08/14/2026 | Press release | Distributed by Public on 08/14/2026 14:03
Management's Discussion and Analysis of Financial Condition and Results of Operations
The following Management's Discussion and Analysis of Financial Condition and Results of Operations of Cue Biopharma, Inc. and its subsidiary ("Cue Biopharma", "we", "us", "our" or the "Company") should be read in conjunction with our financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and the financial statements and accompanying notes thereto for the fiscal year ended December 31, 2025 and the related Management's Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 16, 2026, or the 2025 Annual Report.
Overview
We are a clinical-stage biopharmaceutical company focused on advancing a portfolio of potentially transformative therapies aimed at enabling functional cures across immunological disorders. Our lead asset, CUE-221, is a novel humanized anti-IgE monoclonal antibody with a dual-mechanism of action currently in Phase 2 development for allergic diseases. In addition, we developed the Immuno-STAT® platform designed to engineer therapies that selectively target disease-specific T cells in vivo without broad immune modulation. Our lead autoimmune candidate, CUE-401, is advancing towards Phase 1 development and was designed to regulate inflammation and drive Treg-mediated tolerance.
CUE-221
On April 30, 2026, we entered into an exclusive license agreement with Ascendant Health Sciences Ltd., or Ascendant Health, to develop, manufacture and commercialize CUE-221. IgE-mediated allergic diseases remain an area of significant unmet medical need, as many patients continue to experience persistent symptoms despite available therapies. In addition, approved treatments directly targeting IgE remain limited.
CUE-221, is a humanized anti-IgE IgG1 monoclonal antibody that binds in a differentiated way to IgE leading to a distinct IgE conformation. CUE-221 has a dual mechanism of action; it neutralizes free IgE with picomolar potency and leverages the naturally occurring CD23-mediated IgE downregulation pathway to suppress new IgE synthesis. By targeting key drivers of IgE-mediated disease, CUE-221 is designed to enable deeper and more sustained control of free IgE levels, and therefore of allergic conditions.
Under Ascendant Health, the program completed a Phase 1 single-ascending dose clinical trial. Pre-clinical experiments and results from the Phase 1 clinical trial were published in the Journal of Clinical Investigation in 2022. In a Phase 1 single ascending dose trial, CUE-221 demonstrated a favorable safety and tolerability profile with rapid and durable suppression of free IgE for longer than twelve weeks with a single dose, consistent with its dual mechanism of action. We believe these early findings support continued clinical development of CUE-221 with the potential to possibly enhance anti-IgE therapy, through less frequent dosing and expanded treatment potential for patients with high-IgE who remain underserved by current therapeutic options.
We have recently submitted an Investigational New Drug, or IND, to the U.S. Food and Drug Administration, or FDA, to expand development into food allergy. CUE-221 is currently being evaluated in a Phase 2 clinical trial in chronic spontaneous urticaria, or CSU, by Ascendent Health's related company Genesis Life Sciences. The Phase 2 clinical trial is a placebo-and active-comparator-controlled dose-ranging study in CSU in China with clinical results expected by the end of the third quarter of 2026. We intend to initiate a global Phase 2b trial in food allergy, following completion of the Ascendant Phase 2 study and review of the data.
CUE-401
In autoimmune disease, Tregs are the master regulators of maintaining immune homeostasis, or balance, and health. Autoreactive T cells, referred to as T effector cells, or Teff cells, are reactive against "self" proteins and foster inflammation and induce chronic tissue damage. Tregs are important to maintaining immune balance in that they possess the ability to dampen and control the Teff cells.
Our lead autoimmune candidate within the Immuno-STAT® platform, CUE-401, is an IND ready, bifunctional therapeutic that incorporates an innovative TGF-beta breathing-mask moiety with our clinically validated interleukin-2, or IL-2, mutein in a single injectable biologic. The design of CUE-401 was validated by Nobel Prize winning science in 2025 for the role of IL-2 and TGF-beta as essential components in helping establish immune tolerance by regulating FOXP3 signaling. CUE-401 is designed to promote immune regulation and tolerance by three complementary mechanisms: direct regulation of proinflammatory mechanisms by TGF-beta; expansion of existing Tregs by IL-2, and conversion of FOXP3- conventional
CD4+ T cells into FOXP3+ induced Tregs through the coordinated provision of TGF-beta and IL-2 signals, both of which are required for the de novo induction of FOXP3 expression.
We expect to submit an IND to the FDA and begin a Phase 1 study of CUE-401 by the end of 2026. We believe this could represent a potential breakthrough as a new standard of care in multiple high-value autoimmune disease indications.
Partnered Programs
CUE-500 Series
The CUE-500 series is designed to selectively target and deplete disease-causing cells by redirecting existing anti-viral memory T cells toward pathogenic cell populations, including autoreactive B cells implicated in autoimmune disease. We believe this approach may enable targeted immune modulation while potentially reducing the broader immune effects associated with certain existing therapies. CUE-501, which is being developed under our collaboration and license agreement with Boehringer Ingelheim, or BI, is focused on the treatment of autoimmune diseases driven by pathogenic B cells. We believe the modular design of the CUE-500 series may support development across multiple disease areas by incorporating different cell-targeting domains into the platform framework.
CUE-100 Series
Historically, we primarily focused our resources on the development of our CUE-100 series for oncology, namely the CUE-101 and CUE-102 drug product candidates, which are representative of our approach to selectively activate targeted CD8+ T cells against cancer, both of which have been licensed to ImmunoScape Pte. Ltd., or IMSCP, to advance a novel in vivo approach to cell therapy for the treatment of solid tumors. Under our Collaboration and License Agreement with IMSCP, IMSCP is developing a novel Seed-and-Boost immunotherapy that combines our clinically validated Immuno-STAT T-cell engagers, the CUE-100 series, with IMSCP's proprietary tumor-specific T cell receptors, or TCRs. The combination therapy is designed to overcome core limitations of existing cell therapies and to potentially establish a new standard of care with superior anti-tumor activity, durable T cell persistence and product scalability.
Plan of Operation
As a clinical stage company, the majority of our business activities to date have been, and our planned future activities will be, devoted to furthering research and development of our drug product candidates. We intend that the majority of our business activities will be devoted to furthering the development of our two lead assets: CUE-221 and CUE-401. We also plan to continue to support our collaborations across our pipeline, such as our strategic collaboration and license agreements with BI for the development of CUE-501, and ImmunoScape Pte. Ltd. for the development of our CUE-100 series.
Liquidity
We have incurred significant losses since our inception and have never generated revenue or profit from product sales, and it is possible we will never generate revenue or profit from product sales. During the three months ended June 30, 2026, we had one-time cash outflows related to the license agreement with Ascendant totaling approximately $28 million, which consisted primarily of a $15 million upfront payment to Ascendant and other one-time legal fees, consulting fees and employee related costs. As of June 30, 2026 we had cash and cash equivalents of $17.4 million. Based on our current operating plans, we believe that our cash and cash equivalents as of June 30, 2026, together with the net proceeds we received from our July 2026 private placement, will be sufficient to meet our projected operating needs at least through the next twelve months from the issuance date of our condensed consolidated financial statements included in this Quarterly Report. We have based our estimate as to how long we expect we will be able to fund our obligations on assumptions that may prove to be wrong and we may use our available capital resources sooner than we currently expect. Beyond that, we will need to raise substantial additional capital to fund our future operations. We expect to finance our future cash needs through a combination of equity offerings, collaborations, and other strategic alliances. Volatility in capital markets and general economic conditions in the U.S. may be a significant obstacle to raising the required funds and, as a result, we may be unable to secure the necessary funding on acceptable terms, if at all. To the extent that we raise additional capital through future equity offerings, the ownership interest of common stockholders will be diluted, which dilution may be significant. We cannot guarantee that we will be able to obtain any or sufficient additional funding or that such funding, if available, will be obtainable on terms satisfactory to us. In the event that we are unable to obtain any or sufficient additional funding, we may be forced to delay, reduce or discontinue our product development programs or consider other various strategic alternatives, including the sale or disposition of our rights or assets or our dissolution and liquidation with little or no return to investors. Any such change in our product development programs or strategic alternatives may have a material adverse effect on the price per share of our common stock.
Critical Accounting Estimates and Significant Judgments
Our management's discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our financial statements, and the reported revenue and expenses during the reported periods. We evaluate these estimates and judgments, including those described below, on an ongoing basis. We base our estimates on historical experience, known trends and events, contractual milestones and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are more fully described in Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, we believe that the estimates, assumptions and judgments involved in the accounting policies described in Management's Discussion and Analysis of Financial Condition and Results of Operations in Item 7 of our 2025 Annual Report may have the greatest potential impact on our financial statements, so we consider those estimates, assumptions and judgments to be our critical accounting policies and estimates. There were no material changes to our critical accounting policies and estimates during the six months ended June 30, 2026.
Recent Accounting Pronouncements and Adopted Standards
A discussion of recent accounting pronouncements is included in Note 2 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
Reverse Stock Split
We held our 2026 annual meeting of stockholders on April 13, 2026, where our stockholders approved a reverse stock split at a ratio within a range of 1-for-30 and 1-for-50 and granted our board of directors, or the Board, the discretion to determine the timing and ratio of the split within such range. On April 13, 2026, our Board determined to effect the reverse stock split of the common stock at a 1-for-30 ratio, or the Reverse Split, and approved the filing of a charter amendment to our Certificate of Incorporation to effect the Reverse Split. On April 22, 2026, we filed the charter amendment with the Delaware Secretary of State to effect the Reverse Split at 5:00 P.M. Eastern Time on April 23, 2026, or the Effective Time. At the Effective Time, every 30 shares of issued and outstanding common stock were automatically combined into one issued share of common stock, with no change in par value. No fractional shares were issued as a result of the Reverse Split. Stockholders of record who would otherwise hold fractional shares of our common stock as a result of the Reverse Split were entitled to receive a cash payment in lieu of such fractional shares. The Reverse Split did not modify any voting rights or other terms of the common stock. Our common stock began trading on a Reverse Split-adjusted basis on The Nasdaq Capital Market on April 24, 2026. The Reverse Split was implemented for the purpose of regaining compliance with the minimum bid price requirement for continued listing of our common stock on the Nasdaq Capital Market. The Reverse Split did not proportionately reduce the total number of shares of our capital stock and common stock that we are authorized to issue. Unless otherwise indicated, all issued, and outstanding stock and per share amounts have been adjusted to reflect the Reverse Split for all prior periods presented. Proportionate adjustments for the Reverse Split were made to the exercise prices and number of shares issuable under our equity incentive plans, and the number of shares underlying outstanding equity awards, as applicable. In connection with such proportionate adjustments, the number of shares of common stock issuable upon exercise of outstanding stock options and warrants was rounded down to the nearest whole share, and the exercise prices of outstanding stock options and warrants were rounded up to the nearest cent. On May 8, 2026, we received notification from The Nasdaq Stock Market that, since the closing bid price of our common stock had been at $1.00 per share or greater for ten consecutive business days, from April 24 through May 7, 2026, we regained compliance with the minimum bid price requirement for continued listing, and this matter is now closed.
Significant Contracts and Agreements Related to Research and Development Activities
Einstein License Agreement
On January 14, 2015, we entered into a license agreement, as amended and restated on July 31, 2017, and as further amended on October 30, 2018, January 13, 2024 and April 10, 2025, or the Einstein License, with Albert Einstein College of Medicine, or Einstein, for certain patent rights, or the Patents, relating to our core technology platform for the engineering of biologics to control T cell activity, precision, immune-modulatory drug product candidates, and two supporting technologies that enable the discovery of costimulatory signaling molecules (ligands) and T cell targeting peptides.
We hold an exclusive worldwide license, with the right to sublicense, import, make, have made, use, provide, offer to sell, and sell all products, processes and services that use the Patents, including certain technology received from Einstein related thereto, which we refer to as the Einstein Licensed Products. Under the Einstein License, we are required to:
The Einstein License requires us to pay a percentage of sublicenses related to our patent rights for components of our core technology that is licensed from Einstein. On April 10, 2025, we entered into an amendment to the Einstein License. Pursuant to the amendment, Einstein consented to our entry into the BI Collaboration and License Agreement and granted us the right to sublicense to BI. In addition, we and Einstein agreed to amend specified upstream payment obligations that may be owed to Einstein by us, solely in connection with the sublicense to BI. In the second quarter of 2025, we paid Einstein $0.9 million in fees in relation to the amendment to this license with Einstein.
As of June 30, 2026, we were in compliance with our obligations under the Einstein License.
We account for the costs incurred in connection with the Einstein License in accordance with Accounting Standards Codification, or ASC, Topic 730, Research and Development.
We pay $0.1 million in annual maintenance license fees to Einstein, which are amortized equally throughout the year. We incurred less than $0.1 million in annual maintenance fees for each of the three and six months ended June 30, 2026 and 2025. Such costs are included in research and development costs in our condensed consolidated statements of operations.
Pursuant to the Einstein License, we issued to Einstein 22,385 shares of our common stock in connection with the consummation of the initial public offering of our common stock on December 27, 2017.
See Note 8 to the condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional discussion of the Einstein License.
Collaboration and Option Agreement with Ono
In February 2023, we entered into a strategic collaboration agreement, or the Ono Collaboration and Option Agreement, with Ono Pharmaceutical Co., Ltd., or Ono, to further develop CUE-401. In March 2025, we and Ono agreed to terminate the Ono Collaboration and Option Agreement, effective as of March 6, 2025. At such time, the Ono Collaboration and Option Agreement had no further force or effect with the exception of certain customary provisions which are intended to survive termination and expiration of the Ono Collaboration and Option Agreement. We retained all rights to CUE-401.
Both we and Ono have satisfied all of our respective performance obligations and made all outstanding payments under the agreement as of June 30, 2026. For the three and six months ended June 30, 2026, we did not recognize any revenue related to the Ono Collaboration and Option Agreement. For each of the three and six months ended June 30, 2025, we
recognized revenue of $0.4 million related to the Ono Collaboration and Option Agreement. As of June 30, 2026, we had recorded $14.8 million in collaboration revenue related to this agreement since the agreement was entered into.
See Note 11 to the condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional discussion of the Ono Collaboration and Option Agreement.
BI Collaboration and License Agreement
On April 10, 2025, we entered into the BI Collaboration and License Agreement, to research, develop and commercialize differentiated B cell depletion molecules, including CUE-501.
Under the terms of the BI Collaboration and License Agreement, we and BI will conduct collaborative research focused on CUE-501 during a four-year period or, if earlier, the completion of activities under the research plans, or the BI Research Term. In addition to, or instead of, CUE-501, BI may elect, at its sole discretion, to include additional or alternative compounds targeted at B cell depletion. BI will have an exclusive, royalty-bearing, worldwide, sublicensable license, under our applicable patents and know-how, to develop, manufacture and commercialize such compounds and their derivatives, or BI Licensed Products, for all uses, and BI shall be responsible for all further research, preclinical and clinical development, manufacturing, regulatory approvals, and commercialization of BI Licensed Products at its expense. During the BI Research Term, we are prohibited from developing or commercializing any molecule for applications in B cell depletion.
Pursuant to the terms of the BI Collaboration and License Agreement, we received an upfront payment of $10.1 million in cash in the second quarter of 2025, which is net of $1.9 million of German withholding taxes that we expect to be refunded in the second half of 2026. We will also be eligible to receive up to an aggregate of approximately $345.0 million in success-based research, development and commercial milestone payments, beginning with two preclinical development milestones, as well as royalty payments on net sales. The royalty payments will be subject to reduction due to patent expiration, payments made under certain licenses for third-party intellectual property and generic competition. BI has agreed to reimburse us for agreed upon costs incurred in conducting research during the BI Research term, including certain pass-through costs from third party contractors and full-time employee salaries.
The BI Collaboration and License Agreement will continue, on a product-by-product and country-by-country basis, until the expiration of the applicable royalty term, unless earlier terminated. BI has the right to terminate the BI Collaboration and License Agreement for any reason after a specified notice period. Each party has the right to terminate the BI Collaboration and License Agreement on account of the other party's bankruptcy or material, uncured breach. In connection with our entry into the BI Collaboration and License Agreement, we entered into an amendment to our Einstein License whereby Einstein consented to our entry into the BI Collaboration and License Agreement and granted us the right to sublicense to BI. In addition, we and Einstein agreed to amend specified upstream payment obligations that may be owed to Einstein by us, solely in connection with the sublicense to BI.
For the three and six months ended June 30, 2026, we recognized revenue of $7.6 million and $13.3 million related to the BI Collaboration and License Agreement, respectively. For the three and six months ended June 30, 2025, we recognized revenue of $2.9 million related to the BI Collaboration and License Agreement. We recorded accounts receivable of $0.1 million and $0.5 million on our condensed consolidated balance sheets as of June 30, 2026 and December 31, 2025, respectively. We did not record short or long-term research and development liabilities on our condensed consolidated balance sheets dated June 30, 2026, as the research term is substantially completed. We recorded short-term research and development liabilities of $5.3 million on our condensed consolidated balance sheets as of December 31, 2025.
On April 1, 2026, we received notice from BI that BI had approved selection of its first compound for lead optimization under the BI Collaboration and License Agreement. This preclinical milestone event triggered a $7.5 million payment to us, which was received in May 2026.
See Note 11 to the condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional discussion of the BI Collaboration and License Agreement.
ImmunoScape Collaboration and License Agreement
On November 6, 2025, ImmunoScape Pte. Ltd., or IMSCP, exercised its option, or Option, to obtain licenses to research, develop and commercialize molecules from our CUE-100 series, including CUE-101 and CUE-102, subject to certain exclusions, for all oncology indications pursuant to a Collaboration and License Agreement, effective November 6, 2025,
between us and IMSCP, or the IMSCP Collaboration and License Agreement. The licenses provided pursuant to the IMSCP Collaboration and License Agreement include a co-exclusive development license for five years or, if longer, for so long as IMSCP has a specified number of CUE-100 series molecules under active development and, pursuant to which, we retain non-exclusive research rights to support our other programs. We also retained our rights to the CUE-100 series, including CUE-101 and CUE-102, for use in any manner other than as a component of a cell therapy product for 18 months past the effective date of the IMSCP Collaboration and License Agreement. The licenses include an exclusive commercial license to IMSCP for any CUE-100 series molecule that IMSCP advances to IND-enabling studies while the co-exclusive development license is in effect. The licensed series of molecules will be further developed and potentially commercialized by IMSCP. The Option was exercised pursuant to an Option Agreement between us and IMSCP, dated October 22, 2025, or Option Agreement. In connection with entry into the Option Agreement and IMSCP's exercise of the Option, we received an aggregate of $9.5 million, net of withholding taxes, in the fourth quarter of 2025 and are entitled to receive an additional $5.0 million before the first anniversary of the effective date of the IMSCP Collaboration and License Agreement.
Pursuant to the IMSCP Collaboration and License Agreement, we (a) received equity of IMSCP equal to 40% of the issued and outstanding equity of IMSCP and are entitled to receive additional equity, in the form of warrants, upon certain dilution events in the future, (b) received time-based payments of $10.0 million in the fourth quarter of 2025, (c) are entitled to receive an additional time-based payment of $5.0 million before the first anniversary of the effective date of the IMSCP Collaboration and License Agreement, and (d) are entitled to receive high single-digit royalties on global net sales and low- to mid-double digit royalties from sublicensing royalties and income. The IMSCP Collaboration and License Agreement includes customary termination provisions, including IMSCP's ability to terminate the agreement in its entirety on 60 days' advanced written notice to us.
For the three and six months ended June 30, 2026, we recognized revenue of $0.3 million related to the IMSCP Collaboration and License Agreement. We recorded accounts receivable from IMSCP of $5.3 million and $5.0 million on our condensed consolidated balance sheet as of June 30, 2026 and December 31, 2025, respectively.
See Note 11 to the condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional discussion of the IMSCP Collaboration and License Agreement.
Ascendant License Agreement
On April 30, 2026, we entered into a License Agreement, or the License Agreement, with Ascendant Health, or the Licensor. Pursuant to the License Agreement and subject to certain rights retained by the Licensor, the Licensor granted us: (1) the exclusive and sublicensable rights to develop, manufacture, commercialize and otherwise exploit the Licensor's anti-IgE monoclonal antibody known as Ascendant-221, which was formerly known as UB-221 (together with certain related molecules, or the Licensed Molecules) and products containing a Licensed Molecule (or, collectively, the Licensed Products) throughout the world (except the mainland of China, Hong Kong, Macau and Taiwan (or, together, the Ascendant Territory)) (such territory of the Company, the Cue Territory) for any and all uses; and (2) the non-exclusive and sublicensable rights to manufacture the Licensed Molecules and Licensed Products in the Ascendant Territory solely for the purposes of developing and commercializing the Licensed Molecules and Licensed Products in the Cue Territory.
As consideration for the rights granted to us by the Licensor, we paid the Licensor $15.0 million as the upfront payment, and will pay up to an aggregate of $676.5 million in additional potential milestone payments, and tiered royalty payments (at percentages ranging from high single-digit to low double-digit) on future net sales of Licensed Products. The additional milestone payments include $5.0 million upon the completion of manufacturing technology transfer, $6.5 million upon the completion of data and know-how transfer, up to $205.0 million upon the achievement of specified development and regulatory milestone events, including upon receipt of threshold data from a specified Phase 2 clinical trial, and up to $460.0 million upon the achievement of specified commercial milestone events. In the event we grant a sublicense of its rights under the License Agreement within the first 18 months after the effective date of the License Agreement, certain sublicensing revenues received by us will be shared with Licensor at specified percentages between 20% and 40% for a period of up to 18 months after the effective date. In addition, in the event of a specified change of control transaction with respect to us within the first 18 months after the effective date of the License Agreement, certain milestone payments will accelerate, in an amount up to $215.0 million.
See Note 8 to the condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional discussion of the Ascendant Health License Agreement.
Components of Results of Operations
Collaboration Revenue
We have not yet generated commercial revenue from product sales. To date, we have generated revenue from collaboration agreements with BI, IMSCP, LG Chem, Ono (which terminated in March 2025), and Merck Sharp & Dohme Corp. (which terminated in December 2022). Our collaboration revenue may vary from period to period depending on the progress of our work in connection with our collaboration agreements.
Research and Development Expenses
Research and development expenses consist primarily of compensation costs, license fees, fees paid to consultants, outside service providers and organizations (including research institutes at universities), facility costs, and development and clinical trial costs with respect to our drug product candidates. We utilize our employee and infrastructure resources across multiple research and development programs, and do not track these costs by project. We believe the attempted allocation of these costs by project would be arbitrary and not meaningful.
Research and development expenses incurred under contracts are expensed ratably over the life of the underlying contracts, unless the achievement of milestones, the completion of contracted work, or other information indicates that a different pattern of performance is more appropriate. Other research and development expenses are charged to operations as incurred.
Nonrefundable advance payments are recognized as an expense as the related services are performed. We evaluate whether we expect the services to be rendered at each quarter end and year end reporting date. If we do not expect the services to be rendered, the advance payment is recorded as expense. Nonrefundable advance payments for research and development services are included in prepaid and other current assets on the balance sheet. To the extent that a nonrefundable advance payment is for contracted services to be performed within 12 months from the reporting date, such advance is included in current assets; otherwise, such advance is included in non-current assets.
We evaluate the status of our research and development agreements and contracts, and the carrying amount of the related assets and liabilities, at each quarter end and year end reporting date, and adjust the carrying amounts and their classification on the balance sheet as appropriate.
The following table summarizes our research and development expenses by category for the three months ended June 30, 2026 and 2025 (in millions):
|
June 30, |
|||||||||
|
2026 |
2025 |
||||||||
|
Employee compensation |
$ |
9.2 |
$ |
2.4 |
|||||
|
License fees |
36.0 |
- |
|||||||
|
Clinical trial costs |
0.7 |
0.9 |
|||||||
|
Facilities and overhead |
0.7 |
1.3 |
|||||||
|
Contract manufacturing costs |
1.1 |
1.8 |
|||||||
|
Lab costs |
0.1 |
0.3 |
|||||||
|
Professional fees |
1.2 |
1.2 |
|||||||
|
Total |
$ |
49.0 |
$ |
7.9 |
|||||
The following table summarizes our research and development expenses by category for the six months ended June 30, 2026 and 2025 (in millions):
|
June 30, |
|||||||||
|
2026 |
2025 |
||||||||
|
Employee compensation |
$ |
10.8 |
$ |
5.5 |
|||||
|
License fees |
36.0 |
0.1 |
|||||||
|
Clinical trial costs |
1.3 |
2.7 |
|||||||
|
Facilities and overhead |
1.8 |
2.6 |
|||||||
|
Contract manufacturing costs |
3.0 |
3.7 |
|||||||
|
Lab costs |
0.4 |
0.5 |
|||||||
|
Professional fees |
2.6 |
1.4 |
|||||||
|
Total |
$ |
55.9 |
$ |
16.5 |
|||||
General and Administrative Expenses
General and administrative expenses consist of salaries and related expenses for executive, legal, finance, human resources, information technology and administrative personnel, as well as professional fees, insurance costs, and other general corporate expenses. We expect general and administrative expenses to remain consistent in future periods as we continue to incur expenses related to our operation as a public company, which requires our ongoing compliance with certain laws and regulations.
Interest Income
We earn interest income from cash invested in money market funds.
Interest Expense
We incurred interest expense from borrowings under our Loan and Security Agreement, as amended, or the Loan Agreement, with Silicon Valley Bank, a division of First Citizens Bank & Trust Company, or SVB. As of June 30, 2026, the loan principal balance was fully paid off. Beginning in 2026, we incurred interest expense from the financing of insurance payments.
Results of Operations
Three Months Ended June 30, 2026 and 2025
Our condensed consolidated statements of operations for the three months ended June 30, 2026 and 2025, as discussed herein, are presented below in thousands.
|
Three Months Ended |
||||||||
|
2026 |
2025 |
|||||||
|
Collaboration revenue |
$ |
7,877 |
$ |
2,954 |
||||
|
Operating expenses: |
||||||||
|
General and administrative |
46,565 |
3,679 |
||||||
|
Research and development |
49,007 |
7,910 |
||||||
|
Total operating expenses |
95,572 |
11,589 |
||||||
|
Loss from operations |
(87,695 |
) |
(8,635 |
) |
||||
|
Other income (expense): |
||||||||
|
Interest income |
157 |
198 |
||||||
|
Interest expense |
(5 |
) |
(45 |
) |
||||
|
Loss on issuance of liability-classified warrants and related issuance costs |
(90,011 |
) |
- |
|||||
|
Changes in fair value of financial instruments |
24,487 |
- |
||||||
|
Total other income (expense), net |
(65,372 |
) |
153 |
|||||
|
Net loss |
$ |
(153,067 |
) |
$ |
(8,482 |
) |
||
Collaboration Revenue
Collaboration revenue increased by $4.9 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to more revenue earned during the three months ended June 30, 2026 compared to revenue earned during the three months ended June 30, 2025 from our BI Collaboration and License Agreement due to a preclinical milestone event triggered in the second quarter of 2026.
General and Administrative Expenses
General and administrative expenses increased by $42.9 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to an increase of $40.6 million in employee compensation, which is comprised of a $19.7 million increase in stock-based compensation and a $19.3 million increase in payroll tax expense related to one-time restricted stock units granted in the second quarter of 2026, a $1.0 million increase in salary expense, and a $0.6 million increase in severance expense. In addition, professional fees increased by $2.2 million due to higher one-time legal fees incurred related to the License Agreement with Ascendant and related filings with the Securities and Exchange Commission, or the SEC.
Research and Development Expenses
Research and development expenses increased by $41.1 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily due to expenses totaling $35.1 million associated with the License Agreement with Ascendant. These comprised of a one-time $15.0 million upfront cash payment and non-cash items comprising of $20.1 million related recognition of initial fair value of pre-funded warrants issued to Ascendant (the "Ascendant Pre-Funded Warrants") as well as related top-up share obligations. In addition, the increase also included an increase in compensation expense of $6.8 million, which comprised a $3.3 million increase in stock-based compensation expense and a $3.5 million increase in payroll tax expense related to one-time restricted stock units granted in the second quarter of 2026, an increase in license fees of $0.9 million associated with the Einstein License Agreement, partially offset by a $0.7 million decrease in manufacturing costs, a $0.6 million decrease in facility costs, and a $0.4 million decrease in clinical trial and lab costs.
Interest Income
Interest income remained approximately the same for the three months ended June 30, 2026 compared to the three months ended June 30, 2025.
Interest Expense
Interest expense decreased by less than $0.1 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. Interest expense incurred during the three months ended June 30, 2026 consisted of interest related to the financing of insurance payments. Interest expense incurred during the three months ended June 30, 2025 consisted of interest incurred from borrowings under our Loan Agreement with SVB, which was repaid in full in December 2025.
Loss on Issuance of Liability-Classified Warrants and related Issuance Costs
In May 2026, we issued the May 2026 Pre-Funded Warrants (as defined below), May 2026 Warrants (as defined below), and Ascendant Pre-Funded Warrants, each of which was initially classified as a liability and measured at fair value. Due to our stock price increasing from the April 30, 2026 pricing date to the closing date of the May 2026 Offering (as described below), the aggregate fair value of the instruments exceeded the proceeds received, resulting in a loss upon issuance and related issuance costs of $90.0 million.
Changes in Fair Value of Financial Instruments
The May 2026 Pre-Funded Warrants, May 2026 Warrants, and Ascendant Pre-Funded Warrants were all initially classified as liabilities measured at fair value. All subsequent changes in the fair value of the liability-classified instruments
through the date of stockholder approval in accordance with the listing standards of the Nasdaq Stock Market of the issuance of shares of common stock upon excise of the warrants (the "Issuance Stockholder Approval"), were recognized within other income (expense). The related top-up share obligations remain classified as a liability and are remeasured at fair value at each reporting date, with the changes in fair value recognized within other income (expense). See Note 3 to the condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional discussion of the May 2026 Pre-Funded Warrants, May 2026 Warrants, and Ascendant Pre-Funded Warrants.
Six Months Ended June 30, 2026 and 2025
Our condensed consolidated statements of operations for the six months ended June 30, 2026 and 2025, as discussed herein, are presented below in thousands.
|
Six Months Ended |
||||||||
|
2026 |
2025 |
|||||||
|
Collaboration revenue |
$ |
13,563 |
$ |
3,374 |
||||
|
Operating expenses: |
||||||||
|
General and administrative |
50,717 |
7,852 |
||||||
|
Research and development |
55,904 |
16,457 |
||||||
|
Gain on lease termination |
(10 |
) |
- |
|||||
|
Total operating expenses |
106,611 |
24,309 |
||||||
|
Loss from operations |
(93,048 |
) |
(20,935 |
) |
||||
|
Other income (expense): |
||||||||
|
Interest income |
336 |
368 |
||||||
|
Interest expense |
(9 |
) |
(172 |
) |
||||
|
Loss on issuance of liability-classified warrants and related issuance costs |
(90,011 |
) |
- |
|||||
|
Changes in fair value of financial instruments |
24,487 |
- |
||||||
|
Total other income (expense), net |
(65,197 |
) |
196 |
|||||
|
Net loss |
$ |
(158,245 |
) |
$ |
(20,739 |
) |
||
Collaboration Revenue
Collaboration revenue increased by $10.2 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to more revenue earned during the six months ended June 30, 2026 compared to revenue earned during the six months ended June 30, 2025 from our BI Collaboration and License Agreement due to the timing of activities and a preclinical milestone event triggered in the second quarter of 2026.
General and Administrative Expenses
General and administrative expenses increased by $42.9 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to an increase of $40.1 million in employee compensation, which was comprised of a $19.0 million increase in stock-based compensation and a $19.3 million increase in payroll tax expense related to one-time restricted stock units granted in the second quarter of 2026, a $1.0 million increase in salary expense, and a $0.8 million increase in severance expense. In addition, professional fees increased by $2.6 million due to higher legal fees incurred related to the private placement in the second quarter of 2026, the License Agreement with Ascendant, and related SEC filings.
Research and Development Expenses
Research and development expenses increased by $39.4 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase was primarily due to expenses totaling $35.1 million associated with the License Agreement with Ascendant. These comprised a one-time $15.0 million upfront cash payment and non-cash items comprising of $20.1 million related recognition of initial fair value of the Ascendant Pre-Funded Warrants as well as related top-up share obligations. In addition, the increase also included an increase in employee compensation expense of $5.3 million, which comprised of a $2.2 million increase in stock-based compensation expense and a $3.1 million increase in payroll tax expense related to restricted stock units granted in the second quarter of 2026, increases in legal fees of $1.2 million related to the
private placement in the second quarter of 2026 and the License Agreement with Ascendant, and an increase in license fees of $0.8 million associated with the Einstein License Agreement, partially offset by a decrease in facilities costs of $0.8 million, a decrease in manufacturing costs of $0.7 million, and a decrease in clinical trial and lab costs of $1.5 million.
Interest Income
Interest income remained approximately the same for the six months ended June 30, 2026 compared to the six months ended June 30, 2025.
Interest Expense
Interest expense decreased by $0.2 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. Interest expense incurred during the six months ended June 30, 2026 consisted of interest related to the financing of insurance payments. Interest expense incurred during the six months ended June 30, 2025 consisted of interest incurred from borrowings under our Loan Agreement with SVB which was paid in full in December of 2025.
Loss on Issuance of Liability-Classified Warrants and related Issuance Costs
In May 2026, we issued the May 2026 Pre-Funded Warrants, May 2026 Warrants, and pre-funded warrants to Ascendant, each of which was initially classified as a liability and measured at fair value. Due to our stock price increasing from the April 30, 2026 pricing date to the closing date of the May 2026 Offering, the aggregate fair value of the instruments exceeded the proceeds received, resulting in a loss upon issuance and related issuance costs of $90.0 million.
Changes in Fair Value of Financial Instruments
The May 2026 Pre-Funded Warrants, May 2026 Warrants, and Ascendant Pre-Funded Warrants were all initially classified as liabilities measured at fair value. All subsequent changes in the fair value of the liability-classified instruments through the date of the Issuance Stockholder Approval, were recognized within other income (expense). The related top-up share obligations remain classified as a liability and are remeasured at fair value at each reporting date, with the changes in fair value recognized within other income (expense). See Note 3 to the condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional discussion of the May 2026 Pre-Funded Warrants, May 2026 Warrants, and Ascendant Pre-Funded Warrants.
Liquidity and Capital Resources
We have financed our working capital requirements primarily through private and public offerings of equity securities, cash received under collaboration agreements, and borrowings under the Loan Agreement. At June 30, 2026, we had cash and cash equivalents totaling $17.4 million available to fund our ongoing business activities. Additional information concerning our financial condition and results of operations is provided in the financial statements included in this Quarterly Report on Form 10-Q.
The amounts that we actually spend for any specific purpose may vary significantly and will depend on a number of factors, including, but not limited to, our research and development activities and programs, clinical testing, regulatory approval, market conditions, and changes in or revisions to our business strategy and technology development plans.
On May 9, 2023, we filed a registration statement on Form S-3, which was declared effective on May 26, 2023 (File No. 333-271786), to register for sale from time to time up to $300 million of our common stock, preferred stock, debt securities, warrants, subscription rights and/or units in one or more offerings. In anticipation of the expiration of this registration statement, on March 16, 2026, we filed a new registration statement on Form S-3, which was declared effective on March 31, 2026 (File No. 333-294366), to register for sale from time to time up to $300 million of our common stock, preferred stock, debt securities, warrants, subscription rights, and/or units in one or more offerings.
In October 2021, we entered into an open market sale agreement, or the ATM Sales Agreement, with Jefferies LLC, or Jefferies, to sell shares of our common stock for aggregate gross proceeds of up to $80.0 million, from time to time, through an "at-the-market" equity offering program under which Jefferies acts as sales agent. The ATM Sales Agreement will terminate upon the earliest of (a) the sale of $80.0 million of shares of our common stock pursuant to the ATM Sales Agreement or (b) the termination of the ATM Sales Agreement by us or Jefferies. During the three months ended June 30, 2026, there were no sales under the ATM Sales Agreement. During the six months ended June 30, 2026, we sold 34,652 shares of common stock
under the ATM Sales Agreement for proceeds of $0.3 million, net of commissions paid, but excluding transaction expenses. During the three and six months ended June 30, 2025, we sold 36,566 shares of common stock under the ATM Sales Agreement for proceeds of $0.8 million, net of commissions paid, but excluding transaction expenses. As of June 30, 2026, we had sold an aggregate of 450,866 shares of common stock under the ATM Sales Agreement for proceeds of $43.2 million, net of commissions paid, but excluding transaction expenses, since its inception.
On April 30, 2026, we entered into a securities purchase agreement with accredited investors, pursuant to which we agreed to issue and sell to the investors in a private placement, or the May 2026 Offering, pre-funded warrants to purchase an aggregate of up to 2,727,272 shares of common stock, or the May 2026 Pre-Funded Warrants, and accompanying warrants, or the May 2026 Warrants, to purchase an aggregate of up to 1,363,636 shares of common stock (or, in certain circumstances, May 2026 Pre-Funded Warrants to purchase common stock in lieu thereof) at a price of $11.00 per May 2026 Pre-Funded Warrant and accompanying May 2026 Warrant. The exercise price of the May 2026 Pre-Funded Warrants is $0.001 per share. The exercise price of the May 2026 Warrants is $11.00 per share. The May 2026 Offering closed on May 4, 2026. We received net proceeds from the May 2026 Offering of approximately $27.6 million, after deducting placement agent fees and offering expenses. The May 2026 Pre-Funded Warrants are cashless exercisable. The May 2026 Warrants are exercisable at any time prior to five years after the closing date of the May 2026 Offering.
On July 9, 2026, we entered into a securities purchase agreement with accredited investors, including Cormorant Asset Management and Columbia Threadneedle Investments, pursuant to which we, in a private placement, agreed to issue and sell to the investors an aggregate of (i) 1,418,071 shares of common stock at a price per share of $33.21 and (ii) to certain investors, in lieu of shares of common stock, pre-funded warrants (the "June 2026 Pre-Funded Warrants") to purchase up to 87,500 shares of common stock at a price per June 2026 Pre-Funded Warrant of $33.209 (the "June 2026 Private Placement"), for net proceeds of approximately $49.8 million. Each June 2026 Pre-Funded Warrant has an exercise price of $0.001 per share and is cashless exercisable. The July 2026 Private Placement closed on July 13, 2026.
If we issue additional equity securities to raise funds, the ownership percentage of our existing stockholders would be reduced. New investors may demand rights, preferences or privileges senior to those of existing holders of our common stock. If we issue debt securities, we may be required to grant security interests in our assets, could have substantial debt service obligations, and lenders may have a senior position (compared to stockholders) in any potential future bankruptcy or liquidation. Additionally, corporate collaboration and licensing arrangements may require us to incur non-recurring and other charges, give up certain rights relating to our intellectual property and research and development activities, increase our near and long-term expenditures, issue securities that dilute our existing stockholders, issue debt which may require liens on our assets and which will increase our monthly expense obligations, or disrupt our management and business.
Cash Flows
Based on our current plans and forecasted expenses, we believe our existing cash and cash equivalents as of June 30, 2026, together with the net proceeds we received from the July 2026 Private Placement, will be sufficient to meet our projected operating needs at least through the next twelve months from the issuance date of our condensed consolidated financial statements included in this Quarterly Report. We have based our estimate as to how long we expect we will be able to fund our obligations on assumptions that may prove to be wrong and we may use our available capital resources sooner than we currently expect. However, we will need to raise substantial additional capital to fund our future operations. We expect to finance our future cash needs through a combination of equity offerings, collaborations, and other strategic alliances. Volatility in capital markets and general economic conditions in the United States may be a significant obstacle to raising the required funds and, as a result, we may be unable to secure the necessary funding on acceptable terms.
The following table summarizes our changes in cash, cash equivalents, and restricted cash for the six months ended June 30, 2026 and 2025 in thousands:
|
Six Months Ended |
||||||||
|
June 30, |
||||||||
|
2026 |
2025 |
|||||||
|
Net cash provided by (used in): |
||||||||
|
Operating activities |
$ |
(39,946 |
) |
$ |
(11,587 |
) |
||
|
Investing activities |
(121 |
) |
(177 |
) |
||||
|
Financing activities |
30,323 |
16,798 |
||||||
|
Net change in cash, cash equivalents, and restricted cash |
$ |
(9,744 |
) |
$ |
5,034 |
|||
Operating Activities
Net cash used in operating activities totaled $39.9 million for the six months ended June 30, 2026 compared to $11.6 million for the six months ended June 30, 2025. The increase in cash used in operating activities of $28.4 million was primarily due to an increase in net loss adjusted for non-cash expenses, partially offset by an increase in cashflows from changes in deposits and other receivables.
Investing Activities
Net cash used in investing activities totaled $0.1 million for the six months ended June 30, 2026 compared to net cash used in investing activities of $0.2 million during the six months ended June 30, 2025. Cash used in investing activities remained relatively flat and was primarily due to purchases of property and equipment during the six months ended June 30, 2026 and 2025.
Financing Activities
Net cash provided by financing activities totaled $30.3 million for the six months ended June 30, 2026 compared to $16.8 million for the six months ended June 30, 2025. The increase of $13.5 million was primarily due to higher proceeds from the May 2026 Offering.
Funding Requirements
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of our Immuno-STAT platform and continue ongoing and initiate new clinical trials of and seek marketing approval for our drug product candidates. In addition, we expect to incur additional costs associated with operating as a public company. Our expenses will also increase if, and as, we:
We currently believe that our existing cash and cash equivalents as of June 30, 2026, together with the net proceeds we received from the July 2026 Private Placement, will be sufficient to meet our projected operating needs at least through the next twelve months from the issuance date of our condensed consolidated financial statements included in this Quarterly Report. We have based our estimate as to how long we expect we will be able to fund our obligations on assumptions that may prove to be wrong and we may use our available capital resources sooner than we currently expect.
We will need to raise additional capital or incur additional indebtedness to continue to fund our operations in the near term. Our ability to raise additional funds will depend on financial, economic and market conditions, many of which are outside of our control, and we may be unable to raise financing when needed, or on terms favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts, or grant rights to develop and market drug product candidates that we would otherwise prefer to
develop and market ourselves, which could adversely affect our business prospects, and we may be unable to continue our operations. Because of numerous risks and uncertainties associated with the research, development and commercialization of our drug product candidates, we are unable to estimate the exact amount of our working capital requirements. Factors that may affect our planned future capital requirements and accelerate our need for additional working capital include the following:
A change in the outcome of any of these or other variables with respect to the development of any of our drug product candidates could significantly change the costs and timing associated with the development of that drug product candidate. Further, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic partnerships or marketing, distribution or licensing arrangements with third parties and grants from organizations and foundations. If we raise additional funds by selling shares of our common stock or other equity-linked securities, the ownership interest of our current stockholders will be diluted. New investors may demand rights, preferences or privileges senior to those of existing holders of our common stock. If we issue debt securities, we may be required to grant security interests in our assets, could have substantial debt service obligations, and lenders may have a senior position (compared to stockholders) in any potential future bankruptcy or liquidation. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or drug product candidates or to grant licenses on terms that may not be acceptable to us. Additionally, corporate collaboration and licensing arrangements may require us to incur non-recurring and other charges, give up certain rights relating to our intellectual property and research and development activities, increase our near and long-term expenditures, issue securities that dilute our existing stockholders, issue debt which may require liens on our assets and which will increase our monthly expense obligations, or disrupt our management and business.
If we are unable to raise additional capital when needed, we may be required to curtail the development of our technology or materially curtail or reduce our operations. We could be forced to sell or dispose of our rights or assets. Any inability to raise adequate funds on commercially reasonable terms could have a material adverse effect on our business, results of operations and financial condition, including the possibility that a lack of funds could cause our business to fail, dissolve and liquidate with little or no return to investors.
Principal Commitments
Except as set forth below, there have been no material changes to our contractual obligations and commitments as described in Management's Discussion and Analysis of Financial Condition and Results of Operations in Item 7 of our 2025 Annual Report. Additional information regarding the Ascendant Health License Agreement, BI Collaboration and License Agreement, the amendment to our Einstein License, and the amendments to our License Agreement with MIL 40G, LLC, may be found in Notes 8, 11, 12 and 13 to our condensed consolidated financial statements in this Quarterly Report on Form 10-Q.