UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number:
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.)
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(Address of principal executive offices) |
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(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
On August 8, 2022 there were
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, including the sections entitled “Business,” “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, contains forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements, other than statements of historical facts contained herein, regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, statements about:
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the implementation of our business strategies, including our ability to pursue development pathways and regulatory strategies for MT-6402, MT-5111, MT-0169, MT-8421 and other engineered toxin body (“ETB”) biologic candidates; |
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our utilization of a next-generation ETB scaffold that has been designed to reduce or eliminate the propensity for innate immunity, including capillary leak syndrome (“CLS”); |
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the timing and our ability to advance the development of our drug or biologic candidates; |
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our plans to pursue discussions with regulatory authorities, and the anticipated timing, scope and outcome of related regulatory actions or guidance; |
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our ability to establish and maintain potential new partnering or collaboration arrangements for the development and commercialization of ETB biologic candidates; |
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our ability to obtain the benefits we anticipate from partnering, collaboration, or supply agreements that we may enter into; |
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our financial condition, including our ability to obtain the funding necessary to advance the development of our drug or biologic candidates; |
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the anticipated progress of our drug or biologic candidate development programs, including whether our ongoing and potential future clinical trials will achieve clinically relevant results; |
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our ability to generate data and conduct analyses to support the regulatory approval of our drug or biologic candidates; |
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our ability to establish and maintain intellectual property rights for our drug or biologic candidates; |
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whether any drug or biologic candidates that we are able to commercialize are safer or more effective than other marketed products, treatments or therapies; |
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our ability to discover and develop additional drug or biologic candidates suitable for clinical testing; |
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our ability to identify, in-license or otherwise acquire additional drug or biologic candidates and development programs; |
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our anticipated research and development activities and projected expenditures; |
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our ability to complete preclinical and clinical testing successfully for new drug or biologic candidates that we may develop or license; |
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our ability to have manufactured active pharmaceutical ingredient, or API, and drug or biologic product that meet required release and stability specifications; |
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our ability to have manufactured sufficient supplies of drug product for clinical testing and commercialization; |
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our ability to obtain licenses to any necessary third-party intellectual property; |
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our anticipated use of proceeds from any financing activities; |
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our ability to retain and hire necessary employees and appropriately staff our development programs; |
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the extent to which COVID-19 will continue to impact our business operations or financial condition; |
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our projected financial performance; and |
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the sufficiency of our cash resources; and other risks and uncertainties, including those listed under Part II, Item 1A, “Risk Factors”. |
Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under Part II, Item 1A, “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
This Quarterly Report on Form 10-Q also contains estimates, projections and other information concerning our industry, our business, and the markets for certain diseases, including data regarding the incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources.
As used in this Quarterly Report on Form 10-Q, unless otherwise stated or the context otherwise indicates, references to “Molecular,” the “Company,” “we,” “our,” “us” or similar terms refer to Molecular Templates, Inc., and our wholly-owned subsidiary.
Molecular Templates, Inc.
TABLE OF CONTENTS
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PART I. |
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Item 1. |
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4 |
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5 |
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Condensed Consolidated Statements of Comprehensive Loss (Unaudited) |
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Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) |
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8 |
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Notes to Condensed Consolidated Financial Statements (Unaudited) |
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Item 2. |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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Item 4. |
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PART II. |
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Item 1 |
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Item 1A. |
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30 |
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Item 2. |
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73 |
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Item 3. |
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73 |
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Item 4. |
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73 |
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Item 5. |
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73 |
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Item 6. |
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74 |
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75 |
3
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
Molecular Templates, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
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June 30, 2022(unaudited) |
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December 31, 2021 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Marketable securities, current |
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Prepaid expenses |
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Other current assets |
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Total current assets |
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Marketable securities, non-current |
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Operating lease right-of-use assets |
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Property and equipment, net |
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Other assets |
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Total assets |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued liabilities |
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Deferred revenue, current |
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Other current liabilities |
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Total current liabilities |
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Deferred revenue, long-term |
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Long-term debt, net of current portion |
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Operating lease liabilities |
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Other liabilities |
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Total liabilities |
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Commitments and contingencies (Note 10) |
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Stockholders’ equity |
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Preferred stock, $ |
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Authorized: December 31, 2021; issued and outstanding: June 30, 2022 and December 31, 2021 |
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Common stock, $ |
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Authorized: December 31, 2021; issued and outstanding: June 30, 2022 and |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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Accumulated deficit |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
Molecular Templates, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Research and development revenue, related party |
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$ |
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$ |
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$ |
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$ |
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Research and development revenue, other |
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Total revenue |
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Operating expenses: |
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Research and development |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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Interest and other income, net |
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Interest and other expense, net |
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( |
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( |
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( |
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Net loss |
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Net loss attributable to common shareholders |
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$ |
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$ |
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$ |
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$ |
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Net loss per share attributable to common shareholders: |
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Basic and diluted |
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$ |
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$ |
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$ |
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$ |
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Weighted average number of shares used in net loss per share calculations: |
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Basic and diluted |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
Molecular Templates, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Net loss |
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$ |
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$ |
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$ |
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$ |
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Other comprehensive income: |
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Unrealized gain/(loss) on available-for-sale securities |
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( |
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( |
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( |
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Comprehensive loss |
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$ |
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$ |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
MOLECULAR TEMPLATES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share data)
(unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Total Stockholders' Equity, beginning balances |
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$ |
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$ |
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$ |
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$ |
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Preferred Stock: |
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Beginning balance |
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Issuance of preferred stock |
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— |
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— |
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— |
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— |
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Ending balance |
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Common Stock: |
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Beginning balance |
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Issuance of common stock pursuant to public offering |
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Ending balance |
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Additional Paid-In Capital |
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Beginning balance |
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Issuance of common stock pursuant to stock plans |
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Stock-based compensation |
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Issuance of common stock pursuant to public offering |
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Ending balance |
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Accumulated Other Comprehensive Income, Gain/(Loss): |
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Beginning balance |
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( |
) |
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( |
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Other comprehensive income, gain/(loss) |
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( |
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( |
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( |
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Ending balance |
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( |
) |
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( |
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Accumulated deficit: |
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Beginning balance |
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( |
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( |
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( |
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( |
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Net loss |
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( |
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( |
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( |
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( |
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Ending balance |
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( |
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( |
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( |
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( |
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Total Stockholders' Equity |
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$ |
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$ |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
Molecular Templates, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
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Six Months Ended June 30, |
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2022 |
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2021 |
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Cash flows from operating activities: |
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Net loss |
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$ |
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$ |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation, amortization and other |
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Stock-based compensation expense |
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Interest accrued on long-term debt |
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Amortization of debt discount and accretion related to debt |
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Accretion of asset retirement obligations |
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Loss on disposal of property and equipment |
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Changes in operating assets and liabilities: |
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Prepaid expenses |
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( |
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Accounts receivable, related party |
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Other assets |
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( |
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Operating lease right-of-use assets and liabilities |
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( |
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( |
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Accounts payable |
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( |
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( |
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Accrued liabilities |
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( |
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Other liabilities, related party |
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Deferred revenue |
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Deferred revenue, related party |
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Net cash (used in)/provided by operating activities |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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( |
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( |
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Purchase of marketable securities |
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( |
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Sales of marketable securities |
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Net cash (used in)/provided by investing activities |
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Cash flows from financing activities: |
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Payments of capital and finance lease obligations |
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Proceeds from issuance of long-term debt |
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Proceeds from stock option exercises |
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|
|
|
|
|
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|
Proceeds from issuance of common stock and warrants, net offering expenses |
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|
|
|
|
|
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|
Fees paid on loan modification |
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|
( |
) |
|
|
|
|
Net cash (used in)/provided by financing activities |
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|
( |
) |
|
|
|
|
Net increase in cash, cash equivalents, and restricted cash |
|
|
|
|
|
|
|
|
Cash, cash equivalents and restricted cash, beginning of period |
|
|
|
|
|
|
|
|
Cash, cash equivalents and restricted cash, end of period |
|
$ |
|
|
|
$ |
|
|
Reconciliation of cash, cash equivalents and restricted cash |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
|
|
|
$ |
|
|
Restricted cash included in other assets |
|
|
|
|
|
|
|
|
Total cash, cash equivalents and restricted cash |
|
$ |
|
|
|
$ |
|
|
Supplemental Cash Flow Information |
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|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
|
|
|
$ |
|
|
Non-Cash Investing and Financing Activities |
|
|
|
|
|
|
|
|
Fixed asset additions in accounts payable and accrued expenses |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
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|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
8
Molecular Templates, Inc.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 — ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Nature of the Business
Molecular Templates, Inc. (the “Company”) is a clinical stage biopharmaceutical company formed in 2001, with a biologic therapeutic platform for the development of novel targeted therapeutics for cancer and other serious diseases, headquartered in Austin, Texas. The Company’s focus is on the research and development of therapeutic compounds for a variety of cancers. The Company operates its business as a single segment, as defined by U.S. generally accepted accounting principles (“U.S. GAAP”).
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America and include the accounts of the Company and its wholly owned subsidiary and reflect the elimination of intercompany accounts and transactions.
The preparation of condensed consolidated financial statements requires management to make estimates and assumptions that affect the recorded amounts reported therein. A change in facts or circumstances surrounding the estimates could result in a change to estimates and impact future operating results. Certain accounts in the prior financial statements have been reclassified for comparative purposes to conform to the presentation in the current financial statements. These reclassifications have no material effect on previously reported financials.
The unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the interim unaudited condensed consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding fiscal year. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 29, 2022.
Liquidity
At June 30, 2022, the Company had cash, cash equivalents, and marketable securities of $
Significant Accounting Policies
There have been no material changes to the Company’s significant accounting policies during the six months ended June 30, 2022, as compared to the significant accounting policies disclosed in Note 1, “Summary of Significant Accounting Policies”, to the consolidated financial statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.
Cash and Cash Equivalents
The Company considers temporary investments having original maturities of three months or less from date of purchase to be cash equivalents. Restricted cash is recorded in other assets, based on when the restrictions expire. Other assets include $
Fair Value Measurement
The Company accounts for its marketable securities in accordance with ASC 820 “Fair Value Measurements and Disclosures.” ASC 820 defines fair value, establishes a framework for measuring fair value in GAAP, and expands disclosures about fair value measurements. ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value:
Level 1—Quoted prices in active markets for identical assets or liabilities.
9
Level 2—Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The Company utilizes the market approach to measure fair value for its financial assets and liabilities. The market approach uses prices and other relevant information generated by market transactions involving identical or comparable assets or liabilities. For Level 2 securities that have market prices from multiples sources, a “consensus price” or a weighted average price for each of these securities can be derived from a distribution-curve-based algorithm which includes market prices obtained from a variety of industrial standard data providers (e.g. Bloomberg), security master files from large financial institutions, and other third-party sources. Level 2 securities with short maturities and infrequent secondary market trades are typically priced using mathematical calculations adjusted for observable inputs when available.
Concentration of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to concentrations of risk consist principally of cash and cash equivalents, investments, long term debt and accounts receivable.
The Company’s cash and cash equivalents are with two major financial institutions in the United States.
The Company performs an ongoing credit evaluation of its strategic partners’ financial conditions and generally does not require collateral to secure accounts receivable from its strategic partners. The Company’s exposure to credit risk associated with non-payment will be affected principally by conditions or occurrences within Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd. (“Takeda”), Vertex Pharmaceuticals Incorporated (“Vertex”) and Bristol Myers Squibb Company (“Bristol Myers Squibb”). Takeda accounted for approximately
Drug or biologic candidates developed by the Company may require approvals or clearances from the U.S. Food and Drug Administration (“FDA”) or international regulatory agencies prior to commercial sales. There can be no assurance that the Company’s drug or biologic candidates will receive any of the required approvals or clearances. If the Company were to be denied approval or clearance or any such approval or clearance were to be delayed, it would have a material adverse impact on the Company.
Recently Issued Accounting Pronouncements
In August 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (Subtopic 470-20: Debt with Conversion and Other Options and Subtopic 815-40: Derivatives and Hedging - Contracts in Entity’s Own Equity). The new guidance simplifies accounting for convertible instruments by removing major separation models, removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, and it also simplifies the diluted earnings per share calculation in certain areas. The amendment is effective for the Company for fiscal years beginning after December 15, 2023. The Company is currently evaluating the impact of the adoption of this standard on its consolidated financial statements.
In November 2021, the FASB issued ASU No. 2021-10, “Government Assistance: Disclosures by Business Entities about Government Assistance”. The amendments in this Update improve financial reporting by requiring disclosures that increase the transparency of transactions with a government. The amendments require the following annual disclosures about transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy (i) the type of transaction, (ii) the accounting for the transaction, and (iii) the effect of the transaction on the entity’s financial statements. The Company adopted this standard as of
NOTE 2 — NET LOSS PER COMMON SHARE
Basic net loss per common share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period utilizing the two-class method. Preferred Stock Shareholders participate equally with Common Stock Shareholders in earnings, but do not participate in losses, and are excluded from the basic net loss calculation. Diluted net loss per share is computed by giving effect to all potential dilutive common shares, including outstanding options, warrants and convertible preferred stock. More specifically, at June 30, 2022 and June 30, 2021, stock options, warrants and, if converted, preferred stock
10
totaling approximately
NOTE 3 — RESEARCH AND DEVELOPMENT AGREEMENTS
Disaggregated Research and Development Revenue
Research and development revenue is attributable to regions based on the location of each of the Company’s collaboration partner's parent company headquarters. Research and development revenues disaggregated by location were as follows (in thousands):
|
|
Three Months Ended June 30, |
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Six Months Ended June 30, |
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2022 |
|
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2021 |
|
|
2022 |
|
|
2021 |
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||||
Japan |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
United States |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research and development revenue |
|
$ |
|
|
|
$ |
|
|
|
$ |