AKTS 10-K & 10-Q changes, risk factors and insider trading

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 on Form 10-Q,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 on Form 10-Q and the “Risk FactorFactors” section of our Annual Report -K,Report, our actual results could differ materially from the results described in, or implied by, these forward-looking statements.

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 lifequality-of-life benefits can be conferred by delivering radioisotopes to solid tumors. These leading products, which target prostate specificprostate-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 incurred through March 31, 2026.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 MarchJune 31,30, 2026, we had an accumulated deficit of $174.9$199.0 million and our net losses were $18.3$42.5 million and $15.0$33.1 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. We expect our expenses and operating losses will increase substantially as we:

advance our lead product candidate, [225Ac]Ac-AKY-1189 for Nectin-4 expressing tumors,tumors and [225Ac]Ac-AKY-2519 for B7-H3 expressing tumors through clinical trials;

continue IND-enablinginvestigational new drug, or IND, -enabling preclinical studies for our other programs;

As of MarchJune 31,30, 2026, we had cash, cash equivalentsequivalents, and marketable securities of $538.5$517.3 million. Based upon our current operating plans, we believe our existing cash, cash equivalentsequivalents, 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 factorsFactors” included elsewhere in this Quarterly Report.

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 MarchJune 31,30, 2026 and 2025, we have recorded a full valuation allowance against our net deferred tax assets.

Comparison of the three months ended MarchJune 31,30, 2026 and 2025

Collaboration revenue was $3.2$3.4 million and $1.4$1.6 million for the three months ended MarchJune 31,30, 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 were $20.0$25.3 million for the three months ended MarchJune 31,30, 2026, compared to $15.9$18.6 million for the comparable prior year period. The increase of $4.1$6.7 million was primarily due to:

$2.2$2.5 million increase in direct costs associated with advancing [225Ac]Ac-AKY-2519 through IND-enabling studies and into clinical trials;

$0.8$2.0 million increase primarily driven by an increase in directemployee-related costs for(including [225Ac]Ac-AKY-1189stock-based relatedcompensation) attributable to our increased headcount to support the ongoing operationsadvancement of our Phase 1b clinical trialdevelopment forprograms thisand programmanufacturing; and $0.2$0.5 million increase in facility, lab and depreciation costs primarily related to an increase in laboratory equipment as a result of our expansion of laboratory space and an increase in software subscriptions, partially offset by;

$1.2$1.9 million decrease in discovery and development costsactivities relating to a shift toward increased direct program spend forwith [225Ac]AKY-1189Ac-AKY-2519 andadvancing [225Ac]AKY-2519.into clinical trials.

General and administrative expenses were $5.9$7.0 million for the three months ended MarchJune 31,30, 2026, compared to $3.7$3.9 million for the comparable prior year period. The increase of $2.2$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 was $4.4$4.8 million for the three months ended MarchJune 31,30, 2026, compared to $3.2$2.9 million for the comparable prior year period. The increase of $1.2$1.9 million was primarily driven by an increase in interest income earned due to higher average balances in cash equivalents and marketable securities induring the three months ended MarchJune 31,30, 2026 compared to the threecomparable monthsprior endedyear March 31, 2025.period.

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 costsexpenses 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, after deducting underwriter discounts, commissions and other offering expenses incurred through March 31, 2026,million from the sale of shares of common stock in our initial public offering.offering, after deducting underwriter discounts, commissions and other offering costs. As of MarchJune 31,30, 2026, we had cash, cash equivalentsequivalents, and marketable securities of $538.5$517.3 million.

Net cash used in operating activities was $24.2$44.8 million for the threesix months ended MarchJune 31,30, 2026, primarily consisting of our net loss of $18.3$42.5 million and net changes in operating assets and liabilities of $9.1$8.6 million, offset by non-cash charges of $3.2$6.2 million related to accretion of investment discounts, stock-based compensation and depreciation.

Net cash used in operating activities was $17.5$33.7 million for threethe six months ended MarchJune 31,30, 2025, primarily consisting of our net loss of $15.0$33.1 million, changes in operating assets and liabilities of $2.4$1.2 million, andoffset $0.1 million ofby non-cash charges of $0.6 million related to stock-based compensation, depreciation, and accretion of investment discounts.discounts, stock-based compensation and depreciation.

Net cash providedused byin investing activities was $39.0$248.2 million for the threesix months ended MarchJune 31,30, 2025,2026, primarily consisting of maturities of marketable securities of $51.7 million, partially offset by purchases of marketable securities and property and equipment of $10.8$300.4 million and $1.9$3.1 million, respectively.respectively, partially offset by the maturities of marketable securities of $55.4 million.

Net cash provided by financing activities was $337.5$337.7 million for the threesix months ended MarchJune 31,30, 2026, primarily consisting of grossnet proceeds from the IPO of $339.8 millionmillion, partially offset by payment of offering costs of $2.3 million.

Net cash used in financing activities was $0.5 million for the threesix months ended MarchJune 31,30, 2025, primarily consisting of payments of offering costs of $0.5 million.

As of MarchJune 31,30, 2026, we had cash, cash equivalentsequivalents, and marketable securities of $538.5$517.3 million. Based upon our current operating plans, we believe that our existing cash, cash equivalentsequivalents, 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.

the scope, progress, results and costs related to the clinical development of [225Ac]Ac-AKY-1189 for Nectin-4 expressing tumors and [225Ac]Ac-AKY-2519 for B7-H3 expressing tumors;

the extent to which we acquire or in-license other product candidates and technologies; and the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory clearances to market [225Ac]Ac-AKY-1189 for any Nectin-4of expressingour tumorscurrent or any future product candidates.

As of MarchJune 31,30, 2026, we had future minimum operating lease payment obligations under non-cancellable leases of $16.1$15.5 million related to leases we have recognized on our consolidated balance sheets,sheet, which are due over the following 6.546.33 years.

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.