Cue Biopharma, Inc.

Previous wording

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, 2024 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, or SEC, on March 31, 2025, or the 2024 Annual Report.

Current wording

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, 2024 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 31, 2025, or the 2024 Annual Report.

Previous wording

CUE-400 series (Autoimmune Diseases): Exploit transforming growth factor beta (TGF-β) signaling to induce an anti-inflammatory process, with a novel and unique mechanism to not only foster proliferation of regulatory T cells (Tregs) but also induce Tregs from T effector cells with the potential of restoring immune balance and functional immune tolerance (e.g., CUE-401 for autoimmune conditions).

Current wording

CUE-400 series (Autoimmune Diseases): Exploit transforming growth factor beta (TGF-β) and Interleukin 2 (IL2) signaling to induce an anti-inflammatory process, with a novel and unique mechanism to not only foster proliferation of regulatory T cells (Tregs) but also induce Tregs from T effector cells with the potential of restoring immune balance and functional immune tolerance (e.g., CUE-401 for autoimmune conditions).

Previous wording

CUE-100 series (Oncology): Selectively activate and expand tumor-specific T cells (e.g., CUE-101 for HPV+ cancers and CUE-102 for Wilms’ tumor 1 protein (WT1), expressing cancers).

Current wording

CUE-100 series (Oncology): Selectively activate and expand tumor-specific T cells (e.g., CUE-101 for HPV+ cancers and CUE-102 for Wilms’ tumor 1 protein (WT1), expressing cancers, both of which have been licensed to ImmunoScape Pte. Ltd. for development in oncology indications).

Previous wording

CUE-401 is a preclinical, bispecific fusion protein designed to promote immune tolerance by modulating key components of the immune system, including the induction of newly formed Tregs (iTregs) from Teff cells, as well as expansion of existing or natural regulatory T cells (nTregs). Through the co-activity of engineered variants of TGF-β and interleukin 2 (IL-2), CUE-401 has the therapeutic potential to re-establish immune balance and induce tolerance across a range of T cell mediated autoimmune and inflammatory diseases.

Current wording

Our lead candidate, CUE-401, is a preclinical, bifunctional fusion protein designed to promote immune tolerance by modulating key components of the immune system, including the induction of newly formed Tregs (iTregs) from Teff cells, as well as expansion of existing or natural regulatory T cells (nTregs). Through the co-activity of engineered variants of TGF-β and IL-2, CUE-401 has the therapeutic potential to re-establish immune balance and induce tolerance across a range of T cell mediated autoimmune and inflammatory diseases.

Previous wording

CUE-401, our first-in-class, bispecific molecule integrating a masked TGF-ß with our clinically validated, attenuated IL-2 variant, is designed to address multiple hurdles to fully exploiting the therapeutic potential of an immunology master switch. This novel design provides for “conditional binding” to avoid off target activity and has generated highly differentiated data in multiple preclinical autoimmune animal disease models.

Current wording

CUE-401, our first-in-class, bifunctional molecule integrating a masked TGF-ß with our clinically validated, attenuated IL-2 variant, is designed to address multiple hurdles to fully exploit the therapeutic potential of an immunology master switch. This novel design provides for “conditional binding” to avoid off target activity and has generated highly differentiated data in multiple preclinical autoimmune animal disease models.

Previous wording

In these preclinical animal models, CUE-401 behaves as a master switch to ameliorate inflammation as well as convert autoreactive effector T cells into stable iTregs. These findings suggest that CUE-401 acts by establishing a “tolerance positive feedback loop” that not only increases nonspecific Treg populations, but also reduces and converts specific autoreactive T cells into transdifferentiated iTregs that are specific for the disease-causing autoantigens.

Current wording

In these preclinical animal models, CUE-401 behaves as a master switch to reduce inflammation as well as convert autoreactive effector T cells into iTregs, which express FoxP3, the hallmark transcription factor that characterizes stable Tregs. These findings suggest that CUE-401 acts by establishing a “tolerance positive feedback loop” that not only increases nonspecific Treg populations but also reduces and converts specific autoreactive T cells into transdifferentiated iTregs that are specific to the disease-causing autoantigens.

Previous wording

We believe these results, along with advances in the manufacturing of CUE-401, have substantially reduced the risk profile for the development of this program and we have selected a lead candidate molecule. Scale-up manufacturing and other IND-enabling studies for CUE-401 are presently ongoing. We are preparing to file an investigational new drug (IND) application in the second quarter of 2026, with human proof-of-mechanism data anticipated in the first half of 2027. These early clinical trial results are anticipated to provide mechanistic evidence and validation further supporting the underlying premise of establishing immune balance and inducing durable immune tolerance which could represent a potential breakthrough as a new standard of care in multiple high-value autoimmune disease indications.

Current wording

We believe these results, along with advances in the manufacturing of CUE-401, have substantially reduced the risk profile for the development of this program and we have selected a lead candidate molecule. Scale-up manufacturing and other IND-enabling studies for CUE-401 are presently ongoing. We are preparing to file an investigational new drug (IND) application in the second quarter of 2026. We have selected atopic dermatitis as our lead indication for our Phase 1b trial for CUE-401. We anticipate receiving human safety data in the second half of 2026 and human proof-of-concept data in the second half of 2027. These early clinical trial results are anticipated to provide mechanistic evidence and validation further supporting the underlying premise of establishing immune balance and inducing durable immune tolerance, which could represent a potential breakthrough as a new standard of care in multiple high-value autoimmune disease indications.

Previous wording

The CUE-500 series has been developed to enable targeted anti-viral T cell-mediated depletion of pathogenic cell types, including autoreactive B cells. We believe these biologics have the potential to achieve immune balance in autoimmune patients and are significantly differentiated from other competing approaches such as bispecific antibody drug conjugates, pan-T cell engagers, IL-2 muteins, TNFR2 agonists, and CAR-T therapies.

Current wording

The CUE-500 series has been developed to enable targeted anti-viral T cell-mediated depletion of pathogenic cell types, including autoreactive B cells. We believe these biologics have the potential to achieve immune balance in autoimmune patients and are significantly differentiated from other competing approaches such as bifunctional antibody drug conjugates, pan-T cell engagers, IL-2 muteins, TNFR2 agonists, and CAR-T therapies.

Previous wording

The CUE-500 series represents a novel approach to selectively target disease-causing cells by redirecting existing anti-viral memory T cells to target and deplete such disease-causing cells. CUE-501, for which we recently established a collaboration and license agreement with Boehringer Ingelheim International GmbH (BI), is being developed to target and deplete autoimmune disease-causing B cells, in patients with autoimmune disease caused by autoreactive, pathogenic B cells. Targeted B cell depletion is widely recognized in the industry as a clinically validated and important approach for the treatment of B cell mediated autoimmune and inflammatory diseases, and we believe the selective mechanism of action exploiting the anti-viral memory T cell repertoire will provide highly effective killing of the targeted cells while preventing or substantially reducing the side effect profile often experienced with competing approaches.

Current wording

The CUE-500 series represents a novel approach to selectively target disease-causing cells by redirecting existing anti-viral memory T cells to target and deplete such disease-causing cells. CUE-501, for which we entered into a collaboration and license agreement with Boehringer Ingelheim International GmbH (BI) in April 2025, is being developed to target and deplete autoimmune disease-causing B cells, in patients with autoimmune disease caused by autoreactive, pathogenic B cells. Targeted B cell depletion is widely recognized in the industry as a clinically validated and important approach for the treatment of B cell mediated autoimmune and inflammatory diseases, and we believe the selective mechanism of action exploiting the anti-viral memory T cell repertoire will provide highly effective killing of the targeted cells while preventing or substantially reducing the side effect profile often experienced with competing approaches.

Previous wording

Historically, we have 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.

Current wording

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.

Previous wording

Although we are prioritizing CUE-401 and the CUE-500 series, we are currently continuing to treat and monitor patients in a Phase 1b open-label expansion study investigating CUE-101 in the treatment of HPV+ recurrent metastatic, or R/M, head and neck squamous cell carcinoma (HNSCC), in second line and beyond patients as a monotherapy, and as a first line therapy in combination with pembrolizumab (KEYTRUDA®). We are also continuing to monitor patients in a Phase 1b clinical trial of CUE-102 as a monotherapy in late line R/M WT1+ colorectal, gastric, ovarian, and pancreatic cancer and are enabling an investigator sponsored trial to evaluate CUE-102 in recurrent glioblastoma (rGBM).

Current wording

While we are prioritizing CUE-401, we are preparing study reports for the CUE-101 and CUE-102 trials. A total of 80 patients were dosed in the CUE-101 Phase 1b open-label study investigating CUE-101 in the treatment of HPV+ recurrent metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), in second line and beyond in patients as a monotherapy, and as a first line therapy in combination with pembrolizumab (KEYTRUDA®). All patient dosing has been completed and post-dose safety follow-up is ongoing for one study patient. Database lock preparations are ongoing with lock expected in the fourth quarter of 2025. In addition, we are enabling an investigator sponsored trial to evaluate CUE-101 as neoadjuvant therapy in locally advanced HPV+ HNSCC.

Previous wording

Key data highlights (data cutoff date of July 14, 2025) from the ongoing open-label Phase 1b study of CUE-101 in HPV+ R/M HNSCC include:

Current wording

Key data highlights (data cutoff date of September 17, 2025) from the open-label Phase 1b study of CUE-101 in HPV+ R/M HNSCC include:

Previous wording

Median OS of 32 months compared to 12.3 months in the historical KEYNOTE-048 trial.

Current wording

Median OS of 32.7 months compared to 12.3 months in the historical KEYNOTE-048 trial.

Previous wording

We intend to maximize this value by focusing on the development of CUE-401, for which we are preparing to file an IND application in the second quarter of 2026, while also establishing collaborations across our pipeline, such as our strategic collaboration and license agreement with BI for the development of CUE-501.

Current wording

We intend to maximize this value by focusing on the development of CUE-401, for which we are preparing to file an IND application in the second quarter of 2026. We have also successfully established 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.

Previous wording

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 2024 Annual Report 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, 2025.

Current wording

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 2024 Annual Report 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 nine months ended September 30, 2025.

Previous wording

Make significant payments based upon the achievement of certain milestones, as defined in the Einstein License. As of June 30, 2025, two of these milestones had been achieved, as we had filed an IND application in 2019, and initiated the investigator sponsored Phase 1b neoadjuvant clinical trial for CUE-101 in 2021.

Current wording

Make significant payments based upon the achievement of certain milestones, as defined in the Einstein License. As of September 30, 2025, two of these milestones had been achieved, as we had filed an IND application in 2019, and initiated an investigator sponsored Phase 1b neoadjuvant clinical trial for CUE-101 in locally advanced HNSCC in 2021.

Previous wording

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, 2025 and 2024. Such costs are included in research and development costs in our condensed consolidated statements of operations and comprehensive loss.

Current wording

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 nine months ended September 30, 2025 and 2024. Such costs are included in research and development costs in our condensed consolidated statements of operations and comprehensive loss.

Previous wording

We did not recognize any revenue related to the LG Chem Collaboration Agreement for the three and six months ended June 30, 2025. For each of the three and six months ended June 30, 2024 we recognized revenue of less than $0.1 million related to the LG Chem Collaboration Agreement. As of June 30, 2025, we had recorded $20.0 million in collaboration revenue related to this agreement since the agreement was entered into. The majority of the research phase of the LG Chem Collaboration Agreement was completed by March 31, 2022.

Current wording

We did not recognize any revenue related to the LG Chem Collaboration Agreement for the three and nine months ended September 30, 2025. For each of the three and nine months ended September 30, 2024 we recognized revenue of less than $0.1 million related to the LG Chem Collaboration Agreement. As of September 30, 2025, we had recorded $20.0 million in collaboration revenue related to this agreement since the agreement was entered into. The majority of the research phase of the LG Chem Collaboration Agreement was completed by March 31, 2022.

Previous wording

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.

Current wording

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

Previous wording

As of the date of this report, both we and Ono have satisfied all of our respective performance obligations and made all outstanding payments required under the 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. For each of the three and six months ended June 30, 2024, we recognized revenue of $2.6 million and $4.3 million, respectively, related to the Ono Collaboration and Option Agreement. We did not record short or long-term research and development liabilities on our condensed consolidated balance sheet as of June 30, 2025, as the performance obligation has been met and completed. For the year ended December 31, 2024, we recorded short-term research and development liabilities on our consolidated balance sheets of $0.1 million.

Current wording

As of the date of this report, both we and Ono have satisfied all of our respective performance obligations and made all outstanding payments required under the agreement. For the nine months ended September 30, 2025, we recognized revenue of $0.4 million related to the Ono Collaboration and Option Agreement. We did not recognize revenue for the three months ended September 30, 2025 related to the Ono Collaboration and Option Agreement. For each of the three and nine months ended September 30, 2024, we recognized revenue of $3.4 million and $7.7 million, respectively, related to the Ono Collaboration and Option Agreement. We did not record short or long-term research and development liabilities on our condensed consolidated balance sheet as of September 30, 2025, as the performance obligation has been met and completed. For the year ended December 31, 2024, we recorded short-term research and development liabilities on our consolidated balance sheets of $0.1 million.

Previous wording

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 short or long-term research and development liabilities of $9.6 million on our condensed consolidated balance sheet dated June 30, 2025.

Current wording

For the three and nine months ended September 30, 2025, we recognized revenue of $2.1 million and $5.1 million, respectively, related to the BI Collaboration and License Agreement. We recorded short-term research and development liabilities of $7.8 million on our condensed consolidated balance sheet dated September 30, 2025.

Previous wording

We have not yet generated commercial revenue from product sales. To date, we have generated revenue from collaboration agreements with BI, 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.

Current wording

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.

Previous wording

The following table summarizes our research and development expenses by category for the six months ended June 30, 2025 and 2024 (in millions):

Current wording

The following table summarizes our research and development expenses by category for the nine months ended September 30, 2025 and 2024 (in millions):

Previous wording

Our condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025 and 2024, as discussed herein, are presented below in thousands.

Current wording

Our condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2025 and 2024, as discussed herein, are presented below in thousands.

Previous wording

Collaboration revenue increased by $0.3 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. The increase was due to more revenue earned during the three months ended June 30, 2025 from our BI Collaboration and License Agreement compared to revenue earned during the three months ended June 30, 2024 from our Ono Collaboration and Option Agreement due to the timing of activities pursuant to the respective agreements.

Current wording

Collaboration revenue decreased by $1.2 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. The decrease was due to less revenue earned during the three months ended September 30, 2025 from our BI Collaboration and License Agreement compared to revenue earned during the three months ended September 30, 2024 from our Ono Collaboration and Option Agreement due to the timing of activities pursuant to the respective agreements.

Previous wording

Collaboration revenue decreased by $1.0 million for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. The decrease was due to more revenue earned during the six months ended June 30, 2024 from our Ono Collaboration and Option Agreement 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 pursuant to the respective agreements.

Current wording

Collaboration revenue decreased by $2.2 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The decrease was due to less revenue earned during the nine months ended September 30, 2025 from our BI Collaboration and License Agreement compared to revenue earned during the nine months ended September 30, 2024 from our Ono Collaboration and Option Agreement due to the timing of activities pursuant to the respective agreements.

Previous wording

General and administrative expenses increased by $0.2 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. The increase was primarily due to an increase in professional fees.

Current wording

General and administrative expenses increased by $2.1 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. The increase was primarily due to a one-time employee severance accrual in September of 2025, as well as an increase in professional fees.

Previous wording

General and administrative expenses increased by $0.2 million for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. The increase was primarily due to an increase in professional fees, partially offset by a decrease in employee compensation, which includes stock-based compensation.

Current wording

General and administrative expenses increased by $2.2 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The increase was primarily due to an increase in professional fees and a one-time employee severance payment, partially offset by a decrease in stock-based compensation.

Previous wording

Research and development expenses decreased by $1.6 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. The decrease was primarily due to decreases in clinical trial costs for our CUE-100 series Phase 1 trials, as activities shifted to patient survival monitoring, as well as decreases in employee compensation, which includes stock-based compensation.

Current wording

Research and development expenses decreased by $4.6 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. The decrease was primarily due to decreases in clinical trial costs for our CUE-100 series, as well as decreases in employee compensation, which includes stock-based compensation.

Previous wording

Research and development expenses decreased by $3.3 million for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. The decrease was primarily due to decreases in clinical trial costs for our CUE-100 series Phase 1 trials, as activities shifted to patient survival monitoring, as well as decreases in employee compensation, which includes stock-based compensation.

Current wording

Research and development expenses decreased by $7.9 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The decrease was primarily due to decreases in clinical trial costs for our CUE-100 series, as well as decreases in employee compensation, which includes stock-based compensation.

Previous wording

Interest income decreased by $0.2 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. The decrease was due to lower interest earned on cash and cash equivalents.

Current wording

Interest income decreased by $0.1 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. The decrease was due to lower interest earned on cash and cash equivalents.

Previous wording

Interest income decreased by $0.6 million for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. The decrease was due to lower interest earned on cash and cash equivalents.

Current wording

Interest income decreased by $0.7 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The decrease was due to lower interest earned on cash and cash equivalents.

Previous wording

Interest expense decreased by $0.2 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. This was due to a decrease in interest owed from borrowings under our Loan Agreement with SVB.

Current wording

Interest expense decreased by $0.1 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. This was due to a decrease in interest owed from borrowings under our Loan Agreement with SVB.

Previous wording

Interest expense decreased by $0.3 million for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. This was due to a decrease in interest owed from borrowings under our Loan Agreement with SVB.

Current wording

Interest expense decreased by $0.3 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. This was due to a decrease in interest owed from borrowings under our Loan Agreement with SVB.

Previous wording

We have financed our working capital requirements primarily through private and public offerings of equity securities, cash received from BI, LG Chem, Ono, and Merck Sharp & Dohme Corp. under the respective collaboration agreements we have with them, and borrowings under the Loan Agreement.

Current wording

We have financed our working capital requirements primarily through private and public offerings of equity securities, cash received from BI, IMSCP, LG Chem, Ono, and Merck Sharp & Dohme Corp. under collaboration agreements, and borrowings under the Loan Agreement.

Previous wording

In October 2021, we entered into an open market sale agreement, or the ATM Sales Agreement, with Jefferies LLC, or Jefferies, as agent, to sell shares of our common stock for aggregate gross proceeds of up to $80 million, from time to time, through an at-the-market equity offering program. The ATM Sales Agreement will terminate upon the earliest of (a) the sale of $80 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 and six months ended June 30, 2025, we sold 1,097,003 shares of common stock under the ATM Sales Agreement for proceeds of $0.8 million, net of commissions paid, but excluding transaction expenses. During the three months ended June 30, 2024, there were no sales under the ATM Sales Agreement. During the six months ended June 30, 2024, we sold 1,428,200 shares of common stock under the ATM Sales Agreement for proceeds of $3.4 million, net of commissions paid, but excluding transaction expenses. As of June 30, 2025, we had sold an aggregate of 10,169,234 shares of common stock under the ATM Sales Agreement for proceeds of $41.2 million, net of commissions paid, but excluding transaction expenses, since its inception.

Current wording

In October 2021, we entered into an open market sale agreement, or the ATM Sales Agreement, with Jefferies LLC, or Jefferies, as agent, to sell shares of our common stock for aggregate gross proceeds of up to $80 million, from time to time, through an at-the-market equity offering program. The ATM Sales Agreement will terminate upon the earliest of (a) the sale of $80 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 September 30, 2025, we sold 1,334,859 shares of common stock under the ATM Sales Agreement for proceeds of $1.0 million, net of commissions paid, but excluding transaction expenses. During the three months ended September 30, 2024, there were no sales under the ATM Sales Agreement. During the nine months ended September 30, 2025, we sold 2,431,862 shares of common stock under the ATM Sales Agreement for proceeds of $1.8 million, net of commissions paid, but excluding transaction expenses. During the nine months ended September 30, 2024, we sold 1,428,200 shares of common stock under the ATM Sales Agreement for proceeds of $3.4 million, net of commissions paid, but excluding transaction expenses. As of September 30, 2025, we had sold an aggregate of 11,504,093 shares of common stock under the ATM Sales Agreement for proceeds of $42.2 million, net of commissions paid, but excluding transaction expenses, since its inception.

Previous wording

On September 26, 2024, we entered into an underwriting agreement, or the 2024 Underwriting Agreement, with Oppenheimer & Co. Inc., as representative of the several underwriters named therein, or, collectively, the 2024 Underwriters, relating to an underwritten public offering of (i) 11,564,401 shares, or the 2024 Shares, of our common stock, $0.001 par value per share, and accompanying common stock warrants, or the2024 Common Stock Warrants, to purchase 2,891,100 shares of our common stock, and (ii) to certain investors in lieu of common stock, pre-funded warrants, or the 2024 Pre-Funded Warrants, to purchase 12,435,599 shares of our common stock and accompanying 2024 Common Stock Warrants to purchase 3,108,900 shares of common stock. All of the 2024 Shares, the 2024 Pre-Funded Warrants and the 2024 Common Stock Warrants were sold by us. Each 2024 Share was offered and sold together with an accompanying 2024 Common Stock Warrant at a combined offering price of $0.50, and each 2024 Pre-Funded Warrant was offered and sold together with an accompanying 2024 Common Stock Warrant at a combined offering price of $0.499, which is equal to the combined offering price per share of common stock and accompanying 2024 Common Stock Warrant less the $0.001 exercise price of each 2024 Pre-Funded Warrant. The 2024 Underwriters purchased (i) each 2024 Share and accompanying 2024 Common Stock Warrant from us pursuant to the 2024 Underwriting Agreement at a combined price of $0.47 and (ii) each 2024 Pre-Funded Warrant and accompanying 2024 Common Stock Warrant from us pursuant to the 2024 Underwriting Agreement at a combined price of $0.46906. We recorded net proceeds from the offering of $10.8 million, after deducting underwriting discounts and commissions and offering expenses of $1.1 million, excluding any proceeds that may be received from exercise of the 2024 Common Stock Warrants and the 2024 Pre-Funded Warrants.

Current wording

On September 26, 2024, we entered into an underwriting agreement, or the 2024 Underwriting Agreement, with Oppenheimer & Co. Inc., as representative of the several underwriters named therein, or, collectively, the 2024 Underwriters, relating to an underwritten public offering of (i) 11,564,401 shares, or the 2024 Shares, of our common stock, $0.001 par value per share, and accompanying common stock warrants, or the2024 Common Stock Warrants, to purchase 2,891,100 shares of our common stock, and (ii) to certain investors in lieu of common stock, pre-funded warrants, or the 2024 Pre-Funded Warrants, to purchase 12,435,599 shares of our common stock and accompanying 2024 Common Stock Warrants to purchase 3,108,900 shares of common stock. All of the 2024 Shares, the 2024 Pre-Funded Warrants and the 2024 Common Stock Warrants were sold by us. Each 2024 Share was offered and sold together with an accompanying 2024 Common Stock Warrant at a combined offering price of $0.50, and each 2024 Pre-Funded Warrant was offered and sold together with an accompanying 2024 Common Stock Warrant at a combined offering price of $0.499, which is equal to the combined offering price per share of common stock and accompanying 2024 Common Stock Warrant less the $0.001 exercise price of each 2024 Pre-Funded Warrant. The 2024 Underwriters purchased (i) each 2024 Share and accompanying 2024 Common Stock Warrant from us pursuant to the 2024 Underwriting Agreement at a combined price of $0.47 and (ii) each 2024 Pre-Funded Warrant and accompanying 2024 Common Stock Warrant from us pursuant to the 2024 Underwriting Agreement at a combined price of $0.46906. We recorded net proceeds from the offering of $10.8 million, after deducting underwriting discounts and commissions and offering expenses of $1.2 million, excluding any proceeds that may be received from exercise of the 2024 Common Stock Warrants and the 2024 Pre-Funded Warrants.

Previous wording

Based on our current plans and forecasted expenses, we believe our existing cash and cash equivalents as of June 30, 2025 will enable us to fund our operations into the second quarter of 2026. However, we will need to raise substantial additional capital to fund our future operations and remain as a going concern. 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. This raises substantial doubt about our ability to continue as a going concern.

Current wording

Based on our current plans and forecasted expenses, we believe our existing cash, cash equivalents and marketable securities as of September 30, 2025, as well as the upfront payments we have received and are entitled to receive from IMSCP, will enable us to fund our operations into the third quarter of 2026. However, we will need to raise substantial additional capital to fund our future operations and remain as a going concern. 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. This raises substantial doubt about our ability to continue as a going concern.

Previous wording

The following table summarizes our changes in cash, cash equivalents, and restricted cash for the six months ended June 30, 2025 and 2024 in thousands:

Current wording

The following table summarizes our changes in cash, cash equivalents, and restricted cash for the nine months ended September 30, 2025 and 2024 in thousands:

Previous wording

Net cash used in operating activities totaled $11.6 million for the six months ended June 30, 2025 compared to $19.8 million for the six months ended June 30, 2024. The decrease of $8.2 million was primarily due to decreases in cash outflows from changes in stock-based compensation and changes in right-of-use assets, partially offset by increases from changes in research and development contract liabilities.

Current wording

Net cash used in operating activities totaled $20.6 million for the nine months ended September 30, 2025 compared to $27.3 million for the nine months ended September 30, 2024. The decrease of $6.7 million was primarily due to decreases in cash outflows from changes in accounts payable, prepaid expense and other current assets, partially offset by increases from changes in research and development contract liabilities.