UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
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QUARTERLY Report PURSUANT TO Section 13 or 15(d) of the Securities Exchange Act of 1934 |
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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 |
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For the transition period from __________ to ____________ |
Commission File Number:
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or |
(I.R.S. Employer |
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(Address of principal executive offices) |
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Registrant’s telephone number, including area code: ( |
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Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
Number of shares outstanding of each of the issuer’s classes of common stock as of the latest practicable date:
Class |
Outstanding as of May 7, 2025 |
Common stock, $0.001 par value |
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
In addition to historical information, this Quarterly Report on Form 10-Q (Form 10-Q), contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). This statement is included for the express purpose of availing Perspective Therapeutics, Inc. of the protections of the safe harbor provisions of the PSLRA.
This Form 10-Q, including Management’s Discussion and Analysis of Financial Condition and Results of Operations in Part I, Item 2, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements contained in this Form 10-Q other than statements of historical fact, including, without limitation, statements regarding our future financial condition, results of operations, business strategy and plans and objectives of management for future operations, industry trends and other future events are forward-looking statements. In some cases, you can identify forward-looking statements by terminology, such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “forecast,” “project,” “may,” “could,” “might,” “plan,” “should,” “will,” “would” or the negative of these terms and other similar expressions, although not all forward-looking statements contain these identifying terms. Forward-looking statements in this Form 10-Q include, among other things:
i
These statements are based on certain assumptions and analyses made by us in light of our experience and our assessment of historical trends, current conditions and expected future developments as well as other factors we believe are appropriate under the circumstances. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Whether actual results will conform to the expectations and predictions of management is subject to a number of risks and uncertainties described under the heading “Risk Factors” in Part I, Item IA of our Annual Report on Form 10-K for the period ended December 31, 2024 filed with the Securities and Exchange Commission on March 26, 2025 and amended on March 28, 2025 that may cause actual results to differ materially. Consequently, all of the forward-looking statements made in this Form 10-Q are qualified by such risks and uncertainties, and there can be no assurance that the actual results anticipated by management will be realized or, even if substantially realized, that they will have the expected consequences to or effects on our business operations. Readers are cautioned not to place undue reliance on such forward-looking statements as they speak only of our views as of the date the statement was made (or any earlier date indicated in such statement). While we may update certain forward-looking statements from time to time, we undertake no obligation to do so, whether as a result of new information, future events or otherwise, except as required by applicable law. Our U.S. Securities and Exchange Commission (SEC) filings are available publicly on the SEC’s website at www.sec.gov.
AVAILABLE INFORMATION
As soon as reasonably practicable after they are filed electronically with the SEC, our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, other SEC filings and amendments to those reports are available without charge on our website, www.perspectivetherapeutics.com, which we also use to announce material information to the public. We are providing the address to our website solely for the information of investors. We do not intend the address to be an active link or to otherwise incorporate the contents of the website into this Form 10-Q.
ii
PERSPECTIVE THERAPEUTICS, INC.
Table of Contents
PART I |
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Item 1 |
1 |
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Condensed Consolidated Balance Sheets as of March 31, 2025 (unaudited) and December 31, 2024 |
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2 |
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3 |
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4 |
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Notes to the Unaudited Condensed Consolidated Financial Statements |
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Item 2 |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
18 |
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Item 3 |
29 |
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Item 4 |
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PART II |
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Item 1 |
30 |
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Item 1A |
30 |
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Item 2 |
30 |
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Item 3 |
30 |
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Item 4 |
30 |
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Item 5 |
30 |
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Item 6 |
31 |
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32 |
iii
PART I - FINANCIAL INFORMATION
ITEM 1 - FINANCIAL STATEMENTS
Perspective Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(In thousands, except shares and par value data)
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March 31, |
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December 31, |
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2025 |
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2024 |
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(unaudited) |
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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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Short-term investments |
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Accounts receivable, net (allowance for doubtful accounts was $ |
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Prepaid expenses and other current assets |
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Total current assets |
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Noncurrent assets: |
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Property and equipment, net |
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Right-of-use asset, net |
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Intangible assets, in-process research and development |
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Other assets, net |
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Total assets |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERSʼ 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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Lease liability |
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Accrued personnel expenses |
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Note payable |
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Deferred Income (Note 3) |
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Total current liabilities |
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Noncurrent liabilities: |
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Lease liability, net of current portion |
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Note payable, net of current portion |
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Deferred Income, net of current portion (Note 3) |
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Deferred tax liability |
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Other noncurrent liabilities |
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Total liabilities |
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(Note 10) |
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Stockholdersʼ 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 other comprehensive income (loss) |
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Accumulated deficit |
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( |
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Total stockholdersʼ equity |
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Total liabilities and stockholdersʼ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
1
Perspective Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)
(Dollars and shares in thousands, except for per-share amounts)
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Three Months Ended March 31, |
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2025 |
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2024 |
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Grant revenue |
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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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General and administrative |
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Total operating expenses |
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Operating loss |
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Non-operating income (expense): |
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Interest income |
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Interest and other expense |
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Other income from a related party (Note 3) |
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Equity in loss of affiliate |
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Total non-operating income, net |
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Net loss from continuing operations |
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( |
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Net loss from discontinued operations |
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( |
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Net loss |
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$ |
( |
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$ |
( |
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Basic and diluted loss per share: |
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Loss from continuing operations1 |
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$ |
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$ |
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Loss from discontinued operations1 |
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Basic and diluted loss per share1 |
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$ |
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$ |
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Weighted average shares used in computing net loss per share: |
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Basic and diluted1 |
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Unrealized income on available-for-sale securities |
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$ |
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$ |
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Comprehensive loss |
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$ |
( |
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$ |
( |
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1.
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Perspective Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows (unaudited)
(In thousands)
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Three Months Ended March 31, |
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2025 |
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2024 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net loss |
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$ |
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$ |
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Adjustments to reconcile net loss to net cash (used in) provided by operating activities: |
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Net accretion of discounts on available-for-sale securities |
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Depreciation and amortization expense |
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Accrued interest on held-to-maturity investments |
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( |
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Share-based compensation |
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Other noncash income, net |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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Interest receivable |
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( |
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Inventory |
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Prepaid expenses and other current assets |
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( |
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Accounts payable and accrued expenses |
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( |
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( |
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Deferred Income1 |
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( |
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Accrued personnel expenses |
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( |
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( |
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Other noncurrent liabilities |
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Net cash (used in) provided by operating activities |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Additions to property and equipment |
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( |
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Additions to other assets |
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Purchases of held-to-maturity securities |
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Purchases of available-for-sale securities |
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( |
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Maturities of available-for-sale securities |
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Net cash used in investing activities |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Repayment of note payable |
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( |
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Proceeds from sales of common stock, pursuant to exercise of options |
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Proceeds from the issuance of common stock and Pre-funded Warrants, net1 |
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Proceeds from the sale of common stock pursuant to at-the-market offering, net1 |
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Net cash provided by financing activities |
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Net (decrease) increase in cash, cash equivalents and restricted cash |
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Cash, cash equivalents and restricted cash beginning of period |
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CASH, CASH EQUIVALENTS AND RESTRICTED CASH END OF PERIOD |
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$ |
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$ |
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Reconciliation of cash, cash equivalents and restricted cash to the Condensed Consolidated Balance Sheets: |
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Cash and cash equivalents |
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$ |
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$ |
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Restricted cash |
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Total cash, cash equivalents and restricted cash shown on the Condensed Consolidated Statements of |
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$ |
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$ |
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Supplemental schedule of noncash investing and financing activities: |
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Recognition of operating lease liability and right-of-use asset |
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$ |
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$ |
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1.
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Perspective Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Changes in Stockholders’ Equity (unaudited)
(In thousands, except shares)
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Common Stock |
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Shares |
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Amount |
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Additional Paid-in Capital |
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Accumulated Other |
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Accumulated Deficit |
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Total |
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Balances at December 31, 2024 |
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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 pursuant |
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- |
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Unrealized gain on available-for-sale securities |
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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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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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Balances at March 31, 2025 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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Common Stock |
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Shares1 |
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Amount1 |
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Additional Paid-in Capital1 |
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Accumulated Deficit |
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Total |
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Balances at December 31, 2023 |
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$ |
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$ |
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$ |
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$ |
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Issuance of common stock pursuant to the |
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- |
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Issuance of Jan. 2024 Pre-funded Warrants, |
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- |
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- |
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- |
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Issuance of common stock pursuant to the |
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- |
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Issuance of common stock pursuant to the |
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- |
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Issuance of common stock pursuant to |
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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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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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Balances at March 31, 2024 |
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$ |
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$ |
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$ |
( |
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$ |
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1.
2.
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Perspective Therapeutics, Inc. and Subsidiaries
Notes to the Unaudited Condensed Consolidated Financial Statements
Perspective Therapeutics, Inc. is a radiopharmaceutical development company that is pioneering advanced treatment applications for cancers throughout the body. The accompanying consolidated financial statements are those of Perspective Therapeutics, Inc., and its wholly owned subsidiaries, referred to herein as “Perspective Therapeutics” or the “Company.” All significant intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, all adjustments necessary for the fair presentation of the condensed consolidated financial statements for the interim periods presented have been included. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and related notes as set forth in the Company’s Annual Report on Form 10-K for the period ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on March 26, 2025 and amended on March 28, 2025 (2024 Form 10-K).
The unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (U.S. GAAP). Certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures are adequate for the information not to be misleading. The unaudited condensed consolidated financial statements reflect, in management’s opinion, all adjustments of a normal, recurring nature that are necessary for the fair statement of the Company’s financial position, results of operations and cash flows for the interim periods, but are not necessarily indicative of the results expected for the full fiscal year or any other period.
Discontinued Operations
On April 12, 2024, the Company completed the sale of its Cesium-131 brachytherapy business and substantially all of the assets of Isoray Medical, Inc. (Isoray), a wholly owned subsidiary of Perspective Therapeutics, to GT Medical Technologies, Inc., a Delaware corporation (GT Medical) (such transaction being the GT Medical Closing). Pursuant to the GT Medical Closing, GT Medical issued to Isoray
Reverse Stock Split
On June 14, 2024, the Company effected a reverse stock split (Reverse Split) of the Company’s issued and outstanding shares of common stock, par value $
Segment Information
A segment is defined as a component of an entity that has discrete financial information available for regular evaluation by the Chief Operating Decision Maker (CODM) and is used to make decisions on how to allocate resources and assess performance. The Company has one operating and reportable segment, which is its radiopharmaceutical development segment. The accounting policies of the radiopharmaceutical development segment are the same as those reported in Note 2, Summary of Significant Accounting Policies, in the 2024 Form 10-K. The measurement of segment profit or loss is reported as “net loss” in the Condensed Consolidated Statements of Operations and Comprehensive Loss. The Company monitors its cash, cash equivalents and short-term investments, as reported on the Condensed Consolidated Balance Sheets, to determine funding for its research and development. To allocate resources, the Company’s CODM, who is its ,
5
Liquidity
The Company assesses its liquidity in terms of its ability to generate cash to fund its operating, investing and financing activities. The Company has had a history of operating losses and an absence of significant recurring cash inflows from revenue. At March 31, 2025, the Company had cash, cash equivalents and short-term investments of $
The Company believes that its $
The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The operating plan may change as a result of many factors currently unknown to management, and there can be no assurance that the current operating plan will be achieved in the timeframe anticipated by management or at all, and the Company may need to seek additional funds sooner than anticipated. The unaudited condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from potential unknown factors.
Reclassifications
In addition to the changes to the Company’s financial statement presentation related to the matters discussed under “Discontinued Operations” above, the Company has made certain reclassifications to prior period amounts in the condensed consolidated financial statements and accompanying notes to conform to the current period presentation. The reclassification of these items had no impact on net loss, financial position or cash flows in the current or prior periods. Specifically, the following items were updated in the Condensed Consolidated Statements of Cash Flows:
Significant Accounting Policies
The Company’s significant accounting policies and recent accounting pronouncements are described in Note 2, Summary of Significant Accounting Policies, to the consolidated financial statements in Item 8 of the 2024 Form 10-K. There have been no changes to the Company’s significant accounting policies, and the Company has not adopted any significant accounting policies during the three months ended March 31, 2025.
Basic and diluted loss per share is calculated by dividing net loss by the weighted average number of shares of Common Stock outstanding and does not include the impact of any potentially dilutive common stock equivalents. In January 2024 and May 2024, the Company issued pre-funded warrants in connection with the Public Offering (as defined below) and the Registered Offering (as defined below), respectively (see Note 3, Investments and Agreements, in this Form 10-Q). As the pre-funded warrants’ exercise price is nominal and there are no conditions that must be satisfied prior to their exercise, the pre-funded warrants are included in the calculation of the basic and diluted earnings per share as of March 31, 2025 and 2024. At each of March 31, 2025 and 2024, the calculation of diluted weighted average shares did not include common stock warrants or options that were potentially convertible into Common Stock as those would be antidilutive due to the Company’s net loss position.
Securities not considered in the calculation of diluted loss per share, but that could be dilutive in the future, are as follows:
|
|
March 31, 2025 |
|
|
March 31, 2024 |
|
||
Common stock warrants |
|
|
|
|
|
|
||
Common stock options |
|
|
|
|
|
|
||
Total potential dilutive securities |
|
|
|
|
|
|
||
6
2024 At-the-Market (ATM) Agreement
On August 13, 2024, the Company entered into a Controlled Equity OfferingSM Sales Agreement (2024 ATM Agreement) with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC (each, an ATM Agent, and together, the ATM Agents) pursuant to which the Company from time to time may offer and sell shares (2024 ATM Shares) of its Common Stock, through or to the ATM Agents having an aggregate sales price of up to $
Subject to the terms and conditions of the 2024 ATM Agreement, each ATM Agent is required to use its commercially reasonable efforts to sell the ATM Shares from time to time, based upon the Company’s instructions. The Company has provided the ATM Agents with customary indemnification rights, and the ATM Agents will be entitled to a commission of up to
Sales of the 2024 ATM Shares under the 2024 ATM Agreement may be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended. The Company has no obligation to sell any of the 2024 ATM Shares and may at any time suspend offers under the 2024 ATM Agreement or terminate the 2024 ATM Agreement.
Any Common Stock sold under the 2024 ATM Agreement will be issued and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-279692) (the May 2024 Registration Statement), which initially became effective on May 24, 2024 and which was subsequently amended on March 26, 2025 and April 4, 2025, with Post-Effective Amendment #3 being declared effective by the SEC on April 8, 2025. On August 13, 2024, the Company initially filed a prospectus supplement to the May 2024 Registration Statement with the SEC in connection with the offer and sale of up to $
On February 18, 2025, the Company sold
May 2024 Registered Offering
On May 24, 2024, the Company entered into an underwriting agreement with BofA Securities, Inc., as representative of the underwriters named therein, in connection with its previously announced underwritten offering (Registered Offering) of
The gross proceeds to the Company from the Registered Offering were approximately $
The May 2024 Pre-funded Warrants became exercisable subsequent to the filing and effectiveness of an amendment to the Company’s Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware on June 14, 2024. The exercise price and the number of shares of Common Stock issuable upon exercise of each May 2024 Pre-funded Warrant are subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to the Company’s stockholders. The May 2024 Pre-funded Warrants will not expire and are exercisable in cash or by means of a cashless exercise. A holder of May 2024 Pre-funded Warrants may not exercise such May 2024 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would be more than
7
March 2024 Private Placement with Institutional Investors
On March 4, 2024, the Company entered into an investment agreement (March 2024 Investment Agreement) with certain accredited institutional investors (Institutional Investors) pursuant to which the Company agreed to issue and sell, in a private placement (the March 2024 Private Placement),
The gross proceeds to the Company from the March 2024 Private Placement were approximately $
The March 2024 Private Placement was conducted pursuant to a Placement Agency Agreement, dated March 4, 2024 (the Placement Agency Agreement), by and between the Company and Oppenheimer & Co. Inc., as representative of the placement agents named therein (the Placement Agents). Per the Placement Agency Agreement, the Company agreed to: (i) pay the Placement Agents a cash fee equal to
Lantheus Agreements
Investment Agreement
On January 8, 2024, the Company entered into an investment agreement (Lantheus Investment Agreement) with Lantheus Alpha Therapy, LLC, a Delaware limited liability company and wholly owned subsidiary of Lantheus Holdings, Inc. (Lantheus), pursuant to which the Company agreed to sell and issue to Lantheus in a private placement transaction certain shares (Lantheus Shares) of Common Stock. The closing of the purchase and sale of the Lantheus Shares to Lantheus by the Company (the Lantheus Closing) was subject to the Company raising at least $
The number of Lantheus Shares sold was
The Lantheus Investment Agreement also contains agreements of the Company and Lantheus whereby Lantheus is provided certain board observer and information rights of the Company, subject to certain exceptions.
The Lantheus Investment Agreement also provides Lantheus with certain pro rata participation rights to maintain its ownership position in the Company in the event that the Company makes any public or non-public offering of any equity or voting interests in the Company or any securities that are convertible or exchangeable into (or exercisable for) equity or voting interests in the Company, subject to certain exceptions.
Pursuant to the Lantheus Investment Agreement, the Company is required to notify Lantheus within 10 business days of the end of a fiscal quarter in which the Company issued shares of Common Stock pursuant to at-the-market programs, including the 2024 ATM Agreement, of (i) the number of shares of Common Stock issued during such fiscal quarter pursuant to the 2024 ATM Agreement and (ii) the average price per share received by the Company before commissions (ATM Average Price). Upon receipt of such notice, Lantheus may elect, at its option, to purchase all or a portion of its Pro Rata Portion (as defined in the Lantheus Investment Agreement) of such shares at an aggregate price equal to the number of shares purchased multiplied by the ATM Average Price for such quarter (ATM Participation Right). Pursuant to the Lantheus Investment Agreement, Lantheus may not exercise the ATM Participation Right more than two times per calendar year.
Asset Purchase Agreement
On January 8, 2024, the Company entered into an Asset Purchase Agreement (Progenics APA) with Progenics Pharmaceuticals, Inc., a Delaware corporation (Progenics) and affiliate of Lantheus, pursuant to which the Company acquired certain assets and the associated lease of Progenics’ radiopharmaceutical manufacturing facility in Somerset, New Jersey for a purchase price of $
8
Option Agreement
On January 8, 2024, the Company entered into an option agreement (Option Agreement) with Lantheus whereby Lantheus was granted an exclusive option to negotiate an exclusive, worldwide, royalty- and milestone-bearing right and license to [212Pb]VMT-α-NET, the Company’s clinical-stage alpha therapy developed for the treatment of neuroendocrine tumors. If good-faith negotiations fail, Lantheus has a one-year right to reenter negotiations if a third party offers to purchase or license the [212Pb]VMT-α-NET program. Additionally, Lantheus has a right to co-fund the Investigational New Drug (IND) application, enabling studies for early-stage therapeutic candidates targeting prostate-specific membrane antigen and gastrin-releasing peptide receptor and, prior to IND filing, a right to negotiate for an exclusive license to such candidates. In consideration of the rights granted by the Company to Lantheus pursuant to the Option Agreement, Lantheus paid to the Company a one-time payment of $
Under the terms of the Option Agreement, Lantheus also had a right of first offer and last look protections for any third-party merger and acquisition transactions involving the Company for a 12-month period which expired on January 8, 2025.
The Company determined that the Option Agreement should be accounted for as a research and development arrangement in accordance with Accounting Standards Codification (ASC) 730-20, Research and Development Arrangements, as Lantheus held approximately
Accordingly, the Condensed Consolidated Balance Sheets report current and long-term liabilities related to these options under the caption, “Deferred Income.” The values for each distinct option within the Option Agreement were determined by estimating the fair value of each distinct option by a third-party valuation firm and the liabilities will be recognized as income in the Condensed Consolidated Statements of Operations and Comprehensive Loss as the various options expire. In connection with the January 8, 2025 expiration of the right of first offer and last look provisions provided under the Option Agreement, the Company recognized $
January 2024 Public Offering
On January 17, 2024, the Company entered into an underwriting agreement (Underwriting Agreement) with Oppenheimer & Co. Inc., as representative of the underwriters named therein (Underwriters), in connection with its previously announced underwritten public offering (Public Offering) of
The gross proceeds to the Company from the Public Offering were approximately $
The Public Offering was made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-275638), declared effective by the SEC on December 14, 2023, a base prospectus dated December 14, 2023, and the related prospectus supplement dated January 17, 2024.
The Jan. 2024 Pre-funded Warrants were exercisable at any time after the date of issuance. The exercise price and the number of shares of Common Stock issuable upon exercise of each Jan. 2024 Pre-funded Warrant were subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to the Company’s stockholders. The Jan. 2024 Pre-funded Warrants did not have an expiration date and were exercisable in cash or by means of a cashless exercise. A holder of Jan. 2024 Pre-funded Warrants could not exercise such Jan. 2024 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would beneficially own more than
9
2023 ATM Agreement
The Company entered into an ATM Issuance Sales Agreement, dated November 17, 2023, by and among the Company, Oppenheimer & Co., Inc., B. Riley Securities, Inc. and JonesTrading Institutional Services LLC, to create an ATM equity program under which it may offer and sell shares of its Common Stock, from time to time (2023 ATM Agreement).
On November 17, 2023, the Company filed a shelf registration statement on Form S-3 with the SEC (File No. 333-275638) and accompanying base prospectus, declared effective by the SEC on December 14, 2023, for the offer and sale of up to $
On April 11, 2024, the Company sold
On May 25, 2024, the Company terminated the offering of securities pursuant to the December 2023 Registration Statement in connection with the filing and effectiveness of the May 2024 Registration Statement.
On August 7, 2024, the Company delivered written notice to Oppenheimer & Co., Inc., B. Riley Securities, Inc. and JonesTrading Institutional Services LLC that it was terminating the 2023 ATM Agreement, which termination became effective August 12, 2024.
For additional information related to certain of the agreements discussed above, see Note 3 in the 2024 Form 10-K.
The GT Medical Closing occurred on April 12, 2024 (GT Medical Closing Date). Previously, the Company announced that on December 7, 2023, Isoray entered into an Asset Purchase Agreement (GT Medical APA) by and among Isoray, the Company, and GT Medical pursuant to which Isoray would sell to GT Medical, and GT Medical would purchase from Isoray, all of Isoray’s right, title and interest in and to substantially all of the assets of Isoray related to Isoray’s commercial Cesium-131 business (the Business) including equipment, certain contracts, inventory and intellectual property. Subject to limited exceptions set forth in the GT Medical APA, GT Medical did not assume the liabilities of Isoray.
Pursuant to the terms of, and subject to the conditions specified in, the GT Medical APA, at the GT Medical Closing, (i) GT Medical issued to Isoray
10
In accordance with ASC 205-20, Presentation of Financial Statements – Discontinued Operations,
|
|
Three Months Ended March 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
|
|
|
|
|
|
|
||
Sales, net |
|
$ |
|
|
$ |
|
||
Cost of sales |
|
|
|
|
|
|
||
Gross profit |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Operating expenses: |
|
|
|
|
|
|
||
Research and development |
|
|
|
|
|
|
||
Sales and marketing |
|
|
|
|
|
|
||
General and administrative |
|
|
|
|
|
|
||
Gain recognized on classification as held for sale |
|
|
|
|
|
( |
) |
|
Total operating expenses |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Total loss from discontinued operations |
|
$ |
|
|
$ |
( |
) |
|
The Company recognized a loss on classification as held for sale in December 2023 by identifying the assets and liabilities that were included in the GT Medical APA. Additionally, the loss recognized on classification as held for sale was determined using the estimated fair value of the GT Medical stock of $
There are
For the three months ended March 31, 2025 and 2024, there was
In 2024, the Company purchased buildings located in the metropolitan areas of Houston, TX, Chicago, IL, and Los Angeles, CA, which it intends to use to manufacture its program candidates upon completion of modifications and installation of equipment. Also in 2024, the Company entered into a Master Equipment and Services Agreement (MESA) and statements of work (SOWs) thereunder with Comecer SpA (Comecer), pursuant to which the Company agreed to purchase from Comecer manufacturing equipment for the production of the Company’s radiopharmaceutical product candidates including, but not limited to, isotope processing hot cells and production suites and related equipment (collectively, the Deliverables) and services for installation and validation of the Deliverables at several of the Company’s production facilities in the United States. The aggregate consideration for such equipment and services pursuant to the MESA and SOWs is approximately €
11
The Company’s property and equipment consisted of the following (in thousands):
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
||
|
|
|
|
|||||
Building |
|
$ |
|
|
$ |
|
||
Land |
|
|
|
|
|
|
||
Equipment |
|
|
|
|
|
|
||
Leasehold improvements |
|
|
|
|
|
|
||
Other1 |
|
|
|
|
|
|
||
Property and equipment |
|
|
|
|
|
|
||
Less accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
$ |
|
|
$ |
|
||
The following table summarizes the components of the Company’s other intangible assets (in thousands):
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
||||||||||||||||||
|
|
Cost |
|
|
Accumulated Amortization |
|
|
Net Carrying Value |
|
|
Cost |
|
|
Accumulated Amortization |
|
|
Net Carrying Value |
|
||||||
Indefinite-lived intangible assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
In-process research and development (IPR&D) |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||||
The Company’s IPR&D assets represent the estimated fair value of its pipeline of acquired radiotherapy product candidates. The Company tests its indefinite-lived intangible assets for impairment during the fourth quarter of each year, or more frequently should circumstances change or events occur that would more likely than not reduce the fair value of its assets. No testing was deemed necessary during the three months ended March 31, 2025. For additional information related to the Company’s IPR&D assets, see Notes 2, 4 and 10 in the Company’s 2024 Form 10-K.
The Company invests in available-for-sale securities that consist of U.S. Treasury Securities, U.S. Agency bonds, commercial paper, certificates of deposit, corporate debt securities and asset-backed securities.
The Company’s cash equivalents consisted of the following (in thousands):
|
|
March 31, 2025 |
|
|
December 31, 2024 |
|
||
Cash equivalents |
|
|
|
|
|
|
||
Money market funds |
|
$ |
|
|
$ |
|
||
Corporate debt securities |
|
|
|
|
|
|
||
Securities of U.S. government and government agencies |
|
|
|
|
|
|
||
Total cash equivalents |
|
$ |
|
|
$ |
|
||
12
The Company’s available-for-sale securities that are measured at fair value on a recurring basis consisted of the following (in thousands):
|
|
|
|
March 31, 2025 |
|
|||||||||||||
|
|
Maturities |
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
||||
Available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Securities of U.S. government and |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Commercial paper |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
||||
Certificates of deposit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Corporate debt securities |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
||||
Asset-backed securities |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
||||
Total available-for-sale securities |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
December 31, 2024 |
|
|||||||||||||
|
|
Maturities |
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
||||
Available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Securities of U.S. government and |
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Commercial paper |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
||||
Corporate debt securities |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
||||
Asset-backed securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Total available-for-sale securities |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
The Company’s available-for-sale securities are classified as current assets, even though the stated maturity date may be one year or more beyond the current balance sheet date, which reflects management’s intention to use the proceeds from sales of these securities to fund operations as needed. At March 31, 2025, there were
Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
Level 1 - Observable inputs such as quoted prices in active markets;
Level 2 - Inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets with insufficient volume or infrequent transactions (less active markets), or model-driven valuations in which all significant inputs are observable or can be derived principally from, or corroborated with, observable market data; and
Level 3 - Unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.
13
Below is the summary of our cash equivalents and short-term investments measured at fair value on a recurring basis and categorized using the fair value hierarchy (in thousands):
|
|
March 31, 2025 |
|
|||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Estimated Fair Value |
|
|||
Cash equivalents |
|
|
|
|
|
|
|
|
|
|||
Money market funds |
|
$ |
|
|
$ |
- |
|
|
$ |
|
||
Corporate debt securities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
Securities of U.S. government and government agencies |
|
|
- |
|
|
|
- |
|
|
|
- |
|
Corporate debt securities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
Total cash equivalents |
|
|
|
|
|
- |
|
|
|
|
||
Available-for-sale securities |
|
|
|
|
|
|
|
|
|
|||
Securities of U.S. government and government agencies |
|
|
- |
|
|
|
|
|
|
|
||
Commercial paper |
|
|
- |
|
|
|
|
|
|
|
||
Certificates of deposit |
|
|
|
|
|
|
|
|
|
|||
Corporate debt securities |
|
|
- |
|
|
|
|
|
|
|
||
Asset-backed securities |
|
|
- |
|
|
|
|
|
|
|
||
Total available-for-sale securities |
|
|
- |
|
|
|
|
|
|
|
||
Total cash equivalents and available-for-sale securities |
|
$ |
|
|
$ |
|
|
$ |
|
|||
|
|
|
|
|
|
|
|
|
|
|||
|
|
December 31, 2024 |
|
|||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Estimated Fair Value |
|
|||
Cash equivalents |
|
|
|
|
|
|
|
|
|
|||
Money market funds |
|
$ |
|
|
$ |
- |
|
|
$ |
|
||
Corporate debt securities |
|
|
- |
|
|
|
|
|
|
|
||
Securities of U.S. government and government agencies |
|
|
- |
|
|
|
|
|
|
|
||
Total cash equivalents |
|
|
|
|
|
|
|
|
|
|||
Available-for-sale securities |
|
|
|
|
|
|
|
|
|
|||
Securities of U.S. government and government agencies |
|
|
- |
|
|
|
|
|
|
|
||
Commercial paper |
|
|
- |
|
|
|
|
|
|
|
||
Corporate debt securities |
|
|
- |
|
|
|
|
|
|
|
||
Asset-backed securities |
|
|
- |
|
|
|
|
|
|
|
||
Total available-for-sale securities |
|
|
- |
|
|
|
|
|
|
|
||
Total cash equivalents and available-for-sale securities |
|
$ |
|
|
$ |
|
|
$ |
|
|||
There were
For information related to short-term investments, see Note 7, Available-for-Sale Securities.
On May 31, 2024, the Company held its 2024 Annual Meeting of Stockholders (2024 Annual Meeting). At the 2024 Annual Meeting, the Company’s stockholders approved the Company’s Third Amended and Restated 2020 Equity Incentive Plan (the Amended and Restated Plan) which, among other things, (a) increased the aggregate number of shares of Common Stock authorized for issuance under the Amended and Restated Plan by
14
The following table presents the share-based compensation expense recognized for all share-based compensation arrangements, excluding share-based compensation expense reported in Note 4, Discontinued Operations (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
|
|
|
|
|
|
|
||
Research and development expense |
|
$ |
|
|
$ |
|
||
General and administrative expense |
|
|
|
|
|
|
||
Total share-based compensation expense |
|
$ |
|
|
$ |
|
||
The Company has been in settlement negotiations with a representative for
In May 2025, the Company entered into a purchase order with the U.S. Department of Energy (DOE) under which the Company will purchase thorium-228 from the DOE during 2025 and 2026. The purchase order includes a “take-or-pay” provision pursuant to which the Company is committed to purchasing approximately $
In connection with the Lantheus Investment Agreement entered into with Lantheus on January 8, 2024, the Company agreed to sell and issue the Lantheus Shares. The number of Lantheus Shares sold was
On January 8, 2024, the Company entered into the Progenics APA with Progenics, an affiliate of Lantheus, for a purchase price of $
Also on January 8, 2024, the Company entered into the Option Agreement with Lantheus whereby Lantheus was granted an exclusive option to negotiate an exclusive, worldwide, royalty- and milestone-bearing right and license to [212Pb]VMT-α-NET, the Company’s clinical-stage alpha therapy developed for the treatment of neuroendocrine tumors. If good-faith negotiations fail, Lantheus has a one-year right to reenter negotiations if a third party offers to purchase or license the [212Pb]VMT-α-NET program. Additionally, Lantheus has a right to co-fund the IND application, enabling studies for early-stage therapeutic candidates targeting prostate-specific membrane antigen and gastrin-releasing peptide receptor and, prior to IND filing, a right to negotiate for an exclusive license to such candidates. In consideration of the rights granted by the Company to Lantheus pursuant to the Option Agreement, Lantheus paid to the Company a one-time payment of $
Under the terms of the Option Agreement, Lantheus also had a right of first offer and last look protections for any third-party merger and acquisition transactions involving the Company for a 12-month period, which expired on January 8, 2025. In connection with the January 8, 2025 expiration of the right of first offer and last look provisions provided under the Option Agreement, the Company recognized $
On March 4, 2024, the Company entered into the March 2024 Investment Agreement in which the Company agreed to issue and sell
For additional information regarding the Lantheus Investment Agreement, the Progenics APA and the March 2024 Investment Agreement, see Note 3, Investments and Agreements.
On August 8, 2024, the Company entered into an access and license agreement with Lantheus. For additional information, see Note 12, Leases.
15
The Company accounts for its leases under ASC 842, Leases. Effective April 1, 2024, the Company entered into a lease with the Board of Regents, State of Iowa, for lab and office space at the BioVentures Center. The lease terminates in March 2026. Upon entering into this lease, the Company recognized a right-of-use asset and lease liability of approximately $
The Company acquired a lease from Progenics, an affiliate of Lantheus, for a production facility in Somerset, NJ effective on March 1, 2024 (see Note 3, Investments and Agreements, in this Form 10-Q). The lease terminates on November 29, 2028. Upon entering into this lease, the Company recognized a right-of-use asset and lease liability of approximately $
On August 8, 2024, the Company assumed a lease from Progenics for office space in Somerset, NJ (Office). The lease terminates on November 30, 2028. Upon entering into this lease, the Company recognized a right-of-use asset and lease liability of approximately $
Upon assuming the lease, the Company entered into a license and access agreement with Lantheus, which provides access to both dedicated and shared space of the Office (Access Agreement). There is
On July 1, 2023, the Company entered into a lease with Unico Properties LLC for office space in Seattle, WA, that terminates in October 2028. Upon entering into this lease, the Company recognized a right-of-use asset and lease liability of approximately $
The weighted average remaining term and discount rate for the Company’s operating leases as of March 31, 2025 was
The Company’s operating lease expense was $
The following table presents the future operating lease payments and lease liability included on the Condensed Consolidated Balance Sheet related to the Company’s operating leases as of March 31, 2025 (in thousands):
Year Ending December 31, |
|
|
|
|
2025 (remaining nine months) |
|
$ |
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
Total |
|
|
|
|
Less: imputed interest |
|
|
( |
) |
Total lease liability |
|
|
|
|
Less: current portion |
|
|
( |
) |
Noncurrent lease liability |
|
$ |
|
|
16
Asset Retirement Obligation
The Company had an asset retirement obligation (ARO) associated with the facility it leased in Richland, WA. This lease is included in the GT Medical APA and was assigned to GT Medical upon the GT Medical Closing, which occurred on April 12, 2024. As such, this liability is no longer reported as an ARO in the Company’s condensed consolidated financial statements as of March 31, 2025 and December 31, 2024. However, the Company maintains the estimated liability in its condensed consolidated financial statements related to hazardous waste removal that relates to activities prior to the GT Medical Closing. The estimated liability at each of March 31, 2025 and December 31, 2024 was $
On December 29, 2022, the Company obtained a promissory note in the amount of $
The following table presents the current and long-term portions of the note payable (in thousands):
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2025 |
|
|
2024 |
|
||
|
|
|
|
|
|
|
||
Note payable |
|
$ |
|
|
$ |
|
||
Less: current portion |
|
|
( |
) |
|
|
( |
) |
Note payable, long-term portion |
|
$ |
|
|
$ |
|
||
The following table presents the future principal payments included on the Condensed Consolidated Balance Sheets related to the Company’s note payable as of March 31, 2025 (in thousands):
Years ending December 31: |
|
|
|
|
2025 (remaining nine months) |
|
$ |
|
|
2026 |
|
|
|
|
2027 |
|
|
|
|
Total |
|
$ |
|
|
17
ITEM 2 – MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with (i) the unaudited condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 (Form 10-Q), (ii) our audited consolidated financial statements and notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on March 26, 2025 and amended on March 28, 2025 (2024 Form 10-K) and (iii) other filings we have made with the SEC. As discussed under the heading “Cautionary Note Regarding Forward-Looking Statements,” this discussion contains forward-looking statements that reflect our plans, estimates and beliefs, and involves numerous risks and uncertainties, including but not limited to those described under the heading “Risk Factors” in the 2024 Form 10-K that may cause actual results to differ materially from those described in or implied by any forward-looking statements. Unless the context otherwise requires, references in these notes to the “Company,” “Perspective,” “we,” “us” and “our,” except where the context requires otherwise, refer to Perspective Therapeutics, Inc. and its subsidiaries. References to “Isoray” refer to Isoray Medical, Inc., a wholly owned subsidiary.
Overview
We are a radiopharmaceutical development company that is pioneering advanced treatment applications for cancers throughout the body. We have proprietary technology that utilizes the alpha-emitting isotope Lead-212 (212Pb) to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. We are also developing complementary imaging diagnostics that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimize patient outcomes. This theranostic approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity.
Our neuroendocrine tumor (VMT-α-NET), melanoma (VMT01) and solid tumor (PSV359) programs are in Phase 1/2a imaging and therapy trials in the U.S. We are growing our regional network of drug product candidate finishing facilities, enabled by our proprietary 212Pb generator, to deliver patient-ready product candidates for clinical trials and commercial operations.
VMT-α-NET
We designed VMT-α-NET to target and deliver 212Pb to target cancer-specific receptors on tumor cells expressing somatostatin receptor type 2 (SSTR2), a protein that is overexpressed in neuroendocrine tumors (NETs) and other cancers. [212Pb]VMT-α-NET is a targeted alpha therapy (TAT) in development for patients with unresectable or metastatic SSTR2-expressing tumors who have not previously received peptide-targeted radiopharmaceutical therapy, such as Lutathera. NETs are a group of rare, heterogeneous tumors that develop in different organs of the body and arise from specialized cells in the neuroendocrine system.
We have initiated dosing of patients in Cohorts 1 and 2 of our Phase 1/2a study of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs. In January 2025, at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium, we announced updated interim results from our multi-center open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive NETs who have not received prior radiopharmaceutical therapy and have shown radiological evidence of disease progression in the 12 months prior to enrollment. The data cut-off date was January 10, 2025. All nine patients in Cohort 1 and Cohort 2 had completed treatments per the study protocol, and the study team had at least one scan for all patients after their final treatments. No dose limiting toxicities (DLTs), grade 4 or 5 treatment emergent or serious adverse events (AEs) were reported since the start of the study. No new grade 3 AEs were observed aside from the two events that were disclosed at an earlier data cutoff of October 2024 - one case of diarrhea and one case of syncope. No decline in renal function was observed. Hematologic AEs, such as decreased lymphocyte count and anemia, were all grades 1 and 2. No treatment discontinuations due to AEs occurred.
Further anti-tumor activities have been observed with longer follow up, and there were two unconfirmed responses and one confirmed response as defined by response evaluation criteria in solid tumors (RECIST) v1.1 in Cohort 2. As of the January 10, 2025 data cut-off date, the patient who experienced a confirmed objective response has been in response for 17 weeks and remains in the study. This patient received the first two [212Pb]VMT-α-NET doses at administered dose of 5.0 mCi (equivalent to 84.6 µCi/kg), then received the remaining two doses at the next lower activity level of 2.5 mCi (equivalent to 42.4 µCi/kg) due to an adverse event that was determined by the investigator to be unrelated to [212Pb]VMT-α-NET.
One patient was observed to experience an initial (unconfirmed (as of January 10, 2025)) response in the fifth scan after their first dose, which was the first scan conducted after the end of their treatment period. This patient experienced gradual tumor regression throughout the study, with the magnitude of change meeting the criteria for response on their most recent scan. This patient received four doses of 5.0 mCi (equivalent to 68.7 µCi/kg) of [212Pb]VMT-α-NET.
A third patient was observed to experience an initial (unconfirmed (as of January 10, 2025)) response in the seventh scan after their first dose, which was the third scan conducted after the end of their treatment period. This patient received four doses of 5.0 mCi (equivalent to 31.7 µCi/kg) of [212Pb]VMT-α-NET. Gradual tumor regression was first observed in the fifth scan after their first dose, with the magnitude of change meeting the criteria for response on their most recent scan.
18
Five patients continued to have stable disease. One patient was deemed to have progressive disease after one dose under RECIST v1.1, by unambiguous progression of non-target lesions.
After Cohort 2 reopened for enrollment in August 2024 and through February 28, 2025, 30 patients had begun receiving treatment. In March and April 2025, an incremental 10 patients were dosed. Thus, as of April 30, 2025, a total of 40 patients have begun treatment in Cohort 2. More patients are undergoing evaluation for whether they meet the entry criteria to enroll into Cohort 2.
The observation period was completed for DLTs in seven patients enrolled in Cohort 2 during the second quarter of 2024. Subsequently, the safety monitoring committee (SMC) determined that the safety data observations during the DLT period supported proceeding with dose escalation to Cohort 3. A protocol amendment to expand the number of patients dosed at 5 mCi has been submitted to sites, and patient enrollment is open. Based on interactions with the U.S. Federal and Drug Administration (FDA) prior to the initiation of patient dosing in the study, which occurred in late 2023, the decision to open Cohort 3 will follow consultation and alignment with the agency. FDA interactions are ongoing with regard to the initiation of the next dosing cohort. Following alignment with the FDA, we intend to communicate to stakeholders regarding how the trial will move forward.
On April 23, 2025, we announced that data on [212Pb]VMT-α-NET have been accepted for presentation at the 2025 American Society of Clinical Oncology Annual Meeting, which will take place May 30 to June 3 in Chicago, IL (2025 ASCO).
VMT01
We are also leveraging our TAT platform with our second program candidate, VMT01, which is currently in Phase 1/2a clinical trials. We designed VMT01 to target and deliver 212Pb to tumor sites expressing melanocortin 1 receptor (MC1R), a protein that is overexpressed in melanoma cancers. [212Pb]VMT01 is a TAT in development for second-line or later treatment of patients with progressive MC1R-positive metastatic melanoma.
In preclinical experiments [212Pb]VMT01 demonstrated efficacy via two distinct mechanisms of action: direct cell killing at high radiation doses and through immunostimulatory low-dose induction of immune-mediated cell death. Efficacy was augmented by immune checkpoint inhibitors. In September 2024, we announced that on the basis of these results, the FDA granted Fast Track Designation for the clinical development of [212Pb]VMT01. This study is a multi-center, open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05655312) in patients with histologically confirmed melanoma and MC1R-positive imaging scans. Patients were required to have already received standard of care. Eligible patients may receive up to three treatments with [212Pb]VMT01, eight weeks apart.
In March 2024, we entered into a clinical trial collaboration with Bristol Myers Squibb to evaluate the safety and tolerability of [212Pb]VMT01 in combination with Bristol Myers Squibb’s checkpoint inhibitor nivolumab in patients with histologically confirmed melanoma and positive MC1R imaging scans. A protocol amendment was submitted in July 2024 to explore the combination of nivolumab with [212Pb]VMT01 in patients with histologically confirmed melanoma and positive MC1R imaging scans in our ongoing Phase 1/2a clinical study of [212Pb]VMT01.
In October 2024, we announced initial results from the first two dosing cohorts. Three patients were enrolled in Cohort 1 (who received 3 mCi of [212Pb]VMT01), while seven patients were enrolled in Cohort 2 (who received 5 mCi of [212Pb]VMT01). Patients in each cohort received a median of five prior lines of systematic therapy, including a median of three prior lines of immunotherapy. No DLTs were observed among any patients, and no AEs led to treatment discontinuation. Treatment emergent AEs were mostly grades 1 and 2. None of the four cases of grade 3 treatment emergent AEs were deemed to be treatment related. There were no grade 4 or 5 treatment emergent AEs. No renal toxicities had been reported as of October 11, 2024 (there were no clinically significant changes in blood urea nitrogen or serum creatinine) in spite of dosimetry estimated renal radiation that approached the higher end of conventional dosing.
All patients in Cohort 1 completed three treatments, with one patient experiencing an unconfirmed RECIST version 1.1 objective response after completion of treatment, and two patients experiencing stable disease at 9 and 11 months from the start of treatment, respectively, as reported on October 11, 2024. In Cohort 2, patients progressed after either the first cycle (three patients) or the second cycle (four patients). These findings are consistent with published and ongoing preclinical studies showing immunostimulatory effects at lower radiation doses.
The SMC reviewed these findings and recommended exploring a lower dose level of 1.5 mCi per dose, both as a single agent and in combination with the anti-PD-1 antibody, nivolumab. The SMC’s recommendation would allow for the monotherapy and combination cohorts to proceed concurrently. An amendment to further explore lower dose levels for monotherapy has been approved, and Cohort 3 at 1.5 mCi per dose is active and open for enrollment. The combination cohort at 1.5 mCi per dose with nivolumab is also active and open for enrollment. On March 17, 2025, we announced that the first patient was dosed in the combination cohort, and on April 11, 2025, we announced that the first patient was dosed in the monotherapy cohort. As of April 30, 2025, a total of four patients had received their initial monotherapy treatments. On April 23, 2025, we announced that data on [212Pb]VMT01 have been accepted as a poster presentation at 2025 ASCO.
19
PSV359
Tumor stroma cells do not typically express cancer-specific markers like SSTR2 or MC1R. Fibroblast activation protein alpha (FAP-α) is primarily expressed on tumor stroma cells, but also on some cancer cells. FAP-α, a pan-cancer target, is a protein abundantly expressed in certain cancer cells as well as cancer-associated fibroblasts in tumor lesions and involved in promoting disease progression. Our in-house discovery team discovered PSV359, a novel cyclic peptide targeting human FAP-α, via phage display methods. We believe PSV359 is an optimized peptide with potential best-in-class characteristics that has been demonstrated in preclinical models. In March 2024, we released the first-in-human clinical single-photon emission computed tomography (SPECT)/computed tomography (CT) imaging which suggested very favorable tumor targeting and retention by the PSV359 compound, while clearing from normal organs rapidly and completely.
In October 2024, we announced first-in-human SPECT/CT images of [203Pb]PSV359 from an independent investigator revealed strong tumor uptake, fast clearance through the renal system, low accumulation in normal organs, and long tumor retention in three patients with FAP-α expressing cancers.
Preclinical results for PSV359 were presented during the Society of Nuclear Medicine and Molecular Imaging and European Association of Nuclear Medicine annual meetings in June and October 2024, respectively. The purpose of this study was to evaluate the in vitro and in vivo performance of [203/212Pb]PSV359 in preclinical xenograft models. Overall, strong anti-tumor clinical activity of [212Pb]PSV359 was found in both HT1080-human FAP-α (FAP-α on cancer cells) and U87MG (FAP-α in stromal tissues) xenograft models.
We filed an IND application for PSV359 in December 2024, and we received a “study may proceed” letter (i.e., approval to conduct the trial) from the FDA in the first quarter of 2025. We are currently activating clinical sites, and on April 29, 2025, we announced the first patient was treated with [212Pb]PSV359.
Other Pipeline Candidates
In January 2024, we entered into an exclusive in-licensing of Stony Brook University’s Cuburbit[7]uril-admantane (CB7-Adma) pre-targeting platform which covers the global intellectual property rights to such platform. Pre-targeting using the CB7-Adma platform involves two steps. First, an antibody that binds with high specificity to a cancer-specific protein is administered via intravenous injection. This antibody is chemically modified to include the CB7 chemical entity and accumulates over time at the tumor site. Then, a radionuclide held tightly by our proprietary chelator attached to an Adma group is administered. The Adma group binds to the CB7 group that was previously attached to the cancerous cells with specificity, delivering radiation dose selectively to the tumor sites. Central to this innovation is CB7-Adma (host-guest) complex formation, driving the interaction between the antibody and radioligand. The chosen host-guest pair, CB7-Adma, has demonstrated promising in vivo stability, modularity and low immunogenicity. The platform’s potential was validated through in vivo profiling of ligands, employing a CB7-modified carcinoembryonic antigen targeting antibody. The agreement with Stony Brook University will expire on the later of the expiration date of the last to expire licensed patents or 20 years from the date of the first sale of a product utilizing the intellectual property. Preclinical optimization of this platform is underway, and initial targeting antibodies are being identified for further investigation.
Also in January 2024, we announced that we have a license agreement with Mayo Clinic for the rights to Mayo Clinic’s prostate-specific membrane antigen (PSMA) Alpha-PET DoubLET platform technology for the treatment of PSMA-expressing cancers, with an initial focus on prostate. This radiopharmaceutical platform provides detailed PET imaging-based diagnosis and dosimetry using long-lived Copper-64 for imaging and alpha-particle targeted therapies using 212Pb. Preclinical studies are ongoing to assess whether this new molecular entity meets the hurdle for progressing into the clinic.
Discovery Program
Our discovery team is preparing multiple additional novel constructs for potential first-in-human imaging as a de-risking step for potential therapeutic benefit. If and when these constructs meet our criteria for further development, we plan to proceed with pre-IND filing activities.
Intellectual Property (IP)
We have recently received allowance for two patent applications on our key assets. The first patent application, allowed by the U.S. Patent and Trademark Office (USPTO), pertains to our wholly owned, proprietary technology for generation of 212Pb at scale. The full term of this patent (once issued) expires in August 2044. The second patent application, also allowed by the USPTO, pertains to the VMT-α-NET compound for which we have an exclusive license from the University of Iowa. The full term of this patent (once issued) expires in January 2041.
20
Funding Requirements
We have had recurring losses since inception. We expect our expenses to increase in connection with our ongoing activities, particularly as we advance and expand preclinical activities, clinical trials and potential commercialization of our program candidates. Our costs are also expected to increase as we:
As of March 31, 2025, we had cash, cash equivalents and short-term investments of $211.7 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned operations for at least the next 12 months from the date the condensed consolidated financial statements in this report were issued and into late 2026. Monthly operating expenses are budgeted to increase for research and development and general and administrative expenses as management works to implement its strategy to advance our clinical assets in their clinical trials and to progress our preclinical assets towards clinical trials. Management anticipates a significant increase in expenses, particularly in research and development, as we undertake these activities.
Manufacturing and Supply
We assemble and manufacture our finished radiopharmaceutical candidates by chelating or trapping an atom of 212Pb within a specialized chelator or chemical “cage” and connecting the 212Pb within its cage to the targeting peptide with our linker technology. For clinical supply, we intend to use a combination of third-party contract manufacturing organizations, or CMOs, and our own manufacturing sites complying with the FDA’s current good manufacturing practices, or CGMP, to manufacture and distribute our doses. For the drug precursors and isotopes that comprise our TAT platform, a variety of clinical phase manufacturers have been engaged and utilized. We procure chelator-modified peptide precursors from peptide manufacturers who are capable of producing clinical phase precursor material.
In May 2025, we entered into a purchase order with the U.S. Department of Energy (DOE) under which we will purchase thorium-228 from the DOE during 2025 and 2026. The purchase order includes a “take-or-pay” provision pursuant to which we are committed to purchasing approximately $8.4 million of thorium-228 during the term of the agreement.
In 2024, we entered into a Master Equipment and Services Agreement (MESA) and statements of work (SOWs) thereunder with Comecer SpA (Comecer), pursuant to which we agreed to purchase from Comecer manufacturing equipment for the production of our radiopharmaceutical product candidates including, but not limited to, isotope processing hot cells and production suites and related equipment (collectively, the Deliverables) and services for installation and validation of the Deliverables at several of our production facilities in the United States. The aggregate consideration for such equipment and services pursuant to the MESA and SOWs is approximately €49.0 million payable in cash, excluding certain incidental costs, such as taxes, customs and duties, local transport, insurance and rigging. We may also elect to purchase certain additional equipment and services pursuant to the SOWs. The MESA provides for the payment of certain amounts in installments over the course of the production, installation and validation of the Deliverables. For additional information, see Note 7, Property and Equipment, of the 2024 Form 10-K.
Facility Acquisitions
In 2024, we purchased buildings located in the metropolitan areas of Houston, TX, Chicago, IL, and Los Angeles, CA, which we intend to use for the manufacture of our program candidates upon completion of modifications and installation of equipment.
Also in 2024, we acquired the assets and associated lease of Lantheus’ radiopharmaceutical manufacturing facility in Somerset, NJ. Soon after the acquisition, we began the onboarding and operationalization processes and, in October 2024, we achieved the first shipment and patient dosing from our Somerset facility. With three manufacturing suites that can meet CGMP requirements, the Somerset facility is expected to have the capacity to meet future clinical trial and commercial demands at major cancer treatment centers throughout the Northeastern U.S.
We continue to evaluate the suitability of additional facilities as we look to expand our research and development capabilities.
21
2024 At-the-Market (ATM) Agreement
On August 13, 2024, we entered into a Controlled Equity OfferingSM Sales Agreement (2024 ATM Agreement) with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC (each, an ATM Agent, and together, the ATM Agents) pursuant to which we, from time to time, may offer and sell shares (2024 ATM Shares) of our common stock, par value $0.001 per share (Common Stock), through or to the ATM Agents having an aggregate sales price of up to $250.0 million.
Subject to the terms and conditions of the 2024 ATM Agreement, each ATM Agent is required to use its commercially reasonable efforts to sell the ATM Shares from time to time, based upon our instructions. We have provided the ATM Agents with customary indemnification rights, and the ATM Agents will be entitled to a commission of up to 3.0% of the gross proceeds from each sale of the ATM Shares effectuated through or to the applicable ATM Agent selling the ATM Shares.
Sales of the 2024 ATM Shares under the 2024 ATM Agreement may be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended. We have no obligation to sell any of the 2024 ATM Shares and may at any time suspend offers under the 2024 ATM Agreement or terminate the 2024 ATM Agreement.
Any Common Stock sold under the 2024 ATM Agreement will be issued and sold pursuant to our shelf registration statement on Form S-3 (File No. 333-279692) (the May 2024 Registration Statement), which initially became effective on May 24, 2024 and which was subsequently amended on March 26, 2025 and April 4, 2025, with Post-Effective Amendment #3 being declared effective by the SEC on April 8, 2025. On August 13, 2024, we initially filed a prospectus supplement to the May 2024 Registration Statement with the SEC in connection with the offer and sale of up to $250.0 million of the 2024 ATM Shares pursuant to the 2024 ATM Agreement. We re-filed the ATM prospectus supplement with each of the post-effective amendments to the May 2024 Registration Statement.
On February 18, 2025, we sold 3,379,377 shares of our Common Stock under the 2024 ATM Agreement at an average price of approximately $3.02 per share of Common Stock, resulting in gross proceeds of approximately $10.2 million.
Brachytherapy Divestiture
On April 12, 2024 (GT Medical Closing Date), we completed the sale of substantially all of the assets (GT Medical Closing) of Isoray to GT Medical Technologies, Inc. (GT Medical). As previously disclosed, on December 7, 2023, we entered into an Asset Purchase Agreement (the GT Medical APA) with Isoray and GT Medical. Pursuant to the GT Medical APA, Isoray sold to GT Medical, and GT Medical purchased from Isoray, all of Isoray’s right, title and interest in and to substantially all of the assets of Isoray related to Isoray’s commercial Cesium-131 business including equipment, certain contracts and leases, inventory and intellectual property. Subject to limited exceptions set forth in the GT Medical APA, GT Medical did not assume the liabilities of Isoray.
Pursuant to the terms of, and subject to the conditions specified in, the GT Medical APA, at the GT Medical Closing, (i) GT Medical issued to Isoray 279,516 shares of GT Medical’s common stock, par value $0.0001 per share, representing 0.5% of GT Medical’s issued and outstanding capital stock on a fully diluted basis as of the GT Medical Closing Date and (ii) Isoray has the right to receive, and GT Medical is obligated to pay, certain cash royalty payments during each of the first four years beginning upon the GT Medical Closing Date (each such year, a Measurement Period), as summarized below:
For additional information regarding our brachytherapy divestiture, see our Forms 8-K filed with the SEC on December 12, 2023, April 3, 2024 and April 16, 2024.
22
Critical Accounting Policies and Estimates
Management’s discussion and analysis of our financial condition and results of operations are based upon our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these condensed consolidated financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent liabilities. On an ongoing basis, management evaluates critical accounting estimates and judgments. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The accounting policies and related risks described in Part II, Item 7 and Note 2, Summary of Significant Accounting Policies, to the consolidated financial statements included in Part II, Item 8 of the 2024 Form 10-K are those that depend most heavily on these judgments and estimates. As of March 31, 2025, there have been no material changes to any of the critical accounting policies and estimates contained therein.
Results of Operations
We previously presented our results in two segments: Drug Operations and Brachytherapy. Due to the sale of our brachytherapy segment to GT Medical in the second quarter of 2024 and the classification of the assets and operations of the brachytherapy segment as discontinued operations in our condensed consolidated financial statements, we have now determined that we operate in only one segment. The following does not include a discussion of the results of our discontinued operations. For additional information regarding our discontinued operations, see Note 4, Discontinued Operations, to the condensed consolidated financial statements in this Form 10-Q and Note 5, Discontinued Operations, in the 2024 Form 10-K.
The following table sets forth our results of operations for the periods presented (in thousands):
|
|
Three Months Ended March 31, |
|
|
|
|
||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Grant revenue |
|
$ |
342 |
|
|
$ |
325 |
|
|
$ |
17 |
|
|
|
|
|
|
|
|
|
|
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development expenses |
|
|
14,332 |
|
|
|
7,452 |
|
|
|
6,880 |
|
General and administrative expenses |
|
|
7,842 |
|
|
|
5,878 |
|
|
|
1,964 |
|
Total operating expenses |
|
|
22,174 |
|
|
|
13,330 |
|
|
|
8,844 |
|
|
|
|
|
|
|
|
|
|
|
|||
Operating loss |
|
$ |
(21,832 |
) |
|
$ |
(13,005 |
) |
|
$ |
(8,827 |
) |
Grant Revenue
Grant revenue for all periods presented relates to our work for the National Institutes of Health. Our alpha-therapy business is in the clinical stage and, therefore, none of our revenues reflect sales of any of our alpha-therapy candidates, which are still under development.
Operating Expenses
Research and Development
Research and development expenses were $14.3 million for the three months ended March 31, 2025, compared to $7.5 million for the three months ended March 31, 2024, an increase of $6.9 million. The increase in research and development expenses was related to the expanded development of our TAT drug programs, including higher personnel costs and third-party research and development fees.
Management believes that research and development expenses will continue to increase as we continue to invest in the development of novel radiopharmaceutical drugs and product candidates and expand our manufacturing capabilities. We are investing in equipment and modifications for the three buildings we acquired in 2024 located in the Houston, TX, Chicago, IL, and Los Angeles, CA, metropolitan areas. Upon completion, we intend to use the buildings to manufacture our product candidates. We are also working towards expanding capacity in our second manufacturing facility in Somerset, NJ, following the commencement of shipping of 212Pb-labeled radiopharmaceuticals in the fourth quarter of 2024. We expect the capital expenditure associated with this capacity expansion to be a small portion of our total capital expenditures.
Management believes that the cost of certain raw materials used in the production of our novel radiopharmaceutical drugs and product candidates may increase in the coming years, including as a result of increased demand for materials required for the production of radiopharmaceuticals. We are also currently evaluating how potential U.S. and international trade policies, including tariffs, might impact our costs for supplies, equipment and materials used in the development and production of our TAT drug product candidates.
23
We currently source much of the raw materials that are used to produce our product candidates in the U.S. Some equipment and other materials that will be used at our manufacturing sites is sourced from outside the U.S. Based on our initial analysis of recently announced tariffs, we do not expect to experience any material incremental tariff-related cost impacts in 2025. We will continue to monitor new tariffs and their implementation dates as we evaluate the potential impacts along with alternatives suppliers.
General and Administrative
General and administrative expenses consist primarily of the costs related to our executive, finance, human resources and information technology functions.
General and administrative expenses were $7.8 million for the three months ended March 31, 2025, compared to $5.9 million for the three months ended March 31, 2024, an increase of $2.0 million. The increase in general and administrative expenses for the three months ended March 31, 2025 was primarily due to increased personnel costs, partially offset by decreased fees for professional services.
Liquidity and Capital Resources
We assess our liquidity in terms of our ability to generate cash to fund our operating, investing and financing activities. We have historically financed our operations primarily through selling equity to investors. The following table summarizes our cash flows for the periods presented (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Net cash (used in) provided by operating activities |
|
$ |
(21,582 |
) |
|
$ |
13,848 |
|
Net cash used in investing activities |
|
|
(5,565 |
) |
|
|
(47,297 |
) |
Net cash provided by financing activities |
|
|
9,973 |
|
|
|
166,328 |
|
Net (decrease) increase in cash and cash equivalents |
|
$ |
(17,174 |
) |
|
$ |
132,879 |
|
Cash Flows from Operating Activities
Net cash used in operating activities of $21.6 million in the three months ended March 31, 2025, was comprised of a net loss of approximately $18.2 million, adjusted for non-cash expenses totaling $2.0 million (such as share-based compensation and depreciation and amortization expense), and changes in operating assets and liabilities of $5.4 million.
Net cash provided by operating activities of $13.8 million in the three months ended March 31, 2024, was primarily due to amounts received pursuant to that certain option agreement, dated January 8, 2024, of $28.0 million, between us and Lantheus Alpha Therapy, LLC, partially offset by a net loss of approximately $12.3 million, as adjusted for non-cash expenses totaling $0.7 million (such as share-based compensation and depreciation and amortization expense), and $2.6 million in changes to our accrued expenses and accounts payable.
Cash Flows from Investing Activities
Net cash used in investing activities of $5.6 million in the three months ended March 31, 2025, was primarily due to acquisitions of property and equipment and purchases of available-for-sale securities, partially offset by proceeds from the maturity of available-for-sale securities.
Net cash used in investing activities of $47.3 million in the three months ended March 31, 2024, was primarily due to transactions related to the purchase of fixed assets and purchases of held-to-maturity securities.
Cash Flows from Financing Activities
Net cash provided by financing activities of $10.0 million in the three months ended March 31, 2025, was primarily related to the proceeds received from the sale of Common Stock pursuant to the 2024 ATM Agreement.
Net cash provided by financing activities of $166.3 million in the three months ended March 31, 2024, was primarily related to various capital markets transactions and other agreements we entered into.
For additional information regarding the cash we raised, see Sources of Liquidity below.
24
Sources of Liquidity
2024 At-the-Market (ATM) Agreement
On August 13, 2024, we entered into a Controlled Equity OfferingSM Sales Agreement (2024 ATM Agreement) with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC (each, an ATM Agent, and together, the ATM Agents) pursuant to which we, from time to time, may offer and sell shares (2024 ATM Shares) of our Common Stock, through or to the ATM Agents having an aggregate sales price of up to $250.0 million.
Subject to the terms and conditions of the 2024 ATM Agreement, each ATM Agent is required to use its commercially reasonable efforts to sell the ATM Shares from time to time, based upon our instructions. We have provided the ATM Agents with customary indemnification rights, and the ATM Agents will be entitled to a commission of up to 3.0% of the gross proceeds from each sale of the ATM Shares effectuated through or to the applicable ATM Agent selling the ATM Shares.
Sales of the 2024 ATM Shares under the 2024 ATM Agreement may be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended. We have no obligation to sell any of the 2024 ATM Shares and may at any time suspend offers under the 2024 ATM Agreement or terminate the 2024 ATM Agreement.
Any Common Stock sold under the 2024 ATM Agreement will be issued and sold pursuant to our shelf registration statement on Form S-3 (File No. 333-279692) (the May 2024 Registration Statement), which initially became effective upon filing with the SEC on May 24, 2024 and which was subsequently amended on March 26, 2025 and April 4, 2025, with Post-Effective Amendment #3 being declared effective by the SEC on April 8, 2025. On August 13, 2024, we initially filed a prospectus supplement to the May 2024 Registration Statement with the SEC in connection with the offer and sale of up to $250.0 million of the 2024 ATM Shares pursuant to the 2024 ATM Agreement. We re-filed the ATM prospectus supplement with each of the post-effective amendments to the May 2024 Registration Statement.
On February 18, 2025, we sold 3,379,377 shares of our Common Stock under the 2024 ATM Agreement at an average price of approximately $3.02 per share of Common Stock, resulting in gross proceeds of approximately $10.2 million.
May 2024 Registered Offering
On May 24, 2024, we entered into an underwriting agreement with BofA Securities, Inc., as representative of the underwriters named therein, in connection with its previously announced underwritten offering (Registered Offering) of 5,151,588 shares (Registered Offering Shares) of our Common Stock and, in lieu of Registered Offering Shares to certain investors, pre-funded warrants (May 2024 Pre-funded Warrants) to purchase 146,425 shares of Common Stock. The price to the investors for the Registered Offering Shares was $15.10 per Registered Offering Share, and the price to the investors for the May 2024 Pre-funded Warrants was $15.09 per May 2024 Pre-funded Warrant, which represents the per share price for the Registered Offering Shares less the $0.01 per share exercise price for each such May 2024 Pre-funded Warrant. The Registered Offering closed on May 29, 2024. BofA Securities, Inc., Oppenheimer & Co. Inc. and RBC Capital Markets, LLC acted as joint book-running managers for the Registered Offering and B. Riley Securities, Inc. acted as a co-manager for the Registered Offering. JonesTrading Institutional Services LLC acted as a financial advisor for the Registered Offering.
Our gross proceeds from the Registered Offering were approximately $80.0 million, before underwriting discounts and commissions and estimated expenses of the Offering.
The May 2024 Pre-funded Warrants became exercisable subsequent to the filing and effectiveness of an amendment to our Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware on June 14, 2024. The exercise price and the number of shares of Common Stock issuable upon exercise of each May 2024 Pre-funded Warrant are subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to our stockholders. The May 2024 Pre-funded Warrants will not expire and are exercisable in cash or by means of a cashless exercise. A holder of May 2024 Pre-funded Warrants may not exercise such May 2024 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would be more than 4.99% or 9.99%, as elected by such holder, of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the May 2024 Pre-funded Warrants. A holder of May 2024 Pre-funded Warrants may increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to us. The holders of the pre-funded warrants exercised all of the May 2024 Pre-funded Warrants during the second quarter of 2025 by means of the cashless exercise provision and within the other constraints noted above.
25
March 2024 Private Placement with Institutional Investors
On March 4, 2024, we entered into an investment agreement with certain accredited institutional investors pursuant to which we agreed to issue and sell, in a private placement (March 2024 Private Placement), 9,200,998 shares of our Common Stock, for a purchase price of $9.50 per share, representing the closing price of the Common Stock on March 1, 2024. The closing of the March 2024 Private Placement occurred on March 6, 2024. The gross proceeds to us from the March 2024 Private Placement were approximately $87.4 million, before deducting fees and other estimated transaction expenses.
Investment Agreement
On January 8, 2024, we entered into an investment agreement (Lantheus Investment Agreement) with Lantheus Alpha Therapy, LLC, a Delaware limited liability company and wholly owned subsidiary of Lantheus Holdings, Inc. (Lantheus), pursuant to which we agreed to sell and issue to Lantheus in a private placement transaction certain shares (Lantheus Shares) of our Common Stock. The closing of the purchase and sale of the Lantheus Shares to Lantheus by us (Lantheus Closing) was subject to us raising at least $50.0 million of gross proceeds (excluding Lantheus’ investment) in a qualifying third-party financing transaction, which occurred on January 22, 2024. The number of Lantheus Shares sold was 5,634,235, representing 19.99% of the outstanding shares of Common Stock as of January 8, 2024. Pursuant to the Lantheus Investment Agreement, we agreed to cooperate in good faith to negotiate and enter into a registration rights agreement with Lantheus, obligating us to file a registration statement on Form S-3 with the SEC to register for resale the Lantheus Shares issued at the Lantheus Closing. We filed such Form S-3 on March 29, 2024, and the SEC declared it effective on April 9, 2024 (File No. 333-278362). The Lantheus Investment Agreement also contains agreements between us and Lantheus whereby Lantheus is provided certain board observer and information rights of us, subject to certain exceptions.
January 2024 Public Offering
On January 17, 2024, we entered into an underwriting agreement (Underwriting Agreement) with Oppenheimer & Co. Inc., as representative of the underwriters named therein (Underwriters), in connection with our underwritten public offering (Public Offering) of 13,207,521 shares (Public Shares) of our Common Stock and in lieu of Public Shares to certain investors, pre-funded warrants (Jan. 2024 Pre-funded Warrants) to purchase 3,008,694 shares of Common Stock. The price to the public for the Public Shares was $3.70 per Public Share, and the price to the public for the Jan. 2024 Pre-funded Warrants was $3.69 per Jan. 2024 Pre-funded Warrant, which represents the per share price for the Public Shares less the $0.01 per share exercise price for each such Jan. 2024 Pre-funded Warrant. Under the terms of the Underwriting Agreement, we granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 2,432,432 shares of Common Stock at the same price per share as the Public Shares, which such option was fully exercised by the Underwriters on January 18, 2024. The Public Offering closed on January 22, 2024.
The gross proceeds to us from the Public Offering were approximately $69.0 million, before underwriting discounts and commissions and estimated expenses of the Public Offering.
The Public Offering was made pursuant to our shelf registration statement on Form S-3 (File No. 333-275638), declared effective by the SEC on December 14, 2023, a base prospectus dated December 14, 2023, and the related prospectus supplement dated January 17, 2024.
The Jan. 2024 Pre-funded Warrants were exercisable at any time after the date of issuance. The exercise price and the number of shares of Common Stock issuable upon exercise of each Jan. 2024 Pre-funded Warrant were subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the Common Stock as well as upon any distribution of assets, including cash, stock or other property, to our stockholders. The Jan. 2024 Pre-funded Warrants did not have an expiration date and were exercisable in cash or by means of a cashless exercise. A holder of Jan. 2024 Pre-funded Warrants could not exercise such Jan. 2024 Pre-funded Warrants if the aggregate number of shares of Common Stock beneficially owned by such holder, together with its affiliates, would beneficially own more than 4.99% of the issued and outstanding shares of Common Stock following such exercise, as such percentage ownership is determined in accordance with the terms of the Jan. 2024 Pre-funded Warrants. A holder of Jan. 2024 Pre-funded Warrants could increase or decrease this percentage not in excess of 19.99% by providing at least 61 days’ prior notice to us. The holder of the Jan. 2024 Pre-Funded Warrants exercised all of the Jan. 2024 Pre-Funded Warrants during the fourth quarter of 2024 by means of the cashless exercise provision and within the other constraints noted above.
2023 ATM Agreement
On April 11, 2024, we sold shares of our Common Stock pursuant to that certain At Market Issuance Sales Agreement (2023 ATM Agreement), dated as of November 17, 2023, by and among us, Oppenheimer & Co. Inc., B. Riley Securities, Inc. and JonesTrading Institutional Services LLC. The sales resulted in gross proceeds to us of approximately $49.5 million. For additional information regarding the 2023 ATM Agreement, see our Form S-3 filed on November 17, 2023 and Form S-3/A filed on December 7, 2023.
26
Funding Requirements
We expect our expenses to increase in connection with our ongoing activities, particularly as we advance and expand preclinical activities, clinical trials and potential commercialization of our program candidates. Our costs are also expected to increase as we:
At March 31, 2025, we had cash, cash equivalents and short-term investments of $211.7 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned operations and capital investments into late 2026. Monthly operating expenses are budgeted to increase for research and development and general and administrative expenses as management works to implement our strategy to advance our clinical assets in our clinical trials and to progress our preclinical assets towards clinical trials. Management anticipates a significant increase of expenses, particularly in research and development, as we undertake these activities.
We expect we will need to raise additional capital until we are profitable, which may never occur. If no additional capital is raised through either additional public or private equity financings, debt financings, strategic relationships, alliances and licensing agreements, or a combination thereof, we may delay, limit or reduce discretionary spending in areas related to research and development activities and other general and administrative expenses in order to fund our operating costs and working capital needs.
We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We expect that we will require additional capital to pursue in-licenses or acquisitions of other program candidates. If we receive regulatory approvals for our program candidates, we expect to incur commercialization expenses related to program manufacturing, sales, marketing and distribution, depending on where we choose to commercialize or whether we commercialize jointly or on our own.
Because of the numerous risks and uncertainties associated with research, development and commercialization of our program candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:
27
Until such time, if ever, that we can generate program revenue sufficient to achieve profitability, we expect to finance our cash needs through a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through other third-party funding, strategic alliances, licensing arrangements, outright sales of program candidates or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we will be required to delay, limit, reduce or terminate our program development or future commercialization efforts or grant rights to develop and market programs or program candidates that we would otherwise prefer to develop and market ourselves.
Capital expenditures
Management regularly reviews our research and development and general and administrative functions to evaluate the most efficient deployment of capital to ensure that the appropriate materials, systems and personnel are available to support clinical trials, preclinical activities and product candidate supply.
Financing activities
When we do require capital in the future, we expect to finance our cash needs through sales of equity, possible strategic collaborations, debt financing or through other sources that may be dilutive to existing stockholders. Management anticipates that if it raises additional financing that it will be at a discount to the market price and it will be dilutive to stockholders.
Other Commitments and Contingencies
We presented our other commitments and contingencies in the 2024 Form 10-K. There have been no material changes outside of the ordinary course of business in those obligations during the three months ended March 31, 2025, other than those disclosed in Note 10, Commitments and Contingencies, to the condensed consolidated financial statements in this Form 10-Q.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements.
28
ITEM 3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company, as defined by Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the Exchange Act), and are not required to provide the information required under this item.
ITEM 4 – CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the design and operation of our disclosure controls and procedures, as such term is defined under Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as of March 31, 2025. Based on that evaluation, our principal executive officer and our principal financial officer concluded that the design and operation of our disclosure controls and procedures were effective. The design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote. However, management believes that our system of disclosure controls and procedures are designed to provide a reasonable level of assurance that the objectives of the system will be met.
Changes in Internal Control over Financial Reporting
There have not been any changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, during the most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
29
PART II - OTHER INFORMATION
ITEM 1 – LEGAL PROCEEDINGS
From time to time, we may be a party to legal proceedings or subject to claims arising in the ordinary course of business. We are not currently a party to any material legal proceedings, and we are not aware of any pending or threatened legal proceedings against us that we believe could have a material adverse effect on our business, operating results or financial condition.
ITEM 1A – RISK FACTORS
In the ordinary course of business, we are exposed to a variety of risks, any of which have affected or could materially adversely affect our business, financial condition, and results of operations. The market price of our securities could decline, possibly significantly or permanently, if one or more of these risks and uncertainties occur. Before you make a decision to buy our securities, in addition to the risks and uncertainties discussed above under “Cautionary Statement Regarding Forward-Looking Statements,” you should carefully consider the specific risk factors set forth in the “Risk Factors” section in the 2024 Form 10-K. We may also face other risks and uncertainties that are not presently known, are not currently believed to be material, or are not yet identified because they are common to all businesses. There have been no material changes to the risk factors disclosed in Part I, Item 1A of the 2024 Form 10-K.
ITEM 2 – UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3 – DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4 - MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5 – OTHER INFORMATION
Rule 10b5-1 Trading Arrangements
During the three months ended March 31, 2025, none of our directors or executive officers
30
ITEM 6 – EXHIBITS
Exhibits: |
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2.1 |
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2.2 |
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3.1 |
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3.2 |
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3.3 |
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10.1! |
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31.1* |
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31.2* |
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32** |
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101.INS* |
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Inline XBRL Instance Document |
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101.SCH* |
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Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Documents |
|
|
|
104 |
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
|
|
|
* |
|
Filed herewith |
** |
|
Furnished herewith |
! |
|
Denotes Management Contract or Compensatory Plan or Arrangement |
31
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.
Dated: May 12, 2025 |
|
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PERSPECTIVE THERAPEUTICS, INC., a Delaware corporation
|
|
|
/s/ Johan (Thijs) Spoor |
|
|
Johan (Thijs) Spoor |
|
|
Chief Executive Officer |
|
|
|
|
|
/s/ Juan Graham |
|
|
Juan Graham |
|
|
Chief Financial Officer (Principal Financial Officer) |
32