The accompanying notes are an integral part of these consolidated financial statements.
The accompanying notes are an integral part of these consolidated financial statements.
The accompanying notes are an integral part of these consolidated financial statements.
The accompanying notes are an integral part of these consolidated financial statements.
Notes to Consolidated Financial Statements
Note 1. Description of Business and Summary of Significant Accounting Policies
Nature of operations and basis of presentation
Organovo Holdings, Inc. (“Organovo Holdings,” “Organovo,” and “the Company”) is an early-stage biotechnology company that has historically been focused on pioneering the development of bioprinted human tissues that emulate key aspects of human biology and disease. Organovo has focused on developing its in vivo liver tissues to treat end-stage liver disease and a select group of life-threatening, orphan diseases, for which there are limited treatment options other than organ transplantation. Organovo has also explored the development of other potential pipeline in vivo tissue constructs in-house and through collaborations with academic and government researchers. The Company’s current limited operations include managing certain collaborations with research institutions and universities with respect to its NovoGen Bioprinters® for research purposes. Organovo’s NovoGen Bioprinters® are automated devices that enable the fabrication of 3D living tissues comprised of mammalian cells. The Company believes that the use of its bioprinting platform by major research institutions may help to advance the capabilities of the platform and generate new applications for bioprinted tissues. In some instances, an academic institution or other third party has provided funding to support the academic collaborator’s access to the Company’s technology platform. This funding is typically reflected as collaboration revenues in its financial statements; however, the Company is not currently generating any revenues from these collaborations. The Company’s research collaborations typically involve both the Company and the academic partner contributing resources directly to projects, but also involves sponsored research agreements where the Company funds specific research programs. The Company also continues to retain certain key management, employees and consultants, its core intellectual property and licenses, and proprietary equipment.
Strategic Alternatives Process
In August 2018, following a pre-pre-Investigational New Drug application (“IND”) meeting with the Food and Drug Administration (the “FDA”) regarding its lead liver therapeutic candidate, Organovo announced that it was concentrating its financial resources around supporting its healthy liver therapeutic tissue development, and that it would continue to opportunistically generate revenue to support its therapeutics program by leveraging its cell and in vitro tissue platform including providing funded access to its developmental in vitro liver tissue platform to clients for their own R&D programs.
In August 2019, after a rigorous assessment of its liver therapeutic tissue program, Organovo concluded that the variability of biological performance and related duration of potential benefits no longer supported an attractive opportunity due to redevelopment challenges and lengthening timelines to compile sufficient data to support an IND filing. As a result, Organovo suspended development of its lead program and all other related in-house pipeline development activities. The Organovo board of directors also engaged a financial advisory firm to explore its available strategic alternatives, including evaluating a range of ways to generate value from its technology platform and intellectual property, its commercial and development capabilities, its listing on The Nasdaq Capital Market, and its remaining financial assets. These strategic alternatives included possible mergers and business combinations, sales of part or all of Organovo’s assets, and licensing and partnering arrangements. Organovo implemented various restructuring steps to manage its resources and extend its cash runway, including reducing commercial activities related to its liver tissues, except for sales of primary human cells out of inventory, negotiating an exit from its long-term facility lease, selling various assets, and reducing its workforce. Additionally, in November 2019, Organovo sold certain inventory and equipment and related proprietary information held by its wholly owned subsidiary, Samsara Sciences, Inc. (“Samsara”), and as a result of such sale, Samsara ceased its operations in March 2020.
After conducting a diligent and extensive process of evaluating strategic alternatives for Organovo and identifying and reviewing potential candidates for a strategic acquisition or other transaction, which included the receipt of more than 27 non-binding indications of interest from interested parties and careful evaluation and consideration of those proposals, and following extensive negotiation with Tarveda Therapeutics, Inc. (“Tarveda”), on December 13, 2019, Organovo and Tarveda entered into an agreement and plan of merger agreement (the “Merger Agreement”). Pursuant to the Merger Agreement, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, a wholly-owned merger subsidiary of Organovo would merge (the “Merger”) into Tarveda, with Tarveda surviving the Merger. The Merger Agreement included various conditions to the consummation of the Merger, including approval by Organovo’s stockholders at a special meeting of stockholders (the “Special Meeting”).
F-7
On April 7, 2020 at the Special Meeting, the Merger was not approved by Organovo stockholders. As a result, Organovo is currently reconsidering its strategic alternatives and may pursue one of the following courses of action, which include but are not limited to the following actions:
|
•
|
Pursue another strategic transaction similar to the Merger. Organovo may resume its process of evaluating other candidate companies interested in pursuing a strategic transaction and, if a candidate is identified, focus its attention on negotiating and completing such strategic transaction with such candidate.
|
|
•
|
Continue to operate and expand its business. Organovo could elect to continue to operate and expand its business and pursue licensing or partnering transactions or utilize its intellectual property and platform technology to pursue the redevelopment of its liver tissues or the development of therapeutic tissues currently being studied by its collaborators. Due to the early development stage of Organovo’s, and its collaborators’, potential therapeutic tissues, any such redevelopment or development efforts would require a significant amount of time and financial resources, and would be subject to all the risk and uncertainties involved in the development of novel, early stage therapeutic products, research tools, and drug screening technologies. There is no assurance that Organovo could raise sufficient capital to support these efforts, that its development efforts would be successful commercially in the case of research applications or that it could successfully obtain any required regulatory approvals required to market any therapeutic product it pursued. The Company would also need to increase qualified scientific, sales and marketing, and administrative staffing, lease a suitable facility and make other expenditures necessary to support these efforts.
|
|
•
|
Dissolve and liquidate its assets. If Organovo is unable, or does not believe that it will be able, to find a suitable candidate for another strategic transaction or continue to operate its business, Organovo may dissolve and liquidate its assets, subject to approval by Organovo’s stockholders. In that event, Organovo would be required to pay all of its debts and contractual obligations and to set aside certain reserves for potential future claims. If Organovo dissolves and liquidates its assets, there can be no assurance as to the amount or timing of available cash that will remain for distribution to Organovo’s stockholders after paying Organovo’s debts and other obligations and setting aside funds for its contingent liabilities.
|
Except where specifically noted or the context otherwise requires, references to “Organovo Holdings,” “the Company,” and “Organovo” in these notes to the consolidated financial statements refers to Organovo Holdings, Inc. and its wholly owned subsidiaries, Organovo, Inc., Samsara Sciences, Inc, and Opal Merger Sub, Inc.
COVID-19
In December 2019 a respiratory illness caused by a novel strain of coronavirus, SARS-CoV-2, causing the Coronavirus Disease 2019, also known as COVID-19 or coronavirus emerged. While initially the outbreak was largely concentrated in China it has spread globally. Global health concerns relating to the COVID-19 pandemic have been weighing on the macroeconomic environment, and the pandemic has significantly increased economic volatility and uncertainty. The pandemic has resulted in government authorities implementing numerous measures to try to contain the virus, such as travel bans and restrictions, quarantines, shelter-in-place or stay-at-home orders, and business shutdowns.
The extent to which the coronavirus impacts the Company’s operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak and travel bans and restrictions, quarantines, shelter-in-place or stay-at-home orders, and business shutdowns. In particular, the continued coronavirus pandemic could adversely impact the Company’s operations, including among others, the timing and ability to pursue strategic alternatives, given the impact it may have on the manufacturing and supply chain, sales and marketing and clinical trial operations of potential strategic partners, and the ability, if we elect to do so, to advance our research and development activities and pursue development of any of our pipeline products, each of which could have an adverse impact on the Company’s business and financial results.
Nasdaq listing
On June 25, 2019, the Company received a notice letter from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (“Nasdaq”) indicating that, based upon the closing bid price of our common stock for the last 30 consecutive business days, the Company no longer met the requirement to maintain a minimum closing bid price of $1 per share, as set forth in Nasdaq Listing Rule 5450(a)(1). On December 26, 2019, the Company obtained an additional compliance period of 180 calendar days by electing to transfer to The Nasdaq Capital Market to take advantage of the additional compliance period offered on that market. On March 26, 2020, the Company obtained shareholder approval to effect a reverse stock split in a range from 20:1 to 40:1, which remains subject to the approval of the Company’s board of directors (such final ratio, as determined by our board of directors, the “Reverse Stock Split Ratio” such reverse stock split, the “Reverse Stock Split”). On April 17, 2020, the Company received an additional notice letter from
F-8
Nasdaq indicating that based on extraordinary market conditions, Nasdaq has determined to toll the compliance periods for bid price and market value of publicly held shares requirements (collectively, the “Price-based Requirements”) through June 30, 2020. Accordingly, since the Company had 66 calendar days remaining in the compliance period as of April 16, 2020, the Company will, upon reinstatement of the Price-based Requirements, still have 66 calendar days from July 1, 2020, or until September 4, 2020, to regain compliance. The Company can regain compliance, either during the suspension or during the compliance period resuming after the suspension, by evidencing compliance with the Price-based Requirements for a minimum of 10 consecutive trading days. The Company intends to comply with the Price-based Requirements by effecting the Reverse Stock Split. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market.
Liquidity
As of March 31, 2020, the Company had cash and cash equivalents of approximately $27.4 million and no restricted cash. The Company had an accumulated deficit of approximately $279.5 million. The Company also had negative cash flows from operations of approximately $14.9 million during the year ended March 31, 2020.
Through March 31, 2020, the Company has financed its operations primarily through the sale of convertible notes, warrants, the private placement of equity securities, the sale of common stock through public and at-the-market (“ATM”) offerings, and through revenue derived from product and research service-based agreements, collaborative agreements, licenses, and grants. During the year ended March 31, 2020, the Company issued 6,087,382 shares of its common stock through its ATM facility and received net proceeds of approximately $5.0 million.
Throughout the strategic alternatives assessment process, the Company has taken steps to manage its resources and extend its cash runway including reducing commercial activities related to its liver tissues, except for sales of primary human cells out of inventory, negotiating an exit from its long-term facility lease, selling various assets, and reducing its workforce to the minimum level necessary to explore and support these strategic alternatives as well as to support the remainder of the Company’s on-going business activities and assets, including its intellectual property platform and collaborations with research institutions and universities. As a result, the Company terminated the employment of 52 employees, or 90% of its workforce and recorded a restructuring charge during the year ended March 31, 2020 of approximately $2.7 million, related to employee severance and benefits costs, of which $1.7 million was paid out during the fiscal second quarter, $0.9 million was paid out during the fiscal third quarter, and $0.1 million was paid out during the fiscal fourth quarter.
While the Company believes that it can maintain its current operations for at least the next 12 months, based on its current plans and available resources, the assessment by the Company discussed above with respect to its strategic alternatives raises uncertainty over the Company’s ability to successfully finance itself on a long-term basis. The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Use of estimates
The preparation of the financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect certain reported amounts and disclosures. Accordingly, actual results could differ from those estimates. Significant estimates used in preparing the consolidated financial statements include those assumed in revenue recognition, the measurement of operating lease right-of-use assets and lease liabilities, the valuation of stock-based compensation expense, the valuation of impairment of long-lived assets, our assessment of contingent liabilities that would require the establishment of a reserve, and the valuation allowance on deferred tax assets. On an ongoing basis, management reviews these estimates and assumptions. Though the impact of the COVID-19 pandemic to our business and operating results presents additional uncertainty, we continue to use the best information available to inform our critical accounting estimates.
Financial instruments
For certain of the Company’s financial instruments, including cash and cash equivalents, inventory, prepaid expenses and other assets, accounts payable, accrued expenses, deferred revenue, and capital lease obligations, the carrying amounts are generally considered to be representative of their respective fair values because of the short-term nature of those instruments.
Cash and cash equivalents
The Company considers all highly liquid investments with original maturities of 90 days or less to be cash equivalents.
F-9
Restricted cash
As of March 31, 2020 and 2019, the Company had approximately $0 and $79,000 of restricted cash, respectively, deposited with a financial institution. The entire amount was held in certificates of deposit to support a letter of credit agreement related to the Company’s facility lease, which was terminated in November 2019.
Inventory
Inventories are stated at the lower of the cost or net realizable value (first-in, first-out). The Company had no inventory at March 31, 2020. Inventory at March 31, 2019 consists of approximately $361,000 in raw materials, no work-in-process inventory, and approximately $129,000 in finished goods net of reserve.
Fixed assets and depreciation
Property and equipment are carried at cost. Expenditures that extend the life of the asset are capitalized and depreciated. Depreciation and amortization are provided using the straight-line method over the estimated useful lives of the related assets or, in the case of leasehold improvements, over the lesser of the useful life of the related asset or the remaining lease term. The estimated useful lives of the fixed assets range between one and seven years.
Impairment of long-lived assets
In accordance with ASC 360-10, the Company records an impairment loss on long-lived assets used in operations when events and circumstances indicate that long-lived assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of those assets (i.e. not able to be recovered). During the second quarter of fiscal 2020, the Company announced the restructuring of its operations. This event required the reevaluation of the recoverability of the gross carrying value of its long-lived assets. Upon the Company’s announcement and at each quarter-end, the Company performed an asset impairment analysis on its long-lived asset group, consisting primarily of licensed intangible assets, computer equipment, and software following the completion of various asset sales prior to March 31, 2020, which concluded that the carrying amount is not recoverable. However, the Company’s analysis indicated that carrying amount of the asset group did not exceed its fair value. As such, no impairment loss is required to be recognized. Nonetheless, it is reasonably possible that the impairment analysis may change in the near term resulting in the need to write down those assets to fair value. The Company will continue to monitor assets for impairment.
Assets held for sale
The Company classifies assets held for sale if all held for sale criteria is met pursuant to ASC 360-10. Assets classified as held for sale are not depreciated and are measured at the lower of their carrying amount or fair value less cost to sell. Further, assets held for sale are presented as current assets on the consolidated balance sheet.
Research and development
Research and development expenses, including direct and allocated expenses, consist of independent research and development costs, as well as costs associated with sponsored research and development. Research and development costs are expensed as incurred.
Income taxes
Deferred income taxes are recognized for the tax consequences in future years for differences between the tax basis of assets and liabilities and their financial reporting amounts at each year end based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Income tax expense is the combination of the tax payable for the year and the change during the year in deferred tax assets and liabilities. The Company’s policy regarding uncertainty in income taxes is pursuant to ASC 740-10. Interest and penalties that would be assessed in relation to the settlement value of unrecognized tax benefits is recognized as a component of income tax expense.
Revenue recognition
The Company has generated revenues from payments received from research service agreements, product sales, collaborative agreements with partners including pharmaceutical and biotechnology companies and academic institutions, licenses, and grants from the National Institutes of Health (“NIH”) and private not-for-profit organizations.
F-10
Billings to customers or payments received from customers are included in deferred revenue on the consolidated balance sheet until all revenue recognition criteria are met. As of March 31, 2020 and 2019, the Company had approximately $0 and $525,000, respectively, in deferred revenue related to its research service agreements, collaborative agreements, and licenses within the scope of Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers (“Topic 606”). In the year ended March 31, 2020, the Company recognized revenue on approximately $525,000, of which $490,000 related to the expiration of an agreement with a non-refundable up-front fee, that had been recorded as deferred revenue at March 31, 2019.
Service revenues
The Company’s service-based business, Organovo, Inc., utilized its NovoGen® bioprinting platform to provide customers access to its highly specialized tissues that model human biology and disease, and to in vitro testing services based on that technology. These contracts with customers contained multiple performance obligations including: (i) bioprinting tissues for the customer, (ii) reporting the results of tests performed on the printed tissues pursuant to the agreed upon work plan through exposure of the tissue to various factors (including the customer’s proprietary compound), and (iii) delivering specific byproduct study materials, which were satisfied, respectively, at each of the following points in time: (i) upon completion of manufacturing of the bioprinted tissue for the customer, (ii) upon delivery of the report on tests performed on the tissue, and (iii) upon making certain study materials generated from the aforementioned testing process available to the customer. The customer did not have access or control of any performance obligation prior to the point in time of full completion of the corresponding performance satisfying event as defined above. Furthermore, although the service could be customized for each customer, it was not so highly customized as to not have an alternative use either to other customers or to the Company without significant economic consequences or rework. Accordingly, the Company’s service-based business utilized point-in-time recognition under Topic 606.
For service contracts, the Company allocates the transaction price to each performance obligation based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations. The transaction price for service business contracts is a fixed consideration.
In connection to the Company’s decision to pursue its strategic alternatives, the Company halted commercial activities related to its liver tissues. The Company is expected to continue to maintain its external research collaborations and its intellectual property portfolio.
Product sales, net
The Company’s product-based business, Samsara, produced high-quality cell-based products for use in Organovo’s 3D tissue manufacturing and for use by life science customers. The Company recognizes product revenue when the performance obligation is satisfied, which is at the point in time the customer obtains control of the Company’s product, typically upon delivery. Product revenues are recorded at the transaction price, net of any estimates for variable consideration under Topic 606. The Company’s process for estimating variable consideration does not differ materially from its historical practices. Variable consideration is estimated using the expected value method which considers the sum of probability-weighted amounts in a range of possible amounts under the contract. Product revenue reflects the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the individual contracts. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results vary materially from the Company’s estimates, the Company will adjust these estimates, which will affect revenue from product sales and earnings in the period such estimates are adjusted.
The Company provides no right of return to its customers except in cases where a customer obtains authorization from the Company for the return. To date, there have been no product returns.
On November 7, 2019, the Company entered into an agreement to sell substantially all of the Samsara inventory and associated assets for $1.5 million, which was recorded to other income. As a result, the Company will have no further product sales of cells nor tissues beyond what it sold prior to the November 2019 sale. In March 2020, the Company dissolved Samsara.
Collaborative research, development, and licenses
The Company has entered into collaborative agreements with partners that typically include one or more of the following: (i) non-exclusive license fees; (ii) non-refundable up-front fees; (iii) payments for reimbursement of research costs; (iv) payments associated with achieving specific development milestones; and (v) royalties based on specified percentages of net product sales, if any. At the initiation of an agreement, the Company has analyzed whether it results in a contract with a customer under Topic 606 or in an arrangement with a collaborator subject to guidance under ASC 808, Collaborative Arrangements (“Topic 808”).
F-11
The Company has considered a variety of factors in determining the appropriate estimates and assumptions under these arrangements, such as whether the elements are distinct performance obligations, whether there are determinable stand-alone prices, and whether any licenses are functional or symbolic. The Company has evaluated each performance obligation to determine if it can be satisfied and recognized as revenue at a point in time or over time. Typically, non-exclusive license fees, non-refundable upfront fees, and funding of research activities have been considered fixed, while milestone payments have been identified as variable consideration which must be evaluated to determine if it has been constrained and, therefore, excluded from the transaction price.
The Company’s collaborative agreements that were not completed at the implementation of Topic 606 on April 1, 2018, consisted of research collaboration and limited technology access licenses. These agreements provide the licensee with a non-exclusive, non-transferable, limited, royalty-free technology license, including access to Organovo’s proprietary bioprinter platform, training, and continued support by means of consumables and consultation throughout the duration of the contract. The Company has determined that the intellectual property license is not distinct from the continued support promised under the agreement and is therefore a single combined performance obligation. The Company recognized revenue for these combined performance obligations over time for the duration of the license period, as the combined performance obligation would not be fully satisfied until the end of the contract.
For the year ended March 31, 2020, all collaborations and licenses revenue was within the scope of Topic 606 and recognized accordingly. As of September 30, 2019, the Company completed its obligations under the existing agreements with respect to receipts of revenue and does not anticipate recording any further revenue. See “Note 4. Collaborative Research, Development, and License Agreements” for more information on the Company’s collaborative agreements.
Grant revenues
In July 2017, the NIH awarded the Company a “Research and Development” grant totaling approximately $1,657,000 of funding over three years. The Company has concluded this government grant is not within the scope of Topic 606, as government entities do not meet the definition of a “customer” as defined by Topic 606, as there is not considered to be a transfer of control of goods or services to the government entity funding the grant. Additionally, the Company has concluded this government grant does meet the definition of a contribution and is a non-reciprocal transaction, however, Subtopic 958-605, Not-for-Profit-Entities-Revenue Recognition does not apply, as the Company is a business entity and the grant is with a governmental agency.
Revenues from this grant have been based upon internal costs incurred that are specifically covered by the grant, plus an additional rate that provides funding for overhead expenses. Revenue has been recognized as the Company incurs expenses that are related to the grant. The Company believes this policy is consistent with the overarching premise in Topic 606, to ensure that it recognizes revenues to reflect the transfer of promised goods or services to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services, even though there is no “exchange” as defined in the Financial Accounting Standards Board’s Accounting Standards Codification (“ASC”). The Company believes the recognition of revenue as costs are incurred and amounts become earned/realizable is analogous to the concept of transfer of control of a service over time under Topic 606.
Revenue recognized under this grant was approximately $52,000 and $587,000 during the years ended March 31, 2020 and 2019, respectively.
In connection to the Company’s decision to pursue its strategic alternatives, specific to the NIH grant, all internal research activities have been halted and transferred to the University of California, San Diego, leaving a remaining available balance of approximately $0.5 million that will not be utilized by the Company.
Cost of revenue
The Company reported $0.3 million and $0.5 million in cost of revenue for the years ended March 31, 2020 and 2019, respectively, which includes an inventory write-off during the current year fiscal second quarter of approximately $0.2 million consisting of raw materials related to the Company’s bioprinting and testing services and is a result of the Company’s decision to pursue its strategic alternatives. Cost of revenues consists of our costs related to manufacturing and delivering our product and service revenue.
Stock-based compensation
The Company accounts for stock-based compensation in accordance with the ASC Topic 718, Compensation — Stock Compensation, which establishes accounting for equity instruments exchanged for employee services. Under such provisions, stock-based compensation cost is measured at the grant date, based on the calculated fair value of the award, and is recognized as an expense, under the straight-line method, over the employee’s requisite service period (generally the vesting period of the equity grant).
F-12
The Company accounts for equity instruments, including restricted stock or stock options, issued to non-employees in accordance with authoritative guidance for equity-based payments to non-employees. Stock options issued to non-employees are accounted for at their estimated fair value determined using the Black-Scholes option-pricing model. As of April 1, 2019, the fair value of options granted to non-employees is consistent with the measurement and classification of share-based payment to employees. Restricted stock issued to non-employees is accounted for at its estimated fair value as it vests.
Comprehensive income (loss)
Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. The Company is required to record all components of comprehensive income (loss) in the financial statements in the period in which they are recognized. Net income (loss) and other comprehensive income (loss), including unrealized gains and losses on investments, are reported, net of their related tax effect, to arrive at comprehensive income (loss). For the years ended March 31, 2020 and 2019, the comprehensive loss was equal to the net loss.
Net loss per share
Basic and diluted net loss per share has been computed using the weighted-average number of shares of common stock outstanding during the period. The weighted-average number of shares used to compute diluted loss per share excludes any assumed exercise of stock options and warrants, shares reserved for purchase under the Company’s 2016 Employee Stock Purchase Plan (“ESPP”), the assumed release of restriction of restricted stock units, and shares subject to repurchase as the effect would be anti-dilutive. No dilutive effect was calculated for the years ended March 31, 2020 and 2019 as the Company reported a net loss for each respective period and the effect would have been anti-dilutive.
Common stock equivalents excluded from computing diluted net loss per share were approximately 12.1 million shares and 14.4 million shares for the years ended March 31, 2020 and 2019, respectively.
Note 2. Fixed Assets
Fixed assets consisted of the following (in thousands):
|
|
March 31,
2020
|
|
|
March 31,
2019
|
|
Construction in Progress
|
|
$
|
—
|
|
|
$
|
47
|
|
Laboratory equipment
|
|
$
|
—
|
|
|
$
|
3,690
|
|
Leasehold improvements
|
|
|
—
|
|
|
|
1,809
|
|
Computer software and equipment
|
|
|
415
|
|
|
|
645
|
|
Furniture and fixtures
|
|
|
—
|
|
|
|
213
|
|
Vehicles
|
|
|
—
|
|
|
|
9
|
|
Fixed Assets, gross
|
|
|
415
|
|
|
|
6,413
|
|
Less accumulated depreciation
|
|
|
(415
|
)
|
|
|
(4,581
|
)
|
Fixed Assets, net
|
|
$
|
—
|
|
|
$
|
1,832
|
|
Depreciation expense for the years ended March 31, 2020 and 2019 was approximately $1,128,000 and $969,000, respectively.
Assets held for sale consisted of the following (in thousands):
|
|
March 31,
2020
|
|
|
March 31,
2019
|
|
Laboratory equipment
|
|
$
|
683
|
|
|
$
|
—
|
|
Vehicles
|
|
|
9
|
|
|
|
—
|
|
Assets held for sale, gross
|
|
|
692
|
|
|
|
—
|
|
Less accumulated depreciation
|
|
|
(659
|
)
|
|
|
—
|
|
Assets held for sale, net
|
|
$
|
33
|
|
|
$
|
—
|
|
Assets held for sale are reflected on the consolidated balance sheet at March 31, 2020 as other current assets.
F-13
Note 3. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
|
|
March 31,
2020
|
|
|
March 31,
2019
|
|
Accrued compensation
|
|
$
|
829
|
|
|
$
|
2,160
|
|
Accrued legal and professional fees
|
|
|
240
|
|
|
|
152
|
|
Other accrued expenses
|
|
|
21
|
|
|
|
237
|
|
|
|
$
|
1,090
|
|
|
$
|
2,549
|
|
Note 4. Collaborative Research, Development, and License Agreements
Collaboration Agreements
In December 2016, the Company signed a collaborative non-exclusive research affiliation with a university medical school and a non-profit medical charity, under which the Company received a one-time grant from the charity towards the placement of a NovoGen® Bioprinter at the university for the purpose of developing a kidney organoid for potential therapeutic applications. The Company received up-front payments in January and March 2017, which has been recorded as deferred revenue. Revenue of $19,000 and $39,000 was recorded under this agreement for the years ended March 31, 2020 and 2019, respectively. The Company completed its obligations under this agreement and does not anticipate recording any further revenue.
In April 2017, the Company signed a collaborative non-exclusive research affiliation with a university, under which the Company received a one-time non-refundable payment toward the placement of a NovoGen® Bioprinter at the university for the purpose of specific research projects mutually agreed upon by the university and the Company in the field of volumetric muscle loss. The Company received an up-front payment in May 2017, which was recorded as deferred revenue. Revenue of approximately $0 and $57,000 has been recorded under this agreement for the years ended March 31, 2020 and 2019, respectively. In addition, during April 2017, the Company signed a non-exclusive patent license agreement with the university including an annual fee of $75,000 for each of the two years for the license to the Company patents for research use limited to the field of volumetric muscle loss. The Company received the first annual payment of $75,000 in April 2017 and the second annual payment of $75,000 in May 2018, which were initially recorded as deferred revenue. Revenue of $0 and $75,000 was recorded under this agreement for the years ended March 31, 2020 and 2019, respectively. The Company completed its obligations under these agreements with respect to receipts of revenue and does not anticipate recording any further revenue.
In November 2019, the Company signed a non-exclusive patent license agreement with Viscient Biosciences, a related party, including a one-time, non-refundable fee of $70,000 for a license to certain Company patents for in vitro research limited to certain fields of use. The Company received the one-time payment in November 2019, which was recorded as revenue. The Company completed its obligations under these agreements with respect to receipts of revenue and does not anticipate recording any further revenue. See “Note. 10 Related Parties” for more information.
University of Missouri
In March 2009, the Company entered into a license agreement with the Curators of the University of Missouri to in-license certain technology and intellectual property relating to self-assembling cell aggregates and to intermediate cellular units. The Company received the exclusive worldwide rights to commercialize products comprising this technology for all fields of use. The Company is required to pay the University of Missouri royalties ranging from 1% to 3% of net sales of covered tissue products, and of the fair market value of covered tissues transferred internally for use in the Company’s commercial service business, depending on the level of net sales achieved by the Company each year. The Company paid minimum annual royalties of $25,000 in January 2020 and January 2019 for their respective calendar years, which is credited against royalties due during the subsequent twelve months. No payments have been made in excess of the minimum annual royalties in the years ended March 31, 2020 and 2019.The license agreement terminates upon expiration of the patents licensed and is subject to certain conditions as defined in the license agreement, which are expected to expire after 2029.
In March 2010, the Company entered into a license agreement with the Curators of the University of Missouri to in-license certain technology and intellectual property relating to engineered biological nerve grafts. The Company received the exclusive worldwide rights to commercialize products comprising this technology for all fields of use. The Company is required to pay the University of Missouri royalties ranging from 1% to 3% of net sales of covered tissue products depending on the level of net sales achieved by the Company each year. The license agreement terminates upon expiration of the patents licensed and is subject to certain conditions as defined in the license agreement. No payments have been made in the years ended March 31, 2020 and 2019.
F-14
Clemson University
In May 2011, the Company entered into a license agreement with Clemson University Research Foundation to in-license certain technology and intellectual property relating to ink-jet printing of viable cells. The Company received the exclusive worldwide rights to commercialize products comprising this technology for all fields of use. The Company is required to pay the University royalties ranging from 1.5% to 3% of net sales of covered tissue products and the fair market value of covered tissues transferred internally for use in the Company’s commercial service business, depending on the level of net sales reached each year. The license agreement terminates upon expiration of the patents licensed, which is expected to expire in May 2024, and is subject to certain conditions as defined in the license agreement. Minimum annual royalty payments of $20,000 were due for each of the two years beginning with calendar 2014, and $40,000 per year beginning with calendar 2016. The annual minimum royalty is creditable against royalties owed during the same calendar year.
UniQuest
In August 2015, the Company entered into a license agreement with UniQuest Pty Limited to in-license certain technology and intellectual property relating to technologies for in vitro applications with the exclusion of individual cell types isolated and purified from the organoids or induced pluripotent stem-derived kidney structures. The Company received the exclusive worldwide rights to commercialize products comprising this technology for all fields of use. The Company is required to pay UniQuest certain royalties based on net sales of licensed products, depending on the level of net sales reached each year, and certain royalties for any consideration invoiced or received by the Licensee in return for the grant of sub-licenses, options, marketing, or distribution rights, arising from the licensed intellectual property. In addition, the Company is required to pay certain milestone payments. As of March 31, 2020, the Company has made two milestone payments of $20,000. The license agreement terminates upon expiration of the patents licensed, which is expected to expire in August 2025, and is subject to certain conditions as defined in the license agreement. The Company paid an initial fee of $35,000 in September 2015, as well as minimum annual royalty payments of $15,000 AUD, which are due annually following the third anniversary of the agreement (i.e. August 2018).
In December 2016, the Company entered into a license agreement with UniQuest Pty Limited to in-license certain technology and intellectual property relating to technologies for generation of organoids or cells in a 3D configuration via a bioprinter or other device for additive cellular manufacturing and use in in vivo applications. The Company received the exclusive worldwide rights to commercialize products comprising this technology for all fields of use. The Company is required to pay UniQuest certain royalties based on net sales of licensed products, depending on the level of net sales reached each year, and certain royalties for any consideration invoiced or received by the Licensee in return for the grant of sub-licenses, options, marketing, or distribution rights, arising from the licensed intellectual property. In addition, the Company is required to pay certain milestone payments. As of March 31, 2020, the Company has not made any milestone payments. The license agreement terminates upon expiration of the patents licensed, which is expected to expire in December 2026, and is subject to certain conditions as defined in the license agreement. The Company paid an initial fee of $35,000 for each of the two licenses in June 2017. Minimum annual royalty payments of $25,000 are due annually following the third anniversary of the agreement (i.e. December 2019).
Capitalized license fees consisted of the following (in thousands):
|
|
March 31,
2020
|
|
|
March 31,
2019
|
|
License fees
|
|
$
|
218
|
|
|
$
|
218
|
|
Less accumulated amortization
|
|
|
(95
|
)
|
|
|
(81
|
)
|
License fees, net
|
|
$
|
123
|
|
|
$
|
137
|
|
The above license fees, net of accumulated amortization, are included in Other Assets in the accompanying consolidated balance sheets and are being amortized over the life of the related patents. Amortization expense of licenses was approximately $14,000 for the years ended March 31, 2020 and 2019. At March 31, 2020, the weighted average remaining amortization period for all licenses was approximately 10 years. The annual amortization expense of licenses for the next five years is estimated to be approximately $14,000 per year.
F-15
Note 5. Stockholders’ Equity
Stock-based compensation expense and valuation information
Stock-based awards include stock options and restricted stock units under the 2012 Equity Incentive Plan, as amended (“2012 Plan”) and Inducement Awards, performance-based restricted stock units under an Incentive Award Performance-Based Restricted Stock Unit Agreement, and rights to purchase stock under the ESPP. The Company calculates the grant date fair value of all stock-based awards in determining the stock-based compensation expense.
Stock-based compensation expense for all stock awards consists of the following (in thousands):
|
|
Year Ended
March 31, 2020
|
|
|
Year Ended
March 31, 2019
|
|
Research and development
|
|
$
|
111
|
|
|
$
|
911
|
|
General and administrative
|
|
$
|
3,997
|
|
|
$
|
4,282
|
|
Total
|
|
$
|
4,108
|
|
|
$
|
5,193
|
|
The total unrecognized compensation cost related to unvested stock option grants as of March 31, 2020 was approximately $3,184,000 and the weighted average period over which these grants are expected to vest is 1.76 years.
The total unrecognized stock-based compensation cost related to unvested restricted stock units (not including performance-based restricted stock units) as of March 31, 2020 was approximately $854,000, which will be recognized over a weighted average period of 1.63 years.
The total unrecognized stock-based compensation cost related to unvested performance-based restricted stock units as of March 31, 2020 was approximately $1,278,000, which will be recognized over a weighted average period of 1.42 years.
As of March 31, 2020, there are no participants enrolled into the employee stock purchase plan for the current purchase period, beginning March 1, 2020.
The Company uses the Black-Scholes valuation model to calculate the fair value of stock options. Stock-based compensation expense is recognized over the vesting period using the straight-line method. The fair value of stock options was estimated at the grant date using the following weighted average assumptions:
|
|
Year Ended
March 31, 2020
|
|
|
Year Ended
March 31, 2019
|
|
Dividend yield
|
|
|
—
|
|
|
|
—
|
|
Volatility
|
|
|
84.36
|
%
|
|
|
72.99
|
%
|
Risk-free interest rate
|
|
|
1.53
|
%
|
|
|
2.75
|
%
|
Expected life of options
|
|
6.00 years
|
|
|
6.00 years
|
|
Weighted average grant date fair value
|
|
$
|
0.23
|
|
|
$
|
0.84
|
|
The assumed dividend yield was based on the Company’s expectation of not paying dividends in the foreseeable future. Prior to fiscal year 2020, the Company used a blend of historical volatility and implied volatility of comparable companies. As of April 1, 2019, the Company is using the Company-specific historical volatility rate as it is more reflective of market conditions and a better indicator of expected volatility. The risk-free interest rate assumption was based on U.S. Treasury rates. The weighted average expected life of options was estimated using the average of the contractual term and the weighted average vesting term of the options. Prior to fiscal year 2020, certain options granted to consultants were subject to variable accounting treatment and were required to be revalued until vested. As of April 1, 2019, the measurement and classification of share-based payment to non-employees is consistent with the measurement and classification of share-based payment to employees.
The fair value of each restricted stock unit is recognized as stock-based compensation expense over the vesting term of the award. The fair value is based on the closing stock price on the date of the grant.
F-16
The Company uses the Black-Scholes valuation model to calculate the fair value of shares issued pursuant to the Company’s ESPP. Stock-based compensation expense is recognized over the purchase period using the straight-line method. The fair value of ESPP shares was estimated at the purchase period commencement date using the following weighted average assumptions:
|
|
Year Ended
March 31, 2020*
|
|
|
Year Ended
March 31, 2019
|
|
Dividend yield
|
|
|
—
|
|
|
|
—
|
|
Volatility
|
|
|
43.69
|
%
|
|
43.7 - 80.2%
|
|
Risk-free interest rate
|
|
|
2.52
|
%
|
|
1.85 - 2.52%
|
|
Expected term
|
|
6 months
|
|
|
6 months
|
|
Grant date fair value
|
|
$
|
0.29
|
|
|
$ 0.29 - $0.45
|
|
*There were no participants in the ESPP for the purchase period September 1, 2019 – February 29, 2020 nor any participants in the ESPP for the current purchase period (beginning March 1, 2020).
The assumed dividend yield was based on the Company’s expectation of not paying dividends in the foreseeable future. The Company uses the Company-specific historical volatility rate as the indicator of expected volatility. The risk-free interest rate assumption was based on U.S. Treasury rates. The expected life is the 6-month purchase period.
Preferred stock
The Company is authorized to issue 25,000,000 shares of preferred stock. There are no shares of preferred stock currently outstanding, and the Company has no present plans to issue shares of preferred stock.
Common stock
In May of 2008, the Board of Directors of the Company approved the 2008 Equity Incentive Plan (the “2008 Plan”). The 2008 Plan authorized the issuance of up to 1,521,584 common shares for awards of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock award units, and stock appreciation rights. The 2008 Plan terminated on July 1, 2018. As of March 31, 2019, 896,256 shares under the 2008 Plan have been issued.
In January 2012, the Board of Directors of the Company approved the 2012 Plan. The 2012 Plan authorized the issuance of up to 6,553,986 shares of common stock for awards of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units, performance units, performance shares, and other stock or cash awards. The Board of Directors and stockholders of the Company approved an amendment to the 2012 Plan in August 2013 to increase the number of shares of common stock that may be issued under the 2012 Plan by 5,000,000 shares. In August 2015, the Board of Directors and stockholders of the Company approved an amendment to the 2012 Plan in August 2015 to further increase the number of shares of common stock that may be issued under the 2012 Plan by 6,000,000 shares. In July 2018, the Board of Directors and stockholders of the Company approved an amendment to the 2012 Plan to further increase the number of shares of common stock that may be issued under the 2012 Plan by 11,000,000 shares, bringing the aggregate shares issuable under the 2012 Plan to 28,553,986. The 2012 Plan as amended and restated became effective on July 26, 2018 and terminates ten years after such date. As of March 31, 2020, 14,158,654 shares remain available for issuance under the 2012 Plan.
On April 24, 2017 the Company filed a Registration Statement on Form S-8 with the SEC authorizing the issuance of 2,297,034 shares of the Company’s Common Stock, pursuant to the terms of an Inducement Award Stock Option Agreement and an Inducement Award Performance-Based Restricted Stock Unit Agreement (collectively, the “Inducement Award Agreements”).
On August 14, 2018 the Company filed a Registration Statement on Form S-8 with the SEC authorizing the issuance of 1,135,408 shares of the Company’s Common Stock, pursuant to the terms of an Inducement Award Stock Option Agreement and an Inducement Award Restricted Stock Unit Agreement (collectively, the “Inducement Award Agreements”).
The Company has an effective shelf registration statement on Form S-3 (File No. 333-222929) and the related prospectus previously declared effective by the Securities and Exchange Commission (the “SEC”) on February 22, 2018, as supplemented by a prospectus supplement, dated March 16, 2018 (the “2018 Shelf”), that expires on February 22, 2021. This replaces the 2015 Shelf which expired on March 17, 2018.
F-17
On March 16, 2018, the Company entered into a Sales Agreement (“2018 Sales Agreement”) with H.C. Wainwright & Co., LLC and Jones Trading Institutional Services LLC (each an “Agent” and together, the “Agents”) and filed a prospectus supplement to the 2018 Shelf, pursuant to which the Company may offer and sell, from time to time through the Agents, shares of its common stock in at-the-market sales transactions having an aggregate offering price of up to $50,000,000. Any shares offered and sold will be issued pursuant to the Company’s 2018 Shelf. During the years ended March 31, 2020 and 2019, the Company issued 6,087,382 shares and 11,631,803 shares of common stock, respectively, for net proceeds of $5.0 million and $13.2 million in at-the-market offerings under the 2018 Sales Agreement. As of March 31, 2020, the Company has sold an aggregate of 17,719,185 shares of common stock in at-the-market offerings under the 2018 Sales Agreement, with gross proceeds of approximately $18.7 million. Based on these sales, the Company cannot raise more than an aggregate of $81.3 million in future offerings under the 2018 Shelf, including the $31.3 million remaining available for future issuance through its at-the-market program under the 2018 Sales Agreement. On July 26, 2018, the Company filed an amendment to its certificate of incorporation to increase the number of authorized shares of common stock to 200,000,000 shares.
During the years ended March 31, 2020 and 2019, the Company issued 0 and 622,192 shares of common stock upon exercise of 0 and 622,192 stock options, respectively.
On June 25, 2019, the Company received a notice letter from the Listing Qualifications Staff of Nasdaq indicating that, based upon the closing bid price of the Company’s common stock for the last 30 consecutive business days, the Company no longer met the requirement to maintain a minimum closing bid price of $1 per share, as set forth in Nasdaq Listing Rule 5450(a)(1). On December 26, 2019, the Company obtained an additional compliance period of 180 calendar days by electing to transfer to The Nasdaq Capital Market. On March 26, 2020, the Company obtained shareholder approval to effect a reverse stock split in a range from 20:1 to 40:1, which remains subject to the approval of the Company’s board of directors, in order to meet the minimum closing bid price per share requirement under the Nasdaq Listing Rules. On April 17, 2020 the Company received an additional notice letter from Nasdaq indicating that based on extraordinary market conditions, Nasdaq has determined to toll the compliance periods for bid price and market value of publicly held shares requirements (collectively, the “Price-based Requirements”) through June 30, 2020. Accordingly, since the Company had 66 calendar days remaining in its compliance period as of April 16, 2020, the Company will, upon reinstatement of the Price-based Requirements, still have 66 calendar days from July 1, 2020, or until September 4, 2020, to regain compliance. The Company can regain compliance, either during the suspension or during the compliance period resuming after the suspension, by evidencing compliance with the Price-based Requirements for a minimum of 10 consecutive trading days. The Company intends to comply with the Price-based Requirements by effecting the Reverse Stock Split. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market. There can be no assurance that the Company will be able to regain compliance with the minimum bid price requirement or maintain compliance with the other listing requirements necessary to maintain the listing of its common stock on The Nasdaq Capital Market. The Company’s failure to regain compliance during this second compliance period could result in delisting.
Restricted stock units
During the year ended March 31, 2020, the Company issued restricted stock units for an aggregate of 585,926 shares of common stock to its employees. These shares of common stock will be issued upon vesting of the restricted stock units.
On August 14, 2018, in connection with the appointment of a new Chief Medical Officer (“CMO”), the Company allocated 160,714 Restricted Stock Units (“RSUs”) outside of the 2012 Plan. The Company intends for these to be “inducement awards” within the meaning of Nasdaq Marketplace Rule 5635(c)(4). While outside the Company’s 2012 Plan, the terms and conditions of these awards are consistent with awards granted to the Company’s executive officers pursuant to the 2012 Plan. These RSUs vest over a four-year period, with a quarter of the option shares vesting on the one-year anniversary of the vesting commencement date and the remaining options shares vesting in equal quarterly installments over the 12 quarterly periods thereafter. The CMO was terminated in August 2019.
F-18
The following table summarizes the Company’s restricted stock unit (not including performance-based restricted stock units) activity for the year ended March 31, 2020:
|
|
Number of
Shares
|
|
|
Weighted
Average Price
|
|
Unvested at March 31, 2019
|
|
|
2,080,723
|
|
|
$
|
1.80
|
|
Granted
|
|
|
585,926
|
|
|
$
|
0.97
|
|
Vested
|
|
|
(563,271
|
)
|
|
$
|
2.29
|
|
Canceled / forfeited
|
|
|
(1,623,122
|
)
|
|
$
|
1.29
|
|
Unvested at March 31, 2020
|
|
|
480,256
|
|
|
$
|
1.95
|
|
Performance-based restricted stock units
On April 24, 2017, the Company issued a Performance-Based Restricted Stock Unit Award for 208,822 shares of common stock (the “PBRSU”) to its newly hired Chief Executive Officer (“CEO”). The PBRSU was issued outside of the 2012 Plan, in the Inducement Award Agreement, as an “inducement award” within the meaning of Nasdaq Marketplace Rule 5635(c)(4). While outside the Company’s 2012 Plan, the terms and conditions of this award are consistent with awards granted to the Company’s executive officers pursuant to the 2012 Plan. On August 23, 2017, the Board of Directors formally approved the vesting criteria for the PBRSU. The vesting of the PBRSU was divided into five separate tranches each with independent vesting criteria. The first four tranches had performance criteria related to annual revenue goals with measurement at the end of fiscal year 2018 (20 percent), fiscal year 2019 (20 percent), fiscal year 2020 (20 percent), and fiscal year 2021 (20 percent). The fifth tranche has a performance metric related to a path to profitability goal measured as Negative Adjusted Earnings Before Interest, Taxes, Depreciation and Amortization (“EBITDA”) achievable at any point between the grant date and the end of fiscal year 2020 (20 percent). The number of units that could ultimately vest for each tranche ranged from 0 percent to 120 percent of the target amount, not to exceed 208,822 in aggregate. On December 12, 2018, the Board of Directors formally approved an amendment to the vesting criteria for the PBRSUs. As of March 31, 2020, 100% of the Negative Adjusted EBITDA tranche, or 41,764 shares had vested and 8,352 units had been forfeited. Based on the amendment to the vesting criteria, the remaining 158,706 units eligible to vest upon future performance were divided into three separate but equal tranches with independent vesting criteria based on the achievement of certain regulatory milestones. As of March 31, 2020, none of the amended tranches had vested.
Based on the amended PBRSU vesting terms, a Type III modification, the modified grant date fair value of the PBRSUs is $165,000 of which one-third is being recognized over the expected service period of each tranche ending April 23, 2023. The Company began recording stock-based compensation expense for the initial performance tranches after the August 23, 2017 grant date when the initial financial performance goals were established and approved and has modified its recording of compensation expense in accordance with the amended performance tranches beginning on December 12, 2018.
On July 2, 2019, the Company issued Performance-Based Restricted Stock Unit Awards (the “PBRSU Retention Awards”) for an aggregate of 6,027,899 shares of common stock to its management team. The PBRSUs were issued pursuant to the 2012 Plan. The PBRSU Retention Awards will vest in full upon the earlier of the Company’s engagement in a pre-IND meeting with the FDA, twenty-four months from the grant date, or a change in control. As of March 31, 2020, all PBRSUs are expected to vest twenty-four months from the grant date.
The following table summarizes the Company’s performance-based restricted stock unit activity for the year ended March 31, 2020:
|
|
Number of
Shares
|
|
|
Weighted
Average Price
|
|
Unvested at March 31, 2019
|
|
|
158,706
|
|
|
$
|
1.04
|
|
Granted
|
|
|
6,027,899
|
|
|
$
|
0.49
|
|
Vested
|
|
|
—
|
|
|
$
|
—
|
|
Canceled / forfeited
|
|
|
(2,233,678
|
)
|
|
$
|
0.49
|
|
Unvested at March 31, 2020
|
|
|
3,952,927
|
|
|
$
|
0.51
|
|
F-19
Stock options
During the year ended March 31, 2020 under the 2012 Equity Incentive Plan, 342,500 stock options were issued at various exercise prices.
On April 24, 2017, in connection with the appointment of a new CEO, the Company granted 2,088,212 stock options outside of the 2012 Plan. The Company intends for these to be “inducement awards” within the meaning of Nasdaq Marketplace Rule 5635(c)(4). While granted outside the Company’s 2012 Plan, the terms and conditions of this stock option award are consistent with awards granted to the Company’s executive officers pursuant to the 2012 Plan. On August 14, 2018, in connection with the appointment of a new CMO, the Company allocated 974,694 stock options outside of the 2012 Plan. The Company intends for these to be “inducement awards” within the meaning of Nasdaq Marketplace Rule 5635(c)(4). While outside the Company’s 2012 Plan, the terms and conditions of these awards are consistent with awards granted to the Company’s executive officers pursuant to the 2012 Plan. These stock options vest over a four-year period, with a quarter of the option shares vesting on the one-year anniversary of the vesting commencement date and the remaining options shares vesting in equal quarterly installments over the next 12 quarterly periods. The CMO was terminated in August 2019.
The following table summarizes stock option activity for the year ended March 31, 2020:
|
|
Options
Outstanding
|
|
|
Weighted-
Average
Exercise Price
|
|
|
Aggregate
Intrinsic
Value
|
|
Outstanding at March 31, 2019
|
|
|
12,039,264
|
|
|
$
|
2.24
|
|
|
$
|
—
|
|
Options granted
|
|
|
342,500
|
|
|
$
|
0.32
|
|
|
$
|
—
|
|
Options canceled
|
|
|
(4,743,688
|
)
|
|
$
|
2.35
|
|
|
$
|
—
|
|
Options exercised
|
|
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Outstanding at March 31, 2020
|
|
|
7,638,076
|
|
|
$
|
2.08
|
|
|
$
|
37,440
|
|
Vested and Exercisable at March 31, 2020
|
|
|
4,184,674
|
|
|
$
|
2.53
|
|
|
$
|
—
|
|
The weighted-average remaining contractual term of stock options exercisable and outstanding at March 31, 2020 was approximately 7.34 years.
Employee Stock Purchase Plan
In June 2016, the Company’s board of directors adopted, and in August 2016 stockholders subsequently approved, the 2016 Employee Stock Purchase Plan (“ESPP”). The Company reserved 1,500,000 shares of common stock for issuance thereunder. The ESPP permits employees after five months of service to purchase common stock through payroll deductions, limited to 15 percent of each employee’s compensation up to $25,000 per employee per year or 10,000 shares per employee per six-month purchase period. Shares under the ESPP are purchased at 85 percent of the fair market value at the lower of (i) the closing price on the first trading day of the six-month purchase period or (ii) the closing price on the last trading day of the six-month purchase period. The initial offering period commenced in September 2016. During the year ended March 31, 2020, no shares were issued under the ESPP. At March 31, 2020, there were 1,188,718 shares remaining available for the purchase under the ESPP.
Warrants
The following table summarizes warrant activity for the year ended March 31, 2020:
|
|
Warrants
|
|
|
Weighted-Average
Exercise Price
|
|
Balance at March 31, 2019
|
|
|
145,000
|
|
|
$
|
7.11
|
|
Granted
|
|
|
—
|
|
|
$
|
—
|
|
Expired / Canceled
|
|
|
(145,000
|
)
|
|
$
|
7.11
|
|
Exercised
|
|
|
—
|
|
|
$
|
—
|
|
Balance at March 31, 2020
|
|
|
—
|
|
|
$
|
—
|
|
There were no warrants outstanding at March 31, 2020.
F-20
Common stock reserved for future issuance
Common stock reserved for future issuance consisted of the following at March 31, 2020:
Common stock options outstanding and reserved under the 2012 Plan
|
|
|
5,549,864
|
|
Common stock reserved under the 2012 Plan
|
|
|
14,158,654
|
|
Common stock reserved under the 2016 Employee Stock Purchase Plan
|
|
|
1,188,718
|
|
Restricted stock units outstanding under the 2012 Plan
|
|
|
480,256
|
|
Performance-based restricted stock units outstanding under the 2012 Plan
|
|
|
3,794,221
|
|
Common stock options outstanding and reserved under the Incentive
Award Agreement
|
|
|
2,088,212
|
|
Performance-based restricted stock units outstanding under the Incentive Award
Agreement
|
|
|
158,706
|
|
Total at March 31, 2020
|
|
|
27,418,631
|
|
Note 6. Leases
Adoption of ASC 842
As of April 1, 2019, the Company adopted ASC 842, which requires lessees to recognize a right-of-use asset (“ROU asset”) and lease liability for leases with terms of greater than twelve months. ROU 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. The Company implemented this new accounting standard using the modified retrospective method for its existing leases, which did not cause any adjustments to prior year financial statements. The Company elected the package of practical expedients available for existing contracts, which allowed it to carry forward its historical assessments of whether contracts are or contain leases and the classification of its existing operating leases. Additionally, the Company elected the practical expedient to treat lease and non-lease components as a single lease component.
At the time of adoption, the Company leased property and equipment under operating leases, specifically its office building and various copier machines. The Company also had a short-term lease (lease term is less than 12 months), which is not required to be recorded on the balance sheet under ASC 842. Instead, under ASC 842, the Company elected the accounting policy for short term leases to recognize lease payments as an expense on a straight-line basis over the lease term. Upon adoption of ASC 842, the Company recognized ROU assets and corresponding lease liabilities based on the present value of remaining lease payments over the lease terms. ROU assets were measured as lease liabilities plus prepaid rent less any deferred rent. As interest rates were not implicitly stated in the respective lease agreements, nor were they readily determinable, the Company used its incremental borrowing rate as the discount rate when measuring lease liabilities. As a result, the Company recorded ROU assets and lease liabilities of $4.5 million and $5.0 million, respectively. The Company also classified deferred rent of $0.6 million as an offset to the Company’s ROU asset upon adoption.
The impact of the adoption of ASC 842 on the consolidated balance sheet as of April 1, 2019 is as follows (in thousands):
|
|
ASC 840
|
|
|
|
|
|
|
ASC 842
|
|
|
|
March 31, 2019
|
|
|
Impact of Adoption
|
|
|
April 1, 2019
|
|
Deferred Rent
|
|
$
|
35
|
|
|
$
|
(35
|
)
|
|
$
|
—
|
|
Deferred Rent, net of current portion
|
|
$
|
588
|
|
|
$
|
(588
|
)
|
|
$
|
—
|
|
Prepaid Rent
|
|
$
|
88
|
|
|
$
|
(88
|
)
|
|
$
|
—
|
|
Operating right-of-use assets
|
|
$
|
—
|
|
|
$
|
4,451
|
|
|
$
|
4,451
|
|
Operating lease liability
|
|
$
|
—
|
|
|
$
|
1,038
|
|
|
$
|
1,038
|
|
Operating lease liability, net of current portion
|
|
$
|
—
|
|
|
$
|
3,948
|
|
|
$
|
3,948
|
|
After the initial adoption of ASC 842, on an on-going basis, the Company evaluates all contracts upon inception and determines whether the contract contains a lease by assessing whether there is an identified asset and whether the contract conveys the right to control the use of identified asset in exchange for consideration over a period of time. If a lease is identified, the Company will apply the guidance from ASC 842 to properly account for the lease.
F-21
Operating Leases
From July 2012 to November 2019, the Company leased its main facilities at 6275 Nancy Ridge Drive, San Diego, California 92121. The lease, as amended in 2013, 2015, 2016, 2018, and 2019, consisted of approximately 45,580 rentable square feet containing laboratory, clean room and office space. Monthly rental payments are approximately $87,000 with 3% annual escalators. The lease for 14,685 of the total rentable square footage was amended to accelerate the expiration date from December 15, 2018 to October 31, 2018. On November 30, 2018, the Company agreed to extend the term for the remainder of the total rentable square footage under the lease from August 31, 2021 to August 31, 2024 in exchange for $500,000 of landlord funded tenant improvements and a rescission of its option to terminate the lease on or after September 1, 2019 with 9 months prior written notice. On October 11, 2019, the Company entered into an agreement to accelerate the expiration date of the term of the lease for its main facilities on 6275 Nancy Ridge Drive from August 31, 2024 to November 15, 2019. Under this agreement, the Landlord and Tenant agreed that the other is excused as of the termination date from any further obligations. As such, the Company wrote-off its associated right-of-use asset of approximately $4.1 million and lease liabilities of approximately $4.6 million in fiscal 2020, which resulted in a $0.5 million gain on lease termination.
In addition to the Company’s main facility lease, on March 21, 2019, the Company entered into an agreement to lease several copy machines for a term of 36 months. The lease contained fixed monthly payments through the entire term of the lease, and it did not contain an option to extend the term or a bargain purchase option. This lease was also carried forward as an operating lease through the adoption of Topic 842. On October 9, 2019, the Company entered into an agreement to assume its leased copy machines, which terminates future obligations. As such, the Company wrote-off its associated right-of-use asset of approximately $26,000 and lease liabilities of approximately $26,000 in the third quarter of fiscal 2020.
On October 2, 2019, the Company entered into an agreement to rent office space at 440 Stevens Avenue, Suite 200, Solana Beach, California 92075. This agreement is a month-to-month contract and can be terminated at-will by either party at any time. As such, the Company has concluded that this agreement does not contain a lease and will be expensed as incurred. Monthly rental payments are approximately $4,000 per month.
The Company recorded operating lease expense on a straight-line basis over the life of the leases. This is consistent with the Company’s historical treatment of the lease costs included in operating expenses (referred to as “Rent Expense” prior to adoption of Topic 842). For the year ended March 31, 2020, the Company recorded operating lease expense of approximately $568,000. In addition, the Company recorded rent expense for the office space of approximately $19,000 for the year ended March 31, 2020. For the year ended March 31, 2019, the Company recorded rent expense of approximately $1,173,000. Variable lease costs associated with the Company’s leases, such as payments for additional monthly fees to cover the Company’s share of certain facility expenses (common area maintenance, or CAM) are not included in operating lease right-of-use assets and lease liabilities, but rather expensed as incurred. Variable lease expense was approximately $305,000 for the year ended March 31, 2020, respectively. Short-term lease cost for the year ended March 31, 2020 was approximately $37,000. The short-term lease was terminated in the fiscal 2020 second quarter.
The table below is a summary of the cash flows associated with the Company’s leases for the year ended March 31, 2020 (in thousands):
|
|
For the Year Ended
|
|
|
|
March 31, 2020
|
|
Cash paid for amount included in measurement of liabilities:
|
|
|
|
|
Operating cash flows from operating leases
|
|
$
|
579
|
|
Note 7. Commitments and Contingencies
Legal matters
In addition to commitments and obligations in the ordinary course of business, the Company may be subject, from time to time, to various claims and pending and potential legal actions arising out of the normal conduct of its business. On October 10, 2019, a putative class action lawsuit was filed in the U.S. District Court for the District of Delaware against the Company and its board of directors in connection with the annual proxy statement filed by the Company on July 26, 2019. The case was captioned Rianhard v. Crouch., et al., Case No. 19-cv-1922 (D. Del. Oct. 10, 2019) (the “Action”). The complaint alleged that the Schedule 14A proxy statement contained material misrepresentations in connection with the reverse stock split proposal recommended therein and asserted claims for violations of Section 14(a) of the Securities Exchange Act of 1934 and Rule 14a-9 promulgated thereunder, as well as claims for breach of fiduciary duty. On November 25, 2019, the Action was voluntarily dismissed.
F-22
On December 31, 2019, the Company received a demand pursuant to Delaware General Corporation Law Section 220 for certain books and records of the Company (the “Demand”). The Company has objected to the Demand and made a limited production of certain records to the demanding stockholder.
On January 30, 2020, the Company received a demand letter (the “Letter”) from a purported stockholder alleging that the disclosures in the Form S-4 filed with the SEC on December 23, 2019 violated federal securities laws by failing to disclose certain allegedly material information. The Letter demands, among other things, that the Company make corrective disclosures and reserves the right to pursue legal action. The Company believes the assertions in the Letter are without merit.
On March 4, 2020, the Company received a letter from the SEC regarding an inquiry into certain of the Company’s prior disclosures and related operations. The Company is cooperating with the SEC in response to a subpoena.
The Company assesses contingencies to determine the degree of probability and range of possible loss for potential accrual in its financial statements. Because litigation is inherently unpredictable and unfavorable resolutions could occur, assessing litigation contingencies is subjective and requires judgments about future events. When evaluating contingencies, the Company may be unable to provide a meaningful estimate due to a number of factors, including the procedural status of the matter in question, the presence of complex or novel legal theories, and/or the ongoing discovery and development of information important to the matters. In addition, damage amounts claimed in litigation against it may be unsupported, exaggerated or unrelated to possible outcomes, and as such are not meaningful indicators of its potential liability.
The Company regularly reviews contingencies to determine the adequacy of its accruals and related disclosures. During the period presented, the Company has not recorded any accrual for loss contingencies associated with any claims or legal proceedings; determined that an unfavorable outcome is probable or reasonably possible; or determined that the amount or range of any possible loss is reasonably estimable. However, the outcome of legal proceedings and claims brought against the Company is subject to significant uncertainty. Therefore, although management considers the likelihood of such an outcome to be remote, if one or more of these legal matters were resolved against the Company in a reporting period, the Company’s consolidated financial statements for that reporting period could be materially adversely affected.
Note 8. Income Taxes
A reconciliation of the statutory federal rate and the effective rate, for operations, is as follows for the years ended March 31, 2020 and March 31, 2019 (in thousands):
|
March 31,
2020
|
|
|
|
March 31,
2019
|
|
|
Tax computed at federal statutory rate
|
$
|
(3,929
|
)
|
21%
|
|
$
|
(5,593
|
)
|
21.0%
|
State income tax, net of federal benefit
|
|
(714
|
)
|
3.8%
|
|
|
(884
|
)
|
3.3%
|
Executive compensation
|
|
—
|
|
0.0%
|
|
|
—
|
|
0.0%
|
Stock based compensation
|
|
893
|
|
-4.8%
|
|
|
871
|
|
-3.3%
|
Research credits
|
|
(421
|
)
|
2.2%
|
|
|
(1,033
|
)
|
3.9%
|
Change in tax rate
|
|
(193
|
)
|
1.0%
|
|
|
(380
|
)
|
1.4%
|
Removal of net operating losses and research development credits
|
|
5,091
|
|
-27.2%
|
|
|
4,171
|
|
-15.7%
|
Rate adjustment - tax law
|
|
—
|
|
0.0%
|
|
|
14
|
|
-0.1%
|
Other
|
|
70
|
|
-0.3%
|
|
|
2,795
|
|
-10.5%
|
Valuation allowance
|
|
(797
|
)
|
4.2%
|
|
|
39
|
|
-0.1%
|
Provision (benefit) for income taxes
|
$
|
—
|
|
0.0%
|
|
$
|
—
|
|
0.0%
|
F-23
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s net deferred tax assets are as follows as of March 31, 2020 and March 31, 2019 (in thousands):
|
March 31,
2020
|
|
|
March 31,
2019
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
Net operating loss carry forwards
|
$
|
—
|
|
|
$
|
—
|
|
Research and development credits
|
|
—
|
|
|
|
—
|
|
Depreciation and amortization
|
|
5
|
|
|
|
28
|
|
Accrued expenses and reserves
|
|
173
|
|
|
|
886
|
|
Stock compensation
|
|
3,899
|
|
|
|
3,941
|
|
Other, net
|
|
1
|
|
|
|
20
|
|
Total deferred tax assets
|
|
4,078
|
|
|
|
4,875
|
|
Valuation allowance
|
|
(4,078
|
)
|
|
|
(4,875
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
A full valuation allowance has been established to offset the deferred tax assets as management cannot conclude that realization of such assets is more likely than not. Under the Internal Revenue Code (“IRC”) Sections 382 and 383, annual use of our net operating loss and research tax credit carryforwards to offset taxable income may be limited based on cumulative changes in ownership. We have not completed an analysis to determine whether any such limitations have been triggered as of March 31, 2020. Until this analysis is completed, we have removed the deferred tax assets related to net operating losses and research credits from our deferred tax asset schedule. Further, until a study is completed and any limitation known, no amounts are being considered as an uncertain tax position or disclosed as an unrecognized tax benefit. Due to the existence of the valuation allowance, future changes in the Company’s unrecognized tax benefits will not impact its effective tax rate. Any carryforwards that will expire prior to utilization as a result of such limitations will be removed from deferred tax assets with a corresponding reduction of the valuation allowance. The valuation allowance decreased by approximately $798,000 and increased by approximately $39,000 for the years ended March 31, 2020 and 2019, respectively.
The Company had federal and state net operating loss carryforwards of approximately $183.8 million and $33.4 million, respectively, as of March 31, 2020. Federal net operating loss carryforwards of approximately $40.2 million will carryforward indefinitely and be available to offset up to 80% of future taxable income each year subject to revisions made by the CARES Act. The remaining federal net operating losses will begin to expire in 2028, unless previously utilized. The state net operating loss carryforwards (“NOLs”) will begin to expire in 2028, unless previously utilized.
The Company had federal and state research tax credit carryforwards of approximately $4.2 million and $3.7 million at March 31, 2020, respectively. The federal research tax credit carryforwards begin expiring in 2028. The state research tax credit carryforwards do not expire.
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the "CARES Act") was enacted in response to the COVID-19 pandemic. The CARES Act contains temporary taxpayer favorable provisions related to the use of net operating losses and the deductibility of interest expense, charitable contributions, and qualified improvement property. Due to the generation of losses, the Company does not expect to be materially impacted by the CARES Act.
On April 1, 2019, the Company adopted ASU 2016-02, Leases (“Topic 842”). There was no net tax impact recorded as a result of the adoption.
The Company did not record any accruals for income tax accounting uncertainties for the year ended March 31, 2020.
The Company did not accrue either interest or penalties from inception through March 31, 2020.
The Company does not expect its unrecognized tax benefits to significantly increase or decrease within the next 12 months.
The Company is subject to tax in the United States and in various state jurisdictions. As of March 31, 2020, the Company’s tax years from inception are subject to examination by the tax authorities due to the generation of net operating losses. The Company is not currently under examination by any jurisdiction.
F-24
Note 9. Concentrations
Credit risk and significant customers
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of temporary cash investments. The Company maintains cash balances at various financial institutions located within the United States. Accounts at these institutions are secured by the Federal Deposit Insurance Corporation. Balances may exceed federally insured limits. The Company has not experienced losses in such accounts, and management believes that the Company is not exposed to any significant credit risk with respect to its cash and cash equivalents.
The Company is also potentially subject to concentrations of credit risk in its revenues and accounts receivable. Because it is in the early commercial stage, the Company’s revenues to date have been derived from a relatively small number of customers and collaborators. However, the Company has not historically experienced any accounts receivable write-downs and management does not believe significant credit risk exists as of March 31, 2020.
Note 10. Related Parties
From time to time, the Company will enter into an agreement with a related party in the ordinary course of its business and on terms and conditions it believes are as fair as those it offers and receives from independent third parties. These agreements are ratified by the Company’s Board of Directors or a committee thereof pursuant to its related party transaction policy.
In August 2017, the Company entered into a research services agreement with Cirius Therapeutics, Inc. (“Cirius”), an entity for which Robert Baltera, Jr., a former director of the Company, serves as Chief Executive Officer and President. Under this agreement, the Company is providing standard research services to Cirius utilizing its ExVive™ Liver Tissue platform. The Company has provided and recognized revenue for ExVive™ Liver Tissue Services for Cirius in the amount of $281,000 to date. Organovo completed its obligations as of December 2018. No further revenues are expected.
In November 2018, the Company entered into a research services Quote with Viscient Biosciences (“Viscient”), an entity for which Keith Murphy, the Company’s former director, Chief Executive Officer, and President, serves as the Chief Executive Officer and President. Under this Quote, the Company provided research services in the amount of $142,000, amended in April 2019 to include an additional $7,000 of services. As of March 31, 2019, the Company recognized revenue of $42,000 for services provided and the remaining amount of $107,000 was recognized as revenue in the year ended March 31, 2020. In November 2019, the Company entered into an agreement with Viscient to sell certain bioprinting equipment and a non-exclusive license to certain intellectual property for approximately $171,000, of which $101,000 was recognized as other income and $70,000 was recognized as revenue in the year ended March 31, 2020. In addition to the services provided by Organovo, Viscient has purchased primary human cell-based products from our subsidiary, Samsara. Pursuant to the terms of multiple Quotes, $128,000 and $96,000 was recognized as revenue in the year ended March 31, 2020 and 2019, respectively. There is approximately $111,000 of accounts receivable outstanding as of March 31, 2020 and $39,000 of accounts receivable outstanding as of March 31, 2019. The balance owing at March 31, 2020 is several months past due (as of that date) and the Company is currently attempting to secure an informal resolution of these outstanding invoices, but if unable to do so, the Company intends to pursue a formal collection action. Since there has been no history of bad debt with Viscient and the customer indicated a willingness to settle the debt, the Company deemed that a reserve against the receivable was not necessary.
Note 11. Defined Contribution Plan
The Company has a defined contribution 401(k) plan covering substantially all employees. During the year ended March 31, 2015, the 401(k) plan was amended (the “Amended Plan”) to include an employer matching provision. Under the terms of the Amended Plan, the Company will make matching contributions on up to the first 6% of compensation contributed by its employees. Amounts expensed under the Company’s 401(k) plan for the years ended March 31, 2020 and 2019 were approximately $152,000 and $240,000, respectively.
Note 12. Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies. Unless otherwise stated, the Company believes that the impact of the recently issued accounting pronouncements that are not yet effective will not have a material impact on its consolidated financial position or results of operations upon adoption.
F-25
Adoption of New Accounting Pronouncements
In February 2016, the FASB issued ASU 2016-02, Leases (“ASC 842”), which supersedes the lease guidance under ASC 840, Leases. The new accounting standard requires an entity to recognize right-of-use assets and corresponding lease liabilities on the balance sheet for all leases with terms of more than 12 months and to disclose key information about leasing arrangements. This new guidance became effective for the Company on April 1, 2019. The Company adopted ASC 842 on April 1, 2019 and elected the optional transition method that allows for a cumulative-effect adjustment in the period of adoption, which was not applicable, and did not require restatement of prior periods. The Company elected the package of practical expedients permitted under the transition guidance, but not the hindsight practical expedient. Please refer to “Note 6. Leases” for more information regarding the Company’s adoption of the new lease standard.
In February 2018, the FASB issued ASU No. 2018-02, Income Statement – Reporting Comprehensive Income (“Topic 220”), which allows stranded tax effects resulting from the Tax Cuts and Jobs Act to be reclassified from accumulated other comprehensive income to retained earnings. The amendment only relates to the reclassification of the income tax effects of the Tax Cuts and Jobs Act; thus, the underlying guidance relating to the effect of a change in tax laws be included in income from continuing operations is not affected. The amendments in Topic 220 are effective for all entities for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. This new guidance became effective for the Company on April 1, 2019. The requirements of Topic 220 did not have a significant impact on the Company’s consolidated financial statements.
Recent Accounting Pronouncements Not Yet Adopted
In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606, which provides guidance on whether certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606. The amendments in this update provide more comparability in the presentation of revenue for certain transactions between collaborative arrangement participants. The key improvements to GAAP for collaborative arrangements resulting from this amendment are to (i) clarify that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit-of-account, (ii) add unit-of-account guidance in Topic 808 to align with the guidance in Topic 606, and (iii) require that in a transaction with a collaborative arrangement participant that is not directly related to sales to third parties, presenting the transaction together with revenue recognized under Topic 606 is precluded if the collaborative arrangement participant is not a customer. The amendments in this ASU are effective for all entities for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years with early adoption permitted. This new guidance is effective for us on April 1, 2020. The Company does not expect this guidance to have an impact on its consolidated financial statements.
Note 13. Restructuring
In August 2019, after a rigorous assessment of the Company’s lead liver therapeutic tissue program following completion of various preclinical studies, the Company’s board of directors concluded that the variability of biological performance and related duration of potential benefits presented development challenges and lengthy redevelopment timelines that no longer supported an attractive opportunity for the Company and its stockholders. Furthermore, the Company’s board of directors deemed the stage of development of the Company’s other therapeutic pipeline assets, including stem cell based tissue programs, to be too premature to potentially reach IND filing status within an acceptable investment horizon and with the Company’s available resources. As a result, the Company suspended all development of its lead program and all other related pipeline development activity and engaged a financial advisory firm to explore its strategic alternatives, including evaluating a range of ways to generate value from the Company’s technology platform and intellectual property, its commercial and development capabilities, its listing on The Nasdaq Capital Market, and its remaining financial assets. Under the restructuring plan, the Company terminated the employment of 52 employees, or 90% of its workforce and recorded a restructuring charge during the year ended March 31, 2020 of approximately $2.7 million, related to employee severance and benefits costs, of which $1.7 million was paid out during the fiscal second quarter, $0.9 million was paid out during the fiscal third quarter, and $0.1 million was paid out during the fiscal fourth quarter.
Restructuring charges were recorded in selling, general and administrative expenses and were comprised of the following (in thousands):
|
|
Year Ended
|
|
|
Year Ended
|
|
|
|
March 31, 2020
|
|
|
March 31, 2019
|
|
Severance for Involuntary Employee Terminations
|
|
$
|
2,727
|
|
|
$
|
441
|
|
Total Restructuring Expense
|
|
$
|
2,727
|
|
|
$
|
441
|
|
F-26
The following table summarizes the activity and balances of the restructuring reserve (in thousands):
|
|
Severance for
Involuntary
Employee
Terminations
|
|
Balance at March 31, 2019
|
|
$
|
-
|
|
Reserve established
|
|
|
2,456
|
|
Increase to reserve
|
|
$
|
271
|
|
Utilization of reserve:
|
|
|
|
|
Payments
|
|
$
|
(2,706
|
)
|
Balance at March 31, 2020
|
|
$
|
21
|
|
The restructuring accrual is reflected on the consolidated balance sheet at March 31, 2020 as accrued expenses.
Note 14. Subsequent Events
On April 7, 2020 at the Special Meeting of Shareholders, the Merger was not approved by our stockholders.
On April 17, 2020, the Company received a notice letter from Nasdaq indicating that based on extraordinary market conditions, Nasdaq has determined to toll the compliance periods for bid price and market value of publicly held shares (“MVPHS”) requirements (collectively, the “Price-based Requirements”) through June 30, 2020. Accordingly, since the Company had 66 calendar days remaining in its Bid, compliance period as of April 16, 2020, it will, upon reinstatement of the Price-based Requirements, still have 66 calendar days from July 1, 2020, or until September 4, 2020, to regain compliance.
F-27