 2021 |
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Level 1 |
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Level 2 |
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Level 3 |
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Total |
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Current assets: |
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Cash equivalents: |
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Money market funds |
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$ |
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$ |
— |
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$ |
— |
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$ |
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Corporate debt securities |
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— |
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— |
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Commercial paper |
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— |
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— |
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Total cash equivalents |
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— |
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Short-term investments: |
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Corporate debt securities |
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— |
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— |
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Commercial paper |
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— |
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— |
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U.S. Treasury notes |
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— |
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— |
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Total short-term investments |
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— |
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— |
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Total assets measured at fair value |
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$ |
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$ |
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$ |
— |
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$ |
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Money market funds are highly liquid investments which are actively traded. The pricing information on the Company’s money market funds are based on quoted prices in active markets for identical securities. This approach results in the classification of these securities as Level 1 of the fair value hierarchy.
The fair value of investments is determined from market pricing and other observable market inputs for similar securities obtained from various third-party data providers. The pricing services utilize industry-standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair
11
value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities; issuer credit spreads; benchmark securities; prepayment/default projections based on historical data; and other observable inputs. This approach results in the classification of these securities as Level 2 of the fair value hierarchy.
There were
The following tables present information as to cost, unrealized gains and losses and fair value determination of the Company’s financial assets measured at fair value on a recurring basis (in thousands):
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March 31, 2022 |
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Amortized Cost |
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Unrealized Gains |
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Unrealized Losses |
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Aggregate Fair Value |
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Current assets: |
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Cash equivalents: |
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Money market funds |
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$ |
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$ |
— |
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$ |
— |
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$ |
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Commercial paper |
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Total cash equivalents |
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— |
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— |
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Short-term investments: |
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Corporate debt securities |
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— |
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( |
) |
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Commercial paper |
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— |
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( |
) |
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U.S. Treasury notes |
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— |
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( |
) |
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Total short-term investments |
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— |
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( |
) |
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Total assets measured at fair value |
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$ |
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$ |
— |
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$ |
( |
) |
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$ |
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December 31, 2021 |
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Amortized Cost |
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Unrealized Gains |
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Unrealized Losses |
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Aggregate Fair Value |
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Current assets: |
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Cash equivalents: |
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Money market funds |
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$ |
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$ |
— |
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$ |
— |
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$ |
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Corporate debt securities |
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— |
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— |
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Commercial paper |
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— |
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— |
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Total cash equivalents |
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— |
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— |
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Short-term investments: |
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Corporate debt securities |
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— |
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( |
) |
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Commercial paper |
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( |
) |
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U.S. Treasury notes |
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— |
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( |
) |
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Total short-term investments |
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( |
) |
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Total assets measured at fair value |
|
$ |
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$ |
|
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|
$ |
( |
) |
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$ |
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As of March 31, 2022 and December 31, 2021, the contractual maturities of all available-for-sale investments were less than 12 months. The Company periodically reviews the available-for-sale investments for other-than-temporary impairment loss. All investments with unrealized losses have been in a loss position for less than 12 months. As a result, the Company did
4. Balance Sheet Components
Other Current Liabilities
Other current liabilities consisted of the following (in thousands):
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March 31, 2022 |
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December 31, 2021 |
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Salaries and benefits |
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