AKTS 10-Q
Aktis Oncology, Inc. (AKTS)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from __________________ to __________________
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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The |
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, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
The number of shares of Registrant’s Common Stock and Class A common stock outstanding as of July 31, 2026 was
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Forward-looking statements are neither historical facts nor assurances of future performance. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions intended to identify statements about the future, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, statements about the following:
We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions, including those described in Part II, Item 1A, “Risk Factors” of this Quarterly Report on Form 10-Q. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein for any reason after the date of this report to conform these statements to new information, future events or otherwise.
You should read this Quarterly Report on Form 10-Q and the documents we have filed with the SEC with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.
Note Regarding Trademarks
We are the owner of the U.S. federal trademark registrations ("®") and service marks, including AKTIS® and AKTIS ONCOLOGY. Other trademarks, trade names and service marks that may appear in this Form 10-Q are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Form 10-Q may be referred to without the ® or TM symbol, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.
TABLE OF CONTENTS
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Page |
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PART I. |
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Item 1. |
1 |
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1 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
2 |
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3 |
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4 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
5 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
14 |
Item 3. |
24 |
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Item 4. |
24 |
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PART II. |
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Item 1. |
25 |
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Item 1A. |
25 |
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Item 2. |
25 |
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Item 3. |
25 |
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Item 4. |
25 |
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Item 5. |
25 |
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Item 6. |
27 |
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28 |
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i
PART I—FINANCIAL INFORMATION
Item 1. Condensed Financial Statements.
AKTIS ONCOLOGY, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except shares and par value data)
(Unaudited)
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June 30, |
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December 31, |
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2026 |
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2025 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Marketable securities |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use assets |
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Restricted cash equivalents |
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Other assets |
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Total assets |
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$ |
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$ |
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Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses and other current liabilities |
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Deferred revenue, current portion |
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Operating lease liabilities, current portion |
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Total current liabilities |
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Deferred revenue, net of current portion |
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Operating lease liabilities, net of current portion |
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Total liabilities |
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Redeemable convertible preferred stock: |
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Series Seed redeemable convertible preferred stock, $ |
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Series A redeemable convertible preferred stock, $ |
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Series A-1 redeemable convertible preferred stock, $ |
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Series B redeemable convertible preferred stock, $ |
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Partner redeemable convertible preferred stock, $ |
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Stockholders' deficit: |
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Common stock, $ |
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Class A common stock, $ |
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Additional paid-in capital |
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Accumulated other comprehensive (loss) income |
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( |
) |
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Accumulated deficit |
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( |
) |
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( |
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Total stockholders' equity (deficit) |
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( |
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Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
1
AKTIS ONCOLOGY, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Revenue: |
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Collaboration revenue |
$ |
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$ |
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$ |
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$ |
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Operating expenses: |
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Research and development |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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( |
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( |
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( |
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( |
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Other income (expense): |
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Interest income |
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Other expense, net |
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( |
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( |
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( |
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( |
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Total other income, net |
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Net loss |
$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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Net loss per share - basic and diluted |
$ |
( |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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Weighted-average common stock outstanding, basic and diluted |
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Comprehensive loss: |
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Net loss |
$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
Other comprehensive loss: |
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Net unrealized loss on marketable securities held |
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( |
) |
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( |
) |
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( |
) |
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( |
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Comprehensive loss |
$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
AKTIS ONCOLOGY, INC.
CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
(In thousands, except share amounts)
(Unaudited)
|
Series Seed Redeemable Convertible Preferred Stock |
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Series A Redeemable Convertible Preferred Stock |
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Series A-1 Redeemable Convertible Preferred Stock |
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Series B Redeemable Convertible Preferred Stock |
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Partner Redeemable Convertible Preferred Stock |
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Common Stock |
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Class A Common Stock |
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Additional Paid-in |
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Accumulated Other Comprehensive Income |
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Accumulated |
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Total Stockholders' (Deficit) |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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(Loss) |
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Deficit |
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Equity |
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Balance as of 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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$ |
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$ |
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$ |
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$ |
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$ |
( |
) |
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( |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Exercise of common stock options |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Unrealized loss on marketable securities |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance as of March 31, 2025 |
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( |
) |
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( |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Unrealized loss on marketable securities |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance as of June 30, 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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$ |
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$ |
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$ |
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$ |
( |
) |
$ |
( |
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$ |
( |
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Balance as of December 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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$ |
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$ |
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$ |
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$ |
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$ |
( |
) |
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( |
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Conversion of redeemable convertible preferred stock to common stock upon closing of initial public offering |
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( |
) |
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( |
) |
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( |
) |
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( |
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( |
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( |
) |
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( |
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( |
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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 from initial public offering, net of issuance costs of $ |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Exercise of common stock options |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Unrealized loss on marketable securities |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Balance as of March 31, 2026 |
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( |
) |
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( |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Exercise of common stock options |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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|
|
|||
Unrealized loss on marketable securities |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
— |
|
|
( |
) |
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
( |
) |
|
( |
) |
Balance as of June 30, 2026 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
$ |
|
|
|
$ |
|
$ |
|
$ |
( |
) |
$ |
( |
) |
$ |
|
||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
AKTIS ONCOLOGY, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
|
|
Six Months Ended June 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Cash flows used in operating activities |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash flows used in operating activities: |
|
|
|
|
|
|
||
Depreciation and amortization |
|
|
|
|
|
|
||
Stock-based compensation |
|
|
|
|
|
|
||
Net amortization of premiums and accretion of discounts on investments in marketable securities |
|
|
( |
) |
|
|
( |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
|
( |
) |
|
|
( |
) |
Interest receivable |
|
|
( |
) |
|
|
( |
) |
Operating lease right-of-use assets |
|
|
|
|
|
|
||
Other assets |
|
|
( |
) |
|
|
( |
) |
Accounts payable |
|
|
|
|
|
|
||
Accrued expenses and other current liabilities |
|
|
|
|
|
|
||
Operating lease liabilities |
|
|
( |
) |
|
|
( |
) |
Deferred revenue |
|
|
( |
) |
|
|
( |
) |
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
Cash flows (used in) provided by investing activities |
|
|
|
|
|
|
||
Purchases of marketable securities |
|
|
( |
) |
|
|
( |
) |
Proceeds from maturities of marketable securities |
|
|
|
|
|
|
||
Purchases of property and equipment |
|
|
( |
) |
|
|
( |
) |
Net cash (used in) provided by investing activities |
|
|
( |
) |
|
|
|
|
Cash flows provided by (used in) financing activities |
|
|
|
|
|
|
||
Proceeds from initial public offering, net of underwriter discounts and commissions paid during the period |
|
|
|
|
|
|
||
Payment of offering costs |
|
|
( |
) |
|
|
( |
) |
Proceeds from exercise of common stock options |
|
|
|
|
|
|
||
Net cash provided by (used in) financing activities |
|
|
|
|
|
( |
) |
|
Net increase in cash, cash equivalents, and restricted cash equivalents |
|
|
|
|
|
|
||
Cash, cash equivalents, and restricted cash equivalents at beginning of period |
|
|
|
|
|
|
||
Cash, cash equivalents, and restricted cash equivalents at end of period |
|
$ |
|
|
$ |
|
||
Reconciliation of cash, cash equivalents, and restricted cash equivalents |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Long-term restricted cash equivalents |
|
|
|
|
|
|
||
Total cash, cash equivalents, and restricted cash equivalents |
|
$ |
|
|
$ |
|
||
Supplemental disclosure of non-cash investing and financing activities: |
|
|
|
|
|
|
||
Remeasurement of right-of-use asset and lease liability due to lease modification |
|
$ |
|
|
$ |
|
||
Conversion of redeemable convertible preferred stock into common stock upon closing of initial public offering |
|
$ |
|
|
$ |
|
||
Deferred offering costs transferred to additional paid in capital |
|
$ |
|
|
$ |
|
||
Purchases of property and equipment included in accounts payable |
|
$ |
|
|
$ |
|
||
Purchases of property and equipment included in accrued expenses |
|
$ |
|
|
$ |
|
||
Net unrealized loss on marketable securities |
|
$ |
( |
) |
|
$ |
( |
) |
Deferred offering costs included in accrued expenses |
|
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
AKTIS ONCOLOGY, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except for per share and share amounts)
(Unaudited)
1. Nature of the business and basis of presentation
Aktis Oncology, Inc. (“Aktis” or the “Company”) was incorporated under the laws of the State of Delaware in August 2020. Its principal office is in Boston, Massachusetts. Aktis Security Corporation, its wholly owned subsidiary, was formed under the laws of the State of Delaware in November 2022. The Company is a clinical-stage oncology company focused on unlocking the breakthrough potential of targeted radiopharmaceuticals for large patient populations not currently addressed by existing technologies. The Company has built a proprietary miniprotein radioconjugate platform that aims to safely confer breakthrough efficacy to a broader range of patient populations.
Risks and uncertainties
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, the outcome of clinical trials, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technologies, compliance with government regulations, ability to secure additional capital to fund operations, and potential delays associated with the Company’s anticipated and planned trials.
There can be no assurance that the Company will be able to successfully complete the development of, or receive regulatory approval for, any products developed, and if approved, that any products will be commercially viable. Any products resulting from the Company’s current research and development efforts will require significant additional research and development, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts will require significant amounts of additional capital, adequate personnel, infrastructure, and extensive compliance reporting capabilities. The Company has not generated any revenue from the sale of any products to date. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
Reverse Stock Split
Initial Public Offering
In January 2026, the Company completed its initial public offering ("IPO"), in which the Company sold an aggregate of
In connection with the closing of the IPO, the Company's certificate of incorporation was amended and restated to authorize
Liquidity
In accordance with Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties About an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there are conditions and events that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the condensed consolidated financial statements are issued. The accompanying condensed consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business.
The Company has incurred losses since inception, including net losses of $
5
The Company has evaluated whether there are certain conditions and events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern within the twelve months after the date that these condensed consolidated financial statements are issued. The Company believes that its existing cash, cash equivalents, and marketable securities of $
Basis of presentation and consolidation
The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The accompanying condensed consolidated financial statements include the accounts of the Company’s wholly owned subsidiary, Aktis Security Corporation. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and ASUs of the Financial Accounting Standards Board (“FASB”).
2. Summary of significant accounting policies
The Company’s significant accounting policies are disclosed in Note 2, “Summary of significant accounting policies,” in the audited consolidated annual financial statements in the Annual Report on Form 10-K for the year ended December 31, 2025 (the "Annual Report"), which was filed with the Securities and Exchange Commission ("SEC") on March 30, 2026. Since the date of those annual financial statements, there have been no changes to the Company’s significant accounting policies, except as noted below.
Unaudited interim financial information
The accompanying condensed consolidated balance sheet as of June 30, 2026, and the condensed consolidated statements of operations and comprehensive loss, condensed consolidated statements of redeemable convertible preferred stock and stockholders’ equity (deficit) and condensed consolidated statements of cash flows for the six months ended June 30, 2026 and 2025 are unaudited. The condensed consolidated interim financial statements have been prepared on the same basis as the December 31, 2025 and 2024 audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary for the fair presentation of the Company’s financial position as of June 30, 2026. The results for the three and six months ended June 30, 2026 are not necessarily indicative of results to be expected for the year ending December 31, 2026, or for any other subsequent period.
Recent accounting pronouncements not yet adopted
In November 2024, the FASB issued ASU No. 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures, ("ASU 2024-03"). ASU 2024-03 requires disclosure of additional information about specific expense categories in the notes to the financial statements on an interim and annual basis. The standard is effective for fiscal years beginning after December 15, 2026, and for interim periods beginning after December 15, 2027, with prospective or retrospective application and early adoption permitted. The Company is currently evaluating the disclosure requirements related to this new standard.
3. Fair value measurements
The following table sets forth by level, within the fair value hierarchy, the financial assets and liabilities carried at fair value on a recurring basis (in thousands):
|
|
Fair Value Measurements as of June 30, 2026 |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Financial assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Commercial paper |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Treasury bills |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Agency bonds |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Restricted cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total financial assets |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
6
|
|
Fair Value Measurements as of December 31, 2025 |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Financial assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Commercial paper |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Treasury bills |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Agency bonds |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Restricted cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total financial assets |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
During the three and six months ended June 30, 2026, there were
Valuation of marketable securities
The Company classifies its treasury bills as Level 1 assets under the fair value hierarchy, as these securities have been valued using quoted market prices for identical assets in active markets without any valuation adjustment. The Company classifies its commercial paper, corporate debt securities, and agency bonds as Level 2 assets under the fair value hierarchy, as these assets have been valued using quoted prices in active markets for similar securities.
4. Marketable securities
As of June 30, 2026 and December 31, 2025, the Company’s security portfolio consisted of
Marketable securities, which are classified as available-for-sale, consisted of the following (in thousands):
|
|
June 30, 2026 |
|
|||||||||||||
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
||||
Commercial paper |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Treasury bills |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Corporate debt securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Agency bonds |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total marketable securities |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
|
|
December 31, 2025 |
|
|||||||||||||
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
||||
Commercial paper |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Treasury bills |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt securities |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Agency bonds |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total marketable securities |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
7
5. Property and equipment, net
Property and equipment consisted of the following (in thousands):
|
June 30, |
|
|
December 31, |
|
||
|
2026 |
|
|
2025 |
|
||
Laboratory equipment |
$ |
|
|
$ |
|
||
Computer equipment |
|
|
|
|
|
||
Computer software |
|
|
|
|
|
||
Office equipment & furniture |
|
|
|
|
|
||
Leasehold improvements |
|
|
|
|
|
||
Assets under construction |
|
|
|
|
|
||
Total property and equipment |
|
|
|
|
|
||
Less: Accumulated depreciation and amortization |
|
( |
) |
|
|
( |
) |
Property and equipment, net |
$ |
|
|
$ |
|
||
The Company recorded depreciation expense of $
6. Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
|
June 30, |
|
|
December 31, |
|
||
|
2026 |
|
|
2025 |
|
||
Accrued compensation and benefit costs |
$ |
|
|
$ |
|
||
Accrued research and development costs |
|
|
|
|
|
||
Accrued professional costs |
|
|
|
|
|
||
Other accrued expenses |
|
|
|
|
|
||
Total accrued expenses and other current liabilities |
$ |
|
|
$ |
|
||
7. Stockholders’ deficit
Common stock and Class A common stock
Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders provided, however, that, except as otherwise required by law, holders of common stock are not entitled to vote on any amendment to the Company’s Certificate of Incorporation that relates solely to the terms of one or more outstanding series of Class A common stock or preferred stock if the holders of such affected series are entitled, either separately or together with the holders of one or more other such series, to vote thereon pursuant to the Certificate of Incorporation or pursuant to the Delaware General Corporation Law. Each share of Class A common stock is non-voting. There is no cumulative voting. Both common stockholders and Class A common stockholders are entitled to receive dividends, as may be declared by the Company’s Board, if any. Through June 30, 2026,
8
The Company’s common stock available for future issuance is summarized below:
|
June 30, |
|
|
December 31, |
|
||
|
2026 |
|
|
2025 |
|
||
Common stock authorized |
|
|
|
|
|
||
Common stock outstanding |
|
|
|
|
|
||
Common stock authorized and reserved for future issuances: |
|
|
|
|
|
||
Series Seed preferred stock |
|
|
|
|
|
||
Series A preferred stock |
|
|
|
|
|
||
Series A-1 preferred stock |
|
|
|
|
|
||
Series B preferred stock |
|
|
|
|
|
||
Partner preferred stock |
|
|
|
|
|
||
Stock options outstanding |
|
|
|
|
|
||
Common stock reserved for future grant under the 2020 Equity Incentive Plan |
|
|
|
|
|
||
Common stock reserved for future grant under the 2026 Equity Incentive Plan |
|
|
|
|
|
||
Common stock reserved for future grant under the 2026 Employee Stock Purchase Plan |
|
|
|
|
|
||
Total common stock authorized and reserved for future issuance |
|
|
|
|
|
||
Unreserved common stock available for future issuance |
|
|
|
|
|
||
8
2020 Equity Incentive Plan
The Company’s 2020 Equity Incentive Plan, as amended (the “2020 Plan”), provided for the Company to sell or issue common stock or restricted common stock, and other awards, as determined by the Board, to employees, non-employees and directors of the Company. As of the effective date of the 2026 Equity Incentive Plan (the “2026 Plan”), and as of June 30, 2026, there were
2026 Equity Incentive Plan
In January 2026, the Board and the Company's stockholders adopted and approved the 2026 Plan, which became effective on January 8, 2026. The 2026 Plan initially reserved
2026 Employee Stock Purchase Plan
In January 2026, the Board and the Company's stockholders adopted and approved the 2026 Employee Stock Purchase Plan (the "2026 ESPP"), which became effective on January 8, 2026. The 2026 ESPP initially reserved
9
Stock Option Activity
The following table summarizes the stock option activity during the six months ended June 30, 2026:
|
|
Number of |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
Outstanding as of January 1, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Exercised |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
|
||
Cancelled |
|
|
( |
) |
|
|
|
|
|
— |
|
|
|
— |
|
|
Outstanding as of June 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Options vested and exercisable as of |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Options unvested and expected to vest as of |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Compensation cost is recognized on a straight-line basis over the requisite service period. As of June 30, 2026, the total unrecognized compensation cost related to unvested stock option awards was $
The weighted-average grant date fair value per share of stock options granted during the six months ended June 30, 2026 and 2025 was $
The following table presents, on a weighted-average basis, the assumptions used in the Black-Scholes option-pricing model to determine the grant-date fair value of the stock options granted during the periods ended:
|
|
June 30, |
|
|
June 30, |
|
||
|
|
2026 |
|
|
2025 |
|
||
Expected term (in years) |
|
|
|
|
|
|
||
Risk-free interest rate |
|
|
% |
|
|
% |
||
Expected volatility |
|
|
% |
|
|
% |
||
Dividend yield |
|
|
|
|
|
|
||
Stock-based compensation expense
The following table summarizes stock-based compensation expense included in operating expenses (in thousands):
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
9. Income taxes
The Company did not record a provision or benefit for income taxes during the three and six months ended June 30, 2026 and 2025. The Company continues to maintain a full valuation allowance against its U.S. federal and state deferred tax assets as it is more likely than not that such assets will not be realized in the future.
As of June 30, 2026 and December 31, 2025, the Company had
10
10. License agreements
The Company has entered into several license agreements with third parties that typically involve payments from the Company, including upfront payments, milestone payments and royalty payments. The terms and conditions as well as accounting analysis for the Company’s significant license agreements are described in Note 11, “License agreements” in the audited consolidated annual financial statements for the years ended December 31, 2025. As of June 30, 2026,
11. Collaboration revenue
Eli Lilly collaboration agreement
In May 2024, the Company entered into the Collaboration Agreement with Eli Lilly and Company ("Eli Lilly") to generate anticancer radiopharmaceuticals using the Company's novel miniprotein technology platform. The terms and conditions as well as accounting analysis for the Company’s Collaboration Agreement are described in Note 12, “Collaboration revenue” in the audited consolidated annual financial statements for the year ended December 31, 2025.
The Company recognized $
12. Commitments and contingencies
Legal proceedings
The Company was not subject to any material legal proceedings during the six months ended June 30, 2026 and 2025, and the Company is not aware of any material legal proceedings that are currently pending or threatened.
Royalty transfer agreement
On August 27, 2020, the Company entered into a royalty transfer agreement (the "Royalty Transfer Agreement") with MPM Oncology Charitable Foundation, Inc. (the “MPM Charitable Foundation”), an affiliate of a stockholder holding more than 5% of the total outstanding stock of the Company, and the UBS Optimus Foundation (“UBS" and together with MPM Charitable Foundation, the “Charitable Foundations”). Pursuant to the Royalty Transfer Agreement, the Company will pay
The Company’s payment obligations to MPM Charitable Foundation will terminate immediately upon authorization of the MPM Charitable Foundation's board of directors (or similar body) or upon the winding up or dissolution of MPM Charitable Foundation. The Company’s payment obligations to UBS will terminate immediately upon the winding up of Oncology Impact Fund 2, L.P., a Cayman Islands exempt limited partnership which is affiliated with MPM Charitable Foundation.
The Company will record a liability when the associated net sales are generated.
13. Leases
Operating leases
In March 2021, the Company entered into a lease agreement for a research and development laboratory and related office space located in Durham, North Carolina (the "Durham Lease"). The Durham Lease was extended with a revised termination date of
In January 2022, the Company entered into a lease for office, laboratory and storage space located in Boston, Massachusetts. The lease is set to expire
11
14. Net loss per share
Basic and diluted net loss per share attributable to common stockholders was calculated as follows for the periods presented (in thousands, except share and per share amounts):
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Net loss attributable to common stockholders, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted-average number of common stock used in net loss per share, basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share of common stock, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
The Company’s potentially dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common stock outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same.
As the liquidation and dividend rights are identical for the Company's common stock and Class A common stock, the undistributed earnings are allocated on a proportionate basis and the resulting amount per share for the Company's common stock and Class A common stock was the same for the three and six months ended June 30, 2026. The Company only had one class of common stock outstanding as of June 30, 2025.
The following outstanding potentially dilutive securities have been excluded from the computation of diluted net loss per share attributable to common stockholders, as including them would have had an anti-dilutive effect:
|
|
Six Months Ended June 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Preferred Stock |
|
|
|
|
|
|
||
Options to purchase common stock |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
15. Segment information
The Company has
The chief operating decision-maker (“CODM”) manages the Company’s operations on a consolidated basis and assesses performance based on consolidated net loss, which is reported on the condensed consolidated statements of operations.
Certain segment information for prior periods has been recast to conform to the current period presentation. The recast did not impact the Company's previously reported consolidated results of operations.
12
The following information represents significant segment expenses regularly provided to the CODM with the following categories (in thousands):
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Collaboration revenue |
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Direct external research and development expenses: |
|
|
|
|
|
|
|
|
|
|
|
||||
Discovery and development |
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
[225Ac]Ac-AKY-1189 |
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
[225Ac]Ac-AKY-2519 |
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Unallocated research and development expenses: |
|
|
|
|
|
|
|
|
|
|
|
||||
Employee-related (including stock-based compensation) |
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Information technology, facilities, office and other 1 |
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
General and administrative expenses: |
|
|
|
|
|
|
|
|
|
|
|
||||
Employee-related (including stock-based compensation) |
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Professional and consulting |
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Information technology, facilities, office and other 1 |
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Other segment items 2 |
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
13
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 our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q (the "Quarterly Report") and our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the Securities and Exchange Commission (the "SEC") on March 30, 2026 (the "Annual Report"). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report and the “Risk Factors” section of our Annual Report, our actual results could differ materially from the results described in, or implied by, these forward-looking statements.
Overview
We are a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies. The field of targeted radiopharmaceuticals is currently led by two marketed products that illustrated that transformative survival outcomes and quality-of-life benefits can be conferred by delivering radioisotopes to solid tumors. These leading products, which target prostate-specific membrane antigen or somatostatin-2 receptor, are each currently approved in only one tumor type, but in those indications, have seen considerable commercial uptake and have become fundamental pillars of cancer treatment. Despite these advances, we believe that the field of radiopharmaceuticals is still in its infancy, with many emerging companies still primarily focused on these same two targets. In contrast, we see a significant opportunity to broaden the cancer patient populations benefiting from targeted radiopharmaceuticals by developing next-generation technologies that expand the scope of tumor targets for which it is possible to safely deliver a powerful payload of an alpha-emitting radioisotope. To ensure patient demand is reliably met, we are also establishing efficient end-to-end supply, with a combination of critical internal capabilities paired with experienced external vendors. Through these efforts, we seek to maximize clinical utility across multiple indications in multiple tumor types, and to expand the commercial uptake of radiopharmaceuticals beyond the traditional nuclear medicine setting and into the more expansive clinical oncology setting.
Since our inception in August 2020, we have devoted substantially all of our resources to developing our miniprotein radioconjugate platform, identifying and developing our product candidates and programs, establishing and protecting our intellectual property, conducting research and development activities, building our supply chain and manufacturing capabilities, organizing and staffing our company, raising capital and providing general and administrative support for these operations. We do not have any products approved for commercial sale and have not generated any revenues from product sales. We have funded our operations primarily with proceeds from the issuance and sale of our redeemable convertible preferred stock and upfront payments from a Research and Collaboration Agreement, the Collaboration Agreement, with Eli Lilly and Company, or Eli Lilly, and have received aggregate net proceeds of $345.5 million from the sale of our redeemable convertible preferred stock, $60.0 million in upfront payments upon entering into the Collaboration Agreement, and $1.0 million upon achieving the first development milestone under the Collaboration Agreement. In January 2026, we completed our IPO of 20,297,500 shares of common stock, which included 2,647,500 shares of common stock sold pursuant to the underwriters' full exercise of their option to purchase additional shares. We received net proceeds from the IPO of $334.4 million after deducting underwriter discounts, commissions and other offering expenses.
We have incurred significant operating losses in every year since inception and we expect to continue to incur substantial losses for the foreseeable future. Our ability to generate revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. As of June 30, 2026, we had an accumulated deficit of $199.0 million and our net losses were $42.5 million and $33.1 million for the six months ended June 30, 2026 and 2025, respectively. We expect our expenses and operating losses will increase substantially as we:
14
In addition, we have several clinical development, regulatory, and commercial milestones, as well as royalty payment obligations under our licensing arrangements. Our net losses may fluctuate significantly from quarter to quarter and year to year, depending on the timing of our ongoing and planned clinical trials and our expenditures on other research and development activities.
We do not have any products approved for sale and have not generated any revenue from product sales. We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our current and any future product candidates, which we expect will take a number of years or may never occur. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings or other capital sources, including collaborations, licenses or other strategic arrangements. See “—Liquidity and capital resources.” We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates, or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
Due to the numerous risks and uncertainties associated with the development of radiopharmaceutical candidates, we are unable to accurately predict the timing or amount of increased expenses or the timing of when, or if, we will be able to achieve or maintain profitability. Even if we generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
As of June 30, 2026, we had cash, cash equivalents, and marketable securities of $517.3 million. Based upon our current operating plans, we believe our existing cash, cash equivalents, and marketable securities will be sufficient to fund our operations into 2029. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. See the sections titled “—Liquidity and capital resources” and “Risk Factors” included elsewhere in this Quarterly Report.
License and collaboration agreements
We may incur contingent regulatory and development milestones, commercial milestones and royalty payments that we are required to make under our license and collaboration agreements, in which the amounts to be paid by us are not fixed or determinable at this time. For a more detailed description of these agreements, see Notes 11 and 12 to our audited consolidated financial statements in the Annual Report. There have been no material changes to the terms and conditions, or accounting conclusions, previously disclosed in the Annual Report.
Components of results of operations
Revenue
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the near future, if ever. Substantially all of our revenue to date has been derived from the work performed under the Collaboration Agreement.
If our development efforts for our current or future product candidates are successful and result in regulatory approval or if we enter into additional license or collaboration agreements with third parties, we may generate revenue in the future from product sales, payments from such license or collaboration agreements, or any combination thereof. We cannot predict if, when or to what extent we will generate revenue as we may never succeed in obtaining regulatory approval for any of our product candidates. If we fail to complete preclinical and clinical development of our current or future product candidates or fail to obtain regulatory approval for any that successfully
15
complete clinical trials, our ability to generate future revenues, and our results of operations and financial position would be adversely affected.
Operating expenses
Research and development expenses
We recognize research and development expenses in the periods in which they are incurred. Research and development expenses consist primarily of employee-related costs and other internal and external costs associated with our discovery and development efforts and the preclinical development of our current and future product candidates. In particular, our research and development expenses include:
We track direct external research and development expenses by stage of program, clinical or preclinical. We expect to report external research and development expenses for each clinical drug candidate following development candidate designation. Our internal research and development expenses are deployed across multiple programs and, as such, are not separately tracked. Significant judgments and estimates are made in determining the accrued, or prepaid expense balances at the end of any reporting period.
Research and development activities are central to our business model. We expect that our research and development expenses will continue to increase for the foreseeable future as we advance our product candidates into and through clinical development and as we continue to develop additional product candidates. We expect to fund our research and development expenses from our current cash, cash equivalents, investments in marketable securities, and a combination of public and private equity offerings, debt financings, or other sources of capital, which may include additional collaborations with other companies, marketing, distribution, or licensing arrangements with third parties, or other similar arrangements.
General and administrative expenses
General and administrative expenses consist primarily of employee-related costs, including salaries, bonuses, benefits, and stock-based compensation expenses for personnel in executive, finance, accounting, human resources, and other administrative functions. General and administrative expenses also include professional and consulting expenses, including legal fees relating to patent, intellectual property, and corporate matters, professional fees for accounting, audit, and consulting services, and facility and depreciation expenses, including expenses for rent, director and officer insurance expenses, and other operating costs not included in research and development. We recognize general and administrative expenses in the periods in which they are incurred.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our expansion of the business. We also anticipate that we will incur significantly increased accounting, audit, legal, regulatory, compliance, and director and officer insurance costs as well as investor and public relations expenses associated with operating as a public company.
Other income, net
Other income, net consists of interest earned, the accretion or amortization of discount or premiums on our cash equivalents and investments in marketable securities on investments classified as available-for-sale, and realized and unrealized foreign currency transaction losses.
16
Income taxes
Since our inception, we have not recorded any income tax benefits or expense for the net losses we have incurred in each period or for our earned research and development tax credits, as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss carryforwards and tax credits will not be realized. As of December 31, 2025, we had net operating loss carryforwards, or NOLs, for federal and state income tax purposes of $45.8 million and $40.8 million, respectively. The federal NOLs are not subject to expiration and the state NOLs begin to expire in 2041. These loss carryforwards are available to reduce future federal taxable income, if any. As of the three and six months ended June 30, 2026 and 2025, we have recorded a full valuation allowance against our net deferred tax assets.
Results of operations
Comparison of the three months ended June 30, 2026 and 2025
The following table summarizes our results of operations (in thousands):
|
|
Three Months Ended |
|
|
|
|
||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Revenue: |
|
|
|
|
|
|
|
|
|
|||
Collaboration revenue |
|
$ |
3,384 |
|
|
$ |
1,601 |
|
|
$ |
1,783 |
|
Total revenue |
|
|
3,384 |
|
|
|
1,601 |
|
|
|
1,783 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
|
25,280 |
|
|
|
18,628 |
|
|
|
6,652 |
|
General and administrative |
|
|
7,003 |
|
|
|
3,936 |
|
|
|
3,067 |
|
Total operating expenses |
|
|
32,283 |
|
|
|
22,564 |
|
|
|
9,719 |
|
Loss from operations |
|
|
(28,899 |
) |
|
|
(20,963 |
) |
|
|
(7,936 |
) |
Total other income, net |
|
|
4,755 |
|
|
|
2,888 |
|
|
|
1,867 |
|
Net loss |
|
$ |
(24,144 |
) |
|
$ |
(18,075 |
) |
|
$ |
(6,069 |
) |
Revenue
Collaboration revenue was $3.4 million and $1.6 million for the three months ended June 30, 2026 and 2025, respectively, driven by revenue recognized from our Collaboration Agreement with Eli Lilly, which is recognized over time using the cost incurred input method.
Research and development expenses
The following table summarizes our research and development expenses (in thousands):
|
|
Three Months Ended |
|
|
|
|
||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Direct external research and development expenses: |
|
|
|
|
|
|
|
|
|
|||
Discovery and development |
|
$ |
2,610 |
|
|
$ |
4,523 |
|
|
$ |
(1,913 |
) |
[225Ac]Ac-AKY-1189 |
|
|
6,516 |
|
|
|
2,934 |
|
|
|
3,582 |
|
[225Ac]Ac-AKY-2519 |
|
|
4,271 |
|
|
|
1,755 |
|
|
|
2,516 |
|
Unallocated research and development expenses: |
|
|
|
|
|
|
|
|
|
|||
Employee-related (including stock-based compensation) |
|
|
7,565 |
|
|
|
5,593 |
|
|
|
1,972 |
|
Facility, lab and depreciation |
|
|
3,732 |
|
|
|
3,196 |
|
|
|
536 |
|
Other research and development related expenses |
|
|
586 |
|
|
|
627 |
|
|
|
(41 |
) |
Total research and development expenses |
|
$ |
25,280 |
|
|
$ |
18,628 |
|
|
$ |
6,652 |
|
Research and development expenses were $25.3 million for the three months ended June 30, 2026, compared to $18.6 million for the comparable prior year period. The increase of $6.7 million was primarily due to:
17
General and administrative expenses
The following table summarizes our general and administrative expenses (in thousands):
|
|
Three Months Ended |
|
|
|
|
||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Employee-related (including stock-based compensation) |
|
$ |
3,339 |
|
|
$ |
2,003 |
|
|
$ |
1,336 |
|
Professional and consulting |
|
|
3,065 |
|
|
|
1,678 |
|
|
|
1,387 |
|
Facility, depreciation, and other |
|
|
599 |
|
|
|
255 |
|
|
|
344 |
|
Total general and administrative expenses |
|
$ |
7,003 |
|
|
$ |
3,936 |
|
|
$ |
3,067 |
|
General and administrative expenses were $7.0 million for the three months ended June 30, 2026, compared to $3.9 million for the comparable prior year period. The increase of $3.1 million was primarily due to an increase in employee-related costs (including stock-based compensation) attributable to our increased headcount, as well as higher professional and consulting costs and director and officer insurance costs associated with operating as a public company.
Other income, net
Other income, net was $4.8 million for the three months ended June 30, 2026, compared to $2.9 million for the comparable prior year period. The increase of $1.9 million was primarily driven by an increase in interest income earned due to higher average balances in cash equivalents and marketable securities during the three months ended June 30, 2026 compared to the comparable prior year period.
Comparison of the six months ended June 30, 2026 and 2025
The following table summarizes our results of operations (in thousands):
|
|
Six Months Ended |
|
|
|
|
||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Revenue: |
|
|
|
|
|
|
|
|
|
|||
Collaboration revenue |
|
$ |
6,611 |
|
|
$ |
3,048 |
|
|
$ |
3,563 |
|
Total revenue |
|
|
6,611 |
|
|
|
3,048 |
|
|
|
3,563 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
|
45,316 |
|
|
|
34,491 |
|
|
|
10,825 |
|
General and administrative |
|
|
12,900 |
|
|
|
7,663 |
|
|
|
5,237 |
|
Total operating expenses |
|
|
58,216 |
|
|
|
42,154 |
|
|
|
16,062 |
|
Loss from operations |
|
|
(51,605 |
) |
|
|
(39,106 |
) |
|
|
(12,499 |
) |
Total other income, net |
|
|
9,136 |
|
|
|
6,046 |
|
|
|
3,090 |
|
Net loss |
|
$ |
(42,469 |
) |
|
$ |
(33,060 |
) |
|
$ |
(9,409 |
) |
Revenue
Collaboration revenue was $6.6 million and $3.0 million for the six months ended June 30, 2026 and 2025, respectively, driven by revenue recognized from our Collaboration Agreement with Eli Lilly, which is recognized over time using the cost incurred input method.
18
Research and development expenses
The following table summarizes our research and development expenses (in thousands):
|
|
Six Months Ended |
|
|
|
|
||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Direct external research and development expenses: |
|
|
|
|
|
|
|
|
|
|||
Discovery and development |
|
$ |
5,169 |
|
|
$ |
8,241 |
|
|
$ |
(3,072 |
) |
[225Ac]Ac-AKY-1189 |
|
|
10,261 |
|
|
|
5,841 |
|
|
|
4,420 |
|
[225Ac]Ac-AKY-2519 |
|
|
7,256 |
|
|
|
2,510 |
|
|
|
4,746 |
|
Unallocated research and development expenses: |
|
|
|
|
|
|
|
|
|
|||
Employee-related (including stock-based compensation) |
|
|
14,955 |
|
|
|
10,889 |
|
|
|
4,066 |
|
Facility, lab and depreciation |
|
|
6,754 |
|
|
|
5,983 |
|
|
|
771 |
|
Other research and development related expenses |
|
|
921 |
|
|
|
1,027 |
|
|
|
(106 |
) |
Total research and development expenses |
|
$ |
45,316 |
|
|
$ |
34,491 |
|
|
$ |
10,825 |
|
Research and development expenses were $45.3 million for the six months ended June 30, 2026, compared to $34.5 million for the comparable prior year period. The increase of $10.8 million was primarily due to:
General and administrative expenses
The following table summarizes our general and administrative expenses (in thousands):
|
|
Six Months Ended |
|
|
|
|
||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|||
Employee-related (including stock-based compensation) |
|
$ |
6,763 |
|
|
$ |
3,998 |
|
|
$ |
2,765 |
|
Professional and consulting |
|
|
4,982 |
|
|
|
3,029 |
|
|
|
1,953 |
|
Facility, depreciation, and other |
|
|
1,155 |
|
|
|
636 |
|
|
|
519 |
|
Total general and administrative expenses |
|
$ |
12,900 |
|
|
$ |
7,663 |
|
|
$ |
5,237 |
|
General and administrative expenses were $12.9 million for the six months ended June 30, 2026, compared to $7.7 million for the comparable prior year period. The increase of $5.2 million was primarily due to an increase in employee-related costs (including stock-based compensation) attributable to our increased headcount, as well as higher professional and consulting costs and director and officer insurance costs associated with operating as a public company.
Other income, net
Other income, net was $9.1 million for the six months ended June 30, 2026, compared to $6.0 million for the comparable prior year period. The increase of $3.1 million was primarily driven by an increase in interest income earned due to higher average balances in cash equivalents and marketable securities during the six months ended June 30, 2026 compared to the comparable prior year period.
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Liquidity and capital resources
Sources of liquidity
Since our inception, we have incurred significant operating losses. We have not generated any revenue from product sales and we do not expect to generate revenue from sales of products in the near term, if at all. We expect to incur significant expenses and operating losses for the foreseeable future as we advance our product candidates into and through clinical development and as we continue to develop additional product candidates. As such, we expect our research and development and general and administrative expenses to continue to increase significantly, including the costs associated with operating as a public company. As a result, we will need additional capital to fund our operations, which we may obtain from additional equity or debt financings or strategic agreements.
In January 2026, we raised aggregate net proceeds of $334.4 million from the sale of shares of common stock in our initial public offering, after deducting underwriter discounts, commissions and other offering costs. As of June 30, 2026, we had cash, cash equivalents, and marketable securities of $517.3 million.
Cash flows
The following table sets forth a summary of the net cash flow activity (in thousands):
|
|
Six Months Ended |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Net cash used in operating activities |
|
$ |
(44,829 |
) |
|
$ |
(33,662 |
) |
Net cash (used in) provided by investing activities |
|
|
(248,167 |
) |
|
|
107,186 |
|
Net cash provided by (used in) financing activities |
|
|
337,703 |
|
|
|
(468 |
) |
Net increase in cash, cash equivalents, and restricted cash |
|
$ |
44,707 |
|
|
$ |
73,056 |
|
Operating activities
Net cash used in operating activities was $44.8 million for the six months ended June 30, 2026, primarily consisting of our net loss of $42.5 million and net changes in operating assets and liabilities of $8.6 million, offset by non-cash charges of $6.2 million related to accretion of investment discounts, stock-based compensation and depreciation.
Net cash used in operating activities was $33.7 million for the six months ended June 30, 2025, primarily consisting of our net loss of $33.1 million, changes in operating assets and liabilities of $1.2 million, offset by non-cash charges of $0.6 million related to accretion of investment discounts, stock-based compensation and depreciation.
Investing activities
Net cash used in investing activities was $248.2 million for the six months ended June 30, 2026, primarily consisting of purchases of marketable securities and property and equipment of $300.4 million and $3.1 million, respectively, partially offset by the maturities of marketable securities of $55.4 million.
Net cash provided by investing activities was $107.2 million for the six months ended June 30, 2025, primarily consisting of maturities of marketable securities of $121.4 million, partially offset by purchases of marketable securities and property and equipment of $10.8 million and $3.4 million, respectively.
Financing activities
Net cash provided by financing activities was $337.7 million for the six months ended June 30, 2026, primarily consisting of net proceeds from the IPO of $339.8 million, partially offset by payment of offering costs of $2.3 million.
Net cash used in financing activities was $0.5 million for the six months ended June 30, 2025, primarily consisting of payments of offering costs of $0.5 million.
Future funding requirements
As of June 30, 2026, we had cash, cash equivalents, and marketable securities of $517.3 million. Based upon our current operating plans, we believe that our existing cash, cash equivalents, and marketable securities, will be sufficient to fund our operations into 2029. We have based this estimate on assumptions that may prove to be wrong, and we could expend our capital resources sooner than we expect.
We expect to incur significant expenses and operating losses for the foreseeable future as we advance our product candidates into and through clinical development and as we continue to develop additional product candidates. In addition, we expect to incur additional
20
costs associated with operating as a public company, including significant legal, accounting, investor relations and other expenses that we did not incur as a private company. We may also require additional capital to pursue additional research and collaboration agreements.
Because of the numerous risks and uncertainties associated with research, development, and commercialization of pharmaceutical product candidates, we are unable to estimate the amount of our future working capital requirements. Our future capital requirements will depend on many factors, including:
We have no committed sources of capital. Until such time, if ever, as we can generate substantial product revenue to support our cost structure, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, potentially including collaborations, licenses or other strategic arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. In addition, debt financing and 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 a strategic agreement, we may have to grant rights to develop and market our current and future product candidates even if we would otherwise prefer to develop and market such product candidates ourselves. Our failure to raise capital or enter into such other arrangements when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies. If we are unable to raise additional capital or obtain adequate funding when needed or on acceptable terms, we may be required to delay, scale back, or discontinue our research, product development, or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Contractual obligations and commitments
Royalty transfer agreement
In August 2020, we entered into a royalty transfer agreement, or the Royalty Transfer Agreement, with MPM Oncology Charitable Foundation, Inc., or MPM Charitable Foundation, an affiliate of a stockholder holding more than 5% of our total outstanding stock, and the UBS Optimus Foundation, or UBS, and together with MPM Charitable Foundation, the Charitable Foundations. Pursuant to the Royalty Transfer Agreement, we will pay 0.5% of our annual global net sales to each of the Charitable Foundations, for a total of 1.0% of net sales, subject to customary reductions, for products that incorporate or utilize intellectual property that was discovered or developed by us prior to our initial public offering. Our payment obligations for each product will continue on a country-by-country basis upon the later of the twelfth anniversary of the first commercial sale of our product in such country or the expiration of the last to expire of certain patents owned or controlled by us covering such products in such country.
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Our payment obligations to MPM Charitable Foundation will terminate immediately upon the authorization of the MPM Charitable Foundation’s board of directors (or similar body) or upon the winding up or dissolution of MPM Charitable Foundation. Our payment obligations to UBS will terminate immediately upon the winding up of Oncology Impact Fund 2, L.P., a Cayman Islands exempted limited partnership, which is associated with MPM Charitable Foundation.
Leases
As of June 30, 2026, we had future minimum operating lease payment obligations under non-cancellable leases of $15.5 million related to leases we have recognized on our consolidated balance sheet, which are due over the following 6.33 years.
License agreements
Our agreements with certain third parties to license intellectual property include potential milestone fees, sublicense fees and royalty fees. The milestone fees are dependent upon the development of products using the intellectual property licensed under the arrangements and contingent upon the achievement of development or regulatory approval milestones, as well as commercial milestones. These potential obligations are contingent upon the occurrence of future events and the timing and likelihood of such potential obligations are not known with certainty. For further information regarding these agreements, please see Notes 11 and 12 to our audited consolidated financial statements in the Annual Report.
Purchase and other obligations
We enter into contracts in the normal course of business with CROs and other third-party vendors for preclinical and commercial supply manufacturing, support for pre-commercial activities, research and development activities, and other services and products for our operations. These contracts are generally cancelable upon written notice. For additional information on our contractual obligations and commitments please see Note 13 to our audited consolidated financial statements included in the Annual Report.
Critical accounting policies and estimates
Our management’s discussion and analysis of financial condition and results of operations is based on our condensed financial statements, which are prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of our financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, costs and expenses. We base our estimates and assumptions on historical experience, known trends and other factors that we believe 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. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates. In making estimates and judgments, management employs critical accounting policies.
There have been no material changes to our critical accounting policies from those described in detail in Note 2 to our audited consolidated financial statements included in our Annual Report.
Recently issued accounting pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our audited consolidated financial statements and unaudited interim condensed consolidated financial statements included elsewhere in this Quarterly Report.
Emerging Growth Company and Smaller Reporting Company status
We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, as amended, or JOBS Act, and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. We may take advantage of these exemptions until we are no longer an emerging growth company. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. We have elected to use the extended transition period for complying with new or revised accounting standards and as a result of this election, our consolidated financial statements may not be comparable to companies that comply with public company effective dates. We may take advantage of these exemptions up until the time that we are no longer an “emerging growth company.”
We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of our initial public offering, (b) in which we have total annual gross revenue of at least $1.235 billion or (c) in which we are deemed to be a “large accelerated filer” under the rules of the SEC, which means, among other things, the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the last business day of our most recently completed second fiscal quarter and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.
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We are also a “smaller reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies until for so long as either (i) our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter. Based on the aggregate market value of our common stock and Class A common stock held by non-affiliates as of June 30, 2026, we expect to lose our smaller reporting company status effective January 1, 2027. As such, we will be required to comply with certain requirements that are currently inapplicable to us as a smaller reporting company but are not exempt under our emerging growth company status, including the quantitative market risk disclosures required by Item 305 of Regulation S-K.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk.
As a "smaller reporting company," as defined by Rule 12b-2 of the Exchange Act, and pursuant to Item 305 of Regulation S-K we are not required to provide quantitative and qualitative disclosures about market risk.
Item 4. Controls and Procedures.
Management's Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), as of the end of the period covered by this Quarterly Report. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that as of June 30, 2026, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in legal proceedings arising from the ordinary course of business. We record a liability for such matters when it is probable that future losses will be incurred and that such losses can be reasonably estimated. Significant judgment by us is required to determine both probability and the estimated amount. We are not currently subject to any material legal or arbitration proceedings.
Item 1A. Risk Factors.
There have been no material changes to the risk factors set forth in Part I, Item 1A of our Annual Report filed with the SEC on March 30, 2026.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Set forth below is information regarding shares of equity securities sold, and options granted, by us during the three months ended June 30, 2026 were not registered under the Securities Act.
Recent Sales of Unregistered Equity Securities
None.
Use of Proceeds from our Initial Public Offering
On January 8, 2026, the SEC declared effective our registration statement on Form S-1 (File No. 333-292283), as amended, or the Registration Statement, filed in connection with our IPO. Pursuant to the Registration Statement, we registered the offer and sale of 20,297,500 shares of our common stock with a maximum aggregate offering price of approximately $365.4 million. J.P. Morgan Securities LLC, BofA Securities, Inc., Leerink Partners LLC and TD Securities (USA) LLC acted as representatives of the underwriters for the IPO. We received net proceeds of $334.4 million from the sale of 20,297,500 shares of common stock at a price of $18.00 per share, which included 2,647,500 shares of common stock sold pursuant to the underwriters' full exercise of their option to purchase additional shares, after deducting underwriting discounts and commissions and offering costs payable by us. None of the expenses associated with the IPO were paid to directors, officers, persons owning 10% or more of any class of equity securities, or to our affiliates.
There has been no material change in the expected use of the net proceeds from our IPO as described in our final prospectus filed with the SEC pursuant to Rule 424(b) of the Securities Act on January 9, 2026. We are holding a significant portion of the balance of the net proceeds in money market funds.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
During the three months ended June 30, 2026, the following directors and/or officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted, modified or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” in each case as defined in Item 408 of Regulation S-K.
|
Character of Trading Arrangement |
|
|
|
|
|
|
Name and Title |
Action Taken |
Date of Action |
Rule 10b5-1* |
Non-Rule 10b5-1 |
Nature of Trading |
Aggregate Number of Securities (1) |
Duration of Trading Arrangement |
X |
|
Sale |
9/23/2026 - |
||||
|
|
|
|
|
|
|
|
X |
|
Sale |
9/24/2026 - |
||||
25
* Contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.
(1) This amount represents the maximum total shares that could be sold under the plan.
(2) On July 7, 2026, Ms. Ron-Bigger terminated her trading plan prior to any shares of common stock being sold pursuant to the trading plan.
26
Item 6. Exhibits.
Exhibit Number |
|
Description |
31.1 |
|
|
31.2 |
|
|
32.1* |
|
|
101.INS |
|
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
* The certification attached as Exhibit 32.1 that accompanies this Quarterly Report on Form 10-Q is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Aktis Oncology, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of such Form 10-Q), irrespective of any general incorporation language contained in such filing.
27
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.
|
|
Aktis Oncology, Inc. |
|
|
|
|
|
Date: August 13, 2026 |
|
By: |
/s/ Matthew Roden |
|
|
|
Matthew Roden, PhD |
|
|
|
President, Chief Executive Officer |
|
|
|
|
Date: August 13, 2026 |
|
By: |
/s/ Kyle D. Kuvalanka |
|
|
|
Kyle D. Kuvalanka |
|
|
|
Chief Financial Officer |
28