0000950170-24-127005 | 10-Q | XBRL Viewer

Einstein License Agreement	9 Months Ended
Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Einstein License Agreement	7. Einstein License Agreement On January 14, 2015, the Company entered into a license agreement (the “Einstein License”), with Einstein for certain patent rights relating to the Company’s 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. On July 31, 2017, the Company entered into an amended and restated license agreement which modified certain obligations of the parties under the Einstein License. The Einstein License was further amended on January 13, 2024. Under the Einstein License, the Company holds 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 covered by the Einstein License, including certain technology received from Einstein relating thereto (the “Licensed Products”). Under the Einstein License, the Company is required to: • Pay royalties and amounts based on a certain percentage of proceeds, as defined in the Einstein License, from sales of Licensed Products and sublicense agreements. • Pay escalating annual maintenance fees, which are nonrefundable, but are creditable against the amount due to Einstein for royalties. • Make significant payments based upon the achievement of certain milestones, as defined in the Einstein License. Payments made upon achievement of milestones are nonrefundable and are not creditable against any other payment due to Einstein. At September 30, 2024, the Company has made aggregate payments totaling $1.2 million since inception with respect to achievement of these milestones. • Incur minimum product development costs until the first commercial sale of the first licensed product. The Company was in compliance with its obligations under the Einstein License at September 30, 2024 and 2023. The Einstein License expires upon the expiration of the Company’s last obligation to make royalty payments to Einstein which may be due with respect to certain Licensed Products, unless terminated earlier under the provisions thereof. The Einstein License includes certain termination provisions if the Company fails to meet its obligations thereunder. Pursuant to the Einstein License, the Company issued to Einstein 671,572 shares of the Company’s common stock in connection with the consummation of the initial public offering of its common stock on December 27, 2017. The Company accounts for license fees incurred in connection with the Einstein License in accordance with ASC 730, Research and Development. Please refer to Note 10 Collaboration Revenue.

Einstein License Agreement

9 Months Ended

Sep. 30, 2024

Organization, Consolidation and Presentation of Financial Statements [Abstract]

On January 14, 2015, the Company entered into a license agreement (the “Einstein License”), with Einstein for certain patent rights relating to the Company’s 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. On July 31, 2017, the Company entered into an amended and restated license agreement which modified certain obligations of the parties under the Einstein License. The Einstein License was further amended on January 13, 2024.

Under the Einstein License, the Company holds 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 covered by the Einstein License, including certain technology received from Einstein relating thereto (the “Licensed Products”). Under the Einstein License, the Company is required to:

•

Pay royalties and amounts based on a certain percentage of proceeds, as defined in the Einstein License, from sales of Licensed Products and sublicense agreements.

•

Pay escalating annual maintenance fees, which are nonrefundable, but are creditable against the amount due to Einstein for royalties.

•

Make significant payments based upon the achievement of certain milestones, as defined in the Einstein License. Payments made upon achievement of milestones are nonrefundable and are not creditable against any other payment due to Einstein. At September 30, 2024, the Company has made aggregate payments totaling $1.2 million since inception with respect to achievement of these milestones.

•

Incur minimum product development costs until the first commercial sale of the first licensed product.

The Company was in compliance with its obligations under the Einstein License at September 30, 2024 and 2023.

The Einstein License expires upon the expiration of the Company’s last obligation to make royalty payments to Einstein which may be due with respect to certain Licensed Products, unless terminated earlier under the provisions thereof. The Einstein License includes certain termination provisions if the Company fails to meet its obligations thereunder.

Pursuant to the Einstein License, the Company issued to Einstein 671,572 shares of the Company’s common stock in connection with the consummation of the initial public offering of its common stock on December 27, 2017.

The Company accounts for license fees incurred in connection with the Einstein License in accordance with ASC 730, Research and Development. Please refer to Note 10 Collaboration Revenue.

Fair Value (Tables)

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

Schedule of Fair Value Assets Measured on Recurring Basis

The following table presents information about the Company’s assets that are measured at fair value on a recurring basis as of September 30, 2024 and December 31, 2023, and indicate the level of the fair value hierarchy utilized to determine such fair value:


	Fair Value Measurements as of September 30, 2024
	(in thousands)
	Level 1		Level 2		Level 3		Fair Value
Cash equivalents	$	31,784	$	—	$	—	$	31,784
Total	$	31,784	$	—	$	—	$	31,784

	Fair Value Measurements as of December 31, 2023
	(in thousands)
	Level 1		Level 2		Level 3		Fair Value
Cash equivalents	$	39,148	$	—	$	—	$	39,148
Total	$	39,148	$	—	$	—	$	39,148

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash flows from operating activities
Net Loss	$ (31,178,000)	$ (37,299,000)
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation and amortization	299,000	443,000
Stock-based compensation	5,284,000	6,108,000
Decrease in the carrying amount of right-of-use-assets	2,289,000	2,142,000
Gain on sale of property and equipment	(97,000)	(2,000)
Amortization of premium/discount on purchased securities	0	(234,000)
Amortization of debt issuance costs	27,729	27,729
Accretion of final payment on term loans	98,000	98,000
Changes in operating assets and liabilities:
Account receivable	(1,454,000)	(1,603,000)
Prepaid expenses and other current assets	(442,000)	(324,000)
Deposits	0	139,000
Accounts payable	2,972,000	(251,000)
Accrued expenses	(938,000)	1,573,000
Research and development contract liability	(1,853,000)	2,238,000
Operating lease liability	(2,309,000)	(2,064,000)
Accrued interest	0	5,000
Net cash used in operating activities	(27,301,000)	(29,003,000)
Cash flows from investing activities
Purchases of property and equipment	(64,000)	0
Cash received from the sale of property and equipment	97,000	2,000
Redemption of marketable securities	0	25,000,000
Net cash provided by investing activities	33,000	25,002,000
Cash flows from financing activities
Proceeds from ATM offering, net of sales agent commission and fees	3,354,000	7,605,000
Proceeds from issuance of common stock, warrants and pre-funded warrants, net of transaction costs	10,821,000	0
Repayment of term loans	(3,000,000)	(1,000,000)
Proceeds from exercise of stock options	0	473,000
Net cash provided by financing activities	11,175,000	7,078,000
Net (decrease) increase in cash, cash equivalents, and restricted cash	(16,093,000)	3,077,000
Cash, cash equivalents, and restricted cash at beginning of period	48,665,000	51,764,000
Cash, cash equivalents, and restricted cash at end of period	32,572,000	54,841,000
Supplemental disclosures of non-cash investing and financing activities:
Cash paid for interest	$ 547,000	$ 768,000

Subsequent Events

9 Months Ended

Sep. 30, 2024

Subsequent Events [Abstract]

Subsequent Events

13. Subsequent Events

On October 2, 2024 (the “Effective Date”), the Company entered into a second amendment (the “Second Amendment”) to its Loan Agreement, as amended by that certain Waiver and First Amendment to Loan and Security Agreement dated as of April 10, 2023. As of the Effective Date, the Second Amendment removed the requirement for the Company to maintain in accounts of the Company at SVB cash equal to at least $20,000,000. The Second Amendment retains the requirement that the Company have at all times on deposit in accounts of the Company maintained with SVB, unrestricted and unencumbered cash in an amount equal to the lesser of (i) $20,000,000 and (ii) 100% of the dollar value of the Company’s consolidated cash, in the aggregate, at all financial institutions. For further information about the Loan Agreement, please refer to Note 5.

On October 8, 2024, the Company filed a Certificate of Amendment (the “Certificate of Amendment”) to its Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware effecting an amendment to increase the number of authorized shares of the Company’s capital stock from 110,000,000 to 210,000,000 and increase the number of authorized shares of the Company’s common stock from 100,000,000 to 200,000,000. The Certificate of Amendment was approved by the Company’s stockholders at a Special Meeting of Stockholders held on October 8, 2024.

Fair Value - Schedule of Fair Value Assets Measured on Recurring Basis (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cash equivalents	$ 32,400	$ 39,100
Total	31,800	39,100
Fair Value Measurements, Recurring Basis
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cash equivalents	31,784	39,148
Total	31,784	39,148
Fair Value Measurements, Recurring Basis \| Level 1
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cash equivalents	31,784	39,148
Total	31,784	39,148
Fair Value Measurements, Recurring Basis \| Level 2
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cash equivalents	0	0
Total	0	0
Fair Value Measurements, Recurring Basis \| Level 3
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cash equivalents	0	0
Total	$ 0	$ 0

Collaboration Revenue

9 Months Ended

Sep. 30, 2024

Revenue from Contract with Customer [Abstract]

Collaboration Revenue

10.

Collaboration Revenue

The Company recognizes collaboration revenue under certain of the Company’s license or collaboration agreements that are within the scope of ASC 606. The Company’s contracts with customers typically include promises related to licenses to intellectual property and research and development services. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and if, over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company’s contracts may include options to acquire additional goods and/or services.

The terms of the Company’s arrangements with customers typically include the payment of one or more of the following: (i) non-refundable, up-front payment, and pass through costs related to research activities, (ii) development, regulatory and commercial milestone payments, (iii) future options and (iv) royalties on net sales of licensed products. Accordingly, the transaction price is generally comprised of a fixed fee due at contract inception and variable consideration in the form of pass through costs and milestone payments due upon the achievement of specified events and tiered royalties earned when customers recognize net sales of licensed products. The Company measures the transaction price based on the amount of consideration to which it expects to be entitled in exchange for transferring the promised goods and/or services to the customer. The Company utilizes the “expected value method” method to estimate the amount of variable consideration, to predict the amount of consideration to which it will be entitled for its one open contract. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Milestone payments that are not within the control of the Company or the licensee, such as those dependent upon receipt of regulatory approval, are not considered to be probable of achievement until the triggering event occurs. At the end of each reporting period, the Company reevaluates the probability of achievement of each milestone and any related constraint, and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment.

For arrangements that include sales-based royalties, including milestone payments based upon the achievement of a certain level of product sales, the Company recognizes revenue upon the later of: (i) when the related sales occur or (ii) when the performance obligation to which some or all of the payment has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any development, regulatory or commercial milestones or royalty revenue resulting from any of its collaboration arrangements. Consideration that would be received for optional goods and/or services is excluded from the transaction price at contract inception.

The Company allocates the transaction price to each performance obligation identified in the contract on a relative standalone selling price basis, when applicable. However, certain components of variable consideration are allocated specifically to one or more particular performance obligations in a contract to the extent both of the following criteria are met: (i) the terms of the payment relate specifically to the efforts to satisfy the performance obligation or transfer the distinct good or service and (ii) allocating the variable amount of consideration entirely to the performance obligation or the distinct good or service is consistent with the allocation objective of the standard whereby the amount allocated depicts the amount of consideration to which the entity expects to be entitled in exchange for transferring the promised goods or services. The Company develops assumptions that require judgment to determine the standalone selling price for each performance obligation identified in each contract. The key assumptions utilized in determining the standalone selling price for each performance obligation may include forecasted revenues, development timelines, estimated research and development costs, discount rates, likelihood of exercise and probabilities of technical and regulatory success.

Revenue is recognized based on the amount of the transaction price that is allocated to each respective performance obligation when or as the performance obligation is satisfied by transferring a promised good and/or service to the customer. For performance obligations that are satisfied over time, the Company recognizes revenue by measuring the progress toward complete satisfaction of the performance obligation using a single method of measuring progress which depicts the performance in transferring control of the associated goods and/or services to the customer. The Company uses input methods to measure progress toward the complete satisfaction of performance obligations satisfied over time. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. The Company measures progress toward satisfaction of the performance obligation over time as effort is expended.

Collaboration Agreement with LG Chem

On November 6, 2018, the Company entered into a collaboration agreement (the “LG Chem Collaboration Agreement”) with LG Chem Ltd. (“LG Chem”) related to the development of the Company’s Immuno-STATs focused in the field of oncology. Pursuant to the LG Chem Collaboration Agreement, the Company granted LG Chem an exclusive license to develop, manufacture and commercialize the Company’s lead product, CUE-101, as well as Immuno-STATs that target T cells against two additional cancer antigens, in certain Asian countries (collectively, the “LG Chem Territory”). On April 30, 2021, LG Chem’s option pursuant to the Global License and Collaboration Agreement entered into between the Company and LG Chem on December 18, 2019 and as amended on November 5, 2020 (the "Global License and Collaboration Agreement"), expired, and accordingly the Company no longer has any material obligations under the Global License and Collaboration Agreement. In June 2021, after ongoing discussions regarding the selection of the second of the two additional cancer antigens, LG Chem and the Company agreed to let the selection period expire without a second antigen being selected. The Company retains rights to develop and commercialize all assets included in the LG Chem Collaboration Agreement in the United States and in global markets outside of the LG Chem Territory. In exchange for the licenses and other rights granted to LG Chem under the LG Chem Collaboration Agreement, LG Chem made a $5.0 million equity investment in common stock of the Company and a $5.0 million nonrefundable up-front cash payment. The Company is also eligible to receive up to an additional $400.0 million in research, development, regulatory and sales milestones. In addition, the LG Chem Collaboration Agreement also provides that LG Chem will pay the Company tiered single-digit percentage royalties on net sales of commercialized drug product candidates in the LG Chem Territory.

On May 16, 2019, LG Chem paid the Company a $2.5 million milestone payment for the U.S. Food and Drug Administration’s (“FDA”) acceptance of the investigational new drug application (“IND”) for the Company’s lead drug product candidate, CUE-101, pursuant to the LG Chem Collaboration Agreement. The $2.5 million milestone payment was recorded as a contract liability upon receipt of payment as it requires deferral of revenue recognition to a future period until the Company performs its obligations under the arrangement. Of the $2.5 million milestone payment, $0.4 million was recognized as tax withholding, shown as income tax expense on the consolidated statement of operations and comprehensive loss.

On December 7, 2020, the Company earned a $1.3 million milestone payment on the selection of a preclinical candidate pursuant to the LG Chem Collaboration Agreement. The $1.3 million milestone payment was recorded as a contract liability upon receipt. Revenue related to this milestone payment was recognized by the Company pursuant to the Company’s revenue recognition policy in relation to the performance of its obligations related to the development of this preclinical candidate. Of the $1.25 million milestone payment, $0.2 million was withheld as payment of foreign tax withholding and shown as income tax expense on the consolidated statement of operations and comprehensive loss.

On November 23, 2021, the Company earned a $3.0 million milestone payment for the selection of a clinical product candidate in partnership with LG Chem. The $3.0 million milestone payment was recorded as a contract liability upon receipt. Revenue related to this milestone payment was recognized by the Company pursuant to the Company’s revenue recognition policy in relation to the performance of its obligations related to the development of this preclinical candidate. Of the $3.0 million milestone payment, $0.5 million was withheld as payment of foreign tax withholding and shown as income tax expense on the condensed consolidated statements of operations and comprehensive loss. Cash was collected in relation to this milestone payment in February 2022.

Aside from the $6.8 million in milestone payments earned to date, the Company does not believe that any variable consideration should be included in the transaction price as of September 30, 2024. Such assessment considered the application of the constraint to ensure that estimates of variable consideration would be included in the transaction price only to the extent the Company had a high degree of confidence that revenue would not be reversed in a subsequent reporting period. The Company will re-evaluate the transaction price, including the estimated variable consideration included in the transaction price and all constrained amounts, in each reporting period and as other changes in circumstances occur. For the nine months ended September 30, 2024, the Company recognized revenue of $0.05 million related to the LG Chem Collaboration Agreement. There was no revenue recognized for the three months ended September 30, 2024 related to the LG Chem Collaboration Agreement. For both the three and nine months ended September 30, 2023, the Company recognized revenue of $0.2 million related to the LG Chem Collaboration Agreement. The Company did not record short or long-term research and development liabilities on its balance sheets dated September 30, 2024 and December 31, 2023, as the performance obligation was met and completed. Research and development cost sharing provisions under the agreement expired on March 31, 2022, and thereafter, the Company recognized revenue on intellectual patent filing passthrough costs in the LG Chem Territory.

Collaboration and Option Agreement with Ono

On February 22, 2023, the Company entered into a strategic collaboration agreement (the "Ono Collaboration and Option Agreement") with Ono Pharmaceutical Co., Ltd. ("Ono") to further develop CUE-401 and provide dedicated resources and capabilities to help advance CUE-401 toward the clinic. Under the terms of the Ono Collaboration and Option Agreement, Ono paid the Company an upfront payment and agreed to fully fund all research activities related to CUE-401 through a specified option period. During this option period, the Company will be responsible for the research and development of CUE-401. Upon Ono’s exercise of its option to license CUE-401, the Company will receive an option exercise payment and be eligible for development and commercial milestone payments up to an aggregate of $220.0 million, as well as tiered royalties on sales. Upon any such exercise, Ono will receive worldwide rights to develop and commercialize CUE-401, with the Company retaining a 50% co-development and co-commercialization right in the United States. The Company’s decision to elect the co-development and co-commercialization option may be made within 30 days of Ono’s option exercise to license CUE-401. The amount paid by Ono to the Company for the option exercise and future milestone payments will vary based upon the Company’s decision to exercise the co-development and co-commercialization option.

Under the terms of the Ono Collaboration and Option Agreement, the Company will perform research activities related to CUE-401 through a specified option period of 24 months (the “Research Term”). During this Research Term, the Company will be responsible for the execution of scientific investigation, nonclinical, preclinical, and clinical drug research and development activities designed to progress CUE-401 toward a potential IND and regulatory approval (such activities, collectively referred to as “R&D”). Ono is responsible for the funding of R&D activities performed by the Company. Per the agreement, as consideration for the R&D activities performed by the Company, Ono (i) made a one-time, non-refundable, non-creditable upfront payment of $3.0 million to the Company and (ii) will reimburse the Company for all costs incurred in conducting research, including (a) pass through costs from third party contractors and (b) full time employee salaries capped at $2.1 million in the first 18 months of the Research Term. Subsequently, the Company and Ono agreed to increase this cap for full time employee salaries to $2.8 million. The term of the Ono Collaboration and Option Agreement extends until the expiration of the Research Term which cannot exceed a 24-month period. The Company has forecasted that it will be able to complete the R&D activities within this time period. The Company received the $3.0 million upfront payment in March 2023.

Aside from the $3.0 million upfront payment and funding related to pass through costs, the Company does not believe that any variable consideration should be included in the transaction price as of September 30, 2024. Such assessment considered the application of the constraint to ensure that estimates of variable consideration would be included in the transaction price only to the extent the Company had a high degree of confidence that revenue would not be reversed in a subsequent reporting period. The Company will re-evaluate the transaction price, including the estimated variable consideration included in the transaction price and all constrained amounts, in each reporting period and as other changes in circumstances occur. For the three and nine months ended September 30, 2024, the Company recognized revenue of $3.4 million and $7.7 million, respectively, related to the Ono Collaboration and Option Agreement. For the three and nine months ended September 30, 2023, the Company recognized revenue of $1.9 million and $3.4 million, respectively, related to the Ono Collaboration and Option Agreement. The Company recorded short-term research and development liabilities on its balance sheet dated September 30, 2024 of $0.3 million. The Company also reduced its accounts receivable by $0.5 million for amounts billed to Ono in excess of amounts incurred. The Company recorded short-term research and development liabilities on its balance sheet dated December 31, 2023 of $2.1 million.

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-9

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 10
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-10

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 15
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-15

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (e)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (b)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-13

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Name Accounting Standards Codification
-Topic 606
-Publisher FASB
-URI https://asc.fasb.org/606/tableOfContent

+ Details

Einstein License Agreement (Additional Information) (Details) - Einstein License Agreement $ in Millions		9 Months Ended
	Jan. 14, 2015	Sep. 30, 2024 USD ($) SupportingTechnology shares
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
License agreement entered date	Jan. 14, 2015
Number of supporting technology \| SupportingTechnology		2
Nonrefundable milestone payments \| $		$ 1.2
Issuance of common stock from public offerings, net of underwriter discounts, Shares \| shares		671,572

Accrued Expenses

9 Months Ended

Sep. 30, 2024

Accrued Liabilities, Current [Abstract]

Accrued Expenses

6. Accrued Expenses

Accrued expenses consist of the following:


	September 30,		December 31,
(In thousands)	2024		2023
Contract research services	$	1,534	$	1,411
Employee and board compensation		800		2,219
Professional services		499		344
Contract manufacturing services		367		163
Total	$	3,199	$	4,137

Organization and Basis of Presentation - Additional Information (Details) $ in Millions	Sep. 30, 2024 USD ($)
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Cash and cash equivalents, and marketable securities	$ 32.4

Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2024

Accrued Liabilities, Current [Abstract]

Summary of Accrued Expenses

Accrued expenses consist of the following:


	September 30,		December 31,
(In thousands)	2024		2023
Contract research services	$	1,534	$	1,411
Employee and board compensation		800		2,219
Professional services		499		344
Contract manufacturing services		367		163
Total	$	3,199	$	4,137

Organization and Basis of Presentation

9 Months Ended

Sep. 30, 2024

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Organization and Basis of Presentation

Cue Biopharma, Inc. (the "Company") is a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells directly within the patient’s body. The Company's vision is to translate nature's signals, or "cues", into protein therapeutics by generating a new class of T cell engagers for selective modulation of disease specific T cells. The Company’s corporate office and research facilities are located in Boston, Massachusetts.

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company is in the development stage and has incurred recurring losses and negative cash flows from operations since inception. As of September 30, 2024, the Company had cash and cash equivalents of $32.4 million. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations and to fund research and development costs in order to seek approval for commercialization of its drug product candidates. While the Company is exploring raising additional capital through a combination of equity offerings, collaborations, and other strategic alliances, and, depending on the availability and level of additional financings, cash expenditure reduction, there is no guarantee that the Company will be successful in these mitigation efforts. The Company’s failure to raise capital as and when needed would have a negative impact on its financial condition and its ability to pursue its business strategies as this capital is necessary for the Company to perform the research and development activities required to develop and commercialize the Company’s drug product candidates in order to generate future revenue streams. Therefore, management has determined that the Company’s accumulated deficit, history of losses, negative cash flows from operations and future expected losses raise substantial doubt about the Company’s ability to continue as a going concern within one year of the issuance date of these financial statements.

Stock Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock-based compensation	$ 1,583	$ 2,073	$ 5,284	$ 6,108
Stock based payment options outstanding weighted average remaining term			7 years 3 months 10 days		6 years 1 month 13 days
Stock options granted purchase shares		1.1		2,600,000
weighted average grant date fair value		$ 4.17		$ 3.65
Unrecognized stock-based compensation	7,200	$ 12,100	$ 7,200	$ 12,100
Stock Option
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock-based compensation	$ 1,600	$ 2,100	$ 5,300	$ 6,100
Stock based payment options outstanding weighted average remaining term			2 years 7 days	2 years 1 month 28 days

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 718
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-Name Accounting Standards Codification
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Fair Value - Additional Information (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Fair Value Disclosures [Abstract]
Cash equivalents	$ 31,800	$ 39,100
Fair value assets transfers between Level 2 and Level 3	$ 0	$ 0

Stock Based Compensation - Schedule of Estimated Fair Value of Each Stock Option Award (Details)	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Risk-free interest rate, minimum	3.83%	3.40%
Risk-free interest rate, maximum	4.43%	4.16%
Expected dividend yield	0.00%	0.00%
Expected volatility, minimum	36.24%	97.03%
Expected volatility, maximum	109.86%	110.40%
Minimum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected life	5 years 6 months	5 years 6 months
Maximum
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected life	8 years 10 months 28 days	6 years 3 months

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

Stock-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2024

Schedule of Estimated Fair Value of Each Stock Option Award

For stock options requiring an assessment of value during the nine months ended September 30, 2024 and 2023, the fair value of each stock option award was estimated using the Black-Scholes option-pricing model utilizing the following assumptions:


		September 30, 2024
Risk-free interest rate		3.83% - 4.43%
Expected dividend yield		0%
Expected volatility		36.24% - 109.86%
Expected life		5.50 to 8.91 years

		September 30, 2023
Risk-free interest rate		3.40% - 4.16%
Expected dividend yield		0%
Expected volatility		97.03% - 110.4%
Expected life		5.50 to 6.25 years

Summary of Stock Option Activity

A summary of stock option activity for the nine months ended September 30, 2024 is as follows:


	Number of Shares			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life (in Years)
Stock options outstanding at December 31, 2023		7,492,917		$	8.41		6.12
Granted		4,183,300			1.42		—
Exercised		—			—		—
Cancelled		(1,064,600	)		7.27		—
Stock options outstanding at September 30, 2024		10,611,617			5.77		7.28
Stock options exercisable at September 30, 2024		5,240,539		$	9.27		5.27

Schedule of Stock-Based Compensation Included in Statement of Operations

Stock-based compensation expense for the three and nine months ended September 30, 2024 and 2023 was included in the Company’s condensed consolidated statements of operations and comprehensive loss as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2024		2023		2024		2023
General and administrative	$	843	$	858	$	2,659	$	2,709
Research and development		740		1,215		2,625		3,399
Total stock-based compensation expense	$	1,583	$	2,073	$	5,284	$	6,108

Property and Equipment

9 Months Ended

Sep. 30, 2024

Property, Plant and Equipment [Abstract]

Property and Equipment

Property and equipment as of September 30, 2024 and December 31, 2023 consisted of the following:


	September 30, 2024			December 31, 2023
	(in thousands)
Laboratory equipment	$	4,098		$	4,069
Furniture and fixtures		74			81
Computer equipment		180			143
Leasehold improvements		118			118
Total property and equipment		4,470			4,411
Less: accumulated depreciation		(3,900	)		(3,616	)
Property and equipment, net	$	570		$	795

Depreciation expense for the three months ended September 30, 2024 and 2023 was $0.1 million and $0.1 million, respectively. Depreciation expense for the nine months ended September 30, 2024 and 2023 was $0.3 million and $0.4 million, respectively. Depreciation expense for both the three months ended September 30, 2024 and 2023 excludes trademark amortization expense of $3,000. Depreciation expense for both the nine months ended September 30, 2024 and 2023 excludes trademark amortization expense of $9,000. The Company sold fully depreciated lab equipment and collected cash of $0.1 million for both the three and nine months ended September 30, 2024. During the nine months ended September 30, 2023, the Company sold fully depreciated lab equipment with an acquisition cost of $41,450 and collected cash of $2,000. The Company recorded a gain on the sale of fixed assets of $2,000, which is presented in other income on the condensed consolidated statements of operations and comprehensive loss.

Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands		3 Months Ended		9 Months Ended
	Sep. 26, 2024	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Summary Of Significant Accounting Policies [Line Items]
Common stock, par value		$ 0.001		$ 0.001		$ 0.001
Stock options granted purchase shares			1.1		2,600,000
Common Stock Warrant at a combined offering price		0.47		0.47
Pre-Funded Warrant Offer Price		$ 0.46906		$ 0.46906
Proceeds from ATM offering, net of sales agent commission and fees				$ 3,354	$ 7,605
Useful life of trademark				15 years
Type of Cost, Good or Service [Extensible List]		us-gaap:LicenseMember		us-gaap:LicenseMember
Cash equivalents		$ 32,400		$ 32,400		$ 39,100
Marketable securities		0		$ 0		0
Pre Funded Warrants				13,967,039
General and Administrative Expense [Member]
Summary Of Significant Accounting Policies [Line Items]
Patent expenses		500	$ 500	$ 1,500	1,600
Trademarks
Summary Of Significant Accounting Policies [Line Items]
Amortization of intangible assets		3,000	$ 3,000	9,000	$ 9,000
Certificate of Deposit
Summary Of Significant Accounting Policies [Line Items]
Restricted cash used to collateralize a credit card		200		200		$ 200
Transaction Expense \| Sales Agreement November 2019
Summary Of Significant Accounting Policies [Line Items]
Proceeds from sale of common stock		40,400		$ 40,400
Sale of common stock, number of shares				9,028,573
Jefferies LLC [Member] \| Maximum
Summary Of Significant Accounting Policies [Line Items]
Proceeds from Issuance Initial Public Offering				$ 80,000
Jefferies LLC [Member] \| Transaction Expense
Summary Of Significant Accounting Policies [Line Items]
Proceeds from sale of common stock		80,000		$ 80,000
Jefferies LLC [Member] \| Transaction Expense \| Sales Agreement November 2019
Summary Of Significant Accounting Policies [Line Items]
Stock Issued During Period, Shares, New Issues			1,378,867	1,428,200	1,915,131
Proceeds from sale of common stock			$ 5,600	$ 3,400	$ 7,600
Oppenheimer & Co. Inc. [Member]
Summary Of Significant Accounting Policies [Line Items]
Stock Issued During Period, Shares, New Issues	11,564,401
Proceeds from sale of common stock		$ 10,800		$ 10,800
Common stock, par value	$ 0.001
Stock options granted purchase shares	2,891,100
Common stock warrant purchases common shares	3,108,900
Common Stock Warrant at a combined offering price		$ 0.5		$ 0.5
Pre-Funded Warrant Offer Price		$ 0.499		$ 0.499
Offering expenses		$ 1,100		$ 1,100
Pre Funded Warrants	12,435,599
Oppenheimer & Co. Inc. [Member] \| Maximum
Summary Of Significant Accounting Policies [Line Items]
Exercise Price of Pre-Fund warrant		$ 0.001		$ 0.001

Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Commitments And Contingencies [Line Items]
Type of Cost, Good or Service [Extensible List]	us-gaap:LicenseMember		us-gaap:LicenseMember
Albert Einstein College Of Medicine \| Einstein License And Service Agreement
Commitments And Contingencies [Line Items]
Milestone payments for each product, process or service			$ 1,900
Milestone payments for each new indication of licensed product			1,900
Aggregate amount of additional milestone payments			5,800
Einstein License
Commitments And Contingencies [Line Items]
Patent expenses	$ 30		$ 80
Type of Cost, Good or Service [Extensible List]	us-gaap:LicenseMember	us-gaap:LicenseMember	us-gaap:LicenseMember	us-gaap:LicenseMember

Summary of Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements as of September 30, 2024, and for the three and nine months ended September 30, 2024 and 2023, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (the “SEC”) and generally accepted accounting principles in the United States (“U.S. GAAP”) for financial information, which prescribes elimination of all significant intercompany accounts and transactions in the accounts of the Company and its wholly owned subsidiary, Cue Biopharma Securities Corp., which was incorporated in the Commonwealth of Massachusetts in December 2018. In the opinion of management, these financial statements reflect all adjustments which are necessary for a fair statement of the Company’s financial position and results of its operations, as of and for the periods presented. These financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2024.

Interim results for the three and nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2024, or any future periods.

Public Offerings

On September 26, 2024, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Oppenheimer & Co. Inc., as representative of the several underwriters named therein (collectively, the “Underwriters”), relating to an underwritten public offering of (i) 11,564,401 shares (the “Shares”) of the Company’s common stock, $0.001 par value per share, and accompanying common stock warrants (“Common Stock Warrants”) to purchase 2,891,100 shares of common stock, and (ii) to certain investors in lieu of common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase 12,435,599 shares of common stock and accompanying Common Stock Warrants to purchase 3,108,900 shares of common stock. All of the Shares, the Pre-Funded Warrants and the Common Stock Warrants were sold by the Company. Each Share was offered and sold together with an accompanying Common Stock Warrant at a combined offering price of $0.50, and each Pre-Funded Warrant was offered and sold together with an accompanying 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 Common Stock Warrant less the $0.001 exercise price of each Pre-Funded Warrant. The Underwriters purchased (i) each Share and accompanying Common Stock Warrant from the Company pursuant to the Underwriting Agreement at a combined price of $0.47 and (ii) each Pre-Funded Warrant and accompanying Common Stock Warrant from the Company pursuant to the Underwriting Agreement at a combined price of $0.46906. The Company 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 Common Stock Warrants and the Pre-Funded Warrants.

In October 2021, the Company entered into an open market sale agreement (the “October 2021 ATM Agreement”) with Jefferies LLC ("Jefferies"), as agent, to sell shares of the Company’s common stock for aggregate gross proceeds of up to $80 million, from time to time, through an at-the-market equity offering program. The October 2021 ATM Agreement will terminate upon the earliest of (a) the sale of $80 million of shares of the Company’s common stock pursuant to the October 2021 ATM Agreement or (b) the termination of the October 2021 ATM Agreement by the Company or Jefferies. The Company did not sell any shares during the three months ended September 30, 2024 under the October 2021 ATM Agreement. During the three months ended September 30, 2023, the Company sold 1,378,867 shares of common stock under the October 2021 ATM Agreement, for proceeds of $5.6 million, net of commission paid, but excluding transaction expenses. During the nine months ended September 30, 2024 and September 30, 2023, the Company sold 1,428,200 and 1,915,131 shares, respectively, of common stock under the October 2021 ATM Agreement, for proceeds of $3.4 million and $7.6 million, respectively, net of commission paid, but excluding transaction expenses. As of September 30, 2024, the Company sold an aggregate of 9,028,573 shares of common stock under the October 2021 ATM Agreement for proceeds of $40.4 million, net of commission paid, but excluding transaction expenses, since its inception.

Consolidation

The accompanying condensed consolidated financial statements include the Company and its wholly owned subsidiary, Cue Biopharma Securities Corp. The Company has eliminated all intercompany transactions.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates include estimates related to collaboration revenue, the accounting for potential liabilities and accrued expenses, the assumptions utilized in valuing stock-based compensation issued for services, the realization of deferred tax assets, and the useful life with respect to long-lived assets and intangibles. Actual results could differ from those estimates.

Cash Concentrations

The Company maintains its cash balances with financial institutions in federally insured accounts and may periodically have cash balances in excess of insurance limits. The Company maintains its accounts with financial institutions with a high credit rating. The Company has not experienced any losses to date from its deposits with these financial institutions and believes that it is not exposed to any significant credit risk on cash.

Cash and Cash Equivalents

The Company considers all highly liquid investments with a maturity of three months or less at the date of purchase to be cash equivalents. The Company currently invests available cash in money market funds.

Marketable Securities

Marketable securities consist of investments with original maturities greater than ninety days and less than one year from the date of the Company's condensed consolidated balance sheets. The Company classifies all of its investments as available-for-sale securities. Accordingly, these investments are recorded at fair value, which is based on quoted market prices. Unrealized gains and losses are recognized and determined on a specific identification basis and are included in comprehensive loss. Realized gains and losses are determined on a specific identification basis and are included in other income on the condensed consolidated statements of operations and comprehensive loss. Amortization and accretion of discounts and premiums is recorded in interest income. The Company had no marketable securities as of September 30, 2024 and December 31, 2023. At September 30, 2024, the Company invested available cash in money market funds, and at September 30, 2023 the Company invested available cash in U.S. Treasury securities.

Restricted Cash

The Company had $0.2 million in restricted cash deposited with a separate commercial bank to collateralize Company credit cards as of September 30, 2024 and December 31, 2023.

Property and Equipment

Property and equipment is recorded at cost. Major improvements are capitalized, while maintenance and repairs are charged to expense as incurred. Gains and losses from dispositions of property and equipment are included in income and expense when realized. Amortization of leasehold improvements is provided using the straight-line method over the shorter of the lease term or the useful life of the underlying assets. Depreciation of property and equipment is provided using the straight-line method over the following estimated useful lives:


Laboratory equipment		5 years
Computer equipment		3 years
Furniture and fixtures		3-8 years

The Company recognizes depreciation and amortization expense in general and administrative expenses and in research and development expenses in the Company’s condensed consolidated statements of operations and comprehensive loss, depending on how each category of property and equipment is utilized in the Company’s business activities.

Trademark

Trademark consists of the Company’s right, title and interest to the CUE BIOLOGICS Mark, and any derivative mark incorporating CUE, throughout the world, together with all associated goodwill and common law rights appurtenant thereto, including, but not limited to, any right, title and interest in any corporate name, company name, business, name, trade name, dba, domain name, or other source identifier incorporating CUE.

The Company has classified the trademark as a component of other long-term assets, having a useful life of 15 years. The Company evaluates the status of this intangible asset for amortization and impairment at each quarter end and year end reporting date. For each of the three months ended September 30, 2024 and 2023, the Company recorded approximately $3,000 in amortization expense on a straight-line basis. For each of the nine months ended September 30, 2024 and September 30, 2023, the Company recorded approximately $9,000 in amortization expense on a straight-line basis.

Debt Issuance Costs

Debt issuance costs are deferred and presented as a reduction to long-term debt. Debt issuance costs are amortized using the effective interest rate method over the term of the loan. Amortization of deferred debt issuance costs are included in interest expense in the condensed consolidated statements of operations and comprehensive loss.

Revenue Recognition

The Company recognizes collaboration revenue under certain of the Company’s license and collaboration agreements that are within the scope of Accounting Standards Codification (“ASC”), Topic 606, Revenue from Contracts with Customers (“ASC 606”). The Company’s contracts with customers typically include promises related to licenses to intellectual property and research and development services. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. Accordingly, the transaction price is generally comprised of a fixed fee due at contract inception and variable consideration in the form of milestone payments due upon the achievement of specified events and tiered royalties earned when customers recognize net sales of licensed products. The Company measures the transaction price based on the amount of consideration to which it expects to be entitled in exchange for transferring the promised goods and/or services to the customer. The Company utilizes the “expected value method” method to estimate the amount of variable consideration, to predict the amount of consideration to which it will be entitled for its one open contract. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. At the inception of each arrangement that includes development and regulatory milestone payments, the Company evaluates whether the associated event is considered probable of achievement and estimates the amount to be included in the transaction price using the expected value method.

Research and Development Expenses

Research and development expenses consist primarily of compensation costs, 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 the Company’s drug product candidates.

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. The Company evaluates whether it expects the services to be rendered at each quarter end and year end reporting date. If the Company does not expect the services to be rendered, the advance payment is charged to expense. Nonrefundable advance payments for research and development services are included in prepaid and other current assets on the Company's condensed consolidated balance sheets. 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.

The Company evaluates the status of its 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 adjusts the carrying amounts and their classification on the Company's condensed consolidated balance sheets as appropriate.

Patent Expenses

The Company is the exclusive worldwide licensee of, and has patent applications pending for, numerous domestic and foreign patents. Due to the significant uncertainty associated with the successful development of one or more commercially viable drug product candidates based on the Company’s research efforts and any related patent applications, all patent costs, including patent-related legal fees, filing fees and other costs are charged to general and administrative expense as incurred. For the three and nine months ended September 30, 2024, patent expenses were $0.5 million and $1.5 million, respectively. For the three and nine months ended September 30, 2023, patent expenses were $0.5 million and $1.6 million, respectively.

Licensing Fees and Costs

Licensing fees and costs consist primarily of costs relating to the acquisition of the Company’s license agreement with the Albert Einstein College of Medicine (“Einstein”), including related royalties, maintenance fees, milestone payments and product development costs. Licensing fees and costs are charged to research and development expense as incurred.

Long-Lived Assets

The Company reviews long-lived assets, consisting of property and equipment, for impairment when events or changes in circumstances indicate the carrying value of these assets may exceed their current fair values. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the assets. Assets to be disposed of are separately presented in the Company's condensed consolidated balance sheets and reported at the lower of the carrying amount or fair value less costs to sell and are no longer depreciated. The Company has not historically recorded any impairment to its long-lived assets. In the future, if events or market conditions affect the estimated fair value to the extent that a long-lived asset is impaired, the Company will adjust the carrying value of these long-lived assets in the period in which the impairment occurs.

Leases

The Company accounts for leases under ASC 842, Leases, which requires a lessee to record a right-of-use asset and a corresponding lease liability for most lease arrangements on the Company's condensed consolidated balance sheets. Under the standard, disclosure of key information about leasing arrangements to assist users of the financial statements with assessing the amount, timing and uncertainty of cash flows arising from leases are required.

Stock-Based Compensation

The Company periodically issues stock-based awards to officers, directors, employees, Scientific and Clinical Advisory Board members and consultants for services rendered. Such issuances vest and expire according to terms established at the issuance date.

Stock-based payments to officers, directors, employees, Scientific and Clinical Advisory Board members and consultants, including grants of employee stock options, are recognized in the financial statements based on their grant date fair values. Stock option grants, which are generally time-vested, are measured at the grant date fair value and charged to operations on a straight-line basis over the service period, which generally approximates the vesting term. The Company also grants performance-based awards periodically to officers of the Company. The Company recognizes compensation costs related to performance awards over the requisite service period if and when the Company concludes that it is probable that the performance condition will be achieved.

The fair value of stock options and restricted stock units is determined utilizing the Black-Scholes option-pricing model, which is affected by several variables, including the risk-free interest rate, the expected dividend yield, the life of the equity award, the exercise price of the stock option as compared to the fair value of the common stock on the grant date, and the estimated volatility of the common stock over the term of the equity award.

The Company recognizes the fair value of stock-based compensation in general and administrative expenses and in research and development expenses in the Company’s condensed consolidated statements of operations and comprehensive loss, depending on the type of services provided by the recipient of the equity award. The Company accounts for forfeitures as they occur.

Comprehensive Income (Loss)

Components of comprehensive income or loss, including net income or loss, are reported in the financial statements in the period in which they are recognized. Other comprehensive income or loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss) are reported net of any related tax effect to arrive at comprehensive income (loss). Comprehensive income (loss) includes net income (loss) as well as changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. The Company’s only element of other comprehensive income (loss) in periods presented was unrealized gain or loss on available-for-sale securities.

Earnings (Loss) Per Share

The Company’s computation of earnings (loss) per share (“EPS”) for the respective periods includes basic and diluted EPS. Basic EPS is measured as the income (loss) attributable to common stockholders divided by the weighted average number of common shares outstanding for the period. Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares that would result from the exercise of outstanding stock options and warrants as if they had been exercised at the beginning of the periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS. Basic and diluted loss per common share is the same for all periods presented because all outstanding stock options and warrants are anti-dilutive.

Per ASC 260-10-45-13, shares issuable for little to no consideration should be included in the number of outstanding shares used for basic EPS. The Financial Accounting Standards Board (“FASB”) proposed that warrants or options exercisable for little to no cost (sometimes referred to as “penny warrants”) be included in the denominator of basic EPS (and therefore diluted EPS) once there were no further vesting conditions or contingencies associated with them. The Company included 13,967,039 pre-funded warrants in the denominator of basic EPS at September 30, 2024.

At September 30, 2024 and 2023, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to acquire shares of common stock, from its calculation of EPS, as their effect would have been anti-dilutive.


	September 30,
	2024		2023
Common stock warrants		15,188,406		9,188,406
Common stock options		10,611,617		7,500,480
Total		25,800,023		16,688,886

Fair Value of Financial Instruments

The authoritative guidance with respect to fair value established a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below.

Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active exchange-traded securities and exchange-based derivatives.

Level 2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities, non-exchange-based derivatives, mutual funds, and fair-value hedges.

Level 3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently traded non-exchange-based derivatives and commingled investment funds and are measured using present value pricing models.

The Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company performs an analysis of the assets and liabilities at each reporting period end.

The Company had $32.4 million and $39.1 million in cash equivalents as of September 30, 2024 and December 31, 2023, respectively.

The carrying value of financial instruments (consisting of cash, a certificate of deposit, debt, accounts payable, accrued compensation and accrued expenses) is considered to be representative of their respective fair values due to the short-term nature of those instruments.

Recent Accounting Pronouncements

In November 2023, the FASB issued Accounting Standards Update ("ASU") No. 2023-07, Segment Reporting (Topic 280) (“ASU 2023-07”). The guidance in ASU 2023-07 expands prior reportable segment disclosure requirements by requiring entities to disclose significant segment expenses that are regularly provided to the Chief Operating Decision Maker (“CODM”) and details of how the CODM uses financial reporting to assess their segment’s performance. The standard is effective for fiscal years beginning after December 15, 2023 and interim periods in fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is evaluating this standard's potential impact on its condensed consolidated financial statements and related disclosures.

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard is effective for public companies for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-09 may have on its condensed consolidated financial statements.

Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures.

Condensed Consolidated Balance Sheets (Parenthetical) (Unaudited) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	10,000,000	10,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	100,000,000	100,000,000
Common stock, shares issued	60,207,717	47,215,116
Common stock, shares outstanding	60,207,717	47,215,116

Leases - Schedule of Other Information of Operating Leases (Details)	Sep. 30, 2024	Dec. 31, 2023
Lessee, Lease, Description [Line Items]
Weighted average remaining lease term (years)	1 year 6 months	2 years 1 month 28 days
Weighted average discount rate	5.96%	6.25%

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Income Statement [Abstract]
Collaboration revenue	$ 3,336	$ 2,100	$ 7,711	$ 3,669
Operating expenses:
General and administrative	2,867	3,645	10,564	12,071
Research and development	9,381	9,874	29,111	29,915
Gain on fixed asset disposal	(97)	0	(97)	0
Total operating expenses	12,151	13,519	39,578	41,986
Loss from operations	(8,815)	(11,419)	(31,867)	(38,317)
Other income (expense):
Interest income	343	700	1,332	1,756
Interest expense	(188)	(286)	(643)	(738)
Total other income, net	155	414	689	1,018
Net loss	(8,660)	(11,005)	(31,178)	(37,299)
Unrealized gain from available-for-sale securities	0	5	0	96
Comprehensive loss	$ (8,660)	$ (11,000)	$ (31,178)	$ (37,203)
Net loss per common share, basic	$ (0.17)	$ (0.24)	$ (0.62)	$ (0.82)
Net loss per common share, diluted	$ (0.17)	$ (0.24)	$ (0.62)	$ (0.82)
Weighted average common shares outstanding, basic	51,229,701	46,358,555	50,292,983	45,274,124
Weighted average common shares outstanding, diluted	51,229,701	46,358,555	50,292,983	45,274,124

Collaboration Revenue - Additional Information (Details) - USD ($) $ in Thousands				3 Months Ended			9 Months Ended
	Nov. 23, 2021	Dec. 07, 2020	May 16, 2019	Sep. 30, 2024	Sep. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023	Feb. 22, 2023	Nov. 06, 2018
Disaggregation Of Revenue [Line Items]
Collaboration revenue				$ 3,336	$ 2,100		$ 7,711	$ 3,669
Short-term research and development contract liability				259			259		$ 2,112
Milestone payment associated with contract liability	$ 3,000	$ 1,250	$ 2,500
Income tax expense			400
Prepaid expenses and other short-term assets				1,684			1,684		1,242
Other long-term assets				108			108		117
Accounts receivable				3,152			3,152		1,698
Ono Collaboration and Option Agreement [Member]
Disaggregation Of Revenue [Line Items]
Percentage of right to development and commercialized										50.00%
Development and commercial milestone payment payable cuo biopharma										$ 220,000
One Time Up Front Payment Payable As Consideration RD Activities				$ 3,000			3,000
Milestone payments received						$ 3,000	$ 3,000
First Research Term Processed Milestone Payment Under Agreement				18 months			18 months
Collaboration revenue				$ 3,400	1,900		$ 7,700	3,400
Short-term research and development contract liability				300			300		$ 2,100
Accounts receivable				500			500
Ono Collaboration and Option Agreement [Member] \| Maximum
Disaggregation Of Revenue [Line Items]
Full time employe salary payable in first research term				$ 2,100			2,100
Collaboration Agreement with LG Chem Life Sciences \| LG Chem Life Sciences
Disaggregation Of Revenue [Line Items]
Milestone payments received	3,000	1,300	2,500				6,800
Collaboration revenue					$ 200		$ 50	$ 200
Equity investment nonrefundable upfront cash payment											$ 5,000
Equity investment for research collaboration agreement											5,000
Milestone payment associated with contract liability	3,000	1,300	$ 2,500
Income tax expense	$ 500	$ 200
Collaboration Agreement with LG Chem Life Sciences \| LG Chem Life Sciences \| Maximum
Disaggregation Of Revenue [Line Items]
Additional amount receivable research development regulatory and sales milestones											$ 400,000

Summary of Significant Accounting Policies - Summary of Estimated Useful Lives of Assets (Details)	Sep. 30, 2024
Laboratory Equipment
Property Plant And Equipment [Line Items]
Estimated useful lives	5 years
Computer Equipment
Property Plant And Equipment [Line Items]
Estimated useful lives	3 years
Furniture and Fixtures \| Minimum [Member]
Property Plant And Equipment [Line Items]
Estimated useful lives	3 years
Furniture and Fixtures \| Maximum
Property Plant And Equipment [Line Items]
Estimated useful lives	8 years

Property and Equipment - Additional Information (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Property Plant And Equipment [Line Items]
Depreciation expense	$ 100,000	$ 100,000	$ 300,000	$ 400,000
Amortization of trademark	3,000	3,000	9,000	9,000
Laboratory Equipment
Property Plant And Equipment [Line Items]
Disposal of property and equipment, gross		$ 41,450		41,450
Cash collected from sale of fixed assets	$ 100,000		$ 100,000	2,000
Laboratory Equipment \| Other Income
Property Plant And Equipment [Line Items]
Gain (Loss) on disposal of property and equipment				$ 2,000

Leases - Schedule of Future Minimum Lease Payments on Operating Leases (Details) $ in Thousands	Sep. 30, 2024 USD ($)
Leases [Abstract]
2024 (remaining 6 months)	$ 803
2025	2,799
2026	818
Total lease payments	4,420
Less: imputed interest	(199)
Present value of lease payments	$ 4,221

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2024	Nov. 10, 2024
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2024
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Trading Symbol	CUE
Entity Registrant Name	Cue Biopharma, Inc.
Entity Central Index Key	0001645460
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Interactive Data Current	Yes
Document Transition Report	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Security Exchange Name	NASDAQ
Entity Incorporation, State or Country Code	DE
Document Quarterly Report	true
Entity Emerging Growth Company	false
Entity Common Stock, Shares Outstanding		63,350,327
Entity Current Reporting Status	Yes
Entity Shell Company	false
Entity File Number	001-38327
Entity Tax Identification Number	47-3324577
Entity Address, Address Line One	40 Guest Street
Entity Address, City or Town	Boston
Entity Address State or Province	MA
Entity Address, Postal Zip Code	02135
City Area Code	617
Local Phone Number	949-2680

Leases

9 Months Ended

Sep. 30, 2024

Leases [Abstract]

Leases

12.

Leases

On March 28, 2022, the Company entered into a License Agreement (the “License”) with MIL 40G, LLC (the “Licensor”), pursuant to which the Company leases approximately 13,000 square feet of office, research and development and laboratory space located at 40 Guest Street, Boston, Massachusetts 02135 (the “Premises”). The Company relocated its corporate headquarters to the Premises in April 2022.

The Company recognized a right of use asset of $9.1 million and an operating lease liability of $9.1 million which were recorded as of the Term Commencement Date (as defined below) related to the License.

The term of the License commenced on April 15, 2022 (the “Term Commencement Date”) and expires on April 14, 2026 (the “Term”). The License has a monthly rental rate of $200,700 for the first year of the Term, $208,728 for the second year of the Term, $217,077 for the third year of the Term and $225,760 for the remainder of the Term. Pursuant to the License, the Company prepaid two months of rent and a security deposit. The Licensor is obligated under the License to provide certain services to the Company, including providing certain gases, chemicals and equipment to the Premises’ laboratory space, IT support, security, office support and health and safety training. The Licensor has the right to terminate the License for Cause (as defined in the License).

On May 3, 2022, the Company entered into the First Amendment to the License ("First Amendment”) with the Licensor, pursuant to which the License was expanded to include an additional room effective July 15, 2022. In consideration of the First Amendment, the security deposit was increased from $225,760 to $235,884 effective July 15, 2022. Upon execution of the First Amendment, the Company prepaid three months of rent, two of which will be held in escrow and credited against future rent payments and the other of which was applied to the first month’s rent. Effective July 15, 2022, the monthly rental rate under the First Amendment increased to $209,700 from $200,700. During the year ended December 31, 2022, the Company recognized a right of use asset of $369,000 and a short and long term operating lease liability of $100,300 and $260,600, respectively, using the weighted average discount rate of 8%, which were recorded as of the Term Commencement Date related to the License.

On May 31, 2022, the Company entered into an operating lease for additional laboratory space at 40 Guest Street, Boston, Massachusetts for the period from December 1, 2022, through December 1, 2024 (the “40G Additional Laboratory Lease”). The 40G Additional Laboratory Lease contains escalating payments during the lease period. The monthly rental rate under the 40G Additional Laboratory Lease is $59,152 for the first 12 months and $61,519 for the remainder of the term. Under the terms of this lease agreement, the Company prepaid three months of rent, two of which are held in escrow and will

be credited against future rent payments and the other of which was applied to the first month’s rent. During the year ended December 31, 2022, the Company recognized a right of use asset of $1,307,000 and a short and long term operating lease liability of $712,000, and $535,000, respectively, using the weighted average discount rate of 10%, which were recorded as of the Term Commencement Date related to the 40G Additional Laboratory Lease.

On September 9, 2022, the Company terminated its lab space lease in Cambridge, Massachusetts with MIL 21E, LLC with an effective termination date of December 6, 2022. The Company performed an analysis of the accounting implications of this termination based on ASC 360 Impairments and Abandonments guidance. During the year ended December 31, 2022, the Company recorded an entry to remove the remaining lease liability and right of use asset of $963,000 and $945,000, respectively. The difference between the carrying amounts of the right of use asset and lease liability of $19,000 was recorded to gain on right of use asset and included in the consolidated statement of operations and comprehensive loss.

For the three and nine months ended September 30, 2024, the Company recorded $0.1 million and $0.3 million, respectively, in interest expense to the lease liability. For the three and nine months ended September 30, 2023, the Company recorded $0.1 million and $0.4 million, respectively, in interest expense to the lease liability.

At September 30, 2024, operating lease right-of-use assets were $4.0 million. Corresponding operating lease liabilities were $4.2 million, of which $2.9 million were recorded in current liabilities, and $1.3 million were recorded in long-term liabilities on the Company’s condensed consolidated balance sheets.

As of September 30, 2024 and December 31, 2023, security deposits of $0.6 million related to the 40G Additional Laboratory Lease were included in deposits on the Company’s consolidated balance sheets.

Future minimum lease payments under these leases at September 30, 2024 are as follows:


	(in thousands)
2024 (remaining 3 months)	$	803
2025		2,799
2026		818
Total lease payments		4,420
Less: imputed interest		(199	)
Present value of lease payments	$	4,221

Rent expense of $0.9 million and $2.6 million was included in the condensed consolidated statements of operations and comprehensive loss, respectively, for the three and nine months ended September 30, 2024. Rent expense of $0.9 million and $2.6 million was included in the condensed consolidated statements of operations and comprehensive loss, respectively, for the three and nine months ended September 30, 2023.

The weighted average remaining lease term and discount rate related to the Company's leases were as follows:



	September 30, 2024			December 31, 2023
Weighted average remaining lease term (years)		1.50			2.16
Weighted average discount rate		5.96	%		6.25	%

Stock-Based Compensation

9 Months Ended

Sep. 30, 2024

Share-Based Payment Arrangement [Abstract]

Stock-based compensation

Stock-Based Compensation

Stock Option Valuation


		September 30, 2024
Risk-free interest rate		3.83% - 4.43%
Expected dividend yield		0%
Expected volatility		36.24% - 109.86%
Expected life		5.50 to 8.91 years

		September 30, 2023
Risk-free interest rate		3.40% - 4.16%
Expected dividend yield		0%
Expected volatility		97.03% - 110.4%
Expected life		5.50 to 6.25 years

A summary of stock option activity for the nine months ended September 30, 2024 is as follows:


	Number of Shares			Weighted Average Exercise Price		Weighted Average Remaining Contractual Life (in Years)
Stock options outstanding at December 31, 2023		7,492,917		$	8.41		6.12
Granted		4,183,300			1.42		—
Exercised		—			—		—
Cancelled		(1,064,600	)		7.27		—
Stock options outstanding at September 30, 2024		10,611,617			5.77		7.28
Stock options exercisable at September 30, 2024		5,240,539		$	9.27		5.27

The Company recognized $1.6 million and $5.3 million in stock-based compensation expense during the three and nine months ended September 30, 2024, respectively, related to stock options activity.

The Company recognized $2.1 million and $6.1 million in stock-based compensation expense during the three and nine months ended September 30, 2023, respectively, related to stock options activity.

As of September 30, 2024, total unrecognized stock-based compensation expense was $7.2 million, which is expected to be recognized as an operating expense in the Company’s condensed consolidated statements of operations and comprehensive loss over the weighted average remaining period of 2.02 years.

As of September 30, 2023, total unrecognized stock-based compensation expense was $12.1 million, which is expected to be recognized as an operating expense in the Company’s condensed consolidated statements of operations and comprehensive loss over the weighted average remaining period of 2.16 years.

During the three and nine months ended September 30, 2024, the Company granted stock options to purchase 1.7 million shares of common stock with a weighted average grant date fair value of $0.69 per share and stock options to purchase 4.2 million shares of common stock with a weighted average grant date fair value of $1.42 per share, respectively.

During the three and nine months ended September 30, 2023, the Company granted stock options to purchase 1.1 million shares of common stock with a weighted average grant date fair value of $4.17 per share and stock options to purchase 2.6 million shares of common stock with a weighted average grant date fair value of $3.65 per share, respectively.

As of September 30, 2024, the Company granted performance-based stock options to purchase 1.4 million shares of common stock, all of which remain unvested at September 30, 2024. The Company will incur stock-based compensation expense of $0.4 million should the vesting conditions be met in the future.

Stock-based Compensation


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2024		2023		2024		2023
General and administrative	$	843	$	858	$	2,659	$	2,709
Research and development		740		1,215		2,625		3,399
Total stock-based compensation expense	$	1,583	$	2,073	$	5,284	$	6,108

Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

Summary of Estimated Useful Lives of Assets

Depreciation of property and equipment is provided using the straight-line method over the following estimated useful lives:


Laboratory equipment		5 years
Computer equipment		3 years
Furniture and fixtures		3-8 years

Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share


	September 30,
	2024		2023
Common stock warrants		15,188,406		9,188,406
Common stock options		10,611,617		7,500,480
Total		25,800,023		16,688,886

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (8,660)	$ (11,005)	$ (31,178)	$ (37,299)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-6

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-9

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 805
-SubTopic 60
-Name Accounting Standards Codification
-Section 65
-Paragraph 1
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147476176/805-60-65-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 323
-Name Accounting Standards Codification
-Section 65
-Paragraph 2
-Subparagraph (g)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478666/740-323-65-2

Reference 5: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(20))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483621/220-10-S99-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(g)(1)(ii))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 323
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481687/323-10-50-3

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 825
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 28
-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482907/825-10-50-28

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Paragraph 1
-Subparagraph (f)
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
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Reference 17: http://www.xbrl.org/2003/role/exampleRef
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 20: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 1
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Reference 21: http://www.xbrl.org/2003/role/disclosureRef
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Reference 22: http://www.xbrl.org/2003/role/disclosureRef
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Reference 23: http://www.xbrl.org/2009/role/commonPracticeRef
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Reference 24: http://www.xbrl.org/2003/role/disclosureRef
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Reference 25: http://www.xbrl.org/2003/role/disclosureRef
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Reference 26: http://www.xbrl.org/2003/role/disclosureRef
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Reference 27: http://www.xbrl.org/2003/role/disclosureRef
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Reference 28: http://www.xbrl.org/2003/role/disclosureRef
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Reference 29: http://www.xbrl.org/2003/role/disclosureRef
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Reference 30: http://www.xbrl.org/2003/role/disclosureRef
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Reference 31: http://www.xbrl.org/2003/role/disclosureRef
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Reference 32: http://www.xbrl.org/2003/role/disclosureRef
-Topic 260
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Reference 33: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 34: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
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Reference 35: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 1A
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482790/220-10-45-1A

Reference 36: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 1B
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482790/220-10-45-1B

Reference 37: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 942
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-Paragraph 1
-Subparagraph (SX 210.9-04(22))
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-URI https://asc.fasb.org/1943274/2147478524/942-220-S99-1

+ Details

Leases - Additional Information (Details)	3 Months Ended		9 Months Ended		12 Months Ended
Leases - Additional Information (Details)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Dec. 31, 2022 USD ($)	Dec. 31, 2023 USD ($)	May 31, 2022 USD ($)	May 03, 2022 USD ($)	Apr. 15, 2022 USD ($)	Mar. 28, 2022 ft²
Lessee Lease Description [Line Items]
Operating lease right-of-use	$ 4,034,000		$ 4,034,000			$ 6,323,000
Operating lease, liability	4,221,000		4,221,000
Rent expense	$ 900,000	$ 900,000	$ 2,600,000	$ 2,600,000
Operating lease, weighted average discount rate	5.96%		5.96%			6.25%
Operating lease liability, current portion	$ 2,895,000		$ 2,895,000			$ 3,368,000
Operating lease liability, net of current portion	1,326,000		1,326,000			3,162,000
Non-cash interest expense to the lease liability	100,000	$ 100,000	300,000	$ 400,000
License Agreement
Lessee Lease Description [Line Items]
Operating lease right-of-use	9,100,000		9,100,000
Operating lease, liability	9,100,000		9,100,000
Operating lease, weighted average discount rate					8.00%
Security deposit								$ 225,760
License monthly rental rate								209,700
License monthly rental rate first year									$ 200,700
License monthly rental rate remainder of the term								200,700	225,760
License monthly rental rate second year									208,728
License monthly rental rate third year									$ 217,077
Increase in security deposit								$ 235,884
First Amendment \| License Agreement
Lessee Lease Description [Line Items]
Operating lease right-of-use					$ 369,000
Operating lease liability, current portion					100,300
Operating lease liability, net of current portion					260,600
40G Office and Additional Laboratory
Lessee Lease Description [Line Items]
Security deposit	600,000		600,000			$ 600,000
Lab Space Lease Member
Lessee Lease Description [Line Items]
Operating lease right-of-use					945,000
Operating lease cost (in thousands)					963,000
Gain on right-of-use asset termination			19,000
ASU 2016-02
Lessee Lease Description [Line Items]
Operating lease right-of-use	4,000,000		4,000,000
Operating lease, liability	4,200,000		4,200,000
Operating lease liability, current portion	2,900,000		2,900,000
Operating lease liability, net of current portion	$ 1,300,000		$ 1,300,000
Cambridge, Massachusetts
Lessee Lease Description [Line Items]
Office space for lease \| ft²										13,000
Boston, Massachusetts \| Operating Lease Agreement For Additional Laboratory Space
Lessee Lease Description [Line Items]
Operating lease right-of-use					$ 1,307,000
Lessee operating lease monthly rental payments for remaining term							$ 61,519
Lessee operating lease monthly rental payments							$ 59,152
Operating lease, weighted average discount rate					10.00%
Operating lease liability, current portion					$ 712,000
Operating lease liability, net of current portion					$ 535,000

Stock Based Compensation - Schedule of Stock-Based Compensation Included in Statement of Operations (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Stock-based compensation	$ 1,583	$ 2,073	$ 5,284	$ 6,108
General and Administrative Expense
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Stock-based compensation	843	858	2,659	2,709
Research and Development
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Stock-based compensation	$ 740	$ 1,215	$ 2,625	$ 3,399

Property and Equipment - Summary of Property and Equipment (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 4,470	$ 4,411
Less accumulated depreciation	(3,900)	(3,616)
Net property and equipment	570	795
Laboratory Equipment
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	4,098	4,069
Furniture and Fixtures
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	74	81
Computer and office equipment [Member]
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	180	143
Leasehold Improvements
Property Plant And Equipment [Line Items]
Property, plant and equipment, gross	$ 118	$ 118

Summary of Significant Accounting Policies - Schedule of Anti-dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	25,800,023	16,688,886
Common Stock Warrants
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	15,188,406	9,188,406
Common Stock Options
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share	10,611,617	7,500,480

Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 32,420	$ 48,514
Accounts receivable	3,152	1,698
Prepaid expenses and other current assets	1,684	1,242
Total current assets	37,256	51,454
Property and equipment, net	570	795
Operating lease right-of-use	4,034	6,323
Deposits	2,690	2,690
Restricted cash	152	151
Other long-term assets	108	117
Total assets	44,810	61,530
Current liabilities:
Accounts payable	6,474	3,501
Accrued expenses	3,199	4,137
Research and development contract liability, current portion	259	2,112
Operating lease liabilities, current	2,895	3,368
Current portion of long-term debt, net	3,963	3,963
Total current liabilities	16,790	17,081
Operating lease liabilities, non-current	1,326	3,162
Long-term debt, net	1,328	4,202
Total liabilities	19,444	24,445
Commitments and contingencies (Note 11)
Stockholders' equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized and 0 shares issued and outstanding at September 30, 2024 and December 31, 2023	0	0
Common stock, $0.001 par value; 100,000,000 shares authorized; 60,207,717 and 47,215,116 shares issued and outstanding, at September 30, 2024 and December 31, 2023, respectively	60	47
Additional paid in capital	357,674	338,228
Accumulated deficit	(332,368)	(301,190)
Total stockholders' equity	25,366	37,085
Total liabilities and stockholders' equity	$ 44,810	$ 61,530

Stock Based Compensation - Summary of Stock Option Activity (Details) - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Net of Forfeitures [Abstract]
Number of Shares, Outstanding Beginning Balance	7,492,917
Number of Shares, Granted	4,183,300
Number of Shares, Exercised	0
Number of Shares, Cancelled	(1,064,600)
Number of Shares, Outstanding Ending Balance	10,611,617	7,492,917
Number of Shares, Exercisable	5,240,539
Weighted Average Exercise Price, Outstanding Beginning Balance	$ 8.41
Weighted Average Exercise Price, Granted	1.42
Weighted Average Exercise Price, Exercised	0
Weighted Average Exercise Price, Cancelled	7.27
Weighted Average Exercise Price, Outstanding Ending Balance	5.77	$ 8.41
Weighed Average Exercise Price, Exercisable	$ 9.27
Weighted Average Remaining Contractual Life (in Years)	7 years 3 months 10 days	6 years 1 month 13 days
Weighted Average Remaining Contractual Life (in Years), Exercisable	5 years 3 months 7 days

Loan with First Citizens Bank (formerly with Silicon Valley Bank) - Additional Information (Details) - USD ($)			3 Months Ended		9 Months Ended
	Feb. 15, 2025	Feb. 15, 2024	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Feb. 15, 2022
Line of Credit Facility [Line Items]
Interest expense			$ 100,000	$ 300,000	$ 500,000	$ 800,000
Final payment of debt			100,000	33,000	100,000	98,000
Debt issuance costs			142,000		142,000
Amortization of debt issuance costs			$ 9,000	$ 9,000	$ 27,729	$ 27,729
Silicon Valley Bank
Line of Credit Facility [Line Items]
Final fee (percentage)		5.00%
Prepayment premium rate	1.00%
Silicon Valley Bank \| Term Loan Agreement
Line of Credit Facility [Line Items]
Short-term debt							$ 10,000,000
Interest rate					10.25
Closing Date			Jun. 30, 2023		Jun. 30, 2023
Variable interest rate (percentage)					2.25%
Silicon Valley Bank \| Term Loan Agreement \| Maximum
Line of Credit Facility [Line Items]
Variable interest rate (percentage)					5.50%
Silicon Valley Bank \| Term Loan Agreement \| Minimum
Line of Credit Facility [Line Items]
Variable interest rate (percentage)					2.25%
Silicon Valley Bank \| Tranche A loan
Line of Credit Facility [Line Items]
Monthly installments					30 months

Warrants - Additional Information (Details) - $ / shares			9 Months Ended
	Sep. 26, 2024	Nov. 16, 2022	Sep. 30, 2024
Class Of Warrant Or Right [Line Items]
Pre Funded Warrants			13,967,039
2024 Warrants [Member]
Class Of Warrant Or Right [Line Items]
Common stock warrants outstanding	6,000,000	9,188,406
Exercise price of common stock warrants	$ 0.5	$ 3.93
Common stock warrants life		5 years
2024 Pre-Funded Warrants [Member]
Class Of Warrant Or Right [Line Items]
Exercise price of common stock warrants	$ 0.001	$ 0.0001
Pre Funded Warrants	12,435,599	1,531,440

Loan with First Citizens Bank (formerly with Silicon Valley Bank)

9 Months Ended

Sep. 30, 2024

Debt Disclosure [Abstract]

Loan with Silicon Valley Bank

Loan with First Citizens Bank (formerly with Silicon Valley Bank)

On February 15, 2022 (the “Closing Date”), the Company entered into a Loan and Security Agreement (the “Loan Agreement”), with Silicon Valley Bank, as lender (“SVB”). The Company drew $10,000,000 in term loans under the Loan Agreement (the "Term Loans") on the Closing Date. The Loan Agreement was amended in April 2023 and October 2024.

The Term Loans bear interest at a floating rate per annum equal to the greater of (A) the prime rate (as published in the money rates section of The Wall Street Journal) plus 2.25% and (B) 5.50%. The Term Loans were interest only from the Closing Date through June 30, 2023, after which the Company is required to pay 30 equal monthly installments of principal. At September 30, 2024, the interest rate was 10.25% which is based on the prime rate plus 2.25%.

The Term Loans may be prepaid in full with payment of a 1.00% prepayment premium. Upon prepayment or repayment in full of the Term Loans, the Company will be required to pay a one-time final payment fee equal to 5.00% of the original principal amount of any funded Term Loans being repaid. This one-time final payment fee is recorded to interest expense using the effective interest method over the period of the Term Loans in the condensed consolidated statements of operations and comprehensive loss.

The Term Loans and related obligations under the Loan Agreement are secured by substantially all of the Company’s properties, rights and assets, except for its intellectual property which is subject to a negative pledge under the Loan Agreement.

The Loan Agreement, as amended, contains customary representations, warranties, events of default and covenants. In addition to the foregoing, the Company is required to have at all times on deposit in accounts of the Company maintained with SVB, unrestricted and unencumbered cash in an amount equal to the lesser of (i) 100% of the dollar value of the Company’s consolidated cash, in the aggregate, at all financial institutions and (ii) $20,000,000. On March 10, 2023, SVB was closed and the Federal Deposit Insurance Corporation (the “FDIC”) was appointed receiver for the bank. The FDIC created a successor bridge bank, and all deposits and loans of SVB were transferred to the bridge bank under a systemic risk exception approved by the United States Department of the Treasury, the Federal Reserve and the FDIC. On March 27, 2023, First Citizens Bank & Trust Company (“First Citizens Bank”), assumed all of SVB’s deposits and certain other liabilities and acquired substantially all of SVB’s loans and certain other assets from the FDIC. First Citizens Bank continues to hold the Company’s Term Loans under the same existing terms and covenants which were in place with SVB.

During the three and nine months ended September 30, 2024, the Company recognized interest expense related to the Term Loans of $0.1 million and $0.5 million, respectively, and interest expense related to accretion of the final payment of less than $0.1 million and $0.1 million, respectively. During the three and nine months ended September 30, 2023, the Company recognized interest expense related to the Term Loans of $0.3 million and $0.8 million, respectively, and interest expense related to accretion of the final payment of $33,000 and $98,000, respectively.

The following table presents the aggregate maturities of long-term debt as of September 30, 2024 (in thousands):


Year
2024	$	1,000
2025		4,000
Total	$	5,000

The following table presents long-term and current portions of debt as of September 30, 2024 (in thousands):


Long-term debt	$	1,000
Accretion of final payment		337
Less: unamortized debt issuance costs		(9	)
Long-term debt, net	$	1,328
Current portion of long-term debt	$	4,000
Less: unamortized debt issuance costs		(37	)
Current portion of long-term debt, net	$	3,963

Debt Issuance Costs

The Company has incurred $142,000 in debt issuance costs related to the Loan Agreement. For each of the three months ended September 30, 2024 and 2023, the Company recorded approximately $9,000 in amortization of debt issuance costs to interest expense in the condensed consolidated statements of operations and comprehensive loss. For each of the nine months ended September 30, 2024 and 2023, the Company recorded $27,729 in amortization of debt issuance costs to interest expense in the condensed consolidated statements of operations and comprehensive loss.

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481544/470-10-50-6

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481544/470-10-50-6

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)(1)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 405
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477092/405-40-50-1

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
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+ Details

Subsequent Events (Additional Information) (Details) - USD ($) $ in Thousands	Oct. 08, 2024	Oct. 02, 2024	Sep. 30, 2024	Dec. 31, 2023
Subsequent Event [Line Items]
Common stock, shares authorized			100,000,000	100,000,000
Subsequent Event
Subsequent Event [Line Items]
Threshold Amount		$ 20,000,000
Percentage of Dollar Value		100.00%
Subsequent Event \| Maximum
Subsequent Event [Line Items]
Authorized Share of Company Capital Stock	210,000,000
Common stock, shares authorized	200,000,000
Subsequent Event \| Minimum
Subsequent Event [Line Items]
Authorized Share of Company Capital Stock	110,000,000
Common stock, shares authorized	100,000,000

Loan with First Citizens Bank (formerly with Silicon Valley Bank) (Tables)

9 Months Ended

Sep. 30, 2024

Debt Instruments [Abstract]

Summary of Future Principal Debt Payments on Term Loan Agreement

The following table presents the aggregate maturities of long-term debt as of September 30, 2024 (in thousands):


Year
2024	$	1,000
2025		4,000
Total	$	5,000

The following table presents long-term and current portions of debt as of September 30, 2024 (in thousands):


Long-term debt	$	1,000
Accretion of final payment		337
Less: unamortized debt issuance costs		(9	)
Long-term debt, net	$	1,328
Current portion of long-term debt	$	4,000
Less: unamortized debt issuance costs		(37	)
Current portion of long-term debt, net	$	3,963

Loan with First Citizens Bank (formerly with Silicon Valley Bank) - Summary of Future Principal Debt Payments on Term Loan Agreement (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Debt Instruments [Abstract]
2024	$ 1,000
2025	4,000
Total	5,000
Long-term debt	1,000
Accretion of final payment	337
Less: unamortized debt issuance costs	(9)
Long-term debt, net	1,328	$ 4,202
Current portion of long-term debt	4,000
Less: unamortized debt issuance costs	(37)
Current portion of long-term debt, net	$ 3,963	$ 3,963

Accrued Expenses - Summary of Accrued Expenses (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Accrued Liabilities, Current [Abstract]
Contract research services	$ 1,534	$ 1,411
Employee and board compensation	800	2,219
Professional services	499	344
Contract manufacturing services	367	163
Total	$ 3,199	$ 4,137

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Sep. 30, 2024
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

Property and Equipment (Tables)

9 Months Ended

Sep. 30, 2024

Property, Plant and Equipment [Abstract]

Summary of Property and Equipment

Property and equipment as of September 30, 2024 and December 31, 2023 consisted of the following:


	September 30, 2024			December 31, 2023
	(in thousands)
Laboratory equipment	$	4,098		$	4,069
Furniture and fixtures		74			81
Computer equipment		180			143
Leasehold improvements		118			118
Total property and equipment		4,470			4,411
Less: accumulated depreciation		(3,900	)		(3,616	)
Property and equipment, net	$	570		$	795

Commitments and Contingencies

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

11.

Commitments and Contingencies

Einstein License Agreement

In 2015, the Company entered into the Einstein License with Einstein for certain patent rights relating to the Company’s 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. The Company entered into an amended and restated license agreement on July 31, 2017, as amended on October 2018, which modified certain obligations of the parties under the Einstein License. The Einstein License was further amended on January 13, 2024. For the three and nine months ended September 30, 2024, the Company incurred $0.03 million and $0.08 million, respectively, in fees payable to Einstein in relation to this license. For each of the three and nine months ended September 30, 2023, the Company did not incur any fees payable to Einstein in relation to this license.

The Company’s remaining commitments with respect to the Einstein License are based on the attainment of future milestones. The aggregate amount of milestone payments made under the Einstein License may equal up to $1.9 million for each Licensed Product, and up to $1.9 million for each new indication of a Licensed Product. Additionally, the aggregate amount of one-time milestone payments based on cumulative sales of all Licensed Products may equal up to $5.8 million. The Company is also party to a service agreement with Einstein to support the Company’s ongoing research and development activities.

Collaboration Agreement with LG Chem

See discussion of the LG Chem Collaboration Agreement in Note 10.

Collaboration Agreement with Ono

See discussion of the Ono Collaboration and Option Agreement in Note 10.

Contingencies

The Company accrues contingent liabilities to the extent that the liability is probable and estimable. There are no accruals for contingent liabilities in the Company’s condensed consolidated financial statements.

The Company may be subject to various legal proceedings from time to time as part of its business. As of September 30, 2024, the Company was not a party to any legal proceedings or threatened legal proceedings, the adverse outcome of which, individually or in the aggregate, would have a material adverse effect on its business, financial condition or results of operations.

Leases (Tables)

9 Months Ended

Sep. 30, 2024

Leases [Abstract]

Schedule of Future Minimum Lease Payments for Operating Lease

Future minimum lease payments under these leases at September 30, 2024 are as follows:


	(in thousands)
2024 (remaining 3 months)	$	803
2025		2,799
2026		818
Total lease payments		4,420
Less: imputed interest		(199	)
Present value of lease payments	$	4,221

Schedule of Other Information of Operating Leases

The weighted average remaining lease term and discount rate related to the Company's leases were as follows:



	September 30, 2024			December 31, 2023
Weighted average remaining lease term (years)		1.50			2.16
Weighted average discount rate		5.96	%		6.25	%

Consolidated Statements of Shareholders' Equity (Unaudited) - USD ($) $ in Thousands	Total	Common Stock	Additional Paid-in Capital	AOCI Attributable to Parent	Accumulated Deficit
Balance at Dec. 31, 2022	$ 65,683	$ 43	$ 316,192	$ (96)	$ (250,456)
Balance, Shares at Dec. 31, 2022		43,042,548
Issuance of common stock from ATM offering, net of sales agent commission and fees, Shares		1,915,131
Issuance of common stock from ATM offering, net of sales agent commission and fees, Amount	7,605	$ 2	7,603
Stock-based compensation	6,108		6,108
Exercise of stock options	473		473
Exercise of stock options, Shares		165,602
Unrealized gain from available-for-sale securities	96			96
Net Income (Loss)	(37,299)				(37,299)
Balance at Sep. 30, 2023	42,666	$ 45	330,376		(287,755)
Balance, Shares at Sep. 30, 2023		45,123,281
Balance at Jun. 30, 2023	46,004	$ 44	322,715	(5)	(276,750)
Balance, Shares at Jun. 30, 2023		43,744,414
Issuance of common stock from ATM offering, net of sales agent commission and fees, Shares		1,378,867
Issuance of common stock from ATM offering, net of sales agent commission and fees, Amount	5,589	$ 1	5,588
Stock-based compensation	2,073		2,073
Unrealized gain from available-for-sale securities	5			5
Net Income (Loss)	(11,005)				(11,005)
Balance at Sep. 30, 2023	42,666	$ 45	330,376		(287,755)
Balance, Shares at Sep. 30, 2023		45,123,281
Balance at Dec. 31, 2023	37,085	$ 47	338,228		(301,190)
Balance, Shares at Dec. 31, 2023		47,215,116
Issuance of common stock from ATM offering, net of sales agent commission and fees, Shares		1,428,200
Issuance of common stock from ATM offering, net of sales agent commission and fees, Amount	3,354	$ 1	3,353
Issuance of common stock, warrants and pre-funded warrants, net of issuance costs, Share		11,564,401
Issuance of common stock, warrants and pre-funded warrants, net of issuance costs, Amount	10,821	$ 12	10,809
Stock-based compensation	$ 5,284		5,284
Exercise of stock options, Shares	0
Net Income (Loss)	$ (31,178)				(31,178)
Balance at Sep. 30, 2024	25,366	$ 60	357,674	0	(332,368)
Balance, Shares at Sep. 30, 2024		60,207,717
Balance at Jun. 30, 2024	21,622	$ 48	345,282		(323,708)
Balance, Shares at Jun. 30, 2024		48,643,316
Issuance of common stock, warrants and pre-funded warrants, net of issuance costs, Share		11,564,401
Issuance of common stock, warrants and pre-funded warrants, net of issuance costs, Amount	10,821	$ 12	10,809
Stock-based compensation	1,583		1,583
Net Income (Loss)	(8,660)				(8,660)
Balance at Sep. 30, 2024	$ 25,366	$ 60	$ 357,674	$ 0	$ (332,368)
Balance, Shares at Sep. 30, 2024		60,207,717

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

Basis of Presentation

Public Offerings

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

Consolidation

Use of Estimates

Cash Concentrations

Cash and Cash Equivalents

Marketable Securities

Restricted Cash

The Company had $0.2 million in restricted cash deposited with a separate commercial bank to collateralize Company credit cards as of September 30, 2024 and December 31, 2023.

Property and Equipment


Laboratory equipment		5 years
Computer equipment		3 years
Furniture and fixtures		3-8 years

Trademark

Debt Issuance Costs

Revenue Recognition

Research and Development Expenses

Patent Expenses

Licensing Fees and Costs

Long-Lived Assets

Leases

Stock-Based Compensation

Comprehensive Income (Loss)

Earnings (Loss) Per Share


	September 30,
	2024		2023
Common stock warrants		15,188,406		9,188,406
Common stock options		10,611,617		7,500,480
Total		25,800,023		16,688,886

Fair Value of Financial Instruments

The Company had $32.4 million and $39.1 million in cash equivalents as of September 30, 2024 and December 31, 2023, respectively.

Recent Accounting Pronouncements

Warrants

9 Months Ended

Sep. 30, 2024

Warrants and Rights Note Disclosure [Abstract]

Warrants

On September 26, 2024, the Company issued the Common Stock Warrants, exercisable for an aggregate of 6,000,000 shares of common stock with an exercise price of $0.50 and a 5-year term, and Pre-Funded Warrants, exercisable for an aggregate of 12,435,599 shares of common stock at a nominal exercise price of $0.001 per share. The Common Stock Warrants and Pre-Funded Warrants were outstanding at September 30, 2024.

On November 16, 2022, the Company issued warrants exercisable for an aggregate of 9,188,406 shares of common stock with an exercise price of $3.93 and a 5-year term (the “2022 Common Stock Warrants”) and pre-funded warrants exercisable for an aggregate of 1,531,440 shares of common stock (the “2022 Pre-Funded Warrants”) at a nominal exercise price of $0.0001 per share. The 2022 Common Stock Warrants and 2022 Pre-Funded Warrants were outstanding at September 30, 2024.

The Common Stock Warrants, Pre-Funded Warrants, 2022 Common Stock Warrants and 2022 Pre-Funded Warrants were evaluated under ASC 480, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging, and the Company determined that equity classification was appropriate. The Company determined equity classification for these warrants as they do not embody an obligation for the Company to repurchase its shares and permit the holders to receive a fixed number of shares of common stock upon exercise. Per ASC 815-40-25, the Company accounts for these warrants as equity, as the Company does not provide the holder a fixed or guaranteed return.

Fair Value

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

Fair Value

The Company accounts for its financial assets and liabilities using fair value measurements. The authoritative accounting guidance defines fair value, establishes a framework for measuring fair value under U.S. GAAP and enhances disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.


	Fair Value Measurements as of September 30, 2024
	(in thousands)
	Level 1		Level 2		Level 3		Fair Value
Cash equivalents	$	31,784	$	—	$	—	$	31,784
Total	$	31,784	$	—	$	—	$	31,784

	Fair Value Measurements as of December 31, 2023
	(in thousands)
	Level 1		Level 2		Level 3		Fair Value
Cash equivalents	$	39,148	$	—	$	—	$	39,148
Total	$	39,148	$	—	$	—	$	39,148

As of September 30, 2024, the Company had $31.8 million in cash equivalents. The Company measures the cash equivalents that are invested in money market funds using Level 1 inputs for identical securities. As of December 31, 2023, the Company had $39.1 million in cash equivalents. During the three and nine months ended September 30, 2024, and the year ended December 31, 2023, there were no transfers between Level 2 and Level 3.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References

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+ Details