CNSY 10-Q
Cerenome, Inc. (CNSY)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
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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DELAWARE |
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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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Nasdaq Capital Market |
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 definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large Accelerated Filer |
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Accelerated Filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financing 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
As of October 15, 2021, there were
PLUS THERAPEUTICS, INC.
INDEX
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PART I |
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Item 1. |
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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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18 |
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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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25 |
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Item 1A. |
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Item 6. |
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2
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This report and the exhibits incorporated herein by reference contains “forward-looking statements” which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Statements other than statements of historical fact -constitute “forward-looking statements.” These forward-looking statements do not constitute guarantees of future performance. These forward-looking statements may be identified by terms such as “intend,” “expect,” “believe,” “anticipate,” “will,” “should,” “would,” “could,” “may,” “designed,” “potential,” “evaluate,” “progressing,” “proceeding,” “exploring,” “hopes,” and similar expressions, or the negative of such expressions. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
These statements include, without limitation, statements regarding: our anticipated expenditures, including research and development, sales and marketing, and general and administrative expenses; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; our ability to benefit from the NIH/NCI award for continued clinical development of Rhenium NanoLiposome (RNL) for recurrent glioblastoma; the ability of RNL to safely and effectively deliver radiation directly to the tumor at high doses; our ability to develop additional indications utilizing RNL and the clinical benefits of RNL in such indications; our ability to expand clinical testing of RNL to additional sites; the potential size of the market for our product candidates; our research and development efforts; our IP strategy; competition; future development and/or expansion of our product candidates and therapies in our markets; our ability to generate product or development revenue and the sources of such revenue; the amounts that we may be obligated to pay under license agreements; our ability to effectively manage our gross profit margins; our ability to obtain and maintain regulatory approvals; expectations as to our future performance; portions of the “Liquidity and Capital Resources” section of this report, including our need for additional financing and the availability thereof; our ability to fully access our equity line with Lincoln Park; any changes to our interest expenses; our ability to continue as a going concern; our ability to remain listed on the Nasdaq Capital Market; our ability to repay or refinance some or all of our outstanding indebtedness and our ability to raise capital in the future; expectations as to the impact of recently issued or adopted accounting standards; our expectations as to the impact of the COVID-19 pandemic on our business and operating results; our beliefs as to the impact of any liability that may arise as a result of any legal proceedings; and the potential enhancement of our cash position through development, marketing, and licensing arrangements.
Our actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of our product candidates and therapies, the results of our research and development activities, including uncertainties relating to the clinical trials of our product candidates and therapies; our liquidity and capital resources and our ability to raise additional cash, the outcome of our partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to us, market conditions, product performance, litigation or potential litigation, and competition within the regenerative medicine field, among others. The forward-looking statements included in this report are also subject to a number of additional material risks and uncertainties, including but not limited to the risks described under “Part I – Item 1A – Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020, and under “Part II – Item 1A – Risk Factors” in this Quarterly report. These risks and uncertainties could cause actual results to differ materially from expectations or those expressed in these forward-looking statements.
We encourage you to read the risks described under “Risk Factors” and elsewhere in this report carefully. We caution you not to place undue reliance on the forward-looking statements contained in this report. These statements, like all statements in this report, speak only as of the date of this report (unless an earlier date is indicated) and we undertake no obligation to update or revise the statements except as required by law. Such forward-looking statements are not guarantees of future performance.
3
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
PLUS THERAPEUTICS, INC.
CONSOLIDATED CONDENSED BALANCE SHEETS
(UNAUDITED)
(in thousands, except share and par value data)
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September 30, 2021 |
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December 31, 2020 |
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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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Other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use assets |
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Goodwill |
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Intangible assets, 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 and accrued expenses |
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$ |
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$ |
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Operating lease liability |
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Term loan obligations, net of discount |
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Total current liabilities |
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Noncurrent operating lease liability |
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Warrant liability |
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Total liabilities |
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Commitments and contingencies (Note 7) |
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Stockholders’ equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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See Accompanying Notes to these Consolidated Condensed Financial Statements
4
PLUS THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
(in thousands, except share and per share data)
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For the Three Months Ended September 30, |
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For the Nine Months Ended September 30, |
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2021 |
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2020 |
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2021 |
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2020 |
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Development revenues: |
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Government contracts and other |
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$ |
— |
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$ |
— |
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$ |
— |
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$ |
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Operating expenses: |
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Research and development |
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In process research and development acquired from NanoTx |
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— |
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— |
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— |
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General and administrative |
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Loss on disposal of property and equipment |
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— |
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— |
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Total operating expenses |
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Loss from operations |
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( |
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( |
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( |
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Other income (expense): |
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Interest income |
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Interest expense |
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( |
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( |
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( |
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( |
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Change in fair value of warrants |
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( |
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Total other income (expense) |
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( |
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( |
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( |
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Net loss |
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$ |
( |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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Net loss per share, basic and diluted |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Basic and diluted weighted average shares used in calculating net loss per share attributable to common stockholders |
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See Accompanying Notes to these Consolidated Condensed Financial Statements
5
PLUS THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY
(UNAUDITED)
(in thousands)
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Convertible |
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Additional |
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Total |
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preferred stock |
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Common stock |
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paid-in |
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Accumulated |
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stockholders’ |
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Shares |
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Amount |
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Shares |
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Amount |
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capital |
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deficit |
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equity |
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Balance at December 31, 2019 |
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$ |
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— |
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$ |
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$ |
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$ |
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( |
) |
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$ |
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Stock-based compensation |
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— |
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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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— |
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( |
) |
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( |
) |
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Balance at March 31, 2020 |
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$ |
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— |
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$ |
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$ |
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$ |
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( |
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$ |
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Issuance of common stock for exercise of warrants |
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— |
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— |
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— |
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— |
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Reclassification of warrant liabilities |
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— |
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— |
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— |
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— |
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— |
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Issuance of common stock for in process research and development acquired from NanoTx Therapeutics |
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— |
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— |
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— |
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— |
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Share-based compensation |
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— |
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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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— |
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( |
) |
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( |
) |
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Balance at June 30, 2020 |
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$ |
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— |
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$ |
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$ |
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$ |
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( |
) |
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$ |
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Issuance of common stock for exercise of warrants |
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— |
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— |
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— |
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Reclassification of warrant liabilities |
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— |
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— |
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— |
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— |
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— |
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Conversion of Series B convertible preferred stock into common stock |
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( |
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— |
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— |
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— |
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— |
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— |
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Share-based compensation |
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— |
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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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— |
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( |
) |
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( |
) |
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Balance at September 30, 2020 |
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$ |
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— |
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$ |
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$ |
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$ |
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( |
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$ |
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Balance at December 31, 2020 |
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$ |
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— |
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$ |
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$ |
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$ |
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( |
) |
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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Sale of common stock, net of offering cost |
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— |
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— |
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— |
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Conversion of Series B Convertible Preferred Stock into common stock |
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( |
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— |
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— |
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— |
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— |
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— |
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Issuance of common stock for exercise of warrants |
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— |
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— |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
Net loss |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
( |
) |
|
|
|
( |
) |
|
Balance at March 31, 2021 |
|
|
|
|
|
|
|
$ |
|
— |
|
|
|
|
|
|
$ |
|
|
|
|
$ |
|
|
|
|
$ |
|
( |
) |
|
$ |
|
|
|
|
Sale of common stock, net of offering cost |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
Share-based compensation |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
Net loss |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
( |
) |
|
|
|
( |
) |
|
Balance at June 30, 2021 |
|
|
|
|
|
|
|
$ |
|
— |
|
|
|
|
|
|
$ |
|
|
|
|
$ |
|
|
|
|
$ |
|
( |
) |
|
$ |
|
|
|
|
Sale of common stock, net of offering cost |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
Share-based compensation |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
Net loss |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
( |
) |
|
|
|
( |
) |
|
Balance at September 30, 2021 |
|
|
|
|
|
|
|
$ |
|
— |
|
|
|
|
|
|
$ |
|
|
|
|
$ |
|
|
|
|
$ |
|
( |
) |
|
$ |
|
|
|
See Accompanying Notes to these Consolidated Condensed Financial Statements
6
PLUS THERAPEUTICS, INC.
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(in thousands)
|
|
|
For the Nine Months Ended September 30, |
|
|||||
|
|
|
2021 |
|
|
2020 |
|
||
|
Cash flows used in operating activities: |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
|
|
|
|
|
|
|
Amortization of deferred financing costs and debt discount |
|
|
|
|
|
|
|
|
|
Loss on disposal of property and equipment |
|
|
|
|
|
|
|
|
|
In process research and development acquired from NanoTx Therapeutics |
|
|
|
|
|
|
|
|
|
Non-cash lease expenses |
|
|
|
|
|
|
|
|
|
Change in fair value of warrants |
|
|
( |
) |
|
|
( |
) |
|
Stock-based compensation expense |
|
|
|
|
|
|
|
|
|
Increases (decreases) in cash caused by changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
|
|
|
|
|
|
|
Other current assets |
|
|
|
|
|
|
|
|
|
Other assets |
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
|
|
|
|
|
( |
) |
|
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
|
Cash flows used in investing activities: |
|
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
( |
) |
|
|
( |
) |
|
Proceeds from sale of property and equipment |
|
|
|
|
|
|
|
|
|
In process research and development acquired from NanoTx Therapeutics |
|
|
|
|
|
|
( |
) |
|
Net cash used in investing activities |
|
|
( |
) |
|
|
( |
) |
|
Cash flows provided by (used in) financing activities: |
|
|
|
|
|
|
|
|
|
Principal payments of long-term obligations |
|
|
|
|
|
|
( |
) |
|
Payment of financing lease liability |
|
|
( |
) |
|
|
( |
) |
|
Proceeds from exercise of warrants |
|
|
|
|
|
|
|
|
|
Proceeds from sale of common stock, net |
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities |
|
|
|
|
|
|
( |
) |
|
Net increase (decrease) in cash and cash equivalents |
|
|
|
|
|
|
( |
) |
|
Cash and cash equivalents at beginning of period |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flows information: |
|
|
|
|
|
|
|
|
|
Cash paid during period for: |
|
|
|
|
|
|
|
|
|
Interest |
|
$ |
|
|
|
$ |
|
|
|
Supplemental schedule of non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
|
Unpaid offering cost |
|
$ |
|
|
|
$ |
|
|
|
Right-of-use asset obtained in exchange for lease liabilities |
|
$ |
|
|
|
$ |
|
|
|
Issuance costs paid in common stock |
|
$ |
|
|
|
$ |
|
|
|
Common stock issued in payment for in process research and development |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See Accompanying Notes to these Consolidated Condensed Financial Statements
7
PLUS THERAPEUTICS, INC.
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
September 30, 2021
(UNAUDITED)
|
1. |
Basis of Presentation and New Accounting Standards |
The accompanying unaudited consolidated condensed financial statements as of September 30, 2021 and for the nine months ended September 30, 2021 and 2020 have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for annual financial statements. The consolidated condensed balance sheet at December 31, 2020 has been derived from the audited financial statements at December 31, 2020, but does not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the financial position and results of operations of Plus Therapeutics, Inc., and its subsidiaries (collectively, the “Company”) have been included. Operating results for the nine months ended September 30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021. These financial statements should be read in conjunction with the consolidated financial statements and notes therein included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 22, 2021.
Recently Issued Accounting Pronouncements
In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For available-for-sale debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. This new guidance is effective in the first quarter of 2023 for calendar-year SEC filers that are smaller reporting companies as of the one-time determination date. Early adoption is permitted beginning in 2019. The Company plans to adopt the new guidance on January 1, 2023, and it does not expect that adoption of this standard will have a material impact on its consolidated financial statements and related disclosures.
Recently Adopted Accounting Pronouncement
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes, Simplifying the Accounting for Income Taxes (“ASU 2019-12”). The new guidance eliminates certain exceptions related to the approach for intra-period tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. It also clarifies and simplifies other aspects of the accounting for income taxes. ASU 2019-12 became effective for the Company on
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) (“ASU 2020-06”). ASU 2020-06 eliminates the beneficial conversion and cash conversion accounting models for convertible instruments. It also amends the accounting for certain contracts in an entity’s own equity that are currently accounted for as derivatives because of specific settlement provisions. In addition, ASU 2020-06 modifies how particular convertible instruments and certain contracts that may be settled in cash or shares impact the diluted EPS computation. The amendments in ASU 2020-06 are effective for smaller reporting companies as defined by the SEC for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The Company adopted ASU 2020-06 as of
|
2. |
Use of Estimates |
The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions affecting the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting period. The Company’s most significant estimates and critical accounting policies involve reviewing assets for impairment, determining the assumptions used in measuring stock-based compensation expense and valuing warrants.
Actual results could differ from these estimates. Management’s estimates and assumptions are reviewed regularly, and the effects of revisions are reflected in the consolidated financial statements in the periods they are determined to be necessary.
8
|
3. |
Liquidity and Going Concern |
The Company incurred net losses of $
The Company continues to seek additional capital through strategic transactions and from other financing alternatives. Without additional capital, the Company’s current working capital will not provide adequate funding to make debt repayments or support its research and product development activities at their current levels. If sufficient capital is not raised, the Company will at a minimum need to significantly reduce or curtail its research and development and other operations, and this would negatively affect its ability to achieve corporate growth goals.
On October 23, 2020, the Company entered into an Equity Distribution Agreement (the “Distribution Agreement”) with Canaccord Genuity LLC (“Canaccord”) pursuant to which it could issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $
On September 30, 2020, the Company entered into a purchase agreement (the “2020 Purchase Agreement”) and a registration rights agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase up to $
Should the Company fail to raise additional cash from outside sources, this would have a material adverse impact on its operations.
The accompanying consolidated condensed financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern.
|
4. |
Fair Value Measurements |
Fair value measurements are market-based measurements, not entity-specific measurements. Therefore, fair value measurements are determined based on the assumptions that market participants would use in pricing the asset or liability. The Company follows a three-level hierarchy to prioritize the inputs used in the valuation techniques to derive fair values. The basis for fair value measurements for each level within the hierarchy is described below:
|
|
• |
Level 1: Quoted prices in active markets for identical assets or liabilities. |
|
|
• |
Level 2: Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations in which all significant inputs are observable in active markets. |
9
|
|
• |
Level 3: Valuations derived from valuation techniques in which one or more significant inputs are unobservable in active markets. |
Warrants issued in an underwritten public offering in September 2019 (“Series U Warrants”) are classified as liability instruments. Because some of the inputs to the Company’s valuation model are either not observable or are not derived principally from or corroborated by observable market data by correlation or other means, the warrant liability is classified as Level 3 in the fair value hierarchy.
The Company estimated the fair value of the Series U Warrants with the Black Scholes model. The Series U Warrants will be marked to market as of each balance sheet date until they are exercised or upon expiration, with the changes in fair value recorded as non-operating income or loss in the statements of operations.
|
|
|
September 30, 2021 |
|
|
December 31, 2020 |
|
||
|
Expected term |
|
|
|
|
|
|
||
|
Common stock market price |
|
$ |
|
|
|
$ |
|
|
|
Risk-free interest rate |
|
|
|
% |
|
|
|
% |
|
Expected volatility |
|
|
|
% |
|
|
|
% |
|
Resulting fair value (per warrant) |
|
$ |
|
|
|
$ |
|
|
The following table summarizes the change in Level 3 warrant liability value for the three and nine months ended September 30, 2021 and 2020 (in thousands):
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||
|
Warrant liability |
September 30, 2021 |
|
September 30, 2020 |
|
|
September 30, 2021 |
|
September 30, 2020 |
|
||||
|
Beginning balance |
$ |
|
|
$ |
|
|
|
$ |
|
|
$ |
|
|
|
Change in fair value |
|
( |
) |
|
|
|
|
|
( |
) |
|
( |
) |
|
Reclassification to equity |
|
|
|
|
( |
) |
|
|
— |
|
|
( |
) |
|
Ending balance |
$ |
|
|
$ |
|
|
|
$ |
|
|
$ |
|
|
|
5. |
Term Loan Obligations |
On
From September 2017 to March 2019, the Company entered into a total of seven amendments to the Term Loan which, amongst other things, extended the interest only period, required repayment of $
On March 29, 2020, the Company entered into the Ninth Amendment of the Loan and Security Agreement (the “Ninth Amendment”), pursuant to which Oxford agreed to defer the start date of principal repayment from
Under authoritative guidance, the Ninth Amendment does not meet the criteria to be accounted for as a troubled debt restructuring. In addition, the Company performed a quantitative analysis and determined that the terms of the new debt and
10
original debt instrument are not substantially different. Accordingly, the Ninth Amendment is accounted for as debt modification. A new effective interest rate that equates the revised cash flows to the carrying amount of the original debt is computed and applied prospectively.
The Term Loan, as amended, is collateralized by a security interest in substantially all of the Company’s existing and subsequently acquired assets, including its intellectual property assets, subject to certain exceptions set forth in the Loan and Security Agreement, as amended. The intellectual property asset collateral will be released upon the Company achieving a certain liquidity level when the total principal outstanding under the Loan and Security Agreement is less than $
The Company’s interest expense for the three months ended September 30, 2021 and 2020 was $
The Loan and Security Agreement, as amended, contains customary indemnification obligations and customary events of default, including, among other things, the Company’s failure to fulfill certain obligations under the Term Loan, as amended, and the occurrence of a material adverse change, which is defined as a material adverse change in the Company’s business, operations, or condition (financial or otherwise), a material impairment of the prospect of repayment of any portion of the loan. In the event of default by the Company or a declaration of material adverse change by its lender, under the Term Loan, the lender would be entitled to exercise its remedies thereunder, including the right to accelerate the debt, upon which the Company may be required to repay all amounts then outstanding under the Term Loan, which could materially harm the Company’s financial condition. As of September 30, 2021, the Company has not received any notification or indication from Oxford to invoke the material adverse change clause. However, due to the Company’s current cash flow position and the substantial doubt about its ability to continue as a going concern, the entire principal amount of the Term Loan is presented as short-term. The Company will continue to evaluate the debt classification on a quarterly basis and evaluate for reclassification in the future should its financial condition improve.
|
6. |
Loss per Share |
Basic per share data is computed by dividing net income or loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted per share data is computed by dividing net income or loss applicable to common stockholders by the weighted average number of common shares outstanding during the period increased to include, if dilutive, the number of additional common shares that would have been outstanding as calculated using the treasury stock method. Potential common shares were related to outstanding but unexercised options, multiple series of convertible preferred stock, and warrants for all periods presented.
The following were excluded from the diluted loss per share calculation for the periods presented because their effect would be anti-dilutive:
|
|
|
Nine Months Ended September 30, |
|
|||||
|
|
|
2021 |
|
|
2020 |
|
||
|
Outstanding stock options |
|
|
|
|
|
|
|
|
|
Outstanding warrants |
|
|
|
|
|
|
|
|
|
Preferred stock |
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
|
7. |
Commitments and Contingencies |
Leases
At the inception of a contractual arrangement, the Company 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 the identified asset in exchange for consideration over a period of time. If both criteria are met, the Company calculates the associated lease liability and corresponding right-of-use asset upon lease commencement using a discount rate based on the rate implicit in the lease or an incremental borrowing rate commensurate with the term of the lease.
The Company records lease liabilities within current liabilities or long-term liabilities based upon the length of time associated with the lease payments. The Company records its operating lease right-of-use assets as long-term assets. Right-of-use assets for financing leases are recorded within property and equipment, net in the balance sheet. Leases with an initial term of 12 months
11
or less are not recorded on the balance sheet. Instead, the Company recognizes lease expense for these leases on a straight-line basis over the lease term.
The Company leases laboratory, office and storage facilities in San Antonio, Texas, under operating lease agreements that expire in
Certain leases require the Company to pay taxes, insurance, and maintenance. Payments for the transfer of goods or services such as common area maintenance and utilities represent non-lease components. The Company elected the package of practical expedients and therefore does not separate non-lease components from lease components.
The table below summarizes the Company’s operating lease liabilities and corresponding right-of-use assets (in thousands, except years and rates):
|
|
September 30, 2021 |
|
|
|
Assets |
|
|
|
|
Operating |
$ |
|
|
|
Total leased assets |
$ |
|
|
|
Liabilities |
|
|
|
|
Current: |
|
|
|
|
Operating |
$ |
|
|
|
Noncurrent: |
|
|
|
|
Operating |
|
|
|
|
Total lease liabilities |
$ |
|
|
|
Weighted-average remaining lease term (years) - operating leases |
|
|
|
|
Weighted-average discount rate - operating leases |
|
|
% |
The table below summarizes the Company’s lease costs from its unaudited consolidated condensed statement of operations, and cash payments from its unaudited consolidated condensed statement of cash flows during the three and nine months ended September 30, 2021 and 2020 (in thousands):
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||
|
|
September 30, 2021 |
|
September 30, 2020 |
|
|
September 30, 2021 |
|
September 30, 2020 |
|
||||
|
Lease expense: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease expense |
$ |
|
|
$ |
|
|
|
$ |
|
|
$ |
|
|
|
Finance lease expense: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation of right-of-use assets |
|
— |
|
|
|
|
|
|
|
|
|||
|
Interest expense on lease liabilities |
|
— |
|
|
|
|
|
— |
|
|
|
||
|
Total lease expense |
$ |
|
|
$ |
|
|
|
$ |
|
|
$ |
|
|
|
Cash payment information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating cash used for operating leases |
$ |
|
|
$ |
|
|
|
$ |
|
|
$ |
|
|
|
Financing cash used for financing leases |
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
Total cash paid for amounts included in the measurement of lease liabilities |
$ |
|
|
$ |
|
|
|
$ |
|
|
$ |
|
|
12
Total rent expenses for the nine months ended September 30, 2021 and 2020 was $
The Company’s future minimum annual lease payments under operating and financing leases at September 30, 2021 are as follows (in thousands):
|
|
Operating Leases |
|
|
|
|
|
|
|
|
Remaining 2021 |
$ |
|
|
|
2022 |
|
|
|
|
2023 |
|
|
|
|
2024 |
|
|
|
|
2025 |
|
|
|
|
Thereafter |
|
|
|
|
Total minimum lease payments |
$ |
|
|
|
Less: amount representing interest |
|
( |
) |
|
Present value of obligations under leases |
$ |
|
|
|
Less: current portion |
|
( |
) |
|
Noncurrent lease obligations |
$ |
|
|
Piramal Master Services Agreement
On
Other commitments and contingencies
The Company has entered into agreements with various research organizations for pre-clinical and clinical development studies, which have provisions for cancellation. Under the terms of these agreements, the vendors provide a variety of services including conducting research, recruiting and enrolling patients, monitoring studies and data analysis. Payments under these agreements typically include fees for services and reimbursement of expenses. The timing of payments due under these agreements is estimated based on current study progress. As of September 30, 2021, the Company did
Legal proceedings
On June 22, 2021, the Company was named as a defendant in an action brought by Lorem Vascular, Pte. Ltd. (“Lorem”) in the District Court for the District of Delaware. The complaint alleges false representations were made to Lorem regarding the manufacturing facility in the United Kingdom (the “UK Facility”) that Lorem purchased from the Company under the Equity Purchase Agreement, dated March 29, 2019, between the Company and Lorem (the “Lorem Agreement”). Lorem also claims that false representations were made regarding the UK Facility’s certification to sell and distribute devices in the European Union and export such devices to China. In connection with these allegations, Lorem claims entitlement to at least $
13
The Company is subject to various claims and contingencies related to legal proceedings. Due to their nature, such legal proceedings involve inherent uncertainties including, but not limited to, court rulings, negotiations between affected parties and governmental actions. Management assesses the probability of loss for such contingencies and accrues a liability and/or discloses the relevant circumstances, as appropriate.
|
8. |
NanoTx License Agreement |
On March 29, 2020, the Company and NanoTx, Corp. (“NanoTx”) entered into a Patent and Know-How License Agreement (the “NanoTx License Agreement”), pursuant to which NanoTx granted the Company an irrevocable, perpetual, exclusive, fully paid-up license, with the right to sublicense and to make, develop, commercialize and otherwise exploit certain patents, know-how and technology related to the development of radiolabeled nanoliposomes.
On May 7, 2020, all closing conditions under the NanoTx License Agreement were satisfied and the Company paid an upfront payment of $
9. Stockholders’ Equity
Preferred Stock
The Company has authorized
As of September 30, 2021, there were
Warrants
On September 25, 2019, the Company completed an underwritten public offering. The Company issued
In accordance with authoritative guidance, the pre-funded warrants are classified as equity. The Series U Warrants and the Representative Warrants are classified at issuance as liabilities due to a contingent obligation for the Company to settle the Series U Warrants with cash upon certain change in control events.
Between April and September 2020, the Company entered into revised warrant agreements with the holders of
As of September 30, 2021, there were
14
Common Stock
Lincoln Park Purchase Agreement
On September 30, 2020, the Company entered into the 2020 Purchase Agreement and registration rights agreement pursuant to which Lincoln Park committed to purchase up to $
The 2020 Purchase Agreement provides that the number of shares the Company may sell to Lincoln Park on any single business day in a regular purchase is
On June 16, 2020, the Company received stockholder approval to permit issuances of the Company’s common stock (including the issuance of more than
Lincoln Park has no right to require the Company to sell any shares of common stock to Lincoln Park, but Lincoln Park is obligated to make purchases as the Company directs, subject to certain conditions.
Actual sales of shares of common stock to Lincoln Park under the 2020 Purchase Agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the common stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. The net proceeds under the 2020 Purchase Agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to Lincoln Park.
During the year ended December 31, 2020, the Company issued
At-the-market Issuances
On October 23, 2020, the Company entered into the Distribution Agreement with Canaccord Genuity LLC (“Canaccord”), pursuant to which the Company issued and sold the ATM Shares, depending on market demand, with Canaccord acting as an agent for sales. The Company had
During the year ended December 31, 2020, the Company issued
15
10. Stock-based Compensation
Under the Company’s amended 2015 New Employee Incentive Plan (the “2015 Plan”), awards may be granted to employees who were not previously an employee or director of the Company, or following a bona fide period of non-employment, as a material inducement to entering into employment with the Company. As of September 30, 2021, there were
On May 17, 2021, the stockholders of the Company approved an amendment and restatement to the Company’s 2020 Stock Incentive Plan (the “2020 Plan”) to increase the total number of shares of common stock reserved for issuance under the 2020 Plan by
Generally, options issued under the 2020 Plan are subject to a , or vesting schedule, with options vesting in equal installments on the monthly anniversary of the grant date and have a contractual term of
A summary of activity for the nine months ended September 30, 2021 is as follows:
|
|
|
Options |
|
|
Weighted Average Exercise Price |
|
Weighted Average Remaining Contractual Life (years) |
|
Aggregate Intrinsic Value (in $,000) |
|
||||
|
Outstanding as of December 31, 2020 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
Cancelled/forfeited |
|
|
( |
) |
|
$ |
|
|
|
|
|
|
|
|
|
Outstanding as of September 31, 2021 |
|
|
|
|
|
$ |
|
|
|
|
|
$ |
— |
|
|
Vested as of September 30, 2021 |
|
|
|
|
|
$ |
|
|
|
|
|
$ |
— |
|
|
Vested and expected to be vested as of September 30, 2021 |
|
|
|
|
|
$ |
|
|
|
|
|
$ |
— |
|
As of September 30, 2021, the total compensation cost related to non-vested stock options not yet recognized for all the Company’s plans is approximately $
11. COVID-19 Pandemic and CARES Act
The COVID-19 pandemic has presented substantial public health and economic challenges and is affecting economies, financial markets and business operations around the world. While the Company has implemented additional health and safety precautions and protocols in response to the pandemic and government guidelines, the Company has not experienced a significant impact on its business and operations. However, the Company may experience disruptions that could adversely impact its business operations as well as its preclinical studies and clinical trials. The Company is currently continuing the clinical trials it has underway in sites across the U.S., and, although there has been no significant impact to date, the Company expects that COVID-19 precautions may directly or indirectly impact the timeline for some of its clinical trials. Some of the Company’s clinical trial sites, including those located in areas severely impacted by the pandemic, placed new patient enrollment into clinical trials on hold or, for patients traveling from out-of-state, implemented a 14-day self-quarantine before appointments. In addition, some clinical trial sites imposed limited accessibility to conduct clinical monitoring and training on-site. As the accessibility of vaccines against COVID-19 and the number of adults who have received a vaccine has increased, several of the restrictions have been eased or lifted entirely. The Company considered the impacts of COVID-19 on the assumptions and estimates used to prepare its consolidated financial statements and determined that there were no material adverse impacts on the Company’s results of operations and financial position at September 30, 2021. The full extent to which the COVID-19 pandemic will directly or indirectly impact its business, results of operations and financial condition, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat it, as well as the economic impact on local, regional, national and international markets.
16
In response to the COVID-19 pandemic, the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”) was signed into law on March 27, 2020. The CARES Act, among other things, includes tax provisions relating to refundable payroll tax credits, deferment of employer’s social security payments, net operating loss utilization and carryback periods, modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property (QIP). The CARES Act had no material impact on the Company’s income tax provision for the year ended December 31, 2020 or the nine months ended September 30, 2021. The programs under the CARES Act expired on September 6, 2021.
17
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis should be read in conjunction with the unaudited financial information and the notes thereto included herein, as well as the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our audited financial statements and notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2020, as filed on February 22, 2021, as amended by the Form 10-K/A filed on February 26, 2021. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under the caption “Cautionary Note Regarding Forward-Looking Statements” in this report, as well as under "Part I – Item 1A - Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2020, in other subsequent filings with the SEC, and elsewhere in this Quarterly Report on Form 10-Q. These statements, like all statements in this report, speak only as of the date of this Quarterly Report on Form 10-Q (unless another date is indicated), and we undertake no obligation to update or revise these statements in light of future developments.
Our Management’s Discussion and Analysis of Financial Condition and Results of Operations, or MD&A, includes the following sections:
|
|
• |
Overview that discusses our operating results and some of the trends that affect our business. |
|
|
• |
Results of Operations that includes a more detailed discussion of our revenue and expenses. |
|
|
• |
Liquidity and Capital Resources which discusses key aspects of our statements of cash flows, changes in our financial position and our financial commitments. |
|
|
• |
Significant changes since our most recent Annual Report on Form 10-K in the Critical Accounting Policies and Significant Estimates that we believe are important to understanding the assumptions and judgments underlying our financial statements. |
Overview
Plus Therapeutics is a U.S. pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers. Plus’ investigational drugs are intended for both adult and pediatric patients on a worldwide basis. Plus Therapeutics’ headquarters and manufacturing facility are in Texas, in close proximity to world-class cancer institutions and researchers. Our dedicated team of engineers, physicians, scientists, and other professionals are committed to advancing our novel radiotherapeutic technology for the benefit of cancer patients and healthcare providers. Plus’ technology includes nanoliposome-encapsulated, BMEDA-chelated Rhenium-186 radiotherapeutics. The nanoliposomes facilitate local and precise drug delivery and improved drug retention at the target site while Rhenium-186 releases high-energy beta particles for treatment and gamma photons for imaging. This radiotherapeutic platform, combined with advances in surgery, nuclear medicine, and radiation oncology, affords us the opportunity to treat multiple types of cancer. Our current pipeline is focused on treating rare and central nervous system tumors with significant unmet medical needs.
Pipeline
Plus Therapeutics’ lead investigational drug, Rhenium-186 NanoLiposome (186RNL), is a patented radiotherapy potentially useful for patients with recurrent glioblastoma (GBM). The RNL technology was part of a licensed radiotherapeutic portfolio that we acquired from NanoTx, Corp. (“NanoTx”) on May 7, 2020. The licensed radiotherapeutic can be applied toward several cancer targets, and has an active $3.0 million award from U.S. National Institutes of Health/National Cancer Institute which will provide financial support for the continued clinical development of 186RNL for recurrent glioblastoma through the completion of a Phase 2 clinical trial and enrollment of up to 55 patients.
Plus Therapeutics is currently conducting a clinical trial for ReSPECT GBM for Recurrent Glioblastoma and anticipates beginning a clinical trial for ReSPECT-LM Clinical Trial for Leptomeningeal Metastases in the fourth quarter of 2021:
ReSPECT-GBM Clinical Trial for Recurrent Glioblastoma
186RNL is a novel injectable radiotherapy designed to deliver targeted high dose radiation directly into brain tumors in a safe, effective, and convenient manner to optimize patient outcomes. 186RNL, which is composed of radionuclide Rhenium-186 (186Re) and a nanoliposomal carrier, is infused directly into the brain tumor via precision brain mapping and convection enhanced delivery. The 186RNL radiation dose delivered to patients may be up to 20x greater than what is possible with external beam radiation therapy (EBRT). Some additional potential benefits of RNL compared to EBRT include:
|
|
- |
186RNL can be visualized in real-time during administration, possibly giving doctors better control of radiation dosing and distribution. |
|
|
- |
Potentially more effectively treats the bulk tumor and microscopic disease in surrounding healthy tissue. |
|
|
- |
Using a small catheter, 186RNL is infused directly into the targeted tumor, which may reduce radiation exposure to healthy cells. By contrast, EBRT is less targeted and selective. |
18
|
|
- |
RNL is given during a single 3- to 4-day in-patient hospital visit, while EBRT requires out-patient visits 5 days a week for approximately 4-6 weeks. |
186RNL is currently being evaluated for the treatment of recurrent glioblastoma in the Phase 1 multi-center ReSPECT-GBM dose-finding clinical trial. ReSPECT-GBM is evaluating the safety, tolerability, and distribution of 186RNL for the treatment of recurrent glioblastoma. Thus far, 186RNL has demonstrated safety and potential efficacy signals in patients with adequate dosing and tumor coverage with multiple patients surviving greater than 30 months, compared to a median survival of approximately 9 months with the current standard of care. The seventh dose escalation cohort of this trial has been completed. Recently, the ReSPECT-GBM trial data safety and monitoring board (DSMB) recommended that we proceed to the eighth dosing cohort which provides for a 40% increase in both drug volume and radiation dose. Thus far, treatment emergent serious adverse events have not been observed.
By infusing the 186RNL drug directly into the tumor, bypassing the blood-brain barrier, normal brain and external tissues may be spared from radiation damage. We believe that radiation in the form of high energy electrons may be effective against glioblastoma if an adequate dose can be effectively delivered. For comparison, current EBRT protocols for recurrent glioblastoma typically recommend a total maximum dose of about 35 Gy. In contrast, thus far, we have been able to deliver up to 740 Gy of absorbed radiation to tumor issue without significant toxicities.
Recurrent glioblastoma (GBM) affects approximately 12,000 patients annually in the U.S. and is the most common and lethal form of brain cancer. The average life expectancy with glioblastoma is less than 24 months, with a one-year survival rate of 40.8% and a five-year survival rate of only 6.8%. GBM can cause headaches, seizures, vision changes and other neurological complications. Despite the best available medical treatments to eliminate the initial brain tumor, some microscopic disease frequently remains, with tumor regrowth within months. In fact, approximately 90% of patients experience tumor recurrence. This tumor type is incredibly difficult to remove completely, and often is resistant or quickly develops resistance to most available therapies. The treatment of GBM remains a significant challenge and it has been nearly a decade since the FDA approved a new therapy for this disease. There is no clear standard of care for recurrent GBM and even the few currently approved treatments, in aggregate, provide only marginal survival benefit. Current approved therapies are associated with significant side effects, which limit dosing and prolonged use.
In September 2020, the FDA granted both Orphan Drug designation and Fast Track designations to 186RNL for the treatment of patients with glioblastoma.
ReSPECT-LM Clinical Trial for Leptomeningeal Metastases
Based on substantial preclinical work completed and published, 186RNL is thought to have potential clinical benefits in other difficult to treat cancers for example leptomeningeal metastases and pediatric brain cancer. The ReSPECT-LM Phase 1 clinical trial builds upon preclinical studies in which tolerance to doses of 186RNL as high as 1,075 Gy was shown in animal models with LM with no observed significant toxicity. Furthermore, treatment led to marked reduction in tumor burden in both C6 and MDA-231 LM models.
In October 2021, the Federal Drug Administration (FDA) announced clearance for the Company to proceed with the Investigational New Drug (IND) application for 186RNL for the treatment of leptomeningeal metastases (LM). The Company expects to initiate patient accrual in a Phase 1 dose escalation trial of 186RNL (ReSPECT-LM) in the fourth quarter of 2021.
The ReSPECT-LM multi-center, sequential cohort, open-label, dose escalation study will evaluate the safety, tolerability, and distribution of 186RNL via intrathecal infusion to the ventricle of patients with LM after standard surgical, radiation, and/or chemotherapy treatment. The primary endpoint of the study is the incidence and severity of adverse events and dose limiting toxicities.
LM is a rare complication of cancer in which the disease spreads to the membranes (meninges) surrounding the brain and spinal cord. The incidence of LM is growing and occurs in approximately 5% of people with late-stage cancer, or 110,000 people in the U.S. each year. It is usually terminal with an average 1-year survival of just 7%. LM occurs with cancers that are most likely to spread to the central nervous system. The most common cancers to include the leptomeninges are breast cancer, lung cancer, and melanomas.
Future potential Trials
We are in the process of developing additional indications utilizing 186RNL such as for pediatric brain cancer.
Plus Therapeutics also has two other clinical stage drugs in our pipeline which are:
|
|
|
1)DocePLUS™, a patented chemotherapy incorporating docetaxel for patients with solid tumors that has been evaluated in a completed U.S. single-center Phase 1 clinical trial; and |
|
|
|
2)DoxoPLUS™, a generic chemotherapy incorporating doxorubicin that has been evaluated in a completed, bioequivalence clinical trial in the U.S., Canada, and Ukraine versus Janssen’s CAELYX® in patients with ovarian cancer. |
19
Current business activities related to both DocePLUS and DoxoPLUS are focused on identification of potential partners.
Recent Developments
Lincoln Park Purchase Agreement
On September 30, 2020, we entered into a purchase agreement (the “2020 Purchase Agreement”) and registration rights agreement (the “LPC Registration Rights Agreement”). Under the 2020 Purchase Agreement Lincoln Park Capital Fund, LLC (“Lincoln Park”) has committed to purchase up to $25.0 million of our common stock. Pursuant to the LPC Registration Rights Agreement, we have agreed to register any shares sold to Lincoln Park under the 2020 Purchase Agreement for resale by Lincoln Park. Refer to “Liquidity and Capital Resources” section below for additional details on the 2020 Purchase Agreement.
During the year ended December 31, 2020, we issued 353,113 shares, excluding 180,701 shares issued as commitment fee, under the 2020 Purchase Agreement for net proceeds of approximately $0.7 million. During the nine months ended September 30, 2021 we issued 5,535,186 shares of our common stock under the 2020 Purchase Agreement for total proceeds of $12.3 million.
COVID-19 Impact
The COVID-19 pandemic has presented substantial public health and economic challenges and is affecting economies, financial markets and business operations around the world. While the Company has implemented additional health and safety precautions and protocols in response to the pandemic and government guidelines, the Company has not experienced a significant impact on its business and operations. However, the Company may experience disruptions that could adversely impact its business operations as well as its preclinical studies and clinical trials. The Company is currently continuing the clinical trials it has underway in sites across the U.S., and, although there has been no significant impact to date, the Company expects that COVID-19 precautions may directly or indirectly impact the timeline for some of its clinical trials. Some of the Company’s clinical trial sites, including those located in areas severely impacted by the pandemic, placed new patient enrollment into clinical trials on hold or, for patients traveling from out-of-state, implemented a 14-day self-quarantine before appointments. In addition, some clinical trial sites imposed limited accessibility to conduct clinical monitoring and training on-site. As the accessibility of vaccines against COVID-19 and the number of adults who have received a vaccine has increased, several of the restrictions have been eased or lifted entirely. The Company considered the impacts of COVID-19 on the assumptions and estimates used to prepare its consolidated financial statements and determined that there were no material adverse impacts on the Company’s results of operations and financial position at September 30, 2021. The full extent to which the COVID-19 pandemic will directly or indirectly impact its business, results of operations and financial condition, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat it, as well as the economic impact on local, regional, national and international markets.
In response to the COVID-19 pandemic, the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”) was signed into law on March 27, 2020. The CARES Act, among other things, includes tax provisions relating to refundable payroll tax credits, deferment of employer’s social security payments, net operating loss utilization and carryback periods, modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property (QIP). The CARES Act had no material impact on the Company’s income tax provision for the year ended December 31, 2020 or the nine months ended September 30, 2021. The programs under the CARES Act expired on September 6, 2021.
Results of Operations
Development revenues
Under our government contract with BARDA, we recognized a total of $0 and $0.3 million in revenues for the three and nine months ended September 30, 2020, respectively, and $0 and $0.3 million in qualified expenditures for those periods. The BARDA contract was terminated in December 2019 and the close out process was completed in 2020. There were no revenue or expenses recognized relating to the BARDA contract during the nine months ended September 30, 2021, and we do not expect additional BARDA revenue in the near future.
Research and development expenses
Research and development expenses include costs associated with the design, development, testing, and enhancement of our product candidates, payment of regulatory fees, laboratory supplies, pre-clinical studies, and clinical studies.
20
The following table summarizes the components of our research and development expenses for the three and nine months ended September 30, 2021 and 2020 (in thousands):
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
||||
|
Research and development |
|
$ |
1,475 |
|
|
$ |
325 |
|
|
$ |
3,666 |
|
|
$ |
1,585 |
|
|
Stock-based compensation |
|
|
16 |
|
|
|
11 |
|
|
|
58 |
|
|
|
19 |
|
|
Total research and development expenses |
|
$ |
1,491 |
|
|
$ |
336 |
|
|
$ |
3,724 |
|
|
$ |
1,604 |
|
The increase of $1.2 million and $2.1 million in research and development expenses for the three and nine months ended September 30, 2021 as compared to the same periods in 2020 was due primarily to increased expenditures related to the development of RNL in compliance with current good manufacturing practices, or cGMP, requirements.
We expect aggregate research and development expenditures to increase in absolute dollars during the remainder of 2021 due to the expected costs of development of the RNL therapy acquired from NanoTx.
General and administrative expenses
General and administrative expenses include costs for administrative personnel, legal and other professional expenses, and general corporate expenses. The following table summarizes the general and administrative expenses for the three and nine months ended September 30, 2021 and 2020 (in thousands):
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
||||
|
General and administrative |
|
$ |
1,826 |
|
|
$ |
977 |
|
|
$ |
4,444 |
|
|
$ |
3,977 |
|
|
Stock-based compensation |
|
|
164 |
|
|
|
83 |
|
|
|
367 |
|
|
|
130 |
|
|
Total general and administrative expenses |
|
$ |
1,990 |
|
|
$ |
1,060 |
|
|
$ |
4,811 |
|
|
$ |
4,107 |
|
General and administrative expenses increase by approximately $0.9 million during the three months ended September 30, 2021 as compared to the same period in 2020. The increase was primarily due to an increase of $0.6 million in legal and professional expenses, an increase of $0.1 million for stock-based compensation expenses, an increase of $0.1 million in insurance expenses and $0.1 million in personnel costs. General and administrative expenses increased by $0.7 million during the nine months ended September 30, 2021, as compared to the same period in 2020. The increase was primarily driven by an increase of professional expenses of $0.5 million, and an increase of $0.2 million of stock based compensation expenses.
We expect general and administrative expenditures to remain consistent on a quarterly basis for the remainder of 2021 as compared with 2020.
Loss on disposal of property and equipment
Loss on disposal of property and equipment of $18,000 was due to the proceeds received for used property and equipment were lower than their carrying amount.
Stock-based compensation expense
Stock-based compensation expense includes charges related to options and restricted stock awards issued to employees, directors and non-employees. We measure stock-based compensation expense based on the grant-date fair value of any awards granted to our employees. Such expense is recognized over the requisite service period.
The following table summarizes the components of our stock-based compensation expenses for the three and nine months ended September 30, 2021 and 2020 (in thousands):
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
||||
|
Research and development |
|
$ |
16 |
|
|
|
11 |
|
|
$ |
58 |
|
|
|
19 |
|
|
General and administrative |
|
|
164 |
|
|
|
83 |
|
|
|
367 |
|
|
|
130 |
|
|
Total stock-based compensation |
|
$ |
180 |
|
|
$ |
94 |
|
|
$ |
425 |
|
|
$ |
149 |
|
The increase in stock-based compensation expense for the three and nine months ended September 30, 2021 as compared to the same periods in 2020 is primarily related to increased stock options grants in the three and nine months ended September 30, 2021, as compared to the same periods in 2020.
21
We expect to continue to grant stock options (which will result in an expense) to our employees, directors, and, as appropriate, to non-employee service providers. In addition, previously-granted stock options will continue to vest in accordance with their original terms. As of September 30, 2021, the total compensation cost related to non-vested stock options and stock awards not yet recognized for all our plans is approximately $1.5 million which is expected to be recognized as a result of vesting under service conditions over a weighted average period of 3.0 years.
Financing items
The following table summarizes interest income, interest expense, and other income and expense for the three and nine months ended September 30, 2021 and 2020 (in thousands):
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
||||
|
Interest income |
|
$ |
5 |
|
|
$ |
2 |
|
|
$ |
13 |
|
|
$ |
47 |
|
|
Interest expense |
|
|
(232 |
) |
|
|
(253 |
) |
|
|
(708 |
) |
|
|
(854 |
) |
|
Change in fair value of warrants |
|
|
2 |
|
|
|
(81 |
) |
|
|
4 |
|
|
|
2,342 |
|
|
Total |
|
$ |
(225 |
) |
|
$ |
(332 |
) |
|
$ |
(691 |
) |
|
$ |
1,535 |
|
The decrease in interest expense for the three and nine months ended September 30, 2021 as compared to the same periods in 2020 was primarily due to the repayment of debt principal of $5.0 million in April 2020. The changes in fair value of our warrant liabilities are primarily due to fluctuations in the valuation inputs for the warrants. See Note 4 to the unaudited consolidated condensed financial statements included elsewhere herein for disclosure and discussion of our warrant liabilities.
We expect interest expense in 2021 to decrease as compared with 2020 due to the principal repayment of $5.0 million on April 1, 2020. In April, June, July and September 2020, we entered into revised warrant agreements with the holders of 3,447,500 Series U warrants and in September 2020, we entered into revised warrant agreements for 75,000 of warrants issued to H.C. Wainwright & Co., LLC, as representatives of the underwriters, in the form of Series U warrants. In return for reducing the strike price of the warrants, the warrant holders agreed to amend the settlement provisions upon fundamental transactions. The amended Series U warrants meet the requirements for equity classification under authoritative accounting guidance and are no longer subject to fair value accounting post amendment.
Liquidity and Capital Resources
Short-term and long-term liquidity
The following is a summary of our key liquidity measures at September 30, 2021 and December 31, 2020 (in thousands):
|
|
|
As of September 30, |
|
|
As of December 31, |
|
||
|
|
|
2021 |
|
|
2020 |
|
||
|
Cash and cash equivalents |
|
$ |
21,280 |
|
|
$ |
8,346 |
|
|
|
|
|
|
|
|
|
|
|
|
Current assets |
|
$ |
22,097 |
|
|
$ |
9,175 |
|
|
Current liabilities |
|
|
9,488 |
|
|
|
8,539 |
|
|
Working capital |
|
$ |
12,609 |
|
|
$ |
636 |
|
We incurred net losses of $9.2 million for the nine months ended September 30, 2021. We have an accumulated deficit of $442.8 million as of September 30, 2021. Additionally, we used net cash of $7.7 million to fund our operating activities for the nine months ended September 30, 2021. These factors raise substantial doubt about our ability to continue as a going concern.
To date, these operating losses have been funded primarily from outside sources of invested capital in our common stock, proceeds raised from the Loan and Security Agreement, and gross profits. We have had, and we will continue to have, an ongoing need to raise additional cash from outside sources to fund our future clinical development programs and other operations. Our inability to raise additional cash would have a material and adverse impact on operations and would cause us to default on our loan.
On October 23, 2020, we entered into an Equity Distribution Agreement (the “Distribution Agreement”) with Canaccord Genuity LLC (“Canaccord”), pursuant to which we may issue and sell, from time to time, shares of our common stock having an aggregate offering price of up to $10,000,000 (the “ATM Shares”), depending on market demand, with Canaccord acting as an agent for sales. During the year ended December 31, 2020, we issued 1,616,331 shares under the Distribution Agreement for net proceeds of approximately $3.2 million. During the nine months ended September 30, 2021, we issued 2,179,193 shares under the Distribution Agreement for net
22
proceeds of $6.3 million. As of September 30, 2021, there were no remaining shares to issue and sell under the Distribution Agreement.
On September 30, 2020, we entered into the 2020 Purchase Agreement and a registration rights agreement with Lincoln Park, pursuant to which Lincoln Park committed to purchase up to $25.0 million of our common stock. Under the terms and subject to the conditions of the 2020 Purchase Agreement, we have the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $25.0 million of our common stock. Such sales of common stock by us, if any, will be subject to certain limitations, and may occur from time to time, at our sole discretion, over the 36-month period commencing November 6, 2020, subject to satisfaction of certain conditions. The net proceeds under the 2020 Purchase Agreement will depend on the frequency and prices at which we sell shares of our common stock to Lincoln Park. We expect that any proceeds received from such sales to Lincoln Park will be used for working capital and general corporate purposes. During the year ended December 31, 2020, we issued 353,113 shares, excluding 180,701 shares issued as commitment fee, under the 2020 Purchase Agreement for net proceeds of approximately $0.7 million. On September 3, 2021, we filed a prospectus, which became effective on September 10, 2021, for the offer and sale of up to 5,865,000 shares of our common stock by Lincoln Park under the 2020 Purchase Agreement. During the nine months ended September 30, 2021, we issued 5,535,186 shares of our common stock under the 2020 Purchase Agreement for net proceeds of $12.3 million.
On March 29, 2020, we entered into the Ninth Amendment of the Loan and Security Agreement (the “Ninth Amendment”) which amended that certain Loan and Security Agreement (the “Loan and Security Agreement”), pursuant to which Oxford Finance, LLC (“Oxford”) funded an aggregate principal amount of $17.7 million (the “Term Loan”), subject to the terms and conditions set forth in the Loan and Security Agreement. Under the Ninth Amendment, among other things, Oxford agreed to defer the start date of principal repayments under the Loan and Security Agreement from May 1, 2020 to May 1, 2021. As we met the “Second I/O Extension Equity Event,” as defined in the Ninth Amendment, the principal repayment start date has been deferred to November 1, 2021. In addition, on April 1, 2020, we made a $5.0 million paydown of principal under the Term Loan upon execution of the Ninth Amendment. As a result of this Ninth Amendment, the term of the Term Loan has been extended from September 1, 2021 to September 1, 2024, with all other major terms remained consistent.
We continue to seek additional capital through strategic transactions and other financing alternatives. Without additional capital, current working capital and cash generated from sales will not provide adequate funding for research and product development activities at their current levels. If sufficient capital is not raised, we will at a minimum need to significantly reduce or curtail our research and development and other operations, and this would negatively affect our ability to achieve corporate growth goals. There is likely to be continued market volatility due to the COVID-19 pandemic, risk of inflation or other events, which could cause our stock price to decline. This in turn will likely negatively impact our ability to raise funds through equity-related financings. Further, a continued global economic downturn may impair our ability to obtain additional financing through other means, such as strategic transactions or debt financing. The overall deterioration of the credit and financial markets due to the COVID-19 pandemic will likely generally reduce our ability to obtain additional financing to fund our operations.
Should we be unable to raise additional cash from outside sources or if we are unable to do so in a timely manner or on commercially reasonable terms, it would have a material adverse impact on our operations.
Cash (used in) provided by operating, investing, and financing activities for the nine months ended September 30, 2021 and 2020 is summarized as follows (in thousands):
|
|
|
For the Nine Months Ended September 30, |
|
|||||
|
|
|
2021 |
|
|
2020 |
|
||
|
Net cash used in operating activities |
|
$ |
(7,656 |
) |
|
$ |
(5,210 |
) |
|
Net cash used in investing activities |
|
|
(84 |
) |
|
|
(437 |
) |
|
Net cash provided by (used in) financing activities |
|
|
20,674 |
|
|
|
(4,319 |
) |
|
Net increase (decrease) in cash and cash equivalents |
|
$ |
12,934 |
|
|
$ |
(9,966 |
) |
Operating activities
Net cash used in operating activities for the nine months ended September 30, 2021 was $7.7 million compared to $5.2 million in the same period of 2020. Our operational cash use increased during the nine months ended September 30, 2021 as compared to the same period in 2020, due primarily to timing of cash payments made for operating assets and liabilities.
Investing activities
Net cash used in investing activities for the nine months ended September 30, 2021 were related to purchases of fixed assets of $134,000, offset by proceeds of $50,000 from sale of property and equipment. Net cash used in investing activities for the nine months
23
ended September 30, 2020 was primarily related to cash payments of $0.4 million made for in process research and development assets from NanoTx, and purchases of fixed assets.
Financing Activities
Net cash provided by financing activities for the nine months ended September 30, 2021 was primarily related to sales of common stock of $18.6 million, net of offering cost through the 2020 Purchase Agreement with Lincoln Park and the Distribution Agreement with Canaccord, as well as $2.0 million from exercise of warrants.
Net cash used for financing activities for the nine months ended September 30, 2020 was primarily related to repayment of $5.3 million of the Term Loan in April 2020, and cash payments for our finance leases, offset by cash proceeds received from warrant exercises of $1.1 million.
Critical Accounting Policies and Significant Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires us to make estimates and assumptions that affect the reported amounts of our assets, liabilities, revenues and expenses, and that affect our recognition and disclosure of contingent assets and liabilities.
While our estimates are based on assumptions we consider reasonable at the time they were made, our actual results may differ from our estimates, perhaps significantly. If results differ materially from our estimates, we will make adjustments to our financial statements prospectively as we become aware of the necessity for an adjustment.
Goodwill is reviewed for impairment annually or more frequently if indicators of impairment exist. We perform our impairment test annually during the fourth quarter. The Company operates in a single operating segment and reporting unit. We monitor the fluctuations in our share price and have experienced significant volatility during the year.
We estimate the fair value of liability classified warrants using an option pricing model. Following the authoritative accounting guidance, warrants with potential cash settlement outside control of the Company are accounted for as liabilities, with changes in the fair value included in operating expenses.
We believe it is important for you to understand our most critical accounting policies. Our critical accounting policies and estimates are discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and there have been no material changes during the nine months ended September 30, 2021.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Not applicable.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed in our reports that we file or furnish pursuant to the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer (our principal executive officer) and Chief Financial Officer (our principal financial officer and principal accounting officer), as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
As required by Rule 13a-15(b) under the Exchange Act, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer (our principal executive officer) and Chief Financial Officer (our principal financial officer and principal accounting officer), of the effectiveness of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) and 15d-15(e) promulgated under the Exchange Act, as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on the foregoing, our Chief Executive Officer (our principal executive officer) and Chief Financial Officer (our principal financial officer and principal accounting officer) concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) were effective at the reasonable assurance level as of the end of the period covered by this Quarterly Report.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting during the quarter ended September 30, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
On June 22, 2021, we were named as a defendant in an action brought by Lorem Vascular, Pte. Ltd. (“Lorem”) in the District Court for the District of Delaware. The complaint alleges false representations were made to Lorem regarding the manufacturing facility in the United Kingdom (the “UK Facility”) that Lorem purchased from us under the Equity Purchase Agreement, dated March 29, 2019, between us and Lorem (the “Lorem Agreement”). Lorem also claims that false representations were made regarding the UK Facility’s certification to sell and distribute devices in the European Union and export such devices to China. In connection with these allegations, Lorem claims entitlement to at least $6,000,000 in compensatory damages and operational costs and expenses (collectively, the “Lorem Claim”). We believe that the claims from Lorem are without merit and we intend to vigorously defend the case and on August 12, 2021, we filed a Motion to Dismiss asking the District Court to dismiss the Lorem Claim. Lorem filed an opposition on September 9, 2021, which we responded to on September 30, 2021. As of October 21, 2021 we are still waiting for the District Court’s decision on our motion. No liability was accrued as of September 30, 2021.
Item 1A. Risk Factors
For a discussion of certain factors that could materially affect our business, financial condition, and operating results or that could cause actual results to differ materially from the results described in or implied by the forward-looking statements in this Quarterly Report on Form 10-Q, in addition to the information in the section entitled “Cautionary Statement Regarding Forward-Looking Statements,” you should carefully review and consider the information under “Part I, Item 1A- Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020. There have been no material changes to the risk factors included in our Annual Report on Form 10-K for the year ended December 31, 2020.
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Item 6. Exhibits
EXHIBIT INDEX
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PLUS THERAPEUTICS, INC. |
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Exhibit Number |
Exhibit Title |
Filed with this Form 10-Q |
Incorporated by Reference |
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Form |
File No. |
Date Filed |
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|
3.1 |
|
8-K |
001-34375 Exhibit 3.2 |
09/21/2021 |
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3.2 |
|
8-K |
001-34375 Exhibit 3.2 |
09/21/2021 |
||
|
10.1 |
|
8-K |
001-34375 Exhibit 10.1 |
09/13/2021 |
||
|
31.1 |
X |
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31.2 |
X |
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32.1* |
X |
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101.INS |
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
X |
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101.SCH |
Inline XBRL Schema Document |
X |
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101.CAL |
Inline XBRL Calculation Linkbase Document |
X |
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|
101.DEF |
Inline XBRL Definition Linkbase Document |
X |
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101.LAB |
Inline XBRL Label Linkbase Document |
X |
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101.PRE |
Inline XBRL Presentation Linkbase Document |
X |
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104 |
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
X |
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* |
In accordance with Item 601(b)(32)(ii) of Regulation S‑K and SEC Release No. 34‑47986, the certifications furnished in Exhibit 32.1 hereto is deemed to accompany this Form 10‑Q and will not be deemed “filed” for purposes of Section 18 of the Exchange Act or deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933 except to the extent that the Company specifically incorporates it by reference. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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PLUS THERAPEUTICS, INC. |
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By: |
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/s/ Marc H. Hedrick |
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Dated: October 21, 2021 |
|
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Marc H. Hedrick |
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|
President & Chief Executive Officer (Duly Authorized Officer and Principal Executive Officer) |
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By: |
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/s/ Andrew Sims |
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Dated: October 21, 2021 |
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|
Andrew Sims |
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|
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|
Chief Financial Officer (Duly Authorized Officer and Principal Financial Officer and Principal Accounting Officer) |
27