Cue Biopharma, Inc.

Previous wording

CUE-400 series (Autoimmune Diseases): Induce and expand regulatory T cells, or Tregs, with a novel and unique mechanism to not only proliferate but also generate Tregs, with the potential of restoring immune balance (e.g., CUE-401 for autoimmune conditions).

Current 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).

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, or 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).

Previous wording

The Immuno-STAT framework is engineered to be highly flexible and modular, potentially enabling us to deploy the same or similar core functional elements to restore immune balance across diverse therapeutic approaches.

Current wording

As represented in the following image, the Immuno-STAT framework is engineered to be highly flexible and modular, potentially enabling us to deploy the same or similar core functional elements to restore immune balance across diverse therapeutic approaches.

Previous wording

In autoimmune, we have developed novel approaches to restoring immune balance and health. CUE-401 is a novel bispecific composed of a masked, attenuated TGF-β with an interleukin 2, or IL-2, attenuated variant that together has demonstrated preclinically the ability to potently stimulate the generation and proliferation of Tregs. The masking of TGF-β enables the drug to have a biased, or conditional, binding to immune cells having both the IL-2 receptor, as well as the TGF-β receptors, enabling concurrent, conditional signaling. In autoimmune disease, Tregs are the master regulators of maintaining immune homeostasis, or balance, and health. Autoreactive T cells, referred to as 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. CUE-401 has been specifically engineered and designed to foster Treg control by proliferating existing natural regulatory T cells, or nTregs, that develop in the thymus as well as inducing new Tregs, or iTregs, and reducing the number of inflammatory Teff cells, thereby restoring the essential Treg/Teff balance. As such, we believe that CUE-401 represents a novel approach to selectively induce and expand Tregs with the potential to provide superior therapeutic effects for the treatment for chronic autoimmune diseases.

Current wording

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 (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.

Previous wording

We have conducted preclinical studies to characterize the pharmacokinetics, pharmacodynamics, and tolerability of CUE-401 across multiple animal species and provide insights towards translation to human clinical studies. These results, along with advances in the manufacturing of CUE-401, have derisked the development of this asset and identified a lead candidate molecule. Scale-up manufacturing and other IND-enabling studies for CUE-401 are ongoing. We are preparing to file an investigational new drug, or IND, application in the third quarter of 2026, with human proof-of-mechanism data anticipated in the first half of 2027, subject to sufficient funding. These early clinical trial results are anticipated to validate and further support the underlying mechanism of action representing a potential new standard of care of CUE-401 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, 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.

Previous wording

In addition to CUE-401, we have also developed the CUE-500 series to enable T cell-mediated depletion of pathogenic cell types. We believe these biologics have the potential to achieve immune balance in autoimmune patients and are significantly differentiated from other competing approaches such as antibody drug conjugates, pan-T cell engagers, IL-2 muteins, TNFR2 agonists, and CAR-T therapies. The CUE-500 series represents a novel approach to selectively target disease-causing cells and redirect existing anti-viral memory T cells to targeted disease-causing cells and deplete these cells. CUE-501, for which we recently established a collaboration and license agreement with Boehringer Ingelheim International GmbH, or 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. Due to its modularity, we believe that the CUE-500 series has therapeutic potential across multiple therapeutic areas. The mode of redirecting a defined population of already existing anti-viral T cells may apply to many pathogenic cell types readily addressed by swapping different cell-targeting antibody domains into the CUE-500 series framework.

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 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.

Previous wording

We believe the preclinical data generated to date for the CUE-401 and the CUE-500 series demonstrates the intended mechanistic effect of these novel approaches for the potential treatment of autoimmune disease, and each represent potential breakthrough therapeutic opportunities for significant patient populations and potential near-term value creation opportunities for our shareholders as potential innovations providing transformative therapies to large, underserved patient populations.

Current wording

We believe the preclinical data generated to date for CUE-401 and the CUE-500 series demonstrates the intended mechanistic effect of these novel approaches for the potential treatment of autoimmune disease, and each represent potential breakthrough therapeutic opportunities for significant patient populations and potential near-term value creation opportunities for our shareholders.

Previous 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. 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, or HNSCC, in second line and beyond patients as a monotherapy. We are also conducting a Phase 1b clinical trial investigating CUE-101 in the treatment of HNSCC, as a first line therapy in combination with standard of care KEYTRUDA. We are also currently 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, or GBM.

Current 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).

Previous wording

Our precision immunotherapies are in the development phase. We believe that our platforms have the potential for creating a diverse pipeline of promising drug product candidates addressing multiple medical indications. We also believe that our science is de-risked with clinical tolerability across a wide range of cancers from our Phase 1 trials of CUE-101 and CUE-102, with potential application in autoimmune disease. We intend to maximize the value and probability of commercialization of our Immuno-STAT drug product candidates by focusing on the development of CUE-401, for which we are preparing to file an IND application in the third quarter of 2026, while also establishing collaborations across our pipeline, such as our recent strategic collaboration and license agreement with BI for the development of CUE-501 described below and in Note 13 to the condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.

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, while also establishing collaborations across our pipeline, such as our strategic collaboration and license agreement with BI for the development of CUE-501.

Previous wording

Since a fundamental element of our corporate development strategy is to establish strategic partnerships with leading pharmaceutical or biotechnology organizations that will allow us to more fully exploit the potential of our technology platforms in the areas of oncology and autoimmune disease and accelerate and expand our pipelines, we are actively seeking collaborations for our CUE-101 and CUE-102 assets.

Current wording

As a fundamental element of our corporate development strategy, we are actively seeking collaborations for our oncology assets CUE-101 and CUE-102. This will allow us to more fully exploit the potential of our technology platform in the area of autoimmune disease and accelerate and expand our pipeline.

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 three months ended March 31, 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 six months ended June 30, 2025.

Previous wording

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.

Current wording

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.

Previous wording

We account for the costs incurred in connection with the Einstein License in accordance with Accounting Standards Codification 730, Research and Development. For both the three months ended March 31, 2025 and 2024, we incurred less than $0.1 million in fees payable to Einstein in relation to this license. 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 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.

Previous wording

We did not recognize any revenue related to the LG Chem Collaboration Agreement for the three months ended March 31, 2025 . For the three months ended March 31, 2024 we recognized revenue of less than $0.1 million related to the LG Chem Collaboration Agreement. As of March 31, 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 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.

Previous wording

For the three months ended March 31, 2025 and 2024, we recognized revenue of $0.4 million and $1.7 million, respectively, related to the Ono Collaboration and Option Agreement. We and Ono have satisfied all of our performance obligations and made all outstanding payments required under the agreement.

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 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.

Previous wording

Pursuant to the terms of the BI Collaboration and License Agreement, we received an upfront payment of approximately $12.0 million and will 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. During the BI Research Term, BI will also make research support payments to us.

Current wording

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 are seeking to get refunded. 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.

Previous wording

We have not yet generated commercial revenue from product sales. To date, we have generated revenue from collaboration agreements with Merck Sharp & Dohme Corp. (which terminated in December 2022), LG Chem, and Ono (which terminated in March 2025). We expect to begin to recognize revenue from the BI Collaboration and License Agreement in the second quarter of 2025. 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, 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

Our condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 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 six months ended June 30, 2025 and 2024, as discussed herein, are presented below in thousands.

Previous wording

Collaboration revenue decreased by $1.3 million for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The decrease was due to more revenue earned during the three months ended March 31, 2024 from the Ono Collaboration and Option Agreement, which was terminated in March 2025.

Current 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.

Previous wording

General and administrative expenses decreased by less than $0.1 million for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The decrease was primarily due to a decrease in employee compensation, which includes stock-based compensation, offset by an increase in professional fees.

Current 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.

Previous wording

Research and development expenses decreased by $1.7 million for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The decrease was primarily due to decreases in clinical trial costs for our CUE-101 and CUE-102 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 $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.

Previous wording

Interest income decreased by $0.4 million for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The decrease was due to lower interest earned on cash and cash equivalents.

Current 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.

Previous wording

Interest expense decreased by $0.1 million for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. This was due to a decrease in interest owed from borrowings under our Loan Agreement with SVB.

Current wording

Interest expense decreased by $0.2 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.

Previous wording

We have financed our working capital requirements primarily through private and public offerings of equity securities, cash received from Merck Sharp & Dohme Corp., LG Chem, and Ono under the respective collaboration agreements, 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, LG Chem, Ono, and Merck Sharp & Dohme Corp. under the respective collaboration agreements we have with them, 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. We did not sell any shares under the ATM Sales Agreement during the three months ended March 31, 2025. During the three months ended March 31, 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 March 31, 2025, we sold an aggregate of 9,072,231 shares of common stock under the ATM Sales Agreement for proceeds of $40.4 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 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.

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, and 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 $1.1 million, excluding any proceeds that may be received from exercise of the 2024 Common Stock Warrants and the 2024 Pre-Funded Warrants.

Previous wording

On April 14, 2025, we entered into an underwriting agreement, or the 2025 Underwriting Agreement, with Oppenheimer & Co. Inc., as representative of the several underwriters named therein, or, collectively, the 2025 Underwriters, relating to an underwritten public offering of (i) 13,530,780 shares, or the 2025 Shares, of our common stock, $0.001 par value per share, and accompanying common stock warrants, or the 2025 Common Stock Warrants to purchase 3,382,695 shares of our common stock, and (ii) to certain investors in lieu of common stock, pre-funded warrants, or the 2025 Pre-Funded Warrants, to purchase 11,469,216 shares of our common stock and accompanying 2025 Common Stock Warrants to purchase 2,867,304 shares of common stock. All of the 2025 Shares, the 2025 Pre-Funded Warrants and the 2025 Common Stock Warrants were sold by us. Each 2025 Share was offered and sold together with an accompanying 2025 Common Stock Warrant at a combined offering price of $0.79, and each 2025 Pre-Funded Warrant was offered and sold together with an accompanying 2025 Common Stock Warrant at a combined offering price of $0.789, which is equal to the combined offering price per share of common stock and accompanying 2025 Common Stock Warrant less the $0.001 exercise price of each 2025 Pre-Funded Warrant. The 2025 Underwriters purchased (i) each 2025 Share and accompanying 2025 Common Stock Warrant from us pursuant to the 2025 Underwriting Agreement at a combined price of $0.7426 and (ii) each 2025 Pre-Funded Warrant and accompanying 2025 Common Stock Warrant from us pursuant to the 2025 Underwriting Agreement at a combined price of $0.74166. We received net proceeds from the offering of approximately $18.0 million, after deducting underwriting discounts and commissions and offering expenses, and excluding any proceeds that may be received from exercise of the 2025 Common Stock Warrants and the 2025 Pre-Funded Warrants.

Current wording

On April 14, 2025, we entered into an underwriting agreement, or the 2025 Underwriting Agreement, with Oppenheimer & Co. Inc., as representative of the several underwriters named therein, or, collectively, the 2025 Underwriters, relating to an underwritten public offering of (i) 13,530,780 shares, or the 2025 Shares, of our common stock, $0.001 par value per share, and accompanying common stock warrants, or the 2025 Common Stock Warrants to purchase 3,382,695 shares of our common stock, and (ii) to certain investors in lieu of common stock, pre-funded warrants, or the 2025 Pre-Funded Warrants, to purchase 11,469,216 shares of our common stock and accompanying 2025 Common Stock Warrants to purchase 2,867,304 shares of common stock. All of the 2025 Shares, the 2025 Pre-Funded Warrants and the 2025 Common Stock Warrants were sold by us. Each 2025 Share was offered and sold together with an accompanying 2025 Common Stock Warrant at a combined offering price of $0.79, and each 2025 Pre-Funded Warrant was offered and sold together with an accompanying 2025 Common Stock Warrant at a combined offering price of $0.789, which is equal to the combined offering price per share of common stock and accompanying 2025 Common Stock Warrant less the $0.001 exercise price of each 2025 Pre-Funded Warrant. The 2025 Underwriters purchased (i) each 2025 Share and accompanying 2025 Common Stock Warrant from us pursuant to the 2025 Underwriting Agreement at a combined price of $0.7426 and (ii) each 2025 Pre-Funded Warrant and accompanying 2025 Common Stock Warrant from us pursuant to the 2025 Underwriting Agreement at a combined price of $0.74166. We received net proceeds from the offering of approximately $18.0 million, after deducting underwriting discounts and commissions and offering expenses of $0.5 million excluding any proceeds that may be received from exercise of the 2025 Common Stock Warrants and the 2025 Pre-Funded Warrants.

Previous wording

Based on our current plans and forecasted expenses, we believe our existing cash and cash equivalents as of March 31, 2025, along with the approximately $18.0 million of net proceeds received from our offering in April 2025 and an upfront payment of approximately $12.0 million we received pursuant to the BI Collaboration and License Agreement, 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 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.

Previous wording

The following table summarizes our changes in cash, cash equivalents, and restricted cash for the three months ended March 31, 2025 and 2024 in thousands:

Current 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:

Previous wording

Net cash used in operating activities totaled $8.2 million for the three months ended March 31, 2025 compared to $9.8 million for the three months ended March 31, 2024. The decrease of $1.6 million was primarily due to decreases in cash outflows from changes in stock-based compensation, offset by increases from changes in accounts receivable and accounts payable.

Current 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.

Previous wording

Net cash used in investing activities totaled $0.2 million for the three months ended March 31, 2025 compared to $0.1 million during the three months ended March 31, 2024. The increase of $0.1 million in cash used was due to an increase in purchases of property and equipment during the three months ended March 31, 2025.

Current wording

Net cash used in investing activities totaled $0.2 million for the six months ended June 30, 2025 compared to $0.1 million during the six months ended June 30, 2024. The increase of $0.1 million in cash used was due to an increase in purchases of property and equipment during the six months ended June 30, 2025.

Previous wording

Net cash used in financing activities totaled $1.0 million for the three months ended March 31, 2025 compared to net cash provided by financing activities of $2.4 million for the three months ended March 31, 2024. The change of $3.4 million was due to proceeds received from sales under our ATM Sales Agreement during the three months ended March 31, 2024.

Current wording

Net cash provided by financing activities totaled $16.8 million for the six months ended June 30, 2025 compared to $1.4 million for the six months ended June 30, 2024. The increase of $15.4 million was due to proceeds received from our underwriting agreement entered into in April 2025, as well as sales under our ATM Sales Agreement during the six months ended June 30, 2025.

Previous wording

Under Accounting Standards Update, or ASU, 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40), or, ASC 205-40, we have the responsibility to evaluate whether conditions or events raise substantial doubt about our ability to meet our future financial obligations as they become due within one year after the date the financial statements are issued. Under ASC 205-40, this evaluation initially cannot take into consideration the potential mitigating effects of plans that have not been fully implemented as of the date the financial statements are issued. Since we currently believe that our existing cash and cash equivalents, as of March 31, 2025, and our current operating plans, which reflect the approximately $18.0 million of net proceeds received from our offering in April 2025 and an upfront payment of approximately $12.0 million we received pursuant to the BI Collaboration and License Agreement, will enable us to fund our operations into the second quarter of 2026, we have determined that this cash runway of less than 12 months from the date of issuance of our financial statements included in this Quarterly Report on Form 10-Q, along with our accumulated deficit, history of losses, and future expected losses meet the ASC 205-40 standard for raising substantial doubt about our ability to continue as a going concern within one year of the issuance date of our financial statements included in this Quarterly Report on Form 10-Q. While we have plans in place to mitigate this risk, which primarily consist of raising additional capital through a combination of equity offerings, collaborations, and other strategic alliances, and, depending on the availability and level of additional financings, and cash expenditure reduction, there is no guarantee that we will be successful in these mitigation efforts.

Current wording

Under Accounting Standards Update, or ASU, 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40), or, ASC 205-40, we have the responsibility to evaluate whether conditions or events raise substantial doubt about our ability to meet our future financial obligations as they become due within one year after the date the financial statements are issued. Under ASC 205-40, this evaluation initially cannot take into consideration the potential mitigating effects of plans that have not been fully implemented as of the date the financial statements are issued. Since we currently believe that our existing cash and cash equivalents, as of June 30, 2025, and our current operating plans will enable us to fund our operations into the second quarter of 2026, we have determined that this cash runway of less than 12 months from the date of issuance of our financial statements included in this Quarterly Report on Form 10-Q, along with our accumulated deficit, history of losses, and future expected losses meet the ASC 205-40 standard for raising substantial doubt about our ability to continue as a going concern within one year of the issuance date of our financial statements included in this Quarterly Report on Form 10-Q. While we have plans in place to mitigate this risk, which primarily consist of raising additional capital through a combination of equity offerings, collaborations, and other strategic alliances, and, depending on the availability and level of additional financings, and cash expenditure reduction, there is no guarantee that we will be successful in these mitigation efforts.

Previous wording

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 2024 Annual Report. Additional information regarding the BI Collaboration and License Agreement and the amendment to our Einstein License may be found above and in Note 13 to our condensed consolidated financial statements in this Quarterly Report on Form 10-Q.

Current wording

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 2024 Annual Report. Additional information regarding the BI Collaboration and License Agreement, the amendment to our Einstein License, and the second amendment to our License Agreement with MIL 40G, LLC, may be found in Notes 10 and 12 to our condensed consolidated financial statements in this Quarterly Report on Form 10-Q.