QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or Other Jurisdiction of Incorporation or Organization) |
(I.R.S. Employer Identification No.) |
Title of class |
Trading Symbol(s) |
Name of exchange on which registered | ||
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||
Non-accelerated filer |
☒ | Smaller reporting company | ||||
Emerging growth company |
Page |
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ITEM 1. |
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ITEM 2. |
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ITEM 3. |
26 |
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ITEM 4. |
26 |
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ITEM 1. |
26 |
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ITEM 1A. |
26 |
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ITEM 6. |
27 |
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28 |
ITEM 1. |
FINANCIAL STATEMENTS |
In thousands, except per share data |
March 31, 2022 |
June 30, 2021 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ | $ | ||||||
Investments |
— | |||||||
Prepaid and other current assets |
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Total current assets |
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Property and equipment, net |
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Intangible assets, net |
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Investment in Bionic Sight, LLC |
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Right-of-use |
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Right-of-use |
— | |||||||
Other assets |
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Total assets |
$ | $ | ||||||
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
$ | $ | ||||||
Accrued and other liabilities |
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Lease liabilities - operating |
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Lease liability - finance |
— | |||||||
Current portion of long-term debt |
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Total current liabilities |
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Lease liabilities - operating, net of current portion |
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Long-term debt, net of debt discounts and deferred financing fees |
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Other liabilities |
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Total liabilities |
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Stockholders’ equity: |
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Preferred stock, par value $ |
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Common stock, par value $ |
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Additional paid-in capital |
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Treasury stock at cost; |
( |
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Accumulated deficit |
( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
$ | $ | ||||||
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Three Months Ended March 31, |
Nine Months Ended March 31, |
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In thousands, except per share data |
2022 |
2021 |
2022 |
2021 |
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Revenue |
$ | $ | $ | $ | ||||||||||||
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Operating expenses: |
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Research and development |
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General and administrative and other |
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Total operating expenses |
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Loss from operations |
( |
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Other income (expense), net: |
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Investment income, net |
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Interest expense |
( |
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Total other income (expense), net |
( |
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Loss before provision for income taxes |
( |
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Provision for income taxes |
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Loss before equity in net losses of an affiliate |
( |
) | ( |
) | ( |
) | ( |
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Equity in net losses of an affiliate |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
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Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
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Weighted average shares outstanding: |
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Basic |
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Diluted |
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Net loss per common share: |
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Basic |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) |
Common Stock |
Treasury Stock |
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In thousands |
Outstanding Shares |
Amount |
Shares |
Amount |
Additional Paid-in Capital |
Accumulated Deficit |
Totals |
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Balances at June 30, 2021 |
$ | $ | ( |
) | $ | $ | ( |
) | $ | |||||||||||||||||||
Share-based compensation expense |
— | — | — | — | — | |||||||||||||||||||||||
Shares issued under employee plans and related share repurchases |
— | ( |
) | — | ||||||||||||||||||||||||
Net loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||
Balances at September 30, 2021 |
( |
) | ( |
) | ||||||||||||||||||||||||
Issuance of common stock, net of issuance costs |
— | — | — | — | ||||||||||||||||||||||||
Share-based compensation expense |
— | — | — | — | — | |||||||||||||||||||||||
Shares issued under employee plans and related share repurchases |
— | — | — | — | ||||||||||||||||||||||||
Net loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||
Balances at December 31, 2021 |
( |
) | ( |
) | ||||||||||||||||||||||||
Issuance of common stock, net of issuance costs |
— | — | — | |||||||||||||||||||||||||
Share-based compensation expense |
— | — | — | — | — | |||||||||||||||||||||||
Shares issued under employee plans and related share repurchases |
— | — | — | — | ||||||||||||||||||||||||
Net loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||
Balances at March 31, 2022 |
$ | $ | ( |
) | $ | $ | ( |
) | $ | |||||||||||||||||||
Common Stock |
Treasury Stock |
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In thousands |
Outstanding Shares |
Amount |
Shares |
Amount |
Additional Paid-in Capital |
Accumulated Deficit |
Totals |
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Balances at June 30, 2020 |
$ | $ | ( |
) | $ | $ | ( |
) | $ | |||||||||||||||||||
Share-based compensation expense |
— | — | — | — | — | |||||||||||||||||||||||
Shares issued under employee plans and related share repurchases |
— | ( |
) | — | ( |
) | ||||||||||||||||||||||
Net loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||
Balances at September 30, 2020 |
( |
) | ( |
) | ||||||||||||||||||||||||
Share-based compensation expense |
— | — | — | — | — | |||||||||||||||||||||||
Shares issued under employee plans and related share repurchases |
— | — | — | — | ||||||||||||||||||||||||
Net loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||
Balances at December 31, 2020 |
( |
) | ( |
) | ||||||||||||||||||||||||
Issuance of common stock and accompanying warrants, net of issuance costs |
— | — | — | |||||||||||||||||||||||||
Share-based compensation expense |
— | — | — | — | — | |||||||||||||||||||||||
Shares issued under employee plans and related share repurchases |
— | — | — | — | ||||||||||||||||||||||||
Net loss |
— | — | — | — | — | ( |
) | ( |
) | |||||||||||||||||||
Balances at March 31, 2021 |
$ | $ | ( |
) | $ | $ | ( |
) | $ | |||||||||||||||||||
Nine Months Ended March 31, |
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In thousands |
2022 |
2021 |
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Operating activities: |
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Net loss |
$ | ( |
) | $ | ( |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Share-based compensation expense |
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Expense for shares of common stock issued to a vendor |
— | |||||||
Depreciation and amortization |
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Investment discount accretion, net |
— | ( |
) | |||||
Amortization of debt discounts and deferred financing fees |
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Reduction in the carrying amount of operating lease right-of-use |
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Equity in net losses of an affiliate |
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Changes in operating assets and liabilities: |
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Prepaid and other assets |
( |
) | ||||||
Accounts payable |
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Operating lease liabilities |
( |
) | ( |
) | ||||
Accrued and other liabilities |
( |
) | ||||||
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Cash used in operating activities |
( |
) | ( |
) | ||||
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Investing activities: |
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Purchases of property and equipment |
( |
) | ( |
) | ||||
Purchases of and capitalized costs related to intangible assets |
( |
) | ( |
) | ||||
Maturities of investments |
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Purchases of investments |
— | ( |
) | |||||
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Cash provided by investing activities |
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Financing activities: |
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Proceeds from the issuance of common stock and accompanying warrants, net of issuance costs |
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Proceeds from exercises of common stock options |
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Payments for deferred financing fees |
— | ( |
) | |||||
Taxes paid related to equity awards |
( |
) | ( |
) | ||||
Principal payments on a finance lease |
( |
) | ( |
) | ||||
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Cash provided by financing activities |
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Net increase (decrease) in cash and cash equivalents |
( |
) | ||||||
Cash and cash equivalents, beginning of the period |
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Cash and cash equivalents, end of the period |
$ | $ | ||||||
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Supplemental non-cash information: |
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Costs for purchases of property and equipment included in accounts payable |
$ | $ | — | |||||
Costs for intangible assets included in accrued and other liabilities |
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Right-of-use |
— |
1. |
Organization and Operations |
2. |
Summary of Significant Accounting Policies |
3. |
Share-based Compensation Plans |
Nine Months Ended March 31, |
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2022 |
2021 |
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(In thousands, except per share amounts) |
Shares |
Weighted Average Exercise Price |
Shares |
Weighted Average Exercise Price |
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Outstanding at the beginning of the period |
$ | $ | ||||||||||||||
Granted |
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Exercised |
( |
) | ( |
) | ||||||||||||
Forfeited |
( |
) | ( |
) | ||||||||||||
Expired |
( |
) | ( |
) | ||||||||||||
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Outstanding at the end of the period |
$ | $ | ||||||||||||||
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Exercisable at the end of the period |
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Weighted average fair value of options granted during the period |
$ | $ | ||||||||||||||
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Nine Months Ended March 31, |
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Assumption |
2022 |
2021 |
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Dividend yield |
% |
% | ||||||
Expected term |
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Risk-free interest rate |
% |
% | ||||||
Expected volatility |
% |
% |
4. |
Investments and Fair Values of Financial Instruments |
In thousands |
Level 1 |
Level 2 |
Level 3 |
Total Fair Value |
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March 31, 2022 |
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Cash and cash equivalents |
$ | $ | — | $ | — | $ | ||||||||||
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June 30, 2021 |
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Cash and cash equivalents |
$ | $ | — | $ | — | $ | ||||||||||
Held-to-maturity |
— | — | ||||||||||||||
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Total assets |
$ | $ | — | $ | — | $ | ||||||||||
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5. |
Debt |
6. |
Collaboration Agreements and Contract Liabilities |
7. |
Stockholders’ Equity |
8. |
Commitments and Contingencies |
Lease Months |
Annual Base Rent |
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1 |
$ | |||
2-7 |
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8-19 |
$ | |||
Base rent shall increase (12-month period) thereafter commencing in month 20 for the remainder of the Term. |
ITEM 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
• | continue to conduct clinical trials for our XLRP and ACHM product candidates; |
• | manufacture clinical trial materials and develop larger-scale manufacturing capabilities, including the lease of our new build-to-suit |
• | continue to develop our gene therapy platform and expand our pipeline by investing in our preclinical product candidates, including those for: |
• | additional orphan and non-orphan ophthalmology indications, such as dAMD and other retinal diseases; and |
• | other inherited diseases in CNS and otology; |
• | seek regulatory approval for our product candidates; |
• | add personnel to support our scientific, collaboration, product development and commercialization efforts; and |
• | continue to operate as a public company. |
• | provide 24-month data from patients in the ongoing Phase 1/2 clinical trial in the third quarter of calendar year 2022; |
• | provide 12-month data from the Skyline expansion portion of the Phase 1/2 clinical trial in the first quarter of calendar year 2023; and |
• | provide interim Vista trial data in the first half of calendar year 2023. |
• | employee-related expenses, including salaries, benefits, travel and share-based compensation expense; |
• | expenses incurred under agreements with academic research centers, contract research organizations and investigative sites that conduct our clinical trials; |
• | license and sublicense fees and collaboration expenses; |
• | costs of acquiring, developing and manufacturing clinical trial materials; and |
• | facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies. |
• | the scope, rate of progress and expense of our ongoing clinical trials, as well as any additional clinical trials that we are required to, or decide to, initiate and other research and development activities; |
• | the timing and level of activity as determined by us or jointly with our partners; |
• | the level of funding, if any, received from our partners; |
• | whether or not we elect to cost share with our collaborators; |
• | future clinical trial results; |
• | uncertainties in clinical trial enrollment rates or drop-out or discontinuation rates of patients; |
• | increased cost and delay associated with manufacturing or testing issues, including ongoing quality assurance, qualifying new vendors and developing in-house capabilities through, among other things, our lease of a new cGMP build-to-suit |
• | the countries in which trials are conducted; |
• | potential additional safety monitoring or other studies requested by regulatory agencies or elected as best practice by us; |
• | significant and changing government regulation; |
• | the timing and receipt of any regulatory approvals; and |
• | broader market forces, such as inflation and wage/salary growth. |
Three Months Ended March 31, |
Increase |
% Increase |
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In thousands |
2022 |
2021 |
(Decrease) |
(Decrease) |
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External research and development expenses: |
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XLRP |
$ | 984 | $ | 3,201 | $ | (2,217 | ) | (69 | )% | |||||||
ACHM |
748 | 1,147 | (399 | ) | (35 | )% | ||||||||||
Research and discovery programs and X-linked retinoschisis |
189 | 1,358 | (1,169 | ) | (86 | )% | ||||||||||
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Total external research and development expenses |
1,921 | 5,706 | (3,785 | ) | (66 | )% | ||||||||||
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Internal research and development expenses: |
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Employee-related costs |
4,377 | 3,051 | 1,326 | 43 | % | |||||||||||
Share-based compensation |
412 | 280 | 132 | 47 | % | |||||||||||
Other |
2,452 | 1,923 | 529 | 28 | % | |||||||||||
|
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Total internal research and development expenses |
7,241 | 5,254 | 1,987 | 38 | % | |||||||||||
|
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Total research and development expenses |
$ | 9,162 | $ | 10,960 | $ | (1,798 | ) | (16 | )% | |||||||
|
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|
Three Months Ended March 31, |
Increase |
% Increase |
||||||||||||||
In thousands |
2022 |
2021 |
(Decrease) |
(Decrease) |
||||||||||||
Employee-related costs |
$ | 1,961 | $ | 1,241 | $ | 720 | 58 | % | ||||||||
Share-based compensation |
431 | 315 | 116 | 37 | % | |||||||||||
Legal and professional fees |
102 | 329 | (227 | ) | (69 | )% | ||||||||||
Other |
1,927 | 1,643 | 284 | 17 | % | |||||||||||
|
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|
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Total general and administrative and other expenses |
$ | 4,421 | $ | 3,528 | $ | 893 | 25 | % | ||||||||
|
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|
|
|
|
Nine Months Ended March 31, |
Increase |
% Increase |
||||||||||||||
In thousands |
2022 |
2021 |
(Decrease) |
(Decrease) |
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External research and development expenses: |
||||||||||||||||
XLRP |
$ | 10,085 | $ | 11,930 | $ | (1,845 | ) | (15 | )% | |||||||
ACHM |
2,639 | 3,997 | (1,358 | ) | (34 | )% | ||||||||||
Research and discovery programs and X-linked retinoschisis |
3,402 | 2,527 | 875 | 35 | % | |||||||||||
|
|
|
|
|
|
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Total external research and development expenses |
16,126 | 18,454 | (2,328 | ) | (13 | )% | ||||||||||
|
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|
|
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Internal research and development expenses: |
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Employee-related costs |
12,307 | 9,466 | 2,841 | 30 | % | |||||||||||
Share-based compensation |
1,302 | 866 | 436 | 50 | % | |||||||||||
Other |
6,206 | 5,611 | 595 | 11 | % | |||||||||||
|
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|
|
|||||||||||
Total internal research and development expenses |
19,815 | 15,943 | 3,872 | 24 | % | |||||||||||
|
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|
|
|
|||||||||||
Total research and development expenses |
$ | 35,941 | $ | 34,397 | $ | 1,544 | 4 | % | ||||||||
|
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|
|
|
|
Nine Months Ended March 31, |
Increase |
% Increase |
||||||||||||||
In thousands |
2022 |
2021 |
(Decrease) |
(Decrease) |
||||||||||||
Employee-related costs |
$ | 4,549 | $ | 3,675 | $ | 874 | 24 | % | ||||||||
Share-based compensation |
1,297 | 999 | 298 | 30 | % | |||||||||||
Legal and professional fees |
688 | 1,238 | (550 | ) | (44 | )% | ||||||||||
Other |
5,976 | 4,356 | 1,620 | 37 | % | |||||||||||
|
|
|
|
|
|
|||||||||||
Total general and administrative and other expenses |
$ | 12,510 | $ | 10,268 | $ | 2,242 | 22 | % | ||||||||
|
|
|
|
|
|
Nine Months Ended March 31, |
Increase |
% Increase |
||||||||||||||
In thousands |
2022 |
2021 |
(Decrease) |
(Decrease) |
||||||||||||
Cash provided by (used in): |
||||||||||||||||
Operating activities |
$ | (47,490 | ) | $ | (37,738 | ) | $ | (9,752 | ) | (26)% | ||||||
Investing activities |
846 | 19,158 | (18,312 | ) | (96)% | |||||||||||
Financing activities |
9,441 | 69,648 | (60,207 | ) | (86)% | |||||||||||
|
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|
|
|
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Net increase (decrease) in cash and cash equivalents |
$ | (37,203 | ) | $ | 51,068 | $ | (88,271 | ) | >(100)% | |||||||
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ITEM 3. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
ITEM 4. |
CONTROLS AND PROCEDURES |
a) | Conclusions Regarding the Effectiveness of Disclosure Controls and Procedures |
b) | Changes in Internal Control over Financial Reporting |
ITEM 1. |
LEGAL PROCEEDINGS |
ITEM 1A. |
RISK FACTORS |
ITEM 6. |
EXHIBITS |
* | Filed herewith. |
** | Furnished herewith. |
APPLIED GENETIC TECHNOLOGIES CORPORATION (Registrant) | ||
By: | /s/ Jonathan I. Lieber | |
Jonathan I. Lieber, Chief Financial Officer | ||
Date: May 16, 2022 |
Exhibit 31.1
CERTIFICATION
I, Susan B. Washer, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Applied Genetic Technologies Corporation;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Date: May 16, 2022 | By: | /s/ Susan B. Washer | ||
Susan B. Washer | ||||
President and Chief Executive Officer | ||||
(Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION
I, Jonathan I. Lieber, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Applied Genetic Technologies Corporation;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Date: May 16, 2022 | By: | /s/ Jonathan I. Lieber | ||
Jonathan I. Lieber | ||||
Chief Financial Officer | ||||
(Principal Financial Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Applied Genetic Technologies Corporation (the Company) for the period ended March 31, 2022, as filed with the Securities and Exchange Commission on the date hereof (the Report), each of the undersigned officers of the Company hereby certifies, pursuant to 18 U.S.C. Section 1350, that, to her or his knowledge:
(1) | the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
(2) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: May 16, 2022 | By: | /s/ Susan B. Washer | ||
Susan B. Washer | ||||
President and Chief Executive Officer | ||||
(Principal Executive Officer) | ||||
Date: May 16, 2022 | By: | /s/ Jonathan I. Lieber | ||
Jonathan I. Lieber | ||||
Chief Financial Officer | ||||
(Principal Financial Officer) |
A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to Applied Genetic Technologies Corporation and will be retained by Applied Genetic Technologies Corporation and furnished to the Securities and Exchange Commission or its staff upon request.
Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares |
Mar. 31, 2022 |
Jun. 30, 2021 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 50,786,000 | 42,835,000 |
Common stock, shares outstanding | 50,732,000 | 42,794,000 |
Treasury stock, shares held | 54,000 | 41,000 |
Condensed Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Mar. 31, 2022 |
Mar. 31, 2021 |
Mar. 31, 2022 |
Mar. 31, 2021 |
|
Revenue: | ||||
Total revenue | $ 0 | $ 0 | $ 0 | $ 0 |
Operating expenses: | ||||
Research and development | 9,162 | 10,960 | 35,941 | 34,397 |
General and administrative and other | 4,421 | 3,528 | 12,510 | 10,268 |
Total operating expenses | 13,583 | 14,488 | 48,451 | 44,665 |
Loss from operations | (13,583) | (14,488) | (48,451) | (44,665) |
Other income (expense), net: | ||||
Investment income, net | 9 | 13 | 21 | 106 |
Interest expense | (667) | (330) | (2,011) | (997) |
Total other income (expense), net | (658) | (317) | (1,990) | (891) |
Loss before provision for income taxes | (14,241) | (14,805) | (50,441) | (45,556) |
Provision for income taxes | 0 | 21 | 0 | 62 |
Loss before equity in net losses of an affiliate | (14,241) | (14,826) | (50,441) | (45,618) |
Equity in net losses of an affiliate | (53) | (25) | (116) | (75) |
Net loss | $ (14,294) | $ (14,851) | $ (50,557) | $ (45,693) |
Weighted average shares outstanding: | ||||
Basic | 43,639 | 36,751 | 43,112 | 29,431 |
Diluted | 43,639 | 36,751 | 43,112 | 29,431 |
Net loss per common share: | ||||
Basic | $ (0.33) | $ (0.40) | $ (1.17) | $ (1.55) |
Diluted | $ (0.33) | $ (0.40) | $ (1.17) | $ (1.55) |
Organization and Operations |
9 Months Ended | ||
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Mar. 31, 2022 | |||
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |||
Organization and Operations |
General Applied Genetic Technologies Corporation (the “Company” or “AGTC”) was incorporated as a Florida corporation on January 19, 1999 and reincorporated as a Delaware corporation on October 24, 2003. The Company is a clinical-stage biotechnology company that uses a proprietary gene therapy platform to develop transformational genetic therapies for people suffering from rare and debilitating ophthalmic, otologic and central nervous system diseases. The Company has devoted substantially all of its efforts to research and development activities, including conducting clinical trials for its product candidates, and has not completed the development of any products. The Company has generated revenue from collaboration agreements, licensing of its intellectual property, sponsored research agreements and grants, but has not generated product revenue to date and is subject to a number of risks similar to those of other early stage companies in the biotechnology industry, including dependence on key individuals, the need to obtain additional capital necessary to fund the development of its product candidates, the risk of failure of ongoing or future clinical studies, the difficulties inherent in the development of commercially viable products, the development by the Company or its competitors of technological innovations, the protection of proprietary technology, compliance with government regulations and the ability to transition to large-scale production of products. Liquidity and Financial Condition As of March 31, 2022, the Company had (i) an accumulated deficit of $289.8 million and (ii) cash and cash equivalents of $67.8 million. Management believes that there is presently insufficient funding available to allow the Company to generate data from its ongoing and planned clinical programs and fund currently planned research and discovery programs for a period exceeding one year from the date of this filing with the Securities and Exchange Commission. While the Company expects to generate some revenue from collaborations, sponsored research agreements, grants and licensing of its intellectual property, management believes that the Company will incur losses and generate negative operating cash flows for the foreseeable future. As such, these circumstances collectively raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying Unaudited Condensed Financial Statements do not include any adjustments that might result from the outcome of this uncertainty. The Company has funded its operations to date primarily through public offerings of its common stock and warrants to purchase its common stock, private placements of its preferred stock, collateralized borrowing and collaborations. The ability of an entity to continue as a going concern depends on, among other things, positive cash flows and the availability of suitable financing. The Company’s future liquidity needs will be primarily based on: (i) the success and progression of its product candidates; (ii) its repayment obligations under the long-term debt agreement that is described in Note 5 to these Notes to Unaudited Condensed Financial Statements; and (iii) its costs to operate the leased build-to-suit “at-the-market (iii) out-licensing the rights to certain product candidates; (iv) entering into one or more collaborations to offset the costs of the leased manufacturing and quality control facility through third-party cash milestone and other payments; and (v) reducing spending on research and development activities and/or restructuring the Company’s operations. However, management may be unable to successfully execute any of the plans described above, or raise additional funds or enter into such other arrangements when needed on favorable terms, or at all. |
Summary of Significant Accounting Policies |
9 Months Ended | ||
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Mar. 31, 2022 | |||
Accounting Policies [Abstract] | |||
Summary of Significant Accounting Policies |
Basis of presentation The accompanying Unaudited Condensed Financial Statements have been prepared assuming that the Company will continue as a going concern and in accordance with (i) U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and (ii) the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, such financial statements do not include all the information and footnotes required by U.S. GAAP for a complete set of financial statements. In the opinion of management, the Unaudited Condensed Financial Statements include all adjustments, consisting of normal recurring accruals and other adjustments, considered necessary for a fair presentation of the Company’s financial position, results of operations and cash flows as of and for the periods presented. The accompanying Condensed Balance Sheet as of June 30, 2021 was derived from the Company’s audited financial statements at that date but does not include all of the footnote disclosures required by U.S. GAAP. The Unaudited Condensed Financial Statements should be read in conjunction with the Company’s audited financial statements and related notes included in its Annual Report on Form 10-K for the year ended June 30, 2021 (the “2021 Form 10-K”). The Company’s significant accounting policies are described in Note 2 to the Notes to Financial Statements in the 2021 Form 10-K and are updated, as necessary, in subsequent Form 10-Q filings. The Company’s fiscal year is the twelve-month period from July 1 to June 30. The results of operations for the three and nine months ended March 31, 2022 are not necessarily indicative of the Company’s operating results for the full year ending June 30, 2022 or any subsequent interim period within that year. Management views the Company’s operations and manages its business as one segment. Use of estimates The preparation of financial statements in conformity with U.S. GAAP and guidelines from the Securities and Exchange Commission requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during reporting periods. Actual results could differ from those estimates. Income Taxes The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. Interest and penalties related to uncertain tax positions are reflected in the provision for income taxes. The Company’s provision for income taxes was $21,000 and $62,000 for the three and nine months ended March 31, 2021, respectively, which was entirely attributable to estimated interest and penalties on uncertain tax positions. There was no provision for income taxes during the three and nine months ended March 31, 2022 because, among other things, the Company had no uncertain tax positions in those reporting periods. Net income or loss per share Basic net income or loss per share is calculated by dividing net income or loss by the weighted average shares outstanding during the period, without consideration of common stock equivalents. Diluted net income or loss per share is calculated by adjusting the weighted average shares outstanding for the dilutive effects of common stock equivalents outstanding during the period, determined using the treasury stock method. For purposes of diluted net income or loss per share calculations, warrants to purchase the Company’s common stock, stock options, restricted stock awards, restricted stock units and performance service awards are considered to be common stock equivalents if they are dilutive. The dilutive impact of common stock equivalents for each of the (i) three and nine months ended March 31, 2022 was approximately 0.1 million shares and (ii) three and nine months ended March 31, 2021 was approximately 0.4 million shares. However, those common stock equivalents were excluded from the calculations of diluted net loss per share for all periods presented herein because their effects were anti-dilutive. Common stock equivalents for the three and nine months ended March 31, 2022 and 2021 excluded certain warrants to purchase the Company’s common stock, which are described in Note 7 to these Notes to Unaudited Condensed Financial Statements, because the exercise price of such warrants was greater than the average market price of the Company’s common stock during the related periods. New Accounting Pronouncements Adopted during the nine months ended March 31, 2022 Financial Instruments—Credit Losses In June 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments Income Taxes In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes Investments – Equity Securities, Investments – Equity Method and Joint Ventures, and Derivatives and Hedging In January 2020, the FASB issued ASU No. 2020-01, Investments – Equity Securities (Topic 321), Investments – Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815)—Clarifying the Interactions between Topic 321, Topic 323, and Topic 815 Financial Instruments |
Share-based Compensation Plans |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based Compensation Plans |
The Company uses stock options, performance service awards, restricted stock awards and restricted stock units to provide long-term incentives to its employees, nonemployee directors and certain consultants. The Company has two equity compensation plans under which awards are currently authorized for issuance: the 2013 Employee Stock Purchase Plan and the 2013 Equity and Incentive Plan. No awards have been issued to date under the 2013 Employee Stock Purchase Plan and, as such, all of the 128,571 shares previously authorized under that plan remain available for issuance. Stock Options Information about the Company’s stock options that do not have performance conditions is provided below.
The fair value of each stock option granted is estimated on the date of grant using a Black-Scholes stock option pricing model. Below are the assumptions that were used when estimating fair value for the periods indicated .
In addition to the stock option activity described above, the Company also granted 100,000 performance-based stock options to an officer represents one-sixth of the total award. If any of the performance criteria are not satisfied, the related tranche will be forfeited. As of March 31, 2022, only one of the six performance criteria had been met. In May 2022, the officer ’s employment with the Company ended and, as a result, all unvested performance-based stock options will be forfeited. The Company used a Black-Scholes stock option pricing model to estimate the grant date fair value of each option determining the appropriate periodic share-based compensation expense for this award required management to estimate the likelihood of the achievement of the performance targets . Restricted Stock Units During August 2019, 175,500 restricted stock units with a market-based vesting condition related to the trading price of the Company’s common stock were granted to certain employees under the 2013 Equity and Incentive Plan. Those awards had a weighted average grant date fair value of $2.56. Because the award’s market and service conditions were met, on August 15, 2021 and 2020, 54,500 and 76,500 restricted stock units, respectively, vested and the underlying shares were issued to the grantees. A total of 44,500 restricted stock units were forfeited through August 15, 2021 and, subsequent to that date, no restricted stock units with market-based vesting conditions remain outstanding. The fair value of each restricted stock unit awarded was estimated on the grant date using a Monte Carlo simulation pricing model, which incorporated the probability of satisfying the related market-based vesting condition. From May 2021 to July 2021, the Company granted 579,500 restricted stock units to certain employees under the 2013 Equity and Incentive Plan with a weighted average grant date fair value of $4.16. Those awards generally vest in equal amounts on each of the first and second anniversaries of the date of grant, assuming continuing service by the grantee. As of March 31, 2022, 137,250 restricted stock units have been forfeited. The fair value of each restricted stock unit awarded was determined based on the market value of the Company’s common stock on the date of grant and the related expense is being recognized using a graded vesting schedule that is aligned with the grantees’ vesting dates. No additional restricted stock unit awards are expected to be granted under this program. General Share-based compensation expense for the three and nine months ended March 31, 2022 was $0.8 million and $2.6 million, respectively, compared to $0.6 million and $1.9 million for the three and nine months ended March 31, 2021, respectively. The portion of such expense pertaining to stock options awarded to employees, nonemployee directors and consultants was $1.7 million and $1.8 million for the nine months ended March 31, 2022 and 2021, respectively. Share-based compensation expense pertaining to restricted stock awards and restricted stock units awarded to employees and consultants totaled $0.9 million and $0.1 million for the nine months ended March 31, 2022 and 2021, respectively. |
Investments and Fair Values of Financial Instruments |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments and Fair Values of Financial Instruments |
Cash in excess of immediate requirements is invested in accordance with the Company’s investment policy, which primarily seeks to maintain adequate liquidity and preserve capital. At June 30, 2021, the Company’s investments consisted of a held-to-maturity debt The Company is required to disclose information regarding all assets and liabilities reported at fair value that enables an assessment of the inputs used when determining the reported fair values. ASC Topic 820, Fair Value Measurements and Disclosures Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2—Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly. To the extent that a valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company when determining fair value is greatest for financial instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Certain assets and liabilities are measured at fair value in the Company’s financial statements or have fair values disclosed in these Notes to Unaudited Condensed Financial Statements. Such assets and liabilities are classified into one of the three levels of the fair value hierarchy. The Company’s assessment of the significance of a particular item to the fair value measurement in its entirety requires judgment, including the consideration of inputs specific to the asset or liability. The methods and assumptions described below were used to estimate fair values and determine the fair value hierarchy classification of each class of financial instrument held by the Company. Cash and Cash Equivalents. Debt securities—held-to-maturity. held-to-maturity The fair value hierarchy table below provides information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis or disclosed at fair value in these Notes to Unaudited Condensed Financial Statements.
The Company’s financial instruments also include its variable-rate borrowing under a debt agreement that is described in Note 5 to these Notes to Unaudited Condensed Financial Statements. Management believes that the carrying amount of such debt (i.e., $20.4 million and $19.9 million at March 31, 2022 and June 30, 2021, respectively) reasonably approximates its fair value on those dates because the rate of interest on such borrowing reflects current market rates of interest for similar instruments with comparable maturities and risk profiles. This assessment primarily uses Level 2 inputs under the fair value hierarchy. |
Debt |
9 Months Ended | ||
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Mar. 31, 2022 | |||
Debt Disclosure [Abstract] | |||
Debt |
The following discussion of the Company’s debt should be read in conjunction with Note 8 to the Notes to Financial Statements in the 2021 Form 10-K. On June 30, 2020, the Company entered into a Loan and Security Agreement (as amended effective May 13, 2021, the “Amended Loan Agreement”) with several banks and other financial institutions or entities from time to time parties to the Amended Loan Agreement (collectively, referred to as the “Lenders”) and Hercules Capital, Inc., in its capacity as administrative agent and collateral agent for itself and the Lenders. The Amended Loan Agreement provides for a term loan in an aggregate principal amount of up to $ 25.0 million to be delivered in multiple tranches (the “Term Loan”). In connection with the Amended Loan Agreement, the Company received term loan advances of $ 10.0 million on each of June 30, 2020 and May 13, 2021. Prior to April 1, 2022, the Company had the right to request additional term loan advances in an aggregate principal amount of up to $ 5.0 million; however, no such request was made by the Company. As of March 31, 2022 and June 30, 2021, the per annum variable contractual interest rate on the Term Loan was 10.00% and 9.75%, respectively, and the effective interest rate on the Term Loan was approximately 13.5% and 13.3%, respectively. Prior to completing the loan amendment in May 2021, the effective interest rate on the Term Loan was approximately 13.5%. As of March 31, 2022, the Company was in full compliance with all covenants of the Amended Loan Agreement. |
Collaboration Agreements and Contract Liabilities |
9 Months Ended | ||
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Mar. 31, 2022 | |||
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |||
Collaboration Agreements and Contract Liabilities |
Bionic Sight, LLC On February 2, 2017, the Company entered into a strategic research and development collaboration agreement with Bionic Sight, LLC (“Bionic Sight”) to develop product candidates for patients with visual deficits and blindness due to retinal disease. Through the AGTC-Bionic Sight collaboration, the companies seek to develop a new optogenetic therapy that leverages AGTC’s deep experience in gene therapy and ophthalmology and Bionic Sight’s innovative neuro-prosthetic device and algorithm for retinal coding. The collaboration agreement grants to AGTC, subject to achievement by Bionic Sight of certain development milestones, an option to exclusively negotiate for a limited period of time to acquire: (i) a majority equity interest in Bionic Sight; (ii) the Bionic Sight assets to which the collaboration agreement relates; or (iii) an exclusive license with respect to the product to which the collaboration agreement relates. Under the agreement, AGTC made an initial $2.0 million payment for an equity interest of approximately 5% in Bionic Sight. During March 2020, the Company’s equity interest in Bionic Sight increased to approximately 15.5% in connection with (i) AGTC’s purchase of additional equity for $4.0 million and (ii) the conversion of certain AGTC-provided research and development support costs and in-kind contributions, which aggregated approximately $2.2 million, to an equity interest in Bionic Sight, in each case, consistent with the provisions of the collaboration agreement. AGTC is not obligated to purchase additional equity in Bionic Sight or make any additional in-kind contributions under the agreement. The Company recorded its initial investment in Bionic Sight using the equity method of accounting for investments. Upon receipt of additional equity in March 2020, management concluded that equity method accounting remained appropriate. Otonomy, Inc. During October 2019, the Company entered into a strategic collaboration agreement with Otonomy, Inc. (“Otonomy”) 30% of all genetic hearing loss cases. People with this mutation can to co-develop and co-commercialize an adeno-associated virus-based gene therapy product candidate designed to restore hearing in patients with sensorineural hearing loss caused by a mutation in the gap junction protein beta 2 gene (“GJB2”) – the most common cause of congenital hearing loss. Mutations in GJB2 account for approximatelyhave severe-to-profound The Company concluded that the Otonomy collaboration agreement is within the scope of ASC Topic 808, Collaborative Arrangements Research and Development, Contract Liabilities As of March 31, 2022 and June 30, 2021, accrued and other liabilities on the Company’s balance sheets included $ 449,000 and $ 374,000, respectively, of deferred revenue. In the account balance at June 30, 2021 was $ 225,000 that was billed to a customer and collected by the Company in July 2021. Management expects that $ 300,000 of the deferred revenue at March 31, 2022 will be recognized as revenue during the three months ending June 30, 2022; however, management is unable to estimate when the Company will satisfy the performance obligations pertaining to its residual deferred revenue at March 31, 2022. |
Stockholders' Equity |
9 Months Ended | ||
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Mar. 31, 2022 | |||
Stockholders' Equity Note [Abstract] | |||
Stockholders' Equity |
Public Offerings of AGTC Equity Securities Nine months ended March 31, 2022 On March 24, 2022, the Company closed an underwritten public offering of 7.5 million shares of its common stock, with Cantor Fitzgerald & Co. (“Cantor”) acting as the sole underwriter for the offering. The indicative public offering price of each share of common stock was $ 1.30, generating gross proceeds of $ 9.8 million, before deducting underwriting discounts, commissions and other offering expenses payable by the Company, which totaled $ 1.2 million. Issuance costs totaling $ 329,000 were unpaid on March 31, 2022 and have been included in accounts payable/accrued and other liabilities on the Company’s Unaudited Condensed Balance Sheet as of such date. Separately, the period for Cantor to exercise its option to purchase an additional 1.125 million shares of common stock to cover over-allotments has expired. The Company intends to use the net proceeds from the offering, together with other available funds, to fund its ongoing X-linked retinitis pigmentosa clinical trials, ongoing Phase 1/2 clinical trials in its achromatopsia program and preclinical development programs, and for working capital and other general corporate purposes. Nine months ended March 31, 2021 On February 1, 2021, the Company closed an underwritten public offering of 16,741,573 shares of its common stock, together with accompanying warrants to purchase 8,370,786 shares of its common stock. The combined offering price of each share of common stock and accompanying warrant was $4.45, generating gross proceeds of $74.5 million, before deducting underwriting discounts, commissions and other offering expenses payable by the Company, which totaled $5.2 million. The warrants have an initial exercise price of $6.00 per share (subject to certain adjustments), are immediately exercisable and expire on February 1, 2026. The warrants are legally detachable from the common stock that was issued on February 1, 2021 and are separately exercisable by the warrant holders. While the warrants are outstanding (but unexercised), the warrant holders will participate in any dividend or other distribution of the Company’s assets to its common stockholders by way of return of capital or otherwise. As of March 31, 2022, none of the warrants have been exercised. At-The-Market Offering Program On April 2, 2021, the Company entered into a Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cantor as sales agent to sell shares of the Company’s common stock, from time to time, through an “at-the-market offering” program Shares Issued to a Vendor During the nine months ended March 31, 2022, the Company issued 15,000 shares of its unregistered common stock to a vendor for services rendered. |
Commitments and Contingencies |
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Commitments And Contingencies Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies |
Lease Commitment On May 13, 2021, the Company entered into a non-cancelable long-term lease (the “Lease”) for a to-be-constructed build-to-suit single preparation work, and construction of the shell and core of the building and the quality control laboratory portion of the building. The Company is responsible for completion of the remaining tenant fit out work. On May 3, 2022, the Company entered into a First Amendment to Lease (the “Amendment”). Pursuant to the Amendment, the Company and the landlord finalized the architectural plans and specifications for the development and construction of the Premises and agreed that the budget for the tenant fit out work is approximately $10.9 million. The Company and the landlord also agreed in the Amendment that the landlord’s contribution to the tenant fit out work is $8.0 million, and the Company’s contribution to the fit out work is approximately $2.9 million, which is to be paid by the Company into an escrow account. Because this real property lease agreement that has not yet commenced, it is not recorded on the Company’s balance sheets . The lease will commence upon substantial completion of the Premises, including the tenant fit out work, estimated to be completed in the fourth quarter of 2022 (the “Commencement Date”), and the rent commencement date will occur simultaneous with the Commencement Date. The initial lease term has been extended by the Amendment from 20 years to
from the Commencement Date (the “Term”). As provided by the Amendment, the Company will pay annual base rent aggregating $30.4 million (assuming that the Company does not elect its early termination option) during the Term (beginning on the Commencement Date) as set forth below.
The other substantive terms and conditions of the Lease, which is discussed in Note 3 to the Notes to Financial Statements in the 2021 Form $4.2 million as of March 31, 2022. 10-K under the heading “Build-To-Suit Manufacturing and COVID-19 Pandemic On January 30, 2020, the World Health Organization (the “WHO”) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (“COVID-19”) and the risks to the international community as the virus spread globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic based on the rapid increase in exposure globally. National, state and local governments in affected regions have implemented, and are likely to continue to implement, safety precautions, including quarantines, border closures, increased border controls, travel restrictions, shelter in place orders and shutdowns, business closures, cancellations of public gatherings and other measures. Organizations and individuals are taking additional steps to avoid or reduce infection, including limiting travel and staying home from work. The worldwide spread of COVID-19 led to a global slowdown of economic activity and decreased demand for a broad variety of goods and services, while also disrupting sales channels and marketing activities and precipitating many corporate bankruptcy filings. As a result of the COVID-19 outbreak, the Company has experienced delays in enrollment of its clinical trials and may continue to see delays as the rise in COVID-19 and/or related variants causes capacity constraints at various clinical trial sites. The Company could also experience delays resulting from critical follow-up visits required under clinical trial protocols, which could increase the cost of those trials and also impact their expected timelines. Management’s ability to fully interpret the trial outcomes and the ability of certain lab-based employees to perform their jobs due to stay-at-home orders or related to COVID-19 could also result in delays and increase the Company’s operating expenses. Furthermore, third-party vendors, such as raw material suppliers and contract manufacturing, testing or research organizations, have also been impacted by COVID-19 and could continue to be impacted, which could result in unavoidable delays and/or increases in the Company’s operating costs. Notwithstanding the development and rollout of certain vaccines, it is unknown: (i) how long the COVID-19 outbreak will continue before the virus, including newly identified strains and variants, is adequately contained; (ii) the severity of the virus; and (iii) the effectiveness of actions to prevent transmission and treat those who have contracted COVID-19. The extent to which the COVID-19 outbreak may impact the Company’s financial condition, results of operations or cash flows is uncertain; however, as of the date of these financial statements, management is not aware of any specific event or circumstance that would require the Company to update its estimates or judgments, or adjust the carrying values of its assets or liabilities. Because future events are subject to change, management’s best estimates and judgments may require future modification. Therefore, actual results could differ materially from current estimates. Management is closely monitoring the evolving impact of the pandemic on all aspects of the Company’s business and periodically evaluates its estimates, which are adjusted prospectively based on such evaluations.General From time to time, the Company may be involved in claims and legal actions that arise in the normal course of business. Management has no reason to believe that the outcome of any such legal actions would have a significant adverse effect on the Company’s financial position, results of operations or cash flows. |
Summary of Significant Accounting Policies (Policies) |
9 Months Ended |
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Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of presentation The accompanying Unaudited Condensed Financial Statements have been prepared assuming that the Company will continue as a going concern and in accordance with (i) U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and (ii) the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, such financial statements do not include all the information and footnotes required by U.S. GAAP for a complete set of financial statements. In the opinion of management, the Unaudited Condensed Financial Statements include all adjustments, consisting of normal recurring accruals and other adjustments, considered necessary for a fair presentation of the Company’s financial position, results of operations and cash flows as of and for the periods presented. The accompanying Condensed Balance Sheet as of June 30, 2021 was derived from the Company’s audited financial statements at that date but does not include all of the footnote disclosures required by U.S. GAAP. The Unaudited Condensed Financial Statements should be read in conjunction with the Company’s audited financial statements and related notes included in its Annual Report on Form 10-K for the year ended June 30, 2021 (the “2021 Form 10-K”). The Company’s significant accounting policies are described in Note 2 to the Notes to Financial Statements in the 2021 Form 10-K and are updated, as necessary, in subsequent Form 10-Q filings. The Company’s fiscal year is the twelve-month period from July 1 to June 30. The results of operations for the three and nine months ended March 31, 2022 are not necessarily indicative of the Company’s operating results for the full year ending June 30, 2022 or any subsequent interim period within that year. Management views the Company’s operations and manages its business as one segment. |
Use of estimates | Use of estimates The preparation of financial statements in conformity with U.S. GAAP and guidelines from the Securities and Exchange Commission requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during reporting periods. Actual results could differ from those estimates. |
Income taxes | Income Taxes The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. Interest and penalties related to uncertain tax positions are reflected in the provision for income taxes. The Company’s provision for income taxes was $21,000 and $62,000 for the three and nine months ended March 31, 2021, respectively, which was entirely attributable to estimated interest and penalties on uncertain tax positions. There was no provision for income taxes during the three and nine months ended March 31, 2022 because, among other things, the Company had no uncertain tax positions in those reporting periods. |
Net income or loss per share | Net income or loss per share Basic net income or loss per share is calculated by dividing net income or loss by the weighted average shares outstanding during the period, without consideration of common stock equivalents. Diluted net income or loss per share is calculated by adjusting the weighted average shares outstanding for the dilutive effects of common stock equivalents outstanding during the period, determined using the treasury stock method. For purposes of diluted net income or loss per share calculations, warrants to purchase the Company’s common stock, stock options, restricted stock awards, restricted stock units and performance service awards are considered to be common stock equivalents if they are dilutive. The dilutive impact of common stock equivalents for each of the (i) three and nine months ended March 31, 2022 was approximately 0.1 million shares and (ii) three and nine months ended March 31, 2021 was approximately 0.4 million shares. However, those common stock equivalents were excluded from the calculations of diluted net loss per share for all periods presented herein because their effects were anti-dilutive. Common stock equivalents for the three and nine months ended March 31, 2022 and 2021 excluded certain warrants to purchase the Company’s common stock, which are described in Note 7 to these Notes to Unaudited Condensed Financial Statements, because the exercise price of such warrants was greater than the average market price of the Company’s common stock during the related periods. |
New Accounting Pronouncements | New Accounting Pronouncements Adopted during the nine months ended March 31, 2022 Financial Instruments—Credit Losses In June 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments Income Taxes In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes Investments – Equity Securities, Investments – Equity Method and Joint Ventures, and Derivatives and Hedging In January 2020, the FASB issued ASU No. 2020-01, Investments – Equity Securities (Topic 321), Investments – Equity Method and Joint Ventures (Topic 323), and Derivatives and Hedging (Topic 815)—Clarifying the Interactions between Topic 321, Topic 323, and Topic 815 Financial Instruments |
Share-based Compensation Plans (Tables) |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Stock Option Activity | Information about the Company’s stock options that do not have performance conditions is provided below.
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Stock Option Pricing Model Assumption | The fair value of each stock option granted is estimated on the date of grant using a Black-Scholes stock option pricing model. Below are the assumptions that were used when estimating fair value for the periods indicated .
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Investments and Fair Values of Financial Instruments (Tables) |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Major Category of Company's Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | The fair value hierarchy table below provides information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis or disclosed at fair value in these Notes to Unaudited Condensed Financial Statements.
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Commitments and Contingencies (Tables) |
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Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||
Commitments And Contingencies Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||
Schedule of Rent Payable by Maturity |
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Organization and Operations - Additional Information (Detail) - USD ($) $ in Thousands |
Mar. 31, 2022 |
Jun. 30, 2021 |
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Summary Of Organization And Operations [Line Items] | ||
Accumulated deficit | $ (289,826) | $ (239,269) |
Cash and cash equivalents | $ 67,849 | $ 105,052 |
Summary of Significant Accounting Policies - Additional Information (Detail) $ in Thousands, shares in Millions |
3 Months Ended | 9 Months Ended | ||
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Mar. 31, 2022
USD ($)
shares
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Mar. 31, 2021
USD ($)
shares
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Mar. 31, 2022
USD ($)
Segment
shares
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Mar. 31, 2021
USD ($)
shares
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Summary of Significant Accounting Policies [Line Items] | ||||
Number of operating segments | Segment | 1 | |||
Dilutive impact of common stock equivalents | shares | 0.1 | 0.4 | 0.1 | 0.4 |
Provision for income taxes | $ | $ 0 | $ 21 | $ 0 | $ 62 |
Share-based Compensation Plans - Summary of Stock Option Activity (Detail) - $ / shares shares in Thousands |
9 Months Ended | |
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Mar. 31, 2022 |
Mar. 31, 2021 |
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Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Outstanding Beginning Balance, Shares | 4,186 | 3,846 |
Granted, Shares | 2,444 | 1,280 |
Exercised, Shares | (150) | (165) |
Forfeited, Shares | (339) | (539) |
Expired, Shares | (602) | (87) |
Outstanding Ending Balance, Shares | 5,539 | 4,335 |
Exercisable, end of period, Shares | 2,680 | 2,757 |
Weighted average fair value of options granted during the year | $ 2.17 | $ 3.79 |
Outstanding Beginning Balance, Weighted Average Exercise Price | 7.69 | 7.82 |
Granted, Weighted Average Exercise Price | 3.07 | 5.26 |
Exercised, Weighted Average Exercise Price | 0.89 | 4.10 |
Forfeited, Weighted Average Exercise Price | 4.13 | 4.38 |
Expired, Weighted Average Exercise Price | 10.82 | 10.29 |
Outstanding Ending Balance, Weighted Average Exercise Price | $ 5.71 | $ 7.58 |
Share-based Compensation Plans - Stock Option Pricing Model Assumption (Detail) |
9 Months Ended | |
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Mar. 31, 2022 |
Mar. 31, 2021 |
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Share-Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Dividend yield | 0.00% | 0.00% |
Expected volatility | 82.51% | 82.60% |
Minimum [Member] | ||
Share-Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term | 6 years | 6 years |
Risk-free interest rate, minimum | 0.80% | 0.30% |
Maximum [Member] | ||
Share-Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term | 6 years 3 months | 6 years 3 months |
Risk-free interest rate, maximum | 1.80% | 1.08% |
Investments and Fair Values of Financial Instruments - Additional Information (Detail) - USD ($) $ in Thousands |
Mar. 31, 2022 |
Jun. 30, 2021 |
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Fair Value Disclosures [Abstract] | ||
Carrying amount of long-term debt, net of unamortized deferred financing costs and debt discounts | $ 20,400 | $ 19,900 |
Debt Securities, Held-to-maturity, Fair Value | $ 2,000 | |
Investments | $ 0 | |
Debt Securities, Maturity, Date | Jul. 31, 2021 |
Debt - Additional Information (Detail) - USD ($) $ in Millions |
May 05, 2022 |
Mar. 31, 2022 |
Jun. 30, 2021 |
Jun. 30, 2020 |
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Debt instrument,interest rate | 10.00% | 9.75% | ||
After Amendment To Loan [Member] | ||||
Debt instrument, Effective interest rate | 13.50% | 13.30% | ||
Before Amendment To Loan [Member] | ||||
Debt instrument, Effective interest rate | 13.50% | |||
Maximum [Member] | ||||
Debt instrument,interest rate | 10.50% | |||
Term loan [Member] | ||||
Debt instrument maximum borrowing capacity | $ 25.0 | |||
Long-term Debt, Gross | 10.0 | |||
Line of credit facility additional borrowing capacity | $ 5.0 |
Commitments and Contingencies - Schedule of Rent Payable by Maturity (Detail) $ in Thousands |
Mar. 31, 2022
USD ($)
|
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Lessee, Operating Lease, Liability, Payment, Due [Abstract] | |
1 | $ 0 |
2-7 | 743,750 |
8-19 | $ 1,336,625 |
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