UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For transition period from to .
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(Exact name of registrant as specified in its charter)
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Securities registered pursuant to Section 12(b) of the Exchange Act:
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Emerging growth company |
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Common Stock, par value $.001 per share |
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Class | Outstanding as of May 5, 2022 |
IDERA PHARMACEUTICALS, INC.
FORM 10-Q
TABLE OF CONTENTS
Unless the context otherwise indicates, references in this Quarterly Report on Form 10-Q to “Idera,” the “Company,” “we,” “us,” and “our” refer to Idera Pharmaceuticals, Inc.
IMO® and Idera® are our trademarks. All other trademarks and service marks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners.
i
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (“Form 10-Q”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements, other than statements of historical fact, included or incorporated in this report regarding our strategy, future operations, clinical trials, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” “schedule,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We cannot guarantee that we will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties, and other factors, which may be beyond our control, and which may cause the actual results, performance, or achievements of the Company to be materially different from future results, performance, or achievements expressed or implied by such forward-looking statements.
There are a number of important factors that could cause our actual results to differ materially from those indicated or implied by forward-looking statements. These important factors include those set forth under Part I, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 which was filed with the Securities and Exchange Commission (“SEC”) on March 31, 2022 (the “2021 Form 10-K), in this Quarterly Report on Form 10-Q, and in our other disclosures and filings with the SEC. These factors and the other cautionary statements made in this Quarterly Report on Form 10-Q should be read as being applicable to all related forward-looking statements whenever they appear in this Quarterly Report on Form 10-Q.
In addition, any forward-looking statements represent our estimates only as of the date that this Quarterly Report on Form 10-Q is filed with the SEC and should not be relied upon as representing our estimates as of any subsequent date. All forward-looking statements included in this Quarterly Report on Form 10-Q are made as of the date hereof and are expressly qualified in their entirety by this cautionary notice. We disclaim any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as may be required by law.
ii
PART I — FINANCIAL INFORMATION
Item 1. | Financial Statements. |
IDERA PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(UNAUDITED)
| March 31, |
| December 31, |
| |||
(In thousands) | 2022 | 2021* |
| ||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | | $ | | |||
Prepaid expenses and other current assets |
| |
| | |||
Total current assets |
| |
| | |||
Property and equipment, net |
| |
| | |||
Operating lease right-of-use assets | | | |||||
Other assets |
| |
| | |||
Total assets | $ | | $ | | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | |||||||
Current liabilities: | |||||||
Accounts payable | $ | | $ | | |||
Accrued expenses |
| |
| | |||
Operating lease liability | | | |||||
Total current liabilities |
| |
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Operating lease liability, net of current portion | | | |||||
Total liabilities |
| |
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Commitments and contingencies (Note 12) | |||||||
Preferred stock, $ | |||||||
Stockholders’ equity (deficit): | |||||||
Preferred stock, $ | |||||||
Series A convertible preferred stock; Designated — |
|
| |||||
Common stock, $ |
| |
| | |||
Additional paid-in capital |
| |
| | |||
Accumulated deficit |
| ( |
| ( | |||
Total stockholders’ equity (deficit) |
| |
| | |||
Total liabilities and stockholders’ equity (deficit) | $ | | $ | |
* | The condensed balance sheet at December 31, 2021 has been derived from the audited financial statements at that date. |
The accompanying notes are an integral part of these financial statements.
1
IDERA PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
Three Months Ended | |||||||
March 31, | |||||||
(In thousands, except per share amounts) |
| 2022 |
| 2021 |
| ||
Operating expenses: | |||||||
Research and development | $ | | $ | | |||
General and administrative |
| |
| | |||
Total operating expenses |
| |
| | |||
Loss from operations |
| ( |
| ( | |||
Other income (expense): | |||||||
Interest income |
| |
| | |||
Interest expense |
| — |
| ( | |||
Warrant revaluation gain | — | | |||||
Future tranche right revaluation gain | — | | |||||
Foreign currency exchange gain (loss) |
| |
| ( | |||
Net income (loss) | $ | ( | $ | | |||
Undistributed earnings to preferred stockholders | — | ( | |||||
Net income (loss) applicable to common stockholders | $ | ( | $ | | |||
Net income (loss) applicable to common stockholders (Note 11) | |||||||
— Basic | $ | ( | $ | | |||
— Diluted | $ | ( | $ | ( | |||
Net income (loss) per share applicable to common stockholders (Note 11) | |||||||
— Basic | $ | ( | $ | | |||
— Diluted | $ | ( | $ | ( | |||
Weighted-average number of common shares used in computing net income (loss) per share applicable to common stockholders | |||||||
— Basic |
| |
| | |||
— Diluted |
| |
| | |||
The accompanying notes are an integral part of these financial statements.
2
IDERA PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
Three Months Ended | |||||||
March 31, | |||||||
(In thousands) |
| 2022 |
| 2021 |
| ||
Cash Flows from Operating Activities: | |||||||
Net income / (loss) | $ | ( | $ | | |||
Adjustments to reconcile net income (loss) to net cash used in operating activities: | |||||||
Stock-based compensation |
| |
| | |||
Warrant liability revaluation gain | — | ( | |||||
Future tranche right liability revaluation gain | — | ( | |||||
Issuance of common stock for services rendered | |
| | ||||
Accretion of discounts on short-term investments | — |
| ( | ||||
Depreciation and amortization expense |
| |
| | |||
Changes in operating assets and liabilities: |
| ||||||
Prepaid expenses and other assets | |
| | ||||
Accounts payable, accrued expenses, and other liabilities | ( |
| ( | ||||
Other | | | |||||
Net cash used in operating activities |
| ( |
| ( | |||
Cash Flows from Investing Activities: | |||||||
Proceeds from maturity of available-for-sale securities |
| — |
| | |||
Net cash provided by investing activities |
| — |
| | |||
Cash Flows from Financing Activities: | |||||||
Proceeds from common stock financings, net |
| — | | ||||
Proceeds from employee stock purchases |
| |
| | |||
Proceeds from exercise of common stock options and warrants |
| — | | ||||
Payments on seller-financed purchases | — |
| ( | ||||
Net cash provided by financing activities |
| |
| | |||
Net increase (decrease) in cash and cash equivalents |
| ( |
| | |||
Cash and cash equivalent, beginning of period |
| |
| | |||
Cash and cash equivalents, end of period | $ | | $ | | |||
Supplemental disclosure of cash flow information: | |||||||
Cash paid for interest | $ | — | $ | | |||
Supplemental disclosure of non-cash financing and investing activities: | |||||||
Offering costs in accounts payable and accrued expenses | $ | | $ | |
The accompanying notes are an integral part of these financial statements.
3
IDERA PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
(UNAUDITED)
For the Three Months Ended March 31, 2021 | ||||||||||||||||||||
Series B1 Preferred | Common Stock | Additional | Total | |||||||||||||||||
Number of | $0.01 Par | Number of | $0.001 Par | Paid-In | Accumulated | Stockholders’ | ||||||||||||||
(In thousands) | Shares |
| Value |
| Shares |
| Value |
| Capital |
| Deficit |
| Deficit | |||||||
Balance, December 31, 2020 |
| | $ | — | | $ | | $ | | $ | ( | $ | ( | |||||||
Sale of common stock, net of issuance costs |
| — |
| — | | | | — | | |||||||||||
Conversion of Series B1 preferred stock | ( | — | | | ( | — | — | |||||||||||||
Issuance of common stock under employee stock purchase plan |
| — |
| — | | — | | — |
| | ||||||||||
Issuance of common stock under equity incentive plan (vesting of restricted stock units) | — | — | | — | — | — |
| — | ||||||||||||
Issuance of common stock upon exercise of common stock options and warrants | — |
| — | | | | — | | ||||||||||||
Issuance of common stock for services rendered |
| — |
| — | | — | | — |
| | ||||||||||
Stock-based compensation |
| — |
| — | — | — | | — |
| | ||||||||||
Net income |
| — | — | — | — | — | |
| | |||||||||||
Balance, March 31, 2021 |
| | $ | — | | $ | | $ | | $ | ( | $ | |
For the Three Months Ended March 31, 2022 | ||||||||||||||||||||
Series B1 Preferred | Common Stock | Additional | Total | |||||||||||||||||
Number of | $0.01 Par | Number of | $0.001 Par | Paid-In | Accumulated | Stockholders’ | ||||||||||||||
(In thousands) | Shares |
| Value |
| Shares |
| Value |
| Capital |
| Deficit |
| Equity (Deficit) | |||||||
Balance, December 31, 2021 |
| — | $ | — | | $ | | $ | | $ | ( | $ | | |||||||
Sale of common stock, net of issuance costs |
| — |
| — | — | — | ( | — | ( | |||||||||||
Issuance of common stock under employee stock purchase plan |
| — |
| — | |
| — |
| |
| — |
| | |||||||
Issuance of common stock under equity incentive plan (vesting of restricted stock units) | — |
| — | |
| — |
| — |
| — |
| — | ||||||||
Issuance of common stock for services rendered |
| — |
| — | |
| — |
| |
| — |
| | |||||||
Stock-based compensation |
| — |
| — | — |
| — |
| |
| — |
| | |||||||
Net loss |
| — | — | — |
| — |
| — |
| ( |
| ( | ||||||||
Balance, March 31, 2022 | — | $ | — | | $ | | $ | | $ | ( | $ | |
The accompanying notes are an integral part of these financial statements.
4
IDERA PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS (UNAUDITED)
March 31, 2022
Note 1. Business and Organization
Business Overview
Idera Pharmaceuticals, Inc. (“Idera” or the “Company”), a Delaware corporation, is a biopharmaceutical company with a business strategy focused on the clinical development, and ultimately the commercialization, of drug candidates for rare disease indications characterized by small, well-defined patient populations with serious unmet medical needs. The Company’s current focus is to identify and potentially acquire rights to novel development and commercial stage rare disease programs through new business development opportunities, including additional strategic alternatives. The Company has in the past and may in the future explore collaborative alliances to support development and commercialization of any of our drug candidates.
Until December 2021, the Company was developing tilsotolimod, via intratumoral injection, for the treatment of solid tumors in combination with nivolumab, an anti-PD1 antibody marketed as Opdivo® by Bristol Myers Squibb Company (“BMS”), and/or ipilimumab, an anti-CTLA4 antibody marketed as Yervoy® by BMS. Due to Phase 3 results in anti-PD-1 refractory advanced melanoma, reported in March 2021, which showed the study failed to meet its primary endpoint, as well as a decision in December 2021 to discontinue enrollment in ILLUMINATE-206, the Company’s Phase 2 study in solid tumors, Company-sponsored development of tilsotolimod has been discontinued.
Although clinical trials with tilsotolimod have not yet translated into a new treatment alternative for patients, the Company believes that data supporting tilsotolimod’s mechanism of action and encouraging safety profile from across the array of pre-clinical and clinical work to date, together with its intellectual property protection, are noteworthy. As a result, in December 2021, the Company announced it would consider an out-licensing arrangement so that tilsotolimod’s full potential might continue to be explored on behalf of patients who did not respond to traditional immunotherapy.
Nasdaq Compliance
As previously disclosed, on November 26, 2021, Idera received a deficiency letter (the “Nasdaq Letter”) from the Nasdaq Listing Qualifications Department, notifying it that the Company is not in compliance with Nasdaq Listing Rule 5550(a)(2), which requires the Company to maintain a minimum bid price of at least $1 per share for continued listing on The Nasdaq Capital Market (the “Minimum Bid Requirement”). The Company’s failure to comply with the Minimum Bid Requirement was based on the Company’s common stock per share price being below the $1 threshold for a period of 30 consecutive business days. In accordance with Nasdaq Listing Rule 5810(c)(3)(A) (the “Compliance Period Rule”), the Company has been provided an initial period of 180 calendar days, or by May 25, 2022 (the “Compliance Date”), to regain compliance with the Minimum Bid Requirement. If, at any time before the Compliance Date, the bid price for the Company’s common stock closes at $1.00 or more per share for a minimum of 10 consecutive business days, as required under Nasdaq requirements, the Staff will provide written notification to the Company that it complies with the Minimum Bid Requirement, unless the Staff exercises its discretion to extend this 10-day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H).
If the Company does not regain compliance with the Minimum Bid Requirement by the Compliance Date, the Company may be eligible for an additional 180 calendar day compliance period (the “Second Compliance Period”). To qualify, the Company would need to meet the continued listing requirement for the market value of publicly held shares and all other initial listing standards of the Nasdaq Capital Market, with the exception of the Minimum Bid Requirement, and provide written notice to the Staff of its intention to cure the deficiency during the Second Compliance Period.
Neither the Nasdaq Letter nor the Company’s noncompliance with the Minimum Bid Requirement have an immediate effect on the listing or trading of the Company’s common stock, which continue to trade on The Nasdaq Capital Market under the symbol “IDRA.”
5
Liquidity and Financial Condition
As of March 31, 2022 the Company had an accumulated deficit of $
The Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 205-40, Presentation of Financial Statements—Going Concern, which requires management to assess the Company’s ability to continue as a going concern within one year after the date the financial statements are issued. Management currently anticipates that the Company’s balance of cash and cash equivalents on hand as of March 31, 2022 is sufficient to enable the Company to continue as a going concern through the one-year period subsequent to the filing date of this Form 10-Q. The Company has and will continue to evaluate available alternatives to extend its operations beyond this date, which include the ATM Agreement (Note 7) or additional financing or strategic transactions. Additionally, management’s plans may include the possible deferral of certain operating expenses unless additional capital is received. Management’s operating plan, which underlies the analysis of the Company’s ability to continue as a going concern, involves the estimation of the amount and timing of future cash inflows and outflows. Actual results could vary from the operating plan.
6
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited financial statements included herein have been prepared by the Company in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and pursuant to the rules and regulations of the SEC. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, all adjustments, consisting of normal recurring adjustments, and disclosures considered necessary for a fair presentation of interim period results have been included. Interim results for the three months ended March 31, 2022 are not necessarily indicative of results that may be expected for the year ending December 31, 2022. For further information, refer to the financial statements and footnotes thereto included in the Company’s 2021 Form 10-K.
Cash and Cash Equivalents
The Company considers all highly liquid investments with maturities of 90 days or less when purchased to be “cash equivalents.” Cash and cash equivalents at March 31, 2022 and December 31, 2021 consisted of cash and money market funds.
Financial Instruments
The fair value of the Company’s financial instruments is determined and disclosed in accordance with the three-tier fair value hierarchy specified in Note 3. The Company is required to disclose the estimated fair values of its financial instruments. As of March 31, 2022 and December 31, 2021, the Company’s financial instruments consisted of cash and cash equivalents. The estimated fair values of these financial instruments approximate their carrying values. As of March 31, 2022, the Company did not have any derivatives, hedging instruments or other similar financial instruments.
Concentration of Credit Risk
Financial instruments that subject the Company to credit risk primarily consist of cash and cash equivalents. The Company’s credit risk is managed by investing in highly rated money market instruments, U.S. treasury bills, corporate bonds, commercial paper and/or other debt securities. Due to these factors, no significant additional credit risk is believed by management to be inherent in the Company’s assets. As of March 31, 2022, all of the Company’s cash and cash equivalents were held at
Operating Lease Right-of-use Asset and Lease Liability
The Company accounts for leases under ASC 842, Leases. Operating leases are included in “Operating lease right-of-use assets” within the Company’s balance sheets and represent the Company’s right to use an underlying asset for the lease term. The Company’s related obligation to make lease payments are included in “Operating lease liability” and “Operating lease liability, net of current portion” within the Company’s balance sheets. Operating lease right-of-use (“ROU”) assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As most of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rates, which are the rates incurred to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The ROU assets are tested for impairment according to ASC 360, Property, Plant, and Equipment (“ASC 360”). Leases with an initial term of 12 months or less are not recorded on the balance sheet and are recognized as lease expense on a straight-line basis over the lease term.
As of March 31, 2022 and December 31, 2021, the Company’s operating lease ROU assets and corresponding short-term and long-term lease liabilities primarily relate to its existing Exton, PA facility operating lease which expires on May 31, 2025.
7
Note 2. Summary of Significant Accounting Policies (Continued)
Warrant Liability
The Company accounts for stock warrants as either equity instruments, liabilities or derivative liabilities in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”) and/or ASC 815, Derivatives and Hedging (“ASC 815”), depending on the specific terms of the warrant agreement. Freestanding warrants for shares that are potentially redeemable, whereby the Company may be required to transfer assets (e.g. cash or other assets) outside of its control, are classified as liabilities. Liability-classified warrants are recorded at their estimated fair values at each reporting period until they are exercised, terminated, reclassified or otherwise settled. Changes in the estimated fair value of liability-classified warrants are recorded in Warrant Revaluation Gain (Loss) in the Company’s condensed statements of operations. Equity classified warrants are recorded within additional paid-in capital at the time of issuance and not subject to remeasurement. During the three months ended March 31, 2021, all of the Company’s liability-classified warrants terminated and, accordingly, the liability balance was derecognized.
Future Tranche Right Liability
On December 23, 2019, the Company entered into a Securities Purchase Agreement (the “December 2019 Securities Purchase Agreement”) with institutional investors affiliated with Baker Brothers, an existing stockholder (see Note 10). As more fully described in Note 6, the December 2019 Securities Purchase Agreement contained call options on redeemable preferred shares with warrants (conditionally exercisable for shares that are puttable). The Company determined that these call options represented freestanding financial instruments and accounted for the options as liabilities (“Future Tranche Right Liability”) under ASC 480, which requires the measurement and recognition of the fair value of the liability at the time of issuance and at each reporting period. Any change in fair value was recognized in Future Tranche Right Liability Revaluation Gain (Loss) in the Company’s condensed statements of operations. During the three months ended March 31, 2021, the liability-classified call options provided for under the December 2019 Securities Purchase Agreement terminated and, accordingly, the liability balance was derecognized.
Preferred Stock
The Company applies ASC 480 when determining the classification and measurement of its preferred stock. Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at fair value. Conditionally redeemable preferred shares (including preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) are classified as temporary equity. At all other times, preferred shares are classified as stockholders’ equity.
Income Taxes
In accordance with ASC 270, Interim Reporting, and ASC 740, Income Taxes, the Company is required at the end of each interim period to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis. For the three months ended March 31, 2022 and 2021, the Company recorded
New Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB and rules are issued by the SEC that the Company has or will adopt as of a specified date. Unless otherwise noted, management does not believe that any other recently issued accounting pronouncements issued by the FASB or guidance issued by the SEC had, or is expected to have, a material impact on the Company’s present or future financial statements.
8
Note 2. Summary of Significant Accounting Policies (Continued)
Recently Adopted Accounting Pronouncements
In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies the guidance on an issuer’s accounting for convertible instruments and contracts in its own equity. The Company adopted ASU 2020-06 in the first quarter of 2021. The adoption of this ASU did not have a material effect on the Company’s financial statements.
COVID-19
While the Company is not aware of a material impact from the continuation of the coronavirus ("COVID-19") pandemic through March 31, 2022, the full extent to which COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, depends on future developments.
Note 3. Fair Value Measurements
Assets and Liabilities Measured at Fair Value on a Recurring Basis
The Company applies the guidance in ASC 820, Fair Value Measurement, to account for financial assets and liabilities measured on a recurring basis. Fair value is measured at the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that is determined based on assumptions that market participants would use in pricing an asset or liability.
The Company uses a fair value hierarchy, which distinguishes between assumptions based on market data (observable inputs) and an entity's own assumptions (unobservable inputs). The guidance requires that fair value measurements be classified and disclosed in one of the following three categories:
● | Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; |
● | Level 2: Quoted prices in markets that are not active or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability |
● | Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). |
Determining which category an asset or liability falls within the hierarchy requires significant judgment. The Company evaluates its hierarchy disclosures each reporting period. There were , and three months ended March 31, 2022.
9
Note 3. Fair Value Measurements (Continued)
The table below presents the assets and liabilities measured and recorded in the financial statements at fair value on a recurring basis at March 31, 2022 and December 31, 2021 categorized by the level of inputs used in the valuation of each asset and liability.
| |||||||||||||
March 31, 2022 |
| ||||||||||||
(In thousands) | Total | Level 1 | Level 2 | Level 3 |
| ||||||||
Assets | |||||||||||||
Cash | $ | | $ | | $ | — | $ | — | |||||
Cash equivalents – money market funds | | | — | — | |||||||||
Total assets | $ | | $ | | $ | — | $ | — | |||||
December 31, 2021 | |||||||||||||
(In thousands) | Total | Level 1 | Level 2 | Level 3 | |||||||||
Assets | |||||||||||||
Cash | $ | | $ | | $ | — | $ | — | |||||
Cash equivalents – money market funds | | | — | — | |||||||||
Total assets | $ | | $ | | $ | — | $ | — |
The Level 1 assets consist of money market funds, which are actively traded daily.
Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis
Warrant Liability and Future Tranche Right Liability
The reconciliation of the Company's warrant and future tranche right liability measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows:
Future | ||||||
Warrant | Tranche Right | |||||
(In thousands) | Liability | Liability | ||||
Balance, December 31, 2020 |
| $ | | $ | | |
Change in the fair value of liability (1) |
|
| ( |
| ( | |
Balance, March 31, 2021 |
| $ | — | $ | — |
(1) | During the three months ended March 31, 2021, the Company’s liability-classified warrants and future tranche rights terminated, and accordingly, the liabilities were derecognized. |
10
Note 4. Property and Equipment
At March 31, 2022 and December 31, 2021, property and equipment, at cost, consisted of the following:
March 31, | December 31, | ||||||
(In thousands) |
| 2022 |
| 2021 |
| ||
Leasehold improvements | $ | | $ | | |||
Equipment and other |
| |
| | |||
Total property and equipment, at cost | $ | | $ | | |||
Less: Accumulated depreciation and amortization |
| |
| | |||
Property and equipment, net | $ | | $ | |
Depreciation and amortization expense on property and equipment was less than $
Note 5. Accrued Expenses
At March 31, 2022 and December 31, 2021, accrued expenses consisted of the following:
| March 31, | December 31, |
| ||||
(In thousands) | 2022 |
| 2021 |
| |||
Payroll and related costs | $ | | $ | | |||
Clinical and nonclinical trial expenses |
| |
| | |||
Professional and consulting fees |
| |
| | |||
Other |
| |
| | |||
Total accrued expenses | $ | | $ | |
11
Note 6. Redeemable Convertible Preferred Stock
December 2019 Private Placement
On December 23, 2019, the Company entered into the December 2019 Securities Purchase Agreement under which the Company sold
In addition, the Company agreed to sell to the purchasers, at their option and subject to certain conditions, (i)
The purchase and sale of the securities issuable under the Series B2, B3, and B4 tranches described above were subject to three separate closings, each to be conducted at the purchasers’ discretion. The right of the purchasers to purchase Series B2, Series B3 and Series B4 Preferred Stock was set to expire on the 10th business day following the Company’s ORR Data Announcement, as defined in the December 2019 Securities Purchase Agreement, for its ILLUMINATE-301 study. As a result of the purchasers not exercising the Series B2 Tranche prior to expiration, all future tranche rights and outstanding warrants previously issued pursuant to the December 2019 Securities Purchase Agreement were terminated during the three months ended March 31, 2021. Accordingly, the Company is no longer eligible to receive additional proceeds pursuant to the December 2019 Securities Purchase Agreement and the related warrant liability and future tranche right liability were derecognized during the three months ended March 31, 2021.
Accounting Considerations
The Company determined that the Series B1 Preferred Stock, the accompanying Series B1 warrants, and each of the future tranche rights represent freestanding financial instruments. The Series B1 warrants and the future tranche rights were classified as liabilities until their termination in March 2021 as the underlying shares were potentially redeemable and such redemption was deemed to be outside of the Company’s control.
Due to the redeemable nature of the Series B1 Preferred Stock, the Series B1 Preferred Stock was classified as temporary equity and the carrying value was being accreted to its redemption value while the Series B1 Preferred Stock was outstanding during 2021. During 2021, all the Company’s
12
Note 7. Stockholders’ Equity
Common Stock Purchase Agreement
On March 4, 2019, the Company entered into a Purchase Agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”), which was amended on September 2, 2020 (as amended to date, the “LPC Purchase Agreement”), pursuant to which, upon the terms and subject to the conditions and limitations set forth therein, Lincoln Park committed to purchase an aggregate of $
During the three months ended March 31, 2022, the Company did not sell any shares under the LPC Purchase Agreement. The period noted above for the LPC Purchase Agreement expired on March 4, 2022; accordingly, the Company no longer has access to additional capital under the LPC Purchase Agreement subsequent to this date.
During the three months ended March 31, 2021, the Company sold
"At-The-Market" Equity Program
In November 2018, the Company entered into an Equity Distribution Agreement (the “ATM Agreement”) with JMP Securities LLC (“JMP”) pursuant to which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $
During the three months ended March 31, 2022, the Company sold
During the three months ended March 31, 2021, the Company sold
13
Note 7. Stockholders’ Equity (Continued)
July 2020 Private Placement
On July 13, 2020, the Company entered into a Securities Purchase Agreement (the “July 2020 Securities Purchase Agreement”) with Pillar Partners Foundation, L.P. (“Pillar Partners”), Pillar Pharmaceuticals 6, L.P. (“Pillar 6”), and Pillar Pharmaceuticals 7 L.P. (“Pillar 7”) (collectively, the “July 2020 Purchasers”), each a related party as more fully described in Note 10, pursuant to which, among other things, provided the July Purchasers the option to purchase, at their sole discretion, pre-funded warrants to purchase up to
Common Stock Warrants
In connection with various financing transactions, the Company has issued warrants to purchase shares of the Company’s common stock and preferred stock. The Company accounts for common and preferred stock warrants as equity instruments or liabilities, depending on the specific terms of the warrant agreement.
The following table summarizes outstanding warrants to purchase shares of the Company’s common stock and/or preferred stock as of March 31, 2022 and December 31, 2021:
Number of Shares | ||||||||||
March 31, | December 31, | Weighted-Average | ||||||||
Description | 2022 | 2021 | Exercise Price | Expiration Date |
| |||||
Equity-classified Warrants | ||||||||||
May 2013 warrants |
| | | $ | None | |||||
September 2013 warrants |
| | | $ | None | |||||
February 2014 warrants |
| | | $ | None | |||||
April 2020 Private Placement first closing warrants | | | $ | Apr 2023 | ||||||
April 2020 Private Placement second closing warrants | | | $ | Dec 2023 | ||||||
April 2020 Private Placement second closing warrants | | | $ | None | ||||||
July 2020 Private Placement first closing warrants | | | $ | None | ||||||
July 2020 Private Placement first closing warrants | | | $ | Jul 2023 | ||||||
| | |||||||||
Total outstanding |
| | |
14
Note 8. Collaboration and License Agreements
Scriptr Collaboration and Option Agreement
In February 2021, the Company entered into a collaboration and option agreement with Scriptr Global, Inc. (“Scriptr”), pursuant to which (i) the Company and Scriptr will conduct a research collaboration utilizing Scriptr Platform Technology (“SPT”) to identify, research and develop gene therapy candidates (each, a “Collaboration Candidate”) for the treatment, palliation, diagnosis or prevention of (a) myotonic dystrophy type 1 (“DM1 Field”) and (b) Friedreich’s Ataxia (“FA Field”) on a Research Program-by-Research Program basis, as applicable, and (ii) the Company was granted an exclusive option, in its sole discretion, to make effective the Scriptr License Agreement, as defined below, for a given Research Program, as defined below, to make use of Collaboration Candidates and related intellectual property (collectively, the “Scriptr Agreement”).
Pursuant to the Scriptr Agreement, Scriptr will use commercially reasonable efforts to carry out research activities set forth in accordance with the applicable DM1 Field and FA Field research plans, including certain pre-clinical proof of concept studies, to identify research Collaboration Candidates utilizing SPT (each, a “Research Program”). Following the completion of activities under a given Research Program, Scriptr will prepare and submit to Idera a comprehensive data package (each, a “Data Package”) that summarizes, on a Program-by-Program basis, any Collaboration Candidates researched under the Research Program, including any data and results. Upon receipt of a Data Package, the Company has, in its sole discretion, up to (270) calendar days to make effective the exclusive license agreement entered into by and between the Company and Scriptr, pursuant to which, among other things, Scriptr grants Idera exclusive rights and licenses with respect to the development, manufacture and commercialization of licensed candidates and products, subject to certain conditions and limitations (the “Scriptr License Agreement”), for a given Research Program (each licensed Research Program, a “Licensed Program”). The Scriptr License Agreement provides for customary development milestones on candidates developed under a Licensed Program and royalties on licensed products, if any.
In partial consideration of the rights granted by Scriptr to the Company under the Scriptr Agreement, the Company made a one-time, non-creditable and non-refundable payment to Scriptr during the first quarter of 2021. The Company shall also reimburse Scriptr for costs incurred by or on behalf of Scriptr in connection with the conduct of each Research Program during the Research Term in accordance with the applicable Research Program budget and payment schedule. The Company incurred approximately $
15
Note 9. Stock-Based Compensation
As of March 31, 2022, the only equity compensation plans from which the Company may currently issue new awards are the Company’s 2013 Stock Incentive Plan (as amended to date, the “2013 Plan”) and 2017 Employee Stock Purchase Plan (the “2017 ESPP”), each as more fully described below.
Equity Incentive and Employee Stock Purchase Plans
2013 Stock Incentive Plan
The 2013 Plan allows for the issuance of incentive stock options intended to qualify under Section 422 of the Internal Revenue Code, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units (“RSUs”), other stock-based awards and performance awards. The total number of shares of common stock authorized for issuance under the 2013 Plan is
As of March 31, 2022, options to purchase a total of
Other Awards and Inducement Grants
The Company has not made any awards pursuant to other equity incentive plans, including the 2008 Plan, since the Company’s stockholders approved the 2013 Plan. As of March 31, 2022, options to purchase a total of
2017 Employee Stock Purchase Plan
The 2017 ESPP is intended to qualify as an "employee stock purchase plan" as defined in Section 423 of the Internal Revenue Code, and is intended to encourage our employees to become stockholders of ours, to stimulate increased interest in our affairs and success, to afford employees the opportunity to share in our earnings and growth and to promote systematic savings by them. The total number of shares of common stock authorized for issuance under the 2017 ESPP is
For the three months ended March 31, 2022 and 2021, the Company issued
16
Note 9. Stock-Based Compensation (Continued)
Accounting for Stock-based Compensation
The Company recognizes non-cash compensation expense for stock-based awards under the Company’s equity incentive plans and employee stock purchases under the Company’s 2017 ESPP as follows:
• | Stock Options: Compensation cost is recognized over an award’s requisite service period, or vesting period, using the straight-line attribution method, based on the grant date fair value determined using the Black-Scholes option-pricing model. |
• | RSUs: Compensation cost for time-based RSUs, which vest over time based only on continued service, is recognized on a straight-line basis over the requisite service period based on the fair value of the Company’s common stock on the date of grant. Compensation cost for awards that are subject to market considerations is recognized on a straight-line basis over the implied requisite service period, based on the grant date fair value estimated using a Monte Carlo simulation. Compensation cost for awards that are subject to performance conditions is recognized over the period of time commencing when the performance condition is deemed probable of achievement based on the fair value of the Company’s common stock on the date of grant. |
• | Employee Stock Purchases: Compensation cost is recognized over each plan period based on the fair value of the look-back provision, calculated using the Black-Scholes option-pricing model, considering the |
Total stock-based compensation expense attributable to stock-based awards made to employees and directors and employee stock purchases included in operating expenses in the Company's condensed statements of operations for the three months ended March 31, 2022 and 2021 were as follows:
Three Months Ended | ||||||
| March 31, | |||||
(in thousands) | 2022 |
| 2021 | |||
Stock-based compensation: |
| |||||
Research and development | ||||||
Employee Stock Purchase Plan | $ | |
| $ | | |
Equity Incentive Plan | |
| | |||
$ | |
| $ | | ||
General and administrative |
| |||||
Employee Stock Purchase Plan | $ | |
| $ | | |
Equity Incentive Plan | |
| | |||
$ | |
| $ | | ||
Total stock-based compensation expense | $ | |
| $ | |
During the three months ended March 31, 2022 and 2021, the weighted average fair market value of stock options granted was $
17
Note 9. Stock-Based Compensation (Continued)
The following weighted average assumptions apply to the options to purchase
| 2022 |
| 2021 |
| |||
Average risk-free interest rate |
| ||||||
Expected dividend yield |
| — | — | ||||
Expected lives (years) |
| ||||||
Expected volatility |
| ||||||
Weighted average exercise price (per share) | $ | | $ | |
All options granted during the three months ended March 31, 2022 and 2021 were granted at exercise prices equal to the fair market value of the Company’s common stock on the date of grant. As further described below, the vesting of certain options granted to employees during the three months ended March 31, 2021 were accelerated during the period.
Stock Option Activity
The following table summarizes stock option activity for the three months ended March 31, 2022:
($ in thousands, except per share data) | Stock | Weighted-Average | Weighted-Average |
| ||||
Outstanding at December 31, 2021 |
| | $ | |
| |||
Granted |
| | | |||||
Exercised |
| — | — | |||||
Forfeited |
| — | — | |||||
Expired |
| ( | | |||||
Outstanding at March 31, 2022 (1) |
| | $ | | ||||
Exercisable at March 31, 2022 |
| | $ | |
(1) | Includes both vested stock options as well as unvested stock options for which the requisite service period has not been rendered but that are expected to vest based on achievement of a service condition. |
As of March 31, 2022, there was $
During the three months ended March 31, 2021, the Company accelerated the vesting of
Restricted Stock Activity
The following table summarizes restricted stock activity for the three months ended March 31, 2022:
Time-based Awards |
| Market/Performance-based Awards | |||||||||
($ in thousands, except per share data) | Number of Shares | Weighted-Average |
| Number of Shares | Weighted-Average | ||||||
Nonvested shares at December 31, 2021 |
| | $ | |
| | $ | | |||
Granted |
| — |
| — |
| — |
| — | |||
Cancelled |
| — | — |
| — |
| — | ||||
Vested |
| ( | |
| — |
| — | ||||
Nonvested shares at March 31, 2022 |
| | $ | |
| | $ | |
18
Note 9. Stock-Based Compensation (Continued)
Time-based Restricted Stock Units
During the three months ended March 31, 2021, the Company accelerated the vesting of
During the three months ended March 31, 2022, the Company recognized $
Market/Performance-based Restricted Stock Units
In July 2020, the Company granted RSUs to certain employees, including executive officers, under the 2013 Plan, with vesting that may occur upon a combination of specific performance and/or market conditions. Accordingly, the Company views these RSUs as two separate awards: (i) an award that vests if the market condition is achieved, and (ii) an award that vests whether or not the market condition is achieved, so long as the performance condition is achieved. The Company is currently recognizing compensation expense for these awards over the estimated requisite service period of
Note 10. Related Party Transactions
Baker Brothers
Julian C. Baker, a member of the Company’s Board until his resignation in September 2018, is a principal of Baker Bros. Advisors, LP. Additionally, Kelvin M. Neu, a member of Company’s Board until his resignation in June 2019, is an employee of Baker Bros. Advisors, LP. At December 31, 2020, Baker Bros. Advisors, LP and certain of its affiliated funds (collectively, “Baker Brothers”) held sole voting power with respect to an aggregate of
During the three months ended March 31, 2021, Baker Brothers exercised warrants to purchase
As of March 31, 2021, Baker Brothers held
At March 31, 2022, Baker Brothers held sole voting power with respect to an aggregate of
19
Note 10. Related Party Transactions (Continued)
Pillar Investment Entities
Youssef El Zein, a member of the Company’s board of directors until his resignation in October 2017, is a director and controlling stockholder of Pillar Invest Corporation (“Pillar Invest”), which is the general partner of Pillar Pharmaceuticals I, L.P., Pillar Pharmaceuticals II, L.P., Pillar Pharmaceuticals III, L.P., Pillar Pharmaceuticals IV, L.P., Pillar Pharmaceuticals V, L.P., Pillar 6, Pillar 7, and Pillar Partners (collectively, the “Pillar Investment Entities”). As of March 31, 2022, the Pillar Investment Entities owned approximately
As of March 31, 2022, the Pillar Investment Entities held (i) prefunded warrants to purchase up to
During the three months ended March 31, 2021, Pillar 6 exercised warrants to purchase
Board Fees Paid in Stock
Pursuant to the Company’s director compensation program, in lieu of director board and committee fees of less than $
Note 11. Net Income (Loss) per Common Share
During periods the Company realizes net income, it uses the two-class method to compute net income per common share and has securities outstanding (redeemable convertible preferred stock) that entitle the holder to participate in dividends and earnings of the Company. In addition, the Company analyzes the potential dilutive effect of outstanding redeemable convertible preferred stock under the "if-converted" method when calculating diluted earnings per share and reports the more dilutive of the approaches (two class or "if-converted"). The two-class method is not applicable during periods with a net loss, as the holders of the redeemable convertible preferred stock have no obligation to fund losses.
The Company also analyzes the potential dilutive effect of stock options, restricted stock units, warrants and shares underlying future tranche rights under the treasury stock method (as applicable), during periods of income, or during periods in which income is recognized related to changes in fair value of its liability-classified securities.
For the three months ended March 31, 2021, the Company used the two-class method to compute net income per common share. Under this method, net income is reduced by the amount of any dividends earned and the accretion of redeemable convertible preferred stock to its redemption value, if any, during the period. The remaining earnings (undistributed earnings) are allocated to common stock and each series of redeemable convertible preferred stock to the extent that each preferred security may share in earnings as if all of the earnings for the period had been distributed. The total earnings allocated to common stock is then divided by the number of outstanding shares to which the earnings are allocated to determine the earnings per share.
20
Note 11. Net Income (Loss) per Common Share (Continued)
However, during periods the Company realizes net loss, basic and diluted net loss per common share applicable to common stockholders is calculated by dividing net loss applicable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, without consideration of common stock equivalents. The Company’s potentially dilutive shares, which include outstanding stock option awards, common stock warrants and convertible preferred stock, are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive.
For the three months ended March 31, 2022, diluted net loss per common share applicable to common stockholders was the same as basic net loss per common share applicable to common stockholders as the effects of the Company’s potential common stock equivalents were antidilutive.
Details in the computation of basic and diluted net income (loss) per common share were as follows:
Three Months Ended | ||||||
March 31, | ||||||
($ in thousands except per share data) | 2022 | 2021 | ||||
Net income (loss) per share — Basic: | ||||||
Net income (loss) | $ | ( | $ | | ||
Less: Undistributed earnings to preferred stockholders | — | ( | ||||
Net income (loss) applicable to common stockholders - basic | $ | ( | $ | | ||
Numerator for basic net income (loss) applicable to common stockholders | $ | ( | $ | | ||
Denominator for basic net income (loss) applicable to common stockholders | | | ||||
Net income (loss) applicable to common stockholders - basic | $ | ( | $ | | ||
Net income (loss) per share — Diluted: | ||||||
Net income (loss) | $ | ( | $ | | ||
Less: Warrant revaluation gain applicable to dilutive liability-classified warrants |